[Congressional Record Volume 166, Number 169 (Tuesday, September 29, 2020)]
[House]
[Pages H4996-H4998]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




TIMELY REAUTHORIZATION OF NECESSARY STEM-CELL PROGRAMS LENDS ACCESS TO 
                      NEEDED THERAPIES ACT OF 2019

  Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the 
bill (H.R. 4764) to reauthorize the Stem Cell Therapeutic and Research 
Act of 2005, and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 4764

       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 ``Timely ReAuthorization of 
     Necessary Stem-cell Programs Lends Access to Needed Therapies 
     Act of 2020'' or the ``TRANSPLANT Act of 2020''.

     SEC. 2. REAUTHORIZATION OF THE C.W. BILL YOUNG CELL 
                   TRANSPLANTATION PROGRAM.

       (a) Advisory Council Meetings.--Subsection (a) of section 
     379 of the Public Health Service Act (42 U.S.C. 274k) is 
     amended by adding at the end the following new paragraph:
       ``(7) The Secretary shall convene the Advisory Council at 
     least two times each calendar year.''.
       (b) Increasing Collection.--
       (1) Technical clarification.--Effective as if included in 
     the enactment of Public Law 114-104 (the Stem Cell 
     Therapeutic and Research Reauthorization Act of 2015), the 
     amendment to section 379(d)(2)(B) of the Public Health 
     Service Act (42 U.S.C. 274k(d)(2)(B)) in section 2(a)(2) of 
     Public Law 114-104 is amended by inserting ``goal of 
     increasing collections of high quality'' before ``cord blood 
     units,''.
       (2) Eliminating deadwood.--Subparagraph (B) of section 
     379(d)(2) of the Public Health Service Act (42 U.S.C. 
     274k(d)(2)) is amended by striking the second and third 
     sentences in such subparagraph.
       (c) Periodic Review of State of Science.--Section 379 of 
     the Public Health Service Act (42 U.S.C. 274k) is amended by 
     adding at the end the following new subsection:
       ``(o) Periodic Review of State of Science.--
       ``(1) Review.--Not less than every two years, the 
     Secretary, in consultation with the Director of the National 
     Institutes of Health, the Commissioner of Food and Drugs, the 
     Administrator of the Health Resources and Services 
     Administration, the Advisory Council, 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 Program.
       ``(2) Recommendations.--Not later than June 30, 2024, the 
     Secretary shall--
       ``(A) complete the second review required by paragraph (1); 
     and
       ``(B) informed by such review, 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 the 
     inclusion of new types of therapies in the Program.''.
       (d) Authorization of Appropriations.--Section 379B of the 
     Public Health Service Act (42 U.S.C. 274m) is amended by 
     striking ``$33,000,000 for fiscal year 2015 and $30,000,000 
     for each of fiscal years 2016 through 2020'' and inserting 
     ``$30,000,000 for each of fiscal years 2021 through 2025''.

     SEC. 3. CORD BLOOD INVENTORY.

       Subsection (g) of section 2 of the Stem Cell Therapeutic 
     and Research Act of 2005 (42 U.S.C. 274k note) is amended to 
     read as follows:
       ``(g) Authorization of Appropriations.--To carry out this 
     section, there is authorized to be appropriated $23,000,000 
     for each of fiscal years 2021 through 2025.''.

     SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDICINE.

       Section 402 of the Public Health Service Act (42 U.S.C. 
     282) is amended by adding at the end the following:
       ``(o) Regenerative Medicine.--The Director of NIH shall, as 
     appropriate, continue to consult with the directors of 
     relevant institutes and centers of the National Institutes of 
     Health, other relevant experts from such institutes and 
     centers, and relevant experts within the Food and Drug 
     Administration, to further the field of regenerative medicine 
     using adult stem cells, including autologous stem cells, 
     therapeutic tissue engineering products, human cell and 
     tissue products, human gene therapies, and genetically 
     modified cells.''.

     SEC. 5. GAO REPORT ON REGENERATIVE MEDICINE WORKFORCE.

       Not later than 2 years 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 of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report that 
     assesses the national blood stem cell workforce, including 
     those related to the C.W. Bill Young Cell Transplantation 
     Program established under section 379 of the Public Health 
     Service Act (42 U.S.C. 274k). The report shall include--
       (1) an overview of the current employment levels, in both 
     commercial and academic settings, for--
       (A) positions necessary for the collection and 
     transplantation of stem cell therapeutics, including bone 
     marrow and cord blood; and
       (B) positions in the field of regenerative medicine using 
     adult stem cells and related to product development;
       (2) the identification of gaps, if any, in the projected 
     workforce capacity for--
       (A) positions described in paragraph (1)(A); and
       (B) the field of regenerative medicine using adult stem 
     cells, including workforce gaps related to the development of 
     new cellular therapies using adult stem cells;
       (3) an overview of the availability of training programs 
     related to the development, refinement, and utilization of 
     adult stem cells, including training on good manufacturing 
     practices for such activities, and the performance of such 
     programs; and
       (4) recommendations, if any, for improving the workforce 
     capacity related to--
       (A) the positions described in paragraph (1)(A); or
       (B) the field of regenerative medicine using adult stem 
     cells.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Oregon (Mr. Walden) each 
will control 20 minutes.

[[Page H4997]]

  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on H.R. 4764.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, the C.W. Bill Young Transplantation Program was first 
established through a partnership with the Navy in 1986, transferred to 
the National Institutes of Health for oversight in 1987, and then 
authorized by the Energy and Commerce Committee in 1990. The program 
has since been reauthorized four times, and every time it has been 
accomplished with strong bipartisan support.
  I believe that bipartisan support will continue today with H.R. 4764, 
the TRANSPLANT Act of 2019, which will reauthorize the C.W. Bill Young 
Transplantation Program for the fifth time.
  Year after year, this program provides lifesaving bone marrow and 
umbilical cord blood transplants to help patients suffering from over 
70 diseases. The program assists transplant patients by providing 
additional information about bone marrow and cord blood transplants, 
maintaining an efficient process for identifying donor matches, 
increasing the number of unrelated donors available for transplant, and 
collecting data and expanding research to improve patient outcomes.
  I thank my committee colleagues, Representatives Matsui and 
Bilirakis, for their leadership on this bill.
  Madam Speaker, I urge my colleagues to support this bill, and I 
reserve the balance of my time.
  Mr. WALDEN. Madam Speaker, I yield myself such time as I may consume.
  Madam Speaker, I rise today, also, in support of H.R. 4764, the 
Timely Reauthorization of Necessary Stem-Cell Programs Lends Access to 
Needed Therapies Act, or the TRANSPLANT Act.
  This critical bill, led by Representatives Matsui, Bilirakis, and 
Pingree, reauthorizes the C.W. Bill Young Transplantation Program, 
which provides lifesaving bone marrow and umbilical blood transplants 
to patients suffering from over 70 diseases that can be treated with 
blood or immune system reconstruction using bone marrow, peripheral 
blood, or cord blood. These diseases include leukemia, lymphoma, sickle 
cell anemia, and certain other immune system disorders.
  I thank our colleagues, Representatives Matsui, Bilirakis, and 
Pingree, for being tireless advocates for this program. They truly have 
just never stopped working to get this done.
  I also express my appreciation to Representative Chris Smith from New 
Jersey, who played a critical role in the creation of this program, 
spearheaded previous reauthorizations, and has been a longtime champion 
for patients whose only chance at life is a transplant through this 
program. Representative Smith wanted to be here today to express his 
strong support for this bipartisan initiative, but, unfortunately, he 
could not be present because of a death in his own family.
  All of this is to say that I am incredibly grateful for all of the 
bipartisan efforts from multiple Members of Congress who have 
prioritized this program and worked together to get this bill across 
the finish line.
  Madam Speaker, I strongly urge a ``yes'' vote on this bill, and I 
reserve the balance of my time.
  Mr. PALLONE. Madam Speaker, I reserve the balance of my time.
  Mr. WALDEN. Madam Speaker, I yield myself such time as I may consume.
  I have a statement from Congressman Chris Smith of New Jersey that I 
will include in the Record in support of this legislation.
  Madam Speaker, I yield such time as he may consume to the gentleman 
from Florida (Mr. Bilirakis), who is one of the real advocates of this 
legislation.
  Mr. BILIRAKIS. Madam Speaker, I rise today in support of H.R. 4764, 
the Timely Reauthorization of Necessary Stem-Cell Programs Lends Access 
to Needed Therapies, or the TRANSPLANT, Act.
  As co-chair of the Blood Cancers Caucus, I urge my colleagues to 
support the TRANSPLANT Act. This bill is about providing hope to those 
who are struggling with life-threatening illnesses.
  The TRANSPLANT Act reauthorizes the C.W. Bill Young Cell 
Transplantation Program in addition to the National Cord Blood 
Inventory. I know that this was a priority for Congressman Young, and 
it was an honor to serve with him and help him pass this bill 
initially.
  This Federal program provides critical support in the advancement of 
research for better treatments and the infrastructure necessary to 
organize registries which help ensure transplant patients have access 
to lifesaving procedures. Simply put, its continued reauthorization is 
vital for patients with diseases like blood disorders, blood cancer, 
sickle cell anemia, and inherited metabolic or immune system disorders.

  I sincerely appreciate the work of my friend and colleague and fellow 
Blood Cancers Caucus co-chair, Congresswoman Matsui, in addition to the 
legacy of bipartisan leadership and support of these programs by 
Members like Congressman Chris Smith and, of course, our good chairman 
and ranking member.
  Additionally, I appreciate the critical daily work of the National 
Marrow Donor Program, operating the Be the Match national registry, 
connecting patients in search of a cure with lifesaving bone marrow 
donors, even in the midst of this historic pandemic.
  I also would like to take a moment to recognize the great work of Dr. 
Joanne Kurtzberg, the president of the Cord Blood Association. She also 
serves in multiple roles at Duke University, including director of the 
Carolinas Cord Blood Bank.
  Dr. Kurtzberg has dedicated her professional career to cord blood 
research, banking, and transplantation, and is an internationally 
recognized umbilical cord blood transplanter. She advised Congress on 
the creation of the public cord blood banking program, which was part 
of the Stem Cell Therapeutic and Research Act of 2005, and I believe 
that was led by Representative Chris Smith. Dr. Kurtzberg continues to 
be a trusted adviser to Congress on this important program.
  Again, I urge my colleagues to join us in expediting the passage of 
this lifesaving bipartisan bill, and it is a very crucial bill for a 
lot of people, Madam Speaker.
  Mr. WALDEN. Madam Speaker, I encourage my colleagues to support this 
legislation, and I yield back the balance of my time.
  Mr. PALLONE. Madam Speaker, I also ask for bipartisan support for 
this legislation. I mention that I do intend to seek a recorded vote.
  Madam Speaker, I yield back the balance of my time.
  Mr. SMITH of New Jersey. Madam Speaker, Margaret Hahn--my mother-in-
law--passed away on Friday and a Mass of Christian burial will be held 
today at St. Mary Church in South Amboy, New Jersey. She was 96 and was 
deeply loved and will be deeply missed.
  Margaret--Peg--was a great woman--wife, mother, grandmother, and 
great-grandmother. She selflessly devoted her life to public service 
including her amazing work as Sayreville Borough Clerk for twenty 
years. She had an incredible reputation for getting things done for the 
people. No matter who served as mayor or on Council, everyone knew she 
was the power.
  My wife Marie and I will join family and friends today at her funeral 
and internment making it impossible for me to speak today during the 
debate on the reauthorization of a law I originally authored fifteen 
years ago--the Stem Cell Therapeutic and Research Act of 2005--and the 
Stem Cell Therapeutic and Research Act of 2015.
  So, I submit these comments for the Record:
  Madam Speaker, today the House of Representatives will vote to 
reauthorize the Stem Cell Therapeutic and Research Act.
  This was an original idea of mine 20 years ago. Joined by 70 
cosponsors, I introduced it in 2001 and again in 2003.
  After five long years of hard work and numerous setbacks, my bill was 
finally enacted into law in 2005.
  Beginning in 2001, Dr. Joanne Kurtzberg, who is President of the Cord 
Blood Association, helped draft my original law. Dr. Kurtzberg has 
said, ``Cord blood transplantation is now an established field with 
enormous potential. In the future, it may emerge

[[Page H4998]]

as a source of cells for cellular therapies focused on tissue repair 
and regeneration.''
  The new law created a nationwide umbilical cord blood stem cell 
program, designed to collect, derive, type, and freeze cord blood units 
for transplantation into patients to mitigate and to even cure serious 
disease. Pursuant to the law, it also provided stem cells for research. 
The new cord blood program was combined in our 2005 law with an 
expanded bone marrow initiative, which was crafted over several years 
by our distinguished colleague, Congressman Bill Young.
  I was the prime sponsor again when it was reauthorized in 2015.
  Umbilical cord blood stem cells, obtained after the birth of a child, 
have proved highly efficacious in treating 70 diseases, including 
sickle-cell disease, lymphoma, and leukemia. And scientists are 
continuing to study and better understand the regenerative effects of 
cord blood cell therapies for other diseases and conditions. Bone 
marrow donations provide lifesaving transplants to treat diseases like 
blood cancer, sickle cell anemia, or inherited metabolic or immune 
system disorders.
  The National Cord Blood Inventory (NCBI) provides funding to public 
cord blood banks participating in the program to allow them to expand 
the national inventory of cord blood units available for transplant. 
These units are then listed on the registry by the ``Be the Match'' 
Program. The funds appropriated thus far have led to an important 
increase in the overall number of high-quality cord blood units 
available through the national registry, including 150,000 NCBI units. 
Within the Be the Match registry, there are more than 783,000 NCBI 
units worldwide.
  The Program registry allows patients and physicians to locate 
matching cord blood units, as well as adult donors for marrow and 
peripheral blood stem cells, when a family donor is not available. The 
Program is the world's largest, most diverse donor registry, with more 
than 22 million volunteers and more than 300,000 public cord blood 
units. To date, the National Marrow Donor Program/Be The Match (NMDP), 
through its operation of the Program, has facilitated more than 100,000 
transplants. More than 45,000 patients have received cord blood 
transplants, according to Dr. Joanne Kurtzberg.
  The reauthorization before us authorizes $23 million to be 
appropriated for fiscal year 2021 through fiscal year 2025. It also 
authorizes $30 million to be appropriated for fiscal years 2021 through 
2025 for the bone marrow transplant program. This continues funding at 
the same levels authorized in the 2015 authorization bill.
  Madam Speaker, each year nearly 4 million babies are born in America. 
In the past, virtually every placenta and umbilical cord was tossed as 
medical waste. Today, doctors have turned this medical waste into 
medical miracles.
  Not only has God in His wisdom and goodness created a placenta and 
umbilical cord to nurture and protect the precious life of an unborn 
child, but now we know that another gift awaits us immediately after 
birth. Something very special is left behind--cord blood that is 
teeming with lifesaving stem cells. Indeed, it remains one of the best 
kept secrets in America that umbilical cord blood stem cells and adult 
stem cells in general are curing people of a myriad of terrible 
conditions and diseases--over 70 diseases in adults as well as in 
children.
  The legislation that is before us will enable even more patients to 
receive the treatments that they so desperately need.

                              {time}  1415

  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 4764, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. PALLONE. Madam Speaker, on that I demand the yeas and nays.
  The SPEAKER pro tempore. Pursuant to section 3 of House Resolution 
965, the yeas and nays are ordered.
  Pursuant to clause 8 of rule XX, further proceedings on this motion 
will be postponed.

                          ____________________