89–006 

111TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 2d Session 111–643 

STEM CELL THERAPEUTIC AND RESEARCH 

REAUTHORIZATION ACT OF 2010 

SEPTEMBER 28, 2010.—Committed to the Committee of the Whole House on the 

State of the Union and ordered to be printed 

Mr. WAXMAN, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

[To accompany H.R. 6081] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 6081) to amend the Stem Cell Therapeutic and Research Act of 2005, having considered the same, report favorably 

thereon with an amendment and recommend that the bill as 

amended do pass. 

CONTENTS 

Page 

Amendment .............................................................................................................. 2 

Purpose and Summary ............................................................................................ 5 

Background and Need for Legislation .................................................................... 5 

Committee Consideration ........................................................................................ 5 

Committee Votes ...................................................................................................... 6 

Committee Oversight Findings and Recommendations ........................................ 6 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 6 

Statement of General Performance Goals and Objectives .................................... 6 

Constitutional Authority Statement ...................................................................... 6 

Earmarks and Tax and Tariff Benefits .................................................................. 7 

Federal Advisory Committee Statement ................................................................ 7 

Applicability of Law to the Legislative Branch ..................................................... 7 

Federal Mandates Statement ................................................................................. 7 

Committee Cost Estimate ....................................................................................... 7 

Congressional Budget Office Cost Estimate .......................................................... 7 

Section-by-Section Analysis of the Legislation ...................................................... 8 

Explanation of Amendments ................................................................................... 9 

Changes in Existing Law Made by the Bill, as Reported ..................................... 10 


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AMENDMENT

The amendment is as follows: 

Strike all after the enacting clause and insert the following: 

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 

(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 


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‘‘(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’’. 

(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 (with appropriate indentation); 

(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 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: 


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‘‘(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 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; 


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(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 highquality 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. 

(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. 

PURPOSE AND SUMMARY

H.R. 6081, the ‘‘Stem Cell Therapeutic and Research Reauthorization Act of 2010’’, was introduced by Rep. C. W. Bill Young (R– 

FL) and Doris O. Matsui (D–CA) on August 9, 2010, and referred 

to the Committee on Energy and Commerce. 

The goal of H.R. 6081 is to reauthorize the C.W. Bill Young Cell 

Transplantation Program, which includes the National Registry for 

adult donors of bone marrow, peripheral blood (adult) stem cells, 

and umbilical cord blood units; the Office of Patient Advocacy; and 

the Stem Cell Therapeutic Outcomes Database. H.R. 6081 also reauthorizes the National Cord Blood Inventory (NCBI) Program, a 

program that provides grants to public cord blood banks to assist 

them in collecting donated cord blood units, which, in turn, are listed on the National Registry. 

BACKGROUND AND NEED FOR LEGISLATION

A bone marrow or cord blood transplant replaces a patient’s diseased blood-forming cells with healthy ones. The procedure is used 

in treating some people with a blood cancer (such as leukemia or 

lymphoma) or an inherited metabolic or immune system disorder. 

According to the Health Resources and Services Administration 

(HRSA), at any given time there are some 6,000 people across the 

United States searching for a matched bone marrow donor or cord 

blood unit. 

HRSA funds two major programs that facilitate the provision of 

blood stem cell units to individuals in need of a transplant. The 

C.W. Bill Young Cell Transplantation Program supports activities 

to increase the number of transplants for recipients suitably 

matched to biologically unrelated donors of bone marrow and cord 

blood. The National Cord Blood Inventory (NCBI) Program supports the collection, processing, and storage of a genetically and 

ethnically diverse inventory of high-quality umbilical cord blood for 

transplantation. These cord blood units, as well as other units in 

the inventories of participating cord blood banks, are made available to physicians and patients for blood stem cell transplants 

through the C.W. Bill Young Cell Transplantation Program. 

The reauthorization of both the C.W. Bill Young Cell Transplantation Program and the NCBI Program is necessary to allow HRSA 

to continue these important and life-saving activities. 

COMMITTEE CONSIDERATION

H.R. 6081, the ‘‘Stem Cell Therapeutic and Research Reauthorization Act of 2010’’, was introduced by Mr. Young of Florida and 


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Ms. Matsui of California on August 9, 2010, and referred to the 

Committee on Energy and Commerce. The bill was subsequently 

referred to the Subcommittee on Health on August 10, 2010. On 

September 15, 2010, the Subcommittee held a legislative hearing 

on the bill. The Subcommittee met in open markup session to consider H.R. 6081 on September 16, 2010. During subcommittee consideration, an amendment in the nature of a substitute (manager’s 

amendment) by Mr. Pallone of New Jersey was adopted by a voice 

vote. Subsequently, H.R. 6081 was favorably forwarded to the full 

Committee, amended, by a voice vote. 

On September 23, 2010, the Committee on Energy and Commerce met in open markup session to consider H.R. 6081 as approved by the Subcommittee. During the Committee’s consideration, an amendment in the nature of a substitute was offered by 

Ms. Matsui of California, which was adopted by a voice vote. Subsequently, the Committee ordered H.R. 6081 favorably reported to 

the House, amended, by a voice vote. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list each record vote on the motion 

to report legislation and amendments thereto. A motion by Mr. 

Waxman ordering H.R. 6081 reported to the House, amended, was 

approved by a voice vote. There were no record votes taken during 

consideration of this bill. 

COMMITTEE OVERSIGHT FINDINGS AND RECOMMENDATIONS

In compliance with clause 3(c)(1) of rule XIII and clause (2)(b)(1) 

of rule X of the Rules of the House of Representatives, the oversight findings and recommendations of the Committee are reflected 

in the descriptive portions of this report, including the finding that 

reauthorization of the C.W. Bill Young Cell Transplantation Program is important to support activities to increase the number of 

transplants for recipients suitably matched to biologically unrelated donors of bone marrow and cord blood. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

Regarding compliance with clause 3(c)(2) of rule XIII of the Rules 

of the House of Representatives, the Committee finds that H.R. 

6081 would result in no new budget authority, entitlement authority, or tax expenditures or revenues. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

In accordance with clause 3(c)(4) of rule XIII of the Rules of the 

House of Representatives, the performance goals and objectives of 

the Committee are reflected in the descriptive portions of this report, including the goal of reauthorizing the C.W. Bill Young Cell 

Transplantation Program. 

CONSTITUTIONAL AUTHORITY STATEMENT

Pursuant to clause 3(d)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee finds that the constitutional auVerDate Mar 15 2010 05:37 Oct 05, 2010 Jkt 089006 PO 00000 Frm 00006 Fmt 6659 Sfmt 6602 E:\HR\OC\HR643.XXX HR643

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thority for H.R. 6081 is provided under article I, section 8, clauses 

3 and 18 of the Constitution of the United States. 

EARMARKS AND TAX AND TARIFF BENEFITS

H.R. 6081 does not contain any congressional earmarks, limited 

tax benefits, or limited tariff benefits as defined in clause 9 of rule 

XXI of the Rules of the House of Representatives. 

FEDERAL ADVISORY COMMITTEE STATEMENT

The Committee finds that the legislation does not establish or 

authorize the establishment of an advisory committee within the 

definition of 5 U.S.C. App., section 5(b) of the Federal Advisory 

Committee Act. 

APPLICABILITY OF LAW TO THE LEGISLATIVE BRANCH

Section 102(b)(3) of Public Law 104–1 requires a description of 

the application of this bill to the legislative branch where the bill 

relates to terms and conditions of employment or access to public 

services and accommodations. H.R. 6081 contains no such provisions. 

FEDERAL MANDATES STATEMENT

Section 423 of the Congressional Budget and Impoundment Control Act of 1974 (as amended by section 101(a)(2) of the Unfunded 

Mandates Reform Act, Public Law 104–4) requires a statement on 

whether the provisions of the report include unfunded mandates. 

In compliance with this requirement the Committee adopts as its 

own the analysis of federal mandates prepared by the Director of 

the Congressional Budget Office regarding H.R. 6081. 

COMMITTEE COST ESTIMATE

Pursuant to clause 3(d)(2) of rule XIII of the Rules of the House 

of Representatives, the Committee adopts as its own the cost estimate of H.R. 6081 prepared by the Director of the Congressional 

Budget Office pursuant to section 402 of the Congressional Budget 

Act of 1974. 

CONGRESSIONAL BUDGET OFFICE COST ESTIMATE

With respect to the requirements of clause (3)(c)(3) of rule XIII 

of the Rules of the House of Representatives and section 402 of the 

Congressional Budget Act of 1974, the Committee has received the 

following cost estimate for H.R. 6081 from the Director of Congressional Budget Office: 


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U.S. CONGRESS, CONGRESSIONAL BUDGET OFFICE, Washington, DC, September 23, 2010. 

Hon. HENRY A. WAXMAN, 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 6081, the Stem Cell 

Therapeutic and Research Reauthorization Act of 2010. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Lisa Ramirez-Branum. 

Sincerely, 

DOUGLAS W. ELMENDORF. 

Enclosure. 

H.R. 6081—Stem Cell Therapeutic and Research Reauthorization 

Act of 2010 

H.R. 6081 would reauthorize the National Cord Blood Inventory 

program and the C.W. Bill Young Cell Transplantation program. In 

2010, over $35 million was appropriated for these purposes. The 

bill also would require the Government Accountability Office to 

conduct a report that reviews the studies, demonstration programs, 

and outreach efforts for the purpose of increasing cord blood unit 

donations and collections for the National Cord Blood Inventory 

program. 

The bill would authorize the appropriation of $53 million in fiscal 

year 2011 and $265 million for fiscal years 2011 through 2015. Assuming appropriation of those amounts, and based on historical 

spending patterns for similar programs, CBO estimates that implementing H.R. 6081 would cost $220 million over the 2011–2015 period as shown in the following table. The costs of this legislation 

fall primarily within budget function 550 (health). Enacting H.R. 

6081 would not affect direct spending or revenues; therefore, payas-you-go procedures do not apply. 

By fiscal year, in millions of dollars— 

2011 2012 2013 2014 2015 2011– 

2015 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Authorization Level ........................................................... 53 53 53 53 53 265 

Estimated Outlays ............................................................ 21 44 51 52 52 220 

H.R. 6081 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act and would 

not affect the budgets of state, local or tribal governments. 

The CBO staff contact for this estimate is Lisa Ramirez-Branum. 

This estimate was approved by Holly Harvey, Deputy Assistant Director for Budget Analysis. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title 

Section 1 designates that the Act may be cited as the ‘‘Stem Cell 

Therapeutic and Research Reauthorization Act of 2010’’. 


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Section 2. Amendments to the Stem Cell Therapeutic and Research 

Act of 2005 

Subsection (a) of section 2 clarifies the requirement regarding the 

number of new units of high-quality cord blood for the NCBI Program to be ‘‘the inventory goal of at least 150,000’’. It also makes 

numerous changes to the application requirements for qualified 

blood banks that wish to participate in the Cord Blood Inventory 

and allows for the extension of a cord blood bank contract from 

three to five years under specified circumstances. In addition, subsection (a) provides for the authorization of appropriations for the 

NCBI Program at a level of $23 million for each of FY2011 through 

FY2014 and $20 million for FY2015. 

Subsection (b) of section 2 clarifies the functions with regard to 

cord blood under the C.W. Bill Young Cell Transplantation Program to include support for studies and demonstration and outreach projects designed to increase cord blood unit donation and 

collection from a genetically diverse population and to expand the 

number of cord blood unit collection sites partnering with cord 

blood banks that participate in the NCBI Program. Such studies 

and projects include those designed to explore novel approaches or 

incentives to encourage innovative technological advances that 

could be used to collect cord blood units. Subsection (b) also directs 

the Secretary of Health and Human Services to set an annual goal 

of increasing collections of high-quality cord blood units consistent 

with the inventory goal established through the NCBI Program and 

provides for the expansion of remote collection (as defined in the 

legislation) of high-quality cord units under certain conditions. 

Subsection (c) of section 2 requires the Secretary to submit an interim report to Congress in addition to the annual report required 

under the C.W. Bill Young Cell Transplantation Program. 

Subsection (d) of section 2 provides for the authorization of appropriations for the C.W. Bill Young Cell Transplantation Program 

at a level of $30 million for each of FY2011 through FY2014 and 

$33 million for FY2015. 

Subsection (e) directs the Government Accountability Office 

(GAO) to submit a report to Congress on cord blood unit donation 

and collection, including recommendations on efforts to increase 

cord blood unit donation and collection for the NCBI Program. 

Such report shall address, among other issues, methods used to 

distribute funds to cord blood banks prior to the date of enactment 

of this legislation. 

EXPLANATION OF AMENDMENTS

During the Subcommittee on Health markup of H.R. 6081, Mr. 

Pallone of New Jersey offered an amendment in the nature of a 

substitute (manager’s amendment), which was adopted by a voice 

vote. During the full Committee consideration of the bill as approved by the Subcommittee, Ms. Matsui of California offered an 

amendment in the nature of a substitute, which was also adopted 

by a voice vote. The substance of each amendment is reflected in 

the section-by-section analysis contained in this report. 


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CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, 

existing law in which no change is proposed is shown in roman): 

STEM CELL THERAPEUTIC AND RESEARCH ACT OF 2005 

* * * * * * * 

SEC. 2. CORD BLOOD INVENTORY. 

(a) IN GENERAL.—The Secretary of Health and Human Services 

shall enter into one-time contracts with qualified cord blood banks 

to assist in the collection and maintenance of the inventory goal of 

at least 150,000 new units of high-quality cord blood to be made 

available for transplantation through the C.W. Bill Young Cell 

Transplantation Program and to carry out the requirements of subsection (b). 

* * * * * * * 

(c) RELATED CORD BLOOD DONORS.— (1) * * * 

(2) AVAILABILITY.—Qualified cord blood banks that are operating a program under paragraph (1) shall provide assurances 

that the cord blood units in such banks will be available for directed transplantation until such time that the cord blood unit 

is released for transplantation øor is transferred by the family 

to the C.W. Bill Young Cell Transplantation Program in accordance with guidance or regulations promulgated by the Secretary.¿ for a first-degree relative. 

(3) INVENTORY.—Cord blood units collected through the program under this section shall not be counted toward the 

ø150,000¿ inventory goal under the C.W. Bill Young Cell 

Transplantation Program. 

* * * * * * * 

(d) APPLICATION.—To seek to enter into a contract under this section, a qualified cord blood bank shall submit an application to the 

Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require. At a minimum, 

an application for a contract under this section shall include a requirement that the applicant— 

(1) will participate in the C.W. Bill Young Cell Transplantation Program for 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; 

(2) will make cord blood units collected pursuant to this section available through the C.W. Bill Young Cell Transplantation Program in perpetuity or for such time as determined 

viable by the Secretaryø; and¿; 

(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 


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self-sufficiency of cord blood unit collection and banking operations; and 

ø(3)¿ (5) if the Secretary determines through an assessment, 

or through petition by the applicant, that a cord blood bank is 

no longer operational or does not meet the requirements of section 379(d)(4) of the Public Health Service Act (as added by 

this Act) and as a result may not distribute the units, transfer 

the units collected pursuant to this section to another qualified 

cord blood bank approved by the Secretary to ensure continued 

availability of cord blood units. 

(e) DURATION OF CONTRACTS.— 

(1) IN GENERAL.—Except as provided in paragraph (2), the 

term of each contract entered into by the Secretary under this 

section shall be for ø10 years¿ 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. 

øThe Secretary shall ensure that no Federal funds shall be obligated under any such contract after the earlier of— 

ø(A) the date that is 3 years after the date on which the 

contract is entered into; or 

ø(B) September 30, 2010.¿ 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). 

(2) EXTENSIONS.—øSubject to paragraph (1)(B), the¿ The Secretary may extend the period of funding under a contract 

under this section to exceed a period of ø3¿ 5 years if— 

(A) the Secretary finds that ø150,000 new units of highquality cord blood have not yet been collected pursuant to 

this section; and¿ the inventory goal described in subsection (a) has not yet been met; 

(B) the Secretary does not receive an application for a 

contract under this section meeting the requirements under 

subsection (d) from any qualified cord blood bank that has 

not previously entered into a contract under this section 

øor the Secretary determines that the outstanding inventory need cannot be met by the one or more qualified cord 

blood banks that have submitted an application for a contract under this section.¿; or 

(C) the Secretary determines that the outstanding inventory need cannot be met by the qualified cord blood banks 

under contract under this section. 

ø(3) PREFERENCE.—In considering contract extensions under 

paragraph (2), the Secretary shall give preference to qualified 

cord blood banks that the Secretary determines have demonstrated a superior ability to satisfy the requirements described in subsection (b) and to achieve the overall goals for 

which the contract was awarded.¿ 

(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— 


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(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. 

* * * * * * * 

(g) DEFINITIONS.—In this section: 

(1) * * * 

* * * * * * * 

(4) The term ‘‘first-degree relative’’ means a sibling øor parent¿ who is one meiosis away from a particular individual in 

a family. 

* * * * * * * 

(h) AUTHORIZATION OF APPROPRIATIONS.— 

ø(1) EXISTING FUNDS.—Any amounts appropriated to the Secretary for fiscal year 2004 or 2005 for the purpose of assisting 

in the collection or maintenance of cord blood shall remain 

available to the Secretary until the end of fiscal year 2007. 

ø(2) SUBSEQUENT FISCAL YEARS.—There are authorized to be 

appropriated to the Secretary $15,000,000 for each of fiscal 

years 2007, 2008, 2009, and 2010 to carry out this section.¿ 

(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. 

ø(3)¿ (2) LIMITATION.—Not to exceed 5 percent of the amount 

appropriated under this section øin each of fiscal years 2007 

through 2009¿ for each of fiscal years 2011 through 2015 may 

be used to carry out the demonstration project under subsection (c). 

* * * * * * * 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC 

HEALTH SERVICE 

* * * * * * * 


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PART I—C.W. BILL YOUNG CELL 

TRANSPLANTATION PROGRAM 

SEC. 379. NATIONAL PROGRAM. 

(a) ESTABLISHMENT.—The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall 

by one or more contracts establish and maintain a C.W. Bill Young 

Cell Transplantation Program (referred to in this section as the 

‘‘Program’’), successor to the National Bone Marrow Donor Registry, that has the purpose of increasing the number of transplants 

for recipients suitably matched to biologically unrelated donors of 

bone marrow and cord blood, and that meets the requirements of 

this section. The Secretary may award a separate contract to perform each of the major functions of the Program described in paragraphs (1) and (2) of subsection (d) if deemed necessary by the Secretary to operate an effective and efficient system that is in the 

best interest of patients. The Secretary shall conduct a separate 

competition for the initial establishment of the cord blood functions 

of the Program. The Program shall be under the general supervision of the Secretary. The Secretary shall establish an Advisory 

Council to advise, assist, consult with, and make recommendations 

to the Secretary on matters related to the activities carried out by 

the Program. The members of the Advisory Council shall be appointed in accordance with the following: 

(1) * * * 

* * * * * * * 

ø(6) The Secretary, acting through the Advisory Council, 

shall submit to the Congress— 

ø(A) an annual report on the activities carried out under 

this section; and 

ø(B) not later than 6 months after the date of the enactment of the Stem Cell Therapeutic and Research Act of 

2005, a report of recommendations on the scientific factors 

necessary to define a cord blood unit as a high-quality 

unit.¿ 

(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. 

* * * * * * * 

(d) FUNCTIONS.— 

(1) * * * 

(2) CORD BLOOD FUNCTIONS.—øWith respect to cord blood, 

the Program shall—¿ 

(A) IN GENERAL.—With respect to cord blood, the Program shall— 

ø(A)¿ (i) operate a system for identifying, matching, 

and facilitating the distribution of donated cord blood 

units that are suitably matched to candidate patients 

and meet all applicable Federal and State regulations 

(including informed consent and Food and Drug Administration regulations) from a qualified cord blood 

bank; 


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ø(B)¿ (ii) consistent with paragraph (3), allow transplant physicians, other appropriate health care professionals, and patients to search by means of electronic 

access all available cord blood units made available 

through the Program; 

ø(C)¿ (iii) allow transplant physicians and other appropriate health care professionals to reserve, as defined by the Secretary, a cord blood unit for transplantation; 

ø(D) support studies and demonstration and outreach 

projects for the purpose of increasing cord blood donation 

to ensure a genetically diverse collection of cord blood 

units;¿ 

(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; 

ø(E)¿ (v) provide for a system of patient advocacy 

through the office established under subsection (h); 

ø(F)¿ (vi) coordinate with the qualified cord blood 

banks to support informational and educational activities in accordance with subsection (g); 

ø(G)¿ (vii) maintain and expand medical contingency 

response capabilities, in coordination with Federal programs, to prepare for and respond effectively to biological, chemical, or radiological attacks, and other 

public health emergencies that can damage marrow, 

so that the capability of supporting patients with marrow damage from disease can be used to support casualties with marrow damage; and 

ø(H)¿ (viii) with respect to the system under subparagraph (A), collect, analyze, and publish data in a 

standardized electronic format, as required by the Secretary, on the number and percentage of patients at 

each of the various stages of the search process, including data regarding the furthest stage reached, the 

number and percentage of patients who are unable to 

complete the search process, and the reasons underlying such circumstances. 


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(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 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. 

(3) SINGLE POINT OF ACCESS; STANDARD DATA.— 

(A) SINGLE POINT OF ACCESS.—The Secretary shall ensure that health care professionals and patients are able 

to search electronically for and facilitate access to, in the 

manner and to the extent defined by the Secretary and 

consistent with the functions described in paragraphs 

(1)(A) and ø(2)(A)¿ (2)(A)(i), cells from bone marrow donors 

and cord blood units through a single point of access. 

* * * * * * * 

(f) BONE MARROW CRITERIA, STANDARDS, AND PROCEDURES.—The 

Secretary shall enforce, for participating entities, including the Program, individual marrow donor centers, marrow donor registries, 

marrow collection centers, and marrow transplant centers— 

(1) * * * 

* * * * * * * 

(5) standards that— 

ø(A) require the establishment of a system of strict confidentiality of records relating to the identity, address, 

HLA type, and managing marrow donor center for marrow 

donors and potential marrow donors; and¿ 

(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 

* * * * * * * 


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SEC. 379B. AUTHORIZATION OF APPROPRIATIONS. 

For the purpose of carrying out this part, there are authorized 

to be appropriated ø$34,000,000 for fiscal year 2006 and 

$38,000,000 for each of fiscal years 2007 through 2010.¿ 

$30,000,000 for each of fiscal years 2011 through 2014 and 

$33,000,000 for fiscal year 2015. 

* * * * * * * 

Æ 


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