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.     

Progestational drug products for human use; requirements for labeling directed to the patient. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is revoking its regulation requiring patient labeling for progestational drug products. Patient labeling had been required to inform patients of an increased risk of birth defects reported to be associated with the use of these drugs during the first 4 months of pregnancy. FDA concluded that, based on a review of the scientific data, such labeling for all progestogens is not warranted. In addition, the diversity of drugs that can be described as progestational and the diversity of conditions these drugs may be used to treat make it inappropriate to consider these drugs a single class for labeling purposes. This action is intended to provide consumers with more appropriate labeling for certain drug products.     

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.     

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.     

Delegations of authority and organization; new drug applications--Food and Drug Administration. Final rule

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority regarding approval of new drug applications (NDA's) by redelegating to the Directors of Divisions conducting new drug evaluations authority to approve an additional class of NDA's to expedite the approval process. Published elsewhere in this issue of the Federal Register is a notice reorganizing the Bureau of Drugs and Bureau of Biologics into the National Center for Drugs and Biologics. This document also updates organizational references in accordance with the reorganization.     

Postmarketing studies for approved human drug and licensed biological products; status reports. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is revising the requirements for annual postmarketing status reports for approved human drug and biological products, and is requiring applicants to submit annual status reports for certain postmarketing studies of licensed biological products. This rule describes the types of postmarketing studies covered by these status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. This action will implement the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

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

The Food and Drug Administration (FDA) is issuing a final rule amending the monograph for over-the-counter (OTC) topical antifungal drug products. The amendment makes a minor change in the indications for these drug products. This final rule is part of the ongoing review of OTC drug products conducted by FDA.     

Drug labeling; orally ingested over-the-counter drug products containing calcium, magnesium, and potassium. Final rule

The Food and Drug Administration (FDA) is amending the general labeling provisions for over-the-counter (OTC) drug products to require that the labeling of all OTC drug products intended for oral ingestion include: The calcium content per dosage unit when the product contains 20 milligrams (mg) or more per single dose; a warning statement that persons with kidney stones and persons on a calcium-restricted diet should ask a doctor before using when the product contains more than 3.2 grams (g) of calcium in the labeled maximum daily dose; the magnesium content per dosage unit when the product contains 8 mg or more per single dose; a warning statement that persons with kidney disease and persons on a magnesium-restricted diet should ask a doctor before using if the product contains more than 600 mg magnesium in the labeled maximum daily dose; the potassium content per dosage unit when the product contains 5 mg or more per single dose; and a warning statement that persons with kidney disease and persons on a potassium restricted diet should ask a doctor before using if the product contains more than 975 mg potassium in the labeled maximum daily dose. FDA is issuing this final rule in order to provide uniform calcium, magnesium, and potassium content and warning labeling for all OTC drug products intended for oral ingestion whether marketed under an OTC drug monograph, the ongoing OTC drug review, a new drug application (NDA) or abbreviated new drug application (ANDA), or no application.     

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).     

Medical devices; procedures for investigational device exemptions--Food and Drug Administration. Final rule

This rule sets forth the procedures and conditions under which investigations of medical devices involving human subjects may be exempt from certain requirements of the Federal Food, Drug, and Cosmetic Act, in accordance with the Medical Device Amendments of 1976. The rule sets out the procedures to obtain an investigational device exemption (IDE); it delineates the responsibilities of sponsors, institutional review boards, and clinical investigators with respect to clinical investigations of medical devices; and the rule also prescribes informed consent requirements and specifies recordkeeping and reporting requirements.     

List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its regulations to include a list of drug products that may not be used for pharmacy compounding under the exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the act) because they have had their approval withdrawn or were removed from the market because the drug product or its components have been found to be unsafe or not effective. The list has been compiled under the new statutory requirements of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).     

Delegations of authority and organization; revised organization. Food and Drug Administration. Final rule

The Food and Drug Administration (FDA) is revising the regulation setting forth its organization structure. Several reorganizations have occurred since the structure was last issued. These revised regulations will present FDA's latest organization structure and give the latest addresses for the field organization.     

Anorectal drug products for over-the-counter human use. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing that any over-the-counter (OTC) drug product containing a combination of hydrocortisone and pramoxine hydrochloride (HCl) for anorectal use is not generally recognized as safe and effective and is misbranded. This combination product is not currently marketed OTC. This final rule discusses data on the combination of hydrocortisone and pramoxine HCl that were still under review when an earlier final rule on OTC anorectal drug products was issued. This rule is part of FDA's ongoing review of OTC drug products.     

Additional standards for human blood and blood products; source plasma (human)--Food and Drug Administration. Final rule

The Food and Drug Administration [FDA] is amending the biologics regulations to make clear that an active plasmapheresis donor, who is to be immunized for the production of high-titer plasma, does not need to be reexamined before the first immunization injection if the same donor has previously received a physical examination for plasmapheresis in accordance with section 640.63(b)(1). This rule eliminates a burden on the individual plasmapheresis donor and the plasmapheresis center.