3.0.0 1317 2023-01-13T04:50:26Z 2023-01-13T04:50:26Z Senate S S 2005-06-27 109 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2005-07-11T22:09:01Z Markup by 2005-06-29T21:04:20Z Referred to 2005-06-27T22:50:57Z S. Rept. 109-129 Stem Cell Therapeutic and Research Act of 2005 109 2520 HR 2005-12-20 Became Public Law No: 109-129. Companion bill Senate Related bill House 2005-08-31 sshr00 Health, Education, Labor, and Pensions Committee Senate By Senator Enzi from Committee on Health, Education, Labor, and Pensions filed written report under authority of the order of the Senate of 07/29/2005. Report No. 109-129. Floor 2005-08-31 By Senator Enzi from Committee on Health, Education, Labor, and Pensions filed written report under authority of the order of the Senate of 07/29/2005. Report No. 109-129. Committee 14900 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2005-07-11 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 156. Calendars 2005-07-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. Without written report. Committee 2005-07-11 Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2005-06-29 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2005-06-27 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S7434-7437) IntroReferral 2005-06-27 Sponsor introductory remarks on measure. (CR S7433) IntroReferral B00100 9 Library of Congress 2005-06-27 Introduced in Senate IntroReferral 10000 9 Library of Congress H000338 Sen. Hatch, Orrin G. [R-UT] ORRIN HATCH R UT GRANT N D000388 Sen. Dodd, Christopher J. [D-CT] CHRISTOPHER DODD D CT JOHN 2005-06-27 True B001135 Sen. Burr, Richard [R-NC] Richard Burr R NC Mauze 2005-06-27 True R000122 Sen. Reed, Jack [D-RI] John Reed D RI F. 2005-06-27 True E000194 Sen. Ensign, John [R-NV] JOHN ENSIGN R NV 2005-06-27 True C001041 Sen. Clinton, Hillary Rodham [D-NY] HILLARY CLINTON D NY R 2005-06-28 False M000702 Sen. Mikulski, Barbara A. [D-MD] BARBARA MIKULSKI D MD ANN 2005-06-28 False F000439 Sen. Frist, William H. [R-TN] WILLIAM FRIST R TN H. 2005-06-28 False M001111 Sen. Murray, Patty [D-WA] Patty Murray D WA 2005-06-28 False T000024 Sen. Talent, Jim [R-MO] JIM TALENT R MO 2005-06-28 False C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2005-06-28 False S000148 Sen. Schumer, Charles E. [D-NY] Charles Schumer D NY E. 2005-06-28 False V000126 Sen. Voinovich, George V. [R-OH] GEORGE VOINOVICH R OH V. 2005-06-28 False H000206 Sen. Harkin, Tom [D-IA] THOMAS HARKIN D IA RICHARD 2005-06-28 False B000953 Sen. Brownback, Sam [R-KS] SAM BROWNBACK R KS 2005-06-28 False D000294 Sen. DeWine, Mike [R-OH] MICHAEL DEWINE R OH 2005-06-29 False R000307 Sen. Roberts, Pat [R-KS] PAT ROBERTS R KS 2005-06-29 False D000601 Sen. Dole, Elizabeth [R-NC] Elizabeth Dole R NC H. 2005-06-29 False F000062 Sen. Feinstein, Dianne [D-CA] Dianne Feinstein D CA 2005-06-29 False G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. 2005-06-30 False H001028 Sen. Hagel, Chuck [R-NE] CHUCK HAGEL R NE 2005-07-01 False D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2005-07-11 False K000352 Sen. Kyl, Jon [R-AZ] Jon Kyl R AZ Llewellyn 2005-07-13 False P000590 Sen. Pryor, Mark L. [D-AR] Mark Pryor D AR Lunsford 2005-07-14 False T000250 Sen. Thune, John [R-SD] John Thune R SD R. 2005-07-14 False S000709 Sen. Specter, Arlen [R-PA] ARLEN SPECTER R PA 2005-07-15 False J000072 Sen. Jeffords, James M. [I-VT] JAMES JEFFORDS I VT MERRILL 2005-07-20 False E000285 Sen. Enzi, Michael B. [R-WY] MICHAEL ENZI R WY B. 2005-07-21 False L000504 Sen. Lugar, Richard G. [R-IN] RICHARD LUGAR R IN GREEN 2005-07-22 False C000286 Sen. Chambliss, Saxby [R-GA] SAXBY CHAMBLISS R GA 2005-07-29 False I000055 Sen. Isakson, Johnny [R-GA] Johnny Isakson R GA 2005-09-06 False B001233 Sen. Bayh, Evan [D-IN] EVAN BAYH D IN 2005-10-06 False C001057 Sen. Coleman, Norm [R-MN] Norm Coleman R MN 2005-10-17 False M001153 Sen. Murkowski, Lisa [R-AK] Lisa Murkowski R AK 2005-12-12 False S000059 Sen. Santorum, Rick [R-PA] RICK SANTORUM R PA 2005-12-14 False 2005-07-14T04:00:00Z S. 1317, Stem Cell Therapeutic and Research Act of 2005 http://www.cbo.gov/publication/16979 <p>Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on July 11, 2005</p> 2005-07-14T04:00:00Z S. 1317, Stem Cell Therapeutic and Research Act of 2005 https://www.cbo.gov/publication/16979 Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on July 11, 2005 H.R.2520 https://www.congress.gov/bill/109th-congress/house-bill/2520 Health Accreditation (Medical care) Biological warfare Blood banks Blood diseases Business records Cancer Case management Chemical warfare Childbirth Civil Rights and Liberties, Minority Issues Commerce Confidential communications Congress Congressional investigations Congressional reporting requirements Crime and Law Enforcement Cytology Data banks Donation of organs, tissues, etc. Electronic data interchange Emergency Management Emergency medicine Executive reorganization Families Federal advisory bodies Government Operations and Politics Government paperwork Health education Health information systems Hereditary diseases Immune system Informed consent (Medical law) Law Licenses Medical records Medical research Medical statistics Minorities Minority health Nuclear terrorism Patients' rights Physicians Pregnant women Quality of care Right of privacy Science, Technology, Communications Standards Terrorism Transplantation of organs, tissues, etc. Women Health 00 2005-06-27 Introduced in Senate 2005-07-19T20:31:06Z Bone Marrow and Cord Blood Therapy and Research Act of 2005 - Requires the Secretary of Health and Human Services to contract with qualified cord blood stem cell banks to assist in the collection and maintenance of cord blood to be made available for transplantation through the Bone Marrow and Cord Blood Cell Transplantation Program. Requires the Secretary to require that recipients of such contracts: (1) acquire and store donated units of human cord blood; and (2) make collected cord blood units available for stem cell transplantation or, if not appropriate for clinical use, available for peer-reviewed research.

Requires the Secretary to establish a demonstration project for the collection and storage of cord blood units for a family where a relative has been diagnosed with a condition that will benefit from transplantation.

Amends the Public Health Service Act to rewrite provisions requiring the Secretary to establish and maintain a National Bone Marrow Donor Registry to require the Secretary, acting through the Administrator of the Health Resources and Services Administration (HRSA), to establish and maintain the Bone Marrow and Cord Blood Cell Transplantation Program to increase the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow and cord blood. Requires the Secretary to establish a related Advisory Council. Prescribes new requirements for the Program, including: (1) operating a system for listing, searching, and facilitating the distribution of donated cord blood units; (2) maintaining and expanding medical contingency response capabilities to prepare for and respond effectively to biological, chemical, or radiological attacks and other ublic health emergencies that can damage marrow; and (3) carrying out recruitment programs and educational activities. Requires the Secretary to: (1) enforce quality standards and donor selection criteria; (2) establish an office of patient advocacy; and (3) establish a scientific database of outcome information.

]]> 01 2005-07-11 Reported to Senate with amendment(s) 2005-07-27T20:14:13Z Stem Cell Therapeutic and Research Act of 2005 - (Sec. 2) Requires the Secretary of Health and Human Services to contract with qualified cord blood stem cell banks to assist in the collection and maintenance of 150,000 new units of high-quality cord blood to be made available for transplantation through the C.W. Bill Young Cell Transplantation Program. Requires the Secretary to require that contract recipients: (1) acquire, tissue-type, test, cryopreserve, and store donated units of human cord blood acquired with the informed consent of the donor in a manner that complies with federal and state regulations; (2) encourage donation from a genetically diverse population; (3) make collected cord blood units available for stem cell transplantation or, if not appropriate for clinical use, available for peer-reviewed research; (4) make data available in a standardized electronic format for the Program; and (5) submit data in a standardized format for inclusion in the stem cell therapeutics outcome database.

Requires the Secretary to establish a three-year demonstration project under which qualified cord blood banks may use a portion of the funding received under a contract for the collection and storage of cord blood units for a family where a relative has been diagnosed with a condition that will benefit from transplantation at no cost to such family. Excludes cord blood collected under such project from the 150,000 units to be collected for the Program. Sets forth reporting requirements.

Establishes ten years as the term of such Program contracts. Requires the Secretary to give preference to qualified cord blood banks that have demonstrated a superior ability to satisfy the requirements and achieve the contract goals. Authorizes appropriations.

Amends the Public Health Service Act to rewrite provisions requiring the Secretary to establish and maintain a National Bone Marrow Donor Registry to require the Secretary, acting through the Administrator of the Health Resources and Services Administration (HRSA), to establish and maintain the C.W. Bill Young Cell Transplantation Program to increase the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow and cord blood. Requires the Secretary to establish a related advisory council on Program activities.

Requires the Secretary to: (1) recognize one or more accreditation entities for the accreditation of cord blood banks; and (2) examine issues of informed consent, including the timing of such consent and the information provided to the maternal donor regarding all of her medically appropriate cord blood options.

Adds as Program requirements with respect to bone marrow: (1) permitting transplant physicians, other health care professionals, and patients to search by means of electronic access all available bone marrow donors listed in the Program; (2) maintaining and expanding medical contingency response capabilities to prepare for and respond effectively to biological, chemical, or radiological attacks, and other public health emergencies that can damage marrow, so that the capability of supporting patients with marrow damage from disease can be used to support casualties with marrow damage; and (3) facilitating research with federal agencies to improve the availability, efficiency, safety, and cost of transplants from unrelated donors and the effectiveness of Program operations.

Sets forth Program requirements with respect to cord blood, including: (1) operating a system for identifying, matching, and facilitating the distribution from a qualified cord blood bank of donated cord blood units that are suitably matched to candidate patients and meet all applicable federal and state regulations; (2) allowing transplant physicians, other health care professionals, and patients to search by means of electronic access all available cord blood units made available through the Program; (3) allowing transplant physician and other health care professionals to reserve a cord blood unit for transplantation; (4) supporting studies and demonstration and outreach projects for the purpose of increasing cord blood donation to ensure a genetically diverse collection of cord blood units; (5) providing for a system of patient advocacy; (6) coordinating with the qualified cord blood banks to support informational and educational activities; (7) maintaining and expanding medical contingency response capabilities to prepare for and respond to biological, chemical, or radiological attacks, and other public health emergencies that can damage marrow; and (8) collecting, analyzing, and publishing data in a standardized electronic format on the number and percentage of patients at each of the various stages of the search process.

Requires the Secretary to: (1) ensure that health care professionals and patients are able to search electronically for and facilitate access to cells from bone marrow donors and cord blood units through a single point of access; and (2) require all contract recipients under this Act to make data available in a standardized electronic format that enables transplant physicians to compare among bone marrow donors and cord blood units to ensure the best possible match for the patient.

Requires the Program to carry out activities for the recruitment of bone marrow donors and cord blood donors, including by (1) identifying populations that are underrepresented among potential donors enrolled with the Program; (2) giving priority to increasing representation for such populations; and (3) considering racial and ethnic minority groups to be such populations.

Requires the Program to carry out informational and educational activities to recruit individuals to serve as donors of bone marrow and pregnant women to serve as donors of cord blood, including by: (1) making information available to the general public; (2) educating and providing information to potential donors; (3) training individuals in requesting donors; (4) giving priority to recruiting donors for underrepresented populations; and (5) providing information to physicians, other health care professionals, and the public regarding bone marrow transplants from unrelated donors and cord blood transplants for donors as treatment options.

Requires the Secretary to enforce for participating entities: (1) quality standards and standards for tissue-typing, obtaining the informed consent of donors, and providing patient advocacy; (2) donor selection criteria to protect both the donor and the recipient and to prevent the transmission of potentially harmful infectious diseases; (3) procedures to ensure the proper collection and transportation of the marrow; (4) standards for patient advocacy; and (5) confidentiality standards.

Requires the Secretary to establish and maintain an office of patient advocacy to: (1) operate a system for patient advocacy to serve patients for whom the Program is searching for a bone marrow donor or cord blood unit; (2) serve as an advocate for the patient by directly providing individualized services on the efficient utilization of the system to conduct an ongoing search and assist with information regarding third party payors; (3) monitor the searching system to determine whether the needs of the patient involved are being met; (4) conduct surveys of patients, family members, physicians, or other individuals acting on behalf of a patient to determine the extent of satisfaction with the system for patient advocacy; (5) provide individualized case management services; and (6) provide information and education on the process of receiving a transplant after a completed search.

Requires the Secretary to give consideration to the continued safety of donors and patients and other factors in awarding contracts under this Act. Requires contract recipients to keep records. Prescribes criminal penalties for violations of confidentiality provisions.

Requires the Secretary to establish and maintain a scientific database of information relating to recipients of a stem cell therapeutics product, including bone marrow and cord blood, from a donor. Requires the database to make relevant scientific information not containing individually identifiable information available to the public to encourage medical research and to provide information to interested parties.

Authorizes appropriations.

(Sec. 4) Requires the Secretary to submit to Congress a report on the progress made by the Food and Drug Administration (FDA) in developing requirements for the licensing of cord blood units.

]]> Stem Cell Therapeutic and Research Act of 2005 Display Title Stem Cell Therapeutic and Research Act of 2005 Short Titles as Introduced Bone Marrow and Cord Blood Therapy and Research Act of 2005 Short Titles as Reported to Senate Stem Cell Therapeutic and Research Act of 2005 S Senate Popular Titles Stem Cell Research bill 9 Library of Congress Official Title as Introduced A bill to provide for the collection and maintenance of cord blood units for the treatment of patients and research, and to amend the Public Health Service Act to authorize the Bone Marrow and Cord Blood Cell Transplantation Program to increase the number of transplants for recipients suitable matched to donors of bone marrow and cord blood. Reported to Senate 2005-07-11T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109s1317rs/xml/BILLS-109s1317rs.xml Introduced in Senate 2005-06-27T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-109s1317is/xml/BILLS-109s1317is.xml 2005-08-31 By Senator Enzi from Committee on Health, Education, Labor, and Pensions filed written report under authority of the order of the Senate of 07/29/2005. Report No. 109-129. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.