[Federal Register Volume 74, Number 155 (Thursday, August 13, 2009)]
[Rules and Regulations]
[Pages 40723-40726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]


New Animal Drugs for Use in Animal Feeds; Oxytetracycline; 
Neomycin

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 Pennfield Oil Co. The supplemental NADA 
provides for the use of fixed-combination Type A medicated articles 
containing oxytetracycline and neomycin sulfate to formulate two-way, 
fixed-combination drug Type B and Type C medicated feeds for chickens, 
turkeys, swine, cattle, and sheep. This approval reflects FDA's 
effectiveness conclusions which relied on the National Academy of 
Sciences/National Research Council (NAS/NRC) Drug Efficacy Study 
Group's evaluation of the effectiveness of these drugs when used in 
animal feed as single ingredients.

DATES: This rule is effective August 13, 2009.

FOR FURTHER INFORMATION CONTACT: Harlan Howard, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8111, e-mail: <a href="/cdn-cgi/l/email-protection#0961687b6568672761667e687b6d496f6d682761617a276e667f"><span class="__cf_email__" data-cfemail="bfd7decdd3ded191d7d0c8decddbffd9dbde91d7d7cc91d8d0c9">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 8, 2003 
(68 FR 47332), as corrected October 7, 2003 (68 FR 57911), as part of 
the Drug Efficacy Study Implementation (DESI) program, CVM announced 
the effective conditions of use for several drug products and use 
combinations that were listed in Sec.  558.15 (21 CFR 558.15). CVM 
proposed to withdraw the NADAs for those products or use combinations 
lacking substantial evidence of effectiveness following a 90-day 
opportunity to supplement the NADAs with labeling conforming to the 
relevant findings of effectiveness.
    In response to that notice, Pennfield Oil Co., (Pennfield) 14040 
Industrial Rd., Omaha, NE 68144, filed a hearing request for its 
approved NADA 138-939 NEO-OXY 50/50, NEO-OXY 100/100, and NEO-OXY 100/
100 MR (oxytetracycline and neomycin sulfate). These products are two-
way, fixed-combination Type A medicated articles used to make two-way 
combination drug Type C medicated feeds. Pennfield subsequently filed a 
supplement to NADA 138-939 to revise the labeling of these products to 
comply with these findings of effectiveness. The supplemental NADA 
provided for use of these fixed-combination Type A medicated articles 
to formulate two-way, fixed-combination drug Type B and Type C 
medicated feeds containing oxytetracycline and neomycin sulfate, in a 
1:1 ratio, for several production and therapeutic indications in 
chickens, turkeys, swine, cattle, and sheep. The supplemental NADA is 
approved as of July 2, 2009, and the regulations are amended in 21 CFR 
558.455 to reflect the approval. Pennfield has since withdrawn its 
hearing request for NDA 138-939.
    Approval of this supplemental NADA did not require review of any 
new safety or effectiveness data. Therefore, a freedom of information 
summary was not prepared.
    The DESI evaluation was concerned only with the effectiveness of 
the drug products and use combinations. Nothing in this document 
constitutes a bar to further proceedings with respect to questions of 
safety of the subject drugs in treated animals or of the drugs or their 
metabolites in food products derived from treated animals.
    Products that comply with FDA's findings of effectiveness are 
eligible for copying, as described in the Generic Animal Drug and 
Patent Term Restoration Act Policy Letter Eight, August 21, 1991 (56 FR 
41561). Accordingly, sponsors may now obtain approval of abbreviated 
NADAs for this fixed combination Type A medicated article.
    The agency has determined under 21 CFR 25.33 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

[[Page 40724]]

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 in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
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 558 is 
amended as follows:

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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

0
2. Amend Sec.  558.455 as follows:
0
a. Revise paragraph (b);
0
b. Redesignate paragraph (d) as paragraph (e);
0
c. Add new paragraph (d); and
0
d. Revise newly redesignated paragraph (e).
    The redesignation, additions, and revisions read as follows:


Sec.  558.455  Oxytetracycline and neomycin.

* * * * *
    (b) Sponsors. See Nos. 048164 and 066104 in Sec.  510.600(c) of 
this chapter.
* * * * *
    (d) Special considerations. Cattle feeds shall bear the following 
warning statement: ``Use of more than one product containing neomycin 
or failure to follow withdrawal times may result in illegal drug 
residues.''
    (e) Indications for use--(1) Chickens. It is used in feed as 
follows:

----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin
 sulfate amount in grams per       Indications for use              Limitations                  Sponsors
         ton of feed
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50                  Chickens: For increased rate  Feed continuously; do not                     048164
                               of weight gain and improved   feed to chickens producing                   066104
                               feed efficiency.              eggs for human
                                                             consumption; in low
                                                             calcium feeds withdraw 3
                                                             days before slaughter.
----------------------------------------------------------------------------------------------------------------
(ii) 100 to 200               Chickens: For control of      Feed continuously for 7 to                    048164
                               infectious synovitis caused   14 d; do not feed to                         066104
                               by Mycoplasma synoviae;       chickens producing eggs
                               control of fowl cholera       for human consumption; in
                               caused by Pasteurella         low calcium feed, withdraw
                               multocida susceptible to      3 d before slaughter.
                               oxytetracycline.
----------------------------------------------------------------------------------------------------------------
(iii) 400                      Chickens: For control of     Feed continuously for 7 to                    048164
                               chronic respiratory disease   14 d; do not feed to                         066104
                               (CRD) and air sac infection   chickens producing eggs
                               caused by M. gallisepticum    for human consumption; in
                               and Escherichia coli          low calcium feeds,
                               susceptible to                withdraw 3 d before
                               oxytetracycline.              slaughter.
----------------------------------------------------------------------------------------------------------------
(iv) 500                      Chickens: For reduction of    Feed continuously for 5 d;                    048164
                               mortality due to air          do not feed to chickens                      066104
                               sacculitis (air-sac-          producing eggs for human
                               infection) caused by E.       consumption; withdraw 24
                               coli susceptible to           hours before slaughter; in
                               oxytetracycline.              low calcium feeds withdraw
                                                             3 d before slaughter.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin
       sulfate amount              Indications for use              Limitations                  Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 grams per ton    Growing turkeys: For          Feed continuously; do not                     048164
 (g/ton) of feed               increased rate of weight      feed to turkeys producing                    066104
                               gain and improved feed        eggs for human
                               efficiency.                   consumption.
----------------------------------------------------------------------------------------------------------------
(ii) 100 g/ton of feed        Turkeys: For control of       Feed continuously for 7 to                    048164
                               hexamitiasis caused by        14 d; do not feed to                         066104
                               Hexamita meleagridis          turkeys producing eggs for
                               susceptible to                human consumption.
                               oxytetracycline.
----------------------------------------------------------------------------------------------------------------
(iii) 200 g/ton of feed       Turkeys: For control of       Feed continuously for 7 to                    048164
                               infectious synovitis caused   14 d; withdraw 5 d before                    066104
                               by M. synoviae susceptible    slaughter; do not feed to
                               to oxytetracycline.           turkeys producing eggs for
                                                             human consumption.
----------------------------------------------------------------------------------------------------------------
(iv) To provide 25            Turkeys: For control of       Feed continuously for 7 to                    048164
 milligrams per pound (mg/     complicating bacterial        14 d; withdraw 5 d before                    066104
 lb) of body weight daily.     organisms associated with     slaughter; do not feed to
                               bluecomb (transmissible       turkeys producing eggs for
                               enteritis; coronaviral        human consumption.
                               enteritis) susceptible to
                               oxytetracycline.
----------------------------------------------------------------------------------------------------------------

    (3) Swine. It is used in feed as follows:

[[Page 40725]]



----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin
       sulfate amount              Indications for use              Limitations                  Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 10 to 50 g/ton of feed    Swine: For increased rate of  Feed continuously.                            048164
                               weight gain and improved                                                   066104
                               feed efficiency.
----------------------------------------------------------------------------------------------------------------
(ii) To provide 10 mg/lb of   1. Swine: For treatment of    Feed continuously for 7 to                    048164
 body weight daily.            bacterial enteritis caused    14 d; withdraw 5 d before                    066104
                               by E. coli and Salmonella     slaughter.
                               choleraesuis and treatment
                               of bacterial pneumonia
                               caused by P. multocida
                               susceptible to
                               oxytetracycline; treatment
                               and control of
                               colibacillosis (bacterial
                               enteritis) caused by E.
                               coli susceptible to
                               neomycin.
                              2. Breeding swine: For        Feed continuously for not                     048164
                               control and treatment of      more than 14 d; withdraw 5                   066104
                               leptospirosis (reducing the   d before slaughter.
                               incidence of abortion and
                               shedding of leptospirae)
                               caused by Leptospira pomona
                               susceptible to
                               oxytetracycline.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle and sheep. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
Oxytetracycline and neomycin
       sulfate amount              Indications for use              Limitations                  Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 10 to 20 g/ton of feed    Sheep: For increased rate of  Feed continuously.                            048164
                               weight gain and improved                                                   066104
                               feed efficiency.
----------------------------------------------------------------------------------------------------------------
(ii) To provide 0.05 to 0.1   Calves (up to 250 lb): For    Feed continuously; in milk                    048164
 mg/lb of body weight daily.   increased rate of weight      replacers or starter feed.                   066104
                               gain and improved feed
                               efficiency.
----------------------------------------------------------------------------------------------------------------
(iii) To provide 10 mg/lb of  1. Calves and beef and        Feed continuously for 7 to                    048164
 body weight daily.            nonlactating dairy cattle:    14 d; in feed or milk                        066104
                               For treatment of bacterial    replacers. If symptoms
                               enteritis caused by E. coli   persist after using for 2
                               and bacterial pneumonia       or 3 days, consult a
                               (shipping fever complex)      veterinarian. Treatment
                               caused by P. multocida        should continue 24 to 48
                               susceptible to                hours beyond remission of
                               oxytetracycline; treatment    disease symptoms. A
                               and control of                withdrawal period has not
                               colibacillosis (bacterial     been established for use
                               enteritis) caused by E.       in preruminating calves.
                               coli susceptible to           Do not use in calves to be
                               neomycin.                     processed for veal. A milk
                                                             discard time has not been
                                                             established for use in
                                                             lactating dairy cattle. Do
                                                             not use in female dairy
                                                             cattle 20 months of age or
                                                             older. Withdraw 5 d before
                                                             slaughter.
                              2. Calves (up to 250 lb):     Feed continuously for 7 to                    048164
                               For treatment of bacterial    14 d; in milk replacers or                   066104
                               enteritis caused by E. coli   starter feed. If symptoms
                               susceptible to                persist after using for 2
                               oxytetracycline; treatment    or 3 days, consult a
                               and control of                veterinarian. Treatment
                               colibacillosis (bacterial     should continue 24 to 48
                               enteritis) caused by E.       hours beyond remission of
                               coli susceptible to           disease symptoms. A
                               neomycin.                     withdrawal period has not
                                                             been established for use
                                                             in preruminating calves.
                                                             Do not use in calves to be
                                                             processed for veal. A milk
                                                             discard time has not been
                                                             established for use in
                                                             lactating dairy cattle. Do
                                                             not use in female dairy
                                                             cattle 20 months of age or
                                                             older. Withdraw 5 d before
                                                             slaughter.

[[Page 40726]]

 
                              3. Sheep: For treatment of    Feed continuously for 7 to                    048164
                               bacterial enteritis caused    14 d. If symptoms persist                    066104
                               by E. coli and bacterial      after using for 2 or 3
                               pneumonia caused by P.        days, consult a
                               multocida susceptible to      veterinarian. Treatment
                               oxytetracycline; treatment    should continue 24 to 48
                               and control of                hours beyond remission of
                               colibacillosis (bacterial     disease symptoms. Withdraw
                               enteritis) caused by E.       5 d before slaughter.
                               coli susceptible to
                               neomycin.
----------------------------------------------------------------------------------------------------------------
(iv) To provide 25 mg/head/   Calves (250 to 400 lb): For   Feed continuously.                            048164
 day                           increased rate of weight                                                   066104
                               gain and improved feed
                               efficiency.
----------------------------------------------------------------------------------------------------------------
(v) To provide 75 mg/head/    Growing cattle (over 400      Feed continuously.                            048164
 day                           lb): For increased rate of                                                 066104
                               weight gain; improved feed
                               efficiency, and reduction
                               of liver condemnation due
                               to liver abscesses.
----------------------------------------------------------------------------------------------------------------
(vi) To provide 0.5 to 2.0 g/ Cattle: For prevention and    Feed 3 to 5 d before and                      048164
 head/ day                     treatment of the early        after arrival in feedlots.                   066104
                               stages of shipping fever      A withdrawal period has
                               complex.                      not been established for
                                                             use in preruminating
                                                             calves. Do not use in
                                                             calves to be processed for
                                                             veal. A milk discard time
                                                             has not been established
                                                             for use in lactating dairy
                                                             cattle. Do not use in
                                                             female dairy cattle 20
                                                             months of age or older.
----------------------------------------------------------------------------------------------------------------


    Dated: August 7, 2009.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E9-19414 Filed 8-12-09; 8:45 am]
BILLING CODE 4160-01-S


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