H.R.1862 - Regenerative Medicine Promotion Act of 2011

To launch a national strategy to support regenerative medicine through funding for research and commercial development of regenerative medicine products and development of a regulatory environment that enables rapid approval of safe and effective products, and for other purposes. view all titles (2)

All Bill Titles

  • Official: To launch a national strategy to support regenerative medicine through funding for research and commercial development of regenerative medicine products and development of a regulatory environment that enables rapid approval of safe and effective products, and for other purposes. as introduced.
  • Short: Regenerative Medicine Promotion Act of 2011 as introduced.

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Introduced
 
House
Passes
 
Senate
Passes
 
President
Signs
 

 
05/12/11
 
 
 
 
 
 
 

Official Summary

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 Medicin

Official Summary

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.

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