[Federal Register Volume 59, Number 73 (Friday, April 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8820]
[[Page Unknown]]
[Federal Register: April 15, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
Animal Drugs, Feeds, and Related Products; Morantel Tartrate
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 supplemental new animal drug
application (NADA) filed by Pfizer, Inc. The supplement provides for
use of morantel tartrate Type A medicated article to make a Type C
medicated feed used as an anthelmintic for goats. Also, the regulations
are amended to establish a tolerance for drug residues in edible goat
tissues.
EFFECTIVE DATE: April 15, 1994.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed a supplement to NADA 92-444, which provides for use of
morantel tartrate to make a Type A medicated article used to make a
Type C medicated goat feed in addition to its approved use for a Type C
medicated cattle feed. The Type C medicated goat feed is used for
removal and control of mature gastrointestinal nematodes Haemonchus
contortus, Ostertagia (Teladorsagia) circumcincta, and Trichostrongylus
axei. Also, a tolerance for residues of morantel tartrate and its
metabolites in edible goat tissues is established. Approval is based in
part on data and information in Public Master File (PMF) 5366
established under the IR-4 Project, Southern Region, University of
Florida, College of Veterinary Medicine, Gainesville, FL 32611.
The supplement is approved as of April 15, 1994 and the regulations
are amended in 21 CFR 556.425 and 558.360 to reflect the approval. The
basis for approval is discussed in the freedom of information summary.
Approval of this supplement is for use of a Type A medicated
article to make a Type C medicated feed. Morantel tartrate is a
Category II drug which, as in Sec. 558.4, requires an approved form FDA
1900 for use in making a Type C medicated feed.
In addition, the regulation for tolerances for residues of the drug
or its metabolites in cattle, and now in goats, is amended to remove
the part that is no longer required.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for use in
food producing animals does not qualify for marketing exclusivity
because the supplement does not contain reports of new clinical or
field investigations (other than bioequivalence or residue studies) or
new human food safety studies (other than bioequivalence or residue
studies) essential to the approval and conducted or sponsored by the
applicant.
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.
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 556.425 is revised to read as follows:
Sec. 556.425 Morantel tartrate.
A tolerance of 0.7 part per million is established for N-methyl-
1,3-propanediamine (MAPA, marker residue) in the liver (target tissue)
of cattle and goats. A tolerance for residues of morantel tartrate in
milk is not required.
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 558.360 Morantel tartrate is amended by designating the
text of paragraph (d)(2) as paragraph (d)(2)(i) and adding a new
heading to the newly designated paragaph, by adding new paragraph
(d)(2)(ii), and by revising the last sentence of paragraph (d)(3) to
read as follows:
Sec. 558.360 Morantel tartrate.
* * * * *
(d) * * *
(2) Indications for use--(i) Cattle. * * *
(ii) Goats. For removal and control of mature gastrointestinal
nematode infections of goats including Haemonchus contortus, Ostertagia
(Teladorsagia) circumcincta, and Trichostrongylus axei.
(3) Limitations. * * * Do not treat cattle within 14 days of
slaughter; do not treat goats within 30 days of slaughter.
Dated: April 6, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-8820 Filed 4-14-94; 8:45 am]
BILLING CODE 4160-01-F