[Congressional Record (Bound Edition), Volume 162 (2016), Part 11]
[House]
[Pages 15324-15330]
[From the U.S. Government Publishing Office, www.gpo.gov]




  PROVIDING FOR CONSIDERATION OF SENATE AMENDMENT TO H.R. 34, TSUNAMI 
    WARNING, EDUCATION, AND RESEARCH ACT OF 2015, AND PROVIDING FOR 
 CONSIDERATION OF H.R. 6392, SYSTEMIC RISK DESIGNATION IMPROVEMENT ACT 
                                OF 2016

  Mr. BURGESS. Mr. Speaker, by the direction of the Committee on Rules, 
I call up House Resolution 934 and ask for its immediate consideration.
  The Clerk read the resolution, as follows:

                              H. Res. 934

       Resolved, That upon adoption of this resolution it shall be 
     in order to take from the Speaker's table the bill (H.R. 34) 
     to authorize and strengthen the tsunami detection, forecast, 
     warning, research, and mitigation program of the National 
     Oceanic and Atmospheric Administration, and for other 
     purposes, with the Senate amendment thereto, and to consider 
     in the House, without intervention of any point of order, a 
     motion offered by the chair of the Committee on Energy and 
     Commerce or his designee that the House concur in the Senate 
     amendment with an amendment consisting of the text of Rules 
     Committee Print 114-67 modified by the amendment printed in 
     part A of the report of the Committee on Rules accompanying 
     this resolution. The Senate amendment and the motion shall be 
     considered as read. The motion shall be debatable for 80 
     minutes, with 60 minutes equally divided and controlled by 
     the chair and ranking minority member of the Committee on 
     Energy and Commerce and 20 minutes equally divided and 
     controlled by the chair and ranking minority member of the 
     Committee on Ways and Means. The previous question shall be 
     considered as ordered on the motion to its adoption without 
     intervening motion.
       Sec. 2.  Upon adoption of this resolution it shall be in 
     order to consider in the House the bill (H.R. 6392) to amend 
     the Dodd-Frank Wall Street Reform and Consumer Protection Act 
     to specify when bank holding companies may be subject to 
     certain enhanced supervision, and for other purposes. All 
     points of order against consideration of the bill are waived. 
     The bill shall be considered as read. All points of order 
     against provisions in the bill are waived. The previous 
     question shall be considered as ordered on the bill and on 
     any amendment thereto to final passage without intervening 
     motion except: (1) one hour of debate equally divided and 
     controlled by the chair and ranking minority member of the 
     Committee on Financial Services; (2) the amendment printed in 
     part B of the report of the Committee on Rules accompanying 
     this resolution, if offered by the Member designated in the 
     report, which shall be in order without intervention of any 
     point of order, shall be considered as read, shall be 
     separately debatable for the time specified in the report 
     equally divided and controlled by the proponent and an 
     opponent, and shall not be subject to a demand for a division 
     of the question; and (3) one motion to recommit with or 
     without instructions.

  The SPEAKER pro tempore. The gentleman from Texas (Mr. Burgess) is 
recognized for 1 hour.
  Mr. BURGESS. Mr. Speaker, for the purpose of debate only, I yield the 
customary 30 minutes to the gentleman from Colorado (Mr. Polis), 
pending which I yield myself such time as I may consume. During 
consideration of this resolution, all time yielded is for the purpose 
of debate only.


                             General Leave

  Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days to revise and extend their remarks.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Texas?
  There was no objection.
  Mr. BURGESS. Mr. Speaker, House Resolution 934 provides for a rule to 
consider a critical bill that will help millions of Americans and their 
families who are suffering from diseases. The rule provides 80 minutes 
of debate, with 1 hour being provided to the Energy and Commerce 
Committee, and 20 minutes given to the Committee on Ways and Means. The 
rule provides for a motion to concur with the Senate amendment to H.R. 
34, placing the base text of the 21st Century Cures into the bill. The 
rule further incorporates the manager's amendment into the base text of 
the Cures bill, reflecting the bipartisan and bicameral negotiations 
which took place to get us to where we are today with the legislation.
  Second, the resolution before us today provides for a rule to 
consider H.R. 6392, the Systemic Risk Designation Improvement Act of 
2016, an important bill to remove onerous Federal regulations imposed 
on small and community banks by the ill-conceived Dodd-Frank Act by 
replacing current and arbitrary SIFI designation standards with a more 
effective activity-based standard. The rule provides for 1 hour of 
debate, equally divided between the majority and minority of the 
Committee on Financial Services. Further, the rule makes one amendment 
in order and provides the minority with the standard motion to 
recommit.
  I am pleased that the House is considering both of these pieces of 
legislation today.
  The Energy and Commerce Committee has spent 4 years working to bring 
our healthcare innovation infrastructure into the 21st century.
  Today, there are 10,000 known diseases or conditions, but the bad 
news is we have cures and treatments for only 500.
  There is a gap between innovation and therapy. There are problems 
with

[[Page 15325]]

how we regulate our therapies. It is not unheard of to have a company 
take over 14 years and $2 billion to bring a new drug to market.

                              {time}  1230

  Members held 20 roundtables, discussions, hearings, field hearings, 
and events around the country to ensure that we involved our patients, 
their advocates, researchers, innovators, financiers--all who have 
firsthand experience and who understand the gaps in our current system.
  The House amendment to H.R. 34 includes two bipartisan bills that 
have been developed over the course of several years by the Committee 
on Energy and Commerce and its members to meet some of our country's 
most pressing healthcare needs. The mental health reforms that are 
based on the Helping Families in Mental Health Crisis Act, authored by 
Representative Tim Murphy, passed the House in July by a vote of 422-2. 
This legislative effort represents the most significant reforms in the 
mental health system in over a decade.
  The 21st Century Cures Act title in the bill is the result of a 
unified Energy and Commerce Committee effort, championed by Chairman 
Fred Upton of Michigan and Representative Diana DeGette of Colorado 
over the course of multiple Congresses, to bring our laws into a modern 
era of medicine. The House passed the 21st Century Cures Act in July of 
2015 by a vote of 344-77. Our commitment to this transformational bill 
has not and must not waver until it is across the finish line and 
signed into law. We owe it to the patients, their families, medical 
providers, advocates, scientists, and researchers to see this through.
  Our country is a global leader in medical innovation, but even in 
recognizing that, there is progress that we can make. With 10,000 known 
diseases and with 10,000 known conditions, and with cures and 
treatments for only 500, we must do more to alleviate that gap which is 
causing so much human suffering. Advances in science and technology 
over the past decade have the potential to revolutionize medical 
innovation; yet the way drugs and devices are approved is back in the 
horse-and-buggy days. It is largely unchanged.
  In recognizing the growing divide between innovation and regulation, 
the House Committee on Energy and Commerce launched the 21st Century 
Cures Initiative in the 113th Congress--that was a Congress ago--to 
examine the state of discovery, development, and delivery of medical 
therapies in America. The ensuing process by which the Cures 
legislation was developed should serve as a model for policy 
development long into the future.
  Members of the committee convened hearings, forums, and roundtables 
in Washington, DC, and in centers and locations around the Nation. 
These forums brought together the leading scientists, the medical 
experts, patient and disease group advocates, and researchers and 
innovators across multiple sectors. The objective of these events was 
to uncover opportunities and to strengthen and streamline the process 
by which cures are discovered and made available to patients.
  Based on what we have learned, Representatives worked across the 
aisle--across the dais--on comprehensive legislation that would make 
the government an ally rather than an obstacle in the cycle of medical 
innovation. The 21st Century Cures Act touches each step of the process 
through which new treatments and cures come to market: the discovery, 
the development, the delivery.
  To accelerate discovery, the House amendment to H.R. 34 includes 
provisions that facilitate collaboration and increase access to health 
data. It invests billions of dollars in research through the National 
Institutes of Health, and it incentivizes the exploration of the most 
rare and challenging conditions. To modernize the development, among 
other things, the 21st Century Cures Act establishes a review pathway 
at the Food and Drug Administration for biomarkers and other drug 
development tools that can be used to help shorten drug development 
time while, at the same time, maintaining the safety standard that the 
public demands and that we have all come to expect from the agency.
  The very confused regulation of combination products by the very 
different centers at the Food and Drug Administration will be improved 
to cut down on inefficiencies and to reduce the cost of development. 
The Food and Drug Administration will be required to work with 
stakeholders and the National Institute of Standards and Technology to 
establish a regulatory framework for the development, evaluation, and 
review of drugs that are classified as regenerative medicine and 
advanced therapies.
  A number of provisions seek to empower patients to engage in their 
health care and to engage in their treatment decisions with their 
doctors, to contribute health information to scientific research, and 
to participate in the drug and device approval process. The Food and 
Drug Administration is required to engage in a range of activities that 
will establish a framework for the consideration of patient experience 
data when weighing the benefits of a new treatment. Individuals will 
have the opportunity to share health data with the global research 
community through platforms, such as the Precision Medicine Initiative 
and a new National Neurological Diseases Surveillance System. Multiple 
measures ensure patients will have better access to secure, up-to-date 
information through their electronic health records, and they ensure 
that this health information technology will continue to be developed 
with patient needs and patient safety and privacy as a priority.
  I am grateful to have had the opportunity to work directly on several 
provisions in the bill. This includes the creation of a national 
surveillance system for neurologic diseases and conditions which may 
then be used to help us further understand these devastating diseases. 
Thousands of Americans are affected--multiple sclerosis, Parkinson's, 
Alzheimer's, other neurologic diseases--but there is very little 
accurate information that exists today to assist those who research, 
treat, and provide care for individuals who suffer from these diseases.
  I have also worked on a provision that will improve patient access to 
pharmaceutical companies' compassionate use policies for drugs that 
treat serious or life-threatening conditions. To increase the 
efficiency and foster robust data collection analysis, the Food and 
Drug Administration will be required to evaluate the use of real-world 
evidence and summary-level review where an application is submitted for 
a new indication for an already approved drug. To help insurers and 
formulary committees make informed coverage decisions, a provision in 
the 21st Century Cures Act clarifies how medical product manufacturers 
can communicate economic information about therapies and technologies.
  I am particularly happy that the House amendment to H.R. 34 includes 
multiple provisions that will make meaningful progress toward achieving 
an interoperable health system. Increasingly, electronic health system 
interoperability is critical to achieving the promises of the 21st 
Century Cures and to scaling up the benefits of health reform more 
broadly. While we have seen the widespread adoption of electronic 
health records, our Nation continues to maintain a fragmented system, 
which makes it difficult to ensure the continuity of evidence-based 
care for patients.
  The 21st Century Cures Act would finally set us on a path towards 
achieving a nationwide interoperable health system that puts the needs 
of patients and that puts the needs of providers first. Federal 
advisory committees are streamlined and directed to prioritize 
interoperability. Preference is directed to utilizing the existing 
standards of implementation rather than of recreating them.
  In addition to increasing the transparency and accountability for 
providers and patients, enforcement mechanisms will arm the Office of 
Inspector General with the authority necessary to punish bad actors for 
improperly impeding the flow of information. Data

[[Page 15326]]

blocking will stop. The provisions in this bill will expedite the 
interoperability of electronic health record systems to make good on 
the $30 billion taxpayer investment in order to benefit patients, 
doctors, and researchers.
  As I have referenced, developing the 21st Century Cures Act was a 
process that brought everyone to the table. No one is getting 
everything that he wanted. I would note my disappointment that this 
bill does not include an important clarification to the Physician 
Payments Sunshine Act that was part of the House-passed version of this 
bill and was supported by over 200 supporting organizations.
  Certified continuing medical education, peer-reviewed medical 
textbooks, and journal reprints play a vital role in improving patient 
outcomes. They play a role in facilitating medical innovation, keeping 
our Nation's medical professionals up to date with the rapid pace of 
scientific discoveries. These materials and activities should not be 
confused with improper payments from pharmaceutical manufacturers to 
physicians. These materials were always intended to be excluded from 
the reporting requirements in the physician sunshine law, but, 
unfortunately, the Centers for Medicare & Medicaid Services' 
interpretation of the exemption has been inconsistent and unreliable. 
The narrowly constructed language in the 21st Century Cures Act was 
carefully drafted to maintain the transparency originally intended in 
the sunshine law while it ensured robust access to medical education.
  Mr. Speaker, I think it goes without saying that we all want our 
doctors to be smart, that we want them to be informed, and that we want 
them to be up to date. Certainly, that is a priority that I will 
continue to pursue going forward.
  Groundbreaking discoveries rely on a robust and reliable investment 
in basic research. The House amendment to H.R. 34 provides the National 
Institutes of Health with almost $5 billion in funding, including 
almost $2 billion for the Cancer Moonshot and $1.5 billion for the 
BRAIN Initiative. It also includes $500 million for the Food and Drug 
Administration and $1 billion in grants to four States in order to 
address the growing and burgeoning opioid crisis that continues to 
claim so many lives across our country. This approach provides 
dedicated funding through 2026 while it ensures spending is subject to 
review and oversight in the annual appropriations process. In addition 
to fully offsetting all of the authorized funds, H.R. 34 will actually 
reduce the deficit by almost $6 billion over the next 10 years.
  Federal regulation, Federal policy, and Federal investment have been 
outpaced by science, medicine, and technology. The bipartisan 21st 
Century Cures Act will make needed changes to bring our laws into a 
modern era of medicine and to keep the Nation at the forefront of 
healthcare innovation. The 21st Century Cures Act not only delivers 
hope to millions of patients who are living with untreatable diseases, 
but it also helps modernize and helps streamline the regulation in 
America's healthcare system.
  I encourage all of my colleagues to vote ``yes'' on the rule and 
``yes'' on the two underlying bills. The 21st Century Cures Act will 
not only deliver hope to millions of people who are living with 
untreatable disease, but it will also help modernize and streamline 
America's healthcare system.
  Mr. Speaker, I reserve the balance of my time.
  Mr. POLIS. Mr. Speaker, I yield myself such time as I may consume.
  I thank the gentleman for yielding me the customary time, but I have 
to say that I think that this somewhat breaks with the custom of this 
body not to delay floor proceedings during the reorganization of the 
Democratic Caucus. I know that, when the Democrats were in the 
majority, we routinely gave deference to the Republican Conference's 
plan for retreats and for caucus reorganizations. We have before us 
several contested races. Of course, the Nation's business comes first, 
which is why we are here making the case on these bills.
  I would like to add that I hope that this is not the tone we are 
going to be setting for the next Congress. I think it is very important 
that, despite our differences on policies, both conferences are 
respectful of the responsibilities that Members have not only within 
the institution of Congress but within their respective conferences and 
caucuses. On our side, we will be brief because we do have additional 
responsibilities, as I mentioned.
  Mr. Speaker, I yield 2\1/2\ minutes to the gentlewoman from Oregon 
(Ms. Bonamici).
  Ms. BONAMICI. I thank the gentleman for yielding.
  Mr. Speaker, I rise in opposition to the rule on H.R. 34, which is 
now the vehicle for the 21st Century Cures Act.
  Although I understand the detailed rules of our Chamber, I am deeply 
disappointed that the underlying bill, the Tsunami Warning, Education, 
and Research Act, was completely stripped out and replaced with 
unrelated language. The Tsunami Warning, Education, and Research Act is 
bipartisan. It was passed by a voice vote on January 7 of 2015, and a 
similar version has passed the Senate. We have worked out our 
differences, and this legislation is ready to be signed into law, and 
it is vital for our West Coast communities.
  My constituents on the Oregon coast know that it is a matter of when, 
not if, our community will face a Cascadia subduction zone earthquake 
and tsunami. Most of the city of Seaside, including all of its public 
schools, is located in the tsunami inundation zone. It is some of my 
youngest constituents--the students of Seaside--who have been the most 
vocal about keeping their communities safe. Recently, I met with the 
students there at the high school. They have spoken all over the State 
about the dangers they face from tsunami. Their presentation was very 
strong. They made a case for moving their schools out of the tsunami 
zone.

                              {time}  1245

  It helped the community pass a bond measure earlier this month to 
move the schools. That is a positive step for Seaside, but there is so 
much more to be done.
  I have an app on my phone. Almost every day, there is an earthquake 
off the coast of Alaska or Hawaii. Two days ago there were two 
earthquakes off the coast of Oregon. When there is a near-shore 
tsunami, the warning time is about 15 minutes. That is all.
  The Tsunami Warning, Education, and Research Act would help 
communities up and down the entire coast by strengthening the warning 
system, providing more assistance to local communities like Seaside to 
prepare for that disaster, coordinating government agencies to make 
sure they're sharing information and working together, and supporting 
community outreach and education programs.
  This is not just about Oregonians. Millions of people in Alaska, 
Hawaii, Washington State, California also face significant risk. We are 
overdue for the really big one.
  Now, I understand that the Cures Act may save lives, but I am very 
disappointed that the provisions of the tsunami bill, which is also 
lifesaving policy, was not retained in the underlying bill.
  Mr. Speaker, again, I urge my colleagues to oppose this rule so we 
can immediately consider swift passage of the Tsunami Warning, 
Education, and Research Act. Our West Coast communities are counting on 
us to keep them safe.
  Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from 
Pennsylvania (Mr. Murphy), the author of the mental health portion of 
this bill.
  Mr. MURPHY of Pennsylvania. Mr. Speaker, this bill includes in it 
elements of H.R. 2646, the Helping Families in Mental Health Crisis 
Act, which is the most revolutionary change to mental health since the 
Community Mental Health Act of 1963.
  It includes fundamental changes in how we think about, talk about, 
and treat serious mental illness. It establishes an assistant secretary 
for mental health and substance use to disseminate evidence-based 
practices, ensure grants meet objective outcome measures, conduct 
ongoing oversight of

[[Page 15327]]

grantees, and collaborates with other Federal departments on mental 
health.
  It creates an interagency coordinating committee to evaluate Federal 
programs related to mental illness and provide recommendations to 
better coordinate those programs. It authorizes a national mental 
health and substance use policy laboratory to promote evidence-based 
models of care and further develop, expand, replicate, or scale those 
programs. It provides funding for treatment and recovery for homeless 
individuals with mental health and substance use disorder services.
  It authorizes for the first time in law the National Suicide 
Prevention Lifeline program and the Minority Fellowship Program. It 
awards grants to develop, maintain, and enhance online psychiatric bed 
registries.
  It funds programs for telehealth so that people in rural communities 
and primary care physicians can have ready access to mental health 
services so sorely needed for their patients. It reauthorizes the 
Garrett Lee Smith Suicide Prevention program, increases funding for 
assisted outpatient treatment and, for the first time, provides Federal 
grants for assertive community treatment.
  It increases access to medical residencies and fellowships in 
psychiatry and addiction medicine in underserved, community-based 
settings for nurse practitioners, physician assistants, health service 
psychologists, and social workers. It removes barriers for providing 
volunteering at community health centers.
  It updates the National Child Traumatic Stress Initiative, which 
supports a national network of child trauma centers, including 
university, hospital, and community-based centers.
  It requires the Secretary of HHS to clarify how healthcare providers 
can communicate with the caregiver of an adult with a mental health or 
substance use disorder. It clarifies the coverage of eating disorder 
benefits, including residential treatment under existing mental parity 
requirements.
  It allows Federal grants to local law enforcement to be used for 
crisis intervention teams to roll back the tragedies of violence that 
occur when a mentally ill person encounters a policeman. It provides 
funding to develop school-based mental health crisis intervention 
teams. And this list goes on.
  I am pleased that this has all been merged into one bill here so that 
we can move forward on this. This truly will provide many lifesaving 
measures and bring mental health treatment out of the shadows.
  I encourage my colleagues to support this bill as we move forward and 
provide help because where there is help, there is hope.
  Mr. POLIS. Mr. Speaker, I just want to note that this rule contains 
two completely different bills. The first is the 21st Century Cures 
Act, which would help address many of the health crises that we face. 
The other bill is H.R. 6392, the Systemic Risk Designation Improvement 
Act, that would weaken many of the protections that were put in place 
in the Dodd-Frank Wall Street reform bill. So there are two very 
different bills here under one rule, a very closed process which the 
Democrats will be opposing.
  Mr. Speaker, I yield 3 minutes to the gentleman from Oregon (Mr. 
Blumenauer).
  Mr. BLUMENAUER. Mr. Speaker, it is a pleasure to follow my friend 
from Pennsylvania, acknowledging his hard work in the mental health 
sphere. I do think that this is setting the platform for the most 
significant initiative in the next half century. There are some good 
things in this bill, but I hope it is just the beginning. I know the 
gentleman has a number of other initiatives that he is working on in a 
bipartisan way, and I am hopeful that this Bill serves as a 
springboard.
  On a personal note, the Garrett Smith Suicide Prevention Act, was 
created by our former colleague, Senator Gordon Smith from Oregon, who 
took a personal tragedy in his family and moved forward with important 
legislation that other families may be spared by that effort.
  There are a number of things here that matter in another context. In 
terms of what happens dealing with the opioid crisis that we have now, 
America has been too slow to respond. I am hopeful that these resources 
will help us move in the right direction. Again, I must, I suppose, 
note with a certain amount of irony that there are other alternatives 
available to deal with the epidemic of opioid overdose deaths.
  I would note that it is interesting that States that actually utilize 
medical marijuana prescribe fewer pills. There is an opportunity here 
for us to do something that is less expensive, less addictive, and not 
deadly. But the provisions in this bill, I think, are a step in the 
right direction.
  It also is important to note the investments in neuroscience. We have 
created a Neuroscience Caucus in Congress because this is an area that 
has stubbornly resisted being able to have the progress that we have 
seen in other areas, like cancer and cardiac health, and building on an 
initiative that the administration has, developed the BRAIN Initiative, 
which is modest but potentially very significant to accelerate the 
understanding of the human brain, leading to new ways to treat and cure 
neurological disorders.
  Everybody in this Chamber knows a variety of people who suffer--
everything from Alzheimer's, multiple sclerosis, addiction problem--and 
being able to double down those investments in a more systematic way 
will pay dividends that are incalculable.
  Already, mental and behavioral disorders are among the leading causes 
of disability around the world. The impact is greater than heart 
disease and cancer combined. As I mentioned, where we have actually 
made some progress.
  Last but not least, there is a technical fix that matters in my 
community and others around the country, which is bringing fairness to 
hospitals. When Congress changed the hospital payment rules last 
November, there were hospitals like Oregon Health & Science University 
that were caught unfairly in the middle of payment changes. We did not 
provide any exceptions for hospital outpatient departments that were 
under development at that time.
  The SPEAKER pro tempore. The time of the gentleman has expired.
  Mr. POLIS. Mr. Speaker, I yield an additional 1 minute to the 
gentleman from Oregon.
  Mr. BLUMENAUER. Mr. Speaker, this means that hospitals like Oregon 
Health & Science University, who made significant investments in 
building off-site departments under one set of Medicare rules, suddenly 
faced a new set of rules that were changed by Congress midstream. I am 
pleased that this will prevent pulling the rug out from underneath 
them.
  So, in sum, Mr. Speaker, this technical fix, which is important, 
support for the BRAIN Initiative, the important work in mental health, 
and dealing with the opioid crisis are reasons that I think this bill 
is worthy of support, although I share the concerns of the gentlewoman 
from Oregon (Ms. Bonamici), whose underlying, bipartisan, very 
important bill somehow is a casualty of this legislation. That is 
unfortunate.
  I hope the rule is defeated so we can fix that and get on with 
business.
  Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from 
Oklahoma (Mr. Cole).
  Mr. COLE. Mr. Speaker, I rise for the purpose of supporting the rule 
and the underlying legislation.
  I want to begin by congratulating Chairman Upton and the members of 
the Energy and Commerce Committee on both sides of the aisle for 
crafting what is genuinely a bipartisan piece of legislation in a very 
divisive era and working it for years and bringing it to a successful 
conclusion. They have given all of us an opportunity to vote for 
something really, really important to every single American.
  Now, a lot of focus will be put on the money aspect of this bill. 
Certainly, $6-plus billion is a nice chunk of change and will be very, 
very gratefully received. But in that same multiple-year period, in 5 
years, if we didn't increase appropriations by a dime, we would spend 
$160 billion dollars at NIH. And over a 10-year period, if we didn't 
increase annual appropriations by a dime, we would spend $320 billion.

[[Page 15328]]

  So the real genius of the bill is not the money. It is actually the 
three things that have been mentioned by multiple speakers before me. 
First is the regulatory reform that, at the FDA and at the NIH, will 
literally save billions of dollars and thousands of lives over the next 
decade.
  Second is the opioid initiative. We all know the crisis. It touches 
all of our districts. To direct money there and then to build on that 
through the appropriations process is extraordinarily important, and I 
congratulate the Energy and Commerce Committee for taking a lead here.
  Finally, the mental health legislation that is wound up in this that 
the gentleman from Pennsylvania (Mr. Murphy) provided is just 
absolutely spectacular in terms of its long-term importance.
  We can all disagree about this or that or some technicality in the 
rule. The reality is this is important legislation. If it doesn't pass 
now, it won't pass and we will be missing an opportunity.
  So I want to urge my friends on both sides of the aisle--I don't 
expect my friends to vote for the rule. They shouldn't. They never do. 
I wouldn't if I were in the minority. But I hope they will vote for the 
underlying legislation because that legislation is worthy of passage. 
It is a bipartisan compromise, and it will improve the life of every 
single American.
  Mr. POLIS. Mr. Speaker, there is a lot of bipartisan support for the 
21st Century Cures Act. I commend Chairman Upton, Ranking Member 
Pallone, Ranking Member DeGette, Ranking Member Gene Green, and so many 
others who worked hard on this legislation that will save lives by 
improving the access that Americans have to potentially lifesaving 
drugs and devices, helping to keep people healthy and independent and 
out of the hospital.
  I plan to support this legislation. I think we also all know that it 
is a starting point. We have additional work to do to make prescription 
drugs more affordable, to make the approval process more streamlined 
for both prescription drugs and medical devices, regenerative medicines 
safe, and, of course, funding levels for research.
  Mr. Speaker, I would like to inquire if there are any speakers 
remaining on the other side?
  Mr. BURGESS. Mr. Speaker, I have two additional speakers and myself 
to close.
  Mr. POLIS. Mr. Speaker, I reserve the balance of my time.
  Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from 
Pennsylvania (Mr. Pitts), the chairman of the Subcommittee on Health 
that played a vital role in getting the 21st Century Cures bill across 
the finish line.
  Mr. PITTS. Mr. Speaker, I rise in strong support of the rule for the 
21st Century Cures Act, a momentous innovation package which will help 
advance the discovery, development, and delivery of new treatments and 
cures for patients and will foster private-sector innovation here in 
the United States.
  Additionally, the package includes provisions of H.R. 2646, the 
Helping Families in Mental Health Crisis Act, as well as provisions to 
increase choice, access, and quality health care for Americans.
  Arriving here today has been a long journey full of lots of steps and 
twists and turns along the way. I especially want to thank legislative 
counsel for their tireless efforts in helping translate our legislative 
aims into legislative language. Together with our health team staff, 
they worked nights and weekends and were consummate professionals 
throughout the process.
  Additionally, I want to thank the healthcare staff of the 
Congressional Budget Office for all of their help in recent months. In 
addition to their role in estimating the budgetary effects of numerous 
policies in the bill, they were instrumental in helping us shape a 
number of proposals the committee considered.
  I would be remiss if I did not thank again the outstanding team on 
Energy and Commerce and most especially the health team led by Chief 
Health Counsel Paul Edattel, supported by Josh Trent, John Stone, Carly 
McWilliams, J.P. Paluskiewicz, Adrianna Simonelli, Adam Buckalew, 
Sophie Trainor, and Jay Gulshen; and Heidi Stirrup and Monica Valenti 
on my staff, without whose expertise, wisdom, and counsel this 
legislative work would not be possible.

                              {time}  1300

  This landmark medical innovation package includes provisions designed 
to help almost every American family, whether it is leading to the 
discovery, development, and delivery of new treatments and cures, or 
advancing the President's Precision Medicine Initiative or the Vice 
President's Cancer Moonshot, or the BRAIN Initiative to advance 
Alzheimer's research. This package is an innovation game changer and 
will truly bring our health innovation into the 21st century. I urge 
support for this bipartisan effort.
  Mr. POLIS. Mr. Speaker, I reserve the balance of my time.
  Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from 
Michigan (Mr. Walberg).
  Mr. WALBERG. Mr. Speaker, I stand in support of the rule and the 
underlying bill. Why? Well, the 21st Century Cures Act is a 
transformational piece of legislation that will allow us to discover 
and develop new lifesaving cures and treatments for some of the worst 
diseases.
  This act will offer hope to millions of patients and families, 
including Gale, a constituent of mine from Newport, who has been 
affected and afflicted with pancreatic cancer. Or Brandon, a boy from 
Rives Junction, who has been on a clinical trial for 8 years as he 
battles Duchenne muscular dystrophy.
  In addition to streamlining the FDA approval process and boosting NIH 
funding, the Cures Act includes significant provisions to update our 
mental health system and help States fight opioid addiction.
  I congratulate my good friend and colleague Chairman Fred Upton for 
his vision in tackling this challenge and for his tireless efforts to 
get this bill to the floor. The Cures Act is innovative; it is 
bipartisan; it is fully paid for and life changing for my constituents 
in Michigan and many others around this great country.
  I ask my colleagues to vote in support of the rule and the underlying 
bill.
  Mr. POLIS. Is the gentleman prepared to close?
  Mr. BURGESS. I am prepared to close.
  Mr. POLIS. Mr. Speaker, I yield myself such time as I may consume.
  Again, I do want to point out, in breaking with custom, there were 
many other Democrats who wanted to discuss this bill; but, as we speak, 
the Democratic Caucus is having elections for the vice chair position. 
While we were on the floor, we had elections for the whip position and 
the assistant leader position, both of which I was unable to 
participate in because, of course, I had to conduct the business of the 
Nation.
  But, again, I would hope that both parties are respectful of the 
scheduling requirements that are incumbent upon being a member of one 
of the two major parties of this body. In the past, we have always been 
able to work in when Republican Conference has a retreat or a 
reorganization meeting. I think that is important to this body because, 
while, of course, as Americans and Representatives we have 
responsibilities to the institution of Congress, as elected officials 
of the Democratic or Republican Party, we do have a responsibility to 
select our leaders and establish our rules.
  I don't think that the amount of time that either party spends doing 
that is unreasonable, but I think that it is very important that both 
parties and leadership of this body, the Speaker and the majority 
leader, are respectful of that while, of course, understanding we have 
important people's business to conduct. There were, of course, many 
other options. This House could have come to order and gotten this work 
done at 8 in the morning or they could do it later in the afternoon. 
There are a number of different ways we could have worked around the 
previously scheduled reorganization of the Democratic Caucus.
  Frankly, I am disappointed not just for myself having been unable to 
participate in those party functions, but

[[Page 15329]]

also on behalf of other members of the Democratic Caucus who were 
unable to come and speak on these very important issues because of 
playing active roles in running for or supporting or speaking on behalf 
of various candidates for party positions, which is occurring as I 
speak.
  This bill has two completely unrelated bills that are in it. Again, 
the 21st Century Cures Act has strong bipartisan support. I add my 
voice to those who have praised this legislation, and hopefully it will 
challenge the next Congress to continue to move forward with 
facilitating the approval process.
  I have often heard the approval process, for instance, for a new drug 
for inception to market can often be in excess of $1 billion or $2 
billion. We hear a number of different figures tossed around. I think 
sometimes it is in the high hundreds of millions. Sometimes it is as 
high as 1.5 or 2 billion. Regardless, that is one of the reasons that 
there is an upward pressure on prices for proprietary prescription 
drugs. It is also one of the reasons that lifesaving prescription drugs 
are often unavailable here even while they are on the market in Europe 
and other areas. Of course, without compromising safety--and Democrats 
and Republicans agree on that--there needs to be a way that we can 
facilitate, particularly in the realm of personalized medicine, 
bringing new lifesaving products to market in an affordable way.
  An excellent model for that that has saved hundreds of thousands of 
lives was put in place during the first administration of the first 
George Bush, which provided an expedited route for HIV drugs. Thanks to 
that route that was used for many of the HIV drugs, some of which are 
still in use today, hundreds of thousands of people affected by HIV, 
including many LGBT Americans, are still alive today because of that 
effort. I am also confident, because of today's effort with the 21st 
Century Cures Act, it will save the lives of many more Americans. 
Again, it is a starting point. We have room to go.
  The other bill would, for some reason--it is not something I hear 
from constituents, but apparently it is something Republicans want to 
do--exempt some of the very biggest banks from some of the requirements 
under Dodd-Frank regarding ensuring their stability and preventing them 
from failing. It is my understanding it only affects a few dozen banks, 
the very largest banks, banks that are worth tens or hundreds of 
billions of dollars. I am sure they like it. It probably reduces their 
ability to have to comply.
  But there is a reason those requirements were put in place for those 
very big banks. We are worried that the failure of any one or certainly 
multiple banks could create a systemic risk and lead to future 
bailouts. So I strongly believe that this bill before us today on the 
banking regulations, if it were to become the law, it would increase 
the likelihood of future bailouts, which surprises me because many of 
us have been traditionally opposed to those very kinds of bailouts.
  It is my understanding there is one remaining speaker on the other 
side, so I reserve the balance of my time to allow that speaker to 
speak.
  Mr. BURGESS. Mr. Speaker, I thank the gentleman for the 
accommodation. I am pleased to yield 2 minutes to the gentleman from 
Oregon (Mr. Walden).
  Mr. WALDEN. Mr. Speaker, I want to thank my colleagues on both sides 
of the aisle and especially for the courtesy to spend a minute or two 
talking about not only this rule, but also the legislation that will be 
coming to the floor soon. I want to thank especially Chairman Fred 
Upton, who has put his whole heart and soul into the 21st Century Cures 
Act, joined by Diana DeGette, certainly Dr. Burgess, Congressman 
Murphy, and others who have really played a key role in trying to find 
cures to diseases that don't exist today, find treatments for those in 
order to bring better health to all Americans, both physical health 
and, certainly in the case of Dr. Murphy, mental health as well.
  This really means a lot. This will make a difference in real people's 
lives back home in our communities. I have heard from those people, 
like Carol Fulkerson in Bend, who has MS. She is ecstatic about this. 
She said it is a great step toward making it possible to find a cure to 
MS. Can you imagine what that means in a person's life?
  There are critical reforms and improvements on mental health and 
substance abuse programs, as we have heard. These changes will help 
people all across America, and certainly in Oregon. A Medford resident, 
Justin, overcame his own battle with addiction through a dual diagnosis 
treatment program that dealt with the underlying issues fueling 
addiction instead of just sort of a Band-Aid approach to his symptoms. 
These are the kinds of ideas coming from our folks back home that are 
now incorporated in legislation.
  I heard from a clinical lab owner in rural Oregon, Judy Kennedy, who 
voiced her support for the provisions in Cures that provide precise 
diagnostic testing services to rural and other underserved communities 
across the country. We are going to do so much to improve the health, 
both mental and physical, in the lives of people we represent when this 
legislation becomes law.
  Mr. Speaker, I am just delighted to support this bill. I think it is 
an enormous step forward in so many ways, and I commend Chairman Upton 
and all those who have been involved in this in its writing. I urge 
passage of the rule so we can get on to this legislation.
  Mr. POLIS. Is the gentleman prepared to close?
  Mr. BURGESS. Once again.
  Mr. POLIS. Mr. Speaker, I yield myself the balance of my time.
  So, again, I think there is some good and some bad in this. The 21st 
Century Cures Act is very important, and I hope that this body sees it 
as a starting point, not an ending point. There are some important 
reforms in there that will save lives and also help remove some of the 
upward pressure on prescription drug prices, something we hear about 
very often from constituents.
  There is another bill in there which most Democrats will be voting 
against with regard to making it potentially more likely that larger 
banks can fail us or need bailouts, and that is not something that most 
of us have an appetite for. Of course, the closed nature of the bill is 
not consistent with the expressed desire of the Speaker to have an open 
process. The Committee on Rules yesterday shut down a number of 
excellent ideas and amendments that were offered, and they are not 
allowed to be debated here on the floor.
  Of course the timing of this bill, particularly for a bipartisan 
bill, to bring it up in a way, in a manner and a time that conflicts 
with the previously noticed meeting that happens to include all of the 
members of one of the two political parties is not the best way to 
foster the type of bipartisan cooperation that is important to get 
things done around here.
  So Democrats will not be supporting the rule. Many of us will, thanks 
to the work of Chairman Upton, Ranking Member Pallone, Ranking Member 
DeGette, Ranking Member Gene Green, and others, be proud to hopefully 
send to the President's desk the 21st Century Cures Act as an excellent 
starting point in helping to save lives.
  I urge a ``no'' vote on the rule.
  Mr. Speaker, I yield back the balance of my time.
  Mr. BURGESS. I yield myself the balance of my time.
  Mr. Speaker, today's rule provides for the consideration of two 
important bills: a bill that will transform and advance the discovery, 
the development, the delivery of treatments and cures; and a bill that 
will help our small and community banks, institutions that, in turn, 
can further assist small and local businesses and help our communities 
grow.
  I want to thank all of the Members who did put a lot of effort into 
the final package on the Cures bill, as well as the staff on both sides 
of the aisle, all members of the Committee on Energy and Commerce, and 
the House as a whole, who were asked to bring their ideas to the table, 
and we worked to include as many of those as we could.
  I would also like to express my thanks to the great attorneys at the

[[Page 15330]]

Legislative Counsel who sometimes worked around the clock to get this 
bill ready for both the committee and floor activity. I want to thank 
Chairman Upton, Representative DeGette, as well as Chairman Pitts and 
Ranking Member Pallone and Ranking Member Gene Green for their 
leadership throughout.
  It has already been mentioned, but I also want to thank the staff, 
both in our personal offices and at the committee staff, who have 
worked so hard on this over the past 4 years. This was truly all hands 
on deck. There is not one staffer on the Subcommittee on Health of the 
Committee on Energy and Commerce who does not have their fingerprints 
all over this bill.
  Mr. Speaker, I yield back the balance of my time, and I move the 
previous question on the resolution.
  The previous question was ordered.
  Mr. DeSAULNIER. Madam Speaker, I rise today in support of H.R. 34, 
the 21st Century Cures Act. It is vital that we ensure that the 
National Institutes of Health (NIH) have the resources they need to 
continue to advance biomedical and mental health research, and improve 
access to innovative treatments for some of the most debilitating 
illnesses.
  The additional $4.8 billion authorized for the NIH to improve 
biomedical research and treatment innovations is commendable, 
particularly the $1.8 billion for the Vice President's Cancer Moonshot, 
in line with the President's budget request, that will advance critical 
life-saving research. I fully support the Cancer Moonshot's mission to 
speed up the advancement of other treatments that will help individuals 
and families who are fighting diseases or disorders. As a Cancer 
survivor, I know all too well the value of these investments and how 
many lives can be saved as a result.
  Additionally, the allocation of $1 billion to step up federal efforts 
combating the growing opioid and heroin epidemic is a positive step 
towards better treatment of addicted individuals. Every day, families 
across California and the nation are torn apart by a loved one or 
neighbor abusing opioids. Hopefully our Republican colleagues consider 
this the first of many steps to advance meaningful policies designed to 
erode the strong grip these drugs have on so many Americans.
  Unfortunately, key aspects of this legislation fall short and are 
clearly designed to benefit Big Pharma over American consumers, 
patients, and doctors. I am deeply troubled by the Majority's decision 
to drastically reduce new NIH funding in the legislation compared to 
H.R. 6, stifling new research and vital progress. Additionally, it is 
disappointing that an amendment I authored, which would have helped to 
improve doctor-patient communication around the diagnosis and treatment 
of severe or chronic illnesses, was not included in this legislation. 
This oversight shows the lack of understanding of the importance of 
communication between patients and doctors in a patient's treatment and 
recovery.
  The SPEAKER pro tempore. The question is on the resolution.
  The question was taken; and the Speaker pro tempore announced that 
the ayes appeared to have it.
  Mr. POLIS. 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, this 15-
minute vote on adopting House Resolution 934 will be followed by a 5-
minute vote on suspending the rules and passing H.R. 5047.
  The vote was taken by electronic device, and there were--yeas 230, 
nays 180, not voting 24, as follows:

                             [Roll No. 590]

                               YEAS--230

     Abraham
     Aderholt
     Allen
     Amash
     Amodei
     Babin
     Barr
     Barton
     Benishek
     Bilirakis
     Bishop (MI)
     Bishop (UT)
     Black
     Blackburn
     Blum
     Bost
     Boustany
     Brady (TX)
     Brat
     Bridenstine
     Brooks (AL)
     Brooks (IN)
     Buchanan
     Buck
     Bucshon
     Burgess
     Byrne
     Calvert
     Carter (GA)
     Carter (TX)
     Chabot
     Chaffetz
     Coffman
     Cole
     Collins (GA)
     Collins (NY)
     Comer
     Comstock
     Conaway
     Cook
     Costello (PA)
     Cramer
     Crawford
     Culberson
     Curbelo (FL)
     Davidson
     Davis, Rodney
     Denham
     Dent
     DeSantis
     DesJarlais
     Diaz-Balart
     Dold
     Donovan
     Duffy
     Duncan (SC)
     Duncan (TN)
     Emmer (MN)
     Farenthold
     Fitzpatrick
     Fleischmann
     Fleming
     Flores
     Forbes
     Fortenberry
     Foxx
     Franks (AZ)
     Frelinghuysen
     Garrett
     Gibbs
     Gibson
     Gohmert
     Goodlatte
     Gosar
     Gowdy
     Granger
     Graves (GA)
     Graves (LA)
     Graves (MO)
     Griffith
     Grothman
     Guinta
     Guthrie
     Hanna
     Hardy
     Harper
     Harris
     Hartzler
     Heck (NV)
     Herrera Beutler
     Hice, Jody B.
     Hill
     Holding
     Hudson
     Huelskamp
     Huizenga (MI)
     Hultgren
     Hunter
     Hurd (TX)
     Issa
     Jenkins (KS)
     Jenkins (WV)
     Johnson (OH)
     Johnson, Sam
     Jordan
     Joyce
     Katko
     Kelly (MS)
     Kelly (PA)
     King (IA)
     King (NY)
     Kinzinger (IL)
     Kline
     Knight
     Labrador
     LaHood
     LaMalfa
     Lamborn
     Lance
     Latta
     LoBiondo
     Long
     Loudermilk
     Lucas
     Luetkemeyer
     Lummis
     MacArthur
     Marchant
     Marino
     Massie
     McCarthy
     McClintock
     McHenry
     McKinley
     McMorris Rodgers
     McSally
     Meadows
     Meehan
     Messer
     Mica
     Miller (FL)
     Miller (MI)
     Moolenaar
     Mooney (WV)
     Mullin
     Mulvaney
     Murphy (PA)
     Neugebauer
     Newhouse
     Noem
     Nunes
     Olson
     Palazzo
     Palmer
     Paulsen
     Pearce
     Perry
     Pittenger
     Pitts
     Poliquin
     Pompeo
     Posey
     Price, Tom
     Ratcliffe
     Reed
     Reichert
     Ribble
     Rice (SC)
     Rigell
     Roby
     Roe (TN)
     Rogers (AL)
     Rogers (KY)
     Rohrabacher
     Rokita
     Rooney (FL)
     Ros-Lehtinen
     Roskam
     Ross
     Rothfus
     Rouzer
     Royce
     Russell
     Salmon
     Sanford
     Scalise
     Schweikert
     Scott, Austin
     Sensenbrenner
     Sessions
     Shimkus
     Simpson
     Sinema
     Smith (MO)
     Smith (NE)
     Smith (NJ)
     Smith (TX)
     Stefanik
     Stewart
     Stivers
     Stutzman
     Thompson (PA)
     Thornberry
     Tiberi
     Tipton
     Trott
     Turner
     Upton
     Valadao
     Wagner
     Walberg
     Walden
     Walker
     Walorski
     Walters, Mimi
     Weber (TX)
     Webster (FL)
     Wenstrup
     Westerman
     Wilson (SC)
     Wittman
     Womack
     Woodall
     Yoder
     Yoho
     Young (AK)
     Young (IA)
     Young (IN)
     Zeldin
     Zinke

                               NAYS--180

     Adams
     Aguilar
     Ashford
     Bass
     Beatty
     Becerra
     Bera
     Beyer
     Bishop (GA)
     Blumenauer
     Bonamici
     Boyle, Brendan F.
     Brady (PA)
     Brownley (CA)
     Bustos
     Butterfield
     Capps
     Capuano
     Cardenas
     Carney
     Carson (IN)
     Cartwright
     Castor (FL)
     Castro (TX)
     Chu, Judy
     Cicilline
     Clark (MA)
     Clarke (NY)
     Clay
     Cleaver
     Clyburn
     Cohen
     Connolly
     Conyers
     Cooper
     Costa
     Courtney
     Crowley
     Cuellar
     Cummings
     Davis (CA)
     Davis, Danny
     DeFazio
     DeGette
     Delaney
     DeLauro
     DelBene
     DeSaulnier
     Deutch
     Dingell
     Doggett
     Doyle, Michael F.
     Duckworth
     Edwards
     Ellison
     Engel
     Eshoo
     Esty
     Evans
     Foster
     Frankel (FL)
     Fudge
     Gabbard
     Gallego
     Garamendi
     Graham
     Grayson
     Green, Al
     Green, Gene
     Grijalva
     Gutierrez
     Hanabusa
     Hastings
     Heck (WA)
     Higgins
     Himes
     Hinojosa
     Honda
     Hoyer
     Huffman
     Israel
     Jackson Lee
     Jeffries
     Johnson (GA)
     Johnson, E. B.
     Kaptur
     Keating
     Kelly (IL)
     Kennedy
     Kildee
     Kilmer
     Kind
     Kuster
     Langevin
     Larsen (WA)
     Larson (CT)
     Lawrence
     Lee
     Levin
     Lewis
     Lieu, Ted
     Lipinski
     Loebsack
     Lofgren
     Lowenthal
     Lowey
     Lujan Grisham (NM)
     Lujan, Ben Ray (NM)
     Lynch
     Maloney, Carolyn
     Maloney, Sean
     Matsui
     McCollum
     McGovern
     McNerney
     Meeks
     Meng
     Moulton
     Nadler
     Napolitano
     Neal
     Nolan
     Norcross
     O'Rourke
     Pallone
     Pascrell
     Payne
     Pelosi
     Perlmutter
     Peters
     Peterson
     Pingree
     Pocan
     Polis
     Price (NC)
     Quigley
     Rangel
     Rice (NY)
     Richmond
     Roybal-Allard
     Ruiz
     Ruppersberger
     Rush
     Ryan (OH)
     Sanchez, Linda T.
     Sanchez, Loretta
     Sarbanes
     Schakowsky
     Schiff
     Schrader
     Scott (VA)
     Scott, David
     Serrano
     Sewell (AL)
     Sherman
     Sires
     Slaughter
     Smith (WA)
     Speier
     Swalwell (CA)
     Takano
     Thompson (CA)
     Thompson (MS)
     Titus
     Tonko
     Torres
     Tsongas
     Van Hollen
     Vargas
     Veasey
     Vela
     Velazquez
     Visclosky
     Walz
     Wasserman Schultz
     Waters, Maxine
     Watson Coleman
     Welch
     Wilson (FL)
     Yarmuth

                             NOT VOTING--24

     Barletta
     Brown (FL)
     Clawson (FL)
     Crenshaw
     Ellmers (NC)
     Farr
     Fincher
     Hahn
     Hensarling
     Hurt (VA)
     Jolly
     Jones
     Kirkpatrick
     Love
     McCaul
     McDermott
     Moore
     Murphy (FL)
     Nugent
     Poe (TX)
     Renacci
     Shuster
     Westmoreland
     Williams

                              {time}  1333

  Mr. HONDA changed his vote from ``yea'' to ``nay.''
  So the resolution was agreed to.
  The result of the vote was announced as above recorded.
  A motion to reconsider was laid on the table.

                          ____________________