New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications, 39187 [2019-16885]
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39187
Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Rules and Regulations
Thiabendazole amount
(i) 2 grams per 100 lb.
body weight.
(ii) 3 grams per 100 lb.
body weight.
(iii) 454 grams per ton of
feed.
Indications for use
Limitations
Sheep and goats: For control of infections of
gastrointestinal roundworms (Trichostrongylus
spp., Haemonchus spp., Ostertagia spp.,
Cooperia
spp.;
Nematodirus
spp.,
Bunostomum
spp.,
Strongyloides
spp.,
Chabertia spp., and Oesophagostomum spp.);
also active against ova and larvae passed by
sheep from 3 hours to 3 days after the feed is
consumed (good activity against ova and larvae of T. colubriformis and axei, Ostertagia
spp., Nematodirus spp., Strongyloides spp.;
less effective against those of Haemonchus
contortus and Oesophagostomum spp.).
Goats: For control of severe infections of gastrointestinal roundworms (Trichostrongylus spp.,
Haemonchus spp., Ostertagia spp., Cooperia
spp., Nematodirus spp., Bunostomum spp.,
Strongyloides spp., Chabertia spp., and
Oesophagostomum spp.).
Pheasants: For the treatment of gapeworms
(Syngamus trachea).
Use 2 grams per 100 lb. body weight at a single
dose. Do not treat animals within 30 days of
slaughter. Milk taken from treated animals
within 96 hours (8 milkings) after the latest
treatment must not be used for food.
050604
Use 3 grams per 100 lb. body weight at a single
dose. Do not treat animals within 30 days of
slaughter. Milk taken from treated animals
within 96 hours (8 milkings) after the latest
treatment must not be used for food.
050604
Feed continuously for 2 weeks (14 days). Do
not use treated pheasants for food for 21
days after last day of treatment. Fertility,
hatchability, and other reproductive data are
not available on use in breeding animals.
050604
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16884 Filed 8–8–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 524 and 558
[Docket No. FDA–2019–N–0002]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of two new animal drug
applications (NADAs) at the sponsors’
request because these products are no
longer manufactured or marketed.
DATES: Withdrawal of approval is
effective August 19, 2019.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Boehringer Ingelheim Animal Health
USA Inc., 3239 Satellite Blvd., Duluth,
GA 30096, has requested that FDA
withdraw approval of NADA 141–054
khammond on DSKBBV9HB2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:42 Aug 08, 2019
Jkt 247001
for use of LINCOMIX (lincomycin
hydrochloride) and IVOMEC
(ivermectin) Type A medicated articles
in the manufacture of 2-way,
combination drug Type C medicated
swine feeds because the product is no
longer manufactured or marketed.
Also, Elanco US Inc., 2500 Innovation
Way, Greenfield, IN 46140, has
requested that FDA withdraw approval
of NADA 141–337 for use of
RECOVYRA (fentanyl) Transdermal
Solution for Dogs because the product is
no longer manufactured or marketed.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and in accordance with § 514.116 Notice
of withdrawal of approval of application
(21 CFR 514.116), notice is given that
approval of NADAs 141–054 and NADA
141–337, and all supplements and
amendments thereto, is hereby
withdrawn, effective August 19, 2019.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16885 Filed 8–8–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
Sponsor
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2019–0673]
Special Local Regulations; Annual Les
Cheneaux Islands Antique Wooden
Boat Show; Hessel, MI.
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
a special local regulation for the Annual
Les Cheneaux Islands Antique Wooden
Boat Show on August 10, 2019, from 7
a.m. to 6:30 p.m. to provide for the
safety of life on navigable waterways
during this event. During the
enforcement period, all vessels will
operate at a no wake speed and follow
the directions of the on-scene Patrol
Commander.
SUMMARY:
The regulations in 33 CFR
100.922 will be enforced on August 10,
2019, from 7 a.m. to 6:30 p.m.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice of
enforcement, call or email LT Sean
Murphy, Coast Guard Sector Sault
Sainte Marie Waterways Management,
U.S. Coast Guard; telephone 906–635–
3223, email Sean.V.Murphy@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the special local
regulation in 33 CFR 100.922 for the
Annual Les Cheneaux Islands Antique
Wooden Boat Show on August 10, 2019
DATES:
E:\FR\FM\09AUR1.SGM
09AUR1
]]>Agencies
[Federal Register Volume 84, Number 154 (Friday, August 9, 2019)]
[Rules and Regulations]
[Page 39187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16885]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 524 and 558
[Docket No. FDA-2019-N-0002]
New Animal Drugs; Withdrawal of Approval of New Animal Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of two new animal drug applications (NADAs) at the sponsors' request
because these products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective August 19, 2019.
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-5761, [email protected].
SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Animal Health USA Inc.,
3239 Satellite Blvd., Duluth, GA 30096, has requested that FDA withdraw
approval of NADA 141-054 for use of LINCOMIX (lincomycin hydrochloride)
and IVOMEC (ivermectin) Type A medicated articles in the manufacture of
2-way, combination drug Type C medicated swine feeds because the
product is no longer manufactured or marketed.
Also, Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140,
has requested that FDA withdraw approval of NADA 141-337 for use of
RECOVYRA (fentanyl) Transdermal Solution for Dogs because the product
is no longer manufactured or marketed.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and in accordance with Sec. 514.116 Notice of withdrawal of
approval of application (21 CFR 514.116), notice is given that approval
of NADAs 141-054 and NADA 141-337, and all supplements and amendments
thereto, is hereby withdrawn, effective August 19, 2019.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16885 Filed 8-8-19; 8:45 am]
BILLING CODE 4164-01-P
