[Federal Register Volume 64, Number 52 (Thursday, March 18, 1999)]
[Rules and Regulations]
[Pages 13341-13342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6530]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 556, and 558
Animal Drugs, Feeds, and Related Products; Lincomycin
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 three supplemental new animal
drug applications (NADA's) filed by Pharmacia & Upjohn Co. The
supplemental NADA's provide new tolerances and withdrawal times for use
of lincomycin, and codification of an acceptable daily intake (ADI).
EFFECTIVE DATE: March 18, 1999.
FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7570.
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd.,
Kalamazoo, MI 49001-0199, filed supplemental NADA's 34-025, 97-505, and
111-636. NADA 34-025 provides for use of Lincocin sterile
solution and Lincomix injectable (lincomycin hydrochloride)
for dogs, cats, and swine. NADA 97-505 provides for use of
Lincomix 20/50 Type A medicated articles and
Lincomix 10 Type B medicated feed (lincomycin hydrochloride)
for swine and broiler chickens. NADA 111-636 provides for use of
Lincomix soluble powder (lincomycin hydrochloride) for swine
and broiler chicken drinking water. The supplemental NADA's provide for
establishing a zero withdrawal period for lincomycin oral products,
establishing residue tolerances of 0.6 parts per million (ppm) in swine
liver and 0.1 ppm in swine muscle, and establishing an ADI of 25
micrograms per kilogram of body weight per day. The supplemental NADA's
are approved as of August 25, 1998, and the regulations in 21 CFR
520.1263c(d)(1)(i)(C), 556.360, and 558.325(c)(2)(ii)(b),
(c)(2)(iii)(b), and (c)(2)(iv)(b) are amended to reflect the approval.
The basis of approval is discussed in each freedom of information
summary.
Since these approvals involve revised tolerances for residues of
lincomycin in edible tissues of swine, Sec. 556.360 is amended to
reflect the revised tolerance for lincomycin residues in swine tissues.
In addition to revising the tolerance for lincomycin residues in
swine tissues, FDA is further amending the tolerance regulation to
codify the ADI for total residues of lincomycin. The ADI is the amount
of total drug residue that can be safely consumed by humans every day.
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)), the supplemental approval
for food-producing animals for Lincocin sterile solution and
Lincomix injectable (NADA 34-025) qualifies for 3 years of
marketing exclusivity beginning August 25, 1998, because the
supplemental application contains substantial evidence of the
effectiveness of the drug involved, 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 and conducted
or sponsored by the applicant. The 3 years of marketing exclusivity
applies only to the new tolerance for lincomycin in swine liver for
which the supplemental NADA 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.
List of Subjects
21 CFR Part 520
Animal drugs.
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 520,
556, and 558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1263c [Amended]
2. Section 520.1263c Lincomycin hydrochloride soluble powder is
amended in paragraph (d)(1)(i)(C) by removing the last sentence.
[[Page 13342]]
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
3. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
4. Section 556.360 is revised to read as follows:
Sec. 556.360 Lincomycin.
(a) Acceptable daily intake (ADI). The ADI for total residues of
lincomycin is 25 micrograms per kilogram of body weight per day.
(b) Chickens. A tolerance for residues of lincomycin in chickens is
not required.
(c) Swine. Tolerances for lincomycin of 0.6 part per million in
liver and 0.1 part per million in muscle are established.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
5. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.325 [Amended]
6. Section 558.325 Lincomycin is amended by redesignating paragraph
(c) as paragraph (d), by reserving paragraph (c), in newly redesignated
paragraph (d)(2)(ii)(b) by removing ``; feed containing 100 grams per
ton lincomycin hydrochloride should be withdrawn 6 days before
slaughter'', and in newly redesignated paragraphs (d)(2)(iii)(b) and
(d)(2)(iv)(b) by removing ``; withdraw 6 days before slaughter''.
Dated: March 2, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 99-6530 Filed 3-17-99; 8:45 am]
BILLING CODE 4160-01-F
