Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and Sulfamethazine, 17927-17928 [2011-7558]
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17927
Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Notices
ACTION:
[FR Doc. 2011–7373 Filed 3–30–11; 8:45 am]
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 13 new animal drug
applications (NADAs). In a final rule
published elsewhere in this issue of the
Federal Register, FDA is amending the
regulations to remove portions reflecting
approval of these NADAs.
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0151]
Withdrawal of Approval of New Animal
Drug Applications; Chorionic
Gonadotropin; Cuprimyxin;
Diethylcarbamazine; Levamisole;
Nitrofurazone; Phenylbutazone;
Pyrantel; Tylosin; Tylosin and
Sulfamethazine
AGENCY:
Food and Drug Administration,
HHS.
The
sponsors of the 13 approved NADAs
listed in table 1 have requested that
FDA withdraw approval because the
products are no longer manufactured or
marketed.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4120–01–C
Withdrawal of approval is
effective April 11, 2011.
DATES:
John
Bartkowiak, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9079, email: john.bartkowiak@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
TABLE 1—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL OF 13 NADAS
Sponsor
NADA No. Product (Established Name of Drug)
Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany,
NJ 07054–1298.
Quali-Tech Products, Inc., 318 Lake Hazeltine Dr.,
Chaska, MN 55318.
Abraxis Pharmaceutical Products, Division of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL
60018.
Furst-McNess Co., Freeport, IL 61032 ..............................
Fort Dodge Animal Health, Division of Wyeth Holdings, a
wholly owned subsidiary of Pfizer, Inc., 235 East 42d
St., New York, NY 10017.
Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA
50704.
Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA
50704.
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL
32514.
Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine,
MN 56011.
Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine,
MN 56011.
Furst-McNess Co., Freeport, IL 61032 ..............................
Furst-McNess Co., Freeport, IL 61032 ..............................
wwoods2 on DSK1DXX6B1PROD with NOTICES
Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY
40511.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
VerDate Mar<15>2010
11:23 Mar 31, 2011
Jkt 223001
NADA 093–029 .................................................................
UNITOP Cream .................................................................
(cuprimyxin) .......................................................................
NADA 097–981 .................................................................
TYLAN 40 Sulfa-G Premix ................................................
(tylosin phosphate/sulfamethazine) ..................................
NADA 100–840 .................................................................
Chorionic Gonadotropin for Injection ................................
(chorionic gonadotropin) ...................................................
NADA 100–991 .................................................................
McNess Custom Premix L200 ..........................................
(tylosin phosphate) ............................................................
NADA 101–079 .................................................................
TRAMISOL–10% Pig Wormer ..........................................
(levamisole) .......................................................................
NADA 101–905 .................................................................
Mill Co-Medicator TY–10 ..................................................
(tylosin phosphate) ............................................................
NADA 101–906 .................................................................
Mill Co-Medicator TS–40 Premix ......................................
(tylosin phosphate/sulfamethazine) ..................................
NADA 102–824 .................................................................
Phenylbutazone Tablets ...................................................
(phenylbutazone) ..............................................................
NADA 108–487 .................................................................
DEC Tabs .........................................................................
(diethylcarbamazine citrate) ..............................................
NADA 108–863 .................................................................
DEC Chewable Tabs ........................................................
(diethylcarbamazine citrate) ..............................................
NADA 140–820 .................................................................
TYLAN 40 Sulfa-G Premix ................................................
(tylosin phosphate/sulfamethazine) ..................................
NADA 140–825 .................................................................
BANMINTH Intermediate Premix ......................................
(pyrantel tartrate) ..............................................................
NADA 140–910 .................................................................
NFZ Wound Powder .........................................................
(nitrofurazone) ...................................................................
approval of application (21 CFR
514.116), notice is given that approval
of NADAs 93–029, 97–981, 100–840,
100–991, 101–079, 101–905, 101–906,
102–824, 108–487, 108–863, 140–820,
PO 00000
Frm 00111
Fmt 4703
Sfmt 4703
21 CFR Section Affected
(Sponsor’s Drug Labeler
Code)
524.520
(063238)
558.630
(016968)
522.1081
(063323)
558.625
(010439)
Not codified
(000856)
558.625
(017139)
558.630
(017139)
520.1720a
(055246)
520.622a
(015579)
520.622c
(015579)
558.630
(010439)
558.485
(010439)
524.1580c
(050749)
140–825, and 140–910, and all
supplements and amendments thereto,
is hereby withdrawn, effective April 11,
2011.
E:\FR\FM\31MR1.SGM
31MR1
17928
Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Notices
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: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–7558 Filed 3–30–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
wwoods2 on DSK1DXX6B1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Epidemiology.
Date: April 18, 2011.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Denise Wiesch, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3150,
MSC 7770, Bethesda, MD 20892, (301) 435–
0684, wieschd@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Hematology and Endothelial
Biology.
Date: April 20–21, 2011.
Time: 8 a.m. to 7 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ai-Ping Zou, MD, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118,
VerDate Mar<15>2010
11:23 Mar 31, 2011
Jkt 223001
MSC 7814, Bethesda, MD 20892, 301–435–
1777, zouai@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Endocrinology and Metabolism.
Date: April 25, 2011.
Time: 11 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Krish Krishnan, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892, (301) 435–
1041, krishnak@csr.nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Biomaterials and Biointerfaces Study
Section.
Date: April 27–28, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: InterContinental Chicago
Magnificent Mile, 505 N. Michigan Avenue,
Chicago, IL 60611.
Contact Person: Steven J Zullo, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5146,
MSC 7849, Bethesda, MD 20892, 301–435–
2810, zullost@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 25, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; DAIDS Clinical Trial
Planning and Implementation Grants.
Date: April 26, 2011.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Erica L. Brown, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, MSC 7616, Bethesda, MD
20892–7616, 301–451–2639,
ebrown@niaid.nih.gov
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Next Generation PrEP.
Date: April 29, 2011.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Roberta Binder, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
Room 3130, Bethesda, MD 20892–7616, 301–
496–7966, rbinder@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
[FR Doc. 2011–7617 Filed 3–30–11; 8:45 am]
Dated: March 25, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
[FR Doc. 2011–7644 Filed 3–30–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
PO 00000
Frm 00112
Fmt 4703
Sfmt 4703
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
E:\FR\FM\31MR1.SGM
31MR1
]]>Agencies
[Federal Register Volume 76, Number 62 (Thursday, March 31, 2011)]
[Notices]
[Pages 17927-17928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7558]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0151]
Withdrawal of Approval of New Animal Drug Applications; Chorionic
Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole;
Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and
Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 13 new animal drug applications (NADAs). In a final rule published
elsewhere in this issue of the Federal Register, FDA is amending the
regulations to remove portions reflecting approval of these NADAs.
DATES: Withdrawal of approval is effective April 11, 2011.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9079, e-mail: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The sponsors of the 13 approved NADAs listed
in table 1 have requested that FDA withdraw approval because the
products are no longer manufactured or marketed.
Table 1--Voluntary Requests for Withdrawal of Approval of 13 NADAs
----------------------------------------------------------------------------------------------------------------
NADA No. Product (Established 21 CFR Section Affected (Sponsor's Drug
Sponsor Name of Drug) Labeler Code)
----------------------------------------------------------------------------------------------------------------
Roche Vitamins, Inc., 45 Waterview NADA 093-029.................. 524.520
Blvd., Parsippany, NJ 07054-1298. UNITOP Cream.................. (063238)
(cuprimyxin)..................
Quali-Tech Products, Inc., 318 Lake NADA 097-981.................. 558.630
Hazeltine Dr., Chaska, MN 55318. TYLAN 40 Sulfa-G Premix....... (016968)
(tylosin phosphate/
sulfamethazine).
Abraxis Pharmaceutical Products, NADA 100-840.................. 522.1081
Division of Abraxis Bioscience, 6133 Chorionic Gonadotropin for (063323)
River Rd., suite 500, Rosemont, IL Injection.
60018. (chorionic gonadotropin)......
Furst-McNess Co., Freeport, IL 61032.. NADA 100-991.................. 558.625
McNess Custom Premix L200..... (010439)
(tylosin phosphate)...........
Fort Dodge Animal Health, Division of NADA 101-079.................. Not codified
Wyeth Holdings, a wholly owned TRAMISOL-10% Pig Wormer....... (000856)
subsidiary of Pfizer, Inc., 235 East (levamisole)..................
42d St., New York, NY 10017.
Waterloo Mills Co., 2050 Mitchell NADA 101-905.................. 558.625
Ave., Waterloo, IA 50704. Mill Co-Medicator TY-10....... (017139)
(tylosin phosphate)...........
Waterloo Mills Co., 2050 Mitchell NADA 101-906.................. 558.630
Ave., Waterloo, IA 50704. Mill Co-Medicator TS-40 Premix (017139)
(tylosin phosphate/
sulfamethazine).
Pegasus Laboratories, Inc., 8809 Ely NADA 102-824.................. 520.1720a
Rd., Pensacola, FL 32514. Phenylbutazone Tablets........ (055246)
(phenylbutazone)..............
Wendt Laboratories, Inc., 100 Nancy NADA 108-487.................. 520.622a
Dr., Belle Plaine, MN 56011. DEC Tabs...................... (015579)
(diethylcarbamazine citrate)..
Wendt Laboratories, Inc., 100 Nancy NADA 108-863.................. 520.622c
Dr., Belle Plaine, MN 56011. DEC Chewable Tabs............. (015579)
(diethylcarbamazine citrate)..
Furst-McNess Co., Freeport, IL 61032.. NADA 140-820.................. 558.630
TYLAN 40 Sulfa-G Premix....... (010439)
(tylosin phosphate/
sulfamethazine).
Furst-McNess Co., Freeport, IL 61032.. NADA 140-825.................. 558.485
BANMINTH Intermediate Premix.. (010439)
(pyrantel tartrate)...........
Hess & Clark, Inc., 944 Nandino Blvd., NADA 140-910.................. 524.1580c
Lexington, KY 40511. NFZ Wound Powder.............. (050749)
(nitrofurazone)...............
----------------------------------------------------------------------------------------------------------------
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, 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
93-029, 97-981, 100-840, 100-991, 101-079, 101-905, 101-906, 102-824,
108-487, 108-863, 140-820, 140-825, and 140-910, and all supplements
and amendments thereto, is hereby withdrawn, effective April 11, 2011.
[[Page 17928]]
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: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7558 Filed 3-30-11; 8:45 am]
BILLING CODE 4160-01-P
