[Congressional Record Volume 159, Number 16 (Monday, February 4, 2013)]
[House]
[Pages H322-H325]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




            NATIONAL PEDIATRIC RESEARCH NETWORK ACT OF 2013

  Mr. PITTS. Mr. Speaker, I move to suspend the rules and pass the bill 
(H.R. 225) to amend title IV of the Public Health Service Act to 
provide for a National Pediatric Research Network, including with 
respect to pediatric rare diseases or conditions.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                                H.R. 225

       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 ``National Pediatric Research 
     Network Act of 2013''.

     SEC. 2. NATIONAL PEDIATRIC RESEARCH NETWORK.

       Section 409D of the Public Health Service Act (42 U.S.C. 
     284h; relating to the Pediatric Research Initiative) is 
     amended--
       (1) by redesignating subsection (d) as subsection (f); and
       (2) by inserting after subsection (c) the following:
       ``(d) National Pediatric Research Network.--
       ``(1) Network.--In carrying out the Initiative, the 
     Director of NIH, acting through the Director of the Eunice 
     Kennedy Shriver National Institute of Child Health and Human 
     Development and in collaboration with other appropriate 
     national research institutes and national centers that carry 
     out activities involving pediatric research, may provide for 
     the establishment of a National Pediatric Research Network 
     consisting of the pediatric research consortia receiving 
     awards under paragraph (2).
       ``(2) Pediatric research consortia.--
       ``(A) In general.--The Director of the Institute may award 
     funding, including through grants, contracts, or other 
     mechanisms, to public or private nonprofit entities--
       ``(i) for planning, establishing, or strengthening 
     pediatric research consortia; and
       ``(ii) for providing basic operating support for such 
     consortia, including with respect to--

       ``(I) basic, clinical, behavioral, or translational 
     research to meet unmet needs for pediatric research; and
       ``(II) training researchers in pediatric research 
     techniques in order to address unmet pediatric research 
     needs.

       ``(B) Research.--The Director of NIH shall ensure that--
       ``(i) each consortium receiving an award under subparagraph 
     (A) conducts or supports at least one category of research 
     described in subparagraph (A)(ii)(I) and collectively such 
     consortia conduct or support all such categories of research; 
     and
       ``(ii) one or more such consortia provide training 
     described in subparagraph (A)(ii)(II).
       ``(C) Number of consortia.--The Director of NIH may make 
     awards under this paragraph for not more than 20 pediatric 
     research consortia.
       ``(D) Organization of consortium.--Each consortium 
     receiving an award under subparagraph (A) shall--
       ``(i) be formed from a collaboration of cooperating 
     institutions;
       ``(ii) be coordinated by a lead institution;
       ``(iii) agree to disseminate scientific findings, including 
     from clinical trials, rapidly and efficiently; and
       ``(iv) meet such requirements as may be prescribed by the 
     Director of NIH.
       ``(E) Supplement, not supplant.--Any support received by a 
     consortium under subparagraph (A) shall be used to 
     supplement, and not supplant, other public or private support 
     for activities authorized to be supported under this 
     paragraph.
       ``(F) Duration of support.--Support of a consortium under 
     subparagraph (A) may be for a period of not to exceed 5 
     years. Such period may be extended at the discretion of the 
     Director of NIH.
       ``(3) Coordination of consortia activities.--The Director 
     of NIH shall--
       ``(A) as appropriate, provide for the coordination of 
     activities (including the exchange of information and regular 
     communication) among the consortia established pursuant to 
     paragraph (2); and
       ``(B) require the periodic preparation and submission to 
     the Director of reports on the activities of each such 
     consortium.
       ``(4) Assistance with registries.--Each consortium 
     receiving an award under paragraph (2)(A) shall provide 
     assistance to the Centers for Disease Control and Prevention 
     in the establishment or expansion of patient registries and 
     other surveillance systems as appropriate and upon request by 
     the Director of the Centers.
       ``(e) Research on Pediatric Rare Diseases or Conditions.--
       ``(1) In general.--In making awards under subsection (d)(2) 
     for pediatric research consortia, the Director of NIH shall 
     ensure that an appropriate number of such awards are awarded 
     to such consortia that agree to--
       ``(A) focus primarily on pediatric rare diseases or 
     conditions (including any such diseases or conditions that 
     are genetic disorders (such as spinal muscular atrophy and 
     Duchenne muscular dystrophy) or are related to birth defects 
     (such as Down syndrome and fragile X)); and
       ``(B) conduct or coordinate one or more multisite clinical 
     trials of therapies for, or approaches to, the prevention, 
     diagnosis, or treatment of one or more pediatric rare 
     diseases or conditions.
       ``(2) Data coordinating center.--
       ``(A) Establishment.--In connection with support of 
     consortia described in paragraph (1), the Director of NIH 
     shall establish a data coordinating center for the following 
     purposes:
       ``(i) To distribute the scientific findings referred to in 
     paragraph (1)(C).
       ``(ii) To provide assistance in the design and conduct of 
     collaborative research projects and the management, analysis, 
     and storage of data associated with such projects.
       ``(iii) To organize and conduct multisite monitoring 
     activities.
       ``(B) Reporting.--The Director of NIH shall--
       ``(i) require the data coordinating center established 
     under subparagraph (A) to provide regular reports to the 
     Director of NIH and the Commissioner of Food and Drugs on 
     research conducted by consortia described in paragraph (1), 
     including information on enrollment in clinical trials and 
     the allocation of resources with respect to such research; 
     and
       ``(ii) as appropriate, incorporate information reported 
     under clause (i) into the Director's biennial reports under 
     section 403.''.

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


                             General Leave

  Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials into the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Pennsylvania?
  There was no objection.
  Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support and urge my colleagues to vote for 
H.R. 225, the National Pediatric Research Network Act of 2013.
  Simply put, this legislation will foster important research on 
diseases that affect children. The bill will allow the National 
Institutes of Health to establish a national research network 
compromised of pediatric research consortia. According to NIH, there 
are between 6,000 and 7,000 diseases considered rare that affect 25 to 
30 million people. Most of the approximately 7,000 rare diseases are 
pediatric diseases and often genetic.
  Sadly, there are insufficient therapies for doctors to treat such 
diseases. The use of pediatric research consortia is a proven way to 
support pediatric applied research and to promote coordinated research 
activities that focus on translating research to practice. This will 
help improve care for children.
  As an example, it is important to note that this bill will address 
some devastating diseases such as spinal muscular atrophy. This is a 
rare pediatric disease that kills more babies than any other genetic 
disease. Right now, it is incurable, untreatable, and fatal.
  H.R. 225, introduced by Representatives Lois Capps and Cathy McMorris 
Rodgers, amends the Public Health Service Act so that the director of 
the NIH, acting through the director of the National Institute of Child 
Health and Human Development, could provide for the establishment of a 
national pediatric research network compromised of pediatric research 
consortia.

[[Page H323]]

                              {time}  1720

  The director could award cooperative agreements to those that 
strengthen and provide basic support to pediatric research consortia 
and train researchers. Consortia that receive an award would be 
comprised of cooperating institutions and coordinated by a lead 
institution. No more than 20 pediatric research consortia could receive 
awards.
  In addition, the Director of NIH would be able to establish a data-
coordinating center to support research and distribute scientific 
findings and provide reports to the Director of the NIH and the 
Commissioner of the Food and Drug Administration.
  The bill would result in no new or increased budget authority, 
entitlement authority, tax expenditure, or revenues. Nor does the bill 
contain any earmarks.
  So I am pleased to support this legislation. It is my hope that the 
National Pediatric Research Network will improve our understanding of 
pediatric diseases, improve treatment and therapies, and provide better 
health care outcomes for our Nation's children.
  I urge my colleagues to vote in favor of H.R. 225, and I reserve the 
balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in strong support of H.R. 225, the National 
Pediatric Research Network Act, and commend our colleagues, 
Congresswoman Capps and Congresswoman McMorris Rodgers, for their 
bipartisan efforts to move this legislation forward.
  There are many rare pediatric diseases, and in some of these diseases 
the children are incredibly fragile. If we can allow for research to 
occur across the country--not just one single location--research can be 
done at a larger level because children could then participate without 
having to travel.
  This bill would allow the National Institutes of Health to establish 
a national pediatric network comprised of up to 20 pediatric research 
consortia, groups of collaborating institutions. The consortia will 
conduct basic clinical, behavioral, and translational research on 
pediatric diseases and conditions.
  Among the 20 consortia, the NIH Director is directed to ensure that 
an appropriate number of awards go to consortia that focus primarily on 
pediatric rare diseases such as spinal muscular atrophy or birth 
defects such as Down syndrome.
  In addition, we all know too well that traditionally pediatric 
research has been underfunded. That can make it hard to train and 
develop the research talent needed to address these devastating 
illnesses. The consortia can therefore be the training grounds for 
future researchers helping to fill the pediatric pipeline.
  Mr. Speaker, no funds are specifically allocated to this effort under 
the bill, but it's our hope and expectation that NIH will choose to 
create the network and build on the important work in pediatric 
research that it already supports.
  In the last Congress, this same bill was considered and approved by 
the Energy and Commerce Committee and the full House by voice vote. It 
was also included in a broader children's health bill at the end of the 
session, but it failed to be considered in the Senate.
  I urge my colleagues to support this bipartisan effort to address 
pediatric research; and with that strong support, it's my hope that we 
can encourage its passage in the Senate this time.
  I reserve the balance of my time.
  Mr. PITTS. Mr. Speaker, at this time, I yield such time as he may 
consume to the chairman of the full committee, the gentleman from 
Michigan (Mr. Upton).
  Mr. UPTON. Mr. Speaker, this legislation, H.R. 225, the National 
Pediatric Research Network Act of 2013, indeed brings us a step closer 
to helping kids with unmet health needs, especially those with rare 
pediatric and genetic diseases. According to the NIH, there are more 
than 6,800 rare diseases, and most of them have no treatment or cure; 
and, yes, they primarily affect children.
  I've met a number of times with one family in my district, the 
Kennedys, who have two precious little girls, Brielle and Brooke. I 
actually call them Sleeping Beauty and Cinderella. They have the rare 
disease called spinal muscular atrophy. They're great kids, and Brielle 
and Brooke have been little warriors in our effort to make the National 
Pediatric Research Network a reality.
  It is so difficult to conduct research into these diseases due to the 
very small number of people with that disease, but tonight we're 
working to provide families like the Kennedys and so many others with 
greater hope for a cure or advances in treatment.
  This bill is going to support and coordinate research on rare 
pediatric and genetic diseases and help improve the health and well-
being of these kids afflicted with these diseases.
  This bill establishes a national pediatric research network comprised 
of pediatric research consortia. These consortia are a proven way to 
overcome the gaps in research. They include leading institutions that 
act as partners to consolidate and coordinate research efforts. They're 
going to promote efficiency and collaboration, which is especially 
important when a disease impacts just a small number of kids.
  This bill is in essence the same bill as H.R. 6163 of the last 
Congress, which passed in September and was part of S. 1440 in December 
of 2012. Last month, in January, our committee, the Energy and Commerce 
Committee, passed this legislation on a very broad bipartisan voice 
vote.
  I want to particularly commend the author of the legislation, Lois 
Capps. I want to thank Cathy McMorris Rodgers on our side, the 
Republican side, for her leadership, as well as Joe Pitts, Mr. Waxman, 
and others. This is a bill that all of us should support, and I would 
urge my colleagues to do the same thing.
  It was unfortunate that last year it took the House a little while to 
pass this; and in the last waning days of the session, we couldn't get 
the Senate to move. This year, there's a reason why this is now one of 
the first bills to pass in the House: to give the Senate the time to 
get this thing done and get it to the President's desk to have him sign 
it into law so that he can help not only the Kennedys in my district, 
but the Kennedys literally in every district around the country and so 
many kids that deserve our help. We can make a difference tonight, and 
we will when we pass this on a bipartisan vote.
  I thank all those Members and staff, particularly, for getting this 
to the floor in such a timely fashion.
  Mr. PALLONE. Mr. Speaker, I now yield 4 minutes to the sponsor of the 
legislation, the gentlewoman from California (Mrs. Capps).
  Mrs. CAPPS. I thank my colleague for yielding.
  Mr. Speaker, I rise in strong support of H.R. 225, the National 
Pediatric Research Network Act.
  I want to associate myself with the remarks of our committee 
chairman, Mr. Upton. He has a family dear to his heart, as I have one 
too; and they reflect families across this country for whom this bill 
will provide a stronger glimmer of hope for the future.
  This is a bipartisan bill. It will improve research in clinical 
trials on pediatric diseases, train future pediatric researchers, and 
disseminate research findings quickly so that all children may benefit.
  It does not replace our current pediatric research investments, but 
instead builds upon the work already being done at the National 
Institutes of Health and at so many research centers across the country 
by creating research consortia to form a nationwide network of 
pediatric researchers. This is important to make sure that we are 
always working with the most current science and that this information 
is quickly shared and verified.
  This bill will also expand the geographic scope of research, giving 
sick kids easier access to research programs and clinical trials. 
Moreover, this bill will help a wider variety of institutions 
participate in this critical research while providing training grounds 
for our next generation of pediatric researchers.
  Another key feature of this bill is that it will place an added 
emphasis on researching children's rare diseases and develop new 
treatments to fight them.
  My colleagues have heard me talk before about diseases like spinal 
muscular atrophy just referenced by our committee chair. This does not 
just affect a sick child, but it also fundamentally changes the daily 
lives of their

[[Page H324]]

family, their school, their community. The low prevalence of such 
diseases makes them particularly hard to research. But for those 
affected, a new cure or treatment could mean a world of difference.
  The National Pediatric Research Network Act will be an important step 
forward to helping these families and those who may develop these 
diseases long into the future.

                              {time}  1730

  I am a nurse, a mother, and a grandmother as well, and I am very 
pleased to have authored this bill that will help bring more treatments 
and cures to many children.
  Children have unique health care experiences, treatment needs, 
research challenges; and while public and private research has come a 
very long way on pediatric diseases over the years, we know that we are 
still far behind on important diagnostics, cures, and treatments for 
far too many of our ailing children, which is why this bill is so 
important.
  I especially thank Representative Cathy McMorris Rodgers for co-
leading this bill through two Congresses with me and for all her hard 
work on children's health issues. I want to thank the leadership of the 
Energy and Commerce Committee. Chairman Upton I have referenced, but I 
also thank Ranking Member Waxman, Chairman Pitts, Ranking Member 
Pallone, and their staffs for their dedication to this bill. I 
especially thank Ruth Katz for helping us move this bill through the 
committee quickly. I thank my colleague Congresswoman DeGette, who has 
worked on this bill with me for many years.
  Finally, I would like to thank my constituents Bill and Victoria 
Strong for their tireless work on behalf of their daughter, Gwendolyn, 
and all the children with spinal muscular atrophy and other rare 
diseases. For them, I wear a particular bracelet, which reads: ``Never 
give up.'' Gwendolyn, who it was once thought would never live past age 
2, is now in kindergarten. The work her parents, Bill and Victoria, do 
day in and day out to make their daughter's world a little better is so 
inspiring. The dedication of her parents and their medical team truly 
allows Gwendolyn to live life to the fullest. They have shown how 
entire communities can come together and fight diseases like SMA.
  I urge my colleagues to follow their example. Come together, and 
support this bill today so we can do all we can to make it law.
  Mr. Speaker, the National Pediatric Research Network Act is an 
important bill, not just for current and future researchers, but for 
sick children and for their families. It is a bipartisan measure that 
received overwhelming support in the 112th Congress, and it's the right 
thing to do, so I urge its full support.
  Mr. PITTS. Mr. Speaker, I am pleased to yield 2 minutes to the 
gentleman from Mississippi (Mr. Harper).
  Mr. HARPER. I rise today to speak about the importance of the 
National Pediatric Research Network Act of 2013. This bill rightfully 
develops pediatric research consortia to identify and promote therapies 
for rare childhood diseases.
  One of the disorders that this proposal targets is spinal muscular 
atrophy, or SMA, which is the number one genetic killer of children 
under the age of 2. This often unforgiving neurological disease leaves 
children weak and unable to move, breathe, swallow or talk; but 
research is promising and a cure is close.
  Recently, a friend of mine, Jeff Horton from my home county in 
Mississippi, shared with my office that his daughter, Evie, who has 
SMA, had an encouraging visit with an SMA specialist in Dallas. You 
see, Evie has toured the country and has met with experts devoted to 
advancing new and innovative SMA therapies. As a result, Evie's quality 
of life continues to improve as she gains mobility and a sense of 
independence.
  I urge you today to please support this legislation for Evie and 
others, such as her cousin, Reese, and the many other families that are 
affected by rare childhood diseases. This is something that we can do 
and that we should do.
  Mr. PALLONE. Mr. Speaker, I have no further requests for time. At 
this point, I would urge the passage of the legislation, and I yield 
back the balance of my time.
  Mr. PITTS. Mr. Speaker, I would like to include in the Record CBO's 
cost estimate for H.R. 225. The cost estimate was not available when 
the committee filed its report on the bill.
  I urge all Members to support this important legislation. With that, 
I yield back the balance of my time.

                                                    U.S. Congress,


                                  Congressional Budget Office,

                                 Washington, DC, February 4, 2013.
     Hon. Fred Upton,
     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. 225, the 
     National Pediatric Research Network Act of 2013.
       If you wish further details on this estimate, we will be 
     pleased to provide them. The CBO staff contact is Jamease 
     Miles, who can be reached at 226-9010.
           Sincerely,
                                             Douglas W. Elmendorf.
       Enclosure.
     H.R. 225--National Pediatric Research Network Act of 2013
       H.R. 225 would authorize the Director of the National 
     Institutes of Health (NIH) to establish a National Pediatric 
     Research Network that could provide support for research and 
     training at up to 20 pediatric research consortia for up to 
     five years. The bill would require the Director of NIH to 
     establish a data coordinating center for the consortia. Upon 
     request by the Centers for Disease Control and Prevention 
     (CDC), consortia participating in the program would be 
     required to provide assistance to the CDC to establish or 
     expand surveillance systems, such as patient registries.
       NIH currently supports many research networks that support 
     research and training focused on pediatric health care needs 
     and operates data coordinating centers for those networks. 
     Those networks perform essentially the same activities as the 
     consortia described in the bill. Existing networks do not 
     routinely provide assistance to the CDC to establish 
     surveillance systems. Based on information provided by NIH, 
     CBO estimates that implementing H.R. 225 would have no effect 
     on the number of research consortia or data coordinating 
     centers that NIH would support. CBO expects that CDC would 
     request assistance from a few networks to establish 
     surveillance systems. Based on past coordination involving 
     patient registries, CBO expects that the cost of providing 
     such support would total about $1 million over five years. 
     Thus, CBO estimates that implementing H.R. 225 would cost $1 
     million over the 2014-2018 period, assuming the availability 
     of appropriated funds.
       Enacting the bill would not affect direct spending or 
     revenues; therefore, pay-as-you-go procedures do not apply.
       H.R. 225 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 Jamease Miles. 
     The estimate was approved by Holly Harvey, Deputy Assistant 
     Director for Budget Analysis.
  Mr. WAXMAN. Mr. Speaker, I am pleased to rise in support of H.R. 225, 
the National Pediatric Research Network Act of 2013. The House passed 
legislation similar to H.R. 225 twice last year. I am hopeful that this 
time around we will get this bill over the finish line.
  H.R. 225 represents a bi-partisan effort to allow the National 
Institutes of Health (NIH) to establish a national pediatric research 
network dedicated to finding treatments and cures for pediatric 
diseases and conditions--especially those that are rare. The network 
would be comprised of up to 20 research consortia or groups of 
collaborating research institutions such as universities and hospitals. 
These consortia would be investigator-initiated and would conduct 
basic, clinical, behavioral, and translational research on pediatric 
diseases and conditions. NIH funding would be used to create the 
infrastructure necessary to carry out this research.
  Within the network, the NIH Director is instructed to ensure that an 
appropriate number of awards go to those consortia that focus primarily 
on pediatric rare diseases such as spinal muscular atrophy--or SMA--or 
birth defects such as Down syndrome. Because these kinds of diseases 
and conditions are rare and some of the children who suffer from them 
are very fragile, it makes it difficult for them to travel great 
distances to participate in clinical trials or other research. This is 
often the case when--not infrequently--only one institution is 
conducting such research. The availability of consortia--by definition, 
multiple cooperating institutions--should make clinical research 
opportunities far more accessible to these kids and their families. In 
turn, we would hope they would help speed up the time and effort in 
finding treatments and cures for these devastating diseases and 
conditions.
  In addition to the research itself, the consortia are expected to 
serve as training grounds for future pediatric researchers. 
Traditionally, pediatric research has been underfunded. This has 
sometimes resulted in real challenges in recruiting the talent 
necessary to

[[Page H325]]

tackle diseases and conditions that affect kids--again, especially 
those that are rare. Thus, H.R. 225 places a special emphasis on 
pediatric research techniques with the goal of helping to ``prime the 
pump'' for a greater number of leading edge pediatric researchers.
  Taken together, the components of H.R. 225 make for a package that 
would allow NIH to build on the strong body of pediatric research that 
it currently conducts and supports. I would encourage NIH to take full 
advantage of this opportunity.
  I want to commend all those members of the Energy and Commerce 
Committee who have come together to make H.R. 225 happen. I especially 
want to the note the efforts of Congresswoman Capps and Congresswoman 
McMorris Rodgers--the sponsors of this bill--for their tireless efforts 
to bring it before us today.
  I urge my colleagues to vote ``yes'' on H.R. 225.
  Mr. GENE GREEN of Texas. Mr. Speaker, I support the National 
Pediatric Research Network Act, H.R. 225. Thank you to Representatives 
Capps and McMorris-Rodgers for their continued leadership on this 
issue.
  This important bill will allow the National Institutes of Health to 
focus funding on researching rare and genetic pediatric diseases such 
as spinal muscular atrophy, muscular dystrophy, Down syndrome, and 
Fragile X. Because there are such a small number of incidences of these 
terrible diseases, they are extremely difficult to study. This bill 
takes steps toward giving our research community the tools necessary to 
increase research of an array of diseases that cause so much pain and 
suffering to children and their families.
  Increasing our nation's commitment to researching rare pediatric 
diseases is an area that enjoys bipartisan support. I look forward to 
voting for this bill and urge my colleagues to do the same.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Pennsylvania (Mr. Pitts) that the House suspend the 
rules and pass the bill, H.R. 225.
  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. PITTS. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this motion will be postponed.

                          ____________________