Tolerances for Residues of New Animal Drugs in Food; Progesterone, 57907 [2011-23867]

Download as PDF Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Rules and Regulations § 522.1014 Gamithromycin. (a) Specifications. Each milliliter (mL) of solution contains 150 milligrams (mg) gamithromycin. (b) Sponsor. See No. 050604 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.292 of this chapter. (d) Conditions of use—(1) Cattle—(i) Amount. Administer 6 mg/kilogram of body weight (2 mL per 110 pounds) one time by subcutaneous injection in the neck. (ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and nonlactating dairy cattle; and for the control of respiratory disease in beef and nonlactating dairy cattle at high risk of developing BRD associated with M. haemolytica and P. multocida. (iii) Limitations. Cattle intended for human consumption must not be slaughtered within 35 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] 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 556.292 is added to read as follows: ■ tkelley on DSKG8SOYB1PROD with RULES § 556.292 Gamithromycin. (a) Acceptable Daily Intake (ADI). The ADI for total residues of gamithromycin is 10 micrograms per kilogram of body weight per day. (b) Tolerances. The tolerances for gamithromycin (the marker residue) are: (1) Cattle—(i) Liver (the target tissue): 500 parts per billion (ppb). (ii) Muscle. 150 ppb. (2) [Reserved] (c) Related conditions of use. See § 522.1014 of this chapter. Dated: September 13, 2011. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2011–23874 Filed 9–16–11; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 13:21 Sep 16, 2011 Jkt 223001 57907 Food and Drug Administration it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. 21 CFR Part 556 List of Subjects in 21 CFR Part 556 DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2011–N–0003] Tolerances for Residues of New Animal Drugs in Food; Progesterone AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. 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 part 556 is amended as follows: ACTION: The Food and Drug Administration (FDA) is amending the animal drug regulations to update the allowable incremental increase for residues of progesterone in edible tissues of cattle and sheep based on the 1994 revised daily consumption values. This action is being taken to improve the accuracy of the regulations. DATES: This rule is effective September 19, 2011. FOR FURTHER INFORMATION CONTACT: Kevin Gaido, Center for Veterinary Medicine (HFV–153), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8212, email: kevin.gaido@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 512(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) (21 CFR 514.105(a)) directs FDA to establish tolerances by regulation, as necessary, when a new animal drug is approved for use in food-producing animals. Progesterone is approved for use in subcutaneous implants used for increased rate of weight gain in suckling beef calves and steers (21 CFR 522.1940) and in vaginal inserts used for management of the estrous cycle in female cattle and ewes (21 CFR 529.1940). FDA has noticed the animal drug tolerance regulations do not reflect levels for progesterone using the daily consumption values in the current guidance document, ‘‘Guideline for Establishing a Safe Concentration’’ (59 FR 37499, July 22, 1994). At this time, FDA is amending 21 CFR 556.540 to reflect the revised daily consumption values as applied to edible tissues of cattle. Sheep are considered a minor species for human food safety assessment, and the updated allowable incremental increase limits for cattle tissues based on the revised daily consumption values are applicable to sheep. This action is being taken to improve the accuracy of the regulations. This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because SUMMARY: PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 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. Revise § 556.540 to read as follows: § 556.540 Progesterone. (a) [Reserved] (b) Tolerances. Residues of progesterone are not permitted in excess of the following increments above the concentrations of progesterone naturally present in untreated animals: (1) Cattle and sheep—(i) Muscle: 5 parts per billion (ppb). (ii) Liver: 15 ppb. (iii) Kidney: 30 ppb. (iv) Fat: 30 ppb. (2) [Reserved] (c) Related conditions of use. See §§ 522.1940 and 529.1940 of this chapter. Dated: September 13, 2011. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2011–23867 Filed 9–16–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF THE TREASURY Fiscal Service 31 CFR Part 240 RIN 1510–AB25 Indorsement and Payment of Checks Drawn on the United States Treasury Financial Management Service, Fiscal Service, Treasury. ACTION: Final rule. AGENCY: This final rule authorizes the Department of the Treasury (Treasury), Financial Management Service (FMS), to direct Federal Reserve Banks to debit a financial institution’s Master Account for all check reclamations against the financial institution that the financial institution has not protested. Financial SUMMARY: E:\FR\FM\19SER1.SGM 19SER1

Agencies

[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Rules and Regulations]
[Page 57907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23867]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 556

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


Tolerances for Residues of New Animal Drugs in Food; Progesterone

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to update the allowable incremental increase for 
residues of progesterone in edible tissues of cattle and sheep based on 
the 1994 revised daily consumption values. This action is being taken 
to improve the accuracy of the regulations.

DATES: This rule is effective September 19, 2011.

FOR FURTHER INFORMATION CONTACT: Kevin Gaido, Center for Veterinary 
Medicine (HFV-153), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8212, e-mail: kevin.gaido@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Section 512(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360b(i)) (21 CFR 514.105(a)) directs FDA to 
establish tolerances by regulation, as necessary, when a new animal 
drug is approved for use in food-producing animals. Progesterone is 
approved for use in subcutaneous implants used for increased rate of 
weight gain in suckling beef calves and steers (21 CFR 522.1940) and in 
vaginal inserts used for management of the estrous cycle in female 
cattle and ewes (21 CFR 529.1940).
    FDA has noticed the animal drug tolerance regulations do not 
reflect levels for progesterone using the daily consumption values in 
the current guidance document, ``Guideline for Establishing a Safe 
Concentration'' (59 FR 37499, July 22, 1994). At this time, FDA is 
amending 21 CFR 556.540 to reflect the revised daily consumption values 
as applied to edible tissues of cattle. Sheep are considered a minor 
species for human food safety assessment, and the updated allowable 
incremental increase limits for cattle tissues based on the revised 
daily consumption values are applicable to sheep. This action is being 
taken to improve the accuracy of the regulations.
    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 in 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 part 556 is 
amended as follows:

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

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

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


0
2. Revise Sec.  556.540 to read as follows:


Sec.  556.540  Progesterone.

    (a) [Reserved]
    (b) Tolerances. Residues of progesterone are not permitted in 
excess of the following increments above the concentrations of 
progesterone naturally present in untreated animals:
    (1) Cattle and sheep--(i) Muscle: 5 parts per billion (ppb).
    (ii) Liver: 15 ppb.
    (iii) Kidney: 30 ppb.
    (iv) Fat: 30 ppb.
    (2) [Reserved]
    (c) Related conditions of use. See Sec. Sec.  522.1940 and 529.1940 
of this chapter.

    Dated: September 13, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-23867 Filed 9-16-11; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.