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Federal Register/Vol. 63, No. 239/Monday, December 14, 1998 Federal Register / Vol. 63, No. 239 / Monday, December 14, 1998 / Notices 68775 issued export certificates. The new facilitate the issuance and tracking of Drug Administration Modernization Act format may also help authenticate export certificates, deter unscrupulous of 1997 (FDAMA). export certificates. persons from making counterfeit or false DATES: Submit data and information by DATES: The agency will begin issuing certificates or otherwise tampering with March 15, 1999. Submit written general export certificates using the new format export certificates, and to help foreign comments by March 15, 1999. after January 1, 1999. governments identify authentic, FDA- ADDRESSES: Submit written general FOR FURTHER INFORMATION CONTACT: issued export certificates more readily, comments on this call-for-data to the Philip L. Chao, Office of Policy (HF±23), FDA has adopted a new format for its Dockets Management Branch (HFA± Food and Drug Administration, 5600 export certificates. The new format 305), Food and Drug Administration, Fishers Lane, Rockville, MD 20857, features the use of several security 5630 Fishers Lane, rm. 1061, Rockville, 301±827±3380. measures in the paper used for export MD 20852. Submit information on certificates. human drug products to the Division of SUPPLEMENTARY INFORMATION: Firms FDA will begin using the new format Over-the-Counter (OTC) Drug Products exporting products from the United on certificates issued after January 1, (HFD±560), Center for Drug Evaluation States are often asked by foreign 1999. The procedures for requesting and and Research, Food and Drug customers or foreign governments to issuing export certificates, as well as the Administration, 5600 Fishers Lane, supply a certification relating to text of the certificates themselves, will Rockville, MD 20857. Submit products subject to the Federal Food, remain unchanged. Drug, and Cosmetic Act (the act) and However, FDA will not use the new information on veterinary drug products other FDA-administered acts. format on European Union (EU) Export to the Division of Epidemiology and Certification is the process by which a Health Certificates. These certificates Surveillance (HFV±210), Center for formal or official attestation is made are for fishery products intended for Veterinary Medicine, Food and Drug concerning a product's regulatory status import into the EU and are not Administration, 5600 Fishers Lane, or the system by which a commodity is considered to be FDA certificates. Rockville, MD 20857. Submit manufactured. Certification does not FDA is notifying foreign embassies information on food products, including show that FDA has ``approved'' the and its counterpart government agencies dietary supplements, to the Office of product for export; however, some of the new format and also advising Special Nutritionals (HFS±456), Center certificates reflect that the product has them that otherwise valid export for Food Safety and Applied Nutrition, been approved for marketing in the certificates issued before January 1, Food and Drug Administration, 200 C United States. 1999, remain valid. Consequently, St. SW., Washington, DC 20204. FDA currently issues several types of persons whose export certificates were FOR FURTHER INFORMATION CONTACT: certificates. In brief, the principal issued before January 1, 1999, but expire For human drug products: Gerald M. certificates are: after that date, should not need to Rachanow, Center for Drug 1. Certificates to Foreign replace those certificates. Evaluation and Research (HFD± GovernmentÐused for products that 560), Food and Drug Dated: December 4, 1998. may be legally marketed, sold, offered Administration, 5600 Fishers Lane, for sale, or distributed in the United William K. Hubbard, Rockville, MD 20857, 301±827± States. For food products, these are Associate Commissioner for Policy 2222. commonly known as ``certificates of free Coordination. For veterinary drug products: William sale'' or ``certificates of export.'' [FR Doc. 98±33052 Filed 12±11±98; 8:45 am] C. Keller, Center for Veterinary 2. Certificates of ExportabilityÐused BILLING CODE 4160±01±F Medicine (HFV±210), Food and for products that meet the requirements Drug Administration, 5600 Fishers for export under section 801(e) or 802 of Lane, Rockville, MD 20857, 301± the act (21 U.S.C. 381(e) or 382)) but DEPARTMENT OF HEALTH AND 827±6641. may not otherwise be marketed, sold, HUMAN SERVICES For food and dietary supplement offered for sale, or distributed in the Food and Drug Administration products: Sharon A. Ross, Center United States. for Food Safety and Applied 3. Certificates of a Pharmaceutical [Docket No. 98N±1109] Nutrition (HFS±456), Food and ProductÐused for pharmaceutical Drug Administration, 200 C St. SW., products and conform to the format in Mercury Compounds in Drugs and Washington, DC 20204, 202±205± the World Health Organization's Food; Request for Data and 5343. Information ``Certification Scheme on the Quality of SUPPLEMENTARY INFORMATION: Pharmaceutical Products Moving in AGENCY: Food and Drug Administration, I. Background International Commerce.'' HHS. FDA's Center for Biologics Evaluation ACTION: Notice; request for data and FDAMA (Pub. L. 105±115) was and Research, Center for Drug information. enacted on November 21, 1997. Section Evaluation and Research, Center for 413 of FDAMA, entitled ``Food and Devices and Radiological Health, Center SUMMARY: The Food and Drug Drug Administration Study of Mercury for Food Safety and Applied Nutrition, Administration (FDA) is announcing a Compounds in Drugs and Food,'' and Center for Veterinary Medicine call-for-data to identify food and drug requires FDA to: (1) Compile a list of receive and process requests for export products that contain intentionally drugs and foods that contain certificates for products subject to their introduced mercury compounds, e.g., intentionally introduced mercury respective authorities. mercurous chloride, mercuric chloride, compounds, and (2) provide a Recently, there has been an increasing phenylmercuric acetate, thimerosal. The quantitative and qualitative analysis of demand for export certificates, as well agency is seeking both quantitative and the mercury compounds in this list. as requests from foreign governments to qualitative information about the FDAMA requires the agency to compile authenticate certificates and instances mercury compounds in these food and the list and provide the analysis within where FDA has found counterfeit or drug products. This request is part of 2 years after the date of its enactment. falsified certificates. Consequently, to the implementation of the Food and The statute does not differentiate 68776 Federal Register / Vol. 63, No. 239 / Monday, December 14, 1998 / Notices whether the mercury compound is used in human drug products. Inorganic FDA has already evaluated the safety present in the products as an active or mercury salts used include mercurous and effectiveness of many of the OTC an inactive ingredient. Therefore, FDA chloride (calomel) and mercuric uses of mercury compounds as part of is requesting data and information on chloride (bichloride of mercury). its OTC drug review. Many mercury any mercury compounds, present as Organic aryl mercury compounds used compounds used as active ingredients active or as inactive ingredients, in any include phenylmercuric acetate and in OTC drug products have been found human or veterinary drug (prescription phenylmercuric nitrate. Some of these to be not generally recognized as safe or OTC) product or any food product, mercury compounds (e.g., (GRAS) and effective and are classified including dietary supplements. phenylmercuric acetate and as new drugs. These mercury phenylmercuric nitrate) have been used II. Mercury Compounds in Human Drug ingredients are listed in § 310.545(a) (21 as both active and inactive ingredients. Products CFR 310.545(a)) (see Table 1 of this Some mercury-containing drug products document). There are several different types of have been marketed by prescription and mercury compounds that have been others have been marketed OTC only. TABLE 1.ÐMERCURY INGREDIENTS LISTED IN 21 CFR 310.545(a) Rulemaking and Ingredients Paragraph Dandruff/seborrheic dermatitis/psoriasis drug products (Docket No. 82N±0214) 310.545(a)(7) Mercury oleate External analgesic drug products: Poison ivy/poison oak/poison sumac drug products (Docket No. 78N± 310.545(a)(10)(vii) 301P) Merbromin (mercurochrome) Mercuric chloride (bichloride of mercury, mercury chloride) Laxative drug products: Stimulant laxatives (Docket No. 78N±036L) 310.545(a)(12)(iv) Calomel (mercurous chloride) Skin bleaching drug products (Docket No. 78N±0065) 310.545(a)(17) Mercury, ammoniated Skin protectant drug products: Poison ivy/poison oak/poison sumac drug products (Docket No. 78N±021P) 310.545(a)(18)(vi) Merbromin (mercurochrome) Mercuric chloride (bichloride of mercury, mercury chloride) Ophthalmic drug products: Anti-infective (Docket No. 80N±0145) 310.545(a)(21)(ii) Mercuric oxide, yellow First aid antiseptic drug products (Docket No. 75N±183F) 310.545(a)(27)(i) Ammoniated mercury Calomel (mercurous chloride) Merbromin (mercurochrome) Mercufenol chloride (ortho-chloromercuriphenol, ortho-hydroxyphenylmercuric chloride) Mercuric chloride (bichloride of mercury, mercury chloride) Mercuric oxide, yellow Mercuric salicylate Mercuric sulfide, red Mercury Mercury oleate Mercury sulfide Nitromersol Para-chloromercuriphenol Phenylmercuric nitrate Thimerosal Vitromersol Zyloxin Antimicrobial diaper rash
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