College Student Hunger Act of 2021

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise to speak in support of the Advanced Research Projects Agency-Health Act, or ARPA-H Act. I know this has been an important priority for researchers, industry, and, most importantly, patients who are waiting for life-changing medical technology to improve or even save their lives.

This legislation will authorize the establishment of ARPA-H within the U.S. Department of Health and Human Services. The agency will specifically be charged with helping to foster high-risk, high-reward treatments and cures for diseases with clinically unmet needs.

Some of my colleagues may be concerned about a new agency, and that is where a number of Republicans on the Committee on Energy and Commerce were early in October when this legislation was introduced.

ARPA-H was funded at $1 billion in the previous appropriations bill in 2021. To ensure that funding was used for the best possible result, the Committee on Energy and Commerce for the past several months has worked hard to ensure that ARPA-H has a clear mission. As a result, it passed out of committee with a strong 55-to-3 vote.

We most notably ensure this newly created agency remains separate from the NIH. We limit administration costs associated with setting up ARPA-H to maximize research investments, which would require a strategic plan and transparent reporting on projects; define the number of offices; and require that the majority of offices within the organization be exclusively devoted to biomedical research and development.

In order to ensure this agency is fostering the development of innovative, transformative health technologies that are not being met by Federal programs or private industry, the technologies the agency should pursue are very explicitly defined in the legislation before us today.

The legislation puts guardrails in place to ensure that priority access is granted to U.S. researchers over researchers abroad. There are additional requirements for international researchers to work in collaboration with a U.S. counterpart if they receive ARPA-H funding.

Importantly, the bill makes clear that funding is prohibited from going to nondomestic recipients of a malign foreign country, most notably Chinese research labs or Russian research labs. This is a significant step to ensure the United States' intellectual property isn't being stolen by our adversaries and to ensure we remain the world leader in biomedical research and innovation.

As the Republican leader on the Health Subcommittee, I am leading efforts to strengthen oversight of NIH-funded research. It is unacceptable that some Federal grants have been supporting foreign researchers with ties to governments of adversarial nations like China. We must prevent this from happening moving forward.

Mr. Speaker, I emphasize the need to pass this bill. The funding has already been appropriated in a previous year. If we don't pass this bill and don't authorize this agency to move forward, then this will erode our oversight role in Congress. Funding decisions made by ARPA-H must require diligence to ensure that resources are being spent as appropriately and as effectively as possible.

The Biden administration ARPA-H organizational chart, without this bill, has 14 offices, less than half of which are actually dedicated to research. This gives us insight into how the Biden administration would manage this new agency without congressional guidance. It is just appropriate that the legislative branch sets up the way this money is being spent.

That is what the bill before us today does. It puts ARPA-H on the right track, gives Congress the opportunity to set high standards, and promotes greater biomedical research and innovation for patients.

Mr. Speaker, I thank the majority for working together. I thank our staff for the excellent work they have done. I encourage the passage of this because if we don't pass it, the money is still going to be spent but without congressional guardrails.

Mr. Speaker, I support this bill, and I reserve the balance of my time.

Mr. Speaker, I yield 5 minutes to the gentlewoman from Washington (Mrs. Rodgers), who is the Republican leader of the full committee.

Mr. Speaker, as the chair of this committee, Mr. Upton made his signature issue the 21st Century Cures, and not just passing that which has changed people's lives already but being able to work with Ms. DeGette and all the others to say that this is something we all need to work on together in a bipartisan way and make a big difference.

Now as chair emeritus, this is, I think, his signature piece. He may have other pieces of legislation, too, but this is the one that I have worked on with him in the very beginning in the Oval Office with the President. We worked together to say: Can we do something big that is really going to change the lives of people in this country?

He has done it. He has done it his entire career. He is a mentor of mine, and, unfortunately, at the end of this year he is going to do something different than being here in Congress. He will be missed for his voice and being a champion of this issue.

Mr. Speaker, I am going to yield to him so that he can speak on this bill for himself. The gentleman certainly has left a legacy here with the previous legislation and this piece of legislation. So let's work together to move it forward.

Mr. Speaker, I yield 3 minutes to the gentleman from Michigan (Mr. Upton).

Mr. Speaker, I yield the gentleman from Michigan an additional 1 minute.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, it is important we are here today.

I thank the chair of the other subcommittee whom I have the privilege to work alongside as the Republican leader. She has been a champion of ARPA-H as it first came out and at the first meeting at the White House. We have discussed quite a bit about where it should be and what the guardrails should be.

I know the funding got out in front of it. We all really wanted Congress to have a say in how this agency operated and not the executive branch the way, unfortunately, getting in front of authorization does.

I appreciate the hard work. I appreciate the work of the colleagues who have spoken and everybody else who is working on this together on our staff.

Mr. Speaker, I think it is important that we pass this bill. I urge my colleagues to vote for the bill tonight, and I yield back the balance of my time.

Mr. Speaker, I claim the time in opposition, even though I am not opposed to the bill.

Mr. Speaker, the Chair of the subcommittee kind of went through what the amendment says. Another thing that we need to make sure is reinforced is that the amendment would ensure that agency and precious U.S. taxpayer dollars can never go to nondomestic recipients organized under the laws of a covered foreign entity as defined by the National Security Act of 1947. This includes China, Russia, Iran, and North Korea. So I want to make sure we understand that.

I said this on the debate on the bill that the Chair and I were talking back and forth. And I understood the mission of what we wanted to accomplish with ARPA-H, but I was concerned about the application of it and how it would actually be put into place. We had a lot of discussions based on that.

This amendment really does define as best as we can define in legislation, without vague terms, what we want ARPA-H to do. This amendment ensures that 85 percent of the money goes to research and not to administration and growing an agency. We think that this really does narrow and, as we said earlier, put guardrails. This amendment is what accomplishes that with the bill. I am for this amendment, and I encourage its adoption.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, America is the envy of the world for our leadership in biomedical innovation. People from all over the world have an incredible amount of hope in the promise of our lifesaving, breakthrough research for more cures and treatments.

That is why I have been a longtime supporter of NIH and projects like the BRAIN Initiative intended to speed scientific research necessary to accelerate cures for neurologic diseases.

When the concept of ARPA-H was first proposed to me, I expressed a healthy dose of skepticism.

First, I was concerned about a clear and targeted strategic mission. I was concerned an unfocused agenda would not be a recipe for success.

The second was the issue of duplication. The Federal Government has several agencies that advance biomedical innovation. Within the National Institutes of Health alone, we already have the National Center for Advancing Translational Science, the Cures Acceleration Network, the Common Fund, and the Foundation for NIH's Accelerating Medicines Partnership Program, to name a few.

Third, I was concerned that the creation of a new agency would lack sufficient transparency and oversight. My questions to supporters of ARPA-H included:

How will projects be selected?

How will the public be kept informed of projects and project funding?

Who will be assessing for duplication of Federal programs, and how will it be managed?

What measure will be used to define success?

What are the guardrails to ensure that we are supporting American innovators?

These concerns were validated earlier this year when the administration began implementing the $1 billion that was appropriated to set up ARPA-H with little to no congressional direction. The Biden administration proposed 14 offices within ARPA-H. DARPA has six to eight. They also placed ARPA-H within NIH, which has its own issues in lacking transparency and accountability related to federally funded research and the origins of COVID-19.

We needed to ensure proper oversight and provide guardrails through congressional direction, so we plowed the hard ground necessary to legislate through the Energy and Commerce Committee. Chairman Frank Pallone and Health Subcommittee Chairwoman Anna Eshoo listened to my concerns. We had very productive negotiations to properly define ARPA- H's mission and place strong safeguards for transparency and accountability.

This bill defines ARPA-H's mission so that it is laser-focused on high-risk breakthrough technologies in health and medicine that are not being addressed by the private sector or current Federal programs.

This bill also prohibits Federal funding to China, Russia, and other recipients subject to malign foreign influence.

It moves the agency back outside of NIH.

We are also making sure ARPA-H sets the right priorities. The director must provide Congress with a strategic plan within 1 year of enactment and every 3 years on how ARPA-H will carry out projects. Projects will be evaluated every 18 months, and those not meeting milestones are expected to be terminated.

We placed guardrails on ARPA-H to prioritize projects that provide the greatest return on investment to improve human health and lower healthcare costs.

This bill also keeps the focus on lifesaving research. The director will have the power to hire and make appointments based on merit and expertise, not based on provisions that reward government bureaucrats.

We require those who receive ARPA-H funding to provide a public itemized report on indirect facilities and administrative costs.

To further cut down on duplication and mission creep, we limited the number of offices to 6, not the 14 proposed by the administration. Of those offices, at least four must be exclusively focused on R&D. In addition, not more than 15 percent of the total agency funding is allowed to go to administrative costs.

Mr. Speaker, I will close by thanking my colleagues for working together on this. I especially recognize the leadership of Chairman Pallone, Health Subcommittee Chairwoman Eshoo, Health Subcommittee Republican leader Brett Guthrie, as well as the 21st Century Cures leaders Fred Upton and Diana DeGette.

I am pleased we were able to come together. We put ARPA-H on the right path with a targeted mission, increased accountability and transparency, and a laser focus on promoting American innovators. It is a strong example of E&C's bipartisan record of success in moving legislation that will continue America's global leadership in biomedical research.

Mr. Speaker, before I close, I want to applaud and thank the members of my team: Grace Graham, Kristen Shatynski, Seth Gold, Kristin Flukey, and Kristin Ashford.

They say that Energy and Commerce has the best staff on the Hill, and that is certainly evident through their service to deliver hope and healing, both through this bill and through the package just before us with the mental health package. At every step of the way, I am grateful for their hard work and passion.

Mr. Speaker, I urge a ``yes'' vote on H.R. 5585, the Advanced Research Projects Agency-Health Act.

Mr. Speaker, pursuant to House Resolution 1191, I call up the bill (H.R. 5585) to establish the Advanced Research Projects Agency-Health, and for other purposes, and ask for its immediate consideration in the House.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include any extraneous material on H.R. 5585.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise to speak in support of H.R. 5585, the Advance Research Projects Agency-Health Act, or ARPA-H Act.

In February, the Energy and Commerce Committee's Health Subcommittee held a hearing to discuss the Biden administration's proposal to establish the Advance Research Projects Agency for Health, better known as ARPA-H.

The agency is modeled after the Defense Advanced Research Projects Agency, or DARPA. The mission of ARPA-H is to translate fundamental biomedical research into breakthrough platform technologies that would change healthcare as we know it.

ARPA-H would focus on the highest-risk, highest-reward issues in disease research. It will attempt to solve the problems that the private and public sectors have not been able to conquer. The expectations we have for this agency are justifiably high.

Our hope is that within 5 years of operations, ARPA-H will have led to the development of cutting-edge treatments and cures for cancer, diabetes, autoimmune disorders, and mental health conditions.

In order to be truly successful, we must ensure that all Americans have access to these innovations. Equity and promoting the health of all Americans must also be part of ARPA-H's mission.

The fiscal year 2022 omnibus appropriations law provided the Department of Health and Human Services with $1 billion to get ARPA-H off the ground. We must now provide the necessary and appropriate authorities to make ARPA-H successful, to clarify its mission and its organizational structure,

and ensure that the work at ARPA-H is not duplicative or redundant. H.R. 5585 does just that.

ARPA-H will be led by a director and cadre of program managers with the autonomy and authority to develop high-risk, high-reward portfolios. This will be coupled with the appropriate contracting, hiring, and procurement authorities that will pull from the best minds and resources in the biomedical research ecosystem.

This legislation authorizes $500 million annually for 5 fiscal years. ARPA-H projects will be time- and milestone-limited, ensuring that each project delivers real and measurable results. The ARPA-H Act includes reporting requirements to ensure proper compliance and avoid the redundancy. The director will be required to submit reports on the actions, results, and forthcoming strategic plans of ARPA-H to Congress so that we can confirm that the agency is meeting our intent.

So last month, the Committee on Energy and Commerce advanced H.R. 5585 by an overwhelming bipartisan vote of 55-3. This was a tremendous achievement and demonstrates Congress' ability to come together and find solutions that will improve the health of all Americans.

I thank Health Subcommittee Chairwoman Eshoo, who is the author of this legislation, along with Health Subcommittee Ranking Member Guthrie, our full committee Ranking Member Rodgers, and also Representatives DeGette and Upton for their work on this important bill.

Mr. Speaker, I strongly urge my colleagues to support H.R. 5585, and I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentlewoman from California (Ms. Eshoo), the Health Subcommittee chair and the author of this legislation.

Mr. Speaker, I yield 3 minutes to the gentlewoman from Colorado (Ms. DeGette), the chair of our Energy and Commerce Oversight and Investigations Subcommittee who has also worked on ARPA-H in the very beginning.

Mr. Speaker, I must say that for many years we had a Congressman Brown on the committee who contributed a lot, particularly on healthcare issues. He chaired the Health Subcommittee. So it is an honor to hear from Ms. Brown of Ohio. We have another Congresswoman Brown from Ohio.

Mr. Speaker, I yield 3 minutes to the gentlewoman from Ohio (Ms. Brown).

Mr. Speaker, I yield 3 minutes to the gentleman from Massachusetts (Mr. Auchincloss), who is also very much involved in healthcare issues with regard to the pharmaceutical industry and so many other health issues.

Mr. Speaker, I yield myself the balance of my time to close.

Mr. Speaker, I just want to say in closing that I think you can feel the real enthusiasm and the hope that is involved with both the sponsors of this bill and those who spoke on both sides of the aisle.

We consider ourselves, the Energy and Commerce Committee, the innovation committee, and I think this is a prime example of the type of innovation that we see for the future and the hope in ARPA-H.

Mr. Speaker, I would ask for everyone on a bipartisan basis to vote for this, so we have a strong vote, and I yield back the balance of my time.

Mr. Speaker, I thank the chairman of the full committee for his full support of this legislation from the very beginning.

Mr. Speaker, this has been somewhat of a long journey. It began in March of last year, 2021, when a group of Members, bipartisan and bicameral, were invited to the White House to meet with President Biden. When we gathered there, he spoke about his vision for creating ARPA-H, an advanced research project for health.

It is modeled after DARPA, the highly innovative and successful small agency that was created many years ago. I think one of its chief assets is its autonomy, and its successes are extraordinary because of the way it is shaped. They have produced the internet, GPS navigation, and Moderna's mRNA vaccines.

This bill is shaped to maximize the promise of ARPA-H.

All of us have a relative or someone in our family, extended family, and our communities that when receiving a diagnosis, it is a death sentence. That is what the mission of ARPA-H is directed to address. I have full confidence that, the way this legislation is shaped, it can meet that challenge.

It will be a place where highly innovative ideas are tested, and if the approaches fail because these are high-risk undertakings, then the agency will quickly move on to new ones and redirect the money. It will be flat and small like DARPA, but it has a mighty mission.

Mr. Speaker, I thank all the members of the Energy and Commerce Committee on the majority and the minority side. We have really worked hard together on this to shape something that is worthy of the American people and has the ability to produce. From the chairman of the full committee to the ranking member, Mrs. McMorris Rodgers, to the ranking member of the subcommittee, Mr. Guthrie, ideas kept coming forward. We polished them, added them to the legislation, and, in some instances, dropped other parts of the draft.

Mr. Speaker, I acknowledge the work of my staffer, Aisling McDonough, who has given her all on this; the staff of the committee; the scientists, because well over 100 of them leaned in and gave us their ideas and advice on how best to create a small agency that would be nimble but highly effective; and the patient advocates. So many of them have cheered us on and given us their best input, as well.

Today is the day. The House is poised. I urge all of my colleagues to

support this because when this mission is executed, I think even if one deadly disease is addressed and cured, we will have succeeded. I think we are going to do better than that.

Mr. Speaker, I have an amendment at the desk made in order under the rule.

Mr. Speaker, I yield myself such time as I may consume.

I offer this bipartisan manager's amendment to improve and strengthen

the bill. I thank my Republican colleagues on the Health Subcommittee, including Ranking Member McMorris Rodgers, Ranking Member Guthrie, and Dr. Burgess for working closely with me on this bill over the last several weeks.

This manager's amendment makes sure that the structure of ARPA-H will help the Agency achieve success. Specifically, the amendment requires: First, two-thirds of the ARPA-H program offices be exclusively dedicated to research and development; number two, not more than 15 percent of the ARPA-H budget to be used on administrative expenses; and, thirdly, removes the requirement of Senate confirmation of the ARPA-H director.

I think these are commonsense provisions that improve the bill and, ultimately, strengthen ARPA-H and its mission; and it is why I urge my colleagues to support this amendment.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I thank my very good friend, and I certainly appreciate his kind words. The good news is I am not done yet. We have a lot of work to do, and this is yet one more piece that we are going to be driving forward. But, certainly, I rise in support of this legislation, the ARPA-H authorization bill.

While I have been a longtime supporter of many different versions of this bill, I thank, in particular, Chairman Pallone, my Republican Leader Rodgers, certainly Anna Eshoo--who is my good friend--and Brett Guthrie for their leadership on working together on language with the goal of really making this issue bipartisan and one that is going to work.

I am glad that we came together to add even more important guardrails to ensure that this bill, ARPA-H, works as it was intended as well as, hopefully, have a very strong bipartisan vote a little bit later this afternoon.

This bill is going to establish an entity not unlike the Defense Advanced Research Projects entity--that was our goal--DARPA. It is going to be game-changing, health research. Like DARPA, this entity is going to be focused on producing research on things that, frankly, may be too risky for the private sector. It is going to move at a faster pace than the current structure. There may be a high failure rate, but its successes are going to have the potential to be absolutely groundbreaking, answering the prayers of millions.

It really is a follow-up to what we did in this body with the 21st Century Cures with the Upton and DeGette effort that passed our committee 53-0, then passed here on the House floor 392-26.

There has been a lot of debate on where ARPA-H is going to be housed.

Should it be in NIH?

Should it be in HHS or someplace else?

Wherever this entity is finally located, we need to make sure that it is lean, that it is independent and nimble, and that there are the appropriate guardrails to keep other agencies from mission creep and siphoning that funding. The legislation that was introduced did a very good job of that and I am pleased to see that these protections were strengthened in the final product that we are going to be voting on this afternoon.

My partner in 21st Century Cures, Diana DeGette, and really everybody on our committee were happy to include language for ARPA-H in our Cures 2.0 bill that we introduced more than a year ago. We thought that it was a great follow-up to the work that we did to enhance basic research on the first Cures bill which added $45 billion--paid for--in additional health research.

Funding for the NIH and the FDA included many important things such as the Cancer Moonshot and the Brain Initiative.

We are still in a pandemic. We have awful diseases that need cures, whether it be cancer, Alzheimer's, lupus, or diabetes that strike literally every single family.

This bill, ARPA-H, can provide the breakthroughs necessary to find cures for those diseases. The President has already signed $1 billion for this program into law. So what we need now is bipartisan authorization to complete the work. This bill certainly accomplishes that goal.

Mr. Speaker, I urge all of my colleagues, like we did before, to vote for this bill a little bit later this afternoon. Again, I just want to commend our great staff. As our leader, Congresswoman Rodgers, said: We have the best staff there is.

Is there any objection to that?

Hearing none--sorry, Ways and Means; sorry appropriators.

We do. We are the Energy and Commerce Committee, and we are going to find a cure for these diseases. This bill is a step in that direction.