Memorandum of Understanding Between the United States Food and Drug Administration Department of Health and Human Services and the Australian Pesticides and Veterinary Medicines Authority, Australia, 2048-2053 [06-251]

Download as PDF 2048 Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices erjones on PROD1PC68 with NOTICES Schering has not discontinued manufacture of Celestone Soluspan injection; however, as a result of a May 2002 consent decree addressing manufacturing concerns, Schering’s manufacture and distribution of Celestone Soluspan injection has been limited to providing the drug for certain medically necessary uses under a limited distribution program. Celestone Soluspan injection is being distributed as medically necessary for the following uses: (1) Neonatal use (fetal lung maturation), (2) epidural route for the management of pain due to radiculopathy in patients not responsive to systemic drug therapy and other adjunctive therapies, and (3) intraarticular and soft tissue injections for synovitis of osteoarthritis, acute gouty arthritis, nonspecific tenosynovitis, and acute and subacute bursitis. Information regarding the current distribution for Celestone Soluspan injection by Schering can be found on FDA’s Drug Shortage Web site: https://www.fda.gov/ cder/drug/shortages/celestone.htm. FDA has reviewed its records and, under § 314.161, has determined that Celestone Soluspan (betamethasone sodium phosphate and betamethasone acetate) injection and Celestone (betamethasone sodium phosphate) injection were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list betamethasone sodium phosphate in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to betamethasone sodium phosphate may be approved by the agency. ANDAs that refer to betamethasone sodium phosphate and betamethasone acetate injection also may be approved by the VerDate Aug<31>2005 17:40 Jan 11, 2006 Jkt 208001 agency; however, FDA recommends that in considering whether to file an ANDA for this drug product, future applicants be advised that the RLD may not be commercially available because it is being made available in certain instances of medical necessity only. An ANDA applicant who is unable to obtain Celestone Soluspan injection for bioequivalence testing must contact the Office of Generic Drugs for a determination of what showing is necessary to satisfy the requirements of section 505(j)(2)(A)(iv) of the act. If an ANDA is approved without a showing of bioequivalence, the approved product will not be granted an AB rating in the Orange Book. Future applicants for betamethasone sodium phosphate and betamethasone acetate injection are advised that if the RLD product becomes commercially available prior to ANDA approval, the ANDA applicant will need to show bioequivalence to the RLD product. Dated: January 4, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–178 Filed 1–11–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA–225–05–8006] Memorandum of Understanding Between the United States Food and Drug Administration Department of Health and Human Services and the Australian Pesticides and Veterinary Medicines Authority, Australia AGENCY: SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the United States Food and Drug Administration, Department of Health and Human Services and the Australian Pesticides and Veterinary Medicines Authority (APVMA), Australia. This MOU is intended to establish an information-sharing arrangement between APVMA and FDA. The Participants intend to strengthen the exchange of knowledge and expertise to enhance the efficiency and effectiveness of their respective roles. This MOU focuses on cooperation in relations to the operational aspects of animal drug regulation and is not intended to cover broader government regulatory policy or to cover areas not falling under the common jurisdictional purview of the Participants. The agreement became effective October 20, 2005. DATES: FOR FURTHER INFORMATION CONTACT: Matthew E. Eckel, Office of International Programs, Food and Drug Administration, 5600 Fishers Lane (HFG–1), Rockville MD, 20857, 301– 827–4480, FAX 301–480–0716. 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. SUPPLEMENTARY INFORMATION: Dated: January 4, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160–01–S Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1 VerDate Aug<31>2005 15:02 Jan 11, 2006 Jkt 208001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4725 E:\FR\FM\12JAN1.SGM 12JAN1 2049 EN12JA06.000</GPH> erjones on PROD1PC68 with NOTICES Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices VerDate Aug<31>2005 Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices 15:02 Jan 11, 2006 Jkt 208001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4725 E:\FR\FM\12JAN1.SGM 12JAN1 EN12JA06.001</GPH> erjones on PROD1PC68 with NOTICES 2050 VerDate Aug<31>2005 15:02 Jan 11, 2006 Jkt 208001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4725 E:\FR\FM\12JAN1.SGM 12JAN1 2051 EN12JA06.002</GPH> erjones on PROD1PC68 with NOTICES Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices VerDate Aug<31>2005 Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices 15:02 Jan 11, 2006 Jkt 208001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\12JAN1.SGM 12JAN1 EN12JA06.003</GPH> erjones on PROD1PC68 with NOTICES 2052 2053 [FR Doc. 06–251 Filed 1–11–06; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 15:02 Jan 11, 2006 Jkt 208001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1 EN12JA06.004</GPH> erjones on PROD1PC68 with NOTICES Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices

Agencies

[Federal Register Volume 71, Number 8 (Thursday, January 12, 2006)]
[Notices]
[Pages 2048-2053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA-225-05-8006]


Memorandum of Understanding Between the United States Food and 
Drug Administration Department of Health and Human Services and the 
Australian Pesticides and Veterinary Medicines Authority, Australia

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between the United States Food and 
Drug Administration, Department of Health and Human Services and the 
Australian Pesticides and Veterinary Medicines Authority (APVMA), 
Australia. This MOU is intended to establish an information-sharing 
arrangement between APVMA and FDA. The Participants intend to 
strengthen the exchange of knowledge and expertise to enhance the 
efficiency and effectiveness of their respective roles. This MOU 
focuses on cooperation in relations to the operational aspects of 
animal drug regulation and is not intended to cover broader government 
regulatory policy or to cover areas not falling under the common 
jurisdictional purview of the Participants.

DATES: The agreement became effective October 20, 2005.

FOR FURTHER INFORMATION CONTACT: Matthew E. Eckel, Office of 
International Programs, Food and Drug Administration, 5600 Fishers Lane 
(HFG-1), Rockville MD, 20857, 301-827-4480, FAX 301-480-0716.

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: January 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160-01-S



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[FR Doc. 06-251 Filed 1-11-06; 8:45 am]
BILLING CODE 4160-01-S
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