Over-the-counter human drugs; labeling requirements. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products. This final rule is intended to assist consumers in reading and understanding OTC drug product labeling so that consumers may use these products safely and effectively. This final rule will require all OTC drug products to carry the new, easy-to-read format and the revised content requirements within prescribed implementation periods.     

Delegations of authority and organization; Center for Devices and Radiological Health. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect redelegations to other officials within the Center for Devices and Radiological Health (CDRH) pertaining to: Certifying true copies and using the Department seal, disclosing official records, issuing reports of minor violations, and medical device reporting procedures. This amendment is intended to reflect those redelegations.     

New drug applications; drug master files. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is revising its regulation governing drug master files (DMF's). FDA is removing the provision for submitting Type I DMF's and will no longer permit information submitted in a Type I DMF to be incorporated by reference in investigational new drug applications (IND's), new drug applications (NDA's), abbreviated new drug applications (ANDA's), or amendments or supplements to any of these. This rule is intended to eliminate submissions of information that are not necessary either to conduct inspections of manufacturing facilities or to review the chemistry, manufacturing, and controls sections of IND's, NDA's, and abbreviated applications.     

Medical devices; revocation of cardiac pacemaker registry. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to revoke a regulation requiring a cardiac pacemaker registry. The registry, which was mandated by the Deficit Reduction Act of 1984, requires any physician and any provider of services who requests or receives Medicare payment for an implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the registry. The information is used by FDA to track the performance of permanent cardiac pacemakers and pacemaker leads and by the Health Care Finance Administration (HCFA) to administer its Medicare payment program for these devices. This action is being taken to implement an act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress in 1996 to remove the cardiac pacemaker registry to eliminate duplicative and unnecessary reporting.     

Medical devices; laser fluorescence caries detection device. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the laser fluorescence caries detection device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.     

Obstetrical and gynecological devices; classification of female condoms. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the preamendments female condom intended for contraceptive and prophylactic purposes. Under this rule, the preamendments female condom is being classified into class III (premarket approval). This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997.     

Laxative drug products for over-the-counter human use. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing that the over-the-counter (OTC) stimulant laxative ingredients danthron and phenolphthalein are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule as part of its ongoing review of OTC drug products after considering data and information on the safety of danthron and phenolphthalein.     

Food labeling: health claims; soy protein and coronary heart disease. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is authorizing the use, on food labels and in food labeling, of health claims on the association between soy protein and reduced risk of coronary heart disease (CHD). Based on its review of evidence submitted with comments to the proposed rule, as well as evidence described in the proposed rule, the agency has concluded that soy protein included in a diet low in saturated fat and cholesterol may reduce the risk of CHD by lowering blood cholesterol levels.     

Dental products devices; reclassification of endosseous dental implant accessories. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is reclassifying the manually powered drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, trial abutments, and other manually powered endosseous dental implant accessories from class III to class I. These devices are intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than an hour. FDA is also exempting these devices from premarket notification. This reclassification is on the Secretary of Health and Human Services' own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Sunscreen drug products for over-the-counter human use; final monograph. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and new data and information on sunscreen drug products that have come to the agency's attention. FDA is also issuing final rules regarding the labeling of certain cosmetic products to inform consumers that these products do not provide protection from the sun.     

Over-the-counter human drugs; labeling requirements; final rule; technical amendment. Food and Drug Administration, HHS. Final rule; technical amendment

The Food and Drug Administration (FDA) is amending the regulation that established a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products, and is amending several related OTC drug product labeling regulations. This amendment corrects and conforms several aspects of the new labeling requirements to other regulatory provisions and eliminates unnecessary text from the new labeling regulation.     

Medical devices; gastroenterology-urology devices; nonimplanted, peripheral electrical continence device. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the nonimplanted, peripheral electrical continence device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.     

Medical devices; reclassification and codification of the stainless steel suture. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Alto Development Corp. (the petitioner) reclassifying the 316L stainless steel suture for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure from class III (premarket approval) to class II (special controls). The order is being codified in the Code of Federal Regulations (CFR). Although FDA reclassified the device in 1986, it inadvertently neglected to publish a notice of the reclassification in the Federal Register or codify the change in the CFR.     

Gastroenterology-urology devices: reclassification of the penile rigidity implant. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is reclassifying the penile rigidity implant from class III to class II when intended to provide penile rigidity in men diagnosed as having erectile dysfunction. The special control is the FDA guidance document entitled "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants." This action is taken on FDA's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997.     

Gastroenterology and urology devices; reclassification of the extracorporeal shock wave lithotripter. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to reclassify from class III to class II the extracorporeal shock wave lithotripter, when intended for use to fragment kidney and ureteral calculi. FDA is taking this action on its own initiative in order to assure that these devices are regulated according to the appropriate degree of regulatory control needed to provide reasonable assurance of their safety and effectiveness.     

Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices.     

Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing regulations on the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis and monitoring of diseases. FDA is issuing these regulations in accordance with the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). These regulations are intended to clarify existing regulations applicable to the approval of radiopharmaceutical drugs and biologics under the Federal Food, Drug, and Cosmetic Act (the act) and the Public Health Service Act (the PHS Act).