Stem Cell Therapeutic and Research Reauthorization Act of 2015

Bill: 114-hr-2820
Sponsor: full_name: Rep. Smith, Christopher H. [R-NJ-4]
Introduced: 2015-06-18
Policy area: Health
Subjects: Administrative law and regulatory procedures

Blood and blood diseases

Cell biology and embryology

Department of Health and Human Services

Health programs administration and funding

Medical research

Organ and tissue donation and transplantation

Public contracts and procurement

Research administration and funding
Latest action: action_date: 2015-12-18
text: Became Public Law No: 114-104.

Summaries:
action_date: 2015-06-18
action_desc: Introduced in House
text: <p><b>Stem Cell Therapeutic and Research Reauthorization Act of 2015</b></p> <p>This bill amends the Stem Cell Therapeutic and Research Act of 2005 to reauthorize the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program through FY2020. (These programs help match patients in need of a transplant with unrelated bone marrow and cord blood donors.)</p>

action_date: 2015-09-08
action_desc: Passed House without amendment
text: <p>(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)</p> <p><b>Stem Cell Therapeutic and Research Reauthorization Act of 2015</b></p> <p>(Sec. 2) This bill amends the Stem Cell Therapeutic and Research Act of 2005 to reauthorize the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program through FY2020. (These programs help match patients in need of a transplant with unrelated bone marrow and cord blood donors.)</p>

action_date: 2015-12-03
action_desc: Reported to Senate with amendment(s)
text: <p><b>Stem Cell Therapeutic and Research Reauthorization Act of 2015</b></p> <p>(Sec. 2) This bill amends the Public Health Service Act and the Stem Cell Therapeutic and Research Act of 2005 to revise and extend through FY2020 the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory program. (These programs help match patients in need of a transplant with unrelated bone marrow and cord blood donors.) </p> <p> <p>The Department of Health and Human Services (HHS) must review the state of the science of using adult stem cells and birthing tissues to develop new therapies and consider the inclusion of new therapies in the C.W. Bill Young Cell Transplantation Program.</p> <p>(Sec. 3) Requirements for HHS contracts under the Stem Cell Therapeutic and Research Act of 2005 are revised.</p> (Sec. 4) HHS must determine whether to include peripheral blood stem cells and umbilical cord blood in the definition of human organ.

action_date: 2015-12-09
action_desc: Passed Senate amended
text: <p>(This measure has not been amended since it was reported to the Senate on December 3, 2015. The summary of that version is repeated here.)</p> <p><b>Stem Cell Therapeutic and Research Reauthorization Act of 2015</b></p> <p>(Sec. 2) This bill amends the Public Health Service Act and the Stem Cell Therapeutic and Research Act of 2005 to revise and extend through FY2020 the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory program. (These programs help match patients in need of a transplant with unrelated bone marrow and cord blood donors.) </p> <p>The Department of Health and Human Services (HHS) must review the state of the science of using adult stem cells and birthing tissues to develop new therapies and consider the inclusion of new therapies in the C.W. Bill Young Cell Transplantation Program. <p>(Sec. 3) Requirements for HHS contracts under the Stem Cell Therapeutic and Research Act of 2005 are revised.</p> (Sec. 4) HHS must determine whether to include peripheral blood stem cells and umbilical cord blood in the definition of human organ.

action_date: 2015-12-18
action_desc: Public Law
text: <p>(This measure has not been amended since it was reported to the Senate on December 3, 2015. The summary of that version is repeated here.)</p> <p><b>Stem Cell Therapeutic and Research Reauthorization Act of 2015</b></p> <p>(Sec. 2) This bill amends the Public Health Service Act and the Stem Cell Therapeutic and Research Act of 2005 to revise and extend through FY2020 the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory program. (These programs help match patients in need of a transplant with unrelated bone marrow and cord blood donors.) </p> <p>The Department of Health and Human Services (HHS) must review the state of the science of using adult stem cells and birthing tissues to develop new therapies and consider the inclusion of new therapies in the C.W. Bill Young Cell Transplantation Program. <p>(Sec. 3) Requirements for HHS contracts under the Stem Cell Therapeutic and Research Act of 2005 are revised.</p> (Sec. 4) HHS must determine whether to include peripheral blood stem cells and umbilical cord blood in the definition of human organ.

tv_txt: I 114th CONGRESS 1st Session H. R. 2820 IN THE HOUSE OF REPRESENTATIVES June 18, 2015 Mr. Smith of New Jersey (for himself, Ms. Matsui , Mr. Jolly , and Mr. Fattah ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes.

1. Short title This Act may be cited as the Stem Cell Therapeutic and Research Reauthorization Act of 2015 . 2. Amendments to the Stem Cell Therapeutic and Research Act of 2005 (a) Cord blood inventory Section 2 of the Stem Cell Therapeutic and Research Act of 2005 ( 42 U.S.C. 274k note) is amended in subsection (h)— (1) in paragraph (1)— (A) by striking $23,000,000 for each of fiscal years 2011 through 2014 and ; and (B) by inserting before the period at the end the following: and $23,000,000 for each of fiscal years 2016 through 2020 ; and (2) in paragraph (2), by striking 2011 through 2015 and inserting 2015 through 2020 . (b) National program Section 379B of the Public Health Service Act ( 42 U.S.C. 274m ) is amended by striking 2011 through 2014 and inserting 2016 through 2020 .

tv_txt: I 114th CONGRESS 1st Session H. R. 2820 IN THE HOUSE OF REPRESENTATIVES AN ACT To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes.

1. Short title This Act may be cited as the Stem Cell Therapeutic and Research Reauthorization Act of 2015 . 2. Amendments to the Stem Cell Therapeutic and Research Act of 2005 (a) Cord blood inventory Section 2 of the Stem Cell Therapeutic and Research Act of 2005 ( 42 U.S.C. 274k note) is amended in subsection (h)— (1) in paragraph (1)— (A) by striking $23,000,000 for each of fiscal years 2011 through 2014 and ; and (B) by inserting before the period at the end the following: and $23,000,000 for each of fiscal years 2016 through 2020 ; and (2) in paragraph (2), by striking 2011 through 2015 and inserting 2015 through 2020 . (b) National program Section 379B of the Public Health Service Act ( 42 U.S.C. 274m ) is amended by striking 2011 through 2014 and inserting 2016 through 2020 .

Passed the House of Representatives September 8, 2015. Karen L. Haas, Clerk.

tv_txt: IB Union Calendar No. 183 114th CONGRESS 1st Session H. R. 2820 [Report No. 114–242] IN THE HOUSE OF REPRESENTATIVES June 18, 2015 Mr. Smith of New Jersey (for himself, Ms. Matsui , Mr. Jolly , and Mr. Fattah ) introduced the following bill; which was referred to the Committee on Energy and Commerce September 8, 2015 Additional sponsors: Mr. Grijalva , Mr. Huelskamp , Mr. Bilirakis , Mr. Murphy of Pennsylvania , Mrs. Ellmers of North Carolina , Mr. Roskam , Mr. Harris , Mr. DeFazio , Mr. Aderholt , Mr. Nolan , Mr. Newhouse , Mr. Ross , Mr. Lance , Mr. Barletta , Mr. Burgess , Ms. Eshoo , Mr. Loebsack , Mr. Hudson , and Ms. Pingree September 8, 2015 Committed to the Committee of the Whole House on the State of the Union and ordered to be printed A BILL To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes.

1. Short title This Act may be cited as the Stem Cell Therapeutic and Research Reauthorization Act of 2015 . 2. Amendments to the Stem Cell Therapeutic and Research Act of 2005 (a) Cord blood inventory Section 2 of the Stem Cell Therapeutic and Research Act of 2005 ( 42 U.S.C. 274k note) is amended in subsection (h)— (1) in paragraph (1)— (A) by striking $23,000,000 for each of fiscal years 2011 through 2014 and ; and (B) by inserting before the period at the end the following: and $23,000,000 for each of fiscal years 2016 through 2020 ; and (2) in paragraph (2), by striking 2011 through 2015 and inserting 2015 through 2020 . (b) National program Section 379B of the Public Health Service Act ( 42 U.S.C. 274m ) is amended by striking 2011 through 2014 and inserting 2016 through 2020 .

September 8, 2015 Committed to the Committee of the Whole House on the State of the Union and ordered to be printed

tv_txt: IIB 114th CONGRESS 1st Session H. R. 2820 IN THE SENATE OF THE UNITED STATES September 9, 2015 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes.

1. Short title This Act may be cited as the Stem Cell Therapeutic and Research Reauthorization Act of 2015 . 2. Amendments to the Stem Cell Therapeutic and Research Act of 2005 (a) Cord blood inventory Section 2 of the Stem Cell Therapeutic and Research Act of 2005 ( 42 U.S.C. 274k note) is amended in subsection (h)— (1) in paragraph (1)— (A) by striking $23,000,000 for each of fiscal years 2011 through 2014 and ; and (B) by inserting before the period at the end the following: and $23,000,000 for each of fiscal years 2016 through 2020 ; and (2) in paragraph (2), by striking 2011 through 2015 and inserting 2015 through 2020 . (b) National program Section 379B of the Public Health Service Act ( 42 U.S.C. 274m ) is amended by striking 2011 through 2014 and inserting 2016 through 2020 .

Passed the House of Representatives September 8, 2015. Karen L. Haas, Clerk

tv_txt: 114th CONGRESS 1st Session H.R. 2820 In the Senate of the United States, December 9, 2015. Amendment:

That the bill from the House of Representatives (H.R. 2820) entitled An Act to reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes. , do pass with the following Strike out all after the enacting clause and insert: 1. Short title This Act may be cited as the Stem Cell Therapeutic and Research Reauthorization Act of 2015 . 2. Reauthorization of the C.W. Bill Young Cell Transplantation Program (a) In general Section 379(d)(2)(B) of the Public Health Service Act ( 42 U.S.C. 274k(d)(2)(B) ) is amended— (1) by striking remote collection and inserting collection ; and (2) by inserting including remote collection, after cord blood units, . (b) Authorization of appropriations Section 379B of the Public Health Service Act ( 42 U.S.C. 274m ) is amended— (1) by striking $30,000,000 for each of fiscal years 2011 through 2014 and ; and (2) by inserting and $30,000,000 for each of fiscal years 2016 through 2020 before the period at the end. (c) Secretary review on state of science The Secretary of Health and Human Services, in consultation with the Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, and the Administrator of the Health Resources and Services Administration, including the Advisory Council on Blood Stem Cell Transplantation established under section 379(a) of the Public Health Service Act ( 42 U.S.C. 274k(a) ), and other stakeholders, where appropriate given relevant expertise, shall conduct a review of the state of the science of using adult stem cells and birthing tissues to develop new types of therapies for patients, for the purpose of considering the potential inclusion of such new types of therapies in the C.W. Bill Young Cell Transplantation Program (established under such section 379) in addition to the continuation of ongoing activities. Not later than June 30, 2019, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives recommendations on the appropriateness of such new types of therapies for inclusion in the C.W. Bill Young Cell Transplantation Program. 3. Cord blood inventory Section 2 of the Stem Cell Therapeutic and Research Act of 2005 ( 42 U.S.C. 274k note) is amended— (1) in subsection (a), by striking one-time ; (2) by striking subsection (c); (3) by redesignating subsections (d) through (h) as subsections (c) through (g), respectively; (4) in subsection (d) (as so redesignated)— (A) in paragraph (1), by striking paragraphs (2) and (3) and inserting paragraphs (2), (3), and (4) ; (B) in paragraph (2)(B), by striking subsection (d) and inserting subsection (c) ; and (C) by adding at the end the following: (4) Consideration of best science The Secretary shall take into consideration the best scientific information available in order to maximize the number of cord blood units available for transplant when entering into contracts under this section, or when extending a period of funding under such a contract under paragraph (2). (5) Consideration of banked units of cord blood In extending contracts pursuant to paragraph (3), and determining new allocation amounts for the next contract period or contract extension for such cord blood bank, the Secretary shall take into account the number of cord blood units banked in the National Cord Blood Inventory by a cord blood bank during the previous contract period, in addition to consideration of the ability of such cord blood bank to increase the collection and maintenance of additional, genetically diverse cord blood units. ; (5) in subsection (f) (as so redesignated)— (A) by striking paragraph (4); and (B) by redesignating paragraphs (5) and (6) as paragraphs (4) and (5), respectively; and (6) in subsection (g) (as so redesignated)— (A) in paragraph (1)— (i) by striking $23,000,000 for each of fiscal years 2011 through 2014 and ; and (ii) by inserting and $23,000,000 for each of fiscal years 2016 through 2020 before the period at the end; and (B) by striking paragraph (2). 4. Determination on the definition of human organ Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue determinations with respect to the inclusion of peripheral blood stem cells and umbilical cord blood in the definition of human organ.

Secretary

tv_txt: II Calendar No. 311 114th CONGRESS 1st Session H. R. 2820 IN THE SENATE OF THE UNITED STATES September 9, 2015 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions December 3, 2015 Reported by Mr. Alexander , with an amendment Strike out all after the enacting clause and insert the part printed in italic AN ACT To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes.

1. Short title This Act may be cited as the Stem Cell Therapeutic and Research Reauthorization Act of 2015 . 2. Amendments to the Stem Cell Therapeutic and Research Act of 2005 (a) Cord blood inventory Section 2 of the Stem Cell Therapeutic and Research Act of 2005 ( 42 U.S.C. 274k note) is amended in subsection (h)— (1) in paragraph (1)— (A) by striking $23,000,000 for each of fiscal years 2011 through 2014 and ; and (B) by inserting before the period at the end the following: and $23,000,000 for each of fiscal years 2016 through 2020 ; and (2) in paragraph (2), by striking 2011 through 2015 and inserting 2015 through 2020 . (b) National program Section 379B of the Public Health Service Act ( 42 U.S.C. 274m ) is amended by striking 2011 through 2014 and inserting 2016 through 2020 .

1. Short title This Act may be cited as the Stem Cell Therapeutic and Research Reauthorization Act of 2015 . 2. Reauthorization of the C.W. Bill Young Cell Transplantation Program (a) In general Section 379(d)(2)(B) of the Public Health Service Act ( 42 U.S.C. 274k(d)(2)(B) ) is amended— (1) by striking remote collection and inserting collection ; and (2) by inserting including remote collection, after cord blood units, . (b) Authorization of appropriations Section 379B of the Public Health Service Act ( 42 U.S.C. 274m ) is amended— (1) by striking $30,000,000 for each of fiscal years 2011 through 2014 and ; and (2) by inserting and $30,000,000 for each of fiscal years 2016 through 2020 before the period at the end. (c) Secretary review on state of science The Secretary of Health and Human Services, in consultation with the Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, and the Administrator of the Health Resources and Services Administration, including the Advisory Council on Blood Stem Cell Transplantation established under section 379(a) of the Public Health Service Act ( 42 U.S.C. 274k(a) ), and other stakeholders, where appropriate given relevant expertise, shall conduct a review of the state of the science of using adult stem cells and birthing tissues to develop new types of therapies for patients, for the purpose of considering the potential inclusion of such new types of therapies in the C.W. Bill Young Cell Transplantation Program (established under such section 379) in addition to the continuation of ongoing activities. Not later than June 30, 2019, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives recommendations on the appropriateness of such new types of therapies for inclusion in the C.W. Bill Young Cell Transplantation Program. 3. Cord blood inventory Section 2 of the Stem Cell Therapeutic and Research Act of 2005 ( 42 U.S.C. 274k note) is amended— (1) in subsection (a), by striking one-time ; (2) by striking subsection (c); (3) by redesignating subsections (d) through (h) as subsections (c) through (g), respectively; (4) in subsection (d) (as so redesignated)— (A) in paragraph (1), by striking paragraphs (2) and (3) and inserting paragraphs (2), (3), and (4) ; (B) in paragraph (2)(B), by striking subsection (d) and inserting subsection (c) ; and (C) by adding at the end the following: (4) Consideration of best science The Secretary shall take into consideration the best scientific information available in order to maximize the number of cord blood units available for transplant when entering into contracts under this section, or when extending a period of funding under such a contract under paragraph (2). (5) Consideration of banked units of cord blood In extending contracts pursuant to paragraph (3), and determining new allocation amounts for the next contract period or contract extension for such cord blood bank, the Secretary shall take into account the number of cord blood units banked in the National Cord Blood Inventory by a cord blood bank during the previous contract period, in addition to consideration of the ability of such cord blood bank to increase the collection and maintenance of additional, genetically diverse cord blood units. ; (5) in subsection (f) (as so redesignated)— (A) by striking paragraph (4); and (B) by redesignating paragraphs (5) and (6) as paragraphs (4) and (5), respectively; and (6) in subsection (g) (as so redesignated)— (A) in paragraph (1)— (i) by striking $23,000,000 for each of fiscal years 2011 through 2014 and ; and (ii) by inserting and $23,000,000 for each of fiscal years 2016 through 2020 before the period at the end; and (B) by striking paragraph (2). 4. Determination on the definition of human organ Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue determinations with respect to the inclusion of peripheral blood stem cells and umbilical cord blood in the definition of human organ.

December 3, 2015 Reported with an amendment

tv_txt: I One Hundred Fourteenth Congress of the United States of America At the First Session Begun and held at the City of Washington on Tuesday, the sixth day of January, two thousand and fifteen H. R. 2820 AN ACT To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes.

1. Short title This Act may be cited as the Stem Cell Therapeutic and Research Reauthorization Act of 2015 . 2. Reauthorization of the C.W. Bill Young Cell Transplantation Program (a) In general Section 379(d)(2)(B) of the Public Health Service Act ( 42 U.S.C. 274k(d)(2)(B) ) is amended— (1) by striking remote collection and inserting collection ; and (2) by inserting including remote collection, after cord blood units, . (b) Authorization of appropriations Section 379B of the Public Health Service Act ( 42 U.S.C. 274m ) is amended— (1) by striking $30,000,000 for each of fiscal years 2011 through 2014 and ; and (2) by inserting and $30,000,000 for each of fiscal years 2016 through 2020 before the period at the end. (c) Secretary review on state of science The Secretary of Health and Human Services, in consultation with the Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, and the Administrator of the Health Resources and Services Administration, including the Advisory Council on Blood Stem Cell Transplantation established under section 379(a) of the Public Health Service Act ( 42 U.S.C. 274k(a) ), and other stakeholders, where appropriate given relevant expertise, shall conduct a review of the state of the science of using adult stem cells and birthing tissues to develop new types of therapies for patients, for the purpose of considering the potential inclusion of such new types of therapies in the C.W. Bill Young Cell Transplantation Program (established under such section 379) in addition to the continuation of ongoing activities. Not later than June 30, 2019, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives recommendations on the appropriateness of such new types of therapies for inclusion in the C.W. Bill Young Cell Transplantation Program. 3. Cord blood inventory Section 2 of the Stem Cell Therapeutic and Research Act of 2005 ( 42 U.S.C. 274k note) is amended— (1) in subsection (a), by striking one-time ; (2) by striking subsection (c); (3) by redesignating subsections (d) through (h) as subsections (c) through (g), respectively; (4) in subsection (d) (as so redesignated)— (A) in paragraph (1), by striking paragraphs (2) and (3) and inserting paragraphs (2), (3), and (4) ; (B) in paragraph (2)(B), by striking subsection (d) and inserting subsection (c) ; and (C) by adding at the end the following: (4) Consideration of best science The Secretary shall take into consideration the best scientific information available in order to maximize the number of cord blood units available for transplant when entering into contracts under this section, or when extending a period of funding under such a contract under paragraph (2). (5) Consideration of banked units of cord blood In extending contracts pursuant to paragraph (3), and determining new allocation amounts for the next contract period or contract extension for such cord blood bank, the Secretary shall take into account the number of cord blood units banked in the National Cord Blood Inventory by a cord blood bank during the previous contract period, in addition to consideration of the ability of such cord blood bank to increase the collection and maintenance of additional, genetically diverse cord blood units. ; (5) in subsection (f) (as so redesignated)— (A) by striking paragraph (4); and (B) by redesignating paragraphs (5) and (6) as paragraphs (4) and (5), respectively; and (6) in subsection (g) (as so redesignated)— (A) in paragraph (1)— (i) by striking $23,000,000 for each of fiscal years 2011 through 2014 and ; and (ii) by inserting and $23,000,000 for each of fiscal years 2016 through 2020 before the period at the end; and (B) by striking paragraph (2). 4. Determination on the definition of human organ Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue determinations with respect to the inclusion of peripheral blood stem cells and umbilical cord blood in the definition of human organ.

Speaker of the House of Representatives. Vice President of the United States and President of the Senate.