Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications, 74822-74823 [05-24103]
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74822
Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Notices
Dated: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–24102 Filed 12–15–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0150]
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of 15 new animal drug
applications (NADAs) because the
products are no longer manufactured or
marketed. In a final rule published
elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to remove portions
reflecting approval of the NADAs.
Pl., Rockville, MD 20855, 240–276–
9067, e-mail: pesposit@cvm.fda.gov.
The
following sponsors have requested that
FDA withdraw approval of the 15
NADAs listed in table 1 of this
document because the products are no
longer manufactured or marketed:
SUPPLEMENTARY INFORMATION:
Withdrawal of approval is
effective December 27, 2005.
DATES:
Animal Drugs, Feeds, and Related
Products; Withdrawal of Approval of
New Animal Drug Applications
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration,
HHS.
Pamela K. Esposito, Center for
Veterinary Medicine (HFV–210), Food
and Drug Administration, 7519 Standish
TABLE 1.
Sponsor
NADA Number, Product (Drug)
21 CFR Section Affected (Sponsor Drug Labeler Code)
Bioproducts, Inc., 320 Springside Dr., Suite
300, Fairlawn, OH 44333–2435
NADA 119–063, Pyrantel Tartrate Ton Pack
(pyrantel tartrate)
558.485 (051359)
Farmland Industries, Inc., Kansas City, MO
64116
NADA 138–656, BN Wormer—19.2
BANMINTH Premix (pyrantel tartrate)
558.485 (021676)
I.M.S. Inc., 13619 Industrial Rd., Omaha, NE
68137
NADA 129–395, HYGROMIX 0.6 Premix
(hygromycin B)
NADA 129–646, TYLAN 10 Sulfa-G (tylosin,
sulfamethazine)
NADA 136–601, Swine Guard-BN (pyrantel
tartrate)
558.274 (050639)
J. & R. Specialty Supply Co., 310 Second
Ave., SW,, P.O. Box 506, Waseca, MN
56093
NADA 96–780, TYLAN 10; TYLAN 40
(tylosin)
n/a (049768)
Kerber Milling Co., Box 152, 1817 E. Main
St., Emmetsburg, IA 50536
NADA 98–687, Hy-Test Hy-Boost TY 5 Medicated (tylosin)
558.625 (029341)
M & M Livestock Products Co., Eagle Grove,
IA 50533
NADA 96–837, M & M Tylosin Premix
(tylosin)
558.625 (026282)
Nutra-Blend Corp., P.O. Box 485, Neosho,
MO 64850
NADA 129–161, Nutra-Blend TYLAN 10 Sulfa
Premix (tylosin, sulfamethazine)
NADA 136–384, Swine Wormer-BN
BANMINTH (pyrantel tartrate)
558.630 (050568)
South St. Paul Feeds, Inc., 500 Farwell Ave.,
South St. Paul, MN 55075
NADA 136–369, Custom Ban Wormer 9.6
(pyrantel tartrate)
558.485 (001800)
Stockton Hay & Grain Co.
NADA 49–462, Rainbrook Broiler Premix No.
1 (ampolium, arsanilic acid, ethopabate,
penicillin G procaine, streptomycin)
NADA 91–646, Rainbow Broiler Base Concentrate (ampolium, bacitracin zinc,
ethopabate)
NADA 91–647, Broiler Base Concentrate
(ampolium, chlortetracyline, ethopabate)
n/a (036541)
NADA 131–146, FLAVOMYCIN 0.4
(bambermycins)
558.95 (011490)
and in accordance with § 514.115
Withdrawal of approval of applications
(21 CFR 514.115), notice is given that
approval of NADAs 49–462, 91–646,
91–647, 96–780, 96–837, 98–687, 119–
063, 129–161, 129–395, 129–646, 131–
146, 136–369, 136–384, 136–601, 138–
656, and all supplements and
Triple ‘‘F’’, Inc., 10104 Douglas Ave., Des
Moines, IA 50322
Therefore, under authority delegated
to the Commissioner of Food and Drugs
(21 CFR 5.10), redelegated to the Center
for Veterinary Medicine (21 CFR 5.84),
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558.630 (050639)
558.485 (050639)
558.485 (050568)
n/a (036541)
n/a (036541)
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Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Notices
amendments thereto, is hereby
withdrawn, effective December 27,
2005.
In a final rule published elsewhere in
this issue of the Federal Register, FDA
is amending the animal drug regulations
to reflect the withdrawal of approval of
these NADAs.
Dated: December 7, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–24103 Filed 12–15–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Nonprescription
Drugs Advisory Committee and the
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees:
Nonprescription Drugs Advisory
Committee (NDAC) and the
Endocrinologic and Metabolic Drugs
Advisory Committee (EMDAC).
General Function of the Committees:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on January 23, 2006, from 8 a.m.
to 5 p.m.
Location: Holiday Inn Select
Bethesda, Versailles Ballrooms, 8120
Wisconsin Ave., Bethesda, MD. The
hotel telephone number is 301–652–
2000.
Contact Person: Darrell Lyons, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail: lyonsd@cder.fda.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area) codes 3014512541 or 3014512536.
Please call the Information Line for upto-date information on this meeting.
Agenda: The committees will
consider the safety and efficacy of new
drug application (NDA) 21–887,
proposing over-the-counter (OTC) use of
VerDate Aug<31>2005
19:37 Dec 15, 2005
Jkt 208001
ORLISTAT (tetrahydrolipstatin)
capsules (60 milligrams (mg)),
GlaxoSmithKline Consumer Healthcare,
L.P., to promote weight loss in
overweight adults when used along with
a reduced calorie and low fat diet. The
background material will become
available no later than the day before
the meeting and will be posted under
NDAC or EMDAC’s docket site at https://
www.fda.gov/ohrms/dockets/ac/
acmenu.htm (click on the year 2006 and
scroll down to NDAC or EMDAC).
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. Written
submissions may be made to the contact
person by January 13, 2006. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before January 13, 2006, and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Darrell Lyons
at least 7 days in advance of the
meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: December 2, 2005.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. 05–24101 Filed 12–15–05; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA 225–05–8000]
Memorandum of Understanding
Between the United States Food and
Drug Administration and the C–Path
Institute
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between the
United States Food and Drug
Administration and the C–Path
Institute. The specific purpose of this
MOU is to establish an overarching
framework for collaboration between the
parties. This framework will be based
on mutually agreed upon programs and
activities in the areas of applied
scientific research and training/
education to foster the development of
new evaluation tools to inform medical
product development. The parties shall
each leverage its own expertise and
resources to facilitate programs of
shared interests across the diverse
disciplines of therapeutics, biological
sciences, engineering and medical
devices in building applied research
and training/education programs. The
appropriate formal agreements will be
executed as required by law for any
activities that result from this
collaboration.
DATES: The agreement became effective
October 14, 2005.
FOR FURTHER INFORMATION CONTACT: For
C–Path Institute: Raymond L. Woosley,
The Critical Path Institute, 4280 N.
Campbell Ave., #214, Tucson, AZ
85718, 520–547–3440, FAX: 520–547–
3456, e-mail: rwoosley@c-path.org.
For The Food and Drug
Administration: Mary I. Poos, Office
of External Relations, Food and
Drug Administration (HF–10), 5600
Fishers Lane, Rockville, MD 20857,
301–827–2825, FAX: 301–827–
3042, e-mail: mary.poos@fda.gov.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
Dated: December 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 70, Number 241 (Friday, December 16, 2005)]
[Notices]
[Pages 74822-74823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24103]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0150]
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval
of New Animal Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 15 new animal drug applications (NADAs) because the products are no
longer manufactured or marketed. In a final rule published elsewhere in
this issue of the Federal Register, FDA is amending the animal drug
regulations to remove portions reflecting approval of the NADAs.
DATES: Withdrawal of approval is effective December 27, 2005.
FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for
Veterinary Medicine (HFV-210), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9067, e-mail:
pesposit@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: The following sponsors have requested that
FDA withdraw approval of the 15 NADAs listed in table 1 of this
document because the products are no longer manufactured or marketed:
Table 1.
----------------------------------------------------------------------------------------------------------------
21 CFR Section Affected (Sponsor
Sponsor NADA Number, Product (Drug) Drug Labeler Code)
----------------------------------------------------------------------------------------------------------------
Bioproducts, Inc., 320 Springside NADA 119-063, Pyrantel Tartrate Ton 558.485 (051359)
Dr., Suite 300, Fairlawn, OH 44333- Pack (pyrantel tartrate)
2435
----------------------------------------------------------------------------------------------------------------
Farmland Industries, Inc., Kansas NADA 138-656, BN Wormer--19.2 558.485 (021676)
City, MO 64116 BANMINTH Premix (pyrantel tartrate)
----------------------------------------------------------------------------------------------------------------
I.M.S. Inc., 13619 Industrial Rd., NADA 129-395, HYGROMIX 0.6 Premix 558.274 (050639)
Omaha, NE 68137 (hygromycin B)
NADA 129-646, TYLAN 10 Sulfa-G 558.630 (050639)
(tylosin, sulfamethazine)
NADA 136-601, Swine Guard-BN 558.485 (050639)
(pyrantel tartrate)
----------------------------------------------------------------------------------------------------------------
J. & R. Specialty Supply Co., 310 NADA 96-780, TYLAN 10; TYLAN 40 n/a (049768)
Second Ave., SW,, P.O. Box 506, (tylosin)
Waseca, MN 56093
----------------------------------------------------------------------------------------------------------------
Kerber Milling Co., Box 152, 1817 NADA 98-687, Hy-Test Hy-Boost TY 5 558.625 (029341)
E. Main St., Emmetsburg, IA 50536 Medicated (tylosin)
----------------------------------------------------------------------------------------------------------------
M & M Livestock Products Co., Eagle NADA 96-837, M & M Tylosin Premix 558.625 (026282)
Grove, IA 50533 (tylosin)
----------------------------------------------------------------------------------------------------------------
Nutra-Blend Corp., P.O. Box 485, NADA 129-161, Nutra-Blend TYLAN 10 558.630 (050568)
Neosho, MO 64850 Sulfa Premix (tylosin,
sulfamethazine)
NADA 136-384, Swine Wormer-BN 558.485 (050568)
BANMINTH (pyrantel tartrate)
----------------------------------------------------------------------------------------------------------------
South St. Paul Feeds, Inc., 500 NADA 136-369, Custom Ban Wormer 9.6 558.485 (001800)
Farwell Ave., South St. Paul, MN (pyrantel tartrate)
55075
----------------------------------------------------------------------------------------------------------------
Stockton Hay & Grain Co. NADA 49-462, Rainbrook Broiler Premix n/a (036541)
No. 1 (ampolium, arsanilic acid,
ethopabate, penicillin G procaine,
streptomycin)
NADA 91-646, Rainbow Broiler Base n/a (036541)
Concentrate (ampolium, bacitracin
zinc, ethopabate)
NADA 91-647, Broiler Base Concentrate n/a (036541)
(ampolium, chlortetracyline,
ethopabate)
----------------------------------------------------------------------------------------------------------------
Triple ``F'', Inc., 10104 Douglas NADA 131-146, FLAVOMYCIN 0.4 558.95 (011490)
Ave., Des Moines, IA 50322 (bambermycins)
----------------------------------------------------------------------------------------------------------------
Therefore, under authority delegated to the Commissioner of Food
and Drugs (21 CFR 5.10), redelegated to the Center for Veterinary
Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal
of approval of applications (21 CFR 514.115), notice is given that
approval of NADAs 49-462, 91-646, 91-647, 96-780, 96-837, 98-687, 119-
063, 129-161, 129-395, 129-646, 131-146, 136-369, 136-384, 136-601,
138-656, and all supplements and
[[Page 74823]]
amendments thereto, is hereby withdrawn, effective December 27, 2005.
In a final rule published elsewhere in this issue of the Federal
Register, FDA is amending the animal drug regulations to reflect the
withdrawal of approval of these NADAs.
Dated: December 7, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-24103 Filed 12-15-05; 8:45 am]
BILLING CODE 4160-01-S
