PUBLIC LAW 111–264—OCT. 8, 2010 124 STAT. 2789 

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 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 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 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 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. 

Plan. 

Plan. 

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 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 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 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 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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PUBLIC LAW 111–264—OCT. 8, 2010 124 STAT. 2791 

(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 Program 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 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 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, consistent 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, consistent 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 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 

Plan. 

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 inventory 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 locations 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 following: 

‘‘(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, scientificallyjustified 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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PUBLIC LAW 111–264—OCT. 8, 2010 124 STAT. 2793 

the Committee on Appropriations of the House of Representatives, 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 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 outstanding national inventory 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 partnerships for cord blood unit collection at medical facilities 

with a high number of minority births; 

(F) potential and proven incentives to encourage hospitals 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 Therapeutic 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 requirements 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. 

Æ 

(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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