H.R. 6081 (111th): Stem Cell Therapeutic and Research Reauthorization Act of 2010

Introduced:
Aug 09, 2010 (111th Congress, 2009–2010)
Sponsor:
Rep. W. Bill Young [R-FL10]
Status:
Died (Reported by Committee)
See Instead:

S. 3751 (same title)
Signed by the President — Oct 08, 2010

The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.

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Status

This bill was introduced on September 23, 2010, in a previous session of Congress, but was not enacted.

Progress
Introduced Aug 09, 2010
Reported by Committee Sep 23, 2010
Cosponsors
10 cosponsors (10D) (show)
Committees

House Energy and Commerce

The committee chair determines whether a bill will move past the committee stage.

Full Title

To amend the Stem Cell Therapeutic and Research Act of 2005.

Summary

No summaries available.

Text

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Last updated Sep 28, 2010.
18 pages

Primary Source

View on THOMAS (The Library of Congress)

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

9/28/2010.
Section 2 -
Amends the Stem Cell Therapeutic and Research Act of 2005 to revise provisions related to the National Cord Blood Inventory (the Inventory), including to establish an inventory goal of at least 150,000 new units of cord blood to be made available under the C.W. Bill Young Cell Transplantation Program (the Program). (Currently, the number of units of cord blood is capped at 150,000.) Revises application requirements for cord blood banks participating in the Inventory to require such banks to: (1) make assurances that cord blood units will be available for direct transplantation until it is released for transplantation for a first degree relative; (2) participate in the Program for a period of at least ten years, beginning on the last date on which the recipient receives federal funds under a contract; (3) provide a plan to increase cord blood unit collections at collection sites that exist at the time of application, assist with the establishment of new collection sites, or contract with new collection sites; and (4) annually provide to the Secretary of Health and Human Services (HHS) a plan for, and demonstrate, ongoing measurable progress toward achieving self-sufficiency of cord blood unit collection and banking operations. Revises the requirements for a contract extension to make a qualified cord blood bank eligible for a five-year extension if the bank demonstrates a superior ability to satisfy the requirements of the contract and achieve the overall goals for which the contract was awarded. Redefines the term "first-degree relative" to exclude a parent. Authorizes appropriations for FY2011-FY2015 for the Inventory. Amends the Public Health Service Act to require the Program to support and expand studies and demonstration and outreach projects that focus on: (1) remote collection of cord blood units; and (2) novel approaches or incentives to encourage innovative technological advances that could be used to collect cord blood units. Defines "remote collection" to mean the collection of cord blood units at locations that do not have written contracts with cord blood banks for collection support. Requires the Secretary to: (1) set an annual goal of increasing collections of high quality cord blood units; (2) identify at least one demonstration or outreach project to replicate and expand nationwide, as appropriate; and (3) submit a plan for meeting such goal to the relevant congressional committees if no such project can be identified. Revises privacy requirements to protect the identity and privacy of patients and donors in accordance with federal and state law. Requires the Secretary to submit an interim report to Congress within 180 days of enactment of this Act describing: (1) the methods to distribute federal funds to cord blood banks; (2) how cord blood banks contract with collection sites for the collection of cord blood units; and (3) recommendations for improving the methods to distribute federal funds to encourage the efficient collection of high-quality and diverse cord blood units. Directs the Advisory Council on Blood Stem Cell Transplantation to submit recommendations to the Secretary with respect to remote collection of cord blood units. Authorizes appropriations for FY2011-FY2015 to carry out the Program. Directs the Comptroller General to submit to the relevant congressional committees and the Secretary a report reviewing studies, demonstration programs, and outreach efforts for the purpose of increasing cord blood unit donation and collection for the Inventory to ensure a high-quality and genetically diverse inventory of cord blood units.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

This summary can be found at http://www.gop.gov/bill/111/2/hr6081.

Background

In 2005, Congress approved the Stem Cell Therapeutic and Research Act of 2005, which facilitated the use of umbilical-cord-blood stem cells in biomedical research and in the treatment of disease. Cord-blood stem cells, collected from the placenta and umbilical cord after birth without doing harm to mother or child, have been used in the treatment of thousands of patients suffering from more than 60 different diseases, including leukemia, Fanconi anemia, sickle cell disease, and thalassemia. Researchers also believe cord-blood stem cells may have the capacity to be differentiated into other cell types, making them useful in the exploration of ethical stem cell therapies for regenerative medicine.

Summary

H.R. 6081 would reauthorize the C.W. Bill Young Cell Transplantation Program, which includes the National Registry for adult donors of bone marrow, peripheral blood [adult] stem cells, and umbilical cord blood units, as well as the National Cord Blood Inventory (NCBI) for an additional 5 year period.  The current authorization expires at the end of Fiscal Year 2010.

Specifically, H.R. 6081 would do the following:

 

  • Remove the 150,000 cap on cord blood units to be made available for transplant. 

 

  • Extend the term of initial and contract extensions from three to five years, making it easier for banks to engage in long-term relationship building with birthing hospitals.

 

  • Require cord blood banks to establish a plan for increasing cord blood unit collections and/or expand the number of collection sites with which they work.

 

  • Require cord blood banks to provide a plan for becoming self-sufficient.

 

  • Clarify the minimum timeframe for maintaining NCBI cord blood units on the National Registry.

 

  • Correct the definition of “first-degree relative” to exclude a parent.

 

  • Authorize $23 million to be appropriated for fiscal year 2011 through fiscal year 2014 and $20 million for fiscal year 2015 for the NCBI (when combined with the funding levels for the program, the overall bill does not increase federal spending).

 

  • Allow Health Resources and Service Administration (HRSA) to allocate funds appropriated in the following year, as needed, for both the program and the NCBI.

 

  • Update the annual reporting requirements for the program.

 

  • Enhance the studies, demonstration programs, and outreach projects related to cord blood donation and collection to include exploring innovative technologies, novel approaches, and expanding the number of collection sites.

 

  • Update the confidentiality language that applies to adult donors to make it consistent with the requirements for cord blood donors and existing federal and state privacy laws.

 

  • Authorize $30 million to be appropriated for fiscal year 2011 through fiscal year 2014 and $33 million for fiscal year 2015 for the program (when combined with the funding levels for the NCBI, the overall bill does not increase federal spending).

 

  • Require a GAO report to review studies, demonstration programs, and outreach efforts for the purpose of increasing cord blood unit donation and collection for the NCBI to ensure high-quality and genetically diverse inventory of cord blood units.

Cost

As of publication, the Congressional Budget Office had not released a score of H.R. 6081.   

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

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