Department of Health and Human Services January 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.'' The guidance describes the amount, type, and quality of evidence that FDA recommends a manufacturer have to substantiate a claim under this section of the Federal Food, Drug, and Cosmetic Act (the act).

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Clinical Center, the National Institutes of Health will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget for review and approval. Proposed Collection: Title: The impact of clinical research training and medical education at the Clinical Center on physician careers in academia and clinical research: Type of Information Collection Request: New. Need and Use of Information Collection: This study will assess the value of the training programs administered by the Office of Clinical Research Training and Medical Education. The primary objective of the survey is to determine if training programs have had an impact on whether the trainees are performing clinical research, hold an academic appointment, have National Institutes of Health funding sources as well as to obtain information from the trainees as to what part of the National Institutes of Health medical education program they feel could be improved upon, the quality of the mentoring program, and how their National Institutes of Health training has contributed to their current clinical competence. Frequency of response: On occasion. Affected Public: Physicians, dentists, medical students, dental students, nurses, and PhDs. The annual reporting burden is as follows:

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is classifying enterovirus nucleic acid assay 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: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA'' (ribonucleic acid). 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 the guidance document that will serve as the special control for this device.

Consistent with section 4312(a) of the Balanced Budget Act of 1997 (BBA), this final rule implements section 1834(a)(16) of the Social Security Act (the Act) by requiring certain Medicare suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) to furnish CMS with a surety bond.