E PL UR UM IB N U U S Congressional Record United States th of America PROCEEDINGS AND DEBATES OF THE 115 CONGRESS, FIRST SESSION

Vol. 163 WASHINGTON, WEDNESDAY, AUGUST 2, 2017 No. 131 House of Representatives The House was not in session today. Its next meeting will be held on Friday, August 4, 2017, at 1 p.m. Senate WEDNESDAY, AUGUST 2, 2017

The Senate met at 10 a.m. and was RECOGNITION OF THE MAJORITY when it comes to protecting the Amer- called to order by the President pro LEADER ican people, especially at a time when tempore (Mr. HATCH). The PRESIDING OFFICER (Mr. COT- we face a range of threats both at home TON). The majority leader is recog- and abroad. Wray’s impressive creden- f nized. tials, demeanor, and commitment to f the rule of law make clear that he is PRAYER the right person to lead the Bureau in WORK BEFORE THE SENATE The Chaplain, Dr. Barry C. Black, of- its efforts to keep our communities fered the following prayer: Mr. MCCONNELL. Mr. President, as I safe. The work of an FBI Director is Let us pray. said yesterday, the Senate has more difficult, but I am confident that Wray work ahead this legislative period, in- Holy God, You make the clouds Your is capable of shouldering this impor- cluding passing the FDA user fees leg- chariot and walk upon the wind. You tant responsibility and that he will illuminate the darkness with Your islation and confirming a number of nominees. lead the FBI with the strength and pro- presence and provide for the salvation fessionalism that the position de- of our souls. Great is Your faithfulness. We have made important progress al- mands. Today, make our lawmakers heirs of ready, and just last night we passed the peace, demonstrating that they are critical Veterans Choice legislation. Our work on nominees continues Your children, as they strive to stay That bill, which is now on its way to today. We will, for instance, take a within the circle of Your loving provi- the President’s desk, will allow many procedural vote on the nomination for veterans to bypass long wait and travel dence for their lives. May they take the National Labor Relations Board pleasure in doing Your will, knowing times at VA facilities by accessing pri- vate care. later this morning. But there is more that by so doing, they are fulfilling to do. I was pleased to hear the Demo- Your purposes in our world. We also confirmed several nominees. We confirmed eight officials who will cratic leader reaffirm his interest in Lord, You are never far from us, but be critical to advancing administration working with us now to clear more often we are far from You. So show us policy in the Defense Department. It is nominees before the conclusion of this Your ways and teach us Your paths. a good start, but we have other nomi- work period. Many of these nominees Thank You that Your mercy is from nees to confirm for many other posi- everlasting to everlasting upon those have been held up far too long, leaving tions, both security- and nonsecurity- who come to You with reverence. May the administration without a number related, across many different agencies Your glory endure forever. of key officials at various agencies. and departments. In the national secu- We pray in Your great Name. Amen. rity realm, for instance, we must con- I look forward to our Democratic col- firm nominees for the Department of leagues working with us to finish up f Homeland Security, Department of the FDA user fees legislation that I State, and the intelligence community. mentioned earlier, as well. Members PLEDGE OF ALLEGIANCE The Senate also came together to will continue to work on other issues The President pro tempore led the confirm a well-qualified judicial nomi- in the meantime, such as tax reform, Pledge of Allegiance, as follows: nee for the Eleventh Circuit Court of which is one of the things the Senate— I pledge allegiance to the Flag of the Appeals, as well as the Director of the led by the Finance Committee—will United States of America, and to the Repub- Federal Bureau of Investigation, Chris- turn its collective attention toward topher A. Wray. The position of FBI lic for which it stands, one nation under God, after the State work period. indivisible, with liberty and justice for all. Director is one of great importance

∑ This ‘‘bullet’’ symbol identifies statements or insertions which are not spoken by a Member of the Senate on the floor.

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VerDate Sep 11 2014 23:41 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00001 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.000 S02AUPT1 S4698 CONGRESSIONAL RECORD — SENATE August 2, 2017 TAX REFORM These are some of the key goals of HEALTHCARE Mr. MCCONNELL. Mr. President, tax reform. They sound like goals we Mr. SCHUMER. Mr. President, first, during the 8 years of the Obama admin- should all share, regardless of party. on the topic of healthcare: I was very istration, our economy failed to live up For years, the tax-writing committees happy to hear the statement from have focused on this particular sub- to its full potential—meager growth Chairman ALEXANDER and Ranking ject—holding hearings, soliciting input rates, wages that failed to keep pace, Member MURRAY yesterday in which from stakeholders, and considering the and a decline in opportunities. Middle- they pledged the HELP Committee to views and priorities of Members, both class families were hurting, and they the task of restabilizing and strength- on and off these committees. They are needed policies that would allow the ening the markets, particularly by eager now to begin the process of devel- economy to begin to grow again. Unfor- guaranteeing the cost-sharing reduc- tunately, the last administration often oping tax reform legislation that achieves the shared goals I outlined tion program. As Chairman ALEXANDER gave them exactly the opposite. Some said: ‘‘Without the payment of these were sins of commission, such as mak- above. The administration and congres- cost-sharing reductions, Americans ing things worse with an aggressive will be hurt.’’ That is clear. Everyone regulatory rampage. Others were sins sional leaders stated: We have always been in agreement that has said it, even the insurance indus- of omission, such as failing to address try, and yet President Trump con- an outdated tax code that has made tax relief for American families should be at the heart of our plan. . . . And we are now tinues to treat this critical program as American companies increasingly un- confident that . . . there is a viable approach if it is some kind of political hostage. competitive in a global economy and, for ensuring a level playing field between The President treats the critical pro- as a result, has moved investment and American and foreign companies and work- gram as if it is some kind of hostage. jobs offshore. ers, while protecting American jobs and the Insurers in three States—North Caro- Then, in November Americans chose U.S. tax base. lina, Pennsylvania, Iowa—have each to go in a different direction. They Our expectation is for this legislation released separate rates for 2018: one if elected a pro-growth President who to move through the committees this the payments are made, and one that is would sign legislation from a pro- fall under regular order, followed by 20 percent higher if they are not. In growth Congress. Ever since, we have consideration on both the House and these three States, premiums will be 20 been working to turn the tide back in Senate floors. There is a great deal of percent higher if President Trump re- favor of the middle class. We have un- bipartisan consensus about what ails fuses to carry out the law. Every dertaken what has been described as our Tax Code, and my hope is that our American will see that increase in the ‘‘most ambitious regulatory friends on the other side of the aisle their monthly bill and know it is a rollbacks since Reagan.’’ We have pur- will join us in a serious way to address Trump premium tax. sued policies that can once again en- it, because the American people de- courage job growth and American in- serve a tax system that works for them Insurers from coast to coast have vestment. instead of against them. They deserve said that uncertainty surrounding the Just last week, the administration a tax code that encourages companies cost-sharing reductions are the No. 1 and congressional leaders and, most to bring jobs home instead of encour- threat to the stability of our markets. importantly, the chairmen of the Sen- aging just the opposite. Americans de- State insurance commissioners—many ate Finance and the House Ways and serve true comprehensive tax reform. of them Republican—are announcing Means Committees issued a joint state- I appreciate the good work of our col- higher rates for next year and directly ment outlining shared principles for leagues in the administration and by blaming the President’s failure to unleashing the American economy Members in both Chambers already to guarantee these payments, as the in- through comprehensive tax reform. get us there, particularly Finance surance commissioner of Idaho did yes- Comprehensive tax reform represents Committee Chairman ORRIN HATCH. terday. the single most important action we Chairman HATCH has been working We have enough problems in the can take now to grow the economy and hard with his fellow Finance Com- world right now without President to help middle-class families finally mittee members—Senators from both Trump creating entirely new ones out get ahead. It is no secret that the cur- sides of the aisle—literally for years, of political spite and a petty vindic- rent Tax Code is overly complex and on this issue, and he continues to lead tiveness. When you lose politically, highly punitive and makes it harder for the way today. Under his leadership you don’t take it out on the American individuals and small businesses to and the leadership of Chairman BRADY people. That is not Presidential; that is succeed. just small. Fortunately, we now have a once-in- in the House, Congress’s tax-writing committees will advance these prin- So we would say to the President: a-generation opportunity to fundamen- Stop holding this critical program as if tally rethink it. It has been over three ciples through regular order, so that Members on both sides of the aisle will it is some kind of political hostage, decades since that last happened. In stop the sabotage, make the payments the years since, the international econ- have an opportunity to participate in this month so Chairman ALEXANDER omy has grown much more competi- this historic effort, if that is what they and Ranking Member MURRAY can get tive. American workers and American choose to do. This will not be an easy process, but to work in a bipartisan way on a longer businesses have only found it harder to the people we represent are depending stabilization package. keep up with foreign contenders. Put on us for help. Now is the time to de- Let me salute a large number of my simply, the rest of the world is running liver tax reform, and I look forward to Republican colleagues who agree we circles around us in this area, making working with my colleagues to accom- have to do cost sharing. They have re- it more difficult for American firms to plish it. alized that just sticking with President hire, invest, and compete. I suggest the absence of a quorum. Trump—particularly when his motiva- The time has come to fix this so we The PRESIDING OFFICER. The can help our economy grow and help tions are not Presidential but are sort clerk will call the roll. of nasty, vindictive—is a bad idea. I sa- the individuals and families we rep- The senior assistant legislative clerk resent realize their true potential. For lute you because, for the good of Amer- proceeded to call the roll. ica, we have to work together. families, we want to make their taxes Mr. SCHUMER. Mr. President, I ask simpler, fairer, and lower. For small unanimous consent that the order for f businesses, we want to provide the con- the quorum call be rescinded. TAX REFORM ditions they need to form, invest, and The PRESIDING OFFICER. Without grow. For all American businesses and objection, it is so ordered. Mr. SCHUMER. Mr. President, now, on taxes, another matter. Yesterday, their employees, we want to ensure f they have the best chance to compete my friend the majority leader brought with foreign companies and succeed. RECOGNITION OF THE MINORITY down the curtain on bipartisan tax re- We want a tax system that encourages LEADER form before a discussion between our American companies to bring jobs The PRESIDING OFFICER. The two parties could even start, dis- home again. Democratic leader is recognized. missing the prospect of Democratic

VerDate Sep 11 2014 23:41 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00002 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.002 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4699 input, promising the Republicans now let’s cut Medicare because we I certainly applaud the sentiment. I would again use reconciliation to lock don’t have the money. We don’t have have been decrying for years how the us out of the process, repeating the the money because they cut taxes on Chinese have been taking advantage of same mistake they did with the rich, the very wealthy. us in a way that has sent trillions of healthcare. I don’t know which of these three dollars of American wealth to China Leader MCCONNELL’s announcement principles the majority leader is and millions of jobs to China so we just came a few hours after 45 Members against, but when he closed the door on should certainly go after them. The of the Democratic caucus sent him a Democrats—when we sent him this let- problem is, we don’t need another in- letter saying we were open to bipar- ter which simply outlined our prin- vestigation to know what China is up tisan discussions on tax reform. We had ciples, that is all we wanted to do, give to. That is what the President called three simple, straightforward prin- him notice we agree on these three for: Let’s investigate—another inves- ciples. Let me read the Democratic things, at least on our side—which one tigation. principles on tax reform: First, don’t or all of them made him close the door? It is clear what China is up to. By cut taxes for the 1 percent—the top 1 We Democrats hoped we could work dumping counterfeit and artificially percent. They are doing fine. God bless together on tax reform, but the major- cheap goods into our markets, denying them. ity leader has drawn down the curtain U.S. companies fair access to its mar- Second, don’t increase the debt and before the play has even begun. Repub- kets, and relentlessly stealing and ex- deficit, something many of my col- licans will spend the entire first year of porting intellectual property of U.S. leagues on the other side of the aisle this Congress trying to pass their agen- companies, China, as I said, has robbed have been talking about for a long da on reconciliation, a process that de- the U.S. economy of trillions of dollars time. liberately excludes Democrats, ex- and caused the loss of millions of good- Third, negotiate in a fair and open cludes hearings, excludes amendments, paying U.S. jobs. process, not reconciliation but hear- with no shred of bipartisan input. Just Estimates by our own government— ings, amendments, the things that like with healthcare, I believe it will already made estimates; we don’t need have made America great and have be another dead-end road for Repub- a study, President Trump—pin the cost brought this Senate the acclaim over licans. of cyber espionage alone at $400 billion the decades it has had. I tell my friend the majority leader— a year to the U.S. economy—$400 bil- Now, I would like to know which of I quote his speech in 2014, entitled ‘‘Re- lion a year, and 90 percent of it comes these principles the majority leader storing the Senate.’’ I truly believe—I from China’s Government. This is not a does not agree with. I would like to truly believe that Leader MCCONNELL benign process. This is not some rogue know. Is he closing the door on biparti- believes in the institution of the Sen- company. This is the Chinese Govern- sanship because he so dearly wants to ate, and he has shown examples of that ment. cut taxes on the top 1 percent? The most recently when he said we don’t Here is what our four-star general, wealthy are doing great right now— want to change the rules, despite Presi- Keith Alexander, the former Director God bless them—but they don’t need dent Trump pushing to do that, but of the National Security Agency and another tax break while middle-class here is what he said in 2014: commander of the U.S. Cyber Com- families and working Americans are When the Senate is allowed to work the mand said. He called the loss of indus- struggling just to make ends meet. way it was designed to, it arrives at a result trial information and IP through cyber Many of us on this side of the aisle sus- acceptable to people all along the political theft ‘‘the greatest transfer of wealth pect that to some, that is the No. 1 mo- spectrum. But if it’s an assembly line for one in history’’—the greatest transfer of tivation—not tax reform, not close party’s partisan legislative agenda, [it cre- wealth in history. loopholes, not clean up the system but ates] instability and strife rather than good, That pains me—this country, with its give that top 1 percent a huge tax stable law. entrepreneurial vigor, with its accept- break to please so many like the Koch Those are the majority leader’s ance of people from all corners of the brothers. words. Well, if you believe that, my globe for centuries to go work hard and Again, I would ask the leader: Are dear friend from Kentucky, then why create good things, China is stealing it. you closing the door on bipartisanship are you instituting reconciliation, the They are not doing it on their own. simply because you want to cut taxes exclusionary process, before we even Every American, when they hear that on the top 1 percent or maybe the lead- begin the debate? And why—might the statement, it should make them er is closing the door on bipartisanship American people ask—haven’t you cringe. It makes me cringe almost because he has a fervent desire to blow learned the lesson of healthcare that every day. up the deficit? That sure doesn’t sound that process doesn’t work? Those are the facts. So I would say to like something Republicans have been The American people want to see us President Trump: We don’t need an- interested in over the years—they have work together. We may not always suc- other study that takes months and been spending lots of time, with good ceed. It may not be easy. It is hard months to complete while no action is reason, deficit scolding and debt scold- work, but we ought to try. This assem- taken. We need a plan of action now. ing—or is my friend from Kentucky, bly line of partisan legislation—no Unfortunately, this is what the our majority leader, closing the door Democratic input, no hearings, no Trump administration is doing on all on bipartisanship because he thinks amendments—is not what any of us issues of trade. They really talked reconciliation, which means you ex- want to see. It is not what the Amer- tough on the issue of steel and alu- clude the Democrats from the get-go, is ican people are calling out for, and it minum dumping. As someone who has a good process because he doesn’t want will not produce good, stable law. aluminum plants in the State up there to have hearings, because he doesn’t Again, I would ask the majority lead- in Massena—Alcoa—and all along Lake want amendments, and maybe it is the er to reconsider these three principles Ontario—what used to be called Alcan same reason on healthcare? Maybe probably supported by 80 percent of the is now called Novelis—I know the issue they are ashamed of their proposal. I American people. Why aren’t our Re- of aluminum dumping. It hurts jobs in would like to see somebody on the floor publicans supporting them? Why are my State. The President early on get up and say: We believe in tax cuts— they running away from them? talked tough, tweeted tough on illegal on the Republican side get up on the f steel dumping, illegal aluminum dump- floor and say: We believe in tax cuts for ing, but it is 7 months into this admin- the top 1 percent. That is why we want TRADE istration, and we are still reviewing its to do this. Mr. SCHUMER. Finally, Mr. Presi- effects on our economy. But, no, they want to hide it, cloak dent, on the issue of trade, according The administration failed to secure it, give a crumb to the middle class, to reports, the Trump administration any deal with China in a number of fo- and say: See, we are helping you. is preparing an open investigation into rums, and they continue to delay on We all know that what happens after China’s trade practices, focusing on action that was promised in June. we have a big deficit, they come back economic espionage and the theft of in- Tough talk and tweets are cheap, but and say: Now, let’s cut Social Security, tellectual property. strong and decisive action on trade is

VerDate Sep 11 2014 23:41 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00003 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.003 S02AUPT1 S4700 CONGRESSIONAL RECORD — SENATE August 2, 2017 required. American workers have wait- of Kansas, to be a Member of the Na- billion each year in State and local ed too long for our country to crack tional Labor Relations Board for the taxes. down on abusive trade practices that term of five years expiring August 27, As I said at the beginning, I have had rob our country of millions of good- 2020. many differences with President paying jobs. The PRESIDING OFFICER. Under Trump, particularly on the issue of im- Today, I am proud to announce that the previous order, the time until 11 migration in some of the speeches and the Democratic Party will be laying a.m. will be equally divided between statements he has made, but I do ap- out our new policy on trade, which in- the two leaders or their designees. preciate—personally appreciate—that cludes, among other things, an inde- The assistant Democratic leader. this President has kept the DACA Pro- pendent trade prosecutor to combat DACA gram in place. trade cheating, not one of these endless Mr. DURBIN. Mr. President, many I have spoken directly to President WTO processes that China takes advan- times over the last 6 months, I have Trump only two times—three times, tage of over and over again; a new come to the Senate to speak out on perhaps. The first two times—one on American jobs security council that issues and to disagree with President Inauguration Day—I thanked him for will be able to review and stop foreign Trump. It is clear that we have very the kind words he had said about acquisitions of U.S. companies if they profound political differences when it Dreamers and the DACA students and are likely to have a detrimental effect comes to the issues that face us, but I those protected by the President’s Ex- on U.S. jobs; penalties for Federal con- come to the floor this morning in an ecutive action. tractors that outsource jobs; stronger unusual position to express my grati- President Trump said to me: Don’t ‘‘Buy American’’ rules; and an out- tude to President Trump for a position worry about those kids. sourcing tax on companies that leave he has taken, which I think is the right Well, Mr. President, I continue to the United States. position for America. worry about those kids. I worry about On the issue of NAFTA negotiations, Let me explain. Five years ago, them now more than ever, not because we are laying out a set of tough prin- President Barack Obama created the I have heard any change of heart or re- ciples that must be a bottom line for Deferred Action for Childhood Arrivals versal from you but because of other any new NAFTA text. I voted against Program, known as DACA. It enabled circumstances that are bringing this NAFTA in 1994. That was 23 years ago. approximately 790,000 talented young issue to a head. The Texas attorney We have seen how it has hurt us in so people to contribute more fully to this general, Ken Paxton, and nine other many ways. There have been some ben- country. They are teachers, nurses, en- States have threatened to sue you, Mr. efits, but overall the loss of jobs is gineers, small business owners, and President, unless by September 5 you painful. More jobs and higher wages more. DACA, which was an Executive rescind the memorandum that estab- have to be our guiding principle, and it action by President Obama, provides a lished DACA by President Obama and needs full transparency with workers temporary legal status to immigrant announce that your administration and the public at the table, not just students who arrived in the United will not renew or issue any new DACA corporations. States as infants, toddlers, and chil- permits. This direct, specific threat to So I hope the administration—and I dren. They have to come forward under the DACA Program has left hundreds always said when I heard Donald this Executive action and register with of thousands of these Dreamers anx- Trump campaign that my views on our government. They have to pay a ious, concerned, and worried about trade are probably closer—I am closer substantial fee for processing. Then their future. to his views than I was to either Presi- they have to submit themselves to a Last week I was joined by Senator dent Obama’s or President Bush’s. I criminal and national security back- CHUCK SCHUMER, our Democratic lead- hope he will listen to us and work with ground check. If they are successful, er, and 40 other Senate Democratic col- us. These are good things to do. We can they are given 2 years of temporary re- leagues in writing a letter to President do them quickly. We can save jobs, cre- lief from deportation. Trump, asking him to order his Attor- ate good-paying jobs. But I say to the This program is based on the Dream ney General, Jeff Sessions, to use all President: We don’t need another in- Act, a bill that I first introduced in the legal options to defend DACA so that vestigation, another study that lan- U.S. Senate 16 years ago—in 2001. That these young people can continue to guishes for months and maybe even bill would give undocumented students contribute to a country they love. years. We need strong, bold action on who grew up in this country a chance Some of my friends on the other side trade, and Democrats will offer those to become legal and to earn their way of the aisle oppose the DACA Program. strong bold ideas later this morning. to citizenship. To them I say: If you don’t support Thank you. These young people have come to be DACA, let’s immediately pass the bi- I yield the floor. known as Dreamers. They came to the partisan Dream Act. If you think United States under the age of 16, some President Obama went beyond his Pres- f of them 1 or 2 years old. They grew up idential authority with this Executive RESERVATION OF LEADER TIME in the United States, going to our pub- action, then let’s take up this matter The PRESIDING OFFICER. Under lic schools, singing the ‘‘Star Spangled where it should be taken up, here in the previous order, the leadership time Banner,’’ pledging allegiance to the the legislative branch of the govern- is reserved. only flag they have ever known, the ment in the U.S. Senate. American flag. They are American in I recently reintroduced the Dream f every way except for their immigration Act with my friend and colleague, CONCLUSION OF MORNING status. We have already invested in LINDSEY GRAHAM of South Carolina. BUSINESS them, as you can tell—invested in their Now that I am in the mood of thanking The PRESIDING OFFICER. Morning education, bringing them up in Amer- Republican leaders, including Presi- business is closed. ican schools. I can’t believe it makes dent Trump, let me thank Senator any sense for the future of our country LINDSEY GRAHAM, as well as Senator f to squander their talents by deporting JEFF FLAKE and Senator LISA MUR- EXECUTIVE SESSION them to countries that many of them KOWSKI. They have stepped forward to have never known. join me in cosponsoring this Dream A recent study by the Center for Act. EXECUTIVE CALENDAR American Progress finds that ending Our government should give these The PRESIDING OFFICER. Under DACA, President Obama’s Executive young people a chance to earn their the previous order, the Senate will pro- action, would cost our economy at way to citizenship. They were brought ceed to executive session to resume least $433 billion in gross domestic to this country as children. They didn’t consideration of the following nomina- product over the next 10 years. The In- make the family decision to cross the tion, which the clerk will report. stitute on Taxation and Economic Pol- border. They have been raised in this The senior assistant legislative clerk icy estimates that the 1.3 million country. They have created no prob- read the nomination of Marvin Kaplan, young people eligible for DACA pay $2 lems in terms of criminal background.

VerDate Sep 11 2014 23:41 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00004 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.005 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4701 They have gone to our schools. All lowing DACA to continue under your a solution toward these runaway pre- they are asking for is a chance. administration. Thank you for keeping miums I have talked about ad nauseam When we introduced the Dream Act a your word to me and so many others on the Senate floor? week or so ago, Senator GRAHAM said when you said that these young people We have almost become numb to the that the young people who have re- don’t have to worry. But we are reach- pain people across this country are ex- ceived DACA should be treated fairly ing a moment, Mr. President, when we periencing because of the skyrocketing and not have the rug pulled out from have to come together and do some- rate of their insurance premiums, and under them. LINDSEY GRAHAM is right. thing. We need you and you need us so we know that 28 million, roughly, have Over the years, I have come to the that we can pass important legislation dropped out and are uninsured. In my floor nearly 100 times to tell the stories and you can sign it—legislation that State alone, because of the individual of these Dreamers and to make it per- will give these young people the pro- mandate, which is the penalty the gov- sonal so that we come to know who tection they deserve, the opportunity ernment imposes for one’s failing to they are and why I have taken the time they seek, the chance to make America buy a government-approved health in- to make this a major part of my serv- a greater nation. surance plan—as the Presiding Officer ice in the Senate. These stories put a I know the reality of this issue. I knows because I got the figures from human face on the DACA Program and know it from both political sides. I wit- him—more than 400,000 Texans who on the Dream Act. They show what im- nessed it for over a decade. I know it is earn less than $25,000 a year paid the migration actually means to our coun- not popular, Mr. President, that you penalty because they could not afford try in real terms. have taken this position, to stand be- to buy the insurance. All in all, about This is Juan Martinez. When he was hind the Dreamers and those protected a million Texans paid the penalty be- less than 2 years old, Juan was brought by DACA, but you told me that you cause of the individual mandate. to America from Mexico. He grew up in thought it was the right thing to do, When we tried to do something about Dallas, TX, with his parents and broth- and I am sure you still feel that way. that last week, in working with our ers. He was an honor student in high Your new Chief of Staff, General House colleagues, what was the re- school. He graduated and was valedic- Kelly, and I have had many conversa- sponse from the other side? It was torian of his class with a 3.9 GPA, a tions about this, and I believe that he, crickets—silence. Unfortunately, the member of the National Honor Society, too, thinks that legislation is nec- people who were hurt by ObamaCare an active member of the debate team, essary to protect these young people. I are still being hurt by ObamaCare. and in student government. hope we can come together. I stand Now, here is the narrative. I have al- He was an accomplished student, but ready. Senator GRAHAM stands ready. ready seen it on social media and have he was also a very active community We have a bipartisan coalition pre- read about it in the paper and else- volunteer. Juan helped organize food pared to work with you. where. Some people are saying: Well, drives at the local food banks, he cared Let’s not let this decision be made in the reason insurance companies are for children at recreation centers while a courtroom somewhere far from Wash- saying that premiums are going to go their parents worked, and he volun- ington. Let’s take on our responsi- up 30 percent next year is that Presi- teered in soup kitchens. bility, yours as President and ours in dent Trump will not commit to the In his senior year of high school, he the Senate, to address this critical subsidies for insurance companies, the applied to his dream school—once my issue that really cries out for justice. so-called CSRs. dream school—Georgetown University, This is the time to do it. The concern, That is utterly false. How do they ex- and he was accepted. As a college stu- anxiety, and stress is higher than ever plain the 105-percent increase from 2013 dent, Juan has studied international among these populations of people af- to currently? How do they explain last politics, concentrating on security, fected by DACA and the Dream Act year’s increase in insurance premiums, minoring in the Arabic language. In his and, of course, their families as well. I 25 percent, on average, and 145 percent first year of college, Juan was elected hope you will join us in creating a legal in places like Arizona before President as a student senator. option that will defend the DACA Pro- Trump even took office? It is a demon- In his spare time here in Washington, gram and will work with us in Congress strably false narrative, and I cannot he mentors disadvantaged high school to make the Dream Act the law of the tell you how disappointed I am that we students so that they can apply suc- land so that we can say to young peo- were not able to make some progress cessfully for college. His dream one day ple like Juan Martinez and hundreds of toward a solution on behalf of the peo- is to work for our government, to help thousands of others: Yes, we will give ple whom I represent in my State but our country—the country that he calls you your chance—give you your chance also on behalf of the people whom we home—and to make the world a safer to prove that you can become a valu- all represent across the United States. place. able part of America’s future, give you I dare say, as we search for a path Juan sent me a letter, and this is a chance to make America a stronger forward, we ought to get our facts what he said: nation. That is all they have asked for, straight, and the idea that premiums are going to go up 30 percent next year, Thanks to DACA I can focus on my studies and that is something we, on a bipar- without worrying that it may all be taken tisan basis with the President, should unless something changes, is a product away from me any second. I have always give them. of the failure of ObamaCare. It is noth- thought of myself as an American, but it is I yield the floor. ing that this administration has done thanks to DACA that I can begin to truly The PRESIDING OFFICER (Mr. or will do that has caused that. So let’s feel like one, too. And that feeling is some- DAINES). The Senator from Texas. get our facts straight because starting thing I am thankful for every single day. HEALTHCARE with the correct facts is absolutely es- Juan and other Dreamers have so Mr. CORNYN. Mr. President, I note sential to coming up with real solu- much to contribute to this country. in this morning’s news that insurance tions. But without DACA, without a similar companies that provide health insur- WORK BEFORE THE SENATE protection, Juan could be deported ance policies on the ObamaCare ex- Mr. President, we sometimes are our back to Mexico, a country where he changes are projecting that insurance own worst enemy in the U.S. Senate. hasn’t been since he was 2 years old. premiums will go up about 30 percent We do something really important, Would we be a stronger nation if we next year. really good, and really bipartisan, and lost Juan Martinez—if he were de- Since 2013, we have seen the nation- then we do not tell anybody about it. ported? I don’t think so. I think the an- wide average of premiums go up 105 We leave it to them to discover it for swer is clearly no. percent. That was before this latest an- themselves. Last night, for example, When we introduced the Dream Act nouncement. We know that in 2017, the we passed major, bipartisan, bicameral last week, Senator LINDSEY GRAHAM national average increase in premiums legislation to continue the Veterans said: ‘‘The moment of reckoning is was 25 percent, and in Arizona, for ex- Choice Program. At a time when so coming.’’ ample, it was 145 percent. much is polarized here in Washington I would say to the President first: So why did all of the Senate Demo- and people are hungry for bipartisan- Again, thank you. Thank you for al- crats vote against making progress on ship and solution-oriented leadership,

VerDate Sep 11 2014 23:41 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00005 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.006 S02AUPT1 S4702 CONGRESSIONAL RECORD — SENATE August 2, 2017 when they get it on something like the I heard one of our colleagues last Some people seem to have forgotten Veterans Choice Program, we do not week stand in front of the Nation and that. talk about it. This is really important say nothing ever gets done. Well, we Again, I hope we have a big, robust to our veterans—people to whom, I be- are doing some important things. The package of noncontroversial nomina- lieve, we have a solemn commitment Veterans Choice Program and the FDA tions approved before we leave for the as a result of their service to our coun- reauthorization bill are important, rest of the month of August. I think it try. lifesaving bills that are being passed on is too important to leave town without Over the last few years, we have a bipartisan basis. that. We need our President to succeed heard how the Veterans Health Admin- Then, of course, there is the backlog so the country can succeed. This is istration has been plagued by ineffi- of the President’s nominees. what every American who voted for ciency, unaccountability, and poor I have never seen anything quite like President Trump hoped for, and they quality of care. The VA has been hin- it. We had an election on November 8, trusted him to choose men and women dered too long by unnecessary bureau- but for many of our colleagues, the for his Cabinet to lead and guide our cratic hurdles, which have been incred- election remains undecided. They do country. I have to say, he has done a ibly frustrating and deadly, I am not accept the verdict of the American remarkably good job in the people afraid, in some cases, for our veterans. people and the electoral college that whom he has chosen for his Cabinet so We have heard stories about veterans President Trump won the election and let’s come together and confirm these having to travel hours to get medical that Hillary Clinton lost. That is how appointees so the administration can care, sometimes causing them to ac- they, somehow, justify their consistent better serve our Nation and all Ameri- cept lower quality care or to forgo that foot-dragging and obstruction when it cans. care entirely. Sadly, in some cases, comes to the President’s nominees for I yield the floor. The PRESIDING OFFICER. The Sen- veterans turn to coping mechanisms, important offices, including his Cabi- self-destructive activity—self-medi- ator from Washington. net. Mrs. MURRAY. Mr. President, thank cating—with drugs or alcohol because It is the President’s prerogative to they simply cannot get access to genu- you. nominate whom he wants to serve in I come to the floor today to urge my inely helpful medical care. the executive branch, but it is our The Veterans Choice Program was colleagues to vote no on the nomina- duty, our responsibility, to carefully tion that we will vote on shortly. designed to help address that by ensur- consider their qualifications before ing that veterans could receive timely On the campaign trail, President coming together to confirm them. Now, Trump promised to put workers first. appointments close to where they live. we have had people who had been wait- Instead, President Trump’s administra- If they had to drive too far or if they ing months for their nominations to be tion has rolled back worker protections had to wait too long for an appoint- confirmed and who were confirmed by and prioritized corporate interests at ment at a veterans facility, we said: almost unanimous votes of the Senate, the expense of workers. You could show up at your local which tells me we were delaying those It is critical, now more than ever, healthcare provider’s, and we will pay votes unnecessarily. If they were truly that the NLRB remain independent and for it through the Veterans Choice Pro- controversial, I think it would be re- committed to advocating for workers gram. and their right to organize, but I am The VA Choice and Quality Employ- flected in the votes for their confirma- deeply concerned that President ment Act of 2017 continues that impor- tions, but they are not. Let me just name one—our former Trump’s nominee, Mr. Kaplan, does not tant program and guarantees veterans colleague, Kay Bailey Hutchison, who have a record of supporting the rights that they will have access to care with- has been nominated to serve as the of workers and unions. out interruption. At his nomination hearing, Mr. This bill also strengthens the VA’s Ambassador to NATO. I cannot think of a more qualified person than my Kaplan confused basic labor issues and ability to recruit, train, and retain its decisions, further proving he lacks the valuable workforce, which will help the good friend, the former Senator from Texas. Our country needs leadership in knowledge and experience to serve on VA continue to improve veterans’ care. this important board. NLRB members I am glad we were able to pass this leg- Brussels, at NATO, to help counter Russian aggression and threats and in- should be committed to standing up for islation last night to ensure that this workers, and it is clear Mr. Kaplan program can continue serving veterans. timidation against our allies in the re- gion, but that is just one example. does not make the cut. In moving forward, both Chambers I urge my colleagues to join me in should continue to work with the VA Last night, the Senate confirmed the FBI Director—I am grateful for that— doing what President Trump has failed to get the agency back on track and to do, and that is to put workers first. right the years of poor quality of care but they also confirmed—again, in the dead of night when nobody was paying Vote against this nomination. and of service to our veterans for Thank you. attention—eight other Department of whom, I believe, we have a sacred obli- I yield the floor. Defense nominees. Now, if our Demo- gation, a solemn commitment, based CLOTURE MOTION cratic colleagues had good reason to on their service to our country. The PRESIDING OFFICER. Pursuant delay those confirmations because they Next, we will focus on another impor- to rule XXII, the Chair lays before the felt like they were controversial, that tant piece of legislation. This is au- Senate the pending cloture motion, is their right, but evidently they were thorizing the Food and Drug Adminis- which the clerk will state. tration’s user fee program. willing to let those people who had The legislative clerk read as follows: been nominated to the Department of This is how the Food and Drug Ad- CLOTURE MOTION Defense be confirmed, basically, by ministration actually considers and ap- We, the undersigned Senators, in accord- proves new drugs that can save lives consent after months and months of ance with the provisions of rule XXII of the and improve the quality of lives. These delay. Standing Rules of the Senate, do hereby partnerships between the public and We have a lot of other nominations move to bring to a close debate on the nomi- private sectors ensure that patients that are backlogged due to the unfortu- nation of Marvin Kaplan, of Kansas, to be a will have access to safe and effective nate obstruction and foot-dragging of Member of the National Labor Relations drugs and medical devices while also our Democratic colleagues, and I, for Board for the term of five years expiring Au- maintaining America’s position as a one, do not think we ought to leave in gust 27, 2020. Mitch McConnell, Chuck Grassley, Marco global leader in medical innovation. August—this month—without a big, ro- Rubio, Deb Fischer, John Cornyn, Faster approvals mean treatments and bust package of the confirmations of Susan M. Collins, Lamar Alexander, cures reach patients sooner. Increased these noncontroversial nominees. Roy Blunt, Luther Strange, Pat Rob- competition leads to lower costs, and It is time to get over the election. erts, James Lankford, Bob Corker, that, in turn, means more lives saved. That was on November 8. We used to Richard C. Shelby, John Barrasso, Joni This is another example of what, I be- see a difference between elections and Ernst, Orrin G. Hatch. lieve, will be a bipartisan accomplish- the responsibility of governing. Re- The PRESIDING OFFICER. By unan- ment of the current Senate and current gardless of who wins the election, we imous consent, the mandatory quorum Congress. still have the responsibility to govern. call has been waived.

VerDate Sep 11 2014 23:41 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00006 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.008 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4703 The question is, Is it the sense of the We all know that strong unions have This is not a difficult concept for Senate that debate on the nomination helped to create our middle class, and workers across the country to grasp. If of Marvin Kaplan, of Kansas, to be a for many working families in the 20th you are not qualified for a job that is Member of the National Labor Rela- century, a good union job, or the right this important or if you want to under- tions Board, shall be brought to a to collective bargaining, helped them mine the basic goals of the law, you close? move up the economic ladder. But over shouldn’t get the job. The yeas and nays are mandatory the past few decades, we have seen a So I will be voting no on Mr. under the rule. decline in unions and union member- Kaplan’s confirmation. I urge my col- The clerk will call the roll. ship across the country. As a result of leagues to do the same. The legislative clerk called the roll. that, our economy has started to favor I know my colleagues on both sides Mr. CORNYN. The following Senators corporations and those at the top. This of the aisle want to strengthen our are necessarily absent: the Senator paved the way for President Trump and economy and rebuild our middle class. from North Carolina (Mr. BURR) and billionaires like him to take advantage So I hope we can stand with working the Senator from Arizona (Mr. of their workers, with little recourse families across the country who today MCCAIN). for everyday people who are the back- are simply asking for a fair shot. The PRESIDING OFFICER (Mr. SUL- bone of our country. Thank you, Mr. President. LIVAN). Are there any other Senators in The National Labor Relations Board I yield the floor. the Chamber desiring to vote? gives workers the opportunity to file The PRESIDING OFFICER. The Sen- The yeas and nays resulted—yeas 50, charges against corporations when ator from Hawaii. nays 48, as follows: they are illegally fired or when cor- Mr. SCHATZ. Mr. President, there porations retaliate against workers for [Rollcall Vote No. 183 Leg.] are two reasons why every Member of exercising their rights. President YEAS—50 the Senate should vote against con- Trump should be familiar with the firming Marvin Kaplan to the NLRB. Alexander Flake Perdue NLRB, as his own businesses have had Barrasso Gardner Portman The first is that he is just not quali- Blunt Graham Risch complaints filed numerous times. That fied. Boozman Grassley Roberts is precisely why it is so important that The NLRB is the Federal agency that Capito Hatch Rounds the Board is independent and is com- enforces our labor laws. It protects the Cassidy Heller Rubio mitted to advocating for workers and Cochran Hoeven rights of workers and the private sec- Sasse their right to organize. Collins Inhofe Scott tor to organize for better wages and Corker Isakson The preamble of the National Labor Shelby better working conditions. It is up to Cornyn Johnson Strange Relations Act clearly states that it is Cotton Kennedy them to make sure that their employ- Sullivan the policy of the United States to en- Crapo Lankford ers follow the law and that when there Cruz Lee Thune courage collective bargaining and to is an issue between employers and em- Tillis Daines McConnell give workers a voice, allowing them to ployees, everyone acts reasonably. Enzi Moran Toomey speak up for fair wages and safe work- Ernst Murkowski Wicker Democrats and Republicans who have Fischer Paul Young ing conditions. It is the responsibility served on the NLRB have been the top of the NLRB to ensure that workers NAYS—48 labor and employment attorneys in are being treated fairly and to resolve their fields. They have had long careers Baldwin Gillibrand Murray disputes between corporate manage- working on labor issues, either as law- Bennet Harris Nelson ment and workers. Blumenthal Hassan Peters yers or as law professors. Many of them So it is clear to me that Board mem- Booker Heinrich Reed have spent time as staffers on the Brown Heitkamp bers should believe in the core mission Sanders NLRB board. In other words, they un- Cantwell Hirono Schatz that I just stated of the NLRB and derstand the labor issues better than Cardin Kaine Schumer should be committed to standing up for Carper King Shaheen anyone. They may have a unique per- workers and their right to collective Casey Klobuchar Stabenow spective on it one way or the other— Coons Leahy Tester bargaining, which is exactly why I sort of pro-management or pro-labor— Cortez Masto Manchin Udall have very serious concerns about Mr. Donnelly Markey Van Hollen but there is no question that previous Marvin Kaplan’s record, which has Duckworth McCaskill Warner nominees and previous members of the largely been in opposition to the work Durbin Menendez Warren Board know labor law. Feinstein Merkley Whitehouse and mission of the NLRB. Franken Murphy Wyden As a labor staffer in the House of Marvin Kaplan doesn’t fit this pro- file. He is not a lawyer with any rel- NOT VOTING—2 Representatives, Mr. Kaplan prepared evant labor experience. He has no Burr McCain and staffed hearings where Republicans consistently attacked the NLRB. In record and no public positions on rel- The PRESIDING OFFICER. On this fact, I would be hard-pressed to name a evant labor law. What he is is a well- vote, the yeas are 50, the nays are 48. single example of Mr. Kaplan sup- connected Capitol Hill staffer. His only The motion is agreed to. porting the rights of workers and qualification, that I can find, is that he The Senator from Washington. unions. has drafted some legislation for a com- Mrs. MURRAY. Mr. President, I come In addition to Mr. Kaplan’s opposi- mittee in the House of Representatives. to the floor today to stand up for the tion to the core mission of the Board, That does not stack up against the re- workers President Trump is failing. As I also have deep reservations about Mr. sumes of any other member who has a candidate running for President, Mr. Kaplan’s lack of legal experience prac- served on the Board—Democrat or Re- Trump promised workers that he would ticing before the NLRB. When I asked publican. put them first and that he would bring Mr. Kaplan about his lack of practical This lack of experience is dangerous. back good-paying, respectable jobs to qualifications, his responses were tell- It means he will not know the intrica- their communities, but since day one, ing: Have you ever represented a party, cies and the historical development of President Trump has done the exact employer, or a union in an unfair labor labor law. He will simply be a opposite. He has rolled back worker practice case or representation case be- rubberstamp who brings a political protections and made it harder for fam- fore the Board? No. Have you ever rep- agenda to the Board, because he has no ilies to be more secure. resented a worker in an employment on-the-record opinions on these issues Now, this doesn’t come as a surprise matter? No. of his own. to me, especially when I look at Presi- What is more, when asked to speak That was clear from the hearing on dent Trump’s record as a businessman. on the pressing questions facing the his nomination, when he would not I have to say that he has refused to Board at his confirmation hearing, he properly commit to recuse himself allow even his own hotel workers to or- actually confused basic labor issues from any issues he had worked on and ganize or join a union, preventing them and decisions, further calling into to approach issues with an open mind, from having the opportunity to better question whether he has the experience which brings me to the second reason. advocate for safer working conditions and knowledge to serve on this criti- If somehow Senators can make an ex- and better pay. cally important Board. cuse for his lack of experience, we can’t

VerDate Sep 11 2014 23:49 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00007 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.013 S02AUPT1 S4704 CONGRESSIONAL RECORD — SENATE August 2, 2017 deny that this is the opposite of the rates and the purchasing power of wage sector employment in the 1950s to less message that Congress should have re- earners.’’ than 7 percent of private sector em- ceived during the 2016 election. There are a lot of important words ployment today. This is all the more In November, Americans made clear there. When you have inequality of reason to stop this assault on workers that Washington had failed working bargaining power, the findings of the and labor unions. families and that we have not done Congress at the time said that would Nominees with a partisan history of enough to stand up for American work- burden and affect the flow of com- working to undermine unions or under- ers. merce. So that tells you the impact on mine the National Labor Relations Act Now here we are about to confirm a commerce. It also says that when you or undermine the National Labor Rela- nominee to the NLRB, and the only ex- have inequality of bargaining power, tions Board should not be confirmed to perience he has is that he has drafted that aggravates business depressions, a position where they are supposed to legislation to hurt American workers. and the result of that is depressing act as an arbiter to protect the rights The Board is about to face some im- wages and depressing purchasing of workers to form a union and to bar- portant decisions. They could reverse a power. gain collectively. So I urge my col- decision that holds big companies ac- Everyone here knows that when we leagues to oppose the nomination of countable for how their contractors are measuring the American economy Marvin Kaplan to the National Labor treat workers. The future of American today—I am sure this has been true for Relations Board. workers and their ability to organize many generations but especially Madam President, I yield the floor. will be influenced by this Board, which today—the consumer plays a substan- I suggest the absence of a quorum. includes any members confirmed by tial role in our economy. So if that The PRESIDING OFFICER. The the Senate. consumer, that worker has lower clerk will call the roll. If Mr. Kaplan is appointed, it will wages, that is not good for anyone. So The bill clerk proceeded to call the further silence workers who already giving workers the right to both orga- roll. feel that they aren’t being heard in nize and collectively bargain allows Mr. BROWN. Madam President, I ask Washington, DC. them to demand higher wages, thereby unanimous consent that the order for A vote for Mr. Kaplan is a vote that increasing their incomes and that pur- the quorum call be rescinded. ignores the voices of American work- chasing power which is so critically The PRESIDING OFFICER. Without ers. It is a vote that further politicizes important. That, in turn, of course, in- objection, it is so ordered. the NLRB at a time when we need to creases consumption and demand for Mr. BROWN. Madam President, dur- shore up our institutions against blind, goods, which, of course, increases pro- ing his campaign, President Trump corrosive ideology. duction and employment. So all of made a lot of big promises to workers I urge my colleagues to vote no on these are tied together. Wages and ben- in Ohio and across the country. He told this nominee. efits affect the economy, not just the them he would look out for them. I yield the floor. worker and his or her family. In a letter I sent to the President 2 I suggest the absence of a quorum. I believe there is now a concerning days after the election, on November 10 The PRESIDING OFFICER. The trend to weaken the National Labor or 11, asking the President to work clerk will call the roll. Relations Act and to tilt the Board with me to renegotiate NAFTA, insist- The legislative clerk proceeded to against workers. Mr. Kaplan’s nomina- ing on ‘‘Buy American’’ provisions and call the roll. tion is another sign of this disconnect infrastructure, the President scrawled Mr. CASEY. Madam President, I ask between the rhetoric of the administra- across the top of the letter: ‘‘I will unanimous consent that the order for tion claiming to be pro-worker and its never let down workers.’’ the quorum call be rescinded. actions that are of late anything but He said he would look out for them, The PRESIDING OFFICER (Mrs. pro-worker. The administration claims but too often the people he puts in ERNST). Without objection, it is so or- it is here to support workers, but at charge are along the lines of this latest dered. every turn, we have nominees who have nominee to the National Labor Rela- Mr. CASEY. Thank you, Madam spent their careers working in the op- tions Board, Marvin Kaplan. Mr. President. posite direction. Kaplan has devoted his career—imag- I rise to speak in opposition to the We know that in the 1950s and 1960s, ine such a thing—to working to strip nomination of Marvin Kaplan to serve the economy worked well for working workers of their rights and trying to as a member of the National Labor Re- Americans because 35 percent of work- undermine the workers’ watchdog he is lations Board. Mr. Kaplan has spent ers were in a labor union. The decline now seeking to join. I never question much of his career as a staff member in of unions, the decline of the workers’ people’s motives in this body. I just Congress, where he worked to under- voice, and the decline of collective bar- don’t quite understand why somebody mine unions and the rights of workers gaining have helped to lead us where would devote his work life to trying to to bargain collectively. we are today—stagnant wages over a take away workers’ rights and under- A key role of the National Labor Re- long period of time, as well as power, mine labor protections. Someone who lations Board is to preserve the right of wealth, and income, of course, con- views unions and collective bargaining workers to bargain collectively. The centrated at the top. as a threat to be dealt with rather than Board itself is charged with enforcing So we know that unions helped work- as essential rights to be protected has the National Labor Relations Act, ers to win higher wages, job security, no business serving on the National which Congress passed in 1935 in the and unprecedented benefits, including Labor Relations Board. depths of the Great Depression. The act paid vacations, paid sick leave, and The National Labor Relations Board gave workers the right to join unions, pensions that gave those workers and was created, in part, at this desk. Then and it encouraged and promoted collec- their families a measure of security, Senator Hugo Black of Alabama, in the tive bargaining as a way to set wages but it also increased their purchasing early 1930s, sat at this desk. At this and settle disputes over working condi- power, and it also, of course, strength- desk, one of the pieces of legislation he tions. ened the economy. American family in- wrote was the minimum wage law. One This law that passed in the 1930s— comes grew by an average of 2.8 per- of the other pieces of legislation he and is still in effect today—is not sim- cent per year from 1947 through 1973, worked on with Senator Wagner was ply a benefit to workers; it also bene- with every sector of society seeing its the National Labor Relations Act. In fits businesses, and it also benefits the income roughly double. those days, people understood that you economy. Section 1 of the act says, in We know now that in the last number had created the National Labor Rela- pertinent part: ‘‘The inequality of bar- of years, it has been a different story. tions Act to strengthen workers, to gaining power between employees . . . Families across Pennsylvania and the create workers’ rights, and to protect and employers . . . substantially bur- United States know that the story is those workers’ rights. dens and affects the flow of commerce, much different. It is not a coincidence Mr. Kaplan’s nomination sets that on and tends to aggravate recurrent busi- that union membership has declined its head. It is the latest in a long, long ness depressions, by depressing wage from its peak of 35 percent of private line of evidence that we in this country

VerDate Sep 11 2014 23:49 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00008 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.015 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4705 simply don’t value work the way that I went to my high school reunion in He said: we used to. Workers have continually Mansfield, OH, about a year and a half It gives voice to those who have none . . . seen their rights undermined. Workers’ ago. I sat across from a bank teller who unmasks the powerful who trample on the wages have been stagnant. People who works for one of the largest banks in rights of the most vulnerable workers, de- work hard and play by the rules don’t the United States. She has worked at fends the cause of the foreigner, the least, have the standard of living they had in that bank for 30 years. She makes the discarded. our parents’ generation or even half of $30,000 a year, and she has worked at a This is the Pope talking. a generation ago. bank, as a bank teller, for most of the Think about airline baggage han- We see companies refusing to pay last 30 years. That is not respecting the dlers. Airline baggage handlers used to overtime to workers who have earned dignity of work. That is simply under- make a good union wage. They used to it. We see companies misclassify work- mining the value of work. work for United. They used to work for ers so that companies can pay them Pope Francis said: American. They used to work for less. We see executive salaries and CEO The person thrives in work. Labour is the Delta. Now they work for private com- compensation going up and up and up. most common form of cooperation that hu- panies that are contracted by United, Yet for the broad middle class in this manity has generated in its history. American, and Delta. Airline baggage Work is a form of civil love . . . that handlers’ wages in the last 10 years country, for people who aspire to be makes the world live and carry on. middle class, for low-wage workers, have dropped 40 percent. They are Yet too often that work—the co- they have simply not gotten a raise for working just as hard—they are prob- operation that gives life purpose and the last 20 years. So then, are we going ably working harder—but they are that powers our country—does not pay making 40 percent less than they used to appoint somebody to the National off for the people who are doing it. Labor Relations Board—the President to. While corporate profits are up, the Again, the Pope said: says we are going to confirm somebody GDP is up, and executive salaries have to the National Labor Relations . . . unmasks the powerful who trample on exploded upward, wages have barely the rights of the most vulnerable workers, Board—who has devoted his entire ca- budged. Workers simply have not reer to undermining workers, to taking defends the cause of the foreigner, the least, shared in the wealth they have created. the discarded. away workers’ rights, to scaling back I went to an auto plant once after the The capitalism of our time does not under- workers’ protections, and to scaling passage of the North American Free stand the value of the trade union because it back wages—all these things we as a Trade Agreement. At my own expense, has forgotten the social nature of the econ- country never stood for? I flew to Texas. I was representing a omy, of the business. This is one of the I don’t know what is happening in congressional district in Northeast greatest sins. this country that we think it is right Ohio then. I rented a car with a friend, We know from rightwing attacks on to deprive workers of their wages, to went across the border from New Mex- the labor movement, from so-called take away overtime, to basically hit ico, and I visited an auto plant in Mex- right-to-work bills to Mr. Kaplan’s ef- workers day after day after day in ico. It was an American company, but forts to undercut rules that protect their pocketbooks, all while produc- it was in Mexico. workers, that too many in this country tivity goes up, profits go up, and while This auto plant looked just like an do not understand the value of the executive compensation goes up. American auto plant. It was clean, and trade union. When I was a kid, the average CEO- it was up-to-date. In fact, it was newer Right now, in Mississippi, auto- to-worker ratio of pay was about 35 to than most of our auto plants. The workers at Nissan are organizing and 1 or maybe even less than that. Today floors were clean, the workers were trying to form a union, and the cor- it is often 300 or 400 to 1. The CEO will working hard, and the technology was poration has responded. This foreign make 300 times what the average work- up-to-date. corporation has responded with des- er in the same company makes. How Do you know the difference between picable intimidation tactics. This is much is enough? What moral principle the American auto plant and the Mexi- one of the most powerful, profitable says to pay a CEO 300 or 400 times what can auto plant? The Mexican auto companies in the world that is attack- a worker makes? How much do they plant did not have a parking lot be- ing workers one at a time in Mis- need? Why do they keep doing that? cause the workers did not make sissippi. They keep doing that in part because enough. They were not paid enough by One worker said: ‘‘There is no atmos- of people like Mr. Kaplan, who always this American auto company. They phere of free choice in the Canton sides with the CEOs against the work- were not paid enough in Mexico to buy plant—just fear—which is what Nissan ers. As we think about this, I think ev- the cars they make. The work was not intends.’’ erybody in this body can learn some- respected, profits were going up, the It is shameful the lengths that this thing from Pope Francis. At the end of GDP was going up, executive salaries corporation is going to—all to prevent June, Pope Francis spoke to workers in were going up, and the workers were workers from bargaining for fair pay. Italy at the Italian Confederation of not sharing in the wealth they created. It is why we need a strong, not an un- Trade Unions. He was talking about This is a universal problem. It affects dercut, weakened, emasculated Na- something we do not think about much blue-collar workers, and it affects tional Labor Relations Board. We need in this town that really ought to be at white-collar workers. It is in the indus- a strong National Labor Relations the heart of everything we do. He trial heartland of Ohio, and it is on the Board to defend these workers and de- talked about the value and the dignity farmlands of Iowa. It is a problem on fend our laws on the books because an of work. An employer—a CEO—cannot both coasts. People earn less. People attack on unions is an attack on all say that he—and it is usually a ‘‘he’’— cannot save for retirement. People feel workers. It is an attack on our econ- values work when he takes away work- less stable—all while working harder, omy as a whole because it depresses ers’ rights. He cannot say he appre- all while producing more for their em- wages. ciates the dignity of work, when he ployers, which feeds right into huge ex- There is the idea that you give tax scales back their wages or cheats them ecutive compensation, but they do not cuts to the richest people in the coun- out of their overtime or takes away, by share in the wealth they create for try and that you make sure executive misclassification, the dollars she has their companies. They are also less salaries are $5- and $10- and $15 million. earned. likely to have a union card that pro- You squeeze workers so they do not get When Pope Francis talked about the tects them. increases. Is that a good economy? No. dignity and value of work, he meant all So the President’s appointment to The money does not trickle down and work. He meant looking out for the lit- the National Labor Relations Board is build the economy. You build the econ- tle guy whether she punches a time pretty much a guy who has tried to omy from the middle out. We know clock or fills out a timesheet or makes make sure unions do not get a foothold that. a salary or earns tips, whether she is a in our economy and in our companies. In the 1990s, we built the economy contract worker or a temporary work- The Pope spoke about the labor from the middle out, with 22 million er, whether he works in a call center or group. He said it performs an ‘‘essen- private sector jobs during the Clinton in a bank or on a factory floor. tial role for the common good.’’ years. In the Bush years, they had two

VerDate Sep 11 2014 23:49 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00009 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.017 S02AUPT1 S4706 CONGRESSIONAL RECORD — SENATE August 2, 2017 huge tax cuts for the rich under the for American workers. We can start and like both of his grandfathers, Cor- Wall Street Journal theory that it today by rejecting this anti-worker poral Alexander was stationed at Fort would trickle down and everybody nominee. Lewis in Washington State. would be better. There was literally no I yield the floor. When he first arrived, his unit had net private sector job increase during (Disturbance in the Visitors’ Gal- just returned to Fort Lewis from a de- the Bush years. There were 22 million leries.) ployment. Matthew had to wait until private sector jobs in the Clinton years The PRESIDING OFFICER. Expres- the next deployment cycle to go over- and zero net growth in the Bush years. sion of approval or disapproval is not seas. He did not like that delay. As a That is because, during the Bush years, permitted in the Gallery. brave soldier, eager to defend his coun- they believed the economy was built Mr. BROWN. Madam President, I sug- try, Matthew wanted to be in the fight. from the top down. It is not large busi- gest the absence of a quorum. Several months later, Matthew’s unit nesses that drive the economy—it is The PRESIDING OFFICER. The deployed to Mosul, Iraq. They assisted the workers. That is how you grow the clerk will call the roll. with the training of the Iraqi militia. economy—from the middle class out. If The senior assistant legislative clerk From the beginning of Operation work is not valued, Americans cannot proceeded to call the roll. Iraqi Freedom, Mosul has been the cen- earn their way to better lives for their Mrs. FISCHER. Madam President, I ter of battle. The fighting escalated in families no matter how hard they ask unanimous consent that the order 2006 during the Sunni awakening. Dur- work. for the quorum call be rescinded. ing the training of Iraqi forces and That is what I think of when I hear The PRESIDING OFFICER. Without while conducting combat patrols, Pope Francis talk about the social na- objection, it is so ordered. troops in Mosul encountered enemy at- ture of our economy. Work has to sup- HONORING NEBRASKA’S SOLDIERS WHO LOST tacks on a daily basis. port families and communities. Today THEIR LIVES IN COMBAT Matthew returned home on leave in businesses seem to be more focused on Mrs. FISCHER. Madam President, I February of 2007, and he proposed to cutting costs than on investing in their rise to continue my tribute to Nebras- Kara. They were married 2 weeks later, workforces. Workers are often nothing ka’s heroes and the current generation on February 14, Valentine’s Day. Re- more than a line item in a budget, a of men and women who lost their lives garding their very short engagement, cost to be minimized. More businesses defending our freedom in Iraq and Af- Kara simply explained that Matthew use temp workers, more businesses use ghanistan. Each of these Nebraskans felt strongly about being married be- contractors—look at the airlines—and has a special story to tell. fore he returned to combat. more businesses use subcontractors. CORPORAL MATTHEW ALEXANDER When Matthew returned to Iraq, he They pay a lower wage. They provide Madam President, today, I recall the learned that his unit had moved to less job security. They roll back their life and the service of Army CPL Mat- Baqubah. The Battle of Baqubah began retirement benefits. They undercut thew Alexander, a native of Gretna, in March. The enemy used hit-and-run their health benefits, and they take NE. tactics to harass Allied forces that away legal protections. We have to Matthew was drawn to the military were trying to control the city. During change this. at a young age. His parents Mel and April and May, the fighting intensified, This spring, I laid out a plan to make Monica and brother Marshall described and casualties were high. Some likened work pay off by raising wages and ben- him as always eager to be part of a the fierce fight to the close quarters of efits, including retirement, giving team. He practiced martial arts, played the combat of Vietnam. workers more say and more power in the piano, and participated in band as It was in this heat of battle that CPL the workplace, encouraging companies a kid. As a member of the Gretna High Alexander showed heroism and leader- to invest in their greatest asset—the School band, Matthew helped to orga- ship when an IED hit a Bradley Fight- American worker. My plan to restore nize the uniforms and shoes before con- ing Vehicle on one of his missions. As the value of work has to include the certs to ensure that all of the band Matthew’s section rushed to the burn- labor movement. Modernizing labor members were ready to perform. He ing Bradley, the other vehicle com- law means recognizing the right of all helped his band mates play at their mander told him to block off the south- workers, even those in alternative best, and his caring and compassionate ern approach and prevent the enemy work arrangements, to collectively nature stood out among his classmates. from attacking up the road. While the bargain for higher pay and better Matthew and his wife Kara had been Bradley continued to burn and take wages. friends since childhood. Kara described machine gun fire, Matthew acted with- Pope Francis concluded: the teenage Matthew as somebody who out further instructions, and he saved There is no good society without a good could not sit still and who loved to lives. He set up his vehicle to prevent union, and there is no good union that is not learn. He took a keen interest in his- the attacking enemy forces from shoot- reborn every day in the peripheries that does tory and English classes in high school. ing accurate fire into those helping not transform the discarded stones of the He was also comfortable in talking with that rescue operation. For his economy into its cornerstones. with anyone and often referred to the valor, Matthew received the Army We are a country of discarded mothers of his friends as ‘‘Mom.’’ Kara Commendation Medal. stones—of people who rose from hum- recalled how Matthew always had a One of the members of Matthew’s ble beginnings and joined together to grin or a smile on his face. Matthew platoon, SSG Mark Grover, remem- build institutions that were greater also loved his church youth group, and bered Matthew feeling surprised to than any one of us. We need laws that he embraced his Lord and Savior, Jesus have been recommended for the honor. reflect that—that reflect the dignity of Christ. He said that he was just doing the right work and that reflect, as in the Pope’s Matthew always wanted to be a sol- thing to protect his fellow soldiers. words, the dignity of every discarded dier, and the 9/11 terrorist attacks fur- Days before a mission on Sunday, stone, of each and every American who ther solidified his desire to defend his May 6, Matthew called home to talk to works too many hours for too little country. He enlisted in the Army his mother Monica and to Kara. Trag- pay. shortly before graduating from Gretna ically, this was the last time he spoke The last thing we need for the Na- High School in May of 2004, and he to loved ones. While on the mission, an tional Labor Relations Board is an- shipped off to basic training that sum- improvised explosive device detonated other nominee who does not value mer. near his vehicle, killing him instantly. work, who demeans work, and who de- After he finished training, Matthew Corporal Alexander was laid to rest means the workers and the unions who attended the Advanced Individual on May 18, 2007, in a rural cemetery be- do it. Everyone in this town ought to Training to become an infantry soldier. tween Gretna and Elkhorn, NE. Hun- listen a little more to Pope Francis and This was the first step toward his dreds of Patriot Guard riders led the a little less to corporate lobbyists, a dream of joining the Army Special funeral procession and over 1,500 people little less to big banks, and a little less Forces. He was assigned to the 5th Bat- filled Gretna High School to say their to Wall Street. Maybe, then, we will talion, 20th Infantry Regiment, 3rd Bri- final goodbyes. Staff Sergeant Grover start to make hard work pay off again gade Division, 2nd Infantry Division, traveled to Gretna to represent the

VerDate Sep 11 2014 23:49 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00010 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.018 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4707 Third Platoon, nicknamed the ‘‘Glad- in Afghanistan, and they shared with It was Martin Luther King who saw iators,’’ at the service. Grover was me, in the military tradition, a medal. how challenging it was to progress to- riding in the armored vehicle just in Mr. President, I ask unanimous con- ward that vision, and he noted that front of the one carrying Matthew at sent to use a visual aid. ‘‘human progress is neither automatic the time of the explosion. He said that The PRESIDING OFFICER. Without nor inevitable. . . . Every step towards the entire company loved Matthew and objection, it is so ordered. the goal of justice requires sacrifice, that he was one of the best soldiers in Mr. MERKLEY. Mr. President, this suffering, and struggle; the tireless ex- the platoon. medal has a picture of their son. It ertions and passionate concern of dedi- To honor Matthew’s life, his family says: ‘‘In memory of SSG Bryan A. cated individuals.’’ And it is with that established Matt’s Music Memorial. Burgess, who lived from April 23, 1981, tireless exertion, that passionate con- The charity helps children interested through March 29, 2011.’’ On the back of cern, that dedication, that we have in music but who can’t afford an in- it, it has a picture of a memorial that made progress time and time again. strument, and they receive one from shows a pair of boots and a rifle and a But last week, we did not make the local community. As Matthew’s fa- hat and ‘‘never forget.’’ progress. Last week, we fell back from ther Mel put it, Matthew had two pas- The Tribute to Fallen Soldiers is this vision of opportunity, the freedom sions: music and the military. How- about never forgetting our fallen sol- to engage in our national life with the ever, you didn’t need money to join the diers. We put them into situations of respect and promise accorded to all military. enormous stress and challenge and dan- others. This step back came in the CPL Matthew Alexander is truly a ger, and they are there for all of us. In form of an attack by President Trump hero. He served with great compassion those particular situations, time and and Attorney General Sessions on our and respect. again, one of our soldiers loses their LGBTQ Americans. President Trump I join Nebraskans and Americans life. So may we never forget our sol- announced a ban on transgender Amer- across our country in saluting his will- diers who have died, our soldiers who icans serving in the military, and At- ingness and his family’s sacrifice to have been wounded, and may we con- torney General Sessions filed an ami- keep us free, and I am honored to tell tinue to reach out to Gold Star fami- cus brief in Zarda v. Altitude Express his story. lies to provide a community of support arguing that discrimination is com- Thank you, Madam President. to them. pletely legal under the law, including I yield the floor. I completely respect and appreciate the 1964 Civil Rights Act. The PRESIDING OFFICER. The ma- the Tribute to Fallen Soldiers’ motor- Well, let’s talk for a moment about jority leader. cycle brigade that rides across the our members of the military who have ORDER OF PROCEDURE country visiting with Gold Star fami- joined a Volunteer military, who have Mr. MCCONNELL. Madam President, lies, making sure they have that com- gone through significant training—and I ask unanimous consent that all munity of support and making sure I am not just referring to boot camp postcloture time on the Kaplan nomi- they know that the sacrifices of their but the ongoing training in specialty nation expire at 5 p.m. today; that if son or daughter are not forgotten. after specialty—so they can operate the nomination is confirmed, the mo- TRANSGENDER MILITARY BAN that radar effectively that provides tion to reconsider be considered made Mr. President, while focusing on the warning to an entire ship, or that com- and laid upon the table; that the Presi- military, I want to shift to another as- munication device to make sure that dent be immediately notified of the pect of military service, and I am going patrol is where it is supposed to be and Senate’s action, and the Senate then to start by thinking about the founda- able to follow instructions in the field, resume legislative session and be in a tion of our country, our ‘‘we the peo- or any of the hundreds of specialties period of morning business, with Sen- ple’’ Nation. ‘‘We the People’’ are the within the military that these individ- ators permitted to speak therein for up first three words of our Constitution, uals step forward and gain training on. to 10 minutes each. the mission statement of our Nation. Each one of them is significant to the The PRESIDING OFFICER. Is there We are not a nation that is founded of, overall success of the entire unit. Well, objection? by, and for the powerful, not a nation that is something President Trump Without objection, it is so ordered. founded to govern of, by, and for the didn’t understand last week when he Mr. MCCONNELL. I suggest the ab- privileged, but for the people. It was a attacked and said that he is going to sence of a quorum. very deliberate strategy of our Found- throw our transgender individuals out The PRESIDING OFFICER. The ers not to repeat the type of structure of the military. clerk will call the roll. in America that they saw in Europe, What is important isn’t whether you The senior assistant legislative clerk where government became beholden are gay or lesbian or transgender, it is proceeded to call the roll. and in servitude to simply the powerful whether you serve with your heart and Mr. MERKLEY. Mr. President, I ask class. soul and sinew the purpose of the secu- unanimous consent that the order for Throughout our history, we have rity of the United States, and those in- the quorum call be rescinded. strived to live up to this vision of a na- dividuals who do are respected within The PRESIDING OFFICER (Mr. tion where every individual has the op- their units. They contribute to those TILLIS). Without objection, it is so or- portunity to thrive. Time after time, units. The lives of each member depend dered. we have broken down barriers, we have on the success of the other team mem- TRIBUTE TO FALLEN SOLDIERS’ MOTORCYCLE overcome discrimination, and we have bers. They are a team. And to reach in, BRIGADE thrown open the doors of opportunity in a cavalier fashion, as the President Mr. MERKLEY. Mr. President, a few for one group after another—for did, and say ‘‘I am going to rip thou- moments ago, I had the opportunity to women, for Africa Americans, for in- sands of these team members out of meet with a group called the Tribute to digenous peoples, for immigrants, for their units’’ is wrong in so many ways. Fallen Soldiers. They have an annual the disabled. It is disrespectful, of course, of those cross-country motorcycle ride in honor Freedom, said President Lyndon individuals and their dedicated service of soldiers who died during combat. Baines Johnson, ‘‘is the right to be to our Nation. It is disrespectful and The motorcycle brigade escorts the treated, in every part of our national damaging to the units in which they Fallen Soldiers Memorial Flame from life, as a person equal in dignity and serve and provide those various skills Eugene, OR, all the way to Arlington promise to all others.’’ So we strive to which they have worked so hard to ac- National Cemetery. Along the way, reach that perspective, that point quire and which we have worked so they visit Gold Star families—families where our vision of the pursuit of hap- hard to make sure they have the who have a loved one who died on the piness embraces freedom as Lyndon chance to acquire. And it certainly battlefield in service to the United Baines Johnson described it—‘‘the damages the security of the United States of America. right to be treated, in every part of our States of America to eject individuals One couple who came today was national life, as a person equal in dig- with those talents and that training Terry Burgess and Elizabeth Burgess, nity and promise to all others.’’ It has from our military. Therefore, that whose son Bryan lost his life fighting not been easy. should be reversed.

VerDate Sep 11 2014 23:49 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00011 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.020 S02AUPT1 S4708 CONGRESSIONAL RECORD — SENATE August 2, 2017 By the way, it was done without con- RURAL BROADBAND populated and easily accessed areas, sultation with our military leaders. A Mr. BLUNT. Mr. President, August is and future customers. This is like the Commander in Chief proposing a policy Rural Broadband Month at the Federal same problem the country had 100 through a tweet without consulting Communications Commission. The years ago transitioning to telephones. with the experts who have dedicated Commerce Committee just today put It was hard to get a telephone to a their lives to the national security of forward nominees for the Commission, house that was 5 miles away from the our Nation—that in and of itself is a and the Commission does matter. But I nearest house, as opposed to a house real betrayal of responsibility. want to talk today specifically about that was in the same apartment build- Attorney General Sessions filed an highlighting the importance of ing to the nearest apartment. It is a lot amicus brief in Zarda v. Altitude Ex- broadband in rural America and rural harder to do that. The government at press, and this brief says that title VII Missouri. that time said that there would be a of the 1964 Civil Rights Act, which pro- In January of this year, I joined a universal service fee on phone bills, vides protection against discrimination number of my Senate colleagues on a and then use that money to ensure that based on race, color, religion, national bipartisan letter to President Trump everybody would have equal access to origin, and sex, does not provide pro- regarding the importance of broadband what was obviously seen as a really im- tection against discrimination in terms and expanding its access to all of the portant way to communicate. The con- of one’s LGBT status. By the way, that country and, particularly, the parts of cept of Universal Service was enshrined is the opposite of what court after our country that are not currently in the 1996 act. It said that rural house- court has ruled. served. holds should have the same access to What happened, one might ask, to As part of any infrastructure legisla- advanced telecommunications enjoyed the President Trump who, as Candidate tion that the Congress is talking by their urban counterparts. It is a Trump, said: ‘‘Thank you to the LGBT about, I think we and the administra- good goal for a lot of reasons. community!’’ As a candidate, he said: tion need to consider policies that ad- I saw some figures this week. When ‘‘I will fight for you.’’ What happened vance infrastructure not just solely in looking at the overdose deaths and the to the President who, after the attack terms of roads, bridges, and ports, opioid problems in the country, they on the Pulse nightclub in Orlando, said which are important, particularly are much greater in rural counties in a tweet: ‘‘Will fight for you.’’ This where the Presiding Officer and I live, than they are in urban centers. In our last week, the President did not fight in Arkansas and Missouri. That trans- State, Kansas City, our biggest city by for you in that community; instead, he portation network means so much to population and any of the five counties attacked that community, and he ap- us, but also important is how people that touched it weren’t anywhere close parently approved of Attorney General are able to communicate and compete. Sessions attacking that community. to the top list of other areas in our High speed internet access cannot be This is why we need the Equality State that had this problem. It matters overlooked as we consider what our in- Act. The Equality Act would clarify when you are not connected. It matters that when we say no discrimination on frastructure should look like going for- when opportunities that you otherwise the basis of sex, that is broadly apply- ward. would have simply aren’t there because Broadband can be delivered by wire- ing to one’s status of who they are or somehow a service that is essential to less or wireline technology. It can be whom they love. our society today isn’t available to you If we go back to President Johnson’s brought to customers by traditional in the same way it is available to oth- presentation of the issue in America, communications companies in rural ers. I am not saying it should be free to where he said every individual—the areas. Often, now, rural electric co-ops some and cost other people something, matter of freedom is that you have the show great interest and capacity to do but it should be available to you in the opportunity to be treated as having the this, as do others. Following the sig- same way that it is available to others same promise and be treated with the nificant steps that Congress took to de- in our society, as the 1996 Tele- same respect as everyone else, that it regulate the market as part of the 1996 communications Act stated. is all about being able to thrive in the Telecommunications Act, the Broadband is necessary to attract United States, or to put it quite sim- broadband industry has really re- and retain business for banks, fac- ply, not having a door slammed in your sponded. They invested a lot of money. tories, distribution centers, and small face when you go to rent an apartment, In fact, they invested $1.5 trillion of businesses. It is necessary to start and not having a door slammed in your face private money to deploy better and maintain a business, large or small. If when you go to a restaurant or a movie faster networks. If you have access to business is going to compete outside theater, not having a door slammed in one of those networks, you know what the local marketplace, there has to be your face when you seek to be part of a difference it makes. that connectivity. Frankly, in order to a jury. That is what freedom is in this In 2015 alone—that is the last number compete in the local marketplace and country. That is the freedom that At- I have access to—the investment by to have the ability to buy at the best torney General Sessions and President traditional wireline companies, wire- price and to get the kind of products Trump are seeking to rip away from a less companies, and cable providers was needed, the internet really matters. sizable share of Americans, and that is $76 billion. All of that is really good, Broadband is always there. We have simply wrong. That is why we need the except that there is a real divide be- to have it if we are going to compete in Equality Act—to make sure that this tween the rural areas of my State and the world economy. Many people in is remedied. That is why we need the the rural areas of the country and the rural America are able to do that in courts to stand up against discrimina- other more populated areas. ways that nobody would have dreamed tion on the basis of who you are and Some people say: Oh, that is just a about 10 years ago, but not everybody whom you love. myth; there is no digital divide. I has that same access. It has been a week in which the would have them look at any number Certainly, it is critical for schools President attacked and damaged our of articles. One article in the Wall and libraries. Just today, a parent was military and Attorney General Ses- Street Journal in June made the point telling me that students can’t do their sions attacked and betrayed and at- that 39 percent of the United States’ homework anymore unless they can tempted to steal freedom from a vast rural population lacks access to get internet access somewhere close to swath of Americans. That is a very sad broadband. That sounds like a pretty where they live. Students depend on week on both counts, and we in this big divide to me—that 39 percent of the the internet for education and oppor- Chamber should stand up and say: That entire rural population of the country tunity where we live today. is not OK. We will fight for the secu- doesn’t have broadband, and 61 percent A revolution has taken place in agri- rity of the United States of America, of rural Missourians lack access to culture. The great food-producing and we will fight for opportunity for broadband. These numbers are not ac- economy that we have produces more every single American. ceptable. food all the time. It actually produces Thank you, Mr. President. Most private investment has been di- more food with fewer people. So that The PRESIDING OFFICER (Mr. COT- rected, as you would assume it would creates some displaced people who oth- TON). The Senator from Missouri. be, toward high populations, highly erwise would have had those jobs, but

VerDate Sep 11 2014 23:49 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00012 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.021 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4709 it also uses wireless infrastructure, The President recently designated We are going to be working on this. data, and GPS structures to decide Ajit Pai to be the Chairman of the There will be legislation. There will be what should happen in a field at a FCC. We are finally seeing the Com- continuing efforts to urge the FCC to given time in that part of the field. mission take actions to address rural stay on point. We need to do what we There are data centers, autonomous broadband. In February, I wrote to the can to make communities in rural systems, and fiber optics that are a Chairman and urged him to act on the America productive and competitive part of agriculture today. If you are $2 billion available for rural broadband and as healthy as they can be. linked to broadband and you are in and open this money up to auction so By the way, there are a lot of stories your combine and have a problem, new entrants into the field, like elec- here to be told. I hope the next time I sometimes that problem can be solved tric co-ops, can competitively bid come to the floor on this topic that I in a couple of minutes by quickly ac- alongside everybody else. The FCC has will come to the floor with some things cessing your system, seeing where the decided to do that. that are happening in my State that problem is, resetting what you need to Tomorrow the Commission will con- would not have happened if there had set and moving on, as opposed to the sider a notice to initiate the pre-auc- not been the access to broadband in not other option, which is calling the re- tion process for this money to deploy very big communities that are sud- pair person, having the technologist fiber optics in parts of Missouri. This denly doing business all over the come out with their computer, hook it will complement other initiatives un- United States and all over the world. up to your combine, and 5 or 6 hours derway, as the FCC looks at how to ad- How we do that is by not letting any later, at a time when you are in the dress rural broadband. They have of our country wither away, where we critical moments of your annual liveli- launched a $4.5 billion auction for mo- have existing infrastructure and hood, suddenly you are working again, bile wireless service in rural areas. schools and sidewalks and water sys- when you could have been working 5 or They are suspending out-of-date rules tems and by being sure the people who 6 minutes later if you had been con- that forced small carriers to raise tele- want to live there can live there, just nected like many farmers are today. phone rates. They are launching a pro- like we are being sure now, as we see a Broadband is more than just eco- ceeding to reduce costs for companies revitalization of some of our down- nomic opportunity. Rural hospitals and upgrading from copper to fiber optic towns and inner cities. People will health clinics are able to use telemedi- networks—another FCC initiative. want to move back to them and will cine to bring services at a level that They are launching a broadband advi- have reasons and desires to want to do otherwise would not be available. This sory committee. These are all steps in that. We are seeing an upswing there. is particularly important in mental the right direction, where you and I I think we can see the same kind of and behavioral healthcare. A lot of peo- live. They will make a difference. thing happen in other parts of the ple are every bit as comfortable or I look forward to continuing to work country if we work to be sure we have more comfortable with telehealth than with the Chairman and others on the an equity of opportunity. One of the they are with somebody in the room Commission on this issue. I think rural major things that will provide that will with them. Also, with intensive care, broadband is particularly leveling in be having access to broadband that suddenly all of the resources that may creating the opportunities that we works. I hope we can continue to fight be available 100 miles away can be would like to see. The Commission will that fight and see the progress we have right there at the point where ques- now be back up to its five-member in- made just in the last 6 months. tions are asked and that information is tention of how many people are sup- I suggest the absence of a quorum. The PRESIDING OFFICER. The handled. Suddenly, somebody’s life is posed to be there, making those deci- clerk will call the roll. saved because of the capacity to have sions. There is still work to be done. We The bill clerk proceeded to call the that kind of communication. need to reduce the digital divide. roll. For years I have tried to lead when I Mr. PETERS. Mr. President, I ask could, and joined my colleagues when Connectivity is critical. We also need policies that support efficient network unanimous consent that the order for they were leading, with numerous let- the quorum call be rescinded. ters to the FCC urging it to reform the structures that allow people to not just connect to a network but to connect The PRESIDING OFFICER. Without Universal Service Program for the dig- objection, it is so ordered. ital era. Most people who don’t have a with a network that really works. Let me talk about one other Missouri GREAT LAKES ENVIRONMENTAL SENSITIVITY line to their phone have a way to get a issue that relates here. INDEX BILL phone in their hand now, but they I said earlier that Kansas City is now Mr. PETERS. Mr. President, as we don’t have a way to get this important our biggest city, our most populous head into the month of August, many way to communicate and to compete. city. Still, St. Louis, I think, by re- Americans are planning to spend time It is frustrating, when we see the lim- gion, is the bigger region, but the city along our beautiful coasts. Our country ited resources we have—the govern- of St. Louis is not as big as Kansas is fortunate to have such a wide vari- ment resources—to put into something City. In Kansas City, they have an ety of natural resources along the Gulf like this to see limited funds go to internet exchange called KCIX. It is a of Mexico, Alaska, Hawaii, and the east places where you are just creating an- peering center that offers tremendous and west coasts. However, I am partial other provider and more competition, benefits to secondary educational in- to America’s best coast: The 4,500 miles except that the second provider has stitutions, to high schools, to voca- of U.S. coastline along the Great government money on its side to com- tional programs, and to others so they Lakes. pete with the first provider that went really maximize how they commu- Our coastal resources make it pos- in with its own money. There is a big nicate with each other and have the sible to move cargo and goods around difference between unserved and any availability of resources in one place the world. They provide opportunities level of underserved. If you are much more equally available in others, for outdoor recreation like fishing and unserved, like 69 percent of rural Mis- and large amounts of bandwidth can be boating and trips to the beach. Our sourians, the idea that somebody else diverted by using this peering infra- coasts are not only beautiful, providing doesn’t have enough competition in the structure. some of the most scenic vistas and pic- place they live doesn’t seem to make Frankly, what is happening in Kan- turesque landscapes our country has to very much sense to you. If there is a sas City this fall is that the North Kan- offer; these ecosystems also provide competitive marketplace and some- sas City School District will establish many tangible benefits. They serve as body wants to go in there and compete connections to KCIX. It is estimated flooding buffers, critical habitats for and get the prices down, that is all that it may save the district almost fish and wildlife, and locations for fine, but I think the government focus $500,000 a year in bandwidth just by ports and other marine infrastructure. should be just like it was with tele- looking at peering. If peering helps In the Great Lakes, our freshwater phones 100 years ago—to see that peo- there, maybe peering is one of the coastline contains one-fifth of the en- ple had the opportunity to have that other things we can look at that will tire world’s fresh water and provides phone the same as their neighbors in help solve the rural broadband chal- drinking water for over 40 million peo- more densely populated areas. lenge as well. ple. We must be stewards of these areas

VerDate Sep 11 2014 23:49 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00013 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.023 S02AUPT1 S4710 CONGRESSIONAL RECORD — SENATE August 2, 2017 so that future generations can also Michigan haven’t been updated for over While we may often disagree with the benefit from them. In order to do so, 30 years. This bill gives the proper di- opinions of the nominees for the other we must properly document and keep rection and resources to make sure party’s seats—many of us have ensured track of this precious resource. these long overdue updates move for- they had an up or down vote. For ex- That is why I partnered with Senator ward. ample, since 2013, I have voted for clo- YOUNG to introduce the bipartisan Supporters of the bill so far include ture for two board members and the Great Lakes Environmental Sensi- the Great Lakes Charter Boat Associa- current general counsel who I then tivity Index Act of 2017 to require tion, the Coastal States Organization, voted against confirming. NOAA to update environmental sensi- the Great Lakes Commission, the Alli- Marvin Kaplan has been nominated tivity index maps and map products. ance for the Great Lakes, the National for a position that has sat vacant for 23 The bill passed unanimously out of the Wildlife Federation, the Great Lakes months since President Obama de- Commerce Committee this morning by Fishery Commission, and the group clined to nominate a Republican for a voice vote and now heads to the full For Love of Water. With nearly 3,300 the then-minority seat. My hope is Senate floor for consideration. miles of coastline in Michigan, the sec- that this nominee will help restore Environmental sensitive index—or ond-most coastline of any State in the some balance to the labor board. ESI—maps provide an inventory of our Nation, we need to update Great Lakes After years of playing the role of ad- valuable natural and human-use re- environmental sensitivity index prod- vocate, the Board should be restored to sources along our coasts. These maps ucts as soon as we can. the role of neutral umpire. Board par- chronicle sensitive ecosystems and the Modernizing these maps will provide tisanship didn’t start under President presence of various species as they mi- a better picture of what resources Obama, but it became worse under him. grate through regions and habitats for could be at risk in the event of a dis- When the Board is too partisan, it cre- threatened and endangered species. aster and will be an important tool to ates instability in our Nation’s work- They also document where we can ac- help us keep our Great Lakes safe and places and does not serve the intent of cess coastal resources from beaches clean for future generations. the law—which is stable labor relations and parks to docks, ferries, and boat I look forward to working with Sen- and free flow of commerce. ramps. ator YOUNG and the rest of my col- For example, under President Obama, We must maintain an up-to-date in- leagues in the Senate to move this bill the Board took three harmful actions, ventory of these precious coastal re- forward and make sure that we have including the joint employer decision— sources so that we know exactly where the tools we need to make the best de- which threatened to destroy the Amer- we need to focus our response efforts in cisions for the Great Lakes, no matter ican dream for owners of the Nation’s a worst-case scenario of a harmful oil the challenges and opportunities facing 780,000 franchise locations; the ambush or chemical spill. Accurate documenta- us. elections rule, which can force a union Thank you. tion of these resources and their vul- Mr. ALEXANDER. Mr. President, election before an employer and many nerabilities is critical to both deploy- today the Senate will vote on the con- employees have a chance to figure out ing the right response effort when a firmation of Marvin Kaplan to be a what is going on; and the micro-union spill or accident occurs and assessing member of the National Labor Rela- decision, which gave factions of em- the damage and restoration efforts tions Board, NLRB. I am glad that we ployees within single stores a path to needed after the fact. are moving this nomination because forming their own unions. In places like the Straits of Mack- the National Labor Relations Board Nominee Marvin Kaplan is currently inac, where a 64-year-old oil pipeline needs to function as intended. chief counsel for the Occupational sits at the bottom of the lake bed, it The board hasn’t been full in nearly 2 Safety and Health Review Commission, should be our top priority to have a years. I am certainly not the only one where he has served since August 2015. current inventory of what shoreline re- of us who thinks a full Board is impor- From 2009 to 2015, Kaplan worked as sources could be impacted by a pipeline tant. One Democratic senator said at a counsel for the House Education and leak. Models have shown that a pipe- hearing on May 16, 2013: ‘‘I strongly Workforce Committee and the House line spill in the Straits of Mackinac support a fully functioning NLRB with Oversight and Government Reform could likely result in oil reaching the five members. I think confirming the Committee. shores of Mackinac Island within entire slate will ensure that the NLRB Today some Senators have argued hours, which would be an absolute ca- is working for American workers and about Mr. Kaplan’s experience prac- tastrophe for Michigan’s top tourist at- American employers.’’ ticing law. I want to note that Mr. traction. Another said at the same hearing: Kaplan is in fact well-qualified under ESI maps don’t just help with oilspill ‘‘What we don’t need now—the last the National Labor Relations Act stat- response; they can also be used for thing we need here in Washington or ute. He is an experienced lawyer. He coastal development activities, and across the country—is more rancor, earned his law degree at Washington they even have significant research ap- more division, more ideology, at a time University in St. Louis and is a mem- plications. They provide a clear ref- we need this Board fully functioning. ber of the New York and New Jersey erence point prior to natural disasters We need five people to get confirmed State bars. The years he has spent con- or major storms that may damage, de- here. Any Senator who is standing in sidering cases and writing opinions at stroy, or significantly alter resources the way of getting five people con- the Occupational Safety and Health along our coasts. Decision makers at firmed and having a functioning Board Review Commission, OSHRC, are an ex- the local and State level may use them has a lot of explaining to do . . .’’ cellent preparation for the work of the for restoration efforts or to make in- Then-Chairman Harkin said in Sep- National Labor Relations Board, formed decisions about how to balance tember 2014: ‘‘Keeping the NLRB fully NLRB. I will also point out that there all of the various uses in that coastal staffed and able to do its work will have been a number of NLRB members zone. send a strong message to the American confirmed with limited experience rep- ESI maps need regular updates in people that yes, Washington can work, resenting clients in labor law matters. order for them to be truly effective. and our government can function.’’ Mr. Kaplan has an admirable record These updates are happening now for The National Labor Relations Board of public service spanning a decade. He other areas of the country. Stretches of has five members with 5-year, stag- could have taken a number of different the west coast, along the Gulf of Mex- gered terms, and a general counsel career paths, but he chose public serv- ico, and along the east coast have all with a 4-year term. There is no statu- ice, and that should be praised. There received updates over the last 5 years. tory requirement regarding party af- is bipartisan respect for Mr. Kaplan. One region is continually absent filiation, but the tradition has been for At a July 2015 business meeting of from these updates: my home region of the President to appoint members on a the House Education and the Work- the Great Lakes. In fact, the most re- 3–2 ratio favoring the administration, force Committee, Ranking Member cent updates for some of the Great with nominations for the two minority Bobby Scott said this of Mr. Kaplan: Lakes were completed over 20 years seats recommended by the Senate mi- ‘‘A lot is said about the working rela- ago, but Lake Erie and parts of Lake nority leader. tionships around here and how bad

VerDate Sep 11 2014 23:49 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00014 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.025 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4711 they are from time to time. Staff can America—is being dismantled by Nico- seen the ravages of government control contribute to that. I just would like to las Madura and his flailing Chavista re- of the economy. The Venezuelan people say that Mr. Kaplan has not been part gime. It is a human tragedy impacting are suffering, and when combined with of that; he’s been very cooperative even more than 30 million people who are dictatorship, it is a toxic mix. when you disagree. We have been able literally witnessing society collapse Maduro’s actions must not continue to work with my staff, have had good around them. unchallenged. I support the Treasury working relationships; a cooperative The numbers, sadly, speak for them- Department’s sanctions against senior relationships. I want to add my two selves. According to estimates from the Venezuelan officials, including Maduro, cents worth to your congratulations International Monetary Fund, Ven- placing him in the ignominious com- and God speed.’’ ezuela’s GDP contracted by almost 20 pany of Kim Jong Un and Robert Mr. Kaplan was nominated to be a percent last year, with inflation reach- Mugabe. We must keep the pressure on member of the NLRB on June 20, 2017. ing some 550 percent and unemploy- and continue to isolate and We held his hearing on July 13, and he ment spiking to more than 21 percent. delegitimize Maduro’s regime, for be- completed all paperwork in accordance The Pharmaceutical Federation of hind Maduro can be found China, with with the HELP Committee’s rules, Venezuela estimates that the country its billions in infrastructure invest- practices, and procedures. Our rules re- suffers from an 85-percent shortage of ments, and Russia, with its growing quire that their HELP paperwork be medicine and a 90-percent deficit of control over Venezuela’s energy sector, submitted 5 days before their hearing. medical supplies, including those need- and Iran, whose Hezbollah proxy laun- We received Mr. Kaplan’s HELP paper- ed to treat various types of cancer. ders money with Maduro’s acquies- work and his Office of Government Men and women, young and old, are cence. Ethics, OGE, paperwork on June 26, 17 going hungry. Thanks to Maduro’s de- Yet Maduro is not without opposi- days before his hearing. Mr. Kaplan struction of the Venezuelan currency, tion. Brave men and women in the tens also offered to meet with all HELP flour, cooking oil, and other basic com- of thousands have taken to the streets members. Mr. Kaplan met with 10 of modities have disappeared from store to demand a better future for them- them, including 5 Democrats. Fol- shelves. Students and teachers leave selves and their families. Many dozens lowing the hearing, Mr. Kaplan re- their classrooms for hours on end to have been killed by the regime’s secu- sponded to 53 questions for the record, stand in line, hoping to receive a loaf rity forces, and hundreds have been de- QFRs, or 81 if you include subques- of bread as a week’s meal. The most tained. These freedom-loving people tions, and those responses were pro- vulnerable are going on what are called represent the best of Venezuela and vided to Senators prior to the markup. Maduro diets—skipping meals and re- fearlessly follow in the footsteps of The HELP Committee favorably re- ducing their food consumption. generations of dissidents against So- ported out his nomination on July 19. And Maduro’s response? The would- cialist repression. Recent comparisons show that this be dictator is threatening to seize busi- Just yesterday, Maduro’s security process was far from rushed. In com- nesses that don’t produce enough and forces seized two prominent opposition parison, under Chairman Harkin, the has told Venezuelans that doing with- leaders—Leopoldo Lopez and Antonio HELP Committee held hearings and out makes them tougher. Thousands of Ledezma—for daring to criticize his re- markups on NLRB nominees with far Venezuelans have crossed borders in gime on social media. These two men less time for consideration. For former search of food and medicine, while were carted away in the middle of the Board member Kent Hirozawa’s seat, Maduro and his cronies spin conspir- night, leaving their loved ones trauma- which Mr. William Emanuel has been acies and rail against phantom enemies tized and frantic without information. nominated to fill, Mr. Hirozawa’s hear- on state media. The situation is so dire To Lilian and Mitzi, the wives of ing was held 7 days after his nomina- that the regime has begun ‘‘rewarding’’ these two extraordinary men, I want to tion, and his markup was held the next some of its most loyal supporters with say that you are two of the strongest day. Former Board member Nancy toilet paper. people I have ever been blessed to Schiffer’s hearing was held 7 days after Alongside the disintegration of Ven- meet. You inspire me. Your husbands’ her nomination. The HELP Committee ezuela’s economy is the specter of fight inspires me and millions of Amer- also held a markup on her nomination Maduro’s growing dictatorship. We icans and people across the globe. I the next day. Committee members have just witnessed the sham election urge you to continue to stand and fight were not able to get responses to any of a so-called constituent assembly, on behalf of your husbands and the QFRs from Kent Hirowzawa or Nancy which Maduro intends to use to try to many others who are held captive by Schiffer before being forced to vote on rewrite Venezuela’s Constitution, to the Chavista government. them. crush what is left of its free political I look forward to welcoming I look forward to voting for this institutions, and to consolidate his Leopoldo and Antonio back to freedom nominee. I hope the Senate will take grip on power. His electoral commis- up the nomination of William Eman- and, I hope, they will play leading roles sion lied about the turnout and uel, also for the NLRB, very soon, so leading a free Venezuela, a post- downplayed the number of government we have a full board. Maduro Venezuela. Mr. PETERS. I suggest the absence workers whom the regime pressured to Members of my own family have of a quorum. participate. While Maduro preached lived through this sort of oppression in The PRESIDING OFFICER. The dialogue on television, his security Cuba, where a lawless government can clerk will call the roll. forces were busy rounding up political raid your home without warning, arbi- The assistant bill clerk proceeded to opponents and murdering peaceful trarily detain your relatives and neigh- call the roll. demonstrators. bors, and ensure that you hardly, if Mr. CRUZ. Mr. President, I ask unan- This was not Maduro’s first power ever, see them again. imous consent that the order for the grab. Earlier this year, his handpicked To Lilian and Mitzi, I will continue quorum call be rescinded. supreme court temporarily dissolved to raise my voice and to call for ac- The PRESIDING OFFICER. Without Venezuela’s duly-elected National As- tion—real action—to help Leopoldo, objection, it is so ordered. sembly and stripped its members of im- Antonio, and every other Venezuelan VENEZUELA munity in what the head of Organiza- willing to stand and risk everything to Mr. CRUZ. Mr. President, I stand tion of American States called a ‘‘self- live in a free and prosperous and demo- here today to speak about the devasta- coup.’’ The regime backtracked only cratic country. It is well past time to tion befalling Venezuela—the people after ferocious pressure and condemna- consign Chavismo to the dustbin of his- raging in the streets against unfair tion. tory. elections, the dissidents being seized But this week’s actions make plain To the millions of Venezuelans wait- from their homes and detained by secu- Maduro’s intent to complete the proc- ing in lines for food, clothes, and medi- rity forces, and those starving without ess begun under his mentor, Hugo Cha- cine, struggling with galloping infla- food and water. vez, to transform Venezuela into a full tion, fearful of Maduro’s henchmen de- Venezuela—once one of the most socialistic dictatorship. We have seen taining their friends and families or richly resourced countries in Latin that socialism doesn’t work. We have gunning them down in the streets, and

VerDate Sep 11 2014 02:15 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00015 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.003 S02AUPT1 S4712 CONGRESSIONAL RECORD — SENATE August 2, 2017 thinking themselves helpless in the and attention deficit hyperactivity dis- cisive. If the EPA and this administra- face of their country’s decay, you are order, or ADHD, she suspected the pes- tion will not act to protect the public, not alone and should not be afraid. ticides she was exposed to. to protect children, then Congress America and our allies will help see A few years ago, European scientists must. you through this crisis and help you re- tested some of Isaac’s hair. He had I have studied the case for banning cover. Each new outrage from the traces of over 50 pesticides in his body, chlorpyrifos. There is no question it Maduro regime only makes our soli- and the highest concentration was needs to come off the market. In this darity with you grow. You are strong chlorpyrifos. It has long been known situation, I believe Congress must step and Maduro is weak. You are Ven- that exposure to chlorpyrifos can be in to protect children’s health. That is ezuela’s future, and Maduro is its past. deadly. After years of study, research- why I have introduced the Protect You will win, and Maduro will lose. ers in the United States and a number Children, Farmers, and Farmworkers Venezuela is not the private preserve of other countries now believe there is from Nerve Agent Pesticides Act—to of a ‘‘busdriver turned authoritarian a strong connection between do what the EPA Administrator Scott thug in a tracksuit,’’ but instead Ven- chlorpyrifos exposure and mental dis- Pruitt refuses to do: ban chlorpyrifos. ezuela is a proud and free nation with ability, ADHD, and memory deficit in Let’s look at the reasons for banning a glorious past and an even greater fu- children. They believe the chemical chlorpyrifos. There are three very good ture. damages children’s developing brains, ones. There are three reasons, I believe, Through its words and deeds, the even if they are exposed before birth. this bill is necessary. First, Adminis- Maduro regime has abandoned what lit- Latino children, whose parents are ex- trator Pruitt is wrong. The science is tle legitimacy it might have had. When posed to the pesticide, and grow up established that chlorpyrifos is a this regime expires, Venezuela will re- near fields treated with it, are at the threat to health in its current use. The store its place at the forefront of Latin greatest risk. EPA has studied and studied the tox- America and become a good friend and Scientists believe the pesticide poses icity of chlorpyrifos for over a decade. partner to America once again. a threat even to children exposed to it I have talked to the scientists who We stand with the Venezuelan people from produce from the grocery store or have been studying it for over 30 years. as your friend against this socialist op- through drinking water. The connec- pression, and we tell you that there are tion is so strong that scientists at the In a December 2014 risk assessment, brighter days ahead, brighter days of Environmental Protection Agency rec- the EPA found chlorpyrifos caused un- economic cooperation, of energy ommended that the EPA ban all uses of safe drinking water contamination. growth, of abundance of prosperity, of the pesticide in 2015. The agency had Based on that assessment, the EPA for- throwing off the shackles of totali- already negotiated a ban on household mally proposed, in November 2015, to tarianism. use 15 years ago. revoke the use of chlorpyrifos on food. Estamos contigo Venezuela, tus This March, the EPA Administrator As recently as December 2016, the EPA mejores dias estan por venir. Scott Pruitt ignored his own scientists reaffirmed its determination. Mr. President, I yield the floor. and the body of scientific evidence that The pesticide is intended to act on The PRESIDING OFFICER (Mr. chlorpyrifos is dangerous. Instead, he the nervous system of insects, but it TOOMEY). reversed course and refused to ban can act on the human nervous system The Senator from New Mexico. chlorpyrifos. That is why I rise to talk as well. It can cause immediate symp- PROTECT CHILDREN, FARMERS, AND FARM- about this danger to our children. toms like nausea, vomiting, convul- WORKERS FROM NERVE AGENT PESTICIDES ACT When moms and dads feed fruits and sions, respiratory paralysis—as Bonnie Mr. UDALL. Mr. President, this May, vegetables to their children, they are Wirtz and farmworkers in California a spray of pesticide from a nearby or- trying to do the right thing. They experienced. In extreme cases, it can chard drifted over to a field, exposing shouldn’t have to worry that these kill. nearly 50 farmworkers in California. foods are laced with dangerous nerve More worrisome, even low-level expo- They soon became sick with nausea agents. They shouldn’t have to worry sure of chlorpyrifos to developing and vomiting. Several were hospital- that the farmworkers who picked that fetuses in young children can interrupt ized. The workers described it as a liv- produce or the farmers living near it the development processes of the nerv- ing nightmare. were exposed. ous system. Exposure during gestation The chemical they were exposed to is I have been part of the fight to pro- or childhood is linked with lower birth called chlorpyrifos, a neurotoxic pes- tect public health and the environment weight, slower motor development, and ticide related to sarin gas. It has been from toxic chemicals most of my life. I attention problems. in use since it was developed by Dow remember when Rachel Carson pub- Long-lasting effects on child brain Chemical over 50 years ago. Today, it is lished ‘‘Silent Spring’’ in 1962. My fa- development from in utero exposure most often used on fruits and nuts, in- ther, Stewart Udall, was her champion also include impaired perceptual rea- cluding strawberries, citrus, apples, when she was fiercely attacked by the soning and working memory and un- and pecans from my home State of New chemical industry. dermined intellectual development by Mexico. It is also used on grains and Just over a year ago, I led the bipar- age 7. Exposure to organophosphate vegetables like broccoli and cauli- tisan effort to reform the broken Toxic pesticides like chlorpyrifos is associ- flower. Substances Control Act. I spent several ated with changes in children’s cog- A few years ago, Bonnie Wirtz also years working to reform how the EPA nitive, behavioral, and motor perform- experienced the effects of chlorpyrifos. regulates chemicals, fighting to stand ance. In plain English, chlorpyrifos Bonnie is a farmer in Minnesota. She up a credible program that could be re- damages children’s brains. was exposed when spray drift came into spected, that could restore confidence her home through the air-conditioner. in the EPA on chemical safety. Second, chlorpyrifos was one of the Her heart started racing, almost to the I am very disappointed to have to do most widely used household insecti- point of cardiac arrest, and she this, to introduce a bill on a related cides until the EPA raised concerns in couldn’t breathe. At the hospital, her matter, pesticide regulation. Normally, 2000—17 years ago. Household use was nurse practitioner told her she wasn’t I would argue that Congress should phased out. That same year, the EPA surprised. She had seen others with stay out of the business of regulating discontinued use of chlorpyrifos on to- similar reactions. individual chemicals. That is why the matoes altogether and restricted its About 10 years ago, Claudia Angulo— EPA was created, to make thoughtful, uses on apples and grapes. Currently, a farmworker in California’s San Joa- science-based decisions on issues that chlorpyrifos is still widely used in agri- quin Valley—was exposed to affect public health and the economy. culture, but its use is on the decline. chlorpyrifos when she was pregnant. In his first decision at the EPA, the In 2012, EPA required no-spray buff- Claudia worked sorting oranges, ap- administrator has shown his hand. He ers around schools, homes, play fields, ples, broccoli, and other produce treat- did not respect the science, not even daycare centers, hospitals, and other ed with the chemical. When her son his own scientific team, and not even public places. Growers are already Isaac was born with a mental disability when the science is overwhelmingly de- working to find alternatives.

VerDate Sep 11 2014 02:15 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00016 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.028 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4713 The third reason is, scientists, doc- the world, but we can follow the money This bipartisan measure now goes to tors, advocates, I, and many of our col- and guess one reason. While the Presi- the President. It provides a significant leagues were shocked when Adminis- dent and the Administrator ignore step toward securing benefits veterans trator Pruitt changed course on science and the law, they have not ig- have earned. Once these reforms are chlorpyrifos in March, choosing to wait nored Dow Chemical Company. Dow fully funded—and they should be—our until 2022—5 years from now. gave the President $1 million for his in- Nation’s veterans will no longer be The American Academy of Pediatrics auguration. Its CEO attended the sign- bogged down by a cumbersome, time- wrote a letter to Administrator Pruitt ing ceremony when the President consuming, irksome, and, in fact, ag- in June telling him that ‘‘EPA has no issued his Executive order requiring gravating process that denies them fair new evidence indicating that agencies to roll back what he called and full consideration when they ap- chlorpyrifos exposures are safe.’’ As a unnecessary regulations. The CEO even peal their claim’s denial. This reform result, EPA has no basis to allow con- got the signing pen. And the CEO met will begin—it is only a beginning—a tinued use of chlorpyrifos, and its in- with Administrator Pruitt shortly be- better system involving transparency sistence on doing so puts all children fore the order not to ban one of Dow’s and communication for veterans and at risk. big moneymakers. their families. The science hasn’t changed since the Administrator Pruitt may choose to As ranking member of the Senate EPA proposed to ban chlorpyrifos in put aside science, public health, and Veterans’ Affairs Committee, I heard 2015 and in 2016. Only the politics have. environmental protection in favor of testimony that the Department of Vet- The law should protect Americans big chemical profits, but Congress erans Affairs’ appeals process des- from unsafe pesticides. Under the Food should not. I urge all of my colleagues, perately needs updating and reform. Quality Protection Act, the EPA Ad- especially those across the aisle, to We all in this body have heard from our ministrator ‘‘may establish or leave in stand with me and pass this protection constituents again and again and again effect a tolerance for a pesticide chem- for children, families, farmers, and about the antiquated delay and burden- ical residue in or on food only if the farmworkers. some process that exists today. The av- Administrator determines that the tol- I thank my cosponsors and the co- erage wait time on an appeal today is erance is safe.’’ sponsors who are coming aboard every 5 years. Let me repeat that. The aver- ‘‘’Safe’ means . . . that there is a rea- day: Senators BLUMENTHAL, BOOKER, age wait time on an appeal is 5 years. sonable certainty that no harm will DURBIN, GILLIBRAND, HARRIS, MARKEY, Nearly half a million veterans are [come] from aggregate exposure.’’ MERKLEY, and CARDIN. caught in a quagmire—often a quick- If the Administrator can’t determine There have been many public health sand—of repeated consideration, unable that a pesticide is safe, the Adminis- and labor groups that have stood up on to claim benefits because of the VA’s trator must revoke or modify the toler- this issue—just to name some of them existing backlog. ance. today: National Hispanic Medical Asso- Between fiscal year 2015 and fiscal In the case of chlorpyrifos, Adminis- ciation, Learning Disabilities Associa- year 2017, the number of pending ap- trator Pruitt did not determine the tion of America, Farmworker Justice, peals increased from about 380,000 to pesticide is safe with reasonable cer- Project TENDR, United Farm Workers, 470,000. That is an increase of more tainty, nor could he. Instead, he hid be- Earthjustice, GreenLatinos, Labor than 20 percent. The increase in those hind his claim that the issue requires Council for Latin American Advance- appeals was the ‘‘bad news’’ side of im- years more study. ment, LULAC, National Resources De- provements in the process to consider This issue has been the subject of fense Council, Environmental Working the initial appeal. There were more ap- litigation for many years. When the Group, Pesticide Action Network, peals because more claims were dis- EPA asked the Federal court over- Pineros y Campesinos Unidos del posed of, but that is no excuse for that seeing the lawsuit for a mere 6-month Noroeste, Mana, and others. kind of delay in appeals. extension for more study, the court The pesticide registration informa- We worked with the VA and veterans gave a resounding no. It called the re- tion act is currently moving through groups to devise a new appeals system quest ‘‘another variation on the theme Congress. This gives Congress the op- that allows veterans to choose an op- of ‘partial reports, missed deadlines, portunity to address chlorpyrifos use tion that is right for them. The bill and vague promises of future action’ and worker protection. This bill is a that passed yesterday will create three that has been repeated for the last nine good start for those discussions. separate paths. They can choose among years.’’ I yield the floor. them for veterans seeking redress from The EPA Administrator has now The PRESIDING OFFICER (Mr. a decision by the Veterans Benefits Ad- given himself a 5-year extension. He is GARDNER). The Senator from Con- ministration. This reform is vitally im- failing to follow the Food Quality Pro- necticut. portant because it gives Secretary tection Act, and he is tying up the Fed- VETERANS LEGISLATION Shulkin the authority to test the new eral Government in more unnecessary Mr. BLUMENTHAL. Mr. President, system before its full implementation. and wasteful taxpayer-funded litiga- sometimes bipartisanship and comity I know it will take time to imple- tion. In the meantime, children, farm- do work. They have in the last 24 and ment these changes. It should take less ers, and farmworkers are at risk be- 48 hours on two measures that are time than is predicted because the Vet- cause the Administrator refuses to fol- critically important to help our Na- erans Administration owes it to our he- low the law. tion’s veterans have access to benefits roes—the men and women who have It doesn’t stop there. Administrator and healthcare that they vitally need, served and sacrificed for our Nation. Pruitt wants to dismantle protections that they deserve, and that they have My constituent caseworkers in Hart- for farmworkers. The EPA is proposing earned. Those measures relate to ap- ford have tried to assist many indi- to delay two rules vital to protecting peals reform and to the Choice Pro- vidual veterans with their claims, and our Nation’s farmworkers: The agricul- gram. these efforts must continue around the tural worker protection standard and Last night the Senate passed by country in all of our offices even as the certificate of pesticide applicators unanimous consent—which means these new reforms are implemented. rule. Farmworkers have one of the without any objection—H.R. 2288, the The second area where we joined to- highest rates of chemical exposure Veterans Appeals Improvement and gether in a bipartisan way relates to among U.S. workers. They are regu- Modernization Act of 2017. the Choice Program. We have agreed to larly exposed to pesticides. Despite the I am proud to have worked on this continue funding by providing $2.1 bil- urgent need to protect them and their measure with the chairman of the VA lion and authorizing 28 new leases for families, they actually are less pro- Committee, Senator ISAKSON, when I medical facilities across the country to tected than other workers. was the ranking member of that com- improve access to the high-quality care We don’t know exactly why Adminis- mittee during the last session. I thank provided at VA hospitals. Make no mis- trator Pruitt is choosing to believe a him for his leadership, his vision, and take, this action is a down payment, chemical company over respected sci- his commitment to this very important not the final word. I am going to con- entists at his own Agency and around cause. tinue to champion further reforms to

VerDate Sep 11 2014 02:15 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00017 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.029 S02AUPT1 S4714 CONGRESSIONAL RECORD — SENATE August 2, 2017 make sure we improve VA healthcare non-VA providers and the VA facilities He shares his passion for agriculture and enhance access to VA medical fa- and providers who care for our veterans throughout the State, country, and the cilities. directly. That information sharing is world as a representative of Riceland I am particularly concerned by re- not a luxury or convenience; it is a ne- on numerous boards and trade associa- cent findings made by the VA inspector cessity. tions, including the USA Rice Federa- general, Michael Missal, about a trou- We must help veterans of every era tion and the National Council of Farm- bling lack of health information shar- with their need for prompt appeals dis- er Cooperatives. In addition, Bill serves ing between VA and non-VA providers positions and effective healthcare that as chairman of the Associated Indus- relating to chronic pain treatment. To also protects them from opioid addic- tries of Arkansas, vice president for ag- put it very simply and bluntly, the tion. I am hopeful the Senate will riculture of the Arkansas State Coun- lack of information sharing makes quickly pass the Harry Walker cil on Economic Education, and vice opioid addiction far more likely than it Colmery Veterans Educational Assist- chairman of the board of visitors of should be, especially among veterans ance Act, which has been unanimously Phillips Community College of the Uni- who seek care from private providers approved by the House, to make com- versity of Arkansas. through the Choice system. prehensive improvements to the GI He is a faithful servant of Jesus Connecticut was one of the first bill. I helped to draft this measure and Christ and is leading his life as Christ States in the country to have a state- lead it, and I am proud the House has calls us to do. In recent years, Bill wide prescription drug monitoring pro- approved it. began seminary school, and his retire- gram. I urged Secretary Shulkin at a We must also help veterans of all ment from Riceland will allow him to hearing last year to make sure the VA eras suffering from toxic exposure and pursue the ministry full time and help prescription drug monitoring program make sure we award a Congressional people in need. exchanges information with the State Gold Medal to the American Legion I appreciate Bill’s friendship, and I system, which has data from private and make USERRA protections for our am confident that he will excel in this providers. The sharing of information servicemembers meaningful and en- role, just as he had done as an advocate is vital to prevent doctor shopping and forceable. These steps are part of an for Arkansas rice. I wish him well in excessive prescriptions. Without it, unfinished agenda that we owe our vet- all of his future endeavors and look for- veterans potentially are susceptible to erans. We cannot shirk that duty. We ward to the great work he will con- weaknesses and gaps that enable them cannot postpone it. It is an obligation, tinue to do in helping the great State to seek excessive prescriptions of not a convenience. of Arkansas. opioid pain killer treatment that can I look forward to moving forward I yield the floor. lead to addiction and worse. with these efforts, as we have done I suggest the absence of a quorum. We cannot allow the Veterans Choice with Choice and with the appeals re- The PRESIDING OFFICER. The Program to exacerbate opioid addic- form, and to learning what we know al- clerk will call the roll. tion. We must do everything we can to ready—that we can work together The assistant bill clerk proceeded to stop the opioid epidemic that is rav- across the aisle when it comes to keep- call the roll. aging our communities. As Senator ing faith with our veterans and making Mr. MCCONNELL. Mr. President, I MANCHIN of West Virginia and other sure that no veteran of any era is left ask unanimous consent that the order colleagues have made clear, the VA behind. for the quorum call be rescinded. must close the information gap on I yield the floor. The PRESIDING OFFICER. Without opioid prescriptions through improved The PRESIDING OFFICER. The Sen- objection, it is so ordered. opioid safety initiative guidelines and ator from Arkansas. f enhanced prescription drug monitoring TRIBUTE TO BILL REED LEGISLATIVE SESSION programs. While we work in Congress Mr. BOOZMAN. Mr. President, I rise Mr. MCCONNELL. Mr. President, I today to recognize Bill Reed, an Arkan- to reform the Choice Program, I call on ask unanimous consent that the Sen- san who is retiring after more than 34 the VA to immediately take certain ate proceed to legislative session and years of dedicated service at Riceland commonsense steps, none of them that following my remarks the Senate Foods, the world’s largest miller and novel or original. They have been iden- resume executive session as under the tified by the inspector general: marketer of rice. Bill is a member of the company’s previous order. First, require all participating VA The PRESIDING OFFICER. Without senior management team whose re- Purchased Care providers to receive objection, it is so ordered. and review evidence-based guidelines sponsibilities include government af- for prescribing opioids. fairs, public relations, and the Riceland f Second, implement a process to en- Sustainability Initiative. His interest AFG AND SAFER PROGRAM sure all Purchased Care consults for in agriculture at a young age led him REAUTHORIZATION ACT OF 2017 non-VA care include a complete, up-to- to pursue degrees in this field. Bill Mr. MCCONNELL. Mr. President, I date list of medications and medical earned a bachelor’s degree with honors ask unanimous consent that the Sen- history. in plant and soil science from the Uni- ate proceed to the immediate consider- Third, require non-VA providers to versity of Tennessee and a master’s de- ation of Calendar No. 168, S. 829. submit opioid prescriptions directly to gree in agricultural journalism from The PRESIDING OFFICER. The a VA pharmacy for dispensing and re- the University of Wisconsin. clerk will report the bill by title. cording in the patient’s VA electronic In 1976, he moved to the Natural The senior assistant legislative clerk health record. State to work as a State specialist read as follows: Fourth, ensure that if facility leaders with the University of Arkansas Coop- A bill (S. 829) to reauthorize the Assistance determine that a non-VA provider’s erative Extension Service. He has con- to Firefighters Grants program, the Fire opioid prescribing practices conflict tinued his commitment not only to Ar- Prevention and Safety Grants program, and with the guidelines, immediate action kansas but to Arkansas agriculture for the Staffing for Adequate Fire and Emer- is taken to ensure the safety of all vet- more than 40 years. gency Response grant program, and for other erans receiving care from that non-VA Bill is recognized as one of the most purposes. provider. passionate advocates on behalf of the There being no objection, the Senate These are basic protections for our Arkansas rice industry. Bill is con- proceeded to consider the bill, which veterans. They are protections against stantly looking out for the rice farmers had been reported from the Committee overprescribing opioids or negligent and businesses by promoting policies to on Homeland Security and Govern- misconduct—and worse—on the part of grow the industry and pushing for ex- mental Affairs, with an amendment to non-VA providers and others. panding markets. His advocacy ex- strike all after the enacting clause and My hope is that we are beginning on tended beyond the boundaries of agri- insert in lieu thereof the following: a path to better information sharing culture. He was always ready to lend a SECTION 1. SHORT TITLE. between those prescription drug moni- hand to me or to my staff on any issue This Act may be cited as the ‘‘AFG and toring programs at the State level for important to Arkansas. SAFER Program Reauthorization Act of 2017’’.

VerDate Sep 11 2014 03:41 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00018 Fmt 0637 Sfmt 6333 E:\CR\FM\G02AU6.040 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4715 SEC. 2. REAUTHORIZATION OF ASSISTANCE TO ministrator of the Federal Emergency Manage- geting seniors and to assist the Commission FIREFIGHTERS GRANTS PROGRAM ment Agency, acting through the Administrator with the following: AND THE FIRE PREVENTION AND of the United States Fire Administration, shall (1) OVERSIGHT.—The advisory office shall SAFETY GRANTS PROGRAM. develop and implement a grant monitoring and monitor the market for mail, television, (a) REPEAL OF SUNSET.—Section 33 of the Fed- eral Fire Prevention and Control Act of 1974 (15 oversight framework to mitigate and minimize Internet, telemarketing, and recorded mes- U.S.C. 2229) is amended by striking subsection risks of fraud, waste, abuse, and mismanage- sage telephone call (hereinafter referred to (r). ment relating to the grants programs under sec- as ‘‘robocall’’) fraud targeting seniors and (b) AUTHORIZATION OF APPROPRIATIONS.— tions 33 and 34 of the Federal Fire Prevention shall coordinate with other relevant agencies Subsection (q)(1)(B) of such section is amended and Control Act of 1974 (15 U.S.C. 2229 and regarding the requirements of this section. by striking ‘‘2017’’ and inserting ‘‘2023’’. 2229a). (2) CONSUMER EDUCATION.—The Commission (c) AUTHORIZATION FOR CERTAIN TRAINING (b) ELEMENTS.—The framework required by through the advisory office shall, in con- UNDER ASSISTANCE TO FIREFIGHTERS GRANTS subsection (a) shall include the following: sultation with the Attorney General, the PROGRAM.—Subsection (c)(3) of such section is (1) Developing standardized guidance and Secretary of Health and Human Services, the amended by adding at the end the following: training for all participants in the grant pro- Postmaster General, the Chief Postal Inspec- ‘‘(N) To provide specialized training to fire- grams described in subsection (a). tor for the United States Postal Inspection fighters, paramedics, emergency medical service (2) Conduct of regular risk assessments. Service, and other relevant agencies— workers, and other first responders to recognize (3) Conducting desk reviews and site visits. (A) disseminate to seniors and families and (4) Enforcement actions to recoup potential individuals who have mental illness and how to caregivers of seniors general information on properly intervene with individuals with mental questionable costs of grant recipients. (5) Such other oversight and monitoring tools mail, television, Internet, telemarketing, illness, including strategies for verbal de-esca- and robocall fraud targeting seniors, includ- lation of crisis.’’. as the Administrator of the Federal Emergency Management Agency considers necessary to ing descriptions of the most common fraud SEC. 3. REAUTHORIZATION OF STAFFING FOR schemes; ADEQUATE FIRE AND EMERGENCY mitigate and minimize fraud, waste, abuse, and RESPONSE GRANT PROGRAM. mismanagement relating to the grant programs (B) disseminate to seniors and families and (a) REPEAL OF SUNSET.—Section 34 of the Fed- described in subsection (a). caregivers of seniors information on report- eral Fire Prevention and Control Act of 1974 (15 ing complaints of fraud targeting seniors ei- Mr. MCCONNELL. Mr. President, I ther to the national toll-free telephone num- U.S.C. 2229a) is amended by striking subsection ask unanimous consent that the com- (k). ber established by the Commission for re- (b) AUTHORIZATION OF APPROPRIATIONS.— mittee-reported substitute amendment porting such complaints, or to the Consumer Subsection (j)(1)(I) of such section is amended, be considered and agreed to, the bill, as Sentinel Network, operated by the Commis- in the matter before clause (i), by striking amended, be considered read a third sion, where such complaints will become im- ‘‘2017’’ and inserting ‘‘2023’’. time and passed, and the motion to re- mediately available to appropriate law en- (c) MODIFICATION OF APPLICATION REQUIRE- consider be considered made and laid forcement agencies, including the Federal MENTS.—Subsection (b)(3)(B) of such section is Bureau of Investigation and the attorneys amended by striking ‘‘of subsection (a)(1)(B)(ii) upon the table. The PRESIDING OFFICER. Without general of the States; and (F)’’ and inserting ‘‘of subsection (C) in response to a specific request about (a)(1)(F)’’. objection, it is so ordered. a particular entity or individual, provide (d) MODIFICATION OF LIMITATION.—Subsection The committee-reported amendment publically available information of enforce- (c)(2) of such section is amended by striking in the nature of a substitute was ment action taken by the Commission for ‘‘prior to November 24, 2003’’ and inserting agreed to. mail, television, Internet, telemarketing, ‘‘prior to the date of the application for the The bill (S. 829), as amended, was or- and robocall fraud against such entity; and grant’’. dered to be engrossed for a third read- (D) maintain a website to serve as a re- (e) MODIFICATION OF WAIVER AUTHORITY.— source for information for seniors and fami- Subsection (d)(1)(B) of such section is amended ing, was read the third time, and lies and caregivers of seniors regarding mail, by striking ‘‘subsection (a)(1)(E) or subsection passed. television, Internet, telemarketing, robocall, (c)(2)’’ and inserting ‘‘subsection (a)(1)(E), f and other identified fraud targeting seniors. (c)(2), or (c)(4)’’. SENIORS FRAUD PREVENTION ACT (3) COMPLAINTS.—The Commission through (f) REPEAL OF AUTHORITY FOR CERTAIN USE OF 2017 OF GRANT AMOUNTS TRANSFERRED TO ASSIST- the advisory office shall, in consultation ANCE TO FIREFIGHTERS GRANTS PROGRAM.—Sub- Mr. MCCONNELL. Mr. President, I with the Attorney General, establish proce- section (a)(1)(B) of such section is amended by ask unanimous consent that the Sen- dures to— striking ‘‘and to provide’’ and all that follows ate proceed to the immediate consider- (A) log and acknowledge the receipt of through ‘‘of crises’’. ation of Calendar No. 191, S. 81. complaints by individuals who believe they (g) EXPANSION OF STAFFING FOR ADEQUATE The PRESIDING OFFICER. The have been a victim of mail, television, Inter- FIRE AND EMERGENCY RESPONSE GRANT PRO- net, telemarketing, and robocall fraud in the clerk will report the bill by title. GRAM.—Subsection (a)(1)(B) of such section, as Consumer Sentinel Network, and shall make amended by subsection (f), is further amended The senior assistant legislative clerk those complaints immediately available to by inserting ‘‘or to change the status of part- read as follows: Federal, State, and local law enforcement time or paid-on-call (as defined in section 33(a)) A bill (S. 81) to establish an advisory office authorities; and firefighters to full-time firefighters’’ after ‘‘fire- within the Bureau of Consumer Protection of (B) provide to individuals described in sub- fighters’’. the Federal Trade Commission to prevent paragraph (A), and to any other persons, spe- SEC. 4. TRAINING ON ADMINISTRATION OF FIRE fraud targeting seniors, and for other pur- cific and general information on mail, tele- GRANT PROGRAMS. poses. vision, Internet, telemarketing, and robocall (a) IN GENERAL.—The Administrator of the There being no objection, the Senate fraud, including descriptions of the most Federal Emergency Management Agency, acting proceeded to consider the bill. common schemes using such methods of through the Administrator of the United States Mr. MCCONNELL. I ask unanimous communication. Fire Administration, may develop and make consent that the bill be considered read (b) COMMENCEMENT.—The Commission shall widely available an electronic, online training commence carrying out the requirements of course for members of the fire and emergency re- a third time and passed and the motion this section not later than one year after the sponse community on matters relating to the ad- to reconsider be considered made and date of the enactment of this Act. ministration of grants under sections 33 and 34 laid upon the table. of the Federal Fire Prevention and Control Act The PRESIDING OFFICER. Without f of 1974 (15 U.S.C. 2229 and 2229a). objection, it is so ordered. (b) REQUIREMENTS.—The Administrator of the The bill (S. 81) was ordered to be en- RESOLUTIONS DISCHARGED Federal Emergency Management Agency shall grossed for a third reading, was read Mr. MCCONNELL. Mr. President, I ensure that any training developed and made ask unanimous consent that applicable available under subsection (a) is— the third time, and passed, as follows: (1) tailored to the financial and time con- S. 81 committees be discharged and the Sen- straints of members of the fire and emergency Be it enacted by the Senate and House of Rep- ate proceed to the immediate consider- response community; and resentatives of the United States of America in ation of the following resolutions en (2) accessible to all individuals in the career, Congress assembled, bloc: S. Res. 199, S. Res. 225, S. Res. 227, combination, paid-on-call, and volunteer fire SECTION 1. SHORT TITLE. and S. Res. 238. and emergency response community. This Act may be cited as the ‘‘Seniors The PRESIDING OFFICER. Without SEC. 5. FRAMEWORK FOR OVERSIGHT AND MONI- Fraud Prevention Act of 2017’’. TORING OF THE ASSISTANCE TO objection, it is so ordered. SEC. 2. OFFICE FOR THE PREVENTION OF FRAUD FIREFIGHTERS GRANTS PROGRAM, There being no objection, the Senate TARGETING SENIORS. THE FIRE PREVENTION AND SAFETY proceeded to consider the resolutions (a) ESTABLISHMENT OF ADVISORY OFFICE.— GRANTS PROGRAM, AND THE STAFF- en bloc. ING FOR ADEQUATE FIRE AND EMER- The Federal Trade Commission shall estab- GENCY RESPONSE GRANT PROGRAM. lish an office within the Bureau of Consumer Mr. MCCONNELL. Mr. President, I (a) FRAMEWORK.—Not later than 90 days after Protection for the purpose of advising the ask unanimous consent that the reso- the date of the enactment of this Act, the Ad- Commission on the prevention of fraud tar- lutions be agreed to, the preambles be

VerDate Sep 11 2014 03:44 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00019 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.026 S02AUPT1 S4716 CONGRESSIONAL RECORD — SENATE August 2, 2017 agreed to, and the motions to recon- tutional accountability that taxpayers Mr. MCCONNELL. I ask unanimous sider be considered made and laid upon deserve. consent that the Daines-Tester sub- the table, all en bloc. I am particularly concerned that the stitute amendment at the desk be con- The PRESIDING OFFICER. Without Forever GI Bill does not address the 90/ sidered and agreed to, the bill, as objection, it is so ordered. 10 loophole which incentivizes for-prof- amended, be read a third time and The resolution (S. Res. 199) was it colleges to aggressively recruit and passed, and the motion to reconsider be agreed to. prey on veterans. Under current law, considered made and laid upon the The preamble was agreed to. for-profit colleges are prohibited from table. (The resolution, with its preamble, is receiving more than 90 percent of their The PRESIDING OFFICER. Is there printed in the RECORD of June 22, 2017, revenue from Federal taxpayers, but objection? under ‘‘Submitted Resolutions.’’) due to a loophole in the law, such rev- The resolution (S. Res. 225) was enue does not count Department of Without objection, it is so ordered. agreed to. Veterans Affairs GI bill or Department The amendment (No. 749) in the na- The preamble was agreed to. of Defense Tuition Assistance funding. ture of a substitute was agreed to as (The resolution, with its preamble, is This means that, by targeting veterans follows: and servicemembers, for-profit colleges printed in the RECORD of July 20, 2017, (Purpose: In the nature of a substitute) under ‘‘Submitted Resolutions.’’) can actually receive 100 percent of The resolution (S. Res. 227) was their revenue directly from Federal Strike all after the enacting clause and in- agreed to. taxpayers. sert the following: The preamble was agreed to. And many do. According to data re- SECTION 1. REDESIGNATION OF CERTAIN DE- (The resolution, with its preamble, is leased by the Department of Education PARTMENT OF VETERANS AFFAIRS CLINICS IN MONTANA. printed in the RECORD of July 20, 2017, in 2016, 193 institutions received more under ‘‘Submitted Resolutions.’’) than 90 percent of their revenue from (a) DAVID J. THATCHER VA CLINIC.— The resolution (S. Res. 238) was Federal taxpayers when Department of (1) DESIGNATION.—The clinic of the Depart- agreed to. Education, Department of Veterans Af- ment of Veterans Affairs located at 2687 Palmer Street in Missoula, Montana, shall The preamble was agreed to. fairs, and Department of Defense funds were counted together. after the date of the enactment of this Act (The resolution, with its preamble, is be known and designated as the ‘‘David J. printed in the RECORD of August 1, 2017, I have long called for this loophole to Thatcher VA Clinic’’. under ‘‘Submitted Resolutions.’’) be corrected and for the percentage of (2) REFERENCES.—Any reference in any law, Federal revenue to be returned to the regulation, map, document, paper, or other f original 85 percent. I will soon reintro- record of the United States to the clinic re- HARRY W. COLMERY VETERANS duce legislation, the Protecting Stu- ferred to in paragraph (1) shall be considered EDUCATIONAL ASSISTANCE ACT dents and Taxpayers, POST, Act, to ad- to be a reference to the David J. Thatcher OF 2017 dress this issue. VA Clinic. While not addressed in the Forever (b) DR. JOSEPH MEDICINE CROW VA CLIN- Mr. MCCONNELL. Mr. President, I IC.— ask unanimous consent that the Sen- GI Bill we are passing today, I look for- ward to working with my colleagues— (1) DESIGNATION.—The clinic of the Depart- ate proceed to the immediate consider- ment of Veterans Affairs located at 1775 including Senator CARPER who has au- ation of H.R. 3218, which was received Spring Creek Lane in Billings, Montana, from the House. thored another bill on this topic which shall after the date of the enactment of this I support—veterans service organiza- The PRESIDING OFFICER. The Act be known and designated as the ‘‘Dr. Jo- tions, and others to consider this and clerk will report the bill by title. seph Medicine Crow VA Clinic’’. other important accountability con- (2) REFERENCES.—Any reference in any law, The senior assistant legislative clerk cerns. regulation, map, document, paper, or other read as follows: record of the United States to the clinic re- Mr. MCCONNELL. I ask unanimous ferred to in paragraph (1) shall be considered A bill (H.R. 3218) to amend title 38, United consent that the bill be considered read States Code, to make certain improvements to be a reference to the Dr. Joseph Medicine in the laws administered by the Secretary of a third time and passed and the motion Crow VA Clinic. Veterans Affairs, and for other purposes. to reconsider be considered made and (3) PUBLIC DISPLAY OF NAME.— laid upon the table. (A) IN GENERAL.—Any local public display There being no objection, the Senate The PRESIDING OFFICER. Without of the name of the clinic referred to in para- proceeded to consider the bill. objection, it is so ordered. graph (1) carried out by the United States or Mr. DURBIN. Mr. President, I am The bill (H.R. 3218) was ordered to a through the use of Federal funds shall in- pleased that today the Senate is unani- clude the English name, Dr. Joseph Medicine third reading, was read the third time, mously passing the Harry W. Colmery Crow, and the Crow name, Dakaak Baako, of and passed. Veterans Educational Assistance Act Dr. Joseph Medicine Crow. of 2017, known as the Forever GI Bill, f (B) LOCAL DISPLAY.—For purposes of sub- paragraph (A), a local public display of the which would make important improve- REDESIGNATING CERTAIN CLINICS name of the clinic referred to in paragraph ments to the GI bill. OF THE DEPARTMENT OF VET- (1) includes a display inside the clinic, on the The bill removes time restrictions on ERANS AFFAIRS LOCATED IN campus of the clinic, and in the community using the GI bill, enabling future re- MONTANA surrounding the clinic, such as signs direct- cipients to use benefits their entire ing individuals to the clinic. Mr. MCCONNELL. Mr. President, I lives as opposed to within the current (c) BENJAMIN CHARLES STEELE VA CLINIC.— ask unanimous consent that the Com- 15-year timeline. It provides 100 per- (1) DESIGNATION.—The clinic of the Depart- cent GI bill eligibility to Purple Heart mittee on Veterans’ Affairs be dis- ment of Veterans Affairs located at 1766 Ma- recipients. It also increases GI bill charged from further consideration of jestic Lane in Billings, Montana, shall after funding for Reservists, Guardsmen, de- S. 1282 and the Senate proceed to its the date of the enactment of this Act be known and designated as the ‘‘Benjamin pendents, surviving spouses, and sur- immediate consideration. Charles Steele VA Clinic’’. viving dependents. The PRESIDING OFFICER. Without objection, it is so ordered. (2) REFERENCES.—Any reference in any law, While the bill includes many provi- regulation, map, document, paper, or other sions I support, I also have ongoing The clerk will report the bill by title. record of the United States to the clinic re- concerns about institutions of higher The senior assistant legislative clerk ferred to in paragraph (1) shall be considered education, especially for-profit col- read as follows: to be a reference to the Benjamin Charles leges, which prey on veterans using GI A bill (S. 1282) to redesignate certain clin- Steele VA Clinic. bill benefits. I do not believe this bill ics of the Department of Veterans Affairs lo- The bill (S. 1282), as amended, was or- goes far enough to provide the type of cated in Montana. dered to be engrossed for a third read- protections we owe to our There being no objection, the Senate ing, was read the third time, and servicemembers and the kind of insti- proceeded to consider the bill. passed.

VerDate Sep 11 2014 03:44 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00020 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.044 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4717 EXECUTIVE SESSION accounts to more than 2 million em- in Northampton, MA, where nearly 300 ployees who don’t have access to a re- service workers elected to be rep- tirement account at work. On April 4, resented by SEIU 1199. EXECUTIVE CALENDAR—Continued President Trump delayed the rule pre- With a Republican Congress and The PRESIDING OFFICER. Under venting investment advisers from President determined to deliver the the previous order, the Senate will re- cheating hard-working Americans out knockout blow to the middle class, sume executive session. of their retirement savings. This 60-day hard-working Americans need an The PRESIDING OFFICER. The Sen- delay alone cost Americans an esti- NLRB that is on their side. President ator from Massachusetts. mated $3.7 billion. On April 6, the Trump’s nominee to the NLRB, Marvin Ms. WARREN. Mr. President, for Trump administration delayed a rule Kaplan, has no experience practicing months the American people have been protecting construction workers from labor law, but we actually know where gripped by the sideshow surrounding deadly silica poisonings. On May 3, Re- he stands on protecting workers. President Trump. It seems like every publicans in Congress voted to keep As a Republican House staffer, here day another shoe drops on the Russia State governments from offering re- is what he has done. He spent years ac- investigation, another White House tirement accounts to employees who tively working to strip workers of their staffer is fired, and President Trump don’t have access to accounts at work, right to organize under the law. He tweets something that upends the gov- yanking access away from 15 million spent years working to overturn rul- ernment and causes our allies to move Americans. On May 23, President ings by the NLRB that would protect even further away from us. Trump called for massive budget cuts workers’ rights. He worked on the leg- Despite all of this commotion, all of to the Department of Labor, including islation to delay union elections by at the drama, and all of the disorganiza- the complete elimination of workers’ least 35 days, giving employers and tion, there is one thing that Trump and safety training programs, programs for their armies of lawyers and lobbyists the Republicans in Congress have car- older workers, and funding for workers more time to fight off organizing ef- ried out since day one with complete with disabilities. And on June 23, forts. He worked on legislation to precision. They have carried out a com- President Trump proposed exempting make some workers ineligible to join prehensive all-out assault on American the construction and shipbuilding in- unions at their workplaces. He even workers. Day by day, week by week, dustries from the rule to protect work- fought efforts to ensure that Ameri- month by month, President Trump and ers from lethal cancer-causing beryl- cans get paid the overtime they de- congressional Republicans have acted lium, a move that could prove fatal to serve. to undermine the safety and economic workers in these industries. So after 8 months, the Republicans security of hardworking Americans. That is a pretty despicable record— are about to go on vacation, but not Just observe what they have done. On despicable but consistent. Workers get before they jam the NLRB with a new December 8, President Trump nomi- slammed over and over. Today, Senator anti-worker nominee. The biggest prob- nated Andrew Puzder, who was then MCCONNELL has brought us down to the lem in Washington is that this place CEO of fast food giants Hardee’s and floor to sock it to American workers works great for giant employers and Carl’s Jr., to lead the Department of one more time before he sends us home for giant corporations with armies of Labor. That is right. His first major for summer recess. Today, we are vot- lawyers and lobbyists. But workers and announcement affecting workers was ing on the nomination of Marvin their families just get ignored. Presi- to nominate a man who made his for- Kaplan to serve on the National Labor dent Trump doesn’t seem to have any tune on the backs of hard-working Relations Board. problem turning his back on millions Americans to the top position in gov- Pause here for just a second. The of hard-working people, but that is not ernment charged with protecting NLRB is probably the most important what we are here for. American workers. independent Federal agency that you I will be voting against Marvin On February 1, just days after he was have never heard of. They are respon- Kaplan, and I urge my colleagues to do inaugurated, President Trump delayed sible for protecting the legal rights of the same. a rule protecting workers from work- workers to come together and bargain I yield the floor. place exposure to a lethal cancer-caus- with their bosses for higher wages and I suggest the absence of a quorum. ing substance called beryllium. On better working conditions. The PRESIDING OFFICER. The February 3, President Trump stood Starting a union is not easy. Large clerk will call the roll. with big bank CEOs to announce an Ex- employers fight union organizing cam- The senior assistant legislative clerk ecutive order to make it easier for in- paigns tooth and nail. They hire armies proceeded to call the roll. vestment advisers to cheat hard-work- of union-busting lawyers to run smear Mr. TILLIS. Mr. President, I ask ing Americans out of $17 billion a year campaigns against the unions or to unanimous consent that the order for in retirement savings. On March 1, the delay or kill organizing efforts. the quorum call be rescinded. Trump administration delayed the rule That is why the NLRB is so very im- The PRESIDING OFFICER. Without protecting workers from lethal cancer- portant—to serve as a referee that en- objection, it is so ordered. causing beryllium a second time. On sures employers play by the rules and Under the previous order, all March 6, congressional Republicans fol- workers get a chance to exercise their postcloture time is expired. lowed the directive of big business lob- legal rights. It is the NLRB’s job to The question is, Will the Senate ad- byists and voted to make it easier for stand up for workers—workers like the vise and consent to the Kaplan nomina- government contractors to steal wages nearly 4,000 workers at the Nissan tion? from their employees. On March 16, plant in Canton, MS, who, beginning Mr. TILLIS. Mr. President, I ask for President Trump released his budget tomorrow, will vote on whether to the yeas and nays. blueprint, proposing to slash funding elect a union to represent them. That The PRESIDING OFFICER. Is there a for the Labor Department, whose job is is what the NLRB has traditionally sufficient second? to stand for American workers, by 21 done—stood up for workers. Just last There appears to be a sufficient sec- percent. On March 22, congressional week, they filed a complaint against ond. Republicans voted to make it easier for Nissan, alleging that the corporation The clerk will call the roll. employers to hide injuries and deaths has violated the law by running a The senior assistant legislative clerk that their workers suffer on the job. On union-busting drive, warning workers called the roll. March 24, the Trump administration that they would lose wages and bene- Mr. CORNYN. The following Senators delayed a rule that required mine oper- fits if they took the step of joining a are necessarily absent: the Senator ators to conduct safety inspections and union. from North Carolina (Mr. BURR) and tell miners about any hazardous condi- It is also the NLRB’s job to do the the Senator from Arizona (Mr. tions they discovered before the work- routine but important work of over- MCCAIN). ers go into the mines. On March 30, seeing the elections. Just last month, The PRESIDING OFFICER (Mr. LEE). congressional Republicans voted to the NLRB conducted a secret ballot Are there any other Senators in the block cities from offering retirement election at Cooley Dickinson Hospital Chamber desiring to vote?

VerDate Sep 11 2014 03:44 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00021 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.047 S02AUPT1 S4718 CONGRESSIONAL RECORD — SENATE August 2, 2017 The result was announced—yeas 50, A resolution (S. Res. 222) designating July ments. Regrettably, some have made nays 48, as follows: 26, 2017, as ‘‘United States Intelligence Pro- the highest sacrifice—laying down fessionals Day.’’ [Rollcall Vote No. 184 Ex.] their lives for their country. YEAS—50 There being no objection, the Senate For their service, the risks they take proceeded to consider the resolution. and the sacrifices they make every day Alexander Flake Perdue Barrasso Gardner Portman Mr. WARNER. I ask unanimous con- and because they do not hear this near- Blunt Graham Risch sent that the resolution be agreed to, ly enough, let me say ‘‘thank you’’ to Boozman Grassley Roberts the preamble be agreed to, and the mo- the intelligence community. Capito Hatch Rounds tions to reconsider be considered made As a Senator from the Common- Cassidy Heller Rubio Cochran Hoeven and laid upon the table with no inter- wealth of Virginia, I am proud to rep- Sasse resent thousands of current and former Collins Inhofe Scott vening action or debate. Corker Isakson Shelby The PRESIDING OFFICER. Without members of the intelligence commu- Cornyn Johnson Strange nity who live, work, or retire in our Cotton Kennedy objection, it is so ordered. Sullivan Crapo Lankford The resolution (S. Res. 222) was great State. I am also proud to rep- Cruz Lee Thune agreed to. resent these individuals in my current Daines McConnell Tillis The preamble was agreed to. capacity as vice chairman of the Sen- Enzi Moran Toomey ate Intelligence Committee. Ernst Murkowski Wicker (The resolution, with its preamble, is Fischer Paul Young printed in the RECORD of July 19, 2017, My colleagues and I on the com- under ‘‘Submitted Resolutions.’’) mittee have again submitted a resolu- NAYS—48 Mr. WARNER. Mr. President, for sev- tion that marks July 26 as ‘‘United Baldwin Gillibrand Murray eral years now I have regularly come States Intelligence Professionals Day.’’ Bennet Harris Nelson It was on that day 70 years ago that Blumenthal Hassan Peters to this floor to publicly acknowledge Booker Heinrich Reed the contributions made by our great President Truman signed the National Brown Heitkamp Sanders Federal employees. This is a tradition I Security Act of 1947, which laid the Cantwell Hirono Schatz inherited from one of our former col- foundation for today’s U.S. intelligence Cardin Kaine Schumer community. It was earlier in my state- Carper King Shaheen leagues, Senator Ted Kaufman of Dela- Casey Klobuchar Stabenow ware. Senator Kaufman, who had been ment that we passed that resolution. In Coons Leahy Tester recent years, our committee has had a longtime staffer himself before he Cortez Masto Manchin Udall success, as we try to protect our intel- served as a Senator, would come to this Donnelly Markey Van Hollen ligence community, with greater intel- Duckworth McCaskill Warner floor on a regular basis to acknowledge ligence sharing and interoperability Durbin Menendez Warren and celebrate the tireless work and oc- Feinstein Merkley Whitehouse and because of investments in people Franken Murphy Wyden casional heroics performed by many of and systems. our Federal employees. When Senator Many challenges remain—from the NOT VOTING—2 Kaufmann left this body, I gladly Burr McCain constant barrage of leaks to the secu- picked up that mantle and since then rity of the supply chain, to outdated The nomination was confirmed. have come to the floor to draw atten- processes for security clearances. I The PRESIDING OFFICER. Under tion to the extraordinary contributions hope that this year’s intelligence au- the previous order, the motion to re- of many of our Federal workers. thorization bill will begin to address consider is considered made and laid Over the past few years, this recogni- some of these issues. upon the table and the President will tion has included a Social Security ex- Yet today it is the people in the in- be immediately notified of the Senate’s ecutive who eliminated a claims back- telligence community whom I want to action. log to more quickly meet the urgent acknowledge—their professionalism, f needs of thousands of Social Security their dedication to duty and country, recipients with grave terminal ill- their silent service, their sacrifices. LEGISLATIVE SESSION nesses. We have also celebrated the The men and women of the Nation’s work of a Department of Homeland Se- intelligence agencies deserve our re- curity official who saved taxpayers $750 spect and our thanks. They do not de- MORNING BUSINESS million by streamlining her agency’s serve to be belittled, disrespected, or The PRESIDING OFFICER. Under procurement processes, and we proudly threatened, and certainly not from the previous order, the Senate will be highlighted the work of a group of en- their Commander in Chief. in a period of morning business, with gineers at NASA Langley Research To the men and women of the intel- Senators permitted to speak therein Center in Virginia, who, in 2010, de- ligence community—these great Fed- for up to 10 minutes each. signed a capsule that proved to be cru- eral employees—I conclude with this: The Senator from Arizona. cial in saving the lives of 33 Chilean We, simply, do not say it enough, but (The remarks of Mr. FLAKE per- miners who were trapped underground. thank you for your service. Thank you taining to the submission of S. Res. 243 Too often, our Federal workers are for your dedication, and thank you for are printed in today’s RECORD under disrespected and demeaned by those the great work you do—often ‘‘Submitted Resolutions.’’) who would attempt to use them as unheralded. Mr. FLAKE. Mr. President, I yield scapegoats for all that is allegedly I yield the floor. back. wrong here in Washington. In reality, I suggest the absence of a quorum. The PRESIDING OFFICER. The Sen- thousands of our Nation’s dedicated The PRESIDING OFFICER. The clerk will call the roll. ator from Virginia. civil servants work tirelessly every day The legislative clerk proceeded to to make our government work for and f call the roll. by the people. Mr. RUBIO. Mr. President, I ask UNITED STATES INTELLIGENCE Today, I wish to focus for a moment PROFESSIONALS DAY unanimous consent that the order for on one such group of outstanding Fed- the quorum call be rescinded. Mr. WARNER. Mr. President, I ask eral employees—those who work across The PRESIDING OFFICER. Without unanimous consent that the Com- our Nation’s intelligence agencies to objection, it is so ordered. mittee on the Judiciary be discharged keep our Nation safe. Most of these f from further consideration of S. Res. professionals work in anonymity. 222 and the Senate proceed to its imme- Many risk their lives far away from the RACE FOR CHILDREN ACT diate consideration. limelight. That is how it should be, for Mr. RUBIO. Mr. President, I come to The PRESIDING OFFICER. Without they are sworn to secrecy, even from the floor today to voice my support for objection, it is so ordered. their families and loved ones. the FDA Reauthorization Act. Within The clerk will report the resolution Over the last decade and a half, our this legislation is a very important by title. intelligence professionals have increas- measure that will support the develop- The senior assistant legislative clerk ingly been deployed overseas into war ment of innovative and promising can- read as follows: zones and other high-threat environ- cer drugs—the RACE for Children Act,

VerDate Sep 11 2014 03:44 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00022 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.033 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4719 which is a law that I introduced with So the RACE for Children’s Act, because they had no options to treat Senator MICHAEL BENNET of the State which is a law that Senator BENNET her. of Colorado. and I offered and is included in the There is Princeton, who was diag- RACE for Children is sorely needed, FDA reauthorization, closes that loop- nosed with cancer when he was 5 years as it would close a loophole that exists hole. old. He is now 7. In those 2 years he has in current Federal law and prompt Let me say that getting to this point undergone 6 chemo cycles, a bone mar- companies—pharmaceutical compa- here on the floor was not easy. So I do row transplant, 9 surgeries, 12 rounds nies—to examine the safety and the ef- need to take a moment to thank the of radiation, and 6 cycles of ficacy of powerful cancer drugs and chairman, Senator ALEXANDER of Ten- immunotherapy. Because of this in- how they work on children. This, in nessee, and obviously Senator BENNET, tense and time-consuming treatment turn, will provide doctors with the nec- but also the pediatric cancer commu- schedule, Princeton built friendships essary information to properly treat nity, including organizations like the with others who were also in the hos- children battling cancer. Live Like Bella Foundation in my pital for treatment. Sadly, he has lost Pediatric cancer is a leading cause of hometown of Miami, Lambs for Life, many of these friends. death by disease among children. A the Alliance for Childhood Cancer, St. Princeton’s best friend was Trevor. startling statistic: One in every 285 Jude’s, St. Baldrick’s, Nemours Chil- Trevor passed away right before children is diagnosed with cancer be- dren’s Hospital, Arnold Palmer Hos- Princeton’s birthday party. Princeton fore the age of 20. While the good news pital, the American Cancer Society, came to my office asking the Senate to is that researchers are continuing to and so many others that came together do more for kids like them. Here is make significant advances to treat and to the table to address this important what 7-year-old Princeton said: ‘‘I cure cancer for adults, the progress to issue in a way that would not limit fu- don’t want my friends to die, and I develop safe drugs for pediatric cancer ture innovations for cancer treatment. don’t want me to die.’’ sadly lags far behind. There is the story of Derek. He was a One of the problems is that current It has taken over a year and a half to healthy, happy baby until he developed law, the way it is today, directs phar- reach this point, and I am grateful to an aggressive form of cancer and it pro- maceutical companies to study the all of them for their participation be- duced tumors all over his body. His safety and the efficacy of adult drugs cause I would not be standing here giv- on children. So if you develop a drug on ing this speech without it. body was literally taken over by tu- diabetes or heart disease or anything Suffice it to say that, tragically, mors. At only 5 months of age, baby for adults, it also requires you to do many of my colleagues in Congress, Derek lost his battle against cancer. These are real stories. They are real, some of that on children because you here in the Senate but also across the heartbreaking stories—stories of our want to make sure that it works on country, have been affected by cancer. both populations and you don’t want to Whether you are fighting cancer your- neighbors, friends, and family and what keep a drug out of the market for chil- self or it is your child, your sister, they have endured. But with the developments in medi- dren that could work for them. Of your brother, your cousin, your friend, cine today, there is no reason these course, this requirement is only in I want to make one thing clear: You place if the FDA believes that there is are not alone in your struggle. children shouldn’t have a second a pertinent need—in essence, a condi- I would venture to say that I do not chance. Yet the treatment options for tion that children suffer from. There know anyone who has not been im- children with cancer is much more lim- are some conditions that are unique to pacted by pediatric cancer. I have it in ited than it is for adults, and some of adults; there are few, if any, pediatric my own family, and some have con- the reasons why are the issues we are populations who have that disease, so fronted it in theirs, in loved ones and trying to address about this law here maybe they would decide it wasn’t per- children who went to school with your today. tinent to require it. kids. In fact, Live Like Bella Founda- Recent advancements in cancer However, this provision in the law tion was founded for a young girl by treatment enable oncology drugs to specifically exempts cancer drugs. In the name of Bella from Miami. She was specifically target the genetic struc- essence, it says to a pharmaceutical a classmate of my nephew in grade ture of the cancer, and that makes it company: If you are going to study the school, and she lost her battle with possible to transition certain adult safety and the efficacy of a drug on cancer. Her father has been a tireless cancer drugs for pediatric use. How- adults, if there is a pertinent need, if advocate for this cause. He moved ever, the basic information you need to there is a real population out there Heaven and Earth to try to reach a do that—about dosing and safety— that suffers from the same condition in point where they could find a cure for needs to be determined to guide the children, you have to test it on chil- her. That did not come in time. He has doctors responsible for treating these dren, as well, except if it is a cancer now made it the mission of his life to children. These treatments, these ad- drug. One of the reasons that exemp- honor her life by continuing this work. vances are providing new-found hope tion is in there is because technology— So we have all been impacted in some for cancer patients, but mostly only for medical technology at the time that way. adult cancer patients. law was put in place—didn’t allow re- As I said, unfortunately, across this Fortunately, we have a chance and searchers to target the genetic struc- country this disease is a reality. I want an opportunity to change this, and that ture of cancer. In essence, at the time, to share some stories of a few of the is the goal of the RACE for Children it didn’t allow them to say: We can go children who have been impacted by Act. in and find the genetic markers of a cancer and who have impacted our of- The House recently passed the RACE specific cancer and test against it. fice and helped us to make this a pri- for Children Act as part of the FDA That is why it didn’t have that require- ority over the last year and a half. user fee reauthorization bill that is be- ment. The first is the story of a young boy fore us here today. It is now our turn Now, however, we do have that capa- named Jeremy. He is only 5 years old to do so and to send this important and bility. Today, the technology exists to and has been in treatment for 4 of potentially lifesaving legislation to the pinpoint the similarities in adult and those 5 years. He has had more than 150 President for his signature. childhood cancer genomes. So the tech- surgeries so far, and ultimately had to In a place where we have had some nology has now reached a point where have his eyes removed because of can- heated debates over the last 7 years, you can treat the specific genome of a cer, which left him completely blind, since I have been here—61⁄2, and more cancer whether it is in an adult or in a obviously. to come—sometimes it feels as though, child. That is how far the technology Then there is Tatum, who was diag- perhaps, our service here doesn’t make has advanced, but the law has not been nosed with a rapidly developing brain much of an impact. But from time to updated to keep up with it. The result tumor just before she was supposed to time, we have unique opportunities to is that there are a lot of adult advances start kindergarten. Her parents were vote on laws and legislation that being made, and we don’t know if they told by the doctors that they should slightly alter the arc of history and po- work on children because they haven’t take her home and they should enjoy tentially help people. Standing here been forced to test it. the little time they had with Tatum today, I can’t tell you if there will be

VerDate Sep 11 2014 03:44 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00023 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.052 S02AUPT1 S4720 CONGRESSIONAL RECORD — SENATE August 2, 2017 1,000 children, 100,000 children, or 5 while there are many things we have [From CNN, July 31, 2017] children who will benefit from a cancer not done, we will leave here tomorrow TRUMP ON POLICE BRUTALITY: HAR HAR HAR treatment because of this new require- or next week knowing that at least we (By Brandon del Pozo) ment in which these adult drugs will did one thing that will matter. It is an When I was a New York Police Department have to be tested on children. We don’t important thing because these children cop in East Flatbush in 2000, I once rushed know. whom we are trying to help do not into an apartment building with fellow offi- Standing here today, believing that have the time to continue waiting for cers on a call of an assault. We found a boy we all walk on Earth and our days are us to step up and take action. in the hallway under attack. He was crying, numbered to the glory and grace of I thank the Chair. and bleeding from stab wounds inflicted by his mother’s boyfriend. The boy ran into my God, frankly, we don’t know if one of With that, I yield the floor. arms. Our sergeant confronted his attacker. our own children, God forbid or some- I suggest the absence of a quorum. He could have shot the man. Instead, he one we deeply love or one of our chil- The PRESIDING OFFICER (Mr. fought him into submission. dren’s classmates will be impacted by TILLIS). The clerk will call the roll. The boy had been stabbed because he had pediatric cancer. But we know that 1 in The legislative clerk proceeded to called the police while the man was attack- about 300 children will be. So the call the roll. ing his mother. She was lying on the hallway chances are that at some point, we will Mr. MCCONNELL. Mr. President, I stairs in a pool of blood. That her son had once again have someone we care deep- ask unanimous consent that the order served as a distraction was probably the only for the quorum call be rescinded. reason she survived. ‘‘You saved our lives,’’ ly about impacted. We hope that when the boy sobbed. He hugged me. His blood and that moment comes, if it does, that The PRESIDING OFFICER. Without tears wet my shirt. there will be options for their parents objection, it is so ordered. As the suspect sat there in handcuffs wait- and their doctors and that they will f ing to be led away, I asked him why he had have the opportunity to use for them stabbed a child. ‘‘Boy gotta learn not to get VERMONT POLICE CHIEF’S in a man’s business,’’ he said. ‘‘So now he treatments that perhaps would not RESPONSE TO PRESIDENT TRUMP have been available, had this require- learned.’’ A fury rose within me that nearly ment not been in the law. That is why Mr. LEAHY. Mr. President, Brandon caused me to shake. ‘‘We should have shot you,’’ I said. I hope and I urge my Senate colleagues del Pozo proudly serves as the chief of police in Burlington, VT—Vermont’s But we didn’t shoot him, nor did we lay a to join me in supporting this initiative. hand on him once he’d surrendered. Policing In fact, sometimes we give these largest city. He arrived in Vermont 2 requires dealing with the emotions cops are speeches with a sense of mystery: If years ago, after serving for nearly two bound to feel when they witness the worst this passes; if it doesn’t pass; there is decades with the New York Police De- things one person can do to another. It is no reason this isn’t going to pass. We partment, where he rose through the criminals who act on these emotions and at- all expect the FDA reauthorization bill ranks and learned hard lessons on the tack other people. Restraint is what sepa- to pass. I imagine when people vote on streets of such a large urban center. rates policing from vigilantism. Now we have a President who appears to this tomorrow, they will read the title One needs only to sit with Chief del Pozo for a short while to understand want police to satisfy their primal urges. Ei- of the bill, ‘‘FDA Fee Reauthoriza- ther as a joke—as White House press sec- tion.’’ It sounds like taking care of the his commitment to community service retary, Sarah Huckabee Sanders has now normal course of business—it is impor- and to community. suggested—or as one of many true things tant in its own right, by the way—that So it comes as no surprise that Chief that have been said in jest, President Donald this is just this bureaucratic exercise del Pozo grew alarmed when he heard Trump addressed a roomful of officers on to reauthorize an expiring law. Embed- President Trump recently tell a law en- Long Island on Friday and invited them to ded in that law is a very important forcement gathering that police should be ‘‘rough’’ with their suspects. He advised them to be free with their hands as they law, one that I hope will lead to real not be ‘‘too nice’’ to those who are placed under arrest, seeming to suggest shoved arrestees into squad cars, to ‘‘not be life-changing innovation in a way that too nice.’’ His grin and his pause for an ova- will impact lives, change and save the that police should go against the very tion erased any uncertainty about his mes- lives of children here in our country policies that exist to protect against sage. but ultimately in other parts of the police misconduct. We cannot tolerate An elected official could only say what world as well. this kind of public comment and cer- Trump said if he didn’t understand policing. That is why I felt it was important to tainly not from the President of the People who’ve gained this type of experience come to the Senate floor and, obvi- United States. There is nothing the know the real possibility of a cop losing his least bit humorous in any of this. In temper, how hard we have to guard against ously, urge my colleagues to support it, and how much it would erode the trust we this initiative but also to urge my col- fact, President Trump’s comments strive for between police and the people they leagues to be proud of it. have undermined the efforts of police serve. We are about to go home, whether it departments across our Nation to build It also seems like the President doesn’t un- is tomorrow or next week, and answer trust within their communities at a derstand certain things about America. to our constituents for all the things time when that trust is most needed. There has been enough confirmed police bru- we didn’t do. There are some signifi- As a doctoral candidate holding three tality here to send chills down the spine of a cant issues we have not confronted and master’s degrees, Chief del Pozo is well reasonable person watching the President solved for the country, but this is a sig- studied in the rules of engagement. He and a crowd of cops joke and laugh about it. It’s like laughing about the dire con- nificant issue. There aren’t going to be is also a talented writer. In an essay he sequences of inadequate health care, or the a lot of articles written about it; there submitted to CNN, Chief del Pozo re- opioid crisis. aren’t going to be blaring headlines on sponded directly to the President’s It’s also clear that President Trump has the websites about it, mailers and cam- comments, writing: ‘‘Policing requires never had to fire or arrest a police officer: paign commercials. That doesn’t mean dealing with the emotions cops are The cop sits there in front of you, replaying it isn’t important. We live in a society bound to feel when they witness the a moment in his mind, wishing he could take where oftentimes good news doesn’t worst things one person can do to an- it back. He put on the uniform to be one of draw ratings, and good news doesn’t other. It is criminals who act on these the good guys, and now he’s on the opposite side of the table. He worries about sup- drive eyeballs and clicks to a website. emotions and attack other people. Re- porting his family. It doesn’t make it unimportant. It straint is what separates policing from The way to get our officers to retirement doesn’t make it insignificant. vigilantism.’’ safely, after a satisfying career, is to lead This is significant. This is an oppor- It is a viewpoint that is real, told them through policing’s cauldron. Excessive tunity. This is evidence that more through the eyes of an experienced force could get them fired or arrested. Mak- often than perhaps people realize, fel- street cop who works in reality, not re- ing light of it is a failure of leadership. low Americans of different points of ality TV. I ask unanimous consent that It was hard to watch a roomful of officers view, representing diverse States and Chief del Pozo’s full CNN essay be laugh and applaud in response to Trump’s re- marks. The only charitable explanation was communities, who approach the polit- printed in the RECORD. that it indicated a sense of relief that the ical process with very different There being no objection, the mate- President understood how vicious some ideologies and aims, come together to rial was ordered to be printed in the criminals are and how frustrating the work make a difference. I am pleased that RECORD, as follows: of bringing them to justice can be. The more

VerDate Sep 11 2014 03:44 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00024 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.053 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4721 likely explanation is that the President has dren achieve their academic goals in FOOD AND DRUG ADMINISTRATION a talent for bringing out the darker side of high school and beyond. USER FEE REAUTHORIZATION people, and this was another example of it. The Boys & Girls Club plays an im- What we witnessed will drive a deeper Mr. ALEXANDER. Mr. President, I wedge between the police and the citizens portant role in the lives of more than ask unanimous consent to have printed whose mistrust of them has grown. It will 1,000 Burlington children. Aside from in the RECORD a copy of the commit- cast doubt on legitimate uses of force. the academic services, the club also ment letters from the Secretary of What troubles me the most about the works to ensure a safe and stable com- Health and Human Services to the President’s remarks, however, is the way munity for its young members. When chairman of the Committee on Health, they patronized police officers. He has never Ms. McKenzie began hearing reports of Education, Labor, and Pensions of the held a wounded child in his arms or had to suspected drug use occurring in a park Senate and the chairman of the Com- decide whether to punch or shoot a man with across the street from the club, she as- a knife. He has never had to race to the mittee on Energy and Commerce of the scene of a police shooting and choke on his sembled a task force of local law en- House of Representatives regarding re- feelings as he hunts for a suspect with preci- forcement officials, social workers, and authorization of the Biosimilar User sion and restraint. His remarks failed to policymakers to work towards a solu- Fee Act, Generic Drug User Fee Act, take police work and its hazards seriously. tion that would ensure the safety of Prescription Drug User Fee Act, and When I later served as a precinct com- club kids. The Boys & Girls Club ex- Medical Device User Fee Amendments. mander in the Bronx, a sergeant of mine was panded activities in the park and even- There being no objection, the mate- suspended because he stood there and did tually took over use of an old storage rial was ordered to be printed in the nothing as he watched an officer slam a RECORD, as follows: handcuffed suspect’s head into the street. A building which is now an academic cen- narcotics detective had been shot during a ter. DEPARTMENT OF HEALTH & scuffle with a drug crew, the responding offi- Ms. McKenzie has also focused her ef- HUMAN SERVICES, cers were blind with rage, and one exacted forts on children who have experienced Washington, DC, January 4, 2017. revenge. When a video surfaced, the emo- trauma. Under her leadership, the club Hon. LAMAR ALEXANDER, tions didn’t convey. It just looked thuggish, Chairman, Committee on Health, Education, has started a program to help children Labor and Pensions, U.S. Senate, Wash- like the cop was a criminal, too. By his own deal with the issues that stem from account, it seems the President would also ington, DC. trauma at a young age. Their goal is to DEAR MR. CHAIRMAN: The Generic Drug have been inclined to stand there and do User Fee Amendments of 2012 (GDUFA) en- nothing. There are thousands of American create stability for children whose acted as title III of the Food and Drug Ad- police chiefs who know what these situations home lives may be turbulent due to issues such as homelessness and addic- ministration Safety and Innovation Act require. They want to protect their officers [Pub. L. 112–144], expires at the end of Fiscal by leading them in the right direction. We tion. These are profoundly difficult sit- Year 2017. With this letter the Administra- don’t need the President joking with them uations for youth to handle, and the ef- tion is providing our recommendations for about giving in to their baser instincts. forts of the staff at the Boys & Girls the reauthorization of GDUFA for the Fiscal f Club are surely appreciated. Years 2018–2022 (GDUFA II). These efforts have not gone unno- Under GDUFA, the revenues generated TRIBUTE TO MARY ALICE from fees paid by the generic pharmaceutical MCKENZIE ticed. Not only is Ms. McKenzie be- loved by members of the club who tell industry have been used to expedite the proc- Mr. LEAHY. Mr. President, it is a ess for the review of generic drugs and to stories of her kindness and generosity, support and augment regulatory science and privilege for each of us to represent our but in 2014, Ms. McKenzie was granted constituents, and it is a great honor to drug development. The expenditure of these Champlain College’s Distinguished Cit- funds is in accordance with the statute and be able to recognize the contributions izen Award for her years of service to provides resources to meet the performance many of them make to our commu- the community. This award was well goals and procedures that were developed by nities at home. On this occasion, I deserved; there are few people who the Food and Drug Administration [FDA] in would like to take this opportunity to dedicate themselves to service in the consultation with representatives of regu- recognize Mary Alice McKenzie, a fix- lated industry. FDA estimates that the fees way that Mary Alice McKenzie has. negotiated in GDUFA II will average ap- ture in the Burlington, VT, commu- During her tenure at the Boys & nity. Ms. McKenzie has served as the proximately $493.6 million per year, adjusted Girls Club of Burlington, Mary Alice annually for inflation. executive director of the Boys & Girls McKenzie has repeatedly identified sig- Throughout this process, the FDA has so- Club of Burlington since 2007, and dur- nificant issues within the community licited input and worked with various stake- ing her tenure at the club, she has had and worked to find creative and lasting holders, including representatives from con- a lasting impact on the lives of thou- solutions. As she concludes her years of sumer, patient, academic research, and sands of Vermont children. The com- health provider groups, and negotiated with service with the club, it is clear that the regulated industry, to develop reauthor- munity is grateful for her service. her efforts have paid off. The Boys & Ms. McKenzie comes from a business ization recommendations for GDUFA that Girls Club has more teens moving on to would build upon and enhance the success of and legal background—a nontradi- college than ever before, and the club the program. In addition, we have complied tional path to her current position that continues to expand, providing an in- with the statutory requirements to solicit provided her with a unique set of skills. valuable space for Burlington’s youth public comments on our recommendations, Mary Alice began her work at the Boys to spend their free time. I am very and the summary of public comments is & Girls Club after serving as the chief posted on the agency web site. grateful for Mary Alice’s tireless dedi- Our recommendations build upon the suc- executive officer of McKenzie Meats cation, and I look forward to seeing from 1985 to 2000. She then spent sev- cesses of existing programs and performance what the future of her career brings. goals with step-wise improvements allowing eral years in the Vermont State college Marcelle and I think of her as a dear FDA the resources to establish a generic system as general counsel and served friend. drug review program that can keep up with with the law firm Paul Frank & Collins the ever-expanding generic drug industry. before taking over at the Boys & Girls The recommendations will bring all Abbre- f Club of Burlington in 2007. viated New Drug Applications (ANDAs) At the Boys & Girls Club, Mary Alice under a common review goals scheme which has focused her efforts on education. CBO ESTIMATE OF H.R. 2430 calls for faster review cycles of 10 months for standard ANDAs and eight months for pri- When she realized how few club kids Mr. ENZI. Mr. President, for the in- ority ANDAs. Priority status will be re- were going on to higher education, she formation of my colleagues, the Con- served for drug shortages, first generics, sole enacted the Early Promise program, gressional Budget Office released its source generics and other public health pri- which targets children at a young age estimate of H.R. 2430, the FDA Reau- orities. The negotiated recommendations who may need additional academic thorization Act of 2017, in July 2017. In- provide that FDA will communicate defi- services and then provides college formation related to this House-passed ciencies to industry throughout rather than scholarships to older youth. As of bill can be found at the Congressional at the end of a review cycle, increasing the chances for applicants to remedy deficiencies today, the scholarship fund has invest- Budget Office’s website with the fol- and obtain approval in fewer cycles. This ments totaling $2.3 million from which lowing link: https://www.cbo.gov/ will allow for improved predictability and to draw. In a short time, the club hopes system/files/115th-congress-2017-2018/ transparency and enable industry advanced to be able to help 60 Burlington chil- costestimate/hr2430.pdf business planning.

VerDate Sep 11 2014 04:18 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00025 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.036 S02AUPT1 S4722 CONGRESSIONAL RECORD — SENATE August 2, 2017 The agreement also establishes a robust the Food and Drug Administration [FDA] in Proposed Changes for Reauthorization of Pre-ANDA program for complex products. consultation with representatives of regu- GDUFA in Fiscal Years 2018 through 2022; The program will include meetings with ap- lated industry. FDA estimates that the fees and the summary of public comments. plicants, guidance development and regu- negotiated in GDUFA II will average ap- Thank you for the opportunity to present latory science enhancements aimed at allow- proximately $493.6 million per year, adjusted our recommendations to reauthorize this ing applicants with complex products to sub- annually for inflation. vital program. We would be pleased to brief Throughout this process, the FDA has so- mit more complete applications and FDA to your staff on the details and want to work licited input and worked with various stake- be more prepared for such submissions. closely with Congress in order to reauthorize FDA will also make improvements to the holders, including representatives from con- the program in a timely manner. The Office facility assessment program in order to in- sumer, patient, academic research, and of Management and Budget has advised that crease predictability, transparency and safe- health provider groups, and negotiated with the bill and the enclosed performance goals ty. In addition, FDA has committed to ac- the regulated industry, to develop reauthor- are in accord with the Administration’s pro- countability and reporting enhancements. ization recommendations for GDUFA that gram. FDA will conduct activities to evaluate the would build upon and enhance the success of Sincerely, financial administration and resource alloca- the program. In addition, we have complied SYLVIA BURWELL, tions of the GDUFA II program to help iden- with the statutory requirements to solicit Secretary. tify areas to enhance operational and fiscal public comments on our recommendations, efficiency and transparency. FDA will also and the summary of public comments is expand GDUFA program performance report- posted on the agency web site. DEPARTMENT OF HEALTH & ing to enable the regulated industry, pa- Our recommendations build upon the suc- HUMAN SERVICES, tients and consumer groups, and other stake- cesses of existing programs and performance Washington, DC, January 4, 2017. holders to better gauge the generic drug pro- goals with step-wise improvements allowing Hon. GREG WALDEN, gram’s performance. FDA the resources to establish a generic Chairman, Committee on Energy and Commerce, Lastly, the agreement would revamp the drug review program that can keep up with House of Representatives, Washington, DC. user fee structure. GDUFA II will be funded the ever-expanding generic drug industry. DEAR MR. CHAIRMAN: The Generic Drug at a level commensurate with the volume of The recommendations will bring all Abbre- User Fee Amendments of 2012 (GDUFA) en- ANDA submissions—the primary workload viated New Drug Applications (ANDAs) acted as title III of the Food and Drug Ad- driver of the program. This will allow FDA under a common review goals scheme which ministration Safety and Innovation Act the resources necessary to meet all of its calls for faster review cycles of 10 months for [Pub. L. 112–144], expires at the end of Fiscal commitments. In order to maintain a pre- standard ANDAs and eight months for pri- Year 2017. With this letter the Administra- dictable fee base and to more closely align ority ANDAs. Priority status will be re- tion is providing our recommendations for fee responsibility with program costs and served for drug shortages, first generics, sole the reauthorization of GDUFA for the Fiscal fee-paying ability, FDA and industry have source generics and other public health pri- Years 2018–2022 (GDUFA II). agreed to shift the burden more toward an- orities. The negotiated recommendations nual program fees. To address specific small provide that FDA will communicate defi- Under GDUFA, the revenues generated business concerns, FDA and industry have ciencies to industry throughout rather than from fees paid by the generic pharmaceutical proposed three distinct small business con- at the end of a review cycle, increasing the industry have been used to expedite the proc- siderations. We anticipate that the proposed chances for applicants to remedy deficiencies ess for the review of generic drugs and to GDUFA II will increase public access to af- and obtain approval in fewer cycles. This support and augment regulatory science and fordable, generic drug products. will allow for improved predictability and drug development. The expenditure of these The following five enclosures are provided transparency and enable industry advanced funds is in accordance with the statute and for your consideration: The proposed GDUFA business planning. provides resources to meet the performance II statutory language; a redline of current The agreement also establishes a robust goals and procedures that were developed by law; the GDUFA Reauthorization Perform- Pre-ANDA program for complex products. the Food and Drug Administration [FDA] in ance Goals and Procedures—Fiscal Years The program will include meetings with ap- consultation with representatives of regu- 2018 through 2022; the Background for the plicants, guidance development and regu- lated industry. FDA estimates that the fees Proposed Changes for Reauthorization of latory science enhancements aimed at allow- negotiated in GDUFA II will average ap- GDUFA in Fiscal Years 2018 through 2022; ing applicants with complex products to sub- proximately $493.6 million per year, adjusted and the summary of public comments. mit more complete applications and FDA to annually for inflation. Thank you for the opportunity to present be more prepared for such submissions. Throughout this process, the FDA has so- our recommendations to reauthorize this FDA will also make improvements to the licited input and worked with various stake- vital program. We would be pleased to brief facility assessment program in order to in- holders, including representatives from con- your staff on the details and want to work crease predictability, transparency and safe- sumer, patient, academic research, and closely with Congress in order to reauthorize ty. In addition, FDA has committed to ac- health provider groups, and negotiated with the program in a timely manner. The Office countability and reporting enhancements. the regulated industry, to develop reauthor- of Management and Budget has advised that FDA will conduct activities to evaluate the ization recommendations for GDUFA that the bill and the enclosed performance goals financial administration and resource alloca- would build upon and enhance the success of are in accord with the Administration’s pro- tions of the GDUFA II program to help iden- the program. In addition, we have complied gram. tify areas to enhance operational and fiscal with the statutory requirements to solicit Sincerely, efficiency and transparency. FDA will also public comments on our recommendations, SYLVIA BURWELL, expand GDUFA program performance report- and the summary of public comments is Secretary. ing to enable the regulated industry, pa- posted on the agency web site. tients and consumer groups, and other stake- Our recommendations build upon the suc- DEPARTMENT OF HEALTH & holders to better gauge the generic drug pro- cesses of existing programs and performance HUMAN SERVICES, gram’s performance. goals with step-wise improvements allowing Washington, DC, January 4, 2017. Lastly, the agreement would revamp the FDA the resources to establish a generic Hon. PATTY MURRAY, user fee structure. GDUFA II will be funded drug review program that can keep up with Ranking Member, Committee on Health, Edu- at a level commensurate with the volume of the ever-expanding generic drug industry. cation, Labor and Pensions, U.S. Senate, ANDA submissions—the primary workload The recommendations will bring all Abbre- Washington, DC. driver of the program. This will allow FDA viated New Drug Applications (ANDAs) DEAR SENATOR MURRAY: The Generic Drug the resources necessary to meet all of its User Fee Amendments of 2012 (GDUFA) en- commitments. In order to maintain a pre- under a common review goals scheme which acted as title III of the Food and Drug Ad- dictable fee base and to more closely align calls for faster review cycles of 10 months for ministration Safety and Innovation Act fee responsibility with program costs and standard ANDAs and eight months for pri- [Pub. L. 112–144], expires at the end of Fiscal fee-paying ability, FDA and industry have ority ANDAs. Priority status will be re- Year 2017. With this letter the Administra- agreed to shift the burden more toward an- served for drug shortages, first generics, sole tion is providing our recommendations for nual program fees. To address specific small source generics and other public health pri- the reauthorization of GDUFA for the Fiscal business concerns, FDA and industry have orities. The negotiated recommendations Years 2018–2022 (GDUFA II). proposed three distinct small business con- provide that FDA will communicate defi- Under GDUFA, the revenues generated siderations. We anticipate that the proposed ciencies to industry throughout rather than from fees paid by the generic pharmaceutical GDUFA II will increase public access to af- at the end of a review cycle, increasing the industry have been used to expedite the proc- fordable, generic drug products. chances for applicants to remedy deficiencies ess for the review of generic drugs and to The following five enclosures are provided and obtain approval in fewer cycles. This support and augment regulatory science and for your consideration: The proposed GDUFA will allow for improved predictability and drug development. The expenditure of these II statutory language; a redline of current transparency and enable industry advanced funds is in accordance with the statute and law; the GDUFA Reauthorization Perform- business planning. provides resources to meet the performance ance Goals and Procedures—Fiscal Years The agreement also establishes a robust goals and procedures that were developed by 2018 through 2022; the Background for the Pre-ANDA program for complex products.

VerDate Sep 11 2014 03:44 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00026 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.030 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4723 The program will include meetings with ap- lated industry. FDA estimates that the fees Thank you for the opportunity to present plicants, guidance development and regu- negotiated in GDUFA II will average ap- our recommendations to reauthorize this latory science enhancements aimed at allow- proximately $493.6 million per year, adjusted vital program. We would be pleased to brief ing applicants with complex products to sub- annually for inflation. your staff on the details and want to work mit more complete applications and FDA to Throughout this process, the FDA has so- closely with Congress in order to reauthorize be more prepared for such submissions. licited input and worked with various stake- the program in a timely manner. The Office FDA will also make improvements to the holders, including representatives from con- of Management and Budget has advised that facility assessment program in order to in- sumer, patient, academic research, and the bill and the enclosed performance goals crease predictability, transparency and safe- health provider groups, and negotiated with are in accord with the Administration’s pro- ty. In addition, FDA has committed to ac- the regulated industry, to develop reauthor- gram. countability and reporting enhancements. ization recommendations for GDUFA that Sincerely, FDA will conduct activities to evaluate the would build upon and enhance the success of SYLVIA BURWELL, financial administration and resource alloca- the program. In addition, we have complied Secretary. tions of the GDUFA II program to help iden- with the statutory requirements to solicit tify areas to enhance operational and fiscal public comments on our recommendations, Mr. ALEXANDER. Mr. President, I efficiency and transparency. FDA will also and the summary of public comments is ask unanimous consent to have printed expand GDUFA program performance report- posted on the agency web site. in the RECORD a copy of the commit- ing to enable the regulated industry, pa- Our recommendations build upon the suc- ment letter for the Generic Drug User tients and consumer groups, and other stake- cesses of existing programs and performance Fee Act, GDUFA, reauthorization for holders to better gauge the generic drug pro- goals with step-wise improvements allowing fiscal years 2018 to 2022, known as gram’s performance. FDA the resources to establish a generic drug review program that can keep up with GDUFA II. Lastly, the agreement would revamp the There being no objection, the mate- user fee structure. GDUFA II will be funded the ever-expanding generic drug industry. at a level commensurate with the volume of The recommendations will bring all Abbre- rial was ordered to be printed in the ANDA submissions—the primary workload viated New Drug Applications (ANDAs) RECORD, as follows: driver of the program. This will allow FDA under a common review goals scheme which GDUFA REAUTHORIZATION PERFORM- the resources necessary to meet all of its calls for faster review cycles of 10 months for ANCE GOALS AND PROGRAM ENHANCE- commitments. In order to maintain a pre- standard ANDAs and eight months for pri- MENTS FISCAL YEARS 2018–2022 ority ANDAs. Priority status will be re- dictable fee base and to more closely align I. Submission Review Performance Goals served for drug shortages, first generics, sole fee responsibility with program costs and A. Original ANDAs and ANDA Amend- source generics and other public health pri- fee-paying ability, FDA and industry have ments orities. The negotiated recommendations agreed to shift the burden more toward an- B. PASs and PAS Amendments provide that FDA will communicate defi- nual program fees. To address specific small C. Unsolicited ANDA and PAS Amend- ciencies to industry throughout rather than business concerns, FDA and industry have ments at the end of a review cycle, increasing the proposed three distinct small business con- D. DMFs chances for applicants to remedy deficiencies siderations. We anticipate that the proposed E. Controlled Correspondence and obtain approval in fewer cycles. This GDUFA II will increase public access to af- F. GDUFA I Bridging will allow for improved predictability and fordable, generic drug products. II. Original ANDA Review Program En- transparency and enable industry advanced The following five enclosures are provided hancements for your consideration: The proposed GDUFA business planning. The agreement also establishes a robust A. ANDA Receipt II statutory language; a redline of current Pre-ANDA program for complex products. B. ANDA Review Transparency and Com- law; the GDUFA Reauthorization Perform- The program will include meetings with ap- munications Enhancements ance Goals and Procedures Fiscal Years 2018 plicants, guidance development and regu- C. Review Classification Changes During through 2022; the Background for the Pro- latory science enhancements aimed at allow- the Review Cycle posed Changes for Reauthorization of ing applicants with complex products to sub- D. ANDA Approval and Tentative Approval GDUFA in Fiscal Years 2018 through 2022; E. Dispute Resolution mit more complete applications and FDA to F. Other ANDA Review Program Aspira- and the summary of public comments. be more prepared for such submissions. Thank you for the opportunity to present FDA will also make improvements to the tions our recommendations to reauthorize this facility assessment program in order to in- III. Pre-ANDA Program and Subsequent vital program. We would be pleased to brief crease predictability, transparency and safe- Mid-Review-Cycle Meetings for Complex your staff on the details and want to work ty. In addition, FDA has committed to ac- Products closely with Congress in order to reauthorize countability and reporting enhancements. A. Rationale for Pre-ANDA Program, Guid- the program in a timely manner. The Office FDA will conduct activities to evaluate the ance on Enhanced Pathway for Complex of Management and Budget has advised that financial administration and resource alloca- Products the bill and the enclosed performance goals tions of the GDUFA II program to help iden- B. Controlled Correspondence are in accord with the Administration’s pro- tify areas to enhance operational and fiscal C. Product-Specific Guidance gram. efficiency and transparency. FDA will also D. Product Development Meetings Sincerely, expand GDUFA program performance report- E. Pre-Submission Meetings SYLVIA BURWELL, ing to enable the regulated industry, pa- F. Inactive Ingredient Database Enhance- Secretary. tients and consumer groups, and other stake- ments holders to better gauge the generic drug pro- G. Regulatory Science Enhancements DEPARTMENT OF HEALTH & gram’s performance. H. Safety Determination Letters HUMAN SERVICES, Lastly, the agreement would revamp the I. Other Pre-ANDA Program Aspirations Washington, DC, January 4, 2017. user fee structure. GDUFA II will be funded IV. DMF Review Program Enhancements Hon. FRANK PALLONE, at a level commensurate with the volume of A. Communication of DMF Review Com- Ranking Member, Committee on Energy and ANDA submissions—the primary workload ments Commerce, House of Representatives, Wash- driver of the program. This will allow FDA B. Teleconferences to Clarify DMF First ington, DC. the resources necessary to meet all of its Cycle Review Deficiencies DEAR REPRESENTATIVE PALLONE: The Ge- commitments. In order to maintain a pre- C. DMF First Adequate Letters neric Drug User Fee Amendments of 2012 dictable fee base and to more closely align D. DMF No Further Comment Letters (GDUFA) enacted as title III of the Food and fee responsibility with program costs and E. Guidance on Post-Approval Changes to Drug Administration Safety and Innovation fee-paying ability, FDA and industry have Type II API DMFs Act [Pub. L. 112–144], expires at the end of agreed to shift the burden more toward an- V. Facilities Fiscal Year 2017. With this letter the Admin- nual program fees. To address specific small A. Guidance on Risk-Based Site Selection istration is providing our recommendations business concerns, FDA and industry have Model for the reauthorization of GDUFA for the proposed three distinct small business con- B. Outreach to Foreign Regulators on Fiscal Years 2018–2022 (GDUFA II). siderations. We anticipate that the proposed Risk-Based Site Selection Model Under GDUFA, the revenues generated GDUFA II will increase public access to af- C. Export Support and Education of Other from fees paid by the generic pharmaceutical fordable, generic drug products. Health Authorities industry have been used to expedite the proc- The following five enclosures are provided D. Communications to Foreign Regulators ess for the review of generic drugs and to for your consideration: The proposed GDUFA E. Communication Regarding Inspections support and augment regulatory science and II statutory language; a redline of current F. GDUFA II Facility Compliance Status drug development. The expenditure of these law; the GDUFA Reauthorization Perform- Database funds is in accordance with the statute and ance Goals and Procedures—Fiscal Years VI. Enhanced Accountability and Report- provides resources to meet the performance 2018 through 2022; the Background for the ing goals and procedures that were developed by Proposed Changes for Reauthorization of A. Resource Management Planning and the Food and Drug Administration [FDA] in GDUFA in Fiscal Years 2018 through 2022; Modernized Time Reporting consultation with representatives of regu- and the summary of public comments. B. Financial Transparency and Efficiency

VerDate Sep 11 2014 03:44 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00027 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.031 S02AUPT1 S4724 CONGRESSIONAL RECORD — SENATE August 2, 2017 C. Performance Reporting submission if (i) preapproval inspection is re- b. Review and act on major amendments to VII. Definitions quired and (ii) the applicant does not submit priority PASs within 8 months of the date of GDUFA REAUTHORIZATION PERFORMANCE a Pre-Submission Facility Correspondence 2 amendment submission if (i) preapproval in- GOALS AND PROGRAM ENHANCEMENTS FIS- months prior to amendment submission, or spection is required and (ii) the applicant CAL YEARS 2018–2022 facility information Changes or is found to submits a Pre-Submission Facility Cor- This document contains the performance be incomplete or inaccurate. respondence 2 months prior to the date of goals and program enhancements for the Ge- 5. Review and act on 90 percent of standard amendment submission and the Pre-Submis- neric Drug User Fee Act (GDUFA) reauthor- and priority minor ANDA amendments with- sion Facility Correspondence is found to be ization for Fiscal Years (FYs) 2018–2022, in 3 months of the date of amendment sub- complete and accurate and remains un- changed. known as GDUFA II. It is commonly referred mission. c. Review and act on major amendments to to as the ‘‘goals letter’’ or ‘‘commitment let- TABLE FOR SECTION I(A)(1) AND (2): ORIGINAL ANDAS priority PASs within 10 months of amend- ter’’. The goals letter represents the product ment submission if (i) preapproval inspection of the Food and Drug Administration’s Submission Type Goal is required and (ii) the applicant does not (FDA’s) discussions with the regulated in- submit a Pre-Submission Facility Cor- dustry and public stakeholders, as mandated Standard Original ANDAs ...... 90% within 10 months of submission date. respondence 2 months prior to the date of by Congress. The performance goals and pro- Priority Original ANDAs ...... 90% within 8 months of submission date if applicant meets requirements under amendment submission, or facility informa- gram enhancements specified in this letter I(A)(2)(a). tion changes or is found to be incomplete or apply to aspects of the generic drug review 90% within 10 months of submission date inaccurate. program that are important for facilitating if applicant does not meet requirements as described under I(A)(2)(b). 5. Review and act on 90 percent of minor timely access to quality, affordable generic amendments to standard and priority PASs medicines. FDA is committed to meeting the within 3 months of the date of amendment performance goals specified in this letter and TABLE FOR SECTION I(A)(3)–(5): ANDA AMENDMENTS submission. to continuous improvement of its perform- ance. Submission Type Goal TABLE FOR SECTION I(B)(1) AND (2): PASs Unless otherwise stated, goals apply to co- Standard Major ANDA Amend- 90% within 8 months of submission date if horts of each fiscal year (FY). ments. preapproval inspection not required. Submission Type Goal GDUFA REAUTHORIZATION PERFORMANCE 90% within 10 months of submission date if preapproval inspection required. Standard PASs ...... 90% within 6 months of submission date if GOALS AND PROCEDURES FISCAL YEARS Priority Major ANDA Amend- 90% within 6 months of submission date if preapproval inspection not required. 2018–2022 ments. preapproval inspection not required. 90% within 10 months of submission date 90% within 8 months of submission date if if preapproval inspection required. The performance goals and procedures of preapproval inspection required and ap- Priority PASs ...... 90% within 4 months of submission date if the FDA, as agreed to under the first reau- plicant meets requirements under preapproval inspection not required. 90% within 8 months of submission date if thorization of the generic drug user fee pro- I(A)(4)(b). 90% within 10 months of submission date preapproval inspection required and ap- gram, are summarized below. if preapproval inspection required and plicant meets requirements under I(B)(2)(b). I. SUBMISSION REVIEW PERFORMANCE GOALS applicant does not meet requirements as described under I(A)(4)(c). 90% within 10 months of submission date A. Original ANDAs and ANDA Amendments Standard and Priority Minor 90% within 3 months of submission date. if preapproval inspection required and ANDA Amendments. applicant does not meet requirements as 1. Review and act on 90 percent of standard described under I(B)(2)(c). original Abbreviated New Drug Applications (ANDAs) within 10 months of the date of B. PASs and PAS Amendments ANDA submission. 1. Review and act on 90 percent of standard TABLE FOR SECTION I(B)(3)–(5): PAS AMENDMENTS 2. Review and act on 90 percent of priority Prior Approval Supplements (PASs) within Submission Type Goal original ANDAs within the applicable review the applicable review goal. goal. a. Review and act on standard PASs within Standard PAS Major Amend- 90% within 6 months of submission date if a. Review and act on priority original 6 months of the date of PAS submission if ments. preapproval inspection not required. 90% within 10 months of submission date ANDAs within 8 months of the date of ANDA preapproval inspection is not required. if preapproval inspection required. submission, if the applicant submits a Pre- b. Review and act on standard PASs within Priority PAS Amendments ...... 90% within 4 months of submission date if Submission Facility Correspondence 2 10 months of the date of PAS submission if preapproval inspection not required. 90% within 8 months of submission date if months prior to the date of ANDA submis- preapproval inspection is required. preapproval inspection required and ap- sion and the Pre-Submission Facility Cor- 2. Review and act on 90 percent of priority plicant meets requirements under respondence is found to be complete and ac- PASs within the applicable review goal. I(B)(4)(b). a. Review and act on priority PASs within 90% within 10 months of submission date curate and remains unChanged. if preapproval inspection required and b. Review and act on priority original 4 months of the date of PAS submission if applicant does not meet requirements as ANDAs within 10 months of the date of preapproval inspection is not required. described under I(B)(4)(c). b. Review and act on priority PASs within Standard and Priority Minor 90% within 3 months of submission date. ANDA submission if the applicant does not PAS Amendments. submit a Pre-Submission Facility Cor- 8 months of the date of PAS submission if (i) respondence 2 months prior to the date of preapproval inspection is required and (ii) C. Unsolicited ANDA Amendments and PAS ANDA submission or facility information the applicant submits a Pre-Submission Fa- Amendments cility Correspondence 2 months prior to the changes or is found to be incomplete or inac- 1. Review and act on unsolicited ANDA date of PAS submission and the Pre-Submis- curate. amendments and PAS amendments sub- sion Facility Correspondence is found to be 3. Review and act on 90 percent of standard mitted during the review cycle by the later complete and accurate and remains un- major ANDA amendments within the appli- of the goal date for the original submission/ changed. cable review goal. solicited amendment or the goal date as- c. Review and act on priority PASs within a. Review and act on standard major ANDA signed in accordance with Sections (I)(A)(3), 10 months of PAS submission if (i) amendments within 8 months of the date of (4) and (5) and (I)(B)(3), (4) and (5), respec- amendment submission if preapproval in- preapproval inspection is required and (ii) tively, for the unsolicited amendment. spection is not required. the applicant does not submit a Pre-Submis- 2. Review and act on unsolicited ANDA b. Review and act on standard major ANDA sion Facility Correspondence 2 months prior amendments and PAS amendments sub- amendments within 10 months of the date of to the date of PAS submission, or facility in- mitted between review cycles by the later of amendment submission if preapproval in- formation changes or is found to be incom- the goal date for the subsequent solicited spection is required. plete or inaccurate. amendment or the goal date assigned in ac- 4. Review and act on 90 percent of priority 3. Review and act on 90 percent of major cordance with Sections (I)(A)(3), (4) and (5) major ANDA amendment submissions within amendments to standard PASs within the and (I)(B)(3), (4) and (5), respectively, for the the applicable review goal. applicable review goal. unsolicited amendment. a. Review and act on major amendments to a. Review and act on priority major ANDA D. DMFs amendments within 6 months of the date of standard PASs within 6 months of the date 1. Complete the initial completeness as- amendment submission if preapproval in- of amendment submission if preapproval in- sessment review for 90 percent of Type II Ac- spection is not required. spection is not required. tive Pharmaceutical Ingredient (API) Drug b. Review and act on priority major ANDA b. Review and act on major amendments to Master Files (DMFs) within 60 days of the amendments within 8 months of amendment standard PASs within 10 months of the date later of the date of DMF submission or DMF submission if (i) preapproval inspection is re- of amendment submission if preapproval in- fee payment. quired and (ii) applicant submits a Pre-Sub- spection is required. 4. Review and act on 90 percent of major mission Facility Correspondence 2 months TABLE FOR SECTION I(D): DMFs prior to the date of amendment submission amendments to priority PASs within the ap- and the Pre-Submission Facility Correspond- plicable review goal. Submission Type Goal ence is found to be complete and accurate a. Review and act on major amendments to and remains unchanged. priority PASs within 4 months of the date of Type II API DMF ...... 90% of initial completeness assessments amendment submission if preapproval in- within 60 days of the later of the date c. Review and act on priority major ANDA of DMF submission or DMF fee payment. amendments within 10 months of amendment spection is not required.

VerDate Sep 11 2014 06:34 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00028 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.066 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4725 E. Controlled Correspondence in order to provide applicants with an oppor- ters. FDA will also grant appropriate re- 1. Review and respond to 90 percent of con- tunity for resolution within 7 calendar days. quests for teleconferences requested by ap- trolled correspondences within the applica- If such a deficiency is resolved within 7 cal- plicants upon receiving subsequent major ble review goal. endar days, that deficiency will not be a complete response letters or minor complete a. Review and respond to Standard con- basis for a refuse-to-receive decision. response letters. FDA will provide a sched- trolled correspondence within 60 days of the 3. At the time of receipt, FDA will notify uled date for 90 percent of post-CRL telecon- date of submission. the applicant in the acceptance letter wheth- ferences within 10 days of the request for a b. Review and respond to Complex con- er the ANDA or PAS is subject to priority or teleconference, and conduct 90 percent of trolled correspondence within 120 days of the standard review such post-CRL teleconferences held on the date of submission. B. ANDA Review Transparency and Commu- FDA-proposed date, within 30 days of receipt 2. In the case of controlled correspondence nications Enhancements of the written request. that raises an issue that relates to one or To promote transparency and communica- C. Review Classification Changes During the more pending citizen petitions, the 60- or 120- tion between FDA and ANDA applicants, Review Cycle day time period starts on the date FDA re- FDA will apply the review program enhance- 1. If during a review cycle of an ANDA or sponds to the petition (if there is only one ments below to the review of all ANDAs. The PAS, the review classification of the ANDA petition) or last pending petition. goal of these program enhancements is to or PAS changes from Standard to Priority, 3. FDA will review and respond to 90% of improve predictability and transparency, FDA will notify the applicant within 14 days submitter requests to clarify ambiguities in promote the efficiency and effectiveness of of the date of the change. the controlled correspondence response with- the review process, minimize the number of 2. If a previous ANDA or ANDA amend- in 14 days of receipt of the request. The re- review cycles necessary for approval, in- ment was subject to priority review, but a sponse to the submitter’s request will pro- crease the overall rate of approval, and fa- subsequent ANDA amendment is subject to vide clarification or advice concerning the cilitate greater access to generic drug prod- standard review, FDA will notify applicant ambiguity in the controlled correspondence ucts. within 14 days of the date of receipt of the response. 1. FDA will issue the appropriate Informa- solicited amendment. tion Request(s) (IR(s)) and/or Discipline Re- 3. A request for a change may occur at any TABLE FOR SECTION I(E): CONTROLLED CORRESPONDENCE view Letter(s) (DRL(s)) from each review dis- time during the review. Submission Type Goal cipline as soon as the discipline has com- 4. Once an ANDA or PAS submission is pleted its review, with the first IR(s) and/or classified as being subject to priority review, Standard Controlled Cor- 90% within 60 days of submission date. DRL(s) at about the mid-point of the review. the application will retain such priority re- respondence. 2. Following the IR and/or DRL at about view classification status until FDA takes Complex Controlled Cor- 90% within 120 days of submission date. respondence. the mid-point of the review, IRs and/or DRLs an action on the submission. will, as appropriate, continue from each re- 5. FDA will include an explanation of the FDA will review and respond to 90% of submitter requests to clarify ambi- view discipline on a rolling basis. reasons for any denial of a review status re- guities in the controlled correspondence request within 14 days of re- quest receipt 3. Neither IRs nor DRLs stop the review classification request. clock or add to a GDUFA goal. 6. If an applicant requests a teleconference F. GDUFA I Bridging 4. If an applicant is unable to completely as part of its request to reclassify a major 1. Continue to review and act on ANDAs respond within the time frame requested by amendment or standard review status, FDA and ANDA amendments, PASs and PAS FDA, including any extensions that may be will schedule and conduct the teleconference amendments and controlled correspondence granted by FDA, then FDA will generally and decide 90% of such reclassification re- submitted prior to October 1, 2017 that have issue a Complete Response Letter (CRL). quests within 30 days of the date of FDA’s re- been assigned GDUFA I goal dates pursuant 5. FDA will continue to issue IRs and/or ceipt of the request for a teleconference. to the GDUFA I review metrics applicable to DRLs late in the review cycle, until it is no This goal only applies when applicant ac- those submissions. longer feasible, within the current review cepts the first scheduled teleconference date 2. Review and act on 90% of ANDAs and cycle, for applicant to develop and FDA to offered by FDA. ANDA amendments with Target Action review a complete response to the IR and/or D. ANDA Approval and Tentative Approval DRL. Dates (TADs) by the goal date. The TAD for If applicants submit and maintain ANDAs 6. FDA should continue to work through an ANDA or ANDA amendment becomes its consistent with the statutory requirements the goal date if in FDA’s judgment continued GDUFA II goal date. (Attachment A shows for approval under 505(j); respond to IRs and work would likely result in an imminent how FDA, until September 30, 2017, assigned DRLs completely and within the time frames tentative approval that could prevent for- TADs to ANDA amendments not subject to requested by FDA and timely submit all re- feiture of 180-day exclusivity or in an immi- GDUFA I review goals.) quired information under 21 CFR parts 314 nent approval. 3. Review and act on 90% of ANDAs and and 210, including information concerning 7. FDA will strive to act prior to a goal ANDA amendments pending FDA as of Octo- notice (21 CFR 314.95), litigation status (21 date when the review is done and there are ber 1, 2017 that were not subject to GDUFA CFR 314.107), and commercial marketing (21 no outstanding issues. I goal dates and either (a) were not pre- CFR 314.107); then FDA will strive to approve 8. If in the ordinary course a Regulatory viously assigned TADs or (b) were previously approvable ANDAs in the first review cycle; Project Manager (RPM) learns that a major assigned TADs that came due prior to Octo- to approve potential first generics on the deficiency is likely forthcoming, the RPM ber 1, 2017 but remain pending in the same earliest lawful ANDA approval date, if will notify the Authorized Representative review cycle as of October 1, 2017, by GDUFA known to FDA; and to tentatively approve that a major deficiency is likely forth- II ANDA and ANDA amendment goal dates first to file Paragraph IV ANDAs so as to coming. If the Authorized Representative that FDA will assign on October 1, 2017. No avoid forfeiture of 180-day exclusivity. such goal date shall be later than July 31, raises concerns or seeks additional informa- E. Dispute Resolution 2018. tion regarding the forthcoming major defi- 4. Review and act on amendments received ciency, the RPM will encourage the Author- 1. An applicant may pursue a request for on or after October 1, 2017, to any ANDAs ized Representative to review the forth- reconsideration within the review discipline submitted prior to October 1, 2017, pursuant coming deficiency upon receiving it. at the Division level or original signatory to the amendment review goals set forth in 9. If in the ordinary course an RPM learns authority, as needed. (A)(3)–(5) of this section. that FDA is likely to miss the goal date for 2. The Office of Generic Drugs (OGD) Office the submission, the RPM will notify the Au- of Regulatory Operations Associate Director II. ORIGINAL ANDA REVIEW PROGRAM thorized Representative of the outstanding will track each request for Division level re- ENHANCEMENTS discipline(s), the general nature of the delay consideration through resolution. A. ANDA Receipt (when possible), and the estimated time- 3. Following resolution of a request for re- 1. FDA will strive to determine whether to frame for receiving the response. consideration, an applicant may pursue for- receive ANDAs within 60 days of the date of 10. The Authorized Representative may pe- mal dispute resolution above the Division ANDA submission. riodically request a Review Status Update. level, pursuant to procedures set forth in the 2. To enable FDA to rapidly determine In response to the Authorized Representa- September 2015 Guidance, Formal Dispute whether to receive an ANDA pursuant to 21 tive’s request, the RPM will timely provide a Resolution: Appeals Above the Division Code of Federal Regulations (CFR) 314.101, Review Status Update. Level. and with consideration of final agency guid- 11. FDA will include in the CRL its basis 4. FDA will respond to appeals above the ances that address ANDA receipt determina- for classifying a responding amendment Division level within 30 calendar days of the tions, FDA will issue a Manual of Policies Major. Center for Drug Evaluation and Research’s and Procedures (MAPP) by October 1, 2017 12. Applicants may opt for a post-CRL tele- (CDER’s) receipt of the written appeal pursu- setting forth procedures for filing reviewers conference to seek clarification concerning ant to the applicable goal. on communication of minor technical defi- deficiencies identified in a CRL. FDA will a. In FY 2018, the goal is 70 percent. ciencies (e.g., document legibility); and on grant appropriate requests for telecon- b. In FY 2019, the goal is 80 percent. deficiencies potentially resolved with infor- ferences requested by applicants upon receiv- c. In FY 2020, 2021, and 2022 the goal is 90 mation in the ANDA at original submission, ing first cycle major complete response let- percent.

VerDate Sep 11 2014 04:29 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00029 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.068 S02AUPT1 S4726 CONGRESSIONAL RECORD — SENATE August 2, 2017 5. CDER’s Formal Dispute Resolution c. A controlled correspondence response d. In FYs 2021 and 2022, FDA will conduct Project Manager (or designee) will track would not adequately address the prospec- 90 percent of such meetings within 120 days each formal appeal above the Division level tive applicant’s questions, and of granting them. through resolution d. A Product Development Meeting would 5. If appropriate to the purpose of the F. Other ANDA Review Program Aspirations significantly improve ANDA review effi- meeting, FDA will provide preliminary writ- ciency. ten comments 5 calendar days before each 1. FDA aspires to continually improve the 2. Dependent on available resources, FDA meeting, and meeting minutes within 30 cal- efficiency of the ANDA review program. may grant a prospective applicant a Product 2. The absence of a GDUFA II commitment endar days of the meeting. Development Meeting concerning Complex for a specific program function does not F. Mid-Review-Cycle Meetings for Complex Product development issues other than those imply that the program function is not im- Products described in Section III(D)(1)(a) above if, in portant. For example, other program func- FDA’s judgment: As set forth in guidance issued pursuant to tions include determinations whether listed a. The prospective applicant submits a Section III(A)(1), the Project Manager and drugs were voluntarily withdrawn from sale complete meeting package, including a data other appropriate members of the FDA re- for reasons of safety or effectiveness and package and specific proposals, view team will call the applicant to provide ANDA proprietary name reviews. b. A controlled correspondence response the applicant with an update on the status of III. PRE-ANDA PROGRAM AND SUBSEQUENT MID- would not adequately address the prospec- the review of their application. An agenda REVIEW-CYCLE MEETINGS FOR COMPLEX PROD- tive applicant’s questions, and will be sent to the applicant prior to the UCTS c. A Product Development Meeting would mid-review-cycle meeting. The Project Man- A. Rationale for Pre-ANDA Program, Guidance significantly improve ANDA review effi- ager will coordinate the specific date and on Enhanced Pathway for Complex Prod- ciency. time of the telephone call with the appli- ucts 3. FDA will grant or deny 90% of Product cant. The goal of the pre-ANDA program is to Development Meeting requests within the G. Inactive Ingredient Database Enhancements clarify regulatory expectations for prospec- applicable goal. 1. By October 1, 2020, FDA will complete a. In FYs 2018 and 2019, the goal is 30 days tive applicants early in product develop- enhancements to the Inactive Ingredient from receipt of the request. ment, assist applicants to develop more com- Database so users can perform electronic b. In FYs 2020, 2021 and 2022, the goal is 14 plete submissions, promote a more efficient queries to obtain accurate Maximum Daily days from receipt of the request. and effective ANDA review process, and re- Intake and Maximum Daily Exposure infor- 4. FDA will conduct Product Development duce the number of review cycles required to mation for each route of administration for Meetings granted pursuant to the applicable obtain ANDA approval, particularly for Com- which data is available. goal. 2. FDA will update the Inactive Ingredient plex Products. a. In FY 2018, FDA will conduct 60 percent Database on an ongoing basis, and post quar- 1. FDA will issue guidance describing an of such meetings within 120 days of granting terly notice of updates made. Such notices enhanced pathway for Complex Products, in- them. will include each change made and, for each cluding policies and procedures for Product b. In FY2019, FDA will conduct 70 percent change, the information replaced. Development Meetings, pre-submission of such meetings within 120 days of granting meetings, and mid-review cycle meetings. An them. H. Regulatory Science Enhancements ANDA applicant who was granted a Product c. In FY2020, FDA will conduct 80 percent FDA will conduct internal and external re- Development Meeting has the option of a of such meetings within 120 days of granting search to support fulfilment of submission pre-submission meeting with FDA and also them. review and pre-ANDA commitments set forth the option of a mid-review-cycle meeting d. In FYs 2021 and 2022, FDA will conduct in Sections I and III, respectively. with FDA, subject to policies and procedures 90 percent of such meetings within 120 days 1. Annually, FDA will conduct a public to be set forth in the guidance. of granting them. workshop to solicit input from industry and B. Controlled Correspondence 5. FDA can meet the Product Development stakeholders for inclusion in an annual list 1. FDA will review and respond to standard Meeting Goal by either conducting a meeting of GDUFA II Regulatory Science initiatives. controlled correspondence and to complex or providing a meaningful written response Interested parties may propose regulatory controlled correspondence with meaningful that will inform drug development and/or science initiatives via email to responses that can more consistently inform regulatory decision making to the prospec- [email protected]. After considering drug development and/or regulatory decision tive applicant, within the applicable goal Industry and stakeholder input, FDA will making pursuant to the applicable metric date. post the list on FDA’s website. goals. 6. Unless FDA is providing a written re- 2. If Industry forms a GDUFA II regulatory sponse to satisfy the Product Development C. Product-Specific Guidance science working group, then upon request of Meeting goal, FDA will provide preliminary the working group to the Director of the Of- 1. FDA will issue product-specific guidance written comments before each Product De- fice of Research and Standards in the Office identifying the methodology for developing velopment Meeting (and aspire to provide of Generic Drugs, FDA will meet with the drugs and generating evidence needed to sup- the written comments 5 calendar days before working group twice yearly to discuss cur- port ANDA approval, for 90 percent of new the meeting), and will provide meeting min- rent and emerging challenges and concerns. chemical entity New Drug Applications that utes within 30 calendar days following the FDA will post minutes of these meetings on are approved on or after October 1, 2017, at meeting. its website. least 2 years prior to the earliest lawful E. Pre-Submission Meetings 3. Annually, FDA will report on its website ANDA filing date. the extent to which GDUFA regulatory 2. This goal shall not apply to Complex 1. Prospective applicants may request and science-funded projects support the develop- Products. FDA will strive to issue guidance FDA will conduct pre-submission meetings, ment of generic drug products, the genera- for a Complex Product as soon as scientific subject to Section III(A)(1). An applicant’s tion of evidence needed to support efficient recommendations are available. decision not to request a pre-submission 3. FDA will continue to develop and issue meeting will not prejudice the receipt or re- review and timely approval of ANDAs, and product-specific guidance based on requests view of an ANDA. the evaluation of generic drug equivalence. from industry and public health priorities as 2. FDA will grant or deny 90% of pre-sub- I. Safety Determination Letters set forth in the CDER Prioritization MAPP. mission meeting requests within the applica- 1. FDA will issue 90% of safety determina- 4. Industry may request that FDA develop ble goal. tion letters within 60 days of the date of sub- a. In FYs 2018 and 2019, the goal is 30 days. product-specific guidance via email to mission of disclosure authorization. [email protected]. b. In FYs 2020, 2021, and 2022, the goal is 14 days. J. Other Pre-ANDA Program Aspirations D. Product Development Meetings 3. If an applicant did not have a Product 1. FDA aspires to continually improve the 1. FDA will grant a prospective applicant a Development Meeting, FDA may grant a pre- effectiveness of its pre-ANDA activity. Product Development Meeting if, in FDA’s submission meeting if in FDA’s judgment 2. The absence of a GDUFA II commitment judgment: the pre-submission meeting would improve for a specific program function does not a. The requested Product Development review efficiency. imply that the program function is not im- Meeting concerns: 4. FDA will conduct pre-submission meet- portant. For example, notwithstanding the i. Development of a Complex Product for ings granted pursuant to the applicable goal. absence of a GDUFA II commitment, FDA which FDA has not issued product-specific a. In FY 2018, FDA will conduct 60 percent aspires to respond to Suitability Petitions in guidance or of such meetings within 120 days of granting a more timely and predictable manner. ii. An alternative equivalence evaluation them. IV. DMF REVIEW PROGRAM ENHANCEMENTS (i.e., change in study type, such as in vitro to b. In FY 2019, FDA will conduct 70 percent clinical) for a Complex Product for which of such meetings within 120 days of granting A. Communication of DMF Review Comments FDA has issued product-specific guidance, them. 1. FDA will ensure that DMF review com- b. The prospective applicant submits a c. In FY 2020, FDA will conduct 80 percent ments submitted to the DMF holder are complete meeting package, including a data of such meetings within 120 days of granting issued at least in parallel with the issuance package and specific proposals, them. of review comments relating to the DMF for

VerDate Sep 11 2014 04:29 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00030 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.069 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4727 the ANDA. This commitment applies to com- site named in the ANDA, PAS, or associated the GDUFA program is resourced and how ments to the applicant issued in any ANDA Type II DMF and identifies outstanding those resources are utilized, and recommend CRL and comments issued in the first IR let- issues that could prevent approval of an improvements to the process. ter by the drug product review discipline. ANDA or PAS, the applicant will be notified 2. FDA will use the results of that evalua- B. Teleconferences to Clarify DMF First Cycle that issues exist through an IR, DRL or CRL tion to create an ongoing financial reporting Review Deficiencies pursuant to Section II(B)) above. mechanism to enhance the transparency of 1. FDA will grant and conduct telecon- 2. By October 1, 2018, FDA agrees to com- GDUFA program resource utilization. ferences when requested to clarify defi- municate to the facility owner final inspec- 3. FDA will publish a GDUFA 5-year finan- ciencies in first cycle DMF deficiency let- tion classifications that do not negatively cial plan no later than the 2nd quarter of FY ters. impact approvability of any pending applica- 2018. FDA will publish updates to the 5-year 2. DMF holders must request such telecon- tion within 90 days of the end of the inspec- plan no later than the 2nd quarter of each ferences in writing within 20 business days of tion. FDA agrees to ongoing periodic engage- subsequent fiscal year. issuance of the first cycle DMF deficiency ment with industry stakeholders to provide 4. FDA will convene a public meeting no letter, identifying specific issues to be ad- updates on agency activities and seek stake- later than the third quarter of each fiscal dressed. FDA may initially provide a written holder feedback. year starting in FY 2019 to discuss the response to the request for clarification, but F. GDUFA II Facility Compliance Status GDUFA 5-year financial plan, along with the if the DMF holder indicates that a tele- Database—By January 1, 2019, FDA will up- Agency’s progress in implementing modern- conference is still desired, FDA will schedule date its existing, publicly available database ized time reporting and resource manage- the teleconference. that describes the compliance status of ment planning. 3. FDA will strive to grant such telecon- GDUFA self-ID facilities and sites. Compli- C. Performance Reporting ance status is based on the most recent in- ferences within 30 days, giving priority to 1. FDA will publish the following monthly spection or related FDA action for facilities DMFs based on the priority of the ref- metrics on its website, using a consistent, involved in any manufacturing activities erencing ANDA. publicly disclosed reporting methodology: subject to Current Good Manufacturing 4. In lieu of a teleconference, the DMF a. Number of ANDAs and ANDA amend- Practices (CGMP) inspection and for sites in- holder may submit a request for an email ex- ments, DMFs, Changes Being Effected (CBEs) volved in the conduct or analysis of bio- change between FDA and the DMF holder. and PASs submitted in the reporting month analytical or clinical bioequivalence/bio- The request must identify specific issues to delineated by type of submission, availability studies conducted to support an be addressed. After FDA responds to the re- b. Number each of ANDAs and PASs FDA ANDA. The database will be updated every 30 quest, the DMF holder may submit, and FDA refused for receipt in the reporting month, days and will reflect FDA’s final assessment will respond to, one follow up email to ob- c. Number of actions taken in the report- of the facility or site following an FDA in- tain additional clarification. ing month delineated by the type of action. spection and review of the inspected entity’s C. DMF First Adequate Letters For purposes of the metrics, actions shall timely response to any documented observa- 1. Once a DMF has undergone a full sci- include final approvals, tentative approvals, tions. The public website containing the entific review and has no open issues related complete response letters, information re- database will also include an explanation of to the review of the referencing ANDA, FDA quests, and discipline review letters (or other terms used to describe the compliance status will issue a First Adequate Letter. such nomenclature as FDA determines to re- of facilities and sites. D. DMF No Further Comment Letters flect the concepts of an information request 1. Once a DMF has undergone a complete VI. ENHANCED ACCOUNTABILITY AND REPORTING or complete response letter), and review and the ANDA referencing the DMF FDA will build internal capacity to enable d. Number of first cycle approvals and ten- has been approved or tentatively approved, improved productivity and performance tative approvals in the reporting month. FDA will issue a no further comment letter. through regular assessment of progress to- 2. FDA will publish the following quarterly E. Guidance on Post-Approval Changes to Type wards GDUFA goals, consistent methodolo- metrics on its website, using a consistent, II API DMFs. gies for and timely reporting of GDUFA publicly disclosed reporting methodology: metrics, and transparent and efficient ad- a. Number of ANDAs and PASs withdrawn 1. By October 1, 2018, FDA will issue a guid- ministration; allocation and reporting of in each reporting month, ance regarding post-approval changes to a user fee resources. b. Number of ANDAs awaiting applicant Type II API DMF and submission mecha- action, and nisms for ANDA applicants who reference A. Resource Management Planning and Mod- ernized Time Reporting c. Number of ANDAs awaiting FDA action. the Type II API DMF. d. Mean and median approval and tentative FDA is committed to enhancing manage- V. FACILITIES approval times for the quarterly action co- ment of the GDUFA program in GDUFA II. A. Guidance on Risk-Based Site Selection hort. 1. FDA will conduct activities to develop a Model—Issue a guidance explaining the Agen- 3. FDA will publish the following metrics resource management planning function and cy’s risk-based site surveillance model for annually as part of the GDUFA Performance modernized time reporting approach in human pharmaceutical manufacturing estab- Report: GDUFA II. FDA will staff a planning team lishments, including a discussion of the risk a. Mean and median approval and tentative responsible for these activities and for pub- factors incorporated in the model and how approval times by FY receipt cohort, lishing a GDUFA program resource manage- the model is used to help determine which b. Mean and median ANDA approval times, ment planning and modernized time report- establishments are scheduled to receive a including separate reporting of mean and ing implementation plan no later than surveillance inspection each year. median times for first cycle approvals, fourth quarter FY 2018. B. Outreach to Foreign Regulators on Risk- c. Mean and median number of ANDA re- 2. FDA will obtain through a contract with Based Site Selection Model—Undertake out- view cycles to approval and tentative ap- an independent third party an evaluation of reach activities to better inform other phar- proval by FY receipt cohort, options and recommendations for a new maceutical regulators of FDA’s risk-based d. Number of GDUFA related telecon- methodology to accurately assess changes in surveillance model. ferences requested, granted, denied and con- the resource needs of the human generic C. Export Support and Education of Other ducted, broken down by type of teleconfer- drug review program and how to monitor and Health Authorities—Support the export of safe ence, report on those needs moving forward. The and effective pharmaceutical products by the e. Number of applications received, refused report will be published no later than the U.S.-based pharmaceutical industry, includ- to receive, and average time to receipt deci- end of FY 2020 for public comment. Upon re- ing but not limited to timely updates to sion, view of the report and comments, FDA will FDA’s Facility Compliance Status Database f. Number of product development, pre-sub- implement robust methodologies for assess- as described below, and educating other mission and mid-review cycle meetings re- ing resource needs of the program and track- health authorities regarding FDA’s surveil- quested, granted, denied and conducted, by ing resource utilization across the program lance inspection program and the meaning of face to face or in writing, elements. inspection classifications. g. Number of inspections conducted by do- D. Communications to Foreign Regulators— B. Financial Transparency and Efficiency mestic or foreign establishment location and Upon receipt of a written or email request by FDA is committed to ensuring GDUFA inspection type (Pre-Approval Inspection an establishment physically located in the user fee resources are administered, allo- (PAI), Good Manufacturing Practices (GMP), U.S. that has been included as part of a mar- cated, and reported in an efficient and trans- Bioequivalence (BE) clinical and BE analyt- keting application submitted to a foreign parent manner. FDA will conduct activities ical) and facility type (Finished Dosage regulator, issue within 30 days of the date of to evaluate the financial administration of Form (FDF), API, etc.), receipt of the request a written communica- the GDUFA program to help identify areas h. Median time from beginning of inspec- tion to that foreign regulator conveying the to enhance operational and fiscal efficiency. tion to 483 issuance, current compliance status for the establish- FDA will also conduct activities to enhance i. Median time from 483 issuance to Warn- ment. transparency of how GDUFA program re- ing Letter, Import Alert and Regulatory E. Communication Regarding Inspections sources are used. Meeting for inspections with final classifica- 1. By May 31, 2018, when FDA conducts an 1. FDA will contract with an independent tion of Official Action Indicated (OAI) (or application-related inspection of a facility or third party to evaluate and report on how equivalent),

VerDate Sep 11 2014 04:29 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00031 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.070 S02AUPT1 S4728 CONGRESSIONAL RECORD — SENATE August 2, 2017 j. Median time from date of Warning Let- and associated DMFs as well as consults ufacturing or testing facility, the cor- ter, Import Alert and Regulatory Meeting to with other agency components. respondence includes facility name, oper- resolution of the OAI status (or equivalent), H. Complex controlled correspondence— ation(s) performed, facility contact name, k. Number of ANDAs accepted for standard means: address, FEI number (if a required registrant review and priority review, 1. Controlled correspondence involving or one has been assigned), DUNS number, l. Number of suitability petitions pending evaluation of clinical content, registration information (for required reg- a substantive response for more than 270 2. Bioequivalence protocols for Reference istrants), a confirmation that the facility is days from the date of receipt, Listed Drugs with Risk Evaluation and Miti- ready for inspection, a description of the m. Number of petitions to determine gation Strategies (REMS) Elements To As- manufacturing process, and a certification whether a listed drug has been voluntarily sure Safe Use (ETASU), or by the applicant that any Type II DMF has withdrawn from sale for reasons of safety or 3. Requested evaluations of alternative bio- similarly complete and accurate facility in- effectiveness pending a substantive response equivalence approaches within the same formation as required by 21 CFR for more than 270 days from the date of re- study type (e.g., pharmacokinetic, in vitro, 314.50(d)(1)(i), including complete facility in- ceipt, clinical). formation (i.e., facility name, operation, fa- n. Percentage of ANDA proprietary name I. Complex Product—generally includes: cility contact name, address, FEI number requests reviewed within 180 days of receipt, 1. Products with complex active ingredi- and DUNS number). Facility information o. Number of DMF First Adequate Letters ents (e.g., peptides, polymeric compounds, that is included in a corresponding Type II issued, and complex mixtures of APIs, naturally sourced DMF is not required to be duplicated in the p. Number of email exchanges requested ingredients); complex formulations (e.g., Pre-Submission Facility Correspondence for and conducted in lieu of teleconferences to liposomes, colloids); complex routes of deliv- the ANDA. clarify deficiencies in first cycle DMF defi- ery (e.g., locally acting drugs such as der- 2. All sites or organizations involved in ciency letters. matological products and complex ophthal- bioequivalence and clinical studies used to VII. DEFINITIONS mological products and otic dosage forms support the ANDA submission as described that are formulated as suspensions, emul- in 21 CFR 314.94(a)(7). This information is A. Act on an application—means FDA will sions or gels) or complex dosage forms (e.g., either issue a complete response letter, an provided using a standardized electronic for- transdermals, metered dose inhalers, ex- mat and includes unique identifiers that are approval, a tentative approval, or a refuse- tended release injectables) to-receive action. current and accurate, including site or orga- 2. Complex drug-device combination prod- nization name, address and website; and B. Ambiguity in the controlled correspond- ucts (e.g., auto injectors, metered dose inhal- ence response—means the controlled cor- study information including a listing of ers); and study names, dates of conduct and main in- respondence response or a critical portion of 3. Other products where complexity or un- it, in FDA’s judgment, merits further clari- vestigators. certainty concerning the approval pathway T. Pre-submission meeting—means a meet- fication. or possible alternative approach would ben- ing in which an applicant has an opportunity C. Appropriate, with respect to a request efit from early scientific engagement. to discuss and explain the format and con- for a post-CRL teleconference—means a com- J. Days—unless otherwise specified, means tent of an ANDA to be submitted. Although plete and clear request for a teleconference calendar days. the proposed content of the ANDA will be where the applicant’s goal is to gain an un- K. Discipline review letter (DRL)—means a discussed, pre-submission meetings will not derstanding of specific deficiencies and ex- letter used to convey preliminary thoughts include substantive review of summary data pectations for resolution. on possible deficiencies found by a discipline D. Authorized Representative—means the or full study reports. reviewer and/or review team for its portion U. Priority—means submissions affirma- authorized point of contact identified in ap- of the pending application at the conclusion tively identified as eligible for expedited re- plicant’s letter of authorization or Form of the discipline review. view pursuant to CDER’s Manual of Policy 356h. An Authorized Representative may des- L. Earliest lawful ANDA approval date— and Procedures (MAPP) 5240.3, Prioritization ignate an alternate to serve in the Author- the first date on which no patent or exclu- of the Review of Original ANDAs, Amend- ized Representative’s absence. sivity prevents full approval of an ANDA ments and Supplements, as revised (the E. Change, with respect to facility infor- M. First adequate letter—a communication CDER Prioritization MAPP). mation—means a change to information in from FDA to DMF holder indicating that the V. Product Development Meeting—means a the Pre-Submission Facilities Correspond- DMF has no open issues related to the review meeting involving a scientific exchange to ence that causes FDA to re-evaluate its fa- of the referencing ANDA. Issued only at the discuss specific issues (e.g., a proposed study cility assessment (i.e., assess the impact of conclusion of the first DMF review cycle design, alternative approach or additional the change on its previous recommendation), that determines the DMF does not have any study expectations) or questions, in which such as a change in facility (as described by open issues. FDA will provide targeted advice regarding address, FDA Establishment Identification N. First generic—any received ANDA (1) an ongoing ANDA development program. (FEI) number, or Data Universal Numbering that is a first-to-file ANDA eligible for 180- W. Review Status Update—means a re- System (DUNS) number), change in oper- day exclusivity or for which there are no sponse from the RPM to the Authorized Rep- ation(s) performed by a facility, addition of blocking patents or exclusivities and (2) for resentative to update the Authorized Rep- a new facility, withdrawal of a facility used which there is no previously approved ANDA resentative concerning, at a minimum, the to generate data to meet application require- for the drug product. categorical status of relevant review dis- ments or intended for commercial produc- O. Information Request (IR)—means a let- ciplines with respect to the submission at tion, or a change in inspection readiness ter that is sent to an applicant during a re- that time. The RPM will advise the Author- (i.e., a facility is no longer ready for inspec- view to request further information or clari- ized Representative that the update is pre- tion). fication that is needed or would be helpful to liminary only, based on the RPM’s interpre- F. Complete response letter (CRL)—refers allow completion of the discipline review. tation of the submission, and subject to to a written communication to an applicant P. Major amendment—means a major change at any time. or DMF holder from FDA usually describing amendment as described in CDER’s Decem- X. Safety determination letter—a letter all of the deficiencies that the agency has ber 2001 Guidance for Industry: Major, Minor from FDA stating that a bioequivalence identified in an abbreviated application (in- and Telephone Amendments to Abbreviated study protocol contains safety protections cluding pending amendments) or a DMF that New Drug Applications. comparable to applicable REMS for the Ref- must be satisfactorily addressed before the Q. Mid-review-cycle meeting—after the erence Listed Drug. ANDA can be approved. Complete response last key discipline has issued its IR and/or Y. Standard—means submissions not af- letters will reflect a complete review which DRL, for ANDAs that were the subject of firmatively identified as eligible for expe- includes an application-related facilities as- prior Product Development Meetings or pre- dited review pursuant to the CDER sessment and will require a complete re- submission meetings, CDER will schedule a Prioritization MAPP. sponse from industry to restart the clock. teleconference meeting with the applicant to Z. Standard controlled correspondence— Refer to 21 CFR 314.110 for additional details. discuss current concerns with the applica- means controlled correspondence When a citizen petition may impact the ap- tion and next steps. 1. as described in CDER’s September 2015 provability of the ANDA, FDA will strive to R. Minor amendment—means a minor Guidance for Industry, Controlled Cor- address, where possible, valid issues raised in amendment as described in CDER’s Decem- respondence Related to Generic Drug Devel- a relevant citizen petition in the complete ber 2001 Guidance for Industry: Major, Minor opment, or response letter. If a citizen petition raises an and Telephone Amendments to Abbreviated 2. concerning post-approval submission re- issue that would delay only part of a com- New Drug Applications. quirements that are not covered by CDER plete response, a response that addresses all S. Complete and accurate Pre-Submission post-approval changes guidance and are not other issues will be considered a complete re- Facility Correspondence—lists all of the fol- specific to an ANDA. sponse. lowing: AA. Target Action Date (TAD)—Under G. Complete review—refers to a full divi- 1. All facilities involved in manufacturing GDUFA I, FDA’s aspirational deadline for sion-level review from all relevant review processes and testing for the ANDA and cor- action on a pre-GDUFA I Year 3 original disciplines, including inspections, and in- responding Type II API DMF as required by ANDA and/or a complete response amend- cludes other matters relating to the ANDAs 21 CFR 314.50(d)(1)(i) and (iii). For each man- ment or equivalent IR to an original ANDA.

VerDate Sep 11 2014 04:29 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00032 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.071 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4729 GDUFA I TADs become GDUFA II goal dates response, unless otherwise agreed to by the ments considered routine or administrative on enactment of GDUFA II. applicant. in nature that do not require scientific re- CC. Unsolicited amendment—an amend- view (e.g., requests for final ANDA approval, BB. Teleconference—means a verbal com- ment with information not requested by patent amendments, and general correspond- munication by telephone, and not a written FDA except for those unsolicited amend- ence). GDUFA II COMMITMENT LETTER, ATTACHMENT A

Category Pre-cohort Year 3 ANDAs Pre-cohort Year 3 ANDAs (expedited status)

Major Amendment (Complete Response Letter) ...... 10 months ...... 7 months Minor Amendment (Complete Response Letter) ...... 5 months ...... 3 months Easily Correctable Deficiency ...... 3 months. Information Request ...... 3 months.

Mr. ALEXANDER. Mr. President, I 2017 through 2019, the average Total Time to consists of a fax, email, or other written ask unanimous consent to have printed Decision goal for FDA and industry is 315 communication that a) identifies the re- in the RECORD a copy of the commit- calendar days. viewer assigned to the submission, b) ac- ment letter for the Medical Device For Original PMA and Panel Track Supple- knowledges acceptance/rejection of the sub- ment submissions received in Fiscal Years mission, and c) if the submission included a User Fee Amendments of 2017. 2018 through 2020, the average Total Time to request for a meeting or teleconference and There being no objection, the mate- Decision goal for FDA and industry is 310 is accepted, either confirms one of the appli- rial was ordered to be printed in the calendar days. cant’s requested meeting dates or provides RECORD, as follows: For Original PMA and Panel Track Supple- two alternative dates prior to day 75 from re- MDUFA PERFORMANCE GOALS AND PROCE- ment submissions received in Fiscal Years ceipt of accepted submission. A determina- DURES, FISCAL YEARS 2018 THROUGH 2022 2019 through 2021, the average Total Time to tion that the request does not qualify as a Pre-Submission will require the concurrence GENERAL Decision goal for FDA and industry is 300 of the branch chief and the reason for this The performance goals and procedures calendar days. For Original PMA and Panel Track Supple- determination will be provided to the appli- agreed to by the Center for Devices and Ra- cant in the above written communication. diological Health (CDRH) and the Center for ment submissions received in Fiscal Years 2020 through 2022, the average Total Time to FDA intends to reach agreement with the Biologics Evaluation and Research (CBER) applicant regarding a meeting date within 30 of the United States Food and Drug Adminis- Decision goal for FDA and industry is 290 calendar days. days from receipt of accepted submission. tration (‘‘FDA’’ or ‘‘the Agency’’) for the For all requests for meetings or telecon- medical device user fee program in the Med- B. 510(k) ferences that do not have such a meeting or ical Device User Fee Amendments of 2017, FDA will report on an annual basis the av- teleconference scheduled by 30 days from re- are summarized below. erage Total Time to Decision as defined in ceipt of an accepted submission, an FDA FDA and the industry are committed to Section VII.H for the most recent closed re- manager will contact the applicant to re- protecting and promoting public health by ceipt cohort. solve scheduling issues by the 40th day. providing timely access to safe and effective For 510(k) submissions received beginning FDA will provide written feedback that ad- medical devices. Nothing in this letter pre- in Fiscal Year 2018, the average Total Time dresses the issues raised in the pre-submis- cludes the Agency from protecting the public to Decision goal for FDA and industry is 124 sion request within 70 calendar days of re- health by exercising its authority to provide calendar days. ceipt date or five calendar days prior to a a reasonable assurance of the safety and ef- For 510(k) submissions received beginning scheduled meeting, whichever comes sooner, fectiveness of medical devices. Both FDA in Fiscal Year 2019, the average Total Time for at least 1,530 Pre-Submissions received in and the industry are committed to the spirit to Decision goal for FDA and industry is 120 FY 2018, at least 1,645 Pre-Submissions re- and intent of the goals described in this let- calendar days. ceived in FY 2019, at least 1,765 Pre-Submis- ter. For 510(k) submissions received beginning sions received in FY 2020, at least 1,880 Pre- I. SHARED OUTCOME GOALS in Fiscal Year 2020, the average Total Time Submissions received in FY 2021, and at least The program and initiatives outlined in to Decision goal for FDA and industry is 116 1,950 Pre-Submissions received in FY 2022. this document are predicated on significant calendar days. FDA will provide such timely written feed- interaction between the Agency and appli- For 510(k) submissions received beginning back for additional Pre-Submissions as re- cants. FDA and representatives of the indus- in Fiscal Year 2021, the average Total Time sources permit, but not to the detriment of try agree that the process improvements to Decision goal for FDA and industry is 112 meeting the quantitative review timelines outlined in this letter, when implemented by calendar days. and statutory obligations. Written feedback all parties as intended, should reduce the av- For 510(k) submissions received beginning will be provided to the applicant by email or erage Total Time to Decision for PMA appli- in Fiscal Year 2022, the average Total Time fax and will include: written responses to the cations and 510(k) submissions, provided that to Decision goal for FDA and industry is 108 applicant’s questions; FDA’s suggestions for the total funding of the device review pro- calendar days. additional topics for the meeting or tele- conference, if applicable; or, a combination gram adheres to the assumptions underlying II. REVIEW PERFORMANCE GOALS—FISCAL this agreement. FDA and applicants share of both. If all of the applicant’s questions are YEARS 2018 THROUGH 2022 AS APPLIED TO RE- addressed through written responses to the the responsibility for achieving this objec- CEIPT COHORTS tive of reducing the average Total Time to applicant’s satisfaction, FDA and the appli- The overall objective of the review per- Decision, while maintaining standards for cant can agree that a meeting or teleconfer- formance goals stated herein is to assure safety and effectiveness. Success of this pro- ence is no longer necessary, and the written gram will require the cooperation and dedi- more timely access to safe and effective responses provided by email or fax will be cated efforts of FDA and applicants to re- medical devices. considered the final written feedback to the duce their respective portions of the total A. Pre-Submissions Pre-Submission. Meetings and teleconferences related to time to decision. FDA will continue the Pre-Submission pro- FDA will be reporting total time perform- Pre-Submission will normally be limited to 1 gram as described in the Guidance on ‘‘Re- hour unless the applicant justifies in writing ance quarterly as described in Section VI. quests for Feedback on Medical Device Sub- the need for additional time. FDA may ex- FDA and industry will participate in the missions: The Pre-Submission Program and tend the time for such meetings and/or tele- independent assessment of progress toward Meetings with FDA Staff’’ with process im- conferences. this outcome, as described in Section V provements and performance goals as noted Applicants will be responsible for devel- below. As appropriate, key findings and rec- in this section. oping draft minutes for a Pre-Submission ommendations from this assessment will be For all Pre-Submissions in which the ap- meeting or teleconference, and provide the implemented by FDA. plicant requests a meeting or teleconference, draft minutes to FDA within 15 calendar A. PMA the applicant will provide a minimum of days of the meeting. At the beginning and FDA will report on an annual basis the av- three proposed meeting dates in the initial end of each meeting, the applicant will af- erage Total Time to Decision as defined in submission. firmatively state that they will draft min- Section VII.H for the three most recent Within 15 calendar days of receipt of a Pre- utes and provide them to FDA within 15 cal- closed receipt cohorts. Submission, FDA will communicate with the endar days. The minutes will summarize the For Original PMA and Panel Track Supple- applicant regarding whether the application meeting discussions and include agreements ment submissions received in Fiscal Years has been accepted and, if applicable, regard- and any action items. FDA will provide any 2016 through 2018, the average Total Time to ing scheduling of the meeting or teleconfer- edits to the draft minutes to the applicant Decision goal for FDA and industry is 320 ence. Acceptance will be determined based via email within a timely manner. These calendar days. on the definition of pre-submission in Sec- minutes will become final 15 calendar days For Original PMA and Panel Track Supple- tion VII.F below and an acceptance checklist after the applicant receives FDA’s edits, un- ment submissions received in Fiscal Years in published guidance. This communication less the applicant indicates that there is a

VerDate Sep 11 2014 04:29 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00033 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.072 S02AUPT1 S4730 CONGRESSIONAL RECORD — SENATE August 2, 2017 disagreement with how a significant issue or When FDA issues a major deficiency letter, clude action items for FDA and/or the appli- action item has been documented. In this that letter will be based upon a complete re- cant, as appropriate, with an estimated date case, within a timely manner, the applicant view of the application and will include all of completion for each party to complete and FDA will conduct a teleconference to deficiencies. All deficiency letters will in- their respective tasks. Issues should be re- discuss that issue with FDA. At the conclu- clude a statement of the basis for the defi- solved through interactive review. If all of sion of that teleconference, within 15 days ciencies (e.g., a specific reference to applica- the outstanding issues are adequately pre- FDA will finalize the minutes either to re- ble section of a rule, final guidance, recog- sented through written correspondence, FDA flect the resolution of the issue or note that nized standard unless the entire or most of and the applicant can agree that a meeting this issue remains a point of disagreement. document is applicable). In the instance or teleconference is not necessary. FDA intends that feedback the Agency when the deficiency cannot be traced in the For PMA submissions that receive a provides in a Pre-Submission will not manner above and relates to a scientific or MDUFA decision of Approvable, FDA will change, provided the information submitted regulatory issue pertinent to the determina- issue a decision within 60 days of the spon- in a future IDE or marketing application is tion, FDA will cite the specific scientific sor’s response to the Approvable letter, as consistent with that provided in the Pre- issue and the information to support its posi- resources permit, but not to the detriment of Submission and documented in the Pre-Sub- tion. All deficiency letters will undergo su- meeting the quantitative review timelines mission, and that the data and other infor- pervisory review prior to issuance to ensure and statutory obligations. In addition, information about submissions mation in the future submission do not raise the deficiencies cited are relevant to a deter- that miss the FDA Day goal will be provided any important new issues materially affect- mination of safety and effectiveness. Any subsequent deficiencies will be limited to as part of FDA’s Performance Reports, as de- ing safety or effectiveness. The minutes de- scribed in Section VI. scribed above will serve as the record of the issues raised by the information provided by Agency’s Pre-Submission feedback. Modi- the applicant in its response, unless FDA C. 180-Day PMA Supplements fications to FDA’s feedback will be limited concludes that the initial deficiencies identi- FDA will communicate with the applicant to situations in which FDA concludes that fied do not adequately address important through a Substantive Interaction within 90 the feedback does not adequately address im- new issues materially relevant to a deter- calendar days of receipt of 95% of submis- portant new issues materially relevant to a mination of safety or effectiveness. Such a sions. FDA will issue a MDUFA decision within determination of safety and/or effectiveness determination will be supported by the ap- 180 FDA Days for 95% of submissions. or substantial equivalence. Such a deter- propriate management concurrence con- mination will be supported by the appro- sistent with applicable guidance and SOPs. D. Real-Time PMA Supplements priate management concurrence consistent Issues related to post-approval studies, if ap- FDA will issue a MDUFA decision within with applicable guidance and SOPs. plicable, and revisions to draft labeling will 90 FDA Days for 95% of submissions. By October 1, 2018, the Agency will update typically be addressed through interactive E. De Novo Submissions the Guidance on ‘‘Requests for Feedback on review once major deficiencies have been FDA will issue draft and final guidance Medical Device Submissions: The Pre-Sub- adequately addressed. that includes a submission checklist to fa- mission Program and Meetings with FDA For submissions that do not require Advi- cilitate a more efficient and timely review Staff’’ to include: additional information to sory Committee input, FDA will issue a process. assist applicants in determining the need for MDUFA decision within 180 FDA Days for Deficiencies identified will be based upon a a Pre-Submission, an enhanced Pre-Submis- 90% of submissions. complete review of the submission and will sion acceptance checklist, examples of fre- For submissions that require Advisory include all deficiencies. All deficiency letters quently asked Pre-Submission questions Committee input, FDA will issue a MDUFA will include a statement of the basis for the that lend themselves to productive Pre-Sub- decision within 320 FDA Days from receipt of deficiencies (e.g., a specific reference to ap- mission interactions, and edits to reflect the the accepted submission for 90% of submis- plicable section of a rule, final guidance, rec- revised process outlined above. FDA will pro- sions. FDA will issue a MDUFA decision ognized standard unless the entire or most of vide an opportunity for the public to com- within 60 days of the Advisory Committee document is applicable). In the instance ment on the updated guidance. No later than recommendation, as resources permit, but when the deficiency cannot be traced in the 12 months after the close of the public com- not to the detriment of meeting the quan- manner above and relates to a scientific or ment period, the Agency will issue a final titative review timelines and statutory obli- regulatory issue pertinent to the determina- guidance. FDA will implement this guidance gations. The Office Director shall review tion, FDA will cite the specific scientific once final. each request for Advisory Committee input issue and the information to support its posi- for appropriateness and need for this input. tion. All deficiency letters will undergo su- B. Original Premarket Approval (PMA), Panel- If in any one fiscal year, the number of pervisory review prior to issuance to ensure Track Supplements, and Premarket Report submissions that require Advisory Com- the deficiencies cited are relevant to a clas- Applications mittee input is less than 10, then it is accept- sification determination. Any subsequent de- The performance goals in this section able to combine such submissions with the ficiencies will be limited to issues raised by apply to all Original Premarket Approval, submissions for the following year(s) in order the information provided by the applicant in Panel-Track Supplements, and Premarket to form a cohort of 10 or more submissions, its response, unless FDA concludes that the Report Applications, including those that upon which the combined years’ submissions initial deficiencies identified do not ade- are accepted for priority review (previously will be subject to the performance goal. If quately address important new issues mate- referred to as expedited). the number of submissions that require Ad- rially relevant to a classification determina- FDA will communicate with the applicant visory Committee input is less than 10 for tion. Such a determination will be supported regarding whether the application has been FY 2022, it is acceptable to combine such by the appropriate management concurrence accepted for filing review within 15 calendar submissions in the prior year to form a co- consistent with applicable guidance and days of receipt of the application. This com- hort of 10 or more submissions: in such cases, SOPs. Issues related to revisions to draft la- munication consists of a fax, email, or other FDA will be held to the FY2022 performance beling will typically be addressed through written communication that a) identifies the goal for the combined years’ submissions. interactive review once major deficiencies reviewer assigned to the submission, and b) To facilitate an efficient review prior to have been adequately addressed. acknowledges acceptance/rejection of the the Substantive Interaction, and to FDA will issue a MDUFA decision within submission based upon the review of the sub- incentivize submission of a complete applica- 150 FDA days of receipt of the submission mission against objective acceptance criteria tion, submission of an unsolicited major for: 50% of de novo requests received in FY outlined in a published guidance document amendment prior to the Substantive Inter- 2018; 55% of de novo requests received in FY and consistent with the statute and its im- action extends the FDA Day review clock by 2019; 60% of de novo requests received in FY plementing regulations. the number of FDA Days that have elapsed. 2020; 65% of de novo requests received in FY If the application is not accepted for filing Submission of an unsolicited major amend- 2021 and 70% of de novo requests received in review, FDA will notify the applicant of ment after the Substantive Interaction ex- FY 2022. At Industry’s request and as re- those items necessary for the application to tends the FDA Day goal by the number of sources permit, but not to the detriment of be considered accepted for filing review. FDA Days equal to 75% of the difference be- meeting the quantitative review timelines, if For those applications that are accepted tween the filing date and the date of receipt a final decision has not been rendered within for filing review, FDA will communicate the of the amendment. Requests from FDA that 180 FDA days, FDA will discuss with the ap- filing status within 45 calendar days of re- a submission be made will not be considered plicant all outstanding issues with the sub- ceipt of the application. unsolicited. mission preventing FDA from reaching a de- For those applications that are not filed, For all PMA submissions that do not reach cision. This discussion will reflect appro- FDA will communicate to the applicant the a MDUFA decision by 20 days after the appli- priate management input and approval, and specific reasons for rejection and the infor- cable FDA Day goal, FDA will provide writ- will include action items for FDA and/or the mation necessary for filing. ten feedback to the applicant to be discussed applicant, as appropriate, with an estimated If the application is filed, FDA will com- in a meeting or teleconference, including all date of completion for each party to com- municate with the applicant through a Sub- outstanding issues with the application pre- plete their respective tasks. stantive Interaction within 90 calendar days venting FDA from reaching a decision. The F. 510(k) Submissions of the filing date of the application for 95% information provided will reflect appropriate FDA will communicate with the applicant of submissions. management input and approval, and will in- regarding whether the submission has been

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accepted for review within 15 calendar days 90% of the applications that do not require III. INFRASTRUCTURE of receipt of the submission. For those sub- Advisory Committee input within 150 FDA A. Quality Management missions that are not accepted for review, days. The Agency will establish a dedicated FDA will notify the applicant of those items For ‘‘CLIA Waiver by application’’ submis- Quality Management (QM) Unit that reports necessary for the submission to be consid- sions FDA will issue a MDUFA decision for directly to the CDRH Director or Deputy Di- ered accepted. 90% of the applications that require Advi- rector and establish a quality management This communication includes a fax, email, sory Committee input within 320 FDA days. framework for the premarket submission or other written communication that a) If in any one fiscal year, the number of process in CDRH. The Framework will in- identifies the reviewer assigned to the sub- submissions in any CLIA Waiver by Applica- clude infrastructure, senior management re- mission, and b) acknowledges acceptance/re- tion category is less than 10, then it is ac- sponsibility, resource management, lifecycle jection of the submission based upon the re- ceptable to combine such submissions with management, and quality management sys- view of the submission against objective ac- the submissions for the following year(s) in tem evaluation. ceptance criteria outlined in a published order to form a cohort of 10 or more submis- At least once per year, the Agency will dis- guidance document. This communication sions, upon which the combined years’ sub- cuss with industry the specific areas it in- represents a preliminary review of the sub- missions will be subject to the performance tends to incorporate in its ongoing audit mission and is not indicative of deficiencies goal. plan. FDA will identify, with industry input, that may be identified later in the review For all CLIA waiver by application submis- areas to audit, which will include the effec- cycle. sions and dual submissions that do not reach tiveness of CDRH’s Corrective and Preven- FDA will communicate with the applicant a decision by 20 days after the applicable through a Substantive Interaction within 60 tive Action (CAPA) process. FDA will expand FDA Day goal, FDA will provide written the scope of its annual audits as it imple- calendar days of receipt of the submission feedback to the applicant to be discussed in for 95% of submissions. ments and builds up its auditing capability. a meeting or teleconference, including all As part of these ongoing audits, high-per- Deficiencies identified in a Substantive outstanding issues with the application pre- Interaction, such as a telephone/email hold forming premarket review processes utilized venting FDA from reaching a decision. The or Additional Information Letter, will be in one division will be identified and shared information provided will reflect appropriate based upon a complete review of the submis- accordingly with other divisions to improve management input and approval, and will in- sion and will include all deficiencies. All de- efficiencies and effectiveness. At a min- clude action items for FDA and/or the appli- ficiency letters will include a statement of imum, FDA audits in the following areas will cant, as appropriate, with an estimated date the basis for the deficiencies (e.g., a specific be completed by the end of FY 2020: Defi- of completion for each party to complete reference to applicable section of a rule, ciency Letters and Pre-Submissions. Addi- their respective tasks. Issues should be re- final guidance, recognized standard unless tional audits in the following areas will be solved through interactive review. If all of the entire or most of document is applica- completed by the end of FY 2022: Submission the outstanding issues are adequately pre- ble). In the instance when the deficiency can- Issue Meetings, Interactive Review, With- sented through written correspondence, FDA not be traced in the manner above and re- drawals and Special 510(k) conversions. and the applicant can agree that a meeting lates to a scientific or regulatory issue perti- The effectiveness of the QM framework or teleconference is not necessary. nent to the determination, FDA will cite the will be evaluated in Phase 2 of the Inde- In addition, information about submissions specific scientific issue and the information pendent Assessment (see Section V). that miss the FDA Day goal will be provided to support its position. All deficiency letters B. Scientific and Regulatory Review Capacity as part of FDA’s Performance Reports, as de- will undergo supervisory review prior to The Agency will apply user fee revenues to scribed in Section VI. issuance to ensure the deficiencies cited are In addition, FDA will: reduce the ratio of review staff to front line relevant to a determination of substantial 1. Hold CLIA Waiver Vendor Days, with the supervisors in the premarket review program equivalence. Any subsequent deficiencies first to occur before the end of FY2018. to improve consistency. The Agency will also will be limited to issues raised by the infor- 2. Permit discussion of both 510(k) and apply user fee revenues to enhance and sup- mation provided by the applicant in its re- CLIA waiver process in Pre-Submissions. plement scientific review capacity by hiring sponse, unless FDA concludes that the ini- 3. Specifically permit discussion of appro- device application reviewers as well as tial deficiencies identified do not adequately priate reference/comparator for both 510(k) leveraging external experts needed to assist address important new issues materially rel- and CLIA waiver submissions in Pre-Submis- with the review of device applications. evant to a determination of substantial sions. To ensure such additional positions are equivalence. Such a determination will be 4. Provide a status report on completion filled by qualified experts, the Agency will supported by the appropriate management and issuance of revisions to Section V of the apply user fee revenues to recruitment and concurrence consistent with applicable guid- Guidance on ‘‘Recommendations for CLIA hiring. The Agency will apply user fee reve- ance and SOPs. Waiver Applications’’ to include appropriate nues to retain high-performing supervisors FDA will issue a MDUFA decision for 95% use of comparable performance between a in the premarket review program. CDRH intends to enter into an Inter-Agen- of 510(k) submissions within 90 FDA Days. waived user and moderately complex labora- cy Agreement (IAA) with the Office of Per- For all 510(k) submissions that do not reach tory user to demonstrate accuracy. a MDUFA decision within 100 FDA Days, sonnel Management (OPM) to provide sup- FDA will provide written feedback to the ap- H. Original Biologics Licensing Applications plemental recruitment and staffing support plicant to be discussed in a meeting or tele- (BLAs) throughout MDUFA IV to augment existing conference, including all outstanding issues FDA will review and act on standard origi- FDA Human Resources services. with the application preventing FDA from nal BLA submissions within 10 months of re- C. IT Infrastructure for Submission Manage- reaching a decision. The information pro- ceipt for 90% of submissions. ment FDA will review and act on priority origi- vided will reflect appropriate management FDA will enhance IT infrastructure that nal BLA submissions within 6 months of re- input and approval, and will include action will allow FDA to perform quality manage- ceipt for 90% of submissions. items for FDA and/or the applicant, as ap- ment audits and review consistency. propriate, with an estimated date of comple- I. BLA Efficacy Supplements FDA will implement a new information tion for each party to complete their respec- FDA will review and act on standard BLA management system that provides an indus- tive tasks. Issues should be resolved through efficacy supplement submissions within 10 try dashboard that displays near real-time interactive review. If all of the outstanding months of receipt for 90% of submissions. submission status. issues are adequately presented through FDA will review and act on priority BLA FDA will develop electronic submission written correspondence, FDA and the appli- efficacy supplement submissions within 6 templates that will serve as guided submis- cant can agree that a meeting or teleconfer- months of receipt for 90% of submissions. sion preparation tools for industry to im- ence is not necessary. J. Original BLA and BLA Efficacy Supplement prove submission consistency and enhance In addition, information about submissions Resubmissions efficiency in the review process. By FY 2020, that miss the FDA Day goal will be provided the Agency will issue a draft guidance docu- FDA will review and act on Class 1 original as part of FDA’s Performance Reports, as de- ment on the use of the electronic submission BLA and BLA efficacy supplement resubmis- scribed in Section VI. templates. FDA will provide an opportunity sions within 2 months of receipt for 90% of G. CLIA Waiver by Application for public comment on the guidance. No submissions. later than 12 months after the close of the FDA will engage in a Substantive Inter- FDA will review and act on Class 2 original public comment period, the Agency will action with the applicant within 90 days for BLA and BLA efficacy supplement resubmis- issue a final guidance. FDA will implement 90% of the applications. sions within 6 months of receipt for 90% of Industry will inform FDA that it plans to the guidance once final. In addition, the submissions. submit a dual submission (510(k) and CLIA Agency will update the Guidance ‘‘eCopy Waiver application) during the Pre-Submis- K. BLA Manufacturing Supplements Requiring Program for Medical Device Submissions’’ to sion process. FDA will issue a decision for Prior Approval reflect the respective changes to the tech- 90% of dual submission applications within FDA will review and act on BLA manufac- nical standards and specifications. 180 FDA days. turing supplements requiring prior approval FDA will link pre-submissions with subse- For ‘‘CLIA Waiver by application’’ submis- within 4 months of receipt for 90% of submis- quent premarket submissions when identi- sions FDA will issue a MDUFA decision for sions. fied by the applicant.

VerDate Sep 11 2014 04:29 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00035 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.046 S02AUPT1 S4732 CONGRESSIONAL RECORD — SENATE August 2, 2017 D. Training issuance to ensure the deficiencies cited are 8. FDA, in consultation with stakeholders, FDA will continue to improve training for relevant to a marketing authorization deci- will identify appropriate recognized con- new and existing reviewers under this agree- sion (e.g., 510(k) clearance, PMA approval, sensus standards for consideration as part of ment. FDA will achieve Kirkpatrick Level 3 and de novo classification). Any additional the pilot as the specific focus for ASCA. for curriculum-based premarket training best practices identified by quality audits a. By the end of FY 2022: FDA will have pi- through assessment of work performance be- and/or the Independent Assessment will be loted, and provided a report on the viability havior change and evaluate the effectiveness incorporated in updates to the guidance, as of, an ASCA program which utilizes the sche- of the impact of curriculum-based premarket appropriate. ma identified in guidance to include utiliza- training activities on relevant premarket FDA will train staff and managers on this tion of 5 appropriate cross-cutting/horizontal program metrics and goals (Kirkpatrick process improvement and the updated guid- and/or device-specific areas, at least one of Level 4) by the end of FY 2020. FDA training ance. which will be device-specific. efforts will also be closely coordinated with C. Device Accessories b. Standards included as part of the ASCA the Quality Management Unit described in FDA and Industry will explore additional Program will need to have well established item III.A above to provide more targeted mechanisms for a streamlined, resource endpoints/acceptance criteria built into the and personalized training to staff. minimal pathway to reclassify accessories standard to allow effective tracking of TL competence. E. Time Reporting previously classified as class III devices as a part of a PMA review if they meet the re- FDA will provide an annual report on the FDA will implement complete time report- quirements of a low or moderate risk device. progress of the ASCA program. ing by the end of MDUFA IV such that data FDA will work with stakeholders for fur- D. Enhanced Use of Consensus Standards from time reporting can be used to conduct ther input on programmatic improvements workload analysis and capacity planning. FDA will establish an Accreditation and/or consideration for expansion. Scheme for Conformity Assessment (ASCA) E. Third Party Review F. Fee Setting, Fee Collections, and Workload Program using FDA-recognized consensus FDA will seek authority to eliminate the standards. FDA will define the ‘scheme’ and The Agency will take the following actions fifth-year offset provision and to maintain oversee the Conformity Assessment (CA) to improve the Third Party Review program and use any and all fee collections, including model and ensure that there is appropriate with a goal of eliminating routine re-review collections over the statutory total revenue interaction with parties that serve as Ac- by FDA of Third Party reviews: targets. crediting Bodies (ABs) to accredit test lab- 1. Strengthen the process for accreditation If the collections are in excess of the re- oratories (TLs). When a device type using of Third Parties. a. Provide training for Third Parties seek- sources needed to meet performance goals the ‘scheme’ is evaluated according to a spe- ing accreditation by FDA. This training given the workload, or in excess of inflation- cific recognized standard by an accredited shall include the opportunity for Third Par- adjusted statutory revenue targets, FDA and TL, FDA intends to rely on the results from ties to have access to redacted review memos industry will work together to assess how the accredited TL for the purpose of pre- and other information as appropriate. best to utilize those resources to improve market review (i.e., generally accept a deter- b. When FDA’s expectations for a par- performance on submission types with per- mination that a device conforms with the ticular device type change, FDA will have in formance goals and/or quality management standard) without the need to address fur- place a process to convey this information to programs, using, as input for the discussion: ther questions related to standards conform- workload information, performance objec- the Third Parties and to industry. ance. Assuming that it meets established cri- 2. By the end of FY 2018, establish a plan tives and ongoing reported performance. teria as outlined in the ASCA program, a de- for eliminating routine re-review by FDA of IV. PROCESS IMPROVEMENTS vice company’s internal TL will be eligible Third Party reviews and implement plan A. Interactive Review to participate in the ASCA program. FDA within 12 months. will not review reports from accredited TLs The Agency will continue to incorporate 3. Implement a program to audit reviews except as part of a periodic quality audit or an interactive review process to provide for, conducted by accredited Third Parties. if FDA becomes aware of new information and encourage, informal communication be- a. Provide tailored re-training to accred- materially relevant to safety and/or effec- tween FDA and applicants to facilitate time- ited Third Parties based on the results of au- tiveness. ly completion of the review process based on dits. Specific actions that FDA will undertake 4. By the end of FY 2018, issue draft guid- accurate and complete information. Inter- include the following: active review entails responsibilities for ance outlining criteria for reaccreditation of 1. Conduct a Public Workshop by the end of 3rd Parties and the suspension or withdrawal both FDA and applicants. As described in the FY 2018 to discuss objectives for the estab- guidance document, ‘‘Interactive Review for of accreditation of a Third Party. FDA will lishment of ABs and TLs. Discussion would issue final guidance within 12 months of the Medical Device Submissions: 510(k)s, Origi- include areas (specific FDA-recognized con- nal PMAs, PMA Supplements, Original conclusion of the public comment period. sensus standards) where the ASCA Program 5. Publish performance of individual ac- BLAs, and BLA Supplements,’’ both FDA can be piloted to maximize initial impact of credited Third Parties with at least five and industry believe that an interactive re- existing CA activities and potential new completed submissions on the web (e.g., rate view process for these types of premarket areas. of NSE, average number of holds, average medical device submissions should help fa- 2. Hold educational sessions with stake- time to SE). cilitate timely completion of the review holders by the end of FY 2018 about the pur- 6. Require the independent assessment of based on accurate and complete information. pose of the ASCA Program the Third Party Review Program to evaluate Interactive review is intended to facilitate 3. Develop and initiate the pilot of the efficiency including the circumstances when the efficient and timely review and evalua- ASCA program with stakeholder input by FDA re-reviews were conducted; and to sug- tion by FDA of premarket submissions and is the end of FY 2020. gest process improvements. expected to support reductions in total time a. FDA intends to pilot inclusion of recog- The Agency will seek greater authority to to decision. The interactive review process nized standards of public health significance tailor the program. Specifically, FDA in- contemplates increased informal interaction where specific pass/fail criteria are part of tends to expand the scope of the program to between FDA and applicants, including the the standard some product codes that require clinical 4. Develop an internal IT system to track exchange of scientific and regulatory infor- data and to remove product codes from eligi- CA activities of the ASCA Program mation. bility when appropriate, such as if/when safe- 5. Establish a process for accreditation of B. Deficiency Letters ty signals arise. ABs and TLs. FDA will issue draft guidance As resources permit, FDA will identify By October 1, 2017, the Agency will publish by the end of FY 2019 and issue final guid- pilot device areas to be the specific focus of a level 2 update to the final guidance ‘‘Sug- ance within 12 months post initiation of the an effort where FDA would work with will- gested Format for Developing and Respond- pilot. ing to Deficiencies in Accordance with the a. In limited circumstances, the FDA may ing industry partners to ensure that infor- Least Burdensome Provisions of FDAMA; directly accredit third-party TLs. For exam- mation allowing for high quality Third Final Guidance for Industry and FDA Staff’’ ple, FDA could directly accredit third party Party reviews could be made available to to reflect the following: TLs, if FDA has not identified and recog- provide a proof of concept in certain device All deficiency letters will include a state- nized an AB within 2 years after establishing areas and enable the development of a broad- ment of the basis for the deficiencies (e.g., a the tenets of the ASCA program. er successful program. specific reference to applicable section of a 6. Establish a process for reaccreditation F. Patient Engagement & the Science of Patient rule, final guidance, recognized standard un- and the suspension or withdrawal of accredi- Input less the entire or most of document is appli- tation of poor performing ABs and TLs. FDA The Agency will take the following actions cable). In the instance when the deficiency will issue draft guidance by the end of FY to advance patient input and involvement in cannot be traced in the manner above and re- 2019 and final guidance within 12 months the regulatory process. Where appropriate, lates to a scientific or regulatory issue perti- post initiation of the pilot. the Agency will leverage public private part- nent to the determination, FDA will cite the 7. Establish a publicly-accessible website nerships (PPPs) to advance these actions. specific scientific issue and the information listing TLs accredited by ASCA and the 1. Develop clinical, statistical, and other to support its position. All deficiency letters FDA-recognized consensus standard(s) for scientific expertise and staff capacity to re- will undergo supervisory review prior to which they are accredited spond to submissions containing applicant-

VerDate Sep 11 2014 04:29 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00036 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.047 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4733 proposed use of publicly available and vali- product codes (and related product codes), tion reports from a specific manufacturer dated, voluntary patient preference informa- one of which will cover devices approved and/or for a specific device if necessary to tion (PPI) or voluntary patient reported out- through the PMA process and the other of protect public health. In these situations, comes (PROs). These staff will provide sub- which will cover devices cleared through the FDA will notify the manufacturer they are mission review and early consultation/advice 510(k) process. The NEST Coordinating Cen- not eligible for quarterly summary MDR re- to industry during study planning. ter will seek ways in which to make NEST porting and provide an explanation for that 2. By the end of FY 2020, hold one or more financially self-sustaining so as not to rely decision and the steps necessary to return to public meetings to discuss the topics below on MDUFA user fees in the long term unless eligibility for quarterly summary MDR re- and publish the findings and next steps. FDA and Industry determine continued user porting. a. Discuss approaches for incorporating fee support is warranted and provides a suffi- 4. FDA will not require postmarket sur- PPI and PRO as evidence in device submis- cient return on investment. veillance studies (i.e., 522 Studies) for de- sions, as well as other ways of advancing pa- 2. FDA will contract with an organization vices for which registries and/or other real tient engagement; to serve as the NEST Coordinating Center to world data (RWD) sources exist if FDA has b. Discuss ways to use patient input to in- facilitate use of real world evidence to sup- access to the information/data in the RWD form clinical study design and conduct, with port premarket activities. The contract will source and has determined that the informa- a goal of reducing barriers to patient partici- specify actions the Coordinating Center will tion/data in the RWD source is sufficient to pation and facilitating recruitment and re- take to advance the use of RWE, including: take the place of a postmarket surveillance tention; a. Establish a framework to fund pilot study. c. Public meetings should include specific projects to determine the usability of RWE I. Digital Health examples and case histories for PPIs and for: PROs to ensure clarity and understanding by i. Expanded indications for use The Agency will build expertise and workshop attendees; and ii. New clearances/approvals streamline and align FDA review processes d. Identify priority areas where decisions iii. Improved malfunction reporting with software lifecycles for Software as a are preference-sensitive and PPI data can in- b. No later than October 1, 2020, the Coordi- Medical Device (SaMD) and software inside form regulatory decision-making, in order to nating Center will hold a public meeting to of medical devices (SiMD). Specifically, the advance design and conduct of patient pref- review and evaluate the progress and out- Agency will: erence studies in high impact areas. Publish comes (as of the date of the public meeting) 1. Establish a central digital health unit the priority areas in the Federal Register for of the pilots described in (H)(1) above. within CDRH’s Office of the Center Director public comment following the public meet- c. The pilots will take place over a period to ensure proper coordination and consist- ing. of three years, including data analysis and ency across the Agency. The Agency will not 3. FDA will undertake several activities to the Coordinating Center will issue a publicly reorganize staff such that existing review improve the regulatory predictability and available report of the results. staff would be reassigned to the central dig- impact of PROs, including: d. The pilots will include devices not cur- ital health unit, while retaining and not dis- a. Clarify to device review divisions that rently subject to a registry. rupting the existing digital health talent use of PROs is voluntary and may be one po- e. At the conclusion of the pilots, an inde- within the reviewing divisions who have es- tential way of demonstrating safety or effec- pendent third-party will conduct an assess- tablished, long-term therapeutic and device tiveness (or elements of either or both, such ment to evaluate the strengths, limitations, expertise. The digital health unit will per- as in a composite endpoint). Consistent with and appropriate use of RWE for informing form, at a minimum, the following tasks: least burdensome principles, applicants may premarket decision-making for multiple de- a. Develop software and digital health use alternative approaches. vice types. technical expertise (‘‘Technical Experts’’) to b. Modify the guidance to outline a flexible f. If warranted based on the results of the provide assistance for premarket submis- framework for PRO validation evidentiary pilot(s) described in (H)(1) above, FDA will sions that include SaMD, SiMD, interoper- thresholds. These thresholds may vary de- revise its guidance on the use of RWE to re- able devices, or otherwise incorporate novel pending on the particular regulatory use of flect what has been learned from the pilots digital health technologies. the PRO. as to how RWE can be used to support: b. Utilize Technical Experts as appropriate c. Work on developing a model for ‘‘bridg- i. Expanded indications for use; and or when requested by the manufacturer for ing studies’’ to make efficient use of existing ii. New clearances/approvals. submissions that include SaMD, SiMD, inter- validated PROs which may be improved, or If supported by the pilot(s) described in operable devices, or otherwise incorporate adapted to other subpopulations or other (H)(1) above, the guidance will include dis- novel digital health technologies; and regulatory uses in a more streamlined and cussion of how devices not currently subject c. Incorporate appropriate metrics for dig- expeditious manner than creating novel to a registry can benefit from RWE. ital health improvements to monitor, track, PROs. 3. The Agency will establish criteria for analyze and report the results of digital 4. The existing dispute resolution process streamlining MDR requirements. health premarket review timelines. should be used in the event of disagreement a. For most, if not all, device procodes, 2. Publish final guidance addressing when between the applicant and the Agency on the FDA will permit manufacturers of such de- to submit a 510(k) for a software modifica- need for PPI or PRO. vices in those procodes to report malfunc- tions on a quarterly basis and in a summary tion to an existing device within 18 months G. Emerging Diagnostics of the close of the comment period. FDA will work with industry to continue MDR format. FDA will publish the list of eli- gible device procodes within 12 months of re- 3. Explore opportunities to establish pre- the pilot for emerging diagnostics started market approval/clearance pathways tai- under MDUFA III. ceiving a proposed list from Industry. The list will include, among other device lored to SaMD, SiMD, and novel digital H. Real World Evidence (RWE) procodes, Class II implantable and Class III health technologies that take into account 1. The Agency will use user fee revenue to devices, as appropriate, and will reflect real world evidence while incorporating prin- support the National Evaluation System for FDA’s consideration of Industry’s proposed ciples established through international har- health Technology (NEST) by providing list. monization. To accomplish this task, the funding for the NEST Coordinating Center b. FDA may determine that devices under Agency will: and hiring FDA staff with expertise in the a new procode in existence for less than 2 a. Engage with stakeholders, including in- use of RWE. The NEST governing board will years are not eligible for reporting of mal- dustry, through roundtables, informal meet- include no fewer than 4 representatives of functions on a quarterly basis and in a sum- ings, and teleconferences; the trade associations that participated in mary format. b. Hold a public workshop; and the MDUFA IV negotiations (AdvaMed, c. If a new type of malfunction occurs that c. Revise existing and/or publish new rel- MDMA, MITA, and ACLA), with each asso- the manufacturer has not previously re- evant guidance documents, including pub- ciation appointing an individual to serve. In- ported to FDA, the manufacturer must sub- lishing a draft revised version of the ‘‘Guid- dustry representation on the NEST gov- mit an individual report. The manufacturer ance for the Content of Premarket Submis- erning board will make up at least 25% of the will notify FDA when the issue has been re- sions for Software Contained in Medical De- governing board membership. The represent- solved, using current requirements per 21 vices’’ (issued in 2005) by the end of FY2019, ative from each trade association may be C.F.R. 803, 806. and within 12 months of the close of the com- part of the staff of the association or ap- d. FDA will maintain on its website the ment period, publish the final revised pointed from a member company. If any of list of eligible device procodes for which version. The Agency will incorporate appli- the trade associations elects not to partici- manufacturers are permitted to report mal- cable concepts from its Guidance for ‘‘Off- pate on the NEST governing board or for any functions on a quarterly basis and in a sum- The-Shelf Software Used in Medical De- additional seats allocated to Industry, the mary MDR format. vices.’’ participating trade associations will deter- e. FDA will establish a mechanism at the 4. Participate in international harmoni- mine how to fill any vacant Industry posi- time it publishes the list of eligible devices zation efforts related to digital health, in- tions. The governing board also will include, under 3(a) that permits stakeholders to re- cluding work on developing SaMD and other but not be limited to, representation from quest device procodes be added to the list. digital health convergence efforts through patient organizations. By the end of FY2019, f. Nothing in this section precludes the the International Medical Device Regulators NEST will implement pilots for at least two Agency from requiring individual malfunc- Forum (IMDRF).

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J. Guidance Document Development PHASE 1 iii. Average number of review cycles. FDA will apply user fee revenues to ensure During the first phase, the contractor will iv. Rate of submissions not accepted for re- timely completion of Draft Guidance docu- complete an evaluation of FDA’s implemen- view ments. The Agency will strive to finalize, tation of the corrective action plan devel- 1.2. For PMA submissions, reporting will withdraw, reopen the comment period, or oped in response to recommendations from include: issue a new draft guidance for 80% of draft the MDUFA III independent assessment. i. Average and quintiles of the number of guidance documents within 3 years of the For Phase 1, FDA will award the contract calendar days to Substantive Interaction for close of the comment periods as resources by the end of CY2017. The contractor will Original PMA, Panel-Track PMA Supple- permit. The Agency will strive to finalize, evaluate the implementation of MDUFA III ment, and Premarket Report Submissions ii. Average and quintiles of the FDA Days, withdraw, reopen the comment period, or recommendations and publish a written as- Industry Days, and Total Days to a MDUFA issue a new draft guidance for 100% of draft sessment within 1 year of contract award. decision guidance documents within 5 years of the PHASE 2 iii. Rate of applications not accepted for close of the comment periods as resources During the second phase, the contractor filing review, and rate of applications not permit. The Agency will continue to develop will: filed guidance documents and improve the devel- 1. Evaluate FDA’s premarket review pro- 1.3. For de novo requests, reporting will in- opment process as resources permit, but not gram to identify efficiencies that should be clude: to the detriment of meeting quantitative re- realized as a result of the process improve- i. Average, and quintiles of the number of view timelines and statutory obligations. ments and investments under MDUFA III FDA Days, Industry Days, and Total Days to K. Total Product Life Cycle (TPLC) and IV; a MDUFA decision The establishment of CDRH’s Office of In 2. Evaluate premarket review program in- ii. Average number of review cycles. Vitro Diagnostic Device Evaluation and frastructure and allocation of FTEs; iii. Rate of submissions not accepted for Safety (now the Office of In Vitro 3. Assess the alignment of resource needs review, upon final guidance Diagnostics and Radiological Health (OIR)) with the training and expertise of hires; 1.4. For Pre-Submissions, reporting will in- has led to improved consistency and predict- 4. Identify and share best practices across clude: ability due to the enhanced integration of branches in ODE and OIR; i. Number of all qualified Pre-Submissions premarket, postmarket, and compliance-re- 5. Assess the effectiveness of programs tar- received lated activities and staff and improved infor- geted for improvement under this agree- ii. Rate of submissions not accepted for re- mation sharing among staff. In addition, the ment, including the: view, upon final guidance successful development and evaluation of a. Quality Management program, iii. Average and quintiles of the number of medical devices depends on the integration b. Proportion of deficiencies in which FDA calendar days from submission to written of clinical with scientific and engineering references the basis for the deficiency deter- feedback iv. Number of Pre-Submissions that re- disciplines. CDRH will explore transitioning mination, c. Pre-Submission program (assess whether quire a meeting to a similar TPLC model building in the (a) CDRH is providing guidance specific to v. Percent of submissions with meetings other device areas based on the lessons the questions being asked; (b) CDRH is using for which industry provided minutes within learned from its experience with OIR and Pre-Submissions appropriately; and (c) 15 days taking into account the Center’s mission, vi- CDRH and Industry are adhering to the pro- 1.5. For IDE applications, reporting will in- sion, strategic priorities, and development of cedural aspects as set forth in this agree- clude: a patient-centric benefit-risk framework for ment), i. Number of original IDEs received regulatory and non-regulatory decision mak- d. Third Party Review program (assess effi- ii. Average number of amendments prior to ing across the TPLC. Because an essential ciency of program and suggest process im- approval or conditional approval of the IDE element for the success of the Center’s ben- provements), 2. CDRH will report quarterly, and CBER efit-risk decision making framework and ap- e. Digital Health program, will report annually, the following data at proach to device regulation (particularly f. Patient Engagement program, and the Center level: emerging and innovative technologies) is the g. Real World Evidence program; 2.1. Rate of NSE decisions for 510(k) sub- incorporation of the clinical context and the 6. Analyze conversions of Special 510(k)s to missions impact of a decision on patient health and Traditional 510(k)s; and 2.2. Rate of withdrawals for 510(k), de novo, quality of life, CDRH will take steps to in- 7. Assess other key areas identified by FDA and PMA submissions crease and enhance the integration of its cli- and industry as resources permit. 2.3. Rate of Not Approvable decisions for nicians into its TPLC activities, amongst For Phase 2 of the independent assessment, PMA submissions themselves, and with the Center’s scientists FDA will award the contract no later than 3/ 2.4. Rate of Denial decisions for de novo re- and engineers. Building on the success of 31/2020. However, the contractor would not quests considering and incorporating additional ex- begin the audit of deficiency letters and Pre- 2.5. Key product areas or other issues that pertise and viewpoints into our decision- Submissions before 10/1/2020. The contractor FDA identifies as noteworthy because of a making, such as through the use of the Net- will publish comprehensive findings and rec- potential effect on performance, including work of Experts and the leveraging of pa- ommendations within 1 year. For all rec- significant rates of Additional Information tient perspectives, CDRH will also explore ommendations the contractor will provide an requests ways in which to better learn from and lever- estimate of additional resources needed or 2.6. Specific topic or product area as it re- age the expertise of clinicians in other parts efficiencies gained, as applicable. lates to performance goals, agreed upon at of the agency and outside of the agency to FDA will incorporate findings and rec- the previous meeting inform its decision making, enhance consist- ommendations, as appropriate, into its man- 2.7. Number of submissions that missed the ency, and assure a more holistic clinical per- agement of the premarket review program. goals and the total number of elapsed cal- spective. Clinicians involved in device-re- FDA will analyze the recommendations for endar days broken down into FDA days and lated activities will have appropriate train- improvement opportunities identified in the industry days ing on and make recommendations con- assessment and, as appropriate, develop and 2.8. Newly released draft and final guidance sistent with applicable device statutory pro- implement a corrective action plan, and as- documents, and status of other priority guid- visions, regulations, guidances, and this sure its effectiveness. ance documents Commitment Letter. In addition, CDRH will 2.9. Agency level summary of fee collec- VI. PERFORMANCE REPORTS provide managerial oversight of clinician tions recommendations and device submission de- The Agency will report its progress toward 2.10. Independent assessment implementa- cisions, except for those devices subject to meeting the goals described in this letter, as tion plan status CBER oversight. follows. If, throughout the course of MDUFA 2.11. Results of independent assessment IV, the Agency and Industry agree that a dif- and subsequent periodic audits and progress V. INDEPENDENT ASSESSMENT OF REVIEW ferent format or different metrics would be toward implementation of the recommenda- PROCESS MANAGEMENT more useful, the reporting will be modified tions and any corrective action FDA and the industry will participate in a accordingly as per the agreement of both 2.12. Number of discretionary fee waivers comprehensive assessment of the process for FDA and Industry. or reductions granted by type of submission the review of device applications. The assess- 1. Quarterly reporting at the CDRH Divi- 3. In addition, the Agency will provide the ment will include consultation with both sion level/CBER Center level (in recognition following information on an annual basis: FDA and industry. The assessment shall be of the significantly smaller number of sub- 3.1. Qualitative and quantitative update on conducted in two phases under contract to missions reviewed at CBER): how funding is being used for the device re- FDA by a private, independent consulting 1.1. For 510(k) submissions that do not go view process, including the percentage of re- firm capable of performing the technical through a 3rd party, reporting will include: view time devoted to direct review of appli- analysis, management assessment, and pro- i. Average and quintiles of the number of cations gram evaluation tasks required to address calendar days to Substantive Interaction 3.2. How funding is being used to enhance the assessment scope described below within ii. Average, and quintiles of the number of scientific review capacity the budget provided under this user fee FDA Days, Industry Days, and Total Days to 3.3. The number of Premarket Report Sub- agreement. a MDUFA decision missions received

VerDate Sep 11 2014 04:29 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00038 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.049 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4735 3.4. Summary information on training an application for premarket approval protocols or data requirements; design and courses available to CDRH and CBER em- under section 515 of the Federal Food, Drug, performance of clinical studies and accept- ployees, including new reviewers, regarding and Cosmetic Act (FDCA); ance criteria). A Pre-Submission is appro- device review and the percentage of applica- a premarket notification under section priate when FDA’s feedback on specific ques- ble staff that have successfully completed 510(k) of the FDCA; tions is necessary to guide product develop- each such course. CDRH will provide infor- an application for investigational device ment and/or application preparation. mation concerning any revisions to the new exemption under section 520(g) of the FDCA; The following forms of FDA feedback to reviewer training program curriculum. a Pre-Submission; applicants are not considered Pre-Submis- 3.5. Performance on the shared outcome a de novo request (evaluation of automatic sions. goal for average Total Time to decision class III designation) under section 513(f)(2) Interactions requested by either the appli- 3.6. For 510(k) submissions, reporting will of the FDCA; cant or FDA during the review of a mar- include: a CLIA Waiver by application. keting application (i.e., following submission i. Number of submissions reviewed by a B. Electronic Copy (e-Copy) of a marketing application, but prior to Third Party reaching an FDA Decision). An electronic copy is an exact duplicate of ii. Number of Special Submissions General information requests initiated a submission, created and submitted on a iii. Number of Traditional Submissions through the Division of Industry and Con- iv. Average and number of days to Accept/ CD, DVD, or in another electronic media for- sumer Education (DICE). mat that FDA has agreed to accept, accom- Refuse to Accept General questions regarding FDA policy or v. Number of Abbreviated Submissions panied by a copy of the signed cover letter procedures. 3.7. For 510(k) submissions that go through and the complete original paper submission. Meetings or teleconferences that are in- a 3rd party, reporting will include: An electronic copy is not considered to be an tended to be informational only, including, i. Time from FDA receipt of third party re- electronic submission. port to FDA decision at the 90% percentile but not limited to, those intended to educate C. Electronic submission template ii. Once 3rd party program enhancements the review team on new device(s) with sig- have been implemented, resources saved as a An electronic submission template, or nificant differences in technology from cur- result of enhancements to the 3rd party re- eSubmission template, is a guided submis- rently available devices, or to update FDA view program. sion preparation tool for industry. Similar to about ongoing or future product develop- 3.8. For PMA submissions, reporting will an online form, the eSubmission template ment, without a request for FDA feedback on include the number of the following types of walks industry through the relevant con- specific questions related to a planned sub- PMA submissions received: tents and components for the respective pre- mission. i. Original PMAs market submission type and device in order Requests for clarification on technical ii. Priority PMAs to facilitate submission preparation and en- guidance documents, especially where con- iii. Premarket Reports hance consistency, quality, and efficiency in tact is recommended by FDA in the guidance iv. Panel-Track PMA Supplement the premarket review process. document. However, the following requests v. PMA Modules D. FDA Days will generally need to be submitted as a Pre- vi. 180-Day PMA Supplements Submission in order to ensure appropriate FDA Days are those calendar days when a vii. Real-Time PMA Supplements input from multiple reviewers and manage- viii. Number of submissions FDA classifies submission is considered to be under review ment: recommendations for device types not as unsolicited major, solicited major, and at the Agency for submissions that have specifically addressed in the guidance docu- minor amendments been accepted (510(k) or de novo classifica- ment; recommendations for nonclinical or 3.9. For De Novo requests, reporting will tion request), filed (PMA) or submitted clinical studies not addressed in the guid- include: (CLIA Waiver by application). FDA Days ance document; requests to use an alter- i. Number of submissions received begin on the date of receipt of the submis- native means to address recommendations ii. Average and number of days to Accept/ sion or of the amendment to the submission specified in a guidance document. Refuse to Accept, upon final guidance that enables the submission to be accepted Phone calls or email messages to reviewers 3.10. For CLIA waiver applications, report- (510(k)) or filed (PMA). ing will include: that can be readily answered based on a re- i. Number of CLIA waiver applications re- E. MDUFA Decisions viewer’s experience and knowledge and do ceived Original PMAs: Decisions for Original not require the involvement of a broader ii. Average and quintiles of the number of PMAs are Approval, Approvable, Approvable number of FDA staff beyond the routine in- calendar days to Substantive Interaction Pending GMP Inspection, Not Approvable, volvement of the reviewer’s supervisor and iii. Average and quintiles of the number of withdrawal, and Denial. more experienced mentors. FDA Days, Industry Days, and Total Days to 180-Day PMA Supplements: Decisions for G. Substantive Interaction a MDUFA decision and a discussion of any 180-Day PMA Supplements include Approval, Substantive Interaction is an email, letter, trends in the data Approvable, and Not Approvable. teleconference, video conference, fax, or 3.11. Report on the ASCA program Real-Time PMA Supplements: Decisions other form of communication such as a re- 3.12. Data regarding the reduction in re- for Real-Time PMA supplements include Ap- quest for Additional Information or Major viewer to manager ratio. proval, Approvable, and not Approvable. Deficiency letters by FDA notifying the ap- 3.13. Report on implementation of defi- 510(k)s: Decisions for 510(k)s are substan- plicant of substantive deficiencies identified ciency performance improvements. tially equivalent (SE) or not substantially in initial submission review, or a commu- 3.14. Report on quality management pro- equivalent (NSE). nication stating that FDA has not identified gram De Novo Requests: Decisions for De Novo 3.15. Summary of quality system audits any deficiencies in the initial submission re- requests are grant, withdrawal, and decline. FDA will report annual and quarterly data view and any further minor deficiencies will CLIA Waiver by Application Submissions: on performance within goals for 510(k), de be communicated through interactive re- Decisions for CLIA Waiver by Application novo, and PMA MDUFA decisions for devices view. An approval or clearance letter issued Submissions are Approval, Withdrawal, and identified as LDTs by the submitter com- prior to the Substantive Interaction goal Denial. pared to all non-LDT IVD devices. The fol- date will qualify as a Substantive Inter- Submissions placed on Application Integ- lowing elements will be reported: action. rity Program Hold will be removed from the Number and percentage of LDT 510(k)s and If substantive issues warranting issuance MDUFA cohort. non-LDT IVD 510(k)s completed within 90 of an Additional Information or Major Defi- FDA days F. Pre-Submission ciency letter are not identified, interactive Number and percentage of LDT de novos A Pre-Submission includes a formal writ- review should be used to resolve any minor and non-LDT IVD de novos completed within ten request from an applicant for feedback issues and facilitate an FDA decision. In ad- 150 FDA days from FDA which is provided in the form of a dition, interactive review will be used, Number and percentage of LDT PMAs and formal written response or, if the manufac- where, in FDA’s estimation, it leads to a non-LDT IVD PMAs completed within 180 turer chooses, a meeting or teleconference in more efficient review process during the ini- FDA days which the feedback is documented in meet- tial review cycle (i.e., prior to a Substantive FDA commits to treat LDTs no less favor- ing minutes. A Pre-Submission meeting is a Interaction) to resolve minor issues such as ably than other devices to which MDUFA meeting or teleconference in which FDA pro- revisions to administrative items (e.g., 510(k) performance goals apply. vides its substantive feedback on the Pre- Summary/Statement, Indications for Use On an annual basis, FDA and Industry will Submission. statement, environmental impact assess- discuss the return on investment, which may A Pre-Submission provides the opportunity ment, financial disclosure statements); a include process improvements, improved per- for an applicant to obtain FDA feedback more detailed device description; omitted en- formance, and other enhancements, under prior to intended submission of an investiga- gineering drawings; revisions to labeling; or MDUFA IV. tional device exemption or marketing appli- clarification regarding nonclinical or clin- VII. DEFINITIONS AND EXPLANATIONS OF TERMS cation. The request must include specific ical study methods or data. A. Applicant questions regarding review issues relevant to Minor issues may still be included in an Applicant means a person who makes any a planned IDE or marketing application Additional Information or Major Deficiency of the following submissions to FDA: (e.g., questions regarding pre-clinical testing letter where related to the resolution of the

VerDate Sep 11 2014 04:29 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00039 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.050 S02AUPT1 S4736 CONGRESSIONAL RECORD — SENATE August 2, 2017 substantive issues (e.g., modification of the viously reported with the product are pre- VII. Definitions and Explanation of Terms proposed Indications for Use may lead to re- sented in the resubmission) PDUFA REAUTHORIZATION PERFORM- visions in labeling and administrative (d) Stability updates to support provisional ANCE GOALS AND PROCEDURES FIS- items), or if they were still unresolved fol- or final dating periods CAL YEARS 2018 THROUGH 2022 lowing interactive review attempts. Both (e) Commitments to perform Phase 4 stud- This document contains the performance interactive review and Substantive Inter- ies, including proposals for such studies goals and procedures for the Prescription actions will occur on the review clock except (f) Assay validation data Drug User Fee Act (PDUFA) reauthorization upon the issuance of an Additional Informa- (g) Final release testing on the last 1–2 lots for fiscal years (FYs) 2018–2022, known as tion or Major Deficiency Letter which stops used to support approval PDUFA VI. It is commonly referred to as the the review clock. (h) A minor reanalysis of data previously submitted to the application (determined by ‘‘goals letter’’ or ‘‘commitment letter.’’ The H. Total Time to Decision the Agency as fitting the Class 1 category) goals letter represents the product of FDA’s Total Time to Decision is the number of (i) Other minor clarifying information (de- discussions with the regulated industry and calendar days from the date of receipt of an termined by the Agency as fitting the Class public stakeholders, as mandated by Con- accepted or filed submission to a MDUFA de- 1 category) gress. The performance and procedural goals cision. (j) Other specific items may be added later and other commitments specified in this let- The average Total Time to Decision for as the Agency gains experience with the ter apply to aspects of the human drug re- 510(k) submissions is calculated as the aver- scheme and will be communicated via guid- view program that are important for facili- age of Total Times to Decision for 510(k) sub- ance documents to industry tating timely access to safe, effective, and missions within a closed cohort, excluding Class 2 resubmitted applications—re- innovative new medicines for patients. While the highest 2% and the lowest 2% of values. submissions that include any other items, much of FDA’s work is associated with for- A cohort is closed when 99% of the accepted including any item that would require pres- mal tracked performance goals, the Agency submissions have reached a decision. entation to an advisory committee. and industry mutually agree that it is appro- The average Total Time to Decision for Mr. ALEXANDER. Mr. President, I priate to manage some areas of the human PMA applications is calculated as the three- ask unanimous consent to have printed drug review program with internally tracked year rolling average of the annual Total timeframes. This provides FDA the flexi- in the RECORD a copy of the commit- Times to Decision for applications (for exam- bility needed to respond to a highly diverse ple, for FY2018, the average Total Time to ment letter for the Prescription Drug workload, including unanticipated public Decision for PMA applications would be the User Fee Act, PDUFA, reauthorization health needs. FDA is committed to meeting average of FY2016 through FY2018) within a for fiscal years 2018 to 2022, known as the performance goals specified in this letter closed cohort, excluding the highest 5% and PDUFA VI. and to continuous improvement of its per- the lowest 5% of values. A cohort is closed There being no objection, the mate- formance regarding other important areas when 95% of the applications have reached a rial was ordered to be printed in the specified in relevant published documents decision. RECORD, as follows: that relate to preapproval drug development and post-approval activities for marketed I. Accreditation Scheme for Conformity Assess- PDUFA REAUTHORIZATION PERFORM- products. FDA and the regulated industry ment ANCE GOALS AND PROCEDURES FIS- will periodically and regularly assess the Conformity Assessment is the demonstra- CAL YEARS 2018 THROUGH 2022 progress of the human drug review program tion that specified requirements relating to I. Ensuring the Effectiveness of the Human a product, process, system, person or body throughout PDUFA VI. This will allow FDA Drug Review Program and the regulated industry to identify are fulfilled. A. Review Performance Goals Accreditation is the formal recognition by emerging challenges and develop strategies B. Program For Enhanced Review Trans- to address these challenges to ensure the ef- an independent body, generally known as an parency And Communication For NME NDAs accreditation body, that an organization is ficiency and effectiveness of the human drug And Original BLAs review program. competent to carry out specific conformity C. First Cycle Review Management assessment activities. Accreditation is not Unless otherwise stated, goals apply to co- D. Review Of Proprietary Names To Re- horts of each fiscal year (FY). obligatory but it adds another level of con- duce Medication Errors fidence, as ‘accredited’ means the organiza- E. Major Dispute Resolution I. ENSURING THE EFFECTIVENESS OF THE HUMAN tion has been independently checked to F. Clinical Holds DRUG REVIEW PROGRAM make sure it operates according to inter- G. Special Protocol Question Assessment A. Review Performance Goals national standards. And Agreement 1. NDA/BLA Submissions and Resubmis- A conformity assessment scheme is a sys- H. Meeting Management Goals sions tem for assessing the conformity of specified I. Enhancing Regulatory Science And Ex- a. Review and act on 90 percent of standard objects (e.g., medical devices or management pediting Drug Development NME NDA and original BLA submissions processes) to one or more consensus stand- J. Enhancing Regulatory Decision Tools within 10 months of the 60 day filing date. ards. The system specifies the applicable To Support Drug Development And Review b. Review and act on 90 percent of priority standards as well as the rules, procedures, K. Enhancement And Modernization Of NME NDA and original BLA submissions and management requirements for carrying The FDA Drug Safety System within 6 months of the 60 day filing date. II. Enhancing Management of User Fee Re- out the conformity assessment to meet a c. Review and act on 90 percent of standard sources regulatory need. Informally, such a scheme non-NME original NDA submissions within A. Resource Capacity Planning And Mod- may be referred to as an accreditation 10 months of receipt. ernized Time Reporting scheme. d. Review and act on 90 percent of priority B. Financial Transparency And Efficiency Testing laboratory is an organization that non-NME original NDA submissions within 6 possesses the necessary technical com- III. Improving FDA Hiring and Retention of Review Staff months of receipt. petence and capabilities to conduct testing e. Review and act on 90 percent of Class 1 to making a determination that one or more A. Completion Of Modernization Of The Hiring System Infrastructure And Aug- resubmitted original applications within 2 characteristics of an object are in conform- months of receipt. ance with a set of predefined requirements. mentation Of System Capacity B. Augmentation Of Hiring Staff Capacity f. Review and act on 90 percent of Class 2 J. BLA-related Definitions And Capability resubmitted original applications within 6 Review and act on—the issuance of a com- C. Complete Establishment Of A Dedicated months of receipt. plete action letter after the complete review Function To Ensure Needed Scientific Staff- 2. Original Efficacy Supplements of a filed complete application. The action ing For Medical Product Review a. Review and act on 90 percent of standard letter, if it is not an approval, will set forth D. Set Clear Goals For Drug Review Pro- efficacy supplements within 10 months of re- in detail the specific deficiencies and, where gram Hiring ceipt. appropriate, the actions necessary to place E. Comprehensive And Continuous Assess- b. Review and act on 90 percent of priority the application in condition for approval. ment Of Hiring And Retention efficacy supplement within 6 months of re- Class 1 resubmitted applications—applica- IV. Information Technology Goals ceipt. tions resubmitted after a complete response A. Objective 3. Resubmitted Efficacy Supplements letter that includes the following items only B. Improve The Predictability And Con- a. Review and act on 90 percent of Class 1 (or combinations of these items): sistency Of PDUFA Electronic Submission resubmitted efficacy supplements within 2 (a) Final printed labeling Processes months of receipt. (b) Draft labeling C. Enhance Transparency And Account- b. Review and act on 90 percent of Class 2 (c) Safety updates submitted in the same ability Of FDA Electronic Submission And resubmitted efficacy supplements within 6 format, including tabulations, as the origi- Data Standards Activities months of receipt. nal safety submission with new data and V. Improving FDA Performance Manage- 4. Original Manufacturing Supplements changes highlighted (except when large ment a. Review and act on 90 percent of manu- amounts of new information including im- VI. Progress Reporting for PDUFA VI and facturing supplements requiring prior ap- portant new adverse experiences not pre- Continuing PDUFA V Initiatives proval within 4 months of receipt

VerDate Sep 11 2014 04:29 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00040 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.051 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4737 b. Review and act on 90 percent of all other iii. A major amendment to a manufac- needed to schedule inspections of manufac- manufacturing supplements within 6 months turing supplement submitted at any time turing facilities that may be necessary be- of receipt. during the review cycle may extend the goal fore approval of the original application or 5. Review Performance Goal Extensions date by two months. supplement. a. Major Amendments iv. Only one extension can be given per re- ii. If, during FDA’s review of an original view cycle. i. A major amendment to an original appli- application or supplement, the Agency iden- v. Consistent with the underlying prin- tifies a manufacturing facility that was not cation, efficacy supplement, or resubmission ciples articulated in the GRMP guidance, of any of these applications, submitted at included in the comprehensive and readily FDA’s decision to extend the review clock located list, the goal date may be extended. any time during the review cycle, may ex- should, except in rare circumstances, be lim- 1) If FDA identifies the need to inspect a tend the goal date by three months. ited to occasions where review of the new in- manufacturing facility that is not included ii. A major amendment may include, for formation could address outstanding defi- as part of the comprehensive and readily lo- example, a major new clinical safety/efficacy ciencies in the application and lead to ap- cated list in an original application or effi- study report; major re-analysis of previously proval in the current review cycle. submitted study(ies); submission of a Risk b. Inspection of Facilities Not Adequately cacy supplement, the goal date may be ex- Evaluation and Mitigation Strategy (REMS) Identified in an Original Application or Sup- tended by three months. with Element to Assure Safe Use (ETASU) plement 2) If FDA identifies the need to inspect a not included in the original application; or i. All original applications, including those manufacturing facility that is not included significant amendment to a previously sub- in the ‘‘Program,’’ (see Section I.B.2) and as part of the comprehensive and readily lo- mitted REMS with ETASU. Generally, supplements are expected to include a com- cated list in a manufacturing supplement, changes to REMS that do not include prehensive and readily located list of all the goal date may be extended by two ETASU and minor changes to REMS with manufacturing facilities included or ref- months. ETASU will not be considered major amend- erenced in the application or supplement. 6. These review goals are summarized in ments. This list provides FDA with information the following tables: TABLE 1.—ORIGINAL AND RESUBMITTED APPLICATIONS AND SUPPLEMENTS

Submission Cohort Standard Priority

NME NDAs and original BLAs ...... 90% in 10 months of the 60 day filing date ...... 90% in 6 months of the 60 day filing date Non NME NDAs ...... 90% in 10 months of the receipt date ...... 90% in 6 months of the receipt date Class 1 Resubmissions ...... 90% in 2 months of the receipt date ...... 90% in 2 months of the receipt date Class 2 Resubmissions ...... 90% in 6 months of the receipt date ...... 90% in 6 months of the receipt date Original Efficacy Supplements ...... 90% in 10 months of the receipt date ...... 90% in 6 months of the receipt date Class 1 Resubmitted Efficacy Supplements ...... 90% in 2 months of the receipt date ...... 90% in 2 months of the receipt date Class 2 Resubmitted Efficacy Supplements ...... 90% in 6 months of the receipt date ...... 90% in 6 months of the receipt date

TABLE 2

Prior Approval All Other

Manufacturing Supplements ...... 90% in 4 months of the receipt date ...... 90% in 6 months of the receipt date

B. Program for Enhanced Review Transparency ing minutes. The Formal Communication 1. Pre-submission meeting: The applicant and Communication for NME NDAs and Plan may be reviewed and amended at any is strongly encouraged to discuss the Original BLAs time based on the progress of the review and planned content of the application with the To promote transparency and communica- the mutual agreement of the review team appropriate FDA review division at a pre- tion between the FDA review team and the and the applicant. For example, the review NDA/BLA meeting. This meeting will be at- applicant, FDA will apply the following team and the applicant may mutually agree tended by the FDA review team, including model (‘‘the Program’’) to the review of all at any time to cancel future specified inter- appropriate senior FDA staff. New Molecular Entity New Drug Applica- actions in the Program (e.g., the late-cycle a. The pre-NDA/BLA meeting should be tions (NME NDAs) and original Biologics Li- meeting) that become unnecessary (e.g. be- held sufficiently in advance of the planned cense Applications (BLAs), including appli- cause previous communications between the submission of the application to allow for cations that are resubmitted following a review team and the applicant are suffi- meaningful response to FDA feedback and Refuse-to-File decision, received from Octo- cient). Any amendments made to the Formal should generally occur not less than 2 ber 1, 2017, through September 30, 2022. The Communication Plan should be consistent months prior to the planned submission of goal of the Program is to promote the effi- with the goal of an efficient and timely first the application. ciency and effectiveness of the first cycle re- cycle review process and not impede the re- b. In addition to FDA’s preliminary re- view process and minimize the number of re- view team’s ability to conduct its review. sponses to the applicant’s questions, other view cycles necessary for approval, ensuring Expedited Reviews. In certain cases, an ap- potential discussion topics include prelimi- that patients have timely access to safe, ef- plication reviewed in the Program will be for nary discussions on the need for REMS or fective, and high quality new drugs and bio- a product that the FDA review team identi- other risk management actions, and, where logics. fies as meeting an important public health applicable, the development of a Formal Approach to Application Review. The need. If the FDA review team determines Communication Plan and a timeline for re- standard approach for the review of NME that a first-cycle approval is likely for such view activities associated with a scheduling NDAs and original BLAs is described in this an application, the team intends to make recommendation under the Controlled Sub- section. However, the FDA review team and every effort to conduct an expedited review stances Act for drugs with abuse potential. the applicant may discuss and reach mutual and act early on the application. FDA con- These discussions will be summarized at the agreement on an alternative approach to the ducts expedited reviews to promote timely conclusion of the meeting and reflected in timing and nature of interactions and infor- access to critically needed therapies for pa- the FDA meeting minutes. mation exchange between the applicant and tients without compromising FDA’s high c. The FDA and the applicant will agree on FDA, i.e., a Formal Communication Plan for standards for demonstrating the safety, effi- the content of a complete application for the the review of the NME NDA or original BLA. cacy, and quality of new medicines. Expe- proposed indication(s) at the pre-submission The Formal Communication Plan may in- dited reviews are typically characterized by meeting. The FDA and the applicant may clude elements of the standard approach frequent contact between the applicant and also reach agreement on submission of a lim- (e.g., a mid-cycle communication or a late- the FDA review team throughout the review ited number of application components not cycle meeting) as well as other interactions process. Any parameters of the Program that later than 30 calendar days after the submis- that sometimes occur during the review are intended to facilitate expedited reviews sion of the original application. These sub- process (e.g., a meeting during the filing pe- are noted throughout Section I.B. missions must be of a type that would not be riod to discuss the application, i.e., an ‘‘ap- If significant application deficiencies are expected to materially impact the ability of plication orientation meeting’’). If appro- identified by the review team at any time the review team to begin its review. These priate, the Formal Communication Plan during an expedited review, FDA intends to agreements will be summarized at the con- should specify those elements of the Pro- revert, for the remainder of the review, to clusion of the meeting and reflected in the gram that FDA and the sponsor agree are un- the standard approach to the review of pri- FDA meeting minutes. necessary for the application under review. If ority NME NDAs and original BLAs (as de- i. Examples of application components the review team and the applicant anticipate scribed in this section), and will inform the that may be appropriate for delayed submis- developing a Formal Communication Plan, applicant accordingly. sion include updated stability data (e.g., 15– the elements of the plan should be discussed The remainder of Section I.B describes the month data to update 12–month data sub- and agreed to at the pre-submission meeting parameters that will apply to FDA’s review mitted with the original submission) or the (see Section I.B.1) and reflected in the meet- of applications in the Program. final audited report of a preclinical study

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00041 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.086 S02AUPT1 S4738 CONGRESSIONAL RECORD — SENATE August 2, 2017 (e.g., carcinogenicity) where the final draft tion. If applicable, the Day 74 letter will iii. Following an AC Meeting, FDA and the report is submitted with the original appli- serve as notification to the applicant that applicant may agree on the need to discuss cation. the review division intends to conduct an ex- feedback from the AC for the purpose of fa- ii. Major components of the application pedited review. cilitating the remainder of the review. Such (e.g., the complete study report of a Phase 3 4. Review performance goals: For NME a meeting will generally be held by tele- clinical trial or the full study report of re- NDA and original BLA submissions that are conference without a commitment for formal quired long-term safety data) are expected to filed by FDA under the Program, the PDUFA meeting minutes issued by the agency. be submitted with the original application review clock will begin at the conclusion of c. For applications that will not be dis- and are not subject to agreement for late the 60 calendar day filing review period that cussed at an AC meeting, the late-cycle submission. begins on the date of FDA receipt of the meeting will generally occur not later than 3 2. Original application submission: Appli- original submission. The review performance months (standard review) or two months cations are expected to be complete, as goals for these applications are as follows: (priority review) prior to the PDUFA goal agreed between the FDA review team and a. Review and act on 90 percent of standard date. the applicant at the pre-NDA/BLA meeting, NME NDA and original BLA submissions d. Late-Cycle Meeting Background Pack- at the time of original submission of the ap- within 10 months of the 60 day filing date. ages: The Agency background package for b. Review and act on 90 percent of priority plication. If the applicant does not have a the late-cycle meeting will be sent to the ap- NME NDA and original BLA submissions pre-NDA/BLA meeting with FDA, and no plicant not less than 10 calendar days (or 2 within 6 months of the 60 day filing date. agreement exists between FDA and the ap- calendar days for an expedited review) before 5. Mid-Cycle Communication: The FDA plicant on the contents of a complete appli- the late-cycle meeting. The package will Regulatory Project Manager (RPM), and cation or delayed submission of certain com- consist of a brief memorandum from the re- other appropriate members of the FDA re- ponents of the application, the applicant’s view team outlining substantive application view team (e.g., Cross Discipline Team Lead- submission is expected to be complete at the issues (e.g., deficiencies identified by pri- er (CDTL)), will call the applicant, generally time of original submission. mary and secondary reviews), the Agency’s within 2 weeks following the Agency’s inter- a. All applications are expected to include background package for the AC meeting (in- nal mid-cycle review meeting, to provide the a comprehensive and readily located list of corporated by reference if previously sent to applicant with an update on the status of the all clinical sites and manufacturing facilities the applicant), potential questions and/or review of their application. An agenda will included or referenced in the application. points for discussion for the AC meeting (if b. Any components of the application that be sent to the applicant prior to the mid- planned) and the current assessment of the FDA agreed at the pre-submission meeting cycle communication. Scheduling of the in- need for REMS or other risk management could be submitted after the original appli- ternal mid-cycle review meeting will be han- actions. If the application is subject to an cation are expected to be received not later dled in accordance with the GRMP guidance. expedited review, the background package than 30 calendar days after receipt of the The RPM will coordinate the specific date may be streamlined and brief using a original application. and time of the telephone call with the ap- bulleted list to identify issues to be dis- c. Incomplete applications, including appli- plicant. cussed. cations with components that are not re- a. The update should include any signifi- ceived within 30 calendar days after receipt cant issues identified by the review team to e. Late-Cycle Meeting Discussion Topics: of the original submission, will be subject to date, any information requests, information Potential topics for discussion at the late- a Refuse-to-File decision. regarding major safety concerns and prelimi- cycle meeting include major deficiencies d. The following parameters will apply to nary review team thinking regarding risk identified to date; issues to be discussed at applications that are subject to a Refuse-to- management, proposed date(s) for the late- the AC meeting (if planned); current assess- File decision and are subsequently filed over cycle meeting, updates regarding plans for ment of the need for REMS or other risk protest: the AC meeting (if an AC meeting is antici- management actions; status update of FDA’s i. The original submission of the applica- pated), an update regarding FDA’s review ac- review activities associated with a sched- tion will be subject to the review perform- tivities associated with a scheduling rec- uling recommendation under the Controlled ance goal as described in Section I.B.4. ommendation under the Controlled Sub- Substances Act, if applicable; information ii. The application will not be eligible for stances Act (if applicable), and other pro- requests from the review team to the appli- the other parameters of the Program (e.g., jected milestone dates for the remainder of cant; and additional data or analyses the ap- mid-cycle communication, late-cycle meet- the review cycle. plicant may wish to submit. ing). b. In the case of an expedited review, FDA i. With regard to submission of additional iii. FDA generally will not review amend- will communicate the timelines for the Late- data or analyses, the FDA review team and ments to the application during any review Cycle Meeting and the Late-Cycle Meeting the applicant will discuss whether such data cycle. FDA also generally will not issue in- background package (see Section I.B.6) will be reviewed by the Agency in the cur- formation requests to the applicant during which may occur earlier with more con- rent review cycle and, if so, whether the sub- the agency’s review. densed timeframes compared to a review mission will be considered a major amend- iv. The resubmission goals described in that is not expedited. ment and trigger an extension of the PDUFA Section I.A.1.e and I.A.1.f will not apply to 6. Late-Cycle and Advisory Committee goal date. any resubmission of the application fol- Meetings: A meeting will be held between 7. Inspections: FDA’s goal is to complete lowing an FDA complete response action. the FDA review team and the applicant to all GCP, GLP, and GMP inspections for ap- Any such resubmission will be reviewed as discuss the status of the review of the appli- plications in the Program within 6 months of available resources permit. cation late in the review cycle. Late-cycle the date of original receipt for priority appli- e. Since applications are expected to be meetings will generally be face-to-face meet- cations and within 10 months of the date of complete at the time of submission, unsolic- ings; however, the meeting may be held by original receipt for standard applications. ited amendments are expected to be rare and teleconference if FDA and the applicant This will allow 2 months at the end of the re- not to contain major new information or agree. Since the application is expected to be view cycle to attempt to address any defi- analyses. Review of unsolicited amendments, complete at the time of submission, FDA in- ciencies identified by the inspections. including those submitted in response to an tends to complete primary and secondary re- C. First Cycle Review Management FDA communication of deficiencies, will be views of the application in advance of the handled in accordance with the GRMP guid- planned late-cycle meeting. FDA and industry share a commitment to ance. This guidance includes the underlying a. FDA representatives at the late-cycle ensuring an efficient and effective first cycle principle that FDA will consider the most ef- meeting are expected to include the signa- review process for all applications subject to ficient path toward completion of a com- tory authority for the application, review the PDUFA program. This commitment was prehensive review that addresses application team members from appropriate disciplines, first articulated in the GRMP guidance fi- deficiencies and leads toward a first cycle and appropriate team leaders and/or super- nalized in 2005. FDA will update this guid- approval when possible. visors from disciplines for which substantive ance in PDUFA VI to include review activi- 3. Day 74 Letter: FDA will follow existing issues have been identified in the review to ties (e.g., the NME Program, REMS) that procedures regarding identification and com- date. have been added to the human drug review munication of filing review issues in the b. For applications that will be discussed program since the guidance was finalized, ‘‘Day 74 letter.’’ For applications subject to at an AC meeting, the following parameters principles regarding notification to appli- the Program, the timeline for this commu- apply: cants regarding issues identified during nication will be within 74 calendar days from i. FDA intends to convene AC meetings no FDA’s initial review of the application, prin- the date of FDA receipt of the original sub- later than 2 months (standard review) or no ciples regarding FDA’s notification to appli- mission. The planned review timeline in- later than 6 weeks (priority review) prior to cants regarding planned review timelines, cluded in the Day 74 letter for applications the PDUFA goal date. The late-cycle meet- and the importance of internal review in the Program will include the planned date ing will occur not less than 12 calendar days timelines that govern aspects of the human for the internal mid-cycle review meeting. before the date of the AC meeting. drug review program that are not part of The letter will also include preliminary ii. FDA intends to provide final questions PDUFA performance goals. FDA will publish plans on whether to hold an Advisory Com- for the AC to the sponsor and the AC not less a revised draft guidance for public comment mittee (AC) meeting to discuss the applica- than 2 calendar days before the AC meeting. no later than the end of FY 2018.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00042 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.087 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4739 D. Review of Proprietary Names to Reduce c. If the decision is to deny the appeal, the this paragraph should be construed to mean Medication Errors response should include reasons for the de- those protocols for trials that will form the To enhance patient safety, FDA is com- nial and any actions the sponsor might take primary basis of an efficacy claim no matter mitted to various measures to reduce medi- to persuade the Agency to reverse its deci- what phase of drug development in which cation errors related to look-alike and sion. they happen to be conducted. sound-alike proprietary names and such fac- d. In some cases, further data or further e. If a protocol is reviewed under the proc- tors as unclear label abbreviations, acro- input from others might be needed to reach ess outlined above and agreement with the nyms, dose designations, and error prone a decision on the appeal. In these cases, the Agency is reached on design, execution, and label and packaging design. The following ‘‘response’’ should be the plan for obtaining analyses and if the results of the trial con- performance goals apply to FDA’s review of that information (e.g., requesting further in- ducted under the protocol substantiate the drug and biological product proprietary formation from the sponsor, scheduling a hypothesis of the protocol, the Agency names during development (as early as end- meeting with the sponsor, scheduling the agrees that the data from the protocol can of-phase 2) and during FDA’s review of a issue for discussion at the next scheduled be used as part of the primary basis for ap- marketing application: available advisory committee (AC). proval of the product. The fundamental 1. Proprietary Name Review Performance e. In these cases, once the required infor- agreement here is that having agreed to the Goals During Drug Development mation is received by the Agency (including design, execution, and analyses proposed in a. Review 90% of proprietary name submis- any advice from an AC), the person to whom protocols reviewed under this process, the sions filed within 180 days of receipt. Notify the appeal was made, again has 30 calendar Agency will not later alter its perspective on sponsor of tentative acceptance or non-ac- days from the receipt of the required infor- the issues of design, execution, or analyses ceptance. mation in which to either grant or deny the unless public health concerns unrecognized b. If the proprietary name is found to be appeal. at the time of protocol assessment under unacceptable, the sponsor can request recon- f. Again, if the decision is to deny the ap- this process are evident. sideration by submitting a written rebuttal peal, the response should include the reasons 2. Performance goal: with supporting data or request a meeting for the denial and any actions the sponsor 90% of special protocol assessments and within 60 days to discuss the initial decision might take to persuade the Agency to re- agreement requests completed and returned (meeting package required). verse its decision. to sponsor within the timeframe. c. If the proprietary name is found to be g. N.B. If the Agency decides to present the 3. Reporting: unacceptable, the above review performance issue to an AC and there are not 30 days be- The Agency will track and report the num- goals also would apply to the written request fore the next scheduled AC, the issue will be ber of original special protocol assessments for reconsideration with supporting data or presented at the following scheduled com- and resubmissions per original special pro- the submission of a new proprietary name. mittee meeting to allow conformance with tocol assessment. d. A complete submission is required to AC administrative procedures. H. Meeting Management Goals begin the review clock. F. Clinical Holds Formal PDUFA meetings between sponsors 2. Proprietary Name Review Performance 1. Procedure: and FDA consist of Type A, B, B(EOP), and Goals During Application Review The Center should respond to a sponsor’s C meetings. These meetings are further de- a. Review 90% of NDA/BLA proprietary complete response to a clinical hold within scribed below. name submissions filed within 90 days of re- 30 days of the Agency’s receipt of the sub- Type A meetings are those meetings that ceipt. Notify sponsor of tentative accept- mission of such sponsor response. are necessary for an otherwise stalled drug ance/non-acceptance. 2. Performance goal: development program to proceed (i.e., a b. A supplemental review will be done 90% of such responses are provided within ‘‘critical path’’ meeting) or to address an im- meeting the above review performance goals 30 calendar days of the Agency’s receipt of portant safety issue. Post-action meetings if the proprietary name has been submitted the sponsor’s response. requested within three months after an FDA previously (IND phase after end-of-phase 2) G. Special Protocol Question Assessment and regulatory action other than approval (i.e., and has received tentative acceptance. Agreement issuance of a complete response letter) will c. If the proprietary name is found to be 1. Procedure: also generally be considered Type A meet- unacceptable, the sponsor can request recon- Upon specific request by a sponsor (includ- ings. sideration by submitting a written rebuttal ing specific questions that the sponsor de- Type B meetings include pre-IND meetings with supporting data or request a meeting sires to be answered), the Agency will evalu- and pre-NDA/BLA meetings, while Type B within 60 days to discuss the initial decision ate certain protocols and issues to assess (EOP) meetings are reserved for certain End- (meeting package required). whether the design is adequate to meet sci- of-Phase 1 meetings (i.e. for 21 CFR Part 312 d. If the proprietary name is found to be entific and regulatory requirements identi- Subpart E or 21 CFR Part 314 Subpart H or unacceptable, the above review performance fied by the sponsor. similar products) and End-of-Phase 2/pre- goals apply to the written request for recon- a. The sponsor should submit a limited Phase 3 meetings. Meetings regarding REMS sideration with supporting data or the sub- number of specific questions about the pro- or postmarketing requirements that occur mission of a new proprietary name. tocol design and scientific and regulatory re- outside the context of the review of a mar- e. A complete submission is required to quirements for which the sponsor seeks keting application will also generally be con- begin the review clock. agreement (e.g., is the dose range in the car- sidered Type B meetings. E. Major Dispute Resolution cinogenicity study adequate, considering the A Type C meeting is any other type of 1. Procedure: intended clinical dosage; are the clinical meeting. For procedural or scientific matters in- endpoints adequate to support a specific effi- 1. Responses to Meeting Requests volving the review of human drug applica- cacy claim). a. Procedure: FDA will notify the re- tions and supplements (as defined in PDUFA) b. Within 45 days of Agency receipt of the quester in writing of the date, time, and that cannot be resolved at the signatory au- protocol and specific questions, the Agency place for the meeting, as well as expected thority level (including a request for recon- will provide a written response to the spon- Center participants following receipt of a sideration by the signatory authority after sor that includes a succinct assessment of formal meeting request. Table 3 below indi- reviewing any materials that are planned to the protocol and answers to the questions cates the timeframes for FDA’s response to a be forwarded with an appeal to the next posed by the sponsor. If the Agency does not meeting request. level), the response to appeals of decisions agree that the protocol design, execution will occur within 30 calendar days of the plans, and data analyses are adequate to TABLE 3 achieve the goals of the sponsor, the reasons Center’s receipt of the written appeal. Response Time 2. Performance goal: 90% of such answers for the disagreement will be explained in the Meeting Type (calendar days) are provided within 30 calendar days of the response. Center’s receipt of the written appeal. c. Protocols that qualify for this program A ...... 14 B ...... 21 3. Conditions: include: carcinogenicity protocols, stability B(EOP) ...... 14 a. Sponsors should first try to resolve the protocols, and Phase 3 protocols for clinical C ...... 21 procedural or scientific issue at the signa- trials that will form the primary basis of an tory authority level. If it cannot be resolved efficacy claim. For such Phase 3 protocols to i. For any type of meeting, the sponsor at that level, it should be appealed to the qualify for this comprehensive protocol as- may request a written response to its ques- next higher organizational level (with a copy sessment, the sponsor must have had an end- tions rather than a face-to-face meeting, vid- to the signatory authority) and then, if nec- of-Phase 2/pre-Phase 3 meeting with the re- eoconference or teleconference. FDA will re- essary, to the next higher organizational view division so that the division is aware of view the request and make a determination level. the developmental context in which the pro- on whether a written response is appropriate b. Responses should be either verbal (fol- tocol is being reviewed and the questions or whether a face-to-face meeting, video- lowed by a written confirmation within 14 being answered. conference, or teleconference is necessary. If calendar days of the verbal notification) or d. N.B. For products that will be using a written response is deemed appropriate, written and should ordinarily be to either Subpart E or Subpart H development FDA will notify the requester of the date it grant or deny the appeal. schemes, the Phase 3 protocols mentioned in intends to send the written response in the

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00043 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.088 S02AUPT1 S4740 CONGRESSIONAL RECORD — SENATE August 2, 2017 Agency’s response to the meeting request. 5. Sponsor Notification to FDA drug development is a core Agency activity This date will be consistent with the time- Not later than three calendar days fol- to help achieve the Agency’s mission to fa- frames specified in Table 4 below for the spe- lowing the sponsor’s receipt of FDA’s pre- cilitate the conduct of efficient and effective cific meeting type. liminary responses for a Type B(EOP) or C drug development programs, which can en- ii. For pre-IND and Type C meetings, while meeting, the sponsor will notify FDA of hance public health by making new safe and the sponsor may request a face-to-face meet- whether the meeting is still needed, and if it effective drugs available to the American ing, the Agency may determine that a writ- is, the anticipated agenda of the meeting public in a timely manner. Accordingly, FDA ten response to the sponsor’s questions given the sponsor’s review of the preliminary will maintain dedicated drug development would be the most appropriate means for responses. communication and training staffs in CDER providing feedback and advice to the spon- 6. Meeting Minutes and CBER, focused on enhancing commu- sor. When it is determined that the meeting a. Procedure: The Agency will prepare min- nication between FDA and sponsors during request can be appropriately addressed utes that will be available to the sponsor 30 drug development. through a written response, FDA will notify calendar days after the meeting. The min- One function of the staff is to serve as a li- the requester of the date it intends to send utes will clearly outline the important aison that will facilitate general and, in the written response in the Agency’s re- agreements, disagreements, issues for fur- some cases, specific interactions between sponse to the meeting request. This date will ther discussion, and action items from the sponsors and each Center. The liaison will be consistent with the timeframes specified meeting in bulleted form and need not be in serve as a point of contact for sponsors who in Table 4 below for the specific meeting great detail. Meeting minutes are not re- have general questions about drug develop- type. quired if the Agency transmits a written re- ment or who need clarification on which re- b. Performance Goal: FDA will respond to sponse for any meeting type. view division to contact with their ques- meeting requests and provide notification b. Performance goal: 90% of minutes are tions. The liaison will also serve as a sec- within the response times noted in Table 3 issued within 30 calendar days of the date of ondary point of contact in each Center for for 90% of each meeting type. the meeting. sponsors who are encountering challenges in 2. Scheduling Meetings 7. Conditions communication with the review team for a. Procedure: FDA will schedule the meet- For a meeting to qualify for these perform- their IND (e.g., in instances when they have ing on the next available date at which all ance goals: not received a response from the review team applicable Center personnel are available to a. A written request must be submitted to to a simple or clarifying question or referral attend, consistent with the component’s the review division. to the formal meeting process within 30 days other business; however, the meeting should b. The written request must provide: of the sponsor’s initial request). In such be scheduled consistent with the type of i. A brief statement of the purpose of the cases, the liaison will work with the review meeting requested. Table 4 below indicates meeting and the sponsor’s proposal for either team and the sponsor to facilitate resolution the timeframes for the scheduled meeting a face-to-face meeting or a written response of the issue. date following receipt of a formal meeting from the Agency; The second function of the staff is to pro- request, or in the case of a written response, ii. A listing of the specific objectives/out- vide ongoing training to the review organiza- the timeframes for the Agency to send the comes the requester expects from the meet- tions on best practices in communication written response. If the requested date for ing; with sponsors. The content of training in- any meeting type is greater than the speci- iii. A proposed agenda, including estimated cludes, but is not limited to, FDA’s philos- fied timeframe, the meeting date should be times needed for each agenda item; ophy regarding timely interactive commu- within 14 calendar days of the requested iv. A listing of planned external attendees; nication with sponsors during drug develop- date. v. A listing of requested participants/dis- ment as a core Agency activity, best prac- ciplines representative(s) from the Center tices for addressing sponsor requests for ad- TABLE 4 with an explanation for the request as appro- vice and timely communication of responses priate; and through appropriate mechanisms (e.g., tele- Meeting Type Meeting Scheduling or Written Response Time vi. The date that the meeting background conferences, secure email, or when questions A ...... 30 calendar days from receipt of meeting re- package will be sent to the Center. Refer to are best addressed through the formal meet- quest Table 5 for timeframes for the Agency’s re- ings process), and the role of the liaison staff B ...... 60 calendar days from receipt of meeting re- in each Center in facilitating communica- quest ceipt of background packages. B(EOP) ...... 70 calendar days from receipt of meeting re- c. The Agency concurs that the meeting tion between the review staff and sponsor quest will serve a useful purpose (i.e., it is not pre- community, including the staff’s role in fa- C ...... 75 calendar days from receipt of meeting re- cilitating resolution of individual commu- quest mature or clearly unnecessary). However, re- quests for a Type B or B(EOP) meeting will nication requests. The staff will also collabo- b. Performance goal: 90% of meetings are be honored except in the most unusual cir- rate with sponsor stakeholders (e.g., through held within the timeframe for each meeting cumstances. participation in workshops, webinars, and type, and 90% of written responses are sent 8. Guidance other meetings) to communicate FDA’s phi- within the timeframe for each meeting type. FDA will publish revised draft guidance on losophy and best practices regarding commu- 3. Meeting Background Packages formal meetings between FDA and sponsors nication with sponsors during drug develop- The timing of the Agency’s receipt of the no later than September 30, 2018. ment. sponsor background package for each meet- To continue to enhance timely interactive I. Enhancing Regulatory Science and Expe- communication with sponsors during drug ing type (including those meetings for which diting Drug Development a written response will be provided) is speci- development in PDUFA VI, FDA will do the To ensure that new and innovative prod- fied in Table 5 below. following: ucts are developed and available to patients a. Independent Assessment. FDA will con- TABLE 5 in a timely manner, FDA will build on the tract with an independent third party to as- success of the FDA’s regulatory science pro- sess current practices of FDA and sponsors Meeting Type Receipt of Background Package gram that included advancing the science of in communicating during drug development. meta-analysis methodologies, advancing the The statement of work for this effort will be A ...... At the time of the meeting request use of biomarkers and pharmacogenomics, published for public comment prior to begin- B ...... 30 calendar days before the date of the meeting or expected written response enhancing communications between FDA ning the assessment. The third party will be B(EOP) ...... 50 calendar days before the date of the meeting and sponsors during drug development, and expected to separately engage both FDA or expected written response* advancing the development of drugs for rare staff and individual sponsors through con- C6 ...... 47 calendar days before the date of the meeting or expected written response* diseases. The extension and continuation of tractor-led interviews as part of the assess- this work will encompass further evaluation ment. Due to the significant volume of FDA- * If the scheduled date of a Type B(EOP) or C meeting is earlier than the and enhancement of FDA-sponsor commu- timeframes specified in Table 4, the meeting background package will be sponsor interactions in a given year, the as- due no sooner than 6 calendar days and 7 calendar days following the re- nications, ensuring the sustained success of sessment will be based on a random subset of sponse time for Type B(EOP) and C meetings specified in Table 3, respec- the breakthrough therapy program, estab- drug development programs identified by tively. lishing early consultations between FDA and IND number. The third party will identify 4. Preliminary Responses to Sponsor Ques- sponsors on the use of new surrogate best practices and areas for improvement in tions endpoints as the primary basis for product communication by FDA review staff and a. Procedure: The Agency will send pre- approval, advancing rare disease drug devel- sponsors. FDA will publish the final report of liminary responses to the sponsor’s ques- opment, advancing the development of com- the assessment on FDA’s website no later tions contained in the background package bination products, and exploring the use of than the end of FY 2020. no later than five calendar days before the real world evidence for use in regulatory de- b. Public Workshop. FDA will convene a meeting date for Type B(EOP) and C meet- cision-making. public workshop by the end of March 2021 to ings. 1. Promoting Innovation Through En- discuss the findings of the independent as- b. Performance goal: 90% of preliminary hanced Communication Between FDA and sessment, including anonymized, aggregated responses to questions for Type B(EOP) Sponsors During Drug Development feedback from sponsors and FDA review meetings are issued by FDA no later than FDA’s philosophy is that timely inter- teams resulting from the contractor inter- five calendar days before the meeting date. active communication with sponsors during views.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00044 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.089 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4741 c. Guidance. FDA will consider the third traditional clinical development programs, ii. By no later than December 31, 2017, FDA party’s recommendations for best practices use of adaptive study designs, evaluation of will begin tracking workload and timelines in communication and update the current novel endpoints, application of new ap- for cross-center consultations to enable ap- draft or final guidance on ‘‘Best Practices for proaches to statistical analysis, and appro- propriate allocation of resources and regu- Communication Between IND Sponsors and priate use of FDA’s expedited development larly assess the progress of combination FDA During Drug Development’’ if appro- and review programs (i.e., Fast Track, product review throughout PDUFA VI. priate. If FDA determines that the guidance Breakthrough, Priority Review, and Acceler- iii. By no later than September 30, 2018, for should be updated, based on the rec- ated Approval). CBER, through its Rare Dis- each component within FDA that is con- ommendations of the third party and the ease Program Staff, will also ensure that its sulted to participate in review of combina- feedback received from the public workshop, review offices consider such flexible and fea- tion products, FDA will outline in appro- FDA will update the guidance no later than sible approaches in review. priate internal documents the Agency’s proc- one year following the public workshop. The RDP staff will also continue to provide ess for resolving internally any scientific or 2. Ensuring Sustained Success of Break- training to all CDER and CBER review staff regulatory issues that arise, as well as a through Therapy Program related to development, review, and approval commitment for the medical product centers Breakthrough therapy designation is in- of drugs for rare diseases as part of the re- and OCP to coordinate and complete reviews tended to expedite the development and re- viewer training core curriculum.μ The objec- and related activities when consulted in view of drug and biological products, alone tive of the training will be to familiarize re- timelines set forth by PDUFA and other pub- or in combination, for serious or life-threat- view staff with the challenges associated lished documents (e.g., the GRMP guidance ening diseases or conditions when prelimi- with rare disease applications and strategies and GRMP MAPP). nary clinical evidence indicates that the to address these challenges; to promote best c. FDA will establish Manuals of Policies drug may demonstrate substantial improve- practices for review and regulation of rare and Procedures (MAPPs) and Standard Oper- ment over existing therapies. A break- disease applications; and to encourage flexi- ating Policy and Procedures (SOPPs) to pro- through therapy designation includes the bility and scientific judgment among review- mote efficient, effective, and consistent com- features of the fast track program, intensive ers in the review and regulation of rare dis- bination product development and review. FDA guidance on an efficient drug develop- ease drug development and application re- The documents will describe processes and ment program, and an organizational com- view. The training will also emphasize the procedures for conducting review of com- mitment by FDA involving senior managers. important role of the RDP staff as members bination products, including the expecta- Additional resources will enable the Agency of the core review team to help ensure con- tions for consultation of internal experts to continue to work closely with sponsors sistency of scientific and regulatory ap- outside the reviewing Center. FDA will de- throughout the breakthrough therapy des- proaches across applications and review scribe the responsibilities of staff in each ignation, development, and review processes. teams. Center and Office, expectations for core re- RDP staff will continue to engage in out- Both FDA and the regulated industry are view team members and for other consultant reach to industry, patient groups, and other committed to ensuring the expedited devel- staff in activities and meetings related to stakeholders to provide training on FDA’s opment and review of innovative therapies the combination product development pro- RDP. The staff will continue to foster col- for serious or life-threatening diseases or gram and application review. FDA will de- laborations in the development of tools (e.g., conditions by investing additional resources fine the key terms to be used by staff in re- patient reported outcome measures) and into the breakthrough therapy program. view of combination products to foster clear data (e.g., natural history studies) to support 3. Early Consultation on the Use of New communication within FDA and to regulated development of drugs for rare diseases. In ad- Surrogate Endpoints industry. The topic areas and expected com- dition, the staff will also facilitate inter- FDA and industry believe that early con- pletion dates of these documents are speci- sultation between review teams and sponsors actions between stakeholders and FDA re- view divisions to increase awareness of FDA fied below: is important for development programs i. Human Factors Assessments (March 31, regulatory programs and engagement of pa- where the sponsor intends to use a bio- 2019) tients in FDA’s regulatory decision-making. marker as a new surrogate endpoint that has ii. Quality assessment of combination FDA will include updates on the activities never been previously used as the primary products, including coordination of facility basis for product approval in the proposed and success of the RDP in the PDUFA an- nual performance report to include, for ex- inspections (September 30, 2019) context of use. Early consultation in the iii. Patient-oriented labeling, including in- ample, the number of training courses of- drug development program allows the review structions-for-use materials for those drug- fered and staff trained, the number of review team to consult with FDA senior manage- device and biologic-device combination prod- programs where RDP staff participated as ment to evaluate the sponsor’s proposal be- ucts regulated by CBER and CDER (Sep- fore providing advice regarding the proposed core team members, and metrics related to engagement with external stakeholders. tember 30, 2019) biomarker as a new surrogate endpoint to d. By no later than December 31, 2018, FDA FDA will also continue to include informa- support accelerated or traditional approval. will make available on FDA’s website key tion on rare disease approvals in its annual Requests to engage with FDA on this topic points of contact in OCP and the medical reports on innovative drug approvals, includ- will be considered a Type C meeting request. product centers for combination product re- ing utilization of expedited programs and The purpose of this meeting is to discuss the view. FDA agrees to maintain and update regulatory flexibility and appropriate com- feasibility of the surrogate as a primary end- parative metrics to non-rare disease innova- this information periodically. point, and identify any gaps in knowledge e. FDA will establish submission proce- tive approvals. and how they might be addressed. The out- 5. Advancing Development of Drug-Device dures for Human Factors protocols no later come of this meeting may require further in- and Biologic-Device Combination Products than September 30, 2018. Beginning in FY vestigation by the sponsor and discussion Regulated by CBER and CDER 2019, FDA will establish timelines to review and agreement with the agency before the a. FDA will develop staff capacity and ca- and provide comment on the protocols for surrogate endpoint could be used as the pri- pability across the medical product centers Human Factors studies of combination drug- mary basis for product approval. To qualify and the Office of Combination Products device and biologic-device products within 60 for this consultation, these Type C meeting (OCP) to more efficiently, effectively, and days. requests must be accompanied by the com- consistently review and respond to submis- i. Procedure for review of human factors plete meeting background package at the sions that include combination products. protocols for combination products: Upon time the request is made that includes pre- These staff will advance the development of specific request by a sponsor (including spe- liminary human data indicating impact of combination products by providing combina- cific questions that the sponsor desires to be the drug on the biomarker at a dose that ap- tion product expertise as part of the core re- answered) consistent with the steps below, pears to be generally tolerable. The remain- view team as applicable, and through pro- the Agency will evaluate human factors pro- ing meeting procedures as described in Sec- moting best practices for review of combina- tocols and issues to assess whether the de- tion I.H of this document will apply. tion products. The additional capacity will sign is adequate to meet scientific and regu- 4. Advancing Development of Drugs for include staff who will focus on review of latory requirements identified by the spon- Rare Diseases cGMP, engineering aspects, human factors sor. FDA will build on the success of the Rare and bridging study protocols and study re- (1) The sponsor should submit a limited Disease Program (RDP) in CDER and CBER ports, and labeling, to include instructions- number of specific questions about the by continuing to advance and facilitate the for-use materials. human factors protocol design and scientific development and timely approval of drugs b. FDA will streamline the process for and regulatory requirements for which the and biologics for rare diseases, including rare combination product review and improve the sponsor seeks agreement (e.g., are the study diseases in children. The Rare Disease Pro- Agency’s ability to assess workload and allo- participant groups appropriate to represent gram staff in CDER will be integrated into cate resources to the review of combination intended users, is the study endpoint ade- review teams for rare disease development products. quate, are the critical tasks that should be programs and application review to provide i. By no later than December 31, 2017, FDA evaluated appropriately identified). their unique expertise on flexible and fea- will complete a lean process mapping for (2) Within 60 days of Agency receipt of the sible approaches to studying and reviewing combination product review in order to in- protocol and specific questions, the Agency such drugs to include, for example, innova- form changes to review work flow to improve will provide a written response to the spon- tive use of biomarkers, consideration of non- the inter-center consultation process. sor that includes a succinct assessment of

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00045 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.090 S02AUPT1 S4742 CONGRESSIONAL RECORD — SENATE August 2, 2017 the protocol and answers to the questions ii. Patient-oriented labeling (e.g., instruc- opment and analysis, and the staff will also posed by the sponsor. If the Agency does not tions-for-use). support the public qualification activities agree that the protocol design, execution 6. Enhancing Use of Real World Evidence for COAs. plans, and data analyses are adequate to for Use in Regulatory Decision-Making b. FDA will develop a series of guidance achieve the goals of the sponsor, the reasons As we participate in the current data revo- documents to focus on approaches and meth- for the disagreement will be explained in the lution, it is important that FDA consider the ods to bridge from initial patient-focused response. possibilities of using so-called ‘‘real world’’ drug development meetings, like those pi- (3) Performance goals for FDA will be data as an important tool in evaluating not loted under PDUFA V, to fit-for-purpose phased in, starting in FY 2019 as follows: only the safety of medications but also their tools to collect meaningful patient and care- a. By FY 2019, review 50% of human factors effectiveness. To accomplish this will require giver input for ultimate use in regulatory de- protocol submissions within 60 days and pro- an understanding of what questions to ask, cision making. Prior to the issuance of each vide sponsor with written comments. including how such data can be generated guidance, as part of the development, FDA b. By FY 2020, review 70% of human factors and used appropriately in product evalua- will conduct a public workshop to gather protocol submissions within 60 days and pro- tion, what the challenges are to appropriate input from the wider community of patients, vide sponsor with written comments. generation and use of these data, and how to patient advocates, academic researchers, ex- c. By FY 2021, review 90% of human factors address such challenges. Towards this end, pert practitioners, industry, and other stake- protocol submissions within 60 days and pro- FDA will do the following: holders. vide sponsor with written comments. a. By no later than the end of FY 2018, FDA i. By the end of FY 2018, FDA will publish f. By no later than December 31, 2018, FDA will complete one or more public work- a draft guidance describing approaches to will begin staff training related to develop- shop(s) with key stakeholders, including pa- collecting comprehensive and representative ment, review, and approval of drug-device tients, biopharmaceutical companies, and patient and caregiver input on burden of dis- and biologic-device combination products re- academia, to gather input into issues related ease and current therapy. The guidance will viewed in CDER and CBER. The training will to Real World Evidence (RWE) use in regu- address topics including: standardized no- be provided to all CDER, CBER, Center for latory decision-making. The workshop(s) menclature and terminologies, methods to Devices and Radiological Health (CDRH), should address, among other things, the fol- collect meaningful patient input throughout and Office of Combination Products (OCP) lowing topics: the drug development process, and methodo- staff, and will be part of the reviewer train- Benefits to patients, regulators, and bio- logical considerations for data collection, re- ing core curriculum. The key purposes of pharmaceutical companies of RWE in regu- porting, management, and analysis. this training include familiarizing review latory decision making; ii. By the end of FY 2019, FDA will publish staff with the regulatory requirements and RWE availability, quality, and access chal- a draft guidance describing processes and challenges associated with combination lenges, and approaches to mitigate these; methodological approaches to development product applications and strategies to ad- Methodological approaches for the collec- of holistic sets of impacts that are most im- dress these challenges; promoting best prac- tion, analysis, and communication of RWE; portant to patients. The guidance will ad- tices for review and regulation of combina- and dress topics including: methods for sponsors, tion products regulated by CDER and CBER, Appropriate contexts of use of RWE in reg- patient organizations, academic researchers, and helping ensure coordination and con- ulatory decision-making regarding effective- and expert practitioners to develop and iden- sistent approaches within the Centers in the ness. tify what are most important to patients in review and regulation of combination prod- b. By no later than the end of FY 2019, FDA terms of burden of disease, burden of treat- uct applications. The training will also em- will initiate (or fund by contract), appro- ment, and other critical aspects. The guid- phasize the role of various experts in the priate activities (e.g., pilot studies or meth- ance will address how patient input can in- Centers as members of the review team and odology development projects) aimed at ad- form drug development and review processes, OCP’s roles and responsibilities in order to dressing key outstanding concerns and con- and, as appropriate, regulatory decision help ensure consistency of scientific and reg- siderations in the use of RWE for regulatory making. ulatory approaches across applications and decision making. iii. By the end of FY 2020, FDA will publish review teams. c. By no later than the end of FY 2021, con- a draft guidance describing approaches to g. FDA will contract with an independent sidering available input, such as from activi- identifying and developing measures for an third party to assess current practices for ties noted above, FDA will publish draft identified set of impacts (e.g., burden of dis- combination drug product review. This study guidance on how RWE can contribute to the ease and treatment), which may facilitate will focus on areas where the needs for inter- assessment of safety and effectiveness in reg- collection of meaningful patient input in center coordination and consistent ap- ulatory submissions, for example in the ap- clinical trials. The guidance will address proaches are greatest, including such areas proval of new supplemental indications and methods to measure impacts in a meaningful as the Request-for-Designation, cGMPs/fa- for the fulfillment of postmarketing commit- way, and identify an appropriate set of meas- cilities topics, human factors and bridging ments and requirements. FDA will work to- ure(s) that matter most to patients. studies, and labeling. The contractor will be ward the goal of publishing a revised draft or iv. By the end of FY 2021, FDA will publish expected to engage both FDA staff and indi- final guidance within 18 months after the a draft guidance on clinical outcome assess- vidual sponsors as part of the assessment. close of the public comment period. ments, which, when final, will, as appro- The assessment will be based on a randomly priate, revise or supplement the 2009 Guid- J. Enhancing Regulatory Decision Tools to Sup- selected subset of combination products in ance to Industry on Patient-Reported Out- port Drug Development and Review various phases of development. The assess- come Measures. The draft guidance will also ment will identify best practices and areas 1. Enhancing the Incorporation of the Pa- address technologies that may be used for for improvement by FDA review staff and tient’s Voice in Drug Development and Deci- the collection, capture, storage, and analysis sponsors in the submission and review of sion-Making of patient perspective information. The guid- combination products for consideration by To facilitate the advancement and use of ance will also address methods to better in- both FDA and sponsors. FDA will publish the systematic approaches to collect and utilize corporate clinical outcome assessments into final report of the assessment on FDA’s robust and meaningful patient and caregiver endpoints that are considered significantly website no later than the end of FY 2020. input that can more consistently inform robust for regulatory decision-making. FDA will consider the assessment findings drug development and, as appropriate, regu- v. For each of the above, FDA will work to- regarding best practices on the part of FDA latory decision making, FDA will conduct ward the goal of publishing a revised draft or review staff and sponsors in any updates to the following activities during PDUFA VI: final guidance within 18 months after the relevant documents such as MAPPs, SOPPs, a. FDA will strengthen the staff capacity close of the public comment period on the and submission procedures for human factors to facilitate development and use of patient- draft guidance. protocols, and in the review and submission focused methods to inform drug development c. FDA will create and maintain a reposi- of Combination Product applications. and regulatory decisions. This staff, com- tory of publicly available tools on FDA’s h. By the end of FY 2019, FDA will publish posed primarily of clinical, statistical, psy- website as a resource for stakeholders. The draft guidance or update previously pub- chometric, and health outcomes research ex- repository will also include FDA’s clinical lished guidance issued by the medical prod- pertise, will be integrated into review teams outcome assessment compendium, patient- uct centers and OCP for review staff and in- as core members of the team during drug de- focused drug development meeting resources, dustry describing considerations related to velopment and application review where the and ongoing efforts on patient-focused drug drug-device and biologic-device combination sponsor intends to use patient input or clin- development. product on the topics noted below. The draft ical outcome assessment (COAs) such as pa- d. As appropriate, FDA will revise existing guidance(s) will be finalized by the end of FY tient-reported outcomes (PROs) as part of MAPPs and SOPPs to include suggested ap- 2022. the development program. A core responsi- proaches for incorporating an increased pa- i. Bridging studies, including the bridging bility of the staff will be to engage patient tient focus in other on-going or planned FDA of data from combination products that em- stakeholders and provide timely develop- public meetings (e.g., FDA scientific work- ploy different device components for the ment-phase consultations to sponsors devel- shops). In addition, as appropriate, FDA will same drug or biologic and the same device oping new tools to collect patient and care- develop and implement staff training related component across different drugs and bio- giver input. This additional capacity is ex- to processes, tools, and methodologies de- logics. pected to advance the science of COA devel- scribed in this section.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00046 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.091 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4743 e. By the end of FY 2019, FDA will conduct a. FDA will develop its regulatory science up meeting on the same design, to occur a public workshop, through a qualified third and review expertise and capacity in MIDD within a span of approximately 120 days. party, with the primary purpose of gathering approaches. This staff will support the high- These meetings will be led by the biostatis- ideas and experiences of the patient and ly-specialized evaluation of model-based tical review components within CDER or caregiver community and their recommenda- strategies and development efforts. CBER. The opportunity for increased inter- tions on approaches and best practices that b. FDA will convene a series of workshops action with the agency will provide better would enhance patient engagement in clin- to identify best practices for MIDD. Topics understanding of the agency’s requirements ical trials. The meeting may also gather will include: (1) physiologically-based phar- for trial simulations involved in the use of input from sponsors, academic researchers, macokinetic modeling; (2) design analysis the pilot study design and allow for iteration and expert practitioners. The meeting will and inferences from dose-exposure-response of design modifications, if needed. In return, result in a published report on proceedings studies; (3) disease progression model devel- FDA’s ability to publicly discuss example de- and recommendations from discussions at opment, including natural history and trial signs will provide better clarity on the ac- the meeting. simulation; and (4) immunogenicity and cor- ceptance of different types of trial designs 2. Enhancing Benefit-Risk Assessment in relates of protection for evaluating biologi- that should facilitate their use in future de- Regulatory Decision-Making cal products, including vaccines and blood velopment programs. FDA will further the agency’s implementa- products. Each workshop will focus on cur- i. FDA will publish a Federal Register No- tion of structured benefit-risk assessment, rent and emerging scientific approaches, in- tice announcing the pilot program, clari- including the incorporation of the patient’s cluding methodological limitations. FDA fying pilot program eligibility, and describ- voice in drug development and decision-mak- will produce a written summary of the topics ing the proposal submission and selection ing, in the human drug review program discussed in each workshop. process. through the following commitments to be c. Starting in FY 2018, FDA will conduct a ii. FDA will select up to 2 proposals (e.g., accomplished during PDUFA VI: pilot program for MIDD approaches. For 1 per Center) quarterly each year. FDA will a. By March 31, 2018, FDA will publish an sponsors participating in the pilot program, convene an internal review group to review update to the implementation plan titled FDA will grant a pair of meetings specifi- proposals on a quarterly basis and provide ‘‘Structured Approach to Benefit-Risk As- cally designed for this pilot program, con- recommendations on prioritization and se- sessment in Drug Regulatory Decision-Mak- sisting of an initial and a follow-up meeting lection of proposals and share knowledge and ing.’’ The update will include a report on the on the same drug development issues, to experience. Program selection will be progress made during PDUFA V and a plan occur within a span of approximately 120 prioritized based on trial design features and for continued implementation during FYs days. These meetings will be led by the clin- therapeutic areas of high unmet need. iii. To promote innovation in this area, 2018–2022. ical pharmacology or biostatistical review trial designs developed through the pilot pro- b. By the end of FY 2019, FDA will convene components within CDER or CBER. and/or participate in, at least one meeting, i. FDA will publish a Federal Register No- gram may be presented by FDA (e.g., in a conducted through a qualified third party, to tice announcing the pilot program and out- guidance or public workshop) as case studies, including while the drug studied in the trial gather industry, patient, researcher, and lining the eligibility criteria and process for has not yet been approved by FDA. Before other stakeholder input on key topics. This submitting to FDA requests to participate in FDA grants the initial meeting, FDA and the would include applying the benefit-risk the pilot program. sponsor will agree on the information that framework throughout the human drug ii. FDA will select 2–4 proposals (e.g., 1–2 FDA may share publicly in these case stud- lifecycle, including best approaches to com- per Center) quarterly each year. FDA will ies. Participation in the pilot program, in- municating FDA’s benefit-risk assessment. convene an internal review group to review cluding such agreement on information dis- c. By the end of FY 2020, FDA will publish proposals on a quarterly basis and provide closure, will be voluntary and at the discre- a draft guidance on benefit-risk assessments recommendations on prioritization and se- tion of the sponsor. for new drugs and biologics. This guidance lection of proposals and share knowledge and iv. FDA may periodically review the will: experience. Program selection will take into progress of the pilot program and determine i. Articulate FDA’s decision-making con- account development programs where clin- whether it is appropriate to adjust any as- text and framework for benefit-risk assess- ical data are limited such that integration pects of the program. ment, illustrating the application of the ben- across non-traditional sources may be need- v. Sponsors who do not participate in the efit-risk framework throughout the human ed, and for which MIDD can assess uncer- pilot will have an opportunity to interact drug lifecycle, using a case study approach, tainties about issues such as dosing, dura- with the Agency through traditional chan- if appropriate. tion, and patient selection in a way that can nels. The pilot program will not affect FDA’s ii. Discuss appropriate interactions be- inform regulatory decision-making. existing procedures for providing advice on tween a sponsor and FDA during drug devel- iii. Sponsors who do not participate in the trial designs. opment to understand the therapeutic con- pilot will have an opportunity to interact c. By end of 2nd Quarter FY 2018, FDA will text (i.e., the severity of disease that rep- with the Agency through traditional chan- convene a public workshop to discuss various resents the targeted indication and the ex- nels. complex adaptive, Bayesian, and other novel tent of unmet medical need in the target d. By end of FY 2019, FDA will publish clinical trial designs, with a particular focus population) regarding regulatory decisions draft guidance, or revise relevant existing on clinical trial designs for which simula- for the product at the various stages of drug guidance, on model-informed drug develop- tions are necessary to evaluate the operating development and evaluation. ment. characteristics, and the acceptability of iii. Discuss appropriate approaches to com- e. By end of FY 2021, FDA will develop or those designs in regulatory decision-making. municate to the public FDA’s thinking on a revise, as appropriate, relevant MAPPs or d. By end of FY 2018, FDA will publish product’s benefit-risk assessment, such as SOPPs, and/or review templates and train- draft guidance on complex adaptive (includ- through product-specific discussions using ing, to incorporate guidelines for the evalua- ing Bayesian adaptive) trial designs. the benefit-risk framework at AC meetings. tion of MIDD approaches. e. By end of FY 2020, FDA will develop or d. Beginning in FY 2021, FDA will conduct 4. Enhancing Capacity to Review Complex revise, as appropriate, relevant MAPPs, an evaluation of the implementation of the Innovative Designs SOPPs and/or review templates and training benefit-risk framework in the human drug To facilitate the advancement and use of to incorporate guidelines on evaluating com- review program. This evaluation will assess complex adaptive, Bayesian, and other novel plex clinical trial designs that rely on com- how reviewers across the organization apply clinical trial designs, FDA will conduct the puter simulations to determine operating the benefit-risk framework and identify best following activities during PDUFA VI: characteristics. practices in use of the benefit-risk frame- a. FDA will develop the staff capacity to 5. Enhancing Capacity to Support Analysis work. The evaluation of the benefit-risk enable processes to facilitate appropriate use Data Standards for Product Development framework implementation conducted in of these types of methods. This staff will and Review PDUFA V will serve as a baseline for this support the computationally intensive re- To support the enhancement of analysis PDUFA VI assessment. view work necessary to evaluate complex data standards for product development and e. As appropriate, FDA will revise relevant adaptive, Bayesian, and other novel clinical review in the human drug review program, MAPPs and SOPPs to include new ap- trial designs, with a particular focus on clin- FDA will conduct the following activities proaches that incorporate FDA’s benefit-risk ical trial designs for which simulations are during PDUFA VI: framework into the human drug review pro- necessary to evaluate the operating charac- a. FDA will develop the staff capacity to gram. teristics. efficiently review and provide feedback to 3. Advancing Model-Informed Drug Devel- b. Starting in FY 2018, FDA will conduct a sponsors on the readiness of submitted anal- opment pilot program for highly innovative trial de- ysis data sets and programs for statistical To facilitate the development and applica- signs for which analytically derived prop- review. This staff will support pre- and post- tion of exposure-based, biological, and statis- erties (e.g., Type I error) may not be feasible, submission discussion of standardized tical models derived from preclinical and and simulations are necessary to determine datasets and programs, and maintain the clinical data sources, herein referred to as trial operating characteristics. For INDs in knowledge of and engage in collaborations ‘‘model-informed drug development’’ (MIDD) the pilot program, FDA will grant a pair of about standards models used in the design, approaches, FDA will conduct the following meetings specifically designed for this pilot analysis and review of clinical and non-clin- activities during PDUFA VI: program, consisting of an initial and follow- ical studies. Examples of these standards

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00047 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.092 S02AUPT1 S4744 CONGRESSIONAL RECORD — SENATE August 2, 2017 models could include the Standard for Ex- existing tools for the detection, evaluation, 2. Timely and Effective Evaluation and change of Nonclinical Data (SEND), Clinical prevention, and mitigation of adverse events, Communication of Postmarketing Safety Data Acquisition Standards Harmonization standardization and integration of REMS Findings Related to Human Drugs (CDASH), Study Data Tabulation Model into the healthcare system, enhancing com- FDA will use user fee funds to continue to (SDTM), and Analysis Data Model (ADaM). munication and coordination between post- support the review, oversight, tracking, and b. In parallel, FDA will improve staff ca- marketing and pre-market review staff, and communication of postmarketing drug safe- pacity to assist with FDA development and improving tracking, communication and ty issues. updating of therapeutic area user guides oversight of postmarketing safety issues. En- a. FDA will make improvements to its cur- (TAUGs) to include the appropriate content hancements to the drug safety system will rent processes that capture and track infor- for the analysis data standards used in sub- improve public health by increasing patient mation, including enhancements to its infor- mission and review. protection while continuing to enable access mation technology systems, as needed, in c. By end of FY 2019, FDA will convene a to needed medical products. order to support the management and over- public workshop to advance the development User fees will provide support for A) ad- sight of postmarketing drug safety issues. and application of analysis data standards. vancing postmarketing drug safety evalua- b. By the end of FY 2019, FDA will update d. FDA will collaborate with external tion through expansion of the Sentinel Sys- existing policies and procedures (MAPPs and stakeholders and participate in public work- tem and integration into FDA SOPPs) concerning tracking postmarketing shops held by third parties such as standards pharmacovigilance activities, and B) timely safety signals to include consistent and development organizations, on development and effective evaluation and communication timely notification to a sponsor (1) when a of data standards, processes, documentation of postmarketing safety findings related to serious safety signal involving a product is and continuous improvement of clinical human drugs. identified and (2) to the extent practicable, trials and regulatory science. 1. Advancing Postmarketing Drug Safety not less than 72 hours before public posting e. By end of FY 2020, FDA will develop or Evaluation Through Expansion of the Sen- of a safety notice under section 921 of the revise, as appropriate, relevant guidance, tinel System and Integration into FDA Food and Drug Administration Amendments MAPPs, SOPPs and training associated with Pharmacovigilance Activities Act of 2007. FDA will use user fee funds to conduct a submission and utilization of standardized c. By the end of FY 2022, FDA will conduct, series of activities to systematically imple- analysis datasets and programs used in re- or fund by contract, an assessment of how its ment and integrate Sentinel in FDA view, and on the processes, procedures, and data systems and processes, as described in pharmacovigilance practices. These activi- responsibilities related to the receipt, han- MAPPs and SOPPs, support review, over- ties will involve augmenting the quality and dling, and documentation of submitted anal- sight, and communication of postmarketing quantity of data available through the Sen- ysis data and programs. drug safety issues. tinel System, improving methods for deter- 6. Enhancing Drug Development Tools mining when and how that data is utilized, II. ENHANCING MANAGEMENT OF USER FEE Qualification Pathway for Biomarkers and comprehensive training of review staff RESOURCES To facilitate the enhancement of the drug on the use of Sentinel. FDA will modernize the user fee structure development tools qualification pathway for a. FDA will work toward expanding the to improve the predictability of FDA funding biomarkers, FDA will conduct the following Sentinel System’s sources of data and en- and sponsor invoices, improve efficiency by activities during PDUFA VI: hancing the system’s core capabilities. simplifying the administration of user fees, a. FDA will develop the staff capacity to b. FDA will enhance its communication and enhance flexibility of financial mecha- enhance biomarker qualification review by with sponsors and the public regarding gen- nisms to improve management of PDUFA increasing base capacity. FDA will also pilot eral methodologies for Sentinel queries, in- program funding. FDA is committed to en- processes to engage external experts to sup- cluding what the Agency has learned regard- hancing management of PDUFA resources port review of biomarker qualification sub- ing the most appropriate ways to query and and ensuring PDUFA user fee resources are missions. use Sentinel data. This can be done through administered, allocated, and reported in an b. By the end of FY 2018, FDA will convene enhancement of existing mechanisms and/or efficient and transparent manner. FDA will a public meeting to discuss 1) taxonomy for greater frequency of such mechanisms. conduct a series of resource capacity plan- biomarkers used in drug development, and 2) c. FDA will evaluate additional ways to fa- ning and financial transparency activities to a framework with appropriate standards and cilitate public and sponsor access to Senti- enhance management of PDUFA resources in scientific approaches to support biomarkers nel’s distributed data network to conduct PDUFA VI. under the taxonomy, including scientific cri- safety surveillance. A. Resource Capacity Planning and Modernized teria to determine acceptance of a bio- d. By the end of FY 2019, FDA will hold or Time Reporting marker qualification submission and essen- support a public meeting engaging stake- tial elements of a formal biomarker quali- holders to discuss current and emerging Sen- FDA is committed to enhancing manage- fication plan. tinel projects and seek stakeholder feedback ment of PDUFA resources in PDUFA VI. c. By the end of FY 2018, FDA will publish and input regarding gaps in the current sys- FDA will conduct activities to develop a re- draft guidance on proposed taxonomy of bio- tem to facilitate the further development of source capacity planning function and mod- marker usage and related contexts of use. Sentinel and its system of Active Risk Iden- ernized time reporting approach in PDUFA d. By the end of FY 2020, FDA will publish tification and Analysis (ARIA). VI. draft guidance on general evidentiary stand- e. By the end of FY 2020, FDA will estab- 1. FDA will publish a PDUFA program re- ards for biomarker qualification to be sup- lish policies and procedures (MAPPs and source capacity planning and modernized plemented with focused guidance on specific SOPPs) to facilitate informing sponsors time reporting implementation plan no later biomarker uses and contexts. about the planned use of Sentinel to evalu- than the 2nd quarter of FY 2018. FDA will e. FDA will develop or revise, as appro- ate a safety signal involving their respective continue to utilize information and rec- priate and necessary, relevant MAPPs and products. These MAPPs and SOPPs will ad- ommendations from a third party assess- SOPPs on the biomarker qualification proc- dress what types of evaluations and what in- ment of resource capacity planning, finan- ess. formation about the evaluations will be cial analytics, and modernized time report- f. FDA will list biomarker qualification shared with sponsors, and the timing of such ing for PDUFA as part of the implementa- submissions that are in the qualification communications. tion plan. process on a public website, to be updated f. By the end of FY 2020, FDA will facili- 2. FDA will staff a resource capacity plan- quarterly. Inclusion of a submission on this tate integration of Sentinel into the human ning team that will implement and manage a list will be based on the consent of the sub- drug review program in a systematic, effi- capacity planning system across the PDUFA mitter for FDA to publish information about cient, and consistent way through staff de- program in PDUFA VI. 3. FDA will obtain through a contract with the submission, including stage and current velopment and by updating existing SOPPs an independent accounting or consulting status of qualification and the proposed use and MAPPs, as needed. firm an evaluation of options and rec- of the biomarker. Following qualification of g. By the end of FY 2020, FDA will develop ommendations for a new methodology to ac- a biomarker FDA will post reviews and sum- a comprehensive training program for review curately assess changes in the resource and mary documents that outline the qualifica- staff (e.g., epidemiologists, statisticians, capacity needs of the human drug review tion program and data supporting a quali- medical officers, clinical analysts, project program. The report will be published no fication decision. managers, and other review team members) later than end of FY 2020 for public com- g. Sponsors who do not use this qualifica- to ensure that staff have a working knowl- ment. Upon review of the report and com- tion pathway will have an opportunity to edge of Sentinel, can identify when Sentinel ments, FDA will implement robust meth- interact with the Agency through tradi- can inform important regulatory questions, odologies for assessing resource needs of the tional channels. and are able to consistently participate in use of Sentinel to evaluate safety issues. program. This will include the adoption of a K. Enhancement and Modernization of the FDA h. By the end of FY 2022, FDA will analyze, new resource capacity adjustment method- Drug Safety System and report on the impact of the Sentinel ex- ology, in place of the current PDUFA work- FDA will continue to use user fees to en- pansion and integration on FDA’s use of Sen- load adjuster, that accounts for sustained in- hance and modernize the current U.S. drug tinel for regulatory purposes, e.g., in the creases in PDUFA workload. safety system, including adoption of new sci- contexts of labeling changes, PMRs, or 4. FDA recognizes that revenue generated entific approaches, improving the utility of PMCs. by the workload adjuster and the resource

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00048 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.093 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4745 capacity adjustment will be allocated to and plan no later than the 2nd quarter of each vidual announcements that are posted for a used by organizational review components subsequent fiscal year. limited period to common vacancy an- engaged in direct review work to enhance re- 3. FDA will convene a public meeting no nouncements with open continuous posting sources and expand staff capacity and capa- later than the third quarter of each fiscal to maximize the opportunity for qualified bility. FDA will document in the annual fi- year starting in FY 2019 to discuss the applicants to apply for these positions. nancial report how the workload adjuster PDUFA 5-year financial plan, along with the B. Augmentation of Hiring Staff Capacity and and resource capacity adjustment fee reve- Agency’s progress in implementing modern- Capability nues are being utilized. ized time reporting, resource capacity plan- In recognition of the chronic and con- B. Financial Transparency and Efficiency ning, and the modernized user fee structure. tinuing difficulties of recruiting and retain- III. IMPROVING FDA HIRING AND RETENTION OF FDA is committed to ensuring PDUFA ing sufficient numbers of qualified Human REVIEW STAFF user fee resources are administered, allo- Resources (HR) staff, FDA will engage a cated, and reported in an efficient and trans- To speed and improve development of safe qualified contractor to provide continuous parent manner. FDA will conduct activities and effective new therapies for patients, en- support throughout PDUFA VI to augment to evaluate the financial administration of hancements to the human drug review pro- the existing FDA HR staff capacity and ca- the PDUFA program to help identify areas gram require that FDA hire and retain suffi- pabilities. The utilization of a qualified con- to enhance efficiency. FDA will also conduct cient numbers and types of technical and sci- tractor will assist FDA in successfully ac- activities to enhance transparency of entific experts to efficiently conduct reviews complishing PDUFA goals for recruitment PDUFA program resources. of human drug applications. In order to and retention of human drug review program 1. FDA will contract with an independent strengthen this core function and increase staff. third party to conduct an evaluation of the public health impact of new therapies, PDUFA program resource management dur- the FDA will commit to do the following: C. Complete Establishment of a Dedicated Func- ing FY 2018 to ensure that PDUFA user fee A. Completion of Modernization of the Hiring tion to Ensure Needed Scientific Staffing for resources are administered, allocated, and System Infrastructure and Augmentation of Human Drug Review Program reported in an efficient and transparent System Capacity: 1. Rapid advances in the science and tech- manner in PDUFA VI. The study will in- 1. Complete implementation of FTE-based nology of human drug development and man- clude, but is not limited, to the following position management system capability. ufacturing require FDA’s human drug review areas: a. FDA will complete development of Posi- program staff to keep pace with science and a. Evaluate all components of the PDUFA tion Management baseline accounting of all learn innovative methods and techniques for program resource planning, request, and al- current positions and FTE counts engaged in review of new therapies. FDA will complete location process from when FDA receives the the human drug review program for each ap- the establishment of a new dedicated unit user fee funds through when funds are spent. plicable Center and Office including filled within the Office of Medical Products and The contractor will recommend options to and vacant positions, a governance structure Tobacco charged with the continuous re- improve the process and data needed to en- for on-going position management that will cruiting, staffing, and retention of scientific, hance resource management decisions. be accountable to FDA senior management, technical and professional staff for the proc- b. Assess how FDA administers PDUFA and Position Management policy and guid- ess for the review of human drug applica- user fees organizationally, including, but not ance ratified by FDA senior management, tions. limited to, billing, user fee collection, and outlining processes for adding new positions, a. The unit will continuously develop and execution. The contractor will recommend deleting positions, and changing established implement scientific staff hiring strategies options to enhance the efficiency of user fee positions. and plans, working closely with the center administration. b. FDA will complete implementation of review offices and the FDA HR office, to c. Evaluate FDA’s existing PDUFA pro- the new Position-Based Management Sys- meet discipline-specific hiring commitments gram financial and administrative oversight tem. and other targeted staffing needs. It will and governance functions. Assess alternative 2. Complete implementation of an online function as a scientific-focused recruiter governance models including roles and re- position classification system. conducting ongoing proactive outreach to sponsibilities, organizational location, and a. FDA will finalize the establishment of source qualified candidates, and conducting personnel skill sets required. The contractor an online Position Description (PD) library. competitive recruiting to fill vacancies that will recommend options on the most effec- The library will include all current well-clas- require top scientific, technical and profes- tive governance model to support the human sified PDs and current standardized PDs. sional talent. drug review program. Once operational, any new PDs classified b. The unit will conduct analyses, no less d. Assess FDA’s technical capabilities to using the on-line classification tools, and than annually, of compensation and other conduct effective financial management and any newly created standardized PDs, will be factors affecting retention of key staff in planning in the context of generally accept- stored and accessible within FDA’s PD li- targeted disciplines, providing leadership ed government resource management and brary and available for FDA-wide use as ap- and support for agency compensation over- planning practices. The contractor will rec- propriate. sight boards that currently exist or may be ommend options for the technical capabili- 3. Complete implementation of corporate established as needed to ensure retention of ties needed by financial personnel involved recruiting. key scientific, technical and professional in PDUFA resource management to enhance a. For key scientific and technical dis- staff. financial management and planning. ciplines commonly needed across offices en- e. Evaluate how FDA estimates fee paying gaged in the human drug review program, D. Set Clear Goals for Human Drug Review Pro- units for annual fee setting. The contractor FDA will complete the transition from the gram Hiring will recommend options to enhance the accu- use of individual vacancy announcements for 1. FDA will establish priorities for manage- racy of FDA’s PDUFA user fee estimation individual offices to expanded use of a com- ment of the metric goals for targeted hires methods. mon vacancy announcement and certificate within the human drug review program staff 2. FDA will publish a PDUFA 5-year finan- of eligible job applicants that can be used by for the years of PDUFA VI. These goals for cial plan no later than the 2nd quarter of FY multiple offices. As a part of this effort, FDA targeted hires are summarized in Table 6 2018. FDA will publish updates to the 5-year will complete the transition from use of indi- below: TABLE 6

FY 2018 FY 2019 FY 2020 FY 2021 FY 2022

CDER ...... 43 57 45 17 9 CBER ...... 16 8 7 1 0 Other FDA ...... 12 9 6 0 0 Total FTE ...... 71 74 58 18 9

2. FDA will confirm progress in the hiring ated by a qualified, independent contractor The contractor will conduct a comprehensive of PDUFA V FTEs. FDA will report on with expertise in assessing HR operations review of current hiring processes and hiring progress against the hiring goals for FY 2018– and transformation. This will include contin- staff capacity and capabilities that con- 2022 on a quarterly basis posting updates to uous assessments throughout the course of tribute to achievement of successes, poten- the FDA website PDUFA Performance implementation of the performance initia- tial problems, or delays in human drug re- webpage. tives identified in sections III.A–D, and view program staff hiring. This includes the metrics including, but not limited to, those entire hiring function and related capabili- E. Comprehensive and Continuous Assessment related to recruiting and retention in the ties. FDA and regulated industry leadership of Hiring and Retention human drug review program including, but will periodically and regularly assess the FDA hiring and retention of staff for the not limited to, specifically targeted sci- progress of hiring and retention throughout human drug review program will be evalu- entific disciplines and levels of experience. PDUFA VI.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00049 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.095 S02AUPT1 S4746 CONGRESSIONAL RECORD — SENATE August 2, 2017 1. Initial Assessment: The assessment will complete a submission from each entry point 6. Increased accountability for use of user include an initial baseline assessment to be to its delivery to the appropriate FDA Cen- fee revenues conducted and completed no later than De- ter. 7. Focused investments on improvements cember 31, 2017. The initial baseline study b. Post current ESG operational status on in the process for the review of human drug will include an evaluation of the current its public website. applications state and provide recommended options to c. Publish submission instructions to use 8. Improved communication between the address any identified gaps or areas identi- in the event of an ESG service disruption. FDA and industry fied as priorities for improvement, and a 3. By December 31, 2017, FDA will publish B. Studies Will Include study report to be published no later than target time frames for the 1) expected sub- 1. Assessment of current practices of FDA December 31, 2017. FDA will hold a public mission upload duration(s) and 2) timeframe and sponsors in communicating during drug meeting no later than December 31, 2017, to between key milestones and notifications as development as described in Section I.I.1. present and discuss report findings, and defined in 1(a). 2. Assessment of the current practices for present its specific plans, including agency 4. By September 30, 2018, FDA will imple- combination drug product review as de- senior management oversight, and timeline ment the ability to communicate electronic scribed in Section I.I.5. for implementing recommended enhance- submission milestone notifications, includ- 3. Evaluation of how reviewers across the ments to be fully operational by no later ing final submission upload status (e.g., suc- organization apply the benefit-risk frame- than December 31, 2018. cessfully processed or rejected), to sender/ work and identify best practices in use of the 2. Interim Assessment: An interim assess- designated contact. benefit-risk framework as described in Sec- ment will be published by March 31, 2020, for 5. FDA will provide expert technical sup- tion I.J.2. public comment. By June 30, 2020, FDA will port for electronic submissions to FDA re- 4. Analysis of the impact of the Sentinel hold a public meeting during which the pub- view staff for submission navigation and expansion and use for regulatory purposes as lic may present their views. FDA will discuss troubleshooting. described in Section I.K.1. the findings of the interim assessment, in- 6. For those systems that sponsors interact 5. Assessment of how FDA data systems cluding progress relative to program mile- with directly, FDA will invite industry to and processes, as described in MAPPs and stones and metrics, and other aggregated provide feedback and/or participate in user SOPPs, support review, oversight, and com- feedback from internal customers and par- acceptance testing in advance of imple- munication of postmarketing drug safety ticipants in HR services that may be in- menting significant changes that impact in- issues, as described in Section I.K.2. cluded in the continuous assessment. FDA dustry’s interaction with the system. 6. Evaluation of options and recommenda- will also address any issues identified to date 7. By December 31, 2017, FDA will docu- tions for a new methodology to accurately including actions proposed to improve the ment and implement a process to provide assess changes in the resource and capacity likelihood of success of the program. ample advance notification of systems and needs of the human drug review program as 3. Final Assessment: A final assessment process changes commensurate with the described in Section II.A.3. will be published by December 31, 2021, for complexity of the change and the impact to 7. Evaluation of PDUFA program resource public comment. FDA will hold a public sponsors for ESG scheduled unavailability management to ensure that PDUFA user fee meeting by no later than March 30, 2022, dur- and user interface changes. resources are administered, allocated, and ing which the public may present their C. Enhance Transparency and Accountability reported in an efficient and transparent views. FDA will discuss the findings of the of FDA Electronic Submission and Data manner in PDUFA VI as described in Section final assessment, including progress relative Standards Activities II.B.1. to program milestones and metrics, and 1. FDA staff and industry will jointly plan 8. Comprehensive and continuous assess- other aggregated feedback from internal cus- and hold quarterly meetings and will share ment of hiring and retention as described in tomers and participants in HR services that performance updates prior to each meeting. Section III.E. may be included in the continuous assess- The meeting will address current challenges ment. FDA will also address any issues iden- VI. PROGRESS REPORTING FOR PDUFA VI AND and emerging needs. tified and plans for addressing these issues. CONTINUING PDUFA V INITIATIVES 2. Beginning no later than September 30, A. FDA will include in the annual PDUFA IV. INFORMATION TECHNOLOGY GOALS 2018, FDA will hold annual public meetings Performance Report information on the A. Objective to seek stakeholder input related to elec- Agency’s progress in meeting the specific FDA is committed to achieve the long- tronic submission system past performance, commitments identified in Sections I.I–K of term goal of improving the predictability future targets, emerging industry needs and this document. and consistency of the electronic submission technology initiatives to inform the FDA IT B. FDA will include in the annual PDUFA process (Section IV.B), and enhancing trans- Strategic Plan and published targets. Financial Report information on the Agen- parency and accountability of FDA informa- 3. By December 31, 2017, FDA will post, at cy’s progress in the hiring of new staff used tion technology related activities (Section least annually, historic and current metrics to support the new initiatives as identified IV.C). FDA is pursuing these objectives on ESG performance in relation to published in Section III. targets, characterizations and volume of sub- through IT investments that support the VII. DEFINITIONS AND EXPLANATION OF TERMS PDUFA program. missions, and standards adoption and con- formance. 1. ‘‘Human drug applications’’ refers to B. Improve the Predictability and Consistency 4. By December 31, 2017, FDA will incor- new drug applications submitted under sec- of PDUFA Electronic Submission Processes porate strategic initiatives in support of tion 505(b) of the Federal Food, Drug, and 1. Electronic Submission Documentation: PDUFA goals into the FDA IT Strategic Cosmetic Act and biologics license applica- By December 31, 2017, FDA will publish and Plan. Milestones and metrics for PDUFA ini- tions submitted under section 351(a) of the maintain up-to-date documentation for the tiatives will be included in the plan. The Public Health Service Act, as defined in the following: plan will be updated and discussed annually Prescription Drug User Fee Act. a. The electronic submission process, in- during a meeting described in Section IV.C.1. 2. ‘‘Human drug review program’’ refers to cluding key electronic submission mile- 5. FDA will: the activities to conduct ‘‘the process for the stones and associated sponsor notifications. a. Collaborate with Standards Develop- review of human drug applications,’’ as de- The description should cover the complete ment Organizations and stakeholders to en- fined in the Prescription Drug User Fee Act. process undergone by a submission from the sure long-term sustainability of supported 3. The term ‘‘review and act on’’ means the completion of its upload to the Electronic data standards. issuance of a complete action letter after the System Gateway (ESG) through the time the b. Publish a data standards action plan up- complete review of a filed complete applica- submission is made available to the review dated at least quarterly. tion. The action letter, if it is not an ap- team. c. Publish and maintain a current FDA proval, will set forth in detail the specific b. The rejection process for electronic sub- Data Standards Catalog. deficiencies and, where appropriate, the ac- missions. tions necessary to place the application in V. IMPROVING FDA PERFORMANCE MANAGEMENT c. The electronic submission validation condition for approval. criteria. A. The Studies Conducted Under This Initiative 4. A resubmitted original application is a d. Software names and versions for Elec- are Intended to Foster complete response to an action letter ad- tronic Common Technical Document (eCTD) 1. Development of programs to improve ac- dressing all identified deficiencies. validation and data validation tools. cess to internal and external expertise 5. Class 1 resubmitted applications are ap- 2. Electronic Submission and System Sta- 2. Reviewer development programs, par- plications resubmitted after a complete re- tus: ticularly as they relate to the human drug sponse letter (or a not approvable or approv- By September 30, 2018, FDA will: review program able letter) that include the following items a. Publish targets for and measure ESG 3. Advancing science and use of informa- only (or combinations of these items): availability overall (including scheduled tion management tools a. Final printed labeling downtime) and during business hours (8am to 4. Improving both inter- and intra-Center b. Draft labeling 8pm Eastern Time). ESG availability is de- consistency, efficiency, and effectiveness c. Safety updates submitted in the same fined for the purposes of this commitment 5. Improved reporting of management ob- format, including tabulations, as the origi- letter as the ability for an external user to jectives nal safety submission with new data and

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00050 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.096 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4747 changes highlighted (except when large E. Review of Proprietary Names to Reduce Principles and Practices (GRMP) guidance,1 amounts of new information including im- Medication Errors which FDA intends to update and apply to portant new adverse experiences not pre- F. Major Dispute Resolution the review of biosimilar and interchangeable viously reported with the product are pre- G. Clinical Holds products. sented in the resubmission) H. Special Protocol Question Assessment FDA and the regulated industry will peri- d. Stability updates to support provisional and Agreement odically and regularly assess the progress of or final dating periods I. Meeting Management Goals the biosimilar biological product review pro- e. Commitments to perform Phase 4 stud- II. Advancing Development of Biosimilar gram throughout BsUFA II. This will allow ies, including proposals for such studies Biological Products Through Further Clari- FDA and the regulated industry to identify f. Assay validation data fication of the 351(k) Regulatory Pathway emerging challenges and develop strategies g. Final release testing on the last 1–2 lots III. Enhancing Capacity for Biosimilar to address these challenges to ensure the ef- used to support approval Regulations and Guidance Development, Re- ficiency and effectiveness of the biosimilar h. A minor reanalysis of data previously viewer Training, and Timely Communication biological product review program. IV. Enhancing Management of User Fee submitted to the application I. ENSURING THE EFFECTIVENESS OF THE BIO- i. Other minor clarifying information (de- Resources SIMILAR BIOLOGICAL PRODUCT REVIEW PRO- termined by the Agency as fitting the Class A. Resource Capacity Planning and Mod- GRAM 1 category) ernized Time Reporting j. Other specific items may be added later B. Financial Transparency and Efficiency A. Review Performance Goals as the Agency gains experience with the C. Management of Carryover Balance 1. Biosimilar Biological Product Applica- scheme and will be communicated via guid- V. Improving FDA Hiring and Retention of tion Submissions and Resubmissions ance documents to industry Review Staff a. Review and act on 90 percent of original 6. Class 2 resubmissions are resubmissions A. Completion of Modernization of the Hir- biosimilar biological product application that include any other items, including any ing System Infrastructure and Augmenta- submissions within 10 months of the 60 day items that would require presentation to an tion of System Capacity filing date. advisory committee. B. Augmentation of Hiring Staff Capacity b. Review and act on 90 percent of resub- 7. The performance goals and procedures and Capability mitted original biosimilar biological product also apply to original applications and sup- C. Complete Establishment of a Dedicated applications within 6 months of receipt. plements for human drugs initially mar- Function to Ensure Needed Scientific Staff- 2. Supplements with Clinical Data keted on an over-the-counter (OTC) basis ing for Human Drug Review Including for a. Review and act on 90 percent of original through an NDA or switched from prescrip- Review of Biosimilar Biological Products supplements with clinical data within 10 D. Set Clear Goals for Biosimilar Biologi- tion to OTC status through an NDA or sup- months of receipt. cal Product Review Program Hiring plement. b. Review and act on 90 percent of resub- E. Comprehensive and Continuous Assess- 8. As used in this commitment letter, ‘‘reg- mitted supplements with clinical data with- ment of Hiring and Retention ulatory decision making’’ may include, for in 6 months of receipt. VI. Definitions and Explanation of Terms example, FDA’s process for making a regu- 3. Original Manufacturing Supplements latory decision regarding a drug or biologi- BIOSIMILAR BIOLOGICAL PRODUCT AUTHORIZA- a. In FY 2018, review and act on 70 percent cal product throughout the product lifecycle, TION PERFORMANCE GOALS AND PROCEDURES of manufacturing supplements requiring such as during drug development, following FOR FISCAL YEARS 2018 THROUGH 2022 prior approval within 4 months of receipt. FDA’s review of a marketing application, in- This document contains the performance b. In FY 2019, review and act on 75 percent cluding review of proposed labeling for the goals and procedures for the Biosimilar User of manufacturing supplements requiring product, or in the post-approval period (e.g., Fee Act (BsUFA) reauthorization for fiscal prior approval within 4 months of receipt. FDA’s decision regarding a supplement to an years (FYs) 2018–2022, known as BsUFA II. It c. In FY 2020, review and act on 80 percent approved application). is commonly referred to as the ‘‘goals letter’’ of manufacturing supplements requiring Mr. ALEXANDER. Mr. President, I or ‘‘commitment letter.’’ The goals letter prior approval within 4 months of receipt. represents the product of FDA’s discussions ask unanimous consent to have printed d. In FY 2021, review and act on 85 percent with the regulated industry and public of manufacturing supplements requiring in the RECORD a copy of the commit- stakeholders, as mandated by Congress. The prior approval within 4 months of receipt. ment letter for the Biosimilar User Fee performance and procedural goals and other e. In FY 2022, review and act on 90 percent Act, BsUFA, reauthorization for fiscal commitments specified in this letter apply of manufacturing supplements requiring years 2018 to 2022, known as BsUFA II. to aspects of the biosimilar biological prod- prior approval within 4 months of receipt. There being no objection, the mate- uct review program that are important for f. Review and act on 90 percent of all other rial was ordered to be printed in the facilitating timely access to safe and effec- manufacturing supplements within 6 months tive biosimilar medicines for patients. FDA RECORD, as follows: of receipt. is committed to meeting the performance 4. Goals Summary Tables BIOSIMILAR BIOLOGICAL PRODUCT REAUTHOR- goals specified in this letter, enhancing man- IZATION PERFORMANCE GOALS AND PROCE- agement of BsUFA resources, and ensuring TABLE 1.—ORIGINAL AND RESUBMITTED APPLICATIONS DURES FISCAL YEARS 2018 THROUGH 2022 BsUFA user fee resources are administered, AND SUPPLEMENTS I. Ensuring the Effectiveness of the Bio- allocated, and reported in an efficient and similar Biological Product Review Program transparent manner. Original Biosimilar Biological Product 90% in 10 months of the 60 day A. Review Performance Goals Under BsUFA II, FDA is committed to en- Application Submissions. filing date. B. Program for Enhanced Review Trans- suring effective scientific coordination and Resubmitted Original Biosimilar Bio- 90% in 6 months of the receipt parency and Communication for Original review consistency, as well as efficient gov- logical Product Applications. date. 351(k) BLAs ernance and operations across the biosimilar Original Supplements with Clinical 90% in 10 months of the receipt C. First Cycle Review Management for biological product review program. In addi- Data. date. Supplements with Clinical Data tion, FDA is committed to the principles ar- Resubmitted Supplements with Clin- 90% in 6 months of the receipt ical Data. date. D. Guidance ticulated in the Good Review Management TABLE 2.—MANUFACTURING SUPPLEMENTS

Prior approval All other

Manufacturing Supplements ...... • FY 2018: 70% in 4 months of the receipt date ...... 90% in 6 months of the receipt date. • FY 2019: 75% in 4 months of the receipt date • FY 2020: 80% in 4 months of the receipt date • FY 2021: 85% in 4 months of the receipt date • FY 2022: 90% in 4 months of the receipt date

5. Review Performance Goal Extensions ments to assure safe use (ETASU) not in- iv. Only one extension can be given per re- a. Major Amendments cluded in the original application; or signifi- view cycle. i. A major amendment to an original appli- cant amendment to a previously submitted v. Consistent with the underlying prin- cation, supplement with clinical data, or re- REMS with ETASU. Generally, changes to ciples articulated in the GRMP guidance, submission of any of these applications, sub- REMS that do not include ETASU and minor mitted at any time during the review cycle, changes to REMS with ETASU will not be FDA’s decision to extend the review clock may extend the goal date by three months. considered major amendments. should, except in rare circumstances, be lim- ii. A major amendment may include, for ited to occasions where review of the new in- iii. A major amendment to a manufac- example, a major new clinical study report; formation could address outstanding defi- major re-analysis of previously submitted turing supplement submitted at any time study(ies); submission of a risk evaluation during the review cycle may extend the goal ciencies in the application and lead to ap- and mitigation strategy (REMS) with ele- date by two months. proval in the current review cycle.

VerDate Sep 11 2014 06:34 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00051 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.097 S02AUPT1 S4748 CONGRESSIONAL RECORD — SENATE August 2, 2017 b. Inspection of Facilities Not Adequately nication Plan should be consistent with the than 30 calendar days after receipt of the Identified in an Original Application or Sup- goal of an efficient and timely first cycle re- original application. plement view process and not impede the review c. Incomplete applications, including appli- i. All original applications and supple- team’s ability to conduct its review. cations with components that are not re- ments are expected to include a comprehen- The remainder of this Section I.B. de- ceived within 30 calendar days after receipt sive and readily located list of all manufac- scribes the parameters that will apply to of the original submission, will be subject to turing facilities included or referenced in the FDA’s review of applications in the Program. a Refuse-to-File decision. application or supplement. This list provides 1. Pre-submission meeting: The applicant d. The following parameters will apply to FDA with information needed to schedule in- is strongly encouraged to discuss the applications that are subject to a Refuse-to- spections of manufacturing facilities that planned content of the application with the File decision and are subsequently filed over may be necessary before approval of the appropriate FDA review division at a BPD protest: original application or supplement. Type 4 (pre–351(k) BLA) meeting. This meet- i. The original submission of the applica- ii. If, during FDA’s review of an original ing will be attended by the FDA review tion will be subject to the review perform- application or supplement, the Agency iden- team, including appropriate senior FDA ance goal as described in Section I.A.1.a. ii. The application will not be eligible for tifies a manufacturing facility that was not staff. the other parameters of the Program (e.g., included in the comprehensive and readily a. The BPD Type 4 (pre–351(k) BLA) meet- mid-cycle communication, late-cycle meet- located list, the goal date may be extended. ing should be held sufficiently in advance of ing). 1. If FDA identifies the need to inspect a the planned submission of the application to iii. FDA generally will not review amend- manufacturing facility that is not included allow for meaningful response to FDA feed- ments to the application during any review back and should generally occur not less as part of the comprehensive and readily lo- cycle. FDA also generally will not issue in- than 2 months prior to the planned submis- cated list in an original application or sup- formation requests to the applicant during plement with clinical data, the goal date sion of the application. b. In addition to FDA’s preliminary re- the agency’s review. may be extended by three months. iv. The resubmission goal described in Sec- sponses to the applicant’s questions, other 2. If FDA identifies the need to inspect a tion I.A.1.b will not apply to any resubmis- potential discussion topics include prelimi- manufacturing facility that is not included sion of the application following an FDA nary discussions regarding the approach to as part of the comprehensive and readily lo- complete response action. Any such resub- developing the content for REMS, where ap- cated list in a manufacturing supplement, mission will be reviewed as available re- plicable, patient labeling (e.g., Medication the goal date may be extended by two sources permit. months. Guide and Instructions For Use) and, where e. Since applications are expected to be B. Program for Enhanced Review Transparency applicable, the development of a Formal complete at the time of submission, unsolic- and Communication for Original 351(k) Communication Plan. These discussions will ited amendments are expected to be rare and BLAs be summarized at the conclusion of the not to contain major new information or meeting and reflected in the FDA meeting analyses. Review of unsolicited amendments, To promote transparency and communica- minutes. tion between the FDA review team and the including those submitted in response to an The FDA and the applicant will agree on FDA communication of deficiencies, will be applicant, FDA will apply the following the content of a complete application for the model (‘‘the Program’’) to the review of all handled in accordance with the GRMP guid- proposed indication(s) at the pre-submission ance. This guidance includes the underlying original Biologics License Applications meeting. The FDA and the applicant may (BLAs) submitted under section 351(k) of the principle that FDA will consider the most ef- also reach agreement on submission of a lim- ficient path toward completion of a com- Public Health Service Act (‘‘351(k) BLAs’’), ited number of application components not including applications that are resubmitted prehensive review that addresses application later than 30 calendar days after the submis- deficiencies and leads toward a first cycle following a Refuse-to-File decision, received sion of the original application. These sub- from October 1, 2017, through September 30, approval when possible. missions must be of a type that would not be 3. Day 74 Letter: FDA will follow existing 2022. The goal of the Program is to promote expected to materially impact the ability of the efficiency and effectiveness of the first procedures regarding identification and com- the review team to begin its review. These munication of substantive review issues cycle review process and minimize the num- agreements will be summarized at the con- ber of review cycles necessary for approval, identified during the initial filing review to clusion of the meeting and reflected in the the applicant in the ‘‘Day 74 letter.’’ If no ensuring that patients have timely access to FDA meeting minutes. safe, effective, and high quality biosimilar substantive review issues were identified i. Examples of application components during the filing review, FDA will so notify and interchangeable biological products. that may be appropriate for delayed submis- The standard approach for the review of the applicant. FDA’s filing review represents sion include; stability updates, the final au- a preliminary review of the application and original 351(k) BLAs is described in this sec- dited report of a preclinical study (e.g., toxi- tion. However, the FDA review team and the is not indicative of deficiencies that may be cology) where the final draft report is sub- identified later in the review cycle. applicant may discuss and reach mutual mitted with the original application, or a agreement on an alternative approach to the For applications subject to the Program, limited amount of the data from an assess- the timeline for this communication will be timing and nature of interactions and infor- ment of a single transition from the ref- mation exchange between the applicant and within 74 calendar days from the date of erence product to the proposed biosimilar bi- FDA receipt of the original submission. The FDA, i.e., a Formal Communication Plan for ological product, where applicable. the review of the original 351(k) BLA. The planned timeline for review of the applica- ii. Major components of the application tion included in the Day 74 letter for applica- Formal Communication Plan may include (e.g., the complete analytical similarity as- elements of the standard approach (e.g., a tions in the Program will include: sessment, the complete study report of a a. the planned date for the internal mid- mid-cycle communication or a late-cycle comparative clinical study or the full study cycle review meeting, meeting) as well as other interactions that report of necessary immunogenicity data) b. preliminary plans on whether to hold an sometimes occur during the review process are expected to be submitted with the origi- Advisory Committee (AC) meeting to discuss (e.g., a meeting during the filing period to nal application and are not subject to agree- the application, discuss the application, i.e., an ‘‘application ment for late submission. c. a target date for communication of feed- orientation meeting’’). If appropriate, the 2. Original application submission: Appli- back from the review division to the appli- Formal Communication Plan should specify cations are expected to be complete, as cant regarding proposed labeling and any those elements of the Program that FDA and agreed between the FDA review team and postmarket requirements or postmarket the sponsor agree are unnecessary for the ap- the applicant at the BPD Type 4 (pre–351(k) commitments the Agency will be requesting. plication under review. If the review team BLA) meeting, at the time of original sub- 4. Review performance goals: For original and the applicant anticipate developing a mission of the application. If the applicant 351(k) BLA submissions that are filed by Formal Communication Plan, the elements does not have a BPD Type 4 (pre–351(k) BLA) FDA under the Program, the BsUFA review of the plan should be discussed and agreed to meeting with FDA, and no agreement exists clock will begin at the conclusion of the 60 at the pre-submission meeting (see Section between FDA and the applicant on the con- calendar day filing review period that begins I.B.1) and reflected in the meeting minutes. tents of a complete application or delayed on the date of FDA receipt of the original The Formal Communication Plan may be re- submission of certain components of the ap- submission. The review performance goals viewed and amended at any time based on plication, the applicant’s submission is ex- for these applications are as follows: the progress of the review and the mutual pected to be complete at the time of original a. Review and act on 90 percent of original agreement of the review team and the appli- submission. 351(k) BLA submissions within 10 months of cant. For example, the review team and the a. All applications are expected to include the 60 day filing date. applicant may mutually agree at any time to a comprehensive and readily located list of 5. Mid-Cycle Communication: The FDA cancel future specified interactions in the all clinical sites and manufacturing facilities Regulatory Project Manager (RPM), and Program (e.g., the late-cycle meeting) that included or referenced in the application. other appropriate members of the FDA re- become unnecessary (e.g. because previous b. Any components of the application that view team (e.g., Cross Discipline Team Lead- communications between the review team FDA agreed at the pre-submission meeting er (CDTL)), will call the applicant, generally and the applicant are sufficient). Any could be submitted after the original appli- within 2 weeks following the Agency’s inter- amendments made to the Formal Commu- cation are expected to be received not later nal mid-cycle review meeting, to provide the

VerDate Sep 11 2014 06:34 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00052 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.077 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4749 applicant with an update on the status of the primary and secondary reviews), the Agen- time to resubmission for applications that review of their application. An agenda will cy’s background package for the AC meeting receive a complete response in the first re- be sent to the applicant prior to the mid- (incorporated by reference if previously sent view cycle cycle communication. Scheduling of the in- to the applicant), potential questions and/or This assessment will also include a de- ternal mid-cycle review meeting will be han- points for discussion for the AC meeting (if identified analysis of the issues typically dled in accordance with the GRMP guidance. planned) and the current assessment of the discussed during the mid-cycle communica- The RPM will coordinate the specific date content of proposed REMS or other risk tion and the late-cycle meeting and the abil- and time of the telephone call with the ap- management actions, where applicable. ity of the additional FDA-applicant commu- plicant. e. Late-Cycle Meeting Discussion Topics: nications to (a) achieve resolution of these The update should include any significant Potential topics for discussion at the late- issues during the remainder of the review issues identified by the review team to date, cycle meeting include: clock, or (b) allow the applicant to better any information requests, and information i. major deficiencies identified to date; prepare for a resubmission of the applica- regarding major concerns with the following: ii. analytical similarity data, including the tion. Following an FDA regulatory action, a. The analytical similarity data, includ- potential relevance of any issues (e.g. data the independent contractor will conduct sep- ing the potential relevance of any issues (e.g. analysis issues or potential clinical impact arate interviews of the applicant and the data analysis issues or potential clinical im- of observed analytical differences), intended FDA review team to understand each party’s pact of observed analytical differences), in- to support a demonstration that the pro- perspectives on the review of the applica- tended to support a demonstration that the posed biosimilar biological product is highly tion, including whether issues were or should proposed biosimilar biological product is similar to the reference product; have been identified at the BPD meetings to highly similar to the reference product. iii. data intended to support a demonstra- facilitate application review. b. The data intended to support a dem- tion of no clinically meaningful differences, An interim and final assessment of the onstration of no clinically meaningful dif- including discussion of any immunogenicity Program will be published for public com- ferences, including discussion of any issues; ment, with each report followed by a public immunogenicity issues. iv. data intended to support a demonstra- meeting during which public stakeholders c. The data intended to support a dem- tion of interchangeability; may present their views on the success of the onstration of interchangeability. v. CMC issues; Program to date, including the ability of the d. CMC issues. vi. inspectional findings identified to date; Program to help ensure that patients have In addition, the update should include pre- vii. issues to be discussed at the AC meet- timely access to safe, effective, and high liminary review team thinking regarding the ing (if planned); quality biosimilar biological products. Dur- content of the proposed REMS, where appli- viii. current assessment of the content of ing each public meeting, FDA and the inde- cable, proposed date(s) for the late-cycle proposed REMS or other risk management pendent contractor will discuss the findings meeting, updates regarding plans for the AC actions, where applicable; of the interim assessment, including meeting (if an AC meeting is anticipated), ix. information requests from the review anonymized aggregated feedback from spon- and other projected milestone dates for the team to the applicant; and additional data or sors and FDA review teams resulting from remainder of the review cycle. analyses the applicant may wish to submit. independent contractor interviews. FDA will 6. Late-Cycle and Advisory Committee With regard to submission of additional discuss any issues identified to date includ- Meetings: A meeting will be held between data or analyses, the FDA review team and ing any proposed plans to improve the likeli- the FDA review team and the applicant to the applicant will discuss whether such data hood of the Program’s success. discuss the status of the review of the appli- will be reviewed by the Agency in the cur- a. Interim Assessment: An interim assess- cation late in the review cycle. Late-cycle rent review cycle and, if so, whether the sub- ment of the Program will be published by meetings will generally be face-to-face meet- mission will be considered a major amend- December 31, 2020, and FDA will hold a pub- ings; however, the meeting may be held by ment and trigger an extension of the BsUFA lic meeting by March 31, 2021. teleconference if FDA and the applicant goal date. b. Final Assessment: A final assessment of agree. Since the application is expected to be 7. Inspections: FDA’s goal is to complete the Program will be published by June 30, complete at the time of submission, FDA in- all GCP, GLP, and GMP inspections for ap- 2022, and FDA will hold a public meeting by tends to complete primary and secondary re- plications in the Program within 10 months September 30, 2022. views of the application in advance of the of the date of original receipt of the applica- C. First Cycle Review Management for Supple- planned late-cycle meeting. tion. This will allow 2 months at the end of ments with Clinical Data a. FDA representatives at the late-cycle the review cycle to attempt to address any 1. Notification of Issues Identified during meeting are expected to include the signa- deficiencies identified by the inspections. the Filing Review tory authority for the application, review 8. Assessment of the Program: The Pro- a. Performance Goal: For supplements team members from appropriate disciplines, gram described in this Section I.B shall be with clinical data, FDA will report sub- and appropriate team leaders and/or super- evaluated to determine its impact on the ef- stantive review issues identified during the visors from disciplines for which substantive ficiency and effectiveness of the first review initial filing review to the applicant by let- issues have been identified in the review to cycle for biosimilar biological products. The ter. date. assessment shall be conducted by an inde- b. The timeline for such communication b. For applications that will be discussed pendent contractor with expertise in assess- will be within 74 calendar days from the date at an Advisory Committee (AC) meeting, the ing the quality and efficiency of biopharma- of FDA receipt of the supplement. following parameters apply: ceutical development and regulatory review c. If no substantive review issues were i. FDA intends to convene AC meetings no programs. The statement of work for this ef- identified during the filing review, FDA will later than 2 months prior to the BsUFA goal fort will be published for public comment so notify the applicant. date. The late-cycle meeting will occur not prior to beginning the assessment. The as- d. FDA’s filing review represents a prelimi- less than 12 calendar days before the date of sessments will occur continuously through- nary review of the application and is not in- the AC meeting. out the course of the Program. dicative of deficiencies that may be identi- ii. FDA intends to provide final questions Aspects and other measures of the Pro- fied later in the review cycle. for the AC to the sponsor and the AC not less gram that will be assessed by the inde- e. FDA will notify the applicant of sub- than 2 calendar days before the AC meeting. pendent contractor include, but are not lim- stantive review issues prior to or on the goal iii. Following an AC meeting, FDA and the ited to the following: date for 90% of applications. applicant may agree on the need to discuss adherence by the applicant and FDA to 2. Notification of Planned Review feedback from the committee for the purpose the current GRMP guidance or the GRMP Timelines of facilitating the remainder of the review. guidance as updated in accordance with Sec- a. Performance Goal: For supplements Such a meeting will generally be held by tion I.D, as applicable with clinical data, FDA will inform the ap- teleconference without a commitment for completeness and quality of the sub- plicant of the planned timeline for review of formal meeting minutes issued by the agen- mitted application the application. The information conveyed cy. number of unsolicited amendments sub- will include a target date for communication c. For applications that will not be dis- mitted by the applicant of feedback from the review division to the cussed at an AC meeting, the late-cycle timing and adequacy of Day 74 letters applicant regarding proposed labeling, post- meeting will generally occur not later than 3 conduct of the mid-cycle communication marketing requirements, and postmarketing months prior to the BsUFA goal date. any DR letters issued commitments the Agency will be requesting. d. Late-Cycle Meeting Background Pack- late-cycle meeting background package b. The planned review timeline will be in- ages: The Agency background package for conduct of the late-cycle meeting cluded with the notification of issues identi- the late-cycle meeting will be sent to the ap- time to approval fied during the filing review, within 74 cal- plicant not less than 10 calendar days before percentage of applications that are ap- endar days from the date of FDA receipt of the late-cycle meeting. The package will proved during the first review cycle the original supplement. consist of any discipline review (DR) letters percentage of application reviews that are c. The planned review timelines will be issues to date, a brief memorandum from the extended due to a major amendment consistent with the GRMP guidance. review team outlining substantive applica- number of review cycles for applications d. The planned review timeline will be tion issues (e.g., deficiencies identified by that are ultimately approved based on the supplement as submitted.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00053 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.078 S02AUPT1 S4750 CONGRESSIONAL RECORD — SENATE August 2, 2017 e. FDA will inform the applicant of the 1. Proprietary Name Review Performance e. In these cases, once the required infor- planned review timeline for 90% of all sup- Goals During The BPD Phase mation is received by the Agency (including plements with clinical data. a. Review 90% of proprietary name submis- any advice from an advisory committee), the f. In the event FDA determines that sig- sions filed within 180 days of receipt. Notify person to whom the appeal was made, again nificant deficiencies in the supplement pre- sponsor of tentative acceptance or non-ac- has 30 calendar days from the receipt of the clude discussion of labeling, postmarketing ceptance. required information in which to either deny requirements, or postmarketing commit- b. If the proprietary name is found to be or grant the appeal. ments by the target date identified in the unacceptable, the sponsor can request recon- f. Again, if the decision is to deny the ap- planned review timeline (e.g., significant sideration by submitting a written rebuttal peal, the response should include the reasons safety concern(s), need for a new study(ies) with supporting data or request a meeting for the denial and any actions the sponsor or extensive re-analyses of existing data be- within 60 days to discuss the initial decision might take to persuade the Agency to re- fore approval), FDA will communicate this (meeting package required). verse its decision. determination to the applicant in accord- c. If the proprietary name is found to be g. Note: If the Agency decides to present ance with GRMPs and no later than the tar- unacceptable, the above review performance the issue to an advisory committee and there get date. In such cases the planned review goals also would apply to the written request are not 30 days before the next scheduled ad- timeline will be considered to have been met. for reconsideration with supporting data or visory committee, the issue will be presented Communication of FDA’s determination may the submission of a new proprietary name. at the following scheduled committee meet- occur by letter, teleconference, facsimile, se- d. A complete submission is required to ing to allow conformance with advisory com- cure e-mail, or other expedient means. begin the review clock. mittee administrative procedures. g. To help expedite the development of bio- 2. Proprietary Name Review Performance G. Clinical Holds similar biological products, communication Goals During Application Review 1. Procedure: The Center should respond to of the deficiencies identified in the supple- a. Review 90% of biosimilar biological a sponsor’s complete response to a clinical ment may occur through issuance of a DR product proprietary name submissions filed hold within 30 days of the Agency’s receipt of letter(s) in advance of the planned target within 90 days of receipt. Notify sponsor of the submission of such sponsor response. date for initiation of discussions regarding tentative acceptance/non-acceptance. 2. Performance goal: 90% of such responses labeling, postmarketing requirements, and b. A supplemental review will be done are provided within 30 calendar days of the postmarketing commitments the Agency meeting the above review performance goals Agency’s receipt of the sponsor’s response. may request. if the proprietary name has been submitted f. If the applicant submits a major amend- H. Special Protocol Question Assessment and previously (during the BPD phase) and has Agreement ment(s) (refer to Section I.A.5.a for addi- received tentative acceptance. tional information on major amendments) c. If the proprietary name is found to be 1. Procedure: Upon specific request by a and the review division chooses to review unacceptable, the sponsor can request recon- sponsor (including specific questions that such amendment(s) during that review cycle, sideration by submitting a written rebuttal the sponsor desires to be answered), the the planned review timeline initially com- with supporting data or request a meeting Agency will evaluate certain protocols and municated (under Section I.C.2.a and b) will within 60 days to discuss the initial decision related issues to assess whether the design is generally no longer be applicable. Review of (meeting package required). adequate to meet scientific and regulatory unsolicited amendments, including those d. If the proprietary name is found to be requirements identified by the sponsor. submitted in response to an FDA commu- unacceptable, the above review performance a. The sponsor should submit a limited nication of deficiencies, will be handled in goals apply to the written request for recon- number of specific questions about the pro- accordance with the GRMP guidance. This sideration with supporting data or the sub- tocol design and scientific and regulatory re- guidance includes the underlying principle mission of a new proprietary name. quirements for which the sponsor seeks that FDA will consider the most efficient e. A complete submission is required to agreement (e.g., are the clinical endpoints path toward completion of a comprehensive begin the review clock. adequate to assess whether there are clini- review that addresses supplement defi- cally meaningful differences between the F. Major Dispute Resolution ciencies and leads toward a first cycle ap- proposed biosimilar biological product and proval when possible. 1. Procedure: For procedural or scientific the reference product). matters involving the review of biosimilar D. Guidance b. Within 45 days of Agency receipt of the biological product applications and supple- protocol and specific questions, the Agency FDA and industry share a commitment to ments (as defined in BsUFA) that cannot be will provide a written response to the spon- ensuring an efficient and effective first cycle resolved at the signatory authority level (in- sor that includes a succinct assessment of review process for all applications subject to cluding a request for reconsideration by the the protocol and answers to the questions the BsUFA program. This commitment is signatory authority after reviewing any ma- posed by the sponsor. If the Agency does not consistent with the principles articulated in terials that are planned to be forwarded with agree that the protocol design, execution the GRMP guidance, which FDA applies to an appeal to the next level), the response to plans, and data analyses are adequate to the review of biosimilar and interchangeable appeals of decisions will occur within 30 cal- achieve the goals of the sponsor, the reasons products. FDA will update the GRMP guid- endar days of the Center’s receipt of the for the disagreement will be explained in the ance during BsUFA II to ensure that it en- written appeal. response. compasses all review activities for biosimilar 2. Performance goal: 90% of such responses c. Protocols that qualify for this program and interchangeable products, including are provided within 30 calendar days of the include any necessary clinical study or stud- principles regarding notification to appli- Center’s receipt of the written appeal. ies to prove biosimilarity and/or inter- cants regarding issues identified during 3. Conditions: changeability (e.g., protocols for pharmaco- FDA’s initial review of the application, prin- a. Sponsors should first try to resolve the kinetics and pharmacodynamics studies, pro- ciples regarding FDA’s notification to appli- procedural or scientific issue at the signa- tocols for comparative clinical studies that cants regarding planned review timelines, tory authority level. If it cannot be resolved will form the primary basis for dem- and the importance of internal review at that level, it should be appealed to the onstrating that there are no clinically mean- timelines that govern aspects of biosimilar next higher organizational level (with a copy ingful differences between the proposed bio- and interchangeable product review that are to the signatory authority) and then, if nec- similar biological product and the reference not part of BsUFA performance goals. FDA essary, to the next higher organizational product, and protocols for clinical studies in- will publish a revised draft guidance for pub- level. tended to support a demonstration of inter- lic comment no later than the end of FY b. Responses should be either verbal (fol- changeability). For such protocols to qualify 2018. FDA will work toward the goal of pub- lowed by a written confirmation within 14 for this comprehensive protocol assessment, lishing a revised draft or final guidance with- calendar days of the verbal notification) or the sponsor must have had a BPD Type 2 or in 18 months after the close of the public written and should ordinarily be to either 3 Meeting, as defined in section I.I, below, comment period. grant or deny the appeal. with the review division so that the division E. Review of Proprietary Names to Reduce c. If the decision is to deny the appeal, the is aware of the developmental context in Medication Errors response should include reasons for the de- which the protocol is being reviewed and the To enhance patient safety, FDA is com- nial and any actions the sponsor might take questions being answered. mitted to various measures to reduce medi- to persuade the Agency to reverse its deci- d. If a protocol is reviewed under the proc- cation errors related to look-alike and sion. ess outlined above, and agreement with the sound-alike proprietary names and such fac- d. In some cases, further data or further Agency is reached on design, execution, and tors as unclear label abbreviations, acro- input from others might be needed to reach analyses, and if the results of the trial con- nyms, dose designations, and error prone a decision on the appeal. In these cases, the ducted under the protocol substantiate the label and packaging design. The following ‘‘response’’ should be the plan for obtaining hypothesis of the protocol, the Agency performance goals apply to FDA’s review of that information (e.g., requesting further in- agrees that the data from the protocol can biosimilar biological product proprietary formation from the sponsor, scheduling a be used as part of the primary basis for ap- names during the biosimilar biological prod- meeting with the sponsor, scheduling the proval of the product. The fundamental uct development (BPD) phase and during issue for discussion at the next scheduled agreement here is that having agreed to the FDA’s review of a marketing application: available advisory committee). design, execution, and analyses proposed in

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00054 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.080 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4751 protocols reviewed under this process, the TABLE 1 TABLE 4 Agency will not later alter its perspective on the issues of design, execution, or analyses Response time Meeting type unless public health concerns unrecognized Meeting type (calendar days) BPD Type 2 .... • FY 2018: 70% of preliminary responses to questions are at the time of protocol assessment under issued by FDA no later than five calendar days before this process are evident. Biosimilar Initial Advisory ...... 21 the meeting date. • BPD Type 1 ...... 14 FY 2019, 75% of preliminary responses to questions are 2. Performance goal: 90% of special proto- issued by FDA no later than five calendar days before cols assessments and agreement requests BPD Type 2–4 ...... 21 the meeting date. completed and returned to sponsor within 45 • FY 2020, 80% of preliminary responses to questions are issued by FDA no later than five calendar days before days. For Biosimilar Initial Advisory and BPD the meeting date. 3. Reporting: The Agency will track and re- Type 2 meetings, the sponsor may request a • FY 2021, 85% of preliminary responses to questions are issued by FDA no later than five calendar days before port the number of original special protocol written response to its questions, rather the meeting date. assessments and resubmissions per original than a face-to-face meeting, videoconference • FY 2022, 90% of preliminary responses to questions are special protocol assessment. issued by FDA no later than five calendar days before or teleconference. If a written response is the meeting date. I. Meeting Management Goals deemed appropriate, FDA will notify the re- BPD Type 3 .... 90% of preliminary responses to questions are issued by FDA no later than five calendar days before the meet- Formal BsUFA meetings between sponsors quester of the date it intends to send the ing date. and FDA consist of Biosimilar Initial Advi- written response. This date will be con- sory and BPD Type 1–4 meetings. These sistent with the timeframes specified in 4. Meeting Minutes meetings are further described below. Table 2 below for the specific meeting type. a. Procedure: The Agency will prepare min- utes which will be available to the sponsor 30 A Biosimilar Initial Advisory Meeting is b. Performance Goal: FDA will respond to an initial assessment limited to a general calendar days after the meeting. The min- meeting requests and provide notification utes will clearly outline the important discussion regarding whether licensure under within the response times noted in Table 1 section 351(k) of the Public Health Service agreements, disagreements, issues for fur- for 90 percent of each meeting type. Act may be feasible for a particular product, ther discussion, and action items from the and, if so, general advice on the expected 2. Scheduling Meetings meeting in bulleted form and need not be in content of the development program. Such great detail. Meeting minutes are not nec- a. Procedure: FDA will schedule the meet- essary if the Agency transmits a written re- term does not include any meeting that in- ing on the next available date at which all volves substantive review of summary data sponse for Biosimilar Initial Advisory and applicable Center personnel are available to or full study reports. BPD Type 2 meetings. attend, consistent with the component’s b. Performance Goal: 90% of minutes are A BPD Type 1 Meeting is a meeting which other business; however, the meeting should issued within 30 calendar days of the date of is necessary for an otherwise stalled drug de- be scheduled consistent with the type of the meeting. velopment program to proceed (e.g. meeting 5. Conditions: For a meeting to qualify for to discuss clinical holds, dispute resolution meeting requested. Table 2 below indicates the timeframes for FDA to schedule the these performance goals: meeting), a special protocol assessment a. A written request and supporting docu- meeting, or a meeting to address an impor- meeting following receipt of a formal meet- mentation (i.e., the background package) tant safety issue. ing request and background package, or in must be submitted to the appropriate review A BPD Type 2 Meeting is a meeting to dis- the case of a written response for Biosimilar division or office. cuss a specific issue (e.g., proposed study de- Initial Advisory and BPD Type 2 meetings, b. The request must provide: sign or endpoints) or questions where FDA the timeframes for the Agency to send the i. A brief statement of the purpose of the will provide targeted advice regarding an on- written response. If the requested date for meeting, the sponsor’s proposal for the type going biosimilar biological product develop- any meeting type is greater than the speci- of meeting, and the sponsor’s proposal for a ment program. Such term may include sub- fied timeframe, the meeting date should be face-to-face meeting, teleconference, or for a stantive review of summary data, but does written response (Biosimilar Initial Advisory within 14 calendar days of the requested not include review of full study reports. and BPD Type 2 meetings only); date. A BPD Type 3 Meeting is an in depth data ii. A listing of the specific objectives/out- review and advice meeting regarding an on- comes the requester expects from the meet- going biosimilar biological product develop- TABLE 2 ing; ment program. Such term includes sub- iii. A proposed agenda, including estimated Meeting type Meeting scheduling or written response time stantive review of full study reports, FDA times needed for each agenda item; iv. A list of questions, grouped by dis- advice regarding the similarity between the Biosimilar Ini- 75 calendar days from receipt of meeting request and proposed biosimilar biological product and tial Advisory. background package. cipline. For each question there should be a the reference product, and FDA advice re- BPD 2 ...... 90 calendar days from receipt of meeting request and brief explanation of the context and purpose background package. garding additional studies, including design of the question. Meeting v. A listing of planned external attendees; and analysis. Scheduling and A BPD Type 4 Meeting is a pre-submission Time BPD 1 ...... 30 calendar days from receipt of meeting request and vi. A listing of requested participants/dis- meeting to discuss the format and content of background package. ciplines representative(s) from the Center a complete application for an original bio- BPD 3 ...... 120 calendar days from receipt of meeting request and with an explanation for the request as appro- background package. similar biological product application under priate. the Program or supplement submitted under BPD 4 ...... 60 calendar days from receipt of meeting request and background package. vii. Suggested dates and times (e.g., morn- 351(k) of the PHS Act. The purpose of this ing or afternoon) for the meeting that are meeting is to discuss the format and content within or beyond the appropriate time frame b. Performance goal: of the planned submission and other items, of the meeting type being requested. including identification of those studies that c. The Agency concurs that the meeting the sponsor is relying on to support a dem- TABLE 3 will serve a useful purpose (i.e., it is not pre- onstration of biosimilarity or interchange- mature or clearly unnecessary). However, re- ability, discussion of any potential review Meeting type Goal quests for BPD Type 2, 3, and 4 Meetings will issues identified based on the information BPD Type 2 .... FY 2018–2019: 80% of meetings are held or written re- be honored except in the most unusual cir- provided, identification of the status of on- sponses are sent within the timeframe. cumstances. going or needed studies to adequately to ad- FY 2020–2022: 90% of meetings are held or written re- The Center may determine that a different dress the Pediatric Research Equity Act sponses are sent within the timeframe. Biosimilar Ini- 90% of meetings are held or written responses are sent type of meeting (i.e., Biosimilar Initial Advi- (PREA), acquainting FDA reviewers with the tial Advisory. within the timeframe. sory, or BPD Type 1–4) is more appropriate general information to be submitted in the BPD Type 1, 3, 90% of meetings are held within the timeframe for each and it may grant a meeting of a different marketing application (including technical and 4. meeting type. type than requested, which may require the information), and discussion of the best ap- payment of a biosimilar biological product proach to the presentation and formatting of 3. Preliminary Responses development fee as described in section 744H data in the marketing application. of the Federal Food, Drug, and Cosmetic Act a. Procedure: The Agency will send pre- 1. Response to Meeting Requests before the meeting will be provided. If a bio- liminary responses to the sponsor’s ques- a. Procedure: FDA will notify the re- similar biological product development fee is quester in writing of the date, time, and tions contained in the background package required under section 744H, and the sponsor place for the meeting, as well as expected no later than five calendar days before the does not pay the fee within the time frame Center participants following receipt of a face-to-face, videoconference or teleconfer- required under section 744H, the meeting will formal meeting request and background ence meeting date for BPD Type 2 and Type be cancelled. If the sponsor pays the bio- package. Table 1 below indicates the time- 3 meetings. similar biological product development fee after the meeting has been cancelled due to frames for FDA’s response to a meeting re- b. Performance goal: quest. non-payment, the time frame described in

VerDate Sep 11 2014 06:40 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00055 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.081 S02AUPT1 S4752 CONGRESSIONAL RECORD — SENATE August 2, 2017 section I.I.1.a will be calculated from the improve public understanding of biosimi- annual financial report how the capacity ad- date on which FDA received the payment, larity and interchangeability. justment fee revenues are being utilized. not the date on which the sponsor originally D. FDA will strengthen staff capacity to B. Financial Transparency and Efficiency submitted the meeting request. deliver information concerning the date of FDA is committed to ensuring BsUFA user Sponsors are encouraged to consult avail- first licensure and the reference product ex- fee resources are administered, allocated, able FDA guidance to obtain further infor- clusivity expiry date, to be included in the and reported in an efficient and transparent mation on recommended meeting proce- Purple Book. manner. FDA will conduct activities to dures. FDA will update the Purple Book to in- evaluate the financial administration of the 6. Guidance clude the following information: the BLA BsUFA program to help identify areas to en- a. FDA will publish revised draft guidance number, product name, proprietary name, hance efficiency. FDA will also conduct ac- on Formal Meetings Between the FDA and date of licensure, interchangeable or bio- tivities to enhance transparency of BsUFA Biosimilar Biological Product Sponsors or similar determination, and whether the BLA Applicants no later than September 30, 2018. program resources. has been withdrawn. FDA will update this 1. FDA will contract with an independent b. FDA will update the current draft or information in the Purple Book within 30 final guidance on Best Practices for Commu- third party to conduct an evaluation of days after approval or withdrawal. In addi- BsUFA program resource management dur- nication Between IND Sponsors and FDA tion, within 30 days after FDA determines During Drug Development, as appropriate, to ing FY 2018 to ensure that BsUFA user fee the date of first licensure, the date of first li- resources are administered, allocated, and apply to communications between IND spon- censure and the reference product exclu- sors and FDA during biosimilar biological reported in an efficient and transparent sivity expiry date will be included in the manner in BsUFA II. The BsUFA evaluation product development. FDA will publish a re- Purple Book. vised draft or final guidance by December 31, will be conducted under the same contract 2018. IV. ENHANCING MANAGEMENT OF USER FEE and by the same independent third party RESOURCES that will conduct an evaluation of the II. ADVANCING DEVELOPMENT OF BIOSIMILAR BI- FDA will establish an independent user fee PDUFA program resource management. The OLOGICAL PRODUCTS THROUGH FURTHER structure and fee amounts to ensure stable study will include, but is not limited to, the CLARIFICATION OF THE 351(K) REGULATORY and predictable user fee funding, improve the following areas: PATHWAY predictability of FDA funding and sponsor a. Evaluate all components of the BsUFA A. On or before December 31, 2017, FDA will invoices, improve efficiency by simplifying program resource planning, request, and al- publish draft guidance describing consider- the administration of user fees, and enhance location process from when FDA receives the ations in demonstrating interchangeability flexibility of financial mechanisms to im- user fee funds through when funds are spent. with a reference product. FDA will work to- prove management of BsUFA program fund- The contractor will recommend options to ward the goal of publishing a revised draft or ing. FDA is committed to enhancing man- improve the process and data needed to en- final guidance within 24 months after the agement of BsUFA resources and ensuring hance resource management decisions. close of the public comment period. BsUFA user fee resources are administered, b. Assess how FDA administers BsUFA B. On or before December 31, 2017, FDA will allocated, and reported in an efficient and user fees organizationally, including, but not publish draft guidance describing statistical transparent manner. FDA will conduct a se- limited to, billing, user fee collection, and considerations for the analysis of analytic ries of resource capacity planning and finan- execution. The contractor will recommend similarity data intended to support a dem- cial transparency activities to enhance man- options to enhance the efficiency of user fee onstration of ‘‘highly similar’’ for biosimilar agement of BsUFA resources in BsUFA II. administration. biological products. FDA will work toward c. Evaluate FDA’s existing BsUFA pro- A. Resource Capacity Planning and Modernized the goal of publishing a revised draft or final gram financial and administrative oversight Time Reporting guidance within 18 months after the close of and governance functions. Assess alternative the public comment period. FDA is committed to enhancing manage- governance models including roles and re- C. On or before March 31, 2019, FDA will ment of BsUFA resources in BsUFA II. FDA sponsibilities, organizational location, and publish draft guidance describing processes will conduct activities to develop a resource personnel skill sets required. The contractor and further considerations related to post- capacity planning function and modernized will recommend options on the most effec- approval manufacturing changes for bio- time reporting approach in BsUFA II. tive governance model to support the bio- similar biological products. FDA will work 1. FDA will publish a resource capacity similar biological product review program. toward the goal of publishing a revised draft planning and modernized time reporting im- d. Assess FDA’s technical capabilities to or final guidance within 18 months after the plementation plan that includes BsUFA no conduct effective financial management and close of the public comment period. later than the 2nd quarter of FY 2018. FDA planning in the context of generally accept- D. FDA will work towards the goal of pub- will continue to utilize information and rec- ed government resource management and lishing revised draft guidance or final guid- ommendations from a third party assess- planning practices. The contractor will rec- ance documents on or before May 31, 2019 for ment of resource capacity planning, finan- ommend options for the technical capabili- draft guidances published between January cial analytics, and modernized time report- ties needed by financial personnel involved 1, 2014 and September 30, 2017, other than ing for BsUFA as part of the implementation in BsUFA resource management to enhance those described in (II.A–C). These draft guid- plan. financial management and planning. ances will include: 2. FDA will staff a resource capacity plan- 2. FDA will publish a BsUFA five-year fi- 1. Clinical Pharmacology Data to Support ning team that will implement and manage a nancial plan no later than the 2nd quarter of a Demonstration of Biosimilarity to a Ref- capacity planning system across the BsUFA FY 2018. FDA will publish updates to the erence Product (draft guidance published in program in BsUFA II. five-year plan no later than the 2nd quarter May 2014) 3. FDA will obtain through a contract with of each subsequent fiscal year. 2. Nonproprietary Naming of Biological an independent accounting or consulting 3. FDA will convene a public meeting no Products (draft guidance published in August firm an evaluation of options and rec- later than the third quarter of each fiscal 2015) ommendations for a new methodology to ac- year starting in FY 2019 to discuss the 3. Labeling for Biosimilar Biological Prod- curately assess changes in the resource and BsUFA five-year financial plan, report on ucts (draft guidance published in March 2016) capacity needs of the biosimilar biological the contribution of the BsUFA spending trig- III. ENHANCING CAPACITY FOR BIOSIMILAR REGU- product review program. The BsUFA evalua- ger to the BsUFA program, along with the LATIONS AND GUIDANCE DEVELOPMENT, RE- tion will be conducted under the same con- Agency’s progress in implementing modern- VIEWER TRAINING, AND TIMELY COMMUNICA- tract and by the same independent account- ized time reporting, resource capacity plan- TION ing or consulting firm that will evaluate op- ning, and the modernized user fee structure. tions and recommendations for a new meth- A. FDA will strengthen the staff capacity C. Management of Carryover Balance to develop new regulations and guidance to odology to accurately assess changes in the FDA is committed to reducing the carry- clarify scientific criteria for biosimilar de- resource and capacity needs of the human over balance to no greater than 21 weeks of velopment and approval to provide certainty drug review program in PDUFA VI. The re- the FY 2022 target revenue by the end of FY to industry and other stakeholders related to port will be published no later than end of 2022. However, if FDA is unable to reduce the key regulatory issues including the scope of FY 2020 for public comment. Upon review of carryover balance to no greater than 21 eligible biosimilar biological products. the report and comments, FDA will imple- B. FDA will strengthen staff capacity to ment robust methodologies for assessing re- weeks during the final year (e.g., over collec- develop or revise MaPPs, SOPPs, and review source needs of the program. This will in- tions in FY 2022 that increase the carryover templates to facilitate rapid update and ap- clude the adoption of a new resource capac- balance beyond 21 weeks), FDA will (1) out- plication of new policies and guidance by re- ity adjustment methodology that accounts line its plan to reduce the carryover balance view staff, and to develop and deliver timely for sustained increases in BsUFA workload. to no greater than 21 weeks in the FY 2022 comprehensive training to all CDER and 4. FDA recognizes that revenue generated BsUFA financial report and (2) update the CBER review staff and special government by the capacity adjustment will be allocated BsUFA five-year financial plan. employees involved in the review of 351(k) to and used by organizational review compo- V. IMPROVING FDA HIRING AND RETENTION OF BLAs. nents engaged in direct review work to en- REVIEW STAFF C. FDA will strengthen staff capacity to hance resources and expand staff capacity To speed and improve development of safe deliver timely information to the public to and capability. FDA will document in the and effective biosimilar biological products

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00056 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.082 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4753 for patients, enhancements to the biosimilar charged with the continuous recruiting, 2. Interim Assessment: An interim assess- biological review program require that FDA staffing, and retention of scientific, tech- ment will be published by March 31, 2020, for hire and retain sufficient numbers and types nical, and professional staff for the PDUFA public comment. By June 30, 2020, FDA will of technical and scientific experts to effi- and BsUFA review programs. hold a public meeting during which the pub- ciently conduct reviews of 351(k) applica- a. The unit will continuously develop and lic may present their views. FDA will discuss tions. In order to strengthen this core func- implement scientific staff hiring strategies the findings of the interim assessment, in- tion and increase public access to biosimilar and plans, working closely with the center cluding progress relative to program mile- biological products, the FDA will commit to review offices and the FDA HR office, to stones and metrics, and other aggregated do the following: meet discipline-specific hiring commitments feedback from internal customers and par- A. Completion of Modernization of the Hiring and other targeted staffing needs. It will ticipants in HR services that may be in- function as a scientific-focused recruiter System Infrastructure and Augmentation of cluded in the continuous assessment. FDA conducting ongoing proactive outreach to System Capacity will also address any issues identified to date source qualified candidates, and conducting including actions proposed to improve the 1. Complete implementation of FTE-based competitive recruiting to fill vacancies that position management system capability. require top scientific, technical, and profes- likelihood of success of the program. a. FDA will complete development of posi- sional talent. 3. Final Assessment: A final assessment tion management baseline accounting of all b. The unit will conduct analyses, no less will be published by December 31, 2021, for current positions and FTE counts engaged in than annually, of compensation and other public comment. FDA will hold a public the biosimilar biological product review pro- factors affecting retention of key staff in meeting by no later than March 30, 2022, dur- gram for each applicable Center and Office targeted disciplines and provide leadership ing which the public may present their including filled and vacant positions, a gov- and support for agency compensation over- views. FDA will discuss the findings of the ernance structure for on-going position man- sight boards that currently exist or may be final assessment, including progress relative agement that will be accountable to FDA established as needed to ensure retention of to program milestones and metrics, and senior management, and position manage- key scientific, technical, and professional other aggregated feedback from internal cus- ment policy and guidelines ratified by FDA staff. tomers and participants in HR services that senior management, outlining processes for D. Set Clear Goals for Biosimilar Biological may be included in the continuous assess- adding new positions, deleting positions, and Product Review Program Hiring changing established positions. ment. FDA will also address any issues iden- 1. FDA will establish priorities for manage- tified and plans for addressing these issues. b. FDA will complete implementation of ment of the metric goals for targeted hires the new position-based management system. within the biosimilar biological product re- V. DEFINITIONS AND EXPLANATION OF TERMS 2. Complete implementation of an online view program staff for BsUFA II. In par- A. The term ‘‘review and act on’’ means position classification system ticular, FDA will target hiring 15 FTE in FY a. FDA will finalize the establishment of 2018, to enhance capacity for biosimilar guid- the issuance of a complete action letter after an online Position Description (PD) library. ance development, reviewer training, and the complete review of a filed complete ap- The library will include all current well-clas- timely communication. plication. The action letter, if it is not an sified PDs and current standardized PDs. 2. FDA will confirm progress in the hiring approval, will set forth in detail the specific Once operational, any new PDs classified of BsUFA I FTEs. FDA will report on deficiencies and, where appropriate, the ac- using the on-line classification tools, and progress against the hiring goal for BsUFA II tions necessary to place the application in any newly created standardized PDs, will be on a quarterly basis posting updates to the condition for approval. stored and accessible within FDA’s PD li- FDA website BsUFA Performance webpage. B. A resubmitted original application is a brary and available for FDA-wide use as ap- E. Comprehensive and Continuous Assessment complete response to an action letter ad- propriate. of Hiring and Retention 3. Complete implementation of corporate dressing all identified deficiencies. recruiting FDA hiring and retention of staff for the a. For key scientific and technical dis- biosimilar biological product review program f ciplines commonly needed across offices en- will be evaluated by a qualified, independent contractor with expertise in assessing HR gaged in the biosimilar biological product re- operations and transformation. The BsUFA ARMS SALES NOTIFICATION view program, FDA will complete the transi- II assessment will be conducted under the tion from the use of individual vacancy an- same contract and by the same independent Mr. CORKER. Mr. President, section 36(b) nouncements for individual offices to ex- contractor that will conduct the assessment of the Arms Export Control Act requires panded use of a common vacancy announce- related to hiring and retention of staff for that Congress receive prior notification of ment and certificate of eligible job appli- the human drug review program in PDUFA certain proposed arms sales as defined by cants that can be used by multiple offices. VI. It will include continuous assessments that statute. Upon such notification, the As a part of this effort, FDA will complete throughout the course of implementation of Congress has 30 calendar days during which the transition from use of individual an- the performance initiatives identified in Sec- the sale may be reviewed. The provision stip- nouncements that are posted for a limited tions V.A–D, and metrics including, but not ulates that, in the Senate, the notification of period to common vacancy announcements limited to, those related to recruiting and with open continuous posting to maximize proposed sales shall be sent to the chairman retention in the PDUFA and BsUFA review of the Senate Foreign Relations Committee. the opportunity for qualified applicants to programs including, but not limited to, spe- apply for these positions. cifically targeted scientific disciplines and In keeping with the committee’s in- B. Augmentation of Hiring Staff Capacity and levels of experience. The contractor will con- tention to see that relevant informa- Capability duct a comprehensive review of current hir- tion is available to the full Senate, I In recognition of the chronic and con- ing processes and hiring staff capacity and ask unanimous consent to have in the capabilities that contribute to achievement tinuing difficulties of recruiting and retain- RECORD the notifications which have ing sufficient numbers of qualified Human of successes, potential problems, or delays in PDUFA or BsUFA review program staff hir- been received. If the cover letter ref- Resources (HR) staff, FDA will engage a erences a classified annex, then such qualified contractor to provide continuous ing. This includes the entire hiring function support throughout BsUFA II to augment and related capabilities. FDA and regulated annex is available to all Senators in the existing FDA HR staff capacity and ca- industry leadership will periodically and reg- the office of the Foreign Relations pabilities. The utilization of a qualified con- ularly assess the progress of hiring and re- Committee, room SD–423. tention throughout BsUFA II. tractor will assist FDA in successfully ac- There being no objection, the mate- complishing BsUFA II goals for recruitment 1. Initial Assessment: The assessment will and retention of biosimilar biological prod- include an initial baseline assessment to be rial was ordered to be printed in the uct review program staff. conducted and completed no later than De- RECORD, as follows: cember 31, 2017. The initial baseline study DEFENSE SECURITY C. Complete Establishment of a Dedicated Func- will include an evaluation of the current tion to Ensure Needed Scientific Staffing for COOPERATION AGENCY, state and provide recommended options to Arlington, VA. Human Drug Review Including for Review address any identified gaps or areas identi- of Biosimilar Biological Products Hon. BOB CORKER, fied as priorities for improvement, and a Chairman, Committee on Foreign Relations, 1. Rapid advances in the science and tech- study report to be published no later than U.S. Senate, Washington, DC. nology of biosimilar biological product de- December 31, 2017. FDA will hold a public velopment and manufacturing require FDA’s meeting no later than December 31, 2017, to DEAR MR. CHAIRMAN: Pursuant to the re- biosimilar biological product review program present and discuss report findings, and porting requirements of Section 36(b)(1) of staff to keep pace with science and learn in- present its specific plans, including agency the Arms Export Control Act, as amended, novative methods and techniques for review senior management oversight, and timeline we are forwarding herewith Transmittal No. of new therapies. FDA will complete the es- for implementing recommended enhance- 17–38, concerning the Navy’s proposed Let- tablishment of a new dedicated unit within ments to be fully operational by no later ter(s) of Offer and Acceptance to the Govern- the Office of Medical Products and Tobacco than December 31, 2018. ment of Australia for defense articles and

VerDate Sep 11 2014 06:34 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00057 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.083 S02AUPT1 S4754 CONGRESSIONAL RECORD — SENATE August 2, 2017

services estimated to cost $108.7 million. TRANSMITTAL NO. 17–38 (ii) Total Estimated Value: After this letter is delivered to your office, Notice of Proposed Issuance of Letter of Major Defense Equipment $29 million we plan to issue a news release to notify the Offer Pursuant to Section 36(b)(1) of the Other $564 million public of this proposed sale. Arms Export Control Act Total $593 million Sincerely, Annex Item No. vii (iii) Description and Quantity or Quan- GREGORY M. KAUSNER, tities of Articles or Services under Consider- (vii) Sensitivity of Technology: ation for Purchase: Acting Director. 1. The ALE–70 is a towed radio frequency Enclosures. Major Defense Equipment (MDE): countermeasure designed for deployment One hundred (100) GBU–12 (500lb) Paveway TRANSMITTAL NO. 17–38 from the F–35 aircraft and is comprised of II (PW–II) Tailkits Notice of Proposed Issuance of Letter of electronic and mechanical sub-assemblies to One hundred (100) GBU–58 (250lb) PW–II Offer Pursuant to Section 36(b)(1) of the accomplish the intended purpose. The ALE– Tailkits Arms Export Control Act, as amended 70 consists of three major components: the Four hundred (400) Laser Guided Rockets reel/launcher assembly, the tow line, and the (i) Prospective Purchaser: Government of including Advanced Precision Kill Weapon T–1687 countermeasure transmitter. Upon de- Australia. System (APKWS) (ii) Total Estimated Value: ployment from the aircraft, the counter- Two thousand (2,000) MK–81 (250lb) bombs Major Defense Equipment *$0.0 million measure transmitter is reeled out to a pre- Five thousand (5,000) 2.75 inch Hydra 70 Other $108.7 million scribed distance, held in tow behind the jet Total $108.7 million Unguided Rockets (70mm rockets) by the tow line and emits waveforms in re- One thousand (1,000) 2.75 inch Hydra 70 (iii) Description and Quantity or Quan- sponse to commands from the counter- tities of Articles or Services under Consider- Unguided Rockets (practice) measure controller located in the jet. The Twenty thousand (20,000) Rounds, .50 Cal- ation for Purchase: waveforms are utilized to confuse or decoy Major Defense Equipment (MDE): None iber Machine Gun Ammo adversary radars or radar guided weapons. Non-MDE includes: Non-Major Defense Equipment (MDE): This One thousand nine hundred fifty-two (1,952) Designed and produced by BAE Systems of request also includes the following Non- ALE–70(V)/T–1687A Electronic Towed Decoy Nashua, New Hampshire, the ALE–70 em- MDE: Twelve (12) A–29 Super Tucano air- Countermeasures, publications and technical ploys amplifiers based on Gallium Nitride craft, seven (7) AN/AAQ–22F Electro-Optical/ documentation, other technical assistance, (GaN) technology to meet stringent output Infrared (EO/IR) Sensor and Laser Designa- U.S. Government and contractor engineer- requirements. tors, Initial Spares, Readiness Spares Pack- 2. The ALE–70 generates, amplifies, and ing, technical and logistics support services, age, Consumables, Support Equipment, transmits signals in response to commands and other related elements of logistical and Technical Data, Repair and Return Support, from the countermeasures controller which program support. Facilities infrastructure and hangar con- (iv) Military Department: Navy (XX–P– remains aboard the jet. Neither the counter- struction, Night Vision Devices (NVDs), Con- AMN Al) measure transmitter nor the reel/launcher tract Logistics Services (CLS), Contractor (v) Prior Related Cases, if any: None assembly contains stored information or Provided Familiarization and Training, USG (vi) Sales Commission, Fee, etc., Paid, Of- software representing critical program infor- Manpower and Services, Field Service Rep- fered, or Agreed to be Paid: None mation. As the ALE–70 contains no software resentatives, Training Services (pilot train- (vii) Sensitivity of Technology Contained or stored waveforms/techniques, Anti-Tam- ing, USAF training, early A–29 training, in the Defense Article or Defense Services pering security measures are not required. flight leader upgrade training, travel and liv- Proposed to be Sold: See Attached Annex ALE–70 hardware is classified SECRET to ing allowance, maintenance training, spe- (viii) Date Report Delivered to Congress: protect specific data elements associated cialized training, computer-based training, August 02, 2017. with the performance of the countermeasure. night vision device training, human rights * As defined in Section 47(6) of the Arms 3. If a technologically advanced adversary and international humanitarian law, and Export Control Act. were to obtain knowledge of the specific munitions training), Training Simulators, hardware and software elements, the infor- POLICY JUSTIFICATION Air Worthiness Support, Forward Operating mation could be used to develop counter- Australia—ALE–70 Radio Frequency Base Facilities, Forward Operating Location measures or equivalent system which might Countermeasures (RFCM) Support, Ferrying, and Non-recurring Engi- reduce system effectiveness or be used in the The Government of Australia has re- neering. Additionally, all aircraft will in- development of a system with similar or ad- quested the possible sale of one thousand clude weapons software to support forward vanced capabilities. nine hundred fifty-two (1,952) ALE–70(V)/T– 4. A determination has been made that looking infrared sensors (FLIRs), ancillary 1687A Electronic Towed Decoy Counter- Australia can provide substantially the same system. measures, publications and technical docu- degree of protection for the sensitive tech- (iv) Military Department: Air Force (X8–D– mentation, other technical assistance, U.S. nology being released as the U.S. Govern- SAB) Government and contractor engineering, ment. This sale is necessary in furtherance (v) Prior Related Cases, if any: None (vi) Sales Commission, Fee, etc., Paid, Of- technical and logistics support services, and of the U.S. foreign policy and national secu- fered. or Agreed to be Paid: None other related elements of logistical and pro- rity objectives outlined in the Policy Jus- (vii) Sensitivity of Technology Contained gram support. The total estimated program tification. cost is $108.7 million. 5. All defense articles and services listed in in the Defense Article or Defense Services This sale will contribute to the foreign pol- this transmittal have been authorized for re- Proposed to be Sold: See Annex attached. icy and national security of the United lease and export to Australia. (viii) Date Report Delivered to Congress: Aug 02 2017 States by helping to improve the security of DEFENSE SECURITY *As defined in Section 47(6) of the Arms a major non-NATO ally and continues to be COOPERATION AGENCY, an important force for political stability, se- Arlington, VA. Export Control Act. curity, and economic development in the Hon. BOB CORKER, POLICY JUSTIFICATION Western Pacific. It is vital to the U.S. na- Chairman, Committee on Foreign Relations U.S. Nigeria—A–29 Super Tucano Aircraft, Weap- tional interest to assist our ally in devel- Senate, Washington, DC. ons and Associated Support oping and maintaining a strong and ready DEAR MR. CHAIRMAN: Pursuant to the re- The Government of Nigeria requests twelve self-defense capability. porting requirements of Section 36(b)(1) of The proposed sale will improve Australia’s (12) A–29 Super Tucano aircraft and weapons, the Arms Export Control Act, as amended, including all associated training, spare F–35 survivability and will enhance its capa- we are forwarding herewith Transmittal No. bility to deter global threats, strengthen its parts, aviation and ground support equip- 16–55, concerning the Department of the Air ment, and hangar, facilities, and infrastruc- homeland defense, and cooperate in coalition Force’s proposed Letter(s) of Offer and Ac- defense initiatives. Australia will have no ture required to support the program. The ceptance to the Federal Republic of Nigeria estimated total case value is $593 million. difficulty absorbing this equipment into its for defense articles and services estimated to armed forces. These aircraft will support Nigerian mili- cost $593 million. After this letter is deliv- tary operations against terrorist organiza- The proposed sale of this equipment and ered to your office, we plan to issue a news support will not alter the basic military bal- tion Boko Haram and to counter illicit traf- release to notify the public of this proposed ficking in Nigeria and the Gulf of Guinea. ance in the region. sale. The principal contractor will be British The Super Tucano is a sustainable platform Sincerely, Aerospace Enterprise (BAE), Nashua, NH. for counterterrorism, counter insurgency, GREGORY M. KAUSNER, There are no offsets proposed in connection border surveillance, and illicit trade inter- Acting Director. diction operations. The proposed sale will with this potential sale. Enclosures. Implementation of this proposed sale will support U.S. foreign policy objectives by not require the assignment of any additional TRANSMITTAL NO. 16–55 helping Nigeria to meet shared counterter- U.S. Government or contractor representa- Notice of Proposed Issuance of Letter of rorism objectives for the region. This pro- tives to Australia. Offer Pursuant to Section 36(b)(1) of the posed sale will strengthen the U.S. security There will be no adverse impact on U.S. de- Arms Export Control Act, as amended relationship with Africa’s largest democ- fense readiness as a result of this proposed (i) Prospective Purchaser: The Federal Re- racy. Nigeria will have no difficulty absorb- sale. public of Nigeria ing these aircraft into its armed forces.

VerDate Sep 11 2014 06:34 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00058 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.059 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4755 The proposed sale of this equipment and this sale, as outlined in the Policy Justifica- looks backwards and reverts to a failed support does not alter the basic military bal- tion, outweigh the potential damage that policy of isolation that has done noth- ance in the region. could result if the sensitive technology were ing to improve the lives of the Cuban The prime contractor is the Sierra Nevada revealed to unauthorized persons. people and has harmed the American Corporation, headquartered in Centennial, 8. All defense articles and services listed in economy. I would like to present an al- Colorado. There are no known offset agree- this transmittal are authorized for release ments proposed in connection with this po- and export to the Government of Nigeria. ternative vision—one that looks to the tential sale. future and at fostering the exchange of Implementation of this proposed sale will f ideas and commerce between the two require the assignment of U.S. Government CONFIRMATION OF CHRISTOPHER countries. or contractor representatives to Nigeria for WRAY It is often noted that Cuba is less mobile training teams and contract logistic than 100 miles away, but decades be- support. Mr. VAN HOLLEN. Mr. President, I hind the United States, in no small There will be no adverse impact on U.S. de- wish to voice my support for Chris- part because of the U.S. embargo. Dec- fense readiness as a result of this proposed topher Wray’s confirmation to be the sale. ades of the same, tired, failing eco- next Director of the FBI. After meeting nomic policies left the Cuban Govern- TRANSMITTAL NO. 16–55 with Mr. Wray and reviewing his ment in place and only hurt the Cuban Notice of Proposed Issuance of Letter of record, I believe he possesses the inde- people and American farmers and man- Offer Pursuant to Section 36(b)(1) of the pendence and integrity necessary to Arms Export Control Act ufacturers. lead the Bureau through this tumul- As Cuban-American relations thawed Annex Item No. vii tuous period. under Presidents Bush and Obama, the (vii) Sensitivity of Technology: This vacancy arose because President Cuban Government decided to try 1. This sale involves the release of sen- Trump abruptly fired then-Director sitive weapons software technology informa- something different. Private entre- tion to Nigeria. Software associated with the James Comey. The circumstances sur- preneurs are operating an increasing following weapons will be included in the rounding Mr. Comey’s firing are alarm- number of restaurants, taxis, and other aircraft operational flight program to sup- ing and suspicious. Mr. Comey testified tourist-related businesses. Cubans are port a future weapons capability. under oath that the President not only opening up their homes for visitors to 2. Sensitive and/or classified (up to SE- demanded his personal loyalty on nu- stay in and selling products directly to CRET) elements of the proposed A–29 sale to merous occasions but also intimated visiting Americans. In addition, the Nigeria includes the hardware and associated that Mr. Comey should stop inves- government’s grip on information and software with: Advanced Precision Kill Weapon System (APKWS) laser guided rock- tigating then-National Security Advi- communication is necessarily weak- ets, Guided Bomb Unit (GBU)–12/58 Paveway sor Michael Flynn and Russian inter- ening as technology and the Internet II laser guided tail kits, and Mark (MK)–81/82 ference in the 2016 elections. inevitably permeate the country. general purpose bombs. Mr. Wray will face numerous chal- The U.S. has come a long way since 3. The Hydra 70 Rocket System is a mod- lenges as the new Director of the FBI. the 1990s and hardly resembles the ernized version of the 2.75 inch (70 mm) He will have to deal with a President world of the 1960s. Our policies toward unguided rocket body with the MK66 Rocket who has shown a complete disregard Cuba should reflect that change. The Motor. for traditional protocols designed to U.S.-Cuba Trade Act of 2017 would com- 4. The APKWS is a low cost semi-active pletely remove the architecture of laser guidance kit developed by BAE Sys- ensure the agency’s independence. Dur- tems which is added to current unguided 70 ing our meeting, Mr. Wray assured me sanctions against Cuba and establish mm rocket motors and warheads similar to that he would remain independent from normal trade relations with that coun- and including the Hydra 70 rocket. It is a low the President and would reject any at- try. collateral damage weapon that can effec- tempts by President Trump to inappro- I want to be clear that this is not a tively strike both soft and lightly armored priately intervene in the work of the free pass for the Cuban Government. I targets. APKWS turns a standard unguided FBI. continue to have grave concerns about 2.75 inch (70 mm) rocket into a precision During our meeting, I also impressed its suppression of pro-democracy move- laser-guided rocket, classification up to SE- upon Mr. Wray the importance of con- ments, but I reject the view that con- CRET. tinuing to try and ostracize Cuba will 5. GBU–12/58 Paveway II (PW–II) Tailkits: solidating the FBI’s staff in one build- 500–lb (GBU–12) and 250–lb (GBU–58) are ing. The FBI has long outgrown its cur- bring positive change. The past five laser-guided ballistic bombs (LGBs) devel- rent space and the building is deterio- decades provide empirical evidence oped by Raytheon and Lockheed Martin. The rating, which compromises the agen- that it will not. I also reject the cyn- LGB is a maneuverable, free-fall weapon that cy’s mission. I look forward to working ical argument that the U.S. must guides to a spot of laser energy reflected off with him to give FBI personnel the fa- choose between engagement with Cuba of the target. The LGB is delivered like a cilities they deserve. and support for basic human rights and normal general purpose (GP) warhead and dignity. Indeed, if the past half century the semi-active guidance corrects for many As Mr. Wray takes his position, he will need to work immediately to af- has shown us anything, it is that of the normal errors inherent in any delivery smart, principled engagement is the system. Laser designation for the weapon firm the FBI’s independence and re- can be provided by a variety of laser target store the confidence of an agency shak- way to bring about greater economic markers or designators. The tailkit consists en by the President’s inappropriate and political freedom for the Cuban people. of a laser guidance kit, a computer control conduct with respect to Mr. Comey and Just as important as what the em- group (CCG) and a warhead specific Air Foil other matters. This Congress must con- Group (AFG), that attach to the nose and bargo means for the Cuban people is duct vigorous oversight to ensure that tail of MK 81 and MK 82 General Purpose what it means for U.S. farmers and (GP) bomb bodies to create an LGB. This Mr. Wray maintains the high standard businesses. Even with the changes sale includes the tailkits to transform Nige- of integrity that he has promised and made by the Obama administration, it ria’s existing 500-lb and 250-lb GP bomb bod- to respond to any attempts by the remains almost impossible to do busi- ies into GBU–12s and GBU–58s respectively. President or his political advisors to ness in Cuba. Cuba is a natural cus- Nigeria is also buying additional GBU–58s, exert undue influence at the FBI. I 250-lb (MK–81) guided bombs. The overall tomer of the United States, but restric- pledge to do everything I can to sup- tions on credit and travel, among oth- weapon is CONFIDENTIAL. port his important mission and the 6. AN/AAQ–22F Brite Star Electro-Optical/ ers, have severely hampered the ability Infrared (EO/IR) Multi-Sensor Targeting vital work of the FBI. of U.S. exporters to do business in the System developed by FLIR. The system is a f Cuban market. The question is: What five field-of-view (FOV) large format thermal are we getting by surrendering a mar- U.S.-CUBA TRADE ACT OF 2017 imager, three FOV color daylight camera ket that should be ours to the EU, with laser designator for terminal guidance Mr. WYDEN. Mr. President, today I China, Brazil, and others? I am afraid of LGBs and IR-guided rockets. The system wish to propose a new day in U.S. rela- is classified as UNCLASSIFIED. that the answer is nothing. 7. This sale is necessary in furtherance of tions with the country of Cuba. With That is why I introduced the U.S.- U.S. foreign policy and national security ob- his recent imposition of new restric- Cuba Trade Act of 2017, to finally put jectives outlined in the Policy Justification. tions, the President presented one vi- an end to the ineffective embargo Moreover, the benefits to be derived from sion of that relationship—one that against Cuba.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00059 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.060 S02AUPT1 S4756 CONGRESSIONAL RECORD — SENATE August 2, 2017 HONORING CORPSMAN FIRST HONORING LIEUTENANT AARON Lt. Allan is survived and deeply CLASS RYAN LOHREY ALLAN missed by his wife, Stacy, their two Mr. DONNELLY. Mr. President, Mr. DONNELLY. Today I wish to rec- sons, his fellow officers in Southport, today I wish to recognize and honor the ognize and honor the extraordinary and citizens across Indiana. Let us strive to remember and emulate the extraordinary service and sacrifice of service and sacrifice of Lt. Aaron Allan shining example Lt. Allan set for us, U.S. Navy Hospital Corpsman First of the Southport Police Department. and honor his selfless commitment to Class Ryan Lohrey of Middletown, IN. Dedication, loyalty, and compassion serving his fellow citizens. May God Dedication to his country, loyalty to for those in need were the qualities welcome Lt. Allan home and give com- his fellow servicemembers, and a deep that defined Lt. Allan’s life. fort to his family and friends. love for his family were the qualities Lt. Aaron Allan was a 6-year veteran that defined Ryan’s life. with the Southport Police Department, f A native of Middletown, IN, Ryan who began his career in law enforce- VENEZUELA ment in 2001. A kind and caring person, graduated from Shenandoah High Lt. Allan was a family man who de- Mr. RUBIO. Mr. President, I ask School in 2005. Two years after gradua- voted his life to serving his commu- unanimous consent that a statement tion, he joined the U.S. Navy, where he nity. Lt. Allan earned the nickname by Julio Andres Borges Junyent, Presi- served our country as a special amphib- ‘‘Teddy Bear’’ because of his kind heart dent of the National Assembly of the ious reconnaissance corpsman, pro- and willingness to help anyone in need. Bolivarian Republic of Venezuela, be viding medical care to his fellow Lt. Allan had dreamed of being a po- printed in the RECORD. servicemembers. lice officer since he was 5 years old. Be- There being no objection, the mate- On Monday, July 10, 2017, Ryan and fore he joined the Southport Police De- rial was ordered to be printed in the 15 other servicemembers died trag- partment in 2011 as a volunteer officer, RECORD, as follows: ically when the KC–130 aircraft they he previously worked as an officer at THE NATIONAL ASSEMBLY OF THE BOLIVARIAN were on crashed in Mississippi. The the Indiana School for the Deaf and for REPUBLIC OF VENEZUELA—IN RESCUE OF THE plane was carrying servicemembers Franklin Township Schools. In 2015, he CONSTITUTION, DEMOCRACY AND HUMAN from Marine Aerial Refueler Transport was named Southport Police Depart- RIGHTS: AGREEMENT IN DISREGARD OF THE Squadron 452 and the 2d Marine Raider FRAUDULENTS ELECTORAL RESULTS ON JULY ment’s ‘‘Officer of the Year,’’ after sav- 30TH, 2017 FOR WHICH WAS INTENDED TO IM- Battalion, a special operations unit. ing two lives. Among his efforts, he POSE AN ILLEGITIMATE NATIONAL CON- Hundreds gathered on July 27 as a mili- performed CPR to save a man at the STITUENT ASSEMBLY, AND IN CLAIM OF THE tary procession honored Ryan from In- Indiana State Fairgrounds before 1999 CONSTITUTION AS A DEMOCRATIC BASIS dianapolis International Airport to backup officers arrived with a OF THE BOLIVARIAN REPUBLIC OF VENEZUELA New Castle, IN. He received military defibrillator. In recognition of his CONSIDERING honors during his funeral in Middle- work, he became the only full-time On July 30th, 2017 the regime of Nicolas town on July 31, 2017. paid officer in an all-volunteer force of Maduro, with the support of the majority of Ryan is remembered for his selfless reserve officers. He was a devout volun- rectors of the National Electoral Council, sacrifice, humility, patience, and infec- teer, leader, and role model in judges of the Supreme Court of Justice and tious smile. He distinguished himself Southport, who believed in community the high dome of the National Bolivarian policing and prided himself on stopping Armed Forces, advanced on the fraudulent through his service in the U.S. Navy, constituent process that initiated on May 1, where he deployed with the 2d Marine to talk with residents and getting to 2017, realizing a supposed illegitimate ‘‘elec- Reconnaissance Battalion and later know them. Lt. Allan made a dif- tion’’ of such illegitimate constituent mem- with the 2d Marine Raider Battalion. ference in the community and always bers; He was a veteran of Operation Endur- put the safety and well-being of his fel- CONSIDERING ing Freedom in Afghanistan and Oper- low citizens first. When he encountered The authorities of the National Bolivarian ation Inherent Resolve in Iraq. Ryan a family whose car would not start and Armed Forces have assumed the prominence had qualification as an enlisted fleet the husband had been diagnosed with a in the announcements concerning the elec- marine force warfare specialist, marine brain tumor and the wife cared for her toral process, investing the constitutional principle of subjection of the military civil- combatant diver, and Navy and Marine husband and young daughter, Allan went to an auto parts store and bought ian authorities; which is a sample of the mil- Corps parachutist. He rose to become a itarism they intend to impose, in contraven- special amphibious reconnaissance the family a new car battery with his own money. It went beyond that. He tion to the enshrined civic and republican corpsman. For his service, among the values on the current Constitution of 1999; participated in ‘‘Shop with a Deputy,’’ awards he earned were a Purple Heart, CONSIDERING volunteering to take underprivileged Navy and Marine Corps Commendation children Christmas shopping. He also That this National Assembly has pointed Medal, Combat Action Ribbon with out in various agreements, and it was rati- excelled responding to difficult calls, Gold Star in lieu of second award, and fied by the Venezuelan people in the ref- whether a citizen had overdosed and Good Conduct Medal with two Bronze erendum of July 16th, 2017, the National Con- needed Narcan or he encountered a Stars in lieu of second and third award. stituent Assembly is a fraudulent and illegit- drunk driver. He enriched and touched imate process that only seeks to repeal the Ryan was a devoted patriot, son, hus- so many lives through his service, and Constitution of 1999 by other mechanisms band, and father, who loved football he made the ultimate sacrifice while than those provided, in order to establish in and making others laugh. He is sur- responding to fellow citizens in need. Venezuela a dictatorship of totalitarian vived and will be deeply missed by his On Thursday, July 27, 2017, Lt. Allan Court, in reason of which all acts and proc- wife, Cassie; his two children, Gavin esses arising from such constituent must be was doing his job, responding to an in- unknown to citizens and government em- and Maelyn; his parents, Michael and cident involving an overturned vehicle Teresa Lohrey of Middletown; and his ployees, who have the duty to restore the va- in Southport, when he was shot. Hours lidity of the 1999 Constitution, all this, in ac- grandparents, Barbara Lohrey of Mid- before Lt. Allan was killed, he walked cordance with the articles 333 and 350; dletown, and George Lohrey, of Sul- his 5-year-old son, Aaron, Jr., to the CONSIDERING phur Springs; as well as friends, the bus for his first day of kindergarten. The fraudulent election of July 30th sought U.S. Navy family, and Hoosiers across He put his life on the line so that Hoo- to give legitimacy to the constitutional the State of Indiana. siers could have the chance to live in process, despite the fact that such procedure As Ryan’s grandmother said, ‘‘Ryan peace and safety, and we are eternally was initiated with the usurpation of the pop- was my hero. He’s everybody’s hero.’’ grateful. He died doing what he loved, ular sovereignty, which was never consulted Ryan set an example for others and and his legacy will live on. about the convocation of the constituent As- will be remembered for his strong char- sembly, as ordered by the constitutional ar- Lt. Allan was a devoted citizen, son, ticle 347; acter. Let us always remember and husband, father, and friend, who loved CONSIDERING emulate the shining example this brave his children and his fellow brothers and In addition, the fraudulent election of July man set for us and honor his commit- sisters in blue. He loved his job as a 30th was held on the sidelines of inter- ment to serving his fellow citizens. Southport Police Officer, and no national guarantees and constitutional min- May God welcome Ryan home and give amount of gratitude can repay Lt. imum that must be presented in any demo- comfort to his family and friends. Allan or his loved ones for his sacrifice. cratic election, which shows the high despite

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00060 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.039 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4757 abstention in the irregular voting stations as a legal and exclusive representative of the President of the Na- admitted for this election, the President of Venezuelan people will take all the measures tional Assembly. the National Electoral Council announced a and actions directed to depose the National FREDDY GUEVARA CORTEZ; false call participation of eight million and Constituent Assembly as a power that is ille- First Vice President. eighty-nine thousand three hundred and gitimate and of fact to establish effectively DENNIS FERNANDEZ twenty (8,089,320) electors, making the com- the validity of the constitution of the SOLORZANO; mitted fraud even more evident; Bolivarian Republic of Venezuela. Second Vice President. CONSIDERING Fifth: Urge the citizen Luisa Ortega Diaz, JOSE IGNACIO GUE´ DEZ; in her responsibility of General Attorney of The Venezuelan people, in exercise of their Secretary. the Republic, to investigate at great length ´ right to resistance, made various peaceful JOSE LUIS CARTAYA; the criminal acts against the protesters, as protests during the day of July 30th, 2017, Subsecretary. well as the committed crimes that took with the deplorable balance of 16 people f place during the organization and in the killed, hundreds injured and many arrested electoral process on July 30th, 2017, and to THE GREAT AMERICAN ECLIPSE in an arbitrary manner, with the repression exercise the relevant actions against the of- which the regime of Nicolas Maduro has at- Mr. WYDEN. Mr. President, today I ficers and people that ordered and executed tended for trying to impose its fraudulent such crimes, with the purpose to make effec- wish to recognize the historic event of and illegitimate National Constituent As- tive the punitive, administrative, and dis- the Great American Eclipse that will sembly; ciplinary responsibilities of those who order cross the continental United States on CONSIDERING and executed the repressive acts against the August 21. That morning, the eclipse That the international community, like people and of those who participated in the will first pass over my home State of countries such as Argentina, Colombia, constitutional fraud of the National Con- Oregon, then sweep across the U.S., Spain, United States of America and Mexico, stituent Assembly. ending in South Carolina. Millions of as well as international organizations such Sixth: Urge to the Public Minister to over- people across Oregon and the country as the Organization of American States take investigations and formalities directed (OAS) and the European Parliament, ex- to establish the penal responsibility of all are planning on watching those few pressed their rejection on the fraudulent public officers and people evolved in the moments when the moon will cover the constituent process of Nicolas Maduro’s re- fraudulent process of the National Con- sun and everything will go dark. gime; stituent Assembly that aims to impose a It has been 99 years since a total CONSIDERING change that violates the constitution and solar eclipse has occurred across the That the fraudulent election of the illegit- changes the republican foundation of the Na- entire country, and whether someone is imate National Constituent Assembly of tion. 5 or 95, this may be the only time they Seventh: Grateful for the solidarity ex- July 30th, 2017, implies a major change in the will ever see a total eclipse. It is truly political and constitutional Venezuelan pressed by the International Community with regard to the people of Venezuela and in a once-in-a-lifetime event. scene, having to represent the definitive at- This solar eclipse is a rare occurrence tempt of restoring the dictatorship of totali- rejection of the fraudulent National Con- tarian court protected on the figure of the stituent Assembly, and for arranging nec- where the wonders of science will come National Constituent Assembly, which de- essary meetings to execute common actions right to the front doors of millions of mands the articulation of effective and im- of states committed to the universal defense people. That fact hasn’t been lost on mediate action orientated to deposing a des- of human rights and of the relevant Inter- schools and science organizations potic form of government, contributing to national Entities, so that through the admit- throughout Oregon. Educators from ted mechanisms of Public International the effective reestablishment of the Con- the coastal areas of the State to the stitution in Venezuela, in context of articles rights and thus contribute to depose the fraudulent and illegal National Constituent mountains of eastern Oregon have been 333 and 350 of the Constitution, with the working hard to use this eclipse as an democratic legitimacy derived from the pop- Assembly and to reestablish the effective va- ular consultation on July 16th and the sup- lidity of the Constitution of 1999. opportunity to engage students in the Eighth: Support to the people of Venezuela port of the international community com- areas of science, technology, engineer- in the exercise of the right to resist the des- mitted on the universal defense of human ing, and mathematics, commonly potism that the National Constituent As- rights and constitutional democracy. called STEM. sembly aims to impose. We support both the ACCORDING organized and planned actions that con- One of the best science museums in First: Confirm that all the acts related to tribute to depose such illegal Constituent the country, the Oregon Museum of the National Constituent Assembly includ- Assembly, and the execution of necessary ac- Science Industry, OMSI, has planned ing the supposed election effected on July tions to reestablish the validity of the Con- an amazing viewing party, with the 30th, 2017 must be unrecognized because it stitution of the Bolivarian Republic of Ven- hope of engaging folks of all ages in the was a process based on usurpation of the pop- ezuela that obeys the mandate of the Pop- science behind the eclipse. Oregon na- ular sovereignty and of the original Con- ular Consultation that took place on July tive Don Pettit, who is a NASA astro- stituent power that belongs exclusively to 16th, 2017. naut, will even be there to share his ex- the people of Venezuela. Likewise, we ratify Ninth: Ratify the people of Venezuela, the right to the resistance of the people of faithful to its republican tradition, to im- perience of viewing eclipses from the Venezuela against the fraudulent and illegal pugn all forms of despotic government that International Space Station. Over the National Constituent Assembly, as the offi- derived from the National Constituent As- years, OMSI has been a leader in get- cials and members of the armed forces must sembly, while the country is linked to the ting students excited about STEM do. Armed forces must disobey all the acts duty of obedience to such constituent and fields. I am so glad the museum is related to the fraudulent Constituent Assem- those who contribute to its installation oper- using this eclipse as yet another oppor- bly, and actively contribute to re-establish ation. The recognized authorities will be the tunity to get communities involved in the effective validity of the Constitution of only ones arising from free and democratic science. 1999. elections. Second: Unrecognized the election effected Tenth: Forward a copy of this agreement Universities throughout the State on July 30th, 2017 of the members of the to the Secretary-General and the Permanent are also doing their part to ensure stu- fraudulent and illegal National Constituent Council of the Organization of American dents and community members get the Assembly that was convened without a pop- States (OAS), the Organization of United Na- most out of the event. In Corvallis, Or- ular referendum, and against the peoples’ tions (UN) to the Inter-American Commis- egon State University is hosting a 3- will and in contrivance of article number 347 sion on human rights (IACHR) and the mem- day eclipse event, with astronomy ex- of the Constitution. bers of the diplomatic corps, specially to the hibits and a series of science lectures. I Third: Reject the massacre and aberrant representatives of those States that have crimes against the Venezuelans who in their spoken out without knowing about the elec- also understand that Portland State legal right to freedom of expression, of pro- tion of the National Constituent Assembly. University, with the help of NASA, will testing and resisting were demonstrating Tenth first: Give publicity to this agree- launch video cameras attached to high- their rejection to the fraudulent Constituent ment. altitude balloons, giving anyone the Assembly, and who were expressing soli- Given, signed and sealed in the Federal ability to tune in and watch a live darity to the parliamentarian body with the Legislative Palace, seat of the National As- stream of the eclipse. Programs like victims of repression, arrests, and family sembly of the Bolivarian Republic of Ven- these are so important because they members of the deceased, and with all the ezuela, in Caracas, the first day of August of Venezuelan people. two thousand seventeen. Year 207 of inde- make scientific events more accessible Fourth: Ratify the mandate of the people pendence and 158 of the Federation. to the younger generations. stated in the Popular Consultation on July JULIO ANDRES BORGES I also want to take a few moments 16th, 2017, by which, this National Assembly, JUNYENT; today to recognize the local leaders,

VerDate Sep 11 2014 06:34 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00061 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.055 S02AUPT1 S4758 CONGRESSIONAL RECORD — SENATE August 2, 2017 first responders, and the National WV; the ship’s wheel and binnacle are volved as citizens. They follow State Guard who are working tirelessly to on display at the Hampton Roads and national issues, always with an eye ensure that communities throughout Naval Museum. Her mast sits in front on how they affect their neighbors. the State enjoy the eclipse festivities of Oglebay Hall at West Virginia Uni- This dedication starts with com- safely. These public servants have been versity, and Interstate 470 in West Vir- mitted leadership. After achieving suc- a shining light in making sure Orego- ginia is named the ‘‘USS West Virginia cess in journalism and publishing in nians and visitors alike have the best Memorial Highway.’’ Philadelphia and New York City, Alan experience while viewing the solar The U.S. Navy resurrected the proud Baker returned home to Maine and, in eclipse. history of the 35th State’s moniker 1986, joined the Ellsworth American’s As the eclipse arcs across the coun- with a 1983 contract to build a Ship, management team, eventually pur- try and folks from the West Coast to Submarine, Ballistic, Nuclear, SSBN, chasing the newspaper. In this age of the East Coast don their eclipse glasses the 11th of an eventual 18 Ohio-class media consolidation, Mr. Baker strong- to look up at the darkened sun, it is submarines, otherwise to be known as ly believes that newspapers should be my sincere hope that it ignites a ray of the USS West Virginia, SSBN 736. She owned by individuals who are in touch passion in students throughout the was launched on October 14, 1989, spon- daily with the readers they serve. As a country to explore STEM fields more sored by Mrs. Erma Byrd, wife—and former member of the Maine State deeply. high school sweetheart—of the now Legislature, he is an effective voice for f late U.S. Senator Robert C. Byrd, of accountability and transparency in all West Virginia—the longest serving levels of government. THE USS ‘‘WEST VIRGINIA’’ Senator and the longest serving Mem- A former ‘‘Maine Journalist of the Mrs. CAPITO. Mr. President, I would ber in the history of the U.S. Con- Year,’’ Earl Brechlin has covered like to recognize the service of the first gress—and commissioned on October Mount Desert Island for more than 35 ship named for our Nation’s 35th 20, 1990. years, and he has been recognized with State—our only State born of war—the The USS West Virginia, SSBN 736 con- more than 100 awards for news, feature armored cruiser USS West Virginia. She ducts a sacred mission. It has often writing, and photography. His commit- was commissioned on February 23, 1905, been said that, if the U.S. Navy could ment to journalism is evident in his and served in both the Atlantic and Pa- only send one platform to sea, it is the election as president of both the Maine cific fleets. On two occasions, she de- SSBN that executes the most impor- and New England press associations. A ployed to Mexico to enforce U.S. diplo- tant mission: the mission of strategic Registered Maine Guide, Mr. Brechlin macy. In 1916, she was renamed the deterrence. is the author of nine books that reflect USS Huntington, in order to permit the Always at the tip of the spear, the his love for our State’s natural beauty, assignment of her old name to a new USS West Virginia conducts operations history, and character. battleship. in order to exploit the advantages of The Maine Seacoast Mission is a non- That new battleship—the second USS undersea operation. It can be deployed denominational, nonprofit organization West Virginia—was commissioned in De- up to 15 months at a time. As the sub- founded in 1905 to support island and cember 1923 and affectionately nick- mariner identity states: ‘‘We are elite, coastal communities in Downeast named the ‘‘Wee Vee.’’ In 1940, she selective and high performing. We op- Maine, and its boat, the Sunbeam V, moved to Hawaii and became part of erate forward at the tip of the spear. helps to connect people in those com- the U.S. Pacific Fleet. She was the This is the only survivable nuclear de- munities with essential services and youngest of all the battleships at Pearl terrent. Last bastion of master and with each other. Through their dedica- Harbor. During the attack on Pearl commander.’’ tion to the craft of journalism, Alan Harbor on December 7, 1941, the USS West Virginia is proud of the honor, Baker and Earl Brechlin have strength- West Virginia was moored outboard the courage, and commitment of the brave ened that support and those commu- USS Tennessee; as a result, the Ten- sailors who crew and have crewed the nity connections, and the Sunbeam nessee was not hit by a single torpedo, USS West Virginia, and we are eternally Award is a fitting recognition of their while the West Virginia was hit by nine grateful for the sacrifices that you and many contributions. torpedoes. your families make in service to the f Despite being mortally wounded by United States of America. shrapnel, the ship’s captain, Mervyn S. ‘‘Montani Semper Liberi.’’ 150TH ANNIVERSARY OF THE JACOB LEINENKUGEL BREWING Bennion, remained on the bridge order- f ing counterflooding of starboard com- COMPANY partments to prevent capsizing; for his TRIBUTE TO ALAN BAKER AND Mr. JOHNSON. Mr. President, today I actions, Captain Bennion post- EARL BRECHLIN wish to honor a true original, the humously received the Congressional Ms. COLLINS. Mr. President, in 2001, Jacob Leinenkugel Brewing Company, Medal of Honor. Captain Bennion’s ac- Maine’s legendary Ellsworth American on 150 years of brewing great beer in tions are regularly cited as the epitome newspaper celebrated its 150th year by Wisconsin’s North Woods. The of proper command under fire. launching a new enterprise, the Mount Leinenkugels were fairly typical Wis- Displaying a resilience befitting the Desert Islander, dedicated to covering consinites in the mid-1800s—German, people of her namesake, the USS West every aspect of life in a place of ex- immigrants, and lovers of beer. Jacob Virginia refused to stay sunk. She was traordinary beauty. It is a pleasure to Leinenkugel started in the business in pumped out and refloated on May 17, congratulate the two outstanding jour- 1867 after he and three brothers learned 1942, and sailed to Puget Sound Navy nalists who have guided the Islander the craft from their father, a brewer Yard for repairs. After being fully mod- since its inception, publisher Alan and distiller. Together, the ernized, she saw action in the invasion Baker and editor Earl Brechlin, for Leinenkugel family started four brew- of the Philippines, the Battle of Iwo being recognized with the 2017 Sun- eries, including the Spring Brewery, Jima, and the Battle of Okinawa, beam Award from the Maine Seacoast which eventually became Jacob among others. She was present in Mission. Leinenkugel Brewing. Tokyo Bay on September 2, 1945, for The recipient of numerous State and While the Leinenkugel family was the formal Japanese surrender. national awards for excellence, the typical, the brewery they started be- The USS West Virginia was decommis- Mount Desert Islander is a great exam- came far from ordinary. For a century sioned on January 9, 1947; her awards ple of the value provided by commu- and a half, the Jacob Leinenkugel included the American Defense Service nity newspapers. From Acadia Na- Brewing Company has put Chippewa Medal with ‘‘Fleet’’ clasp; the Asiatic- tional Park, local government, and Falls, WI, on the map and excellent Pacific Campaign Medal with five bat- businesses, to education, sports, and beer in the hands of people throughout tle stars; the World War II Victory the arts, the Islander’s dedicated staff Wisconsin and the country. Medal; and the Navy Occupation Medal writes the history of their commu- Walk into most any bar in the State with ‘‘Asia’’ clasp. An antiaircraft gun nities as it occurs. They keep people and there will be ‘‘Leinie’s’’ on tap. Go remains at City Park in Parkersburg, informed and help them be more in- to a backyard cookout or a Milwaukee

VerDate Sep 11 2014 06:34 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00062 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.032 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4759 Brewers tailgate on a hot summer’s ees: Jacob Leinenkugel and his part- Cause, a stewardship program aimed at day and there will Summer Shandy in ner, John Miller. Jacob brewed the preserving waterways by removing the cooler. Stop by a Wisconsin supper beer, and John delivered it. Their Ger- trash, debris, and invasive plant spe- club for dinner and odds are you or man brewing methods, combined with cies. They have held Canoes for a Cause someone at the table next to you will excellent grains grown in rich Wis- events in Milwaukee, Madison, Chi- be enjoying their fish fry with a Honey consin soil and the State’s pure water, cago, Denver, Minneapolis, and Cleve- Weiss. made Leinenkugel’s small brewery an land, often collecting more than 1,000 Leinenkugel Brewing is the seventh instant success. The hard-working lum- pounds of trash in a single day. oldest continuously operating brewery berjacks in the logging town of Chip- Today, C.J., Ellie, Matt, and Kirk in the country. This lengthy heritage pewa Falls were Jacob’s first loyal cus- Leinenkugel carry on the did endure trying moments. tomers. Word of Leinenkugel’s beer Leinenkugel’s legacy. They are the Leinenkugel’s survived Prohibition by spread quickly, and its popularity ex- sixth generation of Leinenkugels to producing soda, ginger ale, and a non- panded rapidly throughout Northern continue Jacob’s tradition of excel- alcoholic cereal beverage to stay in Wisconsin. lence, taking a small, local brewery business. Afterward, the brewer even- When Jacob passed away in 1899, run- and turning it into one of the most suc- tually grew into the fourth largest ning the company fell to his son-in- cessful breweries in the Nation. No craft brewer in the United States. law, Henry Casper, and then to his eld- matter how many employees or dis- The original brewery is still oper- est son, Matt, in 1907. Working along- tributors join the team, Leinenkugel’s ating, and its Leinie Lodge visitor cen- side his sisters and brothers-in-law, the will always remain a family company ter in Chippewa Falls welcomes 125,000 second generation of Leinenkugel’s that, to its core, defines what it means visitors annually, making it a top tour- leadership quickly took the company to be kind, hard-working Wisconsinites ist destination in northern Wisconsin. to new heights. and genuine Americans. Along with its original lager, The brewery experienced its first f Leinenkugel’s now brews 24 other major test with the passage of Prohibi- 130TH ANNIVERSARY OF BAR beers, with offerings for every taste tion in 1919. While many American HARBOR BANK & TRUST and season, including a special German breweries cut their losses and closed Mr. KING. Mr. President, today I Marzen-style lager to celebrate the shop during this period, Leinenkugel’s wish to commemorate the 130th anni- family’s roots and the brewery’s 150th adapted to the new American reality versary of Bar Harbor Bank & Trust. anniversary. and began brewing Leino, a non- Based in Bar Harbor, ME, Bar Harbor Leinenkugel Brewing is more than alcoholic version of their popular beer. Bank & Trust now has 14 branches in beer. Leinenkugel’s is a Wisconsin in- Unfortunately, Leino was no match for Maine and 35 branches in New Hamp- stitution that touches the lives of peo- the real thing and was soon discon- shire and Vermont. Known for sup- ple across the State—even those who tinued. Thanks to quick thinking, they porting and understanding the unique have never lifted a pint. The brewery’s pivoted once again and began bottling people, organizations, and culture of Canoes for a Cause outreach program soda water. By the end of Prohibition, northern New England, Bar Harbor has provided education and resources Leinenkugel’s was the largest bottler Bank & Trust has not only achieved a to help improve and protect Wisconsin of soda water in the area. strong reputation for providing quality After the repeal of Prohibition, Matt springs and waterways. Generations of service, but it has also cultivated em- Leinkugel’s wife, Katherine, and his the Leinenkugel family have served ployees who are dedicated to bettering our country in the military and other sister, Rose, mortgaged their homes to their communities. civic capacities. That tradition con- finance updates to the brewery’s equip- Since its founding in 1887, Bar Harbor tinues today as former Marine Corps ment to save the company. Thanks to Bank & Trust has fostered the personal captain and Leinenkugel Brewing the resourcefulness of these women, and professional growth of its employ- president Jake Leinenkugel serves as a the Leinenkugel family was able to re- ees while serving its customers with senior White House adviser for the De- store the brewery to its pre-Prohibi- the highest level of care and concern. partment of Veterans Affairs. tion glory. Leinenkugel’s expanded yet Over the years, Bar Harbor Bank & Six generations have taken a family again in the mid-20th century to the Trust has expanded to New Hampshire- from the North Woods of Wisconsin to greater Midwest area and developed based subsidiaries: McCrillis & Elredge the refrigerators of beer lovers in all 50 new varieties of beer that would meet Insurance, Inc., and Charter Trust States while maintaining its Wisconsin the diverse needs of its newest cus- Company. It recently acquired Lake roots and cherishing its German herit- tomers. Sunapee Bank to make it one of the age. I join my fellow Wisconsinites in In 1988, the Miller Brewing Company largest community banks in New Eng- raising a glass in appreciation for the purchased Leinenkugel’s, allowing the land. It been recognized as a leading last 150 years and hoping for many brewery to distribute products across bank nationwide and ranked among the more to come. the country. Today the brewery is an best places to work in ME. Ms. BALDWIN. Mr. President, today industry leader that produces 25 dif- Bar Harbor Bank & Trust has dem- I rise to recognize the Jacob ferent styles of beer. For every 10 onstrated a commitment to supporting Leinenkugel Brewing Company on shandy-style beers consumed in the the communities it serves. Each year, their 150th anniversary. I am so pleased United States, nine are produced by its employees volunteer thousands of to honor this great Wisconsin com- Leinenkugel’s. hours to local community organiza- pany. Despite their national success, the tions. This commitment is sustained Throughout its history, family has Leinenkugels have never forgotten by their volunteer pay program that always been at the core of the their Wisconsin roots or their commit- allows employees to get paid time off Leinenkugel business. The family’s ment to their hometown of Chippewa for volunteering each month to local brewing tradition began well before Falls, WI. Jake Leinenkugel, who led causes they are passionate about. Fur- they came to America. Jacob’s father, the company until his retirement in thermore, it allows them to contribute Mathais, was a brewer and 2015, said he and his wife, Peg, will al- money from their paychecks to the brandymaker from Meckenheim, Ger- ways live in Chippewa Falls. The cou- Bank’s Community Commitment pro- many, who settled with his family in ple was named ‘‘Chippewa Valley Phi- gram each month, and with every do- Sauk City, WI. Mathais passed his craft lanthropists of the Year’’ in 2007 for nation matched by the bank, the pro- on to his four sons who, in turn, opened their ongoing contributions of time gram donates over thousands of dollars their own breweries throughout Wis- and money to local causes. annually to local nonprofit organiza- consin. Their passion for brewing qual- The Leinenkugel family has also tions, including Maine Veteran’s ity beer remains at the heart of the maintained a strong commitment to Project, Girls and Boys State, Knox Leinenkugel family 150 years later. the conservation of natural resources, County Homeless Coalition, and dozens While it is now the fourth-largest particularly the freshwater that is a more. craft brewer in the United States, the key component in Leinenkugel’s prod- In addition to volunteerism, Bar Har- nascent company had only two employ- ucts. The family created Canoes for a bor bank & Trust employees actively

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00063 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.041 S02AUPT1 S4760 CONGRESSIONAL RECORD — SENATE August 2, 2017 participate in many community fund- in the world’s largest lobster cooker Marion contributed to CBO’s work in raisers, such as the Annual Hancock for the thousands of hungry attendees. ways that went well beyond her admin- Relay for Life for the American Cancer While you may no longer be able to get istrative responsibilities. She routinely Society. The bank also hosts an annual ‘‘all the lobster you can eat for $1,’’ the took the lead to make sure that key charity golf tournament that raises festival promises to have more than life events of staff—such as birthdays, money for a local organization. This enough lobster to go around. weddings, and births—were celebrated, year, the tournament raised money Year-in and year-out, the combined and she was often the first person oth- that was donated to the Acadia Family effort of more than a thousand volun- ers in the organization consulted when Center to sponsor a year’s worth of teers generously donate their time they needed assistance with planning treatment for two individuals battling makes the festival possible. Volunteers and organizing events. In addition, her substance abuse. Additionally, Bar are committed to improving and show- contributions to the charitable works Harbor Bank & Trust employees teach casing midcoast Maine communities to of the agency were well-known and ap- local children lessons about saving the thousands of festival-goers that preciated. Marion is extremely warm, money through the ABA’s Teach Chil- come from different parts of Maine, generous, and giving—she was always dren to Save Day and explain how to from across the country and around there to provide support, encourage- use credit wisely to teenagers in the the world. Not only do they donate ment, and someone to talk to. Her con- community. In 2016 alone, this bank their time and effort, but they also do- tribution to the working environment provided over 450 children with lessons nate all profits of the festival to Maine at CBO was beyond measure, and she communities to provide needed support in savings education. will be greatly missed. to local institutions such as food pan- I wish to join the communities all f around Maine, New Hampshire, and tries, community service groups, emer- Vermont in congratulating Bar Harbor gency services, and college scholar- TRIBUTE TO JEFFREY HOLLAND Bank & Trust for this remarkable ships. Mr. ENZI. Mr. President, the Senate The Maine Lobster Festival is recog- achievement on its 130th anniversary. I Budget Committee wishes to honor and nized nationwide as one of the best look forward to following its continued recognize Jeffrey Holland on his retire- events in the country, and this distinc- growth and service, and I applaud the ment after 26 years of distinguished tion could not be bestowed on a more bank for its dedication to its employ- service to the Congress with the Con- deserving enterprise. I wish to join the gressional Budget Office. Jeff is highly ees, customers, and local communities. greater Rockland community, as well f regarded by Republicans and Demo- as the State of Maine, in congratu- crats on both sides of the Capitol for lating the Maine Lobster Festival on 70TH ANNIVERSARY OF THE his deep knowledge of the budget proc- its 70th year of being an historic and MAINE LOBSTER FESTIVAL ess and his commitment to the non- cherished Maine institution. Mr. KING. Mr. President, today I partisan role that CBO plays in the wish to recognize the Maine Lobster f budget process. Festival on its 70th anniversary. On TRIBUTE TO MARION CURRY Jeff arrived at CBO in 1991 soon after this date, the people of Maine celebrate Mr. ENZI. Mr. President, the Senate graduation from Carnegie Mellon Uni- our rich history in the valuable lobster Budget Committee wishes to honor and versity’s Heinz School of Public Policy trade, as well as the continuing com- recognize Marion Curry on her retire- with a master’s degree in public policy mitment by our coastal communities ment from the Congressional Budget and management. He joined the projec- to support and perpetuate our great Office. Marion has worked in the budg- tions unit in the budget analysis divi- maritime heritage. et analysis division of the Congres- sion, which is responsible for preparing Since 1947, The Maine Lobster Fes- sional Budget Office in various capac- projections of Federal spending, def- tival has provided the people of Maine ities for more than 38 years and has icit, debt, and other data related to the and tourists with exciting events, en- been a full-time employee at CBO since Federal budget, as well as providing tertainment, and Maine seafood. The 1987. During that time, she served as ongoing support to Congress. festival emerged out of a community- the administrative assistant for the In 1999, Jeff became chief of the pro- based effort at reviving summer activi- projections unit, and over the past sev- jections unit, and for the past 18 years, ties that Camden, ME, established eral years, she expanded her respon- he has successfully overseen the pro- prior to World War II. A small group of sibilities to also encompass the health duction of multiple reports on the citizens and summer visitors came to- systems and Medicare unit, as well as Budget and Economic Outlook, annual gether to revel in their coastal marine the low-income health programs and analyses of the President’s budget re- community. Their small gathering, prescription drugs unit. quest, and also several reports on se- which lost money in its first year, During her long tenure at CBO, Mar- questration, the debt ceiling, national moved to Rockland the following year ion has skillfully carried out a variety income, and product accounts, and the and immediately became an annual of tasks—carefully checking cost esti- Troubled Asset Relief Program. staple of the coastal area’s summer mates as she produced drafts, ensuring Through all of these tasks, he has been schedule, creating the Maine Lobster that timesheets were done correctly, the steady hand of the projections unit, Festival to operate as a nonprofit cor- directing callers to the appropriate generous with his time and knowledge, poration that is responsible for the fes- person, and in general assuring that and highly responsive to questions and tival to this day. administrative matters were taken requests for data or information from This nearly weeklong engagement in care of without a hitch. Such duties the staff of the Budget Committee. His August is attended by both inter- have undergone many changes over the persistence, attention to detail, and re- nationally recognized as well as local years—from using telephones as the liably clear thinking have been vital to musicians and entertainers, who fill primary method of contact, typing ta- the smooth functioning of the budget the concert stage with enthralling per- bles by hand, and sending paper copies analysis division. Senate staff and CBO formances. A midway provides excite- of documents, to the current approach colleagues have come to depend on him ment for children of all ages. King Nep- of using email as the primary method for his sage advice and deep under- tune and his court attend the event of contact, transferring spreadsheets to standing of the budget laws. every year and a highlight is the the editorial staff for producing tables, In addition, Jeff has often lent his ex- crowning of the Maine Sea Goddess. and sending PDFs of documents with pertise to legislative branches of other The festival also boasts a wide range of supplemental data posted on the web. countries as they seek to develop their Maine artistry, from craftsmen to Through all of those changes, Marion own capacity for nonpartisan budget painters, as well as one of the region’s readily adapted to new technology and analysis. He is a sought-after explainer largest and most popular parades. In procedures and carried out her respon- of the Federal budget process to stu- addition, there is often a U.S. Navy sibilities with good humor, profes- dents visiting our Nation’s Capital. In ship that offers unique tour opportuni- sionalism, a giving spirit, and a dedica- short, Jeff’s expertise, knowledge, and ties to festival-goers. As the highlight, tion to serving the Congress and the generosity of time and spirit will be there are fresh lobster dinners prepared public. sorely missed. We wish him well as he

VerDate Sep 11 2014 06:34 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00064 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.042 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4761 moves on after years of outstanding at events many times to talk about the and District of Columbia AFL–CIO. He service to the Congress. We are grate- importance of Medicare. I interviewed was elected to serve as president of the ful for that service, and we wish him Belle in the summer of 2015, marking Metropolitan Baltimore AFL–CIO the best in the years to come. the 50th anniversary of the passage of Council in 1987, and he also served as f Medicare and Medicaid. She told me first vice president of the Maryland she was thrilled when it passed because State and DC AFL–CIO. ADDITIONAL STATEMENTS she remember how poor older people Ernie has held many other leadership were when she was growing up—‘‘They positions over the course of his illus- trious career. For instance, he chaired REMEMBERING BELLE LIKOVER didn’t have Medicare, they ended up in poorhouses,’’ she told me. And she the Young Trade Unionists, which was ∑ Mr. BROWN. Mr. President, this added, ‘‘Do you know how many people created to bring younger people into week, the city I call home lost a great can’t wait until they’re 65 to get cov- the labor movement, and he served as Ohioan, and Connie and I lost a friend, ered by Medicare?’’ president of the Union Label & Service Belle Likover of Shaker Heights. Belle Just last fall, she joined us on a call Trades Council, which promoted the passed away at age 97, and over her ex- with Ohio reporters to talk about how purchase of union services and prod- traordinary life, she saw the creation devastating it would be to raise the re- ucts. Ernie has also served on the Bal- of our country’s greatest social insur- tirement age. That was Belle Likover— timore Workforce Investment Board, ance programs: Social Security, Medi- an activist and advocate, full of com- the Maryland Transportation Commis- care, and Medicaid—and fought to pro- passion but never bashful, all the way sion, the Maryland Workers Compensa- tect those lifelines for American sen- through age 97. Our family’s thoughts tion Commission, and the Maryland iors. and prayers are with Belle’s loved ones. Racing Commission. As president of the Metropolitan Bal- Ms. Likover was born the same year We will miss her, and we will strive to timore Council, Ernie established as my mother and grew up in Beaver carry on her advocacy for Ohio sen- monthly meetings with the mayor of Falls, PA. She remembered her child- iors.∑ hood as a happy one, with one big ex- Baltimore City to encourage better f ception: the Great Depression. In an communications and collaboration be- interview several years ago, she talked TRIBUTE TO ERNEST ‘‘ERNIE’’ tween the city and the unions. The about the lasting effects those memo- GRECCO committee consists of all city unions ries had on her, saying, ‘‘We saw every- ∑ Mr. CARDIN. Mr. President, today I and a representative from the building body else suffer. I remember the shan- would like to congratulate a dear trades. Ernie also championed the tytowns. I remember people living in friend of mine, Mr. Ernest ‘‘Ernie’’ council’s community services division. what used to be packing crates. There Grecco, for 55 years of dedicated serv- The community services division pro- was a constant stream of people who ice to the labor movement and to vides assistance to working people came to our backdoor for food. My working men and women and their through information and referral advo- mother never turned anybody away.’’ families in the Baltimore–Washington cacy to help them solve personal and family crises. The services include edu- Those experiences would shape her metropolitan area and across the Na- cation and training for union peer activism throughout her life. In high tion. Ernie recently retired after serv- counselors; Baltimore Works, a job school and later in college, at the Ohio ing for 20 years as president of the Met- placement program for dislocated State University, she said she was ropolitan Baltimore AFL–CIO Council, workers; and Project LEAP, an adult ‘‘never bashful about speaking out.’’ which covers Baltimore City and Anne She joined the high school varsity de- education literacy program. Arundel, Baltimore, Carroll, Cecil, It should come as no surprise that bate team as a sophomore, as the only Harford, and Howard Counties. For the Ernie has received numerous awards girl on the team, and learned how to last 15 years, he also served as sec- for his indefatigable service to people. marshal an argument. She told an retary on the board of directors of the He has the distinction of receiving not interviewer that, ‘‘Every position of United Way of Central Maryland. one, but two, national awards for com- leadership I’ve had, I owe to that de- Ernie’s vocation and his avocation munity service, the Samuel Gompers bate coach.’’ have been to make life better for other Award from the American Red Cross in In college, she put that training to people. There is an old saying, ‘‘You 1991 and the Joseph A. Beirne Award use, first getting involved in political make a living by what you get; you from United Way of America in 1999. causes in 1937, when she and a friend make a life by what you give.’’ Ernie Last year, United Way of Central helped organize an antifascist group at has given so much to so many for so Maryland gave Ernie its Philip H. Van Ohio State. They saw what was hap- long. It is why I feel privileged and Gelder Award for Community Services. pening in Germany and across Europe proud to call him my friend. In 1995, the Baltimore City Fire Fight- and how dangerous that was for the Ernie became involved in the labor ers Local 734 and Baltimore City Fire world. movement in 1962 while he was working Officers Local 964 created the Grecco Growing up in that time of turmoil at Calvert Distilleries. He was a mem- Labor Award to be given to a fire- and as a woman at a time when her ber of Distillery Workers Union Local fighter who ‘‘best exemplifies the con- abilities would be constantly ques- 34 and was elected shop steward. He tinuing and complex efforts of the local tioned, Belle faced setbacks. As a child, served as shop steward until 1970, when union membership to build the rela- she asked for chemistry sets instead of he was elected secretary-treasurer of tionship between labor and manage- dolls, but in college, a chemistry pro- Local 34–D. He also served as trustee of ment.’’ fessor told her, ‘‘If you want a Ph.D., the Distillery Workers International During Ernie’s career, he has been you better marry one.’’ Her first hus- Union. much loved and respected not just in band laid down his life for our country In 1973, then-President Nick Fornaro Baltimore, but in Annapolis and across during World War II, leaving Ms. of the Baltimore Central Labor Council the State of Maryland for his steadfast Likover with a newborn daughter to hired Ernie as a job placement officer commitment to the labor movement raise. for the Institutional Training Project. and working people. He is, understand- She published papers without the In this capacity, Ernie was responsible ably, an avid Orioles, Ravens, and Ph.D. that her male peers had and for helping find jobs for hundreds of horse-racing fan. His retirement is bit- worked at the Cleveland Jewish Com- men and women housed at the Jessup tersweet because his beloved wife Doro- munity Center’s senior department, and Hagerstown Penal Institutions who thy—‘‘Dot’’—recently passed away, but where she saw what a difference Social were qualified for work-release status. I know Ernie will spend much of his Security made in the lives of the elder- In 1976, he became the director of the time with his daughter, Nina Grecco ly—and later how Medicaid and Medi- Metropolitan Baltimore AFL–CIO Dukes, and his son, Gary, and Gary’s care would change their lives. She went Council’s Committee on Political Edu- wife, Kelly, and his grandchildren, Ash- to grad school on a JCC scholarship. cation, COPE. He served in this posi- ley, Adam, Katy, and Ben. Throughout the years, she never tion until 1983 when he became the I have relied on Ernie’s sage counsel ceased in her activism. She joined me COP director for the Maryland State on labor matters and other issues over

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00065 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.035 S02AUPT1 S4762 CONGRESSIONAL RECORD — SENATE August 2, 2017 the years, and I treasure our friend- —Katherine Ann, Taylor Douglas, Phil- job done and doing it right. Although ship. I have been a better and more ef- lip Olsen, Jan Elizabeth, Kenneth he waded into many a difficult polit- fective legislator because of Ernie’s Wright, Steven Edward, and Gregory ical problem, he resisted the urge to friendship and advice for which I am Curtis. Their home was filled with love, become a politician. If there was an truly grateful. On behalf of the entire education, and adventure. ounce of self-promotion in Dan Fauske, U.S. Senate, I congratulate Ernie on From a personal perspective, there I never saw it. Dan was one of the most his accomplishments and his well-de- has never been a better child psycholo- grounded people I have ever met, and served retirement, but knowing Ernie gist or wiser parent and aunt. Betty is that was the key to his influence and as I do, he will find new ways to be of my mother Melba’s youngest sister— effectiveness. service to others; it is simply at the my beloved Aunt Betty, who was a sec- Dan Fauske, like so many builders of core of who he is.∑ ond mother to me. She understood Alaska in the half century after State- f teenagers in a unique manner and hood, adopted our State as his home. knew just when to encourage me at Dan was born in Fargo on December 13, TRIBUTE TO BETTY JENEL OLSEN those times when young people need to 1950. He relocated to Alaska in 1974 CARR hear advice from someone who loves after serving in the Army—not to the ∑ Mr. CRAPO. Mr. President, today I them and is not a parent. Growing up, big city, but to Barrow, now called wish to mark a wonderful occasion, a I always knew I would find welcoming Utqiagvik, the northernmost American birthday that many do not live to cele- arms and a warm shoulder just a few city. A place where the first language brate. Today we honor the 95th birth- blocks from my home. Aunt Betty un- was then and remains today Inupiaq. day and wonderful life of Betty Jenel derstood that, ultimately, love and the His older brother, Dave, was a teacher Olsen Carr, born in Kimberly, ID, on relationship with our loved ones was in the village. Dan worked construc- August 2, 1922. Her early life was very more important than anything else, tion and delivered fresh water, and he much what you would expect from and she epitomized that with her ac- made himself part of the community. rural Idaho in the 1920s, and in many ceptance and encouragement of even Elise Patkotak remembers him as one ways, rural life there now still has the craziest ideas. A few years ago, I who approached the world as if every- some of these echoes of a strong work was delighted to show her around the one were a potential friend. Dan built a ethic and family values. U.S. Capitol when she made the long dog ramp to help Elise get her handi- Betty grew up with seven siblings in trip from Idaho to Washington, DC. A capped dog into the house. This is just a family that learned self-sufficiency treasured item on display in my per- one example of the many random acts and self-reliance on an 80-acre farm. sonal office is a photo with her from of kindness for which Dan was known. Edith, Andy, Lamoin, Melba, Phil, that trip. Bridging the cross-cultural divide, his Vera, Nina, and Betty lived cozily to- Today Betty, the lifelong lover of kindness was reciprocated in the com- gether with their parents, Hannah reading, is as sharp as ever. At 95, she munity. Marie Sandberg and Neils Albert Olsen, remains active, interested, and in- Dan left Alaska to study for an MBA in a small, white wooden farmhouse volved. She races through the cross- at Gonzaga University in Spokane, WA, that had no electricity or running word puzzle, tends her garden and but it was a temporary absence. water when Betty was a child. How- great-grandkids, and never misses exer- Utqiagvik was Dan’s home, and upon ever, the home did have a black pot- cise class or bridge club. She recently graduation, Dan went to work for the belly cast iron stove that kept every- went underwater in a diving bell in North Slope Borough. He was chief fi- one warm and fed. Florida. I am privileged to claim her as nancial officer and chief administra- Education figured prominently in part of my family and honored to rec- tive officer. During his tenure, he pur- Betty’s goals, as she graduated at the ognize her longevity as an Idahoan. sued a vigorous capital construction top of her Kimberly High School class, Happy, happy birthday.∑ program which brought water and even though she skipped her final year f sewer to many of the North Slope vil- of high school to start college. She fos- lages. tered her love of reading through edit- REMEMBERING DAN FAUSKE In 1995, Dan moved his family to An- ing the school newspaper. She also ∑ Ms. MURKOWSKI. Mr. President, chorage. He was named chief executive played flute in the marching band and, Alaskans will gather on August 9 to officer of the Alaska Housing Finance improbably, at just 5 feet, 4 inches tall, celebrate the life of Dan Fauske, a pub- Corporation, AHFC. John Bitney, then played forward on the girls basketball lic servant extraordinaire, who lost his a legislative staffer, remembers the team. She headed off to college at what battle with cancer in April. Upon day that he and the legislative auditor was then called the Southern Branch of learning of Dan’s passing, Representa- presented a bill in committee to liq- the University of Idaho—now Idaho tive Mike Chennault, four-term Speak- uidate AHFC. Just when the com- State University—and studied jour- er of the Alaska House of Representa- mittee was about to move the bill, a nalism, but most importantly, she fol- tives described Dan as ‘‘Superman.’’ In man ventures forward from the audi- lowed through on something she said in Mike’s words, ‘‘Dan Fauske leaped tall ence, announces that he is the CEO of high school. She had been looking buildings in a single bound. Like Su- AHFC, and it is his second day on the through her older sister’s college year- perman, there was not a challenge he job. He asked the committee to allow book and spotted the photo of a hand- couldn’t take on.’’ him to pursue a turnaround of the some young man. She declared, ‘‘When Dan was a dear friend of mine, and agency—and, boy, were we lucky that I get to college, I am going to go out his family is part of our extended fam- the committee agreed. with that guy.’’ She did indeed—she ily in the Murkowski office. Dan’s son, Over the next 18 years, Dan would met and married Taylor Henry Carr a D.J., who now serves as director of gov- not only rescue AHFC from its finan- couple of years into college. Taylor ernment and external affairs for the cial difficulties, but mold it into one of served 3 years in World War II, and a North Slope Borough, helped open my the most respected State housing agen- family treasure is the love letters the Washington office in 2003 as a staff as- cies in the Nation. During his tenure, two sent to each other during that dif- sistant. D.J. subsequently married AHFC pioneered its weatherization and ficult time that they were separated by Gretchen Wieman, a legislative cor- energy rebate program, which helped his wartime service. respondent in my office during that pe- Alaskan families survive the challenge When Taylor returned home, he com- riod. of high energy costs in the frozen pleted his education at the medical I counted on Dan for advice and North. He issued more than $7.5 billion school at the University of Utah with counsel on important public policy in bonds, led AFHC to avoid the the help of the GI bill and became a issues affecting Alaska, as did many subprime mortgage collapse and re- surgeon. Betty and he raised their others in the State. His integrity and turned more than $1.9 billion back to seven children in Idaho Falls, ID. Each wisdom were unsurpassed, but Dan’s the State of Alaska through cash of those children has become remark- greatest attribute was perhaps his hu- transfers, capital projects, and debt able in their own right, contributing to mility. He was known as a straight service payments. The AHFC building their communities, States, and country shooter; one who was about getting the has been renamed the ‘‘Daniel R.

VerDate Sep 11 2014 06:34 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00066 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.052 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4763 Fauske Building’’ by the Alaska Legis- company in 1959, eventually becoming before he finally came up with a way to lature in honor of his many accom- the sole owner in 1972. Jerry’s son, Gale test historic lead levels.’’ He made plishments. Wilson, is the current president of the powerful adversaries in the lead indus- Dan was so successful at AHFC, the company, and his son, Keith White, try, but true to his research, Dr. Alaska Legislature asked him to take serves as vice president. The Wilson’s Needleman found new and inventive on a second duty, that of exploring the legacy of promoting a strong work ways to prove the toxic effects of lead feasibility of constructing a small di- ethic coupled with strict safety re- exposure. ameter pipeline to bring natural gas quirements has built the company into As a researcher at Temple Univer- from the North Slope to serve Alas- a premier helicopter business. In 1968, sity, he developed the ‘‘Tooth Fairy’’ kans. In 2013, he left his job at AHFC to Hillcrest became the first certified Bell approach: a method to test children’s pursue this ‘‘second job’’ full time as customer service facility in Idaho, and baby teeth for lead exposure levels. executive director of the Alaska Gas- 1 year later, in 1969, they became an This method led to pioneering research line Development Corporation, AGDC. approved FAA repair station. Their that found that Black children living He served in that role until November main focus, however, is aerial fire- in cities had lead levels five times 2015. fighting. Whether they are trans- higher than suburban, White children. At AGDC, Dan brought the same porting firefighters to remote areas or In the words of Herb’s son, ‘‘He just focus to the position he had to every dropping hundreds of gallons of water couldn’t tolerate injustice and could other one he had held in his distin- on a raging fire, Hillcrest prides itself not stop seeking the truth.’’ The re- guished career: serving Alaskans. For on protecting communities from dan- sults of Herb’s hard work and his dedi- Dan, AGDC’s mission wasn’t so much gerous wildfires. In fact, they have cation to seeking the truth today reach about commercializing Alaska’s gas as fought fires in all of the lower 48 States from the halls of science to the apart- it was delivering energy to Alaskans. during their 60-plus years of experi- ments of inner cities. His focus on delivering energy relief ence. On top of aerial firefighting, Hill- I got to see his determination first and security drove the State’s efforts crest flies for power and timber compa- hand, working alongside him in fight- and resulted in AGDC joining the inte- nies, photographers, videographers, and ing the lead paint industry in Rhode Is- grated effort to build Alaska LNG as even fish planters. Their comprehen- land. When I was confronting the lead the entity focused on delivering gas to sive background in a variety of indus- industry, over 35,000 Rhode Island chil- Alaskans. tries, dedication to operational safety, dren under the age of 6 had elevated Whether it was building water sys- and commitment to strict ethical levels of lead in their systems. His re- tems on the North Slope, developing standards continue to keep this family- search was instrumental in the fight housing across the State, or delivering owned business busy around the clock. for the health of Rhode Island’s chil- energy, Dan did it for Alaskans first. Hillcrest has always put safety first, dren. I am deeply grateful for Herbert’s That was what we loved about him, he and in 2015 and 2016, they were re- help in my home State, and I know saw policy not at the 50,000-foot level warded for their efforts. Hillcrest Rhode Island families are grateful as but in the face, life, and experience of achieved the necessary requirements well. every person he worked with and for the International Standard for America has lost a beloved pediatri- served. Business Aircraft Operations, IS-BAO, cian, psychiatrist, and brilliant sci- Dependable, trusted, respected—the Stage I registration by implementing a entist. I offer my condolences to the consummate ‘‘go to’’ guy—all of these safety management system, SMS, in Needleman family and to the many phrases are used to describe Dan 2015 and Stage II registration in 2016. people he taught and mentored through Fauske. He believed in Alaska. He be- This safety standard acknowledges the the years. He lives on as a lasting les- lieved in Alaskans. Like all great Alas- company’s efforts to improve their son in the power of science to help oth- kans, he believed anything could be safety risk profile and operating effi- ers.∑ done, but what earned him our unwav- ciency. Hillcrest was one of the first f ering respect is that he followed rotary-wing-only operators to achieve through and got it done. the IS-BAO Stage II. MESSAGES FROM THE PRESIDENT Dan Fauske will long be remembered The future is bright for Hillcrest Air- Messages from the President of the as a true leader who walked with the craft Company as they continue to ex- United States were communicated to people and a key figure in Alaska his- pand their business. Just a couple of the Senate by Ms. Ridgway, one of his tory of the post-Statehood era.∑ months ago in June, Hillcrest opened secretaries. f their very own fixed base operation, f FBO, at the Lewiston-Nez Perce Coun- RECOGNIZING HILLCREST EXECUTIVE MESSAGES REFERRED ty Airport. I would like to congratu- AIRCRAFT COMPANY late Gale Wilson and his family, along In executive session the Presiding Of- ∑ Mr. RISCH. Mr. President, today I with all of the employees at Hillcrest, ficer laid before the Senate messages would like to recognize an outstanding for the hard work they do in trying from the President of the United small business located in my home conditions while still keeping their States submitting sundry nominations State of Idaho. As many of my col- commitment to safety. I wish the best and a withdrawal which were referred leagues in the Western Caucus can tell for Hillcrest Aircraft Company, and I to the appropriate committees. you, catastrophic wildfires are a cause am confident that they will continue (The messages received today are for major concern and costs for large to keep Idahoans and Americans safe.∑ printed at the end of the Senate swathes of the West, particularly in f proceedings.) the summer months. This month’s f small business has found their spe- REMEMBERING HERBERT cialty in helping to control these large NEEDLEMAN MESSAGE FROM THE HOUSE wildfires in a safe and efficient man- ∑ Mr. WHITEHOUSE. Mr. President, I At 3:31 p.m., a message from the ner. As chairman of the Senate Com- recently received the sad news that Dr. House of Representatives, delivered by mittee on Small Business and Entre- Herbert L. Needleman has passed away. Mr. Novotny, one of its reading clerks, preneurship, I am pleased to honor With Herbert’s passing, we lost a great announced that pursuant to 10 U.S.C. Hillcrest Aircraft Company as the U.S. man—and the scientific community 4355(a), and the order of the House of Senate Small Business of the Month lost one of its best. January 3, 2017, the Speaker appoints for August 2017. In the 1970s, Herb undertook the following Member on the part of Hillcrest Aircraft Company is based groundbreaking studies that revealed the House of Representatives to the out of Lewiston, ID, and is a utility the dangers of lead exposure in chil- Board of Visitors to the United States helicopter company with a broad spec- dren. According to the Pittsburgh Ga- Military Academy: Mr. WOMACK of Ar- trum of work. Hillcrest Aircraft Com- zette, Herb ‘‘had been thinking about kansas. pany was founded by local pilots in the impact lead had on children’s cog- The message also announced that 1946. Jerry Wilson partnered with the nitive abilities for nearly two decades pursuant to 44 U.S.C. 2702 and the order

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00067 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.053 S02AUPT1 S4764 CONGRESSIONAL RECORD — SENATE August 2, 2017 of the House of January 3, 2017, the partment of Health and Human Services, Whereas, the Twenty-ninth Legislature in- Speaker appoints the following indi- transmitting, pursuant to law, the report of tends that this continuing application shall vidual on the part of the House of Rep- a rule entitled ‘‘Food Labeling of Standard be considered with the applications that have been adopted by the 2013–2014 Vermont resentatives to the Advisory Com- Menu Items in Restaurants and Similar Re- tail Food Establishments; Extension of Com- Legislature, the 2013–2014 California Legisla- mittee on the Records of Congress: Ms. pliance Date; Extension of Comment Period; ture, the Ninety-eighth Illinois General As- Lori Schwartz of Omaha, Nebraska. Correction’’ ((RIN0910–ZA48) (Docket No. sembly, the 2014–2015 New Jersey Legisla- The message further announced that FDA–2011–F–0172)) received in the Office of ture, and the 2015–2016 Rhode Island Legisla- pursuant to section 114(b) of the John the President of the Senate on July 31, 2017; ture, as well as all applications that are sub- C. Stennis Center for Public Service to the Committee on Health, Education, sequently adopted until two-thirds of the Training and Development Act (2 Labor, and Pensions. several states have applied for, and Congress has convened, a convention for proposing U.S.C. 1103), and the order of the House EC–2460. A communication from the Acting Assistant Attorney General, Office of Legis- amendments to restore free and fair elec- of January 3, 2017, the Speaker ap- lative Affairs, Department of Justice, trans- tions: Now, therefore, be it points the following individual on the mitting, pursuant to law, a report entitled Resolved, By the House of Representatives part of the House of Representatives to ‘‘Uniformed Services Employment and Re- of the Twenty-ninth Legislature of the State the Board of Trustees for the John C. employment Rights Act of 1994 (USERRA) of Hawaii, Regular Session of 2017, the Sen- Stennis Center for Public Service Quarterly Report to Congress; Third Quarter ate concurring, that the people of the State of Hawaii speaking through its Legislature, Training and Development for a term of Fiscal Year 2017’’; to the Committee on Veterans’ Affairs. hereby submit an application to the United of 6 years: Mrs. MARTHA ROBY of Mont- States Congress to restore free and fair elec- gomery, Alabama. EC–2461. A communication from the Sec- retary of the Commission, Bureau of Con- tions as described herein; and be it further Resolved, That certified copies of this Con- The message also announced that sumer Protection, Federal Trade Commis- current Resolution be transmitted to the pursuant to section 214(a) of the Help sion, transmitting, pursuant to law, the re- President of the United States; Vice Presi- America Vote Act of 2002 (52 U.S.C. port of a rule entitled ‘‘Energy Labeling dent of the United States, as presiding offi- 20944), and the order of the House of Rule’’ (RIN3084–AB15) received during ad- cer of the United States Senate; President journment of the Senate in the Office of the January 3, 2017, the Speaker appoints Pro Tempore of the United States Senate; President of the Senate on July 28, 2017; to the following individual on the part of the Minority Leader of the United States the Committee on Commerce, Science, and the House of Representatives to the Senate; the Speaker of the United States Election Assistance Commission Board Transportation. House of Representatives; the Minority of Advisors: Mr. Elliot Berke of Arling- f Leader of the United States House of Rep- ton, Virginia. PETITIONS AND MEMORIALS resentatives; and Hawaii’s Congressional del- egation. f The following petitions and memo- EXECUTIVE AND OTHER rials were laid before the Senate and POM–80. A resolution adopted by the City COMMUNICATIONS were referred or ordered to lie on the Commission of the City of Sunrise, Florida table as indicated: urging the United States Congress to oppose The following communications were the proposed elimination of the Community laid before the Senate, together with POM–79. A resolution adopted by the Leg- Development Block Grant and Home Invest- islature of the State of Hawaii submitting an ment Partnerships Programs and supporting accompanying papers, reports, and doc- application to the United States Congress to uments, and were referred as indicated: full funding in the Fiscal Year 2018 budget restore free and fair elections; to the Com- for the United States Department of Housing EC–2454. A communication from the Direc- mittee on the Judiciary. and Urban Development; to the Committee tor of the Regulatory Management Division, HOUSE RESOLUTION NO. 25 on Banking, Housing, and Urban Affairs. Environmental Protection Agency, transmit- Whereas, according to The Federalist No. POM–81. A resolution adopted by the City ting, pursuant to law, the report of a rule en- 52 by James Madison, the framers of the Con- Commission of the City of Sunrise, Florida titled ‘‘National Priorities List’’ (FRL No. stitution of the United States intended that urging the United States Congress to enact 9965–31–OLEM) received during adjournment the Congress of the United States should be legislation modernizing the immigration of the Senate in the Office of the President ‘‘dependent on the people alone’’; and system during the 115th Congress; to the of the Senate on July 28, 2017; to the Com- Whereas, the ‘‘dependency on the people Committee on the Judiciary. mittee on Environment and Public Works. alone’’ has evolved into a dependency on f EC–2455. A communication from the Board powerful special interests that act through of Trustees of the Federal Old-Age and Sur- campaigns or third-party groups, thereby REPORTS OF COMMITTEES vivors Insurance and Federal Disability In- creating a fundamental imbalance in our surance Trust Funds, transmitting, pursuant The following reports of committees representative democracy; and were submitted: to law, a report relative to the Federal Dis- Whereas, Americans across the political ability Insurance Trust Fund; to the Com- spectrum agree that elections in the United By Mr. BARRASSO, from the Committee mittee on Finance. States should be free from the dispropor- on Environment and Public Works, with an EC–2456. A communication from the Acting tional influence of special interests and fair amendment in the nature of a substitute: S. 810. A bill to facilitate construction of a Assistant Secretary, Bureau of Political- enough that any citizen can be elected into bridge on certain property in Christian Military Affairs, Department of State, trans- office; and County, Missouri, and for other purposes mitting, pursuant to law, an addendum to a Whereas, Article V of the United States (Rept. No. 115–142). certification, of the proposed sale or export Constitution requires Congress to convene a By Mr. HOEVEN, from the Committee on of defense articles and/or defense services to convention for proposing amendments to the a Middle East country (OSS–2017–0837); to the Indian Affairs, without amendment: federal Constitution on the application of S. 669. A bill to authorize the Secretary of Committee on Foreign Relations. two-thirds of the legislatures of the several the Interior to assess sanitation and safety EC–2457. A communication from the Sec- states; and conditions at Bureau of Indian Affairs facili- retary of Education, transmitting, pursuant Whereas, the Twenty-ninth Legislature of ties that were constructed to provide af- to law, the report of a rule entitled ‘‘Defini- the State of Hawaii desires to restore bal- fected Columbia River Treaty tribes access tions and Selection Criteria that Apply to ance and integrity to our elections by pro- to traditional fishing grounds and expend Direct Grant Programs’’ (RIN1855–AA13) re- posing a federal constitutional amendment funds on construction of facilities and struc- ceived in the Office of the President pro tem- to permanently protect free and fair elec- tures to improve those conditions, and for pore of the Senate; to the Committee on tions in the United States by addressing other purposes (Rept. No. 115–143). Health, Education, Labor, and Pensions. issues raised by the decision of the Supreme By Mr. RISCH, from the Committee on EC–2458. A communication from the Direc- Court of the United States in Citizens United Small Business and Entrepreneurship, with- tor of Regulations and Policy Management v. Federal Election Commission, 558 U.S. 310 out amendment: Staff, Food and Drug Administration, De- (2010), and related cases and events; and S. 154. A bill to amend the Small Business partment of Health and Human Services, Whereas, the Twenty-ninth Legislature de- Act to ensure small businesses affected by transmitting, pursuant to law, the report of sires that Hawaii have an equal number of the onset of transmissible diseases are eligi- a rule entitled ‘‘Civil Money Penalty delegates to the Convention as any other ble for disaster relief. Amounts; Technical Amendment’’ (Docket state; provided that former or current fed- S. 650. A bill to amend the Small Business No. FDA–2017–N–0011) received in the Office eral office holders, whether elected or ap- Act to expand tax credit education and of the President of the Senate on July 31, pointed, are not eligible to serve as delegates training for small businesses that engage in 2017; to the Committee on Health, Education, to the Convention; and research and development, and for other pur- Labor, and Pensions. Whereas, the Twenty-ninth Legislature poses. EC–2459. A communication from the Direc- shall retain the ability to restrict or expand S. 690. A bill to extend the eligibility of re- tor of Regulations and Policy Management the authority of its delegates within the lim- designated areas as HUBZones from 3 years Staff, Food and Drug Administration, De- its expressed herein; and to 7 years.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00068 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.005 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4765 By Mr. RISCH, from the Committee on ate and appeared in the Congressional Wall, which nominations were received by Small Business and Entrepreneurship, with Record on July 27, 2017. the Senate and appeared in the Congres- amendments: Army nominations beginning with Alon S. sional Record on July 20, 2017. S. 929. A bill to improve the HUBZone pro- Aharon and ending with Edwin A. Wymer, Navy nominations beginning with Robert gram. which nominations were received by the Sen- E. Bradshaw and ending with Leroy C. By Mr. RISCH, from the Committee on ate and appeared in the Congressional Young, which nominations were received by Small Business and Entrepreneurship, with Record on July 27, 2017. the Senate and appeared in the Congres- an amendment in the nature of a substitute: Army nominations beginning with Julia R. sional Record on July 20, 2017. S. 1038. A bill to require the Administrator Plevnia and ending with Hal E. Vineyard, Navy nominations beginning with Thomas of the Small Business Administration to sub- which nominations were received by the Sen- E. Arnold and ending with Michael P. mit to Congress a report on the utilization of ate and appeared in the Congressional Yunker, which nominations were received by small businesses with respect to certain Fed- Record on July 27, 2017. the Senate and appeared in the Congres- eral contracts. Army nominations beginning with Tressa sional Record on July 20, 2017. By Mr. RISCH, from the Committee on D. Cochran and ending with Karen F. Navy nomination of Clair E. Smith, to be Small Business and Entrepreneurship, with- Wiggins, which nominations were received Lieutenant Commander. out amendment: by the Senate and appeared in the Congres- Navy nomination of Morgan E. McClellan, S. 1428. A bill to amend section 21 of the sional Record on July 27, 2017. to be Lieutenant Commander. Small Business Act to require cyber certifi- Army nominations beginning with Loren Navy nominations beginning with Andrew cation for small business development center D. Adams and ending with Philip A. Wentz, B. Bridgforth and ending with Ronald J. counselors, and for other purposes. which nominations were received by the Sen- Mitchell, which nominations were received By Mr. ISAKSON, from the Committee on ate and appeared in the Congressional by the Senate and appeared in the Congres- Veterans’ Affairs, without amendment: Record on July 27, 2017. sional Record on July 25, 2017. Army nominations beginning with Joanne By Mr. THUNE for the Committee on Com- S. 1598. A bill to amend title 38, United E. Arsenault and ending with Felisha L. merce, Science, and Transportation. States Code, to make certain improvements Rhodes, which nominations were received by *Ajit Varadaraj Pai, of Kansas, to be a in the laws administered by the Secretary of the Senate and appeared in the Congres- Member of the Federal Communications Veterans Affairs, and for other purposes. sional Record on July 27, 2017. Commission for a term of five years from f Army nominations beginning with Michael July 1, 2016. E. Alvis and ending with Jeffrey P. Wood, *Karen Dunn Kelley, of Pennsylvania, to EXECUTIVE REPORTS OF which nominations were received by the Sen- be Under Secretary of Commerce for Eco- COMMITTEES ate and appeared in the Congressional nomic Affairs. Record on July 27, 2017. *Elizabeth Erin Walsh, of the District of The following executive reports of Army nominations beginning with John W. Columbia, to be Assistant Secretary of Com- nominations were submitted: Aldridge and ending with Philip E. Zapanta, merce and Director General of the United By Mr. ROBERTS for the Committee on which nominations were received by the Sen- States and Foreign Commercial Service. Agriculture, Nutrition, and Forestry. ate and appeared in the Congressional *Steven Gill Bradbury, of Virginia, to be *Brian D. Quintenz, of Ohio, to be a Com- Record on July 27, 2017. General Counsel of the Department of Trans- missioner of the Commodity Futures Trad- Army nominations beginning with Scott R. portation. ing Commission for a term expiring April 13, Cheever and ending with Diana E. *Jessica Rosenworcel, of Connecticut, to be 2020. Zschaschel, which nominations were re- a Member of the Federal Communications *Dawn DeBerry Stump, of Texas, to be a ceived by the Senate and appeared in the Commission for a term of five years from Commissioner of the Commodity Futures Congressional Record on July 27, 2017. July 1, 2015. Trading Commission for a term expiring Army nominations beginning with Edward *Mark H. Buzby, of Virginia, to be Admin- April 13, 2022. J. Alexander and ending with Bridget C. istrator of the Maritime Administration. *Rostin Behnam, of New Jersey, to be a Wolfe, which nominations were received by *Peter B. Davidson, of Virginia, to be Gen- Commissioner of the Commodity Futures the Senate and appeared in the Congres- eral Counsel of the Department of Com- Trading Commission for a term expiring sional Record on July 27, 2017. merce. June 19, 2021. Army nominations beginning with Robin *Robert L. Sumwalt III, of South Carolina, By Mr. MCCAIN for the Committee on Crear and ending with Neil P. Woods, which to be Chairman of the National Transpor- Armed Services. nominations were received by the Senate and tation Safety Board for a term of two years. Air Force nomination of Brig. Gen. Mark appeared in the Congressional Record on *Brendan Carr, of Virginia, to be a Member D. Camerer, to be Major General. July 27, 2017. of the Federal Communications Commission Navy nomination of Rear Adm. DeWolfe H. Army nominations beginning with Eric W. for the remainder of the term expiring June Miller III, to be Vice Admiral. Bullock and ending with Crystal R. Romay, 30, 2018. *Brendan Carr, of Virginia, to be a Member Navy nomination of Rear Adm. John D. which nominations were received by the Sen- of the Federal Communications Commission Alexander, to be Vice Admiral. ate and appeared in the Congressional for a term of five years from July 1, 2018. Navy nomination of Vice Adm. John C. Record on July 27, 2017. Navy nominations beginning with Betty S. *Ronald L. Batory, of New Jersey, to be Aquilino, to be Vice Admiral. Alexander and ending with James S. Administrator of the Federal Railroad Ad- Army nomination of Lt. Gen. Robert P. Zmijski, which nominations were received ministration. Ashley, Jr., to be Lieutenant General. by the Senate and appeared in the Congres- By Mr. ALEXANDER for the Committee Army nomination of Brig. Gen. Darrell J. sional Record on July 20, 2017. on Health, Education, Labor, and Pensions. Guthrie, to be Major General. Navy nominations beginning with Dominic *James J. Sullivan, Jr., of Pennsylvania, Army nomination of Col. Brian E. Miller, J. Antenucci and ending with Matthew J. to be a Member of the Occupational Safety to be Brigadier General. Wooten, which nominations were received by and Health Review Commission for a term Mr. MCCAIN. Mr. President, for the the Senate and appeared in the Congres- expiring April 27, 2021. Committee on Armed Services I report sional Record on July 20, 2017. *Brett Giroir, of Texas, to be Medical Di- favorably the following nomination Navy nominations beginning with Clemia rector in the Regular Corps of the Public Health Service, subject to the qualifications lists which were printed in the RECORD Anderson and ending with Michael A. therefor as provided by law and regulations, on the dates indicated, and ask unani- Zundel, which nominations were received by the Senate and appeared in the Congres- and to be an Assistant Secretary of Health mous consent, to save the expense of sional Record on July 20, 2017. and Human Services. reprinting on the Executive Calendar Navy nominations beginning with Eric F. *Heather L. MacDougall, of Florida, to be that these nominations lie at the Sec- Bauman and ending with Evan R. Whitbeck, a Member of the Occupational Safety and retary’s desk for the information of which nominations were received by the Sen- Health Review Commission for a term expir- Senators. ate and appeared in the Congressional ing April 27, 2023. The PRESIDING OFFICER. Without Record on July 20, 2017. *Elinore F. McCance-Katz, of Rhode Island, Navy nominations beginning with Thomas to be Assistant Secretary for Mental Health objection, it is so ordered. B. Ableman and ending with Bruce A. Yee, and Substance Use, Department of Health Army nomination of Damian R. Tong, to which nominations were received by the Sen- and Human Services. be Major. ate and appeared in the Congressional *Lance Allen Robertson, of Oklahoma, to Army nominations beginning with Dennis Record on July 20, 2017. be Assistant Secretary for Aging, Depart- Arroyo and ending with Brian P. Weber, Navy nominations beginning with Eric W. ment of Health and Human Services. which nominations were received by the Sen- Hass and ending with Gail M. Mulleavy, *Jerome M. Adams, of Indiana, to be Med- ate and appeared in the Congressional which nominations were received by the Sen- ical Director in the Regular Corps of the Record on July 27, 2017. ate and appeared in the Congressional Public Health Service, subject to qualifica- Army nominations beginning with Murray Record on July 20, 2017. tions therefor as provided by law and regula- E. Carlock and ending with Carlos V. Silva, Navy nominations beginning with Chris- tions, and to be Surgeon General of the Pub- which nominations were received by the Sen- topher L. Almond and ending with Daniel W. lic Health Service for a term of four years.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00069 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.011 S02AUPT1 S4766 CONGRESSIONAL RECORD — SENATE August 2, 2017

*Robert P. Kadlec, of New York, to be Med- medical expense deduction under the supple- MCCASKILL, Mrs. MURRAY, Ms. HAR- ical Director in the Regular Corps of the mental nutrition assistance program, and for RIS, Ms. STABENOW, Mr. REED, Ms. Public Health Service, subject to qualifica- other purposes; to the Committee on Agri- KLOBUCHAR, Mr. SANDERS, Mr. SCHU- tions therefor as provided by law and regula- culture, Nutrition, and Forestry. MER, Mr. BLUMENTHAL, Ms. CANT- tions, and to be Assistant Secretary for Pre- By Mrs. GILLIBRAND: WELL, Mr. DONNELLY, Ms. paredness and Response, Department of S. 1708. A bill to amend the Food and Nu- DUCKWORTH, Mr. PETERS, Mr. UDALL, Health and Human Services. trition Act of 2008 to provide that certain Mr. MARKEY, Mr. MURPHY, Ms. *Nomination was reported with rec- students who are family caregivers are eligi- HEITKAMP, Mrs. SHAHEEN, Mrs. GILLI- ble to participate in the Supplemental Nutri- ommendation that it be confirmed sub- BRAND, Mr. MERKLEY, Mr. NELSON, tion Assistance Program; to the Committee Mr. KING, Mr. SCHATZ, Mr. WARNER, ject to the nominee’s commitment to on Agriculture, Nutrition, and Forestry. Mr. TESTER, and Mr. MANCHIN): respond to requests to appear and tes- By Mr. KENNEDY (for himself, Mr. S. 1715. A bill to amend the Internal Rev- tify before any duly constituted com- HATCH, and Mr. CORNYN): enue Code of 1986 to clarify that all provi- mittee of the Senate. S. 1709. A bill to amend title 18, United sions shall apply to legally married same-sex (Nominations without an asterisk States Code, to provide a certification proc- couples in the same manner as other married were reported with the recommenda- ess for the issuance of nondisclosure require- couples, and for other purposes; to the Com- ments accompanying certain administrative mittee on Finance. tion that they be confirmed.) subpoenas, to provide for judicial review of By Mrs. FISCHER (for herself and Mr. f such nondisclosure requirements, and for KING): INTRODUCTION OF BILLS AND other purposes; to the Committee on the Ju- S. 1716. A bill to amend the Internal Rev- diciary. enue Code of 1986 to provide a credit to em- JOINT RESOLUTIONS By Mr. MENENDEZ (for himself, Mr. ployers who provide paid family and medical The following bills and joint resolu- BLUMENTHAL, Mr. LEAHY, Mr. WHITE- leave, and for other purposes; to the Com- tions were introduced, read the first HOUSE, Mr. SCHUMER, Mr. NELSON, mittee on Finance. and second times by unanimous con- Mr. FRANKEN, Mrs. SHAHEEN, Mr. By Mr. WYDEN (for himself and Mr. RUBIO): sent, and referred as indicated: PETERS, Ms. HASSAN, Mr. CARDIN, Mr. REED, Mrs. MURRAY, Mr. DURBIN, Ms. S. 1717. A bill to amend title 31, United By Mr. UDALL (for himself, Mr. STABENOW, Ms. KLOBUCHAR, Mrs. States Code, to ensure that persons who PORTMAN, Mr. PETERS, Mr. WYDEN, FEINSTEIN, Mr. MERKLEY, Mr. MAR- form corporations or limited liability com- Mr. GRAHAM, Mr. GARDNER, Mr. KEY, Ms. HIRONO, Ms. HARRIS, and Mr. panies in the United States disclose the ben- eficial owners of those corporations or lim- BROWN, Mr. FRANKEN, Ms. BALDWIN, BOOKER): and Mr. ALEXANDER): S. 1710. A bill to reduce the Federal budget ited liability companies, in order to prevent S. 1700. A bill to amend the Energy Policy deficit by closing big oil tax loopholes, and wrongdoers from exploiting United States and Conservation Act to establish a for other purposes; to the Committee on Fi- corporations and limited liability companies WaterSense program within the Environ- nance. for criminal gain, to assist law enforcement mental Protection Agency, and for other By Mrs. SHAHEEN: in detecting, preventing, and punishing ter- purposes; to the Committee on Environment S. 1711. A bill to amend the Public Utility rorism, money laundering, and other mis- and Public Works. Regulatory Policies Act of 1978 to assist conduct involving United States corpora- By Mr. CORNYN (for himself and Mr. States in adopting updated interconnection tions and limited liability companies, and WYDEN): procedures and tariff schedules and stand- for other purposes; to the Committee on S. 1701. A bill to provide for Federal agen- ards for supplemental, backup, and standby Banking, Housing, and Urban Affairs. cies to develop public access policies relating power fees for projects for combined heat and By Mr. KENNEDY (for himself, Mr. to research conducted by employees of that power technology and waste heat to power NELSON, Mr. INHOFE, Mr. RUBIO, Mr. agency or from funds administered by that technology, and for other purposes; to the CASSIDY, and Ms. WARREN): agency; to the Committee on Homeland Se- Committee on Energy and Natural Re- S. 1718. A bill to authorize the minting of a coin in honor of the 75th anniversary of the curity and Governmental Affairs. sources. end of World War II, and for other purposes; By Mr. RISCH: By Mr. WYDEN: S. 1702. A bill to amend the Marine Mam- S. 1712. A bill to amend the Higher Edu- to the Committee on Banking, Housing, and mal Protection Act of 1972 to reduce preda- cation Act of 1965 to provide for the auto- Urban Affairs. tion by sea lions on endangered Columbia matic recertification of income for income- By Mr. BLUNT (for himself and Ms. River salmon and other species not listed driven repayment plans, and for other pur- CANTWELL): S. 1719. A bill to eliminate duties on im- under the Endangered Species Act of 1973, poses; to the Committee on Health, Edu- ports of recreational performance outerwear, and for other purposes; to the Committee on cation, Labor, and Pensions. to establish the Sustainable Textile and Ap- Commerce, Science, and Transportation. By Mrs. SHAHEEN (for herself, Mr. parel Research Fund, and for other purposes; By Ms. DUCKWORTH: COONS, Ms. COLLINS, and Mr. REED): S. 1703. A bill to amend section 212(d)(5) of S. 1713. A bill to require certain financial to the Committee on Finance. the Immigration and Nationality Act to assistance under the State energy program By Mr. COTTON (for himself and Mr. allow certain alien veterans to be paroled and the Weatherization Assistance Program PERDUE): S. 1720. A bill to amend the Immigration into the United States to receive health care to be distributed without undue delay to sup- and Nationality Act to establish a skills- furnished by the Secretary of Veterans Af- port State and local high-impact energy effi- based immigration points system, to focus fairs; to the Committee on the Judiciary. ciency and renewable energy initiatives; to family-sponsored immigration on spouses By Ms. DUCKWORTH: the Committee on Energy and Natural Re- and minor children, to eliminate the Diver- S. 1704. A bill to require the Secretary of sources. sity Visa Program, to set a limit on the Homeland Security to establish a veterans By Mr. WYDEN (for himself and Mr. number of refugees admitted annually to the visa program to permit veterans who have MERKLEY): United States, and for other purposes; to the S. 1714. A bill to provide for the conduct of been removed from the United States to re- Committee on the Judiciary. certain economic activities in Malheur turn as immigrants, and for other purposes; By Mr. UDALL (for himself, Mr. to the Committee on the Judiciary. County, Oregon, to provide for the conduct ROUNDS, Mr. BOOZMAN, Mrs. MURRAY, By Mr. BENNET (for himself and Mr. of a study on the need for a regional eco- and Mr. HEINRICH): BOOZMAN): nomic commission for certain counties in S. 1721. A bill to amend titles 10 and 37, S. 1705. A bill to provide to the Secretary the State of Oregon, to withdraw certain United States Code, to provide compensation of Agriculture the ability to enter into a Federal land located in Malheur County, Or- and credit for retired pay purposes for ma- lease agreement for administrative sites on egon, from all forms of entry, appropriation, ternity leave taken by members of the re- National Forest System land, and for other or disposal under the public land laws, loca- serve components, and for other purposes; to purposes; to the Committee on Agriculture, tion, entry, and patent under the mining the Committee on Armed Services. Nutrition, and Forestry. laws, and operation under the mineral leas- By Mr. SULLIVAN: By Mr. MENENDEZ (for himself, Mr. ing laws, and for other purposes; to the Com- S. 1722. A bill to require the Committee on GRAHAM, Mr. WHITEHOUSE, Ms. COL- mittee on Agriculture, Nutrition, and For- Foreign Investment in the United States to LINS, Mrs. SHAHEEN, Ms. WARREN, and estry. consider the reciprocity of foreign invest- Mr. COONS): By Mr. WYDEN (for himself, Mr. ment, and for other purposes; to the Com- S. 1706. A bill to prevent human health MENENDEZ, Ms. HIRONO, Ms. BALDWIN, mittee on Banking, Housing, and Urban Af- threats posed by the consumption of equines Ms. WARREN, Mr. WHITEHOUSE, Mrs. fairs. raised in the United States; to the Com- FEINSTEIN, Mr. BENNET, Mr. BOOKER, By Mr. SANDERS: mittee on Health, Education, Labor, and Mr. DURBIN, Mr. KAINE, Mr. BROWN, S. 1723. A bill to appropriate amounts to Pensions. Mr. LEAHY, Mr. FRANKEN, Mr. HEIN- the Department of Veterans Affairs to im- By Mrs. GILLIBRAND: RICH, Mr. CASEY, Ms. CORTEZ MASTO, prove health care furnished by the Depart- S. 1707. A bill to amend the Food and Nu- Mr. CARDIN, Ms. HASSAN, Mr. CARPER, ment, and for other purposes; to the Com- trition Act of 2008 to provide for a standard Mr. VAN HOLLEN, Mr. COONS, Mrs. mittee on Veterans’ Affairs.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00070 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.012 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4767 By Mr. WARNER (for himself, Mr. By Mr. FLAKE (for himself, Mr. GARD- States Code, to provide for the treat- MORAN, Mrs. CAPITO, and Mr. CASEY): NER, Mr. LEE, Mr. COTTON, Mrs. ment of veterans who participated in S. 1724. A bill to amend the Internal Rev- MCCASKILL, and Mr. BENNET): the cleanup of Enewetak Atoll as radi- enue Code of 1986 to establish a new tax cred- S. Res. 243. A resolution expressing the ation exposed veterans for purposes of it and grant program to stimulate invest- sense of the Senate that Joseph Leon George ment and healthy nutrition options in food should be honored for heroism at Pearl Har- the presumption of service-connection deserts, and for other purposes; to the Com- bor, Hawaii, on December 7, 1941; to the Com- of certain disabilities by the Secretary mittee on Finance. mittee on Armed Services. of Veterans Affairs, and for other pur- By Ms. DUCKWORTH (for herself and By Mr. MCCONNELL (for himself and poses. Ms. CORTEZ MASTO): Mr. SCHUMER): S. 322 S. 1725. A bill to require the Secretary of S. Res. 244. A resolution to authorize testi- At the request of Mr. PETERS, the Homeland Security to identify each alien mony, document production, and representa- who has served, or is serving, in the Armed tion in United States of America v. Robert name of the Senator from Maryland Forces of the United States when any alien Menendez, et al; considered and agreed to. (Mr. VAN HOLLEN) was added as a co- applies for an immigration benefit or is f sponsor of S. 322, a bill to protect vic- placed in an immigration enforcement pro- tims of domestic violence, sexual as- ceeding, and for other purposes; to the Com- ADDITIONAL COSPONSORS sault, stalking, and dating violence mittee on the Judiciary. S. 58 from emotional and psychological By Mr. MENENDEZ (for himself, Mr. At the request of Mr. HELLER, the trauma caused by acts of violence or BLUMENTHAL, Mr. MARKEY, Mrs. threats of violence against their pets. FEINSTEIN, Ms. HIRONO, Mr. FRANKEN, names of the Senator from South Caro- Mrs. SHAHEEN, Ms. WARREN, Mr. lina (Mr. SCOTT), the Senator from S. 372 WHITEHOUSE, Mr. DURBIN, Mr. Michigan (Ms. STABENOW), the Senator At the request of Mr. PORTMAN, the MERKLEY, Mr. VAN HOLLEN, Mr. from Alaska (Mr. SULLIVAN) and the name of the Senator from Illinois (Ms. UDALL, Mr. BOOKER, Mr. LEAHY, and Senator from Michigan (Mr. PETERS) DUCKWORTH) was added as a cosponsor Mrs. GILLIBRAND): were added as cosponsors of S. 58, a bill of S. 372, a bill to amend the Tariff Act S. 1726. A bill to amend the Securities Ex- to amend the Internal Revenue Code of of 1930 to ensure that merchandise ar- change Act of 1934 to require shareholder au- 1986 to repeal the excise tax on high thorization before a public company may riving through the mail shall be sub- make certain political expenditures, and for cost employer-sponsored health cov- ject to review by U.S. Customs and other purposes; to the Committee on Bank- erage. Border Protection and to require the ing, Housing, and Urban Affairs. S. 168 provision of advance electronic infor- By Ms. DUCKWORTH (for herself and At the request of Mr. WICKER, the mation on shipments of mail to U.S. Ms. CORTEZ MASTO): name of the Senator from South Caro- Customs and Border Protection and for S. 1727. A bill to establish a naturalization lina (Mr. SCOTT) was added as a cospon- other purposes. office at every initial military training site; to the Committee on Armed Services. sor of S. 168, a bill to amend and en- S. 394 By Mr. CARDIN: hance certain maritime programs of At the request of Mr. ROUNDS, the S. 1728. A bill to require non-Federal pris- the Department of Transportation. name of the Senator from Texas (Mr. on, correctional, and detention facilities S. 253 CRUZ) was added as a cosponsor of S. holding Federal prisoners or detainees under At the request of Mr. CARDIN, the 394, a bill to amend chapter 44 of title a contract with the Federal Government to name of the Senator from Illinois (Ms. 18, United States Code, to provide that make the same information available to the a member of the Armed Forces and the public that Federal prisons and correctional DUCKWORTH) was added as a cosponsor facilities are required to make available; to of S. 253, a bill to amend title XVIII of spouse of that member shall have the the Committee on the Judiciary. the Social Security Act to repeal the same rights regarding the receipt of By Mr. ROBERTS (for himself, Mr. Medicare outpatient rehabilitation firearms at the location of any duty WARNER, Mr. CRAPO, Mr. CARDIN, and therapy caps. station of the member. Mr. YOUNG): S. 256 S. 428 S. 1729. A bill to amend title XVIII of the At the request of Mr. GRASSLEY, the Social Security Act to provide for inde- At the request of Ms. HEITKAMP, the pendent accreditation for dialysis facilities name of the Senator from Massachu- name of the Senator from Illinois (Ms. and assurances of high quality surveys; to setts (Ms. WARREN) was added as a co- DUCKWORTH) was added as a cosponsor the Committee on Finance. sponsor of S. 256, a bill to establish the of S. 428, a bill to amend titles XIX and By Ms. COLLINS (for herself, Mr. Stop, Observe, Ask, and Respond to XXI of the Social Security Act to au- COONS, Mr. MORAN, Mrs. SHAHEEN, Health and Wellness Training pilot pro- thorize States to provide coordinated Mr. RUBIO, Mr. BLUMENTHAL, Mr. gram to address human trafficking in care to children with complex medical ENZI, Mr. ISAKSON, Mr. DURBIN, and the health care system. conditions through enhanced pediatric Mr. MURPHY): health homes, and for other purposes. S. 1730. A bill to implement policies to end S. 261 preventable maternal, newborn, and child At the request of Mr. BLUNT, the S. 456 deaths globally; to the Committee on For- name of the Senator from Mississippi At the request of Mr. BENNET, the eign Relations. (Mr. WICKER) was added as a cosponsor name of the Senator from Maine (Mr. By Mr. THUNE: of S. 261, a bill to amend the Federal KING) was added as a cosponsor of S. S. 1731. A bill to address the forest health Food, Drug, and Cosmetic Act to im- 456, a bill to amend the Federal Food, crisis on National Forest System land, and Drug, and Cosmetic Act to establish a for other purposes; to the Committee on En- prove and clarify certain disclosure re- vironment and Public Works. quirements for restaurants and similar program to increase the development retail food establishments, and to of new drugs to treat pediatric cancers, f amend the authority to bring pro- and for other purposes. SUBMISSION OF CONCURRENT AND ceedings under section 403A. S. 497 SENATE RESOLUTIONS S. 266 At the request of Ms. CANTWELL, the The following concurrent resolutions At the request of Mr. HATCH, the name of the Senator from Illinois (Ms. and Senate resolutions were read, and name of the Senator from North Da- DUCKWORTH) was added as a cosponsor referred (or acted upon), as indicated: kota (Mr. HOEVEN) was added as a co- of S. 497, a bill to amend title XVIII of By Mr. WICKER (for himself, Mr. sponsor of S. 266, a bill to award the the Social Security Act to provide for SCHATZ, Mr. GARDNER, Ms. HASSAN, Congressional Gold Medal to Anwar Medicare coverage of certain Mr. MORAN, and Mr. PETERS): Sadat in recognition of his heroic lymphedema compression treatment S. Res. 242. A resolution expressing the achievements and courageous contribu- items as items of durable medical sense of the Senate about a strategy to de- tions to peace in the Middle East. equipment. ploy fifth generation mobile networks (5G S. 283 S. 581 networks) and next-generation wireless and wired technologies to promote economic de- At the request of Mr. FRANKEN, the At the request of Mr. MANCHIN, the velopment and digital innovation through- name of the Senator from Ohio (Mr. names of the Senator from New Hamp- out the United States; to the Committee on BROWN) was added as a cosponsor of S. shire (Mrs. SHAHEEN) and the Senator Commerce, Science, and Transportation. 283, a bill to amend title 38, United from Maine (Mr. KING) were added as

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00071 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.014 S02AUPT1 S4768 CONGRESSIONAL RECORD — SENATE August 2, 2017 cosponsors of S. 581, a bill to include added as cosponsors of S. 976, a bill to DUCKWORTH) was added as a cosponsor information concerning a patient’s restore States’ sovereign rights to en- of S. 1348, a bill to amend title XI of opioid addiction in certain medical force State and local sales and use tax the Social Security Act to require drug records. laws, and for other purposes. manufacturers to publicly justify un- S. 593 S. 1002 necessary price increases. At the request of Mrs. CAPITO, the At the request of Mr. MORAN, the S. 1354 name of the Senator from Alabama names of the Senator from Colorado At the request of Mr. CARPER, the (Mr. STRANGE) was added as a cospon- (Mr. BENNET) and the Senator from Ne- name of the Senator from Virginia (Mr. sor of S. 593, a bill to amend the Pitt- vada (Mr. HELLER) were added as co- WARNER) was added as a cosponsor of S. man-Robertson Wildlife Restoration sponsors of S. 1002, a bill to enhance 1354, a bill to establish an Individual Act to facilitate the establishment of the ability of community financial in- Market Reinsurance fund to provide additional or expanded public target stitutions to foster economic growth funding for State individual market ranges in certain States. and serve their communities, boost stabilization reinsurance programs. small businesses, increase individual S. 635 S. 1428 savings, and for other purposes. At the request of Mrs. SHAHEEN, the At the request of Mr. RISCH, the S. 1044 name of the Senator from Illinois (Ms. name of the Senator from Delaware At the request of Mrs. CAPITO, the DUCKWORTH) was added as a cosponsor (Mr. COONS) was added as a cosponsor name of the Senator from Mississippi of S. 635, a bill to amend title 28, of S. 1428, a bill to amend section 21 of (Mr. WICKER) was added as a cosponsor United States Code, to prohibit the ex- the Small Business Act to require of S. 1044, a bill to amend title XVIII of cyber certification for small business clusion of individuals from service on a the Social Security Act to ensure equal Federal jury on account of sexual ori- development center counselors, and for access of Medicare beneficiaries to other purposes. entation or gender identity. community pharmacies in underserved S. 1462 S. 655 areas as network pharmacies under At the request of Mrs. SHAHEEN, the At the request of Mr. RISCH, the Medicare prescription drug coverage, name of the Senator from Illinois (Ms. name of the Senator from Wisconsin and for other purposes. (Ms. BALDWIN) was added as a cospon- DUCKWORTH) was added as a cosponsor S. 1113 of S. 1462, a bill to amend the Patient sor of S. 655, a bill to exempt certain At the request of Mrs. FEINSTEIN, the 16- and 17-year-old individuals em- Protection and Affordable Care Act to name of the Senator from Hawaii (Ms. improve cost sharing subsidies. ployed in logging operations from child HIRONO) was added as a cosponsor of S. S. 1500 labor laws. 1113, a bill to amend the Federal Food, At the request of Mr. WARNER, the S. 720 Drug, and Cosmetic Act to ensure the name of the Senator from Nevada (Mr. At the request of Mr. PORTMAN, the safety of cosmetics. HELLER) was added as a cosponsor of S. names of the Senator from Arizona S. 1139 1500, a bill to amend the Federal De- (Mr. FLAKE) and the Senator from Ala- At the request of Mr. TESTER, the posit Insurance Act to ensure that the bama (Mr. SHELBY) were added as co- name of the Senator from Missouri reciprocal deposits of an insured depos- sponsors of S. 720, a bill to amend the (Mrs. MCCASKILL) was added as a co- itory institution are not considered to Export Administration Act of 1979 to sponsor of S. 1139, a bill to amend the be funds obtained by or through a de- include in the prohibitions on boycotts Financial Stability Act of 2010 to mod- posit broker, and for other purposes. against allies of the United States boy- ify the requirements of stress tests. S. 1509 cotts fostered by international govern- S. 1182 At the request of Mr. HATCH, the mental organizations against Israel At the request of Mr. YOUNG, the and to direct the Export-Import Bank names of the Senator from New Mexico names of the Senator from South Caro- COTT of the United States to oppose boycotts (Mr. UDALL) and the Senator from lina (Mr. S ) and the Senator from against Israel, and for other purposes. Maryland (Mr. CARDIN) were added as Florida (Mr. NELSON) were added as co- sponsors of S. 1509, a bill to amend the S. 808 cosponsors of S. 1182, a bill to require the Secretary of the Treasury to mint Federal Food, Drug, and Cosmetic Act At the request of Mr. THUNE, the to authorize an extension of exclu- name of the Senator from Indiana (Mr. commemorative coins in recognition of the 100th anniversary of The American sivity periods for certain drugs that YOUNG) was added as a cosponsor of S. are approved for a new indication for a 808, a bill to provide protections for Legion. At the request of Mr. BARRASSO, his rare disease or condition, and for other certain sports medicine professionals purposes. who provide certain medical services in name was added as a cosponsor of S. S. 1512 a secondary State. 1182, supra. S. 1254 At the request of Mr. LANKFORD, the S. 828 At the request of Ms. STABENOW, the name of the Senator from Alabama At the request of Mr. WARNER, the name of the Senator from Illinois (Ms. (Mr. STRANGE) was added as a cospon- name of the Senator from Michigan DUCKWORTH) was added as a cosponsor sor of S. 1512, a bill to prohibit the Sec- (Ms. STABENOW) was added as a cospon- of S. 1254, a bill to amend the Internal retary of Energy, the Administrator of sor of S. 828, a bill to amend the Fed- Revenue Code of 1986 to expand the the Environmental Protection Agency, eral Deposit Insurance Act to require small employer health insurance cred- the Secretary of the Interior, the Sec- the appropriate Federal banking agen- it. retary of Transportation, and the Chair cies to treat certain municipal obliga- S. 1311 of the Council on Environmental Qual- tions as level 2B liquid assets, and for At the request of Mr. CORNYN, the ity from considering, in taking any ac- other purposes. name of the Senator from Louisiana tion, the social cost of carbon, the so- S. 916 (Mr. KENNEDY) was added as a cospon- cial cost of methane, the social cost of At the request of Mr. CASSIDY, the sor of S. 1311, a bill to provide assist- nitrous oxide, or the social cost of any name of the Senator from Minnesota ance in abolishing human trafficking other greenhouse gas, unless compliant (Ms. KLOBUCHAR) was added as a co- in the United States. with Office of Management and Budget sponsor of S. 916, a bill to amend the S. 1312 guidance, and for other purposes. Controlled Substances Act with regard At the request of Mr. GRASSLEY, the S. 1532 to the provision of emergency medical name of the Senator from Massachu- At the request of Mr. THUNE, the services. setts (Ms. WARREN) was added as a co- name of the Senator from Nevada (Mr. S. 976 sponsor of S. 1312, a bill to prioritize HELLER) was added as a cosponsor of S. At the request of Mr. ENZI, the names the fight against human trafficking in 1532, a bill to disqualify from operating of the Senator from Hawaii (Ms. the United States. a commercial motor vehicle for life an HIRONO), the Senator from Missouri S. 1348 individual who uses a commercial (Mrs. MCCASKILL) and the Senator from At the request of Mr. WYDEN, the motor vehicle in committing a felony South Carolina (Mr. GRAHAM) were name of the Senator from Illinois (Ms. involving human trafficking.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00072 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.016 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4769 S. 1536 prices under part D of the Medicare Mr. CORNYN. Mr. President, I ask At the request of Ms. KLOBUCHAR, the program. unanimous consent that the text of the name of the Senator from Nevada (Mr. S. 1693 bill be printed in the RECORD. HELLER) was added as a cosponsor of S. At the request of Mr. PORTMAN, the There being no objection, the text of 1536, a bill to designate a human traf- names of the Senator from Alaska (Mr. the bill was ordered to be printed in ficking prevention coordinator and to SULLIVAN) and the Senator from Lou- the RECORD, as follows: expand the scope of activities author- isiana (Mr. KENNEDY) were added as co- S. 1701 ized under the Federal Motor Carrier sponsors of S. 1693, a bill to amend the Be it enacted by the Senate and House of Rep- Safety Administration’s outreach and Communications Act of 1934 to clarify resentatives of the United States of America in education program to include human that section 230 of that Act does not Congress assembled, trafficking prevention activities, and prohibit the enforcement against pro- SECTION 1. SHORT TITLE. for other purposes. viders and users of interactive com- This Act may be cited as the ‘‘Fair Access to Science and Technology Research Act of S. 1558 puter services of Federal and State criminal and civil law relating to sex 2017’’. At the request of Mr. RISCH, the SEC. 2. FINDINGS. name of the Senator from Wyoming trafficking. Congress finds that— (Mr. ENZI) was added as a cosponsor of S. CON. RES. 7 (1) the Federal Government funds basic and S. 1558, a bill to amend section 203 of At the request of Mr. ROBERTS, the applied research with the expectation that Public Law 94–305 to ensure proper au- name of the Senator from South Caro- new ideas and discoveries that result from thority for the Office of Advocacy of lina (Mr. SCOTT) was added as a cospon- the research, if shared and effectively dis- the Small Business Administration, sor of S. Con. Res. 7, a concurrent reso- seminated, will advance science and improve the lives and welfare of people of the United and for other purposes. lution expressing the sense of Congress that tax-exempt fraternal benefit soci- States and around the world; S. 1568 eties have historically provided and (2) the Internet makes it possible for this information to be promptly available to At the request of Mr. MARKEY, the continue to provide critical benefits to name of the Senator from Massachu- every scientist, physician, educator, and cit- the people and communities of the izen at home, in school, or in a library; setts (Ms. WARREN) was added as a co- United States. sponsor of S. 1568, a bill to require the (3) the United States has a substantial in- AMENDMENT NO. 575 terest in maximizing the impact and utility Secretary of the Treasury to mint At the request of Mr. NELSON, the of the research it funds by enabling a wide coins in commemoration of President name of the Senator from Massachu- range of reuses of the peer-reviewed lit- John F. Kennedy. setts (Ms. WARREN) was added as a co- erature that reports the results of such re- S. 1598 sponsor of amendment No. 575 intended search, including by enabling computational analysis by state-of-the-art technologies; At the request of Mr. TESTER, the to be proposed to H.R. 2810, to author- names of the Senator from New York (4) the Office of Science and Technology ize appropriations for fiscal year 2018 Policy issued a policy memorandum dated (Mr. SCHUMER) and the Senator from for military activities of the Depart- February 22, 2013, which established the com- Nevada (Ms. CORTEZ MASTO) were added ment of Defense, for military construc- mitment of the executive branch of the Fed- as cosponsors of S. 1598, a bill to amend tion, and for defense activities of the eral Government to ensuring that ‘‘the di- title 38, United States Code, to make Department of Energy, to prescribe rect results of Federally funded scientific re- certain improvements in the laws ad- military personnel strengths for such search are made available to and useful for ministered by the Secretary of Vet- fiscal year, and for other purposes. the public, industry, and the scientific com- munity’’; and erans Affairs, and for other purposes. AMENDMENT NO. 592 (5) the executive branch advises that such S. 1615 At the request of Mr. DURBIN, the public access should be implemented ‘‘with At the request of Mr. GRAHAM, the name of the Senator from California the fewest constraints possible’’. names of the Senator from California (Mrs. FEINSTEIN) was added as a co- SEC. 3. DEFINITION OF FEDERAL AGENCY. (Mrs. FEINSTEIN) and the Senator from sponsor of amendment No. 592 intended In this Act, the term ‘‘Federal agency’’ California (Ms. HARRIS) were added as to be proposed to H.R. 2810, to author- means an Executive agency, as defined under cosponsors of S. 1615, a bill to authorize ize appropriations for fiscal year 2018 section 105 of title 5, United States Code. the cancellation of removal and adjust- for military activities of the Depart- SEC. 4. FEDERAL RESEARCH PUBLIC ACCESS ment of status of certain individuals ment of Defense, for military construc- POLICY. tion, and for defense activities of the (a) REQUIREMENT TO DEVELOP POLICY.— who are long-term United States resi- (1) IN GENERAL.—Not later than 1 year after dents and who entered the United Department of Energy, to prescribe the date of enactment of this Act, each Fed- States as children, and for other pur- military personnel strengths for such eral agency with annual extramural research poses. fiscal year, and for other purposes. expenditures of over $100,000,000 shall develop S. 1636 AMENDMENT NO. 680 a Federal research public access policy that is consistent with and advances the purposes At the request of Mr. DURBIN, the At the request of Mr. BOOZMAN, the name of the Senator from Arkansas of the Federal agency. name of the Senator from Wisconsin (2) COMMON PROCEDURES.—To the extent (Mr. COTTON) was added as a cosponsor (Ms. BALDWIN) was added as a cospon- practicable, Federal agencies required to de- sor of S. 1636, a bill to amend the Inter- of amendment No. 680 intended to be velop a policy under paragraph (1) shall fol- nal Revenue Code of 1986 to modify the proposed to H.R. 2810, to authorize ap- low common procedures for the collection rules relating to inverted corporations. propriations for fiscal year 2018 for and depositing of research papers. military activities of the Department (b) CONTENT.—Each Federal research public S. 1685 of Defense, for military construction, access policy shall provide for— At the request of Mr. SCOTT, the and for defense activities of the De- (1) submission to a digital repository des- name of the Senator from Virginia (Mr. partment of Energy, to prescribe mili- ignated or maintained by the Federal agency KAINE) was added as a cosponsor of S. tary personnel strengths for such fiscal of an electronic version of the author’s final manuscript of original research papers that 1685, a bill to require Fannie Mae and year, and for other purposes. Freddie Mac to establish procedures for have been accepted for publication in peer- considering certain credit scores in f reviewed journals and that result from re- making a determination whether to STATEMENTS ON INTRODUCED search supported, in whole or in part, from funding by the Federal Government; purchase a residential mortgage, and BILLS AND JOINT RESOLUTIONS (2) the incorporation of all changes result- for other purposes. By Mr. CORNYN (for himself and ing from the peer review publication process S. 1688 Mr. WYDEN): in the manuscript described under paragraph At the request of Ms. KLOBUCHAR, the S. 1701. A bill to provide for Federal (1); name of the Senator from Rhode Island agencies to develop public access poli- (3) the replacement of the final manuscript with the final published version if— (Mr. REED) was added as a cosponsor of cies relating to research conducted by (A) the publisher consents to the replace- S. 1688, a bill to amend title XVIII of employees of that agency or from funds ment; and the Social Security Act to allow the administered by that agency; to the (B) the goals of the Federal agency for Secretary of Health and Human Serv- Committee on Homeland Security and functionality and interoperability are re- ices to negotiate fair prescription drug Governmental Affairs. tained;

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00073 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.018 S02AUPT1 S4770 CONGRESSIONAL RECORD — SENATE August 2, 2017 (4) free online public access to such final (2) examines the effectiveness of the Fed- level. The Corporate Transparency Act peer-reviewed manuscripts or published eral research public access policy in pro- of 2017 directs the Treasury Depart- versions within a time period that is appro- viding the public with free online access to ment to issue regulations requiring en- priate for each type of research conducted or papers on research funded by each Federal tities formed in the United States to sponsored by the Federal agency, not later agency required to develop a policy under than 12 months after publication in peer-re- subsection (a)(1), including— declare their beneficial owners—the viewed journals, preferably sooner, or as ad- (A) whether the terms of use applicable to real, natural persons who control each justed under established mechanisms; such research papers in effect are effective in company and benefit from it finan- (5) a means, using established mechanisms enabling productive reuse of the research cially. The bill would do this by setting for making requests to the applicable Fed- and computational analysis by state-of-the- minimum disclosure standards for eral agency, for members of the public and art technologies; and States to follow. If individual States other stakeholders to request to adjust the (B) examines whether such research papers choose to collect this information on period before such a final peer-reviewed should include a royalty-free copyright li- behalf of businesses formed there, then manuscript or published version is made pub- cense that is available to the public and that that’s all that a new business would licly available by presenting evidence dem- permits the reuse of those research papers, onstrating that the period is inconsistent on the condition that attribution is given to need to do to comply. Participation by with the objectives of the Federal research the author or authors of the research and the States is completely voluntary. If public access policy or the needs of the pub- any others designated by the copyright companies are formed in States that do lic, industry, or the scientific community; owner. not collect this information consistent (6) providing research papers as described with the new minimum standards, they in paragraph (4) in formats and under terms By Mr. WYDEN (for himself and will need to disclose their beneficial that enable productive reuse of the research Mr. RUBIO): owners directly to the U.S. Treasury and computational analysis by state-of-the- S. 1717. A bill to amend title 31, Department’s Financial Crimes En- art technologies; United States Code, to ensure that per- (7) improving the ability of the public to forcement Network. sons who form corporations or limited Collecting beneficial ownership infor- locate and access research papers made ac- liability companies in the United cessible under the Federal research public mation at the time a company is access policy; and States disclose the beneficial owners of formed will offer the transparency law (8) long-term preservation of, and free pub- those corporations or limited liability enforcement needs to investigate these lic access to, published research findings— companies, in order to prevent wrong- kinds of financial crimes. Under the (A) in a stable digital repository main- doers from exploiting United States bill, the new beneficial ownership in- tained by the Federal agency; or corporations and limited liability com- formation would not be available to (B) if consistent with the purposes of the panies for criminal gain, to assist law the public, but available only to appro- Federal agency, in any repository meeting enforcement in detecting, preventing, priate state and federal authorities. Fi- conditions determined favorable by the Fed- and punishing terrorism, money laun- eral agency (including free public access), nally, the bill provides civil and crimi- interoperability, and long-term preservation. dering, and other misconduct involving nal penalties for improper disclosure. (c) APPLICATION OF POLICY.—Each Federal United States corporations and limited The bill is constructed to exempt research public access policy shall— liability companies, and for other pur- many legitimate businesses, and the (1) apply to— poses; to the Committee on Banking, information requested is already pro- (A) researchers employed by the Federal Housing, and Urban Affairs. vided by most companies in the normal agency whose works remain in the public do- Mr. WYDEN. Mr. President, today I course of business. Collecting bene- main; and am, along with Senator RUBIO, intro- (B) researchers funded by the Federal agen- ficial ownership information at the ducing the Corporate Transparency Act time of incorporation relieves later cy; of 2017. This bill will help us end the (2) provide that works described under compliance burdens for legitimate paragraph (1)(A) shall be— abuse of anonymous shell companies by businesses, while at the same time pre- (A) marked as being public domain mate- criminals who use these entities to vents illegitimate businesses from op- rial when published; and launder money, finance terrorism, pro- erating in secrecy. (B) made available at the same time such mote sex trafficking, and evade taxes. The House companion to this bill, works are made available under subsection Each year criminals use anonymous H.R. 3089, was introduced with bipar- (b)(4); and shell companies to carry out their elic- tisan support and efforts to identify (3) make effective use of any law or guid- it schemes. Viktor Bout, the so-called the true owners of shell companies ance relating to the creation and reservation ‘‘merchant of death,’’ utilized a vast of a Government license that provides for have the support of business groups network of shell corporations, several like the Clearing House Association the reproduction, publication, release, or of which were in the United States, in- other uses of a final manuscript for Federal and the B-Team, law enforcement cluding one suspected of having pro- purposes. groups like the Fraternal Order of Po- vided weapons to the Taliban. Another (d) EXCLUSIONS.—Each Federal research lice, and anti-corruption advocacy public access policy shall not apply to— anonymous U.S. company owned a groups like the Financial Account- (1) research progress reports presented at large share of a Manhattan skyscraper ability and Corporate Transparency professional meetings or conferences; and used its anonymity to facilitate (2) laboratory notes, preliminary data (FACT) Coalition and Global Witness. $4.5 million in payments to an Iranian The Corporate Transparency Act of analyses, notes of the author, phone logs, or bank that was designated by OFAC as a other information used to produce final 2017 is a much needed step in stopping key financier to Iran’s nuclear and bal- manuscripts; financial crimes and the abuse of anon- listic missiles program. Anonymous (3) classified research, research resulting ymous shell companies. I thank Sen- shell companies have been used to rip in works that generate revenue or royalties ator RUBIO for joining me in intro- off taxpayers as well. In 2010, Michel for authors (such as books) or patentable dis- ducing this bill, and I ask my col- coveries, to the extent necessary to protect a Huarte was sentenced to 22 years in leagues to join me in supporting this copyright or patent; or prison after using a network of 29 shell bipartisan bill. (4) authors who do not submit their work companies in several States to defraud to a journal or works that are rejected by Mr. President, I ask unanimous con- Medicare, using the entities to submit sent that the text of the bill be printed journals. claims of more than $50 million. (e) PATENT OR COPYRIGHT LAW.—Nothing in in the RECORD. Last year, the release of documents this Act shall be construed to affect any There being no objection, the text of known as the Panama Papers leaked right under the provisions of title 17 or 35, the bill was ordered to be printed in from the Panamanian law firm United States Code. the RECORD, as follows: (f) GAO REPORT.—Not later than 3 years Mossack Fonseca highlighted the use S. 1717 after the date of enactment of this Act, and of American shell companies to carry every 5 years thereafter, the Comptroller out potential crimes. Shell company Be it enacted by the Senate and House of Rep- resentatives of the United States of America in General of the United States shall submit to abuse is not just in occurring in off- Congress a report that— Congress assembled, (1) includes an analysis of the period be- shore tax havens, but right here in the SECTION 1. SHORT TITLE. tween the date on which each paper becomes United States, and this bill seeks to This Act may be cited as the ‘‘Corporate publicly available in a journal and the date put a stop to that. Transparency Act of 2017’’. on which the paper is in the online reposi- In the United States, company reg- SEC. 2. FINDINGS. tory of the applicable Federal agency; and istrations take place at the State- Congress finds the following:

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00074 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.019 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4771 (1) Nearly 2,000,000 corporations and lim- (11) To reduce the vulnerability of the ‘‘(III) a unique identifying number from a ited liability companies are being formed United States to wrongdoing by United non-expired passport issued by the United under the laws of the States each year. States corporations and limited liability States or a non-expired driver’s license (2) Very few States obtain meaningful in- companies with hidden owners, to protect issued by a State; and formation about the beneficial owners of the interstate and international commerce from ‘‘(ii) if the applicant is not the beneficial corporations and limited liability companies criminals misusing United States corpora- owner, provides the identification informa- formed under their laws. tions and limited liability companies, to tion described in clause (i) relating to the (3) A person forming a corporation or lim- strengthen law enforcement investigations applicant. ited liability company within the United of suspect corporations and limited liability ‘‘(B) UPDATED INFORMATION.—For each cor- States typically provides less information to companies, to set minimum standards for poration or limited liability company formed the State of incorporation than is needed to and level the playing field among State in- under the laws of the State— obtain a bank account or driver’s license and corporation practices, and to bring the ‘‘(i) the corporation or limited liability typically does not name a single beneficial United States into compliance with its inter- company is required by the State to update owner. national anti-money laundering standards, the list of the beneficial owners of the cor- (4) Criminals have exploited the weak- Federal legislation is needed to require the poration or limited liability company by nesses in State formation procedures to con- collection of beneficial ownership informa- providing the information described in sub- ceal their identities when forming corpora- tion for the corporations and limited liabil- paragraph (A) to the State not later than 60 tions or limited liability companies in the ity companies formed under the laws of such days after the date of any change in the list States. of beneficial owners or the information re- United States, and have then used the newly quired to be provided relating to each bene- created entities to commit crimes affecting SEC. 3. TRANSPARENT INCORPORATION PRAC- TICES. ficial owner; interstate and international commerce such (a) TRANSPARENT INCORPORATION PRAC- ‘‘(ii) in the case of a corporation or limited as terrorism, drug trafficking, money laun- TICES.— liability company formed or acquired by a dering, tax evasion, securities fraud, finan- (1) IN GENERAL.—Chapter 53 of title 31, formation agent and retained by the forma- cial fraud, and acts of foreign corruption. United States Code, is amended by inserting tion agent as a beneficial owner for transfer (5) Law enforcement efforts to investigate after section 5332 the following new section: to another person, the formation agent is re- corporations and limited liability companies ‘‘§ 5333. Transparent incorporation practices quired by the State to submit to the State suspected of committing crimes have been an updated list of the beneficial owners and impeded by the lack of available beneficial ‘‘(a) REPORTING REQUIREMENTS.— ‘‘(1) IN GENERAL.—Not later than the begin- the information described in subparagraph ownership information, as documented in re- (A) for each such beneficial owner not later ports and testimony by officials from the De- ning of fiscal year 2019, the Secretary of the Treasury shall issue regulations requiring than 10 days after date on which the forma- partment of Justice, the Department of tion agent transfers the corporation or lim- Homeland Security, the Financial Crimes each corporation and limited liability com- pany formed in a State that does not have a ited liability company to another person; Enforcement Network of the Department of and the Treasury, the Internal Revenue Service, formation system described under subsection (b) to file with the Financial Crimes Enforce- ‘‘(iii) the corporation or limited liability and the Government Accountability Office, company is required by the State to submit and others. ment Network such information as the cor- poration or limited liability company would to the State an annual filing containing the (6) In July 2006, a leading international be required to provide the State if such State list of the beneficial owners of the corpora- anti-money laundering organization, the Fi- had a formation system described under sub- tion or limited liability company and the in- nancial Action Task Force on Money Laun- section (b). formation described in subparagraph (A) for dering (in this section referred to as the ‘‘(2) DISCLOSURE OF BENEFICIAL OWNERSHIP each such beneficial owner. ‘‘FATF’’), of which the United States is a INFORMATION.—Beneficial ownership informa- ‘‘(C) RETENTION OF INFORMATION.—Bene- member, issued a report that criticizes the tion reported to the Financial Crimes En- ficial ownership information relating to each United States for failing to comply with a forcement Network pursuant to paragraph corporation or limited liability company FATF standard on the need to collect bene- (1) shall be provided by the Financial Crimes formed under the laws of the State is re- ficial ownership information and urged the Enforcement Network upon receipt of— quired to be maintained by the State until United States to correct this deficiency by ‘‘(A) a civil or criminal subpoena or sum- the end of the 5-year period beginning on the July 2008. In December 2016, FATF issued an- mons from a State agency, Federal agency, date that the corporation or limited liability other evaluation of the U.S., which found or congressional committee or subcommittee company terminates under the laws of the that little progress has been made over the requesting such information; State. last ten years to address this problem. It ‘‘(B) a written request made by a Federal ‘‘(D) INFORMATION REQUESTS.—Beneficial identified the ‘‘lack of timely access to ade- agency on behalf of another country under ownership information relating to each cor- quate, accurate and current beneficial own- an international treaty, agreement, or con- poration or limited liability company formed ership information’’ as a fundamental gap in vention, or an order under section 3512 of under the laws of the State shall be provided U.S. efforts to combat money laundering and title 18 or section 1782 of title 28 issued in re- by the State upon receipt of— terrorist finance. sponse to a request for assistance from a for- ‘‘(i) a civil or criminal subpoena or sum- (7) In response to the 2006 FATF report, the eign country; or mons from a State agency, Federal agency, United States has repeatedly urged the ‘‘(C) a written request made by a financial or congressional committee or subcommittee States to strengthen their incorporation institution, with customer consent, as part requesting such information; practices by obtaining beneficial ownership of the institution’s compliance with due dili- ‘‘(ii) a written request made by a Federal information for the corporations and limited gence requirements imposed under the Bank agency on behalf of another country under liability companies formed under the laws of Secrecy Act (Public Law 91508; 84 Stat. 1114), an international treaty, agreement, or con- such States. the USA PATRIOT Act (Public Law 10756; 115 vention, or section 1782 of title 28; (8) Many States have established auto- Stat. 272), or other applicable Federal or ‘‘(iii) a written request made by the Finan- mated procedures that allow a person to State law. cial Crimes Enforcement Network; or form a new corporation or limited liability ‘‘(3) LIMITATION.—In issuing regulations ‘‘(iv) a written request made by a financial company within the State within 24 hours of pursuant to paragraph (1), the Secretary institution, with customer consent, as part filing an online application, without any shall not require such information to be filed of the institution’s compliance with due dili- prior review of the application by a State of- with the Internal Revenue Service. gence requirements imposed under the Bank ficial. In exchange for a substantial fee, 2 ‘‘(b) FORMATION SYSTEM.— Secrecy Act (Public Law 91508; 84 Stat. 1114), States will form a corporation within 1 hour ‘‘(1) IN GENERAL.—With respect to a State, the USA PATRIOT Act (Public Law 10756; 115 of a request. a formation system is described under this Stat. 272), or other applicable Federal or (9) Dozens of Internet Web sites highlight subsection if it meets the following require- State law. the anonymity of beneficial owners allowed ments: ‘‘(E) NOTICE.—The State discloses clearly under the incorporation practices of some ‘‘(A) IDENTIFICATION OF BENEFICIAL OWN- and conspicuously that the beneficial owner- States, point to those practices as a reason ERS.—Except as provided in paragraphs (2) ship information collected under the forma- to incorporate in those States, and list those and (4), and subject to paragraph (3), each ap- tion system may be provided to the entities States together with offshore jurisdictions plicant to form a corporation or limited li- described in subparagraph (D), pursuant to as preferred locations for the formation of ability company under the laws of the State the requirements of such subparagraph. new corporations, essentially providing an is required to provide to the State during the ‘‘(F) NO BEARER SHARE CORPORATIONS OR open invitation to criminals and other formation process a list of the beneficial LIMITED LIABILITY COMPANIES.—A corporation wrongdoers to form entities within the owners of the corporation or limited liability or limited liability company formed under United States. company that— the laws of the State may not issue a certifi- (10) In contrast to practices in the United ‘‘(i) except as provided in subparagraph (F), cate in bearer form evidencing either a States, all 28 countries in the European identifies each beneficial owner by— whole or fractional interest in the corpora- Union are required to have formation agents ‘‘(I) name; tion or limited liability company. identify the beneficial owners of the corpora- ‘‘(II) current residential or business street ‘‘(2) STATES THAT LICENSE FORMATION tions formed under the laws of the country. address; and AGENTS.—

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‘‘(A) IN GENERAL.—Notwithstanding para- ability company or a beneficial owner, offi- tion or limited liability company formed or graph (1), a State described in subparagraph cer, director, or similar agent of a corpora- to be formed under the laws of a State, the (B) may permit an applicant to form a cor- tion or limited liability company who is re- applicant, corporation, or limited liability poration or limited liability company under quired to provide identification information company in which the entity has or will have the laws of the State, or a corporation or under this subsection does not have a non- the ownership interest shall provide the in- limited liability company formed under the expired passport issued by the United States formation required under this subsection re- laws of the State, to provide the required in- or a non-expired driver’s license or identi- lating to the entity, except that the entity formation to a licensed formation agent re- fication card issued by a State, each applica- shall not be required to provide information siding in the State, instead of to the State tion described in paragraph (1)(A) and each regarding any natural person who has an directly, if the application under paragraph update described in paragraph (1)(B) shall in- ownership interest in, exercises substantial (1)(A) or the update under paragraph (1)(B) clude a certification by a formation agent control over, or receives substantial eco- contains— residing in the State that the formation nomic benefits from the entity. ‘‘(i) the name, current business address, agent— ‘‘(c) PENALTIES.— contact information, and licensing number ‘‘(A) has obtained for each such person a ‘‘(1) IN GENERAL.—It shall be unlawful for— of the licensed formation agent that has current residential or business street address ‘‘(A) any person to affect interstate or for- agreed to maintain the information required and a legible and credible copy of the pages eign commerce by— under this subsection; and of a non-expired passport issued by the gov- ‘‘(i) knowingly providing, or attempting to ‘‘(ii) a certification by the licensed forma- ernment of a foreign country bearing a pho- provide, false or fraudulent beneficial owner- tion agent that the licensed formation agent tograph, date of birth, and unique identi- ship information, including a false or fraudu- has possession of the information required fying information for the person; lent identifying photograph, to a State or li- under this subsection and will maintain the ‘‘(B) has verified the name, address, and censed formation agent under State law in information in the State licensing the li- identity of each such person; accordance with this section; censed formation agent in accordance with ‘‘(C) will provide the information described ‘‘(ii) willfully failing to provide complete State law. in subparagraph (A) and the proof of or updated beneficial ownership information ‘‘(B) STATES DESCRIBED.—A State described verification described in subparagraph (B) to a State or licensed formation agent under in this subparagraph is a State that main- upon request under the same circumstances State law in accordance with this section; or tains a formal licensing system for forma- as required for States under paragraph ‘‘(iii) knowingly disclosing the existence of tion agents that requires a formation agent (1)(D); and a subpoena, summons, or other request for to register with the State, meet standards ‘‘(D) will retain the information and proof beneficial ownership information, except— for fitness and honesty, maintain a physical of verification under this paragraph in the ‘‘(I) to the extent necessary to fulfill the office and records within the State, undergo State in which the corporation or limited li- authorized request; regular monitoring, and be subject to sanc- ability company is being or has been formed ‘‘(II) as authorized by the entity that tions for noncompliance with State require- until the end of the 5-year period beginning issued the subpoena, summons, or other re- ments. on the date that the corporation or limited quest; or ‘‘(C) LICENSED FORMATION AGENT DUTIES.—A liability company terminates under the laws ‘‘(III) as prescribed by a State; or licensed formation agent that receives bene- of the State. ‘‘(B) in the case of a formation agent, ficial ownership information under State law ‘‘(4) EXEMPT ENTITIES.— knowingly failing to obtain or maintain in accordance with this paragraph shall— ‘‘(A) IN GENERAL.—A formation system de- ‘‘(i) maintain the information in the State scribed in paragraph (1) shall require that an credible, legible, and updated beneficial own- in which the corporation or limited liability application for an entity described in sub- ership information, including any required company is being or has been formed in the paragraph (C) or (D) of subsection (d)(2) that identifying photograph. same manner as required for States under is proposed to be formed under the laws of a ‘‘(2) CIVIL AND CRIMINAL PENALTIES.—In ad- paragraph (1)(C); State and that will be exempt from the bene- dition to any civil or criminal penalty that ‘‘(ii) provide the information under the ficial ownership disclosure requirements may be imposed by a State, any person who same circumstances as required for States under this subsection shall include in the ap- violates paragraph (1)— under paragraph (1)(D); and plication a certification by the applicant, or ‘‘(A) shall be liable to the United States for ‘‘(iii) perform the duties of a formation a prospective officer, director, or similar a civil penalty of not more than $10,000; and agent under paragraph (3). agent of the entity— ‘‘(B) may be fined under title 18, impris- ‘‘(D) TERMINATION OF RELATIONSHIP.— ‘‘(i) identifying the specific provision of oned for not more than 3 years, or both. ‘‘(i) IN GENERAL.—Except as provided in subsection (d)(2) under which the entity pro- ‘‘(d) DEFINITIONS.—For the purposes of this clause (ii), a licensed formation agent that posed to be formed would be exempt from the section: receives beneficial ownership information re- beneficial ownership disclosure requirements ‘‘(1) BENEFICIAL OWNER.—The term ‘bene- lating to a corporation or limited liability under paragraphs (1), (2), and (3); ficial owner’— company under State law in accordance with ‘‘(ii) stating that the entity proposed to be ‘‘(A) means a natural person who, directly this paragraph and that resigns, dissolves, or formed meets the requirements for an entity or indirectly— otherwise ends a relationship with the cor- described under such provision of subsection ‘‘(i) exercises substantial control over a poration or limited liability company shall (d)(2); and corporation or limited liability company; or promptly— ‘‘(iii) providing identification information ‘‘(ii) has a substantial interest in or re- ‘‘(I) notify the State in writing that the li- for the applicant or prospective officer, di- ceives substantial economic benefits from censed formation agent has resigned or rector, or similar agent making the certifi- the assets of a corporation or limited liabil- ended the relationship; and cation in the same manner as provided under ity company; and ‘‘(II) transmit all beneficial ownership in- paragraph (1) or (3). ‘‘(B) does not include— formation relating to the corporation or lim- ‘‘(B) EXISTING ENTITIES.—On and after the ‘‘(i) a minor child; ited liability company in the possession of date that is 2 years after the effective date of ‘‘(ii) a person acting as a nominee, inter- the licensed formation agent to the licensing the amendments to the formation system of mediary, custodian, or agent on behalf of an- State. a State made to comply with this section, an other person; ‘‘(ii) EXCEPTION.—If a licensed formation entity formed under the laws of the State be- ‘‘(iii) a person acting solely as an employee agent receives written instructions from a fore such effective date shall be considered of a corporation or limited liability company corporation or limited liability company, to be a corporation or limited liability com- and whose control over or economic benefits the licensed formation agent may transmit pany for purposes of, and shall be subject to from the corporation or limited liability the beneficial ownership information relat- the requirements of, this subsection unless company derives solely from the employ- ing to the corporation or limited liability an officer, director, or similar agent of the ment status of the person; company to another licensed formation entity submits to the State a certification— ‘‘(iv) a person whose only interest in a cor- agent that is within the same State and has ‘‘(i) identifying the specific provision of poration or limited liability company is agreed to maintain the information in ac- subsection (d)(2) under which the entity is through a right of inheritance, unless the cordance with this section. exempt from the requirements under para- person also meets the requirements of sub- ‘‘(iii) NOTICE TO STATE.—If a licensed for- graphs (1), (2), and (3); paragraph (A); or mation agent provides beneficial ownership ‘‘(ii) stating that the entity meets the re- ‘‘(v) a creditor of a corporation or limited information to another licensed formation quirements for an entity described under liability company, unless the creditor also agent under clause (ii), the licensed forma- such provision of subsection (d)(2); and meets the requirements of subparagraph (A). tion agent providing the information shall ‘‘(iii) providing identification information ‘‘(2) CORPORATION; LIMITED LIABILITY COM- promptly notify in writing the State under for the officer, director, or similar agent PANY.—The terms ‘corporation’ and ‘limited the laws of which the corporation or limited making the certification in the same manner liability company’— liability company is formed of the identity as provided under paragraph (1) or (3). ‘‘(A) have the meanings given such terms of the licensed formation agent receiving the ‘‘(C) EXEMPT ENTITIES HAVING OWNERSHIP under the laws of the applicable State; information. INTEREST.—If an entity described in subpara- ‘‘(B) include any non-United States entity ‘‘(3) CERTAIN BENEFICIAL OWNERS.—If an ap- graph (C) or (D) of subsection (d)(2) has or eligible for registration or registered to do plicant to form a corporation or limited li- will have an ownership interest in a corpora- business as a corporation or limited liability

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00076 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.023 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4773 company under the laws of the applicable ‘‘(xv) any corporation or limited liability ment of this Act, funds shall be made avail- State; company formed and owned by an entity de- able to each State to pay reasonable costs ‘‘(C) do not include any entity that is, and scribed in clause (i), (ii), (iii), (iv), (v), (vi), relating to compliance with the require- discloses in the application by the entity to (vii), (viii), (ix), (x), (xi), (xii), (xiii), or (xiv); ments of such section. form under the laws of the State or, if the and (2) FUNDING SOURCES.—To protect the entity was formed before the date of the en- ‘‘(D) do not include any individual business United States against the misuse of United actment of this section, in a filing with the concern or class of business concerns which States corporations and limited liability State under State law— the Secretary of the Treasury, with the writ- companies with hidden owners, funds shall ‘‘(i) a business concern that is an issuer of ten concurrence of the Attorney General of be provided to each State to carry out the a class of securities registered under section the United States, has determined in writing purposes described in paragraph (1) from one 12 of the Securities Exchange Act of 1934 (15 should be exempt from the requirements of or more of the following sources: U.S.C. 78l) or that is required to file reports subsection (a), because requiring beneficial (A) Upon application by a State, and with- under section 15(d) of that Act (15 U.S.C. ownership information from the business out further appropriation, the Secretary of 78o(d)); concern would not serve the public interest the Treasury shall make available to the ‘‘(ii) a business concern constituted or and would not assist law enforcement efforts State unobligated balances described in sec- sponsored by a State, a political subdivision to detect, prevent, or punish terrorism, tion 9703(g)(4)(B) of title 31, United States of a State, under an interstate compact be- money laundering, tax evasion, or other mis- Code, in the Department of the Treasury tween 2 or more States, by a department or conduct. Forfeiture Fund established under section agency of the United States, or under the ‘‘(3) FORMATION AGENT.—The term ‘forma- 9703(a) of title 31, United States Code. laws of the United States; tion agent’ means a person who, for com- (B) Upon application by a State, after con- ‘‘(iii) a depository institution (as defined pensation— sultation with the Secretary of the Treas- in section 3 of the Federal Deposit Insurance ‘‘(A) acts on behalf of another person to as- ury, and without further appropriation, the Act (12 U.S.C. 1813)); sist in the formation of a corporation or lim- Attorney General of the United States shall ‘‘(iv) a credit union (as defined in section ited liability company under the laws of a make available to the State excess unobli- 101 of the Federal Credit Union Act (12 U.S.C. State; or gated balances (as defined in section 1752)); ‘‘(B) purchases, sells, or transfers the pub- 524(c)(8)(D) of title 28, United States Code) in ‘‘(v) a bank holding company (as defined in lic records that form a corporation or lim- the Department of Justice Assets Forfeiture section 2 of the Bank Holding Company Act ited liability company.’’. Fund established under section 524(c) of title of 1956 (12 U.S.C. 1841)); (2) RULEMAKING.—To carry out this Act 28, United States Code. ‘‘(vi) a broker or dealer (as defined in sec- and the amendments made by this Act, the (3) MAXIMUM AMOUNTS.— tion 3 of the Securities Exchange Act of 1934 Secretary of the Treasury, in consultation (A) DEPARTMENT OF THE TREASURY.—The (15 U.S.C. 78c)) that is registered under sec- with the Secretary of Homeland Security Secretary of the Treasury may not make tion 15 of the Securities Exchange Act of 1934 and the Attorney General of the United available to States a total of more than (15 U.S.C. 78o); States, may issue guidance or a rule to— $30,000,000 under paragraph (2)(A). ‘‘(vii) an exchange or clearing agency (as (A) clarify the definitions under section (B) DEPARTMENT OF JUSTICE.—The Attor- defined in section 3 of the Securities Ex- 5333(d) of title 31, United States Code, as ney General of the United States may not change Act of 1934 (15 U.S.C. 78c)) that is reg- added by paragraph (1); and make available to States a total of more istered under section 6 or 17A of the Securi- (B) specify how to verify beneficial owner- than $10,000,000 under paragraph (2)(B). ties Exchange Act of 1934 (15 U.S.C. 78f and ship information or other identification in- (4) RULEMAKING.—Not later than the end of 78q–1); formation for purposes of such section 5333, the 180-day period beginning on the date of ‘‘(viii) an investment company (as defined including whether the verification proce- the enactment of this Act, the Secretary of in section 3 of the Investment Company Act dures specified in section 5333(b)(3) should the Treasury and the Attorney General shall, of 1940 (15 U.S.C. 80a–3)) or an investment ad- apply to all applicants under section jointly, issue regulations setting forth the visor (as defined in section 202 of the Invest- 5333(b)(1) or whether such verification proc- procedures for States to apply for funds ment Advisers Act of 1940 (15 U.S.C. 80b–2)), ess should require the notarization of signa- under this subsection, including determining if the company or adviser is registered with tures. which State measures should be funded to the Securities and Exchange Commission, or (3) CONFORMING AMENDMENTS.—Title 31, assess, plan, develop, test, or implement rel- has filed an application for registration United States Code, is amended— evant policies, procedures, or system modi- which has not been denied, under the Invest- (A) in section 5321(a)— fications. ment Company Act of 1940 (15 U.S.C. 80a–1 et (i) in paragraph (1), by striking ‘‘sections (c) COMPLIANCE REPORT.—Nothing in this seq.) or the Investment Advisers Act of 1940 5314 and 5315’’ each place it appears and in- section or the amendments made by this sec- (15 U.S.C. 80b–1 et seq.); serting ‘‘sections 5314, 5315, and 5333’’; and tion authorizes the Secretary of the Treas- ‘‘(ix) an insurance company (as defined in (ii) in paragraph (6), by inserting ‘‘(except ury to withhold from a State any funding section 2 of the Investment Company Act of section 5333)’’ after ‘‘subchapter’’ each place otherwise available to the State because of a 1940 (15 U.S.C. 80a–2)); it appears; and failure by that State to comply with section ‘‘(x) a registered entity (as defined in sec- (B) in section 5322, by striking ‘‘section 5333 of title 31, United States Code. Not later tion 1a of the Commodity Exchange Act (7 5315 or 5324’’ each place it appears and insert- than the end of the 42-month period begin- U.S.C. 1a)), or a futures commission mer- ing ‘‘section 5315, 5324, or 5333’’. ning on the date of the enactment of this chant, introducing broker, commodity pool (4) TABLE OF CONTENTS.—The table of con- Act, the Comptroller General of the United operator, or commodity trading advisor (as tents of chapter 53 of title 31, United States States shall submit to the Committee on Fi- defined in section 1a of the Commodity Ex- Code, is amended by inserting after the item nancial Services of the House of Representa- change Act (7 U.S.C. 1a)) that is registered relating to section 5332 the following: tives and the Committee on Homeland Secu- with the Commodity Futures Trading Com- ‘‘Sec. 5333. Transparent incorporation prac- rity and Governmental Affairs of the Senate mission; tices.’’. a report— ‘‘(xi) a public accounting firm registered in (5) RESTRICTIONS ON PUBLIC ACCESS.—A (1) identifying which States obtain bene- accordance with section 102 of the Sarbanes- State may— ficial ownership information as described in Oxley Act (15 U.S.C. 7212); (A) restrict public access to all or any por- such section 5333; ‘‘(xii) a public utility that provides tele- tion of the beneficial ownership information (2) with respect to each State that does not communications service, electrical power, provided to the State as described under sec- obtain such information, whether corpora- natural gas, or water and sewer services, tion 5332 of title 31, United States Code, as tions and limited liability companies formed within the United States; added by this Act; and under the laws of such State are in compli- ‘‘(xiii) a church, charity, or nonprofit enti- (B) by statute, regulation, order, or inter- ance with such section 5333 and providing the ty that is described in section 501(c), 527, or pretation adopted or issued by the State specified beneficial ownership information to 4947(a)(1) of the Internal Revenue Code of after the date of enactment of this Act, pro- the Financial Crimes Enforcement Network; 1986, has not been denied tax exempt status, vide for public access to all or any portion of and and has filed the most recently due annual such information. (3) whether the Department of the Treas- information return with the Internal Rev- (6) NO DUTY OF VERIFICATION.—This Act and ury is in compliance with such section 5333 enue Service, if required to file such a re- the amendments made by this Act do not im- and, if not, what steps it must take to come turn; pose any obligation on a State to verify the into compliance with this section. ‘‘(xiv) any business concern that— name, address, or identity of a beneficial (d) FEDERAL CONTRACTORS.—Not later than ‘‘(I) employs more than 20 employees on a owner whose information is submitted to the first day of the first full fiscal year be- full-time basis in the United States; such State under section 5333 of title 31, ginning at least 1 year after the date of the ‘‘(II) files income tax returns in the United United States Code, as added by this Act. enactment of this Act, the Administrator for States demonstrating more than $5,000,000 in (b) FUNDING AUTHORIZATION.— Federal Procurement Policy shall revise the gross receipts or sales; and (1) IN GENERAL.—To carry out section 5333 Federal Acquisition Regulation maintained ‘‘(III) has an operating presence at a phys- of title 31, United States Code, during the 3- under section 1303(a)(1) of title 41, United ical office within the United States; or year period beginning on the date of enact- States Code, to require any contractor who

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00077 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.023 S02AUPT1 S4774 CONGRESSIONAL RECORD — SENATE August 2, 2017 is subject to the requirement to disclose ben- formed or registered in the United States has These life-saving interventions in- eficial ownership information under section elicited international criticism and what clude clean birthing practices, vac- 5333 of title 31, United States Code, to pro- steps, if any, the United States has taken or vide the information required to be disclosed is planning to take in response. cines, nutritional supplements, hand- under such section to the Federal Govern- (b) EFFECTIVENESS OF INCORPORATION PRAC- washing with soap, and other basic ment as part of any bid or proposal for a con- TICES.—Not later than 5 years after the date needs that remain elusive for far too tract with a value threshold in excess of the of enactment of this Act, the Comptroller many women and children in devel- General of the United States shall conduct a simplified acquisition threshold under sec- oping countries. This must change. tion 134 of title 41, United States Code. study and submit to the Congress a report (e) ANTI-MONEY LAUNDERING OBLIGATIONS assessing the effectiveness of incorporation In addition, our bill would establish a OF FORMATION AGENTS.— practices implemented under this Act and Maternal and Child Survival Coordi- the amendments made by this Act in— (1) IN GENERAL.—Section 5312(a)(2) of title nator at USAID who would focus on 31, United States Code, is amended— (1) providing law enforcement agencies (A) in subparagraph (Y), by striking ‘‘or’’ with prompt access to reliable, useful, and implementing the ten-year strategy at the end; complete beneficial ownership information; and verifying that the most effective (B) by redesignating subparagraph (Z) as and interventions are being scaled up in (2) strengthening the capability of law en- subparagraph (AA); and target countries. (C) by inserting after subparagraph (Y) the forcement agencies to combat incorporation following: abuses, civil and criminal misconduct, and The bill would also establish an ‘‘(Z) any person who, for compensation— detect, prevent, or punish terrorism, money interagency working group to assist laundering, tax evasion, or other mis- ‘‘(i) acts on behalf of another person to the Coordinator in promoting greater form, or assist in formation of, a corporation conduct. or limited liability company under the laws collaboration among all the federal of a State; or By Ms. COLLINS (for herself, Mr. agencies involved in this effort. COONS, Mr. MORAN, Mrs. SHA- ‘‘(ii) purchases, sells, or transfers the pub- To promote transparency and greater HEEN, Mr. RUBIO, Mr. lic records that form a corporation or lim- accountability, our bill requires that ited liability company; or’’. BLUMENTHAL, Mr. ENZI, Mr. detailed reporting be published on the (2) DEADLINE FOR ANTI-MONEY LAUNDERING ISAKSON, Mr. DURBIN, and Mr. RULE FOR FORMATION AGENTS.— MURPHY): Foreign Assistance Dashboard, where (A) PROPOSED RULE.—Not later than 120 S. 1730. A bill to implement policies it can be assessed by the public, Con- days after the date of enactment of this Act, to end preventable maternal, newborn, gress, and non-governmental organiza- the Secretary of the Treasury, in consulta- and child deaths globally; to the Com- tion with the Attorney General of the United tions to track the implementation of States and the Commissioner of the Internal mittee on Foreign Relations. the strategy and the progress being Revenue Service, shall publish a proposed Ms. COLLINS. Mr. President, today I made. rule in the Federal Register requiring per- am pleased to be joined by my friend sons described in section 5312(a)(2)(Z) of title and colleague from Delaware, Senator Finally, our bill would encourage 31, United States Code, as amended by this CHRIS COONS, in introducing the Reach USAID to pay for successful programs subsection, to establish anti-money laun- Every Mother and Child Act of 2017. run by non-governmental entities. The dering programs under subsection (h) of sec- Our legislation would make it the pol- message we want to send to all our tion 5318 of that title. icy of the United States to lead an ef- partners in the private sector, the non- (B) FINAL RULE.—Not later than 270 days fort to end preventable deaths of moth- profit sector, the faith community, and after the date of enactment of this Act, the ers, newborns, and young children in Secretary of the Treasury shall publish the in local and international civil society rule described in this subsection in final the developing world by 2030. Due in part to American leadership groups is this: if you can figure out a form in the Federal Register. way to increase the likelihood that (C) EXCLUSIONS.—Any rule promulgated and generosity, many lives have al- under this subsection shall exclude from the ready been saved. Since 1990, the an- mothers and their children will survive category of persons involved in forming a nual number of deaths of children childbirth and the first five years of corporation or limited liability company— under the age of five has been cut in life, we want to reward you for your (i) any government agency; and half. Nevertheless, far too many moth- contribution. (ii) any attorney or law firm that uses a ers, newborns, and young children paid formation agent operating within the under the age of five still succumb to Improving the health and well-being United States to form the corporation or disease and malnutrition that could of mothers and children around the limited liability company. easily be prevented, if only we could world has far-reaching social and eco- SEC. 4. STUDIES AND REPORTS. reach the mothers and children with nomic benefits as well. An independent (a) OTHER LEGAL ENTITIES.—Not later than simple, proven, cost-effective interven- group of economists and global health 2 years after the date of enactment of this tions that we know will help them sur- Act, the Comptroller General of the United experts from around the world, known States shall conduct a study and submit to vive. as the Lancet Commission, found that Every day approximately 800 women Congress a report— for every $1 invested in health initia- will die from preventable causes re- (1) identifying each State that has proce- tives in the developing world, there is a dures that enable persons to form or register lated to pregnancy and childbirth. In under the laws of the State partnerships, addition, more than 16,000 children return of $9 to $20 in growing the gross trusts, or other legal entities, and the nature under the age of five will die each day domestic product of the country receiv- of those procedures; of treatable conditions such as pre- ing the investment. (2) identifying each State that requires maturity, pneumonia, and diarrhea— persons seeking to form or register partner- Other bipartisan initiatives, such as with malnutrition being the underlying the successful President’s Emergency ships, trusts, or other legal entities under cause in nearly half those deaths. the laws of the State to provide information According to USAID, a concentrated Plan for AIDS Relief, or PEPFAR, about the beneficial owners (as that term is effort could end preventable maternal which was started by President George defined in section 5333(d)(1) of title 31, United W. Bush, demonstrate that results- States Code, as added by this Act) or bene- and child deaths worldwide by the year ficiaries of such entities, and the nature of 2030; however, U.S. leadership and sup- driven interventions can turn the tide the required information; port of the international community for global health challenges. Applying (3) evaluating whether the lack of avail- are critical to success. lessons learned from past initiatives, able beneficial ownership information for To achieve this ambitious goal, our our bill would provide the focus and partnerships, trusts, or other legal entities— bill would require the implementation the tools necessary to accelerate (A) raises concerns about the involvement of a strategy to scale up the most effec- of such entities in terrorism, money laun- tive interventions to save as many progress toward ending preventable dering, tax evasion, securities fraud, or other lives as possible. This idea is central to maternal and child deaths. misconduct; and (B) has impeded investigations into enti- our bill. We do not have to guess at I urge my colleagues to join Senator ties suspected of such misconduct; and what interventions will work—the re- COONS and me in supporting this bill to (4) evaluating whether the failure of the ality is that more than 16,000 children save the lives of mothers and children United States to require beneficial owner- under 5 years old die each day of condi- around the world. ship information for partnerships and trusts tions we know today how to treat.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00078 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.023 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4775 SUBMITTED RESOLUTIONS adequate spectrum bands will be essential to Second Class Alvin Dvork, Seaman First the deployment of 5G networks and next- Class Donald Stratton, and Fire Controlman generation wireless technologies, and the re- Third Class Lauren Bruner, were trapped in SENATE RESOLUTION 242—EX- alization of all its promised economic and the control tower main mast after a massive PRESSING THE SENSE OF THE social benefits; explosion on the ship; Whereas wireless and wired broadband net- Whereas those 6 sailors suffered severe SENATE ABOUT A STRATEGY TO works, in addition to other technologies, are burns; DEPLOY FIFTH GENERATION MO- essential to closing the digital divide, deliv- Whereas those wounded sailors searched BILE NETWORKS (5G NETWORKS) ering broadband service to rural areas, cre- for a way to escape the ship; AND NEXT-GENERATION WIRE- ating jobs, and powering economic develop- Whereas Boatswain’s Mate Second Class LESS AND WIRED TECHNOLOGIES ment and innovation across the United George saw the 6 wounded sailors on the TO PROMOTE ECONOMIC DEVEL- States: Now, therefore, be it U.S.S. Arizona from the U.S.S. Vestal and OPMENT AND DIGITAL INNOVA- Resolved, That it is the sense of the Senate threw a heaving line and a heavy line; TION THROUGHOUT THE UNITED that the United States should— Whereas all 6 sailors climbed, nearly 40 (1) promote the deployment of 5G networks feet in the air, hand over hand across the STATES in a manner that encourages robust invest- heavy line 70 feet to safety onboard the Mr. WICKER (for himself, Mr. ment, job creation, economic growth, and U.S.S. Vestal; SCHATZ, Mr. GARDNER, Ms. HASSAN, Mr. continued United States leadership in devel- Whereas 2 sailors died shortly after from MORAN, and Mr. PETERS) submitted the oping next-generation wireless technologies; their injuries, but the remaining 4 survived; following resolution; which was re- (2) advance 5G networks as a way of clos- Whereas Boatswain’s Mate Second Class ing the digital divide and reducing the dis- George was commended for his actions, but ferred to the Committee on Commerce, parity in quality communications services he was never given a medal for his role in the Science, and Transportation: available in rural areas; rescue of the 6 sailors; S. RES. 242 (3) recognize that 5G networks will facili- Whereas the 2 surviving sailors rescued Whereas wireless and wired broadband net- tate the development of a new generation of from the U.S.S. Arizona, Donald Stratton works are essential to economic growth, job technologies that will open opportunities for and Lauren Bruner, seek to honor Boat- creation, and the global competitiveness of increased efficiency, mobility, accessibility, swain’s Mate Second Class George; the United States; economic development, and prosperity in Whereas U.S.S. Arizona survivor Donald Whereas wireless and wired broadband net- communities throughout the country; Stratton stated, ‘‘Joe George was never works provide connectivity to billions of de- (4) commit to modernizing the infrastruc- awarded anything for his bravery. He is no vices, applications, and services that are in- ture policies of the United States and identi- longer with us, but I believe in his memory, creasing productivity and efficiency across fying additional spectrum in low, mid, and should be awarded the Navy Cross.’’; and every industry and economic sector; high bands for licensed and unlicensed uses Whereas U.S.S. Arizona survivor Lauren Whereas wireless and wired broadband net- and to support the deployment of 5G net- Bruner stated, ‘‘The six of us would not have works create and support millions of jobs; works and meet the increasing demands for survived except for his courage, in spite of Whereas wireless and wired broadband net- wireless broadband service; being at high risk himself. He fully deserves works are vital to providing communications (5) recognize that 5G networks will give high commendations for his actions. I feel he services and access to internet connectivity consumers access to more choices and enable should be recognized for this courage and to people in the United States living in rural them to derive greater value from mobile presented the Navy Cross.’’: Now, therefore, and remote geographic areas; connections; be it Whereas wireless and wired broadband net- (6) commit to deploying 5G networks that Resolved, That the Senate— works are a platform for innovation and in- are resilient and secure; (1) honors the heroism of Boatswain’s Mate genuity, powering advancements in the (7) continue to participate in global efforts Second Class Joseph Leon George in saving Internet of Things and other revolutionary to create standards for 5G networks that im- the lives of 6 sailors on December 7, 1941; and technologies; prove user experiences, maximize use-cases, (2) believes the United States Navy, in Whereas 5G networks will have the capac- enable interoperability, sustain multiple, si- light of new information, should consider re- ity to deliver enhanced mobile broadband multaneous connections, increase network visiting decorating and honoring the heroism with significantly faster data transmission capacity through virtualization or other of Boatswain’s Mate Second Class Joseph speeds, low latency, more reliable connec- software developments, and adapt to new Leon George in saving the lives of 6 sailors tions, and greater data capacity, which will technologies and future network applica- on December 7, 1941. provide for seamless internet connectivity tions; and Mr. FLAKE. Mr. President, recently, throughout all regions across the United (8) promote the deployment of broadband I was fortunate enough to have the op- States; technologies to expand the availability, af- fordability, and quality of broadband service portunity to host several veterans who Whereas 5G networks are expected to cre- survived the sinking of the USS Ari- ate more than 3,000,000 new jobs in the throughout the United States. zona in the attack on Pearl Harbor. United States, generate $275,000,000,000 in in- f vestment from the wireless industry, and add I would like to briefly share an in- $500,000,000,000 to the economy of the United SENATE RESOLUTION 243—EX- credible story they told me about a States over the next decade; PRESSING THE SENSE OF THE true American hero named Joe George. Whereas next-generation, gigabit Wi-Fi so- SENATE THAT JOSEPH LEON On December 7, 1941, Joe was a 26- lutions that rely on unlicensed spectrum GEORGE SHOULD BE HONORED year-old Boatswain’s Mate Second bands are poised to unleash a new round of FOR HEROISM AT PEARL HAR- Class aboard the repair ship USS Vestal innovation and consumer benefit from an in- BOR, HAWAII, ON DECEMBER 7, in Pearl Harbor, HI, moored alongside dustry that generates an economic surplus of 1941 the USS Arizona. $547,000,000,000 and contributes $50,000,000,000 annually in gross domestic product to the Mr. FLAKE (for himself, Mr. GARD- At 7:48 a.m., many sailors, including economy of the United States; NER, Mr. LEE, Mr. COTTON, Mrs. MCCAS- Joe, had finished their breakfast when Whereas 5G networks will enable innova- KILL, and Mr. BENNET) submitted the the Imperial Japanese Navy Air Serv- tive consumer and industrial applications following resolution; which was re- ice attacked Pearl Harbor. As we know, that will enhance and maximize the capa- ferred to the Committee on Armed the Arizona suffered a direct hit by a bility, uses, and quality of technological de- Services: Japanese bomb that detonated in the velopments, including telemedicine, preci- S. RES. 243 ship’s powder magazine. The resulting sion agriculture, self-driving cars, virtual explosion sank the ship and claimed and augmented reality, robotics, smart com- Whereas, on December 7, 1941, Boatswain’s munities, and advancements in public safety; Mate Second Class Joseph Leon George was the lives of 1,177 servicemembers. Whereas the United States is a global lead- 26 years old; During the unimaginable chaos and er in developing new technology and fos- Whereas Boatswain’s Mate Second Class carnage, Joe George displayed stunning tering digital innovation that has generated George was a crewmember aboard the U.S.S. composure and courage. Joe spotted six significant economic and social advancement Vestal (AR–4), a repair ship, on that day; sailors trapped in the control tower of and opportunity in the United States and Whereas the U.S.S. Vestal was moored the sinking Arizona. These men were around the world; next to the U.S.S. Arizona (BB–39); severely burned, and they were search- Whereas many states and localities are Whereas the Japanese began the attack on ing for a way to safety. The six wound- streamlining policies to facilitate siting and Pearl Harbor, Hawaii, at 7:48 a.m.; small cell deployment in support of 5G net- Whereas 6 sailors on the U.S.S. Arizona, ed sailors were Seaman First Class works; Seaman First Class Harold Kuhn, Seaman Harold Kuhn, Seaman First Class Rus- Whereas modernizing the infrastructure First Class Russell Lott, Gunner’s Mate sell Lott, Gunner’s Mate Third Class policies of the United States and securing Third Class Earl Riner, Boatswain’s Mate Earl Riner, Boatswain’s Mate Second

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00079 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.057 S02AUPT1 S4776 CONGRESSIONAL RECORD — SENATE August 2, 2017 Class Alvin Dvorak, Seaman First ward to working with them on its swift AMENDMENTS SUBMITTED AND Class Donald Stratton, and Fire adoption. PROPOSED Controlman Third Class Lauren f SA 747. Mr. TESTER submitted an amend- Bruner. SENATE RESOLUTION 244—TO AU- ment intended to be proposed by him to the Upon seeing the men, Joe threw a bill H.R. 2810, to authorize appropriations for THORIZE TESTIMONY, DOCU- heaving line between the Vestal and the fiscal year 2018 for military activities of the MENT PRODUCTION, AND REP- Arizona to rescue the wounded sailors Department of Defense, for military con- RESENTATION IN UNITED from the sinking ship. Suspended 40 struction, and for defense activities of the STATES OF AMERICA V. ROBERT Department of Energy, to prescribe military feet in the air, the six sailors climbed MENENDEZ, ET AL personnel strengths for such fiscal year, and 70 feet hand over hand across the rope for other purposes; which was ordered to lie to safety onboard the Vestal. These Mr. MCCONNELL (for himself and on the table. sailors did all this while enduring inju- Mr. SCHUMER) submitted the following SA 748. Mr. CARPER (for himself and Mr. ries so severe that two would succumb resolution; which was considered and GRASSLEY) submitted an amendment in- to their wounds in the weeks following agreed to: tended to be proposed by him to the bill H.R. 2810, supra; which was ordered to lie on the the attack. S. RES. 244 table. As they struggled across the heavy Whereas, in the case of United States of SA 749. Mr. MCCONNELL (for Mr. DAINES line, Joe George remained close by, all America v. Robert Menendez, et al., Cr. No. 15– (for himself and Mr. TESTER)) proposed an the while encouraging the men to push 155, pending in the United States District amendment to the bill S. 1282, to redesignate on. Court for the District of New Jersey, testi- certain clinics of the Department of Vet- The four sailors who survived their mony and the production of documents may erans Affairs located in Montana. injuries each returned to serve with be needed from various current and former SA 750. Mr. WHITEHOUSE (for himself, Members and employees of the Senate, relat- Mr. PETERS, Mr. TESTER, and Ms. WARREN) honor during World War II and then ing to their official responsibilities; submitted an amendment intended to be pro- went on to live long lives. Whereas, pursuant to sections 703(a) and posed by him to the bill H.R. 2810, to author- I spoke with two of them, and hear- 704(a)(2) of the Ethics in Government Act of ize appropriations for fiscal year 2018 for ing about the injuries they had and 1978, 2 U.S.C. §§ 288b(a) and 288c(a)(2), the military activities of the Department of De- that they still were able to return to Senate may direct its counsel to represent fense, for military construction, and for de- service in the Second World War was current or former Members and employees of fense activities of the Department of Energy, amazing. the Senate with respect to any subpoena, to prescribe military personnel strengths for Joe George’s legacy of heroism will order, or request for testimony relating to such fiscal year, and for other purposes; their official responsibilities; which was ordered to lie on the table. remain alive forever in the children, Whereas, by the privileges of the Senate of SA 751. Mr. REED submitted an amend- grandchildren, and great-grandchildren the United States and rule XI of the Stand- ment intended to be proposed by him to the of the four sailors who survived the in- ing Rules of the Senate, no evidence under bill H.R. 2430, to amend the Federal Food, famous day, thanks to Joe George. the control or in the possession of the Senate Drug, and Cosmetic Act to revise and extend Joe George was never awarded a may, by the judicial or administrative proc- the user-fee programs for prescription drugs, medal for his role in the rescue of the ess, be taken from such control or possession medical devices, generic drugs, and bio- six sailors, although his commanding but by permission of the Senate; and similar biological products, and for other officer commended his courageous ac- Whereas, when it appears that evidence purposes; which was ordered to lie on the under the control or in the possession of the table. tions. When I met with one of the Ari- Senate may promote the administration of f zona survivors who was rescued by Joe, justice, the Senate will take such action as he told me, ‘‘Joe George was never will promote the ends of justice consistent TEXT OF AMENDMENTS awarded anything for his bravery. He is with the privileges of the Senate: Now, SA 747. Mr. TESTER submitted an no longer with us, but I believe in his therefore, be it amendment intended to be proposed by memory he should be awarded the Resolved, That current and former Mem- him to the bill H.R. 2810, to authorize bers and employees of the Senate are author- Navy Cross.’’ appropriations for fiscal year 2018 for Lauren Bruner was another survivor ized to testify and produce documents in the case of United States of America v. Robert military activities of the Department whom Joe saved. He said to me: Menendez, et al., and related proceedings, ex- of Defense, for military construction, The six of us would not have survived ex- cept concerning matters for which a privi- and for defense activities of the De- cept for his courage, in spite of being at high lege should be asserted. partment of Energy, to prescribe mili- risk himself. He fully deserves high com- SEC. 2. The Senate Legal Counsel is author- tary personnel strengths for such fiscal mendations for his actions. I feel he should ized to represent current and former Mem- year, and for other purposes; which was be recognized for this courage and presented bers and employees of the Senate in connec- ordered to lie on the table; as follows: the Navy Cross. tion with the production of evidence author- Strike section 601 and the following: In his own words, during an interview ized in section one of this resolution. SEC. 601. FISCAL YEAR 2018 INCREASE IN MILI- in 1978, Joe said: ‘‘I’ll tell you, the only Mr. MCCONNELL. Mr. President, on TARY BASIC PAY. thing I could tell you about that day behalf of myself and the Democratic (a) WAIVER OF SECTION 1009 ADJUSTMENT.— . . . my conscience was my guide.’’ Leader, I send to the desk a resolution The adjustment to become effective during Well, his conscience was that of a authorizing testimony, production of fiscal year 2018 required by section 1009 of hero. We need more people like Joe documents, and representation by the title 37, United States Code, in the rates of George in this world. That is why I am Senate Legal Counsel, and ask for its monthly basic pay authorized members of committed to honoring Joe and why I immediate consideration. the uniformed services shall not be made. (b) INCREASE IN BASIC PAY.—Effective on rise today with the honor and privilege Mr. President, this resolution con- January 1, 2018, the rates of monthly basic to submit a resolution honoring Joseph cerns the case pending in the United pay for members of the uniformed services Leon George. States District Court for the District shall be increased by a percentage that is Joe passed away in 1996, and it is long of New Jersey against Senator ROBERT equal to or greater than the percentage by overdue that the Senate, the U.S. MENENDEZ. Both the Department of which— Navy, and a grateful nation honor the Justice and Senator MENENDEZ are ex- (1) the ECI for the final fiscal quarter of heroism of Boatswain’s Mate Second pected to seek trial testimony from fiscal year 2017, exceeds (2) the ECI for the final fiscal quarter of Class Joseph Leon George. Members and Senate staff. fiscal year 2016. God bless Joe George, whose im- This resolution would authorize Sen- (c) DETERMINATION OF PERCENTAGE.—The mense and astounding composure ate individuals called to appear to tes- Secretary of Defense shall determine the serves as an example of the men and tify and produce documents in this percentage increase in rates of monthly women in uniform who follow in his case and related proceedings, except basic pay provided for by subsection (b) in wake. Let us never forget his heroism concerning matters for which a privi- consultation with the Secretary of Homeland and sacrifice. lege is asserted. It would also authorize Security, the Secretary of Commerce, and the Secretary of Health and Human Services. I would like to also thank my col- the Senate Legal Counsel to represent (d) ECI DEFINED.—In this section, the term leagues Senators GARDNER, LEE, COT- individuals called to testify at trial as ‘‘ECI’’ has the meaning givern that term in TON, MCCASKILL, and BENNET for join- fact witnesses regarding their perform- section 1009(a)(3)(A) of title 37, United States ing me on this resolution. I look for- ance of official Senate responsibilities. Code.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00080 Fmt 0637 Sfmt 0634 E:\CR\FM\G02AU6.049 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4777 SA 748. Mr. CARPER (for himself and agency charge card data management group of the Office of Management and Budget on Mr. GRASSLEY) submitted an amend- established under section 1095, shall issue that agency’s activities to implement this ment intended to be proposed by him guidance on improving information sharing subtitle. (c) OFFICE OF MANAGEMENT AND BUDGET to the bill H.R. 2810, to authorize ap- by government agencies for the purposes of section 1093(a)(1). REPORT TO CONGRESS.—The Director of the propriations for fiscal year 2018 for (b) ELEMENTS.—The guidance issued under Office of Management and Budget shall sub- military activities of the Department subsection (a) shall— mit to Congress a consolidated report of of Defense, for military construction, (1) require relevant officials at Federal agency activities to implement this subtitle, and for defense activities of the De- agencies to identify high-risk activities and which may be included as part of another re- partment of Energy, to prescribe mili- communicate that information to the appro- port submitted to Congress by the Director. tary personnel strengths for such fiscal priate management levels within the agen- (d) REPORT ON ADDITIONAL SAVINGS OPPOR- year, and for other purposes; which was cies; TUNITIES.—Not later than one year after the date of the enactment of this Act, the Ad- ordered to lie on the table; as follows: (2) require that appropriate officials at Federal agencies review the reports issued by ministrator of General Services shall submit At the end of title X, add the following: charge card-issuing banks on questionable a report to Congress identifying and explor- Subtitle H—Government Purchase and transaction activity (such as purchase and ing further potential savings opportunities Travel Cards travel card pre-suspension and suspension re- for government agencies under the Federal SEC. 1091. SHORT TITLE. ports, delinquency reports, and exception re- charge card programs. This report may be This subtitle may be cited as the ‘‘Saving ports), including transactions that occur combined with the report required under Federal Dollars Through Better Use of Gov- with high-risk activities, and suspicious tim- subsection (a). ernment Purchase and Travel Cards Act of ing or amounts of cash withdrawals or ad- 2017’’. vances; SA 749. Mr. MCCONNELL (for Mr. SEC. 1092. DEFINITIONS. (3) provide for the appropriate sharing of DAINES (for himself and Mr. TESTER)) In this subtitle: information related to potential question- proposed an amendment to the bill S. (1) IMPROPER PAYMENT.—The term ‘‘im- able transactions, fraud schemes, and high- 1282, to redesignate certain clinics of proper payment’’ has the meaning given the risk activities with the General Services Ad- the Department of Veterans Affairs lo- term in section 2 of the Improper Payments ministration and the appropriate officials in cated in Montana; as follows: Federal agencies; Information Act of 2002 (31 U.S.C. 3321 note). Strike all after the enacting clause and in- (2) QUESTIONABLE TRANSACTION.—The term (4) consider the recommendations made by Inspectors General or the best practices In- sert the following: ‘‘questionable transaction’’ means a charge SECTION 1. REDESIGNATION OF CERTAIN DE- card transaction that from initial card data spectors General have identified; and (5) include other requirements determined PARTMENT OF VETERANS AFFAIRS appears to be high risk and may therefore be CLINICS IN MONTANA. appropriate by the Director for the purposes improper due to non-compliance with appli- (a) DAVID J. THATCHER VA CLINIC.— of carrying out this subtitle. cable law, regulation or policy. (1) DESIGNATION.—The clinic of the Depart- (3) STRATEGIC SOURCING.—The term ‘‘stra- SEC. 1095. INTERAGENCY CHARGE CARD DATA ment of Veterans Affairs located at 2687 tegic sourcing’’ means analyzing and modi- MANAGEMENT GROUP. Palmer Street in Missoula, Montana, shall fying a Federal agency’s spending patterns (a) ESTABLISHMENT.—The Administrator of after the date of the enactment of this Act to better leverage its purchasing power, re- General Services and the Director of the Of- be known and designated as the ‘‘David J. duce costs, and improve overall performance. fice of Management and Budget shall estab- Thatcher VA Clinic’’. SEC. 1093. EXPANDED USE OF DATA ANALYTICS. lish a purchase and travel charge card data (2) REFERENCES.—Any reference in any law, (a) STRATEGY.—Not later than 180 days management group to develop and share best regulation, map, document, paper, or other after the date of the enactment of this Act, practices for the purposes described in sec- record of the United States to the clinic re- the Director of the Office of Management tion 1093(a). ferred to in paragraph (1) shall be considered and Budget, in consultation with the Admin- (b) ELEMENTS.—The best practices devel- to be a reference to the David J. Thatcher istrator for General Services, shall develop a oped under subsection (a) shall— VA Clinic. strategy to expand the use of data analytics (1) cover rules, edits, and task order or (b) DR. JOSEPH MEDICINE CROW VA CLIN- in managing government purchase and travel contract modifications related to charge IC.— charge card programs. These analytics may card-issuing banks; (1) DESIGNATION.—The clinic of the Depart- employ existing General Services Adminis- (2) include the review of accounts payable ment of Veterans Affairs located at 1775 tration capabilities, and may be in conjunc- information and purchase and travel card Spring Creek Lane in Billings, Montana, tion with agencies’ capabilities, for the pur- transaction data of agencies for the purpose shall after the date of the enactment of this pose of— of identifying potential strategic sourcing Act be known and designated as the ‘‘Dr. Jo- (1) identifying examples or patterns of and other additional opportunities (such as seph Medicine Crow VA Clinic’’. questionable transactions and developing en- recurring payments, utility payments, and (2) REFERENCES.—Any reference in any law, hanced tools and methods for agency use in— grant payments) for which the charge cards regulation, map, document, paper, or other (A) identifying questionable purchase and or related payment products could be used as record of the United States to the clinic re- travel card transactions; and a payment method; and ferred to in paragraph (1) shall be considered (B) recovering improper payments made (3) include other best practices as deter- to be a reference to the Dr. Joseph Medicine with purchase and travel cards; mined by the Administrator and Director. Crow VA Clinic. (2) identifying potential opportunities for (c) MEMBERSHIP.—The purchase and travel (3) PUBLIC DISPLAY OF NAME.— agencies to further leverage administrative charge card data management group shall (A) IN GENERAL.—Any local public display process streamlining and cost reduction from meet regularly as determined by the co- of the name of the clinic referred to in para- purchase and travel card use, including addi- chairs, for a duration of three years, and in- graph (1) carried out by the United States or tional agency opportunities for card-based clude those agencies as described in section through the use of Federal funds shall in- strategic sourcing; 2 of the Government Charge Card Abuse Pre- clude the English name, Dr. Joseph Medicine (3) developing a set of purchase and travel vention Act of 2012 (Public Law 112–194) and Crow, and the Crow name, Dakaak Baako, of card metrics and benchmarks for high-risk others identified by the Administrator and Dr. Joseph Medicine Crow. activities, which shall assist agencies in Director. (B) LOCAL DISPLAY.—For purposes of sub- identifying potential emphasis areas for SEC. 1096. REPORTING REQUIREMENTS. paragraph (A), a local public display of the their purchase and travel card management (a) GENERAL SERVICES ADMINISTRATION RE- name of the clinic referred to in paragraph and oversight activities, including those re- PORT.—Not later than one year after the date (1) includes a display inside the clinic, on the quired by the Government Charge Card of the enactment of this Act, the Adminis- campus of the clinic, and in the community Abuse Prevention Act of 2012 (Public Law trator for General Services shall submit a re- surrounding the clinic, such as signs direct- 112–194); and port to Congress on the implementation of ing individuals to the clinic. (4) developing a plan, which may be based this subtitle, including the metrics used in (c) BENJAMIN CHARLES STEELE VA CLINIC.— on existing capabilities, to create a library determining whether the analytic and (1) DESIGNATION.—The clinic of the Depart- of analytics tools and data sources for use by benchmarking efforts have reduced, or con- ment of Veterans Affairs located at 1766 Ma- Federal agencies (including inspectors gen- tributed to the reduction of, questionable or jestic Lane in Billings, Montana, shall after eral of those agencies). improper payments as well as improved uti- the date of the enactment of this Act be SEC. 1094. GUIDANCE ON IMPROVING INFORMA- lization of card-based payment products. known and designated as the ‘‘Benjamin TION SHARING TO CURB IMPROPER (b) AGENCY REPORTS AND CONSOLIDATED RE- Charles Steele VA Clinic’’. PAYMENTS. PORT TO CONGRESS.—Not later than one year (2) REFERENCES.—Any reference in any law, (a) IN GENERAL.—Not later than 180 days after the date of the enactment of this Act, regulation, map, document, paper, or other after the date of the enactment of this Act, the head of each Federal agency described in record of the United States to the clinic re- the Director of the Office of Management section 2 of the Government Charge Card ferred to in paragraph (1) shall be considered and Budget, in consultation with the Admin- Abuse Prevention Act of 2012 (Public Law to be a reference to the Benjamin Charles istrator of General Services and the inter- 112–194) shall submit a report to the Director Steele VA Clinic.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00081 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.073 S02AUPT1 S4778 CONGRESSIONAL RECORD — SENATE August 2, 2017 SA 750. Mr. WHITEHOUSE (for him- thorized to meet during today’s session gust 2, 2017, at 10 a.m., to hold a hear- self, Mr. PETERS, Mr. TESTER, and Ms. of the Senate: ing entitled ‘‘Assessing the Colombia WARREN) submitted an amendment in- COMMITTEE ON AGRICULTURE, NUTRITION AND Peace Process: The Way Forward in tended to be proposed by him to the FORESTRY U.S.-Colombia Relations.’’ bill H.R. 2810, to authorize appropria- The Committee on Agriculture, Nu- f tions for fiscal year 2018 for military trition, and Forestry, is authorized to UNANIMOUS CONSENT AGREE- activities of the Department of De- meet during the session of the Senate MENT—EXECUTIVE CALENDAR fense, for military construction, and on August 2, 2017 at 5 p.m. to conduct for defense activities of the Depart- a business meeting to report nomina- Mr. MCCONNELL. Mr. President, I ment of Energy, to prescribe military tions. ask unanimous consent that at 11:45 personnel strengths for such fiscal COMMITTEE ON COMMERCE, SCIENCE, AND a.m. on Thursday, August 3, the Senate year, and for other purposes; which was TRANSPORTATION proceed to executive session for consid- ordered to lie on the table; as follows: The Committee on Commerce, eration of Calendar No. 103, the nomi- At the appropriate place, insert the fol- Science, and Transportation is author- nation of the Deputy Secretary at the lowing: ized to hold an Executive Session dur- Department of Energy. I further ask SEC. lll. TEMPORARY EXTENSION OF EX- ing the session of the Senate on that there be 15 minutes of debate on TENDED PERIOD OF PROTECTIONS Wednesday, August 2, 2017, at 10 a.m. in the nomination equally divided in the FOR MEMBERS OF UNIFORMED usual form, and that following the use SERVICES RELATING TO MORT- room 216 of the Hart Senate Office GAGES, MORTGAGE FORECLOSURE, Building. or yielding back of time, the Senate AND EVICTION. COMMITTEE ON ENVIRONMENT AND PUBLIC vote on confirmation with no inter- Section 710(d) of the Honoring America’s WORKS vening action or debate, and that, if Veterans and Caring for Camp Lejeune Fami- The Committee on Environment and confirmed, the motion to reconsider be lies Act of 2012 (Public Law 112–154; 50 U.S.C. Public Works is authorized to meet considered made and laid upon the 3953 note) is amended— table and the President be immediately (1) in paragraph (1), by striking ‘‘December during the session of the Senate on Wednesday, August 2, 2017, at 10 a.m., notified of the Senate’s action. 31, 2017’’ and inserting ‘‘December 31, 2019’’; The PRESIDING OFFICER. Without and in room 406 of the Dirksen Senate of- (2) in paragraph (3), by striking ‘‘January fice building, to conduct a hearing en- objection, it is so ordered. 1, 2018’’ and inserting ‘‘January 1, 2020’’. titled, ‘‘FBI Headquarters Consolida- f tion Project—What Happened and AUTHORIZING TESTIMONY, DOCU- Mr. REED submitted an SA 751. What’s Next.’’ MENT PRODUCTION, AND REP- amendment intended to be proposed by COMMITTEE ON HEALTH, EDUCATION, LABOR, RESENTATION him to the bill H.R. 2430, to amend the AND PENSIONS Federal Food, Drug, and Cosmetic Act Mr. MCCONNELL. Mr. President, I The Committee on Health, Edu- ask unanimous consent that the Sen- to revise and extend the user-fee pro- cation, Labor, and Pensions is author- grams for prescription drugs, medical ate proceed to the consideration of S. ized to meet in executive session dur- Res. 244, submitted earlier today. devices, generic drugs, and biosimilar ing the session of the Senate on biological products, and for other pur- The PRESIDING OFFICER. The Wednesday, August 2, at 11 a.m. in the clerk will report the resolution by poses; which was ordered to lie on the President’s Room. We will be consid- table; as follows: title. ering the nominations. The senior assistant legislative clerk On page 97, strike line 20 and all that fol- COMMITTEE ON FOREIGN RELATIONS read as follows: lows through line 9 on page 98 and insert the The Committee on Foreign Relations following: A resolution (S. Res. 244) to authorize tes- ‘‘(k) RELATION TO ORPHAN DRUGS.— is authorized to meet during the ses- timony, document production, and represen- ‘‘(1) IN GENERAL; EXEMPTION FOR ORPHAN IN- sion of the Senate on Wednesday, Au- tation in United States of America v. Robert DICATIONS.—Unless the Secretary requires gust 2, 2017 at 11 a.m., to hold a hearing Menendez, et al. otherwise by regulation, this section does entitled ‘‘Nominations.’’ There being no objection, the Senate not apply to any drug for an indication for COMMITTEE ON FOREIGN RELATIONS proceeded to consider the resolution. which orphan designation has been granted The Committee on Foreign Relations Mr. MCCONNELL. Mr. President, I under section 526, except as provided in para- is authorized to meet during the ses- ask unanimous consent that the reso- graph (2). lution be agreed to, the preamble be ‘‘(2) APPLICABILITY DESPITE ORPHAN DES- sion of the Senate on Wednesday, Au- agreed to, and the motions to recon- IGNATION OF CERTAIN INDICATIONS.—This sec- gust 2, 2017 at 2 p.m., to hold a briefing tion shall apply with respect to a drug or bi- entitled ‘‘The Authorizations for the sider be considered made and laid upon ological product for which an indication has Use of Military Force: Administration the table with no intervening action or been granted orphan designation under sec- Perspective.’’ debate. tion 526— The PRESIDING OFFICER. Without COMMITTEE ON SMALL BUSINESS AND ‘‘(A) if the pediatric cancer investigation ENTREPRENEURSHIP objection, it is so ordered. described in subsection (a)(3) applies to the The resolution (S. Res. 244) was drug or biological product as described in The Committee on Small Business and Entrepreneurship is authorized to agreed to. subsection (a)(1)(B); or The preamble was agreed to. meet during the session of the Senate ‘‘(B) if such orphan indication is limited to (The resolution, with its preamble, is a pediatric subpopulation and such indica- Wednesday, August 2, 2017 off the floor printed in today’s RECORD under ‘‘Sub- tion in the adult population does not qualify at the start of the first vote to conduct mitted Resolutions.’’) for orphan designation. a business meeting. ‘‘(3) EFFECT OF APPLICATION.—Application f COMMITTEE ON ENERGY AND NATURAL RE- of this section to drugs and biological prod- SOURCES SUBCOMMITTEE ON WATER AND APPOINTMENTS ucts described in paragraph (2)(B) does not POWER limit the applicability of section 526 to such The PRESIDING OFFICER. The drugs and biological products.’’. The Senate Committee on Energy Chair, on behalf of the majority leader, and Natural Resources’ Subcommittee f pursuant to the provisions of Public on Water and Power is authorized to Law 115–31, appoints the following indi- AUTHORITY FOR COMMITTEES TO meet during the session of the Senate viduals to serve as members of the MEET in order to hold a hearing on Wednes- Women’s Suffrage Centennial Commis- Mrs. FISHER. Mr. President, I have 9 day, August 2, 2017, at 10 a.m. in Room sion: Marjorie Dannenfelser of Virginia requests for committees to meet during 366 of the Dirksen Senate Office Build- and Cleta Mitchell of North Carolina. ing Washington, DC. today’s session of the Senate. They f have the approval of the Majority and SUBCOMMITTEE ON WESTERN HEMISPHERE Minority leaders. The Committee on Foreign Relations ORDERS FOR THURSDAY, AUGUST Pursuant to Rule XXVI, paragraph Subcommittee on Western Hemisphere 3, 2017 5(a), of the Standing Rules of the Sen- is authorized to meet during the ses- Mr. MCCONNELL. Mr. President, I ate, the following committees are au- sion of the Senate on Wednesday, Au- ask unanimous consent that when the

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00082 Fmt 0637 Sfmt 0634 E:\CR\FM\A02AU6.073 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — SENATE S4779 Senate completes its business today, it DEPARTMENT OF AGRICULTURE THE REMAINDER OF THE TERM EXPIRING JUNE 30, 2018, VICE NORMAN C. BAY, RESIGNED. adjourn until 10 a.m., Thursday, Au- TED MCKINNEY, OF INDIANA, TO BE UNDER SEC- KEVIN J. MCINTYRE, OF VIRGINIA, TO BE A MEMBER OF gust 3; that following the prayer and RETARY OF AGRICULTURE FOR TRADE AND FOREIGN AG- THE FEDERAL ENERGY REGULATORY COMMISSION FOR RICULTURE AFFAIRS. (NEW POSITION) THE TERM EXPIRING JUNE 30, 2023. (REAPPOINTMENT) pledge, the morning hour be deemed DEPARTMENT OF DEFENSE DEPARTMENT OF STATE expired, the Journal of proceedings be JOHN HENDERSON, OF SOUTH DAKOTA, TO BE AN AS- JAMIE MCCOURT, OF CALIFORNIA, TO BE AMBASSADOR approved to date, the time for the two SISTANT SECRETARY OF THE AIR FORCE, VICE MIRANDA EXTRAORDINARY AND PLENIPOTENTIARY OF THE leaders be reserved for their use later A. A. BALLENTINE, RESIGNED. UNITED STATES OF AMERICA TO THE FRENCH REPUBLIC, DEPARTMENT OF THE INTERIOR AND TO SERVE CONCURRENTLY AND WITHOUT ADDI- in the day, and morning business be TIONAL COMPENSATION AS AMBASSADOR EXTRAOR- closed; further, that following leader RYAN DOUGLAS NELSON, OF IDAHO, TO BE SOLICITOR DINARY AND PLENIPOTENTIARY OF THE UNITED STATES OF THE DEPARTMENT OF THE INTERIOR, VICE HILARY OF AMERICA TO THE PRINCIPALITY OF MONACO. remarks, the Senate resume consider- CHANDLER TOMPKINS. ation of the motion to proceed to H.R. EQUAL EMPLOYMENT OPPORTUNITY COMMISSION f 2430, with the time until 11 a.m. equal- DANIEL M. GADE, OF NORTH DAKOTA, TO BE A MEMBER ly divided between the two leaders or OF THE EQUAL EMPLOYMENT OPPORTUNITY COMMIS- CONFIRMATION SION FOR A TERM EXPIRING JULY 1, 2021, VICE CON- their designees. STANCE S. BARKER, TERM EXPIRED. Executive nomination confirmed by The PRESIDING OFFICER. Without DEPARTMENT OF HOMELAND SECURITY the Senate August 2, 2017: objection, it is so ordered. JOHN MARSHALL MITNICK, OF VIRGINIA, TO BE GEN- NATIONAL LABOR RELATIONS BOARD ERAL COUNSEL, DEPARTMENT OF HOMELAND SECURITY, f VICE STEVAN EATON BUNNELL. MARVIN KAPLAN, OF KANSAS, TO BE A MEMBER OF THE NATIONAL LABOR RELATIONS BOARD FOR THE ADJOURNMENT UNTIL 10 A.M. DEPARTMENT OF JUSTICE TERM OF FIVE YEARS EXPIRING AUGUST 27, 2020. TOMORROW ROBERT J. HIGDON, JR., OF NORTH CAROLINA, TO BE UNITED STATES ATTORNEY FOR THE EASTERN DISTRICT f Mr. MCCONNELL. Mr. President, if OF NORTH CAROLINA FOR THE TERM OF FOUR YEARS, VICE THOMAS GRAY WALKER, RESIGNED. WITHDRAWALS there is no further business to come be- THOMAS L. KIRSCH II, OF INDIANA, TO BE UNITED STATES ATTORNEY FOR THE NORTHERN DISTRICT OF IN- fore the Senate, I ask unanimous con- DIANA FOR THE TERM OF FOUR YEARS, VICE DAVID A. Executive Message transmitted by sent that it stand adjourned under the CAPP, RESIGNED. the President to the Senate on August previous order. DEPARTMENT OF VETERANS AFFAIRS 2, 2017 withdrawing from further Sen- There being no objection, the Senate, MELISSA SUE GLYNN, OF THE DISTRICT OF COLUMBIA, ate consideration the following nomi- at 6:40 p.m., adjourned until Thursday, TO BE AN ASSISTANT SECRETARY OF VETERANS AF- nations: FAIRS (ENTERPRISE INTEGRATION), VICE LINDA A. August 3, 2017, at 10 a.m. SCHWARTZ. GEORGE NESTERCZUK, OF VIRGINIA, TO BE DIRECTOR FEDERAL ENERGY REGULATORY COMMISSION OF THE OFFICE OF PERSONNEL MANAGEMENT FOR A f TERM OF FOUR YEARS, VICE KATHERINE ARCHULETA, RICHARD GLICK, OF VIRGINIA, TO BE A MEMBER OF RESIGNED, WHICH WAS SENT TO THE SENATE ON MAY 25, NOMINATIONS THE FEDERAL ENERGY REGULATORY COMMISSION FOR 2017. THE TERM EXPIRING JUNE 30, 2022, VICE COLETTE JAMIE MCCOURT, OF CALIFORNIA, TO BE AMBASSADOR Executive nominations received by DODSON HONORABLE, TERM EXPIRED. EXTRAORDINARY AND PLENIPOTENTIARY OF THE KEVIN J. MCINTYRE, OF VIRGINIA, TO BE A MEMBER OF UNITED STATES OF AMERICA TO THE KINGDOM OF BEL- the Senate: THE FEDERAL ENERGY REGULATORY COMMISSION FOR GIUM, WHICH WAS SENT TO THE SENATE ON JUNE 26, 2017.

VerDate Sep 11 2014 04:52 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00083 Fmt 0637 Sfmt 9801 E:\CR\FM\G02AU6.056 S02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — Extensions of Remarks E1111 EXTENSIONS OF REMARKS

SENATE COMMITTEE MEETINGS mation, the Office of the Senate Daily to be United States Circuit Judge for Title IV of Senate Resolution 4, Digest will prepare this information for the Seventh Circuit. agreed to by the Senate of February 4, printing in the Extensions of Remarks SD–226 section of the CONGRESSIONAL RECORD 1977, calls for establishment of a sys- SEPTEMBER 7 tem for a computerized schedule of all on Monday and Wednesday of each meetings and hearings of Senate com- week. 10 a.m. mittees, subcommittees, joint commit- Committee on Energy and Natural Re- Meetings scheduled for Thursday, sources tees, and committees of conference. August 3, 2017 may be found in the To hold hearings to examine the nomina- This title requires all such committees Daily Digest of today’s RECORD. tions of Joseph Balash, of Alaska, to be to notify the Office of the Senate Daily an Assistant Secretary of the Interior, Digest—designated by the Rules Com- and Richard Glick, of Virginia, and mittee—of the time, place and purpose MEETINGS SCHEDULED Kevin J. McIntyre, of Virginia, both to of the meetings, when scheduled and AUGUST 8 be a Member of the Federal Energy any cancellations or changes in the 10 a.m. Regulatory Commission. meetings as they occur. Committee on the Judiciary SD–366 As an additional procedure along To hold hearings to examine the nomina- with the computerization of this infor- tion of Amy Coney Barrett, of Indiana,

∑ This ‘‘bullet’’ symbol identifies statements or insertions which are not spoken by a Member of the Senate on the floor. Matter set in this typeface indicates words inserted or appended, rather than spoken, by a Member of the House on the floor.

VerDate Sep 11 2014 23:56 Aug 02, 2017 Jkt 069060 PO 00000 Frm 00001 Fmt 0626 Sfmt 0634 E:\CR\FM\M02AU8.000 E02AUPT1 Wednesday, August 2, 2017 Daily Digest Senate and Safety Grants program, and the Staffing for Ade- Chamber Action quate Fire and Emergency Response grant program, Routine Proceedings, pages S4697–S4779 after agreeing to the committee amendment in the Measures Introduced: Thirty-two bills and three nature of a substitute. Pages S4714–15 resolutions were introduced, as follows: S. Seniors Fraud Prevention Act: Senate passed S. 1700–1731, and S. Res. 242–244. Pages S4766–67 81, to establish an advisory office within the Bureau Measures Reported: of Consumer Protection of the Federal Trade Com- S. 810, to facilitate construction of a bridge on mission to prevent fraud targeting seniors. certain property in Christian County, Missouri, with Page S4714 an amendment in the nature of a substitute. (S. Great Outdoors Month: Committee on the Judici- Rept. No. 115–142) ary was discharged from further consideration of S. S. 669, to authorize the Secretary of the Interior Res. 199, designating June 2017 as ‘‘Great Outdoors to assess sanitation and safety conditions at Bureau Month’’, and the resolution was then agreed to. of Indian Affairs facilities that were constructed to Pages S4715–16 provide affected Columbia River Treaty tribes access National Day of the American Cowboy: Com- to traditional fishing grounds and expend funds on mittee on the Judiciary was discharged from further construction of facilities and structures to improve consideration of S. Res. 225, designating July 22, those conditions. (S. Rept. No. 115–143) 2017, as ‘‘National Day of the American Cowboy’’, S. 154, to amend the Small Business Act to en- and the resolution was then agreed to. Pages S4715–16 sure small businesses affected by the onset of trans- missible diseases are eligible for disaster relief. National Youth Sports Week: Committee on S. 650, to amend the Small Business Act to ex- Commerce, Science, and Transportation was dis- pand tax credit education and training for small charged from further consideration of S. Res. 227, businesses that engage in research and development. recognizing ‘‘National Youth Sports Week’’ and the S. 690, to extend the eligibility of redesignated efforts by parents, volunteers, and national organiza- areas as HUBZones from 3 years to 7 years. tions in their efforts to promote healthy living and S. 929, to improve the HUBZone program, with youth development, and the resolution was then amendments. agreed to. Pages S4715–16 S. 1038, to require the Administrator of the Small 10th Anniversary of the collapse of Interstate Business Administration to submit to Congress a re- 35W Mississippi River Bridge: Committee on the port on the utilization of small businesses with re- Judiciary was discharged from further consideration spect to certain Federal contracts, with an amend- of S. Res. 238, recognizing the 10th anniversary and ment in the nature of a substitute. honoring the victims of the collapse of the Interstate S. 1428, to amend section 21 of the Small Busi- 35W Mississippi River bridge, and the resolution ness Act to require cyber certification for small busi- was then agreed to. Pages S4715–16 ness development center counselors. Harry W. Colmery Veterans Educational Assist- S. 1598, to amend title 38, United States Code, ance Act: Senate passed H.R. 3218, to amend title to make certain improvements in the laws adminis- 38, United States Code, to make certain improve- tered by the Secretary of Veterans Affairs. ments in the laws administered by the Secretary of Pages S4764–65 Veterans Affairs. Page S4716 Measures Passed: VA Clinics in Montana: Committee on Veterans’ AFG and SAFER Program Reauthorization Act: Affairs was discharged from further consideration of Senate passed S. 829, to reauthorize the Assistance S. 1282, to redesignate certain clinics of the Depart- to Firefighters Grants program, the Fire Prevention ment of Veterans Affairs located in Montana, and the D877

VerDate Sep 11 2014 05:45 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00001 Fmt 0627 Sfmt 0627 E:\CR\FM\D02AU7.REC D02AUPT1 D878 CONGRESSIONAL RECORD — DAILY DIGEST August 2, 2017 bill was then passed, after agreeing to the following By 50 yeas to 48 nays (Vote No. 183), Senate amendment proposed thereto: Page S4716 agreed to the motion to close further debate on the McConnell (for Daines/Tester) Amendment No. nomination. Pages S4700–03 749, in the nature of a substitute. Page S4716 Nominations Received: Senate received the fol- United States Intelligence Professionals Day: lowing nominations: Committee on the Judiciary was discharged from Ted McKinney, of Indiana, to be Under Secretary further consideration of S. Res. 222, designating July of Agriculture for Trade and Foreign Agriculture Af- 26, 2017, as ‘‘United States Intelligence Profes- fairs. sionals Day’’, and the resolution was then agreed to. John Henderson, of South Dakota, to be an As- Page S4718 sistant Secretary of the Air Force. Authorize Testimony, Document Production, Ryan Douglas Nelson, of Idaho, to be Solicitor of and Representation: Senate agreed to S. Res. 244, the Department of the Interior. to authorize testimony, document production, and Daniel M. Gade, of North Dakota, to be a Mem- representation in United States of America v. Robert ber of the Equal Employment Opportunity Commis- Menendez, et al. Page S4778 sion for a term expiring July 1, 2021. Appointments: John Marshall Mitnick, of Virginia, to be General Counsel, Department of Homeland Security. Women’s Suffrage Centennial Commission: The Robert J. Higdon, Jr., of North Carolina, to be Chair, on behalf of the Majority Leader, pursuant to United States Attorney for the Eastern District of the provisions of Public Law 115–31, appointed the North Carolina for the term of four years. following individuals to serve as members of the Women’s Suffrage Centennial Commission: Marjorie Thomas L. Kirsch II, of Indiana, to be United Dannenfelser of Virginia and Cleta Mitchell of States Attorney for the Northern District of Indiana for the term of four years. North Carolina. Page S4778 Melissa Sue Glynn, of the District of Columbia, FDA Reauthorization Act—Agreement: A unani- to be an Assistant Secretary of Veterans Affairs (En- mous-consent agreement was reached providing that terprise Integration). at approximately 10 a.m., on Thursday, August 3, Richard Glick, of Virginia, to be a Member of the 2017, Senate resume consideration of the motion to Federal Energy Regulatory Commission for the term proceed to consideration of H.R. 2430, to amend the expiring June 30, 2022. Federal Food, Drug, and Cosmetic Act to revise and Kevin J. McIntyre, of Virginia, to be a Member extend the user-fee programs for prescription drugs, of the Federal Energy Regulatory Commission for medical devices, generic drugs, and biosimilar bio- the remainder of the term expiring June 30, 2018. logical products, with the time until 11 a.m., equal- Kevin J. McIntyre, of Virginia, to be a Member ly divided between the two Leaders, or their des- of the Federal Energy Regulatory Commission for ignees. Pages S4778–79 the term expiring June 30, 2023. Brouillette Nomination—Agreement: A unani- Jamie McCourt, of California, to be Ambassador mous-consent-time agreement was reached providing to the French Republic, and to serve concurrently that at 11:45 a.m., on Thursday, August 3, 2017, and without additional compensation as Ambassador Senate begin consideration of the nomination of Dan to the Principality of Monaco. Page S4779 R. Brouillette, of Texas, to be Deputy Secretary of Energy; provided further that there be 15 minutes of Nominations Withdrawn: Senate received notifica- debate on the nomination, equally divided in the tion of withdrawal of the following nominations: usual form; and that following the use or yielding George Nesterczuk, of Virginia, to be Director of back of time, Senate vote on confirmation of the the Office of Personnel Management for a term of nomination, with no intervening action or debate. four years, which was sent to the Senate on May 25, Page S4778 2017. Jamie McCourt, of California, to be Ambassador Nomination Confirmed: Senate confirmed the fol- to the Kingdom of Belgium, which was sent to the lowing nomination: Senate on June 26, 2017. Page S4779 By 50 yeas to 48 nays (Vote No. EX. 184), Marvin Kaplan, of Kansas, to be a Member of the Messages from the House: Pages S4763–64 National Labor Relations Board for the term of five Executive Communications: Page S4764 years expiring August 27, 2020. Petitions and Memorials: Page S4764 Pages S4700–18, S4779 During consideration of this nomination today, Executive Reports of Committees: Pages S4765–66 Senate also took the following action: Additional Cosponsors: Pages S4767–69

VerDate Sep 11 2014 05:45 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00002 Fmt 0627 Sfmt 0627 E:\CR\FM\D02AU7.REC D02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — DAILY DIGEST D879 Statements on Introduced Bills/Resolutions: S. 1536, to designate a human trafficking preven- Pages S4769–76 tion coordinator and to expand the scope of activities Additional Statements: Pages S4761–63 authorized under the Federal Motor Carrier Safety Administration’s outreach and education program to Amendments Submitted: Pages S4776–78 include human trafficking prevention activities, with Authorities for Committees to Meet: Page S4778 an amendment in the nature of a substitute; Record Votes: Two record votes were taken today. S. 1586, to require the Under Secretary for Oceans and Atmosphere to update periodically the environ- (Total—184) Pages S4703, S4718 mental sensitivity index products of the National Adjournment: Senate convened at 10 a.m. and ad- Oceanic and Atmospheric Administration for each journed at 6:40 p.m., until 10 a.m. on Thursday, coastal area of the Great Lakes, with an amendment August 3, 2017. (For Senate’s program, see the re- in the nature of a substitute; marks of the Majority Leader in today’s Record on S. 1621, to require the Federal Communications page S4778.) Commission to establish a methodology for the col- lection by the Commission of information about Committee Meetings commercial mobile service and commercial mobile data service; and (Committees not listed did not meet) The nominations of Ajit Varadaraj Pai, of Kansas, Jessica Rosenworcel, of Connecticut, and Brendan BUSINESS MEETING Carr, of Virginia, each to be a Member of the Fed- Committee on Agriculture, Nutrition, and Forestry: Com- eral Communications Commission, Peter B. David- mittee ordered favorably reported the nominations of son, of Virginia, to be General Counsel, Karen Dunn Rostin Behnam, of New Jersey, Brian D. Quintenz, Kelley, of Pennsylvania, to be Under Secretary for of Ohio, and Dawn DeBerry Stump, of Texas, each Economic Affairs, and Elizabeth Erin Walsh, of the to be a Commissioner of the Commodity Futures District of Columbia, to be Assistant Secretary and Trading Commission. Director General of the United States and Foreign Commercial Service, all of the Department of Com- BUSINESS MEETING merce, Steven Gill Bradbury, of Virginia, to be Gen- Committee on Armed Services: Committee ordered favor- eral Counsel, Mark H. Buzby, of Virginia, to be Ad- ably reported 660 nominations in the Army, Navy, ministrator of the Maritime Administration, and and Air Force. Ronald L. Batory, of New Jersey, to be Adminis- trator of the Federal Railroad Administration, all of BUSINESS MEETING the Department of Transportation, and Robert L. Committee on Commerce, Science, and Transportation: Sumwalt III, of South Carolina, to be Chairman of Committee ordered favorably reported the following the National Transportation Safety Board. business items: WATER SECURITY AND DROUGHT S. 374, to enable concrete masonry products man- PREPAREDNESS ufacturers to establish, finance, and carry out a co- Committee on Energy and Natural Resources: Sub- ordinated program of research, education, and pro- committee on Water and Power concluded a hearing motion to improve, maintain, and develop markets to examine increasing water security and drought for concrete masonry products; preparedness through infrastructure, management, S. 754, to support meeting our Nation’s growing and innovation, after receiving testimony from cybersecurity workforce needs by expanding the cy- Thomas Buschatzke, Arizona Department of Water bersecurity education pipeline, with an amendment Resources, Phoenix; Heiner Markhoff, GE Power, in the nature of a substitute; Trevose, Pennsylvania; Carlos A. Riva, Poseidon S. 1322, to establish the American Fisheries Advi- Water, LLC, Boston, Massachusetts; Martha Sheils, sory Committee to assist in the awarding of fisheries University of Southern Maine New England Envi- research and development grants, with an amend- ronmental Finance Center, Portland; and Shirlee ment in the nature of a substitute; Zane, Sonoma County Water Agency, Santa Rosa, S. 1425, to reauthorize the Integrated Coastal and California. Ocean Observation System Act of 2009, with an amendment in the nature of a substitute; FBI HEADQUARTERS CONSOLIDATION S. 1532, to disqualify from operating a commer- PROJECT cial motor vehicle for life an individual who uses a Committee on Environment and Public Works: Com- commercial motor vehicle in committing a felony in- mittee concluded a hearing to examine the Federal volving human trafficking; Bureau of Investigation headquarters consolidation

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project, including issues related to funding other fu- tions of Lance Allen Robertson, of Oklahoma, to be ture projects, after receiving testimony from Michael Assistant Secretary for Aging, and Brett Giroir, of Gelber, Acting Commissioner, Public Buildings Texas, to be Assistant Secretary, and Robert P. Service, General Services Administration; Richard L. Kadlec, of New York, to be Assistant Secretary for Haley II, Assistant Director, Facilities and Finance Preparedness and Response, both to be a Medical Di- Division, Federal Bureau of Investigation, Depart- rector in the Regular Corps of the Public Health ment of Justice; and Dave Wise, Director, Physical Service, and Elinore F. McCance-Katz, of Rhode Is- Infrastructure, Government Accountability Office. land, to be Assistant Secretary for Mental Health and COLOMBIA PEACE PROCESS Substance Use, all of the Department of Health and Committee on Foreign Relations: Subcommittee on Human Services, Jerome M. Adams, of Indiana, to Western Hemisphere, Transnational Crime, Civilian be Medical Director in the Regular Corps of the Security, Democracy, Human Rights, and Global Public Health Service, and to be Surgeon General of Women’s Issues concluded a hearing to examine as- the Public Health Service, and Heather L. sessing the Colombia peace process, focusing on the MacDougall, of Florida, and James J. Sullivan, Jr., way forward in United States-Colombia relations, of Pennsylvania, both to be a Member of the Occu- after receiving testimony from William R. pational Safety and Health Review Commission. Brownfield, Assistant Secretary for International Narcotics and Law Enforcement Affairs, and Fran- BUSINESS MEETING cisco Palmieri, Acting Assistant Secretary, Bureau of Committee on Small Business and Entrepreneurship: Com- Western Hemisphere Affairs, both of the Depart- mittee ordered favorably reported the following busi- ment of State; Jose R. Cardenas, former Acting As- ness items: sistant Administrator for Latin America and the Car- ibbean, United States Agency for International De- S. 154, to amend the Small Business Act to en- velopment; and Juan Sebastian Gonzalez, The Cohen sure small businesses affected by the onset of trans- Group, Washington, D.C. missible diseases are eligible for disaster relief; S. 650, to amend the Small Business Act to ex- NOMINATION pand tax credit education and training for small Committee on Foreign Relations: Committee concluded businesses that engage in research and development; a hearing to examine the nomination of Doug Man- S. 690, to extend the eligibility of redesignated chester, of California, to be Ambassador to the Com- areas as HUBZones from 3 years to 7 years; monwealth of The Bahamas, Department of State, S. 929, to improve the HUBZone program, S. after the nominee testified and answered questions in 1038, to require the Administrator of the Small his own behalf. Business Administration to submit to Congress a re- AUTHORIZATIONS FOR THE USE OF port on the utilization of small businesses with re- MILITARY FORCE spect to certain Federal contracts; Committee on Foreign Relations: Committee received a S. 1038, to require the Administrator of the Small closed briefing on the Authorizations for the Use of Business Administration to submit to Congress a re- Military Force, focusing on Administration perspec- port on the utilization of small businesses with re- tives from Rex Tillerson, Secretary of State; and spect to certain Federal contracts, with an amend- Jame Mattis, Secretary of Defense. ment in the nature of a substitute; and BUSINESS MEETING S. 1428, to amend section 21 of the Small Busi- ness Act to require cyber certification for small busi- Committee on Health, Education, Labor, and Pensions: ness development center counselors. Committee ordered favorably reported the nomina-

VerDate Sep 11 2014 05:45 Aug 03, 2017 Jkt 069060 PO 00000 Frm 00004 Fmt 0627 Sfmt 0627 E:\CR\FM\D02AU7.REC D02AUPT1 August 2, 2017 CONGRESSIONAL RECORD — DAILY DIGEST D881 House of Representatives Committee on Finance: to hold hearings to examine the Chamber Action nominations of Gilbert B. Kaplan, of the District of Co- The House was not in session today. The House lumbia, to be Under Secretary of Commerce for Inter- is scheduled to meet in a Pro Forma session at 1 national Trade, and Matthew Bassett, of Tennessee, to be p.m. on Friday, August 4, 2017. an Assistant Secretary, and Robert Charrow, of Maryland, to be General Counsel, both of the Department of Health Committee Meetings and Human Services, 10 a.m., SD–215. No hearings were held. Committee on Foreign Relations: business meeting to con- sider an original bill entitled, ‘‘Taylor Force Act’’, and the nominations of Michael Arthur Raynor, of Maryland, Joint Meetings to be Ambassador to the Federal Democratic Republic of No joint committee meetings were held. Ethiopia, Maria E. Brewer, of Indiana, to be Ambassador f to the Republic of Sierra Leone, and John P. Desrocher, of New York, to be Ambassador to the People’s Demo- NEW PUBLIC LAWS cratic Republic of Algeria, all of the Department of State, (For last listing of Public Laws, see DAILY DIGEST, p. D736) 10 a.m., S–116, Capitol. Committee on the Judiciary: business meeting to consider H.R. 3364, to provide congressional review and to S. 705, to amend the National Child Protection Act of counter aggression by the Governments of Iran, the 1993 to establish a national criminal history background Russian Federation, and North Korea. Signed on Au- check system and criminal history review program for gust 2, 2017. (Public Law 115–44) certain individuals who, related to their employment, f have access to children, the elderly, or individuals with disabilities, and the nominations of Jeffrey Bossert Clark, COMMITTEE MEETINGS FOR THURSDAY, of Virginia, to be an Assistant Attorney General, Peter E. AUGUST 3, 2017 Deegan, Jr., to be United States Attorney for the North- (Committee meetings are open unless otherwise indicated) ern District of Iowa, D. Michael Dunavant, to be United States Attorney for the Western District of Tennessee, Senate Louis V. Franklin, Sr., to be United States Attorney for Committee on Commerce, Science, and Transportation: Sub- the Middle District of Alabama, Marc Krickbaum, to be committee on Consumer Protection, Product Safety, In- United States Attorney for the Southern District of Iowa, surance, and Data Security, to hold hearings to examine Jessie K. Liu, of Virginia, to be United States Attorney insurance fraud in America, focusing on current issues for the District of Columbia, and Richard W. Moore, to facing industry and consumers, 9:45 a.m., SR–253. be United States Attorney for the Southern District of Committee on Energy and Natural Resources: to hold hear- Alabama, all of the Department of Justice, 10 a.m., ings to examine Federal and nonfederal collaboration, in- SD–226. cluding through the use of technology, to reduce House wildland fire risk to communities and enhance fire- fighting safety and effectiveness, 10 a.m., SD–366. No hearings are scheduled.

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Next Meeting of the SENATE Next Meeting of the HOUSE OF REPRESENTATIVES 10 a.m., Thursday, August 3 1 p.m., Friday, August 4

Senate Chamber House Chamber Program for Thursday: Senate will resume consideration Program for Friday: House will meet in Pro Forma ses- of motion to proceed to consideration of H.R. 2430, FDA sion at 1 p.m. Reauthorization Act, and vote on the motion to invoke cloture on the motion to proceed to consideration of the bill at 11 a.m. At 11:45 a.m., Senate will begin consideration of the nomination of Dan R. Brouillette, of Texas, to be Deputy Secretary of Energy, and vote on confirmation of the nomination at approximately 12 noon.

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