IB 
Union Calendar No. 383 
111TH CONGRESS 
2D SESSION 
H. R. 6081 
[Report No. 111–643] 
To amend the Stem Cell Therapeutic and Research Act of 2005. 
IN THE HOUSE OF REPRESENTATIVES 
AUGUST 9, 2010 
Mr. YOUNG of Florida (for himself and Ms. MATSUI) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
SEPTEMBER 28, 2010 
Additional sponsors: Mr. HIMES, Ms. RICHARDSON, Mr. JACKSON of Illinois, 
Mr. OBERSTAR, Mrs. CAPPS, Ms. EDDIE BERNICE JOHNSON of Texas, 
Mr. WEINER, Mr. COHEN, and Mr. ELLISON 
SEPTEMBER 28, 2010 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on August 9, 2010] 
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A BILL 
To amend the Stem Cell Therapeutic and Research Act of 
2005. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Stem Cell Therapeutic 
and Research Reauthorization Act of 2010’’. 
SEC. 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— 
(1) in subsection (a), by inserting ‘‘the inventory 
goal of at least’’ before ‘‘150,000’’; 
(2) in subsection (c)— 
(A) in paragraph (2), by striking ‘‘or is 
transferred’’ and all that follows through the pe-
riod and inserting ‘‘for a first-degree relative.’’; 
and 
(B) 
in 
paragraph 
(3), 
by 
striking 
‘‘150,000’’; 
(3) in subsection (d)— 
(A) in paragraph (1), by inserting ‘‘begin-
ning on the last date on which the recipient of 
a contract under this section receives Federal 
funds under this section’’ after ‘‘10 years’’; 
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(B) in paragraph (2), by striking ‘‘; and’’ 
and inserting ‘‘;’’; 
(C) by redesignating paragraph (3) as 
paragraph (5); and 
(D) by inserting after paragraph (2) the fol-
lowing: 
‘‘(3) will 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; 
‘‘(4) will annually provide to the Secretary a 
plan for, and demonstrate, ongoing measurable 
progress toward achieving self-sufficiency of cord 
blood unit collection and banking operations; and’’; 
(4) in subsection (e)— 
(A) in paragraph (1)— 
(i) by striking ‘‘10 years’’ and insert-
ing ‘‘a period of at least 10 years beginning 
on the last date on which the recipient of a 
contract under this section receives Federal 
funds under this section’’; and 
(ii) by striking the second sentence and 
inserting ‘‘The Secretary shall ensure that 
no Federal funds shall be obligated under 
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any such contract after the date that is 5 
years after the date on which the contract is 
entered into, except as provided in para-
graphs (2) and (3).’’; 
(B) in paragraph (2)— 
(i) in the matter preceding subpara-
graph (A)— 
(I) by striking ‘‘Subject to para-
graph (1)(B), the’’ and inserting 
‘‘The’’; and 
(II) by striking ‘‘3’’ and inserting 
‘‘5’’; 
(ii) in subparagraph (A) by striking 
‘‘150,000’’ and all that follows through 
‘‘and’’ at the end and inserting ‘‘the inven-
tory goal described in subsection (a) has not 
yet been met;’’; 
(iii) in subparagraph (B)— 
(I) by inserting ‘‘meeting the re-
quirements under subsection (d)’’ after 
‘‘receive an application for a contract 
under this section’’; and 
(II) by striking ‘‘or the Secretary’’ 
and all that follows through the period 
at the end and inserting ‘‘; or’’; and 
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(iv) by adding at the end the following: 
‘‘(C) the Secretary determines that the out-
standing inventory need cannot be met by the 
qualified cord blood banks under contract under 
this section.’’; and 
(C) by striking paragraph (3) and inserting 
the following: 
‘‘(3) EXTENSION ELIGIBILITY.—A qualified cord 
blood bank shall be eligible for a 5-year extension of 
a contract awarded under this section, as described in 
paragraph (2), provided that the qualified cord blood 
bank— 
‘‘(A) demonstrates a superior ability to sat-
isfy the requirements described in subsection (b) 
and achieves the overall goals for which the con-
tract was awarded; 
‘‘(B) provides a plan for how the qualified 
cord blood bank will increase cord blood unit col-
lections at collection sites that exist at the time 
of consideration for such extension of a contract, 
assist with the establishment of new collection 
sites, or contract with new collection sites; and 
‘‘(C) annually provides to the Secretary a 
plan for, and demonstrates, ongoing measurable 
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progress toward achieving self-sufficiency of cord 
blood unit collection and banking operations.’’; 
(5) in subsection (g)(4), by striking ‘‘or parent’’; 
and 
(6) in subsection (h)— 
(A) by striking paragraphs (1) and (2) and 
inserting the following: 
‘‘(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to the Sec-
retary to carry out the program under this section 
$23,000,000 for each of fiscal years 2011 through 
2014 and $20,000,000 for fiscal year 2015.’’; 
(B) by redesignating paragraph (3) as 
paragraph (2); and 
(C) in paragraph (2), as so redesignated, by 
striking ‘‘in each of fiscal years 2007 through 
2009’’ and inserting ‘‘for each of fiscal years 
2011 through 2015’’. 
(b) NATIONAL PROGRAM.—Section 379 of the Public 
Health Service Act (42 U.S.C. 274k) is amended— 
(1) by striking subsection (a)(6) and inserting 
the following: 
‘‘(6) The Secretary, acting through the Adminis-
trator of the Health Resources and Services Adminis-
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tration, shall submit to Congress an annual report on 
the activities carried out under this section.’’; 
(2) in subsection (d)— 
(A) in paragraph (2)— 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘With respect to cord 
blood, the Program shall—’’ and inserting 
the following: 
‘‘(A) IN
GENERAL.—With respect to cord 
blood, the Program shall—’’; 
(ii) by redesignating subparagraphs 
(A) through (H) as clauses (i) through (viii) 
respectively (with appropriate indentation); 
(iii) by striking clause (iv), as so re-
designated, and inserting the following: 
‘‘(iv) support and expand new and ex-
isting studies and demonstration and out-
reach projects for the purpose of increasing 
cord blood unit donation and collection 
from a genetically diverse population and 
expanding the number of cord blood unit 
collection sites partnering with cord blood 
banks receiving a contract under the Na-
tional Cord Blood Inventory program under 
section 2 of the Stem Cell Therapeutic and 
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Research Act of 2005, including such studies 
and projects that focus on— 
‘‘(I) remote collection of cord 
blood units, consistent with the re-
quirements under the Program and the 
National Cord Blood Inventory pro-
gram goal described in section 2(a) of 
the Stem Cell Therapeutic and Re-
search Act of 2005; and 
‘‘(II) exploring novel approaches 
or incentives to encourage innovative 
technological advances that could be 
used to collect cord blood units, con-
sistent with the requirements under the 
Program and such National Cord 
Blood Inventory program goal;’’; and 
(iv) by adding at the end the following: 
‘‘(B) EFFORTS
TO
INCREASE
COLLECTION 
OF HIGH QUALITY CORD BLOOD UNITS.—In car-
rying out subparagraph (A)(iv), not later than 1 
year after the date of enactment of the Stem Cell 
Therapeutic and Research Reauthorization Act 
of 2010 and annually thereafter, the Secretary 
shall set an annual goal of increasing collections 
of high quality cord blood units, consistent with 
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the inventory goal described in section 2(a) of 
the Stem Cell Therapeutic and Research Act of 
2005 (referred to in this subparagraph as the 
‘inventory goal’), and shall identify at least one 
project under subparagraph (A)(iv) to replicate 
and expand nationwide, as appropriate. If the 
Secretary cannot identify a project as described 
in the preceding sentence, the Secretary shall 
submit a plan, not later than 180 days after the 
date on which the Secretary was required to 
identify such a project, to the Committee on 
Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives for ex-
panding remote collection of high quality cord 
blood units, consistent with the requirements 
under the National Cord Blood Inventory pro-
gram under section 2 of the Stem Cell Thera-
peutic and Research Act of 2005 and the inven-
tory goal. Each such plan shall be made avail-
able to the public. 
‘‘(C) DEFINITION.—In this paragraph, the 
term ‘remote collection’ means the collection of 
cord blood units at locations that do not have 
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written contracts with cord blood banks for col-
lection support.’’; and 
(B) in paragraph (3)(A), by striking 
‘‘(2)(A)’’ and inserting ‘‘(2)(A)(i)’’; and 
(3) by striking subsection (f)(5)(A) and inserting 
the following: 
‘‘(A) require the establishment of a system 
of strict confidentiality to protect the identity 
and privacy of patients and donors in accord-
ance with Federal and State law; and’’. 
(c) ADDITIONAL REPORTS.— 
(1) INTERIM REPORT.—In addition to the an-
nual report required under section 379(a)(6) of the 
Public Health Service Act (42 U.S.C. 274k(a)(6)), the 
Secretary of Health and Human Services (referred to 
in this subsection as the ‘‘Secretary’’), in consultation 
with the Advisory Council established under such sec-
tion 379, shall submit to Congress an interim report 
not later than 180 days after the date of enactment 
of this Act describing— 
(A) the methods to distribute Federal funds 
to cord blood banks used at the time of submis-
sion of the report; 
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(B) how cord blood banks contract with col-
lection sites for the collection of cord blood units; 
and 
(C) recommendations for improving the 
methods to distribute Federal funds described in 
subparagraph (A) in order to encourage the effi-
cient collection of high-quality and diverse cord 
blood units. 
(2) RECOMMENDATIONS.—Not later than 1 year 
after the date of enactment of this Act, the Advisory 
Council shall submit recommendations to the Sec-
retary with respect to— 
(A) whether models for remote collection of 
cord blood units should be allowed only with lim-
ited, scientifically-justified safety protections; 
and 
(B) whether the Secretary should allow for 
cord blood unit collection from routine deliveries 
without temperature or humidity monitoring of 
delivery rooms in hospitals approved by the 
Joint Commission. 
(d) AUTHORIZATION
OF APPROPRIATIONS.—Section 
379B of the Public Health Service Act (42 U.S.C. 274m) 
is amended by striking ‘‘$34,000,000’’ and all that follows 
through the period at the end, and inserting ‘‘$30,000,000 
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for each of fiscal years 2011 through 2014 and $33,000,000 
for fiscal year 2015.’’. 
(e) REPORT ON CORD BLOOD UNIT DONATION AND 
COLLECTION.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Comptroller 
General of the United States shall submit to the Com-
mittee on Health, Education, Labor, and Pensions 
and the Committee on Appropriations of the Senate, 
the Committee on Energy and Commerce and the 
Committee on Appropriations of the House of Rep-
resentatives, and the Secretary of Health and Human 
Services a report reviewing studies, demonstration 
programs, and outreach efforts for the purpose of in-
creasing cord blood unit donation and collection for 
the National Cord Blood Inventory to ensure a high- 
quality and genetically diverse inventory of cord 
blood units. 
(2) CONTENTS.—The report described in para-
graph (1) shall include a review of such studies, dem-
onstration programs, and outreach efforts under sec-
tion 2 of the Stem Cell Therapeutic and Research Act 
of 2005 (42 U.S.C. 274k note) (as amended by this 
Act) and section 379 of the Public Health Service Act 
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(42 U.S.C. 274k) (as amended by this Act), includ-
ing— 
(A) a description of the challenges and bar-
riers to expanding the number of cord blood unit 
collection sites, including cost, the cash flow re-
quirements and operations of awarding con-
tracts, the methods by which funds are distrib-
uted through contracts, the impact of regulatory 
and administrative requirements, and the capac-
ity of cord blood banks to maintain high-quality 
units; 
(B) remote collection or other innovative 
technological advances that could be used to col-
lect cord blood units; 
(C) appropriate methods for improving pro-
vider education about collecting cord blood units 
for the national inventory and participation in 
such collection activities; 
(D) estimates of the number of cord blood 
unit collection sites necessary to meet the out-
standing national inventory need and the char-
acteristics of such collection sites that would help 
increase the genetic diversity and enhance the 
quality of cord blood units collected; 
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(E) best practices for establishing and sus-
taining partnerships for cord blood unit collec-
tion at medical facilities with a high number of 
minority births; 
(F) potential and proven incentives to en-
courage hospitals to become cord blood unit col-
lection sites and partner with cord blood banks 
participating in the National Cord Blood Inven-
tory under section 2 of the Stem Cell Thera-
peutic and Research Act of 2005 and to assist 
cord blood banks in expanding the number of 
cord blood unit collection sites with which such 
cord blood banks partner; 
(G) recommendations about methods cord 
blood banks and collection sites could use to 
lower costs and improve efficiency of cord blood 
unit collection without decreasing the quality of 
the cord blood units collected; and 
(H) a description of the methods used prior 
to the date of enactment of this Act to distribute 
funds to cord blood banks and recommendations 
for how to improve such methods to encourage 
the efficient collection of high-quality and diverse 
cord blood units, consistent with the require-
ments of the C.W. Bill Young Cell Transplan-
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tation Program and the National Cord Blood In-
ventory program under section 2 of the Stem 
Cell Therapeutic and Research Act of 2005. 
(f) DEFINITION.—In this Act, the term ‘‘remote collec-
tion’’ has the meaning given such term in section 
379(d)(2)(C) of the Public Health Service Act. 
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Union Calendar No. 383 
111TH CONGRESS 
2D SESSION 
H. R. 6081 
[Report No. 111–643] 
A BILL 
To amend the Stem Cell Therapeutic and Research 
Act of 2005. 
SEPTEMBER 28, 2010 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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