[Congressional Record Volume 167, Number 64 (Wednesday, April 14, 2021)]
[House]
[Pages H1752-H1754]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                              {time}  1300
TIMELY REAUTHORIZATION OF NECESSARY STEM-CELL PROGRAMS LENDS ACCESS TO 
                      NEEDED THERAPIES ACT OF 2021

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 941) to reauthorize the Stem Cell Therapeutic and Research 
Act of 2005, and for other purposes.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                                H.R. 941

       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 2021'' or the ``TRANSPLANT Act of 2021''.

     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 frequently than every 2 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, 2025, 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 
     ``$31,009,000 for each of fiscal years 2022 through 2026''.

     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 2022 through 2026.''.

     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

[[Page H1753]]

     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report that 
     assesses a specialized health care workforce in the field of 
     regenerative medicine. 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 Florida (Mr. Bilirakis) 
each will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. 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. 941.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, the C.W. Bill Young Transplant Program and the National 
Cord Blood Inventory Program facilitate lifesaving bone marrow and 
umbilical cord blood donations to help patients suffering from blood 
cancers, disorders, and diseases.
  These critical programs assist transplant patients by providing 
additional information about bone marrow and cord blood transplants, 
maintaining an efficient process for identifying donor matches, and 
increasing the number of unrelated donors available for transplant. The 
programs also collect data and expand research to improve patient 
outcomes.
  I thank my colleagues--Representatives Matsui, Bilirakis, and 
Pingree--for their bipartisan leadership on this bill, and I would urge 
my colleagues to support H.R. 941.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise today in support of H.R. 941, the Timely 
Reauthorization of Necessary Stem-Cell Programs Lends Access to Needed 
Therapies Act, 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 Transplant Program, in addition to the 
National Cord Blood Inventory Program.
  I remember Bill Young, Chairman Young, a great friend of ours, and he 
said that this was one of his greatest accomplishments. I also know 
that Chris Smith, who will be speaking later, was also involved in 
this. He has been a champion on this issue, Mr. Speaker. So I 
appreciate both of them.
  This Federal program provides critical support in the advancement of 
research for better treatments and the infrastructure necessary to 
organize registries, which will help ensure transplant patients have 
access to lifesaving procedures. Simply put, its continued 
reauthorization is vital for patients with diseases like 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, as I said, Chris Smith.
  I thank the chairman, as well and the ranking member, for placing 
this particular bill on the agenda. I know it will get through the 
Senate this time.
  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 would also 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 the director of 
Carolinas Cord Blood Bank. Dr. Kurtzberg has dedicated her professional 
career to cord blood research, banking, and transplantation; and she 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. Dr. Kurtzberg continues to be a trusted adviser to Congress on 
this important program.
  Mr. Speaker, I urge all my colleagues to join us in expediting 
passage of this lifesaving bipartisan bill.
  Mr. Speaker, I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I have no additional speakers, but I think 
my colleague does, so I reserve the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield 4 minutes to the gentleman from 
New Jersey (Mr. Smith).
  Mr. SMITH of New Jersey. Mr. Speaker, I thank the gentleman for 
yielding.
  Mr. Speaker, today, the House of Representatives will vote to 
reauthorize the Stem Cell Therapeutic and Research Act, a law that I 
authored in 2005. This was an original idea of mine 20 years ago.
  My good friend from Florida just mentioned Dr. Kurtzberg. Dr. 
Kurtzberg was in the meetings that we held in drafting this 
legislation, and she provided incredible insights as to what we should 
do, what path we should follow. So I appreciate him recognizing her.
  I also thank Artur Davis, who was my Democratic colleague and the 
principal Democratic cosponsor of the bill during those several years. 
It took 5 long years of hard work and numerous setbacks, but the bill 
was finally signed into law on December 20, 2005.
  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 even cure serious 
disease. Pursuant to the law, it also provided stem cells for research. 
The new cord blood program was combined with an expanded bone marrow 
initiative, which was crafted over several years by our distinguished 
colleague, Congressman Bill Young.
  Umbilical cord blood stem cells, Mr. Speaker, obtained after the 
birth of a child have proved to be highly efficacious in treating some 
70 diseases, including sickle cell disease, lymphoma, leukemia, and in 
treating metabolic and immune deficiencies. Scientists are continuing 
to study and better understand the regenerative effects of cord blood 
cell therapies for other diseases and disabilities, including autism. I 
would say in like manner, bone marrow donations are also providing 
lifesaving transplants for some of those very same diseases. So we have 
great regenerative initiatives that will be continued.

  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, now totaling 111,000 NCBI 
units. Within the Be the Match Registry, there are now more than 
800,000 worldwide.
  The program registry, Mr. Speaker, allows patients and physicians to 
locate matching cord blood units, as well as adult donors for marrow 
and peripheral blood stem cells. The program is the world's largest, 
most diverse donor registry, with more than 23 million volunteers. To 
date, the National Marrow Donor Program/Be the Match, through its 
operation of the program, has facilitated more than 105,000 
transplants.

[[Page H1754]]

According to Be the Match, more than 40,000 patients have received cord 
blood transplants.
  The reauthorization before us authorizes $23 million each year for 5 
years for the cord blood side and, again, some $30 million each year 
for the bone marrow program.
  Mr. 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 
an umbilical cord to nurture and protect the precious life of an unborn 
child, but now we know that another gift awaits immediately after 
birth. Something very special is left behind: Cord blood that is 
teeming with lifesaving stem cells.
  Mr. BILIRAKIS. Mr. Speaker, this is a very important bill and needs 
to pass as soon as possible. I really appreciate the chairman placing 
the bill on the agenda. I urge the Senate to pass it as soon as 
possible, and, of course, my colleagues today, if we can pass this bill 
immediately so we can get it to the Senate.
  Mr. Speaker, I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, I also urge support for the bill, and I 
yield back the balance of my time.
  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. 941.
  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. CLINE. Mr. Speaker, on that I demand the yeas and nays.
  The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution 
8, the yeas and nays are ordered.
  Pursuant to clause 8 of rule XX, further proceedings on this motion 
are postponed.

                          ____________________