[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Rules and Regulations]
[Pages 72617-72619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 500, 522, and 556

[Docket No. FDA-2011-N-0003]


Animal Drugs, Feeds, and Related Products; Eprinomectin; N-
Methyl-2-Pyrrolidone

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 an original new animal drug 
application (NADA) filed by Merial Ltd. The NADA provides for the 
veterinary prescription use of eprinomectin by

[[Page 72618]]

injection for the treatment and control of internal and external 
parasites of cattle on pasture with persistent effectiveness. The 
current tolerance for the marker residue for total residues of 
eprinomectin in edible tissues of cattle is being lowered. The method 
of detection for residues of the carcinogenic excipient n-methyl-2-
pyrrolidone (NMP) in edible tissues of cattle is also being codified.

DATES: This rule is effective November 25, 2011. The incorporation by 
reference of a certain method listed in this rule is approved by the 
Director of the Federal Register as of November 25, 2011.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, (240) 276-8341, email: 
[email protected].

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640 filed NADA 141-327 that provides for 
veterinary prescription use of LONGRANGE (eprinomectin) Extended-
Release Injectable Parasiticide for the treatment and control of 
internal and external parasites of cattle on pasture with persistent 
effectiveness. The NADA is approved as of September 26, 2011, and the 
regulations are amended in 21 CFR part 522 to reflect the approval.
    As a consequence of the residue depletion characteristics of this 
product, the current tolerance for the marker residue for eprinomectin 
in the target tissue of cattle is being lowered. Accordingly, the 
regulations are amended in 21 CFR part 556. Elsewhere in this issue of 
the Federal Register, the approved NADA for an eprinomectin topical 
solution used on cattle is being supplemented to provide for this lower 
tolerance.
    In addition, FDA has determined that an inactive ingredient in this 
product, the excipient n-methyl-2-pyrrolidone (NMP), is a carcinogen. 
As required by section 512(d)(1)(I) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(d)(1)(I)), a method of 
detection for residues of NMP in edible tissues of cattle is being 
codified in 21 CFR part 500, new subpart F, through incorporation by 
reference.
    A summary of safety and effectiveness data and information 
submitted to support approval of this application may be seen in the 
Division of Dockets Management (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)(ii) of the FD&C Act, this approval 
qualifies for 3 years of marketing exclusivity beginning on the date of 
approval.
    The Agency has carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
    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 500

    Animal drugs, Animal feeds, Cancer, Labeling, Packaging and 
containers, Polychlorinated biphenyls (PCBs), Incorporation by 
reference.

21 CFR Part 522

    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 500, 
522, and 556 are amended as follows:

PART 500--GENERAL

0
1. The authority citation for 21 CFR part 500 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 
360b, 371.

0
2. Add subpart F, consisting of Sec.  500.1410, to read as follows:

Subpart F--Methods for Detection of Residues of Carcinogenic 
Compounds Used in Food-Producing Animals


Sec.  500.1410  N-methyl-2-pyrrolidone.

    (a) Standard for residues. No residues of n-methyl-2-pyrrolidone 
may be found in the uncooked edible tissues of cattle as determined by 
a method entitled ``Method of Analysis: N-methyl-2-pyrrolidone,'' 
September 26, 2011, Center for Veterinary Medicine, Food and Drug 
Administration, which is incorporated by reference with the approval of 
the Director of the Federal Register under 5 U.S.C. 522(a) and 1 CFR 
part 51. You may obtain a copy of the method from the Communications 
Staff (HFV-12), Center for Veterinary Medicine, Food and Drug 
Administration, 7519 Standish Pl., Rockville, MD 20855; (240) 276-9120; 
or go to: http://www.fda.gov/aboutfda/centersoffices/cvm/cvmfoiaelectronicreadingroom/default.htm. You may inspect a copy at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, (301) 827-6860, 
between 9 a.m. and 4 p.m., Monday through Friday or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call (202) 741-6030, or go to: 
http://www.archives.gov/federal-register/cfr/ibr-locations.html.
    (b) Related conditions of use. See Sec. Sec.  522.814 and 522.955 
of this chapter.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


0
4. Add Sec.  522.814 to read as follows:


Sec.  522.814  Eprinomectin.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) eprinomectin.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  500.1410 and 556.227 of this 
chapter.
    (d) Conditions of use in cattle on pasture--(1) Amount. Administer 
1 mg/kilogram of body weight by subcutaneous injection.
    (2) Indications for use. For the treatment and control of the 
following internal and external parasites: Gastrointestinal roundworms 
(adults and fourth-stage larvae) Cooperia oncophora, C. punctata, C. 
surnabada, Trichostrongylus axei, Ostertagia ostertagi (including 
inhibited stage); (adults) Haemonchus placei, Oesophagostomum radiatum, 
O. lyrata, T. colubriformis; lungworms (adults) Dictyocaulus viviparus; 
cattle grubs Hypoderma bovis; mites Sarcoptes scabiei var. bovis. 
Prevents reinfection with C. oncophora, C. punctata, and T. axei for 
100 days following treatment; H. placei, O. radiatum, O. lyrata, and O. 
ostertagi for 120 days following treatment; and D. viviparus for 150 
days following treatment.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Animals

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intended for human consumption must not be slaughtered within 48 days 
of the last treatment. Do not use in female dairy cattle 20 months of 
age or older. Use in lactating dairy cows may cause drug residues in 
milk. A withdrawal period has not been established for pre-ruminating 
calves. Do not use in calves to be processed for veal.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
5. The authority citation for 21 CFR part 556 continues to read as 
follows:

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


0
6. In Sec.  556.227, revise paragraph (b) and add paragraph (c) to read 
as follows:


Sec.  556.227  Eprinomectin.

* * * * *
    (b) Tolerances. The tolerances for eprinomectin B1a 
(marker residue) are:
    (1) Cattle--(i) Liver (target tissue): 1.5 parts per million.
    (ii) Muscle: 100 parts per billion (ppb).
    (iii) Milk: 12 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  522.814 and 524.814 
of this chapter.

    Dated: November 17, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-30329 Filed 11-23-11; 8:45 am]
BILLING CODE 4160-01-P