Stem Cell Therapeutic and Research Reauthorization Act of 2010
PL 111-264 (S.3751), enacted 10/08/2010

124 STAT. 2789 
PUBLIC LAW 111–264—OCT. 8, 2010 
Public Law 111–264 
111th Congress 
An Act 
To amend the Stem Cell Therapeutic and Research Act of 2005. 
Be it enacted by the Senate and House of Representatives 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 Thera-
peutic 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 period 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 ‘‘beginning on the 
last date on which the recipient of a contract under this 
section receives Federal funds under this section’’ after 
‘‘10 years’’; 
(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 following: 
‘‘(3) will provide a plan to increase cord blood unit collec-
tions 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 inserting ‘‘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 
Deadline. 
Plans. 
Plans. 
42 USC 201 note. 
Stem Cell 
Therapeutic and 
Research 
Reauthorization 
Act of 2010. 
Oct. 8, 2010 
[S. 3751] 
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124 STAT. 2790 
PUBLIC LAW 111–264—OCT. 8, 2010 
(ii) by striking the second sentence and inserting 
‘‘The Secretary shall ensure that no Federal funds 
shall be obligated under any such contract after the 
date that is 5 years after the date on which the contract 
is entered into, except as provided in paragraphs (2) 
and (3).’’; 
(B) in paragraph (2)— 
(i) in the matter preceding subparagraph (A)— 
(I) by striking ‘‘Subject to paragraph (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 inventory goal described in subsection (a) has 
not yet been met;’’; 
(iii) in subparagraph (B)— 
(I) by inserting ‘‘meeting the requirements 
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 
(iv) by adding at the end the following: 
‘‘(C) the Secretary determines that the outstanding 
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 fol-
lowing: 
‘‘(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 satisfy the 
requirements described in subsection (b) and achieves the 
overall goals for which the contract was awarded; 
‘‘(B) provides a plan for how the qualified cord blood 
bank will increase cord blood unit collections at collection 
sites that exist at the time of consideration for such exten-
sion 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 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 Secretary 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’’. 
Contracts. 
Determination. 
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124 STAT. 2791 
PUBLIC LAW 111–264—OCT. 8, 2010 
(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 Administrator of 
the Health Resources and Services Administration, 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 subparagraph (A), by 
striking ‘‘With respect to cord blood, the Program 
shall—’’ and inserting the following: 
‘‘(A) IN GENERAL.—With respect to cord blood, the Pro-
gram shall—’’; 
(ii) by redesignating subparagraphs (A) through 
(H) as clauses (i) through (viii) respectively; 
(iii) by striking clause (iv), as so redesignated, 
and inserting the following: 
‘‘(iv) support and expand new and existing studies 
and demonstration and outreach projects for the pur-
pose of increasing cord blood unit donation and collec-
tion from a genetically diverse population and 
expanding the number of cord blood unit collection 
sites partnering with cord blood banks receiving a con-
tract under the National Cord Blood Inventory program 
under section 2 of the Stem Cell Therapeutic and 
Research Act of 2005, including such studies and 
projects that focus on— 
‘‘(I) remote collection of cord blood units, con-
sistent with the requirements under the Program 
and the National Cord Blood Inventory program 
goal described in section 2(a) of the Stem Cell 
Therapeutic and Research 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 carrying 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 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 Sec-
retary 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 
Plans. 
Deadline. 
Deadlines. 
Deadline. 
Reports. 
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124 STAT. 2792 
PUBLIC LAW 111–264—OCT. 8, 2010 
on Energy and Commerce of the House of Representatives 
for expanding remote collection of high quality cord blood 
units, consistent with the requirements under the National 
Cord Blood Inventory program under section 2 of the Stem 
Cell Therapeutic and Research Act of 2005 and the inven-
tory goal. Each such plan shall be made available to the 
public. 
‘‘(C) DEFINITION.—In this paragraph, the term ‘remote 
collection’ means the collection of cord blood units at loca-
tions that do not have written contracts with cord blood 
banks for collection 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 fol-
lowing: 
‘‘(A) require the establishment of a system of strict 
confidentiality to protect the identity and privacy of 
patients and donors in accordance with Federal and State 
law; and’’. 
(c) ADDITIONAL REPORTS.— 
(1) INTERIM
REPORT.—In addition to the annual 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 section 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 submission of the report; 
(B) how cord blood banks contract with collection 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 efficient 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 Secretary with respect to— 
(A) whether models for remote collection of cord blood 
units should be allowed only with limited, 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 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 Committee on Health, Education, 
Labor, and Pensions and the Committee on Appropriations 
of the Senate, the Committee on Energy and Commerce and 
Public 
information. 
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124 STAT. 2793 
PUBLIC LAW 111–264—OCT. 8, 2010 
the Committee on Appropriations of the House of Representa-
tives, and the Secretary of Health and Human Services a report 
reviewing studies, demonstration programs, and outreach 
efforts for the purpose of increasing 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 paragraph (1) shall 
include a review of such studies, demonstration programs, and 
outreach efforts under section 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 (42 U.S.C. 274k) (as amended by this Act), including— 
(A) a description of the challenges and barriers to 
expanding the number of cord blood unit collection sites, 
including cost, the cash flow requirements and operations 
of awarding contracts, the methods by which funds are 
distributed through contracts, the impact of regulatory and 
administrative requirements, and the capacity of cord blood 
banks to maintain high-quality units; 
(B) remote collection or other innovative technological 
advances that could be used to collect cord blood units; 
(C) appropriate methods for improving provider edu-
cation about collecting cord blood units for the national 
inventory and participation in such collection activities; 
(D) estimates of the number of cord blood unit collec-
tion sites necessary to meet the outstanding national inven-
tory need and the characteristics of such collection sites 
that would help increase the genetic diversity and enhance 
the quality of cord blood units collected; 
(E) best practices for establishing and sustaining part-
nerships for cord blood unit collection at medical facilities 
with a high number of minority births; 
(F) potential and proven incentives to encourage hos-
pitals to become cord blood unit collection sites and partner 
with cord blood banks participating in the National Cord 
Blood Inventory 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 Transplantation Program 
and the National Cord Blood Inventory program under 
section 2 of the Stem Cell Therapeutic and Research Act 
of 2005. 
Review. 
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124 STAT. 2794 
PUBLIC LAW 111–264—OCT. 8, 2010 
LEGISLATIVE HISTORY—S. 3751: 
CONGRESSIONAL RECORD, Vol. 156 (2010): 
Sept. 28, considered and passed Senate. 
Sept. 29, considered and passed House. 
(f) DEFINITION.—In this Act, the term ‘‘remote collection’’ has 
the meaning given such term in section 379(d)(2)(C) of the Public 
Health Service Act. 
Approved October 8, 2010. 
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