Decentralization: The latest fashion in development administration?

There has been a resurgence of interest in decentralization, but decentralization is now somewhat differently conceived from the way it was in the 1960s. With somewhat different objectives, decentralization also take different forms and this calls into question the value of the well established categories of devolution and deconcentration.     

Medical devices; obstetrical and gynecological devices; classification of the assisted reproduction laser system. Final rule

The Food and Drug Administration (FDA) is classifying the assisted reproduction laser system into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems." 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. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the guidance document that is the special control for this device.     

Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.     

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 devices; dental noble metal alloys and dental base metal alloys; designation of special controls. Final rule

The Food and Drug Administration is amending the identification and classification regulations of gold-based alloys and precious metal alloys for clinical use and base alloys devices in order to designate a special control for these devices. FDA is also exempting these devices from premarket notification requirements. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance documents that would serve as special controls for these devices.     

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.     

Analysis of the CODIS autosomal STR loci in four main Colombian regions

Genotype polymorphism studies at the 13 loci STRs included in the combined DNA index system [CODIS and PCR-based short tandem repeat loci, in: Proceedings of the Second European Symposium on Human Identification, Promega Corporation, Madison, WI, 1998, pp. 73-88; J. Forensic Sci. 46 (2001) 453] (CODIS: D3S1358, HUMvWA31, HUMFGA, D8S1179 D21S11, D18S51, D5S818, D13S317, D7S820, HUMTH01, HUMTPOX, HUMCSF1PO and D16S539) were carried out in a sample of 1429 unrelated Colombian individuals belonging to 25 different departments. As many other countries in Latino-America, Colombia shows an important admixture component, basically integrated by Amerindians, European-descendants and African-descendants. Due to the fact that only partial population analyses have been carried out in the country, the main aim of the present analysis is to establish a database of forensic interest based on the widely used CODIS systems covering the main Colombian regions.     

Smallpox Vaccine Injury Compensation Program: administrative implementation. Interim final rule

The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), authorizes the Secretary of Health and Human Services (the Secretary), to establish the Smallpox Vaccine Injury Compensation Program ("the Program"). This program is designed to provide benefits and/or compensation to certain persons harmed as a direct result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a direct result of contracting vaccinia through certain accidental exposures. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of these injuries. On August 27, 2003, the Secretary published an interim final rule that set out a Smallpox (Vaccinia) Vaccine Injury Table ("the Table"). The table includes adverse effects (including injuries, disabilities, conditions, and deaths) within specific time periods that shall be presumed to result from the receipt of, or exposure to, the smallpox vaccine. The Secretary will use this table, as well as the procedures set out in this regulation, in deciding whether persons are eligible to receive benefits under the program. In this interim final rule, the Secretary is setting out the administrative policies, procedures, and requirements governing the program, as authorized by the SEPPA. The Secretary is seeking public comment on this interim final rule.     

International Conference on Harmonisation; Stability Data Package for Registration Applications in Climatic Zones III and IV; Stability Testing of New Drug Substances and Products; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of two guidances prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The first is a guidance entitled "Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV' (the Q1F guidance). The second is a revised guidance entitled "Q1A(R2) Stability Testing of New Drug Substances and Products' (the Q1A guidance). The Q1F guidance, which is an annex to the Q1A guidance, defines an approach for broader use of the Q1A guidance for territories in climatic zones III and IV. The revised Q1A guidance incorporates relevant Q1F recommendations.