[Federal Register Volume 61, Number 250 (Friday, December 27, 1996)]
[Rules and Regulations]
[Pages 68147-68148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32881]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 556 and 558
Animal Drugs, Feeds, and Related Products; Tilmicosin Phosphate
Type A Medicated Article
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a new animal drug application
(NADA) filed by Elanco Animal Health. The NADA provides for the use of
a Type A medicated article containing tilmicosin phosphate in
manufacturing a Type B or Type C medicated feed indicated for the
control of swine respiratory disease associated with certain bacterial
organisms.
EFFECTIVE DATE: December 27, 1996.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1644.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed
NADA 141-064, which provides for the use of a Type A medicated article
containing 90.7 grams (g) of tilmicosin (as tilmicosin phosphate) per
pound in manufacturing a Type C medicated feed (181.8 g to 363.6 g of
tilmicosin per ton) indicated for the control of swine respiratory
disease associated with Actinobacillus pleuropneumoniae and Pasteurella
multocida. The NADA is approved as of December 27, 1996, and the
regulations are amended by adding new Sec. 558.618 to reflect the
approval. The basis of approval is discussed in the freedom of
information summary.
In addition, the agency is amending 21 CFR 556.735 to establish a
tolerance for residues of tilmicosin in edible swine tissues. As
discussed in the freedom of information summary, parent tilmicosin was
selected as the marker residue, and liver as the target tissue, for
determination of tilmicosin residues in edible swine tissues.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness
data and information submitted to support approval of this application
may be seen in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity for the use of tilmicosin in swine
beginning December 27, 1996, because the application contains
substantial evidence of the effectiveness of the drug involved, any
studies of animal safety, or, in the case of food producing animals,
human food safety studies (other than bioequivalence or residue
studies) required for the approval of the application and conducted or
sponsored by the applicant.
A high performance liquid chromatographic method is available to
determine the presence and amount of the marker residue in swine liver.
In addition, a high performance liquid chromatographic/mass
spectrometric method is available to confirm the presence of the marker
residue in liver. Both methods have been validated by FDA and the U.S.
Department of Agriculture and are for regulatory purposes. The methods
are available for public inspection at the Dockets Management Branch
(address above) and are attached to the freedom of information summary
for this NADA. Requests for copies of these methods should be made
under the Freedom of Information Act.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
Tilmicosin phosphate is a new animal drug used in a Type A
medicated article to make Type B or Type C medicated feeds. Tilmicosin
phosphate is a Category II drug as defined in 21 CFR 558.3(b)(1)(ii).
Therefore, as provided in 21 CFR 558.4(b), an approved Form FDA 1900 is
required for making a Type B or Type C medicated feed containing
tilmicosin phosphate as in the approved subject NADA and in newly added
Sec. 558.618. Under section 512(m) of the act, as amended by the Animal
Drug Availability Act of 1996 (ADAA), Pub. L. 104-250, medicated feed
applications have been replaced by feed mill licensing.
Tilmicosin phosphate is limited to use under the professional
supervision of a licensed veterinarian. It is the first veterinary feed
directive (VFD) drug to be approved since the enactment of the ADAA.
Pending issuance of regulations to implement veterinary feed
directives, Congress directed FDA to set forth in the new animal drug
approval notice required by section 512(i) of the act any necessary
conditions relating to the
[[Page 68148]]
labeling, advertising, distribution, holding, and use of a VFD drug.
Accordingly, this regulation sets forth necessary conditions for
tilmicosin phosphate (NADA 141-064) including the information that
shall be included in a VFD:
The name, address, and phone number of the veterinarian and
the client;
Identification of the animals to be treated, including,
identification of the species, number of animals, and the location of
the animals;
Date of treatment and, if different, date of prescribing
the VFD drug;
The condition or disease being diagnosed or treated;
Name of the animal drug;
Level of animal drug in the feed and the amount of feed;
Feeding instructions with withdrawal time;
Any special instructions and cautionary statements
necessary for use of the drug in conformance with the approval;
Expiration date of the VFD;
Number of refills, if permitted by the approval;
Signature of the veterinarian; and
The veterinarian's license number and name of the State
issuing the license.
At such time as FDA finalizes general regulations governing VFD
drugs, the general regulations may supersede certain specific VFD
requirements of this approval regulation.
List of Subjects
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 556 and
558 are amended as follows:
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
1. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: Secs. 402, 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 360b, 371).
2. Section 556.735 is revised to read as follows:
Sec. 556.735 Tilmicosin.
A tolerance is established for residues of parent tilmicosin
(marker residue) in liver (target tissue) of cattle at 1.2 parts per
million (ppm) and of swine at 7.2 ppm.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
4. Section 558.4 is amended in paragraph (d) in the ``Category II''
table by alphabetically adding a new entry for ``Tilmicosin'' to read
as follows:
Sec. 558.4 Medicated feed applications.
* * * * *
(d) * * *
Category II
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Assay limits percent1 Assay limits percent1
Drug Type A Type B maximum (100x) Type B/C2
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* * * * *
Tilmicosin........................... 90--110................ 18.2 g/lb (4.0 %)...... 85--115
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\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
medicated feed with lower assay limits to make Type C medicated feed.
* * * * *
5. New Sec. 558.618 is added to read as follows:
Sec. 558.618 Tilmicosin.
(a) Approvals. Type A medicated articles: 90.7 grams of tilmicosin
(as tilmicosin phosphate) per pound (200 grams per kilogram) to 000986
in Sec. 510.600(c) of this chapter.
(b) Special considerations. Do not use in any feed containing
bentonite.
(c) Related tolerances. See Sec. 556.735 of this chapter.
(d) Conditions of use. It is used in swine feed as follows:
(1) Amount per ton. 181.8 grams to 363.6 grams tilmicosin.
(2) Indications for use. For the control of swine respiratory
disease associated with Actinobacillus pleuropneumoniae and Pasteurella
multocida.
(3) Limitations. For use in swine feed only. The safety of
tilmicosin has not been established in pregnant swine or swine intended
for breeding purposes. Feed continuously as the sole ration for 21-day
period, beginning approximately 7 days before an expected disease
outbreak. Withdraw 7 days before slaughter. Federal law restricts this
drug to use under the professional supervision of a licensed
veterinarian. Any animal feed bearing or containing this drug shall be
fed to animals only by or upon a lawful veterinary feed directive (VFD)
issued by a licensed veterinarian in the course of the veterinarian's
professional practice. VFD's for tilmicosin phosphate shall not be
refilled.
(4) VFD Requirements. This drug and any article or feed
manufactured from it shall bear the following cautionary statements:
``Caution: Federal law limits this drug to use under the professional
supervision of a licensed veterinarian. Animal feed bearing or
containing this veterinary feed directive drug shall be fed to animals
only by or upon a lawful veterinary feed directive issued by a licensed
veterinarian in the course of the veterinarian's professional
practice.'' A VFD shall contain the following information: The name,
address, and phone number of the veterinarian and the client;
identification of the animals to be treated, including, identification
of the species, number of animals, and the location of the animals;
date of treatment and, if different, date of prescribing the VFD drug;
the condition or disease being diagnosed or treated; name of the animal
drug; level of animal drug in feed and amount of feed; feeding
instructions with withdrawal time; any special instructions and
cautionary statements necessary for use of the drug in conformance with
the approval; expiration date of VFD; number of refills, if permitted
by approval; signature of the veterinarian; veterinarian's license
number and name of the State issuing the license.
Dated: December 17,1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-32881 Filed 12-26-96; 8:45 am]
BILLING CODE 4160-01-F