Department of Health and Human Services October 4, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is classifying AFP-L3% (alpha-fetoprotein L3 subfraction) immunological test systems 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: AFP-L3% Immunological Test Systems.'' The agency is classifying the 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 announcing the availability of a guidance document that will serve as the special control for the device.

The Food and Drug Administration (FDA) is announcing the opening of a docket to receive information and comments on the June 13 and 14, 2005, public workshop entitled ``Biological Products for Treatment of Rare Plasma Protein Disorders'' (the workshop). We are opening the docket to gather additional information from interested persons on the challenges in the development of products to treat rare plasma protein disorders and on current and future opportunities to facilitate development of such products. Interested persons may also submit comments on the workshop presentations and discussions, which we are also making available.

The House Appropriations Committee Report 108-636 includes a provision for the Health and Human Services Assistant Secretary for Planning and Evaluation (HHS/ASPE) and the Office of Management and Budget (OMB) to establish an interagency committee, to be coordinated by HHS. The committee's role is to examine major federal regulations governing the health care industry and to make suggestions regarding how health care regulation could be coordinated and simplified to reduce costs and burdens and improve translation of biomedical research into medical practice, while continuing to protect patients. This committee will examine the economic impact of the major federal regulations governing the health care industry, and will explore both immediate steps and longer-term proposals for reducing regulatory burden, while maintaining the highest quality health care and other patient protections. In accord with the House Appropriations Committee's intent, ASPE and OMB are undertaking several complementary activities. First, we are establishing an interagency committee to undertake a comprehensive review of federal health care regulations, guidance, and paperwork requirements in order to identify areas for reform. Second, we are planning to hold a series of public meetings in order to hear directly from health care administrators, institutional providers, physicians, practitioners, patients, and others about the impact of regulations, and to identify other potential areas for reform. The public meetings will be held in several cities across the country to provide an opportunity for input. Individuals may also submit written comments, regardless of their ability to attend the public meetings, for consideration by the interagency committee. Information about the schedule of public meetings and registration procedures will be available on the Web site https://aspe.hhs.gov/arrb. In order to assist the committee in studying regulatory impact and reform, in this notice ASPE is also requesting public nominations of federal health care regulations that could be coordinated and simplified to reduce costs and burdens and improve the translation of biomedical research into medical practice. In particular, commenters are requested to suggest specific reforms to regulations, guidance documents, or paperwork requirements that would improve the delivery of health care by increasing efficiency, reducing unnecessary costs, removing uncertainty, and increasing flexibility, while maintaining or improving patient safety and quality of care and other patient protections. The emphasis is on major regulations issued within the last ten (10) years. ASPE requests that commenters, in the selection of which reform ideas to submit, consider the extent to which (1) Benefits (quantitative and/or qualitative) are likely to exceed costs for the reform, (2) benefits (quantitative and/or qualitative) can be increased without exceeding costs, (3) the suggested change would improve patients' health and quality of care, (4) the agency or multiple agencies have statutory authority to make the suggested change, and (5) the rule or program is a major contributor to the regulatory burden imposed on the health care sector. While both legislative and administrative reforms are welcome, administrative reforms such as those that require discretionary rulemaking are more likely to be initiated in a timely manner. The reforms may include modifying, extending, or rescinding regulatory programs, guidance documents or paperwork requirements. Once we receive the nominations from the public, HHS, in cooperation with OMB, will assemble and evaluate the reform nominations and discuss each of them with the relevant HHS Operating Divisions, taking into account statutory, economic, public health, and budgetary considerations.