Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices 10651 growth between the smoking process for the following: (1) L. monocytogenes information to the Division of Dockets and distribution at retail, and (3) levels in raw fish, smoked fish, and Management (see ADDRESSES). Three recontamination with L. monocytogenes finished product; (2) effect of mitigation copies of all comments, scientific data, during the manufacturing and/or measures (e.g., ozonation, acidified and information are to be submitted. processing of smoked finfish. sodium chlorite) to reduce L. Individuals submitting written Listeria monocytogenes monocytogenes levels in raw and information or anyone submitting contamination is a problem in cold- finished product; (3) potential for electronic comments may submit one smoked finfish because the heat applied transfer of L. monocytogenes to food copy. Submissions are to be identified during processing is not sufficient to from contaminated food contact and with the docket number found in inactivate the organism, and the fish are noncontact surfaces during brackets in the heading of this consumed without further cooking. manufacturing and/or processing (e.g., document and may be accompanied by Cold-smoked finfish may become equipment, workers, floor drains, etc.); supporting information. Received contaminated during processing due to (4) potential for transfer of L. submissions may be seen in the Division inadequate sanitation, particularly monocytogenes from the slicer to cold- of Dockets Management between 9 a.m. because of insufficient cleaning and smoked fish; (5) impact of adding and 4 p.m., Monday through Friday. sterilizing of the slicer. For hot-smoked inhibitors (e.g., bacteriocins and Information submitted after the closing finfish, although L. monocytogenes is bacteriocins-producing bacterial strains date will not be considered except by killed by adequate hot-smoking, or sodium lactate) to smoked finfish to petition under 21 CFR 10.30. recontamination after hot-smoking can reduce or prevent L. monocytogenes result in high numbers of the organism growth; (6) impact of frozen versus III. References in the finished products. Additionally, refrigerated storage conditions on levels The following references are on the ability of the organism to grow of L. monocytogenes; (7) impact of time display in the Division of Dockets under both refrigerated aerobic and and temperature on levels of L. Management (see ADDRESSES) and may anaerobic conditions makes it a concern monocytogenes for commercial and be seen by interested persons between 9 in products packed in permeable home storage conditions of finished a.m. and 4 p.m., Monday through wrappers and under modified product; and (8) effect of training Friday. atmosphere or vacuum. This sealing of regarding sanitation and hygienic 1. U.S. Department of Health and Human the product extends shelf-life and, practices on reducing the levels of L. Services, Healthy People 2010, v. 1. therefore, provides additional time for monocytogenes in smoked finfish. Washington, DC, 2000, http:// the organism to grow. Preventive Controls for L. www.healthypeople.gov. Preventive Controls for L. monocytogenes in Retail and 2. U.S. Department of Health and Human monocytogenes in Retail and Foodservice Establishments: Under the Services and U.S. Department of Agriculture/ Foodservice Establishments: FDA is FDA/CDC Listeria Action Plan, FDA is Food Safety and Inspection Service, evaluating the Food Code to determine ‘‘Quantitative Assessment of Relative Risk to continuing its commitment to review Public Health from Foodborne Listeria whether it should consider the Food Code to determine whether it monocytogenes Among Selected Categories recommending revisions to the should consider recommending of Ready-to-Eat Foods,’’ September 2003, provisions addressing preventive revisions to the provisions that address http://www.foodsafety.gov/~dms/lmr2– controls for L. monocytogenes in retail preventive controls for Listeria in retail toc.html. and foodservice establishments. and foodservice establishments. The 3. U.S. Department of Health and Human Specifically, FDA will take the agency specifically requests the Services, Food and Drug Administration/ following steps: (1) Review the Food following data and information: (1) L. Centers for Disease Control and Prevention, Code to determine whether it should monocytogenes levels in products stored ‘‘Reducing the Risk of Listeria consider recommending revisions to the in retail and foodservice establishments; monocytogenes FDA/CDC 2003 Update of the provisions that address preventive Listeria Action Plan,’’ November 2003, http:/ (2) levels of environmental /www.cfsan.fda.gov/~dms/lmr2plan.html. controls, such as approved source, date contamination and harborage of L. 4. U.S. Department of Health and Human marking, and cold holding times and monocytogenes on food contact and Services, Public Health Service, Food and temperatures; and (2) in conjunction nonfood contact surfaces in retail and Drug Administration, Food Code, 2001, http:/ with the Conference for Food foodservice establishments (e.g., /www.cfsan.fda.gov/~dms/fc01–toc.html. Protection, issue guidance to the retail equipment, workers, floor drains, etc.); Dated: February 25, 2005. and food service industries and State (3) effects of short- and long-term Jeffrey Shuren, and local regulatory professionals on the refrigerated storage on levels of L. use of Hazard Analysis Critical Control monocytogenes in retail and foodservice Assistant Commissioner for Policy. Point (HACCP) principles to identify establishments; (4) impact of time and [FR Doc. 05–4217 Filed 3–3–05; 8:45 am] and control risk factors contributing to temperature on levels of L. BILLING CODE 4160–01–S foodborne illness. FDA intends for such monocytogenes in products stored in guidance to discuss intervention retail and foodservice establishments; strategies that industry can use to (5) efficacy of cleaning procedures and DEPARTMENT OF HEALTH AND control L. monocytogenes and other sanitizing agents on environmental HUMAN SERVICES pathogens. surfaces and utensils; (6) frequency of Food and Drug Administration use and impact of adding inhibitors to II. Request for Comments and for food products in retail and foodservice [Docket No. 2005N–0058] Scientific Data and Information establishments to reduce or prevent L. Smoked Finfish Risk Assessment: monocytogenes growth; and (7) effect of Hospira, Inc. et al.; Withdrawal of FDA requests comments on the risk training regarding hygienic practices Approval of 76 New Drug Applications assessment approach outlined and sanitation on levels of L. and 60 Abbreviated New Drug previously in this document and the monocytogenes in products in retail and Applications submission of data and any information foodservice establishments. relevant to this risk assessment. The Interested persons should submit AGENCY: Food and Drug Administration, agency specifically requests information comments, scientific data, and HHS. VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1 10652 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices ACTION: Notice. longer marketed and requested that the SUPPLEMENTARY INFORMATION: The approval of the applications be holders of the applications listed in the SUMMARY: The Food and Drug withdrawn. table in this document have informed Administration (FDA) is withdrawing EFFECTIVE DATE: April 4, 2005. FDA that these drug products are no approval of 76 new drug applications FOR FURTHER INFORMATION CONTACT: longer marketed and have requested that (NDAs) and 60 abbreviated new drug Florine P. Purdie, Center for Drug FDA withdraw approval of the applications (ANDAs) from multiple Evaluation and Research (HFD–7), Food applications. The applicants have also, applicants. The holders of the and Drug Administration, 5600 Fishers by their requests, waived their applications notified the agency in Lane, Rockville, MD 20857, 301–594– opportunity for a hearing. writing that the drug products were no 2041. Application No. Drug Applicant NDA 6–095 Tubocurarine Chloride Injection Hospira, Inc., 275 North Field Dr., Bldg. 2–J45–2, Lake Forest, IL 60045–5046 NDA 6–412 Decapryn (doxylamine succinate) Tablets and Aventis Pharmaceuticals, Inc., 200 Crossing Syrup Blvd., Bridgewater, NJ 08807–0890 NDA 6–460 Protamine Sulfate Injection USP Eli Lilly and Co., Lilly Corporate Center, Indian- apolis, IN 46285 NDA 8–032 Telepaque (iopanoic acid) Tablets Amersham Health, 101 Carnegie Center, Prince- ton, NJ 08540 NDA 10–288 Betadine (10% povidone iodine) Solution and The Purdue Frederick Co., One Stamford Forum, Isodine (10% povidone iodine) Solution Stamford, CT 06901–3431 NDA 11–097 Dimetane (brompheniramine maleate) Elixir Wyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940 NDA 11–270 Furoxone (furazolidone) Tablets Shire Laboratories, Inc., c/o Shire Pharma- ceutical Development, Inc., 1801 Research Blvd., suite 600, Rockville, MD 20850 NDA 11–323 Furoxone (furazolidone) Oral Suspension Do. NDA 11–325 Vesprin (triflupromazine hydrochloride (HCl)) In- Apothecon, c/o Bristol-Myers Squibb Co., P.O. jection, 10 milligrams (mg)/milliliter (mL) and Box 4500, Princeton, NJ 08543–4500 20 mg/mL NDA 11–367 Enzactin (triacetin) Spray Wyeth Consumer Healthcare NDA 12–265 Naqua (trichlormethiazide) Tablets and Naquival Schering Corp., 2000 Galloping Hill Rd., Ken- (trichlormethiazide and reserpine) Tablets