Pfizer, Inc.; Withdrawal of Approval of a New Drug Application for BEXTRA, 46984-46985 [2013-18657]

Download as PDF 46984 Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices sroberts on DSK5SPTVN1PROD with NOTICES end of FY 2013, FDA estimates that 490 establishments will have been billed for establishment fees, before all decisions on requests for waivers or reductions are made. FDA estimates that a total of 20 establishment fee waivers or reductions will be made for FY 2013. In addition, FDA estimates that another 15 full establishment fees will be exempted this year based on the orphan drug exemption in section 736(k) of the FD&C Act. Subtracting 35 establishments (20 waivers, plus the estimated 15 establishments under the orphan exemption) from 490 leaves a net of 455 fee-paying establishments. FDA will use 455 for its FY 2014 estimate of establishments paying fees, after taking waivers and reductions into account. The fee per establishment is determined by dividing the adjusted total fee revenue to be derived from establishments ($252,342,667) by the estimated 455 establishments, for an establishment fee rate for FY 2014 of $554,600 (rounded to the nearest $100). TABLE 7—FEE SCHEDULE FOR FY 2014—Continued B. Establishment and Product Fees FDA will issue invoices for establishment and product fees for FY 2014 under the new fee schedule in 1,084,550 August 2013. Payment will be due on 554,600 October 1, 2013. FDA will issue 104,060 invoices in November 2014 for any products and establishments subject to fees for FY 2014 that qualify for fee assessments after the August 2013 billing. Fee rates for FY 2014 Fee category Supplements requiring clinical data .... Establishments ............... Products .......................... VI. Fee Payment Options and Procedures A. Application Fees The appropriate application fee established in the new fee schedule must be paid for any application or supplement subject to fees under PDUFA that is received after September 30, 2013. Payment must be made in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration. Please include the user fee identification (ID) number on your check, bank draft, or postal money B. Product Fees order. Your payment can be mailed to: Food and Drug Administration, P.O. At the beginning of FY 2013, the Box 979107, St. Louis, MO 63197–9000. product fee was based on an estimate If checks are to be sent by a courier that 2,435 products would be subject to that requests a street address, the and would pay product fees. By the end courier can deliver the checks to: U.S. of FY 2013, FDA estimates that 2,510 Bank, Attention: Government Lockbox products will have been billed for 979107, 1005 Convention Plaza, St. product fees, before all decisions on Louis, MO 63101. (Note: This U.S. Bank requests for waivers, reductions, or exemptions are made. FDA assumes that address is for courier delivery only. Contact the U.S. Bank at 314–418–4013 there will be 45 waivers and reductions granted. In addition, FDA estimates that if you have any questions concerning courier delivery.) another 40 product fees will be Please make sure that the FDA post exempted this year based on the orphan office box number (P.O. Box 979107) is drug exemption in section 736(k) of the written on the check, bank draft, or FD&C Act. FDA estimates that 2,425 products will qualify for product fees in postal money order. Wire transfer payment may also be FY 2013, after allowing for waivers and used. Please reference your unique user reductions, including the orphan drug fee ID number when completing your products, and will use this number for transfer. The originating financial its FY 2014 estimate. The FY 2014 institution may charge a wire transfer product fee rate is determined by fee. Please ask your financial institution dividing the adjusted total fee revenue about the fee and add it to your payment to be derived from product fees to ensure that your fee is fully paid. The ($252,342,667) by the estimated 2,425 account information is as follows: New products for a FY 2014 product fee of York Federal Reserve Bank, U.S. $104,060 (rounded to the nearest $10). Department of the Treasury, TREAS V. Fee Schedule for FY 2014 NYC, 33 Liberty St., New York, NY The fee rates for FY 2014 are set out 10045, Acct. No.: 75060099, Routing in table 7 of this document: No.: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Drive, TABLE 7—FEE SCHEDULE FOR FY Rockville, MD. Application fees can also be paid 2014 online with an electronic check (ACH). Fee rates for FY FDA has partnered with the U.S. Fee category 2014 Department of the Treasury to use Pay.gov, a Web-based payment Applications: application, for online electronic Requiring clinical data ...................... $2,169,100 payment. The Pay.gov feature is available on the FDA Web site after the Not requiring clinical data ...................... 1,084,550 user fee ID number is generated. VerDate Mar<15>2010 18:55 Aug 01, 2013 Jkt 229001 PO 00000 Frm 00080 Fmt 4703 The tax identification number of FDA is 53–0196965. Sfmt 4703 Dated: July 29, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–18624 Filed 8–1–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0869] Pfizer, Inc.; Withdrawal of Approval of a New Drug Application for BEXTRA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for BEXTRA (valdecoxib) 10 milligram (mg) and 20 mg Tablets, held by Pfizer, Inc. (Pfizer), 235 East 42nd St., New York, NY 10017–5755. Pfizer has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing. DATES: Effective August 2, 2013. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6250, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: FDA approved BEXTRA (valdecoxib) 10 mg and 20 mg Tablets on November 16, 2001. BEXTRA is indicated for relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis and for the treatment of primary dysmenorrhea. On April 7, 2005, FDA announced that it had concluded that the overall risk versus benefit profile of BEXTRA was unfavorable and that it had asked Pfizer to voluntarily withdraw BEXTRA from the market. Pfizer agreed and voluntarily suspended all sales and marketing of BEXTRA on July 21, 2005. In letters dated May 27, 2011, August 8, SUMMARY: E:\FR\FM\02AUN1.SGM 02AUN1 Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices 2011, and October 31, 2011, Pfizer requested that FDA withdraw approval of NDA 21–341 for BEXTRA. In the letter dated October 31, 2011, Pfizer waived any opportunity for a hearing otherwise provided under 21 CFR 314.150 (§ 314.150). In FDA’s letter of November 9, 2011, responding to Pfizer’s letters dated May 27, 2011, August 8, 2011, and October 31, 2011, the Agency acknowledged Pfizer’s request to withdraw approval of BEXTRA under § 314.150(d) and waive its opportunity for a hearing. Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and § 314.150(d), and under authority delegated by the Commissioner to the Director, Center for Drug Evaluation and Research, approval of NDA 21–341, and all amendments and supplements thereto, is withdrawn (see DATES). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). Dated: July 30, 2013. Janet Woodcock, Director, Center for Drug Evaluation and Research. [FR Doc. 2013–18657 Filed 8–1–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Office of Direct Service and Contracting Tribes; National Indian Health Outreach and Education; Cooperative Agreement Program sroberts on DSK5SPTVN1PROD with NOTICES Announcement Type: Limited New and Competing Continuation Funding Announcement Number: HHS– 2013–IHS–NIHOE–0001 Catalog of Federal Domestic Assistance Number: 93.933 Key Dates Application Deadline Date: September 6, 2013 Review Date: September 10, 2013 Earliest Anticipated Start Date: September 30, 2013 Proof of Non-Profit Status Due Date: September 6, 2013 I. Funding Opportunity Description Statutory Authority The Indian Health Service (IHS) is accepting competitive cooperative agreement applications for the National Indian Health Outreach and Education VerDate Mar<15>2010 18:55 Aug 01, 2013 Jkt 229001 (NIHOE) I limited competition cooperative agreement program. This award includes the following four components, as described in this announcement: ‘‘Line Item 128 Health Education and Outreach funds,’’ ‘‘Health Care Policy Analysis and Review,’’ ‘‘Budget Formulation’’ and ‘‘Tribal Leaders Diabetes Committee’’ (TLDC). This program is authorized under the Snyder Act, codified at 25 U.S.C. 13. This program is described in the Catalog of Federal Domestic Assistance (CFDA) under 93.933. Background The NIHOE program carries out health program objectives in the American Indian and Alaska Native (AI/ AN) community in the interest of improving Indian health care for all 566 Federally-recognized Tribes, including Tribal governments operating their own health care delivery systems through self-determination contracts with the IHS and Tribes that continue to receive health care directly from the IHS. This program addresses health policy and health program issues and disseminates educational information to all AI/AN Tribes and villages. This program requires that public forums be held at Tribal educational consumer conferences to disseminate changes and updates in the latest health care information. This program also requires that regional and national meetings be coordinated for information dissemination as well as the inclusion of planning and technical assistance and health care recommendations on behalf of participating Tribes to ultimately inform IHS based on Tribal input through a broad based consumer network. Purpose The purpose of this IHS cooperative agreement is to further IHS’s mission and goals related to providing quality health care to the AI/AN community through outreach and education efforts with the sole outcome of improving Indian health care. This award includes the following four health services components: Line Item 128 Health Education and Outreach funds, Health Care Policy Analysis and Review, Budget Formulation, and Tribal Leaders Diabetes Committee (TLDC). Limited Competition Justification Competition for the award included in this announcement is limited to national Indian health care organizations with at least ten years of experience providing education and outreach on a national scale. This limitation ensures that the awardee will PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 46985 have: (1) A national information-sharing infrastructure which will facilitate the timely exchange of information between the Department of Health and Human Services (HHS) and Tribes and Tribal organizations on a broad scale; (2) a national perspective on the needs of AI/ AN communities that will ensure that the information developed and disseminated through the projects is appropriate, useful and addresses the most pressing needs of AI/AN communities; and (3) established relationships with Tribes and Tribal organizations that will foster open and honest participation by AI/AN communities. Regional or local organizations will not have the mechanisms in place to conduct communication on a national level, nor will they have an accurate picture of the health care needs facing AI/ANs nationwide. Organizations with less experience will lack the established relationships with Tribes and Tribal organizations throughout the country that will facilitate participation and the open and honest exchange of information between Tribes and HHS. With the limited funds available for these projects, HHS must ensure that the education and outreach efforts described in this announcement reach the widest audience possible in a timely fashion, are appropriately tailored to the needs of AI/AN communities throughout the country, and come from a source that AI/ANs recognize and trust. For these reasons, this is a limited competition announcement. II. Award Information Type of Award Cooperative Agreement. Estimated Funds Available The total amount of funding identified for the current fiscal year 2013 is approximately $716,000. Three hundred thousand dollars ($300,000) is estimated for outreach, education, and support to Tribes who have elected to leave their Tribal Shares with the IHS (this amount could vary based on Tribal Shares assumptions; Line Item 128 Health Education and Outreach funding will be awarded in partial increments based on availability and amount of funding); $100,000 for the Health Care Policy Analysis and Review; $16,000 for the Budget Formulation; and $300,000 associated with providing legislative education, outreach and communications support to the IHS TLDC and to facilitate Tribal consultation on the Special Diabetes Program for Indians (SDPI). All competing and continuation awards E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46984-46985]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0869]


Pfizer, Inc.; Withdrawal of Approval of a New Drug Application 
for BEXTRA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new drug application (NDA) for BEXTRA (valdecoxib) 10 milligram 
(mg) and 20 mg Tablets, held by Pfizer, Inc. (Pfizer), 235 East 42nd 
St., New York, NY 10017-5755. Pfizer has voluntarily requested that 
approval of this application be withdrawn and has waived its 
opportunity for a hearing.

DATES: Effective August 2, 2013.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: FDA approved BEXTRA (valdecoxib) 10 mg and 
20 mg Tablets on November 16, 2001. BEXTRA is indicated for relief of 
the signs and symptoms of osteoarthritis and adult rheumatoid arthritis 
and for the treatment of primary dysmenorrhea. On April 7, 2005, FDA 
announced that it had concluded that the overall risk versus benefit 
profile of BEXTRA was unfavorable and that it had asked Pfizer to 
voluntarily withdraw BEXTRA from the market. Pfizer agreed and 
voluntarily suspended all sales and marketing of BEXTRA on July 21, 
2005. In letters dated May 27, 2011, August 8,

[[Page 46985]]

2011, and October 31, 2011, Pfizer requested that FDA withdraw approval 
of NDA 21-341 for BEXTRA. In the letter dated October 31, 2011, Pfizer 
waived any opportunity for a hearing otherwise provided under 21 CFR 
314.150 (Sec.  314.150). In FDA's letter of November 9, 2011, 
responding to Pfizer's letters dated May 27, 2011, August 8, 2011, and 
October 31, 2011, the Agency acknowledged Pfizer's request to withdraw 
approval of BEXTRA under Sec.  314.150(d) and waive its opportunity for 
a hearing.
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and Sec.  314.150(d), 
and under authority delegated by the Commissioner to the Director, 
Center for Drug Evaluation and Research, approval of NDA 21-341, and 
all amendments and supplements thereto, is withdrawn (see DATES). 
Distribution of this product in interstate commerce without an approved 
application is illegal and subject to regulatory action (see sections 
505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: July 30, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-18657 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P
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