CCM-CARE Act

Summary

Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2017 or the CCM-CARE Act This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to strengthen and coordinate its efforts concerning cerebral cavernous malformation (CCM). (CCM is a condition in which blood vessels in the brain and spinal cord become enlarged, which can lead to seizures, paralysis, hearing or vision loss, or bleeding in the brain.) The NIH may award grants and enter into cooperative agreements for CCM research. The NIH must: (1) award grants and contracts to plan and provide support for a network of CCM Clinical Research Centers; (2) identify and support additional centers to facilitate medical research to develop a cure for CCM and enhance medical care for CCM; and (3) convene a Cerebral Cavernous Malformations Research Consortium to develop programs for clinicians, scientists, and patients. The Centers for Disease Control and Prevention may award grants and enter into cooperative agreements for the collection, analysis, and reporting of data on CCM. The Department of Health and Human Services must award grants and enter into cooperative agreements for epidemiological activities related to CCM and must provide for a national CCM surveillance program. The Food and Drug Administration must, in order to hasten clinical trials for CCM, coordinate with clinical centers, investigators, and advocates to support: (1) qualification of biomarkers, (2) qualification of patient reported outcome measures for quality of life, (3) investigational new drug applications, and (4) adaptive trial designs for rare disease research and expedited review of medications.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 28 February 2017

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 28 February 2017

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• Introduced in Senate

  summary · EN · 28 February 2017

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