H6138 CONGRESSIONAL RECORD — HOUSE September 19, 2012 

shall be due 30 calendar days after publication of the notice provided for in section 

744B(a)(2)(C)(i) of such Act. 

(2) Notwithstanding section 

744B(a)(3)(C)(ii) of such Act, the fee authorized under section 744B(a)(3) of such Act for 

fiscal year 2013 shall be due on the later of— 

(A) the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies; 

or 

(B) 30 calendar days after publication of 

the notice referred to in section 

744B(a)(3)(B)(i) of such Act. 

(3) Notwithstanding section 744B(a)(4)(D)(i) 

of such Act, the fee authorized under section 

744B(a)(4) of such Act for fiscal year 2013 

shall be due not later than 45 days after the 

publication of the notice under section 

744B(a)(4)(C)(i) of such Act. 

The bill was ordered to be engrossed 

and read a third time, was read the 

third time, and passed, and a motion to 

reconsider was laid on the table. 

GENERAL LEAVE

Mr. UPTON. 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 in the 

RECORD on this bill, H.R. 6433. 

The SPEAKER pro tempore. Is there 

objection to the request of the gentleman from Michigan? 

There was no objection. 

f 

NATIONAL PEDIATRIC RESEARCH 

NETWORK ACT OF 2012 

Mr. UPTON. Mr. Speaker, I move to 

suspend the rules and pass the bill 

(H.R. 6163) 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, as 

amended. 

The Clerk read the title of the bill. 

The text of the bill is as follows: 

H.R. 6163 

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 2012’’. 

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 and contracts, 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. 

‘‘(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; 

and 

‘‘(iii) 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 by the Director of NIH 

for additional periods of not more than 5 

years. 

‘‘(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. 

‘‘(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)); 

‘‘(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; and 

‘‘(C) rapidly and efficiently disseminate 

scientific findings resulting from such trials. 

‘‘(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. 

‘‘(iv) To provide assistance to the Centers 

for Disease Control and Prevention in the establishment or expansion of patient registries and other surveillance systems. 

‘‘(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 

Michigan (Mr. UPTON) and the gentlewoman from California (Mrs. CAPPS) 

each will control 20 minutes. 

The Chair recognizes the gentleman 

from Michigan. 

Mr. UPTON. Mr. Speaker, I yield myself 3 minutes. 

Mr. Speaker, this legislation brings 

us a step closer to providing more help 

to children with unmet health needs, 

especially those with rare pediatric and 

genetic diseases. 

According to the National Institutes 

of Health, the NIH, there are 6,800 rare 

diseases, and most of these conditions 

have no treatment or cure, and they 

primarily affect children. I would guess 

that everyone in this Chamber is personally aware of the devastating impact of these diseases with some family 

that they know. I, myself, have spent 

some time with a family from my district whose children have spinal muscular atrophy, SMA. It is a very rare 

pediatric disease that is the leading genetic cause of death in infants and toddlers. 

These are great kids. I’ve got a picture of one of them here. When they 

came to see me, they told me that 

their names were Cinderella and Sleeping Beauty. They really are. These are 

just really marvelous children. They’re 

great kids, and it’s a source of real sadness that their disease is the kind that 

is often incurable and often untreatable. 

The barriers to research on rare and 

genetic diseases are those that are 

common to most research. It’s already 

difficult to initiate the experimental 

and lengthy research needed to find 

treatments and cures; however, when 

the population of patients is so small, 

maybe only a couple dozen in a State, 

these problems are even more difficult 

to solve. 

This legislation is going to help us 

establish pediatric research networks 

and a consortia that are a proven way 

to overcome those gaps in research. 

Networks and consortia will be comprised of leading institutions that act 


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September 19, 2012 CONGRESSIONAL RECORD — HOUSE H6139 

as partners to consolidate and coordinate research efforts. It promotes efficiency and collaboration, especially 

when a disease affects just a small 

number of children. 

Mr. Speaker, I would urge all my colleagues to support this bipartisan legislation. I look forward to a strong 

vote tonight and working with our colleagues in the Senate to make sure 

that this bill really does get to the 

President’s desk and makes a difference for families that are in search 

of something that will help them with 

their kids. 

With that, I reserve the balance of 

my time. 

Mrs. CAPPS. Mr. Speaker, I yield 

myself 5 minutes. 

Mr. Speaker, in the health care profession, we know that children aren’t 

just little adults. They have unique 

health experiences, treatment needs, 

and research challenges. 

While public and private research has 

come a long way on pediatric diseases 

over the years, we also know that we 

are still far behind on important 

diagnostics, cures, and treatments for 

far too many ailing children. That’s 

why I am so pleased to have coauthored the National Pediatric Research 

Network Act with my colleague and 

friend, Representative CATHY MCMORRIS RODGERS. 

This bipartisan bill would improve 

research and clinical trials on pediatric 

diseases. It would train future pediatric researchers and disseminate research findings so quickly so that all 

children may benefit. It does not replace our current pediatric research investments. Instead, it builds upon the 

work already being done at the NIH 

and at research centers across the 

country by creating, as Chairman 

UPTON said, research consortia to form 

a nationwide network of pediatric researchers. This is important so that we 

can make sure that we’re always working with the most current science and 

that information is shared and also 

verified. 

It will 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 participating in this critical research while 

providing training grounds for our next 

generation of pediatric researchers. 

Another key feature to this bill is 

that it will place an added emphasis on 

researching children’s rare diseases, 

such as the one already described, spinal muscular atrophy, and to develop 

new treatments to fight them. 

The low prevalence of these diseases 

makes them particularly hard to research, yet these diseases have such a 

marked impact on the lives of far too 

many families and communities. The 

National Pediatric Research Network 

Act will be an important step forward 

to help these families and those who 

may develop these diseases long into 

the future. 

I want to thank again the leadership 

of the Energy and Commerce Committee, Chairman UPTON, Ranking 

Member WAXMAN, Chairman PITTS, and 

Ranking Member PALLONE, for their 

dedication to this bill; and to the staff, 

my staff, and especially Ruth Katz, a 

committee staffer, working to improve 

the language and to bring this to the 

floor. I also include my colleague, Congresswoman DEGETTE, for her leadership on this issue over the years. 

And just like Chairman UPTON, I 

would especially like to thank my constituents, dear friends, and a very remarkable family, Bill and Victoria 

Strong, who are the parents, for their 

tireless work on behalf of their own 

daughter, Gwendolyn, who has spinal 

muscular atrophy as well and just a 

few weeks ago celebrated an amazing 

achievement by entering public kindergarten at the age of 5. She’s the favorite of all her classmates, and the parents are beside themselves with joy 

that this remarkable milestone has 

been achieved. They work day in and 

day out to make their daughter’s world 

better, and in doing so they have created a very strong community within 

our larger community of people who 

care about Gwendolyn, but also care 

about other children with similar kinds 

of conditions and what we should be 

doing as a Nation to stand with them. 

They have shown how entire communities can come together to fight diseases like SMA. 

I urge my colleagues to follow their 

example. We need to come together 

now to support this bill, and in doing 

so we support families like those in 

Michigan and in Santa Barbara, California, and other places, as well, to do 

all we can do to make this a law and 

give them hope and courage for the future. 

Mr. Speaker, I reserve the balance of 

my time. 

Mr. UPTON. Mr. Speaker, I yield myself 30 seconds. 

I just want to again thank Mrs. 

CAPPS. As we met these families, we 

really did not know about these diseases until we saw their courage and 

what they do as they confront this 

every day. It’s marvelous for me, as I 

now have visited my family that has 

this disease 2 years in a row. It’s great 

to see them grow and remember where 

they were and to really think that 

there’s going to be hope with the legislation that we can see that is done. 

With that, I yield 5 minutes to the 

gentlelady from Washington State, 

CATHY MCMORRIS RODGERS, who has 

also been, as we look at a bipartisan 

leadership, a real trooper to move this 

legislation not only through our committee, but now on the House floor. 

Mrs. MCMORRIS RODGERS. Mr. 

Speaker, I thank the chairman. I thank 

my colleague and friend, Representative LOIS CAPPS, and rise today in 

strong support of this legislation, H.R. 

6163, the National Pediatric Research 

Network Act, which is going to build 

on America’s commitment to pediatric 

medical research. 

That commitment has already led to 

the prevention and treatment of terrible conditions such as polio, meningitis, childhood leukemia, congenital 

heart disease. With budgets being 

squeezed like no time in recent memory, it has never been more important 

to support projects which leverage 

every single dollar. 

Research networks have a proven 

track record in their ability to ensure 

collaboration and the sharing of resources which, in turn, have led to 

medical discoveries that have improved 

lives. 

b 2100 

For example, the National Cancer Institute-funded Children’s Oncology 

Group has advanced our understanding 

and treatment of childhood cancers, 

and this group has resulted in a cure 

for some types of childhood leukemia. 

The Pediatric Heart Network has improved the outcome for children born 

with congenital heart disease. 

I am proud to have introduced this 

legislation with my colleague, Representative CAPPS. This legislation is 

going to authorize NIH to establish up 

to 20 pediatric research networks 

across this country, and each network 

will be selected by NIH through a competitive review process. These networks will allow multiple institutions 

to work together in a ‘‘hub and spoke’’ 

fashion to encourage collaboration. 

Some of those networks will focus on 

rare diseases such as spinal muscular 

atrophy. Other networks will focus on 

the genetic diseases that have their 

onset in childhood, including Fragile X 

and Down Syndrome. 

It’s important to develop a framework for these rare and genetic diseases for a number of reasons. First of 

all, researchers in these areas are often 

working in isolation, and this legislation is going to help overcome that 

barrier. Secondly, there are not many 

children with these disorders in one 

place, so it makes it difficult to connect the researchers to those that want 

to participate in the studies. 

Finally, the study of these rare and 

genetic diseases may lead to treatments that will help many people. For 

example, we’ve learned that there is a 

specific biological link between Down 

Syndrome and Alzheimer’s disease. It’s 

conceivable that the research that can 

result in the improvement in cognition 

in Down Syndrome could also prevent 

the loss of cognition that is seen in 

Alzheimer’s. 

These pediatric networks will improve health outcomes for children and 

adults by encouraging teamwork 

among the researchers, the patients, 

and NIH. This is important and positive legislation. I’m proud to support 

it, and I urge my colleagues to support 

it. 

Mrs. CAPPS. In closing, Mr. Speaker, 

the National Pediatric Research Network Act is a very important bill, not 

just for current and future researchers, 

but for sick children and their families, 

today and in the future. It’s a bipartisan measure that will really leverage 


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H6140 CONGRESSIONAL RECORD — HOUSE September 19, 2012 

all the good work that is currently 

being done on pediatric diseases but 

that will also fill gaps that make it so 

hard for progress to be made. 

I urge full support for this bill, and I 

yield back the balance of my time. 

Mr. UPTON. Mr. Speaker, I yield 2 

minutes to the chairman of the Health 

Subcommittee, the gentleman from 

Pennsylvania, JOE PITTS, in support of 

the legislation. 

Mr. PITTS. Mr. Speaker, H.R. 6163, 

the National Pediatric Research Network Act, seeks to address important 

unmet needs in pediatric health. 

Pediatric research is so important to 

the health of our children, and it is essential to finding answers for unmet 

health needs. According to the National Institutes for Health, 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. Unfortunately, the doctors do not have sufficient therapies to 

treat them. 

This bill seeks to alleviate that problem by establishing pediatric research 

networks and consortia. They will help 

by coordinating research efforts among 

participating institutions, concentrating that effort on the most pressing needs and enlisting the help of 

well-trained researchers. 

Through my association with Children’s Hospital of Philadelphia, I’m 

aware that there are too many diseases 

that children and their families face 

that do not have easy answers, and few 

adequate treatments. This bill will 

strengthen basic and clinical research 

and bring us closer to finding new 

treatments and cures. 

Mr. Speaker, this bill has strong bipartisan support. I urge my colleagues 

to support the bill. 

Mr. UPTON. Mr. Speaker, in closing, 

I know the hour is late. I would just 

urge my colleagues to support this bipartisan legislation. I, too, commend 

every Member that’s had a role here 

and truly appreciate the staff to get 

this bill prepared and ready for us to 

vote on tonight. 

I yield back the balance of my time. 

Mr. WAXMAN. Mr. Speaker, I am pleased to 

rise in support of H.R. 6163, the National Pediatric Research Network Act of 2012. 

H.R. 6163 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 pediatric 

birth defects such as Down syndrome. These 

kinds of diseases and conditions are rare and 

some of the children who suffer from them are 

very fragile, making 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 

tackle diseases and conditions that affect 

kids—again, especially those that are rare. 

Thus, H.R. 6163 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. 

6163 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. 

As we move forward with this legislation— 

here, and hopefully, in the Senate—I want to 

commend all those members of the Energy 

and Commerce Committee who have come together to make it happen. I especially want to 

the note the effort of Congresswoman CAPPS. 

She is the lead Democratic sponsor of the bill 

and has worked tirelessly to bring it before us 

today. 

I urge my colleagues to vote ‘‘yes’’ on H.R. 

6163. 

The SPEAKER pro tempore. The 

question is on the motion offered by 

the gentleman from Michigan (Mr. 

UPTON) that the House suspend the 

rules and pass the bill, H.R. 6163, as 

amended. 

The question was taken; and (twothirds being in the affirmative) the 

rules were suspended and the bill, as 

amended, was passed. 

A motion to reconsider was laid on 

the table. 

f 

TAKING ESSENTIAL STEPS FOR 

TESTING ACT OF 2012 

Mr. PITTS. Mr. Speaker, I move to 

suspend the rules and pass the bill 

(H.R. 6118) to amend section 353 of the 

Public Health Service Act with respect 

to suspension, revocation, and limitation of laboratory certification. 

The Clerk read the title of the bill. 

The text of the bill is as follows: 

H.R. 6118 

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 ‘‘Taking Essential Steps for Testing Act of 2012’’. 

SEC. 2. SUSPENSION, REVOCATION, AND LIMITATION OF LABORATORY CERTIFICATION. 

Section 353 of the Public Health Service 

Act (42 U.S.C. 263a) is amended— 

(1) in subsection (d)(1)(E), by inserting ‘‘, 

except that no proficiency testing sample 

shall be referred to another laboratory for 

analysis as prohibited under subsection 

(i)(4)’’ before the period at the end; and 

(2) in subsection (i)— 

(A) in paragraph (3), by inserting before 

the period at the end of the first sentence 

the following: ‘‘, except that if the revocation occurs pursuant to paragraph (4) the 

Secretary may substitute intermediate sanctions under subsection (h) instead of the 2- 

year prohibition against ownership or operation which would otherwise apply under 

this paragraph’’; and 

(B) in paragraph (4), by striking ‘‘shall’’ 

the first place it appears and inserting 

‘‘may’’. 

The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 

Pennsylvania (Mr. PITTS) and the gentlewoman from California (Mrs. CAPPS) 

each will control 20 minutes. 

The 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 H.R. 6118. 

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 today to support 

H.R. 6118, the Taking Essential Steps 

for Testing Act of 2012. 

H.R. 6118 would give the Centers for 

Medicare and Medicaid Services much 

needed regulatory flexibility to enforce 

prohibitions against improper referrals 

of proficiency testing under the clinical laboratory improvement amendments. 

In order to operate as a business, laboratories must adhere to CMS procedures for processing samples, must 

share testing results with CMS periodically and are prohibited from intentionally referring testing samples to 

any other lab. 

Currently the Centers for Medicare 

and Medicaid Services is required 

under statute to revoke the CLIA certificate of any laboratory that intentionally refers its proficiency testing 

samples to another laboratory for testing for a period of 1 year. 

In addition, the statute requires that 

a person who has owned or operated a 

laboratory which has had its CLIA certification revoked, including those 

owning multiple labs, may not own or 

operate a laboratory for a period of 2 

years following such revocation. 

However, there have been instances 

where a hospital or independent laboratory has accidently referred a PT sample to another lab due to mistakes by 

employees or through automated systems. In such instances CMS is not allowed by law to consider the circumstances under which the test was 

accidently referred or if the lab acted 

in good faith to report and address the 

incident. 


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