[Federal Register Volume 69, Number 103 (Thursday, May 27, 2004)]
[Rules and Regulations]
[Pages 30194-30199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11943]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

[Docket No. 1993P-0174]


Requirements for Liquid Medicated Animal Feed and Free-Choice 
Medicated Animal Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is changing the 
regulations for liquid medicated feed and free-choice medicated feed. 
By changing the regulations for liquid medicated feed, FDA is 
clarifying: What data are required to demonstrate chemical and physical 
stability of a drug in liquid feed, how such data may be submitted for 
use in the new animal drug approval process, and which liquid medicated 
feeds may be manufactured in a feed manufacturing facility that has not 
obtained a medicated feed mill license from FDA. By changing the 
regulations for free-choice medicated feed, FDA is ensuring that they 
are consistent with the requirements for liquid medicated feed, and 
that provisions for free-choice medicated feed and liquid medicated 
feed comply with the terms of the Animal Drug Availability Act (ADAA) 
of 1996.

DATES: This rule is effective June 28, 2004.

FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for 
Veterinary Medicine (HFV-226), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 28, 2003 (68 FR 31645), FDA proposed 
changing regulations for liquid medicated feed and free-choice 
medicated feed and provided 90 days for comments on the proposed 
changes.
    Several events led to the development of the proposed rule. First, 
an April 30, 1993, citizen petition requested that FDA amend Sec.  
558.5 (21 CFR 558.5) to clarify the information and data needed to 
demonstrate chemical and positional (physical) stability in liquid 
medicated feeds and describe circumstances under which a medicated feed 
application (MFA) will or will not be required. Second, our November 
21, 1996 (61 FR 59209) advanced notice of proposed rulemaking, which we 
issued seeking comments concerning various issues for the development 
of regulations implementing provisions of ADAA, prompted the Animal 
Feed Industry Association to propose changes to the new animal drug 
requirements regarding free choice administration in feeds (Sec.  
510.455 (21 CFR 510.455)).The proposed changes to Sec.  510.455 would 
adopt the terms of feed mill licensing in accordance with ADAA and 
allow a feed manufacturer to submit a new animal drug application 
(NADA) for the approval of a Type A medicated article for use in the 
subsequent manufacture of a free-choice medicated feed. This document 
contains the liquid medicated feed and free-choice medicated feed final 
rules.

II. Summary of the Proposed Rule

A. Liquid Medicated Feed

    The proposed rule had the following objectives: (1) Replaced the 
references to ``medicated feed application'' in the current rule with 
the term ``medicated feed mill license,'' (2) defined the types of 
liquid medicated feed covered by this regulation, (3) clarified the 
types of approvals required for liquid medicated feed, (4) explained 
that an approval is required for a drug intended for use in a liquid 
feed and clarifies the procedures and requirements for demonstrating 
chemical and physical stability of a drug in liquid feed, (5) permitted 
submission of the stability data through a master file (MF) for 
reference by a subsequent applicant, (6) explained what information 
will be included in the published approval of a drug for use in liquid 
feed, (7) identified the conditions under which an approved medicated 
feed mill license will be required for the manufacture of a liquid 
medicated feed, and (8) described the labeling provisions for several 
drugs approved for use in water but not in liquid feed. We invited 
comments on whether or not the waiver provision needs to continue to be 
available because no one has invoked the provision since its inception 
in 1973.

B. Free-Choice Medicated Feed

    The proposed rule had the following objectives: (1) Modified the 
current rule

[[Page 30195]]

by providing a definition of free-choice medicated feed, (2) explained 
that one of three types of NADAs is required for a drug intended for 
use in a free-choice feed, (3) specified the data required for such 
applications and the procedures for their submission, (4) explained how 
such data must be submitted, (5) stated what information will be 
included in the published approval of a new animal drug intended for 
use in free-choice feed, and (6) explained the situations that will 
require a medicated feed mill license for the manufacture of a free-
choice medicated feed.

III. Comments on the Proposed Rule

    We received three letters commenting on the proposed rule: Two from 
trade associations and one from a feed manufacturer. The letters were 
supportive of the proposed rule. Issues addressed in the comments 
included waivers from labeling provisions, certified letters containing 
proprietary information, and the free-choice and liquid feed stability 
data requirements.
    Following is our response to comments, grouped by issue:

A. Waiver From Labeling Provisions

    (Comment 1) Two comments stated that the proposed rule should 
retain the labeling provisions allowing a waiver of warning statements 
on labels of dry medicated feeds containing bacitracin, 
oxytetracycline, and/or chlortetracycline, as specified in Sec.  
558.5(i). One of the two comments pointed out that the waiver option 
should be retained because it provides needed information to liquid 
feed manufacturers while granting appropriate labeling flexibility to 
new animal drug applicants. The other comment indicated that although 
the waiver has not been sought in the past, there are indications that 
several firms are considering to request such a waiver in the future.
    We agree with the two comments and are retaining the waiver option 
in this final rule.

B. Providing a Certified Letter With the Formula and/or Specifications 
of a Free-Choice or a Liquid Medicated Feed Product

    (Comment 2) Two comments expressed concern about our intention, 
expressed in the preamble of the proposed rule, to provide both the 
NADA and the MF holder with a certified letter setting forth the 
formula and/or specifications of a free-choice or a liquid medicated 
feed product, where the formula and/or specifications are not published 
in a regulation. The two comments argued that the certified letter, 
which contains proprietary information, should only be issued to the MF 
holder who owns that information, and not to the NADA holder.
    We agree with these two comments and intend to provide a certified 
letter only to the owner of the proprietary formula and/or 
specifications, who is typically the MF holder.
    (Comment 3) Two comments stated that currently there are many free-
choice and liquid medicated feed products approved through an MF for 
which no such certified letters have been provided to the MF holders. 
In order to avoid possible confusion at feed mill inspections, where 
some products may have a certified letter and others may not, the two 
comments stated that FDA should either issue such certified letters to 
the MF holders of all such previously approved free-choice and liquid 
medicated feeds, or make it clear in this rule that the certified 
letter route applies only to free-choice and liquid feeds approved 
after a certain date.
    We intend to provide a certified letter to the owner of the 
proprietary formula and/or specifications of those free-choice and 
liquid medicated feed products that are approved after the effective 
date of this rule. We do not intend to issue certified letters for feed 
products approved before the effective date of this rule. Firms that 
are making such feed products must be in compliance with existing 
requirements and regulations pertaining to the manufacture of those 
products.

C. The Free-Choice and Liquid Feed Stability Data Requirements

    (Comment 4) Two comments stated that the agency should revisit the 
stability data requirements as well as the consumption data and 
manufacturing chemistry requirements articulated in the original April 
30, 1993, citizen petition and revise the present liquid feed and free 
choice feed guidances regarding these topics.
    This comment falls outside of the scope of this rulemaking. 
Comments pertaining to FDA guidance documents should be sent to the 
dockets for those documents. More information on how to submit comments 
to FDA guidance documents can be found at http://www.fda.gov/cvm/guidance/guidance.html#purpose.

IV. Final Rules

    The final rules for liquid medicated feed and free-choice medicated 
feeds adopt the proposed rules without change. For both the liquid 
medicated feed and free-choice medicated feed final rules, FDA 
concluded that an approved medicated feed mill license should be 
required for facilities that manufacture free-choice or liquid 
medicated feeds with proprietary formulas and/or specifications. Where 
the formula and/or specifications are published, FDA has an assurance 
that medicated feed mills have access to the information necessary to 
manufacture the approved free-choice or liquid medicated feed. Where 
the formula and/or specifications are proprietary, medicated feed mills 
might attempt to manufacture the free choice or liquid medicated feed 
knowing only that the drug is approved for use in free-choice or liquid 
medicated feed, but not knowing the formula and/or specifications. 
Manufacture of such feeds without this crucial information could 
endanger animal health and public health. Section 510(h) of the act (21 
U.S.C. 360(h)) requires that FDA inspect licensed medicated feed mills 
at least once every 2 years. During such inspections, FDA can ensure 
that medicated feed mills manufacturing free-choice or liquid medicated 
feed with proprietary formulas and/or specifications have the approved 
formula and/or specifications.

V. Environmental Impact

    We have carefully considered the potential environmental impacts of 
this rule and determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    This final rule merely clarifies existing regulations concerning 
liquid medicated feeds and free-choice medicated feeds.

VI. Analysis of Impacts

    FDA has examined the impacts of this final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages, distributive impacts and equity). We believe that this 
final rule is consistent with the regulatory philosophy and principles 
identified in Executive Order 12866. We have also determined that the 
rule is not a significant regulatory action as defined

[[Page 30196]]

by the Executive order and so is not subject to review under the 
Executive order. Under the Regulatory Flexibility Act, if a regulation 
has a significant impact on a substantial number of small entities, the 
agency must analyze regulatory options that would minimize the impact 
on small entities. FDA certifies in accordance with the Regulatory 
Flexibility Act (5 U.S.C. 601-612) that this rule will not have a 
significant economic impact on a substantial number of small entities, 
and therefore, a regulatory flexibility analysis is not required.
    Section 202(a) of the Unfunded Mandates Reform Act requires that 
agencies prepare a written statement of anticipated costs and benefits 
before proposing any regulation that may result in an expenditure by 
state, local and tribal governments in the aggregate, or by the private 
sector, of $100 million or more (adjusted annually for inflation) in 
any one year. The Unfunded Mandates Reform Act does not require FDA to 
prepare a statement of costs and benefits for this final rule because 
the rule is not expected to result in any 1 year expenditure that would 
exceed $100 million adjusted for inflation. The current inflation-
adjusted statutory threshold is approximately $110 million.
    The rule is intended to clarify, simplify, and elaborate on the 
current regulations concerning liquid medicated feeds and free-choice 
medicated feeds. This rule, which provides more precise and detailed 
provisions than the previous regulations, responds to requests 
submitted in citizen petitions and comments by an industry association. 
It also makes changes to the regulatory language for free-choice 
medicated feeds in order to be consistent with the ADAA provision that 
replaced the medicated feed application system with the medicated feed 
mill licensing system.
    We did not receive any comments to the proposed rule that 
questioned the conclusions of the cost and benefit discussions. 
Further, changes made to the proposed rule as a result of other 
comments would not affect these conclusions. As such, we restate them 
for this final rule.

A. Liquid Medicated Feeds

    The final rule for liquid medicated feeds clarifies the types of 
liquid medicated feeds for which a separate new animal drug approval is 
necessary and for which a medicated feed mill license is necessary. In 
particular, it fully elaborates on the procedures and requirements for 
demonstrating the chemical and physical stability of a drug in liquid 
feeds, as well as how the data from such a demonstration can be 
submitted to the agency.
    The rule references requirements under 21 CFR 514.1 that are 
currently required for the approval of all new animal drugs. As these 
requirements do not represent a new burden, there is no cost associated 
with this aspect of the rule. Likewise, the rule adds to the current 
labeling provisions for certain drugs that are approved for use in 
animal feed or drinking water but not approved for use in certain 
liquid feeds. The rule describes the waiver process for the exclusion 
of certain products from these labeling requirements. Because this 
waiver process already exists under the current rule, it will not 
impose any additional cost to industry.

B. Free-Choice Medicated Feed

    The revisions to Sec.  510.455 concern free-choice medicated feed 
and very closely follow the liquid medicated feed proposal. Section 
510.455 clarifies and elaborates on the NADA requirements for drugs 
intended for use in free-choice medicated feeds. In addition, it 
replaces the language that provided for the medicated feed application 
with language for the medicated feed mill licensing system that was 
created by ADAA. Because the estimated costs and benefits of the feed 
mill licensing system were prepared for the final regulations 
implementing that system, these costs and benefits are not considered 
to be effects of this rule. In total, the rule is not expected to 
impose any new compliance burdens on the industry and is not associated 
with any costs.
    It is possible that the final rule will, in fact, result in some 
cost savings due to the provision that eliminates the requirement for a 
medicated feed mill license for the manufacture of some liquid and 
free-choice medicated feeds that contain a Category I drug. In recent 
years, we have received an average of 128 medicated feed mill license 
applications annually. Since the applications do not explicitly specify 
the types of medicated feed that would be manufactured, we are not able 
to estimate the size of the decrease in applications that would be 
expected as a result of the rule. However, we would expect there to be 
some decrease in applications as some feed mills would be exempted from 
this requirement in the future. We believe this could lead to a modest 
cost savings for these feed mills. Further, the increased clarity and 
simplification of Sec. Sec.  510.455 and 558.5 would be expected to 
result in additional cost savings to industry in the preparation of new 
animal drug applications to the agency. We cannot precisely quantify 
such savings, but believe the impact to be modest.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the final rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VIII. Paperwork Reduction Act of 1995

    In this final rule, Sec.  558.5 specifies procedures for obtaining 
a waiver from labeling requirements for certain drugs intended for use 
in animal feed or drinking water but not approved for use in liquid 
medicated feed. The following items must be included in a request for 
waiver: (1) A copy of the product label; (2) a description of the 
formulation; and (3) information to establish that the physical, 
chemical, or other properties of the product are such that diversion to 
use in liquid medicated feeds is unlikely. This information would be 
collected if the manufacturer or sponsor chose not to include the 
required warning ``FOR USE IN --------ONLY, NOT FOR USE IN LIQUID 
MEDICATED FEEDS'' on its product label. The sponsor or manufacturers 
would then need to satisfy the requirements of the waiver section of 
the regulation. The proposed burden estimate for this collection of 
information is 5 hours and will be included under the clearance for 
``New Animal Drug Application,'' Office of Management and Budget (OMB) 
control number 0910-0032. All related data collections are already 
covered under OMB control number 0910-0032.

IX. Conforming Changes

    FDA has made conforming changes in its regulations in 21 CFR 
558.95, 558.305, 558.311, 558.342, 558.355, and 558.625 to remove 
references to the term ``medicated feed application.'' These conforming 
changes ensure the accuracy and consistency of the regulations.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,

[[Page 30197]]

Reporting and recordkeeping requirements.

21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
510 and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

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

0
2. Section 510.455 is revised to read as follows:


Sec.  510.455  Requirements for free-choice medicated feeds.

    (a) What is free-choice medicated feed? For the purpose of this 
part, free-choice medicated feed is medicated feed that is placed in 
feeding or grazing areas and is not intended to be consumed fully at a 
single feeding or to constitute the entire diet of the animal. Free-
choice feeds include, but are not limited to, medicated blocks 
(agglomerated feed compressed or rendered into a solid mass and 
cohesive enough to hold its form), mineral mixes, and liquid feed tank 
supplements (``lick tank'' supplements) containing one or more new 
animal drugs. The manufacture of medicated free-choice feeds is subject 
to the current good manufacturing practice regulations in part 225 of 
this chapter for medicated feeds.
    (b) What types of approvals are required for new animal drugs 
intended for use in free-choice feed? New animal drugs intended for use 
in free-choice feed must be approved for such use under section 512 of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)), 
as:
    (1) An original new animal drug application (NADA),
    (2) A supplemental NADA, or
    (3) An abbreviated NADA.
    (c) What are the approval requirements for new animal drugs 
intended for use in free-choice feed? (1) An approval under section 512 
of the act is required for any new animal drug intended for use in a 
free-choice feed.
    (2) An approved NADA for a Type A medicated article intended for 
use in free-choice feed must contain the following information:
    (i) Data, or reference to data in a master file (MF), showing that 
the target animal consumes the new animal drug in the Type C free-
choice feed in an amount that is safe and effective (consumption/
effectiveness data); and
    (ii) Data, or reference to data in a MF, showing the relevant 
ranges of conditions under which the drug will be chemically and 
physically stable in the Type C free-choice feed under field 
conditions.
    (d) How are consumption/effectiveness and/or stability data to be 
submitted? The data must be submitted as follows:
    (1) Directly in the NADA, by a sponsor; and/or
    (2) To an MF that a sponsor may then reference in its NADA with 
written consent of the MF holder.
    (e) What will be stated in the published approval for a new animal 
drug intended for use in free-choice feed? The approval of a new animal 
drug intended for use in free-choice feed, as published in this 
subchapter, will include:
    (1) The formula and/or specifications of the free-choice medicated 
feed, where the owner of this information requests such publication, or
    (2) A statement that the approval has been granted for a 
proprietary formula and/or specifications.
    (f) When is a medicated feed mill license required for the 
manufacture of a free-choice medicated feed? An approved medicated feed 
mill license is required for the manufacture of the following types of 
feeds:
    (1) All free-choice medicated feeds that contain a Category II 
drug, and
    (2) Free-choice medicated feeds that contain a Category I drug and 
use a proprietary formula and/or specifications.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
4. Section 558.5 is revised to read as follows:


Sec.  558.5  Requirements for liquid medicated feed.

    (a) What types of liquid medicated feeds are covered by this 
section? This section covers the following types of liquid medicated 
feed:
    (1) Type B feed that is intended for further manufacture of other 
medicated feeds (Sec.  558.3(b)(3)) or:
    (2) Type C feed that is intended for the following:
    (i) Further manufacture of another Type C feed, or
    (ii) Top-dressing (adding on top of the usual ration) (Sec.  
558.3(b)(4)).
    (b) How is liquid free-choice medicated feed regulated? Liquid 
free-choice medicated feed is covered by this section and by Sec.  
510.455.
    (c) What types of approvals are required for new animal drugs 
intended for use in liquid feed? New animal drugs intended for use in 
liquid feed must be approved for such use under section 512 of the act, 
as:
    (1) An original NADA,
    (2) A supplemental NADA, or
    (3) An abbreviated NADA.
    (d) What are the approval requirements for new animal drugs 
intended for use in liquid feed? (1) An approval under section 512 of 
the act is required for any new animal drug intended for use in a 
liquid feed; and
    (2) An approved new animal drug application (NADA) for a drug 
intended for use in liquid feed must contain the following information:
    (i) Data, or a reference to data in a master file (MF), that shows 
the relevant ranges of conditions under which the drug will be 
chemically stable in liquid feed under field use conditions; and
    (ii) Data, or a reference to data in an MF, that shows that the 
drug is physically stable in liquid feed under field conditions; or
    (iii) Feed labeling with recirculation or agitation directions as 
follows:
    (A) For liquid feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for not less than 10 minutes, 
moving not less than 1 percent of the tank contents per minute from the 
bottom of the tank to the top. Recirculate daily as described even when 
not used.
    (B) For liquid feeds stored in mechanical, air, or other agitation-
type tank systems: Agitate immediately prior to use for not less than 
10 minutes, creating a turbulence at the bottom of the tank that is 
visible at the top. Agitate daily as described even when not used.
    (e) How are chemical and physical stability data to be submitted? 
The data must be submitted as follows:
    (1) Directly in the NADA,
    (2) By a sponsor, or
    (3) To an MF that a sponsor may then reference in its NADA with 
written consent of the MF holder.
    (f) What will be stated in the published approval for a new animal 
drug intended for use in liquid feed? The approval of a new animal drug 
intended for use in liquid feed as published in this subchapter will 
include the following requirements:
    (1) The formula and/or specifications of the liquid medicated feed, 
where the owner of this information requests such publication; and/or
    (2) A statement that the approval has been granted for a 
proprietary formula and/or specifications.
    (g) When is a medicated feed mill license required for the 
manufacture of

[[Page 30198]]

a liquid medicated feed? An approved medicated feed mill license is 
required for the manufacture of the following types of feeds:
    (1) All liquid medicated feeds that contain a Category II drug, and
    (2) Liquid medicated feeds that contain a Category I drug and use a 
proprietary formula and/or specifications.
    (h) What measures are in place to prevent certain drugs, approved 
for use in animal feed or drinking water but not in liquid medicated 
feed, from being diverted to use in liquid feeds? Any product 
containing any form of bacitracin, oxytetracycline, or 
chlortetracycline, intended for oral administration via animal feed 
and/or drinking water, and not approved for use in a liquid medicated 
feed must include in its labeling the following statement: ``FOR USE IN 
--------ONLY. NOT FOR USE IN LIQUID MEDICATED FEEDS.'' The blank may be 
filled in with the words: ``DRY FEEDS'', ``DRINKING WATER'', or ``DRY 
FEEDS AND DRINKING WATER''.
    (i) Can the labeling provisions of paragraph (h) of this section be 
waived, and how can I apply for a waiver? (1) The labeling provisions 
of paragraph (h) of this section may be waived if there is evidence to 
indicate that it is unlikely a new animal drug would be used in the 
manufacture of a liquid medicated feed.
    (2) To obtain a waiver, you must submit a letter requesting a 
waiver to the Office of New Animal Drug Evaluation (HFV-100), Center 
for Veterinary Medicine, Food and Drug Administration, 7500 Standish 
Pl., Rockville, MD 20855.
    (3) The letter must include a copy of the product label; a 
description of the formulation; and information to establish that the 
physical, chemical, or other properties of the new animal drug are such 
that diversion to use in liquid medicated feed is unlikely.
    (j) What else do I need to know about the labeling provisions of 
paragraph (h) of this section? The labeling provisions of paragraph (h) 
of this section may be implemented without prior approval as provided 
for in Sec.  514.8(d) and (e) of this chapter.


Sec.  558.95  [Amended]

0
5. Section 558.95 is amended in paragraph (d)(4)(iii)(d) by removing 
the last sentence.


Sec.  558.305  [Amended]

0
6. Section 558.305 is amended in paragraphs (d)(1)(i) and (d)(1)(ii) by 
removing ``Type B'' wherever it appears.

0
7. Section 558.311 is amended by revising paragraph (d); in paragraph 
(e)(2)(iv) by removing ``; each use of this Type C free-choice feed 
must be the subject of an approved FD-1900 as provided in Sec.  510.455 
of this chapter''; and in paragraph (e)(3)(iv) by removing the last 
sentence to read as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (d) Special considerations. (1) Type C cattle and sheep feeds may 
be manufactured from lasalocid liquid Type B feeds which have a pH of 
4.0 to 8.0 and bear appropriate mixing directions as follows:
    (i) For liquid feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for no less than 10 minutes, 
moving not less than 1 percent of the tank contents per minute from the 
bottom of the tank to the top. Recirculate daily as described even when 
not used.
    (ii) For liquid feeds stored in mechanical, air, or other 
agitation-type tank systems: Agitate immediately prior to use for not 
less than 10 minutes, creating a turbulence at the bottom of the tank 
that is visible at the top. Agitate daily as described even when not 
used.
    (2) A physically stable lasalocid liquid feed will not be subject 
to the requirements for mixing directions prescribed in paragraph 
(d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains 
a suspending agent(s) sufficient to maintain a viscosity of not less 
than 300 centipoises per second for 3 months.
    (3) If a manufacturer is unable to meet the requirements of 
paragraph (d)(1) or (d)(2) of this section, the manufacturer may secure 
approval of a positionally stable liquid feed by:
    (i) Either filing a new animal drug application for the product or 
establishing a master file containing data to support the stability of 
its product;
    (ii) Authorizing the agency to reference and rely upon the data in 
the master file to support approval of a supplemental new animal drug 
application to establish physical stability; and
    (iii) Requesting the sponsor of an approved new animal drug 
application to file a supplement to provide for use of its lasalocid 
Type A article in the manufacture of the liquid feed specified in the 
appropriate master file. If the data demonstrate the stability of the 
liquid feed described in the master file, the supplemental new animal 
drug application will be approved. The approval will provide a basis 
for the individual liquid feed manufacturer to manufacture under a 
medicated feed license the liquid mediated feed described in the master 
file. A manufacturer who seeks to market a physically unstable 
lasalocid liquid feed with mixing directions different from the 
standard directions established in paragraph (d)(1) of this section may 
also follow this procedure.
    (4) If adequate information is submitted to show that a particular 
liquid feed containing lasalocid is stable outside the pH of 4.0 to 
8.0, the pH restriction described in paragraphs (d)(1) and (d)(2) of 
this section may be waived.
* * * * *


Sec.  558.342  [Amended]

0
8. Section 558.342 is amended in paragraphs (d)(1)(i) and (d)(1)(ii) by 
removing the phrase ``Type B or C''; and in paragraph (d)(2) by 
removing ``positionally'' and by adding in its place ``physically.''

0
9. Section 558.355 is amended by adding paragraph (d)(12); and by 
revising paragraphs (f)(3)(i)(b)(1), (f)(3)(i)(b)(2), (f)(3)(ix)(b), 
(f)(6)(i)(b)(1), and (f)(6)(i)(b)(2) to read as follows:


Sec.  558.355  Monensin.

* * * * *
    (d) * * *
    (12) Mixing directions for liquid feeds requiring recirculation or 
agitation:
    (i) For liquid feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for not less than 10 minutes, 
moving not less than 1 percent of the tank contents per minute from the 
bottom of the tank to the top. Recirculate daily as described even when 
not used.
    (ii) For liquid feeds stored in mechanical, air, or other 
agitation-type tank systems: Agitate immediately prior to use for not 
less than 10 minutes, creating a turbulence at the bottom of the tank 
that is visible at the top. Agitate daily as described even when not 
used.
* * * * *
    (f) Conditions of use. It is used as follows:
    (3) Cattle--(i) Amount per ton. Monensin, 5-30 grams.
    (b) Limitations. (1) Feed only to cattle being fed in confinement 
for slaughter. Feed continuously in complete feed at a rate of 50 to 
360 milligrams of monensin per head per day; as monensin sodium. 
Complete feeds may be manufactured from monensin liquid Type B feeds. 
The liquid Type B feeds have a pH of 4.3 to 7.1 and their labels must 
bear appropriate mixing directions as defined in paragraph (d)(12) of 
this section. The liquid feed must bear caution statement as follows: 
Inadequate mixing, (recirculation or agitation), of liquid feeds has 
resulted in increased

[[Page 30199]]

monensin concentration which has been fatal to cattle.
    (2) An approved physically stable monensin liquid feed will not be 
subject to the requirements for mixing directions defined in paragraph 
(d)(12) of this section. A manufacturer may secure approval of a 
physically stable liquid feed by:
    (i) Either filing an NADA for the product or by establishing a 
master file containing data to support the stability of its product;
    (ii) Authorizing the agency to reference and rely upon the data in 
the master file to support approval of a supplemental NADA to establish 
physical stability; and
    (iii) Requesting No. 000986 in Sec.  510.600(c) of this chapter to 
file a supplemental NADA to provide for the use of its monensin Type A 
article in the manufacture of the liquid feed specified in the 
appropriate master file. If the data demonstrate the stability of the 
liquid feed described in the master file, the agency will approve the 
supplemental NADA. The approval will provide a basis for the individual 
liquid feed manufacturer to manufacture the liquid medicated feed under 
a medicated feed mill license described in the master file. A 
manufacturer who seeks to market a physically unstable monensin liquid 
feed with mixing directions different from the standard established in 
paragraph (d)(12) of this section may also follow this procedure.
* * * * *
    (ix) Amount. * * *
* * * * *
    (b) Limitations. Feed only to cattle being fed in confinement for 
slaughter. Feed continuously at the rate of 8.2 to 10.2 kilograms (18 
to 22.5 pounds) of Type C medicated feed per head per day to supply 240 
milligrams of monensin and 90 milligrams of tylosin per head per day; 
as monensin sodium; as tylosin phosphate. Do not allow horses or other 
equines access to feeds containing monensin. Ingestion of monensin by 
equines has been fatal. Safe use in unapproved species and breeding 
cattle has not been established. The liquid medicated feed must bear 
expiration date of 14 days after date of manufacture. The mixing 
directions for this liquid medicated feed stored in recirculation or 
agitation tank systems are as defined in paragraph (d)(12) of this 
section.
* * * * *
    (6) Goats--(i) Amount per ton. Monensin, 20 grams.
* * * * *
    (b) Limitations. (1) Feed only to goats being fed in confinement. 
Do not feed to lactating goats. Feed continuously in Type C feed as 
monensin sodium. Type C feed may be manufactured from monensin liquid 
Type B feeds. The liquid Type B feeds have a pH of 4.3 to 7.1 and their 
labels must bear appropriate mixing directions, as defined in paragraph 
(d)(12) of this section. The liquid feed must bear caution statement as 
follows: Inadequate mixing, (recirculation or agitation), of liquid 
feeds has resulted in increased monensin concentration which could be 
fatal to goats.
    (2) An approved physically stable monensin liquid feed will not be 
subject to the requirements for mixing directions defined in paragraph 
(d)12) of this section. A manufacturer may secure approval of a 
physically stable liquid feed by:
    (i) Either filing an NADA for the product or by establishing a 
master file containing data to support the stability of its product;
    (ii) Authorizing the agency to reference and rely upon the data in 
the master file to support approval of a supplemental NADA to establish 
physical stability; and
    (iii) Requesting No. 000986 in Sec.  510.600(c) of this chapter to 
file a supplemental NADA to provide for the use of its monensin Type A 
article in the manufacture of the liquid feed specified in the 
appropriate master file. If the data demonstrate the stability of the 
liquid feed described in the master file, the agency will approve the 
supplemental NADA. The approval will provide a basis for the individual 
liquid feed manufacturer to manufacture the liquid medicated feed under 
a medicated feed mill license described in the master file. A 
manufacturer who seeks to market a physically unstable monensin liquid 
feed with mixing directions different from the standard established in 
paragraph (d)(12) of this section may also follow this procedure.


Sec.  558.625  [Amended]

0
10. Section 558.625 is amended in paragraphs (c)(1)(i) and (c)(1)(ii) 
by removing ``Type B'' and by removing the phrase ``no fewer than 10 
minutes'' and adding in its place the phrase ``not less than 10 
minutes''.

    Dated: May 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11943 Filed 5-26-04; 8:45 am]
BILLING CODE 4160-01-S