Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications, 50376-50377 [05-16994]
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50376
Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Notices
copy of the oral presentation to Lynne
Johnson, Health Insurance Specialist,
Division of Partnership Development,
Center for Beneficiary Choices, Centers
for Medicare & Medicaid Services, 7500
Security Boulevard, Mail stop S2–23–
05, Baltimore, MD 21244–1850 or by
email at Lynne.Johnson@cms.hhs.gov,
no later than 12 noon, e.d.t., September
20, 2005. The number of oral
presentations may be limited by the
time available. Individuals not wishing
to make a presentation may submit
written comments to Ms. Johnson by 12
noon, (e.d.t.), September 20, 2005. The
meeting is open to the public, but
attendance is limited to the space
available.
Special Accommodation: Individuals
requiring sign language interpretation or
other special accommodations should
contact Ms. Johnson at least 15 days
before the meeting.
of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a)
and 41 CFR 102–3).
(Catalog of Federal Domestic Assistance
Program No. 93.733, Medicare—Hospital
Insurance Program; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Authority: Sec. 222 of the Public Health
Service Act (42 U.S.C. 217a) and sec. 10(a)
Title: Temporary Assistance for Needy
Families (TANF) State Plan Guidance.
Dated: August 19, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–16800 Filed 8–25–05; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
OMB No.: 0970–0145.
Description: The State plan is a
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Executive Officer. Its submittal triggers
the State’s family assistance grant
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Respondents: The 50 States, the
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Submission for OMB Review;
Comment Request
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of responses per
respondent
Average
burden hours
per response
Total burden
hours
Temporary Assistance for Needy Families (TANF) State Plan Guidance ......
54
0.5
33
891
Estimated Total Annual Burden
Hours: 891
Additional Information
Copies of the proposed collection may
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Office of Information Services, 370
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information collection should be sent
VerDate jul<14>2003
16:18 Aug 25, 2005
Jkt 205001
directly to the following: Office of
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Reduction Project, Attn: Desk Officer for
ACF, E-mail address:
Katherine_T._Astrich@omb.eop.gov.
Dated: August 23, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–17008 Filed 8–25–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0149]
Animal Drugs, Feeds, and Related
Products; Withdrawal of Approval of
New Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00086
Fmt 4703
Sfmt 4703
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of 16 new animal drug
applications (NADAs) and 1 abbreviated
NADA (ANADA) 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 September 6, 2005.
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for
Veterinary Medicine (HFV–210), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 301–827–
7818, or e-mail: pesposit@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: The
following sponsors have requested that
FDA withdraw approval of the 16
NADAs and 1 ANADA listed in table 1
of this document because the products
are no longer manufactured or
marketed:
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50377
Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Notices
TABLE 1.
Sponsor
21 CFR Section Affected,
(Sponsor Drug Labeler
Code)
NADA Number, Product (Drug)
Abbott Laboratories, North Chicago, IL
60064
NADA 99–568, FURANACE Caps (nifurpirinol)
529.1526 (000074)
Biocraft Laboratories, Inc., 92 Route 46,
Elmwood Park, NJ 07407
NADA 140–889, DERM–OTIC Ointment (neomycin sulfate, nystatin, thiostrepton, triamcinolone acetonide)
524.1600a (000332)
First Priority, Inc., 1585 Todd Farm Dr.,
Elgin, IL 60123
NADA 48–646, THERAZONE Injection (phenylbutazone)
522.1720 (058829)
Happy Jack, Inc., Snow Hill, NC 28580
NADA 121–556, Selenium Sulfide Suspension (selenium disulfide)
NADA 121–723, Nitrofurazone Dressing
NADA 125–137, FILARICIDE Capsules (diethylcarbamazine citrate)
524.2101 (023851)
524.1580b (023851)
520.622d (023851)
IMPAX Laboratories, Inc., 30831 Huntwood
Ave., Hayward, CA 94544
NADA 92–151, N-Butyl Chloride Canine Worming Caps
520.260 (000115)
NADA 65–065, Tetracycline HCl Caps
NADA 138–900, Dichlorophene/Toluene
520.2345a (000115)
520.580 (000115)
Jorgensen Laboratories, Inc., 1450 North
Van Buren Ave., Loveland, CO 80538
NADA 10–481, SUREJETS (salacylic acid)
529.2090 (048087)
Pliva d.d., Ulica grada Vukovara 49, 10000
Zagreb, Croatia
ANADA, 200–232, GEOMYCIN 200 Injection (oxytetracycline)
522.1660a (011722)
Purina Mills, Inc., P.O. Box 66812, St. Louis,
MO 63166-6812
NADA 65–113 AUREO Sulfa Soluble Powder (chlortetracycline/
sulfamethazine)
N/A (017800)
Roche Vitamins, Inc., 45 Waterview Blvd.,
Parsippany, NJ 07054–1298
NADA 140–848, VETEEZE Injection (diazepam)
522.575 (063238)
Teva Pharmaceuticals USA, 650 Cathill Rd.,
Sellersville, PA 18960
NADA 131–806, Furosemide Tablets
520.1010 (000093)
Virbac AH, Inc., 3200 Meacham Blvd., Ft.
Worth, TX 76137
NADA 10–886, Purina Liquid Wormer (piperazine citrate)
N/A (051311)
Wyeth Laboratories, Division of American
Home Products Corp., P.O. Box 8299,
Philadelphia, PA 19101
NADA 10–782, SPARINE Injection (promazine)
522.1962 (000008)
NADA 55–008, BICILLIN Fortified (penicillin G benzathine and
penicillin G procaine)
522.1696a (000008)
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 § 514.115
Withdrawal of approval of applications
(21 CFR 514.115), notice is given that
approval of NADAs 10–481, 10–782,
10–886, 48–646, 55–008, 65–065, 65–
113, 99–568, 121–556, 121–723, 125–
137, 131–806, 138–900, 140–848, 140–
889, and ANADA 200–232, and all
supplements and amendments thereto,
is hereby withdrawn, effective
September 6, 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.
VerDate jul<14>2003
16:18 Aug 25, 2005
Jkt 205001
Dated: July 5, 2005.
Linda Tollefson,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. 05–16994 Filed 8–25–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Establishment
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
Appendix 2), the Director, National
Institutes of Health (NIH), announces
the establishment of the National
Commission on Digestive Diseases
(Commission).
This Commission shall conduct an
overview of the state-of-the-science in
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
the field of digestive diseases research
and develop a long-range plan for
digestive diseases research consistent
with the research mission of NIH. The
overall plan will focus on the goal of
improving the health of the nation
through digestive diseases research and
will include specific objectives and
goals and a recommended time line for
their implementation.
Recommendations shall be made to the
Director, NIH and to Congress.
The Commission shall be composed
of 16 members appointed by the
Director, NIH and 18 nonvoting ex
officio members. Of the appointed
members, who shall have a broad
diversity of scientific and professional
experience, 12 shall be knowledgeable
about digestive diseases as members of
academic or medical research and
practice communities involved in
digestive diseases research, including
E:\FR\FM\26AUN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 165 (Friday, August 26, 2005)]
[Notices]
[Pages 50376-50377]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0149]
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 16 new animal drug applications (NADAs) and 1 abbreviated NADA
(ANADA) 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 September 6, 2005.
FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for
Veterinary Medicine (HFV-210), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-7818, or e-mail:
pesposit@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: The following sponsors have requested that
FDA withdraw approval of the 16 NADAs and 1 ANADA listed in table 1 of
this document because the products are no longer manufactured or
marketed:
[[Page 50377]]
Table 1.
------------------------------------------------------------------------
21 CFR Section
Affected,
Sponsor NADA Number, Product (Drug) (Sponsor Drug
Labeler Code)
------------------------------------------------------------------------
Abbott Laboratories, NADA 99-568, FURANACE Caps 529.1526
North Chicago, IL (nifurpirinol) (000074)
60064
------------------------------------------------------------------------
Biocraft Laboratories, NADA 140-889, DERM-OTIC 524.1600a
Inc., 92 Route 46, Ointment (neomycin sulfate, (000332)
Elmwood Park, NJ nystatin, thiostrepton,
07407 triamcinolone acetonide)
------------------------------------------------------------------------
First Priority, Inc., NADA 48-646, THERAZONE 522.1720
1585 Todd Farm Dr., Injection (phenylbutazone) (058829)
Elgin, IL 60123
------------------------------------------------------------------------
Happy Jack, Inc., Snow NADA 121-556, Selenium Sulfide 524.2101
Hill, NC 28580 Suspension (selenium (023851)
disulfide)
NADA 121-723, Nitrofurazone 524.1580b
Dressing (023851)
NADA 125-137, FILARICIDE 520.622d
Capsules (diethylcarbamazine (023851)
citrate)
------------------------------------------------------------------------
IMPAX Laboratories, NADA 92-151, N-Butyl Chloride 520.260
Inc., 30831 Huntwood Canine Worming Caps (000115)
Ave., Hayward, CA
94544
NADA 65-065, Tetracycline HCl 520.2345a
Caps (000115)
NADA 138-900, Dichlorophene/ 520.580
Toluene (000115)
------------------------------------------------------------------------
Jorgensen NADA 10-481, SUREJETS 529.2090
Laboratories, Inc., (salacylic acid) (048087)
1450 North Van Buren
Ave., Loveland, CO
80538
------------------------------------------------------------------------
Pliva d.d., Ulica ANADA, 200-232, GEOMYCIN 200 522.1660a
grada Vukovara 49, Injection (oxytetracycline) (011722)
10000 Zagreb, Croatia
------------------------------------------------------------------------
Purina Mills, Inc., NADA 65-113 AUREO Sulfa Soluble N/A (017800)
P.O. Box 66812, St. Powder (chlortetracycline/
Louis, MO 63166-6812 sulfamethazine)
------------------------------------------------------------------------
Roche Vitamins, Inc., NADA 140-848, VETEEZE Injection 522.575
45 Waterview Blvd., (diazepam) (063238)
Parsippany, NJ 07054-
1298
------------------------------------------------------------------------
Teva Pharmaceuticals NADA 131-806, Furosemide 520.1010
USA, 650 Cathill Rd., Tablets (000093)
Sellersville, PA
18960
------------------------------------------------------------------------
Virbac AH, Inc., 3200 NADA 10-886, Purina Liquid N/A (051311)
Meacham Blvd., Ft. Wormer (piperazine citrate)
Worth, TX 76137
------------------------------------------------------------------------
Wyeth Laboratories, NADA 10-782, SPARINE Injection 522.1962
Division of American (promazine) (000008)
Home Products Corp.,
P.O. Box 8299,
Philadelphia, PA
19101
NADA 55-008, BICILLIN Fortified 522.1696a
(penicillin G benzathine and (000008)
penicillin G procaine)
------------------------------------------------------------------------
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 10-481, 10-782, 10-886, 48-646, 55-008, 65-065, 65-
113, 99-568, 121-556, 121-723, 125-137, 131-806, 138-900, 140-848, 140-
889, and ANADA 200-232, and all supplements and amendments thereto, is
hereby withdrawn, effective September 6, 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: July 5, 2005.
Linda Tollefson,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-16994 Filed 8-25-05; 8:45 am]
BILLING CODE 4160-01-S
