[Federal Register: November 14, 2006 (Volume 71, Number 219)]
[Rules and Regulations]
[Page 66231-66232]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no06-2]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Monensin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to simplify the organization of special labeling
requirements for formulations (Type A medicated articles, Type B and
Type C medicated feeds) containing monensin sodium. This action is
being taken to improve the clarity of the regulations.
DATES: This rule is effective November 14, 2006.
FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-453-6856, e-mail:
dragan.momcilovic@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On October 28, 2004, FDA approved a
supplemental new animal drug application (sNADA 95-735) filed by Elanco
Animal Health for RUMENSIN (monensin sodium) Type A medicated article
adding use in a new class of cattle (dairy cows) for increased milk
production efficiency (69 FR 68783, November 26, 2004). On December 15,
2005, FDA approved another supplement to NADA 95-735 for use in dairy
cow component feeding systems (71 FR 1689, January 11, 2006). The
approval of each of these new conditions of use resulted in the
amendment of the animal drug regulations for monensin in Sec. 558.355
(21 CFR 558.355).
Since these approvals for use of monensin in dairy cow feeds as
well as beef cattle feeds, FDA has become aware of confusion regarding
which statements on the approved Type A medicated article labeling also
appear on the approved representative labeling (Blue Bird labeling) for
Type B and Type C medicated feeds for each class of cattle. At this
time, the regulations are being amended in Sec. 558.355 to simplify
the organization of special labeling requirements for formulations
(Type A medicated articles, Type B and Type C medicated feeds)
containing monensin sodium. This action is being taken to improve the
clarity of the regulations.
Publication of this document constitutes final action on this
change under the Administrative Procedures Act (5 U.S.C. 553). Notice
and public procedure are unnecessary because FDA is merely correcting
nonsubstantive errors.
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. 558.355 as follows:
a. Revise paragraphs (d)(6) through (d)(11);
b. Remove paragraph (d)(13); and
c. Revise the second sentence of paragraph (f)(3)(xiii)(B), the
third sentence of paragraph (f)(3)(xiv)(B), and the sixth sentence of
paragraph (f)(6)(i)(b)(1).
The revisions read as follows:
Sec. 558.355 Monensin.
* * * * *
(d) * * *
(6) All formulations containing monensin shall bear the following
caution statement: Do not allow horses or other equines access to feed
containing monensin. Ingestion of monensin by horses has been fatal.
(7) Type A medicated articles containing monensin intended for use
in cattle and goats shall bear, in addition to the caution statement in
paragraph (d)(6) of this section, the following statements:
(i) Monensin medicated cattle and goat feeds are safe for use in
cattle and goats only. Consumption by unapproved species may result in
toxic reactions.
(ii) Feeding undiluted or mixing errors resulting in high
concentrations of monensin has been fatal to cattle and could be fatal
to goats.
(iii) Must be thoroughly mixed in feeds before use.
(iv) Do not feed undiluted.
(v) Do not exceed the levels of monensin recommended in the feeding
directions, as reduced average daily gains may result.
(vi) Do not feed to lactating goats.
(vii) If feed refusals containing monensin are fed to other groups
of cattle, the concentration of monensin in the refusals and amount of
refusals fed should be taken into consideration to prevent monensin
overdosing.
(viii) A withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in calves to be processed
for veal.
(ix) You may notice the following: Reduced voluntary feed intake in
dairy cows fed monensin. This reduction increases with higher doses of
monensin fed. Rule out monensin as the cause of reduced feed intake
before attributing to other causes such as illness, feed management, or
the environment. Reduced milk fat percentage in dairy cows fed
monensin. This reduction increases with higher doses of monensin fed.
Increased incidence of cystic ovaries and metritis in dairy cows fed
monensin. Reduced conception rates, increased services per animal, and
extended days open and corresponding calving intervals in dairy cows
fed monensin. Have a comprehensive and ongoing nutritional,
reproductive, and herd health program in place when feeding monensin to
dairy cows.
(x) Inadequate mixing (recirculation or agitation) of monensin
liquid Type B or Type C medicated feeds has resulted in increased
monensin concentration which has been fatal to cattle and could be
fatal to goats.
(8) Type A medicated articles containing monensin intended for use
in chickens shall bear the caution statements specified in paragraphs
(d)(6), (d)(7)(iii), and (d)(7)(iv) of this section.
[[Page 66232]]
(9) Type B feeds containing monensin shall bear the statements
specified in the following paragraphs of this section when intended for
use in:
(i) Cattle (as described in paragraphs (f)(3)(i) through
(f)(3)(xii) of this section): See paragraphs (d)(6), (d)(7)(i) through
(d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of this section.
(ii) Dairy cows (as described in paragraphs (f)(3)(xiii) and
(f)(3)(xiv) of this section): See paragraphs (d)(6), (d)(7)(i) through
(d)(7)(iv), (d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of this section.
(iii) Goats: See paragraphs (d)(6) and (d)(7)(i) through (d)(7)(vi)
of this section.
(10) Type C feeds containing monensin shall bear the statements
specified in the following paragraphs of this section when intended for
use in:
(i) Cattle (as described in paragraphs (f)(3)(i) through
(f)(3)(xii) of this section): See paragraphs (d)(6), (d)(7)(i),
(d)(7)(v), (d)(7)(vii), and (d)(7)(viii) of this section.
(ii) Dairy cows (as described in paragraphs (f)(3)(xiii) and
(f)(3)(xiv) of this section): See paragraphs (d)(6), (d)(7)(i),
(d)(7)(vii), (d)(7)(viii), and (d)(7)(ix) of this section.
(iii) Goats: See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), and
(d)(7)(vi) of this section.
(11) Type B and Type C liquid feeds requiring recirculation or
agitation that contain monensin and are intended for use in cattle
(including dairy cows) and goats shall bear the caution statement
specified in paragraph (d)(7)(x) of this section.
* * * * *
(f) * * *
(3) * * *
(xiii) * * *
(B) * * * See special labeling considerations in paragraph (d) of
this section.
(xiv) * * *
(B) * * * See special labeling considerations in paragraph (d) of
this section.
* * * * *
(6) * * *
(i) * * *
(b) * * *
(1) * * * See special labeling considerations in paragraph (d) of
this section.
* * * * *
Dated: October 31, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-19203 Filed 11-13-06; 8:45 am]
BILLING CODE 4160-01-S