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HHS Seeks Advice on Improving Cooperation between NIH, FDA, CDC, and CMS

NEW YORK, May 25 (GenomeWeb News) - The US Department of Health and Human Services yesterday issued a request for comments on how HHS agencies can "work together to facilitate the development and approval of new medical technologies."


The HHS solicitation, posted here, comes a month after a similar request for comments from the Food and Drug Administration. HHS oversees the activities of the FDA, as well as the National Institutes of Health, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services. HHS said that the FDA notice, which followed a white paper that it released in March calling for new approaches to post-genomic drug and device development, "focused exclusively on FDA," while the HHS notice requests "that all constituents comment on what HHS agencies can do together to stimulate innovation in medical technologies."


Comments, which can be submitted here, are due on August 23.


HHS proposed seven specific questions for consideration in the notice:

  • What strategies and approaches could HHS implement to accelerate the development and application of new medical technologies?
  • How can HHS help its agencies to work together more effectively to eliminate obstacles to development of medical technologies?
  • How can the HHS scientific and regulatory agencies work more effectively with the Centers for Medicare and Medicaid Services to eliminate obstacles to development?
  • What forums should HHS use to survey constituents about obstacles to innovation?
  • How can the portability of information between HHS agencies be optimized?
  • Which HHS policies and programs effectively spur innovation? Which policies and programs at NIH (and its grantees), CMS, FDA, and CDC should be expanded to help spur innovation? Do any policies and programs pose obstacles to innovation?
  • What role should be played by nongovernmental partners in assisting the Federal Government in this process?
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