New Animal Drugs for Use in Animal Feeds; Fenbendazole, 58873-58874 [E8-23845]
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Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations
§ 522.2630
Tulathromycin.
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(d) * * *
(1) * * *
(ii) Indications for use. For the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida,
Histophilus somni, and Mycoplasma
bovis. For the control of respiratory
disease in cattle at high risk of
developing BRD associated with M.
haemolytica, P. multocida, H. somni,
and M. bovis. For the treatment of
infectious bovine keratoconjunctivitis
(IBK) associated with Moraxella bovis.
For the treatment of bovine foot rot
(interdigital necrobacillosis) associated
with Fusobacterium necrophorum and
Porphyromonas levii.
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Dated: September 29, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–23832 Filed 10–7–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2008–N–0039]
New Animal Drugs for Use in Animal
Feeds; Fenbendazole
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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
Intervet Inc. The supplemental NADA
provides for use of a fenbendazole free
choice, liquid Type C medicated feed in
dairy and beef cattle for the removal and
control of various internal parasites.
DATES: This rule is effective October 8,
2008.
FOR FURTHER INFORMATION CONTACT:
Donald A. Prater, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8343, email: donald.prater@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed a supplement
to NADA 131–675 for SAFE-GUARD
(fenbendazole) 20% Type A medicated
article. The supplemental NADA
provides for manufacture of a
fenbendazole free choice, liquid Type C
medicated feed for use in dairy and beef
cattle for the removal and control of
various internal parasites. The
supplemental NADA is approved as of
September 5, 2008, and the regulations
are amended in 21 CFR 558.258 to
reflect the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 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 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)(iii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
supplemental approval qualifies for 3
years of marketing exclusivity beginning
on the date of approval. The 3 years of
exclusivity apply only to the use of
fenbendazole liquid Type C medicated
feed for the removal and control of
lungworms (Dictyocaulus viviparus),
one of the parasite species for which the
supplement is approved.
FDA has determined under 21 CFR
25.33(a) 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.
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.
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
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
2. In § 558.258, in the table in
paragraph (e)(1), in the ‘‘Indications for
use’’ column, remove ‘‘round worms’’
and in its place add ‘‘roundworms’’; and
revise paragraph (e)(3) to read as
follows:
■
§ 558.258
*
Indications for use
Dairy and beef cattle: For the removal and control of: Lungworms
(Dictyocaulus viviparus); Stomach
worms: barberpole worms
(Haemonchus contortus), brown
stomach worms (Ostertagia
ostertagi), small stomach worms
(Trichostrongylus axei); Intestinal
worms: hookworms (Bunostomum
phlebotomum), thread-necked intestinal worms (Nematodirus
helvetianus), small intestinal
worms (Cooperia oncophora and
C. punctata); Bankrupt worms
(Trichostrongylus colubriformis);
and Nodular worms
(Oesophagostomum radiatum).
Feed as the sole ration or as a
top dress for one day. Retreatment may be needed after 4 to 6
weeks. Cattle must not be slaughtered within 13 days following last
treatment. For dairy cattle the milk
discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in
calves to be processed for veal.
*
Limitations
(i) 5 mg/kg body weight (2.27 mg/
lb)
dwashington3 on PRODPC61 with RULES
Fenbendazole.
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(e) * * *
(3) Cattle.
Amount fenbendazole
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Sponsor
057926
(ii) [Reserved]
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58873
08OCR1
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Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations
(iii) Free-choice feeds—(A) Amount. 5
mg/kg body weight (2.27 mg/lb),
including the following formulations:
Ingredient1
Percent
(1) Free-choice, dry Type C feed:
Salt (sodium chloride)
Monosodium phosphate
Dried cane molasses
Zinc sulfate
Copper sulfate
Fenbendazole 20% Type A article
(2) Free-choice, dry Type C feed:
Salt (sodium chloride)
Dicalcium phosphate (18.5% P)
Calcium carbonate (38% Ca)
Magnesium oxide (56% Mg)
Zinc sulfate
Mineral oil
Dried cane molasses (46% sugars)
Potassium iodide
Fenbendazole 20% Type A article
(3) Free-choice, liquid Type C feed:
Cane molasses2
Water
Urea solution, 55%
Phosphoric acid 75% (feed grade)
Xantham gum
Trace minerals
Vitamin premix
Fenbendazole 20% Type A article
International Feed No.
59.00
31.16
3.12
0.76
0.45
5.51
6–04–152
6–04–288
4–04–695
6–05–556
6–01–720
n/a
35.93
32.44
15.93
10.14
1.47
1.00
0.98
0.01
2.10
6–04–152
6–00–080
6–01–069
6–02–756
6–05–556
8–03–123
4–04–695
6–03–759
n/a
80.902
9.36
7.05
2.00
0.20
0.20
0.01
0.278
4–13–251
n/a
5–05–707
6–03–707
8–15–818
n/a
n/a
n/a
1The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer
for other free-choice cattle feeds. Formulation modifications require FDA approval prior to marketing. Selenium is not approved for the freechoice formulations described in paragraph (e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published
regulations (see 21 CFR 573.920).
2The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the brix value of the molasses to
the industry standard of 79.5 brix.
(B) Indications for use. As in
paragraph (e)(3)(i) of this section.
(C) Limitations. Feed a total of 5 mg
of fenbendazole per kg (2.27 mg/lb) of
body weight to cattle over a 3- to 6-day
period. Retreatment may be needed after
4 to 6 weeks. Cattle must not be
slaughtered within 13 days following
last treatment. For dairy cattle the milk
discard time is zero hours. A
withdrawal period has not been
established for this product in preruminating calves. Do not use in calves
to be processed for veal.
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*
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*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 29, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–23845 Filed 10–7–08; 8:45 am]
SUMMARY: The Food and Drug
Administration (FDA) is confirming the
effective date of October 15, 2008, for
the final rule that appeared in the
Federal Register of June 2, 2008 (73 FR
31358). The direct final rule amends the
hearing aid labeling to reference the
most recent version of the consensus
standard used to determine the
technical data to be included in labeling
for hearing aids. This document
confirms the effective date of the direct
final rule.
DATES: Effective date confirmed:
October 15, 2008.
dwashington3 on PRODPC61 with RULES
BILLING CODE 4160–01–S
VerDate Aug<31>2005
14:27 Oct 07, 2008
Jkt 217001
Food and Drug Administration
21 CFR Part 801
[Docket No. FDA–2008–N–0148]
Medical Devices; Hearing Aids;
Technical Data Amendments;
Confirmation of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
Direct final rule; confirmation
of effective date.
ACTION:
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
Eric
A. Mann, Center for Devices and
Radiological Health (HFZ–460), Food
and Drug Administration,9200
Corporate Blvd., Rockville, MD 20850,
240–276–4242.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 2, 2008 (73 FR
31358), FDA solicited comments
concerning the direct final rule for a 75day period ending August 18, 2008.
FDA stated that the effective date of the
direct final rule would be on October
15, 2008, 60 days after the end of the
comment period, unless any significant
adverse comment was submitted to FDA
during the comment period. FDA
received one letter of comment on the
direct final rule. However, this comment
does not constitute a significant adverse
comment. Therefore, FDA is confirming
the effective date of the direct final rule.
The comment received and FDA’s
response to the comment are discussed
as follows:
The only comment on the direct final
rule requested clarification regarding
the applicability of the proposed change
in the standard of the American
National Standards Institute to hearing
aid models that were tested and
characterized prior to the effective date
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\08OCR1.SGM
08OCR1
]]>Agencies
[Federal Register Volume 73, Number 196 (Wednesday, October 8, 2008)]
[Rules and Regulations]
[Pages 58873-58874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23845]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2008-N-0039]
New Animal Drugs for Use in Animal Feeds; Fenbendazole
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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 Intervet Inc. The supplemental NADA
provides for use of a fenbendazole free choice, liquid Type C medicated
feed in dairy and beef cattle for the removal and control of various
internal parasites.
DATES: This rule is effective October 8, 2008.
FOR FURTHER INFORMATION CONTACT: Donald A. Prater, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail:
donald.prater@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed a supplement to NADA 131-675 for SAFE-
GUARD (fenbendazole) 20% Type A medicated article. The supplemental
NADA provides for manufacture of a fenbendazole free choice, liquid
Type C medicated feed for use in dairy and beef cattle for the removal
and control of various internal parasites. The supplemental NADA is
approved as of September 5, 2008, and the regulations are amended in 21
CFR 558.258 to reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 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)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval. The 3 years of exclusivity apply only to the use of
fenbendazole liquid Type C medicated feed for the removal and control
of lungworms (Dictyocaulus viviparus), one of the parasite species for
which the supplement is approved.
FDA has determined under 21 CFR 25.33(a) 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.
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. In Sec. 558.258, in the table in paragraph (e)(1), in the
``Indications for use'' column, remove ``round worms'' and in its place
add ``roundworms''; and revise paragraph (e)(3) to read as follows:
Sec. 558.258 Fenbendazole.
* * * * *
(e) * * *
(3) Cattle.
------------------------------------------------------------------------
Amount Indications for
fenbendazole use Limitations Sponsor
------------------------------------------------------------------------
(i) 5 mg/kg body Dairy and beef Feed as the sole 057926
weight (2.27 mg/ cattle: For the ration or as a
lb) removal and top dress for
control of: one day.
Lungworms Retreatment may
(Dictyocaulus be needed after
viviparus); 4 to 6 weeks.
Stomach worms: Cattle must not
barberpole worms be slaughtered
(Haemonchus within 13 days
contortus), following last
brown stomach treatment. For
worms dairy cattle
(Ostertagia the milk
ostertagi), discard time is
small stomach zero hours. A
worms withdrawal
(Trichostrongylu period has not
s axei); been
Intestinal established for
worms: hookworms this product in
(Bunostomum pre-ruminating
phlebotomum), calves. Do not
thread-necked use in calves
intestinal worms to be processed
(Nematodirus for veal.
helvetianus),
small intestinal
worms (Cooperia
oncophora and C.
punctata);
Bankrupt worms
(Trichostrongylu
s
colubriformis);
and Nodular
worms
(Oesophagostomum
radiatum).
(ii) [Reserved] ................. ................ ................
------------------------------------------------------------------------
[[Page 58874]]
(iii) Free-choice feeds--(A) Amount. 5 mg/kg body weight (2.27 mg/
lb), including the following formulations:
----------------------------------------------------------------------------------------------------------------
Ingredient\1\ Percent International Feed No.
----------------------------------------------------------------------------------------------------------------
(1) Free-choice, dry Type C feed: .................................. ..................................
Salt (sodium chloride) 59.00 6-04-152
Monosodium phosphate 31.16 6-04-288
Dried cane molasses 3.12 4-04-695
Zinc sulfate 0.76 6-05-556
Copper sulfate 0.45 6-01-720
Fenbendazole 20% Type A article 5.51 n/a
(2) Free-choice, dry Type C feed: .................................. ..................................
Salt (sodium chloride) 35.93 6-04-152
Dicalcium phosphate (18.5% P) 32.44 6-00-080
Calcium carbonate (38% Ca) 15.93 6-01-069
Magnesium oxide (56% Mg) 10.14 6-02-756
Zinc sulfate 1.47 6-05-556
Mineral oil 1.00 8-03-123
Dried cane molasses (46% sugars) 0.98 4-04-695
Potassium iodide 0.01 6-03-759
Fenbendazole 20% Type A article 2.10 n/a
(3) Free-choice, liquid Type C feed: .................................. ..................................
Cane molasses\2\ 80.902 4-13-251
Water 9.36 n/a
Urea solution, 55% 7.05 5-05-707
Phosphoric acid 75% (feed grade) 2.00 6-03-707
Xantham gum 0.20 8-15-818
Trace minerals 0.20 n/a
Vitamin premix 0.01 n/a
Fenbendazole 20% Type A article 0.278 n/a
----------------------------------------------------------------------------------------------------------------
\1\The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those
used by the manufacturer for other free-choice cattle feeds. Formulation modifications require FDA approval
prior to marketing. Selenium is not approved for the free-choice formulations described in paragraph
(e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published
regulations (see 21 CFR 573.920).
\2\The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the
brix value of the molasses to the industry standard of 79.5 brix.
(B) Indications for use. As in paragraph (e)(3)(i) of this section.
(C) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27
mg/lb) of body weight to cattle over a 3- to 6-day period. Retreatment
may be needed after 4 to 6 weeks. Cattle must not be slaughtered within
13 days following last treatment. For dairy cattle the milk discard
time is zero hours. A withdrawal period has not been established for
this product in pre-ruminating calves. Do not use in calves to be
processed for veal.
* * * * *
Dated: September 29, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-23845 Filed 10-7-08; 8:45 am]
BILLING CODE 4160-01-S
