[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Proposed Rules]
[Pages 18262-18337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04840]



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Vol. 89

Tuesday,

No. 49

March 12, 2024

Part V





Department of Health and Human Services





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 Food and Drug Administration





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21 CFR Parts 201, 500, 501, et al.





Labeling Requirements for Approved or Conditionally Approved New Animal 
Drugs; Proposed Rule

  Federal Register / Vol. 89 , No. 49 / Tuesday, March 12, 2024 / 
Proposed Rules  

[[Page 18262]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 500, 501, 510, 514, and 516

[Docket No. FDA-2023-N-5160]
RIN 0910-AI43


Labeling Requirements for Approved or Conditionally Approved New 
Animal Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to revise 
the requirements for the content and format of labeling for approved or 
conditionally approved new animal drugs to provide for a more 
comprehensive set of requirements in one location in the Code of the 
Federal Register (CFR). As part of this revision, certain current 
requirements would be updated and moved, and certain obsolete 
requirements would be removed. The proposed requirements would apply to 
the labeling of prescription and over-the-counter (OTC) new animal 
drugs, as well as new animal drugs for use in animal feeds.

DATES: Either electronic or written comments on the proposed rule must 
be submitted by June 10, 2024. Submit written comments (including 
recommendations) on information collection issues under the Paperwork 
Reduction Act of 1995 by April 11, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 10, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-5160 for ``Labeling Requirements for Approved or 
Conditionally Approved New Animal Drugs.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents, the 
plain language summary of the proposed rule of not more than 100 words 
are required by the ``Providing Accountability Through Transparency 
Act,'' or the electronic and written/paper comments received, go to 
https://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 Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 to the Office of Management and Budget 
(OMB) https://www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under Review--Open for 
Public Comments'' or by using the search function. The title of this 
proposed collection is ``Labeling Requirements for Approved or 
Conditionally Approved New Animal Drugs.''

FOR FURTHER INFORMATION CONTACT: 
    With regard to the proposed rule: Suzanne Sechen, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0814, [email protected].
    With regard to the information collection: Amber Sanford, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits

[[Page 18263]]

II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Introduction
    B. Need for the Regulation
    C. FDA's Current Regulatory Framework
    D. History of the Rulemaking
IV. Legal Authority
V. Description of the Proposed Rule
    A. Scope (Proposed Sec.  201.401)
    B. Definitions (Proposed Sec.  201.403)
    C. General Requirements (Proposed Sec.  201.404)
    D. Content and Format for Prescription (Rx) New Animal Drug 
Labeling--Overview (Proposed Sec.  201.405)
    E. Content and Format for Over-The-Counter (OTC) New Animal Drug 
Labeling--Overview (Proposed Sec.  201.407)
    F. Content and Format of Labeling for New Animal Drugs for Use 
in Animal Feeds--Overview (Proposed Sec.  201.409)
    G. Exemptions From Labeling Requirements for Approved or 
Conditionally Approved New Animal Drugs (Proposed Sec.  201.411)
    H. Labeling Requirements for Certain Approved or Conditionally 
Approved New Animal Drugs (Proposed Sec.  201.413)
    I. Proposed Conforming Amendments
VI. Proposed Effective/Compliance Dates
VII. Preliminary Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose and Coverage of the Proposed Rule

    FDA proposes to revise the existing regulations regarding the 
content and format of labeling for approved or conditionally approved 
new animal drugs. These proposed regulations would apply to the 
labeling of prescription and OTC new animal drugs, as well as new 
animal drugs for use in animal feeds. Certain existing regulations 
regarding the labeling of new animal drugs would be updated and moved 
from their current location and incorporated into the proposed 
regulations, including a new subpart H in part 201 (21 CFR part 201). 
FDA also proposes to amend or remove certain current regulations to 
ensure consistency with the proposed regulations.
    Proposed subpart H would not apply to heritable intentional genomic 
alterations in animals. Proposed subpart H would also not apply to 
labeling of indexed legally marketed unapproved new animal drugs for 
minor species. In addition, proposed subpart H would not apply to 
promotional labeling or advertising.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule would revise the existing requirements for the 
content and format of labeling for approved or conditionally approved 
new animal drugs. If finalized, sponsors of these new animal drugs 
would need to comply with these proposed regulations on a staggered 
schedule, over the course of 6 years, according to a schedule based on 
application number, with approved NADAs with higher application numbers 
having the earliest compliance date because they are more recently 
approved and therefore likely to need the fewest labeling revisions.
    If finalized, this rule would enable FDA to provide sponsors with 
predictable requirements for the content and format of labeling for new 
animal drugs and codify FDA's longstanding practices with respect to 
the review of labeling submitted as part of a new animal drug 
application (NADA), certain abbreviated new animal drug applications 
(ANADAs) that reference a new animal drug for which the NADA has been 
withdrawn, or a new animal drug application for conditional approval 
(CNADA).
    Currently a comprehensive set of regulations establishing labeling 
requirements for the content and format of labeling for new animal 
drugs does not exist in the CFR. These proposed regulations would 
provide sponsors with predictable requirements for the content and 
format of labeling for new animal drugs. Also, these proposed 
regulations would help sponsors more efficiently prepare labeling for 
new animal drugs to be submitted as part of an NADA, CNADA, or certain 
ANADAs by providing clear and consistent requirements for the 
information that would need to be included on each component of 
labeling for a new animal drug, as well as the format in which the 
information is to be presented.
    FDA is proposing specific requirements for content and format of 
the labeling for approved or conditionally approved prescription and 
OTC new animal drugs, as well as approved or conditionally approved new 
animal drugs for use in animal feeds.
    The proposed regulations would provide the following:
     The content and format of labeling components applicable 
to approved or conditionally approved new animal drugs.
     Definitions of labeling terms for approved or 
conditionally approved new animal drugs.
     A schedule for sponsors of approved or conditionally 
approved and marketed new animal drugs to comply with these proposed 
regulations within a maximum of 6 years from the effective date of any 
final rule.
     Provisions for foreign language translation of the 
labeling for approved or conditionally approved new animal drugs.
     A process for sponsors of new animal drugs to request 
exemptions from the proposed labeling requirements.
     Consolidation of the labeling requirements for the content 
and format of labeling for approved or conditionally approved new 
animal drugs into one section of the regulations. At present, existing 
requirements are dispersed throughout the regulations.

C. Legal Authority

    FDA's revisions to the content and format requirements for animal 
drug labeling are authorized by various provisions of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act). The premarket approval provisions of 
the FD&C Act authorize FDA to require that new animal drug labeling 
provide adequate information to permit safe and effective use of the 
drug.
    The FD&C Act requires certain information be included on a drug's 
label and provides for certain exemptions from these requirements. 
Also, the FD&C Act authorizes FDA to establish additional exemptions by 
regulation.
    The FD&C Act requires that new animal drug applications include 
specimens of the labeling proposed to be used for the drug. A new 
animal drug will be deemed unsafe if its labeling fails to conform to 
the approved labeling in the applicable approved new animal drug 
application, conditionally approved new animal drug application, or new 
animal drug index listing. Unsafe drugs are deemed adulterated under 
the provisions of the FD&C Act. The FD&C Act prohibits the marketing of 
drugs that are adulterated or misbranded as well as their adulteration 
or misbranding while in interstate commerce.
    In addition to the other statutory provisions described above, the 
FD&C Act gives the FDA general rulemaking authority to issue 
regulations for the efficient enforcement of the FD&C Act.

D. Costs and Benefits

    If this proposed rule is finalized, industry and FDA would incur 
cost savings from a reduction in the quantity and time burden of new 
animal drug labeling amendments and informal communications related to 
new animal drug labeling. There may be additional

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benefits to users of approved or conditionally approved new animal 
drugs from greater predictability and ease of reading new animal drug 
labeling in the form of time saved searching for content, as well as 
benefits to animal or human health, which we are unable to quantify.
    We expect that new animal drug sponsors would incur one-time costs 
to read and understand the rule, revise standard operating procedures 
(SOPs) related to labeling, and train employees on the revised SOPs. 
New animal drug sponsors would also bear costs to update labeling and 
prepare supplemental labeling applications to conform to the proposed 
requirements. FDA would incur costs to review these supplemental 
applications.
    FDA estimates that the annualized benefits over 10 years would 
range from $0.143 million to $0.243 million at a 2 percent discount 
rate, with a primary estimate of $0.193 million. The annualized costs 
would range from $2.16 million to $2.77 million at a 2 percent discount 
rate, with a primary estimate of $2.45 million.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

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     Abbreviation/acronym                    What it means
------------------------------------------------------------------------
ADAA.........................  Animal Drug Availability Act.
ANADA........................  Abbreviated New Animal Drug Application
CFR..........................  Code of Federal Regulations.
CNADA........................  Conditionally Approved New Animal Drug
                                Application.
FD&C Act.....................  Federal Food, Drug, and Cosmetic Act.
FDA..........................  Food and Drug Administration.
FR...........................  Federal Register.
HHS..........................  Health and Human Services.
INAD.........................  Investigational New Animal Drug.
MUMS.........................  Minor Use Minor Species.
NADA.........................  New Animal Drug Application.
NDC..........................  National Drug Code.
NEPA.........................  National Environmental Policy Act.
OMB..........................  Office of Management and Budget.
OTC..........................  Over-the-counter.
PCBs.........................  Polychlorinated biphenyls.
PRA..........................  Paperwork Reduction Act of 1995.
RLNAD........................  Reference-Listed New Animal Drug.
Rx...........................  Prescription.
U.S..........................  United States.
U.S.C........................  United States Code.
VFD..........................  Veterinary Feed Directive.
VMF..........................  Veterinary Master File.
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III. Background

A. Introduction

    In accordance with the definition in section 201(k) of the FD&C Act 
(21 U.S.C. 321(k)) the ``label'' is a display of written, printed, or 
graphic matter upon the immediate container of any article. Under 
section 201(m) of the FD&C Act, the term ``labeling'' means ``all 
labels and other written, printed, or graphic matter (1) upon any 
article or any of its containers or wrappers, or (2) accompanying such 
article.'' Labeling, therefore, includes the label of any article, 
including new animal drugs.
    Under existing regulations, proposed labeling must be included as 
part of an application filed with FDA for approval of a new animal 
drug, in accordance with section 512(b)(1)(F) of the FD&C Act (21 
U.S.C. 360b(b)(1)(F)). Labeling for nonprescription, known as over-the-
counter (OTC), new animal drugs should include adequate directions for 
use by the layperson under all conditions of use for which the new 
animal drug is intended, recommended, or suggested in any of the 
labeling or advertising sponsored by the applicant (see Sec.  
514.1(b)(3)(ii) (21 CFR 514.1(b)(3)(ii)). Labeling for prescription new 
animal drugs should bear adequate information for use under which 
veterinarians can use the new animal drug safely and for the purposes 
for which it is intended, including those purposes for which it is to 
be advertised or represented, in accordance with Sec.  201.105 (21 CFR 
201.105) (see Sec.  514.1(b)(3)(iii)). All labeling for prescription or 
OTC new animal drugs must provide any necessary use restrictions 
prominently and conspicuously displayed (see Sec.  514.1(b)(3)(iv)).
    Labeling for new animal drugs intended for use in the manufacture 
of medicated feeds must include: (1) specimens of labeling to be used 
for such new animal drug with adequate directions for the manufacture 
and use of finished feeds for all conditions for which the new animal 
drug is intended, recommended, or suggested in any of the labeling, 
including advertising, sponsored by the applicant; and (2) 
representative labeling proposed to be used for Type B and Type C 
medicated feeds containing the new animal drug (see Sec.  
514.1(b)(3)(v)). Sponsors of new animal drug applications commit to 
providing labeling for the new animal drug that prescribes, recommends, 
or suggests its use only under the conditions stated in the labeling 
included as part of the application (see Sec.  514.1(b)(11)). All 
representations of labeling in the application apply to the new animal 
drug produced until changes are made in conformity with Sec.  514.8 (21 
CFR 514.8) (see Sec.  514.1(b)(11)).
    Sponsors of new animal drug applications may submit draft labeling 
for FDA's preliminary consideration of an application (see Sec.  
514.1(b)(3)(vi)). For example, sponsors sometimes include draft 
labeling content pertinent to key components of an application that are 
submitted for preliminary FDA review (e.g., manufacturing components 
and composition, evidence to establish safety and effectiveness, and 
environmental assessment).
    Under section 502(a)(1) of the FD&C Act (21 U.S.C. 352(a)(1)), a 
drug shall be deemed to be misbranded if its labeling is false or 
misleading in any particular. A new animal drug for which an approval 
or conditional approval is in effect will be considered unsafe if its 
labeling fails to conform to the approved or conditionally approved 
application (section 512(a)(1)(A) and (B) of the FD&C Act).

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B. Need for the Regulation

    Based on FDA's experience in reviewing labeling for approved or 
conditionally approved prescription new animal drugs and informal 
feedback from sponsors of such new animal drugs in the past 60 years, 
it has become clear that sponsors would benefit from having more 
detailed requirements on the content, format, and order of information 
on labeling so that they can efficiently prepare adequate labeling for 
approved or conditionally approved prescription new animal drugs to be 
submitted as part of an NADA, CNADA, or certain ANADAs that reference a 
new animal drug for which the NADA has been withdrawn.
    For example, existing Sec.  201.105(c) provides requirements for 
labeling ``on or within the package'' from which prescription animal 
drugs are dispensed, and paragraph (d) of that section provides 
requirements for all labeling for prescription new animal drugs. 
Labeling for prescription new animal drugs typically consists of 
multiple components, such as the label, one or more package inserts, 
secondary container labeling, multiple unit carton labeling, shipping 
labeling, and/or display carton labeling. However, neither paragraph 
(c) nor (d) of Sec.  201.105 provides direction on the format or order 
of information with respect to specific labeling components. 
Furthermore, it is not clear whether the information required by 
paragraph (d) of Sec.  201.105 needs to be presented on all components 
of labeling for prescription new animal drugs, or if not, what critical 
information needs to be provided on specific labeling components, 
particularly smaller components of limited size.
    Whereas existing Sec.  201.105 provides at least some requirements 
for the content of labeling for prescription new animal drugs, there 
are currently no regulations that provide requirements for the general 
content and format of labeling for OTC new animal drugs and new animal 
drugs administered in animal feeds.
    The lack of direction regarding format and content for each 
component of labeling has resulted in confusion for sponsors as they 
prepare labeling for FDA's review and sometimes results in poor quality 
labeling submissions. Poor quality labeling submissions increase the 
time needed by sponsors to revise and resubmit adequate labeling, and 
they increase time needed by FDA to review and approve labeling, and 
consequently, the application.
    New animal drug labeling that presents information in an 
inconsistent manner can contribute to medication errors by making it 
difficult for veterinarians and animal owners to readily locate and 
understand critical directions and safety information. Information in 
the labeling for approved or conditionally approved new animal drugs 
presented in a consistent manner communicates information that is 
important to the safe use of a new animal drug in the medication use 
process (i.e., from prescription, to procurement, preparation, and 
dispensing and administration of the medication to the animal).
    Other regulations specifically pertaining to the labeling of 
certain new animal drugs include Sec.  500.25 (21 CFR 500.25), 
``Anthelmintic drugs for use in animals,'' Sec.  500.55 (21 CFR 
500.55), ``Exemption from certain drug-labeling requirements,'' Sec.  
510.105 (21 CFR 510.105), ``Labeling of drugs for use in milk-producing 
animals,'' Sec.  510.106 (21 CFR 510.106), ``Labeling of antibiotic and 
antibiotic-containing drugs intended for use in milk-producing 
animals,'' and Sec.  510.410 (21 CFR 510.410), ``Corticosteroids for 
oral, injectable, and ophthalmic use in animals; warnings and labeling 
requirements.''
    The proposed rule would locate the labeling requirements for 
``Anthelmintic drugs for use in animals,'' currently in Sec.  500.25, 
with other labeling requirements for new animal drugs.
    The proposed rule would remove the exemption in Sec.  500.55, 
``Exemption from certain drug-labeling requirements,'' because we 
believe that full disclosure labeling is needed for all prescription 
new animal drugs to ensure veterinarians are able to use these products 
safely and effectively.
    In addition, the proposed rule would remove the labeling 
requirements in Sec.  510.105, ``Labeling of drugs for use in milk-
producing animals,'' and Sec.  510.106, ``Labeling of antibiotic and 
antibiotic-containing drugs intended for use in milk-producing 
animals.'' The labeling requirements in these regulations do not 
provide adequate flexibility for targeted and informative statements 
with respect to human food safety warnings, including milk discard 
times, withdrawal periods, and residue warning statements for the 
labeling of new animal drugs intended for use in milk-producing 
animals.
    Section 510.410, ``Corticosteroids for oral, injectable, and 
ophthalmic use in animals; warnings and labeling requirements,'' 
contains background information and warning and labeling requirements 
for this category of new animal drugs. We propose a conforming 
amendment to remove Sec.  510.410 and to move portions of that section 
to be located with the other labeling requirements for new animal 
drugs.

C. FDA's Current Regulatory Framework

    Current Sec.  201.105 provides conditions that must be met for 
exempting prescription animal drugs from section 502(f)(1) of the FD&C 
Act, which requires the labeling to bear adequate directions for use. 
Section 201.105(b) requires the following information to appear on the 
label for prescription animal drugs for such products to be exempt from 
section 502(f)(1) of the FD&C Act:
     a standard statement restricting use to or on the order of 
a licensed veterinarian,
     dosage,
     route of administration if it is not oral,
     quantity or proportion of each active ingredient as well 
as information required, in accordance with section 502(e) of the FD&C 
Act,
     names of inactive ingredients if the drug is for other 
than oral use (with some exemptions), and
     an identifying lot or control number.
    For containers too small or otherwise unable to fit a label with 
enough space to display all the required information, Sec.  201.105(b) 
allows eliminating some information from these labels and placing it on 
other approved labeling.
    Labeling for prescription new animal drugs must bear adequate 
information for use, including indications, effects, dosages, routes, 
methods, and frequency and duration of administration; any relevant 
warnings, hazards, contraindications, side effects, and precautions 
under which veterinarians can use the drug safely and for the intended 
purposes; and ingredient information as required for the label (see 
Sec.  201.105(c) through (e)). All prescription animal drug labeling, 
except for labels and cartons, must bear the issuance dates of the 
latest revisions of such labeling (see Sec.  201.105(e)). Applicants 
may submit a written request to the Commissioner of Food and Drugs for 
an exemption from inclusion of adequate information for use required in 
Sec.  201.105(c)(1) from the dispensing package of prescription new 
animal drugs for which directions, hazards, warnings, and use 
information are commonly known to licensed veterinarians (see Sec.  
201.105(c)(2)).
    A prescription drug intended for both human and veterinary use must 
comply with paragraphs (e) and (f) of Sec.  201.105, in addition to 
Sec.  201.100, which provides

[[Page 18266]]

requirements for prescription drugs for human use (see Sec.  
201.105(f)).

D. History of the Rulemaking

    In 1955, FDA issued regulations at Sec.  1.106(c) establishing 
requirements primarily for the label of prescription animal drugs (20 
FR 9525 at 9533, December 20, 1955). The initial requirements were 
expanded in 1960 to cover the labeling of such drugs more fully (25 FR 
12592, December 9, 1960). As part of FDA's reorganization of its 
regulations, in 1975 Sec.  1.106(c) was redesignated as Sec.  201.105 
(40 FR 13494 at 13496, March 27, 1975). Most provisions in current 
Sec.  201.105 are similar to the 1960 version of Sec.  1.106(c).

IV. Legal Authority

    FDA's revisions to the content and format requirements for animal 
drug labeling are authorized by various provisions of the FD&C Act, 
including sections 201, 301, 501, 502, 503, 504, 512, 571, and 701 (21 
U.S.C. 321, 331, 351, 352, 353, 354, 360b, 360ccc, and 371). Section 
201 contains definitions relevant to the proposed content and format 
requirements, including for the terms ``label'' and ``labeling''. 
Pursuant to section 201(k) of the FD&C Act, the term ``label'' means 
``a display of written, printed, or graphic matter upon the immediate 
container of any article.'' That provision requires that any words, 
statements, or other information appearing on the label also appear on 
the outside container or wrapper of the retail package, or be easily 
legible through the outside container or wrapper. Section 201(m) of the 
FD&C Act defines ``labeling'' to mean ``all labels and other written, 
printed, or graphic matter (1) upon any article or any of its 
containers or wrappers, or (2) accompanying such article.''
    Section 301 of the FD&C Act prohibits the marketing of drugs that 
are adulterated or misbranded as well as their adulteration or 
misbranding while in interstate commerce. Section 501(a)(5) of the FD&C 
Act deems a new animal drug to be adulterated if it is unsafe within 
the meaning of section 512 of the FD&C Act. Under section 512 of the 
FD&C Act, a new animal drug will be deemed unsafe if its labeling fails 
to conform to the applicable approved application under section 512 of 
the FD&C Act, conditionally approved application under section 571 of 
the FD&C Act, or index listing under section 572 of the FD&C Act (21 
U.S.C. 360ccc-1).
    Section 502 of the FD&C Act specifies conditions that cause a drug 
to be misbranded. Under section 502(a) of the FD&C Act, a drug is 
deemed to be misbranded if its labeling is false or misleading ``in any 
particular.'' Section 201(n) of the FD&C Act deems a product's labeling 
misleading if it fails to reveal facts regarding the consequences that 
may result from using the article under the conditions of use 
prescribed in the labeling or under such conditions of use as are 
customary or usual. Under section 502(b) of the FD&C Act, a drug in 
package form is deemed to be misbranded unless its label bears the name 
and place of business of the manufacturer, packer, or distributor, and 
it contains an accurate statement of the quantity of the contents in 
terms of weight, measure, or numerical count. Section 502(c) of the 
FD&C Act, deems a drug misbranded if any word, statement, or other 
information required by law or regulation to be included on the label 
or labeling does not appear with such prominence and conspicuousness, 
and in such terms, that it is likely to be read and understood by 
ordinary individuals under customary conditions of purchase and use.
    Section 502(e) of the FD&C Act specifies requirements for including 
the established name of the drug and for listing the active and 
inactive ingredients on the drug's label. It also provides for certain 
exemptions from the requirement to list active and inactive ingredients 
and authorizes the Secretary to establish additional exemptions from 
some of the requirements in section 502(e) by promulgating regulations 
where compliance would be impracticable.
    Section 502(f) of the FD&C Act deems a drug to be misbranded if its 
labeling lacks adequate directions for use and adequate warnings 
against use in those pathological conditions where its use may be 
dangerous to health, as well as adequate warnings against unsafe dosage 
or methods or duration of administration or application, in such manner 
and form, as are necessary for the protection of users.
    Section 502(j) of the FD&C Act deems a drug to be misbranded if it 
is dangerous to health when used in the dosage or manner, or with the 
frequency or duration, prescribed, recommended, or suggested in its 
labeling.
    Under section 502(w)(1) of the FD&C Act, a new animal drug that has 
been conditionally approved is deemed to be misbranded if its labeling 
fails to conform with the approved application or fails to include the 
labeling information required under section 571(f) of the FD&C Act. 
Section 571(f) requires the label and labeling of a new animal drug 
with a conditional approval to contain the statement ``conditionally 
approved by FDA pending a full demonstration of effectiveness under 
application number,'' in addition to other information as required by 
the Secretary. Effective September 30, 2023, section 502(w)(3) requires 
the labeling of new animal drugs that have received approval under 
section 512 of the FD&C Act to include the application number in the 
format ``Approved by FDA under (A)NADA # xxx-xxx.''
    Section 503(f) of the FD&C Act provides certain labeling 
requirements specific to prescription animal drugs, including a 
required cautionary statement. Section 503(f)(2) exempts prescription 
animal drugs from having to comply with some of the requirements in 
section 502 of the FD&C Act, including the requirement for there to be 
adequate directions for use (section 502(f)), provided certain 
dispensing and labeling requirements specified in section 503(f) are 
met.
    Section 504 of the FD&C Act authorizes the Secretary to issue 
regulations specific to veterinary feed directive (VFD) drugs for use 
in or on animal feed, including regulations prescribing a cautionary 
statement and other information to be included on the labeling of VFD 
drugs and animal feed containing such drugs. Under section 504(b), VFD 
drugs and feed containing such drugs will be deemed to be misbranded if 
their labeling fails to include such required information.
    In addition, the premarket approval provisions of the FD&C Act 
authorize FDA to require that animal drug labeling provide adequate 
information to permit safe and effective use of the drug. Under section 
512 of the FD&C Act, FDA will approve a NADA only if the drug is shown 
to be both safe and effective under the conditions of use set forth in 
the drug's labeling. Under section 571 of the FD&C Act, FDA will 
conditionally approve a new animal drug application (CNADA) only if the 
drug is shown to be safe, and there is a reasonable expectation of 
effectiveness for use, under the conditions of use set forth in the 
drug's labeling. Section 512(b)(1)(F) of the FD&C Act requires that the 
application for approval of a new animal drug include specimens of the 
labeling proposed to be used for the drug. A new animal drug that has 
been approved or conditionally approved by FDA will be deemed to be 
unsafe (and therefore adulterated under section 501(a)(5) of the FD&C 
Act) if its labeling does not conform to its approved application.
    In addition to the other statutory provisions described above, 
section 701(a) of the FD&C Act gives the Secretary general rulemaking 
authority

[[Page 18267]]

to issue regulations for the efficient enforcement of the FD&C Act.
    FDA has previously issued implementing regulations governing the 
format and content of labeling for animal drugs. This proposed rule, 
when finalized, would revise the content and format of labeling 
requirements applicable to approved and conditionally approved new 
animal drugs and would consolidate these requirements in subpart H of 
part 201.

V. Description of the Proposed Rule

    FDA proposes to add subpart H to part 201 (hereafter called 
proposed subpart H) to revise the existing requirements for the content 
and format of labeling for approved or conditionally approved new 
animal drugs. Proposed subpart H would be titled ``Labeling 
Requirements for Approved or Conditionally Approved New Animal Drugs'' 
and would apply to new animal drugs that are approved under section 512 
of the FD&C Act or conditionally approved under section 571 of the FD&C 
Act. These regulations would not apply to legally marketed unapproved 
new animal drugs for minor species that are indexed in accordance with 
section 572 of the FD&C Act. These regulations would not apply to the 
labeling of heritable intentional genomic alterations in animals, or to 
promotional labeling or advertising.
    Sponsors of approved or conditionally approved and marketed new 
animal drugs would need to comply with these requirements per the 
schedule in proposed Sec.  201.404(a)(4), (b), (c), or (d). Consistent 
with current practice, we expect that sponsors of new animal drugs that 
are the subject of an ANADA approved or submitted pursuant to section 
512(n) of the FD&C Act (i.e., a generic new animal drug) will submit a 
supplemental application to their ANADA to conform the labeling of 
their generic new animal drugs with the revised labeling of the 
reference-listed new animal drug (RLNAD). Therefore, in the preliminary 
regulatory impact analysis we examine the costs and benefits of these 
requirements for ANADAs that reference an NADA that has not been 
withdrawn. However, for generic new animal drugs that are the subject 
of an ANADA that reference a new animal drug for which the NADA has 
been voluntarily withdrawn for reasons other than safety or 
effectiveness, or that reference a new animal drug for which the NADA 
that has been withdrawn on the basis of one or more of the grounds 
included under section 512(e) of FD&C Act and for which the ANADA's 
approval was not affected by the withdrawal, labeling for such ANADAs 
would need to comply with proposed subpart H per the proposed schedule 
described in proposed Sec.  201.404(a)(4)(iii).
    The proposed requirements are based on FDA's experience in 
reviewing labeling submitted for the approval or conditional approval 
of new animal drugs and its experience in implementing existing 
regulations for labeling of new animal drugs, as well as input received 
from new animal drug sponsors, end users of animal drugs, information 
collected from post approval surveillance, and other stakeholders. We 
intend for these proposed regulations to provide consistent formatting 
of new animal drug labeling by identifying the specific labeling 
components that would be required and permitted for each new animal 
drug, the information needed for each component, and the order in which 
information would appear on labeling. Consistent and standardized 
content and format of new animal drug labeling may make it easier for 
end users (veterinarians, animal owners, or persons treating the 
animals) to access, read, and use the information to make informed 
decisions quickly, while promoting safe use of the drug. Such labeling 
may contribute to reducing medication errors.
    Providing clear and consistent requirements in these proposed 
regulations should help to reduce the amount of time needed by sponsors 
of new animal drugs to prepare high quality proposed labeling for their 
new animal drugs. The submission of higher quality proposed labeling by 
sponsors of new animal drugs may reduce the amount of time needed by 
FDA to review and approve labeling, and consequently, the new animal 
drug application.
    We include the following eight sections in proposed subpart H:
     Sec.  201.401 Scope.
     Sec.  201.403 Definitions.
     Sec.  201.404 General requirements.
     Sec.  201.405 Content and format for prescription new 
animal drug labeling.
     Sec.  201.407 Content and format for OTC new animal drug 
labeling.
     Sec.  201.409 Content and format of labeling for new 
animal drugs for use in animal feeds.
     Sec.  201.411 Exemptions from labeling requirements for 
approved or conditionally approved new animal drugs.
     Sec.  201.413 Labeling requirements for certain approved 
or conditionally approved new animal drugs.

A. Scope (Proposed Sec.  201.401)

    The proposed rule would revise the existing requirements for the 
content and format of labeling for prescription (Rx) new animal drugs, 
OTC new animal drugs other than those for use in animal feeds in 
accordance with part 558 (21 CFR part 558), and new animal drugs for 
use in animal feeds that are subject to part 558, including VFD drugs, 
that are subject of the specific applications identified in proposed 
Sec.  201.401(a)(1) through (4).
    Subpart H would apply to the labeling of new animal drugs that are 
the subject of an NADA approved or submitted pursuant to section 512 of 
the FD&C Act (see proposed Sec.  201.401(a)(1)), new animal drugs that 
are the subject of a CNADA conditionally approved or submitted pursuant 
to section 571 of the FD&C Act (see proposed Sec.  201.401(a)(2)), and 
new animal drugs that are the subject of an ANADA approved or submitted 
pursuant to section 512(n) of the FD&C Act (i.e., a generic new animal 
drug) that reference a new animal drug for which the NADA has been 
voluntarily withdrawn for reasons other than safety or effectiveness, 
or that reference a new animal drug for which the NADA has been 
withdrawn on the basis of one or more of the grounds included under 
section 512(e) of the FD&C Act and for which the generic new animal 
drug's approval was not affected by the withdrawal (see proposed Sec.  
201.401(a)(3)).
    For some proprietary Type B or Type C medicated feeds, the 
formulation and labeling are approved and maintained in an NADA or 
CNADA file. In other situations, the underlying data and labeling for 
the proprietary Type B or Type C medicated feed to support the approved 
uses are maintained in a Veterinary Master File (VMF). The latter would 
include, as an example, situations in which a proprietary Type B or 
Type C medicated feed is manufactured via modification to an approved 
formulation published in the CFR or where a feed manufacturer creates 
its own proprietary formulation. The labeling of these proprietary 
medicated feeds is maintained in a VMF and would be required to comply 
with proposed subpart H (see proposed Sec.  201.401(a)(4)).
    The proposed requirements would apply to the applications described 
in proposed Sec.  201.401(a)(1) through (4) for new animal drugs that 
are approved before the effective date of any final rule based on this 
proposed rule, pending on the effective date of any final rule based on 
this proposed rule, or submitted on

[[Page 18268]]

or after the effective date of any final rule based on this proposed 
rule (see proposed Sec.  201.401(c)). The schedule for compliance is 
provided in proposed Sec.  201.404(a)(4).
    The proposed requirements would deem any approved or conditionally 
approved new animal drug subject to this subpart that does not fully 
comply with the applicable requirements in accordance with the schedule 
proposed in Sec.  201.404(a)(4) to be misbranded under section 502 of 
the FD&C Act and, if that drug is a VFD drug, also under section 504(b) 
of the FD&C Act (see proposed Sec.  201.401(c)).
    The proposed requirements would not apply to the labeling of 
legally marketed unapproved new animal drugs for minor species that are 
indexed in accordance with section 572 of the FD&C Act (see proposed 
Sec.  201.401(d)(1)) or to the labeling of heritable intentional 
genomic alterations in animals (see proposed Sec.  201.401(d)(2)).
    The proposed requirements would not apply to promotional labeling 
or advertising (see proposed Sec.  201.401(d)(3)). Promotional labeling 
for new animal drugs is generally any labeling other than labeling 
required in an application for a new animal drug (see Sec.  
514.1(b)(3)). Materials that may be considered promotional labeling or 
advertising include, for example, brochures, booklets, mailing pieces, 
or reminder labeling. These materials are described in more detail for 
prescription human drugs and prescription new animal drugs in existing 
21 CFR 202.1.

B. Definitions (Proposed Sec.  201.403)

    Proposed Sec.  201.403 would establish definitions for terms used 
in proposed subpart H.
    The proposed definitions for the following terms would be the same 
as those already in the FD&C Act or elsewhere in the regulations:

 ``active ingredient''
 ``adverse drug experience''
 ``ANADA''
 ``drug product''
 ``established name''
 ``extralabel use''
 ``free-choice medicated feed''
 ``inactive ingredient''
 ``label''
 ``labeling''
 ``lot number''
 ``control number''
 ``batch number''
 ``NADA''
 ``new animal drug''
 ``sponsor''
 ``strength''
 ``Type A medicated article''
 ``Type B medicated feed''
 ``Type C medicated feed''
 ``veterinary feed directive (VFD)''
 ``VFD drug''

    We would base the definition of ``full prescribing information'' 
for prescription new animal drugs on the requirements for full 
prescribing information for prescription human drugs and biologics 
established in Sec.  201.57(c) (21 CFR 201.57(c)).
    For OTC new animal drugs, we would create a similar term, called 
``full product information.'' We would define ``full product 
information'' as all information necessary for the safe and effective 
use of an OTC new animal drug.
    We would base the definitions of other terms on the requirements 
established in Sec.  201.57(c) for full prescribing information of 
prescription human drugs and biologics. These terms include ``adverse 
reaction,'' ``boxed warning,'' and ``contraindication.'' The proposed 
definition of ``precaution'' would be based on the requirements for the 
``Other special care precautions'' labeling section described in Sec.  
201.57(c)(6)(ii). The proposed definition of ``warning'' would be based 
on general requirements for the ``Warnings and Precautions'' section 
described in Sec.  201.57(c)(6)(i).
    We would define ``active moiety'' as the molecule or ion, excluding 
those appended portions of the molecule that cause the drug to be an 
ester, salt (including a salt with hydrogen or coordination bonds), or 
other noncovalent derivative (such as a complex, chelate, or clathrate) 
of the molecule, responsible for the physiological or pharmacological 
action of the drug substance.
    We would define ``field study'' as a type of adequate and well-
controlled study designed to assess the effectiveness and/or safety of 
a new animal drug in the target animal under conditions that closely 
approximate the actual conditions of use.
    The term ``indication'' would mean ``the use for which the new 
animal drug is approved or conditionally approved.''
    We would define ``milk discard time'' as the interval between the 
time of the last administration of a new animal drug and the time when 
the milk can be safely consumed.
    We would define ``residue warning statement'' as a statement that 
warns against the use of the new animal drug in animals for which the 
withdrawal period and/or milk discard time has not been determined, 
and/or provides other information to prevent illegal drug residues in 
food products from animals treated with the new animal drug.
    The term ``target animal'' would mean the species, or collection of 
species, of animals, and if applicable, the specific subset(s) of 
animals (e.g., life stage, production class, age, gender) for which the 
new animal drug is approved or conditionally approved. Particularly for 
food-producing animals, new animal drugs may be approved for use only 
during a specific life stage (e.g., growing, pregnant, lactating), 
production class (e.g., growing beef steers and heifers fed in 
confinement for slaughter, broiler chickens, finishing pigs), age, or 
gender of the animal.
    We would define ``environmental warning'' as a warning that 
identifies any potential hazard to the human environment associated 
with the use of the new animal drug. We would define ``user safety 
warning'' as a warning that identifies any serious adverse reaction or 
potential hazard to human health associated with human exposure during 
use of a new animal drug via contact, inhalation, ingestion, injection, 
or by other means.
    The term ``withdrawal period'' would mean the interval between the 
time of the last administration of a new animal drug and the time when 
the animal can be safely slaughtered for food.
    The proposed regulations would provide definitions for terms 
associated with key labeling components for new animal drugs, including 
``immediate container,'' ``package insert,'' ``secondary container,'' 
``small label,'' ``shipping labeling,'' ``representative Type B 
medicated feed labeling,'' and ``representative Type C medicated feed 
labeling.''

C. General Requirements (Proposed Sec.  201.404)

    The proposed rule would require the labeling for approved or 
conditionally approved new animal drugs to conform to an application 
approved under section 512 of the FD&C Act or conditionally approved 
under section 571 of the FD&C Act (see proposed Sec.  201.404(a)(1)).
    The proposed rule would require the labeling to be informative and 
accurate and neither promotional in tone nor false or misleading in any 
particular and would require the labeling to be updated if new 
information becomes available to cause the labeling to become 
inaccurate, false, or misleading, in accordance with Sec.  514.8 of 
this chapter (see proposed Sec.  201.404(a)(2) and (3)).
    The proposed rule would require labeling conforming to this subpart 
to be submitted to FDA per the earliest applicable compliance date 
provided in the schedule, unless Sec.  201.404(b), (c), or (d) was 
applicable (see proposed Sec.  201.404(a)(4)). See also section VI for

[[Page 18269]]

discussion of Proposed Effective/Compliance Dates.
    Labeling included in NADAs, CNADAs, or supplements to NADAs or 
CNADAs subject to Sec.  514.8(c)(2) that are submitted to FDA for 
approval more than 180 days after the effective date of any final rule 
based on this proposed rule would be required to conform to the 
regulations as part of the application (see proposed Sec.  
201.404(a)(4)(i)).
    The proposed rule would require sponsors with NADAs, CNADAs, or 
supplements to NADAs or CNADAs subject to Sec.  514.8(c)(2) that are 
pending with FDA on the effective date of any final rule based on this 
proposed rule, or submitted within 180 days after the effective date of 
any final rule based on this proposed rule, to submit conforming 
labeling as part of the application or supplemental application, or 
alternatively, as a supplement to the approved application or 
supplemental application within 180 days after the approval date of the 
application or supplemental application, as determined by FDA (see 
proposed Sec.  201.404(a)(4)(ii)).
    The proposed rule would establish a timeline for submission of 
supplements with conforming labeling for marketed new animal drugs 
originally approved before the effective date of any final rule based 
on this proposed rule, based on NADA number (see proposed Sec.  
201.404(a)(4)(iii) through (vii)).
    For an ANADA that references a new animal drug for which the NADA 
has been voluntarily withdrawn for reasons other than safety or 
effectiveness, or that references a new animal drug for which the NADA 
has been withdrawn on the basis of one or more grounds included under 
section 512(e) of the FD&C Act and the ANADA's approval was not 
affected by the withdrawal, the labeling for such an ANADA would be 
required to be submitted between the [effective date of a final rule 
plus 1 year] and the [effective date of a final rule plus 2 years] (see 
proposed Sec.  201.404(a)(4)(iii)). For an ANADA that references a new 
animal drug for which the NADA has not been withdrawn, consistent with 
current practice, we expect that the sponsor of such a generic new 
animal drug will submit a supplemental application to the ANADA to 
conform the labeling of the generic new animal drug with the revised 
labeling of the RLNAD once the labeling of the RLNAD has been revised 
in accordance with the schedule in proposed Sec.  201.404.
    Sponsors of proprietary Type B or Type C medicated feeds for which 
the underlying data and labeling are maintained in a VMF would be 
required to submit conforming labeling to the VMF within 180 days after 
all conforming labeling has been approved for the NADA or CNADA that is 
the approved or conditionally approved source of the new animal drug 
used to manufacture the proprietary medicated feed (see proposed Sec.  
201.404(b)).
    The labeling for new animal drugs conditionally approved before the 
effective date of a final rule would not be required to comply with 
proposed subpart H until an application for full approval is submitted 
unless a supplement subject to Sec.  514.8(c)(2) is submitted to the 
CNADA after the effective date of a final rule (see proposed Sec.  
201.404(c)). The conditional approval is valid for 1 year and can be 
renewed annually for up to a total of 5 years by the sponsor showing 
active progress towards demonstrating substantial evidence of 
effectiveness. The conditional approval will be terminated if 
substantial evidence of effectiveness is not demonstrated (section 
571(d) of the FD&C Act).
    The proposed rule would also establish an alternative schedule for 
submitting conforming labeling for combination new animal drugs 
intended for use in animal feed or drinking water and approved, on or 
before the effective date of a final rule, in accordance with section 
512(d)(4) of the FD&C Act, i.e., per the Animal Drug Availability Act 
(ADAA) of 1996. Section 512(d)(4) was amended as part of the Minor Use 
Minor Species (MUMS) Act of 2004 to clarify that only products approved 
under section 512(b)(1) of the FD&C Act can be used in ADAA 
combinations. Thus, ADAA combination new animal drugs exclude 
conditionally approved drugs subject to section 571 of the FD&C Act. 
These ADAA combination new animal drugs generally provide for more than 
one approved new animal drug (as a Type A medicated article) to be 
mixed into medicated feed or drinking water. These ADAA combination new 
animal drug approvals result in new representative (``Blue Bird'') 
labeling for medicated feeds containing the combination (see proposed 
Sec.  201.409).
    Representative labeling for medicated feed containing the approved 
combination of new animal drugs includes information from the approved 
labeling for the individual drugs. Thus, it would be appropriate that 
the labeling for individual drugs included in the combination be 
updated to conform to any final regulations before representative 
labeling for the feeds containing the combination approval is updated. 
However, the ADAA combination approval would occur after the individual 
drugs are approved; therefore, the NADA number for the combination 
approval would be higher than the NADA numbers for the individual new 
animal drugs. Thus, according to the schedule proposed in Sec.  
201.404(a)(4), the conforming labeling for a combination approval would 
likely need to be submitted before the conforming labeling for the 
individual drugs in the combination. To address this problem, the 
proposed rule would require the conforming labeling for the combination 
new animal drug to be submitted within 180 days of the approval of all 
conforming labeling for the individual new animal drugs used in the 
combination (see proposed Sec.  201.404(d)).
    The range of NADA numbers provided as ``breakpoints'' in the 
proposed schedule for the submission of conforming labeling are 
intended to provide for a relatively uniform number of labeling 
supplements during each 1-year interval. The schedule would require 
more recently approved new animal drugs to conform to the requirements 
first because they are more likely to be consistent with the new 
requirements than the labeling of older new animal drugs. Sponsors of 
older new animal drug applications would have a longer amount of time 
to comply with the new requirements. Table 1 provides these NADA ranges 
in the first column. Table 1 provides in the second column the number 
of currently approved and marketed NADAs within the ranges of NADAs 
calculated by FDA as of September 2023 and adjusts for ADAA combination 
new animal drugs that would need to conform after all individual new 
animal drugs in the combination have conformed (see proposed Sec.  
201.404(d)). The first row of the second column of table 1 includes 
ANADAs that reference a new animal drug for which the NADA has been 
voluntarily withdrawn for reasons other than safety or effectiveness, 
or that reference a new animal drug for which the NADA has been 
withdrawn on the basis of one or more of the grounds included under 
section 512(e) of FD&C Act and for which the ANADA's approval was not 
affected by the withdrawal. Table 1 also provides in the third column 
the number of currently approved and marketed ANADAs with a RLNAD that 
has not been withdrawn, as calculated by FDA as of September 2023; 
these ANADAs are included in the row that corresponds to the NADA 
number for the RLNAD.

[[Page 18270]]



                        Table 1--Number of Affected Applications as of September 2023 \1\
----------------------------------------------------------------------------------------------------------------
                                                                                   ANADA with  a
                            NADA Nos.                                  NADA          RLNAD \2\         Total
----------------------------------------------------------------------------------------------------------------
N-141-300 +; certain ANADAs.....................................         \3\ 104               9             113
N-141-000 to N-141-299..........................................             101              86             187
N-115-000 to N-140-999..........................................             105              87             192
N-045-000 to N-114-999..........................................             116              68             184
N-000-001 to N-044-999..........................................              86              66             152
                                                                 -----------------------------------------------
    Total.......................................................             512             316             828
----------------------------------------------------------------------------------------------------------------
\1\ These numbers will be updated in a final rule.
\2\ These are ANADAs with a RLNAD that has not been withdrawn, and they are in the row that corresponds to the
  NADA number for the RLNAD.
\3\ This number includes six ANADAs that reference a withdrawn NADA.

    The proposed rule would provide direction for situations in which 
it may not be clear how a requirement in subpart H applies to a 
particular new animal drug, or whether it applies. FDA approves and 
conditionally approves new animal drugs for many species of animals. 
For some new animal drugs, certain sections or subsections of labeling 
required by proposed subpart H would not be applicable. For example, 
new animal drugs approved or conditionally approved for use in non-
food-producing animals (e.g., cats, dogs) would not require the 
labeling subsection entitled either ``Withdrawal Periods and Residue 
Warnings'' or ``Withdrawal Periods''. As another example, certain new 
animal drugs may not have contraindications. We would make the final 
determination in these situations as to the applicability of 
requirements in subpart H to specific new animal drugs (see proposed 
Sec.  201.404(e)).
    In addition, some sections in subpart H propose different options 
to meet the labeling requirements. For example, proposed Sec.  
201.405(b) would provide various options for presenting the 
``Indications for Use'' section on the label for a prescription new 
animal drug, depending on size of the label. In those situations where 
the most appropriate option is not clear, we would make the final 
determination (see proposed Sec.  201.404(e)). Ordinarily, such 
determinations would be made during the review of the new animal drug 
and its labeling.
    When sponsors would submit labeling for purposes of conforming to 
the requirements of proposed subpart H according to the schedule in 
proposed Sec.  201.404(a)(4), the proposed rule would require all 
labeling components for an approved or conditionally approved new 
animal drug to be provided in one submission. FDA would refuse to file 
labeling submissions intended to conform to this subpart that are 
incomplete. This would ensure that the content and format is consistent 
across all the labeling components for a particular new animal drug. 
Also, this would enable FDA to review and compare all labeling 
components at the same time to ensure that they conform to the proposed 
regulations when finalized (see proposed Sec.  201.404(f)).
    The proposed rule would establish general requirements for the 
format of labeling of approved or conditionally approved new animal 
drugs in proposed Sec.  201.404(g). The format and content of labeling 
for prescription new animal drugs, OTC new animal drugs, or new animal 
drugs for use in animal feeds would be required to comply with the 
general requirements in proposed Sec.  201.404(g), as applicable, in 
addition to format and content specific requirements for each type of 
new animal drug (see proposed Sec. Sec.  201.405, 201.407, or 201.409, 
respectively).
    The proposed rule would establish requirements for the placement, 
size, and prominence of the established name relative to the 
proprietary name for approved or conditionally approved prescription 
new animal drugs in proposed Sec.  201.404(g)(1). These requirements 
are in accordance with Sec.  201.10(g)(1) and (2) (21 CFR 210.10(g)(1) 
and (2)) and section 502(e)(1)(B) of the FD&C Act.
    The proposed rule would establish requirements for the placement, 
size, and prominence of the established name relative to the 
proprietary name of approved or conditionally approved OTC new animal 
drugs and labeling for approved or conditionally approved new animal 
drugs for use in animal feeds, excluding representative Type B and Type 
C medicated feed labeling (see proposed Sec.  201.404(g)(2)).
    The proposed rule would provide the requirements for the placement, 
size, and prominence of the established name on representative Type B 
and Type C medicated feed labeling for approved or conditionally 
approved new animal drugs for use in animal feeds (see proposed Sec.  
201.404(g)(3)).
    The proposed rule would require labeling text to be easy to read 
and with letters that do not touch. For certain text on labeling for 
new animal drugs, we believe that black text on a white background and 
use of a single type style is the easiest to read. Accordingly, the 
proposed rule would require that the running text, section headings, 
and subsection headings of package inserts must be in black type and on 
a white background and use a single type style because package inserts 
provide full prescribing information for prescription new animal drugs 
and full product information for OTC new animal drugs. Black text on a 
white background also would be required for representative labeling for 
Type B and C medicated feeds. For all other labeling components for new 
animal drugs, other color combinations would be allowed, provided that 
there is sufficient contrast between text and the background colors to 
ensure readability. See proposed Sec.  201.404(g)(4) and (5).
    The proposed rule would establish requirements for presentation of 
graphics and designs on labeling for approved or conditionally approved 
new animal drugs (see proposed Sec.  201.404(g)(6)). Representative 
labeling for Type B and C medicated feeds would not be permitted to 
have logos, graphics, or designs other than illustrations or tables 
that FDA determines are necessary for proper use of the medicated feed. 
This proposed format is consistent with the purpose of representative 
labeling for Type B and C medicated feeds for use as template labeling 
and is also consistent with the format of representative labeling for 
Type B and C medicated feeds currently used in the medicated feeds 
industry. The proposed rule would require the presentation of graphics 
and designs on other labeling components for approved or conditionally 
approved new animal drugs to comply with Sec.  201.15(b)(1) (21

[[Page 18271]]

CFR 201.15(b)(1)) and proposed Sec.  201.404(a)(2) (see proposed Sec.  
201.404(g)(6)). If graphics are incorporated into the background of 
these labeling components, for any text appearing over the graphics 
there would need to be sufficient contrast between the text and the 
graphics colors to ensure readability of the text. The use of 
compressed arrows on labeling would be limited to the subsection 
entitled either ``Withdrawal Periods and Residue Warnings'' or 
``Withdrawal Periods,'' in accordance with the requirements in proposed 
Sec.  201.404(g)(8) (see proposed Sec.  201.404(g)(6)).
    The proposed rule would establish minimum letter height or type 
size requirements that would vary for each labeling component and 
ensure appropriate space on each component while maintaining 
readability of text (see proposed Sec.  201.404(g)(7)).
    Section headings and subsection headings would be required to be in 
bold type that prominently distinguishes them from other approved 
labeling information. Section headings would be required to be left 
justified or centered, whereas subsection headings would be required to 
be left justified. An exception would be the subsection of labeling 
entitled either ``Withdrawal Periods and Residue Warnings'' or 
``Withdrawal Periods,'' in which the subsection heading, and the 
contents of the subsection, would be required to be centered within 
compressed arrows (see proposed Sec.  201.404(g)(8)).
    The proposed rule would require that, if the National Drug Code is 
included on labeling of new animal drugs, then it must appear in 
accordance with 21 CFR 207.33 (see proposed Sec.  201.404(h)).
    The proposed rule would require all words, statements, and other 
information on the labeling for approved or conditionally approved new 
animal drugs to appear in English. In addition, the proposed rule would 
also establish requirements for additional foreign language 
translations of new animal drug labeling (see proposed Sec.  
201.404(i)).
    For approved or conditionally approved prescription new animal 
drugs, the proposed rule would require that if any section or wording 
of a labeling component is translated into a foreign language, the 
entire full prescribing information would also be required to be 
translated into the foreign language. In certain situations, FDA may 
also require additional wording on other labeling components for the 
prescription new animal drug to be translated into the foreign 
language. These requirements would ensure that all information 
necessary for the safe and effective use of the prescription new animal 
drug would be provided in the foreign language (see proposed Sec.  
201.404(i)(1)).
    For approved or conditionally approved OTC new animal drugs, the 
proposed rule would require that if any section or wording of a 
labeling component is translated into a foreign language, the entire 
full product information would also be required to be translated into 
the foreign language. In certain situations, FDA may also require 
additional wording on other labeling components for the OTC new animal 
drug to be translated into the foreign language. These requirements 
would ensure that all information necessary for the safe and effective 
use of the OTC new animal drug would be provided in the foreign 
language (see proposed Sec.  201.404(i)(2)).
    For approved or conditionally approved new animal drugs for use in 
animal feeds, the proposed rule would require that if the labeling 
contains any representation in a foreign language, all labeling must 
also appear in the foreign language (see proposed Sec.  201.404(i)(3)).
    For all situations where labeling for new animal drugs is 
translated into a foreign language, the translated wording would be 
required to comply with the format and content requirements for 
prescription, OTC, or new animal drugs for use in animal feeds in 
proposed Sec.  201.405(a), Sec.  201.407(a), or Sec.  201.409, 
respectively.
    FDA may limit the number of languages into which labeling 
information is translated to ensure clarity of information and the safe 
and effective use of the new animal drug. This proposed limitation 
would avoid multipage labeling in multiple languages. We intend for 
this limitation to reduce medication errors and reduce the time needed 
to locate information on labeling (see proposed Sec.  201.404(i)(4)).
    The proposed rule would allow the predominant language to be 
substituted for English on the labeling for new animal drugs 
distributed solely in the Commonwealth of Puerto Rico or in a Territory 
where the predominant language is other than English. We may determine 
that such new animal drugs may be altogether exempt from the 
requirements in proposed Sec.  201.404(i) (see proposed Sec.  
201.404(j)).

D. Content and Format for Prescription (Rx) New Animal Drug Labeling--
Overview (Proposed Sec.  201.405)

    The proposed rule provides content and format requirements for all 
components of labeling for approved or conditionally approved 
prescription (Rx) new animal drugs. Proposed Sec.  201.405 would not 
apply to approved or conditionally approved new animal drugs intended 
for use in or on animal feed under the professional supervision of a 
licensed veterinarian because, in accordance with section 504(a) of the 
FD&C Act, such drugs are approved or conditionally approved as VFD 
drugs. Proposed Sec.  201.409 would establish the content and format 
requirements for all components of labeling for approved or 
conditionally approved new animal drugs intended for use in animal 
feeds that are subject to part 558, including VFD drugs.
    The proposed rule would require that labeling sections or 
subsections that do not apply be omitted from the labeling for approved 
or conditionally approved Rx new animal drugs (see proposed Sec.  
201.405). For example, Rx new animal drugs approved or conditionally 
approved for use in non-food-producing animals (e.g., cats, dogs) would 
not require the labeling subsection entitled either ``Withdrawal 
Periods and Residue Warnings'' or ``Withdrawal Periods''.
    FDA determines the final content of each applicable section of 
labeling during the review of each new animal drug as part of the 
approval process.
    Full prescribing information for Rx new animal drugs would include 
all information necessary for safe and effective use of the Rx new 
animal drug. Thus, all approved or conditionally approved Rx new animal 
drugs would be required to provide a labeling component that includes 
full prescribing information. The proposed rule would identify the 
information that would be required to be included on the labeling 
component that would provide full prescribing information for Rx new 
animal drugs. If a package insert is provided with an Rx new animal 
drug, the proposed rule would require the package insert to include 
full prescribing information. If only partial information is provided 
on a package insert, the user may mistakenly assume the package insert 
includes complete information on the safe and effective use of the drug 
when in fact it does not. If no package insert is provided with an Rx 
new animal drug, the secondary container labeling would be required to 
include full prescribing information (see proposed Sec.  201.405(a)).
    The label is the labeling component that appears on the immediate 
container, which is the container in contact with the drug. The 
proposed rule would establish content and format requirements for the 
label for an approved or conditionally approved Rx new animal drug (see 
proposed Sec.  201.405(b)) and for a small label for an

[[Page 18272]]

approved or conditionally approved Rx new animal drug that FDA 
determines lacks sufficient space to comply with proposed Sec.  
201.405(b) (see proposed Sec.  201.405(c)).
    For purposes of proposed subpart H, the proposed rule would define 
a package insert for an approved or conditionally approved Rx new 
animal drug as a labeling component that contains full prescribing 
information and is included with the immediate container or secondary 
container or is attached to the label (see proposed Sec.  201.403). 
Where the package insert is attached to the label, which is sometimes 
referred to as, for example, ``extended labeling,'' ``onserts,'' or 
``outserts,'' for purposes of proposed subpart H, the package insert 
providing full prescribing information and attached to the label would 
need to comply with proposed Sec.  201.405(a). The label would need to 
comply with proposed Sec.  201.405(b) or (c), as applicable.
    FDA considers the secondary container for a new animal drug to be 
the packaging that surrounds the immediate container. The proposed rule 
would establish content and format requirements for secondary container 
labeling for an approved or conditionally approved Rx new animal drug 
(see proposed Sec.  201.405(d)). If a package insert is provided with 
an Rx new animal drug, then the secondary container labeling would be 
required to comply with proposed Sec.  201.405(d), and the package 
insert would be required to provide full prescribing information to 
comply with proposed Sec.  201.405(a). If no package insert is provided 
with an Rx new animal drug, the proposed rule would require full 
prescribing information to appear on the secondary container labeling 
(see proposed Sec.  201.405(a)).
    In accordance with the definition of ``label'' in section 201(k) of 
the FD&C Act, information on the label must also appear on an outside 
container or wrapper of the retail package, if it exists, or be easily 
legible through the outside container or wrapper. For purposes of these 
proposed regulations, FDA considers the secondary container to be an 
``outside container or wrapper of the retail package'' for new animal 
drugs. Therefore, if a secondary container exists, the proposed rule 
would require the secondary container labeling to include all 
information that would be on the label in accordance with proposed 
Sec.  201.405(b) or (c), unless the information on the label is easily 
legible through the secondary container (see proposed Sec.  201.405(a) 
and (d)).
    Shipping labeling is associated with the outermost carton 
containing a new animal drug, which is intended for shipping, but not 
displaying the product. The proposed rule would establish content and 
format requirements for the shipping labeling of approved or 
conditionally approved Rx new animal drugs, including a requirement 
that such shipping labeling identify the new animal drug, the 
manufacturer, and drug storage and handling information. However, 
approved or conditionally approved Rx new animal drugs that are 
controlled substances would not include information that identifies the 
drug, in accordance with Sec.  1301.74(e) (21 CFR 1301.74(e)), to guard 
against storage or in-transit losses (see proposed Sec.  201.405(e)).
    Depending on how a sponsor intends to sell or display an approved 
or conditionally approved Rx new animal drug, there may be other 
containers such as display cartons and multiple unit (multi-unit) 
cartons that contain immediate containers or secondary containers. 
These containers may be packaged in shipping cartons. The proposed rule 
would establish content and format requirements for the labeling of 
these other containers for Rx new animal drugs (see proposed Sec.  
201.405(f)).
    Labeling sections and subsections for Rx new animal drugs would not 
be numbered. Headings of sections and subsections that would be 
required to appear verbatim on labeling are identified in the proposed 
regulations in quotations. Similarly, certain other labeling text would 
be required to appear verbatim on labeling; this text is also 
identified in the proposed regulations in quotations.
    The proposed rule would require the labeling of approved or 
conditionally approved Rx new animal drugs to comply with other 
applicable requirements in proposed subpart H (see proposed Sec.  
201.405).
1. Labeling Providing Full Prescribing Information (Proposed Sec.  
201.405(a))
    FDA uses the term ``full prescribing information'' to identify all 
information necessary for the safe and effective use of approved or 
conditionally approved Rx new animal drugs. The proposed rule would 
establish content and format requirements for the component of labeling 
that provides full prescribing information for approved or 
conditionally approved Rx new animal drugs (see proposed Sec.  
201.405(a)).
    If a package insert is provided with an approved or conditionally 
approved Rx new animal drug, the proposed rule would require the 
package insert to include full prescribing information (see proposed 
Sec.  201.405(a)). If a package insert is provided with an approved or 
conditionally approved Rx new animal drug, any secondary container 
labeling would be required to comply with proposed Sec.  201.405(d).
    If a package insert is not provided with an approved or 
conditionally approved Rx new animal drug, then secondary container 
labeling would be required, and the secondary container labeling would 
be required to provide full prescribing information (see proposed Sec.  
201.405(a)). If full prescribing information is provided on the 
secondary container labeling, in accordance with section 201(k) of the 
FD&C Act, proposed Sec.  201.405(a) would allow the secondary container 
labeling to exclude any portions of full prescribing information that 
would be required to appear on the label if such information is easily 
legible through the secondary container (see proposed in Sec.  
201.405(d)).
    The proposed rule would require the following information to be 
presented in full prescribing information for approved or conditionally 
approved Rx animal drugs and in the following order:
    a. Drug product identification. The proposed rule would require 
this section of full prescribing information to include the proprietary 
name of the finished drug product and the established name of the drug 
product. If not included as part of the established name of the drug 
product, the route(s) of administration and dosage form of the finished 
drug product would be required to be included in this section as well 
(see proposed Sec.  201.405(a)(1)(i) through (iv)).
    The established name and strength or concentration of each active 
ingredient would also be required. The strength or concentration of 
each active ingredient would be allowed to be excluded from full 
prescribing information provided on a package insert if the package 
insert applies to multiple strengths or concentrations for the same Rx 
new animal drug (see proposed Sec.  201.405(a)(1)(v)).
    If FDA determines that identifying the pharmacological class of an 
Rx new animal drug on labeling would be helpful in facilitating its 
safe and effective use by the prescribing veterinarian, the proposed 
rule would require that the pharmacological class be included in this 
section of full prescribing information (see proposed Sec.  
201.405(a)(1)(vi)).
    For Rx new animal drugs that are controlled substances, symbols 
provided in part 1302 (21 CFR part

[[Page 18273]]

1302) to identify the controlled substance schedule would also appear 
in this section of full prescribing information. See proposed Sec.  
201.405(a)(1)(vii).
    Prescription statement. The proposed rule would require this 
section of full prescribing information to include the prescription 
statement, ``Caution: Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.'' Prescription new animal drugs 
are limited to use under the professional supervision of a licensed 
veterinarian (section 503(f)(1)(A) of the FD&C Act). The prescription 
statement would indicate that the Rx new animal drug is restricted to 
use by or under the order of a licensed veterinarian. Including the 
prescription statement on full prescribing information would be 
consistent with its inclusion on the label for Rx new animal drugs, 
which is required by section 503(f)(4) of the FD&C Act. The requirement 
for including the prescription statement as part of full prescribing 
information is proposed under the authority granted to FDA under 
sections 502(a), 201(n), and 701(a) of the FD&C Act. See proposed Sec.  
201.405(a)(2).
    c. Conditional approval statement. For conditionally approved Rx 
new animal drugs, the proposed rule would require this section of full 
prescribing information to include, in accordance with section 
571(f)(1)(A) of the FD&C Act, the statement indicating conditional 
approval by FDA and the application number: ``conditionally approved by 
FDA pending a full demonstration of effectiveness under application 
number [insert number]''. This statement would be required to be 
prominent and conspicuous (see proposed Sec.  201.405(a)(3)).
    d. Boxed warnings. For Rx new animal drugs requiring boxed 
warnings, the proposed rule would require this section of full 
prescribing information to include the boxed warnings. Boxed warnings 
convey the most significant risks associated with the use of a Rx new 
animal drug. If applicable to the product, they would appear at this 
prominent location. An upper case ``WARNING'' heading would be included 
in the box, and the box, heading, and contents would be bolded. The 
boxed warning would be brief, with reference to more detailed 
information in other sections of full prescribing information if 
applicable (see proposed Sec.  201.405(a)(4)).
    e. Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use, in accordance with Sec.  530.41 
(21 CFR 530.41), the proposed rule would require this section of full 
prescribing information to include an extralabel use prohibition 
statement that begins with the phrase: ``Federal law prohibits the 
extralabel use of this drug . . .'' and concludes with a description of 
the prohibition as described in Sec.  530.41 (see proposed Sec.  
201.405(a)(5)). For example, ``Federal law prohibits the extralabel use 
of this drug in lactating dairy cows.''
    Certain new animal drugs are prohibited from extralabel use in some 
or all animals, in accordance with Sec.  530.41. This information is 
critical for inclusion on labeling. If a user fails to comply with an 
extralabel use prohibition statement, there could be serious safety 
consequences for the target animal, or in the case of a food-producing 
animal, also for humans consuming food derived from the target animal.
    f. ``Description.'' The proposed rule would require this section of 
full prescribing information to have the heading ``Description,'' 
followed by a description of the new animal drug. The description would 
include the proprietary name of the finished drug product and 
established name of the drug product, and the route(s) of 
administration and dosage form if not included as part of the 
established name. The description would also include identifying 
characteristics of the dosage form, such as color, shape, coating, 
scoring, and imprinting. All approved and available strengths or 
concentrations of the new animal drug to which full prescribing 
information applies would need to be identified in this section of full 
prescribing information. If the drug product was sterile, this fact 
would also be identified in this section of full prescribing 
information (see proposed Sec.  201.405(a)(6)).
    The established name of each inactive ingredient would be required 
to be included in the ``Description'' section of full prescribing 
information. The proposed rule would require all inactive ingredients 
to be listed in decreasing order of predominance, by weight or 
concentration (see proposed Sec.  201.405(a)(6)(viii)). FDA believes 
that listing inactive ingredients in decreasing order of predominance 
based on either weight or concentration would provide the most 
clinically useful information to users.
    In accordance with section 502(e)(1)(A)(iii) of the FD&C Act, the 
proposed rule would not require the listing of inactive ingredients on 
full prescribing information under circumstances that would result in 
disclosure of trade secret information. Therefore, where sponsors 
believe the listing of inactive ingredients on product labeling would 
result in disclosure of trade secret information, they would be able to 
request exemption from this labeling requirement under proposed Sec.  
201.411. If an exemption from the listing of inactive ingredients to 
avoid divulgence of trade secret information is granted under Sec.  
201.411, this section of full prescribing information would be required 
to state: ``Certain inactive ingredients are not listed to avoid 
disclosing trade secret information.'' (see proposed Sec.  
201.405(a)(6)(viii)(A)).
    Section 502(e)(1)(B) of the FD&C Act allows an exemption from 
listing inactive ingredients on the label of Rx drugs if doing so would 
be impracticable. The current regulations at Sec.  201.105(b)(5) for Rx 
animal drugs state that names of flavorings, perfumes, certain color 
additives, and ``trace amounts of harmless substances added solely for 
individual product identification'' may be exempt from listing on the 
labels for products other than for oral use. The regulations at Sec.  
201.105 predate the requirements in section 502(e)(1)(B) of the FD&C 
Act and are outdated. The proposed rule would replace the requirements 
for labels for approved or conditionally approved Rx new animal drugs 
currently provided in Sec.  201.105(b) with the requirements in 
proposed Sec.  201.405(b) and (c) (see discussion in section V.D.2. and 
3). Thus, the labels for approved or conditionally approved Rx new 
animal drugs would no longer qualify for the exemptions currently 
identified in Sec.  201.105(b)(5).
    If under proposed Sec.  201.411 FDA grants an exemption from 
listing inactive ingredients because their listing would be 
impracticable, this section of full prescribing information would need 
to state the following: ``Certain inactive ingredients are not listed 
because their listing would be impracticable.'' (see proposed Sec.  
201.405(a)(6)(viii)(B)).
    g. ``Indications for Use.'' This section of full prescribing 
information would be required to have the heading ``Indications for 
Use,'' followed by the approved or conditionally approved indication(s) 
and target animal(s) in the following format: ``For [indication(s)] in 
[target animal(s)]'' (see proposed Sec.  201.405(a)(7)(i)).
    Consistent with regulations for the labeling of Rx human products 
in Sec.  201.57(c)(2)(i)(A), if a Rx new animal drug is approved or 
conditionally approved for use only under specific conditions, e.g., in 
conjunction with a primary mode of therapy, special diet, surgery, 
behavioral modification, or some other drug, the proposed rule

[[Page 18274]]

would require that this information be specified in the ``Indications 
for Use'' section of full prescribing information (see proposed Sec.  
201.405(a)(7)(ii)).
    If, in approving or conditionally approving an application, FDA 
requires, for safety and/or effectiveness reasons, a statement(s) on 
labeling identifying animals for which the Rx new animal drug has not 
been approved or conditionally approved, the proposed rule would 
require that statement(s) to appear in the ``Indications for Use'' 
section of full prescribing information (see proposed Sec.  
201.405(a)(7)(iii)). We currently require the statement(s) proposed in 
Sec.  201.405(a)(7)(iii) to appear on labeling of some approved new 
animal drugs, particularly new animal drugs for use in food-producing 
animals, to clarify the target animal for which the drug is approved. 
The statements are typically required if we determine that unapproved 
use of a drug in animals similar to the target animal(s) is reasonably 
foreseeable and we believe that inclusion of such a statement on the 
labeling of the new animal drug could increase the safe and effective 
use of the drug. For example, feedlot beef cattle are not intended to 
provide milk for human consumption. Therefore, we will not likely 
require an evaluation of the human food safety of a new animal drug in 
lactating dairy cows if the new animal drug is only to be approved for 
use in feedlot cattle. However, we will often require a statement on 
labeling that the drug is not for use in lactating dairy cows intended 
to produce milk for human consumption to avoid use of the drug in this 
unapproved and unevaluated manner.
    The statement(s) proposed in Sec.  201.405(a)(7)(iii) is not 
intended to prohibit extralabel use of approved new animal drugs 
allowed under specific circumstances, in accordance with section 
512(a)(4) of the FD&C Act and part 530 (21 CFR part 530), but would 
help to clarify that some specific uses are extralabel and have not 
been evaluated for safety and effectiveness by FDA. Currently, there is 
no uniform place on the labeling for new animal drugs for such 
statements to appear. If we require such statements on labeling to 
ensure safe and effective use of a new animal drug, the proposed rule 
would require the statements to be placed within the ``Indications for 
Use'' section of full prescribing information. Inclusion of such 
statements in the ``Indications for Use'' section would not necessarily 
preclude also including similar statements in other sections or 
subsections of full prescribing information if warranted. For example, 
it may be appropriate to include a similar statement as a residue 
warning statement in the ``Withdrawal Periods and Residue Warnings'' 
subsection to expand upon human food safety risks of the extralabel use 
of the new animal drug in animals other than the target animal.
    h. ``Dosage and Administration.'' The proposed rule would require 
this section of full prescribing information to have the heading 
``Dosage and Administration,'' followed by the dosage and 
administration information for the new animal drug for each indication 
and target animal (see proposed Sec.  201.405(a)(8)).
    Sometimes FDA requires additional labeling for Rx new animal drugs 
that provides important information for the animal owner or person 
treating the animal. If such additional labeling is required, the 
proposed ``Dosage and Administration'' section of full prescribing 
information would advise the veterinarian to provide the additional 
labeling to the animal owner or person treating the animal (see 
proposed Sec.  201.405(a)(8)(i)).
    The remainder of this section of full prescribing information would 
be required to include information necessary for treatment of the 
animal with the Rx new animal drug in accordance with FDA approval or 
conditional approval, including: route(s) of administration and 
specific site(s) of administration, if applicable; dose or dose range; 
intervals between doses, if applicable; and duration of treatment. For 
some injectable products, FDA may require a statement of the maximum 
volume per injection site to facilitate the drug's safe and effective 
use, and the proposed rule would require this information to be 
included in this section of full prescribing information. Also, certain 
animal populations may require modifications to the dosage and 
administration for safe and effective use. These modifications would be 
required to appear in this section of full prescribing information. 
Other required dosage and administration information would also be 
included in this section of full prescribing information. See proposed 
Sec.  201.405(a)(8).
    i. ``Contraindications.'' For Rx new animal drugs with 
contraindications, the proposed rule would require this section of full 
prescribing information to have the heading ``Contraindications,'' 
followed by the contraindications (see proposed Sec.  201.405(a)(9)). 
As defined in proposed Sec.  201.403, a contraindication would include 
any situation in which the new animal drug should not be used because 
the risk of use clearly outweighs any possible benefit to the animal 
and includes only known hazards.
    j. ``Warnings and Precautions.'' The proposed rule would require 
this section of full prescribing information for all approved or 
conditionally approved Rx new animal drugs, and it would have the 
heading ``Warnings and Precautions'' (see proposed Sec.  
201.405(a)(10)). As defined in proposed Sec.  201.403, warnings would 
describe any serious adverse reactions or potential hazards associated 
with the use of the new animal drug. In addition, precautions would be 
defined as any special care to be exercised for safe and effective use 
of the new animal drug, which may include recommended screening, 
monitoring, or diagnostic tests. Multiple subsections, if applicable, 
would be included in the ``Warnings and Precautions'' section of full 
prescribing information as described below and in the following order, 
and the warnings and precautions would be provided in the applicable 
subsection:
    i. ``Withdrawal Periods and Residue Warnings'' or ``Withdrawal 
Periods.'' All Rx new animal drugs approved or conditionally approved 
for use in food-producing animals would be required to have as the 
first subsection of the ``Warnings and Precautions'' section of full 
prescribing information a subsection entitled either ``Withdrawal 
Periods and Residue Warnings'' or ``Withdrawal Periods'' (see proposed 
Sec.  201.405(a)(10)(i)). This subsection would provide all human food 
safety warnings, including milk discard times, withdrawal periods, and 
residue warning statements, as applicable to the new animal drug.
    As defined in proposed Sec.  201.403, a withdrawal period is the 
interval between the time of the last administration of a new animal 
drug and the time when the animal can be safely slaughtered for food. 
Withdrawal periods apply to all food-producing animals. As defined in 
proposed Sec.  201.403, a milk discard time is the interval between the 
time of the last administration of a new animal drug and the time when 
the milk can be safely consumed. Milk discard times apply to female 
animals that produce milk for human consumption. A new animal drug 
approved for use in female animals that produce milk for human 
consumption may have both a milk discard time and a withdrawal period.
    As defined in proposed Sec.  201.403, a residue warning statement 
warns against the use of the new animal drug in animals for which the 
withdrawal period and/or milk discard time has not been determined, 
and/or provides other

[[Page 18275]]

information to prevent illegal drug residues in food products from 
animals treated with the new animal drug.
    If there are any residue warning statements for the new animal 
drug, the proposed rule would require this subsection of full 
prescribing information to have the title ``Withdrawal Periods and 
Residue Warnings.'' If there are no residue warning statements 
associated with the new animal drug, this subsection of full 
prescribing information would be required to have the title 
``Withdrawal Periods'' (see proposed Sec.  201.405(a)(10)(i)(A)).
    If the new animal drug is approved or conditionally approved for 
use in food-producing animals excluding female animals that produce 
milk for human consumption, the proposed rule would require this 
subsection of full prescribing information to include the withdrawal 
period(s) followed by any residue warning statements (see proposed 
Sec.  201.405(a)(10)(i)(B)).
    If the new animal drug is approved or conditionally approved for 
use in food-producing animals excluding female animals that produce 
milk for human consumption and there is no withdrawal period, the 
proposed rule would require this subsection of full prescribing 
information to state, ``No withdrawal period is required when used 
according to labeling.'' This statement would be followed by any 
residue warnings statements (see proposed Sec.  201.405(a)(10)(i)(C)).
    If the new animal drug is approved or conditionally approved for 
use in female animals that produce milk for human consumption, the 
proposed rule would require this subsection of full prescribing 
information to include the milk discard time(s), followed by the 
withdrawal period(s), followed by any residue warning statements (see 
proposed Sec.  201.405(a)(10)(i)(D)).
    If the new animal drug is approved or conditionally approved for 
use in female animals that produce milk for human consumption, and 
there is a milk discard time(s) but no withdrawal period, the proposed 
rule would require this subsection of full prescribing information to 
include the milk discard time(s), followed by the statement, ``No 
withdrawal period is required when used according to labeling.'' This 
statement would be followed by any residue statements (see proposed 
Sec.  201.405(a)(10)(i)(E)).
    If the new animal drug is approved or conditionally approved for 
use in female animals that produce milk for human consumption and there 
is no milk discard time but there is a withdrawal period(s), the 
proposed rule would require this subsection of full prescribing 
information to include the withdrawal period(s), followed by the 
statement, ``No milk discard time is required when used according to 
labeling.'' This statement would be followed by any residue warnings 
statements (see proposed Sec.  201.405(a)(10)(i)(F)).
    If the new animal drug is approved or conditionally approved for 
use in female animals that produce milk for human consumption and there 
is no milk discard time and no withdrawal period, the proposed rule 
would require this subsection of full prescribing information to state, 
``No milk discard time and no withdrawal period is required when used 
according to labeling.'' This statement would be followed by any 
residue warnings statements (see proposed Sec.  201.405(a)(10)(i)(G)).
    Currently, new animal drugs approved for use in food-producing 
animals that have no milk discard time and/or withdrawal period may or 
may not indicate this information on labeling. If this information is 
not provided on labeling, potentially it could be confusing to the user 
of the new animal drug as to whether or not there is a milk discard 
time or withdrawal period for the new animal drug. Requiring this 
subsection of full prescribing information for all new animal drugs 
approved or conditionally approved for use in food-producing animals, 
and requiring a statement, if appropriate, to indicate that there is no 
milk discard time or withdrawal period when the new animal drug is used 
according to labeling, will better ensure the safe use of animal drugs 
in food-producing animals.
    To further highlight for users this critical subsection of full 
prescribing information, the title of this subsection and all 
information in this subsection would be required to be centered and 
placed entirely within compressed arrows, in accordance with proposed 
Sec.  201.404(g)(8). The compressed arrows would be black for package 
inserts, or a color that clearly contrasts from background colors for 
other approved labeling (see proposed Sec.  201.405(a)(10)(i)(A)). 
Currently, the compressed arrows are used voluntarily, although not 
consistently, on the labeling for many new animal drugs approved for 
use in food-producing animals. Currently other statements not 
associated with human food safety may also appear within the compressed 
arrows. The proposed rule would limit the use of compressed arrows to 
the subsection entitled either ``Withdrawal Periods and Residue 
Warnings'' or ``Withdrawal Periods'' (see proposed Sec.  
201.404(g)(6)), which would only contain human food safety information.
    ii ``User Safety Warnings.'' The proposed rule would require this 
subsection of the ``Warnings and Precautions'' section of full 
prescribing information to have the heading ``User Safety Warnings,'' 
followed by the user safety warnings. As defined in proposed Sec.  
201.403, a user safety warning would be a warning that identifies 
serious adverse reactions or potential hazards to human health 
associated with human exposure during use of a new animal drug via 
contact, inhalation, ingestion, injection, or by other means. This 
information would be required to prevent or decrease the risk of harm 
to humans.
    The first statements that would be included in this subsection of 
full prescribing information are: ``Not for use in humans. Keep out of 
reach of children.'' The subsection would next list all additional user 
safety warnings listed in decreasing order of severity or frequency. 
The final information that would be included in this subsection of full 
prescribing information would be a sentence explaining how to obtain 
Safety Data Sheet(s) for the drug. Chemical manufacturers, 
distributors, and/or importers are required pursuant to 29 CFR 
1910.1200(g) to provide Safety Data Sheets for each hazardous chemical 
to downstream users to communicate information on these hazards. Safety 
Data Sheets include information such as the properties of each 
chemical; their physical, health, and environmental health hazards; 
protective measures; and safety precautions for handling, storing, and 
transporting the chemical. The sentence in this subsection of full 
prescribing information would be required to be formatted as follows: 
``To obtain a Safety Data Sheet(s), contact [insert name of 
manufacturer] at [insert manufacturer's telephone number] or [insert 
manufacturer's website].'' See proposed Sec.  201.405(a)(10)(ii).
    iii. ``Animal Safety Warnings and Precautions.'' For Rx new animal 
drugs with target animal safety warnings and precautions, the proposed 
rule would require this subsection of the ``Warnings and Precautions'' 
section of full prescribing information to have the heading ``Animal 
Safety Warnings and Precautions,'' followed by the target animal safety 
warnings and precautions (see proposed Sec.  201.405(a)(10)(iii)). 
Target animal safety warnings identify any serious adverse reactions or 
potential hazards to the target animal(s) associated with the use of 
the new animal drug. Precautions for Rx new

[[Page 18276]]

animal drugs often include recommendations for specific screening, 
monitoring, diagnostic tests, or special care that should be taken by 
the prescribing veterinarian for safe and effective use of the new 
animal drug (see definition in proposed Sec.  201.403). The heading of 
the subsection would include the term ``animal safety warnings'', i.e., 
``Animal Safety Warnings and Precautions,'' because we believe the term 
``animal safety warnings'' is more familiar to users of Rx new animal 
drugs than ``target animal safety warnings.''
    Precautions are sometimes difficult to distinguish from target 
animal safety warnings. Currently, target animal safety warnings and 
precautions are sometimes presented separately on the labeling for Rx 
new animal drugs. However, because the two sets of information are 
often closely related, it is advantageous to combine them into one 
subsection of full prescribing information.
    Warnings and precautions are combined in the ``Highlights'' and 
``Full Prescribing Information'' for human Rx drugs and biologics (see 
Sec. Sec.  201.56 and 57). Similarly, combining target animal safety 
warnings and precautions in the ``Animal Safety Warnings and 
Precautions'' subsection of full prescribing information would be less 
burdensome for sponsors of Rx new animal drugs because sponsors would 
not be required to distinguish one from the other.
    iv. ``Environmental Warnings.'' For approved or conditionally 
approved new animal drugs that have environmental warnings, the 
proposed rule would require this subsection of the ``Warnings and 
Precautions'' section of full prescribing information to have the 
heading ``Environmental Warnings,'' followed by the environmental 
warnings (see proposed Sec.  201.405(a)(10)(iv)). FDA's regulations at 
21 CFR part 25 implementing the National Environmental Policy Act 
(NEPA), 42 U.S.C. 4321 et seq., address the environmental impact 
considerations required for products regulated by FDA, including new 
animal drugs. Under NEPA, the responsible Agency official examines the 
environmental risks of the proposed action and the alternative courses 
of action, selects a course of action, and ensures that any necessary 
mitigating measures are implemented as a condition for approving the 
selected course of action (see 21 CFR 25.40(e)). In some instances, 
sponsors may choose to include environmental warnings on the labeling 
for their new animal drugs as a means to mitigate or reduce the 
potential for environmental impacts to occur from the use or disposal 
of the drug (see 21 CFR 25.45). These warnings would generally include 
information to prevent or decrease the risk of any environmental 
effects. The proposed rule would require any environmental warnings 
applicable to the new animal drug that are included in an approved or 
conditionally approved application be provided in this subsection of 
full prescribing information (see proposed Sec.  201.405(a)(10)(iv)).
    v. ``Other Warnings.'' For new animal drugs having warnings not 
more appropriately placed in other ``Warnings and Precautions'' 
subsections, the proposed rule would require the last subsection of the 
``Warnings and Precautions'' section of full prescribing information to 
have the heading ``Other Warnings,'' followed by those warnings (see 
proposed Sec.  201.405(a)(10)(v)).
    k. ``Adverse Reactions.'' For Rx new animal drugs that we determine 
have adverse reactions, this section of full prescribing information 
would be required to have the heading ``Adverse Reactions,'' followed 
by the adverse reactions (see proposed Sec.  201.405(a)(11)). Adverse 
reactions would be defined in proposed Sec.  201.403 as undesirable 
effects, reasonably associated with the use of the drug product, that 
may occur as part of the pharmacological action of the drug or that may 
be unpredictable in occurrence. The proposed rule would require this 
section of full prescribing information to include adverse reactions 
that occur with use of the Rx new animal drug and with use of drugs in 
the same pharmacologically active and chemically related classes, if 
applicable. Furthermore, we may require additional information as 
necessary for the prescribing veterinarian to interpret the adverse 
reactions, such as the total number of animals exposed to the drug and 
the extent and nature of exposure.
    The proposed rule would also require that adverse reactions be 
presented within the following categories, as applicable, in decreasing 
order of severity or frequency: preapproval experience, foreign market 
experience known prior to U.S. approval for drugs also commercially 
marketed outside of the United States, and post-approval experience 
(see proposed Sec.  201.405(a)(11)). For previously approved Rx new 
animal drugs for which the labeling would be updated in accordance with 
the schedule provided in this rule, if the preapproval experience and/
or foreign market experience categories were not included on full 
prescribing information when the drug was approved, we may allow one or 
both of these subsections to be excluded from the ``Adverse Reactions'' 
section of full prescribing information if we determine that including 
such information is not necessary to ensure the safe and effective use 
of the drug. Post-approval experience would typically be added to 
labeling of the drug after it has been approved in the United States 
and if additional adverse drug experiences (as defined by Sec.  514.3) 
associated with the use of the drug have been identified.
    l. ``Contact Information.'' The proposed rule would require this 
section of full prescribing information to have the heading ``Contact 
Information,'' followed by the sponsor's contact information for 
veterinarians or consumers to facilitate requesting additional 
information or to report suspected adverse drug experiences. FDA's 
contact information for voluntary reporting of adverse drug experiences 
for animal drugs would also be required. Requiring contact information 
on new animal drug labeling increases the likelihood that a user will 
report adverse drug events to the sponsor and/or to the Center for 
Veterinary Medicine (CVM). Increasing the likelihood of receiving 
adverse drug event reports would allow new animal drug sponsors and CVM 
to better monitor and detect emerging safety issues with approved or 
conditionally approved new animal drugs on the market. Any increase in 
adverse drug event reporting and monitoring resulting from this 
proposed requirement would benefit both animal and human health.
    The sponsor's contact information would be the name of the 
manufacturer, packer, or distributor, whichever is identified in the 
``Name and place of business'' section of full prescribing information 
per proposed Sec.  201.405(a)(22). If more than one business is 
identified in the ``Name and place of business'' section of full 
prescribing information, the drug sponsor would select the most 
appropriate of these businesses to use in the ``Contact Information'' 
section to provide additional information about the Rx new animal drug 
and to contact regarding suspected adverse drug experiences.
    The statements in this section of full prescribing information 
would be required to be structured as follows: ``Contact [insert name 
of business] at [insert business telephone number] or [insert business 
web address]. To report suspected adverse drug experiences, contact 
[insert name of business] at [insert business telephone number]. For 
additional information about reporting adverse drug experiences for 
animal drugs, contact FDA at [insert current

[[Page 18277]]

FDA telephone number for voluntary reporting of adverse drug 
experiences] or [insert current FDA web address for voluntary reporting 
of adverse drug experiences].'' See proposed Sec.  201.405(a)(12). 
Sponsors can search FDA's website or contact FDA by telephone to find 
the current FDA telephone number and web address for voluntary 
reporting of adverse drug experiences for animal drugs.
    m. ``Information for Animal Owner.'' For Rx new animal drugs 
required to have additional information to be communicated by the 
prescribing veterinarian to the animal owner or person treating the 
animal to ensure safe and effective use of the Rx new animal drug, the 
proposed rule would require this section of full prescribing 
information to have the heading ``Information for Animal Owner,'' 
followed by the specific information.
    For some new animal drugs, FDA may determine it is necessary for 
sponsors to provide the animal owner or person treating the animal with 
additional labeling, such as a ``client information sheet,'' to ensure 
the safe and effective use of the Rx new animal drug. If we determine 
that such additional labeling is necessary, a printed copy of the 
additional labeling would be required to be attached to or accompany 
the package insert or secondary container labeling if no package insert 
is provided. See proposed Sec.  201.405(a)(13).
    n. ``Clinical Pharmacology.'' For Rx new animal drugs required to 
include clinical pharmacology information on labeling, the proposed 
rule would require this section of full prescribing information to have 
the heading ``Clinical Pharmacology,'' followed by the clinical 
pharmacology information for the Rx new animal drug in the target 
animal(s). The required information would be relevant for understanding 
the relationship between dose, systemic drug exposure, safety, and 
clinical effectiveness. This information may help the prescribing 
veterinarian to predict how the Rx new animal drug would perform in the 
different animal patient populations likely to be encountered under 
clinical use conditions. This section of full prescribing information 
would be required to include the following three separate subsections, 
as applicable to the Rx new animal drug: ``Mechanism of action,'' 
``Pharmacodynamics,'' and ``Pharmacokinetics'' (see proposed Sec.  
201.405(a)(14)).
    o. ``Microbiology.'' For antimicrobial Rx new animal drugs, the 
proposed rule would require this section of full prescribing 
information to have the heading ``Microbiology,'' followed by a 
description of microbiologic data associated with the studies used to 
support the effectiveness of the drug against the indicated pathogens. 
The microbiology data would be required to be restricted to organisms 
named in the approved or conditionally approved indications.
    If in vitro data for antimicrobial new animal drugs are included in 
this section of full prescribing information and the data have not been 
correlated to clinical effectiveness, then such in vitro data would be 
required to be immediately preceded by the following statement: ``The 
following in vitro data are available, but their clinical significance 
is unknown.'' See proposed Sec.  201.405(a)(15).
    p. ``Target Animal Safety.'' The proposed rule would require this 
section of full prescribing information to have the heading ``Target 
Animal Safety,'' followed by a summary of the basis for the conclusion 
that the new animal drug is safe in the target animal(s) when used as 
approved or conditionally approved (see proposed Sec.  201.405(a)(16)).
    q. ``Effectiveness.'' The proposed rule would require this section 
of full prescribing information to have the heading ``Effectiveness,'' 
followed by a summary of the basis for the conclusion that the new 
animal drug is effective in the target animal(s) when used as approved. 
For conditionally approved drugs, the ``Effectiveness'' section of full 
prescribing information would be required to include a summary of the 
basis for the reasonable expectation of effectiveness (see proposed 
Sec.  201.405(a)(17)).
    r. ``Net Contents.'' The proposed rule would require this section 
of full prescribing information, when presented on the secondary 
container labeling, to have the heading ``Net Contents,'' followed by 
the contents of the secondary container. The proposed rule would 
exclude a ``Net Contents'' section from package inserts (see proposed 
Sec.  201.405(a)(18)).
    s. ``How Supplied.'' The proposed rule would require this section 
of full prescribing information to have the heading ``How Supplied,'' 
followed by information on available drug strengths, concentrations, 
and container sizes to which the labeling applies. The information in 
this section would be required to be revised if new strengths, 
concentrations, or container sizes are added (see proposed Sec.  
201.405(a)(19)).
    t. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of full prescribing information to have the 
heading ``Storage, Handling, and Disposal'' (see proposed Sec.  
201.405(a)(20)). Drug storage information would be included in this 
section and may include, for example, required temperature, humidity, 
and/or light exposure conditions to maintain the potency of the Rx new 
animal drug until its established expiration date. Also, any handling 
and drug disposal information that we determine to be necessary for 
safe and effective use of the Rx new animal drug would be included in 
this section. Handling information may include, for example, 
recommendations to reseal reusable bottles promptly after opening and 
conditions necessary to maintain potency of reconstituted new animal 
drugs. Drug disposal information may include, for example, instructions 
on disposal of unused portions of new animal drugs remaining after 
treatment, as well as used needles and/or syringes.
    u. NADA/ANADA approval statement. In accordance with section 
502(w)(3) of the FD&C Act, by no later than September 30, 2023, 
approved new animal drugs must include the following statement on 
labeling: ``Approved by FDA under NADA # xxx-xxx''. By no later than 
September 30, 2023, approved generic Rx new animal drugs must include 
the following statement on labeling: ``Approved by FDA under ANADA # 
xxx-xxx''. For approved Rx new animal drugs, the proposed rule would 
require this section of full prescribing information to include the 
``NADA approval statement,'' indicating the product's NADA number and 
that it was approved by FDA. For approved generic Rx new animal drugs 
that would be covered by these regulations (i.e., those that reference 
an NADA that has been withdrawn for reasons other than safety or 
effectiveness or under section 512(e) of the FD&C Act and the ANADA's 
approval was not affected by the withdrawal), the proposed rule would 
require this section of full prescribing information to include the 
``ANADA approval statement.'' The proposed rule would establish format 
requirements for the approval statement and would require that the 
approval statement not be so prominent as to obscure other required 
information. The approval statement could not be incorporated into a 
seal, stamp, logo, or graphic. See proposed Sec.  201.405(a)(21).
    v. Name and place of business. The proposed rule would require this 
section of full prescribing information to identify the name and place 
of business of the manufacturer, packer, or distributor (see proposed 
Sec.  201.405(a)(22)).
    w. ``Lot Number and Expiration Date.'' The proposed rule would 
require

[[Page 18278]]

this section of full prescribing information when provided on the 
secondary container labeling. Package inserts are excluded from this 
requirement because they might apply to multiple lots of secondary or 
immediate containers of the Rx new animal drug. When full prescribing 
information is provided on the secondary container labeling, this 
section would be required to have the heading ``Lot Number and 
Expiration Date,'' followed by the identifying lot or control number of 
the Rx new animal drug within the secondary container (see proposed 
Sec.  201.405(a)(23)). Should a problem be reported to FDA, a lot or 
control number would help us more easily to identify and trace back a 
specific lot of a product. The proposed rule would also require this 
section to include the expiration date of the Rx new animal drug within 
the secondary container, in accordance with Sec.  201.17 (21 CFR 
201.17). An expiration date better ensures that the new animal drug 
would not be used after it expires.
    Alternatively, the proposed rule would allow for this section of 
full prescribing information to refer to the location on the secondary 
container labeling or secondary container where the lot or control 
number and expiration date are printed (see proposed Sec.  
201.405(a)(23)). As an example, if the lot number and expiration date 
are printed on the bottom flap of a secondary container, then the 
secondary container labeling may state in this section, ``See carton 
bottom flap for lot number and expiration date.'' However, in 
accordance with Sec.  201.17, the proposed rule would allow an 
expiration date to be excluded from the secondary container labeling or 
secondary container if the expiration date provided on the label or 
immediate container is easily legible through the secondary container.
    x. ``Revision Date.'' The proposed rule would require this section 
of full prescribing information to have the heading ``Revision Date,'' 
followed by the date of the most recent revision of the component of 
labeling that provides full prescribing information, listing the month 
followed by the year (see proposed Sec.  201.405(a)(24)). This 
information is important to ensure that the most current approved 
version of the labeling is being used.
2. Prescription New Animal Drug Label (Rx Label) (Proposed Sec.  
201.405(b))
    The proposed rule would establish content and format requirements 
for the information presented on the label for approved or 
conditionally approved Rx new animal drugs (Rx label) (see proposed 
Sec.  201.405(b)). As defined in proposed Sec.  201.403, ``label'' has 
the same meaning as given in section 201(k) of the FD&C Act, which 
defines the term ``label'' to mean a display of written, printed, or 
graphic matter upon the immediate container of any article. As defined 
in proposed Sec.  201.403, the immediate container means the container 
in contact with the new animal drug, and it excludes package liners.
    Proposed Sec.  201.405(b) would apply to Rx labels that are of 
adequate size to contain the proposed required information per that 
paragraph, whereas proposed Sec.  201.405(c) would apply to small 
labels for Rx new animal drugs that are not of adequate size to contain 
all the proposed required information in proposed Sec.  201.405(b).
    Prescription new animal drugs labels to which Sec.  201.405(b) 
would apply may consist of a single panel, a front panel and one side 
or back panel, or a front panel and multiple side and/or back panels, 
and the proposed rule would provide for such label designs (see Sec.  
201.405(b)). For Rx labels with a front panel and one side or back 
panel, the proposed rule would require certain information for the 
front panel (see proposed Sec.  201.405(b)(1)), and the side or back 
panel (see proposed Sec.  201.405(b)(2)). For Rx labels consisting of a 
single panel, the proposed rule would require the information 
identified in proposed Sec.  201.405(b)(1) followed by the information 
identified in proposed Sec.  201.405(b)(2), in order, on the single 
panel. For Rx labels with a front panel and multiple side and/or back 
panels, the information identified in proposed Sec.  201.405(b)(1) 
followed by the information identified in proposed Sec.  201.405(b)(2) 
would be required in order, starting on the front panel, continuing on 
the panel immediately to the right of the front panel, and continuing 
to fill the panels to the right until all of the information in 
proposed Sec.  201.405(b)(1) and (b)(2) was presented. In all 
instances, the information proposed in Sec.  201.405(b)(2)(iii) and 
(iv), i.e., ``Active Ingredient'' or ``Active Ingredients'' and 
``Inactive Ingredients,'' would need to appear on the same panel.
    a. Front panel. The proposed rule would require the following 
information to be presented on the front panel of the Rx label for an 
approved or conditionally approved Rx new animal drug and in the 
following order. Unless otherwise indicated, this information would be 
the same as that required by proposed Sec.  201.405(a) for full 
prescribing information.
    i. Drug product identification. The proposed rule would require 
this section of the Rx label to include drug product identification 
information (see proposed Sec.  201.405(b)(1)(i)). This information may 
help the user quickly and correctly identify the product and 
distinguish it from other, similar products. The information included 
in this section of the Rx label would include the same information as 
that in the drug product identification section of full prescribing 
information, as described in proposed Sec.  201.405(a)(1), in addition 
to a statement that the drug product is sterile, if applicable. Full 
prescribing information would require a drug product identification 
section and a ``Description'' section. Full prescribing information for 
sterile Rx new animal drugs would be required to identify in the 
``Description'' section that the drug is sterile. However, due to space 
limitations, no ``Description'' section is proposed for the Rx label. 
Instead, the drug product identification section of the Rx label for 
sterile Rx new animal drugs would be required to state that the drug 
product is sterile. See proposed Sec.  201.405(b)(1)(i).
    ii. Prescription statement. The proposed rule would require this 
section of the Rx label to include the prescription statement (see 
proposed Sec.  201.405(b)(1)(ii)). In accordance with section 503(f)(4) 
of the FD&C Act, all Rx new animal drugs must state on the label: 
``Caution: Federal law restricts this drug to use by or on the order of 
a licensed veterinarian.''
    iii. Conditional approval statement. For conditionally approved new 
animal drugs, the proposed rule would require this section of the Rx 
label to include a conditional approval statement, as described in 
proposed Sec.  201.405(a)(3) for full prescribing information (see 
proposed Sec.  201.405(b)(1)(iii)).
    iv. Boxed warnings. For approved or conditionally approved Rx new 
animal drugs requiring boxed warnings, the proposed rule would require 
this section of the Rx label to include the boxed warnings, as 
described in proposed Sec.  201.405(a)(4) for full prescribing 
information (see proposed Sec.  201.405(b)(1)(iv)).
    v. ``Indications for Use.'' The proposed rule would require this 
section of the Rx label to have the heading ``Indications for Use,'' 
followed by the ``Indications for Use'' section, as described in 
proposed Sec.  201.405(a)(7) for full prescribing information. If we 
determine that there is insufficient space on the Rx label for the 
complete ``Indications for Use'' section as described in proposed Sec.  
201.405(a)(7), then the proposed rule would require

[[Page 18279]]

the sponsor to include in this section of the Rx label the statement 
required in proposed Sec.  201.405(a)(7)(i), i.e., ``For 
[indication(s)] in [target animal(s)]''. If there is insufficient space 
on the Rx label for the statement in proposed Sec.  201.405(a)(7)(i), 
then an abbreviated version of the statement would be required: ``For 
[abbreviated indication(s)] in [target animal(s)]''. In either 
situation where there is insufficient space on the Rx label for the 
complete ``Indications for Use'' section as specified in proposed Sec.  
201.405(a)(7), the required statement would be followed by one of the 
following statements: ``See package insert for complete `Indications 
for Use' '' if full prescribing information is provided on a package 
insert; or ``See package labeling for complete `Indications for Use' '' 
if full prescribing information is provided on the secondary container 
labeling. See proposed Sec.  201.405(b)(1)(v).
    The complete ``Indications for Use'' section as described in 
proposed Sec.  201.405(a)(7) may exceed the available space on the Rx 
label if, for example, it includes specific conditions of use (proposed 
Sec.  201.405(a)(7)(ii)) or animals for which the new animal drug is 
not approved or conditionally approved (proposed Sec.  
201.405(a)(7)(iii)), and/or the indication(s) is lengthy and/or 
complex. For example, a new animal drug approved to treat and control 
multiple species of roundworms, lungworms, lice, and mites in beef 
cattle would ordinarily identify all of those species in the 
``Indications for Use'' section of the label. However, if space is 
insufficient on the Rx label to provide the identity of all of the 
species of the roundworms, lungworms, lice, and mites for which the 
drug is effective, an acceptable ``abbreviated'' version of the 
``Indications for Use'' section on the Rx label for this product might 
include, for example, ``For treatment and control of certain species of 
roundworms, lungworms, lice, and mites in beef cattle. See package 
insert for complete `Indications for Use'.''
    vi. Extralabel use prohibition statement. For approved Rx new 
animal drugs prohibited from extralabel use, in accordance with Sec.  
530.41, the proposed rule would require this section of the Rx label to 
include the extralabel use prohibition statement, as described in 
proposed Sec.  201.405(a)(5) for full prescribing information (see 
proposed Sec.  201.405(b)(1)(vi)).
    vii. ``Withdrawal Periods and Residue Warnings'' or ``Withdrawal 
Periods.'' For new animal drugs approved or conditionally approved for 
use in food-producing animals, the proposed rule would require this 
section of the Rx label to have the heading ``Withdrawal Periods and 
Residue Warnings'' or ``Withdrawal Periods,'' followed by all human 
food safety warnings, including milk discard times, withdrawal periods, 
and residue warning statements, as described in proposed Sec.  
201.405(a)(10)(i) for full prescribing information. If there is 
insufficient space on the front panel of Rx labels with only a front 
panel and one side or back panel, the proposed rule would require this 
section to be provided on the side or back panel of the Rx label 
immediately following the full prescribing information statement 
specified in proposed Sec.  201.405(b)(2)(i). See proposed Sec.  
201.405(b)(1)(vii).
    viii. ``Net Contents.'' The proposed rule would require this 
section of the Rx label to have the heading ``Net Contents,'' followed 
by the contents of the immediate container, in accordance with Sec.  
201.51 (see proposed Sec.  201.405(b)(1)(viii)).
    ix. NADA/ANADA approval statement. For approved new animal drugs or 
approved generic new animal drugs, the proposed rule would require this 
section of the Rx label to include the NADA or ANADA approval 
statement, as described in proposed Sec.  201.405(a)(21) for full 
prescribing information (see proposed Sec.  201.405(b)(1)(ix)).
    b. Side or back panel. The proposed rule would require the 
following information to be presented on the side or back panel of the 
Rx label for an approved or conditionally approved Rx new animal drug 
in the following order (see proposed Sec.  201.405(b)(2)). Unless 
otherwise indicated, this information would be the same as that 
required by proposed Sec.  201.405(a) for full prescribing information.
    i. Full prescribing information statement. The proposed rule would 
require this section of the Rx label to include one of two statements 
(see proposed Sec.  201.405(b)(2)(i)). If full prescribing information 
is provided on the package insert, the following statement would be 
used: ``Before using this drug, read package insert for full 
prescribing information.'' If full prescribing information is provided 
on the secondary container labeling, the following statement would be 
used: ``Before using this drug, read package labeling for full 
prescribing information.'' Because full prescribing information would 
not be provided on the Rx label, the purpose of the statements would be 
to remind the veterinarian to read full prescribing information before 
using the Rx new animal drug.
    ii. ``Dosage and Administration.'' The proposed rule would require 
this section of the Rx label to have the heading ``Dosage and 
Administration,'' followed by the ``Dosage and Administration'' 
section, as described in proposed Sec.  201.405(a)(8) for full 
prescribing information. If there is insufficient space on the Rx label 
for the complete requirements as specified in proposed Sec.  
201.405(a)(8), or if it is necessary for additional information 
provided in full prescribing information that is not provided on the Rx 
label to be read before administering the drug (e.g., complete warnings 
and precautions, contraindications, and/or target animal safety), then 
FDA may exclude this section from the Rx label (see proposed Sec.  
201.405(b)(2)(ii)). For example, with respect to the latter situation, 
if careful observation of the animal after dosing is advised to watch 
for adverse reactions, this information typically would be described in 
the ``Animal Safety Warnings and Precautions'' subsection, which would 
not be required on the Rx label but would be required on full 
prescribing information. Excluding the ``Dosage and Administration'' 
section from the Rx label in this situation helps to ensure that the 
veterinarian would read full prescribing information, which would 
include the ``Dosage and Administration'' section as well as the 
``Animal Safety Warnings and Precautions'' subsection, before treating 
the animal. Users would also be reminded to read full prescribing 
information before using the drug via the full prescribing information 
statement that would be required in the previous section of the Rx 
label by proposed Sec.  201.405(b)(2)(i).
    iii. ``Active Ingredient'' or ``Active Ingredients.'' The proposed 
rule would require this section of the Rx label to have the heading 
``Active Ingredient'' or ``Active Ingredients,'' followed by the 
established name and strength or concentration of each active 
ingredient. If the Rx new animal drug contains one active ingredient, 
the proposed rule would require this section of the Rx label to be 
entitled ``Active Ingredient.'' If the Rx new animal drug contains more 
than one active ingredient, the proposed rule would require this 
section of the Rx label to be entitled ``Active Ingredients.'' The 
requirement to provide established name and strength or concentration 
of each active ingredient on the Rx label would be consistent with the 
requirement for the established name and quantity or proportion of each 
active ingredient on the label of prescription drugs, in

[[Page 18280]]

accordance with section 502(e)(1)(A)(ii), (B), and (g) of the FD&C Act 
(see proposed Sec.  201.405(b)(2)(iii)). This information is currently 
required to be on the label for Rx animal drugs, in accordance with 
Sec.  201.105(b)(4). Proposed Sec.  201.405(b) and (c) would establish 
the content and format requirements for the label for approved or 
conditionally approved Rx new animal drugs and would replace the 
requirements for the label of approved or conditionally approved Rx new 
animal drugs currently provided in Sec.  201.105(b). Furthermore, Sec.  
201.105 would be amended to refer to proposed Sec.  201.405 for the 
content and format requirements for labeling components for approved or 
conditionally approved Rx new animal drugs.
    iv. ``Inactive Ingredients.'' The proposed rule would require this 
section of the Rx label to have the heading ``Inactive Ingredients,'' 
followed by the established name of each inactive ingredient, as 
described in proposed Sec.  201.405(a)(6)(viii) for full prescribing 
information (see proposed Sec.  201.405(b)(2)(iv)).
    v. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of the Rx label to have the heading ``Storage, 
Handling, and Disposal,'' followed by drug storage, handling, and 
disposal information, as described in proposed Sec.  201.405(a)(20) for 
full prescribing information (see proposed Sec.  201.405(b)(2)(v)).
    vi. Name and place of business. The proposed rule would require 
this section of the Rx label to identify the name and place of business 
of the manufacturer, packer, or distributor, as required in section 
502(b) of the FD&C Act (see proposed Sec.  201.405(b)(2)(vi)).
    vii. ``Lot Number and Expiration Date'' or ``Lot Number.'' The 
proposed rule would require this section of the Rx label to have the 
heading ``Lot Number and Expiration Date'' or ``Lot Number,'' followed 
by the identifying lot or control number of the Rx new animal drug 
within the immediate container (see proposed Sec.  201.405(b)(2)(vii)). 
A lot or control number would allow us to more easily identify and 
trace back a specific lot of a product should a problem be reported to 
FDA. We would also require this section of the Rx label to include the 
expiration date of the Rx new animal drug within the immediate 
container, in accordance with Sec.  201.17.
    An expiration date on the Rx label better ensures that the new 
animal drug would not be used after it expires. Alternatively, the 
proposed rule would allow for this section to refer to the location on 
the Rx label or immediate container where the lot or control number and 
expiration date are printed (see proposed Sec.  201.405(b)(2)(vii)). As 
an example, if the lot number and expiration date are printed at the 
top of the immediate container, then the Rx label may state in this 
section, ``See top of container for lot number and expiration date.'' 
If the immediate container provides a single dose of the Rx new animal 
drug and is packaged individually in a secondary container that 
provides an expiration date on the secondary container labeling or 
secondary container, the proposed rule would not require an expiration 
date on the Rx label or immediate container, in accordance with Sec.  
201.17. Under such provision, this section of the Rx label would be 
required to be entitled ``Lot Number.''
    viii. ``Revision Date.'' The proposed rule would require the last 
section of the Rx label to have the heading ``Revision Date,'' followed 
by the date of the most recent revision of the Rx label, listing the 
month followed by the year (see proposed Sec.  201.405(b)(2)(viii)).
3. Prescription New Animal Drug Small Label (Rx Small Label) (Proposed 
Sec.  201.405(c))
    The proposed rule would establish content and format requirements 
for the small label for Rx new animal drugs (Rx small label) (see 
proposed Sec.  201.405(c)). Some immediate containers, such as blister 
packs, pre-filled syringes, and small vials, are so small that only a 
minimal amount of information can be included on their label. The 
proposed rule would establish requirements for Rx small labels for 
approved or conditionally approved Rx new animal drugs (see proposed 
Sec.  201.405(c)). We recognize that the size of the label is dependent 
upon the size of the immediate container. If an immediate container 
lacks sufficient space to contain a label that accommodates all of the 
information required by proposed Sec.  201.405(b), the requirements of 
proposed Sec.  201.405(c) would instead apply. We would ordinarily make 
this determination during the review of the new animal drug and its 
labeling, taking into consideration the readability and legibility of 
the information.
    The proposed rule would require the following information to be 
presented on the Rx small label for an approved or conditionally 
approved Rx new animal drug and in the following order (see proposed 
Sec.  201.405(c)).
    a. Proprietary name of the finished drug product. The proposed rule 
would require this section of the Rx small label to include the 
proprietary name of the finished drug product (see proposed Sec.  
201.405(c)(1)). This requirement already exists for small labels for 
drugs in general in Sec.  201.10(i)(1), but is repeated in these 
proposed regulations to include all requirements for labeling of 
approved or conditionally approved new animal drugs in proposed subpart 
H.
    b. Established name of the drug product. The proposed rule would 
require this section of the Rx small label to include the established 
name of the drug product (see proposed Sec.  201.405(c)(2)). This 
requirement already exists for small labels for drugs in general in 
Sec.  201.10(i)(1), but is repeated in these proposed regulations to 
include all requirements for labeling of approved or conditionally 
approved new animal drugs in proposed subpart H.
    c. Active ingredient(s). The proposed rule would require this 
section of the Rx small label to include the established name and 
strength or concentration of each active ingredient, which is 
consistent with the requirement for the established name and quantity 
or proportion of each active ingredient on the label of prescription 
drugs, in accordance with section 502(e)(1)(A)(ii), (B), and (g) of the 
FD&C Act (see proposed Sec.  201.405(c)(3)). This information is 
currently required to be on the label for Rx animal drugs, in 
accordance with Sec.  201.105(b)(4).
    Proposed Sec.  201.405(b) and (c) would establish the content and 
format requirements for the label for approved or conditionally 
approved Rx new animal drugs and would replace the requirements for the 
label of approved or conditionally approved Rx new animal drugs 
currently provided in Sec.  201.105(b). Furthermore, Sec.  201.105 
would be amended to cross-reference proposed Sec.  201.405 for the 
content and format requirements for labeling components for approved or 
conditionally approved Rx new animal drugs (see discussion in section 
V.I.).
    d. Controlled substance symbol. For Rx new animal drugs that are 
controlled substances, the proposed rule would require this section of 
the Rx small label to include the controlled substance schedule symbol 
in accordance with part 1302 designating the schedule for the drug 
substance (see proposed Sec.  201.405(c)(4)).
    e. Prescription statement. The proposed rule would require this 
section of the Rx small label to state: ``Rx Animal Use'' (see proposed 
Sec.  201.405(c)(5)). In accordance with section 503(f)(4) of the FD&C 
Act, the label for all Rx new animal drugs must include the following 
statement: ``Caution: Federal law restricts this drug to use by or on 
the order of a licensed

[[Page 18281]]

veterinarian.'' However, since 1960 (25 FR 12592) Sec.  201.105(b)(6) 
exempts ``containers too small or otherwise unable to accommodate a 
label with sufficient space'' to include the full prescription 
statement provided that the full statement may be placed on the outer 
container only. We are proposing the ``Rx Animal Use'' statement for a 
Rx small label for Rx new animal drugs. This statement would 
appropriately identify the Rx status of the new animal drug and would 
require minimal space.
    f. ``For [target animal(s)] only.'' The proposed rule would require 
this section of the Rx small label to include a brief listing of the 
approved target animal(s) as follows: ``For [target animal(s)] only'' 
(see proposed Sec.  201.405(c)(6)). The brief listing of the approved 
target animal(s) would be used in place of full ``Indications for Use'' 
information because Rx small labels lack sufficient space. This listing 
would not require as much space on the Rx small label.
    g. Full prescribing information statement. The proposed rule would 
require this section of the Rx small label to include one of two 
statements. If full prescribing information is provided on the package 
insert, the following statement would be used: ``Read package insert 
for full prescribing information.'' If full prescribing information is 
provided on the secondary container labeling, the following statement 
would be used: ``Read package labeling for full prescribing 
information.'' See proposed Sec.  201.405(c)(7). Because full 
prescribing information would not be provided on the Rx small label, 
the purpose of the statements would be to remind the veterinarian to 
read full prescribing information before using the Rx new animal drug.
    h. ``Net Contents.'' The proposed rule would require this section 
of the Rx small label to have the heading ``Net Contents,'' followed by 
the contents of the immediate container, in accordance with Sec.  
201.51 (see proposed Sec.  201.405(c)(8)).
    i. Name and place of business. The proposed rule would require this 
section of the Rx small label to identify the name and place of 
business of the manufacturer, packer, or distributor, as required in 
section 502(b) of the FD&C Act (see proposed Sec.  201.405(c)(9)).
    j. ``Lot, Exp. and Storage'' or ``Lot and Storage.'' The proposed 
rule would require this section of the Rx small label to have the 
heading ``Lot, Exp. and Storage'' or ``Lot and Storage,'' followed by 
the identifying lot or control number of the Rx new animal drug within 
the immediate container (see proposed Sec.  201.405(c)(10)). Should a 
problem be reported to FDA, a lot or control number would allow us more 
easily to identify and trace back a specific lot of a product. We would 
also require this section of the Rx small label to include the 
expiration date of the Rx new animal drug within the immediate 
container, in accordance with Sec.  201.17. An expiration date on the 
Rx small label better ensures that the new animal drug would not be 
used after it expires.
    The proposed rule would also require this section of the Rx small 
label to include drug storage information for the new animal drug (see 
proposed Sec.  201.405(c)(10)). Storage information is necessary to 
maintain potency of the drug before its expiration date. Requiring this 
information on the Rx small label is needed for safe and effective use 
of new animal drugs. If the immediate container provides a single dose 
of the Rx new animal drug and is packaged individually in a secondary 
container that provides an expiration date on the secondary container 
labeling or secondary container, the proposed rule would not require an 
expiration date on the Rx small label or immediate container, in 
accordance with Sec.  201.17. Under such provision, this section of the 
Rx small label would be required to be entitled ``Lot and Storage.''
    k. ``Revision Date.'' The proposed rule would require this section 
of the Rx small label to have the heading ``Revision Date,'' followed 
by the date of the most recent revision of the Rx small label, listing 
the month followed by the year (see proposed Sec.  201.405(c)(11)).
4. Labeling for Secondary Containers for Rx New Animal Drugs That 
Include a Package Insert (Rx Secondary Container Labeling) (Proposed 
Sec.  201.405(d))
    The proposed rule would establish content and format requirements 
for the information on the labeling for secondary containers of 
approved or conditionally approved Rx new animal drugs that include a 
package insert (Rx secondary container labeling) (see proposed Sec.  
201.405(d)). In this situation, the package insert would be required to 
include full prescribing information, as described in proposed Sec.  
201.405(a).
    In accordance with section 201(k) of the FD&C Act, the Rx secondary 
container labeling could exclude any information described in proposed 
Sec.  201.405(d) that would be required to appear on the Rx label or Rx 
small label (see proposed Sec.  201.405(b) or (c), respectively) if 
such information on the Rx label or Rx small label was easily legible 
through the secondary container.
    The Rx secondary container labeling to which proposed Sec.  
201.405(d) would apply may consist of a front panel and one side or 
back panel, or a front panel and multiple side and/or back panels. 
Proposed Sec.  201.405(d) would provide for such Rx secondary container 
labeling designs. For Rx secondary container labeling with a front 
panel and one side or back panel, proposed Sec.  201.405(d)(1) would 
provide required information for the front panel, and proposed Sec.  
201.405(d)(2) would provide required information for the side or back 
panel. For Rx secondary container labeling with a front panel and 
multiple side and/or back panels, the information identified in 
proposed Sec.  201.405(d)(1) followed by the information identified in 
proposed Sec.  201.405(d)(2) would be required in order, starting on 
the front panel, continuing on the panel immediately to the right of 
the front panel, and continuing to fill the panels to the right until 
all of the information in proposed Sec.  201.405(d)(1) and (d)(2) was 
presented. In all instances, the information proposed in Sec.  
201.405(d)(2)(v) and (vi), i.e., ``Active Ingredient'' or ``Active 
Ingredients'' and ``Inactive Ingredients,'' would need to appear on the 
same panel.
    a. Front panel. The proposed rule would require the following 
information to be presented on the front panel of the Rx secondary 
container labeling and in the following order (see proposed Sec.  
201.405(d)(1)). Unless otherwise indicated, this information would be 
the same as that required by proposed Sec.  201.405(a) for full 
prescribing information.
    i. Drug product identification. The proposed rule would require 
this section of the Rx secondary container labeling to include drug 
product identification (see proposed Sec.  201.405(d)(1)(i)). The 
information would be the same as that included in the drug product 
identification section for full prescribing information, as described 
in proposed Sec.  201.405(a)(1), and would also identify if the drug 
product is sterile. Full prescribing information would require a drug 
product identification section and a ``Description'' section. Full 
prescribing information for sterile Rx new animal drugs would be 
required to identify in the ``Description'' section that the drug is 
sterile. However, due to space limitations, no ``Description'' section 
would be required on the Rx secondary container labeling. Instead, the 
drug product identification section of the Rx secondary container 
labeling for sterile Rx new animal drugs would be required to state 
that the drug is sterile.
    ii. Prescription statement. The proposed rule would require this 
section of the Rx secondary container

[[Page 18282]]

labeling to include the prescription statement, as described in 
proposed Sec.  201.405(a)(2) for full prescribing information (see 
proposed Sec.  201.405(d)(1)(ii)).
    iii. Conditional approval statement. For conditionally approved Rx 
new animal drugs, the proposed rule would require this section of the 
Rx secondary container labeling to include a conditional approval 
statement, as described in proposed Sec.  201.405(a)(3) for full 
prescribing information (see proposed Sec.  201.405(d)(1)(iii)).
    iv. Boxed warnings. For approved or conditionally approved Rx new 
animal drugs requiring boxed warnings, the proposed rule would require 
this section of the Rx secondary container labeling to include the 
boxed warnings, as described in proposed Sec.  201.405(a)(4) for full 
prescribing information (see proposed Sec.  201.405(d)(1)(iv)).
    v. ``Indications for Use.'' The proposed rule would require this 
section of the Rx secondary container labeling to have the heading 
``Indications for Use,'' followed by the ``Indications for Use'' 
section, as described in proposed Sec.  201.405(a)(7) for full 
prescribing information (see proposed Sec.  201.405(d)(1)(v)).
    vi. Extralabel prohibition statement. For approved new animal drugs 
prohibited from extralabel use, in accordance with Sec.  530.41, the 
proposed rule would require this section of the Rx secondary container 
labeling to include the extralabel use prohibition statement, as 
described in proposed Sec.  201.405(a)(5) for full prescribing 
information (see proposed Sec.  201.405(d)(1)(vi)).
    vii. ``Net Contents.'' The proposed rule would require this section 
of the Rx secondary container labeling to have the heading ``Net 
Contents,'' followed by the contents of the secondary container (see 
proposed Sec.  201.405(d)(1)(vii)).
    viii. NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the proposed rule would require 
this section of the Rx secondary container labeling to include the NADA 
or ANADA approval statement, as described in proposed Sec.  
201.405(a)(21) for full prescribing information (see proposed Sec.  
201.405(d)(1)(viii)).
    b. Side or back panel. The proposed rule would require the 
following information to be presented on the side or back panel of the 
Rx secondary container labeling and in the following order (see 
proposed Sec.  201.405(d)(2)). Unless otherwise indicated, this 
information would be the same as that required by proposed Sec.  
201.405(a) for full prescribing information.
    i. Full prescribing information statement. The proposed rule would 
require this section of the Rx secondary container labeling to include 
the statement: ``Before using this drug, read package insert for full 
prescribing information'' (see proposed Sec.  201.405(d)(2)(i)). 
Because full prescribing information would not be provided on the Rx 
secondary container labeling, the purpose of the full prescribing 
information statement would be to remind the veterinarian to read full 
prescribing information before using the Rx new animal drug.
    ii. ``Dosage and Administration.'' The proposed rule would require 
this section of the Rx secondary container labeling to have the heading 
``Dosage and Administration,'' followed by the ``Dosage and 
Administration'' section, as described in proposed Sec.  201.405(a)(8) 
for full prescribing information (see proposed Sec.  
201.405(d)(2)(ii)).
    iii. ``Contraindications.'' The proposed rule would require this 
section of the Rx secondary container labeling to have the heading 
``Contraindications,'' followed by the ``Contraindications'' section, 
as described in proposed Sec.  201.405(a)(9) for full prescribing 
information (see proposed Sec.  201.405(d)(2)(iii)).
    iv. ``Warnings and Precautions.'' The proposed rule would require 
this section of the Rx secondary container labeling to have the heading 
``Warnings and Precautions,'' followed by the ``Warnings and 
Precautions'' section, as described in proposed Sec.  201.405(a)(10) 
for full prescribing information (see proposed Sec.  
201.405(d)(2)(iv)).
    v. ``Active Ingredient'' or ``Active Ingredients.'' The proposed 
rule would require this section of the Rx secondary container labeling 
to have the heading ``Active Ingredient'' or ``Active Ingredients,'' 
followed by the established name and strength or concentration of each 
active ingredient, as described in proposed Sec.  201.405(b)(2)(iii) 
for the Rx label (see proposed Sec.  201.405(d)(2)(v)).
    vi. ``Inactive Ingredients.'' The proposed rule would require this 
section of the Rx secondary container labeling to have the heading 
``Inactive Ingredients,'' followed by the established name of each 
inactive ingredient, as described in proposed Sec.  201.405(a)(6)(viii) 
for full prescribing information (see proposed Sec.  
201.405(d)(2)(vi)).
    vii. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of the Rx secondary container labeling to have the 
heading ``Storage, Handling, and Disposal,'' followed by drug storage, 
handling, and disposal information, as described in proposed Sec.  
201.405(a)(20) for full prescribing information (see proposed Sec.  
201.405(d)(2)(vii)).
    viii. Name and place of business. The proposed rule would require 
this section of the Rx secondary container labeling to identify the 
manufacturer, packer, or distributor, as described in proposed Sec.  
201.405(a)(22) for full prescribing information (see proposed Sec.  
201.405(d)(2)(viii)).
    ix. ``Lot Number and Expiration Date.'' The proposed rule would 
require this section of the Rx secondary container labeling to have the 
heading ``Lot Number and Expiration Date,'' followed by the identifying 
lot or control number of the Rx new animal drug within the secondary 
container. The proposed rule would also require this section of the Rx 
secondary container labeling to include the expiration date of the Rx 
new animal drug within the secondary container, in accordance with 
Sec.  201.17. Alternatively, the proposed rule would allow for this 
section to refer to the location on the Rx secondary container labeling 
or secondary container where the lot or control number and expiration 
date are printed (see proposed Sec.  201.405(d)(2)(ix)). As an example, 
if the lot number and expiration date are printed on the bottom flap of 
a secondary container, then the labeling may state in this section, 
``See carton bottom flap for lot number and expiration date. However, 
in accordance with Sec.  201.17, the proposed rule would allow an 
expiration date to be excluded from the Rx secondary container labeling 
or secondary container if the expiration date provided on the Rx label, 
Rx small label, or immediate container is easily legible through the 
secondary container.
    x. ``Revision Date.'' The proposed rule would require this section 
of the Rx secondary container labeling to have the heading ``Revision 
Date,'' followed by the date of the most recent revision of the Rx 
secondary container labeling, listing the month followed by the year 
(see proposed Sec.  201.405(d)(2)(x)).
5. Shipping Labeling for Rx New Animal Drugs (Rx Shipping Labeling) 
(Proposed Sec.  201.405(e))
    The proposed rule would establish content and format requirements 
for the information on the shipping labeling for approved or 
conditionally approved Rx new animal drugs (Rx shipping labeling). As 
defined in proposed Sec.  201.403, shipping labeling is associated with 
the outermost carton containing immediate containers, secondary 
containers, and/or multiple

[[Page 18283]]

unit (multi-unit) cartons of a new animal drug and intended for 
shipment, but not display, of the product. The proposed rule would 
require the Rx shipping labeling to include, among additional 
information, drug product identity, the manufacturer, packer, or 
distributor, and drug storage and handling conditions (see proposed 
Sec.  201.405(e)). However, the Rx shipping labeling for controlled 
substances would not include information that would identify the drug, 
in accordance with Sec.  1301.74(e), to guard against storage or in-
transit losses due to theft or diversion.
    The proposed rule would require the following information to be 
presented on the Rx shipping labeling and in the following order (see 
proposed Sec.  201.405(e)). Unless otherwise indicated, this 
information would be the same as that required by proposed Sec.  
201.405(a) for full prescribing information.
    a. Proprietary name of the finished drug product. The proposed rule 
would require this section of the Rx shipping labeling to include the 
proprietary name of the finished drug product (see proposed Sec.  
201.405(e)(1)). This section would be excluded from the Rx shipping 
labeling for a controlled substance.
    b. Established name of the drug product. The proposed rule would 
require this section of the Rx shipping labeling to include the 
established name of the drug product (see proposed Sec.  
201.405(e)(2)). This section would be excluded from the Rx shipping 
labeling for a controlled substance.
    c. Established name and strength or concentration of each active 
ingredient. The proposed rule would require this section of the Rx 
shipping labeling to provide the established name and strength or 
concentration of each active ingredient. This section would be excluded 
from the Rx shipping labeling for a controlled substance (see proposed 
Sec.  201.405(e)(3)).
    d. Conditional approval statement. For conditionally approved Rx 
new animal drugs, the proposed rule would require this section of the 
Rx shipping labeling to include a conditional approval statement, as 
described in proposed Sec.  201.405(a)(3) for full prescribing 
information (see proposed Sec.  201.405(e)(4)). This section would be 
excluded from the Rx shipping labeling for a controlled substance.
    e. ``Net Contents.'' The proposed rule would require this section 
of the Rx shipping labeling to have the heading ``Net Contents,'' 
followed by the contents of the shipping carton (see proposed Sec.  
201.405(e)(5)).
    f. ``Storage and Handling.'' The proposed rule would require this 
section of the Rx shipping labeling to have the heading ``Storage and 
Handling,'' followed by drug storage information (see proposed Sec.  
201.405(e)(6)). Also, any handling information required for safe and 
effective use of the new animal drug would be included in this section. 
Information on disposal of the new animal drug would not be required to 
be included on the Rx shipping labeling.
    g. NADA/ANADA approval statement. For approved new animal drugs or 
approved generic new animal drugs, the proposed rule would require this 
section of the Rx shipping labeling to include the NADA or ANADA 
approval statement, as described in proposed Sec.  201.405(a)(21) for 
full prescribing information (see proposed Sec.  201.405(e)(7)). This 
section would be excluded from the Rx shipping labeling for a 
controlled substance.
    h. Name and place of business. The proposed rule would require this 
section of the Rx shipping labeling to identify the name and place of 
business of the manufacturer, packer, or distributor, as described in 
proposed Sec.  201.405(a)(22) for full prescribing information (see 
proposed Sec.  201.405(e)(8)).
    i. ``Lot Number and Expiration Date.'' The proposed rule would 
require this section of the Rx shipping labeling to have the heading 
``Lot Number and Expiration Date,'' followed by the identifying lot or 
control number(s) and the expiration date(s) of the Rx new animal drug 
within the shipping carton (see proposed Sec.  201.405(e)(9)). The 
shipping carton may contain more than one lot of the new animal drug, 
and therefore, more than one lot or control number and expiration date 
may be listed in this section of the Rx shipping labeling.
    j. ``Revision Date.'' The proposed rule would require the last 
section of the Rx shipping labeling to have the heading ``Revision 
Date,'' followed by the date of the most recent revision of the Rx 
shipping labeling, listing the month followed by the year (see proposed 
Sec.  201.405(e)(10)).
6. Other Approved Labeling for Rx New Animal Drugs (Rx Other Approved 
Labeling) (Proposed Sec.  201.405(f))
    The proposed rule would establish content and format requirements 
for the information presented on other approved labeling for approved 
or conditionally approved Rx new animal drugs (Rx other approved 
labeling) (see proposed Sec.  201.405(f)). Rx other approved labeling 
includes, but is not limited to, labeling on display cartons and multi-
unit cartons (excluding shipping cartons), containing the immediate 
containers or the secondary containers of the Rx new animal drug.
    The proposed rule would require the following information to be 
presented on the Rx other approved labeling and in the following order 
(see proposed Sec.  201.405(f)). Unless otherwise indicated, this 
information would be the same as required by proposed Sec.  201.405(a) 
for full prescribing information.
    a. Proprietary name of the finished drug product. The proposed rule 
would require this section of the Rx other approved labeling to include 
the proprietary name of the finished drug product (see proposed Sec.  
201.405(f)(1)).
    b. Established name of the drug product. The proposed rule would 
require this section of the Rx other approved labeling to include the 
established name of the drug product (see proposed Sec.  
201.405(f)(2)).
    c. Established name and strength or concentration of each active 
ingredient. The proposed rule would require this section of the Rx 
other approved labeling to provide the established name and strength or 
concentration of each active ingredient (see proposed Sec.  
201.405(f)(3)).
    d. Controlled substance symbol. The proposed rule would require 
this section of the Rx other approved labeling for controlled 
substances to include the controlled substance schedule symbol, in 
accordance with part 1302 designating the schedule for the drug 
substance (see proposed Sec.  201.405(f)(4)).
    e. Prescription statement. The proposed rule would require this 
section of the Rx other approved labeling to include the prescription 
statement, as described in proposed Sec.  201.405(a)(2) for full 
prescribing information (see proposed Sec.  201.405(f)(5)).
    f. Conditional approval statement. For conditionally approved new 
animal drugs, the proposed rule would require this section of the Rx 
other approved labeling to include a conditional approval statement, as 
described in proposed Sec.  201.405(a)(3) for full prescribing 
information (see proposed Sec.  201.405(f)(6)).
    g. Boxed warnings. For approved or conditionally approved Rx new 
animal drugs requiring boxed warnings, the proposed rule would require 
this section of the Rx other approved labeling to include the boxed 
warnings, as described in proposed Sec.  201.405(a)(4) for full 
prescribing information (see proposed Sec.  201.405(f)(7)).

[[Page 18284]]

    h. Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use, in accordance with Sec.  530.41, 
the proposed rule would require this section of the Rx other approved 
labeling to include the extralabel use prohibition statement, as 
described in proposed Sec.  201.405(a)(5) for full prescribing 
information (see proposed Sec.  201.405(f)(8)).
    i. ``Net Contents.'' The proposed rule would require this section 
of the Rx other approved labeling to have the heading ``Net Contents,'' 
followed by the contents of the container to which the Rx other 
approved labeling applies (see proposed Sec.  201.405(f)(9)).
    j. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of the Rx other approved labeling to have the 
heading ``Storage, Handling, and Disposal,'' followed by drug storage, 
handling, and disposal information, as described in proposed Sec.  
201.405(a)(20) for full prescribing information (see proposed Sec.  
201.405(f)(10)).
    k. NADA/ANADA approval statement. For approved new animal drugs or 
approved generic new animal drugs, the proposed rule would require this 
section of the Rx other approved labeling to include the NADA or ANADA 
approval statement, as described in proposed Sec.  201.405(a)(21) for 
full prescribing information (see proposed Sec.  201.405(f)(11)).
    l. Name and place of business. The proposed rule would require this 
section of the Rx other approved labeling to identify the name and 
place of business of the manufacturer, packer, or distributor, as 
described in proposed Sec.  201.405(a)(22) for full prescribing 
information (see proposed Sec.  201.405(f)(12)).
    m. ``Lot Number and Expiration Date.'' The proposed rule would 
require this section of the Rx other approved labeling to have the 
heading ``Lot Number and Expiration Date,'' followed by the identifying 
lot or control number of the Rx new animal drug within the container to 
which the Rx other approved labeling applies. This section of the Rx 
other approved labeling would also be required to include the 
expiration date of the Rx new animal drug within the container to which 
the Rx other approved labeling applies, in accordance with Sec.  
201.17. In accordance with Sec.  201.17, the proposed rule would allow 
an expiration date to be excluded from the Rx other approved labeling 
if the expiration date provided on containers within or their labeling 
is easily legible through the container to which the Rx other approved 
labeling applies (see proposed Sec.  201.405(f)(13)).
    n. ``Revision Date.'' The proposed rule would require the last 
section of the Rx other approved labeling to have the heading 
``Revision Date,'' followed by the date of the most recent revision of 
the Rx other approved labeling, listing the month followed by the year 
(see proposed Sec.  201.405(f)(14)).

E. Content and Format for Over-The-Counter (OTC) New Animal Drug 
Labeling--Overview (Proposed Sec.  201.407)

    The proposed rules provides content and format requirements for all 
components of labeling for approved or conditionally approved OTC new 
animal drugs other than those for use in animal feeds that are subject 
to part 558 (see proposed Sec.  201.407). Proposed Sec.  201.409 would 
establish the content and format requirements for all components of 
labeling for approved or conditionally approved new animal drugs 
intended for use in animal feeds that are subject to part 558. OTC new 
animal drugs are new animal drugs that can be used without a 
prescription from a veterinarian. They are intended for use by the 
layperson, such as pet owners and livestock producers. In accordance 
with section 502(f) of the FD&C Act, OTC drugs must bear adequate 
directions for use on labeling. Adequate directions for use means 
directions under which the layperson can use a drug safely and for the 
purposes for which it is intended (see Sec.  201.5).
    The proposed rule would require that labeling sections or 
subsections that do not apply be omitted from the labeling for approved 
or conditionally approved OTC new animal drugs (see proposed Sec.  
201.407). For example, OTC new animal drugs approved or conditionally 
approved for use in non-food-producing animals (e.g., cats, dogs) would 
not require the labeling subsection entitled either ``Withdrawal 
Periods and Residue Warnings'' or ``Withdrawal Periods''.
    FDA determines the final content of each applicable section of 
labeling during the review of each new animal drug as part of the 
approval process.
    The proposed rule would identify the information that would be 
required to be included on the labeling component that would provide 
full product information for OTC new animal drugs in proposed Sec.  
201.407(a). Full product information for OTC new animal drugs would be 
similar in concept to full prescribing information for Rx new animal 
drugs in that it would include all information necessary for the safe 
and effective use of the OTC new animal drug. Thus, all approved or 
conditionally approved OTC new animal drugs would be required to 
provide a labeling component that includes full product information. If 
a package insert is provided with an OTC new animal drug, the proposed 
rule would require the package insert to include full product 
information. If only partial information is provided on a package 
insert, the user may mistakenly assume the package insert includes 
complete information on the safe and effective use of the drug when in 
fact it does not. If no package insert is provided with an OTC new 
animal drug, the secondary container labeling would be required to 
include full product information. If no package insert or secondary 
container labeling is provided with the OTC new animal drug, then full 
product information would need to be provided on the label (see 
proposed Sec.  201.407(a)).
    The label is the labeling component that appears on the immediate 
container, which is the container in contact with the drug. The 
proposed rule would establish content and format requirements for the 
label for an approved or conditionally approved OTC new animal drug 
that does not provide full product information (see proposed Sec.  
201.407(b)). The proposed rule would establish content and format 
requirements for a small label for an approved or conditionally 
approved OTC new animal drug that we determine lacks sufficient space 
to comply with proposed Sec.  201.407(b) (see proposed Sec.  
201.407(c)).
    For purposes of proposed subpart H, we would define a package 
insert for an approved or conditionally approved OTC new animal drug as 
a labeling component that contains full product information and is 
included with the immediate container or secondary container or is 
attached to the label (see proposed Sec.  201.403). Where the package 
insert is attached to the label, which is sometimes referred to as, for 
example, ``extended labeling,'' ``onserts,'' or ``outserts,'' for 
purposes of proposed subpart H, the package insert providing full 
product information and attached to the label would need to comply with 
proposed Sec.  201.407(a). The label would need to comply with proposed 
Sec.  201.407(b) or (c), as applicable.
    FDA considers the secondary container for a new animal drug to be 
the packaging that surrounds the immediate container. The proposed rule 
would establish content and format requirements for secondary container 
labeling for an approved or conditionally approved OTC new animal drug 
(see proposed Sec.  201.407(d)). If a package insert is provided with 
an OTC new animal drug, then the secondary container labeling would be

[[Page 18285]]

required to comply with proposed Sec.  201.407(d) and the package 
insert would be required to provide full product information to comply 
with proposed Sec.  201.407(a). If no package insert is provided with 
an OTC new animal drug, the proposed rule would require full product 
information to appear on the secondary container labeling (see proposed 
Sec.  201.407(a)).
    In accordance with the definition of ``label'' in section 201(k) of 
the FD&C Act, information on the label must also appear on an outside 
container or wrapper of the retail package, if it exists, or be easily 
legible through the outside container or wrapper. For purposes of these 
proposed regulations, FDA considers the secondary container to be an 
``outside container or wrapper of the retail package'' for new animal 
drugs. Therefore, if a secondary container exists, the proposed rule 
would require the secondary container labeling to include all 
information that would be on the label in accordance with proposed 
Sec.  201.407(b) or (c), unless the information on the label is easily 
legible through the secondary container (see proposed Sec.  201.407(a) 
or (d)).
    Shipping labeling is associated with the outermost carton 
containing a new animal drug, which is intended for shipping, but not 
displaying the product. The proposed rule would establish content and 
format requirements for the shipping labeling of approved or 
conditionally approved OTC new animal drugs including a requirement 
that such shipping labeling identify the new animal drug, the 
manufacturer, and drug storage and handling information(see proposed 
Sec.  201.407(e)).
    Depending on how a sponsor intends to sell or display an approved 
or conditionally approved OTC new animal drug, there may be other 
containers such as display cartons and multiple unit (multi-unit) 
cartons that contain immediate containers or secondary containers. 
These containers may be packaged in shipping cartons. The proposed rule 
would establish content and format requirements for the labeling of 
these other containers for OTC new animal drugs (see proposed Sec.  
201.407(f)).
    Labeling sections and subsections for OTC new animal drugs would 
not be numbered. Headings of sections and subsections that would be 
required to appear verbatim on labeling are identified in the proposed 
regulations in quotations. Similarly, certain other labeling text would 
be required to appear verbatim on labeling; this text is also 
identified in the proposed regulations in quotations.
    The proposed rule would require the labeling of approved or 
conditionally approved OTC new animal drugs to comply with other 
applicable requirements in proposed subpart H (see proposed Sec.  
201.407).
1. Labeling Providing Full Product Information (Proposed Sec.  
201.407(a))
    The proposed rule uses the term ``full prescribing information'' to 
identify all information necessary for the safe and effective use of 
approved or conditionally approved Rx new animal drugs, and the 
proposed regulations use that term for Rx new animal drugs. The concept 
of a component of labeling providing all information necessary for the 
safe and effective use of an approved or conditionally approved OTC new 
animal drug is equally important. FDA proposes that the term used for 
this information for approved or conditionally approved OTC new animal 
drugs would be ``full product information'' because OTC new animal 
drugs are not prescribed.
    The proposed rule would establish content and format requirements 
for the component of labeling that provides full product information 
for approved or conditionally approved OTC new animal drugs (see 
proposed Sec.  201.407(a)).
    If a package insert is provided with an approved or conditionally 
approved OTC new animal drug, the proposed rule would require the 
package insert to include full product information (see proposed Sec.  
201.407(a)). If a package insert is provided with an approved or 
conditionally approved OTC new animal drug, the label would be required 
to comply with proposed Sec.  201.407(b) or (c), and any secondary 
container labeling would be required to comply with proposed Sec.  
201.407(d).
    If a package insert is not provided with an approved or 
conditionally approved OTC new animal drug, but a secondary container 
is provided, then the secondary container labeling would be required to 
provide full product information (see proposed Sec.  201.407(a)). If 
full product information is provided on the secondary container 
labeling, in accordance with section 201(k) of the FD&C Act, proposed 
Sec.  201.407(a) would allow the secondary container labeling to 
exclude any portions of full product information that would be required 
to appear on the label if such information is easily legible through 
the secondary container (see proposed Sec.  201.407(a)).
    If no package insert or secondary container is provided with an 
approved or conditionally approved OTC new animal drug, then the label 
would be required to include full product information (see proposed 
Sec.  201.407(a)).
    The proposed rule would require the following information to be 
presented in full product information for approved or conditionally 
approved OTC new animal drugs and in the following order. Unless 
otherwise indicated, this information would be the same as that 
required by proposed Sec.  201.405(a) for full prescribing information 
for approved or conditionally approved Rx new animal drugs.
    a. Drug product identification. The proposed rule would require 
this section of full product information to include the proprietary 
name of the finished drug product and the established name of the drug 
product. If not included as part of the established name of the drug 
product, the route(s) of administration and dosage form of the finished 
drug product would be required to be included in this section as well 
(see proposed Sec.  201.407(a)(1)(i) through (iv)).
    The established name and strength or concentration of each active 
ingredient would also be required. The strength or concentration of 
each active ingredient would be allowed to be excluded from full 
product information provided on a package insert if the package insert 
applies to multiple strengths or concentrations for the same OTC new 
animal drug (see proposed Sec.  201.407(a)(1)(v)).
    If FDA determines that identifying the pharmacological class of an 
OTC new animal drug on labeling would be helpful in facilitating its 
safe and effective use, the proposed rule would require that the 
pharmacological class be included in this section of full product 
information (see proposed Sec.  201.407(a)(1)(vi)).
    b. Conditional approval statement. For conditionally approved OTC 
new animal drugs, the proposed rule would require this section of full 
product information to include a conditional approval statement, as 
described in proposed Sec.  201.405(a)(3) for full prescribing 
information for conditionally approved Rx new animal drugs (see 
proposed Sec.  201.407(a)(2)).
    c. ``Uses.'' This section of full product information would be 
required to have the heading ``Uses,'' followed by the approved or 
conditionally approved indication(s) and target animal(s) in the 
following format: ``For [indication(s)] in [target animal(s)]'' (see 
proposed Sec.  201.407(a)(3)).
    This section of full product information would be similar to the 
``Indications for Use'' section of full prescribing information for Rx 
new animal drugs, as described in proposed

[[Page 18286]]

Sec.  201.405(a)(7). For OTC new animal drugs, the heading ``Uses'' may 
be better understood by the layperson and is consistent with the 
requirements for labeling of OTC human drugs (see Sec.  201.66(c)(4)).
    If FDA approves or conditionally approves an OTC new animal drug 
for use only under specific conditions, such as in conjunction with a 
specific diet, then the proposed rule would require that this 
information be specified in the ``Uses'' section of full product 
information (see proposed Sec.  201.407(a)(3)(ii)).
    FDA may require a statement in the ``Uses'' section of full product 
information describing the relative effectiveness of doses within the 
approved range of doses (see proposed Sec.  201.407(a)(3)(iii)). This 
requirement primarily pertains to OTC new animal drugs that affect the 
structure or function of the body of an animal (section 201(g)(1)(C) of 
the FD&C Act) but are not intended for use in the diagnosis, cure, 
mitigation, treatment, or prevention of disease (section 201(g)(1)(B) 
of the FD&C Act), e.g., drugs that increase the rate of weight gain or 
feed efficiency in food-producing animals. For these new animal drugs, 
all doses within the range presented on the approved labeling must be 
effective for their intended use(s) (see 21 CFR 514.4(b)(2)(i)). For 
new animal drugs intended for use in the diagnosis, cure, mitigation, 
treatment, or prevention of disease, the lowest dose of the dose range 
must be effective for the intended use(s). However, the doses within 
the approved range do not need to be more effective than any other 
doses within the same range. For OTC new animal drugs approved for 
structure or function indications, if the highest approved dose(s) is 
not more effective compared to the next lower approved dose(s), the 
proposed rule would be able to require a statement in the ``Uses'' 
section to inform the user that a higher dose(s) is not more effective 
than the next lower dose(s).
    For safety and/or effectiveness reasons, we may require a 
statement(s) in the ``Uses'' section of full product information 
identifying animals for which the OTC new animal drug has not been 
approved or conditionally approved (see proposed Sec.  
201.407(a)(3)(iv)).
    d. Extralabel use statement. The proposed rule would require this 
section of full product information to include an extralabel use 
statement (see proposed Sec.  201.407(a)(4)). In accordance with part 
530, extralabel use of approved new animal drugs is not permitted 
except by or on the order of a licensed veterinarian and under the 
conditions described in that chapter. The required statement would be: 
``It is a violation of Federal law to use this drug product other than 
as directed in the labeling or as directed by your veterinarian.'' It 
is important for the layperson to know when it is a violation of 
Federal law to use drugs in animals in an extralabel manner.
    e. Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use, in accordance with Sec.  530.41, 
the proposed rule would require this section of full product 
information to include an extralabel use prohibition statement, as 
described in proposed Sec.  201.405(a)(5) for full prescribing 
information for Rx new animal drugs (see proposed Sec.  201.407(a)(5)). 
Few OTC new animal drugs are prohibited from extralabel use under Sec.  
530.41. However, for the rare situation in which an approved OTC new 
animal drug is prohibited from extralabel use under Sec.  530.41, this 
statement would be included in addition to the appropriate extralabel 
use statement that would be required by proposed Sec.  201.407(a)(4).
    f. ``Description.'' The proposed rule would require this section of 
full product information to have the heading ``Description,'' followed 
by a description of the new animal drug. The description would include 
the proprietary name of the finished drug product and established name 
of the drug product, and the route(s) of administration and dosage form 
if not included as part of the established name. The description would 
also include identifying characteristics of the dosage form, such as 
color, shape, coating, scoring, and imprinting. All approved and 
available strengths or concentrations of the new animal drug to which 
full product information applies would need to be identified in this 
section of full product information. If the drug product was sterile, 
this fact would also be identified in this section of full product 
information (see proposed Sec.  201.407(a)(6)).
    When inactive ingredients are provided on the labeling, the 
proposed rule would require they be listed in the ``Description'' 
section in decreasing order of predominance, by weight or concentration 
(see proposed Sec.  201.407(a)(6)(viii)). We encourage sponsors to list 
all inactive ingredients on labeling to better inform users about the 
product.
    g. ``Warnings.'' The proposed rule would require this section of 
full product information for all approved or conditionally approved OTC 
new animal drugs, and it would have the heading ``Warnings'' (see 
proposed Sec.  201.407(a)(7)). This section of full product information 
would be similar to the ``Warnings and Precautions'' section proposed 
for full prescribing information for Rx new animal drugs, as described 
in proposed Sec.  201.405(a)(10). However, ``precautions'' would be 
excluded from this section of full product information and instead be 
provided in the ``Additional Recommendations'' section of full product 
information, as described in proposed Sec.  201.407(a)(8). A more 
complete explanation of the basis for this proposal is provided in the 
discussion of the ``Animal Safety Warnings'' subsection for OTC new 
animal drugs in proposed Sec.  201.407(a)(7)(iii).
    i. ``Withdrawal Periods and Residue Warnings'' or ``Withdrawal 
Periods.'' All OTC new animal drugs approved or conditionally approved 
for use in food-producing animals, would be required to have as the 
first subsection of the ``Warnings'' section of full product 
information a subsection with the heading ``Withdrawal Periods and 
Residue Warnings'' or ``Withdrawal Periods.'' This subsection would 
provide human food safety warnings, including milk discard times, 
withdrawal periods, and residue warning statements, as applicable to 
the new animal drug (see proposed Sec.  201.407(a)(7)(i)). This 
subsection of full product information would be the same as described 
in proposed Sec.  201.405(a)(10)(i) for full prescribing information 
for Rx new animal drugs.
    ii. ``User Safety Warnings.'' The proposed rule would require this 
subsection of the ``Warnings'' section of full product information to 
have the heading ``User Safety Warnings,'' followed by the user safety 
warnings (see proposed Sec.  201.407(a)(7)(ii)). This subsection of 
full product information would be the same as described in proposed 
Sec.  201.405(a)(10)(ii) for full prescribing information for Rx new 
animal drugs.
    iii. ``Animal Safety Warnings.'' For OTC new animal drugs with 
contraindications, target animal safety warnings that identify any 
serious adverse reaction or potential hazard to the target animal(s) 
associated with the use of the new animal drug, adverse reactions, or 
post-approval adverse drug experiences, the proposed rule would require 
this subsection of the ``Warnings'' section of full product information 
to have the heading ``Animal Safety Warnings,'' followed by the 
contraindications, target animal safety warnings, adverse reactions, 
and post-approval adverse drug experiences

[[Page 18287]]

(see proposed Sec.  201.407(a)(7)(iii)). This proposed subsection of 
full product information would differ in some ways from the ``Animal 
Safety Warnings and Precautions'' subsection of full prescribing 
information proposed for Rx new animal drugs, as described in proposed 
Sec.  201.405(a)(10)(iii), and these differences are the basis for the 
different proposed titles of these sections, i.e., ``Warnings'' for OTC 
new animal drugs versus ``Warnings and Precautions'' for Rx new animal 
drugs.
    The definition of ``precautions'' in proposed Sec.  201.403 is 
``any special care to be exercised for safe and effective use of the 
new animal drug. This may include recommended screening, monitoring, or 
diagnostic tests.'' Precautions related to Rx new animal drugs may 
include screening, special care and monitoring, or diagnostic tests 
intended to be performed by a veterinarian. Furthermore, precautions 
related to Rx new animal drugs are often related to, and difficult to 
distinguish from, target animal safety warnings. On the other hand, OTC 
new animal drugs do not require professional veterinary expertise to 
properly administer the drug, provide adequate post-treatment care, or 
monitor effects after use of the drug. For OTC new animal drugs, 
precautions provide additional recommendations to the layperson and are 
distinguishable from target animal safety warnings. For example, this 
may include information on when to administer the drug relative to 
feeding, or a recommendation to have a sound mastitis monitoring 
program before using the drug, etc. This advice is distinguishable from 
warnings for OTC new animal drugs. Therefore, for better clarity to the 
layperson, we propose that precautions for OTC new animal drugs not be 
included in the ``Animal Safety Warnings'' section of full product 
information and instead would be included in a separate section called 
``Additional Recommendations,'' as described in proposed Sec.  
201.407(a)(8).
    In addition, the ``Animal Safety Warnings'' subsection of full 
product information for OTC new animal drugs would differ from the 
``Animal Safety Warnings and Precautions'' subsection of full 
prescribing information for Rx new animal drugs in terms of 
presentation of warning information. For OTC new animal drugs, all 
potential risks of the drug to the target animal would be included: 
contraindications, target animal safety warnings, adverse reactions, 
and post-approval adverse drug experiences as determined by FDA. For Rx 
new animal drugs, this information would be provided in different 
sections of full prescribing information.
    For OTC new animal drugs, including all potential risks to the 
target animal in one subsection of full product information might be 
clearer for the layperson and increase the likelihood that all of the 
information would be read. Furthermore, identifying the risks to the 
target animal on labeling as ``contraindications,'' ``target animal 
safety warnings,'' ``adverse reactions,'' or ``post-approval adverse 
drug experience'' may be confusing to a layperson because they may not 
know the differences between the terms. The subsection heading ``Animal 
Safety Warnings'' would be understood by the layperson as meaning risks 
to the target animal. Therefore, the proposed rule would require that 
all risks to the target animal for OTC new animal drugs be simply 
identified as ``Animal Safety Warnings'' and placed in this subsection 
of full product information. All risk information listed under ``Animal 
Safety Warnings'' would be required to be listed in decreasing order of 
severity to emphasize the most critical risks to the target animal (see 
proposed Sec.  201.407(a)(7)(iii)).
    iv. ``Environmental Warnings.'' For new animal drugs having 
environmental warnings, the proposed rule would require this subsection 
of the ``Warnings'' section of full product information to have the 
heading ``Environmental Warnings,'' followed by the environmental 
warnings (see proposed Sec.  201.407(a)(7)(iv)). This subsection of 
full product information would be the same as described in proposed 
Sec.  201.405(a)(10)(iv) for full prescribing information for Rx new 
animal drugs.
    v. ``Other Warnings.'' For OTC new animal drugs having warnings not 
more appropriately placed in other ``Warnings'' subsections, the 
proposed rule would require the last subsection of the ``Warnings'' 
section of full product information to have the heading ``Other 
Warnings,'' followed by those warnings (see proposed Sec.  
201.407(a)(7)(v)). This subsection of full product information would be 
the same as described in proposed Sec.  201.405(a)(10)(v) for full 
prescribing information for Rx new animal drugs.
    h. ``Additional Recommendations.'' For OTC new animal drugs having 
precautions, the proposed rule would require this section of full 
product information to have the heading ``Additional Recommendations,'' 
followed by all precautions (see proposed Sec.  201.407(a)(8)). As 
described in its proposed definition, precautions include any special 
care to be exercised for safe and effective use of the new animal drug. 
As discussed with respect to proposed Sec.  201.407(a)(7)(iii), 
regarding ``Animal Safety Warnings,'' precautions are distinguishable 
from target animal safety warnings for OTC new animal drugs. However, 
because the term ``precautions'' as intended by these proposed 
regulations may not be known or understood by the layperson, the title 
``Additional Recommendations'' is proposed.
    i. ``Other Effects You May Notice.'' For OTC new animal drugs that 
have effects on the target animal(s) that are not considered 
contraindications, target animal safety warnings, adverse reactions, or 
post-approval adverse drug experiences, and FDA determines these 
effects are required to be described on labeling, the proposed rule 
would require this section of full product information to have the 
heading ``Other Effects You May Notice,'' followed by a description of 
the effects (see proposed Sec.  201.407(a)(9)). We consider this 
information important for owners of animals, and this information is 
currently provided on the labeling of some OTC new animal drugs.
    For example, some OTC new animal drugs approved for increased rate 
of weight gain and/or feed efficiency in feedlot beef cattle have 
effects on the leanness or tenderness of the carcass of those animals. 
Similarly, OTC new animal drugs that increase milk production in dairy 
cows or the efficiency by which they produce milk may alter the fat 
percent content of the milk. These effects, which are currently 
described on the approved labeling for these products, are not 
considered negative health effects on the target animal nor are they of 
human food safety concern. However, these effects could be mistaken for 
symptoms of an underlying health problem in the target animal, such as 
poor nutritional status. For this reason, information of this type may 
be considered material under section 201(n) of the FD&C Act such that 
it would be required to be disclosed in the labeling for these products 
on the basis that such disclosures may preclude unnecessary concern and 
inappropriate medical treatment. Similarly, some topically applied OTC 
new animal drugs for companion animals might permanently (but 
harmlessly) alter the color of the fur at the application site. These 
types of potential effects that are not safety concerns, but rather 
provide important information to the layperson, would be included in 
this section of full product information.
    j. ``Directions.'' The proposed rule would require this section of 
full

[[Page 18288]]

product information to have the heading ``Directions,'' followed by the 
directions for use of the OTC new animal drug for each indication and 
target animal (see proposed Sec.  201.407(a)(10)). The corresponding 
section of full prescribing information for Rx new animal drugs would 
be called ``Dosage and Administration,'' as described in proposed Sec.  
201.405(a)(9). However, for OTC new animal drugs, the term 
``Directions'' may be better understood by the layperson. In addition, 
the term ``Directions'' is also used in labeling of OTC human drugs 
(see Sec.  201.66(c)(6)).
    The ``Directions'' section of full product information is 
intentionally proposed for placement after the ``Warnings'' section. 
This is in contrast to the ``Dosage and Administration'' section in 
full prescribing information for Rx new animal drugs, which, except for 
``Boxed Warnings,'' would be placed before ``Contraindications,'' 
``Warnings and Precautions,'' ``Adverse Reactions,'' and other 
information about the effects of the drug. The intent in presenting 
``Directions'' after the ``Warnings'' section in full product 
information for OTC new animal drugs is to increase the likelihood that 
the layperson will read the ``Warnings'' section before using the drug. 
This placement approach is similar to that used in labeling of OTC 
human drugs (see Sec.  201.66(c)(6)).
    The ``Directions'' section of full product information would be 
required to include information necessary for treatment of the animal 
with the OTC new animal drug in accordance with FDA approval or 
conditional approval, including route(s) of administration; specific 
site(s) of administration, if applicable; dose or dose range, intervals 
between doses, if applicable; and duration of treatment. For some 
injectable products, FDA may require a statement of maximum volume per 
injection site to facilitate the drug's safe and effective use, and the 
proposed rule would require this information to be included in this 
section of full product information. Other required dosage and 
administration information would be included in this section of full 
product information. See proposed Sec.  201.407(a)(10).
    k. ``Net Contents.'' The proposed rule would require this section 
of full product information, when presented on the label or the 
secondary container labeling, to have the heading ``Net Contents,'' 
followed by the contents of the immediate container, in accordance with 
Sec.  201.62 (21 CFR 201.62), or the secondary container, respectively. 
The proposed rule would exclude a ``Net Contents'' section from package 
inserts (see proposed Sec.  201.407(a)(11)).
    l. ``How Supplied.'' The proposed rule would require this section 
of full product information to have the heading ``How Supplied,'' 
followed by information on available strengths, concentrations, and 
container sizes to which the labeling applies (see proposed Sec.  
201.407(a)(12)). This section of full product information would be the 
same as described in proposed Sec.  201.405(a)(19) for full prescribing 
information for Rx new animal drugs.
    m. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of full product information to have the heading 
``Storage, Handling, and Disposal,'' followed by drug storage 
information, as well as any required handling and drug disposal 
information (see proposed Sec.  201.407(a)(13)). This section of full 
product information would be the same as described in proposed Sec.  
201.405(a)(20) for full prescribing information for Rx new animal 
drugs.
    n. ``Questions/Comments?'' The proposed rule would require this 
section of full product information to have the heading ``Questions/
Comments?,'' followed by the sponsor's contact information for 
consumers to facilitate requesting additional information or to report 
suspected adverse drug experiences. FDA's contact information for 
voluntary reporting of adverse drug experiences for animal drugs would 
also be required (see proposed Sec.  201.407(a)(14)). The ``Questions/
Comments?'' section of full product information would be similar to the 
``Contact Information'' section in proposed Sec.  201.405(a)(12) for 
full prescribing information for Rx new animal drugs.
    The ``Questions/Comments?'' heading might be clearer than ``Contact 
Information'' to the layperson using OTC new animal drugs. Furthermore, 
the heading ``Questions?'' or ``Questions or comments?'' is used for 
OTC human drug labeling (see Sec.  201.66(c)(9)). Also, the phrase ``To 
report side effects, contact . . .'' is proposed for full product 
information for OTC new animal drugs rather than ``To report suspected 
adverse drug experiences, contact . . .,'' which is the phrase proposed 
for full prescribing information for Rx new animal drugs. The term 
``side effects'' may be better understood by the layperson than the 
term ``suspected adverse drug experiences.'' Also, the term ``side 
effects'' may be used in labeling of OTC human drugs (see Sec.  
201.66(c)(5)(vii) (21 CFR 201.66(c)(5)(vii)).
    The sponsor's contact information would be the name of the 
manufacturer, packer, or distributor, whichever is identified in the 
``Name and place of business'' section of full product information (see 
proposed Sec.  201.407(a)(16)). If more than one business is identified 
in the ``Name and place of business'' section of full product 
information, the drug sponsor would select the most appropriate of 
these businesses to use in the ``Questions/Comments?'' section to 
provide additional information about the OTC new animal drug and to 
contact regarding suspected adverse drug experiences.
    The statements in this section of full product information would be 
required to be structured as follows: ``Contact [insert name of 
business] at [insert business telephone number] or [insert business web 
address]. To report side effects, contact [insert name of business] at 
[insert business telephone number]. For additional information about 
reporting side effects for animal drugs, contact FDA at [insert current 
FDA telephone number for voluntary reporting of adverse drug 
experiences] or [insert current FDA web address for voluntary reporting 
of adverse drug experiences].'' Sponsors can search FDA's website or 
contact FDA by telephone to find the current FDA telephone number or 
web address for voluntary reporting of adverse drug experiences for 
animal drugs.
    o. NADA/ANADA approval statement. For approved new animal drugs or 
approved generic new animal drugs, the proposed rule would require this 
section of full product information to include an ``NADA approval 
statement'' or ``ANADA approval statement,'' respectively (see proposed 
Sec.  201.407(a)(15)). This section of full product information would 
be the same as described in proposed Sec.  201.405(a)(21) for full 
prescribing information for Rx new animal drugs.
    p. Name and place of business. The proposed rule would require this 
section of full product information to identify the name and place of 
business of the manufacturer, packer, or distributor (see proposed 
Sec.  201.407(a)(16)). This section of full product information would 
be the same as described in proposed Sec.  201.405(a)(22) for full 
prescribing information for Rx new animal drugs.
    q. ``Lot Number and Expiration Date.'' The proposed rule would 
require this section of full product information when provided on the 
secondary container labeling or the label. Package inserts are excluded 
from this requirement because they might apply to multiple lots of 
secondary or immediate containers of the OTC new animal drug. When full 
product

[[Page 18289]]

information is provided on the secondary container labeling or the 
label, this section would be required to have the heading ``Lot Number 
and Expiration Date,'' followed by the identifying lot or control 
number of the OTC new animal drug within the secondary container or 
immediate container (see proposed Sec.  201.407(a)(17)). A lot or 
control number would help us more easily to identify and trace back a 
specific lot of a product should a problem be reported to FDA. The 
proposed rule would also require this section to include the expiration 
date of the OTC new animal drug within the secondary container or 
immediate container, in accordance with Sec.  201.17. An expiration 
date better ensures that the new animal drug would not be used after it 
expires.
    Alternatively, the proposed rule would allow for this section of 
full product information to refer to the location on the secondary 
container labeling, secondary container, label, or immediate container 
where the lot or control number and expiration date are printed (see 
proposed Sec.  201.407(a)(17)). As an example, if the lot number and 
expiration date are printed on the bottom flap of a secondary 
container, then the secondary container labeling may state in this 
section, ``See carton bottom flap for lot number and expiration date.'' 
However, if full product information is provided on the secondary 
container labeling, in accordance with Sec.  201.17, the proposed rule 
would allow an expiration date to be excluded from the secondary 
container labeling or secondary container if the expiration date 
provided on the label or immediate container is easily legible through 
the secondary container.
    r. ``Revision Date.'' The proposed rule would require this section 
of full product information to have the heading ``Revision Date,'' 
followed by the date of the most recent revision of the component of 
labeling that provides full product information, listing the month 
followed by the year (see proposed Sec.  201.407(a)(18)). This 
information is important to ensure that the most current approved 
version of the labeling is being used.
2. OTC New Animal Drug Label Not Providing Full Product Information 
(OTC Label) (Proposed Sec.  201.407(b))
    The proposed rule would establish content and format requirements 
for the information presented on the label for approved or 
conditionally approved OTC new animal drugs (OTC label) where the label 
does not provide full product information (see proposed Sec.  
201.407(b)). As described previously in section V.E.1 regarding 
labeling providing full product information, the label for an OTC new 
animal drug would include full product information only if there is no 
package insert or secondary container labeling.
    Proposed Sec.  201.407(b) would apply to OTC labels that are of 
adequate size to contain the proposed required information per that 
paragraph, whereas proposed Sec.  201.407(c) would apply to small 
labels for OTC new animal drugs that are not of adequate size to 
contain all the proposed required information in proposed Sec.  
201.407(b).
    OTC new animal drugs labels to which Sec.  201.407(b) would apply 
may consist of a single panel, a front panel and one side or back 
panel, or a front panel and multiple side and/or back panels, and the 
proposed rule would provide for such label designs (see proposed Sec.  
201.407(b)). For OTC labels with a front panel and one side or back 
panel, the proposed rule would require certain information for the 
front panel (see proposed Sec.  201.407(b)(1)), and the side or back 
panel (see proposed Sec.  201.407(b)(2)). For OTC labels consisting of 
a single panel, the proposed rule would require the information 
identified in proposed Sec.  201.407(b)(1) followed by the information 
identified in proposed Sec.  201.407(b)(2), in order, on the single 
panel. For OTC labels with a front panel and multiple side and/or back 
panels, the information identified in proposed Sec.  201.407(b)(1) 
followed by the information identified in proposed Sec.  201.407(b)(2) 
would be required in order, starting on the front panel, continuing on 
the panel immediately to the right of the front panel, and continuing 
to fill the panels to the right until all of the information in 
proposed Sec.  201.407(b)(1) and (2) was presented. In all instances, 
the information in proposed Sec.  201.407(b)(2)(iii) and (iv), 
concerning active ingredients and inactive ingredients, would need to 
appear on the same panel.
    a. Front panel. The proposed rule would require the following 
information to be presented on the front panel of the OTC label for an 
approved or conditionally approved OTC new animal drug and in the 
following order (see proposed Sec.  201.407(b)(1)). Unless otherwise 
indicated, this information would be the same as that required by 
proposed Sec.  201.405(a) for full prescribing information for approved 
or conditionally approved Rx new animal drugs or proposed Sec.  
201.407(a) for full product information for approved or conditionally 
approved OTC new animal drugs.
    i. Drug product identification. The proposed rule would require 
this section of the OTC label to include drug product identification 
(see Sec.  201.407(b)(1)(i)). This information may help the user to 
identify the product quickly and correctly and distinguish it from 
other, similar products. The information included in this section of 
the OTC label would include the same information as that in the drug 
product identification section of full product information, as 
described in proposed Sec.  201.407(a)(1), in addition to a statement 
that the drug product is sterile, if applicable. Full product 
information would require a drug product identification section and 
``Description'' section. Full product information for sterile OTC new 
animal drugs would be required to identify in the ``Description'' 
section that the drug is sterile. However, due to space limitations, no 
``Description'' section is proposed for the OTC label. Instead, the 
drug product identification section of the OTC label for sterile OTC 
new animal drugs would be required to state that the drug product is 
sterile. See proposed Sec.  201.407(b)(1)(i).
    ii. Conditional approval statement. For conditionally approved new 
animal drugs, the proposed rule would require this section of the OTC 
label to include a conditional approval statement, as described in 
proposed Sec.  201.405(a)(3)) for full prescribing information for Rx 
new animal drugs (see proposed Sec.  201.407(b)(1)(ii)).
    iii. ``Uses.'' The proposed rule would require this section of the 
OTC label to have the heading ``Uses,'' followed by the ``Uses'' 
section, as described in proposed Sec.  201.407(a)(3) for full product 
information. If there is insufficient space on the OTC label for the 
complete ``Uses'' section as described in proposed Sec.  201.407(a)(3), 
then the proposed rule would require the sponsor to include in this 
section of the OTC label the statement required in proposed Sec.  
201.407(a)(3)(i), i.e., ``For [indication(s)] in [target animal(s)]''. 
If there is insufficient space on the OTC label for the statement in 
proposed Sec.  201.407(a)(3)(i), then an abbreviated version of the 
statement would be required: ``For [abbreviated indication(s)] in 
[target animal(s)].'' In either situation where there is insufficient 
space on the OTC label for the complete ``Uses'' section as specified 
in proposed Sec.  201.407(a)(3), the required statement would be 
followed by one of the following statements: ``See package insert for 
complete `Uses''' if full product information is provided on a package 
insert; or ``See package labeling for

[[Page 18290]]

complete `Uses''' if full product information is provided on the 
secondary container labeling. See proposed Sec.  201.407(b)(1)(iii). 
The complete ``Uses'' section as described in proposed Sec.  
201.407(a)(3) may exceed the available space on the OTC label if, for 
example, it includes specific conditions of use (proposed Sec.  
201.407(a)(3)(ii)), a statement describing the relative effectiveness 
of doses within the approved range of doses (proposed Sec.  
201.407(a)(3)(iii)), animals for which the new animal drug is not 
approved or conditionally approved (proposed Sec.  201.407(a)(3)(iv), 
and/or the indication(s) is lengthy and/or complex.
    iv. Extralabel use statement. The proposed rule would require this 
section of the OTC label to include the extralabel use statement, as 
described in proposed Sec.  201.407(a)(4) for full product information 
(see proposed Sec.  201.407(b)(1)(iv)).
    v. Extralabel use prohibition statement. For approved OTC new 
animal drugs prohibited from extralabel use, in accordance with Sec.  
530.41, the proposed rule would require this section of the OTC label 
to include the extralabel use prohibition statement, as described in 
proposed Sec.  201.405(a)(5) for full prescribing information for Rx 
new animal drugs (see proposed Sec.  201.407(b)(1)(v)).
    vi. ``Withdrawal Periods and Residue Warnings'' or ``Withdrawal 
Periods.'' For new animal drugs approved or conditionally approved for 
use in food-producing animals, the proposed rule would require this 
section of the OTC label to have the heading ``Withdrawal Periods and 
Residue Warnings'' or ``Withdrawal Periods,'' followed by all human 
food safety warnings, including milk discard times, withdrawal periods, 
and residue warning statements, as described in proposed Sec.  
201.405(a)(10)(i) for full prescribing information for Rx new animal 
drugs. If there is insufficient space on the front panel of the OTC 
labels with only a front panel and one side or back panel, the proposed 
rule would require this section to be provided on the side or back 
panel of the OTC label immediately following the complete product 
information statement specified in proposed Sec.  201.407(b)(2)(i). See 
proposed Sec.  201.407(b)(1)(vi).
    vii. ``Net Contents.'' The proposed rule would require this section 
of the OTC label to have the heading ``Net Contents,'' followed by the 
contents of the immediate container, in accordance with Sec.  201.62 
(see proposed Sec.  201.407(b)(1)(vii)).
    viii. NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the proposed rule would require 
this section of the OTC label to include the NADA or ANADA approval 
statement, as described in proposed Sec.  201.405(a)(21) for full 
prescribing information for Rx new animal drugs (see proposed Sec.  
201.407(b)(1)(viii)).
    b. Side or back panel. The proposed rule would require the 
following information to be presented on the side or back panel of the 
OTC label for an approved or conditionally approved OTC new animal drug 
in the following order (see proposed Sec.  201.407(b)(2)). Unless 
otherwise indicated, this information would be the same as that 
required by proposed Sec.  201.405(a) for full prescribing information 
for approved or conditionally approved Rx new animal drugs or proposed 
Sec.  201.407(a) for full product information for approved or 
conditionally approved OTC new animal drugs.
    i. Complete product information statement. The proposed rule would 
require this section of the OTC label to include one of two statements 
(see proposed Sec.  201.407(b)(2)(i)). If full product information is 
provided on the package insert, the following statement would be used: 
``Before using this drug, read package insert for complete product 
information.'' If full product information is provided on the secondary 
container labeling, the following statement would be used: ``Before 
using this drug, read package labeling for complete product 
information.'' Because full product information would not be provided 
on the OTC label, the purpose of the statements would be to remind the 
user to read full product information before using the OTC new animal 
drug.
    ii. ``Directions.'' The proposed rule would require this section of 
the OTC label to have the heading ``Directions,'' followed by the 
``Directions'' section as described in proposed Sec.  201.407(a)(10) 
for full product information. If there is insufficient space on the OTC 
label for the complete requirements as specified in Sec.  
201.407(a)(10), or if it is necessary for additional information 
provided in full product information that is not provided on the OTC 
label to be read before administering the drug (e.g., complete warnings 
and/or additional recommendations), then FDA may exclude this section 
from the OTC label (see proposed Sec.  201.407(b)(2)(ii)). For example, 
if an OTC new animal drug is approved for multiple indications and/or 
target animals, there may be different target animal safety warnings or 
precautions associated with each indication and/or target animal. This 
information would be provided in full product information for the OTC 
new animal drug (in the ``Animal Safety Warnings'' subsection and 
``Additional Recommendations'' section, respectively), but there may be 
insufficient space for it on the OTC label. Excluding the 
``Directions'' section from the OTC label in this situation helps to 
ensure that the user would read full product information, which would 
include the ``Directions'' section as well as the ``Animal Safety 
Warnings'' subsection and ``Additional Recommendations'' section, 
before treating the animal. The user would also be reminded to read 
full product information before using the drug via the complete product 
information statement that would be required in the previous section of 
the OTC label by proposed Sec.  201.407(b)(2)(i).
    iii. ``Active Ingredient'' or ``Active Ingredients.'' The proposed 
rule would require this section of the OTC label to have the heading 
``Active Ingredient'' or ``Active Ingredients,'' followed by the 
established name and strength or concentration of each active 
ingredient (see proposed Sec.  201.407(b)(2)(iii)).
    iv. ``Inactive Ingredients.'' When inactive ingredients are 
provided on the OTC label, the proposed rule would require they be 
listed in the ``Inactive Ingredients'' section in decreasing order of 
predominance, by weight or concentration, as described in proposed 
Sec.  201.405(a)(6)(viii) for full prescribing information for Rx new 
animal drugs (see proposed Sec.  201.407(b)(2)(iv)).
    v. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of the OTC label to have the heading ``Storage, 
Handling, and Disposal,'' followed by drug storage, handling, and 
disposal information, as described in proposed Sec.  201.405(a)(20) for 
full prescribing information for Rx new animal drugs (see proposed 
Sec.  201.407(b)(2)(v)).
    vi. Name and place of business. The proposed rule would require 
this section of the OTC label to identify the name and place of 
business of the manufacturer, packer, or distributor, as required in 
section 502(b) of the FD&C Act (see proposed Sec.  201.407(b)(2)(vi)).
    vii. ``Lot Number and Expiration Date'' or ``Lot Number''. The 
proposed rule would require this section of the OTC label to have the 
heading ``Lot Number and Expiration Date'' or ``Lot Number,'' followed 
by the identifying lot or control number of the OTC new animal drug 
within the immediate container (see proposed Sec.  201.407(b)(2)(vii)). 
A lot or control number would allow us more easily to identify and 
trace back a specific lot of a product should a problem be reported

[[Page 18291]]

to FDA. We would also require this section of the OTC label to include 
the expiration date of the OTC new animal drug within the immediate 
container, in accordance with Sec.  201.17. An expiration date on the 
OTC label better ensures that the new animal drug would not be used 
after it expires. Alternatively, the proposed rule would allow for this 
section to refer to the location on the OTC label or immediate 
container where the lot or control number and expiration date are 
printed (see proposed Sec.  201.407(b)(2)(vii)). As an example, if the 
lot number and expiration date are printed at the top of the immediate 
container, then the OTC label may state in this section, ``See top of 
container for lot number and expiration date.'' If the immediate 
container provides a single dose of the OTC new animal drug and is 
packaged individually in a secondary container that provides an 
expiration date on the secondary container labeling or secondary 
container, the proposed rule would not require an expiration date on 
the OTC label or immediate container, in accordance with Sec.  201.17. 
Under such provision, this section of the OTC label would be required 
to be entitled ``Lot Number.''
    viii. ``Revision Date.'' The proposed rule would require the last 
section of the OTC label to have the heading ``Revision Date,'' 
followed by the date of the most recent revision of the OTC label, 
listing the month followed by the year (see proposed Sec.  
201.407(b)(2)(viii)).
3. OTC New Animal Drug Small Label (OTC Small Label) (Proposed Sec.  
201.407(c))
    The proposed rule would establish content and format requirements 
for the small label for OTC new animal drugs (OTC small label) where 
the label does not provide full product information (see proposed Sec.  
201.407(c)).
    Some immediate containers, such as blister packs, pre-filled 
syringes, and small vials, are so small that only a minimal amount of 
information can be included on their label. The proposed rule would 
establish requirements for OTC small labels for approved or 
conditionally approved OTC new animal drugs (see proposed Sec.  
201.407(c)). We recognize that the size of the label is dependent upon 
the size of the immediate container. If an immediate container lacks 
sufficient space to contain a label that accommodates all of the 
information required by proposed Sec.  201.407(a) or (b), the 
requirements of proposed Sec.  201.407(c) would instead apply. We would 
ordinarily make this determination during the review of the new animal 
drug and its labeling, taking into consideration the readability and 
legibility of the information.
    The proposed rule would require the following information to be 
presented on the OTC small label for an approved or conditionally 
approved OTC new animal drug and in the following order (see proposed 
Sec.  201.407(c)).
    a. Proprietary name of the finished drug product. The proposed rule 
would require this section of the OTC small label to include the 
proprietary name of the finished drug product (see proposed Sec.  
201.407(c)(1)). This requirement already exists for small labels for 
drugs in general in Sec.  201.10(i)(1), but is repeated in these 
proposed regulations to include all requirements for labeling of 
approved or conditionally approved new animal drugs in proposed subpart 
H.
    b. Established name of the drug product. The proposed rule would 
require this section of the OTC small label to include the established 
name of the drug product (see proposed Sec.  201.407(c)(2)). This 
requirement already exists for small labels for drugs in general in 
Sec.  201.10(i)(1), but is repeated in these proposed regulations to 
include all requirements for labeling of approved or conditionally 
approved new animal drugs in proposed subpart H.
    c. Active ingredient(s). The proposed rule would require this 
section of the OTC small label to include the established name and 
strength or concentration of each active ingredient (see proposed Sec.  
201.407(c)(3)). This information should reduce the risk of 
miscalculating doses.
    d. ``For [target animal(s)] only.'' The proposed rule would require 
this section of the OTC small label to include a brief listing of the 
approved target animal(s) as follows: ``For [target animal(s)] only'' 
(see proposed Sec.  201.407(c)(4)). The brief listing of the approved 
target animal(s) is used in place of full ``Uses'' information because 
OTC small labels lack sufficient space. This listing would not require 
as much space on the OTC small label.
    e. Complete product information statement. The proposed rule would 
require this section of the OTC small label to include one of two 
statements. If full product information is provided on the package 
insert, the following statement would be used: ``Read package insert 
for complete product information''. If full product information is 
provided on the secondary container labeling, the following statement 
would be used: ``Read package labeling for complete product 
information.'' See proposed Sec.  201.407(c)(5). Because full product 
information would not be provided on the OTC small label, the purpose 
of the statements would be to remind the user to read full product 
information before using the OTC new animal drug.
    f. ``Net Contents.'' The proposed rule would require this section 
of the OTC small label to have the heading ``Net Contents,'' followed 
by the contents of the immediate container, in accordance with Sec.  
201.62 (see proposed Sec.  201.407(c)(6)).
    g. Name and place of business. The proposed rule would require this 
section of the OTC small label to identify the name and place of 
business of the manufacturer, packer, or distributor, as required in 
section 502(b) of the FD&C Act (see proposed Sec.  201.407(c)(7)).
    h. ``Lot, Exp. and Storage'' or ``Lot and Storage.'' The proposed 
rule would require this section of the OTC small label to have the 
heading ``Lot, Exp. and Storage'' or ``Lot and Storage,'' followed by 
the identifying lot or control number of the OTC new animal drug within 
the immediate container. A lot or control number would allow FDA more 
easily to identify and trace back a specific lot of a product should a 
problem be reported to FDA. The proposed rule would also require this 
section of the OTC small label to include the expiration date of the 
OTC new animal drug within the immediate container, in accordance with 
Sec.  201.17. An expiration date on the OTC small label better ensures 
that the new animal drug would not be used after it expires.
    The proposed rule would also require this section of the OTC small 
label to include and drug storage information for the new animal drug 
(see proposed Sec.  201.407(c)(8)). Storage information is necessary to 
maintain potency of the drug before its expiration date. Requiring this 
information on the OTC small label is needed for safe and effective use 
of new animal drugs. If the immediate container provides a single dose 
of the OTC new animal drug and is packaged individually in a secondary 
container that provides an expiration date on the secondary container 
labeling or secondary container, the proposed rule would not require an 
expiration date on the immediate container or OTC small label, in 
accordance with Sec.  201.17, in which case this section of the OTC 
small label would be required to be entitled ``Lot and Storage.''
    i. ``Revision Date.'' The proposed rule would require this section 
of the OTC small label to have the heading ``Revision Date,'' followed 
by the date of the most recent revision of the OTC small label, listing 
the month followed

[[Page 18292]]

by the year (see proposed Sec.  201.407(c)(9)).
4. Labeling for Secondary Containers for OTC New Animal Drugs That 
Include a Package Insert (OTC Secondary Container Labeling) (Proposed 
Sec.  201.407(d))
    The proposed rule would establish content and format requirements 
for the information on the labeling for secondary containers of 
approved or conditionally approved OTC new animal drugs that include a 
package insert (OTC secondary container labeling) (see proposed Sec.  
201.407(d)). In this situation, the package insert would be required by 
the proposed regulations to include full product information as in 
proposed Sec.  201.407(a)).
    In accordance with section 201(k) of the FD&C Act, the OTC 
secondary container labeling could exclude any information described in 
proposed Sec.  201.407(d) that would be required to appear on the OTC 
label or OTC small label (see proposed Sec.  201.407(b) or (c), 
respectively) if such information on the OTC label or OTC small label 
was easily legible through the secondary container.
    The OTC secondary container labeling to which proposed Sec.  
201.407(d) would apply may consist of a front panel and one side or 
back panel, or a front panel and multiple side and/or back panels. 
Proposed Sec.  201.407(d) would provide for such OTC secondary 
container labeling designs. For OTC secondary container labeling with a 
front panel and one side or back panel, proposed Sec.  201.407(d)(1) 
would provide required information for the front panel, and proposed 
Sec.  201.407(d)(2) would provide required information for the side or 
back panel. For OTC secondary container labeling with a front panel and 
multiple side and/or back panels, the information identified in 
proposed Sec.  201.407(d)(1) followed by the information identified in 
proposed Sec.  201.407(d)(2) would be required in order, starting on 
the front panel, continuing on the panel immediately to the right of 
the front panel, and continuing to fill the panels to the right until 
all of the information in proposed Sec.  201.407(d)(1) and (2) was 
presented. In all instances, the information proposed in Sec.  
201.407(d)(2)(iv) and (v), concerning active ingredients and inactive 
ingredients, would need to appear on the same panel.
    a. Front panel. The proposed rule would require the following 
information to be presented on the front panel of the OTC secondary 
container labeling and in the following order (see proposed Sec.  
201.407(d)(1)). Unless otherwise indicated, this information would be 
the same as that required by proposed Sec.  201.405(a) for full 
prescribing information for approved or conditionally approved Rx new 
animal drugs or proposed Sec.  201.407(a) for full product information 
for approved or conditionally approved OTC new animal drugs.
    i. Drug product identification. The proposed rule would require 
this section of the OTC secondary container labeling to include drug 
product identification (see proposed Sec.  201.407(d)(1)(i)). The 
information would be the same as that included in the drug product 
identification section for full product information, as described in 
proposed Sec.  201.407(a)(1), and would also identify if the drug 
product is sterile. Full product information would require a drug 
product identification section and a ``Description'' section. Full 
product information for sterile OTC new animal drugs would be required 
to identify in the ``Description'' section that the drug is sterile. 
However, due to space limitations, no ``Description'' section would be 
required on the OTC secondary container labeling. Instead, the drug 
product identification section of the OTC secondary container labeling 
for sterile OTC new animal drugs would be required to state that the 
drug is sterile.
    ii. Conditional approval statement. For conditionally approved OTC 
new animal drugs, the proposed rule would require this section of the 
OTC secondary container labeling to include a conditional approval 
statement, as described in proposed Sec.  201.405(a)(3) for full 
prescribing information for Rx new animal drugs (see proposed Sec.  
201.407(d)(1)(ii)).
    iii. ``Uses.'' The proposed rule would require this section of the 
OTC secondary container labeling to have the heading ``Uses,'' followed 
by the ``Uses'' section, as described in proposed Sec.  201.407(a)(3) 
for full product information (see proposed Sec.  201.407(d)(1)(iii)).
    iv. Extralabel use statement. The proposed rule would require this 
section of the OTC secondary container labeling to include the 
extralabel use statement as described in proposed Sec.  201.407(a)(4) 
for full product information (see proposed Sec.  201.407(d)(1)(iv)).
    v. Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use, in accordance with Sec.  530.41, 
the proposed rule would require this section of the OTC secondary 
container labeling to include the extralabel use prohibition statement, 
as described in proposed Sec.  201.405(a)(5) for full prescribing 
information for Rx new animal drugs (see proposed Sec.  
201.407(d)(1)(v)).
    vi. ``Net Contents.'' The proposed rule would require this section 
of the OTC secondary container labeling to have the heading ``Net 
Contents,'' followed by the contents of the secondary container (see 
proposed Sec.  201.407(d)(1)(vi)).
    vii. NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the proposed rule would require 
this section of the OTC secondary container labeling to include the 
NADA or ANADA approval statement, as described in proposed Sec.  
201.405(a)(21) for full prescribing information for Rx new animal drugs 
(see proposed Sec.  201.407(d)(1)(vii)).
    b. Side or back panel. The proposed rule would require the 
following information to be presented on the side or back panel of the 
OTC secondary container labeling and in the following order (see 
proposed Sec.  201.407(d)(2)). Unless otherwise indicated, this 
information would be the same as that required by proposed Sec.  
201.405(a) for full prescribing information for approved or 
conditionally approved Rx new animal drugs or proposed Sec.  201.407(a) 
for full product information for approved or conditionally OTC new 
animal drugs.
    i. Complete product information statement. The proposed rule would 
require this section of the OTC secondary container labeling to include 
the statement, ``Before using this drug, read package insert for 
complete product information'' (see proposed Sec.  201.407(d)(2)(i)). 
Because full product information would not be provided on the OTC 
secondary container labeling, the purpose of the Complete product 
information statement would be to remind the user to read full product 
information before using the OTC new animal drug.
    ii. ``Directions.'' The proposed rule would require this section of 
the OTC secondary container labeling to have the heading 
``Directions,'' followed by the ``Directions'' section, as described in 
proposed Sec.  201.407(a)(10) for full product information (see 
proposed Sec.  201.407(d)(2)(ii)).
    iii. ``Warnings.'' The proposed rule would require this section of 
the OTC secondary container labeling to have the heading ``Warnings,'' 
followed by the ``Warnings'' section, as described in proposed Sec.  
201.407(a)(7) for full product information (see proposed Sec.  
201.407(d)(2)(iii)).
    iv. ``Active Ingredient'' or ``Active Ingredients.'' The proposed 
rule would require this section of the OTC

[[Page 18293]]

secondary container labeling to have the heading ``Active Ingredient'' 
or ``Active Ingredients,'' followed by the established name and 
strength or concentration of each active ingredient, as described in 
proposed Sec.  201.407(b)(2)(iii) for the OTC label (see proposed Sec.  
201.407(d)(2)(iv)).
    v. ``Inactive Ingredients.'' When inactive ingredients are provided 
on the OTC secondary container labeling, the proposed rule would 
require they be listed in the ``Inactive Ingredients'' section by their 
established name in decreasing order of predominance, by weight or 
concentration, as described in proposed Sec.  201.405(a)(6)(viii) (see 
proposed Sec.  201.407(d)(2)(v)).
    vi. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of the OTC secondary container labeling to have 
the heading ``Storage, Handling, and Disposal,'' followed by drug 
storage, handling, and disposal information, as described in proposed 
Sec.  201.405(a)(20) for full prescribing information for Rx animal 
drugs (see proposed Sec.  201.407(d)(2)(vi)).
    vii. Name and place of business. The proposed rule would require 
this section of the OTC secondary container labeling to identify the 
manufacturer, packer, or distributor, as described in proposed Sec.  
201.405(a)(22) for full prescribing information for Rx animal drugs 
(see proposed Sec.  201.407(d)(2)(vii)).
    viii. ``Lot Number and Expiration Date.'' The proposed rule would 
require this section of the OTC secondary container labeling to have 
the heading ``Lot Number and Expiration Date,'' followed by the 
identifying lot or control number of the OTC new animal drug within the 
secondary container. The proposed rule would also require this section 
of the OTC secondary container labeling to include the expiration date 
of the OTC new animal drug within the secondary container, in 
accordance with Sec.  201.17. Alternatively, the proposed rule would 
allow for this section to refer to the location on the OTC secondary 
container labeling or secondary container where the lot or control 
number and expiration date are printed (see proposed Sec.  
201.407(d)(2)(viii)). As an example, if the lot number and expiration 
date are printed on the bottom flap of a secondary container, then the 
labeling may state in this section, ``See carton bottom flap for lot 
number and expiration date.'' However, in accordance with Sec.  201.17, 
the proposed rule would allow an expiration date to be excluded from 
the OTC secondary container labeling or secondary container if the 
expiration date provided on the OTC label, OTC small label, or 
immediate container is easily legible through the secondary container.
    ix. ``Revision Date.'' The proposed rule would require this section 
of the OTC secondary container labeling to have the heading ``Revision 
Date,'' followed by the date of the most recent revision of the OTC 
secondary container labeling, listing the month followed by the year 
(see proposed Sec.  201.407(d)(2)(ix)).
5. Shipping Labeling for OTC New Animal Drugs (OTC Shipping Labeling) 
(Proposed Sec.  201.407(e)
    The proposed rule would establish content and format requirements 
for the information on the shipping labeling for approved or 
conditionally approved OTC new animal drugs (OTC shipping labeling). As 
defined in proposed Sec.  201.403, shipping labeling is associated with 
the outermost carton containing immediate containers, secondary 
containers, and/or multiple unit (multi-unit) cartons of a new animal 
drug and intended for shipment, but not display, of the product. The 
proposed rule would require the OTC shipping labeling to include, among 
additional information, drug product identity, the manufacturer, 
packer, or distributor, and drug storage and handling conditions. See 
proposed Sec.  201.407(e).
    The proposed rule would require the following information to be 
presented on the OTC shipping labeling and in the following order (see 
proposed Sec.  201.407(e)). Unless otherwise indicated, this 
information would be the same as that required by proposed Sec.  
201.405(a) for full prescribing information for approved or 
conditionally approved Rx new animal drugs or proposed Sec.  201.407(a) 
for full product information for approved or conditionally approved OTC 
new animal drugs.
    a. Proprietary name of the finished drug product. The proposed rule 
would require this section of the OTC shipping labeling to include the 
proprietary name of the finished drug product (see proposed Sec.  
201.407(e)(1)).
    b. Established name of the drug product. The proposed rule would 
require this section of the OTC shipping labeling to include the 
established name of the drug product (see proposed Sec.  
201.407(e)(2)).
    c. Established name and strength or concentration of each active 
ingredient. The proposed rule would require this section of the OTC 
shipping labeling provide the established name and strength or 
concentration of each active ingredient (see proposed Sec.  
201.407(e)(3)).
    d. Conditional approval statement. For conditionally approved OTC 
new animal drugs, the proposed rule would require this section of the 
OTC shipping labeling to include a conditional approval statement, as 
described in proposed Sec.  201.405(a)(3) for full prescribing 
information for Rx new animal drugs (see proposed Sec.  201.407(e)(4)).
    e. ``Net Contents.'' The proposed rule would require this section 
of the OTC shipping labeling to have the heading ``Net Contents,'' 
followed by the contents of the shipping carton (see proposed Sec.  
201.407(e)(5)).
    f. ``Storage and Handling.'' The proposed rule would require this 
section of the OTC shipping labeling to have the heading ``Storage and 
Handling,'' followed by drug storage information (see proposed Sec.  
201.407(e)(6)). Also, any handling information required for safe and 
effective use of the new animal drug would be included in this section. 
Information on disposal of the new animal drug would not be required to 
be included on the OTC shipping labeling.
    g. NADA/ANADA approval statement. For approved new animal drugs or 
approved generic new animal drugs, the proposed rule would require this 
section of the OTC shipping labeling to include the NADA or ANADA 
approval statement, as described in proposed Sec.  201.405(a)(21) for 
full prescribing information for Rx new animal drugs (see proposed 
Sec.  201.407(e)(7)).
    h. Name and place of business. The proposed rule would require this 
section of the OTC shipping labeling to identify the name and place of 
business of the manufacturer, packer, or distributor, as described in 
proposed Sec.  201.405(a)(22) for full prescribing information for Rx 
new animal drugs (see proposed Sec.  201.407(e)(8)).
    i. ``Lot Number and Expiration Date.'' The proposed rule would 
require this section of the OTC shipping labeling to have the heading 
``Lot Number and Expiration Date,'' followed by the identifying lot or 
control number(s) and the expiration date(s) of the OTC new animal drug 
within the shipping carton (see proposed Sec.  201.407(e)(9)). The 
shipping carton may contain more than one lot of the OTC new animal 
drug, and therefore, more than one lot or control number and expiration 
date may be listed in this section of the OTC shipping labeling.
    j. ``Revision Date.'' The proposed rule would require the last 
section of the OTC shipping labeling to have the heading ``Revision 
Date,'' followed by

[[Page 18294]]

the date of the most recent revision of the OTC shipping labeling, 
listing the month followed by the year (see proposed Sec.  
201.407(e)(10)).
6. Other Approved Labeling for OTC New Animal Drugs (OTC Other Approved 
Labeling) (Proposed Sec.  201.407(f))
    The proposed rule would establish content and format requirements 
for the information presented on other approved labeling for approved 
or conditionally approved OTC new animal drugs (OTC other approved 
labeling) (see proposed Sec.  201.407(f)). OTC other approved labeling 
includes, but is not limited to, labeling on display cartons and multi-
unit cartons (excluding shipping cartons), containing the immediate 
containers or the secondary containers of the OTC new animal drug.
    The proposed rule would require the following information to be 
presented on the OTC other approved labeling and in the following order 
(see proposed Sec.  201.407(f)). Unless otherwise indicated, this 
information would be the same as that required by proposed Sec.  
201.405(a) for full prescribing information for approved or 
conditionally approved Rx new animal drugs or proposed Sec.  201.407(a) 
for full product information for approved or conditionally approved OTC 
new animal drugs.
    a. Proprietary name of the finished drug product. The proposed rule 
would require this section of the OTC other approved labeling to 
include the proprietary name of the finished drug product (see proposed 
Sec.  201.407(f)(1)).
    b. Established name of the drug product. The proposed rule would 
require this section of the OTC other approved labeling to include the 
established name of the drug product (see proposed Sec.  
201.407(f)(2)).
    c. Established name and strength or concentration of each active 
ingredient. The proposed rule would require this section of the OTC 
other approved labeling to provide the established name and strength or 
concentration of each active ingredient (see proposed Sec.  
201.407(f)(3)).
    d. Conditional approval statement. For conditionally approved new 
animal drugs, the proposed rule would require this section of the OTC 
other approved labeling to include a conditional approval statement, as 
described in proposed Sec.  201.405(a)(3) for full prescribing 
information for Rx animal drugs (see proposed Sec.  201.407(f)(4)).
    e. Extralabel use statement. The proposed rule would require this 
section of the OTC other approved labeling to include the extralabel 
use statement as described in proposed Sec.  201.407(a)(4) for full 
product information (see proposed Sec.  201.407(f)(5)).
    f. Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use, in accordance with Sec.  530.41, 
the proposed rule would require this section of the OTC other approved 
labeling to include the extralabel use prohibition statement, as 
described in proposed Sec.  201.405(a)(5) for full prescribing 
information for Rx new animal drugs (see proposed Sec.  201.407(f)(6)).
    g. ``Net Contents.'' The proposed rule would require this section 
of the OTC other approved labeling to have the heading ``Net 
Contents,'' followed by the contents of the container to which the OTC 
other approved labeling applies (see proposed Sec.  201.407(f)(7)).
    h. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of the OTC other approved labeling to have the 
heading ``Storage, Handling, and Disposal,'' followed by drug storage, 
handling, and disposal information, as described in proposed Sec.  
201.405(a)(20) for full prescribing information for Rx new animal drugs 
(see proposed Sec.  201.407(f)(8)).
    i. NADA/ANADA approval statement. For approved new animal drugs or 
approved generic new animal drugs, the proposed rule would require this 
section of the OTC other approved labeling to include the NADA or ANADA 
approval statement, as described in proposed Sec.  201.405(a)(21) for 
full prescribing information for Rx new animal drugs (see proposed 
Sec.  201.407(f)(9)).
    j. Name and place of business. The proposed rule would require this 
section of the OTC other approved labeling to identify the name and 
place of business of the manufacturer, packer, or distributor, as 
described in proposed Sec.  201.405(a)(22) for full prescribing 
information for Rx new animal drugs (see proposed Sec.  
201.407(f)(10)).
    k. ``Lot Number and Expiration Date.'' The proposed rule would 
require this section of the OTC other approved labeling to have the 
heading ``Lot Number and Expiration Date,'' followed by the identifying 
lot or control number of the OTC new animal drug within the container 
to which the OTC other approved labeling applies. This section of the 
OTC other approved labeling would also be required to include the 
expiration date of the OTC new animal drug within the container to 
which the OTC other approved labeling applies, in accordance with Sec.  
201.17. In accordance with Sec.  201.17, the proposed rule would allow 
an expiration date to be excluded from the OTC other approved labeling 
if the expiration date provided on containers within or their labeling 
is easily legible through the container to which the OTC other approved 
labeling applies (see proposed Sec.  201.407(f)(11)).
    l. ``Revision Date.'' The proposed rule would require the last 
section of the OTC other approved labeling to have the heading 
``Revision Date,'' followed by the date of the most recent revision of 
the OTC other approved labeling, listing the month followed by the year 
(see proposed Sec.  201.405(f)(12)).

F. Content and Format of Labeling for New Animal Drugs for Use in 
Animal Feeds--Overview (Proposed Sec.  201.409)

    The proposed rule provides content and format requirements for all 
components of labeling for approved or conditionally approved new 
animal drugs for use in animal feeds and that are subject to part 558, 
including VFD drugs. New animal drugs for use in animal feeds are 
approved in accordance with section 512 of the FD&C Act or 
conditionally approved in accordance with section 571 of the FD&C Act 
(see proposed Sec.  201.409). Most combination new animal drugs are 
currently approved for use in animal feeds or drinking water in 
accordance with section 512(d)(4) of the FD&C Act. The majority of new 
animal drugs approved or conditionally approved for use in animal feeds 
are intended for use in food-producing animals and to be fed to 
multiple animals at one time.
    As described above, proposed Sec.  201.405 (``Content and format 
for prescription (Rx) new animal drug labeling'') would not apply to 
approved or conditionally approved new animal drugs intended for use in 
or on animal feeds under the professional supervision of a licensed 
veterinarian because, in accordance with section 504(a) of the FD&C 
Act, such drugs are approved or conditionally approved as VFD drugs. 
The proposed rule would establish the content and format requirements 
for all components of labeling for approved or conditionally approved 
new animal drugs intended for use in animal feeds that are subject to 
part 558, including VFD drugs (see proposed Sec.  201.409).
    The proposed rule would require that labeling sections or 
subsections that do not apply be omitted from the labeling for approved 
or conditionally approved new animal drugs for use in animal feeds (see 
proposed Sec.  201.409). For example, new animal drugs approved or 
conditionally approved for use in animal feeds that are not VFD drugs 
would not require a VFD cautionary statement section.

[[Page 18295]]

    FDA determines the final content of each applicable section of 
labeling during the review of each new animal drug as part of the 
approval process.
    Sponsors of new animal drugs for use in animal feeds often submit 
an application for approval or conditional approval of a ``Type A 
medicated article,'' which is a concentrated form of the drug intended 
solely for use in the manufacture of another Type A medicated article 
or medicated feeds (i.e., ``Type B medicated feeds'' and/or ``Type C 
medicated feeds,'' see below), The Type A medicated article consists of 
a new animal drug(s), with or without a carrier, with or without 
inactive ingredients (see Sec.  558.3(b)(2) (21 CFR 558.3(b)(2))).
    Type B medicated feed is intended solely for the manufacture of 
other medicated feeds (Type B or Type C). It serves as an intermediate 
medicated feed not approved for feeding to the target animals. It is 
manufactured by diluting a Type A medicated article or another Type B 
medicated feed with non-medicated feed, and at least 25 percent of its 
weight is from nutritional ingredients (see Sec.  558.3(b)(3)). The 
maximum approvable concentrations of new animal drugs in Type B 
medicated feeds must be established in accordance with Sec.  
558.3(b)(3). The specific maximum concentrations for approved new 
animal drugs in Type B medicated feeds are listed in Sec.  558.4(d).
    Type C medicated feed is fed directly to target animals. It may 
also be used in the manufacture of another Type C medicated feed. When 
fed directly to target animals, it is intended to be the animals' 
complete feed or part of their total diet. It is manufactured by 
diluting a Type A medicated article, a Type B medicated feed, or 
another Type C medicated feed with non-medicated feed, and it contains 
a substantial quantity of nutritional ingredients (see Sec.  
558.3(b)(4)).
    Labeling for new animal drugs intended for use in feed must be 
included in the new animal drug application (see Sec.  514.1(b)(3)(v)). 
Such labeling may include a Type A medicated article label, 
representative labeling for Type B and Type C medicated feeds 
containing the new animal drug, proprietary labeling for Type B or Type 
C medicated feeds, and/or other approved labeling associated with the 
Type A medicated article.
    Proposed Sec.  201.409(a) identifies the information that would be 
required to be included on Type A medicated article labels. A Type A 
medicated article label is on the immediate container, which is 
typically a bag. The Type A medicated article label provides all 
information necessary for the safe and effective use of the new animal 
drug.
    Similar to the labeling of other approved or conditionally approved 
new animal drugs, the Type A medicated article label includes product 
and manufacturer, packer or distributor identification, approved or 
conditionally approved indications for use, warnings, and directions 
for use. In addition, the directions for use for a Type A medicated 
article must include mixing directions for the manufacture of medicated 
feeds from the Type A medicated article, as well as feeding directions 
for the finished Type C medicated feeds manufactured from the Type A 
medicated article (see Sec.  514.1(b)(3)(v)(a)).
    Proposed Sec.  201.409(b) and (c) identify the information that 
would be required to be included on representative Type B medicated 
feed labeling and representative Type C medicated feed labeling, 
respectively. Sponsors of a Type A medicated article must include in 
their application representative labeling proposed for use in 
manufacturing Type B and Type C medicated feeds containing the new 
animal drug (see Sec.  514.1(b)(3)(v)(b)). FDA approves or 
conditionally approves the use of the Type A medicated article to 
manufacture Type B and Type C medicated feeds and also approves or 
conditionally approves the Type A medicated article label and the 
representative labeling for the Type B and Type C medicated feeds.
    Representative Type B and Type C medicated feed labeling is 
template labeling approved by FDA as part of an NADA or CNADA for a 
Type A medicated article. Representative Type B and Type C medicated 
feed labeling approved in the NADA or CNADA provide feed mills the 
minimal information that must be included on the final printed labels 
prepared for the respective Type B and Type C medicated feeds 
manufactured containing the Type A medicated article to provide for 
safe and effective use of the new animal drug for its approved or 
conditionally approved indication(s) for use. FDA also uses the term 
``Blue Bird labels'' to refer to representative Type B and Type C 
medicated feed labeling (see 64 FR 63195 at 63197, November 19, 1999).
    Because the approved or conditionally approved Type C medicated 
feeds will be used as part of the diet, or as the complete diet, of the 
target animals, the representative Type B and Type C medicated labeling 
also provide for the nutritional requirements or content to be 
specified in the final printed labels for the medicated feed.
    If a final printed label for a Type B or Type C medicated feed 
fails to conform to the approved representative Type B or Type C 
medicated feed labeling, the medicated feed will be deemed unsafe, in 
accordance with section 512(a)(2) of the FD&C Act, and adulterated, in 
accordance with section 501(a)(6) of the FD&C Act.
    If Type A medicated article(s) are approved or conditionally 
approved for more than one indication and/or target animal, the 
concentration of the new animal drug(s) may differ in the medicated 
feed approved or conditionally approved for these indication(s) and/or 
target animal(s). Also, the nutritional requirements or content 
specified in the representative labeling for the medicated feeds may 
vary for different target animals. These applications for Type A 
medicated articles may include representative Type B medicated feed 
labeling and representative Type C medicated feed labeling for each of 
the approved uses.
    Some Type A medicated articles are approved or conditionally 
approved to be manufactured only directly into Type C medicated feeds. 
In addition to the Type A medicated article label, the applications for 
these Type A medicated articles must provide representative labeling 
only for Type C medicated feeds.
    If new animal drugs for use in animal feeds or drinking water are 
approved for combination use, in accordance with section 512(d)(4) of 
the FD&C Act, these ``combination new animal drugs'' generally provide 
for more than one approved Type A medicated article to be mixed into 
medicated feed or drinking water for the approved target animal. The 
only labeling approved for such combination new animal drugs is 
representative labeling for the medicated feeds that combines 
information from the representative labeling of each individual Type A 
medicated article. Combination new animal drugs exclude conditionally 
approved drugs subject to section 571 of the FD&C Act. Section 
512(d)(4) of the FD&C Act was amended as part of the MUMS Act of 2004 
to clarify that only products approved under section 512(b)(1) of the 
FD&C Act can be used in new animal drug combinations.
    Proposed Sec.  201.409(f) identifies the information that would be 
required to be included on other approved labeling for Type A medicated 
articles. Other approved labeling for Type A medicated articles may 
include shipping labeling associated with shipment of bags of the Type 
A medicated article.

[[Page 18296]]

    Proposed Sec.  201.409(d) identifies the information that would be 
required to be included on proprietary Type B medicated feed labels. In 
addition to approving or conditionally approving applications for Type 
A medicated articles, FDA may also approve or conditionally approve 
applications for proprietary final formulations of Type B medicated 
feeds. A proprietary Type B medicated feed is intended solely for the 
manufacture of Type C medicated feeds or other Type B medicated feeds 
and is not approved or conditionally approved for feeding to the target 
animals. For some proprietary Type B medicated feeds, the formulation 
and labeling are approved in an NADA or CNADA. In other situations, the 
underlying data and labeling for the proprietary Type B medicated feed 
to support the approved uses are maintained in a VMF. For example, this 
would include situations in which a proprietary Type B medicated feed 
is manufactured via modification to an approved formulation published 
in the CFR or where a feed manufacturer creates its own proprietary 
formulation. The application for a proprietary Type B medicated feed 
will include the proprietary label for the final Type B medicated feed 
and representative Type C medicated feed labeling that directs the 
preparation of final printed labels for Type C medicated feeds 
manufactured from the proprietary Type B medicated feed. Applications 
for proprietary final formulations of Type B medicated feeds will not 
include a Type A medicated article label.
    Proposed Sec.  201.409(e) identifies the information that would be 
required to be included on proprietary Type C medicated feed labels. 
FDA may also approve or conditionally approve applications for 
proprietary final formulations of Type C medicated feeds. For some 
proprietary Type C medicated feeds, the formulation and labeling are 
approved in an NADA or CNADA. In other situations, the underlying data 
and labeling for the proprietary Type C medicated feed to support the 
approved uses are maintained in a VMF. For example, this would include 
situations in which a proprietary Type C medicated feed is manufactured 
via modification to an approved formulation published in the CFR or 
where a feed manufacturer creates its own proprietary formulation. The 
application for a proprietary Type C medicated feed will include the 
proprietary label for the final Type C medicated feed.
    Prior to the enactment of the ADAA, new animal drugs for use in 
animal feeds were approved almost exclusively for OTC use. The ADAA 
allowed for approval or conditional approval of a new type of new 
animal drugs for use in or on animal feeds called the ``veterinary feed 
directive drug'' (VFD drug). Although not identical, the use of VFD 
drugs shares similar requirements to the use of Rx new animal drugs.
    A veterinarian may only issue a VFD for use in animals under his or 
her supervision or oversight in the course of his or her professional 
practice, and in compliance with all applicable veterinary licensing 
and practice requirements (see Sec.  558.6(b) (21 CFR 558.6(b))). 
Information that must be included in a VFD is in Sec.  558.6(b).
    In accordance with Sec.  558.6(a)(6), the following cautionary 
statement must appear on all labeling and advertising associated with a 
VFD drug: ``Caution: Federal law restricts medicated feed containing 
this veterinary feed directive (VFD) drug to use by or on the order of 
a licensed veterinarian.''
    Some sections of proposed Sec.  201.409 are patterned after 
sections of proposed Sec.  201.405 for labeling of Rx new animal drugs 
or proposed Sec.  201.407 for labeling of OTC new animal drugs. These 
sections include the conditional approval statement or NADA/ANADA 
approval statement, indications for use, warnings, and other 
information associated with the effects of the new animal drug. Other 
sections of proposed Sec.  201.409 are uniquely associated with 
medicated articles and feeds, such as mixing directions, feeding 
directions, and information on nutritional content.
    The labeling sections and subsections for new animal drugs for use 
in animal feeds would not be numbered. Headings of sections and 
subsections that would be required to appear verbatim on labeling are 
identified in the proposed regulations in quotations. Similarly, 
certain other labeling text would be required to appear verbatim on 
labeling; this text is also identified in the proposed regulations in 
quotations.
    The proposed rule would require the labeling of approved or 
conditionally approved new animal drugs for use in animal feeds and 
that are subject to part 558 of this chapter to comply with other 
applicable requirements in proposed subpart H (see proposed Sec.  
201.409).
1. Type A Medicated Article Label (Proposed Sec.  201.409(a))
    The proposed rule would establish content and format requirements 
for the Type A medicated article label for new animal drugs approved or 
conditionally approved for use in animal feeds (see proposed Sec.  
201.409(a)). A Type A medicated article is a concentrated form of the 
new animal drug intended solely for use in the manufacture of another 
Type A medicated article or Type B medicated feeds and/or Type C 
medicated feeds. As defined in Sec.  558.3(b)(2), a Type A medicated 
article consists of a new animal drug(s), with or without a carrier, 
with or without inactive ingredients. A Type A medicated article label 
is on the immediate container, which is typically a bag.
    The Type A medicated article label provides all information 
necessary for the safe and effective use of the new animal drug.
    The proposed rule would require the following information to be 
presented on the Type A medicated article label for an approved or 
conditionally approved new animal drug and in the following order (see 
proposed Sec.  201.409(a)). Unless otherwise indicated, this 
information would be the same as that required by proposed Sec.  
201.405(a) for full prescribing information for approved or 
conditionally approved Rx new animal drugs or proposed Sec.  201.407(a) 
for full product information for approved or conditionally approved OTC 
new animal drugs.
    a. Type A medicated article identification. The proposed rule would 
require this section of the Type A medicated article label to include 
the proprietary name, the established name of the Type A medicated 
article, and the phrase ``Type A medicated article'' or ``Type A liquid 
medicated article,'' as applicable, if not included as part of the 
established name of the Type A medicated article (see proposed Sec.  
201.409(a)(1)).
    b. VFD cautionary statement. For VFD new animal drugs, the proposed 
rule would require this section of the Type A medicated article label 
to include the following cautionary statement, in accordance with Sec.  
558.6(a)(6): ``Caution: Federal law restricts medicated feed containing 
this veterinary feed directive (VFD) drug to use by or on the order of 
a licensed veterinarian.'' This statement would be required to be 
displayed prominently and conspicuously on the Type A medicated article 
label (see proposed Sec.  201.409(a)(2)).
    c. ``For further manufacturing only.'' The proposed rule would 
require this section of the Type A medicated label to include the 
statement, ``For further manufacturing only'' (see proposed Sec.  
201.409(a)(3)). This statement would indicate that the Type A medicated 
article can only be used to manufacture another Type A medicated 
article or a medicated feed. A Type A medicated article cannot be fed 
directly to animals.

[[Page 18297]]

    d. Conditional approval statement. For conditionally approved new 
animal drugs, the proposed rule would require this section of the Type 
A medicated article label to include a conditional approval statement, 
as described in proposed Sec.  201.405(a)(3) for full prescribing 
information for conditionally approved Rx new animal drugs (see 
proposed Sec.  201.409(a)(4)).
    e. ``Indications for Use.'' The proposed rule would require this 
section of the Type A medicated article label to have the heading 
``Indications for Use,'' followed by the approved or conditionally 
approved indication(s) and target animal(s), as described in proposed 
Sec.  201.407(a)(3) for full product information for OTC new animal 
drugs, with the exception of the heading of the section (see proposed 
Sec.  201.409(a)(5)).
    f. Extralabel use statement. The proposed rule would require this 
section of the Type A medicated article label to include an extralabel 
use statement (see proposed Sec.  201.409(a)(6)). Extralabel use of an 
approved new animal drug or human drug in or on an animal feed is not 
permitted (see section 512(a)(4) of the FD&C Act and part 530). The 
required statement would be: ``It is a violation of Federal law to use 
other than as directed in the labeling.'' It is important for the 
layperson and veterinarian to know that it is a violation of Federal 
law to use new animal drugs in or on animal feeds in an extralabel 
manner.
    g. ``Active Ingredient'' or ``Active Ingredients.'' The proposed 
rule would require this section of the Type A medicated article label 
to have the heading ``Active Ingredient'' or ``Active Ingredients,'' 
followed by the established name and concentration of each active 
ingredient in the Type A medicated article (see proposed Sec.  
201.409(a)(7)). If the Type A medicated article contains one active 
ingredient, the proposed rule would require this section of the Type A 
medicated article label to be entitled ``Active Ingredient.'' If the 
Type A medicated article contains more than one active ingredient, the 
proposed rule would require this section of the Type A medicated 
article label to be entitled ``Active Ingredients.'' Including the 
concentration of the active ingredient(s) is critical so that feed 
manufacturers can properly mix Type B and C medicated feeds from the 
Type A medicated article with the approved concentration(s) of the 
active ingredient(s).
    h. ``Inactive Ingredients.'' When inactive ingredients are provided 
on the Type A medicated article label, the proposed rule would require 
they be listed in the ``Inactive Ingredients'' section in decreasing 
order of predominance, by weight or concentration, as described in 
proposed Sec.  201.405(a)(6)(viii) for full prescribing information for 
Rx new animal drugs (see proposed Sec.  201.409(a)(8)).
    i. ``Directions.'' The proposed rule would require this section of 
the Type A medicated article label to have the heading ``Directions,'' 
followed by the directions for use of the Type A medicated article (see 
proposed Sec.  201.409(a)(9)). The ``Directions'' section of the Type A 
medicated article label would include three subsections.
    i. ``Approved Concentration(s) of [Active Ingredient or Active 
Moiety] in Type C Medicated Feeds.'' The proposed rule would require 
the first subsection of the ``Directions'' section of the Type A 
medicated article label to have the heading ``Approved Concentration(s) 
of [Active Ingredient or Active Moiety] in Type C Medicated Feeds,'' 
followed by the approved concentration(s) of each active ingredient in 
Type C medicated feed(s) to be manufactured from the Type A medicated 
article for the approved or conditionally approved indications for use 
(see proposed Sec.  201.409(a)(9)(i)). If an active ingredient is a 
salt or other noncovalent derivative, its concentration in the Type A 
medicated article in the ``Active Ingredient'' or ``Active 
Ingredients'' section (see proposed Sec.  201.409(a)(7)) may be 
expressed on the basis of the full active ingredient (i.e., including 
the salt or other noncovalent derivative) or the active moiety. If an 
active ingredient is a salt or other noncovalent derivative and its 
concentration in the Type A medicated article was expressed in the 
``Active Ingredient'' or Active Ingredients'' section based on the 
active moiety, the proposed rule would require the approved 
concentration(s) in the Type C medicated feeds to also be expressed 
based on the active moiety, and the title of this subsection would be 
required to include the name of the active moiety instead of the active 
ingredient (see proposed Sec.  201.409(a)(9)(i)). Consistent expression 
of the concentrations of active ingredients on the Type A medicated 
article label may reduce the risk of mixing errors when manufacturing 
medicated feeds from the Type A medicated article.
    Multiple Type C medicated feeds may be approved or conditionally 
approved for a Type A medicated article. Also, different 
concentrations, or ranges of concentrations, of the active ingredient 
may be approved or conditionally approved for different indications for 
use. This subsection of the Type A medicated article label would 
clarify this information for manufacturers of medicated feeds 
manufactured from the Type A medicated article.
    ii. ``Mixing Directions.'' The proposed rule would require this 
subsection of the ``Directions'' section of the Type A medicated 
article label to have the heading ``Mixing Directions,'' followed by 
the approved mixing directions for the manufacture of approved 
medicated feeds from the Type A medicated article for each approved or 
conditionally approved indication for use (see proposed Sec.  
201.409(a)(9)(ii)). An intermediate mixing step (called preblend step) 
is sometimes required to manufacture medicated feeds from the Type A 
medicated article. For example, the Type A medicated article may need 
to be preblended with a small amount of one or more feed ingredients 
before being added to the rest of the feed ingredients to increase the 
uniformity of the drug distribution in the finished medicated feed. The 
directions for such a preblend step would also be required to be 
included in this subsection of the Type A medicated article label.
    iii. ``Feeding Directions.'' The proposed rule would require the 
last subsection in the ``Directions'' section of the Type A medicated 
article label to have the heading ``Feeding Directions,'' followed by 
the approved feeding directions for each approved or conditionally 
approved indication for use for Type C medicated feeds approved or 
conditionally approved to be manufactured from the Type A medicated 
article (see proposed Sec.  201.409(a)(9)(iii)).
    j. ``Warnings.'' The proposed rule would require this section of 
the Type A medicated article label for all approved or conditionally 
approved Type A medicated articles, and it would have the heading 
``Warnings,'' followed by all warnings (see proposed Sec.  
201.409(a)(10)). This section of the Type A medicated article label 
would have the same subsections as described in Sec.  201.405(a)(10) in 
full prescribing information for Rx new animal drugs, except that the 
``Animal Safety Warnings'' subsection would be the same as described in 
proposed Sec.  201.407(a)(7)(iii) for full product information for OTC 
new animal drugs.
    k. ``Additional Recommendations.'' For new animal drugs having 
precautions, the proposed rule would require this section of the Type A 
medicated article label to have the heading ``Additional 
Recommendations,'' followed by all precautions (see proposed Sec.  
201.409(a)(11)). This section of the Type A medicated article label 
would be

[[Page 18298]]

the same as described in proposed Sec.  201.407(a)(8) for full product 
information for OTC new animal drugs. For VFD new animal drugs, this 
section would include precautions directed to veterinarians as well as 
the layperson.
    l. ``Other Effects You May Notice.'' For new animal drugs that have 
effects on the target animal(s) that are not considered 
contraindications, target animal safety warnings, adverse reactions, or 
post-approval adverse drug experiences, and FDA determines that these 
effects are required to be described on labeling, the proposed rule 
would require this section of the Type A medicated article label to 
have the heading ``Other Effects You May Notice,'' followed by a 
description of the effects (see proposed Sec.  201.409(a)(12)). This 
section of the Type A medicated article label would be the same as 
described in proposed Sec.  201.407(a)(9) for full product information 
for OTC new animal drugs.
    m. ``Net Weight.'' The proposed rule would require this section of 
the Type A medicated article label to have the heading ``Net Weight,'' 
followed by the net weight of the Type A medicated article in the 
immediate container (see proposed Sec.  201.409(a)(13)).
    n. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of the Type A medicated article label to have the 
heading ``Storage, Handling, and Disposal,'' followed by storage 
information for the Type A medicated article, as well as any required 
handling and disposal information (see proposed Sec.  201.409(a)(14)). 
This section of the Type A medicated article label would be the same as 
described in proposed Sec.  201.405(a)(20) for full prescribing 
information for Rx new animal drugs.
    o. ``Questions/Comments?'' The proposed rule would require this 
section of the Type A medicated article label to have the heading 
``Questions/Comments?,'' followed by the sponsor's contact information 
for feed manufacturers or other users of the Type A medicated article 
to facilitate requesting additional information or to report suspected 
adverse drug experiences. FDA's contact information for voluntary 
reporting of adverse drug experiences for animal drugs would also be 
required (see proposed Sec.  201.409(a)(15)). The ``Questions/
Comments?'' section of the Type A medicated article label would be 
similar to the ``Questions/Comments?'' section in proposed Sec.  
201.407(a)(14) for full product information for OTC new animal drugs.
    The sponsor's contact information would be the name of the 
manufacturer, packer, or distributor, whichever is identified in the 
``Name and place of business'' section of the Type A medicated article 
label (see proposed Sec.  201.409(a)(17)). If more than one business is 
identified in the ``Name and place of business'' section of the Type A 
medicated article label, the drug sponsor would select the most 
appropriate of these businesses to use in the ``Questions/Comments?'' 
section to provide additional information about the Type A medicated 
article and to contact regarding suspected adverse drug experiences.
    The statements in this section of the Type A medicated article 
label would be required to be structured as follows: ``Contact [insert 
name of business] at [insert business telephone number] or [insert 
business web address]. To report side effects, contact [insert name of 
business] at [insert business telephone number]. For additional 
information about reporting side effects for animal drugs, contact FDA 
at [insert current FDA telephone number for voluntary reporting of 
adverse drug experiences] or [insert current FDA web address for 
voluntary reporting of adverse drug experiences].'' Sponsors can search 
FDA's website or contact FDA by telephone to find the current FDA 
telephone number or web address for voluntary reporting of adverse drug 
experiences for animal drug.
    p. NADA/ANADA approval statement. For approved or generic approved 
Type A medicated articles, the proposed rule would require this section 
of the Type A medicated article label to include an ``NADA approval 
statement'' or ``ANADA approval statement,'' respectively (see proposed 
Sec.  201.409(a)(16)). This section of the Type A medicated article 
label would be the same as described in proposed Sec.  201.405(a)(21) 
for full prescribing information for Rx new animal drugs.
    q. Name and place of business. The proposed rule would require this 
section of the Type A medicated article label to identify the name and 
place of business of the manufacturer, packer, or distributor (see 
proposed Sec.  201.409(a)(17)). This section of the Type A medicated 
article label would be the same as described in proposed Sec.  
201.405(a)(22) for full prescribing information for Rx new animal 
drugs.
    r. ``Lot Number and Expiration Date.'' The proposed rule would 
require this section of the Type A medicated article label to have the 
heading ``Lot Number and Expiration Date,'' followed by the identifying 
lot or control number of the Type A medicated article within the 
immediate container. A lot or control number would help us to more 
easily identify and trace back a specific lot of a Type A medicated 
article should a problem be reported to FDA (see proposed Sec.  
201.409(a)(18)). In accordance with Sec.  226.58(d) of this chapter, 
the proposed rule would also require this section of the Type A 
medicated article label to include the expiration date of the Type A 
medicated article within the immediate container. An expiration date is 
important to ensure the safe and effective use of products.
    Alternatively, the proposed rule would allow for this section of 
the Type A medicated article label to refer to the location on the Type 
A medicated article label or immediate container where the lot or 
control number and expiration date are printed (see proposed Sec.  
201.409(a)(18)). As an example, if the lot number and expiration date 
are printed on the bottom half of the back of the bag containing the 
Type A medicated article, then the Type A medicated article label may 
state in this section, ``See bottom back half of bag for lot number and 
expiration date.''
    s. ``Revision Date.'' The proposed rule would require this section 
of the Type A medicated article label to have the heading ``Revision 
Date,'' followed by the date of the most recent revision of the Type A 
medicated article label, listing the month followed by the year (see 
proposed Sec.  201.409(a)(19)). This information is important to ensure 
that the most current approved version of the Type A medicated article 
label is being used.
2. Representative Type B Medicated Feed Labeling (Proposed Sec.  
201.409(b))
    The proposed rule would establish content and format requirements 
for representative Type B medicated feed labeling for new animal drugs 
approved or conditionally approved for use in animal feeds (see 
proposed Sec.  201.409(b)). A Type B medicated feed is intended solely 
for the manufacture of other medicated feeds (Type B or Type C). It 
serves as an intermediate medicated feed not approved for feeding to 
the target animals. It is manufactured by diluting a Type A medicated 
article or another Type B medicated feed with non-medicated feed, and 
at least 25 percent of its weight is from nutritional ingredients (see 
Sec.  558.3(b)(3)). Representative Type B medicated feed labeling is 
template labeling approved by FDA as part of an NADA or CNADA for a 
Type A medicated article.
    Representative Type B medicated feed labeling approved in the NADA 
or CNADA provide feed mills the minimal information that must be 
included on

[[Page 18299]]

the final printed labels prepared for the Type B medicated feeds 
manufactured containing the Type A medicated article to provide for 
safe and effective use of the new animal drug for its approved or 
conditionally approved indication(s) for use.
    The proposed rule would require the following information to be 
presented on the representative Type B medicated feed labeling for an 
approved or conditionally approved new animal drug and in the following 
order (see proposed Sec.  201.409(b)). Unless otherwise indicated, this 
information would be the same as that required by proposed Sec.  
201.405(a) for full prescribing information for approved or 
conditionally approved Rx new animal drugs, proposed Sec.  201.407(a) 
for full product information for approved or conditionally approved OTC 
new animal drugs, or proposed Sec.  201.409(a) for the Type A medicated 
article label.
    a. Description of the Type B medicated feed. The proposed rule 
would require this section of the representative Type B medicated feed 
labeling to provide a description of the Type B medicated feed (see 
proposed Sec.  201.409(b)(1)). This section of the representative Type 
B medicated feed labeling would serve as a placeholder for the 
proprietary name of the final Type B medicated feed to be added by the 
feed manufacturer to the label of the final Type B medicated feed 
manufactured in accordance with the approved representative Type B 
labeling.
    Representative Type B medicated labeling may be approved or 
conditionally approved for multiple Type B medicated feeds within an 
application. The proposed rule would require the description of each 
approved Type B medicated feed to distinguish it from any other Type B 
medicated feeds approved or conditionally approved within the same 
application (see proposed Sec.  201.409(b)(1)(i)). Distinguishing 
information may include the animals and/or indications for use for 
which Type C medicated feeds manufactured from the Type B medicated 
feed are approved or conditionally approved and/or other 
characteristics of the Type B medicated feeds.
    The proposed rule would require that the description of the 
approved Type B medicated feed not include the proprietary name of a 
Type A medicated article (see proposed Sec.  201.409(b)(1)(ii)). The 
proprietary name of a Type A medicated article is specific to the Type 
A medicated article; use of that proprietary name in the description of 
a Type B medicated feed may incorrectly imply that the Type B medicated 
feed is a Type A medicated article.
    b. Established name of the Type B medicated feed. The proposed rule 
would require this section of the representative Type B medicated feed 
labeling to include the established name of the Type B medicated feed. 
The established name of the Type B medicated feed would include the 
active moiety or active ingredient of each new animal drug, as 
determined by FDA, followed by an identifying statement of either 
``Type B medicated feed'' or ``Type B liquid medicated feed,'' as 
applicable (see proposed Sec.  201.409(b)(2)). The identifying 
statements also clearly designate the medicated feeds as Type B (as 
opposed to a Type C) medicated feeds. The identifying statements also 
distinguish Type B liquid medicated feeds from other Type B medicated 
feeds, which is important because Type B liquid medicated feeds have 
unique approval and labeling requirements (see Sec.  558.5 (21 CFR 
558.5)).
    c. VFD cautionary statement. For VFD new animal drugs, the proposed 
rule would require this section of the representative Type B medicated 
feed labeling to provide the VFD cautionary statement, in accordance 
with Sec.  558.6(a)(6), as described in proposed Sec.  201.409(a)(2) 
for the Type A medicated article label (see proposed Sec.  
201.409(b)(3)).
    d. ``Do Not Feed Undiluted.'' The proposed rule would require this 
section of the representative Type B medicated feed labeling to state, 
``Do Not Feed Undiluted'' (see proposed Sec.  201.409(b)(4)). This 
statement would remind users that the Type B medicated feed is not to 
be fed directly to animals.
    e. Conditional approval statement. For conditionally approved new 
animal drugs, the proposed rule would require this section of the 
representative Type B medicated feed labeling to include a conditional 
approval statement, as described in proposed Sec.  201.405(a)(3) for 
full prescribing information for Rx new animal drugs (see proposed 
Sec.  201.409(b)(5)).
    f. ``Indications for Use.'' The proposed rule would require this 
section of the representative Type B medicated feed labeling to have 
the heading ``Indications for Use,'' followed by the approved or 
conditionally approved indications(s) and target animal(s), as 
described in proposed Sec.  201.407(a)(3) for full product information 
for OTC new animal drugs, with the exception of the heading. In 
addition, this section of the representative Type B medicated feed 
labeling would include only the indications for use applicable to the 
specific Type B medicated feed to which the representative labeling 
applies (see proposed Sec.  201.409(b)(6)).
    g. Extralabel use statement. The proposed rule would require this 
section of the representative Type B medicated feed labeling to include 
an extralabel use statement, as described in proposed Sec.  
201.409(a)(6) for the Type A medicated article label (see proposed 
Sec.  201.409(b)(7)).
    h. ``Active Ingredient'' or ``Active Ingredients.'' The proposed 
rule would require this section of the representative Type B medicated 
feed labeling to have the heading ``Active Ingredient'' or ``Active 
Ingredients,'' followed by the established name and approved 
concentration(s) of each active ingredient (see proposed Sec.  
201.409(b)(8)). If the Type B medicated feed contains one active 
ingredient, the proposed rule would require this section of the 
representative Type B medicated feed labeling to be titled ``Active 
Ingredient.'' If the Type B medicated feed contains more than one 
active ingredient, the proposed rule would require this section of the 
representative Type B medicated feed labeling to be titled ``Active 
Ingredients.'' FDA approves a single concentration or a range of 
concentrations of each active ingredient for Type B medicated feeds and 
their representative Type B medicated feed labeling. However, the final 
Type B medicated feed label would only include a single concentration 
of each active ingredient. If a range of concentrations of the active 
ingredient(s) is approved or conditionally approved for Type B 
medicated feeds, the representative Type B medicated feed labeling 
would be required to include a footnote, placed at the bottom of the 
page of the representative Type B medicated feed labeling containing 
the ``Active Ingredient'' or ``Active Ingredients'' section, which 
instructs feed manufacturers that the final printed Type B medicated 
feed label must only include a single concentration for each active 
ingredient.
    i. ``Guaranteed Analysis.'' The proposed rule would require this 
section of the representative Type B medicated feed labeling to have 
the heading ``Guaranteed Analysis,'' followed by the nutritional 
content guarantees of the Type B medicated feed appropriate for the 
approved target animals in addition to any other required 
specifications (see proposed Sec.  201.409(b)(9)). The Type B medicated 
feed will be used to make a Type C medicated feed that will be included 
as part of the target animals' diet or serve

[[Page 18300]]

as their complete diet. Therefore, the feed manufacturer and user must 
be aware of the nutritional content of the Type B medicated feed to 
properly balance the nutritional content of the diet of the target 
animal. Without this nutritional content information being made 
available to the manufacturer and user of the medicated feed, the 
animals' diet may be imbalanced, e.g., either under- or over-feeding 
critical nutrients, which could be harmful to the health of the target 
animals. For this reason, information of this type may be considered 
material under section 201(n) of the FD&C Act such that it would be 
required to be disclosed on the representative Type B feed labeling.
    Additional specifications may also be required in this section of 
the representative Type B medicated feed labeling, such as the range of 
pH and/or range of percent dry matter. For example, the pH and/or ratio 
of dry matter to moisture (expressed as percent dry matter) of a liquid 
medicated feed may affect the stability of the new animal drug(s) it 
contains, such that a specific Type B liquid medicated feed would be 
approved only within a specific range of pH and/or percent dry matter 
(see Sec.  558.5(d)(1) and (2)).
    j. ``Ingredients.'' The proposed rule would require this section of 
the representative Type B medicated feed labeling to have the heading 
``Ingredients,'' followed by information relative to feed ingredients 
(see proposed Sec.  201.409(b)(10)). This information would include a 
statement that the feed ingredients must be listed on each final 
printed Type B medicated feed label by their common or usual names in 
descending order of predominance by weight, in accordance with Sec.  
501.4(a) (21 CFR 501.4(a)), including their collective names where 
permitted, in accordance with Sec.  501.4(b)(13). Also included would 
be a statement that spices, flavorings, colorings, and chemical 
preservatives, if used, must be declared on each final printed Type B 
medicated feed label, in accordance with Sec.  501.22 (21 CFR 501.22).
    k. ``Mixing Directions.'' The proposed rule would require this 
section of the representative Type B medicated feed labeling to have 
the heading ``Mixing Directions,'' followed by approved mixing 
directions for the manufacture of a Type C medicated feed(s) or another 
Type B medicated feed(s), as applicable, from the Type B medicated feed 
for which the representative Type B medicated feed labeling applies 
(see proposed Sec.  201.409(b)(11)).
    l. ``Warnings.'' The proposed rule would require this section of 
the representative Type B medicated feed labeling to have the heading 
``Warnings,'' followed by the ``Warnings'' section, as described in 
proposed Sec.  201.409(a)(10) for the Type A medicated article label. 
In addition, this section of the representative Type B medicated feed 
labeling would include only the warnings applicable to the specific 
Type B medicated feed to which the representative labeling applies (see 
proposed Sec.  201.409(b)(12)).
    m. ``Additional Recommendations.'' For new animal drugs having 
precautions, the proposed rule would require this section of the 
representative Type B medicated feed labeling to have the heading 
``Additional Recommendations,'' followed by the precautions, as 
described in proposed Sec.  201.407(a)(8) for full product information 
for OTC new animal drugs. In addition, this section of the 
representative Type B medicated feed labeling would include only the 
precautions applicable to the specific Type B medicated feed to which 
the representative labeling applies (see proposed Sec.  
201.409(b)(13)).
    n. ``Other Effects You May Notice.'' For new animal drugs that have 
effects on the target animal(s) that are not considered 
contraindications, target animal safety warnings, adverse reactions, or 
post-approval adverse drug experiences, and FDA determines that these 
effects are required to be described on labeling, the proposed rule 
would require this section of the representative Type B medicated feed 
labeling to have the heading ``Other Effects You May Notice,'' followed 
by a description of the effects. This section of the representative 
Type B medicated feed labeling would be the same as described in 
proposed Sec.  201.407(a)(9) for full product information for OTC new 
animal drugs. In addition, this section of the representative Type B 
medicated feed labeling would include only statements of other effects 
applicable to the specific Type B medicated feed to which the 
representative Type B medicated feed labeling applies (see proposed 
Sec.  201.409(b)(14)).
    o. Name and place of business. The proposed rule would require this 
section of the representative Type B medicated feed labeling to provide 
for identification of the name and place of business of the 
manufacturer, packer, or distributor of the final Type B medicated feed 
on the final printed Type B medicated feed label, in accordance with 
Sec.  501.5 (see proposed Sec.  201.409(b)(15)).
    p. ``Net Weight.'' The proposed rule would require this section of 
the representative Type B medicated feed labeling to have the heading 
``Net Weight,'' followed by space to provide for a statement on the 
final printed Type B medicated feed label of the net weight of the Type 
B medicated feed in the immediate container (see proposed Sec.  
201.409(b)(16)).
    q. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of the representative Type B medicated feed 
labeling to have the heading ``Storage, Handling, and Disposal,'' 
followed by storage information for the Type B medicated feed, as well 
as any required handling and disposal information, as described in 
proposed Sec.  201.405(a)(20) for full prescribing information for Rx 
new animal drugs (see proposed Sec.  201.409(b)(17)).
    r. ``Questions/Comments?'' The proposed rule would require this 
section of the representative Type B medicated feed labeling to have 
the heading ``Questions/Comments?,'' followed by statements providing 
contact information for use by feed manufacturers or other users of the 
final Type B medicated feed to request additional information on the 
product and/or to report problems with the medicated feed (see proposed 
Sec.  201.409(b)(18)). The first statement would provide placeholders 
for the name and contact information of the business of the 
manufacturer, packer, or distributor of the final Type B medicated feed 
to later be inserted by the business. The second statement would 
provide FDA contact information for reporting adverse drug experiences 
for animal drugs and would be required to be inserted by the sponsor of 
the new animal drug application.
    s. ``Lot, Batch, or Control Number.'' The proposed rule would 
require this section of the representative Type B medicated feed 
labeling to have the heading ``Lot, Batch, or Control Number,'' 
followed by space to provide for an identifying lot, batch, or control 
number on the final printed Type B medicated feed label (see proposed 
Sec.  201.409(b)(19)).
    t. ``Expiration Date.'' For Type B medicated feeds requiring an 
expiration date, in accordance with Sec.  514.1(b)(5)(x), the proposed 
rule would require this section of the representative Type B medicated 
feed labeling to have the heading ``Expiration Date,'' followed by 
space to provide for the expiration date to be printed on the final 
printed Type B medicated feed label. In addition, the approved 
expiration period would need to be included in this section of the 
representative Type B medicated feed labeling (see proposed Sec.  
201.409(b)(20)).

[[Page 18301]]

    u. ``Revision Date.'' The proposed rule would require this section 
of the representative Type B medicated feed labeling to have the 
heading ``Revision Date,'' followed by the date of the most recent 
revision of the representative Type B medicated feed labeling, listing 
the month followed by the year (see proposed Sec.  201.409(b)(21)). 
This information is important to ensure that the most current approved 
version of the representative Type B medicated feed labeling is being 
used.
3. Representative Type C Medicated Feed Labeling (Proposed Sec.  
201.409(c))
    The proposed rule would establish content and format requirements 
for representative Type C medicated feed labeling for new animal drugs 
approved or conditionally approved for use in animal feeds (see 
proposed Sec.  201.409(c)). Type C medicated feed is fed directly to 
target animals. It may also be used in the manufacture of another Type 
C medicated feed. When fed directly to target animals, it is intended 
to be the animals' complete feed or part of their total diet. It is 
manufactured by diluting a Type A medicated article, a Type B medicated 
feed, or another Type C medicated feed with non-medicated feed, and it 
contains a substantial quantity of nutritional ingredients (see Sec.  
558.3(b)(4)).
    Representative Type C medicated feed labeling approved in the NADA 
or CNADA provide feed mills the minimal information that must be 
included on the final printed labels prepared for the Type C medicated 
feeds manufactured containing the Type A medicated article to provide 
for safe and effective use of the new animal drug for its approved or 
conditionally approved indication(s) for use.
    The proposed rule would require the following information to be 
presented on the representative Type C medicated feed labeling for an 
approved or conditionally approved new animal drug and in the following 
order (see proposed Sec.  201.409(c)). Unless otherwise indicated, this 
information would be the same as that required by proposed Sec.  
201.405(a) for full prescribing information for approved or 
conditionally approved Rx new animal drugs, proposed Sec.  201.407(a) 
for full product information for approved or conditionally approved OTC 
new animal drugs, proposed Sec.  201.409(a) for the Type A medicated 
article label, or proposed Sec.  201.409(b) for representative Type B 
medicated feed labeling.
    a. Description of the Type C medicated feed. The proposed rule 
would require this section of the representative Type C medicated feed 
labeling to provide a description of the Type C medicated feed (see 
proposed Sec.  201.409(c)(1)). This section of the representative Type 
C medicated feed labeling would serve as a placeholder for the 
proprietary name of the final Type C medicated feed to be added by the 
feed manufacturer to the label of the final Type C medicated feed 
manufactured in accordance with the approved representative Type C 
labeling.
    Representative Type C medicated labeling may be approved or 
conditionally approved for multiple Type C medicated feeds within an 
application. The proposed rule would require the description of each 
approved Type C medicated feed to distinguish it from any other Type C 
medicated feeds approved or conditionally approved within the same 
application (see proposed Sec.  201.409(c)(1)(i)). Distinguishing 
information may include the animals and/or indications for use for 
which Type C medicated feeds are approved or conditionally approved 
and/or other characteristics of the Type C medicated feeds.
    The proposed rule would require that the description of the 
approved Type C medicated feed not include the proprietary name of a 
Type A medicated article (see proposed Sec.  201.409(c)(1)(ii)). The 
proprietary name of a Type A medicated article is specific to the Type 
A medicated article; use of that proprietary name in the description of 
a Type C medicated feed may incorrectly imply that the Type C medicated 
feed is a Type A medicated article.
    b. Established name of the Type C medicated feed. The proposed rule 
would require this section of the representative Type C medicated feed 
labeling to include the established name of the Type C medicated. The 
established name of the Type C medicated feed would include the active 
moiety or active ingredient of each new animal drug, as determined by 
FDA, followed by an identifying statement of, ``Type C medicated 
feed,'' ``Type C liquid medicated feed,'' ``Type C top-dress medicated 
feed,'' ``Type C free-choice medicated feed,'' or ``Type C liquid free-
choice medicated feed,'' as applicable (see proposed Sec.  
201.409(c)(2)). The identifying statements also clearly designate the 
medicated feeds as Type C (as opposed to a Type B) medicated feeds. The 
identifying statements also distinguish Type C liquid medicated feeds 
from other Type C medicated feeds, which is important because Type C 
liquid medicated feeds have unique approval and labeling requirements 
(see Sec.  558.5). Similarly, Type C free-choice medicated feeds have 
specific requirements for their approval (see Sec.  510.455 (21 CFR 
510.455)).
    c. VFD cautionary statement. For VFD new animal drugs, the proposed 
rule would require this section of the representative Type C medicated 
feed labeling to provide the VFD cautionary statement, in accordance 
with Sec.  558.6(a)(6), as described in proposed Sec.  201.409(a)(2) 
for the Type A medicated article label (see proposed Sec.  
201.409(c)(3)).
    d. Conditional approval statement. For conditionally approved new 
animal drugs, the proposed rule would require this section of the 
representative Type C medicated feed labeling to include a conditional 
approval statement, as described in proposed Sec.  201.405(a)(3) for 
full prescribing information for Rx new animal drugs (see proposed 
Sec.  201.409(c)(4)).
    e. ``Indications for Use.'' The proposed rule would require this 
section of the representative Type C medicated feed labeling to have 
the heading ``Indications for Use,'' followed by the approved or 
conditionally approved indications(s) and target animal(s), as 
described in proposed Sec.  201.407(a)(3) for full product information 
for OTC new animal drugs, with the exception of the heading. In 
addition, this section of the representative Type C medicated feed 
labeling would include only the indications for use applicable to the 
specific Type C medicated feed to which the representative labeling 
applies (see proposed Sec.  201.409(c)(5)).
    f. Extralabel use statement. The proposed rule would require this 
section of the representative Type C medicated feed labeling to include 
an extralabel use statement, as described in proposed Sec.  
201.409(a)(6) for the Type A medicated article label (see proposed 
Sec.  201.409(c)(6)).
    g. ``Active Ingredient'' or ``Active Ingredients.'' The proposed 
rule would require this section of the representative Type C medicated 
feed labeling to have the heading ``Active Ingredient'' or ``Active 
Ingredients,'' followed by the established name and approved 
concentration(s) of each active ingredient (see proposed Sec.  
201.409(c)(7)). If the Type C medicated feed contains one active 
ingredient, the proposed rule would require this section of the 
representative Type C medicated feed labeling to be entitled ``Active 
Ingredient.'' If the Type C medicated feed contains more than one 
active ingredient, the proposed rule would require this section of the 
representative Type C medicated feed

[[Page 18302]]

labeling to be entitled ``Active Ingredients.'' We approve a single 
concentration or a range of concentrations of each active ingredient 
for Type C medicated feeds and their representative Type C medicated 
feed labeling. However, the final Type C medicated feed label would 
only include a single concentration of each active ingredient. If a 
range of concentrations of the active ingredient(s) is approved or 
conditionally approved for Type C medicated feeds, the representative 
Type C medicated feed labeling would be required to include a footnote, 
placed at the bottom of the page of the representative Type C medicated 
feed labeling containing the ``Active Ingredient'' or ``Active 
Ingredients'' section, which instructs feed manufacturers that the 
final printed Type C medicated feed label must include only a single 
concentration for each active ingredient.
    h. ``Guaranteed Analysis.'' The proposed rule would require this 
section of the representative Type C medicated feed labeling to have 
the heading ``Guaranteed Analysis,'' followed by the nutritional 
content guarantees of the Type C medicated feed and any other required 
specifications, as described in proposed Sec.  201.409(b)(9) for 
representative Type B medicated feed labeling (see proposed Sec.  
201.409(c)(8)).
    i. ``Ingredients.'' The proposed rule would require this section of 
the representative Type C medicated feed labeling to have the heading 
``Ingredients,'' followed by information relative to feed ingredients 
(see proposed Sec.  201.409(c)(9)).
    For Type C medicated feeds that are not Type C free-choice 
medicated feeds, proposed Sec.  201.409(b)(9)(i) would require the 
heading to be followed by a statement that the feed ingredients must be 
listed on each final printed Type C medicated feed label by their 
common or usual names in descending order of predominance by weight, in 
accordance with Sec.  501.4(a), including their collective names where 
permitted, in accordance with Sec.  501.4(b)(13). Also included would 
be a statement that spices, flavorings, colorings, and chemical 
preservatives, if used, must be declared on the final printed Type C 
medicated feed label, in accordance with Sec.  501.22.
    For Type C free-choice medicated feeds, the proposed rule would 
require the heading to be followed by a listing of the feed ingredients 
and their inclusion rates, including the drug concentrations exactly as 
they appear in the approved non-proprietary formula published for the 
specific new animal drug in part 558 (see proposed Sec.  
201.409(b)(9)(ii)).
    j. ``Feeding Directions.'' The proposed rule would require this 
section of the representative Type C medicated feed labeling to have 
the heading ``Feeding Directions,'' followed by the approved feeding 
directions (see proposed Sec.  201.409(c)(10)). This section of 
representative Type C medicated feed labeling would include only the 
feeding directions applicable to the specific Type C medicated feed to 
which the representative Type C medicated feed labeling applies.
    k. ``Warnings.'' The proposed rule would require this section of 
the representative Type C medicated feed labeling to have the heading 
``Warnings,'' followed by the ``Warnings'' section, as described in 
proposed Sec.  201.409(a)(10) for the Type A medicated article label. 
In addition, this section of the representative Type C medicated feed 
labeling would include only the warnings applicable to the specific 
Type C medicated feed to which the representative labeling applies (see 
proposed Sec.  201.409(c)(11)).
    l. ``Additional Recommendations.'' For new animal drugs having 
precautions, the proposed rule would require this section of the 
representative Type C medicated feed labeling to have the heading 
``Additional Recommendations,'' followed by the precautions, as 
described in proposed Sec.  201.407(a)(8) for full product information 
for OTC new animal drugs. In addition, this section of the 
representative Type C medicated feed labeling would include only the 
precautions applicable to the specific Type C medicated feed to which 
the representative labeling applies (see proposed Sec.  
201.409(c)(12)).
    m. ``Other Effects You May Notice.'' For new animal drugs that have 
effects on the target animal(s) that are not considered 
contraindications, target animal safety warnings, adverse reactions, or 
post-approval adverse drug experiences, and FDA determines that these 
effects are required to be described on labeling, the proposed rule 
would require this section of the representative Type C medicated feed 
labeling to have the heading ``Other Effects You May Notice,'' followed 
by a description of the effects. This section of the representative 
Type C medicated feed labeling would be the same as described in 
proposed Sec.  201.407(a)(9) for full product information for OTC new 
animal drugs. In addition, this section of the representative Type C 
medicated feed labeling would include only statements of other effects 
applicable to the specific Type C medicated feed to which the 
representative Type C labeling applies (see proposed Sec.  
201.409(c)(13)).
    n. Name and place of business. The proposed rule would require this 
section of the representative Type C medicated feed labeling to provide 
for identification of the name and place of business of the 
manufacturer, packer, or distributor of the final Type C medicated feed 
on the final printed Type C medicated feed label, in accordance with 
Sec.  501.5 (see proposed Sec.  201.409(c)(14)).
    o. ``Net Weight.'' The proposed rule would require this section of 
the representative Type C medicated feed labeling to have the heading 
``Net Weight,'' followed by space to provide for a statement on the 
final printed Type C medicated feed label of the net weight of the Type 
C medicated feed in the immediate container (see proposed Sec.  
201.409(c)(15)).
    p. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of the representative Type C medicated feed 
labeling to have the heading ``Storage, Handling, and Disposal,'' 
followed by storage information for the Type C medicated feed, as well 
as any required, handling and disposal information, as described in 
proposed Sec.  201.405(a)(20) for full prescribing information for Rx 
new animal drugs (see proposed Sec.  201.409(c)(16)).
    q. ``Questions/Comments?'' The proposed rule would require this 
section of the representative Type C medicated feed labeling to have 
the heading ``Questions/Comments?,'' followed by statements providing 
contact information for use by feed manufacturers or other users of the 
final Type C medicated feed to request additional information on the 
product and/or to report problems with the medicated feed (see proposed 
Sec.  201.409(c)(17)). The first statement would provide placeholders 
for the name and contact information of the business of the 
manufacturer, packer, or distributor of the final Type C medicated feed 
to later be inserted by the business. The second statement would 
provide FDA contact information for reporting adverse drug experiences 
for animal drugs and would be required to be inserted by the sponsor of 
the new animal drug application.
    r. ``Lot, Batch, or Control Number.'' The proposed rule would 
require this section of the representative Type C medicated feed 
labeling to have the heading ``Lot, Batch, or Control Number,'' 
followed by space to provide for an identifying lot, batch, or control

[[Page 18303]]

number on the final printed Type C medicated feed label (see proposed 
Sec.  201.409(c)(19)).
    s. ``Expiration Date.'' For Type C medicated feeds requiring an 
expiration date, in accordance with Sec.  514.1(b)(5)(x), the proposed 
rule would require this section of the representative Type C medicated 
feed labeling to have the heading ``Expiration Date,'' followed by 
space to provide for the expiration date to be printed on the final 
printed Type C medicated feed label. In addition, the approved 
expiration period would need to be included in this section of the 
representative Type C medicated feed labeling (see proposed Sec.  
201.409(c)(19)).
    t. ``Revision Date.'' The proposed rule would require this section 
of the representative Type C medicated feed labeling to have the 
heading ``Revision Date,'' followed by the date of the most recent 
revision of the representative Type C medicated feed labeling, listing 
the month followed by the year (see proposed Sec.  201.409(c)(20)). 
This information is important to ensure that the most current approved 
version of the representative Type C medicated feed labeling is being 
used.
4. Proprietary Type B Medicated Feed Label (Proposed Sec.  201.409(d))
    The proposed rule would establish content and format requirements 
for a proprietary Type B medicated feed label for new animal drugs 
approved or conditionally approved for use in animal feeds (see 
proposed Sec.  201.409(d)). A proprietary Type B medicated feed is 
intended solely for the manufacture of Type C medicated feeds or other 
Type B medicated feeds and is not approved or conditionally approved 
for feeding to the target animals. For some proprietary Type B 
medicated feeds, the formulation and labeling are approved in an NADA. 
In other situations, the underlying data and labeling for the 
proprietary Type B medicated feed to support the approved uses are 
maintained in a VMF. For example, this would include situations in 
which a proprietary Type B medicated feed is manufactured via 
modification to an approved formulation published in the CFR or where a 
feed manufacturer creates its own proprietary formulation. The 
application for a proprietary Type B medicated feed will include the 
proprietary label for the final Type B medicated feed and 
representative Type C medicated feed labeling that directs the 
preparation of final printed labels for Type C medicated feeds 
manufactured from the proprietary Type B medicated feed. A proprietary 
Type B medicated feed label is on the immediate container, which is 
typically a bag or bulk container.
    The proposed rule would require the following information to be 
presented on the proprietary Type B medicated feed label for an 
approved or conditionally approved new animal drug and in the following 
order (see proposed Sec.  201.409(d)). Unless otherwise indicated, this 
information would be the same as that required by proposed Sec.  
201.405(a) for full prescribing information for approved or 
conditionally approved Rx new animal drugs, proposed Sec.  201.407(a) 
for full product information for approved or conditionally approved OTC 
new animal drugs, or proposed Sec.  201.409(a) for the Type A medicated 
article label.
    a. Proprietary Type B medicated feed identification. The proposed 
rule would require this section of the proprietary Type B medicated 
feed label to identify the Type B medicated feed (see proposed Sec.  
201.409(d)(1)). This section of the proprietary Type B medicated feed 
label would be required to include the following components in order:
    i. Proprietary name of the Type B medicated feed. The proposed rule 
require this subsection of the proprietary Type B medicated feed label 
to include the proprietary name of the Type B medicated feed (see 
proposed Sec.  201.409(d)(1)(i)).
    ii. Established name of the Type B medicated feed. The proposed 
rule would require this subsection of the proprietary Type B medicated 
feed label to include the established name of the Type B medicated 
feed. The established name of the Type B medicated feed would include 
the active moiety or active ingredient of each new animal drug, as 
determined by FDA, followed by an identifying statement of either 
``Type B medicated feed'' or ``Type B liquid medicated feed,'' as 
applicable (see proposed Sec.  201.409(d)(1)(ii)). The identifying 
statements also clearly designate the medicated feed as a Type B (as 
opposed to a Type C) medicated feed. The identifying statements also 
distinguish Type B liquid medicated feeds from other Type B medicated 
feeds, which is important because Type B liquid medicated feeds have 
unique approval and labeling requirements (see Sec.  558.5).
    b. VFD cautionary statement. For VFD new animal drugs, the proposed 
rule would require this section of the proprietary Type B medicated 
feed label to provide the VFD cautionary statement, in accordance with 
Sec.  558.6(a)(6), as described in proposed Sec.  201.409(a)(2) for the 
Type A medicated article label (see proposed Sec.  201.409(d)(2)).
    c. ``Do Not Feed Undiluted.'' The proposed rule would require this 
section of the proprietary Type B medicated feed label to state, ``Do 
Not Feed Undiluted'' (see proposed Sec.  201.409(d)(3)). This statement 
would remind users that the Type B medicated feed is not to be fed 
directly to animals.
    d. Conditional approval statement. For conditionally approved new 
animal drugs, the proposed rule would require this section of the 
proprietary Type B medicated feed label to include a conditional 
approval statement, as described in proposed Sec.  201.405(a)(3) for 
full prescribing information for Rx new animal drugs (see proposed 
Sec.  201.409(d)(4)).
    e. ``Indications for Use.'' The proposed rule would require this 
section of the proprietary Type B medicated feed label to have the 
heading ``Indications for Use,'' followed by the approved or 
conditionally approved indications(s) and target animal(s), as 
described in proposed Sec.  201.407(a)(3) for full product information 
for OTC new animal drugs, with the exception of the heading (see 
proposed Sec.  201.409(d)(5)).
    f. Extralabel use statement. The proposed rule would require this 
section of the proprietary Type B medicated feed label to include an 
extralabel use statement, as described in proposed Sec.  201.409(a)(6) 
for the Type A medicated article label (see proposed Sec.  
201.409(d)(6)).
    g. ``Active Ingredient'' or ``Active Ingredients.'' The proposed 
rule would require this section of the proprietary Type B medicated 
feed label to have the heading ``Active Ingredient'' or ``Active 
Ingredients,'' followed by the established name and approved 
concentration of each active ingredient (see proposed Sec.  
201.409(d)(7)). If the proprietary Type B medicated feed contains one 
active ingredient, the proposed rule would require this section of the 
proprietary Type B medicated feed label to be entitled ``Active 
Ingredient.'' If the proprietary Type B medicated feed contains more 
than one active ingredient, the proposed rule would require this 
section of the proprietary Type B medicated feed label to be entitled 
``Active Ingredients.'' Because the proprietary Type B medicated feed 
label applies to a final Type B medicated feed, a single concentration 
would be required for each active ingredient rather than a range.
    h. ``Guaranteed Analysis.'' The proposed rule would require this 
section of the proprietary Type B

[[Page 18304]]

medicated feed label to have the heading ``Guaranteed Analysis,'' 
followed by the nutritional content guarantees and any other required 
specifications for the proprietary Type B medicated feed (see proposed 
Sec.  201.409(d)(8)).
    i. ``Ingredients.'' The proposed rule would require this section of 
the proprietary Type B medicated feed label to have the heading 
``Ingredients,'' followed by a listing of the feed ingredients in the 
proprietary Type B medicated feed. The feed ingredients would be 
required to be listed by their common or usual names in descending 
order of predominance by weight, in accordance with Sec.  501.4(a), 
including their collective names where permitted, in accordance with 
Sec.  501.4(b)(13) (see proposed Sec.  201.409(d)(9)(i)). Spices, 
flavorings, colorings, and chemical preservatives, if used, would be 
required to be declared, in accordance with Sec.  501.22 (see proposed 
Sec.  201.409(d)(9)(ii)).
    j. ``Mixing Directions.'' The proposed rule would require this 
section of the proprietary Type B medicated feed label to have the 
heading ``Mixing Directions,'' followed by the approved mixing 
directions for the manufacture of a Type C medicated feed(s) or another 
Type B medicated feed(s), if applicable, from the proprietary Type B 
medicated feed (see proposed Sec.  201.409(d)(10)).
    k. ``Warnings.'' The proposed rule would require this section of 
the proprietary Type B medicated feed label to have the heading 
``Warnings,'' followed by the ``Warnings'' section, as described in 
proposed Sec.  201.409(a)(10) for the Type A medicated article label 
(see proposed Sec.  201.409(d)(11)).
    l. ``Additional Recommendations.'' For new animal drugs having 
precautions, the proposed rule would require this section of the 
proprietary Type B medicated feed label to have the heading 
``Additional Recommendations,'' followed by all precautions, as 
described in proposed Sec.  201.407(a)(8) for full product information 
for OTC new animal drugs (see proposed Sec.  201.409(d)(12)).
    m. ``Other Effects You May Notice.'' For new animal drugs that have 
effects on the target animal(s) that are not considered 
contraindications, target animal safety warnings, adverse reactions, or 
post-approval adverse drug experiences, and FDA determines that these 
effects are required to be described on labeling, the proposed rule 
would require this section of the proprietary Type B medicated feed 
label to have the heading ``Other Effects You May Notice,'' followed by 
a description of the effects. This section of the proprietary Type B 
medicated feed label would be the same as described in proposed Sec.  
201.407(a)(9) for full product information for OTC new animal drugs 
(see proposed Sec.  201.409(d)(13)).
    n. ``Net Weight.'' The proposed rule would require this section of 
the proprietary Type B medicated feed label to have the heading ``Net 
Weight,'' followed by the net weight of the Type B medicated feed in 
the immediate container (see proposed Sec.  201.409(d)(14)).
    o. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of the proprietary Type B medicated feed label to 
have the heading ``Storage, Handling, and Disposal,'' followed by 
storage information for the Type B medicated feed, as well as any 
required handling and disposal information, as described in proposed 
Sec.  201.405(a)(20) for full prescribing information for Rx new animal 
drugs (see proposed Sec.  201.409(d)(15)).
    p. ``Questions/Comments?'' The proposed rule would require this 
section of the proprietary Type B medicated feed label to have the 
heading ``Questions/Comments?,'' followed by the sponsor's contact 
information for feed manufacturers or other users of the Type B 
medicated feed to facilitate requesting additional information on the 
product or to report suspected adverse drug experiences. FDA's contact 
information for voluntary reporting of adverse drug experiences for 
animal drugs would also be required (see proposed Sec.  
201.409(d)(16)).
    The sponsor's contact information would be the name of the 
manufacturer, packer, or distributor, whichever is identified in the 
``Name and place of business'' section of the Type B medicated feed 
(see proposed Sec.  201.409(d)(18)). If more than one business is 
identified in the ``Name and place of business'' section of the 
proprietary Type B medicated feed label, the drug sponsor would select 
the most appropriate of these businesses to use in the ``Questions/
Comments?'' section to provide additional information about the Type B 
medicated feed and to contact regarding suspected adverse drug 
experiences.
    The statements in this section of the proprietary Type B medicated 
feed label would be required to be structured as follows: ``Contact 
[insert name of business] at [insert business telephone number] or 
[insert business web address]. To report side effects, contact [insert 
name of business] at [insert business telephone number]. For additional 
information about reporting problems with medicated feeds, contact FDA 
at [insert current FDA telephone number for voluntary reporting of 
adverse drug experiences] or [insert current FDA web address for 
voluntary reporting of adverse drug experiences].'' Sponsors can search 
FDA's website or contact FDA by telephone to find the current FDA 
telephone number or web address for voluntary reporting of adverse drug 
experiences for animal drug.
    q. NADA/ANADA approval statement. For approved or generic approved 
proprietary Type B medicated feeds, the proposed rule would require 
this section of the proprietary Type B medicated feed label to include 
an ``NADA approval statement'' or ``ANADA approval statement,'' 
respectively, as described in proposed Sec.  201.405(a)(21) for full 
prescribing information for Rx new animal drugs (see proposed Sec.  
201.409(d)(17)).
    r. Name and place of business. The proposed rule would require this 
section of the proprietary Type B medicated feed label to identify name 
and place of business of the manufacturer, packer, or distributor, as 
described in proposed Sec.  201.405(a)(22) for full prescribing 
information for Rx new animal drugs (see proposed Sec.  
201.409(d)(18)).
    s. ``Lot, Batch, or Control Number.'' The proposed rule would 
require this section of the proprietary Type B medicated feed label to 
have the heading ``Lot, Batch, or Control Number,'' followed by the 
identifying lot, batch, or control number of the Type B medicated feed. 
Alternatively, the proposed rule would allow for this section of the 
proprietary Type B medicated feed label to refer to the location on the 
proprietary Type B medicated feed label or immediate container where 
the lot, batch, or control number is printed (see proposed Sec.  
201.409(d)(19)).
    t. ``Expiration Date.'' For Type B medicated feeds requiring an 
expiration date, in accordance with Sec.  514.1(b)(5)(x), the proposed 
rule would require this section of the proprietary Type B medicated 
feed label to have the heading ``Expiration Date,'' followed by the 
expiration date of the proprietary Type B medicated feed. 
Alternatively, the proposed rule would allow for this section of the 
proprietary Type B medicated feed label to refer to the location on the 
proprietary Type B medicated feed label or immediate container where 
the expiration date is printed (see proposed Sec.  201.409(d)(20)).
    u. ``Revision Date.'' The proposed rule would require this section 
of the proprietary Type B medicated feed label to have the heading 
``Revision Date,''

[[Page 18305]]

followed by the date of the most recent revision of the proprietary 
Type B medicated feed label, listing the month followed by the year 
(see proposed Sec.  201.409(d)(21)). This information is important to 
ensure that the most current approved version of the proprietary Type B 
medicated feed label is being used.
5. Proprietary Type C Medicated Feed Label (Proposed Sec.  201.409(e))
    The proposed rule would establish content and format requirements 
for a proprietary Type C medicated feed label for new animal drugs 
approved or conditionally approved for use in animal feeds (see 
proposed Sec.  201.409(e)). FDA may approve or conditionally approve 
applications for proprietary final formulations of Type C medicated 
feeds. For some proprietary Type C medicated feeds, the formulation and 
labeling are approved in an NADA. In other situations, the underlying 
data and labeling for the proprietary Type C medicated feed to support 
the approved uses are maintained in a VMF. For example, this would 
include situations in which a proprietary Type C medicated feed is 
manufactured via modification to an approved formulation published in 
the CFR or where a feed manufacturer creates its own proprietary 
formulation. The application for a proprietary Type C medicated feed 
will include the proprietary label for the final Type C medicated feed. 
A proprietary Type C medicated feed label is on the immediate 
container, which is typically a bag or bulk container.
    The proposed rule would require the following information to be 
presented on the proprietary Type C medicated feed label for an 
approved or conditionally approved new animal drug and in the following 
order (see proposed Sec.  201.409(e)). Unless otherwise indicated, this 
information would be the same as that required by proposed Sec.  
201.405(a) for full prescribing information for approved or 
conditionally approved Rx new animal drugs, proposed Sec.  201.407(a) 
for full product information for approved or conditionally approved OTC 
new animal drugs, proposed Sec.  201.409(a) for the Type A medicated 
article label, or proposed Sec.  201.409(d) for the proprietary Type B 
medicated feed label.
    a. Proprietary Type C medicated feed identification. The proposed 
rule would require this section of the proprietary Type C medicated 
feed label to identify the Type C medicated feed (see proposed Sec.  
201.409(e)(1)). This section of the proprietary Type C medicated feed 
label would be required to include the following components in order:
    i. Proprietary name of the Type C medicated feed. The proposed rule 
would require this subsection of the proprietary Type C medicated feed 
label to include the proprietary name of the Type C medicated feed (see 
proposed Sec.  201.409(e)(1)(i)).
    ii. Established name of the Type C medicated feed. The proposed 
rule would require this subsection of the proprietary Type C medicated 
feed label to include the established name of the Type C medicated 
feed. The established name of the proprietary Type C medicated feed 
would include the active moiety or active ingredient of each new animal 
drug, as determined by FDA, followed by an identifying statement of, 
``Type C medicated feed,'' ``Type C liquid medicated feed,'' ``Type C 
top-dress medicated feed,'' ``Type C free-choice medicated feed,'' or 
``Type C liquid free-choice medicated feed,'' as applicable (see 
proposed Sec.  201.409(e)(1)(ii)). The identifying statements also 
clearly designate the medicated feeds as Type C (as opposed to a Type 
B) medicated feeds. The identifying statements also distinguish Type C 
liquid medicated feeds from other Type C medicated feeds, which is 
important because Type C liquid medicated feeds have unique approval 
and labeling requirements (see Sec.  558.5). Similarly, Type C free-
choice medicated feeds have specific requirements for their approval 
(see Sec.  510.455).
    b. VFD cautionary statement. For VFD new animal drugs, the proposed 
rule would require this section of the proprietary Type C medicated 
feed label to provide the VFD cautionary statement, in accordance with 
Sec.  558.6(a)(6), as described in proposed Sec.  201.409(a)(2) for the 
Type A medicated article label (see proposed Sec.  201.409(e)(2)).
    c. Conditional approval statement. For conditionally approved new 
animal drugs, the proposed rule would require this section of the 
proprietary Type C medicated feed label to include a conditional 
approval statement, as described in proposed Sec.  201.405(a)(3) for 
full prescribing information for Rx new animal drugs (see proposed 
Sec.  201.409(e)(3)).
    d. ``Indications for Use.'' The proposed rule would require this 
section of the proprietary Type C medicated feed label to have the 
heading ``Indications for Use,'' followed by the approved or 
conditionally approved indications(s) and target animal(s), as 
described in proposed Sec.  201.407(a)(3) for full product information 
for OTC new animal drugs, with the exception of the heading (see 
proposed Sec.  201.409(e)(4)).
    e. Extralabel use statement. The proposed rule would require this 
section of the proprietary Type C medicated feed label to include an 
extralabel use statement, as described in proposed Sec.  201.409(a)(6) 
for the Type A medicated article label (see proposed Sec.  
201.409(e)(5)).
    f. ``Active Ingredient'' or ``Active Ingredients.'' The proposed 
rule would require this section of the proprietary Type C medicated 
feed label to have the heading ``Active Ingredient,'' or ``Active 
Ingredients,'' followed by the established name and approved 
concentration of each active ingredient (see proposed Sec.  
201.409(e)(6)). If the proprietary Type C medicated feed contains one 
active ingredient, the proposed rule would require this section of the 
proprietary Type C medicated feed label to be entitled ``Active 
Ingredient.'' If the proprietary Type C medicated feed contains more 
than one active ingredient, the proposed rule would require this 
section of the proprietary Type C medicated feed label to be entitled 
``Active Ingredients.'' Because the proprietary Type C medicated feed 
label applies to a final Type C medicated feed, a single concentration 
would be required for each active ingredient rather than a range.
    g. ``Guaranteed Analysis.'' The proposed rule would require this 
section of the proprietary Type C medicated feed label to have the 
heading ``Guaranteed Analysis,'' followed by the nutritional content 
guarantees and other required specifications for the final proprietary 
Type C medicated feed, as described in Sec.  201.409(d)(8) for the 
proprietary Type B medicated feed label (see proposed Sec.  
201.409(e)(7)).
    h. ``Ingredients.'' The proposed rule would require this section of 
the proprietary Type C medicated label to have the heading 
``Ingredients,'' followed by a listing of the feed ingredients in the 
proprietary Type C medicated feed, as described in Sec.  201.409(d)(9) 
for the proprietary Type B medicated feed label (see proposed Sec.  
201.409(e)(8)).
    i. ``Feeding Directions.'' The proposed rule would require this 
section of the proprietary Type C medicated feed label to have the 
heading ``Feeding Directions,'' followed by the approved feeding 
directions (see proposed Sec.  201.409(e)(9)).
    j. ``Warnings.'' The proposed rule would require this section of 
the proprietary Type C medicated feed label to have the heading 
``Warnings,''

[[Page 18306]]

followed by the ``Warnings'' section, as described in proposed Sec.  
201.409(a)(10) for the Type A medicated article label (see proposed 
Sec.  201.409(e)(10)).
    k. ``Additional Recommendations.'' For new animal drugs having 
precautions, the proposed rule would require this section of the 
proprietary Type C medicated feed label to have the heading 
``Additional Recommendations,'' followed by all precautions, as 
described in proposed Sec.  201.407(a)(8) for full product information 
for OTC new animal drugs (see proposed Sec.  201.409(e)(11)).
    l. ``Other Effects You May Notice.'' For new animal drugs that have 
effects on the target animal(s) that are not considered 
contraindications, target animal safety warnings, adverse reactions, or 
post-approval adverse drug experiences, and FDA determines that these 
effects are required to be described on labeling, the proposed rule 
would require this section of the proprietary Type C medicated feed 
label to have the heading ``Other Effects You May Notice,'' followed by 
a description of the effects. This section of the proprietary Type C 
label would be the same as described in proposed Sec.  201.407(a)(9) 
for full product information for OTC new animal drugs (see proposed 
Sec.  201.409(e)(12)).
    m. ``Net Weight.'' The proposed rule would require this section of 
the proprietary Type C medicated feed label to have the heading ``Net 
Weight,'' followed by the net weight of the Type C medicated feed in 
the immediate container (see proposed Sec.  201.409(e)(13)).
    n. ``Storage, Handling, and Disposal.'' The proposed rule would 
require this section of the proprietary Type C medicated feed label to 
have the heading ``Storage, Handling, and Disposal,'' followed by 
storage information for the Type C medicated feed, as well as any 
required handling, and disposal information, as described in proposed 
Sec.  201.405(a)(20) for full prescribing information for Rx new animal 
drugs (see proposed Sec.  201.409(e)(14)).
    o. ``Questions/Comments?'' The proposed rule would require this 
section of the proprietary Type C medicated feed label to have the 
heading ``Questions/Comments?,'' followed by the sponsor's contact 
information for users of the Type C medicated feed to facilitate 
requesting additional information on the product or to report suspected 
adverse drug experiences. FDA's contact information for voluntary 
reporting of adverse drug experiences for animal drugs would also be 
required (see proposed Sec.  201.409(e)(15)).
    The sponsor's contact information would be the name of the 
manufacturer, packer, or distributor, whichever is identified in the 
``Name and place of business'' section of the Type C medicated feed 
(see proposed Sec.  201.409(e)(17)). If more than one business is 
identified in the ``Name and place of business'' section of the 
proprietary Type C medicated feed label, the drug sponsor would select 
the most appropriate of these businesses to use in the ``Questions/
Comments?'' section to provide additional information about the Type C 
medicated feed and to contact regarding suspected adverse drug 
experiences.
    The statements in this section of the proprietary Type C medicated 
feed label would be required to be structured as follows: ``Contact 
[insert name of business] at [insert business telephone number] or 
[insert business web address]. To report side effects, contact [insert 
name of business] at [insert business telephone number]. For additional 
information about reporting side effects or other problems with 
medicated feeds, contact FDA at [insert current FDA telephone number 
for voluntary reporting of adverse drug experiences] or [insert current 
FDA web address for voluntary reporting of adverse drug experiences].'' 
Sponsors can search FDA's website or contact FDA by telephone to find 
the current FDA telephone number or web address for voluntary reporting 
of adverse drug experiences for animal drugs.
    p. NADA/ANADA approval statement. For approved or generic approved 
proprietary Type C medicated feeds, the proposed rule would require 
this section of the proprietary Type C medicated feed label to include 
an ``NADA approval statement'' or ``ANADA approval statement,'' 
respectively, as described in proposed Sec.  201.405(a)(21) for full 
prescribing information for Rx new animal drugs (see proposed Sec.  
201.409(e)(16)).
    q. Name and place of business. The proposed rule would require this 
section of the proprietary Type C medicated feed label to identify name 
and place of business of the manufacturer, packer, or distributor, as 
described in proposed Sec.  201.405(a)(22) for full prescribing 
information for Rx new animal drugs (see proposed Sec.  
201.409(e)(17)).
    r. ``Lot, Batch, or Control Number.'' The proposed rule would 
require this section of the proprietary Type C medicated feed label to 
have the heading ``Lot, Batch, or Control Number,'' followed by the 
identifying lot, batch, or control number of the Type C medicated feed. 
Alternatively, the proposed rule would allow for this section of the 
proprietary Type C medicated feed label to refer to the location on the 
proprietary Type C medicated feed label or immediate container where 
the lot, batch, or control number is printed (see proposed Sec.  
201.409(e)(18)).
    s. ``Expiration Date.'' For Type C medicated feeds requiring an 
expiration date, in accordance with Sec.  514.1(b)(5)(x), the proposed 
rule would require this section of the proprietary Type C medicated 
feed label to have the heading ``Expiration Date,'' followed by the 
expiration date of the proprietary Type C medicated feed. 
Alternatively, the proposed rule would allow for this section of the 
proprietary Type C medicated feed label to refer to the location on the 
proprietary Type C medicated feed label or immediate container where 
the expiration date is printed (see proposed Sec.  201.409(e)(19)).
    t. ``Revision Date.'' The proposed rule would require this section 
of the proprietary Type C medicated feed label to have the heading 
``Revision Date,'' followed by the date of the most recent revision of 
the proprietary Type C medicated feed label, listing the month followed 
by the year (see proposed Sec.  201.409(e)(20)).
6. Other Approved Labeling for Type A Medicated Articles (Proposed 
Sec.  201.409(f))
    The proposed rule would establish content and format requirements 
for the information presented on other approved labeling for Type A 
medicated articles approved or conditionally approved for use in animal 
feeds. Other approved labeling for Type A medicated articles includes, 
but is not limited to, labeling on shipping cartons containing bags of 
Type A medicated articles (see proposed Sec.  201.409(f)).
    The proposed rule would require the following information to be 
presented on other approved labeling for Type A medicated articles and 
in the following order (see proposed Sec.  201.409(f)). Unless 
otherwise indicated, this information would be the same as that 
required by proposed Sec.  201.405(a) for full prescribing information 
for approved or conditionally approved Rx new animal drugs, or proposed 
Sec.  201.409(a) for a Type A medicated article label.
    a. Type A medicated article identification. The proposed rule would 
require this section of the other approved labeling for Type A 
medicated articles to include, in order, the proprietary name and the 
established

[[Page 18307]]

name of the Type A medicated article (see proposed Sec.  
201.409(f)(1)).
    b. VFD cautionary statement. For VFD new animal drugs, the proposed 
rule would require this section of the other approved labeling for Type 
A medicated articles to provide the VFD cautionary statement, in 
accordance with Sec.  558.6(a)(6), as described in proposed Sec.  
201.409(a)(2) for the Type A medicated article label (see proposed 
Sec.  201.409(f)(2)).
    c. ``Active Ingredient'' or ``Active Ingredients.'' The proposed 
rule would require this section of the other approved labeling for Type 
A medicated articles to have the heading ``Active Ingredient'' or 
``Active Ingredients,'' followed by the established name and 
concentration of each active ingredient in the Type A medicated 
article. If the Type A medicated article contains one active 
ingredient, the proposed rule would require this section of the other 
approved labeling for Type A medicated articles to be entitled ``Active 
Ingredient.'' If the Type A medicated article contains more than one 
active ingredient, the proposed rule would require this section of the 
other approved labeling for Type A medicated articles to be entitled 
``Active Ingredients'' (see proposed Sec.  201.409(f)(3)).
    d. Conditional approval statement. For conditionally approved new 
animal drugs, the proposed rule would require this section of the other 
approved labeling for Type A medicated articles to include a 
conditional approval statement, as described in proposed Sec.  
201.405(a)(3) for full prescribing information for Rx new animal drugs 
(see proposed Sec.  201.409(f)(4)).
    e. ``Net Contents.'' The proposed rule would require this section 
of the other approved labeling for Type A medicated articles to have 
the heading ``Net Contents,'' followed by the contents of the container 
to which the other approved labeling for Type A medicated articles 
applies (see proposed Sec.  201.409(f)(5)).
    f. ``Storage and Handling.'' The proposed rule would require this 
section of the other approved labeling for Type A medicated articles to 
have the heading ``Storage and Handling,'' followed by storage 
information for the Type A medicated article (see proposed Sec.  
201.409(f)(6)). Also, any handling information required for safe and 
effective use of the Type A medicated article would be included in this 
section. Information on disposal of the Type A medicated article would 
not be required to be included on other approved labeling for Type A 
medicated articles.
    g. NADA/ANADA approval statement. For approved or generic approved 
proprietary Type A medicated articles, the proposed rule would require 
this section of the other approved labeling for Type A medicated 
articles to include an ``NADA approval statement'' or ``ANADA approval 
statement,'' respectively, as described in proposed Sec.  
201.405(a)(21) for full prescribing information for Rx new animal drugs 
(see proposed Sec.  201.409(f)(7)).
    h. Name and place of business. The proposed rule would require this 
section of the other approved labeling for Type A medicated articles to 
identify name and place of business of the manufacturer, packer, or 
distributor, as described in proposed Sec.  201.405(a)(22) for full 
prescribing information for Rx new animal drugs (see proposed Sec.  
201.409(f)(8)).
    i. ``Lot Number and Expiration Date.'' The proposed rule would 
require this section of the other approved labeling for Type A 
medicated articles to have the heading ``Lot Number and Expiration 
Date,'' followed by the identifying lot or control number(s) and the 
expiration date(s) of the Type A medicated article within the container 
(see proposed Sec.  201.409(f)(9)). The container may include more than 
one lot of the Type A medicated article, and therefore, more than one 
lot or control number and expiration date may be listed in this section 
of other approved labeling for Type A medicated articles.
    j. ``Revision Date.'' The proposed rule would require this section 
of the other approved labeling for Type A medicated articles to have 
the heading ``Revision Date,'' followed by the date of the most recent 
revision of the other approved labeling for Type A medicated articles, 
listing the month followed by the year (see proposed Sec.  
201.409(f)(10)).

G. Exemptions From Labeling Requirements for Approved or Conditionally 
Approved New Animal Drugs (Proposed Sec.  201.411)

    FDA would provide sponsors the opportunity to request an exemption 
from one or more specific requirements set forth in this proposed 
subpart on the basis that the requirements are not appropriate for the 
specific approved or conditionally approved new animal drug (see 
proposed Sec.  201.411).
    An exemption request would be required to be submitted to the 
corresponding application or investigational new animal drug file 
(INAD) for the new animal drug. A separate request would be required to 
be submitted for each new animal drug for which an exemption is sought. 
Requests for exemptions would be granted or denied by the Director of 
FDA's Center for Veterinary Medicine or the Director's designee (see 
proposed Sec.  201.411(a)). The sponsor seeking an exemption would be 
required to: (1) describe why the particular requirement for which the 
exemption is requested was not appropriate for the new animal drug; (2) 
describe why granting the exemption would not adversely impact the 
safety or effectiveness of the use of the new animal drugs; and (3) 
include copies of all draft labeling proposed to be used for the new 
animal drug (see proposed Sec.  201.411(b)). We anticipate that such 
exemptions would be rare.

H. Labeling Requirements for Certain Approved or Conditionally Approved 
New Animal Drugs (Proposed Sec.  201.413)

    This section of the proposed regulations would consolidate, and 
where appropriate, update existing labeling requirements pertaining to 
certain approved or conditionally approved new animal drugs that would 
continue to apply in addition to the other labeling requirements in 
proposed subpart H. Currently, the labeling requirements for these new 
animal drugs are dispersed throughout the regulations. It would be 
helpful to new animal drug sponsors and FDA reviewers if the proposed 
rule were to consolidate, and where appropriate, update the additional 
labeling requirements for these specific new animal drugs in the same 
subpart of the CFR as general labeling requirements for approved or 
conditionally approved new animal drugs.
    This section also proposes a new labeling provision for all new 
animal drugs approved or conditionally approved for use in horses and 
anthelmintic new animal drugs for certain species of animals.
    We may propose to amend Sec.  201.413 in the future to include 
additional labeling requirements for certain specific new animal drugs 
as appropriate.
1. Approved or Conditionally Approved Corticosteroid-Containing New 
Animal Drugs for Oral, Injectable, and/or Ophthalmic Use
    The proposed rule would move labeling requirements currently 
provided in Sec.  510.410 relating to corticosteroid-containing new 
animal drugs intended for oral, injectable, and/or ophthalmic use to 
proposed Sec.  201.413(a). We also propose a conforming amendment to 
remove current Sec.  510.410.
    Section 510.410 was originally issued by FDA in 1970 as Sec.  
135.101 (35 FR 11556, July 18, 1970) and provided

[[Page 18308]]

background information and established certain labeling requirements 
for corticosteroid animal drugs administered orally or parenterally. 
The regulation stated that such corticosteroid animal drugs must bear 
the veterinary prescription legend and meet the labeling requirements 
in Sec.  201.105 for prescription new animal drugs. The regulation also 
required the labeling of these products to bear a warning statement 
regarding potential adverse reproductive effects to the treated animals 
when these drugs are administered during the last trimester of 
pregnancy, specifically premature parturition followed by dystocia, 
fetal death, retained placenta, and metritis. The regulation was 
subsequently revised in 1972 (37 FR 24343, November 16, 1972) to 
address corticosteroid animal drugs for oral, injectable, and 
intramammary use. In 1984, FDA amended the regulation on labeling 
requirements for use of corticosteroid animal drugs again to add 
ophthalmic products, delete intramammary products, and to include an 
additional warning concerning certain potential congenital/teratogenic 
effects (49 FR 48535, December 13, 1984). Ophthalmic products were 
added to the regulation based on the results of a published study 
supporting the need for these warning statements for ophthalmic use 
corticosteroid drugs. Intramammary corticosteroid animal drugs were 
removed from the regulation because intramammary products no longer 
included steroids in their formulations.
    The proposed rule would redesignate Sec.  510.410 as proposed Sec.  
201.413(a) and revise its contents to remove some of the background 
information because we believe it is now well understood. Furthermore, 
we propose to update some of the warning statements to use more concise 
language. These animal drug products would continue to be subject to 
the labeling requirements for prescription new animal drugs. However, 
because the labeling requirements for approved or conditionally 
approved prescription new animal drugs would no longer be in Sec.  
201.105, we would update the citation to refer to the labeling 
requirements for prescription new animal drugs in proposed subpart H.
    The proposed rule would require the warning statements for adverse 
reproductive effects to be included in the ``Animal Safety Warnings and 
Precautions'' subsection of labeling for approved or conditionally 
approved corticosteroid new animal drugs for oral, and/or injectable 
use (see proposed Sec.  201.413(a)). For corticosteroid new animal 
drugs approved or conditionally approved for ophthalmic use, per this 
proposal, we may require these statements to also be included in the 
``Animal Safety Warnings and Precautions'' subsection of labeling. For 
example, the warning statements might not be necessary for ophthalmic 
corticosteroid new animal drugs if data are provided to us that 
demonstrate the intended use is not associated with adverse 
reproductive effects in the treated animal.
2. Anthelmintic New Animal Drugs
    The proposed rule would move labeling requirements currently 
provided in Sec.  500.25 for approved or conditionally approved OTC 
anthelmintic new animal drugs to proposed Sec.  201.413(b)(1). Labeling 
requirements currently provided in Sec.  500.25 for OTC anthelmintic 
new animal drugs that are indexed would be moved to Sec.  516.155 (21 
CFR 516.155), ``Labeling of indexed drugs''. We also propose a 
conforming amendment to remove current Sec.  500.25. Furthermore, the 
proposed rule would require that all approved or conditionally approved 
anthelmintic new animal drugs for use in sheep, goats, cattle, horses, 
swine, and/or poultry include statements on labeling on appropriate use 
of these drugs to minimize anthelmintic resistance development (see 
proposed Sec.  201.413(b)(2)).
    Section 500.25 was originally issued by FDA in 1974 as Sec.  
135.111 (39 FR 7165 at 7166, February 25, 1974) and required that 
labeling for anthelmintic animal drugs not carrying the prescription 
statement bear the following statement ``Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism.'' 
Labeling of approved anthelmintic animal drugs not carrying the 
prescription statement were to be revised accordingly by February 25, 
1975, and labeling of all subsequently approved non-prescription 
anthelmintic new animal drugs were to bear the statement. In 2007, 
Sec.  500.25 was amended to add the labeling requirement for indexed 
non-prescription anthelmintic new animal drugs (72 FR 69108 at 69120, 
December 6, 2007).
    The proposed rule would redesignate portions of Sec.  500.25 for 
approved or conditionally approved OTC anthelmintic new animal drugs, 
including OTC anthelmintic new animal drugs for use in animal feeds, as 
proposed Sec.  201.413(b)(1) and update some of its contents. VFD 
anthelmintic new animal drugs for use in or on animal feeds would be 
excluded from this requirement. The labeling statement would be 
required to be placed in the ``Additional Recommendations'' section of 
labeling. Reference to being able to revise labeling without prior 
approval would be removed because the labeling statement would be 
required for approval or conditional approval. Reference to an 
effective date of February 25, 1975 would be removed.
    Portions of Sec.  500.25 for indexed OTC anthelmintic new animal 
drugs would be redesignated as paragraph (c) in Sec.  516.155, 
``Labeling of indexed drugs''. Reference to an effective date of 
February 25, 1975 would be removed. The current Sec.  516.155(c) would 
be redesignated as Sec.  516.155(d).
    The proposed rule would also require all approved or conditionally 
approved anthelmintic new animal drugs for use in sheep, goats, cattle, 
horses, swine, and/or poultry to include statements on their labeling 
providing information to end users on appropriate use of these drugs to 
minimize anthelmintic resistance development. FDA's Center for 
Veterinary Medicine held a public meeting on antiparasitic drug use and 
resistance in ruminants and equines on March 5 and 6, 2012. During that 
meeting, a panel of veterinary parasitology experts discussed the 
emerging problem of anthelmintic resistance cattle, horses, and 
especially small ruminants in the United States, contributing factors 
to resistance development, strategies to detect and manage anthelmintic 
resistance, and the importance of educating both veterinarians and 
other end users about how to detect and manage anthelmintic resistance. 
Since this meeting, published reports in the United States continue to 
support that anthelmintic resistance is spreading and is particularly 
concerning in grazing species (cattle, sheep, goats, and horses), but 
is also becoming a problem in swine and poultry.
    It is in the interest of animal health to take a proactive approach 
to ensure that anthelmintics are used appropriately to help maintain 
the effectiveness of these drugs. Therefore, the proposed rule would 
require that all approved or conditionally approved anthelmintic new 
animal drugs for use in sheep, goats, cattle, horses, swine, and/or 
poultry include statements on their labeling providing information to 
end users on appropriate use of these drugs to minimize antiparasitic 
resistance development. These statements would include information on 
appropriate dosing, anthelmintic drug selection, effectiveness 
monitoring, the integration of anthelmintic drug use with other 
parasite management practices, and other information as needed (see

[[Page 18309]]

proposed Sec.  201.413(b)(2)). The statements would be required in the 
``Other Warnings'' subsection of labeling, and if applicable, 
additional statements may be required in the ``Dosage and 
Administration'' section of labeling for Rx anthelmintic new animal 
drugs, the ``Directions'' section of labeling for OTC anthelmintic new 
animal drugs, or the ``Feeding Directions'' section or subsection of 
labeling for anthelmintic new animal drugs for use in animal feeds. We 
would determine specific statements during review of the new animal 
drug and its labeling as part of the approval process and/or via 
guidance developed by FDA.
3. Approved or Conditionally Approved New Animal Drugs for Use in 
Horses
    The proposed rule would require that all approved or conditionally 
approved new animal drugs for use in horses include in the ``Other 
Warnings'' subsection of labeling a statement advising against the use 
of the drug in certain horses (see proposed Sec.  201.413(c)). 
Historically, drugs approved or conditionally approved for use in 
horses do not have tolerance levels established because FDA does not 
consider horses to be food-producing animals. Therefore, FDA currently 
does not require a human food safety evaluation of new animal drugs 
intended for use in horses. Because there is no human food safety 
evaluation of the new animal drug, FDA does not have the data needed to 
ensure that horses that have been treated with the drugs could safely 
be used for human consumption and sponsors may not label their drugs as 
appropriate for use in horses intended for use as human food. Proposed 
Sec.  201.413(c) would require that all new animal drugs approved or 
conditionally approved for use in horses include a statement in the 
``Other Warnings'' subsection of labeling advising against use of the 
drug in horses intended for human consumption.

I. Proposed Conforming Amendments

    We also propose to amend the following sections:
     Sec.  201.15 pertaining to foreign translations of 
labeling,
     Sec.  201.100 pertaining to prescription drugs for human 
use,
     Sec.  201.105 pertaining to prescription drugs for animal 
use,
     part 501 pertaining to animal food labeling,
     Sec.  514.1 pertaining to new animal drug applications, 
and
     Sec.  516.155 pertaining to labeling of indexed drugs.
    Also, we propose to remove the following sections and incorporate 
their requirements in proposed new subpart H:
     Sec.  500.25 pertaining to OTC anthelmintic drug use in 
animals, and
     Sec.  510.410 pertaining to corticosteroids for oral, 
injectable, and ophthalmic use in animals.
    We propose to remove the following sections:
     Sec.  500.55 pertaining to the exemption of certain drug-
labeling requirements, and
     Sec. Sec.  510.105 and 510.106 pertaining to labeling of 
drugs for use in milk-producing animals.
    The proposed rule would establish translation requirements for 
approved or conditionally approved new animal drug labeling that 
contains any representation of a foreign language in proposed Sec.  
201.404(i) and (j). Therefore, we propose a change to Sec.  201.15, 
``Drugs; prominence of required label statements.'' We propose adding 
paragraph (4) to Sec.  201.15(c). Proposed paragraph (c)(4) would 
exempt approved or conditionally approved new animal drugs from the 
requirements established in Sec.  201.15(c) and state that foreign 
translations of the labeling for approved or conditionally approved new 
animal drugs must comply with Sec.  201.404(i) and (j).
    The proposed rule would amend Sec.  201.100, ``Prescription drugs 
for human use,'' in paragraph (d) to remove the words, ``and Sec.  
201.105(b)(2)'' from the introductory text. This conforming amendment 
would be in conjunction with conforming amendments proposed for Sec.  
201.105, ``Veterinary drugs'' (see discussion below), which includes 
the removal of Sec.  201.105(f). Paragraph (f) provides labeling 
requirements for prescription drugs intended for both human and 
veterinary use.
    Current Sec.  201.105, entitled ``Veterinary drugs,'' provides 
requirements, including labeling requirements, for drugs subject to 
section 503(f)(1) of the FD&C Act, which are prescription drugs for 
animal use. These drugs include approved or conditionally approved 
prescription new animal drugs, prescription new animal drugs listed in 
the index of legally marketed unapproved new animal drugs for minor 
species, and prescription animal drugs not subject to an approved or 
conditionally approved application or index listing. Section 201.100, 
``Prescription drugs for human use,'' serves a similar purpose for 
prescription human drugs. The proposed rule would revise the title of 
Sec.  201.105 to read ``Prescription drugs for animal use.'' This would 
clarify the scope of the section and be consistent with the title of 
its counterpart for human prescription drugs in Sec.  201.100.
    We propose minor editorial changes to update Sec.  201.105(a), 
which provides requirements, other than labeling requirements, for 
prescription animal drugs.
    To accommodate the proposed content and format requirements in 
proposed subpart H for labeling authorized in approved or conditionally 
approved new animal drug applications, the proposed rule would change 
Sec.  201.105 to provide the labeling requirements for approved or 
conditionally approved prescription new animal drugs separately from 
the labeling requirements for prescription new animal drugs listed in 
the index of legally marketed unapproved new animal drugs for minor 
species, and prescription animal drugs not subject to an approved or 
conditionally approved application or index listing. Accordingly, we 
propose to insert a new paragraph Sec.  201.105(b) that would provide 
labeling requirements for prescription new animal drugs approved under 
section 512 of the FD&C Act or conditionally approved under section 571 
of the FD&C Act. The provisions in the proposed paragraph Sec.  
201.105(c) would apply to prescription new animal drugs listed in the 
index of legally marketed unapproved new animal drugs for minor species 
established under section 572 of the FD&C Act, and prescription animal 
drugs not subject to an approved or conditionally approved application 
or index listing.
    The proposed rule would provide requirements for the labeling 
components for approved or conditionally approved prescription new 
animal drugs identified in proposed Sec.  201.405 (see proposed Sec.  
201.105(b)(1)), which include labeling providing full prescribing 
information, labels, small labels, labeling for secondary containers 
that include a package insert, shipping labeling, and other approved 
labeling for prescription new animal drugs. Such labeling would be 
required to contain adequate information for use of the drug, including 
indications for use, dosages, routes of administration, frequency and 
duration of administration, and any relevant contraindications, 
warnings, precautions, and adverse reactions, under which veterinarians 
licensed by law to administer the drug can use the drug safely and for 
the purposes for which it is intended, including all purposes for which 
it is advertised or represented (see proposed Sec.  201.105(b)(1)(i)). 
The labeling

[[Page 18310]]

components identified in proposed Sec.  201.405 also would be required 
to be the labeling authorized by the approved new animal drug 
application or conditionally approved new animal drug application for 
the prescription new animal drug (see proposed Sec.  
201.105(b)(1)(ii)).
    These requirements for the labeling components identified in 
proposed Sec.  201.405 would be consistent with requirements in current 
paragraph Sec.  201.105(c) for labeling on or within the package from 
which the approved or conditionally approved prescription new animal 
drugs is dispensed. We also propose editorial revisions to use more 
current terminology regarding the types of information required to 
provide adequate information for use of the drug by veterinarians. 
These labeling components also would be required to comply with the 
applicable content and format requirements of proposed subpart H (see 
proposed Sec.  201.105(b)(1)(iii)).
    The exemption currently provided in Sec.  201.105(c)(2) permits, 
upon written request to the Commissioner of Food and Drugs, the 
labeling information required by Sec.  201.105(c)(1) (i.e., adequate 
information for use) to be omitted from the dispensing container of 
prescription animal drugs for which the directions, hazards, warnings, 
and use information are commonly known to licensed veterinarians. 
Providing an exemption from the requirement that all prescription 
animal drugs must provide labeling that bears adequate information for 
use by veterinarians does not ensure safe and effective use of these 
drugs and is no longer warranted. Additional risks relating to the use 
of an animal drug may become known long after the drug is first 
marketed, even when veterinarians have become familiar with the 
directions, hazards, and warnings concerning its use. Moreover, in some 
cases, labeling may need to be revised to include additional safety 
information. Therefore, the proposed rule would revoke the exemption 
provided in current Sec.  201.105(c)(2). As discussed below, we also 
propose to remove Sec.  500.55, which lists the animal drugs to which 
this exemption has been applied.
    The proposed rule would set forth requirements for any labeling, as 
defined in section 201(m) of the FD&C Act, for approved or 
conditionally approved prescription new animal drugs, distributed by or 
on behalf of the manufacturer, packer, or distributor of the drug, that 
provides or purports to provide information for use or prescribes, 
recommends, or suggests a dosage for use of the drug (see proposed 
Sec.  201.105(b)(2)), consistent with the requirements in current Sec.  
201.105(d) for such prescription new animal drugs. Labeling, as defined 
in section 201(m) of the FD&C Act, means ``all labels and other 
written, printed, or graphic matter (1) upon any article or any of its 
containers or wrappers, or (2) accompanying such article.'' Thus, 
labeling includes material such as promotional labeling, in addition to 
the labeling authorized in the approved new animal drug application or 
the conditionally approved new animal drug application. Such labeling 
that provides or purports to provide information or a dosage for the 
drug's use would be required to contain adequate information to ensure 
licensed veterinarians can use the drug safely and for the purposes for 
which the drug is intended, including all conditions for which the drug 
is advertised or represented. For the labeling of the approved or 
conditionally approved prescription animal drug to contain adequate 
information for use by veterinarians, proposed Sec.  201.105(b)(2) 
would require such labeling to include the indications for use, 
dosages, routes of administration, frequency and duration of 
administration, and any relevant contraindications, warnings, 
precautions, and adverse reactions, and information relevant to 
compliance with the new animal drug provisions of the FD&C Act. It 
would also require the labeling components providing such information 
for use to be the same in language and emphasis as the labeling 
authorized by the approved or conditionally approved new animal drug 
application, and any other labeling components would have to be 
consistent with and not contrary to such authorized labeling (see 
proposed Sec.  201.105(b)(2)(i)). The labeling would be required to 
contain the same information concerning the ingredients of the drug as 
appears on the labeling authorized by the approved new animal drug 
application or the conditionally approved new animal drug application 
(see proposed Sec.  201.105(b)(2)(ii)).
    We propose requirements for the label of prescription new animal 
drugs listed in the index of legally marketed unapproved new animal 
drugs for minor species established under section 572 of the FD&C Act, 
and prescription animal drugs not subject to an approved or 
conditionally approved application or index listing, that are 
consistent with those currently provided in Sec.  201.105(b) (see 
proposed Sec.  201.105(c)(1)). The proposed rule includes requirements 
for the labeling on or within the package from which such drugs are to 
be dispensed that are consistent with the requirements currently 
provided in Sec.  201.105(c) (see proposed Sec.  201.105(c)(2)). In 
addition, the proposed rule includes editorial revisions to use more 
current terminology to identify the types of information that would 
need to be included on the labeling on or within the dispensing 
container in order to provide adequate information for use of such 
drugs by veterinarians (see proposed Sec.  201.105(c)(2)). The proposed 
rule would revoke the exemption provided in current Sec.  201.105(c)(2) 
for the reasons described previously.
    Proposed Sec.  201.105(c)(3) would require that any labeling, as 
defined in section 201(m) of the FD&C Act, for prescription new animal 
drugs listed in the index of legally marketed unapproved new animal 
drugs for minor species, or prescription animal drugs not subject to an 
approved or conditionally approved application or an index listing, 
that is distributed by or on behalf of the manufacturer, packer, or 
distributor of the drug, that provides information for use or a dosage 
for use of the drug contain adequate information for use of the drug by 
licensed veterinarians. This provision is consistent with the 
requirements currently provided in Sec.  201.105(d) for these 
prescription animal drugs. In addition, all labeling for such 
prescription animal drugs, except labels and cartons, that contain 
information for use of the drug would be required to include the date 
of the issuance or latest revision of such labeling, consistent with 
the requirements currently provided in Sec.  201.105(e) (see proposed 
Sec.  201.105(c)(4)).
    The proposed rule would replace the current proviso language in 
Sec.  201.105(d)(2) relating to prescription animal drug reminder-piece 
labeling with a provision that is similar to the reminder labeling 
provision at Sec.  201.100(f) (21 CFR 201.100(f)) for human 
prescription drugs (see proposed Sec.  201.105(d)). Specifically, the 
proposed provision would replace the term reminder-piece labeling with 
the term reminder labeling and define reminder labeling for 
prescription animal drugs in a manner similar to how that term is 
defined for prescription human drugs. In the past, we have relied on 
the definition for reminder labeling in Sec.  201.100(f) as a guide 
when reviewing such labeling because the current proviso language in 
Sec.  201.105 lacks such a detailed definition. We propose to modify 
the definition for reminder labeling found at Sec.  201.100(f) to 
establish a similar definition for prescription animal drugs. The 
proposed use of the term reminder

[[Page 18311]]

labeling for prescription animal drugs and the proposed inclusion of a 
definition for this term that is similar to the definition in Sec.  
201.100(f) is clearer and more accurate than the current definition for 
reminder-piece labeling (see proposed Sec.  201.105(d)).
    Current Sec.  201.105(f) provides labeling requirements for 
prescription drugs intended for both human and veterinary use. The 
proposed rule would remove this provision, which was established in 
1960 (as Sec.  1.106(c)(6)); 25 FR 12592) and is now obsolete. In 1968, 
section 512 of the FD&C Act established separate approval requirements 
for new animal drugs, including their labeling.
    The proposed rule would remove Sec.  500.25, which contains 
labeling requirements for OTC anthelmintic new animal drugs. The 
requirements for the labeling of approved or conditionally approved OTC 
anthelminthic new animal drugs contained in current Sec.  500.25 would 
be moved to proposed Sec.  201.413(b)(1), ``Labeling requirements for 
certain approved or conditionally approved new animal drugs.'' This 
would further consolidate regulations pertaining to labeling of 
approved or conditionally approved new animal drugs. The requirements 
for the labeling of indexed OTC anthelminthic new animal drugs 
contained in current Sec.  500.25 would be moved to Sec.  516.155, 
``Labeling of indexed drugs.''
    To ensure the safe and effective use of new animal drugs, the 
proposed rule would remove from the provision found at Sec.  500.55, 
``Exemption from certain drug-labeling requirements,'' and proviso 
language at Sec.  201.105(c)(2) that permits animal drug sponsors to 
receive an exemption from including certain labeling information 
required by Sec.  201.105(c)(1) on the dispensing package for their 
products where the Commissioner of Food and Drugs has determined that 
such information is already commonly known to veterinarians. Under 
Sec.  201.105(c)(1) of this Agency's regulations, the labeling on or 
within the dispensing package of prescription new animal drugs must 
have adequate information for its use, including indications, effects, 
dosages, routes, methods, and frequency and duration of administration, 
and any relevant hazards, contraindications, side effects, and 
precautions, under which veterinarians licensed by law to administer 
the drug can use it safely and for the purposes for which the drug is 
intended, including all purposes for which the drug is advertised or 
represented. Section 201.105(c)(2) contains certain proviso language 
that permits the ``full disclosure'' labeling required by Sec.  
201.105(c)(1) to be omitted from the dispensing package of prescription 
new animal drugs if the directions, hazards, warnings, and use 
information are commonly known to veterinarians. The Commissioner of 
Food and Drugs has, upon written request, offered an opinion that such 
information may be omitted from the dispensing package for the 
prescription animal drugs listed in Sec.  500.55. Only eight animal 
drugs have received such an exemption from providing the full 
disclosure labeling information otherwise required by Sec.  
201.105(c)(1).
    The list of unapproved prescription animal drugs currently in Sec.  
500.55 that have received an exemption from providing full disclosure 
labeling meeting the requirements of Sec.  201.105(c)(1) on their 
dispensing package was initially created in 1962. This list was added 
to a then-existing provision at 21 CFR 3.515 that permitted full 
disclosure labeling to be omitted from the dispensing package of 
certain prescription drugs for human use in cases where the 
Commissioner of Food and Drugs determined that directions, hazards, 
warnings, and use information for such drugs was commonly known to 
physicians (27 FR 5428, June 8, 1962). In 1971, when FDA issued 
regulations implementing the Animal Drug Amendments of 1968, the human 
and animal drug provisions were recodified in separate sections of 
FDA's regulations. As a result, the list of animal drugs exempt from 
the requirement to have full disclosure labeling on their dispensing 
package was moved to Sec.  135.107 and the list of human prescription 
drugs exempt from similar labeling requirements was moved to Sec.  
201.160. In the mid-1970s, as part of the Agency's reorganization of 
its regulations, the animal drug list was moved again to Sec.  500.55.
    In 1979, FDA removed Sec.  201.160, the human drug provision 
similar to Sec.  500.55, because the Agency's experience had shown that 
risks from the use of a drug may be uncovered long after the drug is 
first marketed, even for long-used drugs for which physicians had 
become familiar with the directions, hazards, and warnings concerning 
their use. FDA concluded that current full disclosure labeling should 
be provided for all human prescription drugs to ensure that physicians 
have the information they need to use these drugs safely. For similar 
reasons, full disclosure labeling is needed for all prescription new 
animal drugs to ensure veterinarians are able to use these products 
safely and effectively. In addition, none of the eight products listed 
in Sec.  500.55 received FDA approval for the uses in animals for which 
they were generally employed by veterinarians at the time the list of 
exempt drugs was initially established in 1962, and several are no 
longer used in veterinary medicine. Therefore, we propose to remove 
Sec.  500.55 and the proviso language at Sec.  201.105(c)(2).
    In part 501 subpart A, we propose to add a new section, Sec.  
501.19, ``Animal food; labeling of animal food containing new animal 
drugs.'' Proposed Sec.  501.19 would require labeling of animal food 
containing an approved or conditionally approved new animal drug to 
comply with proposed Sec.  201.409. The requirements in part 501 would 
apply only as specified in proposed Sec.  201.409.
    The proposed rule would remove Sec.  510.105, ``Labeling of drugs 
for use in milk-producing animals'', and Sec.  510.106, ``Labeling of 
antibiotic and antibiotic-containing drugs intended for use in milk-
producing animals'', which provide statements required to appear on the 
labeling of such drugs for use in milk-producing animals. The 
requirements in proposed Sec.  Sec.  201.405(a)(10)(i), 
201.407(a)(7)(i), and 201.409(a)(10)(i) would supersede the 
requirements in Sec. Sec.  510.105 and 510.106.
    Section 510.105 was originally issued by FDA in 1960 as 21 CFR 3.18 
(25 FR 8321, August 31, 1960) and was recodified as Sec.  135.103 (21 
CFR 135.103) in 1971 (36 FR 18375 at 18393, September 14, 1971). In 
1975 Sec.  135.103 was redesignated as Sec.  510.105 (40 FR 13802, 
March 27, 1975).
    Section 510.106 was originally issued by FDA in 1960 as Sec.  
146.14 (21 CFR 146.14) (25 FR 8321 at 8322, August 31, 1960). In 1964, 
Sec.  146.14 was redesignated as Sec.  148.5 (21 CFR 148.5) (29 FR 
15672, November 21, 1964) and subsequently amended in 1965 (30 FR 7040 
at 7041, May 26, 1965) to update the warning statements. In 1975 Sec.  
148.5 was redesignated as Sec.  510.106 (40 FR 13802, March 27, 1975).
    Both Sec. Sec.  510.105 and 510.106 were amended in 1998 to update 
the warning statements in those provisions to reflect current practices 
in the dairy industry (63 FR 32978, June 17, 1998).
    The proposed rule would remove Sec. Sec.  510.105 and 510.106 
because the labeling requirements proposed for the subsection entitled 
``Withdrawal Periods and Residue Warnings'' or ``Withdrawal Periods'' 
would supersede such requirements in Sec. Sec.  510.105 and 510.106. 
The labeling requirements for the proposed ``Withdrawal Periods and 
Residue Warnings'' or ``Withdrawal Periods'' subsection would provide 
flexibility to have more targeted and informative statements with 
respect to human food safety warnings, including

[[Page 18312]]

milk discard times, withdrawal periods, and residue warning statements 
for the labeling of all new animal drugs intended for use in food-
producing animals (see proposed Sec.  Sec.  201.405(a)(10)(i), 
201.407(a)(7)(i), and 201.409(a)(10)(i)).
    The proposed rule would remove Sec.  510.410. The requirements in 
current Sec.  510.410 would be moved to proposed Sec.  201.413, 
``Labeling requirements for certain approved or conditionally approved 
new animal drugs.'' The warning language would be clarified and updated 
in proposed Sec.  201.413(a). This would further consolidate 
regulations pertaining to labeling of approved or conditionally 
approved new animal drugs.
    The proposed rule would amend Sec.  514.1, which describes the 
requirements for applications for new animal drugs. Current Sec.  
514.1(b)(3) describes the labeling that must be included in a new 
animal drug application. Paragraphs (ii) through (vi) of current Sec.  
514.1(b)(3) describe the labeling required in a new animal drug 
application for prescription and nonprescription new animal drugs and 
new animal drugs intended for use in the manufacture of medicated 
feeds.
    The proposed rule would insert a paragraph after Sec.  
514.1(b)(3)(i) to indicate that the content and format of all proposed 
labeling must comply with subpart H of part 201 of this chapter.
    Paragraphs (ii) through (vi) of Sec.  514.1(b)(3) would be 
redesignated as paragraphs (iii) through (vii). The current text 
``prescription veterinary drugs'' in redesignated paragraphs (iv) and 
(vii) would be changed to ``prescription new animal drugs'' to be 
consistent with the text used in proposed subpart H.

VI. Proposed Effective/Compliance Dates

    If finalized, sponsors of new animal drugs would need to comply 
with these proposed regulations within 6 years of the effective date of 
the final rule, according to the compliance schedule provided in the 
General Requirements section of this proposed rule, discussed in 
section V.C. The compliance schedule is based on application number, 
with approved NADAs with higher application numbers having the earliest 
compliance date because they are more recently approved and therefore 
likely to need the fewest labeling revisions. The 6-year compliance 
period would begin on the effective date of the final rule (see 
proposed Sec.  201.404(a)(4)).

VII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, 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, 13563, and 14094 direct us to assess all 
benefits, costs, and transfers 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). Rules are ``significant'' under Executive Order 12866 
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an 
annual effect on the economy of $200 million or more (adjusted every 3 
years by the Administrator of [the Office of Information and Regulatory 
Affairs (OIRA)] for changes in gross domestic product); or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, territorial, or tribal governments or 
communities.'' OIRA has determined that this proposed rule is not a 
significant regulatory action as defined by Executive Order 12866 
Section 3(f)(1).
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because net annualized compliance costs of the proposed rule 
are less than 2 percent of average annual revenues for the smallest 
firms in the industry, we propose to certify that the proposed 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 impacts, 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 $177 
million, using the most current (2022) Implicit Price Deflator for the 
Gross Domestic Product. This proposed rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    The proposed rule, if finalized, would require that sponsors follow 
specific content and format requirements for labeling of approved or 
conditionally approved new animal drugs. A comprehensive set of 
standardized requirements for the content and format of information on 
labeling of such drugs currently does not exist. Veterinarians, pet 
owners, livestock owners, and other users of new animal drugs may more 
easily locate the information they need with standardized labeling.
    We quantify potential cost savings to industry and FDA from a 
reduction in the quantity and time burden of new animal drug labeling 
amendments and informal communications related to new animal drug 
labeling. There may be additional benefits to users of approved or 
conditionally approved new animal drugs from greater predictability and 
ease of reading new animal drug labeling in the form of time saved 
searching for content, which we are unable to quantify. Additionally, 
animal or human health benefits may result from reductions in 
medication errors or improvements in adverse event reporting, which we 
cannot quantify.
    We expect that new animal drug sponsors would incur one-time costs 
to read and understand the rule, revise standard operating procedures 
(SOPs) related to labeling, and train employees on the revised SOPs. 
New animal drug sponsors would also bear costs to update labeling and 
prepare supplemental labeling applications to conform to the proposed 
requirements. FDA would incur costs to review these supplemental 
applications.
    We summarize the quantified benefits and costs in table 2. We 
estimate that the annualized benefits over 10 years would range from 
$0.143 million to $0.243 million at a 2 percent discount rate, with a 
primary estimate of $0.193 million. The annualized costs would range 
from $2.16 million to $2.77 million at a 2 percent discount rate, with 
a primary estimate of $2.45 million.
    The present value of total benefits over 10 years would range from 
$1.31 million to $2.23 million at a 2 percent discount rate, with a 
primary estimate of $1.77 million. At a 2 percent discount rate, the 
present value of total costs would range from $19.78 million to $25.38 
million, with a primary estimate of $22.48 million.

[[Page 18313]]



                                  Table 2--Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
                                                               [Millions of 2022 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                  Notes (e.g., Risk assumptions; source
                                          Primary       Low        High       Dollar     Discount      Time      citations; whether inclusion of capital
               Category                  estimate    estimate    estimate      year        rate       horizon     effects differs across low, primary,
                                                                                                                          high estimates; etc.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized monetized benefits.....      $0.193      $0.143      $0.243        2022           2          10  Cost savings to industry and FDA.
    Annualized quantified, but non-     ..........  ..........  ..........  ..........  ..........  ..........  ........................................
     monetized, benefits.
                                       -----------------------------------------------------------------------------------------------------------------
    Unquantified benefits.............     Information search cost savings to users of new animal drugs and     ........................................
                                                     potential benefits to animal or human health.
                                       -----------------------------------------------------------------------------------------------------------------
COSTS:
    Annualized monetized costs........        2.45        2.16        2.77        2022           2          10  ........................................
    Annualized quantified, but non-     ..........  ..........  ..........  ..........  ..........  ..........  ........................................
     monetized, costs.
    Unquantified costs................  ..........  ..........  ..........  ..........  ..........  ..........  ........................................
Transfers:
    Annualized monetized Federal        ..........  ..........  ..........  ..........  ..........  ..........  ........................................
     budgetary transfers.
    Bearers of transfer gain and loss?  ..........  ..........  ..........  ..........  ..........  ..........  ........................................
    Other annualized monetized          ..........  ..........  ..........  ..........  ..........  ..........  ........................................
     transfers.
    Bearers of transfer gain and loss?  ..........  ..........  ..........  ..........  ..........  ..........  ........................................
Net Benefits:
    Annualized monetized net benefits.       -2.26       -2.02       -2.53        2022           2          10  ........................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Category                                              Effects
                                                             Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects on State, local, or Tribal                     None.
 governments.
 
Effects on small businesses...........   Quantified effects of less than 2
                                        percent of average annual revenues
                                              for the smallest firms.
 
Effects on wages......................                 None.
 
Effects on growth.....................                 None.
 
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
preliminary analysis of economic impacts is available in the docket for 
this proposed rule (Ref. 2) and at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

VIII. Analysis of Environmental Impact

    The Agency has determined under Sec.  25.30(k) 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.

IX. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the OMB under the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501-3521). A description of these provisions is given 
in the Description section of this document with an estimate of the 
annual reporting burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on these topics: (1) whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Reporting Associated With New Animal Drug Applications and 
Veterinary Master Files; OMB control number 0910-0032--Revision.
    Description: The proposed rule, if finalized, would revise the 
existing requirements for the content and format of labeling for 
approved or conditionally approved new animal drugs that sponsors 
submit as part of NADAs or CNADAs, respectively. The proposed rule 
would also place labeling requirements that are specific to approved or 
conditionally approved new animal drugs in a single location in the 
CFR. The proposed rule would apply to the labeling of both Rx and OTC 
new animal drugs, as well as new animal drugs for use in animal feeds.
    The proposed regulations would provide the following for the 
content and format elements of labeling for approved or conditionally 
approved new animal drugs:
    Description of Respondents: Respondents include persons developing, 
manufacturing, and/or researching new animal drugs, commonly referred 
to as new animal drug sponsors.
    We estimate the burden of the information collection as follows:

[[Page 18314]]



                                                      Table 3--Estimated One-Time Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      21 CFR section; activity                          Number of      responses per   Total responses  Average  burden    Total hours
                                                                       respondents       respondent                       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.8 and 514.8(c)(2); supplements and changes to an approved                    66        \1\ 12.55          \2\ 828               20           16,560
 application.......................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Decimal rounded up.
\2\ Decimal rounded down.

    To ease the burden of the information collection on respondents, we 
have established a 6-year implementation period. We estimate 828 
supplemental labeling applications of approved and marketed new animal 
drugs over the course of 6 years to comply with the labeling 
regulations, if finalized. Based on internal data, there were 78 unique 
firms with an approved or conditionally approved new animal drug 
application (sponsors) in September 2023. Sixty-six of these sponsors 
currently had an approved and marketed new animal drug. We assume 828 
submissions regarding supplements and changes to an application for an 
approved and marketed new animal drug, for an average of 12.55 
submissions per respondent. We further assume it takes an average of 20 
hours to prepare each submission for a total of 16,560 hours.

                                Table 4--Estimated One-Time Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Activity                Number of       records per    Total annual         per         Total hours
                                  Recordkeepers    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Reading and understanding the                156               1             156               6             936
 rule..........................
Writing new labeling SOPs......              156               1             156            2.14         \1\ 334
Training.......................              156               1             156            0.89         \1\ 139
                                --------------------------------------------------------------------------------
    Total......................  ...............  ..............  ..............  ..............           1,409
----------------------------------------------------------------------------------------------------------------
\1\ Decimal rounded up.

    We estimate that approved new animal drug sponsors will incur one-
time burden attributable to reading and understanding the rule, 
revising SOPs related to labeling, and training employees on the 
revised SOPs. We estimate the average time to read and understand the 
proposed rule is 6 hours (156 x 6 = 936 hours). We estimate that small 
businesses will spend 4 hours and large business will spend 8 hours 
revising SOPs related to labeling. Based on data from the 2017 
Statistics of U.S. Businesses, there are 72 small business entities and 
6 large business entities. ((72 x 4) + (6 x 8) / 156 = 2.14 hours per 
record). We also estimate that small businesses will spend 1 hour and 
large businesses will spend 12 hours to train employees on the revised 
SOPs ((72 x 1) + (6 x 12) / 156 = 0.89 hours per record). We assume at 
least two recordkeepers per drug sponsor.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be submitted through reginfo.gov (see 
ADDRESSES). All comments should be identified with the title of the 
information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), we have submitted the information collection provisions of 
this proposed rule to OMB for review. These information collection 
requirements will not be effective until FDA publishes a final rule, 
OMB approves the information collection requirements, and the rule goes 
into effect. FDA will announce OMB approval of these requirements in 
the Federal Register.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132: Federalism. The Order 
requires Federal Agencies to examine actions carefully to determine if 
they contain policies that have federalism implications or that preempt 
State law. As defined in the Order, ``policies that have federalism 
implications'' refers to regulations, legislative comments or proposed 
legislation, and other policy statements or actions that have 
substantial direct effects on the States, on the relationship between 
the Federal Government and the States, or on the distribution of power 
and responsibilities among the various levels of government.
    Section 4(a) of the Order requires Agencies to ``construe . . . a 
Federal statute to preempt State law only where the statute contains an 
express preemption provision or there is some other clear evidence that 
the Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' The sole statutory provision giving preemptive 
effect to this proposed rule is section 751 of the FD&C Act (21 U.S.C. 
379r), which would apply only with respect to nonprescription animal 
drugs. There are no express preemption provisions of the FD&C Act 
applicable to prescription animal drugs.
    We have complied with all of the applicable requirements under the 
Executive order and have determined that the preemptive effect of this 
proposed rule, if finalized, would be consistent with Executive Order 
13132. Through publication of this proposed rule, we are providing 
notice and an opportunity for State and local officials to comment on 
this rulemaking.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. The

[[Page 18315]]

Agency solicits comments from tribal officials on any potential impact 
on Indian Tribes from this proposed action.

XII. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m. Monday through Friday; they are also 
available electronically at https://www.regulations.gov. Although FDA 
has verified the website addresses in this document, please note that 
websites are subject to change over time.

1. FDA, Preliminary Regulatory Impact, Initial Regulatory 
Flexibility, and Unfunded Mandates Reform Act Analyses, 2023; Docket 
No. FDA-2023-N-5160; https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

List of Subjects

21 CFR Part 201

    Drugs, Labeling, Reporting and Recordkeeping requirements.

21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and 
containers, Polychlorinated biphenyls (PCB's).

21 CFR Part 501

    Animal foods, Packaging and containers, Reporting and recordkeeping 
requirements.

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 514 and 516

    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, we propose 
that 21 CFR parts 201, 500, 501, 510, 514, and 516 be amended as 
follows:

PART 201--LABELING

0
1. The authority citation for part 201 is revised to read as follows:

    Authority:  21 U.S.C. 321, 331, 343, 351, 352, 353, 354, 355, 
358, 360, 360b, 360ccc, 360ccc-1, 360ee, 360gg-360ss, 371, 374, 
379e; 42 U.S.C. 216, 241, 262, 264.

0
2. In Sec.  201.15, add paragraph (c)(4) to read as follows:


Sec.  201.15   Drugs; prominence of required label statements.

* * * * *
    (c) * * *
    (4) Approved or conditionally approved new animal drugs are 
exempted from the requirements in paragraph (c). Foreign language 
translations of the labeling for approved or conditionally approved new 
animal drugs must comply with Sec.  201.404(i) and (j).


Sec.  201.100  [Amended].

0
3. In Sec.  201.100, in paragraph (d) introductory text remove the 
words, ``and Sec.  201.105(b)(2)''.
0
4. Revise Sec.  201.105 to read as follows:


Sec.  201.105   Prescription drugs for animal use.

    A drug subject to the requirements of section 503(f)(1) of the 
Federal Food, Drug, and Cosmetic Act is exempt from section 502(f)(1) 
of the Federal Food, Drug, and Cosmetic Act if all the following 
conditions are met:
    (a) The prescription animal drug is:
    (1)(i) In the possession of a person, or the person's agents or 
employees, regularly and lawfully engaged in the manufacture, 
transportation, storage, or wholesale distribution of drugs that are to 
be used only by or on the prescription or other order of a licensed 
veterinarian; or
    (ii) In the possession of a retail, hospital, or clinic pharmacy, 
or other person authorized under State law to dispense prescription 
animal drugs, who is regularly and lawfully engaged in dispensing drugs 
that are to be used only by or on the prescription or other order of a 
licensed veterinarian; or
    (iii) In the possession of a licensed veterinarian for use in the 
course of his or her professional practice; and
    (2) To be dispensed in accordance with section 503(f) of the 
Federal Food, Drug, and Cosmetic Act.
    (b) For prescription new animal drugs approved under section 512 of 
the Federal Food, Drug, and Cosmetic Act or conditionally approved 
under section 571 of the Federal Food, Drug, and Cosmetic Act:
    (1) The labeling components identified in Sec.  201.405 for the 
prescription new animal drug:
    (i) Contain adequate information for its use, including indications 
for use, dosages, routes of administration, frequency and duration of 
administration, and any relevant contraindications, warnings, 
precautions, and adverse reactions, under which veterinarians licensed 
by law to administer the drug can use the drug safely and for the 
purposes for which it is intended, including all purposes for which it 
is advertised or represented;
    (ii) Are authorized by the approved new animal drug application or 
the conditionally approved new animal drug application for the 
prescription new animal drug; and
    (iii) Comply with the applicable content and format requirements of 
subpart H of this part.
    (2) Any labeling, as defined in section 201(m) of the Federal Food, 
Drug, and Cosmetic Act, for the approved or conditionally approved 
prescription new animal drug, distributed by or on behalf of the 
manufacturer, packer, or distributor of the drug, that provides or 
purports to provide information for its use or a dosage for its use 
contains:
    (i) Adequate information for such use, including indications for 
use, dosages, routes of administration, frequency and duration of 
administration, and any relevant contraindications, warnings, 
precautions, and adverse reactions, and information relevant to 
compliance with the new animal drug provisions of the Federal Food, 
Drug, and Cosmetic Act, under which veterinarians licensed by law to 
administer the drug can use the drug safely and for the purposes for 
which it is intended, including all conditions for which it is 
advertised or represented, and the labeling components providing such 
information for use are the same in language and emphasis as labeling 
authorized by the approved new animal drug application or the 
conditionally approved new animal drug application, and any other 
labeling components are consistent with and not contrary to such 
authorized labeling; and
    (ii) The same information concerning the ingredients of the drug as 
appears on the labeling authorized by the approved new animal drug 
application or the conditionally approved new animal drug application.
    (c) For prescription new animal drugs listed in the index of 
legally marketed unapproved new animal drugs for minor species 
established under section 572 of the Federal Food, Drug, and Cosmetic 
Act, or prescription animal drugs not subject to an approved or 
conditionally approved application or indexed listing:
    (1) The label of the drug bears:
    (i) The statement, ``Caution: Federal law restricts this drug to 
use by or on the order of a licensed veterinarian'';
    (ii) The recommended or usual dosage;
    (iii) The route of administration, if it is not for oral use;
    (iv) The quantity or proportion of each active ingredient as well 
as the information required by section 502(e)

[[Page 18316]]

of the Federal Food, Drug, and Cosmetic Act; and
    (v) If it is for other than oral use, the names of all inactive 
ingredients, except that:
    (A) Flavorings and perfumes may be designated as such without 
naming their components;
    (B) Color additives may be designated as coloring without naming 
specific color components unless the naming of such components is 
required by a color additive regulation prescribed in subchapter A of 
this chapter; and
    (C) Trace amounts of harmless substances added solely for 
individual product identification need not be named.
    (vi) If it is intended for administration by parenteral injection, 
the quantity or proportion of all inactive ingredients, except that 
ingredients added to adjust the pH or to make the drug isotonic may be 
declared by name and a statement of their effect; and if the vehicle is 
water for injection, it need not be named.
    (vii) An identifying lot or control number from which it is 
possible to determine the complete manufacturing history of the package 
of the drug.
    (viii) In the case of containers too small or otherwise unable to 
accommodate a label with sufficient space to bear all of the 
information required by paragraph (c)(1) of this section, but which are 
packaged within an outer container from which they are removed for 
dispensing or use, the information required by paragraphs (c)(1)(ii), 
(iii), (v), and (vi) of this section may be contained in other labeling 
on or within the package from which the drug is to be so dispensed, and 
the information referred to in paragraph (c)(1)(i) of this section may 
be placed on such outer container only, and the information required by 
paragraph (c)(1)(vii) of this section may be placed on the crimp of the 
dispensing tube.
    (2) The labeling on or within the package from which the drug is to 
be dispensed:
    (i) Bears adequate information for its use, including indications 
for use, dosages, routes of administration, frequency and duration of 
administration, and any relevant contraindications, warnings, 
precautions, and adverse reactions, under which veterinarians licensed 
by law to administer the drug can use the drug safely and for the 
purposes for which it is intended, including all purposes for which it 
is advertised or represented; and
    (ii) For prescription new animal drugs listed in the index of 
legally marketed unapproved new animal drugs for minor species 
established under section 572 of the Federal Food, Drug, and Cosmetic 
Act, the labeling bearing such information is the labeling contained in 
the index listing.
    (3) Any labeling, as defined in section 201(m) of the Federal Food, 
Drug, and Cosmetic Act, whether or not it is on or within a package 
from which the drug is to be dispensed, distributed by or on behalf of 
the manufacturer, packer, or distributor of the drug, that provides or 
purports to provide information for use or which prescribes, 
recommends, or suggests a dosage for the use of the drug (other than 
dose information required by paragraph (c)(1)(ii) of this section) 
contains:
    (i) Adequate information for such use, including indications for 
use, dosages, routes of administration, frequency and duration of 
administration, and any relevant contraindications, warnings, 
precautions, and adverse reactions, including information relevant to 
compliance with the new animal drug provisions of the Federal Food, 
Drug, and Cosmetic Act, under which veterinarians licensed by law to 
administer the drug can use the drug safely and for the purposes for 
which it is intended, including all conditions for which it is 
advertised or represented; for prescription new animal drugs listed in 
the index of legally marketed unapproved new animal drugs for minor 
species established under section 572 of the Federal Food, Drug, and 
Cosmetic Act, the labeling components providing such information are 
the same in language and emphasis as labeling indexed under the 
provisions of section 572 of the Federal Food, Drug, and Cosmetic Act, 
and any other labeling components are consistent with and not contrary 
to such indexed labeling; and
    (ii) The same information concerning the ingredients of the drug as 
appears on the label and labeling on or within the package from which 
the drug is to be dispensed.
    (4) All labeling, except labels and cartons, bearing information 
for use of the drug also bears the date of the issuance or the date of 
the latest revision of such labeling.
    (d) Reminder labeling, which calls attention to the name of the 
prescription animal drug product but does not include indications or 
dosage recommendations for use of the drug product, is exempted from 
the provisions of paragraphs (b) and (c) of this section. This reminder 
labeling must contain only the proprietary name of the drug product, if 
any; the established name of the drug product, if any; the established 
name of each active ingredient in the drug product; and, optionally, 
information relating to quantitative ingredient statements, dosage 
form, quantity of package contents, price, the name and address of the 
manufacturer, packer, or distributor or other written, printed, or 
graphic matter containing no representation or suggestion relating to 
the drug product. If the Commissioner finds that there is evidence of 
significant incidence of fatalities or serious injury associated with 
the use of a particular prescription animal drug, the Commissioner may 
withdraw this exemption by so notifying the manufacturer, packer, or 
distributor of the drug by letter. Reminder labeling, other than price 
lists and catalogs solely intended to convey price information, is not 
permitted for a prescription animal drug product whose labeling 
contains a boxed warning relating to a serious hazard associated with 
the use of the drug product.
0
5. Add subpart H, consisting of Sec. Sec.  201.401 through 201.413, to 
read as follows:
Subpart H--Labeling Requirements for Approved or Conditionally Approved 
New Animal Drugs
Sec.
201.401 Scope.
201.403 Definitions.
201.404 General requirements.
201.405 Content and format for prescription new animal drug 
labeling.
201.407 Content and format for over-the-counter (OTC) new animal 
drug labeling.
201.409 Content and format of labeling for new animal drugs for use 
in animal feeds.
201.411 Exemptions from labeling requirements for approved or 
conditionally approved new animal drugs.
201.413 Labeling requirements for certain approved or conditionally 
approved new animal drugs.

Subpart H--Labeling Requirements for Approved or Conditionally 
Approved New Animal Drugs


Sec.  201.401   Scope.

    (a) This subpart establishes requirements for content and format of 
labeling for the following categories of prescription (Rx) new animal 
drugs, over-the-counter (OTC) new animal drugs other than those for use 
in animal feeds in accordance with part 558 of this chapter, and new 
animal drugs for use in animal feeds that are subject to part 558 of 
this chapter, including veterinary feed directive (VFD) drugs:
    (1) New animal drugs that are the subject of a new animal drug 
application (NADA) approved or submitted pursuant to section 512 of the 
Federal Food, Drug, and Cosmetic Act;
    (2) New animal drugs that are the subject of an application for 
conditional

[[Page 18317]]

approval (CNADA) conditionally approved or submitted pursuant to 
section 571 of the Federal Food, Drug, and Cosmetic Act;
    (3) Generic new animal drugs that are the subject of an abbreviated 
new animal drug application (ANADA) approved or submitted pursuant to 
section 512(n) of the Federal Food, Drug, and Cosmetic Act that 
references a new animal drug for which the NADA has been voluntarily 
withdrawn for reasons other than safety or effectiveness, or that 
references a new animal drug for which the NADA has been withdrawn on 
the basis of one or more of the grounds included under section 512(e) 
of the Federal Food, Drug, and Cosmetic Act and for which the generic 
new animal drug's approval was not affected by the withdrawal; and
    (4) New animal drugs for use in proprietary medicated feeds for 
which the labeling is maintained in a Veterinary Master File (VMF). 
Proprietary medicated feeds for which the labeling is maintained in an 
NADA or CNADA are included within the categories of drugs described in 
paragraphs (a)(1) and (2) of this section.
    (b) The provisions of this subpart apply to the applications 
described in paragraphs (a)(1) through (4) of this section for new 
animal drugs that are approved before the [EFFECTIVE DATE OF THE FINAL 
RULE], pending on the [EFFECTIVE DATE OF THE FINAL RULE], or submitted 
on or after the [EFFECTIVE DATE OF THE FINAL RULE], in accordance with 
the schedule in Sec.  201.404(a)(4).
    (c) Any new animal drug subject to this subpart that does not fully 
comply with the applicable requirements of this subpart in accordance 
with the schedule in Sec.  201.404(a)(4) is deemed to be misbranded 
under section 502 of the Federal Food, Drug, and Cosmetic Act and, if 
that drug is a VFD drug, also under section 504(b) of the Federal Food, 
Drug, and Cosmetic Act.
    (d) The provisions of this subpart do not apply to:
    (1) Legally marketed unapproved new animal drugs for minor species 
that are indexed in accordance with section 572 of the Federal Food, 
Drug, and Cosmetic Act;
    (2) Heritable intentional genomic alterations in animals; and
    (3) Promotional labeling or advertising.


Sec.  201.403   Definitions.

    The following definitions apply to this subpart H.
    Active ingredient has the same meaning as given in Sec.  
210.3(b)(7) of this chapter.
    Active moiety means the molecule or ion, excluding those appended 
portions of the molecule that cause the drug to be an ester, salt 
(including a salt with hydrogen or coordination bonds), or other 
noncovalent derivative (such as a complex, chelate, or clathrate) of 
the molecule, responsible for the physiological or pharmacological 
action of the drug substance.
    Adverse drug experience has the same meaning as given in Sec.  
514.3 of this chapter.
    Adverse reaction means an undesirable effect, reasonably associated 
with the use of the drug product, that may occur as part of the 
pharmacological action of the drug or that may be unpredictable in 
occurrence.
    ANADA has the same meaning as given in Sec.  514.3 of this chapter.
    Boxed warning means certain contraindications or serious warnings, 
particularly those that may lead to death or serious injury to animals 
or humans that must be presented in a box on labeling. The box and its 
contents must be bolded. The boxed warning is ordinarily based on data 
from the target animal, but data from other species may also be used.
    Contraindication means any situation in which the new animal drug 
should not be used because the risk of use (e.g., certain potentially 
fatal adverse reactions) clearly outweighs any possible benefit to the 
animal. Those situations may include use of the drug in animals that, 
because of their particular species, class, breed, age, sex, 
concomitant therapy, disease state, or other condition such as 
pregnancy or lactation, have a substantial risk of being harmed by the 
drug and for which no potential benefit makes the risk acceptable. 
Contraindications include only known hazards.
    Drug product has the same meaning as given in Sec.  210.3(b)(4) of 
this chapter.
    Environmental warning means a warning that identifies any potential 
hazard to the human environment associated with the use of the new 
animal drug.
    Established name has the same meaning as given in section 502(e)(3) 
of the Federal Food, Drug, and Cosmetic Act.
    Extralabel use has the same meaning as given in Sec.  530.3(a) of 
this chapter.
    Field study means a type of adequate and well-controlled study 
designed to assess the effectiveness and/or safety of a new animal drug 
in the target animal under conditions that closely approximate the 
actual conditions of use.
    Free-choice medicated feed has the same meaning as given in Sec.  
510.455(a) of this chapter.
    Full prescribing information means all information necessary for 
the safe and effective use of a Rx new animal drug.
    Full product information means all information necessary for the 
safe and effective use of an OTC new animal drug.
    Immediate container means the container in contact with the new 
animal drug. The term ``immediate container'' does not include package 
liners (section 201(l) of the Federal Food, Drug, and Cosmetic Act).
    Inactive ingredient has the same meaning as given in Sec.  
210.3(b)(8) of this chapter.
    Indication means the use for which the new animal drug is approved 
or conditionally approved.
    Label has the same meaning as given in section 201(k) of the 
Federal Food, Drug, and Cosmetic Act.
    Labeling has the same meaning as given in section 201(m) of the 
Federal Food, Drug, and Cosmetic Act.
    Lot number, control number, or batch number has the same meaning as 
given in Sec.  210.3(b)(11) of this chapter.
    Milk discard time means the interval between the time of the last 
administration of a new animal drug and the time when the milk can be 
safely consumed.
    NADA has the same meaning as given in Sec.  514.3 of this chapter.
    New animal drug has the same meaning as given in section 201(v) of 
the Federal Food, Drug, and Cosmetic Act.
    Package insert means a labeling component that contains full 
prescribing information for Rx new animal drugs or full product 
information for OTC new animal drugs and is included with the immediate 
container or secondary container or is attached to the label.
    Precaution means any special care to be exercised for safe and 
effective use of the new animal drug. This may include recommended 
screening, monitoring, or diagnostic tests.
    Representative Type B medicated feed labeling means template 
labeling (also known as ``Blue Bird labels,'' 64 FR 63197, November 19, 
1999) approved by FDA as part of the new animal drug application or an 
application for conditional approval for a Type A medicated article for 
the preparation of final printed labels (for medicated feed bags) or 
labeling (accompanying bulk medicated feed) for Type B medicated feeds 
containing the new animal drug. Representative Type B medicated feed 
labeling provides the minimum

[[Page 18318]]

information that must be included on the final printed labels or 
labeling for Type B medicated feeds.
    Representative Type C medicated feed labeling means template 
labeling (also known as ``Blue Bird labels,'' 64 FR 63197, November 19, 
1999) approved by FDA as part of the new animal drug application or an 
application for conditional approval for a Type A medicated article or 
proprietary Type B medicated feed for the preparation of final printed 
labels (for medicated feed bags) or labeling (accompanying bulk 
medicated feed) for Type C medicated feeds containing the new animal 
drug. Representative Type C medicated feed labeling provides the 
minimum information that must be included on the final printed labels 
or labeling for Type C medicated feeds.
    Residue warning statement means a statement that warns against the 
use of the new animal drug in animals for which the withdrawal period 
and/or milk discard time has not been determined, and/or provides other 
information to prevent illegal drug residues in food products from 
animals treated with the new animal drug.
    Secondary container means the packaging that surrounds the 
immediate container for a new animal drug.
    Shipping labeling means labeling associated with the outermost 
carton containing immediate containers, secondary containers, and/or 
multiple unit (multi-unit) cartons of a new animal drug and intended 
for shipment, but not display, of the product.
    Small label means a label on an immediate container for a new 
animal drug that has insufficient space to accommodate the information 
required for a label by Sec.  201.405(b) for Rx new animal drugs or 
Sec.  201.407(b) for OTC new animal drugs.
    Sponsor has the same meaning as given in Sec.  510.3(k) of this 
chapter.
    Strength has the same meaning as given in Sec.  210.3(b)(16) of 
this chapter.
    Target animal means the species, or collection of species, of 
animals, and, if applicable, the specific subset(s) of animals (e.g., 
life stage, production class, age, gender) for which the new animal 
drug is approved or conditionally approved.
    Type A medicated article has the same meaning as given in Sec.  
558.3(b)(2) of this chapter.
    Type B medicated feed has the same meaning as given in Sec.  
558.3(b)(3) of this chapter.
    Type C medicated feed has the same meaning as given in Sec.  
558.3(b)(4) of this chapter.
    User safety warning means a warning that identifies any serious 
adverse reaction or potential hazard to human health associated with 
human exposure during use of a new animal drug via contact, inhalation, 
ingestion, injection, or by other means.
    Veterinary feed directive (VFD) has the same meaning as given in 
Sec.  558.3(b)(7) of this chapter.
    VFD drug has the same meaning as given in Sec.  558.3(b)(6) of this 
chapter.
    Warning means any serious adverse reaction or potential hazard 
associated with the use of the new animal drug.
    Withdrawal period means the interval between the time of the last 
administration of a new animal drug and the time when the animal can be 
safely slaughtered for food.


Sec.  201.404   General requirements.

    (a) The labeling of a new animal drug subject to these regulations 
as identified in Sec.  201.401(a):
    (1) Must conform to an application approved under section 512 of 
the Federal Food, Drug, and Cosmetic Act or conditionally approved 
under section 571 of the Federal Food, Drug, and Cosmetic Act.
    (2) Must be informative and accurate and neither promotional in 
tone nor false or misleading in any particular.
    (3) Must be updated if new information becomes available that 
causes the labeling to become inaccurate, false, or misleading, in 
accordance with Sec.  514.8 of this chapter.
    (4) Must conform to this subpart in accordance with the earliest 
applicable compliance date provided in the following schedule, unless 
paragraphs (b), (c), or (d) of this section are applicable.

                       Table 1 to Paragraph (a)(4)
------------------------------------------------------------------------
                                         All conforming labeling must be
     Application No. and/or status                  submitted:
------------------------------------------------------------------------
(i) NADA, CNADA, or a supplement to an   As part of the application or
 NADA or CNADA subject to Sec.            supplemental application
 514.8(c)(2) submitted after [effective
 date of the final rule plus 180 days].
(ii) NADA, CNADA, or a supplement to an  As part of the application or
 NADA or CNADA subject to Sec.            supplemental application; or,
 514.8(c)(2) pending on [effective date   as a supplement to an approved
 of the final rule] or submitted          application or supplemental
 between [effective date of the final     application no later than 180
 rule] and [effective date of the final   days after the approval date
 rule plus 180 days].                     of the application or
                                          supplemental application
(iii) NADA number 141-300 or greater     As a supplement to an approved
 and originally approved before           application between [effective
 [effective date of the final rule]; or   date of the final rule plus 1
 ANADA that references an NADA (1)        year] and [effective date of
 voluntarily withdrawn for reasons        the final rule plus 2 years]
 other than safety and effectiveness,
 or (2) withdrawn under section 512(e)
 of the Federal Food, Drug, and
 Cosmetic Act and the ANADA's approval
 was not affected by the withdrawal.
(iv) NADA number 141-000 to 141-299....  As a supplement to an approved
                                          application between [effective
                                          date of the final rule plus 2
                                          years] and [effective date of
                                          the final rule plus 3 years]
(v) NADA number 115-000 to 140-999.....  As a supplement to an approved
                                          application between [effective
                                          date of the final rule plus 3
                                          years] and [effective date of
                                          the final rule plus 4 years]
(vi) NADA number 45-000 to 114-999.....  As a supplement to an approved
                                          application between [effective
                                          date of the final rule plus 4
                                          years] and [effective date of
                                          the final rule plus 5 years]
(vii) NADA number 1 to 44-999..........  As a supplement to an approved
                                          application between [effective
                                          date of the final rule plus 5
                                          years] and [effective date of
                                          the final rule plus 6 years]
------------------------------------------------------------------------


[[Page 18319]]

    (b) For proprietary Type B or Type C medicated feeds in which the 
underlying data and labeling are maintained in a VMF, a submission 
containing the conforming labeling must be made to the VMF within 180 
days after all conforming labeling has been approved for the NADA or 
CNADA that is the approved or conditionally approved source of the new 
animal drug used to manufacture the proprietary medicated feed.
    (c) Unless a supplement subject to Sec.  514.8(c)(2) of this 
chapter is submitted to a CNADA after the [effective date of the final 
rule], new animal drugs conditionally approved before [effective date 
of the final rule] are not required to conform to this subpart until an 
application for full approval is submitted.
    (d) For combination new animal drugs subject to section 512(d)(4) 
of the Federal Food, Drug, and Cosmetic Act that are approved for use 
in animal feed or drinking water on or before [effective date of the 
final rule], a supplement containing the conforming labeling for the 
combination new animal drug must be submitted within 180 days after all 
conforming labeling has been approved for the individual new animal 
drugs in the combination.
    (e) In those circumstances where it may not be clear how a 
requirement in this subpart applies to a particular new animal drug, or 
whether it applies, the final determination will be made by FDA.
    (f) When submitting labeling for the purposes of conforming to the 
requirements of subpart H according to the schedule in paragraph (a)(4) 
of this section, all labeling components for the approved or 
conditionally approved new animal drug must be provided in one 
submission. FDA will refuse to file labeling submissions intended to 
conform to this subpart if they are incomplete.
    (g) All labeling for an approved or conditionally approved new 
animal drug must comply with the general formatting requirements 
described in this paragraph in addition to all content and formatting 
requirements described in this subpart.
    (1) Placement of the established name relative to the proprietary 
name on labeling for approved or conditionally approved Rx new animal 
drugs must comply with Sec.  201.10(g)(1). Size and prominence of the 
established name relative to the proprietary name must comply with 
section 502(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act and 
Sec.  201.10(g)(2).
    (2) Placement, size, and prominence of the established name 
relative to the proprietary name on the labeling for approved or 
conditionally approved OTC new animal drugs and the labeling for 
approved or conditionally approved new animal drugs for use in animal 
feeds (Type A medicated article label, proprietary Type B medicated 
feed label, proprietary Type C medicated feed label, other approved 
labeling associated with a Type A medicated article), excluding 
representative Type B and Type C medicated feed labeling, must comply 
with the following requirements:
    (i) The proprietary name of the new animal drug must be accompanied 
by the established name each time the proprietary name is featured on 
the labeling, except in running text. Running text includes detailed 
information such as found in warnings and directions. On any panel or 
page of a component of labeling in which the proprietary name is not 
featured elsewhere but is used in the running text, the established 
name must be placed in conjunction with the proprietary name at least 
with the first presentation of the proprietary name in running text.
    (ii) Where the established name accompanies the proprietary name, 
it must be placed directly to the right of, or directly below, the 
proprietary name. Except for trademark symbols associated with the 
proprietary name, the proprietary name and the established name must 
not be separated by placement of intervening matter that, in any way, 
detracts from, obfuscates, or de-emphasizes the established name of the 
product, or obscures the relationship between the proprietary name and 
the established name. The established name must be presented entirely 
within parentheses.
    (iii) Except in running text, where the established name 
accompanies the proprietary name, the smallest letter of the 
established name (upper or lower case letters) must be printed in 
letters at least half the size of the largest letter of the proprietary 
name (upper or lower case letters). Within running text, the 
established name accompanying the proprietary name must be printed in 
letters the same size of the letters in the proprietary name (upper and 
lower case letters). The prominence of the established name must be 
consistent with the prominence of the proprietary name, taking into 
account all pertinent factors including typography, layout, contrast, 
and other printing features.
    (3) For representative Type B and Type C medicated feed labeling 
for approved or conditionally approved new animal drugs for use in 
animal feeds, the established name of the Type B or Type C medicated 
feed presented below the description of the Type B or Type C medicated 
feed must comply with the following requirements:
    (i) The established name must be presented directly below the 
description of the Type B or Type C medicated feed and must not be 
separated by placement of intervening matter.
    (ii) The established name must be printed in lower case letters 
except for ``Type B'' or ``Type C''.
    (iii) The established name must be printed in non-bold font of the 
same size letters as the name of the Type B or Type C medicated feed 
(upper and lower case letters).
    (iv) The established name must be presented entirely within 
parentheses.
    (4) All labeling text and type style must be easy to read, and 
letters must not touch.
    (5) Running text, section headings, and subsection headings on 
package inserts and representative Type B and Type C medicated feed 
labeling must be in black and on a white background and use a single 
type style. For other labeling components, other color combinations may 
be used if there is sufficient contrast between text and the background 
colors to ensure readability of the text.
    (6) Representative Type B and Type C medicated feed labeling must 
not contain any logos, graphics, or designs other than illustrations or 
tables that FDA determines are necessary for proper use of the 
medicated feed. For other labeling components for approved or 
conditionally approved new animal drugs, in accordance with Sec.  
201.15(b)(1), graphics or designs associated with the labeling must not 
take up space needed for information required by this subpart. In 
accordance with paragraph (a)(2) of this section, graphics or diagrams 
must not be promotional in tone. If graphics are incorporated into the 
background, for any text appearing over the graphics, there must be 
sufficient contrast between the text and the graphics colors to ensure 
readability of the text. The use of compressed arrows on labeling is 
limited to the subsection entitled either ``Withdrawal Periods and 
Residue Warnings'' or ``Withdrawal Periods,'' in accordance with 
paragraph (g)(8)(iii) of this section.
    (7) The following minimum letter height or type size must be used 
for specific components of labeling, subject to the provisions of 
paragraph (g)(2) of this section:
    (i) Immediate container label, secondary container labeling, 
package inserts, and labeling of multiple unit cartons and display 
cartons: 8 points.
    (ii) Small label: 6 points.

[[Page 18320]]

    (iii) Type A medicated article label, representative Type B 
medicated feed labeling, representative Type C medicated feed labeling, 
proprietary Type B medicated feed label, and proprietary Type C 
medicated feed label: 10 points.
    (iv) Additional labeling for Rx new animal drugs that is to be 
provided to the animal owner: 12 points.
    (v) Shipping labeling for Rx and OTC new animal drugs and other 
approved labeling for Type A medicated articles: 16 points.
    (8) Section headings and subsection headings must be formatted as 
follows:
    (i) All section headings and subsection headings must be in bold 
type that prominently distinguishes them from other approved labeling 
information.
    (ii) Section headings must be either left justified or centered.
    (iii) For the subsection entitled either ``Withdrawal Periods and 
Residue Warnings'' or ``Withdrawal Periods,'' the subsection heading, 
and the contents of the subsection, must be centered within compressed 
arrows.
    (iv) All other subsection headings must be left justified.
    (h) If the National Drug Code (NDC) is included on labeling, it 
must appear in accordance with Sec.  207.33 of this chapter.
    (i) All words, statements, and other information required on the 
labeling for approved or conditionally approved new animal drugs must 
appear in the English language. Additional translations of labeling for 
approved or conditionally approved new animal drugs into foreign 
languages must comply with the following requirements:
    (1) For approved or conditionally approved Rx new animal drugs, if 
a labeling component contains any section or wording translated into a 
foreign language, then the entire full prescribing information must be 
translated into the foreign language and must comply with the format 
and content requirements in Sec.  201.405(a). FDA also may require 
additional wording on other labeling components for the Rx new animal 
drug to be translated into the foreign language when necessary to 
ensure its safe and effective use.
    (2) For approved or conditionally approved OTC new animal drugs 
other than new animal drugs for use in animal feeds, if a labeling 
component contains any section or wording translated into a foreign 
language, then the entire full product information must be translated 
into the foreign language and must comply with the format and content 
requirements in Sec.  201.407(a). FDA also may require additional 
wording on other labeling components for the OTC new animal drug to be 
translated into the foreign language when necessary to ensure its safe 
and effective use.
    (3) For approved or conditionally approved new animal drugs for use 
in animal feeds, if the labeling contains any section or wording 
translated into a foreign language, then all labeling must be 
translated into the foreign language and must comply with the format 
and content requirements in Sec.  201.409.
    (4) FDA may limit the number of languages into which labeling 
information is translated to ensure clarity of information and the safe 
and effective use of the new animal drug.
    (j) For approved or conditionally approved new animal drugs 
distributed solely in the Commonwealth of Puerto Rico or in a Territory 
where the predominant language is other than English, the predominant 
language may be substituted for English. Such new animal drugs may be 
exempt from paragraph (i) of this section.


Sec.  201.405   Content and format for prescription (Rx) new animal 
drug labeling.

    This section describes specific content and format requirements for 
the labeling of approved or conditionally approved Rx new animal drugs. 
This section does not apply to new animal drugs approved or 
conditionally approved as veterinary feed directive (VFD) drugs. See 
Sec.  201.409 for content and format requirements for the labeling of 
approved or conditionally approved new animal drugs for use in animal 
feeds that are subject to part 558 of this chapter, including VFD 
drugs. Omit labeling sections or subsections that do not apply to the 
Rx new animal drug. The final content of each applicable component and 
section of labeling is determined by FDA. In addition to the content 
and format requirements in this section, the labeling of approved or 
conditionally approved Rx new animal drugs must comply with other 
applicable requirements in this subpart.
    (a) Labeling providing full prescribing information. All approved 
or conditionally approved Rx new animal drugs must provide full 
prescribing information as described in this paragraph. The package 
insert must include full prescribing information. If no package insert 
is provided, a secondary container is required, and its labeling must 
include full prescribing information as described in this paragraph. 
The following information, as applicable, must appear in the order 
listed on the labeling component providing full prescribing 
information. If full prescribing information is provided on the 
secondary container labeling, in accordance with section 201(k) of the 
Federal Food, Drug, and Cosmetic Act, the secondary container labeling 
may exclude any of the information described in this subsection that is 
required by paragraphs (b) or (c) of this section to appear on the 
label if such information is easily legible through the secondary 
container. Section headings, subsection headings, and other text 
presented in quotations in this paragraph must appear verbatim on the 
labeling providing full prescribing information. Sections and 
subsections are not numbered on full prescribing information.
    (1) Drug product identification. This section of full prescribing 
information must include:
    (i) The proprietary name of the finished drug product;
    (ii) The established name of the drug product;
    (iii) The route(s) of administration, if not included as part of 
the established name of the drug product;
    (iv) The dosage form of the finished drug product, if not included 
as part of the established name of the drug product;
    (v) The established name and strength or concentration of each 
active ingredient, except that the strength or concentration may be 
excluded from full prescribing information provided on a package insert 
that applies to multiple strengths or concentrations;
    (vi) The pharmacological class of the new animal drug, if required 
to facilitate the drug's safe and effective use; and
    (vii) For controlled substances, the required controlled substance 
symbol, in accordance with part 1302 of this title designating the 
schedule for the drug substance.
    (2) Prescription statement. This section of full prescribing 
information must include the following statement: ``Caution: Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian''.
    (3) Conditional approval statement. All conditionally approved new 
animal drugs must include the following statement in this section of 
full prescribing information in accordance with section 571(f)(1)(A) of 
the Federal Food, Drug, and Cosmetic Act: ``conditionally approved by 
FDA pending a full demonstration of effectiveness under application 
number [insert number]''. This statement must be prominent and 
conspicuous.
    (4) Boxed warnings. All Rx new animal drugs with boxed warnings 
must include the boxed warning in this section of full prescribing 
information.

[[Page 18321]]

The box must contain, in upper case letters, the heading ``WARNING''. 
The contents of the box must briefly explain the risk and, if 
appropriate, refer to more detailed information in other sections of 
full prescribing information. The box, heading, and contents must be 
bolded.
    (5) Extralabel use prohibition statement. An approved new animal 
drug that is prohibited from extralabel use as listed under Sec.  
530.41 of this chapter must include in this section of full prescribing 
information an extralabel use prohibition statement that begins with 
the phrase: ``Federal law prohibits the extralabel use of this drug . . 
.'' and concludes with a description of the prohibition as described in 
Sec.  530.41 of this chapter.
    (6) ``Description''. This section of full prescribing information 
must include:
    (i) The proprietary name of the finished drug product;
    (ii) The established name of the drug product;
    (iii) The route(s) of administration, if not included as part of 
the established name of the drug product;
    (iv) The dosage form of the finished drug product, if not included 
as part of the established name of the drug product;
    (v) A description of the identifying characteristics of the dosage 
form, such as color, shape, coating, scoring, and imprinting;
    (vi) The established name and strength or concentration of each 
active ingredient, including all available strengths or concentrations 
to which full prescribing information applies;
    (vii) If applicable, a statement that the product is sterile; and
    (viii) The established name of each inactive ingredient presented 
in decreasing order of predominance, by weight or concentration.
    (A) If exemption from listing one or more inactive ingredients is 
granted, in accordance with Sec.  201.411, to avoid disclosure of trade 
secret information, this section of full prescribing information must 
also state the following: ``Certain inactive ingredients are not listed 
to avoid disclosing trade secret information.''
    (B) If exemption from listing one or more inactive ingredients is 
granted, in accordance with Sec.  201.411, because their listing would 
be impracticable, this section of full prescribing information must 
also state the following: ``Certain inactive ingredients are not listed 
because their listing would be impracticable.''
    (7) ``Indications for Use''. Include the following information in 
this section of full prescribing information in order:
    (i) The approved or conditionally approved indication(s) and target 
animal(s) in the following format: ``For [indication(s)] in [target 
animal(s)]'';
    (ii) A statement indicating that the new animal drug is approved or 
conditionally approved for use only under specific conditions, if 
applicable; and
    (iii) A statement(s) indicating animals for which the new animal 
drug is not approved or conditionally approved, if FDA determines such 
a statement(s) is required for safety and/or effectiveness reasons.
    (8) ``Dosage and Administration''. This section of full prescribing 
information must include for each indication and target animal:
    (i) The statement, ``Always provide [additional labeling] with each 
prescription'' for Rx new animal drugs requiring additional labeling, 
in accordance with paragraph (a)(14) of this section, inserting the 
title of the additional labeling in the location indicated by the 
bracketed text;
    (ii) The route(s) of administration, and specific site(s) of 
administration, if applicable;
    (iii) The dose (or dose range);
    (iv) The intervals between doses, if applicable;
    (v) The duration of treatment;
    (vi) The maximum volume per injection site, if required to 
facilitate the drug's safe and effective use;
    (vii) Any modification of the information required in paragraphs 
(a)(8)(i) through (vi) of this section that is needed for special 
animal populations (e.g., neonatal, reproducing, lactating, geriatric, 
or those with specific disease states); and
    (viii) Other information regarding dosage and administration, if 
required to facilitate the drug's safe and effective use.
    (9) ``Contraindications''. All Rx new animal drugs with 
contraindications must include the contraindications in this section of 
full prescribing information.
    (10) ``Warnings and Precautions''. This section of full prescribing 
information is required for all approved or conditionally approved Rx 
new animal drugs. Include in the following order all applicable 
subsections, headings, and information:
    (i) ``Withdrawal Periods and Residue Warnings'' or ``Withdrawal 
Periods''. This subsection of full prescribing information is required 
for all new animal drugs approved or conditionally approved for use in 
food-producing animals and must include all human food safety warnings, 
including milk discard times, withdrawal periods, and residue warning 
statements, as applicable. The order of the human food safety warnings 
in this subsection of full prescribing information must be as described 
in paragraphs (a)(10)(i)(B) through (G) of this section, as applicable.
    (A) If there is a residue warning statement(s), this subsection of 
full prescribing information must be entitled ``Withdrawal Periods and 
Residue Warnings''. If there is no residue warning statement, this 
subsection of full prescribing information must be entitled 
``Withdrawal Periods''. The title of this subsection and all 
information in this subsection of full prescribing information must be 
centered and placed entirely within compressed arrows, in accordance 
with Sec.  201.404(g)(8). The compressed arrows must be black for 
package inserts or a color that clearly contrasts from background 
colors for other approved labeling.
    (B) If the new animal drug is approved or conditionally approved 
for use in food-producing animals excluding female animals that produce 
milk for human consumption, include in this subsection of full 
prescribing information the withdrawal period(s) followed by any 
residue warning statements.
    (C) If the new animal drug is approved or conditionally approved 
for use in food-producing animals excluding female animals that produce 
milk for human consumption and there is no withdrawal period, include 
in this subsection of full prescribing information the statement ``No 
withdrawal period is required when used according to labeling.'', 
followed by any residue warning statements.
    (D) If the new animal drug is approved or conditionally approved 
for use in female animals that produce milk for human consumption, 
include in this subsection of full prescribing information the milk 
discard time(s), followed by the withdrawal period(s), followed by any 
residue warning statements.
    (E) If the new animal drug is approved or conditionally approved 
for use in female animals that produce milk for human consumption and 
there is a milk discard time(s) but no withdrawal period, include in 
this subsection of full prescribing information the milk discard 
time(s), followed by the statement ``No withdrawal period is required 
when used according to labeling.'', followed by any residue warning 
statements.
    (F) If the new animal drug is approved or conditionally approved 
for use in female animals that produce milk for human consumption and 
there is no

[[Page 18322]]

milk discard time but there is a withdrawal period(s), include in this 
subsection of full prescribing information the withdrawal period(s), 
followed by the statement ``No milk discard time is required when used 
according to labeling.'', followed by any residue warning statements.
    (G) If the new animal drug is approved or conditionally approved 
for use in female animals that produce milk for human consumption and 
there is no milk discard time and no withdrawal period, include in this 
subsection of full prescribing information the statement ``No milk 
discard time and no withdrawal period is required when used according 
to labeling.'', followed by any residue warning statements.
    (ii) ``User Safety Warnings''. This subsection of full prescribing 
information is required for all new animal drugs and must include in 
the following order:
    (A) ``Not for use in humans. Keep out of reach of children.''
    (B) All additional user safety warnings listed in decreasing order 
of severity or frequency; and
    (C) ``To obtain a Safety Data Sheet(s), contact [insert name of 
manufacturer] at [insert manufacturer's telephone number] or [insert 
manufacturer's website].''
    (iii) ``Animal Safety Warnings and Precautions''. All target animal 
safety warnings that identify any serious adverse reaction or potential 
hazard to the target animal(s) associated with the use of the new 
animal drug and all precautions must be included in this subsection of 
full prescribing information. These items must be listed in decreasing 
order of severity or frequency.
    (iv) ``Environmental Warnings''. All environmental warnings 
applicable to the new animal drug that are included in an approved or 
conditionally approved application must be provided in this subsection 
of full prescribing information.
    (v) ``Other Warnings''. Any other required warnings must be 
included in this subsection of full prescribing information.
    (11) ``Adverse Reactions''. Include in this section of full 
prescribing information the adverse reactions, as determined by FDA, 
that occur with use of the Rx new animal drug and with use of drugs in 
the same pharmacologically active and chemically related class, if 
applicable. Include information necessary to interpret the adverse 
reactions (e.g., for field studies include total number of animals 
exposed, extent and nature of exposure). Within the following 
categories, as applicable, present the adverse reactions in decreasing 
order of severity or frequency.
    (i) ``Pre-approval experience''. Include adverse reactions observed 
in laboratory or field studies in the target animal(s).
    (ii) ``Foreign market experience''. If the drug product has been 
commercially marketed outside the United States, include information 
from foreign adverse drug experience reports known prior to U.S. 
approval.
    (iii) ``Post-approval experience''. Include the adverse reactions 
identified from domestic and foreign adverse drug experience reports.
    (12) ``Contact Information''. The following statements must be 
included in this section of full prescribing information: ``Contact 
[insert name of business] at [insert business telephone number] or 
[insert business web address]. To report suspected adverse drug 
experiences, contact [insert name of business] at [insert business 
telephone number]. For additional information about reporting adverse 
drug experiences for animal drugs, contact FDA at [insert current FDA 
telephone number for voluntary reporting of adverse drug experiences] 
or [insert current FDA web address for voluntary reporting of adverse 
drug experiences].'' Use as the name of the business the manufacturer, 
packer, or distributor identified in the ``Name and place of business'' 
section of full prescribing information according to paragraph (a)(22) 
of this section. If more than one business is identified in the ``Name 
and place of business'' section of full prescribing information, select 
the most appropriate to identify as the ``business'' in the ``Contact 
Information'' section of full prescribing information to provide 
additional information about the Rx new animal drug and to contact 
regarding suspected adverse drug experiences.
    (13) ``Information for Animal Owner''. Any specific information 
that FDA determines is necessary for the animal owner or person 
treating the animal to use the Rx new animal drug safely and 
effectively must be included in this section of full prescribing 
information. If FDA requires additional labeling (e.g., a client 
information sheet), a printed copy must be attached to, or accompany, 
the package insert or secondary container labeling if no package insert 
is provided.
    (14) ``Clinical Pharmacology''. If required by FDA to facilitate 
the drug's safe and effective use, include a summary of the clinical 
pharmacology of the Rx new animal drug in the target animal(s) in this 
section of full prescribing information, including the following three 
subsections, as applicable:
    (i) ``Mechanism of action'';
    (ii) ``Pharmacodynamics''; and
    (iii) ``Pharmacokinetics''.
    (15) ``Microbiology''. This section of full prescribing information 
is required for all antimicrobial Rx new animal drugs and must include 
a description of microbiologic data associated with the studies used to 
support the effectiveness of the drug against the indicated pathogens. 
Microbiology data must be restricted to organisms named in the approved 
or conditionally approved indications. If in vitro data for 
antimicrobial new animal drugs are included in this section of full 
prescribing information that have not been correlated to clinical 
effectiveness, the data must be immediately preceded by the statement: 
``The following in vitro data are available, but their clinical 
significance is unknown.''
    (16) ``Target Animal Safety''. This section of full prescribing 
information must include a summary of the basis for the conclusion that 
the new animal drug is safe in the target animal(s) when used as 
approved or conditionally approved.
    (17) ``Effectiveness''. This section of full prescribing 
information must include a summary of the basis for the conclusion that 
the new animal drug is effective in the target animal(s) when used as 
approved. For a conditionally approved new animal drug, include a 
summary of the basis for the reasonable expectation of effectiveness.
    (18) ``Net Contents''. This section of full prescribing information 
must identify the contents of the secondary container. Exclude this 
section from package inserts.
    (19) ``How Supplied''. This section of full prescribing information 
must include information on the available drug strengths, 
concentrations, and container sizes to which the labeling applies. 
Revise this section of full prescribing information if new strengths, 
concentrations, or container sizes are added.
    (20) ``Storage, Handling, and Disposal''. This section of full 
prescribing information must include drug storage information. Also 
include any required handling and drug disposal information in this 
section.
    (21) NADA/ANADA approval statement. In accordance with section 
502(w)(3) of the Federal Food, Drug, and Cosmetic Act, approved new 
animal drugs must include the following statement in this section of 
full prescribing information: ``Approved by FDA under NADA # xxx-xxx''. 
Approved generic new animal drugs must include the following statement 
in

[[Page 18323]]

this section of full prescribing information: ``Approved by FDA under 
ANADA # xxx-xxx''. This statement must appear in this section of full 
prescribing information and:
    (i) Appear on one straight line unless there is insufficient space, 
in which case the statement may appear on two straight lines;
    (ii) Not be incorporated into a seal, stamp, logo or other graphic;
    (iii) Be of consistent type size, color, and contrast and be of no 
greater prominence than the rest of the labeling text; and
    (iv) Not obscure or otherwise render less conspicuous any word, 
statement, or other information required by FDA.
    (22) Name and place of business. This section of full prescribing 
information must include the name and place of business of the 
manufacturer, packer, or distributor.
    (23) ``Lot Number and Expiration Date''. This section is required 
when full prescribing information is provided on the secondary 
container labeling. This section must include the identifying lot or 
control number of the Rx new animal drug within the secondary 
container. This section must also include the expiration date of the Rx 
new animal drug within the secondary container, in accordance with 
Sec.  201.17. Alternatively, this section must refer to the location on 
the secondary container labeling or secondary container where the lot 
or control number and expiration date are printed. In accordance with 
Sec.  201.17, an expiration date may be excluded from the secondary 
container labeling or secondary container if the expiration date 
provided on the label or immediate container is easily legible through 
the secondary container.
    (24) ``Revision Date''. This section of full prescribing 
information must include the date of the most recent revision of the 
component of labeling that provides full prescribing information, 
listing the month followed by the year.
    (b) Prescription new animal drug label (Rx label). All approved or 
conditionally approved Rx new animal drugs must provide a label (Rx 
label). The following information, as applicable, must appear in the 
order listed on the Rx label. If there is insufficient space on the 
immediate container for a label to provide for all of the following 
information, then an Rx small label is required instead. The 
requirements for an Rx small label are provided in paragraph (c) of 
this section. Section headings and other text presented in quotations 
in this paragraph must appear verbatim on the Rx label. Sections are 
not numbered on the Rx label. For Rx labels with a front panel and one 
side or back panel, the information identified in paragraph (b)(1) of 
this section must be provided on the front panel in the order listed, 
and the information identified in paragraph (b)(2) of this section must 
be provided on the side or back panel in the order listed. If the Rx 
label consists of a single panel, the information identified in 
paragraph (b)(1) must be provided on the Rx label in the order listed 
followed by the information identified in paragraph (b)(2) in the order 
listed. For Rx labels with a front panel and multiple side and/or back 
panels, the information identified in paragraph (b)(1) must be provided 
on the Rx label in the order listed followed by the information 
identified in paragraph (b)(2) in the order listed, starting on the 
front panel, continuing on the panel immediately to the right of the 
front panel, and continuing to fill the panels to the right until all 
of the information is presented. In all instances, the information 
specified in paragraphs (b)(2)(iii) and (iv) must appear on the same 
panel.
    (1) Front panel. The following information must appear on the front 
panel of the Rx label in the order listed.
    (i) Drug product identification. This section of the Rx label must 
include:
    (A) The proprietary name of the finished drug product;
    (B) The established name of the drug product;
    (C) The route(s) of administration, if not included as part of the 
established name of the drug product;
    (D) The dosage form of the finished drug product, if not included 
as part of the established name of the drug product;
    (E) The established name and strength or concentration of each 
active ingredient;
    (F) If applicable, a statement that the product is sterile;
    (G) The pharmacological class of the new animal drug, if required 
to facilitate the drug's safe and effective use; and
    (H) For controlled substances, the required controlled substance 
symbol, in accordance with part 1302 of this title designating the 
schedule for the drug substance.
    (ii) Prescription statement. This section of the Rx label must 
include the following statement, in accordance with section 503(f)(4) 
of the Federal Food, Drug, and Cosmetic Act: ``Caution: Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.''
    (iii) Conditional approval statement. For conditionally approved 
new animal drugs, the requirements of paragraph (a)(3) of this section 
apply.
    (iv) Boxed warnings. For Rx new animal drugs that have boxed 
warnings, the requirements of paragraph (a)(4) of this section apply.
    (v) ``Indications for Use''. The requirements of paragraph (a)(7) 
of this section apply. However, if there is insufficient space on the 
Rx label for the complete ``Indications for Use'' section as specified 
in paragraph (a)(7), then include the statement required in paragraph 
(a)(7)(i) or, if there is insufficient space on the Rx label for the 
statement in paragraph (a)(7)(i), then include the statement, ``For 
[abbreviated indication(s)] in [target animal(s)]''. In either 
situation where there is insufficient space on the Rx label for the 
complete ``Indications for Use'' section as specified in paragraph 
(a)(7), the required statement must be followed by, ``See package 
insert for complete `Indications for Use''' if full prescribing 
information is provided on a package insert, or ``See package labeling 
for complete `Indications for Use''' if full prescribing information is 
provided on the secondary container labeling.
    (vi) Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use as listed under Sec.  530.41 of 
this chapter, the requirements of paragraph (a)(5) of this section 
apply.
    (vii) ``Withdrawal Periods and Residue Warnings'' or ``Withdrawal 
Periods''. For new animal drugs approved or conditionally approved for 
use in food-producing animals, the requirements of paragraph (a)(10)(i) 
of this section apply. If there is insufficient space on the front 
panel of Rx labels consisting of only a front panel and one side or 
back panel for the information required in paragraph (a)(10)(i), this 
section must be provided on the side or back panel of the Rx label 
immediately following the full prescribing information statement 
specified in paragraph (b)(2)(i) of this section.
    (viii) ``Net Contents''. This section of the Rx label must identify 
the contents of the immediate container, in accordance with Sec.  
201.5.
    (ix) NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the requirements of paragraph 
(a)(21) of this section apply.
    (2) Side or back panel. The following information must appear on 
the side or back panel of the Rx label in the order listed.
    (i) Full prescribing information statement. This section of the Rx 
label must include one of two statements. If full prescribing 
information is provided

[[Page 18324]]

on the package insert, the following statement must be used: ``Before 
using this drug, read package insert for full prescribing 
information.'' If full prescribing information is provided on the 
secondary container labeling, the following statement must be used: 
``Before using this drug, read package labeling for full prescribing 
information.''
    (ii) ``Dosage and Administration''. The requirements of paragraph 
(a)(8) of this section apply. If there is insufficient space on the Rx 
label for the complete requirements as specified in paragraph (a)(8) or 
if it is necessary for additional information provided in full 
prescribing information that is not provided on the Rx label to be read 
before administering the drug, FDA may allow this section to be 
excluded from the Rx label.
    (iii) ``Active Ingredient'' or ``Active Ingredients''. This section 
of the Rx label must provide the established name and strength or 
concentration of each active ingredient. If the Rx new animal drug 
contains one active ingredient, this section of the Rx label must be 
entitled ``Active Ingredient''. If the Rx new animal drug contains more 
than one active ingredient, this section of the Rx label must be 
entitled ``Active Ingredients.''
    (iv) ``Inactive Ingredients''. The requirements of paragraph 
(a)(6)(viii) of this section apply.
    (v) ``Storage, Handling, and Disposal''. The requirements of 
paragraph (a)(20) of this section apply.
    (vi) Name and place of business. This section of the Rx label must 
include the name and place of business of the manufacturer, packer, or 
distributor, in accordance with section 502(b) of the Federal Food, 
Drug, and Cosmetic Act.
    (vii) ``Lot Number and Expiration Date'' or ``Lot Number''. This 
section of the Rx label must include the identifying lot or control 
number of the Rx new animal drug within the immediate container. This 
section of the Rx label must also include the expiration date of the Rx 
new animal drug within the immediate container, in accordance with 
Sec.  201.17. Alternatively, this section must refer to the location on 
the Rx label or immediate container where the lot or control number and 
expiration date are printed. In accordance with Sec.  201.17, if the 
immediate container provides a single dose of the Rx new animal drug 
and is packaged individually in a secondary container that provides an 
expiration date on the secondary container labeling or secondary 
container, an expiration date is not required on the Rx label or 
immediate container. If an expiration date is not provided on the Rx 
label or immediate container per this provision, then this section of 
the Rx label must be entitled ``Lot Number.''
    (viii) ``Revision Date''. This section of the Rx label must include 
the date of the most recent revision of the Rx label, listing the month 
followed by the year.
    (c) Prescription new animal drug small label (Rx small label). The 
following information, as applicable, must appear in the order listed 
on the Rx small label. FDA will make the final determination as to 
whether an immediate container lacks sufficient space for the label to 
include all of the information required by paragraph (b) of this 
section, taking into consideration readability and legibility of the 
information. Section headings and other text presented in quotations in 
this paragraph must appear verbatim on the Rx small label. Sections are 
not numbered on the Rx small label.
    (1) Proprietary name. This section of the Rx small label must 
provide the proprietary name of the finished drug product.
    (2) Established name. This section of the Rx small label must 
provide the established name of the drug product.
    (3) Active ingredient(s). This section of the Rx small label must 
provide the established name and strength or concentration of each 
active ingredient.
    (4) Controlled substance symbol. For controlled substances, this 
section of the Rx small label must include the required controlled 
substance symbol, in accordance with part 1302 of this title 
designating the schedule for the drug substance.
    (5) Prescription statement. This section of the Rx small label must 
include the following: ``Rx Animal Use''.
    (6) Target animals. This section of the Rx small label must include 
the statement: ``For [target animal(s)] only''.
    (7) Full prescribing information statement. This section of the Rx 
small label must include one of two statements. If full prescribing 
information is provided on the package insert, the following statement 
must be used: ``Read package insert for full prescribing information.'' 
If full prescribing information is provided on the secondary container 
labeling, the following statement must be used: ``Read package labeling 
for full prescribing information.''
    (8) ``Net Contents''. This section of the Rx small label must 
identify the contents of the immediate container, in accordance with 
Sec.  201.51.
    (9) Name and place of business. This section of the Rx small label 
must include the name and place of business of the manufacturer, 
packer, or distributor, in accordance with section 502(b) of the 
Federal Food, Drug, and Cosmetic Act.
    (10) ``Lot, Exp. and Storage'' or ``Lot and Storage''. This section 
of the Rx small label must include the identifying lot or control 
number of the Rx new animal drug within the immediate container. This 
section of the Rx small label must also include the expiration date of 
the Rx new animal drug within the immediate container, in accordance 
with Sec.  201.17. Drug storage information for the Rx new animal drug 
must also be included in this section of the Rx small label. In 
accordance with Sec.  201.17, if the immediate container provides a 
single dose of the Rx new animal drug and is packaged individually in a 
secondary container that provides an expiration date on the secondary 
container labeling or secondary container, an expiration date is not 
required on the Rx small label or immediate container. If an expiration 
date is not provided on the Rx small label or immediate container per 
this provision, then this section of the Rx small label must be 
entitled ``Lot and Storage.''
    (11) ``Revision Date''. This section of the Rx small label must 
include the date of the most recent revision of the Rx small label, 
listing the month followed by the year.
    (d) Labeling for secondary containers for Rx new animal drugs that 
include a package insert (Rx secondary container labeling). If a 
secondary container is provided for an approved or conditionally 
approved Rx new animal drug and the Rx new animal drug includes a 
package insert, the following information, as applicable, must appear 
in the order listed on the secondary container labeling (Rx secondary 
container labeling). In accordance with section 201(k) of the Federal 
Food, Drug, and Cosmetic Act, the Rx secondary container labeling may 
exclude any of the information described in this subsection that is 
required by paragraphs (b) or (c) of this section to appear on the 
label if such information is easily legible through the Rx secondary 
container. Section headings, subsection headings, and other text 
presented in quotations in this paragraph must appear verbatim on the 
Rx secondary container labeling. Sections and subsections are not 
numbered on the Rx secondary container labeling. For Rx secondary 
container labeling with a front panel and one side or back panel, the 
information identified in paragraph (d)(1) of this section must be 
provided on the front panel in the order listed, and the information 
identified in

[[Page 18325]]

paragraph (d)(2) of this section must be provided on the side or back 
panel in the order listed. For Rx secondary container labeling with a 
front panel and multiple side and/or back panels, the information 
identified in paragraph (d)(1) must be provided on the Rx secondary 
container labeling in the order listed followed by the information 
identified in paragraph (d)(2) in the order listed, starting on the 
front panel, continuing on the panel immediately to the right of the 
front panel, and continuing to fill the panels to the right until all 
of the information is presented. In all instances, the information 
specified in paragraphs (d)(2)(v) and (vi) of this section must appear 
on the same panel.
    (1) Front panel. The following information must appear on the front 
panel of the Rx secondary container labeling in the order listed.
    (i) Drug product identification. This section of the Rx secondary 
container labeling must include:
    (A) The proprietary name of the finished drug product;
    (B) The established name of the drug product;
    (C) The route(s) of administration, if not included as part of the 
established name of the drug product;
    (D) The dosage form of the finished drug product, if not included 
as part of the established name of the drug product;
    (E) The established name and strength or concentration of each 
active ingredient;
    (F) If applicable, a statement that the product is sterile;
    (G) The pharmacological class of the new animal drug, if required 
to facilitate the drug's safe and effective use; and
    (H) For controlled substances, the required controlled substance 
symbol, in accordance with part 1302 of this title designating the 
schedule for the drug substance.
    (ii) Prescription statement. The requirements of paragraph (a)(2) 
of this section apply.
    (iii) Conditional approval statement. The requirements of paragraph 
(a)(3) of this section apply.
    (iv) Boxed warnings. The requirements of paragraph (a)(4) of this 
section apply.
    (v) ``Indications for Use''. The requirements of paragraph (a)(7) 
of this section apply.
    (vi) Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use as listed under Sec.  530.41 of 
this chapter, the requirements of paragraph (a)(5) of this section 
apply.
    (vii) ``Net Contents''. This section of the Rx secondary container 
labeling must identify the contents of the secondary container.
    (viii) NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the requirements of paragraph 
(a)(21) of this section apply.
    (2) Side or back panel. The following information must appear on 
the side or back panel of the Rx secondary container labeling in the 
order listed.
    (i) Full prescribing information statement. This section of the Rx 
secondary container labeling must include the following statement: 
``Before using this drug, read package insert for full prescribing 
information.''
    (ii) ``Dosage and Administration''. The requirements of paragraph 
(a)(8) of this section apply.
    (iii) ``Contraindications''. The requirements of paragraph (a)(9) 
of this section apply.
    (iv) ``Warnings and Precautions''. The requirements of paragraph 
(a)(10) of this section apply.
    (v) ``Active Ingredient'' or ``Active Ingredients''. The 
requirements of paragraph (b)(2)(iii) of this section apply.
    (vi) ``Inactive Ingredients''. The requirements of paragraph 
(a)(6)(viii) of this section apply.
    (vii) ``Storage, Handling, and Disposal''. The requirements of 
paragraph (a)(20) of this section apply.
    (viii) Name and place of business. The requirements of paragraph 
(a)(22) of this section apply.
    (ix) ``Lot Number and Expiration Date''. This section of the Rx 
secondary container labeling must include the identifying lot or 
control number of the Rx new animal drug within the secondary 
container. This section of the Rx secondary container labeling must 
also include the expiration date of the Rx new animal drug within the 
secondary container, in accordance with Sec.  201.17. Alternatively, 
this section must refer to the location on the Rx secondary container 
labeling or secondary container where the lot or control number and 
expiration date are printed. In accordance with Sec.  201.17, an 
expiration date may be excluded from the Rx secondary container 
labeling or secondary container if the expiration date provided on the 
Rx label, Rx small label, or immediate container is easily legible 
through the secondary container.
    (x) ``Revision Date''. This section of the Rx secondary container 
labeling must include the date of the most recent version of the Rx 
secondary container labeling, listing the month followed by the year.
    (e) Shipping labeling for Rx new animal drugs (Rx shipping 
labeling). If shipping labeling is provided for an approved or 
conditionally approved Rx new animal drug (Rx shipping labeling), the 
following information, as applicable, must appear in the order listed 
on the Rx shipping labeling. Section headings and other text presented 
in quotations in this paragraph must appear verbatim on the Rx shipping 
labeling. Sections are not numbered on the Rx shipping labeling.
    (1) Proprietary name. This section of the Rx shipping labeling must 
provide the proprietary name of the finished drug product, unless the 
Rx new animal drug is a controlled substance.
    (2) Established name. This section of the Rx shipping labeling must 
provide the established name of the drug product, unless the Rx new 
animal drug is a controlled substance.
    (3) Active ingredient(s). This section of the Rx shipping labeling 
must provide the established name and strength or concentration of each 
active ingredient, unless the Rx new animal drug is a controlled 
substance.
    (4) Conditional approval statement. The requirements of paragraph 
(a)(3) of this section apply, unless the Rx new animal drug is a 
controlled substance.
    (5) ``Net Contents''. This section of the Rx shipping labeling must 
identify the contents of the shipping carton.
    (6) ``Storage and Handling''. This section of the Rx shipping 
labeling must include drug storage information. If required by FDA to 
facilitate the drug's safe and effective use, also include handling 
information.
    (7) NADA/ANADA approval statement. For approved new animal drugs or 
approved generic new animal drugs, the requirements of paragraph 
(a)(21) of this section apply, unless the Rx new animal drug is a 
controlled substance.
    (8) Name and place of business. The requirements of paragraph 
(a)(22) of this section apply.
    (9) ``Lot Number and Expiration Date''. This section of the Rx 
shipping labeling must include the identifying lot or control number(s) 
and the expiration date(s) of the Rx new animal drug within the 
shipping carton.
    (10) ``Revision Date''. This section of the Rx shipping labeling 
must include the date of the most recent revision of the Rx shipping 
labeling, listing the month followed by the year.
    (f) Other approved labeling for Rx new animal drugs (Rx other 
approved labeling). If other approved labeling is provided for an 
approved or conditionally approved Rx new animal drug (Rx other 
approved labeling), such as labeling on display cartons and multi-unit 
cartons (excluding shipping

[[Page 18326]]

cartons), the following information, as applicable, must appear in the 
order listed on the Rx other approved labeling. Section headings and 
other text presented in quotations in this paragraph must appear 
verbatim on the Rx other approved labeling. Sections are not numbered 
on the Rx other approved labeling.
    (1) Proprietary name. This section of the Rx other approved 
labeling must provide the proprietary name of the finished drug 
product.
    (2) Established Name. This section of the Rx other approved 
labeling must provide the established name of the drug product.
    (3) Active ingredient(s). This section of the Rx other approved 
labeling must provide the established name and strength or 
concentration of each active ingredient.
    (4) Controlled substance symbol. For controlled substances, this 
section of the Rx other approved labeling must include the required 
controlled substance symbol, in accordance with part 1302 of this title 
designating the schedule for the drug substance.
    (5) Prescription statement. The requirements of paragraph (a)(2) of 
this section apply.
    (6) Conditional approval statement. The requirements of paragraph 
(a)(3) of this section apply.
    (7) Boxed warnings. The requirements of paragraph (a)(4) of this 
section apply.
    (8) Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use as listed under Sec.  530.41 of 
this chapter, the requirements of paragraph (a)(5) of this section 
apply.
    (9) ``Net Contents''. This section of the Rx other approved 
labeling must identify the contents of the container to which the Rx 
other approved labeling applies.
    (10) ``Storage, Handling, and Disposal''. The requirements of 
paragraph (a)(20) of this section apply.
    (11) NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the requirements of paragraph 
(a)(21) of this section apply.
    (12) Name and place of business. The requirements of paragraph 
(a)(22) of this section apply.
    (13) ``Lot Number and Expiration Date''. This section of the Rx 
other approved labeling must include the identifying lot or control 
number of the Rx new animal drug within the container to which the Rx 
other approved labeling applies. This section of the Rx other approved 
labeling must also include the expiration date of the Rx new animal 
drug within the container to which the Rx other approved labeling 
applies. In accordance with Sec.  201.17, an expiration date may be 
excluded from the Rx other approved labeling if the expiration date 
provided on containers within or their labeling is easily legible 
through the container to which the Rx other approved labeling applies.
    (14) ``Revision Date''. This section of the Rx other approved 
labeling must include the date of the most recent revision of the Rx 
other approved labeling, listing the month followed by the year.


Sec.  201.407   Content and format for over-the-counter (OTC) new 
animal drug labeling.

    This section describes specific content and format requirements for 
the labeling of approved or conditionally approved OTC new animal drugs 
other than those for use in animal feeds that are subject to part 558 
of this chapter. See Sec.  201.409 for content and format requirements 
for the labeling of approved or conditionally approved new animal drugs 
for use in animal feeds that are subject to part 558 of this chapter. 
Omit labeling sections or subsections that do not apply to the OTC new 
animal drug. The final content of each applicable component and section 
of labeling is determined by FDA. In addition to the content and format 
requirements in this section, the labeling of approved or conditionally 
approved OTC new animal drugs must comply with other applicable 
requirements in this subpart.
    (a) Labeling providing full product information. All approved or 
conditionally approved OTC new animal drugs must provide full product 
information as described in this paragraph. The package insert must 
include full product information. If no package insert is provided, the 
secondary container labeling must include full product information as 
described in this paragraph. If neither a package insert nor a 
secondary container is provided, the label must include full product 
information as described in this paragraph. The following information, 
as applicable, must appear in the order listed on the labeling 
component providing full product information. If full product 
information is provided on the secondary container labeling, in 
accordance with section 201(k) of the Federal Food, Drug, and Cosmetic 
Act, the secondary container labeling may exclude any of the 
information described in this subsection that is required by paragraphs 
(b) or (c) of this section to appear on the label if such information 
is easily legible through the secondary container. Section headings, 
subsection headings, and other text presented in quotations in this 
paragraph must appear verbatim on the labeling providing full product 
information. Sections and subsections are not numbered on full product 
information.
    (1) Drug product identification. This section of full product 
information must include:
    (i) The proprietary name of the finished drug product;
    (ii) The established name of the drug product;
    (iii) The route(s) of administration, if not included as part of 
the established name of the drug product;
    (iv) The dosage form of the finished drug product, if not included 
as part of the established name of the drug product;
    (v) The established name and strength or concentration of each 
active ingredient, except that the strength or concentration may be 
excluded from full product information provided on a package insert 
that applies to multiple strengths or concentrations; and
    (vi) The pharmacological class of the new animal drug, if required 
to facilitate the drug's safe and effective use.
    (2) Conditional approval statement. The requirements of Sec.  
201.405(a)(3) apply.
    (3) ``Uses''. Include the following information in this section of 
full product information in order:
    (i) The approved or conditionally approved indication(s) and target 
animal(s) in the following format: ``For [indication(s)] in [target 
animal(s)]'';
    (ii) A statement indicating that the new animal drug is approved or 
conditionally approved for use only under specific conditions, if 
applicable;
    (iii) A statement describing the relative effectiveness of doses 
within the approved range of doses, if required by FDA to facilitate 
the drug's safe and effective use; and
    (iv) A statement(s) indicating animals for which the new animal 
drug is not approved or conditionally approved, if FDA determines such 
a statement(s) is required for safety and/or effectiveness reasons.
    (4) Extralabel use statement. This section of full product 
information must include the following extralabel use statement: ``It 
is a violation of Federal law to use this drug product other than as 
directed in the labeling or as directed by your veterinarian.''
    (5) Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use as listed under Sec.  530.41 of 
this chapter, the requirements of Sec.  201.405(a)(5) apply.

[[Page 18327]]

    (6) ``Description''. This section of full product information must 
include:
    (i) The proprietary name of the finished drug product;
    (ii) The established name of the drug product;
    (iii) The route(s) of administration, if not included as part of 
the established name of the drug product;
    (iv) The dosage form of the finished drug product, if not included 
as part of the established name of the drug product;
    (v) A description of the identifying characteristics of the dosage 
form, such as color, shape, coating, scoring, and imprinting;
    (vi) The established name and strength or concentration of each 
active ingredient, including all available strengths or concentrations 
to which full product information applies;
    (vii) If applicable, a statement that the product is sterile; and
    (viii) When inactive ingredients are provided on full product 
information, the requirements of Sec.  201.405(a)(6)(viii) apply.
    (7) ``Warnings''. This section of full product information is 
required for all approved or conditionally approved new animal drugs. 
Include in the following order all applicable subsections, headings, 
and information:
    (i) ``Withdrawal Periods and Residue Warnings'' or ``Withdrawal 
Periods''. The requirements of Sec.  201.405(a)(10)(i) apply.
    (ii) ``User Safety Warnings''. The requirements of Sec.  
201.405(a)(10)(ii) apply.
    (iii) ``Animal Safety Warnings''. All contraindications, target 
animal safety warnings that identify any serious adverse reaction or 
potential hazard to the target animal(s) associated with the use of the 
new animal drug, adverse reactions, and post-approval adverse drug 
experiences must be included in this subsection of full product 
information. These items must be listed in decreasing order of severity 
or frequency.
    (iv) ``Environmental Warnings''. The requirements of Sec.  
201.405(a)(10)(iv) apply.
    (v) ``Other Warnings''. The requirements of Sec.  201.405(a)(10)(v) 
apply.
    (8) ``Additional Recommendations''. This section of full product 
information must include all precautions.
    (9) ``Other Effects You May Notice''. This section of full product 
information must include all statements required by FDA that identify 
any effects of the OTC new animal drug on the target animal(s) that are 
not considered contraindications, target animal safety warnings, 
adverse reactions, or post-approval adverse drug experiences.
    (10) ``Directions''. This section of full product information must 
include for each indication and target animal:
    (i) The route(s) of administration, and specific site(s) of 
administration, if applicable;
    (ii) The dose (or dose range);
    (iii) The intervals between doses, if applicable;
    (iv) The duration of treatment;
    (v) The maximum volume per injection site, if required to 
facilitate the drug's safe and effective use; and
    (vi) Other information regarding administration, if required by FDA 
to facilitate the drug's safe and effective use.
    (11) ``Net Contents''. This section of full product information, 
when presented on the label or the secondary container labeling, must 
identify the contents of the immediate container, in accordance with 
Sec.  201.62, or the secondary container, respectively. Exclude this 
section from package inserts.
    (12) ``How Supplied''. The requirements of Sec.  201.405(a)(19) 
apply.
    (13) ``Storage, Handling, and Disposal''. The requirements of Sec.  
201.405(a)(20) apply.
    (14) ``Questions/Comments?''. The following statements must be 
included in this section of full product information: ``Contact [insert 
name of business] at [insert business telephone number] or [insert 
business web address]. To report side effects, contact [insert name of 
business] at [insert business telephone number]. For additional 
information about reporting side effects for animal drugs, contact FDA 
at [insert current FDA telephone number for voluntary reporting of 
adverse drug experiences] or [insert current FDA web address for 
voluntary reporting of adverse drug experiences].'' Use as the name of 
the business the manufacturer, packer, or distributor identified in the 
``Name and place of business'' section of full product information 
according to paragraph (a)(16) of this section. If more than one 
business is identified in the ``Name and place of business'' section of 
full product information, select the most appropriate to identify as 
the ``business'' in the ``Questions/Comments?'' section of full product 
information to provide additional information about the OTC new animal 
drug and to contact regarding suspected adverse drug experiences.
    (15) NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the requirements of Sec.  
201.405(a)(21) apply.
    (16) Name and place of business. The requirements of Sec.  
201.405(a)(22) apply.
    (17) ``Lot Number and Expiration Date''. This section is required 
when full product information is provided on the secondary container 
labeling or the label. This section must include the identifying lot or 
control number of the OTC new animal drug within the secondary 
container or immediate container. This section must also include the 
expiration date of the OTC new animal drug within the secondary 
container or immediate container, in accordance with Sec.  201.17. 
Alternatively, this section must refer to the location on the secondary 
container labeling, secondary container, label, or immediate container 
where the lot or control number and expiration date are printed. If 
full product information is provided on the secondary container 
labeling, in accordance with Sec.  201.17, an expiration date may be 
excluded from the secondary container labeling or secondary container 
if the expiration date provided on the label or immediate container is 
easily legible through the secondary container.
    (18) ``Revision Date''. This section of full product information 
must include the date of the most recent revision of the component of 
labeling that provides full product information, listing the month 
followed by the year.
    (b) OTC new animal drug label not providing full product 
information (OTC label). All approved or conditionally approved OTC new 
animal drugs must provide a label. If a package insert or secondary 
container labeling with full product information is provided for an 
approved or conditionally approved OTC new animal drug and the label 
does not provide full product information in accordance with paragraph 
(a) of this section, the following information, as applicable, must 
appear in the order listed on the label for approved or conditionally 
approved OTC new animal drugs (OTC label). If there is insufficient 
space on the immediate container for a label to provide for all of the 
following information, then an OTC small label is required instead. The 
requirements for an OTC small label are provided in paragraph (c) of 
this section. Section headings and other text presented in quotations 
in this paragraph must appear verbatim on the OTC label. Sections are 
not numbered on the OTC label. For OTC labels with a front panel and 
one side or back panel, the information identified in paragraph (b)(1) 
of this section must be provided on the front panel in the order 
listed,

[[Page 18328]]

and the information identified in paragraph (b)(2) of this section must 
be provided on the side or back panel in the order listed. If the OTC 
label consists of a single panel, the information identified in 
paragraph (b)(1) of this section must be provided on the OTC label in 
the order listed followed by the information identified in paragraph 
(b)(2) in the order listed. For OTC labels with a front panel and 
multiple side and/or back panels, the information identified in 
paragraph (b)(1) must be provided on the OTC label in the order listed 
followed by the information identified in paragraph (b)(2) in the order 
listed, starting on the front panel, continuing on the panel 
immediately to the right of the front panel, and continuing to fill the 
panels to the right until all of the information is presented. In all 
instances, the information specified in paragraphs (b)(2)(iii) and (iv) 
of this section must appear on the same panel.
    (1) Front panel. The following information must appear on the front 
panel of the OTC label in the order listed.
    (i) Drug product identification. This section of the OTC label must 
include:
    (A) The proprietary name of the finished drug product;
    (B) The established name of the drug product;
    (C) The route(s) of administration, if not included as part of the 
established name of the drug product;
    (D) The dosage form of the finished drug product, if not included 
as part of the established name of the drug product;
    (E) The established name and strength or concentration of each 
active ingredient;
    (F) If applicable, a statement that the product is sterile; and
    (G) The pharmacological class of the new animal drug, if required 
to facilitate the drug's safe and effective use.
    (ii) Conditional approval statement. For conditionally approved new 
animal drugs, the requirements of Sec.  201.405(a)(3) apply.
    (iii) ``Uses''. The requirements of paragraph (a)(3) of this 
section apply. However, if there is insufficient space on the OTC label 
for the complete ``Uses'' section as specified in paragraph (a)(3), 
then include the statement required in paragraph (a)(3)(i) or, if there 
is insufficient space on the OTC label for the statement in paragraph 
(a)(3)(i), then include the statement, ``For [abbreviated 
indication(s)] in [target animal(s)]''). In either situation where 
there is insufficient space on the OTC label for the complete ``Uses'' 
section as specified in paragraph (a)(3), the required statement must 
be followed by, ``See package insert for complete `Uses' '' if full 
product information is provided on a package insert, or ``See package 
labeling for complete `Uses' '' if full product information is provided 
on the secondary container labeling.
    (iv) Extralabel use statement. The requirements of paragraph (a)(4) 
of this section apply.
    (v) Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use as listed under Sec.  530.41 of 
this chapter, the requirements of Sec.  201.405(a)(5) apply.
    (vi) ``Withdrawal Periods and Residue Warnings'' or ``Withdrawal 
Periods''. For new animal drugs approved or conditionally approved for 
use in food-producing animals, the requirements of Sec.  
201.405(a)(10)(i) apply. If there is insufficient space on the front 
panel of OTC labels consisting of only a front panel and one side or 
back panel for the information required in Sec.  201.405(a)(10)(i), 
this section must be provided on the side or back panel of the OTC 
label immediately following the complete product information statement 
specified in paragraph (b)(2)(i) of this section.
    (vii) ``Net Contents''. This section of the OTC label must identify 
the contents of the immediate container, in accordance with Sec.  
201.62.
    (viii) NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the requirements of Sec.  
201.405(a)(21) apply.
    (2) Side or back panel. The following information must appear on 
the side or back panel of the OTC label in the order listed.
    (i) Complete product information statement. This section of the OTC 
label must include one of two statements. If full product information 
is provided on the package insert, the following statement must be 
used: ``Before using this drug, read package insert for complete 
product information.'' If full product information is provided on the 
secondary container labeling, the following statement must be used: 
``Before using this drug, read package labeling for complete product 
information.''
    (ii) ``Directions''. The requirements of paragraph (a)(10) of this 
section apply. If there is insufficient space on the OTC label for 
complete requirements as specified in paragraph (a)(10) of this section 
or if it is necessary for additional information provided in full 
product information that is not provided on the OTC label to be read 
before administering the drug, FDA may allow this section to be 
excluded from the OTC label.
    (iii) ``Active Ingredient'' or ``Active Ingredients''. This section 
of the OTC label must provide the established name and strength or 
concentration of each active ingredient. If the OTC new animal drug 
contains one active ingredient, this section of the OTC label must be 
entitled ``Active Ingredient''. If the OTC new animal drug contains 
more than one active ingredient, this section of the OTC label must be 
entitled ``Active Ingredients.''
    (iv) ``Inactive Ingredients''. When inactive ingredients are 
provided on the OTC label, the requirements of Sec.  
201.405(a)(6)(viii) apply.
    (v) ``Storage, Handling, and Disposal''. The requirements of Sec.  
201.405(a)(20) apply.
    (vi) Name and place of business. This section of the OTC label must 
include the name and place of business of the manufacturer, packer, or 
distributor, in accordance with section 502(b) of the Federal Food, 
Drug, and Cosmetic Act.
    (vii) ``Lot Number and Expiration Date'' or ``Lot Number''. This 
section of the OTC label must include the identifying lot or control 
number of the OTC new animal drug within the immediate container. This 
section of the OTC label must also include the expiration date of the 
OTC new animal drug within the immediate container, in accordance with 
Sec.  201.17. Alternatively, this section must refer to the location on 
the OTC label or immediate container where the lot or control number 
and expiration date are printed. In accordance with Sec.  201.17, if 
the immediate container provides a single dose of the OTC new animal 
drug and is packaged individually in a secondary container that 
provides an expiration date on the secondary container labeling or 
secondary container, an expiration date is not required on the OTC 
label or immediate container. If an expiration date is not provided on 
the OTC label or immediate container per this provision, then this 
section of the OTC label must be titled ``Lot Number.''
    (viii) ``Revision Date''. This section of the OTC label must 
include the date of the most recent revision of the OTC label, listing 
the month followed by the year.
    (c) OTC new animal drug small label (OTC small label). The 
following information must appear in the order listed on the OTC small 
label. FDA will make the final determination as to whether an immediate 
container lacks sufficient space for the label to include all of the 
information required by paragraph (b) of this section, taking into 
consideration readability and legibility

[[Page 18329]]

of the information. Section headings and other text presented in 
quotations in this paragraph must appear verbatim on the OTC small 
label. Sections are not numbered on the OTC small label.
    (1) Proprietary name. This section of the OTC small label must 
provide the proprietary name of the finished drug product.
    (2) Established name. This section of the OTC small label must 
provide the established name of the drug product.
    (3) Active ingredient(s). This section of the OTC small label must 
provide the established name and strength or concentration of each 
active ingredient.
    (4) Target animals. This section of the OTC small label must 
include the statement: ``For [target animal(s)] only.''
    (5) Complete product information statement. This section of the OTC 
small label must include one of two statements. If full product 
information is provided on the package insert, the following statement 
must be used: ``Read package insert for complete product information.'' 
If full product information is provided on the secondary container 
labeling, the following statement must be used: ``Read package labeling 
for complete product information.''
    (6) ``Net Contents''. This section of the OTC small label must 
identify the contents of the immediate container, in accordance with 
Sec.  201.62.
    (7) Name and place of business. This section of the OTC small label 
must include the name and place of business of the manufacturer, 
packer, or distributor, in accordance with section 502(b) of the 
Federal Food, Drug, and Cosmetic Act.
    (8) ``Lot, Exp. and Storage'' or ``Lot and Storage''. This section 
of the OTC small label must include the identifying lot or control 
number of the OTC new animal drug within the immediate container. This 
section of the OTC small label must also include the expiration date of 
the OTC new animal drugs within the immediate container, in accordance 
with Sec.  201.17. Drug storage information for the OTC new animal drug 
must also be included in this section of the OTC small label. In 
accordance with Sec.  201.17, if the immediate container provides a 
single dose of the OTC new animal drug and is packaged individually in 
a secondary container that provides an expiration date on the secondary 
container labeling or secondary container, an expiration date is not 
required on the OTC small label or immediate container. If an 
expiration date is not provided on the OTC small label or immediate 
container per this provision, then this section of the OTC small label 
must be entitled ``Lot and Storage.''
    (9) ``Revision Date''. This section of the OTC small label must 
include the date of the most recent revision of the OTC small label, 
listing the month followed by the year.
    (d) Labeling for secondary containers for OTC new animal drugs that 
include a package insert (OTC secondary container labeling). If a 
secondary container is provided for an approved or conditionally 
approved OTC new animal drug and the OTC new animal drug includes a 
package insert, the following information, as applicable, must appear 
in the order listed on the secondary container labeling (OTC secondary 
container labeling). In accordance with section 201(k) of the Federal 
Food, Drug, and Cosmetic Act, the OTC secondary container labeling may 
exclude any of the information described in this subsection that is 
required by paragraphs (b) or (c) of this section to appear on the 
label if such information is easily legible through the OTC secondary 
container. Section headings, subsection headings, and other text 
presented in quotations in this paragraph must appear verbatim on the 
OTC secondary container labeling. Sections and subsections are not 
numbered on the OTC secondary container labeling. For OTC secondary 
container labeling with a front panel and one side or back panel, the 
information identified in paragraph (d)(1) of this section must be 
provided on the front panel in the order listed, and the information 
identified in paragraph (d)(2) of this section must be provided on the 
side or back panel in the order listed. For OTC secondary container 
labeling with a front panel and multiple side and/or back panels, the 
information identified in paragraph (d)(1) of this section must be 
provided on the OTC secondary container labeling in the order listed 
followed by the information identified in paragraph (d)(2) of this 
section in the order listed, starting on the front panel, continuing on 
the panel immediately to the right of the front panel, and continuing 
to fill the panels to the right until all of the information is 
presented. In all instances, the information specified in paragraphs 
(d)(2)(iv) and (v) of this section must appear on the same panel.
    (1) Front panel. The following information must appear on the front 
panel of the OTC secondary container labeling in the order listed.
    (i) Drug product identification. This section of the OTC secondary 
container labeling must include:
    (A) The proprietary name of the finished drug product;
    (B) The established name of the drug product;
    (C) The route(s) of administration, if not included as part of the 
established name of the drug product;
    (D) The dosage form of the finished drug product, if not included 
as part of the established name of the drug product;
    (E) The established name and strength or concentration of each 
active ingredient;
    (F) If applicable, a statement that the product is sterile; and
    (G) The pharmacological class of the new animal drug, if required 
to facilitate the drug's safe and effective use.
    (ii) Conditional approval statement. The requirements of Sec.  
201.405(a)(3) apply.
    (iii) ``Uses''. The requirements of paragraph (a)(3) of this 
section apply.
    (iv) Extralabel use statement. The requirements of paragraph (a)(4) 
of this section apply.
    (v) Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use as listed under Sec.  530.41 of 
this chapter, the requirements of Sec.  201.405(a)(5) apply.
    (vi) ``Net Contents''. This section of the OTC secondary container 
labeling must identify the contents of the secondary container.
    (vii) NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the requirements of Sec.  
201.405(a)(21) apply.
    (2) Side or back panel. The following information must appear on 
the side or back panel of the OTC secondary container labeling in the 
order listed.
    (i) Complete product information statement. This section of the OTC 
secondary container labeling must include the following statement: 
``Before using this drug, read package insert for complete product 
information.''
    (ii) ``Directions''. The requirements of paragraph (a)(10) of this 
section apply.
    (iii) ``Warnings''. The requirements of paragraph (a)(7) of this 
section apply.
    (iv) ``Active Ingredient'' or ``Active Ingredients''. The 
requirements of paragraph (b)(2)(iii) of this section apply.
    (v) ``Inactive Ingredients''. When inactive ingredients are 
provided on the OTC secondary container labeling, the requirements of 
Sec.  201.405(a)(6)(viii) apply.
    (vi) ``Storage, Handling, and Disposal''. The requirements of Sec.  
201.405(a)(20) apply.
    (vii) Name and place of business. The requirements of Sec.  
201.405(a)(22) apply.
    (viii) ``Lot Number and Expiration Date''. This section of the OTC

[[Page 18330]]

secondary container labeling must include the identifying lot or 
control number of the OTC new animal drug within the secondary 
container. This section of the OTC secondary container labeling must 
also include the expiration date of the OTC new animal drug within the 
secondary container, in accordance with Sec.  201.17. Alternatively, 
this section must refer to the location on the OTC secondary container 
labeling or secondary container where the lot or control number and 
expiration date are printed. In accordance with Sec.  201.17, an 
expiration date may be excluded from the OTC secondary container 
labeling or secondary container if the expiration date provided on the 
OTC label, OTC small label, or immediate container is easily legible 
through the secondary container.
    (ix) ``Revision Date''. This section of the OTC secondary container 
labeling must include the date of the most recent revision of the OTC 
secondary container labeling, listing the month followed by the year.
    (e) Shipping labeling for OTC new animal drugs (OTC shipping 
labeling). If shipping labeling is provided for an approved or 
conditionally approved OTC new animal drug (OTC shipping labeling), the 
following information, as applicable, must appear in the order listed 
on the OTC shipping labeling. Section headings and other text presented 
in quotations in this paragraph must appear verbatim on the OTC 
shipping labeling. Sections are not numbered on the OTC shipping 
labeling.
    (1) Proprietary name. This section of the OTC shipping labeling 
must provide the proprietary name of the finished drug product.
    (2) Established name. This section of the OTC shipping labeling 
must provide the established name of the drug product.
    (3) Active ingredient(s). This section of the OTC shipping labeling 
must provide the established name and strength or concentration of each 
active ingredient.
    (4) Conditional approval statement. The requirements of Sec.  
201.405(a)(3) apply.
    (5) ``Net Contents''. This section of the OTC shipping labeling 
must identify the contents of the shipping carton.
    (6) ``Storage and Handling''. This section of the OTC shipping 
labeling must include drug storage information. If required by FDA to 
facilitate the drug's safe and effective use, also include handling 
information.
    (7) NADA/ANADA approval statement. For approved new animal drugs or 
approved generic new animal drugs, the requirements of Sec.  
201.405(a)(21) apply.
    (8) Name and place of business. The requirements of Sec.  
201.405(a)(22) apply.
    (9) ``Lot Number and Expiration Date''. This section of the OTC 
shipping labeling must include the identifying lot or control number(s) 
and the expiration date(s) of the OTC new animal drug within the 
shipping carton.
    (10) ``Revision Date''. This section of the OTC shipping labeling 
must include the date of the most recent revision of OTC shipping 
labeling, listing the month followed by the year.
    (f) Other approved labeling for OTC new animal drugs (OTC other 
approved labeling). If other approved labeling is provided for an 
approved or conditionally approved OTC new animal drug (OTC other 
approved labeling), such as labeling on display cartons and multi-unit 
cartons (excluding shipping cartons), the following information, as 
applicable, must appear in the order listed on the OTC other approved 
labeling. Section headings and other text presented in quotations in 
this paragraph must appear verbatim on the OTC other approved labeling. 
Sections are not numbered on the OTC other approved labeling.
    (1) Proprietary name. This section of the OTC other approved 
labeling must provide the proprietary name of the finished drug 
product.
    (2) Established name. This section of the OTC other approved 
labeling must provide the established name of the drug product.
    (3) Active ingredient(s). This section of the OTC other approved 
labeling must provide the established name and strength or 
concentration of each active ingredient.
    (4) Conditional approval statement. The requirements of Sec.  
201.405(a)(3) apply.
    (5) Extralabel use statement. The requirements of paragraph (a)(4) 
of this section apply.
    (6) Extralabel use prohibition statement. For approved new animal 
drugs prohibited from extralabel use as listed under Sec.  530.41 of 
this chapter, the requirements of Sec.  201.405(a)(5) apply.
    (7) ``Net Contents''. This section of the OTC other approved 
labeling must identify the contents of the container to which the OTC 
other approved labeling applies.
    (8) ``Storage, Handling, and Disposal''. The requirements of Sec.  
201.405(a)(20) apply.
    (9) NADA/ANADA approval statement. For approved new animal drugs or 
approved generic new animal drugs, the requirements of Sec.  
201.405(a)(21) apply.
    (10) Name and place of business. The requirements of Sec.  
201.405(a)(22) apply.
    (11) ``Lot Number and Expiration Date''. This section of the OTC 
other approved labeling must include the identifying lot or control 
number of the OTC new animal drug within the container to which the OTC 
other approved labeling applies. This section of the OTC other approved 
labeling must also include the expiration date of the OTC new animal 
drug within the container to which the OTC other approved labeling 
applies. In accordance with Sec.  201.17, an expiration date may be 
excluded from the OTC other approved labeling if the expiration date on 
containers within or their labeling is easily legible through the 
container to which the OTC other approved labeling applies.
    (12) ``Revision Date''. This section of the OTC other approved 
labeling must include the date of the most recent revision of the OTC 
other approved labeling, listing the month followed by the year.


Sec.  201.409   Content and format of labeling for new animal drugs for 
use in animal feeds.

    This section describes specific content and format requirements for 
the labeling of approved or conditionally approved new animal drugs for 
use in animal feeds and that are subject to part 558 of this chapter, 
including VFD drugs. Omit labeling sections or subsections that do not 
apply to the new animal drug for use in animal feeds. The final content 
of each applicable component and section of labeling is determined by 
FDA. In addition to the content and format requirements in this 
section, the labeling of approved or conditionally approved new animal 
drugs for use in animal feeds and that are subject to part 558 of this 
chapter must comply with other applicable requirements in this subpart.
    (a) Type A medicated article label. All approved or conditionally 
approved Type A medicated articles must provide a Type A medicated 
article label as described in this paragraph. The following 
information, as applicable, must appear in the order listed on the Type 
A medicated article label. Section headings, subsection headings, and 
other text presented in quotations in this paragraph must appear 
verbatim on the Type A medicated article label. Sections and 
subsections are not numbered on the Type A medicated article label.
    (1) Type A medicated article identification. This section of the 
Type

[[Page 18331]]

A medicated article label must include in order:
    (i) The proprietary name of the Type A medicated article;
    (ii) The established name of the Type A medicated article; and
    (iii) The phrase ``Type A medicated article'' or ``Type A liquid 
medicated article,'' as applicable, if not included as part of the 
established name of the Type A medicated article.
    (2) VFD cautionary statement. For VFD drugs, this section of the 
Type A medicated article label must prominently and conspicuously 
display the cautionary statement, in accordance with Sec.  558.6(a)(6) 
of this chapter.
    (3) Manufacturing statement. This section of the Type A medicated 
article label must include the statement: ``For further manufacturing 
only.''
    (4) Conditional approval statement. The requirements of Sec.  
201.405(a)(3) apply.
    (5) ``Indications for Use''. The requirements of Sec.  
201.407(a)(3) apply.
    (6) Extralabel use statement. This section of the Type A medicated 
article label must include the following extralabel use statement: ``It 
is a violation of Federal law to use other than as directed in the 
labeling.''
    (7) ``Active Ingredient'' or ``Active Ingredients''. This section 
of the Type A medicated article label must provide the established name 
and concentration of each active ingredient in the Type A medicated 
article. If the Type A medicated article contains one active 
ingredient, this section of the Type A medicated article label must be 
entitled ``Active Ingredient.'' If the Type A medicated article 
contains more than one active ingredient, this section of the Type A 
medicated article label must be entitled ``Active Ingredients.''
    (8) ``Inactive Ingredients''. When inactive ingredients are 
provided on the Type A medicated article label, the requirements of 
Sec.  201.405(a)(6)(viii) apply.
    (9) ``Directions''. This section of the Type A medicated article 
label must include the following three subsections in order:
    (i) ``Approved Concentration(s) of [Active Ingredient or Active 
Moiety] in Type C Medicated Feeds''. This subsection of the Type A 
medicated article label must provide the approved concentration(s) of 
each active ingredient in Type C medicated feeds to be manufactured 
from the Type A medicated article for each approved or conditionally 
approved indications for use. If an active ingredient is a salt or 
other noncovalent derivative and its concentration(s) in paragraph 
(a)(7) of this section is expressed based on the active moiety, the 
approved concentration(s) in the Type C medicated feeds must be 
expressed based on the active moiety, and the title of this subsection 
must include the name of the active moiety instead of the active 
ingredient.
    (ii) ``Mixing Directions''. This subsection of the Type A medicated 
article label must provide the approved mixing directions for the 
manufacture of approved medicated feeds from this Type A medicated 
article for each approved or conditionally approved indications for 
use, including an intermediate mixing step (i.e., preblend step) if 
required.
    (iii) ``Feeding Directions''. This subsection of the Type A 
medicated article label must provide the approved feeding directions 
for each approved or conditionally approved indications for use for 
Type C medicated feeds manufactured from this Type A medicated article.
    (10) ``Warnings''. This section of the Type A medicated article 
label is required for all Type A medicated articles. Include in the 
following order all applicable subsections, headings, and information:
    (i) ``Withdrawal Periods and Residue Warnings'' or ``Withdrawal 
Periods''. The requirements of Sec.  201.405(a)(10)(i) apply.
    (ii) ``User Safety Warnings''. The requirements of Sec.  
201.405(a)(10)(ii) apply.
    (iii) ``Animal Safety Warnings''. The requirements of Sec.  
201.407(a)(7)(iii) apply.
    (iv) ``Environmental Warnings''. The requirements of Sec.  
201.405(a)(10)(iv) apply.
    (v) ``Other Warnings''. The requirements of Sec.  201.405(a)(10)(v) 
apply.
    (11) ``Additional Recommendations''. The requirements of Sec.  
201.407(a)(8) apply.
    (12) ``Other Effects You May Notice''. The requirements of Sec.  
201.407(a)(9) apply.
    (13) ``Net Weight''. This section of the Type A medicated article 
label must list the net weight of the Type A medicated article in the 
immediate container.
    (14) ``Storage, Handling, and Disposal''. The requirements of Sec.  
201.405(a)(20) apply.
    (15) ``Questions/Comments?''. The following statements must be 
included in this section of the Type A medicated article label: 
``Contact [insert name of business] at [insert business telephone 
number] or [insert business web address]. To report side effects, 
contact [insert name of business] at [insert business telephone 
number]. For additional information about reporting side effects for 
animal drugs, contact FDA at [insert current FDA telephone number for 
voluntary reporting of adverse drug experiences] or [insert current FDA 
web address for voluntary reporting of adverse drug experiences].'' Use 
as the name of the business the manufacturer, packer, or distributor 
identified in the ``Name and place of business'' section of the Type A 
medicated article label according to paragraph (a)(17) of this section. 
If more than one business is identified in the ``Name and place of 
business'' section of the Type A medicated article label, select the 
most appropriate to identify as the ``business'' in the ``Questions/
Comments?'' section of the Type A medicated article label to provide 
additional information about the Type A medicated article and to 
contact regarding suspected adverse drug experiences.
    (16) NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the requirements of Sec.  
201.405(a)(21) apply.
    (17) Name and place of business. The requirements of Sec.  
201.405(a)(22) apply.
    (18) ``Lot Number and Expiration Date''. This section of the Type A 
medicated article label must include the identifying lot or control 
number of the Type A medicated article within the immediate container. 
In accordance with Sec.  226.58(d) of this chapter, this section of the 
Type A medicated article label must also include the expiration date of 
the Type A medicated article within the immediate container. 
Alternatively, this section must refer to the location on the Type A 
medicated article label or immediate container where the lot or control 
number and expiration date are printed.
    (19) ``Revision Date''. This section of the Type A medicated 
article label must include the date of the most recent revision of the 
Type A medicated article label, listing the month followed by the year.
    (b) Representative Type B medicated feed labeling. The following 
information, as applicable, must appear in the order listed on the 
representative Type B medicated feed labeling. Section headings, 
subsection headings, and other text presented in quotations in this 
paragraph must appear verbatim on the representative Type B medicated 
feed labeling. Sections and subsections are not numbered on the 
representative Type B medicated feed labeling.
    (1) Description of the Type B medicated feed. This section of the 
representative Type B medicated feed labeling serves as a placeholder 
for the

[[Page 18332]]

proprietary name to be added by the feed manufacturer to the label of 
the final Type B medicated feed manufactured in accordance with the 
approved representative Type B labeling. The description of the Type B 
medicated feed must:
    (i) Distinguish the Type B medicated feed from any other Type B 
medicated feeds approved or conditionally approved within the same 
application; and
    (ii) Not include the proprietary name of a Type A medicated 
article.
    (2) Established name of the Type B medicated feed. The established 
name of the Type B medicated feed must include in the following order:
    (i) The active moiety or active ingredient of each new animal drug, 
as determined by FDA; and
    (ii) One of the following statements, as applicable: ``Type B 
medicated feed'' or ``Type B liquid medicated feed''.
    (3) VFD cautionary statement. The requirements of paragraph (a)(2) 
of this section apply.
    (4) Undiluted statement. This section of the representative Type B 
medicated feed labeling must include the statement: ``Do Not Feed 
Undiluted.''
    (5) Conditional approval statement. The requirements of Sec.  
201.405(a)(3) apply.
    (6) ``Indications for Use''. The requirements of Sec.  
201.407(a)(3) apply. Include only the approved or conditionally 
approved indications for use for the specific Type B medicated feed to 
which the representative Type B medicated feed labeling applies.
    (7) Extralabel use statement. The requirements of paragraph (a)(6) 
of this section apply.
    (8) ``Active Ingredient'' or ``Active Ingredients''. This section 
of the representative Type B medicated feed labeling must include the 
following information for the specific Type B medicated feed to which 
the representative Type B medicated feed labeling applies. If the Type 
B medicated feed contains one active ingredient, this section of the 
representative Type B medicated feed labeling must be entitled ``Active 
Ingredient.'' If the Type B medicated feed contains more than one 
active ingredient, this section of the representative Type B medicated 
feed labeling must be entitled ``Active Ingredients.''
    (i) The established name of each active ingredient; and
    (ii) The concentration or range of concentrations of each active 
ingredient as approved by FDA. If included as a range, the active 
ingredient concentrations must reference a footnote at the bottom of 
this page of the representative Type B labeling indicating that each 
final printed Type B medicated feed label must only include a single 
concentration of each active ingredient.
    (9) ``Guaranteed Analysis''. This section of the representative 
Type B medicated feed labeling must provide for the nutritional content 
guarantees of the Type B medicated feed appropriate for the target 
animal(s) in addition to any other required specifications.
    (10) ``Ingredients''. This section of the representative Type B 
medicated feed labeling must include the following:
    (i) A statement that feed ingredients must be listed on each final 
printed Type B medicated feed label by their common or usual names in 
descending order of predominance by weight, in accordance with Sec.  
501.4(a) of this chapter, including their collective names where 
permitted, in accordance with Sec.  501.4(b)(13) of this chapter; and
    (ii) A statement that spices, flavorings, colorings, and chemical 
preservatives, if used, must be declared on each final printed Type B 
medicated feed label, in accordance with Sec.  501.22 of this chapter.
    (11) ``Mixing Directions''. This section of the representative Type 
B medicated feed labeling must provide the approved mixing directions 
for the manufacture of a Type C medicated feed(s) or another Type B 
medicated feed(s), as applicable, from the Type B medicated feed for 
which the representative Type B medicated feed labeling applies.
    (12) ``Warnings''. The requirements of paragraph (a)(10) of this 
section apply. Include only the warnings for the specific Type B 
medicated feed to which the representative Type B medicated feed 
labeling applies.
    (13) ``Additional Recommendations''. The requirements of Sec.  
201.407(a)(8) apply. Include only the precautions for the specific Type 
B medicated feed to which the representative Type B medicated feed 
labeling applies.
    (14) ``Other Effects You May Notice''. The requirements of Sec.  
201.407(a)(9) apply. Include only statements of other effects for the 
specific Type B medicated feed to which the representative Type B 
medicated feed labeling applies.
    (15) Name and place of business. This section of the representative 
Type B medicated feed labeling must provide for the name and place of 
business of the manufacturer, packer, or distributor of the final Type 
B medicated feed, in accordance with Sec.  501.5 of this chapter.
    (16) ``Net Weight''. This section of the representative Type B 
medicated feed labeling must provide for the statement on the final 
printed Type B medicated feed label of the net weight of the Type B 
medicated feed in the immediate container.
    (17) ``Storage, Handling, and Disposal''. The requirements of Sec.  
201.405(a)(20) apply.
    (18) ``Questions/Comments?''. The following statements must be 
included in this section of the representative Type B medicated feed 
labeling: ``Contact [name of business] at [business telephone number] 
or [business web address]. For additional information about reporting 
problems with medicated feeds, contact FDA at [insert current FDA 
telephone number for voluntary reporting of adverse drug experiences] 
or [insert current FDA web address for voluntary reporting of adverse 
drug experiences].'' The information in the bracketed areas of the 
first statement are placeholders for the business of the manufacturer, 
packer, or distributor of the final Type B medicated feed to insert 
their name and contact information. The information in the bracketed 
areas of the second statement must be inserted by the sponsor of the 
new animal drug application.
    (19) ``Lot, Batch, or Control Number''. This section of the 
representative Type B medicated feed labeling must provide for an 
identifying lot, batch, or control number on the final printed Type B 
medicated feed label.
    (20) ``Expiration Date''. If an expiration date is required, in 
accordance with Sec.  514.1(b)(5)(x) of this chapter, then this section 
of the representative Type B medicated feed labeling must provide for 
the expiration date to be printed on the final printed Type B medicated 
feed label. The approved expiration period must also be included in 
this section of the representative Type B medicated feed labeling.
    (21) ``Revision Date''. This section of the representative Type B 
medicated feed labeling must include the date of the most recent 
revision of the representative Type B medicated feed labeling, listing 
the month followed by the year.
    (c) Representative Type C medicated feed labeling. The following 
information, as applicable, must appear in the order listed on the 
representative Type C medicated feed labeling. Section headings, 
subsection headings, and other text presented in quotations in this 
paragraph must appear verbatim on the representative Type C medicated 
feed labeling. Sections and subsections are not numbered on the 
representative Type C medicated feed labeling.
    (1) Description of the Type C medicated feed. This section of the

[[Page 18333]]

representative Type C medicated feed labeling serves as a placeholder 
for the proprietary name to be added by the feed manufacturer to the 
label of the final Type C medicated feed manufactured in accordance 
with the approved representative Type C medicated feed labeling. The 
description of the Type C medicated feeds must:
    (i) Distinguish the Type C medicated feed from any other Type C 
medicated feeds approved or conditionally approved within the same 
application; and
    (ii) Not include the proprietary name of a Type A medicated 
article.
    (2) Established name of the Type C medicated feed. The established 
name of the Type C medicated feed must include in the following order:
    (i) The active moiety or active ingredient of each new animal drug, 
as determined by FDA; and
    (ii) One of the following statements, as applicable: ``Type C 
medicated feed,'' ``Type C liquid medicated feed,'' ``Type C top-dress 
medicated feed,'' ``Type C free-choice medicated feed,'' or ``Type C 
liquid free-choice medicated feed''.
    (3) VFD cautionary statement. The requirements of paragraph (a)(2) 
of this section apply.
    (4) Conditional approval statement. The requirements of Sec.  
201.405(a)(3) apply.
    (5) ``Indications for Use''. The requirements of Sec.  
201.407(a)(3) apply. Include only the approved or conditionally 
approved indications for use for the specific Type C medicated feed to 
which the representative Type C medicated feed labeling applies.
    (6) Extralabel use statement. The requirements of paragraph (a)(6) 
of this section apply.
    (7) ``Active Ingredient'' or ``Active Ingredients''. This section 
of the representative Type C medicated feed labeling must include the 
following information for the specific Type C medicated feed to which 
the representative Type C medicated feed labeling applies. If the Type 
C medicated feed contains one active ingredient, this section of the 
representative Type C medicated feed labeling must be entitled ``Active 
Ingredient.'' If the Type C medicated feed contains more than one 
active ingredient, this section of the representative Type C medicated 
feed labeling must be entitled ``Active Ingredients.''
    (i) The established name of each active ingredient; and
    (ii) The concentration or range of concentrations of each active 
ingredient as approved by FDA. If included as a range, the active 
ingredient concentrations must reference a footnote at the bottom of 
this page of the representative Type C medicated feed labeling 
indicating that each final printed Type C medicated feed label must 
only include a single concentration of each active ingredient.
    (8) ``Guaranteed Analysis''. The requirements of paragraph (b)(9) 
of this section apply.
    (9) ``Ingredients''. This section of the representative Type C 
medicated feed labeling must include the following:
    (i) For Type C medicated feeds that are not Type C free-choice 
medicated feeds:
    (A) A statement that feed ingredients must be listed on each final 
printed Type C medicated feed label by their common or usual names in 
descending order of predominance by weight, in accordance with Sec.  
501.4(a) of this chapter, including their collective names where 
permitted, in accordance with Sec.  501.4(b)(13) of this chapter; and
    (B) A statement that spices, flavorings, colorings, and chemical 
preservatives, if used, must be declared on each final printed Type C 
medicated feed label, in accordance with Sec.  501.22 of this chapter.
    (ii) For Type C free-choice medicated feeds, a list of the feed 
ingredients and their inclusion rates, including the drug 
concentrations exactly as they appear in the approved non-proprietary 
formula published for the specific new animal drug in part 558 of this 
chapter.
    (10) ``Feeding Directions''. The requirements of paragraph 
(a)(9)(iii) of this section apply. This section of the representative 
Type C medicated feed labeling must include the approved feeding 
directions for the specific Type C medicated feed for which the 
representative Type C medicated feed labeling applies.
    (11) ``Warnings''. The requirements of paragraph (a)(10) of this 
section apply. Include only the warnings for the specific Type C 
medicated feed to which the representative Type C medicated feed 
labeling applies.
    (12) ``Additional Recommendations''. The requirements of Sec.  
201.407(a)(8) apply. Include only the precautions for the specific Type 
C medicated feed to which the representative Type C medicated feed 
labeling applies.
    (13) ``Other Effects You May Notice''. The requirements of Sec.  
201.407(a)(9) apply. Include only statements of other effects for the 
specific Type C medicated feed to which the representative Type C 
medicated feed labeling applies.
    (14) Name and place of business. This section of the representative 
Type C medicated feed labeling must provide for the name and place of 
business of the manufacturer, packer, or distributor of the final Type 
C medicated feed, in accordance with Sec.  501.5 of this chapter.
    (15) ``Net Weight''. This section of the representative Type C 
medicated feed labeling must provide for the statement of net weight on 
the final printed Type C medicated feed label of the Type C medicated 
feed in the immediate container.
    (16) ``Storage, Handling, and Disposal''. The requirements of Sec.  
201.405(a)(20) apply.
    (17) ``Questions/Comments?''. The following statements must be 
included in this section of the representative Type C medicated feed 
labeling: ``Contact [name of business] at [business telephone number] 
or [business web address]. For additional information about reporting 
side effects or other problems with medicated feeds, contact FDA at 
[insert current FDA telephone number for voluntary reporting of adverse 
drug experiences] or [insert current FDA web address for voluntary 
reporting of adverse drug experiences].'' The information in the 
bracketed areas of the first statement are placeholders for the 
business of the manufacturer, packer, or distributor of the final Type 
C medicated feed to insert their name and contact information. The 
information in the bracketed areas of the second statement must be 
inserted by the sponsor of the new animal drug application.
    (18) ``Lot, Batch, or Control Number''. This section of the 
representative Type C medicated feed labeling must provide for an 
identifying lot, batch, or control number on the final printed Type C 
medicated feed label.
    (19) ``Expiration Date''. If an expiration date is required, in 
accordance with Sec.  514.1(b)(5)(x) of this chapter, then this section 
of the representative Type C medicated feed labeling must provide for 
the expiration date to be printed on the final printed Type C medicated 
feed label. The approved expiration period must also be included in 
this section of the representative Type C medicated feed labeling.
    (20) ``Revision Date''. This section of representative Type C 
medicated feed labeling must include the date of the most recent 
revision of the representative Type C medicated feed labeling, listing 
the month followed by the year.
    (d) Proprietary Type B medicated feed label. The following 
information, as applicable, must appear in the order listed on the 
proprietary Type B medicated feed label. Section headings, subsection 
headings, and other text

[[Page 18334]]

presented in quotations in this paragraph must appear verbatim on the 
proprietary Type B medicated feed label. Sections and subsections are 
not numbered on the proprietary Type B medicated feed label.
    (1) Proprietary Type B medicated feed identification. This section 
of the proprietary Type B medicated feed label must include in order:
    (i) Proprietary name of the Type B medicated feed; and
    (ii) Established name of the Type B medicated feed. The established 
name of the Type B medicated feed must include in the following order:
    (A) The active moiety or active ingredient of each new animal drug, 
as determined by FDA; and
    (B) One of the following statements, as applicable: ``Type B 
medicated feed'' or ``Type B liquid medicated feed''.
    (2) VFD cautionary statement. The requirements of paragraph (a)(2) 
of this section apply.
    (3) Undiluted statement. This section of the proprietary Type B 
medicated feed label must include the statement: ``Do Not Feed 
Undiluted''.
    (4) Conditional approval statement. The requirements of Sec.  
201.405(a)(3) apply.
    (5) ``Indications for Use''. The requirements of Sec.  
201.407(a)(3) apply.
    (6) Extralabel use statement. The requirements of paragraph (a)(6) 
of this section apply.
    (7) ``Active Ingredient'' or ``Active Ingredients''. This section 
of the proprietary Type B medicated feed label must include the 
established name and concentration of each active ingredient in the 
proprietary Type B medicated feed. If the proprietary Type B medicated 
feed contains one active ingredient, this section of the proprietary 
Type B medicated feed label must be entitled ``Active Ingredient.'' If 
the proprietary Type B medicated feed contains more than one active 
ingredient, this section of the proprietary Type B medicated feed label 
must be entitled ``Active Ingredients.''
    (8) ``Guaranteed Analysis''. This section of the proprietary Type B 
medicated feed label must provide the nutritional content guarantees of 
the proprietary Type B medicated feed appropriate for the target 
animal(s) in addition to any other required specifications.
    (9) ``Ingredients''. This section of the proprietary Type B 
medicated feed label must include:
    (i) A listing of the feed ingredients in the proprietary Type B 
medicated feed by their common or usual names in descending order of 
predominance by weight, in accordance with Sec.  501.4(a) of this 
chapter, including their collective names where permitted, in 
accordance with Sec.  501.4(b)(13) of this chapter; and
    (ii) A declaration of spices, flavorings, colorings, and chemical 
preservatives, if used, in accordance with Sec.  501.22 of this 
chapter.
    (10) ``Mixing Directions''. This section of the proprietary Type B 
medicated feed label must provide the approved mixing directions for 
the manufacture of a Type C medicated feed(s) or another Type B 
medicated feed(s), as applicable, from the proprietary Type B medicated 
feed.
    (11) ``Warnings''. The requirements of paragraph (a)(10) of this 
section apply.
    (12) ``Additional Recommendations''. The requirements of Sec.  
201.407(a)(8) apply.
    (13) ``Other Effects You May Notice''. The requirements of Sec.  
201.407(a)(9) apply.
    (14) ``Net Weight''. This section of the proprietary Type B 
medicated feed label must list the net weight of the Type B medicated 
feed in the immediate container.
    (15) ``Storage, Handling, and Disposal''. The requirements of Sec.  
201.405(a)(20) apply.
    (16) ``Questions/Comments?''. The following statements must be 
included in this section of the proprietary Type B medicated feed 
label: ``Contact [insert name of business] at [insert business 
telephone number] or [insert business web address]. For additional 
information about reporting problems with medicated feeds, contact FDA 
at [insert current FDA telephone number for voluntary reporting of 
adverse drug experiences] or [insert current FDA web address for 
voluntary reporting of adverse drug experiences].'' Use as the name of 
the business the manufacturer, packer, or distributor identified in the 
``Name and place of business'' section of the proprietary Type B 
medicated feed label according to paragraph (d)(18) of this section. If 
more than one business is identified in the ``Name and place of 
business'' section of the proprietary Type B medicated feed label, 
select the most appropriate to identify as the ``business'' in the 
``Questions/Comments?'' section of the proprietary Type B medicated 
feed label to provide additional information about the Type B medicated 
feed and to contact regarding problems with this medicated feed.
    (17) NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the requirements of Sec.  
201.405(a)(21) apply.
    (18) Name and place of business. The requirements of Sec.  
201.405(a)(22) apply.
    (19) ``Lot, Batch, or Control Number''. This section of the 
proprietary Type B medicated feed label must include the identifying 
lot, batch, or control number of the Type B medicated feed. 
Alternatively, this section must refer to the location on the 
proprietary Type B medicated feed label or immediate container where 
the lot, batch, or control number is printed.
    (20) ``Expiration Date''. If an expiration date is required, in 
accordance with Sec.  514.1(b)(5)(x) of this chapter, this section must 
be included on the proprietary Type B medicated feed label and must 
provide the expiration date of the proprietary Type B medicated feed. 
Alternatively, this section must refer to the location on the 
proprietary Type B medicated feed label or immediate container where 
the expiration date is printed.
    (21) ``Revision Date''. This section of the proprietary Type B 
medicated feed label must include the date of the most recent revision 
of the proprietary Type B medicated feed label, listing the month 
followed by the year.
    (e) Proprietary Type C medicated feed label. The following 
information, as applicable, must appear in the order listed on the 
proprietary Type C medicated feed label. Section headings, subsection 
headings, and other text presented in quotations in this paragraph must 
appear verbatim on the proprietary Type C medicated feed label. 
Sections and subsections are not numbered on the proprietary Type C 
medicated feed label.
    (1) Proprietary Type C medicated feed identification. This section 
of the proprietary Type C medicated feed label must include in order:
    (i) Proprietary name of the Type C medicated feed; and
    (ii) Established name of the Type C medicated feed. The established 
name of the Type C medicated feed must include in the following order:
    (A) The active moiety or active ingredient of each new animal drug, 
as determined by FDA; and
    (B) One of the following statements, as applicable: ``Type C 
medicated feed,'' ``Type C liquid medicated feed,'' ``Type C top-dress 
medicated feed,'' ``Type C free-choice medicated feed,'' or ``Type C 
liquid free-choice medicated feed.''
    (2) VFD cautionary statement. The requirements of paragraph (a)(2) 
of this section apply.
    (3) Conditional approval statement. The requirements of Sec.  
201.405(a)(3) apply.
    (4) ``Indications for Use''. The requirements of Sec.  
201.407(a)(3) apply.

[[Page 18335]]

    (5) Extralabel use statement. The requirements of paragraph (a)(6) 
of this section apply.
    (6) ``Active Ingredient'' or ``Active Ingredients''. This section 
of the proprietary Type C medicated feed label must include the 
established name and concentration of each active ingredient in the 
proprietary Type C medicated feed. If the proprietary Type C medicated 
feed contains one active ingredient, this section of the proprietary 
Type C medicated feed label must be entitled ``Active Ingredient.'' If 
the proprietary Type C medicated feed contains more than one active 
ingredient, this section of the proprietary Type C medicated feed label 
must be entitled ``Active Ingredients.''
    (7) ``Guaranteed Analysis''. The requirements of paragraph (d)(8) 
of this section apply.
    (8) ``Ingredients''. The requirements of paragraph (d)(9) of this 
section apply.
    (9) ``Feeding Directions''. This section of the proprietary Type C 
medicated feed label must include the approved feeding directions for 
the proprietary Type C medicated feed.
    (10) ``Warnings''. The requirements of paragraph (a)(10) of this 
section apply.
    (11) ``Additional Recommendations''. The requirements of Sec.  
201.407(a)(8) apply.
    (12) ``Other Effects You May Notice''. The requirements of Sec.  
201.407(a)(9) apply.
    (13) ``Net Weight''. This section of the proprietary Type C 
medicated feed label must list the net weight of the Type C medicated 
feed in the immediate container.
    (14) ``Storage, Handling, and Disposal''. The requirements of Sec.  
201.405(a)(20) apply.
    (15) ``Questions/Comments?''. The following statements must be 
included in this section of the proprietary Type C medicated feed 
label: ``Contact [insert name of business] at [insert business 
telephone number] or [insert business web address]. For additional 
information about reporting side effects or other problems with 
medicated feeds, contact FDA at [insert current FDA telephone number 
for voluntary reporting of adverse drug experiences] or [insert current 
FDA web address for voluntary reporting of adverse drug experiences].'' 
Use as the name of the business the manufacturer, packer, or 
distributor identified in the ``Name and place of business'' section of 
the proprietary Type C medicated feed label according to paragraph 
(e)(17) of this section. If more than one business is identified in the 
``Name and place of business'' section of the proprietary Type C 
medicated feed label, select the most appropriate to identify as the 
``business'' in the ``Questions/Comments?'' section of the proprietary 
Type C medicated feed label to provide additional information about the 
Type C medicated feed and to contact regarding suspected adverse drug 
experiences.
    (16) NADA/ANADA approval statement. For approved new animal drugs 
or approved generic new animal drugs, the requirements of Sec.  
201.405(a)(21) apply.
    (17) Name and place of business. The requirements of Sec.  
201.405(a)(22) apply.
    (18) ``Lot, Batch, or Control Number''. This section of the 
proprietary Type C medicated feed label must include the identifying 
lot, batch, or control number of the Type C medicated feed. 
Alternatively, this section must refer to the location on the 
proprietary Type C medicated feed label or immediate container where 
the lot, batch, or control number is printed.
    (19) ``Expiration Date''. If an expiration date is required, in 
accordance with Sec.  514.1(b)(5)(x) of this chapter, this section must 
be included on the proprietary Type C medicated feed label and must 
provide the expiration date of the proprietary Type C medicated feed 
label. Alternatively, this section must refer to the location on the 
proprietary Type C medicated feed label or immediate container where 
the expiration date is printed.
    (20) ``Revision Date''. This section of the proprietary Type C 
medicated feed label must include the date of the most recent revision 
of the proprietary Type C medicated feed label, listing the month 
followed by the year.
    (f) Other approved labeling for Type A medicated articles. If other 
approved labeling associated with approved or conditionally approved 
Type A medicated articles is provided (other approved labeling for Type 
A medicated articles), such as shipping labeling, the following 
information, as applicable, must appear in the order listed on the 
other approved labeling for Type A medicated articles. Section headings 
and other text presented in quotations in this paragraph must appear 
verbatim on the other approved labeling for Type A medicated articles. 
Sections are not numbered on other approved labeling for Type A 
medicated articles.
    (1) Type A medicated article identification. This section of the 
other approved labeling for Type A medicated articles must include in 
order:
    (i) Proprietary name of the Type A medicated article; and
    (ii) Established name of the Type A medicated article.
    (2) VFD cautionary statement. The requirements of paragraph (a)(2) 
of this section apply.
    (3) ``Active Ingredient'' or ``Active Ingredients''. This section 
of the other approved labeling for Type A medicated articles must 
provide the established name and concentration of each active 
ingredient in the Type A medicated article. If the Type A medicated 
article contains one active ingredient, this section of the other 
approved labeling for Type A medicated articles must be entitled 
``Active Ingredient.'' If the Type A medicated article contains more 
than one active ingredient, this section of the other approved labeling 
for Type A medicated articles must be entitled ``Active Ingredients.''
    (4) Conditional approval statement. The requirements of Sec.  
201.405(a)(3) apply.
    (5) ``Net Contents''. This section of the other approved labeling 
for Type A medicated articles must identify the contents of the 
container to which the other approved labeling for Type A medicated 
articles applies.
    (6) ``Storage and Handling''. This section of the other approved 
labeling for Type A medicated articles must include storage information 
for the Type A medicated article. If required by FDA to facilitate the 
drug's safe and effective use, also include handling information.
    (7) NADA/ANADA approval statement. For approved new animal drugs or 
approved generic new animal drugs, the requirements of Sec.  
201.405(a)(21) apply.
    (8) Name and place of business. The requirements of Sec.  
201.405(a)(22) apply.
    (9) ``Lot Number and Expiration Date''. This section of the other 
approved labeling for Type A medicated articles must include the 
identifying lot or control number(s) and the expiration date(s) of the 
Type A medicated article within the container.
    (10) ``Revision Date''. This section of the other approved labeling 
for Type A medicated articles must include the date of the most recent 
revision of the other approved labeling for Type A medicated articles, 
listing the month followed by the year.


Sec.  201.411   Exemptions from labeling requirements for approved or 
conditionally approved new animal drugs.

    (a) In response to a request from the sponsor that includes the 
information in paragraph (b) of this section, FDA may exempt, based on 
the circumstances presented, one or more specific requirements set 
forth in this subpart. A separate request must be submitted for each 
approved or conditionally approved new animal drug for which an

[[Page 18336]]

exemption is sought. Sponsors must submit such requests to the 
application or the investigational new animal drug file (INAD) for the 
new animal drug. Requests will be granted or denied by the Director of 
FDA's Center for Veterinary Medicine or the Director's designee.
    (b) Exemption requests must:
    (1) Describe why the particular requirement for which the exemption 
is requested is not appropriate for the new animal drug;
    (2) Describe why granting the exemption would not adversely impact 
the safety or effectiveness of the use of the new animal drug; and
    (3) Include copies of all draft labeling proposed to be used for 
the new animal drug.


Sec.  201.413   Labeling requirements for certain approved or 
conditionally approved new animal drugs.

    In addition to labeling requirements elsewhere in this subpart, the 
labeling requirements in this section apply to the following approved 
or conditionally approved new animal drugs:
    (a) Approved or conditionally approved corticosteroid-containing 
new animal drugs for oral, injectable, and/or ophthalmic use. Approved 
or conditionally approved corticosteroid-containing new animal drugs 
for oral, injectable, and/or ophthalmic use are subject to the labeling 
requirements for Rx new animal drugs in this subpart. In view of 
adverse reproductive effects associated with use of certain 
corticosteroid drugs in animals, approved or conditionally approved 
corticosteroid new animal drugs intended for oral and/or injectable use 
must also include the following statements in the ``Animal Safety 
Warnings and Precautions'' subsection of labeling: ``Clinical and 
experimental data have demonstrated that corticosteroids administered 
orally or by injection to animals may induce the first stage of 
parturition if used during the last trimester of pregnancy and may 
precipitate premature parturition followed by dystocia, fetal death, 
retained placenta, and metritis. Additionally, corticosteroids 
administered during pregnancy can be teratogenic.'' These statements 
must also be included in the ``Animal Safety Warnings and Precautions'' 
subsection of labeling for approved or conditionally approved 
corticosteroid new animal drugs intended for ophthalmic use, if 
required by FDA to facilitate the drug's safe and effective use.
    (b) Anthelmintic new animal drugs--(1) OTC anthelmintic new animal 
drugs. To ensure that OTC anthelmintic new animal drugs provide 
adequate directions for their effective use, all approved or 
conditionally approved OTC anthelmintic new animal drugs, including OTC 
anthelmintic new animal drugs for use in animal feeds, must include the 
following statement in the ``Additional Recommendations'' section of 
labeling: ``Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.''
    (2) Anthelmintic new animal drugs for use in sheep, goats, cattle, 
horses, swine, and/or poultry. All approved or conditionally approved 
anthelmintic new animal drugs for use in sheep, goats, cattle, horses, 
swine, and/or poultry must include statements on their labeling 
providing information to end users to minimize antiparasitic resistance 
development, including information on appropriate dosing, anthelmintic 
drug selection, effectiveness monitoring, the integration of 
anthelmintic drug use with other parasite management practices, and 
other information as needed. The statements must be included in the 
``Other Warnings'' subsection of labeling, and if applicable, 
additional statements may be required in the ``Dosage and 
Administration'' section of labeling for Rx anthelmintic new animal 
drugs, the ``Directions'' section of labeling for OTC anthelmintic new 
animal drugs, or the ``Feeding Directions'' section or subsection of 
labeling for anthelmintic new animal drugs for use in animal feeds.
    (c) New animal drugs for use in horses. All new animal drugs 
approved or conditionally approved for use in horses must include in 
the ``Other Warnings'' subsection of labeling a statement advising 
against the use of the drug in horses intended for human consumption.

PART 500--GENERAL

0
6. The authority citation for part 500 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 
360b, 371, 379e.


Sec. Sec.  500.25 and 500.55   [Removed]

0
7. Remove Sec. Sec.  500.25 and 500.55.

PART 501--ANIMAL FOOD LABELING

0
8. The authority citation for part 501 continues to read as follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371.
0
9. Add Sec.  501.19 to subpart A to read as follows:


Sec.  501.19   Animal food; labeling of animal food containing new 
animal drugs.

    The requirements for the labeling of animal food containing an 
approved or conditionally approved new animal drug are found in Sec.  
201.409 of this chapter. Requirements of this part apply only as 
specified in Sec.  201.409.

PART 510--NEW ANIMAL DRUGS

0
10. The authority citation for part 510 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec. Sec.  510.105, 510.106, and 510.410   [Removed]

0
11. Remove Sec. Sec.  510.105, 510.106, and 510.410.

PART 514--NEW ANIMAL DRUG APPLICATIONS

0
12. The authority citation for part 514 continues to read as follows:

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

0
13. In Sec.  514.1, revise paragraph (b)(3) to read as follows:


Sec.  514.1   Applications.

* * * * *
    (b) * * *
    (3) Labeling. Three copies of each piece of all labeling to be used 
for the article (total of 9).
    (i) All labeling should be identified to show its position on, or 
the manner in which it is to accompany the market package.
    (ii) The content and format of all proposed labeling must comply 
with subpart H of part 201 of this chapter.
    (iii) Labeling for nonprescription new animal drugs should include 
adequate directions for use by the layperson under all conditions of 
use for which the new animal drug is intended, recommended, or 
suggested in any of the labeling or advertising sponsored by the 
applicant.
    (iv) Labeling for prescription new animal drugs should bear 
adequate information for use under which veterinarians can use the new 
animal drug safely and for the purposes for which it is intended, 
including those purposes for which it is to be advertised or 
represented, in accord with Sec.  201.105 of this chapter.
    (v) All labeling for prescription or nonprescription new animal 
drugs must be submitted with any necessary use restrictions prominently 
and conspicuously displayed.
    (vi) Labeling for new animal drugs intended for use in the 
manufacture of medicated feeds must include:

[[Page 18337]]

    (A) Specimens of labeling to be used for such new animal drug with 
adequate directions for the manufacture and use of finished feeds for 
all conditions for which the new animal drug is intended, recommended, 
or suggested in any of the labeling, including advertising, sponsored 
by the applicant. Ingredient labeling may utilize collective names as 
provided in Sec.  501.110 of this chapter.
    (B) Representative labeling proposed to be used for Type B and Type 
C medicated feeds containing the new animal drug.
    (vii) Draft labeling may be submitted for preliminary consideration 
of an application. Final printed labeling will ordinarily be required 
prior to approval of an application. Proposed advertising for 
prescription new animal drugs may be submitted for comment or approval.
* * * * *

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
14. The authority citation for part 516 continues to read as follows:

    Authority:  21 U.S.C. 360ccc-1, 360ccc-2, 371.
0
15. In Sec.  516.155, redesignate paragraph (c) as paragraph (d) and 
add a new paragraph (c) to read as follows:


Sec.  516.155   Labeling of indexed drugs.

* * * * *
    (c) To ensure that OTC anthelmintic new animal drugs provide 
adequate directions for their effective use, the labeling of all OTC 
indexed anthelmintic drugs, including those used in animal feeds, must 
include the following statement: ``Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism.'' 
The labeling revisions required for compliance with this section may be 
placed into effect without prior granting of a request for a 
modification, as provided for in Sec.  516.161(b)(1).
* * * * *

    Dated: March 1, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-04840 Filed 3-8-24; 8:45 am]
BILLING CODE 4164-01-P