[Federal Register Volume 65, Number 200 (Monday, October 16, 2000)]
[Rules and Regulations]
[Page 61091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26404]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 526 and 556


Intramammary Dosage Form New Animal Drugs; Pirlimycin 
Hydrochloride

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 Pharmacia and Upjohn Co. The supplemental 
NADA provides for use of a sterile solution of pirlimycin hydrochloride 
for intramammary treatment of clinical and subclinical staphylococcal 
and streptococcal mastitis in lactating dairy cows, for reduction in 
the preslaughter withdrawal period, and for revision of the milk 
discard statement in labeling to state the milk discard time only 
(i.e., to remove reference to the number of milkings).

DATES: This rule is effective October 16, 2000.

FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary 
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7569.

SUPPLEMENTARY INFORMATION: Pharmacia and Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed a supplemental application to NADA 141-
036 that provides for use of PIRSUE<Register> (pirlimycin 
hydrochloride) Sterile Solution for intramammary treatment of clinical 
and subclinical mastitis in lactating dairy cattle caused by 
Staphylococcus species, such as Staphylococcus aureus; and 
Streptococcus species, such as Streptococcus agalactiae, Streptococcus 
dysgalactiae, and Streptococcus uberis; for reduction in the 
preslaughter withdrawal period from 28 days to 9 days; and for revision 
of the milk discard statement in labeling to state the 36-hour milk 
discard time only (i.e., to remove reference to the number of 
milkings). The supplemental NADA is approved as of September 7, 2000, 
and the regulations are amended in 21 CFR 526.1810 to reflect the 
approval.
    In addition, the regulations are amended in (21 CFR 556.515) to add 
the previously established acceptable daily intake for total residues 
of pirlimycin, to add a tolerance for residues of pirlimycin in cattle 
muscle and, editorially, to reflect current format.
    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)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning September 7, 2000, 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 and conducted or sponsored by the 
applicant. The 3 years of marketing exclusivity applies only to the new 
formulation for which the supplemental application was approved.
    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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 526

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 526 and 
556 are amended as follows:

PART 526--INTRAMAMMARY DOSAGE FORM

    1. The authority citation for 21 CFR part 526 continues to read as 
follows:

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


Sec. 526.1810  [Amended]

    2. Section 526.1810 Pirlimycin hydrochloride aqueous gel is amended 
by removing ``aqueous gel'' from the section heading, by removing 
``(three milkings)'' from the first sentence in paragraph (d)(3), by 
removing ``28'' from the second sentence in paragraph (d)(3) and by 
adding in its place ``9'', and by removing the third sentence of 
paragraph (d)(3).

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: 21 U.S.C. 342, 360b, 371.

    2. Section 556.515 is revised to read as follows:


Sec. 556.515  Pirlimycin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
pirlimycin is 0.01 milligrams per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for parent pirlimycin (the marker residue) is 0.5 part per 
million (ppm).
    (ii) Muscle. The tolerance for parent pirlimycin (the marker 
residue) is 0.3 ppm.
    (iii) Milk. The tolerance for parent pirlimycin (the marker residue 
in cattle milk) is 0.4 ppm.
    (2) [Reserved]

    Dated: October 6, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-26404 Filed 10-13-00; 8:45 am]
BILLING CODE 4160-01-F