H.R.2521 - Cavernous Angioma Research Resource Act of 2013113th Congress (2013-2014)
|Sponsor:||Rep. Lujan, Ben Ray [D-NM-3] (Introduced 06/26/2013)|
|Committees:||House - Energy and Commerce|
|Latest Action:||06/28/2013 Referred to the Subcommittee on Health.|
This bill has the status Introduced
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Summary: H.R.2521 — 113th Congress (2013-2014)All Bill Information (Except Text)
Introduced in House (06/26/2013)
Cavernous Angioma Research Resource Act of 2013 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH), acting through the Director of the National Institute of Neurological Disorders and Stroke, to expand and intensify NIH programs regarding research and related activities concerning cavernous angioma. Authorizes grants and cooperative agreements to public or nonprofit private entities for such activities.
Authorizes the Director of NIH to: (1) conduct basic, clinical, and translational research on cavernous angioma; (2) identify and support the development of a clinical and research coordinating center with the potential of coordinating a multi-site clinical drug trial for cavernous angioma; and (3) identify and support the development of clinical and research participation centers with the potential to participate in such a trial.
Requires coordinating and participation centers to expand training programs for medical and allied health clinicians and scientists in clinical practice and research relevant to cavernous angioma.
Authorizes the Director to provide for the participation of NIH agencies in a consortium (to include at least one patient advocacy organization) to facilitate the exchange of information and increase the efficiency and effectiveness of the research effort.
Authorizes the Secretary of Health and Human Services (HHS) to award grants and cooperative agreements, including technical assistance, to public or nonprofit private entities for: (1) the collection, analysis, and reporting of data on cavernous angioma; and (2) epidemiological activities, including collecting and analyzing information on the number, incidence, correlates, and symptoms of cases and the clinical utility of specific practice patterns. Requires establishment of a national surveillance program as part of such activities.
Requires the Commissioner of Food and Drugs (FDA) to: (1) work with clinical centers, investigators, and advocates to support appropriate investigational new drug applications under the Federal Food, Drug, and Cosmetic Act in order to hasten the pace of clinical trials for cavernous angioma; and (2) where applicable in rare subpopulations of cavernous angioma requiring unique pharmacological intervention, including those with the Common Hispanic Mutation or CCM3 gene mutations, support appropriate requests for designations of orphan drugs.