[Federal Register Volume 63, Number 237 (Thursday, December 10, 1998)]
[Rules and Regulations]
[Pages 68183-68184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32740]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522, 524, and 556
Animal Drugs, Feeds, and Related Products; Doramectin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of two supplemental new animal
drug applications (NADA's) filed by Pfizer, Inc. The supplemental
NADA's provide for added use of doramectin in cattle for injectable use
for additional persistent efficacy for treatment and control of certain
gastrointestinal roundworms and lungworms and for topical use for
treatment and control of horn flies.
EFFECTIVE DATE: December 10, 1998.
FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7575.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017-5755, filed supplemental NADA 141-061 that provides for
subcutaneous and intramuscular use of Dectomax (doramectin) 1
percent injectable solution in cattle to control infections and to
protect from reinfection with Cooperia oncophora for 14 days and
Oesophagostomum radiatum for 28 days after treatment. The new
persistent use is in addition to the currently approved use in cattle
for treatment and control of various gastrointestinal roundworms,
lungworms, eyeworms, grubs, sucking lice, and mange mites, and to
control infections and to protect from reinfection with Ostertagia
ostertagi for 21 days and C. punctata and Dictyocaulus viviparus for 28
days after treatment.
Pfizer, Inc., also filed supplemental NADA 141-095 that provides
for topical use of Dectomax (doramectin) 0.5 percent pour-on
in beef and nonlactating dairy cattle to treat and control horn flies
(Haematobia irritans) in addition to its use for treatment and control
of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and
sucking lice, and mange mites, and to control infections and to protect
from reinfection with C. oncophora and Dictyocaulus viviparus for 21
days, and O. ostertagi, C. punctata, and O. radiatum for 28 days after
treatment.
The supplemental NADA's are approved as of October 25, 1998, and
the regulations are amended in 21 CFR 522.770(d)(1)(ii) and
524.770(d)(2) to reflect the approvals. The basis of approval is
discussed in the freedom of information summaries.
In addition, a tolerance for doramectin and its residues in cattle
muscle has not been previously established. Also, the acceptable daily
intake (ADI) for doramectin has not been previously codified. At this
time, the regulations are amended in 21 CFR 556.225 to provide for a
tolerance for doramectin residues in cattle muscle and an ADI.
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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
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)), these supplemental
approvals for food-producing animals qualify for 3 years of marketing
exclusivity beginning October 25, 1998, because the supplements contain
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 approval of the supplemental applications and
conducted or sponsored by the applicant. Exclusivity applies only to
the added indication for use of doramectin injection to control
infections and to protect cattle from reinfection with C. oncophora for
14 days and O. radiatum for 28 days after treatment, and for doramectin
topical for the treatment and control of horn flies (H. irritans).
The agency has determined under 21 CFR 25.33(a)(1) 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.
List of Subjects
21 CFR Parts 522 and 524
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 522,
524, and 556 are amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 522.770 is amended by revising paragraph (d)(1)(ii) to
read as follows:
Sec. 522.770 Doramectin.
* * * * *
(d) * * *
(1) * * *
(ii) Indications for use. For treatment and control of
gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice,
and mange mites. To control infections and to protect from reinfection
with Cooperia oncophora for 14 days, Ostertagia ostertagi for 21 days,
and C. punctata, Oesophagostomum radiatum, and Dictyocaulus viviparus
for 28 days after treatment.
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
4. Section 524.770 is amended by revising paragraph (d)(2) to read
as follows:
Sec. 524.770 Doramectin.
* * * * *
(d) * * *
(2) Indications for use. For treatment and control of
gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and
sucking lice, horn flies, and mange mites, and to control infections
and to protect from reinfection with Cooperia oncophora and
Dictyocaulus viviparus for 21 days, and Ostertagia ostertagia, C.
punctata, and Oesophagostomum radiatum for 28 days after treatment.
* * * * *
[[Page 68184]]
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
5. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
6. Section 556.225 is revised to read as follows:
Sec. 556.225 Doramectin.
(a) Acceptable daily intake (ADI). The ADI for total residues of
doramectin is 0.75 microgram per kilogram of body weight per day.
(b) Tolerances--(1) Cattle. A tolerance of 100 parts per billion is
established for parent doramectin (marker residue) in liver (target
tissue) and of 30 parts per billion for parent doramectin in muscle.
(2) Swine. A tolerance is established for parent doramectin (marker
residue) in liver (target tissue) of 160 parts per billion.
Dated: December 2, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-32740 Filed 12-9-98; 8:45 am]
BILLING CODE 4160-01-F
