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H.R. 2820 (114th): Stem Cell Therapeutic and Research Reauthorization Act of 2015

The text of the bill below is as of Oct 6, 2016 (Passed Congress).


I

One Hundred Fourteenth Congress of the United States of America

At the First Session

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.