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H.R. 1862 (112th): Regenerative Medicine Promotion Act of 2011


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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on May 12, 2011.


Regenerative Medicine Promotion Act of 2011 - Requires the Comptroller General to submit to Congress a report identifying all ongoing federal programs and activities regarding regenerative medicine.

Directs the Secretary of Health and Human Services (HHS) to establish a Regenerative Medicine Coordinating Council in the Office of the Secretary, the duties of which shall include: (1) preparing a national strategy to support research into regenerative medicine and the development of drugs, biological products, medical devices, and biomaterials for use in regenerative medicine; (2) identifying sources of funding for research into regenerative medicine and areas where such funding is inadequate; and (3) making recommendations regarding federal policies to support development and marketing of regenerative medicine products.

Authorizes the Secretary, acting through the Director of the National Institutes of Health (NIH), to make grants for: (1) basic or preclinical research into regenerative medicine; (2) research and development of drugs, biological products, medical devices, and biomaterials for use in regenerative medicine; and (3) the making of an investigational new drug application or an investigational device exemption application within four years of receiving such grant.

Amends the Public Health Service Act to authorize the Director of NIH to award grants, contracts, or cooperative agreements to accelerate the development of high need cures through the development of medical products and behavioral therapies for use in regenerative medicine.

Authorizes the Secretary, acting through the Commissioner of Food and Drugs, to: (1) conduct, support, or collaborate in regulatory research to assist the Food and Drug Administration (FDA) in performing its functions with respect to regenerative medicine; or (2) make grants to fund regulatory research for such purpose.