[Federal Register Volume 59, Number 154 (Thursday, August 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19656]


[[Page Unknown]]

[Federal Register: August 11, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

 

Animal Drugs, Feeds, and Related Products; Melengestrol Acetate

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 12 supplemental new animal drug 
applications (NADA's) filed by The Upjohn Co. The applications concern 
the use of Type A medicated articles containing melengestrol acetate 
(MGA) (alone and in combination) to manufacture certain combination 
drug Type B and Type C medicated feeds for heifers fed in confinement 
for slaughter. The supplements provide for a revised tolerance of 25 
parts per billion (ppb) MGA residues, which is a change in the 
regulation of medicated feed applications to a Category I drug, and the 
removal of the requirement for a 48-hour preslaughter withdrawal 
period.

EFFECTIVE DATE: August 11, 1994.

FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1638.

SUPPLEMENTARY INFORMATION: The Upjohn Co., Kalamazoo, MI 49001, filed 
12 supplemental NADA's revising the conditions of use of melengestrol 
acetate (MGA) Type A medicated articles to make Type B and Type C 
medicated feeds for heifers being fed in confinement for slaughter. The 
NADA's supplemented are:
    (1) NADA 34-254: MGA 100/200.
    (2) NADA 39-402: MGA Liquid 500.
    (3) NADA 124-309: MGA 100/200 plus Monensin.
    (4) NADA 125-476: MGA 500 Liquid plus Monensin.
    (5) NADA 138-792: MGA 100/200 plus Monensin and Tylosin.
    (6) NADA 138-870: MGA 500 Liquid plus Monensin and Tylosin.
    (7) NADA 138-904: MGA 100/200 plus Lasalocid and Tylosin.
    (8) NADA 138-992: MGA 500 Liquid plus Lasalocid and Tylosin.
    (9) NADA 138-995: MGA 100/200 plus Tylosin.
    (10) NADA 139-192: MGA 500 Liquid plus Tylosin.
    (11) NADA 139-876: MGA 100/200 plus Lasalocid.
    (12) NADA 140-288: MGA 500 Liquid plus Lasalocid.
    The supplements provide for the following actions: (1) Deleting the 
48-hour preslaughter withdrawal period for use in heifers being fed in 
confinement for slaughter for increased rate of weight gain, improved 
feed efficiency, and suppression of estrus; (2) amending the 
classification in Sec. 558.4 Medicated Feed Applications (21 CFR 558.4) 
from Category II to Category I because the use of the drug no longer 
requires a withdrawal period; and (3) revising the tolerance for 
residues of MGA in uncooked, edible cattle tissues from no residue to a 
finite tolerance of 25 ppb. The tolerance was set based on the 
determination that the endpoint of toxicological concern is hormonal 
activity and that residues of MGA at or below 25 ppb in edible tissues 
of treated animals will not elicit a hormonal response.
    Also, Sec. 556.380 (21 CFR 556.380) includes a gas-liquid 
chromatographic (GLC) method of analysis for residues of MGA in 
tissues. That method was in the regulation recodified from food 
additives to animal drugs in 1970. The Official Methods of Analysis of 
the Association of Official Analytical Chemists (AOAC), 15th ed., 1990, 
in section 976.36 (pp. 629-631) provides an updated GLC method for 
determining MGA residues in animal tissues. The procedure is also 
published in the Journal of the Association of Official Analytical 
Chemists, JAOAC 59: 507-515, 1976. FDA is removing the analytical 
method in Sec. 556.380 and relying on the AOAC for the method of 
analysis for MGA.
    These are new animal drugs used in Type A medicated articles to 
make Type B and C medicated feeds. With approval of these supplements, 
MGA is a Category I drug which, as provided in Sec. 558.4, does not 
require an approved form FDA 1900 for making a Type B or C medicated 
feed from a Type A medicated article. Approved form FDA 1900's may be 
withdrawn at the request of the sponsor.
    The supplements are approved as of June 29, 1994. 21 CFR 556.380 is 
revised to remove the existing text and provide for a finite tolerance. 
Section 558.4 is revised to remove the MGA entry from the Category II 
table and add it to the Category I table. 21 CFR 558.342 is amended by 
revising paragraphs (c)(1)(ii), (c)(2)(ii), (c)(3)(ii), (c)(4)(ii), 
(c)(5)(ii), and (c)(6)(ii), and 21 CFR 558.355 is amended by revising 
paragraphs (f)(3)(iv)(b) and (f)(3)(viii) to remove the 48-hour 
preslaughter withdrawal statement.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, 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 supplements for 
food-producing animals do not qualify for marketing exclusivity because 
the supplements do not contain new clinical or field investigations 
(other than bioequivalence or residue studies) and new human food 
safety studies (other than bioequivalence or residue studies) essential 
to the approval and conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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 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 556 and 
558 are amended as follows:

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: Secs. 402, 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342, 360b, 371).

    2. Section 556.380 is revised to read as follows:

Sec. 556.380  Melengestrol acetate.

    A tolerance of 25 parts per billion is established for residues of 
the parent compound, melengestrol acetate, in fat of cattle.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

    4. Section 558.4 is amended in paragraph (d) in the ``Category I'' 
table by alphabetically adding a new entry for ``melengestrol acetate'' 
and in the ``Category II'' table by removing the entry for 
``melengestrol acetate'' to read as follows:

Sec. 558.4  Medicated feed applications.-

 * * * * *
    (d) *  *  *-
 * * * * *

                                                   Category I                                                   
----------------------------------------------------------------------------------------------------------------
                                Assay limits                                                                    
             Drug                 percent1        Type B maximum (200x)        Assay limits percent1 type B/C2  
                                   type A                                                                       
----------------------------------------------------------------------------------------------------------------
                                                     *******                                                    
Melengestrol acetate..........       90-110   10.0 g/ton (0.0011%).........                              70-120 
                                                                                                                
                                                     *******                                                    
                                                                                                                
----------------------------------------------------------------------------------------------------------------
\1\Percent of labeled amount.                                                                                   
\2\Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two     
  range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. 
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B      
  medicated feed with lower assay limits to make Type C medicated feed.                                         

- * * * * *


Sec. 558.342  [Amended]

    5. Section 558.342 Melengestrol acetate is amended in paragraphs 
(c)(1)(ii), (c)(2)(ii), (c)(3)(ii), (c)(4)(ii), (c)(5)(ii), and 
(c)(6)(ii), by removing the sentence ``Withdraw melengestrol acetate 48 
hours prior to slaughter.'' each time it appears.


Sec. 558.355  [Amended]

    6. Section 558.355 Monensin is amended in paragraph (f)(3)(iv)(b) 
by removing the sentence ``Withdraw melengestrol acetate 48 hours prior 
to slaughter.'', and in paragraph (f)(3)(viii) by removing the last 
sentence ``Medicated feeds containing melengestrol acetate are required 
to be withdrawn 48 hours prior to slaughter.''

    Dated: August 4, 1994.
 Robert C. Livingston,
 Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-19656 Filed 8-10-94; 8:45 am]
BILLING CODE 4160-01-F