[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
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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.
____________________