E PL UR UM IB N U U S Congressional Record United States th of America PROCEEDINGS AND DEBATES OF THE 112 CONGRESS, SECOND SESSION

Vol. 158 WASHINGTON, MONDAY, MAY 21, 2012 No. 73 Senate The Senate met at 2 p.m. and was a Senator from the State of Maryland, to the floor. I am cautiously optimistic called to order by the Honorable BEN- perform the duties of the Chair. that the spirit of bipartisanship will JAMIN L. CARDIN, a Senator from the DANIEL K. INOUYE, continue because Democrats cannot State of Maryland. President pro tempore. pass this legislation without the co- Mr. CARDIN thereupon assumed the operation of our Republican colleagues. PRAYER chair as Acting President pro tempore. I certainly hope they will allow us to The Chaplain, Dr. Barry C. Black, of- f advance this bill this evening without fered the following prayer: additional delay caused by another fili- RECOGNITION OF THE MAJORITY buster. I would like Senators from both Let us pray. LEADER Eternal God, our provider, give to parties to be free to offer relevant our lawmakers provisions for their The ACTING PRESIDENT pro tem- amendments to improve a worthy bill, daily needs. Give them grace to keep pore. The majority leader is recog- but before we can get to work on this Your commandments, to accept Your nized. legislation in earnest, I urge my Re- guidance, to stay on Your path, and to f publican colleagues to stop their fili- walk in Your light. Lord, give them buster. Americans living with cancer FOOD AND DRUG ADMINISTRATION stamina to run until they reach their and other life-threatening illnesses are SAFETY AND INNOVATION ACT— goal and to be true to You until the watching closely to see whether the MOTION TO PROCEED very end. Make them this day wise Senate is capable of moving to quick with Your wisdom and strong with Mr. REID. Mr. President, I now move action to ease shortages of crucial Your strength. Help them to believe in to Calendar No. 400, S. 3187. medicines or whether we will once Your power so that they may be cer- The ACTING PRESIDENT pro tem- more be paralyzed by Republican ob- tain that You are able to do for them pore. The clerk will report the motion. structionism. more than they can ask or imagine. The legislative clerk read as follows: Americans have seen that obstruc- We pray in Your merciful Name. Motion to proceed to Calendar No. 400, S. tion time and time again this Congress. Amen. 3187, a bill to amend the Federal Food, Drug, They are frustrated with the slow pace and Cosmetic Act to revise and extend the of Senate action to reauthorize the Vi- f user-fee programs for prescription drugs and olence Against Women Act, Iran sanc- medical devices, to establish user-fee pro- tions, and on legislation to stop inter- PLEDGE OF ALLEGIANCE grams for generic drugs and biosimilars, and est rates from doubling on student for other purposes. The Honorable BENJAMIN L. CARDIN loans. Earlier this month Republicans led the Pledge of Allegiance, as follows: SCHEDULE blocked an attempt to keep higher edu- I pledge allegiance to the Flag of the Mr. REID. Mr. President, we are now cation affordable for 7 million stu- United States of America, and to the Repub- on the motion to proceed to the FDA dents. But Democrats have not given lic for which it stands, one nation under God, user fees bill. At 4:30 the Senate will up. I hope our Republican colleagues indivisible, with liberty and justice for all. proceed to executive session to con- will come to their senses and allow us sider the nomination of Paul Watford f to prevent this crisis that affects 7 mil- to be U.S. Circuit Judge for the Ninth lion young men and women before it is Circuit. At 5:30 there will be a cloture APPOINTMENT OF ACTING too late. vote on the Watford nomination. If we PRESIDENT PRO TEMPORE Republican obstruction and infight- are able to confirm his nomination, we ing has also stalled critical new sanc- The PRESIDING OFFICER. The should expect a second vote on the mo- tions on Iran. For 2 months Democrats clerk will please read a communication tion to proceed to the FDA user fees have worked to resolve Republican ob- to the Senate from the President pro legislation. jections to this bipartisan measure tempore (Mr. INOUYE). OBSTRUCTIONISM REPEATED which passed out of the Banking Com- The legislative clerk read the fol- Mr. President, this week the Senate mittee unanimously. The stakes lowing letter: must complete work on legislation couldn’t be higher. Sanctions are a key U.S. SENATE, that will enact crucial reforms that tool to stopping Iran from obtaining a PRESIDENT PRO TEMPORE, will prevent drug shortages and bring nuclear weapon, threatening Israel, Washington, DC, May 21, 2012. To the Senate: lifesaving medicines to market more and jeopardizing U.S. national secu- Under the provisions of rule I, paragraph 3, quickly. Senators HARKIN and ENZI, a rity. We cannot afford more delays to of the Standing Rules of the Senate, I hereby Democrat and a Republican, worked putting stronger sanctions in place. I appoint the Honorable BENJAMIN L. CARDIN, very hard to bring this legislation to hope my Republican colleagues will see

∑ 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 Mar 15 2010 01:14 May 22, 2012 Jkt 019060 PO 00000 Frm 00001 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.000 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3296 CONGRESSIONAL RECORD — SENATE May 21, 2012 how important it is to advance these The ACTING PRESIDENT pro tem- try. There was an unduly long wait for important measures and prevent Iran pore. Without objection, it is so or- patients to have access to new medi- from obtaining a nuclear weapon. dered. cines and technologies. For FDA, it Republicans have also needlessly Mr. REID. Mr. President, I suggest often took 2 or 3 years to review a drug blocked progress on reauthorization of the absence of a quorum. application. Materials were submitted the Violence Against Women Act. This The ACTING PRESIDENT pro tem- manually in a very costly fashion. It helps law enforcement effectively com- pore. The clerk will call the roll. cost manufacturers to the tune of al- bat and prosecute domestic crimes The legislative clerk proceeded to most $10 million a month. against women. Although both Cham- call the roll. So we decided to come together in bers have passed a version of this legis- Ms. MIKULSKI. Mr. President, I ask the era when Bill Clinton said big gov- lation, House Republicans have refused unanimous consent that the call of the ernment was over—not to make gov- to go to conference with the Senate. quorum be rescinded. ernment to be bigger but for govern- Their excuse—a hypertechnical budget The PRESIDING OFFICER (Mr. ment to be smaller—and we came up issue called a blue slip—isn’t much of a COONS). The Senator from Maryland. with a public-private partnership figleaf to hide their blatant obstruc- Ms. MIKULSKI. Mr. President, I called the PDUFA, the pharmaceutical tion. The truth is that they are looking come to the floor to lend my voice to user fee legislation. PDUFA supports for any excuse to stall or kill this wor- asking my colleagues to vote for the drug review, so that those who make thy legislation, but American women motion to proceed to the FDA Safety the products pay a fee to be able to have not been fooled. If Republicans and Innovation Act. Like the Presiding have their drugs reviewed. They also really want to give police the tools Officer, who is from Delaware, where expect their government to reduce the they need to prosecute domestic abus- its excellent private sector and public time it takes to move reviews expedi- ers, they will drop this facade. If Re- sector have been the hallmark of inno- tiously yet safely. publicans really care about protecting vation, I represent a State that is abso- Let’s be clear: This is a public-pri- women and families, they will abandon lutely critical to the innovation econ- vate partnership. For FDA, as it looks these hypertechnical objections and omy. at its—remember, FDA has two jobs, join us in conference. Those of us from Maryland know life which are food safety and then the There are differences between the science innovation is one of the impor- safety of drugs and medical devices. House and Senate bills that could be tant economic engines in our economy More than 60 percent of funding for worked out easily. American women both today and in the future. We are drugs and medical devices comes from and families are counting on our ac- the home to flagship government agen- industry fees—$712 million. The re- tion. But in this Congress it seems the cies such as the National Institutes of mainder comes from Federal appropria- Republicans are more interested in in- Health, the FDA, and iconic inter- tions—$473 million. So the private sec- action than action; they are more in- nationally branded universities that do tor carries a big part of this responsi- terested in blocking worthy legislation research and move it into clinical prac- bility. The kind of staffing, expertise, for partisan gain than in working to- tice at Johns Hopkins and the Univer- and modernization we have at FDA gether. Their infighting and partisan sity of Maryland. There are also lots of could not have happened without this games have stopped reauthorization of thriving biotech companies and some public-private partnership. It has been the Violence Against Women Act, Iran medical devices. So for us life science a success. sanctions, and the student loan fix— is part of the lifeblood of the Maryland More than 1,500 new medicines or stopped them right in their tracks. economy, and it is also part of the life- technologies have been approved since These are just a few of their ways of blood of the American economy. 1992 for everything from the dread ‘‘C’’ stopping legislation, a few important Think of what we do. We come up words such as cancer or cardiovascular measures they have stopped over the with new biological products, new disease, to infectious disease, to the past few weeks. But the FDA bill, pharmaceuticals, new medical devices dread ‘‘A’’ words such as Alzheimer’s, which will prevent drug shortages and that not only save and improve lives which we are working on, and others. It make lifesaving medicines available but also enable them to help people in has allowed the FDA to have more sci- more quickly, must not become an- our own country. Because they are entists and staff, and for that it is giv- other victim of this partisanship. I FDA approved—the gold standard for ing value to the private sector to be hope Republicans seize this oppor- safety and efficacy—they can sell these able to decrease review times. We re- tunity to be cooperative rather than be products around the world, often to duced review times from 2 years in 1992 combative. countries that will never be able to af- to 1.1 years today. Mr. President, would you announce ford an FDA. We had excellent hearings. They were the business of the day? We have worked very closely on a bi- very civil, very content rich. But I also partisan basis to be able to create the launched a listening tour in Maryland RESERVATION OF LEADER TIME legislative framework called PDUFA, where I went out to the major biotech The ACTING PRESIDENT pro tem- the Pharmaceutical Drug User Fee Act, companies and heard from over 25 dif- pore. Under the previous order, the and there will be a lot of other UFAs, ferent companies about what they leadership time is reserved. user fees, in this. As I said, we have thought we needed to do. I asked them The motion to proceed is now pend- worked together on a bipartisan basis where their government helped them ing. to bring this legislation to the floor. and where their government hurt Mr. REID. Mr. President, I suggest I note on the Senate floor at this mo- them, where should their government the absence of a quorum. ment is the ranking member of the get out of the way, and where did they The ACTING PRESIDENT pro tem- Health, Education, Labor, and Pen- need a more muscular government, pore. The clerk will call the roll. sions Committee, the Senator from meaning moving things ahead. They The legislative clerk proceeded to Wyoming, Mr. ENZI, who has been a had great ideas. It was fantastic. call the roll. leader in fashioning legislation where What I heard was we have to reau- Mr. REID. Mr. President, I ask unan- we can continue the mission of what thorize PDUFA quickly, and we must imous consent that the order for the we want at FDA: safety and efficacy, make the improvements to the pro- quorum call be rescinded. moving drugs into clinical practice, grams. We need to improve the drug re- The ACTING PRESIDENT pro tem- regulations that are sensible, regulate view process; we need to increase com- pore. Without objection, it is so or- but not strangulate the innovation munication in order to speed the drug dered. economy or the potential for saving review process. We have made sure we ORDER OF PROCEDURE and improving lives. The bill before us have increased a number of mandatory Mr. REID. Mr. President, I ask unan- is integral to achieving this shared performance requirements between imous consent that the cloture votes goal. FDA and the life science product spon- which were scheduled this afternoon on This is not new legislation. PDUFA sors. I say life science because it is bio, Watford be vitiated, all of the provi- was enacted in 1992. At that time we it is pharma, it is medical devices, and sions of that order remain in effect. were almost facing a crisis in our coun- some things that are both. PDUFA V,

VerDate Mar 15 2010 01:14 May 22, 2012 Jkt 019060 PO 00000 Frm 00002 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.004 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3297 which this is—it is the fifth time—al- what will happen is we will need to This bill will make important lows us to use biomarkers to decrease send out RIF notices. We won’t do it, changes to how FDA does business. development time by helping to dem- but Dr. Mary Hamburg, the FDA CEO, Thanks to the efforts of Senators BURR onstrate therapeutic benefit more the Commissioner, will have to, start- and COBURN, the bill now includes new quickly. It requires FDA to develop a ing in July and August, send out RIF requirements that will make FDA dedicated program for drug develop- notices to 4,000 Federal employees at more accountable and transparent. A ment and training of staff. FDA, from the Ph.D. and the M.D. to fundamental principle of effective man- We face a turnover, and there are a the important lab techs and others who agement is that one has to be able to lot of reasons for that which I will keep FDA going. This is no fooling measure performance if one wants to come back to. But we want to make around, I say to my colleagues. This improve it. The ideas of Senators BURR sure those young people who are so isn’t: Let’s wait for the cliff. We will and COBURN will help provide those smart in science know how to work to come to the brink if we do not reau- measurements and, as a result, Ameri- have the science evaluated in a timely thorize. Think about the role of FDA. cans are going to get better access to way. This is absolutely critical. If one thinks one is going to lose their safe, innovative medical devices and We have also incentivized the devel- job, that is what they are going to be medicines. opment of drugs for rare diseases. Par- preoccupied with. They are not going The bill will also modernize how the ticularly for parents of children with to be occupied with looking at these FDA inspects foreign facilities to bet- very unique and poignant, heart-break- clinical trials and moving their ad- ter account for the global nature of ing diseases, we would require FDA to vances forward. drug manufacturing. It will allow FDA develop guidance related to advancing We have worked so hard on this legis- to prioritize and target riskier over- and facilitating increased outreach to lation. The private sector has worked sized facilities, which will help prevent patient representatives, not only to the hard to find a sensible center, and so the recurrence of the problems with industry but to those who represent has Dr. Mary Hamburg and her team. drugs such as heparin. the patient advocacy groups. Again, we Our committee has worked so well. We It will also improve how FDA regu- seek to develop training and certificate can do this. We have to have the will. lates medical devices. For the past sev- programs within FDA on how to review If we want to stay ahead in the global eral years, FDA premarket review of drugs for rare diseases. economy, it has to include passing this medical devices has involved signifi- I could go through the many benefits legislation. cant delay and unpredictability. This of PDUFA. We have done also in here Everybody talks about stopping has threatened American manufac- MDUFA, the medical device act, and China. I don’t know what China is turing jobs which have started to mi- we do generic PDUFA. So there are going to do, but I know we can stop grate overseas because of the unfavor- several bills in this bill. But we have to ourselves if we don’t pass legislation able regulatory environment here in act. There has to be a sense of urgency. that promotes innovation in our coun- the United States. It has also threat- This is a different bill than many oth- try and private sector jobs in a part- ened patient access to new therapies. I ers. If we don’t reauthorize many other nership with government. believe this bill will reverse those bills, they keep on going, but with the I conclude by urging my colleagues trends. The bill reflects the concerns I have PDUFAs and the other user fee legisla- to vote for the motion to proceed. I yield the floor. heard in my meetings with committee tion, they actually will be sunsetted if The PRESIDING OFFICER. The Sen- members regarding the current short- we do not pass them by October. One ator from Wyoming. ages of vital and lifesaving drugs. Sen- might say, Well, we will wait until Oc- Mr. ENZI. Mr. President, I thank the ators BLUMENTHAL, ROBERTS, CASEY, tober. We will deal with it on the cliff. Senator from Maryland, Ms. MIKULSKI, ALEXANDER, BENNET, and HATCH should We can’t do that, because of the im- for her passion and understanding and be thanked for all the work they put pact on both the people in the private intense work on this particular bill. Of into the drug shortage proposal. The sector and those in the public sector. course, she extends her passion and in- new notification and coordination re- Failure to reauthorize in a timely man- tense work on any bill she is involved quirements are important steps that ner would have catastrophic effects on in. I am so pleased this bill has gone to will help prevent future drug short- FDA’s ability to carry out its impor- committee and has had the time for ages. tant role. If the user fee agreement ex- the committee to work on it. We have The bill also enjoys broad support. pires, patients, public health, and in- a very bipartisan approach on the bill We have received numerous letters of dustry will suffer. This isn’t Senator and a very reasonable way to do it. support from industry, patient groups, BARB speaking, this is what our leading I rise to support S. 3187, the Food and consumer groups, and a whole raft of business and public health advocates Drug Administration Safety and Inno- other stakeholders. are telling us. If we don’t reauthorize, vation Act of 2012, and I appreciate We also worked to guarantee that the user fees sunset, so that means U.S. Senator MIKULSKI making the opening any mandatory spending generated by pharmaceutical industries, which sup- statement. This bill will reauthorize the bill would be fully offset. Over the port 4 million jobs, would be adversely FDA’s drug and medical device user fee past several weeks, we have developed affected. There would be no FDA to programs, authorize new user fees for offsets to pay for those provisions that work with. generic drugs and biosimilars, and produce mandatory spending. As a In 2010, Maryland private life science make a small number of targeted bi- matter of fact, according to the Con- companies supported over 25,000 jobs. partisan policy reforms at the same gressional Budget Office, this bill will These companies are true innovators. time. reduce the Federal deficit. On average, it takes a new medicine 10 This legislation represents over a full Chairman HARKIN and I have worked to 15 years to develop. If we fail to re- year of work by the HELP Committee. very hard to make this bill as bipar- authorize PDUFA, which ensures an ef- Fridays have been dedicated to coming tisan and uncontroversial as possible. ficient, consistent, and predictable reg- up with solutions on this for over a We tried to avoid controversy because ulatory environment, our private sec- year, and it has paid off. It reflects the we understand this bill needs to get tor will lose out. We are going to lose information we have learned from hun- done. If we don’t reauthorize the drug out to Europe and we are going to lose dreds of meetings with patients, with and device user fee programs before out to China. China is stealing our pat- advocates, with stakeholders, with out- they expire this fall, the FDA will be ents as we speak. It will have a terrible side experts, and with the FDA. More forced to lay off 2,000 to 4,000 key em- consequence on patients as tens of mil- importantly, it reflects both the ideas ployees. This will cause FDA’s review lions of them rely on drugs and bio- and the feedback we have gotten from of new drugs and devices to grind to a logics and medical devices. every member of the HELP Committee halt. This, in turn, will threaten bio- We know we have legislation that and a lot of people outside the HELP medical industry jobs, patient access works, we have a legislative framework Committee. The HELP Committee ap- to new medical therapies, and Amer- that works and now we need to get to proved this bill by a voice vote on April ica’s global leadership in biomedical work. If we do not pass this bill, and 25 and reported the bill out of com- innovation. We are talking about 4 mil- reauthorize these major programs, mittee on May 7. lion jobs overall and 2,000 to 4,000 that

VerDate Mar 15 2010 01:14 May 22, 2012 Jkt 019060 PO 00000 Frm 00003 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.008 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3298 CONGRESSIONAL RECORD — SENATE May 21, 2012 will have to be chopped off because the viously, failed to achieve the promised the income tax rates are scheduled to money runs out when this bill expires, results. An Associated Press reporter go up, the new taxes from ObamaCare the previous bill expires, so it is crit- wrote shortly before it was signed into will hit—$1⁄2 trillion worth of new taxes ical that we get that done. law: over the next 10 years. Another important thing with those They call it ‘‘stimulus’’ legislation, but the Finally, there is the Dodd-Frank fi- 2,000 to 4,000 people who will have to be economic measures racing through Congress nancial regulatory reform bill. When it laid off at FDA is those are key techni- would devote tens of billions of dollars to comes to financial regulatory reform, I cians, scientists, informed people who causes that have little to do with jolting the think most Americans believe there have been working on this for a long country out of recession. should be two simple goals: preventing time. If we lose this, they will still Of course, that is exactly what hap- new crises from happening and making have jobs, it just will not be where we pened. It seemed more designed to sure the taxpayers are not on the hook can get drugs on the market faster, de- shower taxpayer dollars on certain fa- for Wall Street’s mistakes. vices on the market faster, generic vored constituencies and pet interests Well, the Dodd-Frank bill did not drugs out faster, and all of the other than to actually jump-start the econ- achieve either goal. It is a complex web things this bill covers. omy. Much of it was simply wasteful of regulations that institutionalized So in conclusion, I would like to Washington spending. Many investors ‘‘too big to fail’’ and has served to in- thank Chairman HARKIN and all the must have asked themselves why they crease uncertainty, increase moral haz- other members of the HELP Com- should put their money to risk on new ard, and increase economic distortions, mittee, FDA, industry, and many other job-creating ventures when they have all the while adding 52.9 million paper- groups for working with us on this im- to compete with well-connected firms work hours since its passage. portant legislation. that can simply wring taxpayer-pro- So, as I said, President Obama does I particularly want to point out the vided stimulus dollars out of Congress not seem to be running for reelection cooperation Senator HARKIN has pro- or the Obama administration. on this record of the stimulus package, vided, the leadership he has provided A Washington Post poll released just ObamaCare, or Dodd-Frank regulatory on the bill, and the way his staff mem- last week showed that 48 percent of reform. Instead, he is going to be send- bers and mine have worked together Americans have an unfavorable view of ing—or maybe he has already sent it— for at least a year in regular meetings the stimulus—and this was, after all, to Congress a to-do list, things he with all members of the committee. So the President’s signature effort to spur would like for Congress to do, most of I think a lot of the controversy that the economy. which are tax credits and other very could come up with a bill like this has Indeed, as Jeffrey Anderson notes in short-term proposals that are not like- been taken care of. I am hoping it has a recent issue of the Weekly Standard ly to have a big effect on jobs or so we can get this done expeditiously. magazine, the administration does growth because the business sector is I thank the Chair and yield the floor. seem to be downplaying the law. Not not impressed with a one-time-only, The PRESIDING OFFICER. The Sen- only has the stimulus failed to create short-term proposition. It wants to ator from Arizona. robust growth, the costs have become know that when it invests money, that Mr. KYL. Mr. President, I ask unani- more outrageous. He writes: investment is going to be for the long mous consent to speak as in morning It has now been five months since the Ad- term. Apparently, he is going to cam- business. ministration last put out a report card on paign on this most recent list when he The PRESIDING OFFICER. Without [the stimulus.]. . . . the December report goes out to Iowa later this week. objection, it is so ordered. marked the sixth straight quarterly report Well, this happens to be Small Busi- showing that stimulus’s cost per job is ris- THE ECONOMY ing: In reports spanning January 2010 to De- ness Week, and one would think the Mr. KYL. Mr. President, what I cember 2011, the stimulus’s cost per job more President would turn to something would like to talk about this afternoon than doubled, rising from $146,000 (in Janu- that businesses have actually said they is a bit about the President’s economic ary 2010) to $317,000 (in December 2011). With would like to do; that is, to prevent record. I am sure Americans have no- each passing quarter, the stimulus has be- this tax tsunami coming at the end of ticed the President barely mentions come an even worse deal for taxpayers. this year—as I mentioned, the biggest this economic record when he is out on So this is the administration’s own tax increase in the history of the coun- the campaign trail, and I can well un- report card on the stimulus, concluding try, which automatically would take derstand why. It is not a very impres- in the last report, $317,000 per job. effect on January 1 of next year, unless sive record, especially if you are a tax- Think about that for a moment. To Congress does something about it and payer or a business owner. create each job, the taxpayers shell out the President can sign the legislation. Our national debt creeps closer to $16 $317,000. The NFIB, the National Federation trillion each day. It is now more than Numbers like these remind me of a of Independent Business, recently re- $5 trillion more than it was when the quip from writer Christopher Buckley. leased a list of the top five uncertain- President took office. It now adds up to He said writing political satire these ties in the Tax Code that they say about $50,000 per person in the United days can be difficult because it has to would harm small businesses. Let me States, and that is exclusive of interest compete with reality—$317,000 for one just mention three of these uncertain- payments. By way of contrast, the me- job under the President’s stimulus. ties. dian yearly household income—in Well, second, ObamaCare. The $2.6 One is the pending increase in mar- other words, all the people in the trillion bill is not aging very well. ginal tax rates, which will devastate house—is less than $50,000. It is $49,445. Since its passage, the act has imposed the estimated 75 percent of small busi- Unemployment recently dropped, but an estimated $14.9 billion in private nesses that file as individuals. Every it did so for the simple reason that sector burdens, approximately $7 bil- one of the five tax rates in the IRS fewer people are searching for work. lion in costs to the States, and 58.6 mil- Code will be increased as of January 1. The President’s signature legislative lion annual paperwork hours, accord- Since most of the businesses now pay— items—the stimulus bill, ObamaCare, ing to a weekly regulatory report. especially small businesses—as individ- and Dodd-Frank—have not only been The April Kaiser health tracking poll uals—so-called passthrough entities— unhelpful in boosting growth, but they showed that more Americans have an these rate increases directly will im- have left a trail of crushing debt, un- unfavorable view of the law than favor- pact small businesses. certainty, and new regulations in their able. It is 43 to 42 percent. More than Secondly, they are concerned about wake. I want to make a few points half of Americans oppose its central the death tax. That is going to ensnare about each of those bills because I provision, the so-called individual 900 times more small business owners think they paint a fair picture of the mandate. All told, the new taxes in and 2,200 times more family farmers if President’s economic record. ObamaCare would add up to $1⁄2 trillion the rate increases to 55 percent and the First, let me talk about the stimulus. over 10 years. Many of these taxes will exemption falls to $1 million, as is We have not forgotten about the stim- coincide with the biggest tax increase scheduled to occur on January 1. ulus, even though I suspect the Presi- in history—the one scheduled for the Third is the alternative minimum dent might like to—$1.2 trillion. It, ob- end of this year. So at the very time tax which will hit 27 million more

VerDate Mar 15 2010 01:14 May 22, 2012 Jkt 019060 PO 00000 Frm 00004 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.009 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3299 Americans—including many small taxes would be even more detrimental sage of a gold price that has collapsed by businesses—if it is not patched or re- because we are asking companies in near 20 percent, falling from around $1,900 an pealed. Well, small business cannot af- America to compete with firms all over ounce to the mid-$1,500s. With a risk-averse ford this, what has been called the world, and their rate would be economy at home, and with the Greek and European financial crises abroad, the de- ‘‘taxmageddon’’ and its devastating much higher with this tax increase mand for dollars seems to exceed the dollar consequences. than the rate in all of the other devel- supply printed by the Fed. This could be I would hope, instead of this to-do oped countries, as well as countries solved by more quantitative easing. But a list the President is sending us, he such as Brazil, Russia, India, and better approach for a system already over- would take up the cause of preventing China. How can American businesses supplied with unused liquidity would be the this big tax increase at the end of the compete in that situation? extension of tax-rate growth incentives, not year and help the small businesses and Then, finally, Kudlow notes the ef- more monetary pump-priming. fect of all of this uncertainty on what The uncertainty over the Bush tax cuts al- families that need that help. ready has caused a number of business lead- Finally, I ask unanimous consent to matters most to most Americans; that ers to threaten a hiring freeze and a damp- have printed in the RECORD at the con- is, the fact that they cannot get work. ening of investment until they can figure out clusion of my remarks a piece in Na- He says: the after-tax cost of capital and rate of re- tional Review Online by Larry Kudlow Bizarrely, some 25 million people have van- turn on investment. Hiring has slowed no- dated May 17 called ‘‘Extend the Bush ished from the labor force—from unemploy- ticeably in recent months. And a number of Tax Cuts Now.’’ ment, underemployment, or simply dropping Wall Street economists are marking down The PRESIDING OFFICER. Without out all together. And half of U.S. households the anemic recovery even more, suggesting objection, it is so ordered. are now on some form of federal-transfer- that the 3 percent growth at the end of last (See exhibit 1.) payment assistance. So as we pay so many year, which faltered to 2 percent growth in people not to work, we’re sapping the vital- the first quarter, could be even less in the Mr. KYL. In this piece, Larry ity of the economy. period ahead. Kudlow, a noted economist, notes that This is absolutely true. With half of A bunch of CEOs have even formed their with respect to this ‘‘taxmageddon’’— own march on Washington. Eighteen of them the people in the country on some form the increase in everybody’s taxes at just wrote to Treasury man Timothy of Federal assistance, with 25 million the end of this year—it is the uncer- Geithner, begging him to oppose tax-rate people having just vanished from the tainty of it all that is preventing the hikes on dividends (from 15 to 45 percent) labor force not even looking for work investment by business which would and capital gains (from 15 to near 30 percent, anymore, businesses sitting on the taking the ‘‘Buffett Rule’’ into account). create the jobs we would all like to see. sidelines because they cannot calculate ‘‘Equity capital is the life blood of invest- I would just like to quote three para- what kind of return on investment ment and job creation for U.S. companies,’’ graphs and a couple sentences in a they could get because of the potential they wrote. And they argued that the admin- fourth. He says: istration’s tax-hike plans would do great for the huge tax increase that is going harm to American competitiveness and cap- The uncertainty over the Bush tax cuts al- to occur on January 1, it is no wonder ready has caused a number of business lead- ital formation. ers to threaten a hiring freeze and a damp- we cannot move forward with an eco- According to accounting firm Ernst & ening of investment until they can figure out nomic recovery. Young, the top U.S. integrated tax rate on the after-tax cost of capital and rate of re- So I would just say to President corporate profits and dividends is on course turn on investment. Hiring has slowed no- Obama that providing long-term tax to hit 68.6 percent, significantly higher than ticeably in recent months. And a number of rate certainty would go a long way to- all other OECD countries, as well as Brazil, Wall Street economists are marking down ward establishing a sound economy in Russia, India, and China. Capital gains would the anemic recovery even more, suggesting rise to 56.7 percent. this country, putting Americans back And Speaker Boehner knows this. So he’s that the 3 percent growth at the end of last to work, and, ironically, establishing a year, which faltered to 2 percent growth in begun a valiant fight to get supply-side tax the first quarter, could be even less in the better record on which the President reform at the top of the congressional agen- period ahead. could run. A year and a half ago, the da well before the election. Similarly, House President actually proposed—and I budget chairman Paul Ryan is suggesting at Then he goes on to say: think Congress was very happy to go least a six-month extension of the Bush tax A bunch of CEOs have even formed their along with—a continuation of the ex- cuts, so as not to disrupt business. (By the own march on Washington. Eighteen of them way, the Ryan tax-and-spending-reform just wrote to Treasury man Timothy isting tax rates because, as he said at budget got 41 votes in the Senate, while Geithner, begging him to oppose tax-rate the time, not to do so would be very Obama’s budget got none.) hikes on dividends— damaging to the economy. I would sub- In a recent interview, former top Obama Which would go from 15 to 45 per- mit it is equally damaging for that to economic adviser Larry Summers told me cent— happen at the end of this year. the U.S. recovery is going ‘‘ahead of sched- So I would ask the President, help ule.’’ Really? But former Obama economist and capital gains (from 15 to near 30 percent. Austan Goolsbee gives a more realistic as- . . .) give the American people and Amer- ican businesses the certainty they need sessment by referring to a subpar 2 percent ‘‘Equity capital is the life blood of invest- forecast that is way too slow to spark faster ment and job creation for U.S. companies.’’ to invest, to create jobs, to advance job creation. That is what these CEOs wrote in the our economic growth, and create pros- Bizarrely, some 25 million people have van- letter to Treasury Secretary Geithner. perity for our future. ished from the labor force—from unemploy- Kudlow goes on to say: EXHIBIT 1 ment, underemployment, or simply dropping out all together. And half of U.S. households And they argued that the administration’s [From National Review, May 17, 2012] are now on some form of federal-transfer- tax-hike plans would do great harm to Amer- EXTEND THE BUSH TAX CUTS NOW payment assistance. So as we pay so many ican competitiveness and capital formation. (By Larry Kudlow) people not to work, we’re sapping the vital- Then he quotes the Ernst & Young House Speaker John Boehner is playing a ity of the economy. firm to say this: heroic role right now. In his efforts to pre- Mitt Romney recently gave a fine speech, . . . the top U.S. integrated tax rate on vent the Bush tax cuts from expiring, Boeh- blasting Obama’s profligate spend-and-bor- corporate profits and dividends is on course ner is aggressively taking on President row policies. He described ‘‘a prairie fire of to hit 68.6 percent, significantly higher than Obama’s leadership ineptitude on the econ- debt sweeping across Iowa and the nation,’’ all other OECD countries— omy. In essence, Boehner is pushing a Repub- and he tied our newfound debt to the ‘‘tepid lican policy to wrap up a debt-limitation bill recovery.’’ Those are the developed countries of and extend the Bush tax cuts in one fell But lower spending alone, while important, the world— swoop before the election—and before all the is not going to solve the economic-growth as well as Brazil, Russia, India, and China. last-minute, crisis-oriented, political machi- problem. Yes, moving spending to 20 percent Capital gains would rise to 56.7 percent. nations that would come in a lame-duck of GDP from 24 percent will free up private In other words, he is pointing out Congress, threatening another credit down- resources. But lower tax-rate incentives on that not only would these higher tax grade and leading to a business-hiring freeze the extra dollar earned and invested is a and plunging stock market, all of which hap- more powerful economic-growth tool. Rom- rates hurt the small businesses and the pened last year. ney should push his 20 percent tax-rate-re- families because of the individual tax Tax-cut certainty is so vital right now be- duction plan. That would add liquidity to rate, marginal rate increases, but rais- cause the anemic economic recovery may be fight deflation, and would provide new eco- ing the dividends and capital gains moving towards deflation. That’s the mes- nomic-growth incentives.

VerDate Mar 15 2010 02:24 May 22, 2012 Jkt 019060 PO 00000 Frm 00005 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.013 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3300 CONGRESSIONAL RECORD — SENATE May 21, 2012 As for John Boehner’s goal of an early ex- something else, but I am getting a lit- Congress’s effort to develop a com- tension of the Bush tax cuts, it’s going to be tle tired of hearing it myself. So I am prehensive approach to cybersecurity an uphill climb. Democrats want to raise sure everyone else is as well. must not erode that trust. When Amer- taxes, not cut them. But at least the GOP Again, Democrats have put $2 trillion will have a coherent growth-and-jobs mes- icans go online to consume digital sage. They can tell the public how important of cuts before this body, and we have services and goods, they must believe it is to avoid falling off the massive tax cliff implemented some of them already. and know with some certainty that which looms ahead. Deflationary fears can But we cannot run a government on 14 their privacy is adequately protected. ease. And they can make it plain to voters percent of the GDP. The average has The content that Americans consume that the GOP has a growth message in these been about 20 to 21 percent. So until must be at least as private as their li- perilous economic times, while the Obama they are willing to put some more reve- brary records, their video rentals, and Democrats do not. nues on the table, we are not going to book purchases in the brick-and-mor- f get anywhere, and we are not going to tar world. Our law enforcement and in- The PRESIDING OFFICER. The Sen- be able to extend the tax cuts that cost telligence agencies should not be free ator from Louisiana. people money. to monitor and catalog the speech of Ms. LANDRIEU. Mr. President, I was I hope we can do something so we can Americans just because it is online. not here to hear all of my colleagues’ extend some tax cuts to small busi- But the legislation passed by the remarks. I know there is a lot of con- nesses, which I came to talk about— other body, known as CISPA, would cern about the end of the year and and you, Mr. President, know this well. erode that trust. As an attempt to pro- what might happen to try to balance Instead of giving some of the biggest tect our networks from real cyber our budget and give us a solid platform tax breaks to companies that are the threats, CISPA is an example of what on which this economy could grow. But biggest in the world and put all of their not to do. CISPA repeals important one of the things that is holding us up jobs overseas, I wish the Republicans provisions of existing electronic sur- is the Republicans’ refusal to put any would start talking about tax relief to veillance laws that have been on the new revenues on the table. They have businesses right here at home on Main books for years, without instituting been adamant and wrong and hard- Street. That is what I want to talk corresponding privacy, confidentiality, headed and stubborn. about today. and civil liberty safeguards. It creates They have been very obstructionist (The further remarks of Ms. LAN- uncertainty in place of trust, it erodes DRIEU are printed in today’s RECORD in this way—by not being willing to statutory and constitutional civil put a penny of new revenue on the under ‘‘Morning Business.’’) Ms. LANDRIEU. I yield the floor and rights protections, and it creates a sur- table. As a result, we have come to a suggest the absence of a quorum. veillance regime in place of the tar- standstill because the income coming The PRESIDING OFFICER. The geted, nimble, cybersecurity program into the Federal Treasury to support clerk will call the roll. that is needed to truly protect our Na- this government is at the lowest level The bill clerk proceeded to call the tion. since President Eisenhower was Presi- roll. Unfortunately, S. 2105, the bill before dent. So they can come to the floor all Mr. WYDEN. Mr. President, I ask the Senate, shares some of these de- day long and criticize the President, unanimous consent that the order for fects. Currently, Internet services and criticize the Democrats, but in the last the quorum call be rescinded. service providers have agreements with 2 years Democrats have put over $2 The PRESIDING OFFICER. Without their customers that allow them to po- trillion of cuts and reductions to some objection, it is so ordered. lice and protect their networks and very important programs on the table. Mr. WYDEN. Mr. President, I ask users. Rather than simply allowing Some of us have even been willing to unanimous consent to speak as in these Internet companies to share in- say, yes; we know we have to reform morning business. formation on users who violate their Social Security and Medicare and Med- The PRESIDING OFFICER. Without contracts and pose a security threat, icaid. We have also been willing to objection, it is so ordered. the House and Senate proposals regret- speak those words which are not easy. THE INTERNET tably authorize a broad-based informa- Yet not one single Republican leader, Mr. WYDEN. Mr. President, I believe tion-sharing regime that can operate not one on either side, the House or the the development of the Internet, its with impunity. This would allow the Senate, not one has come to this floor networks, and the digital economy are personal data of individual Americans in public. Now, I have heard them say one of the great achievements of our to be shared across a multitude of bu- it in private. I have been in meetings age. reaucratic, military, and law enforce- when they have said it. But not one has The Internet links humanity to- ment agencies. This would take place come to this floor to say: We are will- gether, facilitating economic growth, regardless of the privacy agreements ing to put revenues on the table so we bringing education and health re- individual Americans have with their can match the cuts and move this sources to remote regions, reshaping Internet service providers. country forward. societies and advancing human rights. In fact, both the House and Senate So I am a little tired of hearing them While networks foster innovation, bills subordinate all existing privacy beat up on either President Obama or job creation, and political and social rules and constitutional principles to the Democrats when they are more to progress, networks can also be used by the poorly defined interests of what is blame for the situation we are in. The actors with nefarious motives. It is in called cybersecurity. American people are getting tired of it our national interest to deter, detect, These bills would allow law enforce- too because they can understand it is and destroy real and viable cyber ment agencies to mine Internet users’ not 100 percent President Obama’s threats, to protect Americans and pre- personal data for evidence of acts en- fault. In fact, when he took office, the serve the benefits of the Internet. tirely unrelated to cybersecurity. More Titanic had already hit the iceberg be- Americans must not be afraid to go on- than that, they would allow law en- cause they had run right smack into it line. forcement to look for evidence of fu- with the economic philosophies and The Internet works not just because ture crimes, opening the door to a policies they had. The ship was already it is open to all but because it is found- dystopian world where law enforce- sinking. But all they want to do is—ei- ed on the principle of trust. Users trust ment evaluates your Internet activities ther MITCH MCCONNELL or JON KYL, one that their browsers are visiting real for the potential that you might com- day the Senator from Arizona or the Web sites, not replicated ones. Internet mit a crime. Senator from Kentucky—every day commerce succeeds because people In establishing this massive new re- come to the floor and talk about how it trust that their transactions are pri- gime, these bills fail to create the nec- is the President’s fault there is no way vate and their financial information essary incentives for operators of crit- forward, there is no sure path forward, won’t be shared with others. People ical networks to keep their networks when they are the ones who have put trust the Internet because they believe secure. boulders in the way every day. their service providers work for them, It is a fundamental principle of cy- So I hope the people can see through not for their advertisers, not for bersecurity policy that any network it. I came to the floor to talk about scammers, and not for the government. whose failure could result in a loss of

VerDate Mar 15 2010 02:24 May 22, 2012 Jkt 019060 PO 00000 Frm 00006 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.015 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3301 life or significant property should be online activities. That would be a rec- gained bipartisan support both in physically isolated from the Internet. ipe to stifle speech, innovation, job cre- House and Senate committees, and it is Unfortunately, many of our critical ation, and social progress. I believe moving through what I would call a network operators have violated this these bills will encourage the develop- regular process. We haven’t seen too principle in order to save money or ment of an industry that profits from much of that in the last year and a half streamline operations. This sort of fear and whose currency is Americans’ or so. This is the regular process. For gross negligence ought to be the first private data. These bills create a cyber those who say Congress can’t get any- target in any cybersecurity program— industrial complex that has an interest thing done, hopefully, with passage of not the privacy of individual Ameri- in preserving the problem to which it is this bill we will take a very significant cans. the solution. step forward in terms of being able to Congress could target this behavior In terms of the process, the Senate provide and bring to patients, doctors, with yet one more rule book and one ought to proceed in a way that is as administrators, and others across the more bureaucracy, creating a cyberse- open and collaborative as the Internet Nation new drugs, new treatments, and curity contractor full employment pro- the Congress seeks to promote and pro- new medical devices that can ensure gram. I am not, however, convinced tect. On substance, any cybersecurity better health, prevent potential ter- this is a problem that requires that bill must contain specific and clear de- minal situations, and provide better kind of solution. scriptions of what types of data and drug availability and device avail- At the same time, Congress should when such data can be captured, with ability. So I think it is very important not allow our critical network opera- whom it can be shared, and under what that this legislation goes forward. tors to ignore best practices with im- circumstances. Anything not specifi- I am pleased we have gotten to this punity. It is vital they understand that cally covered ought to remain private. point on a bipartisan basis. I think any liability for a preventable cyber Privacy in the cybersecurity arena Senators HARKIN and ENZI deserve com- attack is their responsibility. There is should be the default not the excep- mendation for their work in the Sen- not going to be a governmental bailout tion. Legal immunity to corporations ate, and those in the House as well for after the fact in the cybersecurity that share information should be the bringing the bill along on a parallel area. Shareholders and boards of direc- exception not the rule and void if pri- track. tors must be vigilant and understand vacy protections or contracts are dis- the risks to their investments. Execu- regarded. The whole idea of this legislation is tives must understand that ignoring The Congress and the public must to continue to provide the safest, most critical cyber threats in the interest of have the ability to know how any cy- effective and most efficient drugs and cost savings and convenience will leave bersecurity program that is established devices for American citizens and peo- them personally exposed. is to be implemented. That means rou- ple around the world. These are two Internet providers and backbone op- tine public and unclassified reports and very important industries in which the erators clearly have a role in this fight. hearings to examine whether there United States has had the leading edge When they detect abnormal network were any unintended privacy or civil as providers and we don’t want to lose activity or have a user violating their liberty impacts caused by the program. that. It has meant a lot for our econ- contract in a way that constitutes a No secret law, Mr. President. omy, and it has meant a lot of jobs for cyber threat, they can and should in- Bad Internet policy is increasingly Americans. I think the passage of this form our cyber defense officials. If it is premised on false choices. Earlier this bill will continue what has been a re- necessary to grant them immunity to year, during the consideration of the markable nearly three decades’ worth share this kind of information, the Protect IP Act and the Stop Online Pi- of innovation that has taken place Congress could grant it—narrowly and racy Act, the Congress was told again both in the biopharmaceutical industry with careful consideration. it had a false choice. The Congress was as well as the medical device industry. Mr. President, there would be bipar- told it either could protect intellectual Part of this bill deals with drug tisan support for the proposition that property or it could protect the integ- shortages. I have talked to a number of the Federal Government also has a sig- rity of the Internet. This was a false doctors—my staff has been traveling nificant role that does not necessarily choice. I and others said so at the time the State talking to medical pro- require billing taxpayers for legions of because achieving one should not and viders—and there is an alarming num- private cybersecurity contractors. The does not require sacrificing the other. ber of drug shortages in critical drugs, Department of Defense, the Depart- Now the Congress is being asked once particularly those designed to deal ment of National Intelligence, Home- again to make a false choice—a choice with more rare instances of health land Security, and the Justice Depart- between cybersecurity and privacy— problems and yet, obviously, important ment—four major parts of our govern- and I don’t think these two are mutu- to those people who are suffering from ment—all have cybersecurity special- ally exclusive. I think we can have those incidences of disease or health ists. The Congress ought to be pro- both. Our job is to write a cybersecu- threats. moting the cyber capabilities of these rity bill that protects America’s secu- It was reported to me that last year agencies and providing the resources rity and the fundamental right to pri- FDA received a record number of drug that are needed to protect these net- vacy of our people. There is no sound shortage reports—more than 250—in- works. These Federal agencies should policy reason to sacrifice the privacy cluding critical drugs used in surgery, do a better job of consulting the pri- rights of law-abiding American citizens emergency care, and oncology. The vate Internet companies to better un- in the name of cybersecurity. It is my problem continues today, but the this derstand the attacks that are occur- intent to fight any legislation that bill addresses that and, hopefully, will ring every day across the net. would force Members of the Senate to move us forward significantly in terms Some of these steps may require leg- make that choice. of dealing with this current problem. islation, but many can be carried out Mr. President, with that I yield the by responsible actors in the public and floor. In Fort Wayne—my hometown in In- private sector without waiting for the The PRESIDING OFFICER. The Sen- diana—Parkview Health’s pharmacy di- Congress to act. However, the legisla- ator from Indiana. rector said nearly 80 percent of hos- tion before the Senate and the cyberse- Mr. COATS. Mr. President, I rise pitals consistently face shortages in curity legislation that passed the other today to talk about the Food and Drug drugs needed for emergencies, includ- body leads our country away from the Administration Safety and Innovation ing cardiac and diabetic prescriptions. kind of commonsense approach to cy- Act. I believe we are going to have a This bill incorporates significant re- bersecurity I have outlined this after- cloture vote on this bill tonight, and I porting requirements to the FDA that I noon. am pleased that all early indications hope will help mitigate this critical As they stand, these bills are an are it will pass tonight and we will problem. I think we are going to need overreaction to a legitimate and under- move forward on this bill. to figure out ways to further address standable fear. The American people There has been considerable time this, but this can be an important first are going to respond by limiting their spent drafting this legislation. It step.

VerDate Mar 15 2010 01:14 May 22, 2012 Jkt 019060 PO 00000 Frm 00007 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.019 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3302 CONGRESSIONAL RECORD — SENATE May 21, 2012 The whole concept has been some- lapse that exists for approval. They can the Senate to support this important what unique in the Federal Govern- manufacture these products overseas legislation. ment; that is, the makers of the prod- and get approval overseas and sell I yield the floor. ucts essentially pay a fee to a regu- them on a worldwide basis much more The PRESIDING OFFICER. The Sen- latory agency for the regulatory agen- quickly, but they do not want to do ator from Minnesota. cy to conduct the work necessary to that. The United States is their home Ms. KLOBUCHAR. Mr. President, I gain approval to sell their drugs on the and they want to produce here, but thank the Senator from Indiana for his market. We have had a situation which they have to compete with their com- words. is sort of a cornucopia of new innova- petitors across the waters that are sub- We both are from States that have a tions in drugs and medical devices. Yet jected to fewer delays in implementing lot of jobs involved in medical devices, they have been delayed by the bureauc- approvals. and, in fact, this bill is something we racy or the inability of the FDA to To counter that, we simply want to worked on very hard. I am the cochair move in an efficient, effective way to use this medical device user fee in a of the medical device caucus in the run this through the process. way that will help the FDA’s review Senate. This has been our top priority, The biopharmaceutical industry has process and eliminate these unneces- to try to move those FDA rules along, basically said: Look, we are willing to sary delays, unpredictability, and in- and this bill does that. It is an agree- put up between $3.5 billion and $4 bil- consistency of past practices. ment—a rare agreement—between gov- lion in new user fees—I believe it is I do want to thank the FDA for pay- ernment and industry, which is some- over a 5-year period of time—which ing significant attention to our device thing both parties want. We would like will account for nearly 60 percent of users by coming to Indiana and listen- to move those approvals along for the the funding designated by the Center ing to them—a forum that I convened. patients, long-suffering patients who for Drug Evaluation and Research. In There has been interaction back and should have access to medical devices, exchange for putting up those fees, the forth, whether it is FDA traveling to and then also for the industry, where FDA has agreed to new performance Indiana or device manufacturers trav- we have seen way too much venture goals and process improvements that eling here to Washington. I am pleased capital money go to places such as Eu- will reduce the time it takes drugs to that this bill contains some items that rope simply because that process reach the market. are the result of all those negotiations moves faster. So this is a very good So the key is to provide the funds and all those exchanges between the bill, and I am so pleased we have bipar- necessary to hire the right people and two. tisan support. put the right procedures in place to ex- Let me mention one last thing before I see that the Senator from Wyo- pedite the study and approval of safe, closing, and that is the medical device ming, Mr. ENZI, has come into the effective, efficient drugs that have tax, which is not part of this bill. To Chamber, and both he and Senator been sent to the FDA for approval so pay for the so-called affordable health HARKIN deserve a lot of praise. we can get them into the market. Of care law, the administration included a I wish to focus today on one piece of course, the ultimate goal is to get 2.3-percent tax on medical devices, this bill, something I have worked very them not only into the market but use which will begin in 2013. That tax es- hard on, and it really came out of them to provide health and safety ben- sentially was imposed on an industry things I heard in my State, things I efits for the American people. that is paying its full share of taxes, heard from pharmacists literally 2 The Medical Device User Fee Act is contributing to the user fee, and yet it years ago, things I have heard from pa- also part of this. In Indiana, we have was slapped on as a way to pay for the tients. I got together with our staff. I not only a very large biopharma- costly health care bill. That has an see that our legislative director, Rose ceutical company and a number of af- enormous impact over a period of time Baumann, and Andrew Hu, who did a filiated companies, we also have a vi- on these device manufacturers and lot of work on this bill, are here today. brant and dynamic medical device in- jeopardizes manufacturers’ ability to We went and talked to all kinds of peo- dustry. That industry employs over remain based here in the United States ple involved. We talked to pharma- 20,000 Hoosiers directly and many more rather than looking overseas. ceutical companies to try to figure out indirectly with good-paying jobs. Many There are a number of States in addi- what was going wrong with drug short- of these companies are right on the tion to Indiana—and my colleague ages; we talked to the people who were leading edge of new innovation and new from Minnesota is waiting to speak, suffering the most—the patients; we developments. So included in the legis- and her State is also a major manufac- talked to the pharmacists, and we said: lation that we will be voting on is a 5- turer and innovator of medical devices. What would work here? And the FDA year agreement known as the Medical California, Florida, Illinois, Massachu- told us that, in fact, when they did get Device User Fee Act that improves the setts, New Jersey, New York, Ohio, early notification from pharmaceutical regulatory pathway for medical de- Pennsylvania, Texas, and Wisconsin companies that there was going to be vices. will all suffer potential job losses if some kind of shortage, it helped. They This is the medical device equivalent this medical device tax is imposed. were able to avert that shortage. They of the pharmaceutical user fee. Device We are not taking it up in this bill so have done it successfully over 100 companies have worked with the FDA, as not to try to derail the bill. I under- times, and they have done it many again in an agreement where each side stand an agreement has been made times with some key drugs. And the contributes. The medical device manu- that it would be set aside. I know Sen- earlier notice they have, the better it facturers will contribute user fees to go ator HATCH, on our side, is looking for is for everyone because they can, in to the FDA that can be used to stream- an opportunity to bring that up in an- fact, then avert the drug shortage, and line—without compromising safety in other vehicle, and I want to support that is what this is about. any way—the regulatory process so the that. I encourage my colleagues to I will tell you that, for me, this approvals can be made. take a look at the impact of that fee on whole bill and this whole provision Why is this important? Well, it is im- our ability as a nation to be the leader really comes down to a little boy portant not only to getting these prod- in innovation and export of medical de- named Axel Zirbes, a young boy with ucts into the marketplace so they can vices. bright eyes and a big smile. Because of be used to safely improve the health of I thank Senators HARKIN and ENZI for leukemia, this little boy, when I saw American citizens, but this is a dy- shepherding the Food and Drug Admin- him, had no hair on his head. He and namic export industry where America istration Safety and Innovation Act his family were thrown into a panic has been the leading exporter of med- through the committee. I believe this about 1 year ago when they learned ical devices. I have heard from so many legislation will help improve patients’ that an essential drug—cytarabine— medical device manufacturers through- access to new medical technology, and was in short supply and might not be out Indiana that they are faced with it will protect American jobs and im- available for their son, who they had the dilemma of having to potentially prove the FDA so that America can re- just found out was diagnosed with leu- think about moving overseas simply main a global leader in biomedical in- kemia and was supposed to start treat- because of the delays and the time novation. I encourage my colleagues in ment, and the doctor says: You know

VerDate Mar 15 2010 01:14 May 22, 2012 Jkt 019060 PO 00000 Frm 00008 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.024 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3303 what, we don’t know if you should hundreds more for expensive alter- To help correct a poor market envi- start it—you should start it imme- natives or risking their professional ca- ronment or to prevent gray market diately, but we don’t have this critical reers to adjust for their diseases and drugs from contaminating our medica- cancer drug, this critical leukemia spending hours and days just trying to tion supply chain, we must address the drug. find a way to fill a prescription. drug shortage problem at its root. Last They decided they would take Axel When we are dealing with so many year I introduced the Preserving Ac- to Canada, where the drug was readily costs and resource issues with health cess to Life-Saving Medications Act available, and just when they were care, the last we want is for doctors with Senator BOB CASEY. We also have making those plans to go there, they and nurses and pharmacists to be wast- the support of Senator COLLINS and found out that some of the drug had ing away hours trying to find drugs and others. This is a bipartisan bill that been located and that Axel could come then ultimately, in most cases, finding would require drug manufacturers to in for his treatments. Well, that should them, but this is no way to run a rail- provide early notification to the FDA never have happened, not in the United road. Across the country, hospitals, whenever there is a factor that may States of America, not to a family of a physicians, and pharmacists are con- lead to a shortage. We also had support little 4-year-old boy, both parents fronting unprecedented shortages of from the Presiding Officer, as well as working hard to make sure their child these drugs. Senator BLUMENTHAL of Connecticut could have health care and then this So those are the stories, but here are and many other people from across the happens. It makes no sense. the numbers. Senate. There is the story of Mary McHugh The number of drug shortages has This bill will help the FDA take the Morrison, who joined me at a forum I more than tripled over the last 6 years, lead in working with pharmacy groups, held on this topic in Edina, MN. Mary jumping from 61 drug products—re- drug manufacturers, and health care is a woman whose cancer had, unfortu- member, there are thousands of short- providers to better prepare for impend- nately, returned after a shortage of ages, but this is 61 different drug prod- ing shortages, more effectively manage ucts in 2005 to more than 200 drug prod- Doxil. That is a chemotherapy drug shortages when they occur, and mini- uct shortages in 2011. that had kept her ovarian cancer at mize their impact on patient care. And A survey by the American Hospital bay. In fact, this shortage interrupted Association found that virtually every that is why I am pleased that the early her chemotherapy regimen. Mary hospital in the United States has expe- notification provision from my bill is struggled to find remaining vials of rienced shortages of critical drugs in included in the Food and Drug Admin- Doxil and then struggled with the eth- the past 6 months. More than 80 per- istration Safety and Innovation Act, ical dilemmas of using the drug she cent reported delays in patient treat- the one that Senator COATS and I were found when others would not be able to ment due to shortages. just discussing and that we are debat- use it. She literally talked at the For some of these drugs, no sub- ing today. forum about how she had personally stitutes are available or, if they are, I thank Senator HARKIN and Senator called people, used connections, tried they are less effective and may involve ENZI for their leadership on the HELP to find those vials, and she realized greater risk of adverse side effects. The Committee in bringing this legislation that when she got those drugs, other chance of medical errors also rises as forward and including my provision. In people wouldn’t have them. providers are forced to use second- or a bipartisan manner, the HELP Com- Again, this shouldn’t be happening in third-tier drugs that they are less fa- mittee brought together several work- the United States of America. She miliar with using. ing groups to address a wide range of shared her experience with us. And be- A survey conducted by the American issues, from medical device innovation cause of a few delays in treatment, Hospital Association showed that near- to drug shortages. In the drug shortage Mary’s doctor told her that her tumor ly 100 percent of their hospitals experi- working group, we spoke with experts had, unfortunately, returned and that enced a shortage—100 percent. Another from patient groups, providers, drug she was then no longer responding to survey conducted by Premier Health manufacturers, and the FDA to try to that drug. This past February, CT System showed that 89 percent of its find an appropriate solution. scans, unfortunately, showed that hospitals and pharmacists experienced Ultimately, the legislation now in- Mary’s tumor size had doubled. She shortages that may have caused a cludes many policies that I believe will was immediately accepted into a clin- medication safety issue or an error in help address shortages. In addition to ical trial at the Mayo Clinic and began patient care. the early-notification requirement, treatment. Fortunately, she is so far It is clear that there are a large num- again, the FDA is going to be able to responding well and her health is im- ber of overlapping factors that have re- look in our own country, and if they proving. sulted in these unprecedented short- can’t find something in our own coun- These shortages are happening all ages. Experts cite a number of factors: try they can look at safe locations over this country. Every single Senator market consolidation, poor business in- overseas. You simply can’t keep these in this Chamber has heard about one of centives, manufacturing problems, pro- patients waiting for their treatment. them. You heard Senator COATS from duction delays, unexpected increases in In addition, the bill directs the FDA Indiana talking about what he had demand for a drug, inability to procure to improve communications inside and heard. So the fact that we heard this raw materials, and even the influence outside its walls, requires more robust first in Minnesota I don’t think is any of the gray market. Literally, people record-keeping and reporting, and asks surprise. We have an active State. We are trying to make money off of this for studies on how pricing factors im- have people who believe you can still now. They hear there is a shortage, and pact drug shortages. make a difference. We have phar- they buy up the supply and then sell it I believe this bill represents a step macists who are on the front line every at a higher price. Financial decisions forward in our ability to prevent these day, and they came to us to get this in the pharmaceutical industry are shortages—a strong step forward. With bill introduced. We heard from emer- also a major factor. Many of these manufacturers providing early notifi- gency medical responders, who have medications are in short supply be- cation, the FDA’s drug shortage team told me that shortages have made it cause the companies have simply can then appropriately use their tools difficult to stock lifesaving drugs in stopped production. They decided it to prevent shortages from happening. their ambulances. I have listened to didn’t work for their profits to keep As I mentioned, in the last 2 years, the stories from parents whose children producing them. Mergers in the drug FDA, with more information, has suc- rely on drugs to help maintain their industry have narrowed the focus of cessfully prevented nearly 200 drug focus at school. I have seen firsthand product lines. As a result, some prod- shortages. Imagine the hundreds of how doctors and pharmacists have had ucts are discontinued or production is thousands and millions of patients that to struggle to keep their patients alive moved to different sites, leading to has helped. So we need to extend it. as they look for these drugs. delays. When drugs are made by only a That is what this bill does. These shortages have had significant few companies, a decision by any one One such example is the recent short- impact on these patients’ quality of drug company can have a large impact. age of methotrexate. This is a very life, oftentimes forcing them to pay That would make sense. common drug used in chemotherapy to

VerDate Mar 15 2010 02:36 May 22, 2012 Jkt 019060 PO 00000 Frm 00009 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.025 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3304 CONGRESSIONAL RECORD — SENATE May 21, 2012 treat cancers such as leukemia. For have enough on their minds. Let’s get of these agreements will continue to me, the most devastating part about this done. It is a great example of peo- foster biomedical innovation and job the shortage is that I heard about it ple working across the aisle. When growth throughout our country. from the Zirbes family—the family of they heard something from their con- The bill before us reauthorizes the this little 4-year-old boy who had to stituents, they were willing to listen prescription drug user fee agreement, suffer through the shortage of and to put this bill together. Me, I which is known in the nomenclature as cytarabine earlier. Only this time, the would like to have gotten it done 2 PDUFA. The medical device user fee FDA took quick action once it learned years ago, but later is better than agreement is known as MDUFA. These of this potential shortage and worked never. We can get it done this week. will continue and improve the agency’s with other manufacturers to boost pro- Mr. President, I yield the floor and ability to speed market access to both duction and helped stop the bleeding suggest the absence of a quorum. drugs and medical devices while ensur- before this became a major crisis. That The PRESIDING OFFICER. The ing patient safety. is an example of what can happen with clerk will call the roll. We have a new part of the bill called early notification. They are allowed to The assistant bill clerk proceeded to the generic drug user fee agreement, then go to other manufacturers and call the roll. which is expected to slash review times find the people who can make the drug Mr. HARKIN. Mr. President, I ask to a third of current levels—from 30 to get it to the hospitals, to get it to unanimous consent the order for the months to 10 months—and will improve the patients. And today, with strong quorum call be rescinded. the speed with which generic products cooperation between the FDA and The PRESIDING OFFICER (Mr. are made available to patients. This pharmaceutical manufacturers, BLUMENTHAL). Without objection, it is will generate significant savings in our methotrexate is available for patients so ordered. health care system. In the last decade, who rely on it just like that little 4- Mr. HARKIN. Mr. President, after from 2001 to 2010, it saved the U.S. year-old boy Axel Zirbes. many months of bipartisan negotia- health care system more than $931 bil- Together with Senator CASEY, we tion, the Senate will proceed this lion. were able to work with the HELP Com- evening to vote on the motion to pro- This agreement will ensure we con- mittee and in a bipartisan manner ceed to consideration of the Food and tinue to see those savings and that pa- come up with a solution that would Drug Administration Safety and Inno- tients will have access to cheaper drugs give the FDA more tools to prevent vation Act of 2012. I hope it will receive when they need them. It also obviously drug shortages and ensure patients an overwhelming vote so we can move means taxpayers will be saving money such as Axel or Mary have the drugs ahead with it and dispense with the bill because many of these drugs come they need when they need them. Re- on the floor this week. This bill is the through both Medicaid and Medicare. cent announcements by the FDA have product of excellent bipartisan collabo- By having generic drugs available more proven that early notification and co- ration on the Health, Education, rapidly than they have been in the operation with manufacturers have Labor, and Pensions Committee which past, it will mean taxpayers will save a helped reduce the number of drug I chair. All Senators on the committee significant amount of money in the fu- shortages by over half. There have been have been involved. Going back almost ture. 42 newly scarce drugs so far this year, a year, we set up working groups. Dif- This bill also authorizes another new compared to 90 in the same period last ferent Senators had different interests section, the biosimilars user fee agree- year. That is progress. in different parts of the bill. They and ment, which will further spur innova- While I applaud the FDA in their ef- their staffs on both sides were invited, tion by shepherding the biologic indus- forts to address this crisis, 42 drugs in Republican and Democrat, to be in- try as it matures. shortage is still 42 too many for me. volved in those working groups to put These agreements are vital to FDA’s That is why it is so important to pass this bill together. ability to do its job, to the medical this provision and give the FDA the The bill passed overwhelmingly out products industry’s ability to survive tools it needs to get the number down of our committee—actually by voice some very challenging economic times, to zero. vote, with only two reserving their but, most importantly, to the patients I understand that early notification ‘‘no’’ votes. So it had overwhelming who are the primary beneficiaries of requirements may be a short-term so- support on both sides in our com- this longstanding and valuable collabo- lution to a long-term problem. That is mittee. ration between FDA and industry. As I why I will continue to work with my This bill, of course, reauthorizes im- said, after months of negotiations with Senate colleagues to come up with a portant FDA user fee agreements. It our staffs, with FDA, with the indus- broad permanent solution, one that in- modernizes the FDA’s medical product try, and with consumer groups, I think cludes methods to address the root authority to help boost American inno- they have crafted win-win agreements causes of drug shortages. vation and ensure patients have access that they stand behind. So industry is It has been a long road to get to this to the therapies they need. The back- behind this bill, the FDA is behind this point. Nearly 2 years ago I began hear- bone of this legislation is the user fee bill, and hundreds of groups through- ing about this drug shortage issue, and agreements that FDA has negotiated out this country have been supporting when I first talked about it some of the with industry. We must remember that it. They have done their job and now it doctors said: Really? I haven’t heard a sizable part of FDA’s budget comes is time for us to do ours. about it. Now, 2 years later, they have from user fees that the industry agrees It is absolutely imperative that we all heard about it. That is why we in- to pay, that allows the FDA to hire the authorize these user fee agreements be- troduced the Preserving Access to Life- personnel and get the equipment they fore they expire. If we don’t, the FDA saving Medication Act. That is why we need to more quickly review product will lose about 60 percent of its drug came together to get an agreement in applications. We need to reauthorize center budget and 20 percent of its de- this legislation. That is why the Presi- this bill to implement those agree- vice center budget. It will have to lay dent issued an Executive order that ments if we want to keep the FDA run- off nearly 2,000 employees, which would pushed for more voluntary notifica- ning at full steam, which is critical to grind the drug and device approval tions from manufacturers, and the preserving jobs at both the agency and processes to an unacceptably slow FDA released an interim final rule that in industry, and to ensuring that FDA pace, with devastating consequences broadened the scope of the current no- has the resources to get safe medical for patients, jobs, for the industry, and tification requirement. That is why it products to patients quickly. Again, further innovations both in drugs and is so important that we pass this legis- these agreements affect all of us by devices. We cannot let that happen, lation. helping to maintain and create jobs in and that is why for more than a year Patients such as Axel or Mary should our home States. For example, in my we have worked very closely in our not have to be burdened with the added own State of Iowa, these agreements committee. stress and worry about whether they will support our bioscience sector I see the ranking member, Senator are going to have enough medication to which is growing and is increasing em- ENZI, is here. We and our staffs have get through their next treatment. They ployment in our State. Implementation worked together. As I said, we set up

VerDate Mar 15 2010 02:36 May 22, 2012 Jkt 019060 PO 00000 Frm 00010 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.026 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3305 these working groups in our com- bill increases FDA’s accountability and The clock is ticking. Everything ends mittee. They were not divided along transparency. by the end of this summer. We are out any kind of partisan lines. They were That is sort of a broad-brush stroke of here in August. We have the 4th of set up along interest groups so we had of what is in this bill. I will be over in July break and Memorial Day break both Democratic and Republican Sen- the next day perhaps getting into some coming up. In order for us to go to con- ators and their staffs working together more of the specifics. It is imperative ference with the House and work out for years. that we keep pace with and adapt to whatever differences we may have and I am sure I can speak for Senator technological and scientific advances. get this back here so we can finish it ENZI when I say all along our aim has Things move very rapidly in this area by late June or early July—I hope we been to ensure that in addition to the and we want to make sure we get the could even finish this by late June so user fee agreements and all the other drugs and devices approved as quickly there would not be any disruptions at things, this is the product of a con- as possible, but always with keeping all in the FDA and their planning for sensus, bipartisan, policymaking proc- patient safety foremost. That is the the future or in the industry itself. ess that we have had for the last year. single most important aspect, to make I urge my colleagues to join in the bi- It was an open and transparent process. sure that patient protections will re- partisan spirit of cooperation that we We had input not only from our mem- main key. Keeping pace with the bio- have witnessed in the HELP Com- bers but other Senators were also in- medical landscape that changes so rap- mittee over the last year. Let us come volved as they had interest in this bill. idly is the aim of this bill, to ensure together to pass this legislation that is Throughout negotiations on this bill the drugs coming from abroad are safe, of critical importance to the American the stakeholder community-at-large and to take appropriate measures to people. was involved. protect our patients. There being no objection, the mate- Again, I can assure everyone that I believe we have a good compromise. rial was ordered to be printed in the this legislation benefited greatly from Neither Democrats nor Republicans got RECORD, as follows: all of the diverse input from Senators everything they wanted in this bill. As SUPPORT FOR PROVISIONS IN THE FDA SAFETY on both sides, industry stakeholders, I have said before, I didn’t get all of AND INNOVATION ACT consumer groups, and patient groups. what I wanted in this bill. I am sure A. Philip Randolph Institute; Ablitech, It is a result of concerted efforts to de- others didn’t either, but that is the Inc.; Academy of General Dentistry; Acad- emy of Managed Care Pharmacy; Action fine our common interests, and I be- process of a consensus. And where we Aids; Action CF; Advanced Medical Tech- lieve these efforts will directly benefit could not achieve consensus, we didn’t nology Association; AFL–CIO, Maryland and patients and the U.S. biomedical indus- allow those differences to distract us DC Chapter; AIDS Alliance for Children, try. from the important goal of producing a Youth, and Families; AIDS Delaware; AIDS Very briefly, I want to say as a broad bill that everyone could support. Foundation of Chicago; Alder Health; stroke that this bill authorizes key Again, it is a true bipartisan bill that Alexion Pharmaceuticals; Allegheny Con- user fee agreements for both drugs and is broadly supported by the patient ference of Community Development; Alli- medical devices. It streamlines the de- ance of AIDS Services—Carolina; Alz- groups and industry. I have letters heimer’s Association—Capital of Texas vice approval process while again en- from over 100 groups outlining their Chapter; Alzheimer’s Association—Indiana hancing patient protections. support. To name a few: the Pew Chari- Chapter; Alzheimer’s Association; American We do one other thing. We modernize table Trust, Consumers Union, the Academy of Child and Adolescent Psychi- the FDA’s global drug supply chain au- Pharmaceutical Manufacturers Asso- atry; American Academy of Dermatology As- thority so we have a better handle on ciation, the Generic Pharmaceutical sociation. and better information and knowledge Industry, the Biotech Industry Organi- American Academy of Emergency Medi- of where our products are coming from. cine; American Academy of Emergency Med- zation, BIO, the American Academy of icine Residential and Students Association; Of the drugs manufactured in this Pediatrics, Advanced Medical Tech- American Academy of Pediatric Dentistry; country, 80 percent of the ingredients nology Association, American Founda- American Academy of Pediatrics; American come from abroad. In the past we have tion for the Blind, and many more. Academy of Periodontology; American Asso- not had a tight handle on where they Those are just a sampling of over 100 ciation of Nurse Anesthetists; American As- were coming from and what kind of groups. sociation of Oral and Maxillofacial Surgeons; manufacturing processes were in- Mr. President, I ask unanimous con- American Association of Women Dentists; volved. This bill closes that up. It gives sent that the list of those groups be American Cancer Society Cancer Action Net- work, Colorado Chapter; American Cancer the FDA much better authority over printed in the RECORD at the conclu- Society, Delaware Chapter; American Cancer that and much better input from where sion of my remarks. Society, South-Atlantic Division; American the drugs come from to make sure they Mr. HARKIN. We are expecting that College of Clinical Pharmacy; American Col- follow good manufacturing practices. there will probably be some amend- lege of Emergency Physicians; American It spurs innovation and incentivizes ments to this bill, and that is fine. College of Gastroenterology; American drug development for life-threatening That is the way the Senate should op- Council of the Blind; American Dental Asso- conditions. erate. We expect all amendments to ciation; American Foundation for the Blind; We reauthorized the pediatric trial this bill will be relevant to the bill. I American Hospital Association; American program and improved it so we have hope Senators on both sides of the aisle Liver Foundation—Allegheny Division; American Medical Association. specific trial programs for pediatric who want to see this bill passed expedi- American Pediatric Society; American drugs. Children are not just small tiously would keep that in mind. If Pharmacists Association; American Printing adults. What may work for an adult in there is a relevant amendment and House for the Blind; American Psychiatric terms of a drug, we don’t just cut the Senators feel they want to bring that Association; American Public Health Asso- drug in half and give it to a child. up, that is fine. That is the way the ciation, Delaware Chapter; American Soci- Sometimes it takes specialized, spe- Senate should operate. ety for Gastrointestinal Endoscopy; Amer- cific kinds of drugs for children that I hope nonrelevant amendments ican Society for Parenteral and Enteral Nu- are not something an adult gets. So which have nothing to do with the bill trition; American Society of Anesthesiol- ogists; American Society of Clinical Oncol- this reauthorizes and improves those will not be promoted on the Senate ogy; American Society of Dentist Anesthe- trials for children. floor. That would only slow the bill siologists; American Society of Health-Sys- Senator ENZI and I and others in our down and put us into some untenable tem Pharmacists; American Society of He- committee wanted to do something position on the Senate floor in terms of matology; American Society of Pediatric Ne- about preventing and mitigating drug getting this bill expeditiously done. phrology; American Thoracic Society; shortages, so we have provisions in this We cannot allow unrelated, partisan Amgen; Analtech; ARCA Biopharma; Arthri- bill that will do that and help prevent disagreements or Presidential-election tis Foundation; Association of Community and mitigate these drug shortages by year politics to interfere with this bill Cancer Centers; Association of Medical making sure the FDA gets timely in- and keep us from completing our job. School Pediatric Department Chairs; AstraZeneca Pharmaceuticals LP; Augmenta formation from manufacturers if there So amendments that are offered must Biologicals. is going to be any interruption at all in be relevant to the bill, and we must Bayer Healthcare; BHGR Law; BIO; Bio- the supply chain. Also I believe this pass it now. Crossroads; Biogen Idec; BioHouston; BioNJ;

VerDate Mar 15 2010 04:41 May 22, 2012 Jkt 019060 PO 00000 Frm 00011 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.028 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3306 CONGRESSIONAL RECORD — SENATE May 21, 2012 BioOhio; BioRelix, Inc.; Biotech Vendor Science Greenhouse of Central Pennsylvania; Pittsburgh Technology Council; Pittsburgh Services; Black Mental Health Alliance of LifeScience Alley; Lighthouse International; Venture Capital Association; Plymouth/ Massachusetts; Bleeding Disorders Alliance Lupus Alliance of America—Michigan Indi- Terryville Chamber of Commerce; Premier Illinois; Blood Bank of Delmarva; Bloom- ana Affiliate; Lupus Foundation of Amer- healthcare alliance; Prevent Blindness ington Chamber of Commerce; Boehringer ica—Illinois Chapter; Lupus Foundation of America; Prevent Blindness Mid-Atlantic; Ingelheim Chemicals, Inc.; Boehringer America DC/MD/VA Chapter; Lupus Founda- Prevent Blindness Ohio; ProteoTech Inc; Ingelheim Pharmaceuticals, Inc.; Boehringer tion of America, Connecticut Chapter, Inc.; Psychiatric Society of Virginia; Respiratory Ingelheim Vetmedica, Inc.; Boehringer Lupus Foundation of America, DC/MD/VA Health Association of Metro Chicago; Rib-X Ingelheim, Inc.; Bristol-Myers Squibb; Bur- Chapter; Lupus Foundation of New England; Pharmaceuticals; Rio Grande Valley Diabe- lington Chamber of Commerce. Lupus Foundation of Pennsylvania; tes Association; Rocky Mountain Stroke Cambridge Chamber of Commerce; CARA Maetrics; March of Dimes; Maryland Cham- Center; Rush To Live Organization; Rx Part- Therapeutics; Celgene Corporation; Central ber of Commerce; Maryland State Medical nership; San Antonio AIDS Foundation; Connecticut Chambers of Commerce; Cere- Society; Massachusetts Association of Men- Sanofi; Seattle BioMed; Sequella, Inc.; Sheet bral Palsy Association of Eastern Massachu- tal Health; Massachusetts Biotechnology Metal Workers Local 40. setts; Chamber of Commerce of Eastern Con- Council; Massachusetts Chamber of Com- Society for Adolescent Health and Medi- necticut; Child Neurology Society; Chil- merce. cine; Society for Pediatric Research; Som- dren’s Defense Fund; Children’s Hospital As- Mayors Committee on Life Sciences; erset County Business Partnership; South sociation; Citizens Opposed to Additional MedCara Pharmaceuticals; Medical Device Jersey Geriatric Care, P.C.; South Jersey Spending and Taxes (COAST); Cleveland Manufacturers Association; Medical Imaging Senior Marketing Group; South Shore Cham- Clinic; Coaches Against Multiple Myeloma; & Technology Alliance; Medical Society of ber of Commerce; Southwest Michigan Phar- Coalition of Texans with Disabilities; Colo- Virginia; Mental Health America of Colo- macists Association; Spanish American Mer- rado Association of Commerce and Industry; rado; Mental Health America of Greater chants Association (SAMA); Stanford Hos- Colorado Bioscience Association; Colorado Tarrant County; Mental Health America of pital & Clinics; Supercritical Fluid Tech- Gerontological Society; Commerce and In- Illinois; Mental Health America of Indiana; nologies; Susan G. Komen, Denver Metro Af- dustry Association of NJ; Community Health Mental Health Association of Connecticut; filiate; Susan G. Komen for the Cure Advo- Charities of Iowa; Connecticut AIDS Re- Merck; Metro Denver Economic Develop- cacy Alliance; Takeda Pharmaceuticals source Coalition; Connecticut Business & In- ment Corporation; MichBio; Michigan Cham- U.S.A., Inc.; Targepeutics; Tech Council of dustry Association (CBIA). ber of Commerce; Michigan Council of the Maryland; TECHQuest Pennsylvania; Teva Connecticut Retail Merchants Association; Blind and Visually Impaired; Michigan Man- Pharmaceuticals; Texas BioAlliance; Texas Connecticut State Building and Construction ufacturers Association; Middlesex County Health Care & Bioscience Institute. Trades Council; Connecticut United for Re- Chamber of Commerce; Midwest Business The Arc of Connecticut; The Association search Excellence (CURE, CT’s BIO); Con- Group on Health; Millennium, The Takeda for Corporate Health Risk Management; The sumers Union; Council of Pediatric Sub- Oncology Company; Morris County Chamber Center for Health Care Services; Trinity specialties; CT BEACON; Cubist; D’Souza of Commerce; Mylan. Health—Novi, Michigan; Trust for America’s NAACP Columbus Chapter; NAMI Colo- and Associates; Delaware Academy of Medi- Health; Union of Concerned Scientists; rado; NAMI Indiana; NAMI NC; NAMI-IL; cine; Delaware AFL–CIO; Delaware Ecumeni- United Mitochondrial Disease Foundation; National Alliance for Mental Illness—Gulf cal Council on Children and Families; Dela- University City Science Center; University Coast; National Alliance for Mental Illness— ware HIV Consortium; Delaware Technology of Utah Health Care; University of Wash- Park; DelawareBIO; Denver Metro Chamber Metropolitan Houston; National Alliance for Mental Illness—Texas; National Alliance on ington; Virginia Biotechnology Association; of Commerce; Des Moines Area Community Virginia Chamber of Commerce; VisionServe College; Detroit Regional Chamber of Com- Mental Illness; National Alliance on Mental Illness, Michigan; National Association of Alliance; Visiting Angels; Washington Bio- merce; Develop Indy; Dun & Bradstreet. technology & Biomedical Association. East End Group, LLC; Easter Seals of Mas- Chain Drug Stores; National Association of Washington Global Health Alliance; Wash- sachusetts; Economic Alliance Snohomish Manufacturers; National Association of Pe- ington State Department of Commerce; County; Eli Lilly and Company; Elizabeth diatric Nurse Practitioners; National Dental Washington State University; Waterbury Re- Glaser Pediatric AIDS Foundation; Association; National Federation of the gional Chamber of Commerce; We Work For Endocyte; Engineered BioPharmaceuticals; Blind; National Kidney Foundation of Indi- Health; We Work for Health New Jersey; Epilepsy Foundation of Greater Chicago; Ex- ana; National Organization for Rare Dis- WellDoc, Inc.; Western Economic Council; emplar Genetics; Farmington Chamber of orders; National Parkinson Foundation, Cen- Western Michigan University; Westside Commerce; Feed Energy Company; Fort tral and Southeast Ohio Chapter; National Health; Wolcott Chamber of Commerce; Wayne Chamber of Commerce; Generic Phar- Processing Solutions; National Research Worcester Chamber of Commerce; Wright maceutical Association; GlaxoSmithKline; Center for Women & Families. Runstad & Company. GlycoMimetrics; Grand Rapids Area Cham- NC Autism Society; NC Bio NC Chamber; ber of Commerce; Greater Boston Chamber of NC Psychological Association; Neurofibro- I yield the floor. Commerce; Greater Des Moines Partnership; matosis Mid-Atlantic; Neurofibromatosis of The PRESIDING OFFICER. The Sen- Greater New Haven Chamber of Commerce. the Mid-Atlantic; Neurofibromatosis of the ator from Wyoming. HealthHIV; HeathCare Institute of New Mid-Atlantic; New Jersey Business and In- Mr. ENZI. Mr. President, I thank the dustry Association (NJBIA); New Jersey Jersey (HINJ); Hematology/Oncology Phar- chairman for his remarks and wish to macy Association; Hep C Connection; Hon. Community Research Initiative; New Jersey Edd Houck, Former Virginia State Senator; Laborers’ Union; New Jersey Life Science be associated with them. It has been a Hospira; Hudson County Cancer Coalition; Vendors Alliance (NJLSVA); New Jersey very bipartisan process that has re- IBI Scientific; Illinois BIO; Illinois Bio- State League of Municipalities; Newark Sen- sulted in this bill coming to the floor, technology Industry Organization (iBIO); Il- ior Center; NJ Healthcare Advocate Volun- and I am hoping there will only be rel- linois Chamber of Commerce Healthcare teer Effort (NJ Have); North Carolina Asso- evant amendments and that there will Council; Illinois Manufacturers’ Association; ciation for Biomedical Research; North Caro- be few of those. Every amendment has Illinois Science and Technology Coalition; lina Biotechnology; North Dakota Associa- the potential for disrupting the entire tion of the Blind; North Hudson Community Incyte; Indiana Association of Cities and bill. This has been a very inclusive Towns; Indiana Health Industry Forum; Indi- Action Corporation; North Texas Commis- ana Manufacturers Association; Indiana sion; Northwest Connecticut Chamber of process that has led to this legislation. Medical Device Manufacturer’s Council; Indi- Commerce. Over a year ago staff began to meet ana State Chamber of Commerce; Infectious Novo Nordisk Inc.; Nuclea Biotechnologies; with stakeholders on the policy issues Diseases Society of America. NYU Langone Medical Center; Ohio Chamber that are addressed in S. 3187. Starting Innovation NJ; Institute for Safe Medica- of Commerce; Ohio Coalition of Concerned in the spring of 2011, staff from Repub- tion Practices; Institute For Systems Biol- Black Citizens; Ohio Laborers’ District lican and Democratic offices on the Council; Ohio State Building and Construc- ogy; Integrated Laboratory Services— Health, Education, Labor and Pensions Biotech; Iowa Academy of Family Physi- tion Trades Council; One Southern Indiana; cians; Iowa Biotech Association; Iowa Nurses Ovarian Cancer National Alliance; PACT, Committee began a series of standing Association; Johns Hopkins Medicine; John- Greater Philadelphia Alliance for Capital meetings. The groups proceeded to son & Johnson; Joy’s House; Junior Achieve- and Technologies; Parent Project Muscular meet every week for several months. ment of Central Maryland; Junior Achieve- Dystrophy (PPMD); Parkersburg Economic They met with stakeholders and dis- ment of Delaware; Junior Blind of America; Development; Patient Advocates for Ad- cussed policy solutions that each mem- Juvenile Diabetes Awareness Coalition; Ju- vanced Cancer Treatments; Pediatric Infec- ber thought would solve the problem. venile Diabetes Research Foundation; Kala- tious Diseases Society; Pediatric Pharmacy After much discussion of the benefits, Advocacy Group; Pennsylvania Bio; Pennsyl- mazoo Chamber of Commerce; Kidney Cancer costs, and possible unintended con- Association; Kolltan Pharmaceuticals, Inc. vania Chamber of Business and Industry; Lancaster General Health; Legacy Commu- Peoples Settlement Senior Center; Pew sequences, members agreed to a list of nity Health Services; Leukemia & Charitable Trusts; Pfizer, Inc.; PhRMA; policy concepts. If it was not a con- Lymphoma Society Iowa and Nebraska; Life Pittsburgh Life Science Greenhouse. sensus on a particular policy, then it

VerDate Mar 15 2010 04:41 May 22, 2012 Jkt 019060 PO 00000 Frm 00012 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.007 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3307 was not included. The chairman men- Thankfully enough, Senate Repub- nominated by President Obama after tioned the importance of consensus, licans came forward to say they are consultation with the most senior and and that is what we worked on. not going to delay a vote or to con- longest-serving Republican in the Sen- As this process progressed, my staff tinue a filibuster. We ought to just ate, Senator DICK LUGAR of Indiana, met with the Republican staff on the have an up-or-down vote, which we al- who strongly supported the nomina- HELP Committee for at least 2 hours ways used to do. Hopefully, we will not tion. Fortunately, the Senate rejected every week to keep them informed of vote to promote a filibuster, but vote that unjustified filibuster and Judge everything that was happening. I per- up or down, and I thank those Repub- Hamilton was confirmed with Senator sonally met with the members of the licans who came forward and said LUGAR’s support. committee before the markup to make enough of the cloture votes, let’s vote. Senate Republicans previously en- sure I understood their priorities. No This nominee, Paul Watford, is high- gaged in misguided filibusters last year one office got the entirety of what they ly qualified. In fact, he has the highest of Goodwin Liu’s nomination to the wanted. However, we did find the 80 qualifications for the Ninth Circuit. He Ninth Circuit and Caitlin Halligan’s percent of each solution we could all shouldn’t be filibustered. He should not nomination to the D.C. Circuit. Each of agree could help solve whatever policy require a cloture vote. He is a nominee those nominees is the kind of brilliant the group was working on. with impeccable credentials and quali- lawyer we should encourage to join the What we see before us now is the out- fications. He served as a Federal pros- Federal bench. There were certainly no come of the hard work of these groups. ecutor and is now a highly regarded ap- ‘‘extraordinary circumstances’’ for fili- The bill passed the committee by a pellate litigator in private practice. He bustering their nominations. Senate voice vote. The bill reflects the work of served as a law clerk at the United Republicans filibustered them anyway, every member of the Health, Edu- States Supreme Court and at the setting a new and unfortunate standard cation, Labor, and Pensions Com- United States Court of Appeals for the for the Senate. Those filibusters dem- mittee. All of them have at least one Ninth Circuit. The ABA Standing Com- onstrated that any nominee can be fili- provision included in this legislation, mittee on the Federal Judiciary gave bustered based on concocted controver- and many members of the committee Paul Watford the highest possible rat- sies and baseless claims. That was un- worked with us to find consensus meas- ing they could give and they gave it to fortunate and unwise. Senate Repub- ures that addressed their priorities as him unanimously. He also has the licans have already succeeded in pre- well. strong support of his home State Sen- venting confirmation votes on five of This legislation is a model for how ators, Senator FEINSTEIN and Senator President Obama’s judicial nominees the process can and should work no BOXER. He has widespread support who were blocked from a Senate vote matter what the political environment. across the spectrum, including known after being voted out of the Senate Ju- This went to committee, it was worked conservatives such as two former diciary Committee. Presidents of the Los Angeles chapter in committee, it is now at the Senate Paul Watford is the kind of person we floor, and I hope my colleagues will of the Federalist Society, as well as Judge Alex Kozinski, a conservative want in our Federal judiciary. This is join me in supporting this truly bipar- the kind of person when we talk about tisan provision that reduces the debt Reagan appointee who is now Chief Judge of the Ninth Circuit. By any tra- the Federal courts, we can say here is and ensures that the United States will a judge we can look up to and who can maintain its leadership in the innova- ditional measure, Paul Watford is the kind of judicial nominee who should be inspire others who seek to be judges. tion of safe and effective biomedical He is not a nominee against whom a product. confirmed easily by an overwhelming vote—a vote of both Republicans and partisan filibuster would be justifiable, I yield the floor. and I thank some of those Republican f Democrats. I had hoped after the agreement be- Senators who called me this weekend EXECUTIVE SESSION tween the Democratic and Republican who said they would oppose a Repub- Senate leadership to begin finally con- lican filibuster. I thank them for that, sidering the backlog of judicial nomi- because what they are doing is what is NOMINATION OF PAUL J. nations from last year that the Senate best for the Senate. By allowing a vote, WATFORD, OF CALIFORNIA, TO was at last returning to regular order. they are doing the best for the Ninth BE UNITED STATES CIRCUIT The refusal of Senate Republicans to Circuit but, even more importantly, JUDGE FOR THE NINTH CIRCUIT consent to a debate and vote on this they are doing what is best for the independence of our Federal judiciary. The PRESIDING OFFICER. Under nomination for more than 31⁄2 months, the previous order, the Senate will pro- however, again required the Majority Because if one is going to vote to try to ceed to executive session to consider Leader to file cloture to end another block somebody as qualified as Paul the following nomination which the Republican filibuster. Watford, one is basically saying they clerk will report. Senate Republicans continue to don’t care who the nominee is, they are The legislative clerk read the nomi- apply what they have admitted is a going to block it, and that is not the nation of Paul J. Watford, of Cali- ‘‘new standard’’ to President Obama’s message we should send if we are going fornia, to be United States Circuit judicial nominees. From the beginning to have an independent Federal judici- Judge for the Ninth Circuit. of the Obama administration, Senate ary in this country. The PRESIDING OFFICER. Under Republicans abandoned the standards He has a mainstream record. He dem- the previous order, there will be 1 hour and arguments they used to say should onstrates legal excellence and experi- of debate equally divided and con- apply to judicial nominations. During ence at the top of his profession. He trolled in the usual form. the administration of the last Presi- clerked at the United States Supreme The Senator from Vermont. dent, a Republican, they insisted that Court for Justice Ruth Bader Ginsburg Mr. LEAHY. I am glad we are finally filibusters of judicial nominees were and on the Ninth Circuit for now-Chief able to debate and vote on the nomina- unconstitutional. They threatened the Judge Alex Kozinski, a conservative tion of Paul Watford of California to ‘‘nuclear option’’ in 2005 to guarantee appointee of President Ronald Reagan. fill a judicial emergency vacancy on up-or-down votes for each of President Over his 17-year legal career, Paul the Ninth Circuit. As the distinguished Bush’s judicial nominations. Many Re- Watford has worked on briefs in nearly Presiding Officer knows, it was 31⁄2 publican Senators declared that they 20 cases before the United States Su- months ago that we voted Mr. Watford would never support the filibuster of a preme Court, and has argued numerous out of committee. We had not been able judicial nomination. cases before the Ninth Circuit Court of to get an agreement to debate or vote Senate Republicans reversed course Appeals as well as the California appel- on this nomination since it was ap- and filibustered President Obama’s late courts. As a Federal prosecutor in proved. So for the 27th time, the major- very first judicial nomination, that of the 1990s, Mr. Watford handled prosecu- ity leader was forced to file cloture to Judge David Hamilton of Indiana. They tions involving immigration and drug get an up-or-down vote on one of Presi- tried to prevent an up-or-down vote on offenses, firearms trafficking, and dent Obama’s judicial nominations. that nomination even though he was major frauds.

VerDate Mar 15 2010 04:41 May 22, 2012 Jkt 019060 PO 00000 Frm 00013 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.030 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3308 CONGRESSIONAL RECORD — SENATE May 21, 2012 So he should be on the Ninth Circuit, legal and economic challenges faced in both As Chief Justice Roberts noted dur- and I am delighted, as I make a pre- spheres, and an appreciation for the impor- ing his confirmation hearing, lawyers liminary nose count, that he will be tance of fair, consistent application of the represent clients. They do not stand in confirmed as a judge of the Ninth Cir- rules of law that govern business. their client’s shoes and they should not cuit. When confirmed, he will be only The assistant general counsel of have their client’s legal positions used the second African-American judge Mattel joins in this support, writing: against them. serving on the Ninth Circuit, joining ‘‘[I can] personally attest to his reputa- Let’s abandon the crude and inac- Judge Johnnie Rawlinson of Nevada on tion for being remarkably intelligent, curate litmus tests being applied to the bench. And I will not be surprised insightful and evenhanded. He is highly President Obama’s nominees. Let’s when he is confirmed, because of his regarded within his firm, amongst his stop the caricaturing. If not, no lawyer work as a tough but very fair pros- clients, and within the wider legal could ever be confirmed to the Federal ecutor. It is no surprise that he had community for his exceptional skills as bench. When we have a lawyer who has support from conservatives as well as an appellate practitioner.’’ actually been active in his or her prac- liberals. The shock I had was that for a Daniel Collins, an Associate Deputy tice, of course they are going to rep- while, his nomination was being held Attorney General during the adminis- resent some people others disagree up and we couldn’t get a vote. tration of President George W. Bush, with. Of course, they are going to rep- Two former presidents of the Los An- described Paul Watford as ‘‘incredibly resent some issues where others may, geles Chapter of the Federalist Society intelligent and has solid integrity and as individual Senators, feel they would wrote to the Judiciary Committee in great judgment.’’ He concluded that rather be on the other side of the issue. support of Mr. Watford. Jeremy Rosen this judicial nominee would not ‘‘ap- But how quickly would our legal sys- wrote: proach the job with any kind of agenda tem break down if lawyers could only Everyone who knows Paul (whether they other than to do what is right and con- represent one side of an issue, or when are conservative or liberal, or somewhere in sistent with precedent as he under- a matter comes to court we can only between) recognizes that he possesses the stands it.’’ hear from one side and not from the qualities that are most needed in an appel- I ask unanimous consent that copies other? One of the most valued legal late judge. While I find myself in somewhat of letters of support be printed in the systems in the world would disinte- frequent disagreement with the President on RECORD at the conclusion of my state- grate. many issues (and an active supporter of one ment. As an attorney in private practice of his opponents), his nomination of Paul to The PRESIDING OFFICER. Without Paul Watford has advocated positions the Ninth Circuit is a home-run and should objection, it is so ordered. receive bi-partisan support. well within the mainstream of legal ar- (See exhibit 1.) gument. There were only two cases on Henry Weissman, another former Mr. LEAHY. Paul Watford is far from which he worked as a lawyer among Federal Society chapter President, an ideological, partisan selection. He the hundreds and possibly thousands in wrote that he has ‘‘never seen any hint shouldn’t engender any serious objec- which he has been involved, that were of politics in Mr. Watford’s lawyering’’, tion; he is too good for that. He is the criticized by Committee Republicans. and that he has ‘‘every confidence that, kind of nominee who, as my years here In one, the well-known law firm with as a judge, Mr. Watford would apply in the Senate demonstrate, normally which he is affiliated represented the law faithfully, objectively, and receives unanimous support. It would groups challenging the controversial even-handedly.’’ usually not even require a roll call Arizona immigration law, and won a Conservative law professor Eugene vote, because he has the qualifications, preliminary injunction against certain Volokh of UCLA Law and creator of the judgment, and the ability. Maybe provisions for violating the Constitu- the conservative Volokh Conspiracy some were concerned that he was too tion. In his role as an attorney he was blog, expressed his strong support for well qualified or relatively young, and consulted by others working on the Mr. Watford to the Committee, writ- so some feared he might some day be case to review and edit their prelimi- ing: nominated to a still higher court so nary injunction motion. That motion He has all the qualities that an appellate they wanted to avoid voting on his contains arguments based on Federal judge ought to have: intellectual brilliance, nomination as they did when Elena preemption, due process, and other thoughtfulness, fairness, collegiality, an Kagan was nominated to the D.C. Cir- constitutional rights that are well ability to deal civilly and productively with colleagues of all ideological stripes, and a cuit by President Clinton, or when within the mainstream of legal advo- deep capacity for hard work. . . . Paul is the they delayed a vote as they did with cacy and that were raised, as well, by sort of moderate Democratic nominee that Judge Sonia Sotomayor when she was the U.S. Department of Justice in its moderates and conservatives, as well as lib- nominated to the Second Circuit by filings. That a Senator might disagree erals, should solidly support. President Clinton. with the position he assisted in devel- Conservative law professor Orin Kerr I strongly disagree with those who oping on behalf of his firm’s clients in of George Washington University Law, seek to nitpick this man’s legal career. this case is hardly a reason to oppose a former special counsel to Senator Since his service as a Federal pros- his nomination. I did not oppose Chief CORNYN, called him ‘‘extremely bright, ecutor, he has worked at a highly re- Justice Roberts’ nomination because a moderate, and very much a lawyer’s spected Los Angeles law firm on a wide he helped and advised the challenge re- lawyer,’’ and concluded an online post variety of matters. He has always rep- sulting in Bush v. Gore. Paul Watford’s saying, ‘‘I hope he will be confirmed.’’ resented his clients ethically and to legal work at Munger, Tolles was pro- In their letter of support, 32 of the the best of his legal ability. fessional, principled and not out of the clerks who served with him at the Su- The distinguished Presiding Officer, mainstream. preme Court from the chamber of all who has been an attorney general of The other case on which critics have the other Justices concluded: ‘‘We are his State, knows that lawyers are sup- fastened as if to justify their opposi- unanimous in our view that Paul pos- posed to give their best counsel and tion was his legal advocacy on behalf of sesses all the qualities of the most their best effort to those whom they clinical ethicists and critical care pro- highly regarded jurists: powerful ana- are representing. That is what lawyers viders challenging a specific lethal in- lytical abilities, a readiness to listen are supposed to do. In my case, I de- jection protocol. He did not challenge to and consider fairly all points of fended criminals in private practice. I the death penalty as unconstitutional. view, a calm temperament, and a pro- then prosecuted criminals as a pros- The legal challenge was to the manner digious work ethic.’’ ecutor. In both cases, I knew what my in which it was being administered. In A number of corporate general coun- role in the legal system was. As I said, fact, in direct and express answers to sels from leading U.S. corporations that is what lawyers are supposed to questions from Senator GRASSLEY, the have written us urging confirmation: do. Actually, that is what Republicans nominee wrote that he does not have Mr. Watford has represented a broad spec- used to argue to defend the Federalist any personal conviction or religious be- trum of clients, both in private industry as Society and corporate lawyers that liefs that would impact the way he well as in the public sector. In doing so, he were being nominated by a Republican would rule in a death penalty case and has demonstrated an understanding of the President. that he would have no difficulty ruling

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How are doing what they are supposed to do, emergency vacancy on the overbur- this record can be seen as justifying op- if they are making sure that someone dened Ninth Circuit for more than 3 position is beyond me. is adequately represented in court no months. Our legal system is an adversary sys- matter how unpopular that case may There is no justification for refusing tem that is predicated upon legal advo- be, then of course they are going to to address the needs of the Ninth Cir- cacy from both sides. No nominee take on some cases we might not like. cuit. A few years ago the Senate was should be disqualified for representing The distinguished Presiding Officer was forced to invoke cloture to overcome clients zealously. Go back in history. the chief prosecuting officer of his Republican filibusters of President John Adams, one of the most revered State. I was the chief prosecuting offi- Clinton’s nominations of Richard Paez Founders and later President of this cer of my county. I prosecuted some and Marsha Berzon to the Ninth Cir- country, wrote that his representation people whom I wanted to go to jail for cuit. That obstruction is being re- of the British soldiers in the controver- as long as possible. But the last thing peated. sial case regarding the Boston Mas- I wanted was for them not to have a We did not engage in tit for tat when sacre was ‘‘one of the most gallant, good and adequate lawyer on the other the presidency changed. During the generous, manly and disinterested ac- side. I wanted them to have the best of Bush administration, the Senate pro- tions of my whole life, and one of the counsel on the other side, because that ceeded to confirm seven of the nine best pieces of service I ever rendered way, society is protected. That way, Ninth Circuit nominees of President my country.’’ our court system is protected. That Bush. Four of President Bush’s Ninth Did he agree with the British in hold- way, it meant that if any one of us Circuit nominees were confirmed dur- ing the colonies subservient? Of course came in and were innocent and were ing his first 4-year term: Judge Richard not. Did he agree with the efforts of us being charged, we would know there Clifton, Judge Jay Bybee, Judge in this country to be free people—free was an example of always having rep- Consuelo Callahan, and Judge Carlos from alliance with Great Britain? Of resentation. Bea. course he did. That is what he did when Republican obstruction of this nomi- By contrast, Senate Republicans he helped and when he served as one of nation is particularly damaging given have been opposing our moving forward the Founders of this country and when the dire need for judges on the Ninth to consider and confirm Paul Watford he became President. But he also knew Circuit. With three times the number and Andrew Hurwitz, who are both our whole system broke down if some- of cases pending as the next busiest cir- strongly supported by their home State body within a court did not have ade- cuit and twice the caseload of the Senators, to fill judicial emergency va- quate representation on both sides, and judges on other circuits, the Ninth Cir- cancies. Senate Republicans have al- that is why he represented British sol- cuit cannot afford further delay filling ready successfully filibustered the diers in the case involving the Boston its emergency vacancies. The 61 mil- nomination of Goodwin Liu, who also Massacre—not because he was sup- lion people served by the Ninth Circuit had the strong support of his home portive of what the British were doing are not served by this delay. I have State Senators. and not because he wanted anything been asked for months that the Senate I urge Senators to show that we can other than to have us as a free people, expedite consideration of this nomina- work together to reduce the vacancies but because he wanted to make sure tion and that of Justice Hurwitz of Ari- that are burdening the Federal judici- that in a free country, in a free United zona to fill these judicial emergency ary. Do what some of my friends on the States of America, when someone goes vacancies. Republican side of the aisle have said before our courts, they are going to The Chief Judge of the Ninth Circuit, to me, which is to move forward to have representation on both sides, and Judge Alex Kozinski, a Reagan ap- vote for this nominee. They should also that is the way it should be. pointee, along with the members of the help the millions of Americans who At his confirmation hearing to be- Judicial Council of the Ninth Circuit, rely on our Federal courts who seek come the Chief Justice of the United wrote to the Senate months ago em- justice. We can show we intend to do States, John Roberts made the point: phasizing the Ninth Circuit’s ‘‘des- that. We can start right here by voting [I]t’s a tradition of the American Bar that perate need for judges,’’ urging the to confirm this good man, Paul goes back before the founding of the country Senate to ‘‘act on judicial nominees Watford, who is a highly qualified that lawyers are not identified with the posi- without delay,’’ and concluding ‘‘we nominee to the Ninth Circuit Court of tions of their clients. The most famous ex- fear that the public will suffer unless Appeals, and say to the American peo- ample probably was John Adams, who rep- our vacancies are filled very prompt- ple, we believe in justice for everybody resented the British soldiers charged in the ly.’’ The judicial emergency vacancies here. Boston Massacre. He did that for a reason, because he wanted to show that the Revolu- on the Ninth Circuit are harming liti- EXHIBIT 1 tion in which he was involved was not about gants by creating unnecessary and BARTLIT BECK HERMAN PALENCHAR overturning the rule of law, it was about vin- costly delays. The Administrative Of- & SCOTT LLP, dicating the rule of law. fice of U.S. Courts reports that it takes Chicago, IL, April 30, 2012. Our Founders thought that they were not nearly five months longer for the Ninth Re Paul Watford. being given their rights under the British Circuit to issue an opinion after an ap- Hon. HARRY REID, system to which they were entitled, and by peal is filed, compared to all other cir- Majority Leader, U.S. Senate, Hart Senate Of- representing the British soldiers, he helped cuits. The Ninth Circuit’s backlog of fice Building, Washington, DC. show that what they were about was defend- pending cases far exceeds other Federal Hon. PATRICK J. LEAHY, ing the rule of law, not undermining it, and Chairman, Committee on the Judiciary, U.S. that principle, that you don’t identify the courts. As of September 2011, the Ninth Senate, Russell Senate Office Building, lawyer with the particular views of the cli- Circuit had 14,041 cases pending before Washington, DC. ent, or the views that the lawyer advances it, far more than any other circuit. Hon. MITCH MCCONNELL, on behalf of the client, is critical to the fair When Senate Republicans filibus- Minority Leader, U.S. Senate, Russell Senate administration of justice. tered the nomination of Caitlin Office Building, Washington, DC. That has always been our tradition. I Halligan to the D.C. Circuit for posi- Hon. CHARLES GRASSLEY, hope it always will be our tradition, tions she took while representing the Ranking Member, Committee on the Judiciary, but I am concerned that some feel it State of New York, they contended U.S. Senate, Hart Senate Office Building, Washington, DC. should change. This litmus test that that their underlying concern was that DEAR SENATORS: We write to provide our would disqualify nominees because as a the caseload of the D.C. Circuit did not enthusiastic support for Paul Watford’s nom- lawyer they represented a side in a justify the appointment of another ination to serve on the United States Court case on which we disagree is dangerous judge to that Circuit. I disagreed with of Appeals for the Ninth Circuit.

VerDate Mar 15 2010 02:36 May 22, 2012 Jkt 019060 PO 00000 Frm 00015 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.033 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3310 CONGRESSIONAL RECORD — SENATE May 21, 2012 We have known Paul personally and profes- in important and complex appellate matters. ences in public service and private practice, sionally for nearly twenty years, having met Paul has been a lawyer representative to the Mr. Watford has gained the respect and ad- him in 1994 when we served together as Ninth Circuit Judicial Conference, and has miration of his peers. At every stage of his clerks to Judge Kozinski on the Ninth Cir- achieved distinction in the profession. Given career, he has demonstrated a strong work cuit. One of us also spent a second year his experience as a law clerk, as a federal ethic, a judicious temperament, unquestion- working with Paul during the year he spent prosecutor, and as a lawyer in private prac- able 1 integrity, a collaborative and respect- as clerk to Justice Ginsburg at the United tice, Paul has an ideal background for the ful manner, and a deeply thoughtful ap- States Supreme Court. position of a Circuit Judge. proach to each and every issue that has During the crucible those intense years, we The group below is composed of individuals crossed his desk. learned a lot about Paul’s approach to legal with very different political viewpoints and As a close family of Kozinski clerks, we issues, his attitudes about legal rules and represents clerks from the chambers of every share Chief Judge Kozinski’s strong faith in precedents, and perhaps most importantly Justice on the Supreme Court during the Mr. Watford’s abilities. We believe he has the his demeanor when confronted with com- OT95 term. We are unanimous in our view necessary qualifications and characteristics peting views of what the law is or should be. that Paul possesses all the qualities char- to make an exemplary federal appellate Paul is intelligent, thoughtful, balanced and acteristic of the most highly regarded ju- judge. Based on his record and personality, fair. He is moderate, not extreme, in his rists: powerful analytical abilities, a readi- we have no doubt that Mr. Watford would ap- views. As a serious student of the law, his in- ness to listen to and consider fairly all proach each case with an open mind and stinct is to look for the answer dictated by points of view, a calm temperament, and a make thoughtful judgments based on the precedent, not his personal views. And even prodigious work ethic. We respectfully re- law. Accordingly, we recommend him for in the face of heated debate, he maintains an quest that the Senate bring Paul’s nomina- this position without hesitation or reserva- even keel, demonstrating a temperament tion to a vote and confirm him to the Ninth tion. that is well-suited to the act of judging. Circuit. Sincerely, Others can and no doubt will speak to Sincerely, Jerry L. Anderson, Drake University Law Paul’s obvious qualifications, including his Julia Ambrose, David Barron, Stuart School, Judge Alex Kozinski (1986–1987); Fred demonstrable intelligence and distinguished Benjamin, Yochai Benkler, Steve A. Bernstein, Judge Alex Kozinski (1996– professional career. We can speak, from both Chanenson, Nancy Combs, Jeff Dob- 1997); James Burnham, Judge Alex Kozinski sides of the political aisle (one registered bins, Charlie Duggan, Ward (2009–2010); Steven A. Engel, Dechert LLP, Democrat, one registered Republican), to the Farnsworth, Lisa Beattie Freling- Judge Alex Kozinski (2000–2001); Justice An- personal qualities and temperament that huysen, Shawn Fagan, Sean Gallagher, thony M. Kennedy (OT 2001); Kristin A. make Paul not only qualified but uniquely Heather Gerken, Craig Goldblatt, Mark Feeley, Judge Alex Kozinski (2009–2010); Stu- well-suited to the position to which he has Harris, Julie Katzman, Joseph art Banner, UCLA School of Law, Judge Alex been nominated. We could go on (and on) Kearney, Steve Kinnaird, Kelly Klaus, Kozinski (1988–1989); Justice Sandra Day with our praise for Paul, but the simple fact Laurie Allen Mullig, Eileen Mullen, O’Connor (OT 1991); William A. Burck, Quinn is that he will make an excellent judge. Kate Moore, Jennifer Newstead, Emanuel Urquhart & Sullivan LLP, Judge We urge you to bring Paul’s nomination to Gretchen Rubin, Kevin Russell, Maria Alex Kozinski (1998–1999); Justice Anthony a vote, and to vote to confirm. Simon, Simon Steel, Ted Ullyot, Phil M. Kennedy (OT 1999); Jacqueline Gerson Very truly yours, Weiser, Mike Wishnie, Michael Wong, Cooper, Judge Alex Kozinski (1990–1991); Jus- SEAN W. GALLAGHER, Ernie Young. tice Anthony M. Kennedy (OT 1991); Susan E. MARK S. OUWELEEN. Engel, Kirkland & Ellis LLP, Judge Alex Hon. HARRY REID, Kozinski (2000–2001); Justice Antonin Scalia MAY 15, 2012. Majority Leader, U.S. Senate, 522 Hart Senate (OT 2001); Victor Fleischer, Professor of Law, DEAR MAJORITY LEADER REID AND MINOR- Office Building, Washington, DC. University of Colorado, Judge Alex Kozinski ITY LEADER MCCONNELL, We write in strong Hon. PATRICK J. LEAHY, (1997–1998). support of Paul Watford’s nomination to be a Chairman, Committee on the Judiciary, U.S. Troy Foster, Wilson Sonsini Goodrich & Judge on the United States Court of Appeals Senate, 433 Russell Senate Office Building, Rosati, Judge Alex Kozinski (1999–2000); Sean for the Ninth Circuit. All of us served as law Washington, DC. W. Gallagher, Judge Alex Kozinski (1994– clerks at the Supreme Court during the same Hon. MITCH MCCONNELL, 1995), Justice Sandra Day O’Connor (OT 1995); year that Paul clerked for Justice Ruth Minority Leader, U.S. Senate, 361A Russell Sen- Stephanie Grace, Latham & Watkins LLP, Bader Ginsburg (the October 1995 Term of ate Office Building, Washington, DC. Judge Alex Kozinski (2010–2011); Robert K. the Court). During that time, some of us Hon. CHARLES GRASSLEY, Hur, Judge Alex Kozinski (2001–2002), Chief worked with Paul directly in Justice Gins- Ranking Member, Committee on the Judiciary, Justice William H. Rehnquist (OT 2002); T. burg’s chambers; others of us worked di- U.S. Senate, 135 Hart Senate Office Build- Haller Jackson IV, Tulane University School rectly with Paul on cases that we were as- ing, Washington, DC. of Public Health & Tropical Medicine, Judge signed to in common; and all of us got to DEAR MAJORITY LEADER REID, MINORITY Alex Kozinski (2009–2010); Theane Evangelis know Paul as a colleague. Based on what we LEADER MCCONNELL, CHAIRMAN LEAHY, AND Kapur, Gibson, Dunn & Crutcher LLP, Judge saw then, and what we know of Paul’s career RANKING MEMBER GRASSLEY: We write in Alex Kozinski (2003–2004), Justice Sandra in the years since, we believe that Paul is a support of the nomination of Paul J. Watford Day O’Connor (OT 2004); Scott Keller, Judge superb choice to be a Judge on the Ninth Cir- to the United States Court of Appeals for the Alex Kozinski (2007–2008), Justice Anthony cuit. We encourage you to support his nomi- Ninth Circuit. Like Mr. Watford, we have all M. Kennedy (OT 2009); John P. Franz, Judge nation and to bring it to a vote expedi- clerked for the Honorable Alex Kozinski of Alex Kozinski (1996–1997); Daniel L. Geyser, tiously. the U.S. Court of Appeals for the Ninth Cir- Gibson, Dunn & Crutcher LLP, Judge Alex Paul came to the Supreme Court after cuit, and we wish to echo the strong support Kozinski (2002–2003); Leslie Hakala, Judge clerking for Circuit Judge Alex Kozinski, a that Chief Judge Kozinski has given to Mr. Alex Kozinski (1997–1998), Justice Sandra Reagan appointee, and after attending UCLA Watford. Day O’Connor (OT 1999); Eitan Hoenig, Law School. His path to a Supreme Court All of us believe that Mr. Watford has the Wachtell, Lipton, Rosen & Katz, Judge Alex clerkship reflected his work ethic and his ability and character to be an excellent fed- Kozinski (2010–2011); Robert E. Johnson, legal acumen. At the Supreme Court, Paul eral appellate judge. Mr. Watford has a stel- Judge Alex Kozinski (2009–2010); Kevin M. brought those qualities to bear in analyzing lar reputation in the legal community. He is Kelly, Gendler & Kelly, Judge Alex Kozinski difficult legal problems and finding ways to known not only for his intelligence, but also (1989–1990), Justice Sandra Day O’Connor (OT explain them clearly and sensibly. In so for his collegiality and even temperament. 1990); Michael S. Knoll, Theodore K. Warner doing, Paul won respect from everyone he For those of us who know Mr. Watford per- Professor, Law School Professor of Real Es- worked with. Paul invariably got along well sonally, his graciousness, sincerity and bril- tate, Wharton School Co-Director, Center for with his peers, was always a superb listener, liance are immediately apparent. Tax Law, and Policy University of Pennsyl- and treated everyone with kindness and re- Mr. Watford’s legal career confirms that he vania; Judge Alex Kozinski (1986). spect. Those of us who clerked with Paul for has the experience, skills and demeanor well- Tara Kole, Gang, Tyre, Ramer & Brown, Justice Ginsburg know that she praised his suited for the bench. He clerked for two dis- Judge Alex Kozinski, (2003–2004), Justice work as exemplary and that she is a tough tinguished jurists, then-Judge Kozinski on Antonin Scalia (OT 2004); Chi Steve Kwok, judge of legal talent. the U.S. Court of Appeals for the Ninth Cir- Judge Alex Kozinski (2002–2003), Justice An- After leaving the Court, Paul has had a cuit and Justice Ruth Bader Ginsburg on the thony M. Kennedy (OT 2003); C.J. Mahoney, distinguished legal career in public service Supreme Court of the United States. He Judge Alex Kozinski (2006–2007), Justice An- and private practice. At the United States served in the Department of Justice as an thony M. Kennedy (OT 2007); Chris Newman, Attorney’s Office in Los Angeles, Paul was a Assistant United States Attorney in the Cen- George Mason University School of Law, standout lawyer in the criminal division and tral District of California. Mr. Watford is Judge Alex Kozinski (1999–2000); Christopher appeared regularly before the Ninth Circuit. currently a partner in the Los Angeles office R.J. Pace, Weil Gotshal & Manges LLP, For many years, Paul has been a partner at of Munger, Tolles, & Olson LLP, a well-re- Judge Alex Kozinski (1991–1992), Justice An- Munger, Tolles & Olson, where he helps lead spected law firm. He also has taught a course thony M. Kennedy (OT 1992); Mark A. Perry, that firm’s appellate practice and has rep- on judicial writing for prospective law clerks Gibson, Dunn & Crutcher LLP, Judge Alex resented a wide range of commercial clients at USC’s Gould School of Law. In his experi- Kozinski (1991–1992), Justice Sandra Day

VerDate Mar 15 2010 04:41 May 22, 2012 Jkt 019060 PO 00000 Frm 00016 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.004 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3311 O’Connor (OT 1993); David A. Schwarz, Irell different places and often end at very dif- Mrs. BOXER. I rise today to support & Manella LLP, Judge Alex Kozinski, (1988– ferent conclusions. Working closely with Paul Watford, a California nominee for 1989); Kathryn H. Ku, Munger, Tolles & Olson such diverse intellects is emblematic of Mr. the Ninth Circuit Court of Appeals LLP, Judge Alex Kozinski (2003–2004); Joshua Watford’s own capabilities and tempera- whose nomination is before us today. Lipshultz, Gibson, Dunn & Crutcher LLP, ment, and his legal talents are reflective of Judge Alex Kozinski (2005–2006), Justice their skills as well. He is a superb writer, a Mr. Watford has been nominated for Antonin Scalia (OT 2006); Laura Nelson, keen intellect, a strong oral advocate, and a seat that is designated as a judicial Judge Alex Kozinski (1985–1986); Mark someone with a genuine appreciation for the emergency, which means that it is crit- Ouweleen, Bartlitt Beck Herman Palenchar real interests on all sides. He is exactly the ical we move swiftly to confirm him. & Scott LLP, Judge Alex Kozinski (1994– kind of individual that any plaintiff or de- I was pleased when President Obama 1995); Eugene Paige, Keker & Van Nest LLP, fendant—person, business or government— nominated Mr. Watford to serve on the Judge Alex Kozinski (1998–1999); Justice An- would welcome deciding their case, and U.S. Ninth Circuit Court of Appeals. He thony M. Kennedy (OT 2000); Kathryn Haun would trust would do so fairly. has a wide breadth of experience, rang- Rodriguez, Judge Alex Kozinksi (2000–2001), We urge the Committee to swiftly and fa- ing from public service to the private Justice Anthony M. Kennedy (OT 2004); K. vorably act on Mr. Watford’s nomination. John Shaffer, Stutman, Treister & Glatt PC, Respectfully, sector, and he will make an excellent Judge Alex Kozinski (1989–1990), Justice An- Alan J. Glass, Vice President, General addition to the federal bench. thony M. Kennedy (OT 1990). Counsel & Secretary, CIRCOR Inter- Let me say a few words about his Steven M. Shepard, Judge Alex Kozinski national, Inc.; Randal S. Milch, Execu- background. (2007–2008), Justice Anthony M. Kennedy (OT tive Vice President and General Coun- Mr. Watford was born in Garden 2008); Elina Tetelbaum, Wachtell, Lipton, sel, Verizon Communications Inc.; Bob Grove, CA. He is a graduate of the Uni- Rosen & Katz, Judge Alex Kozinski (2010– Normile, Executive Vice President and versity of California at Berkeley, and 2011); Alexander ‘‘Sasha’’ Volokh, Assistant Chief Legal Officer, Mattel, Inc.; Kent received his law degree from the Uni- Professor, Emory Law School, Judge Alex Walker, Senior Vice President and Kozinski (2004–2005); Justice Sandra Day General Counsel, Google, Inc. versity of California at Los Angeles, O’Connor and Justice Samuel Alito (OT where he graduated with honors and 2005); Christopher J. Walker, Assistant Pro- MATTEL, INC., was an editor of the UCLA Law Re- fessor of Law, The Ohio State University, El Segundo, CA, January 31, 2012. view. Judge Alex Kozinski (2006–2007), Justice An- Hon. PATRICK J. LEAHY, Following law school, he clerked for thony M. Kennedy (OT 2008); Harry Susman, Chairman, Senate Judiciary Committee, 224 Judge Alex Kozinski on the Ninth Cir- Judge Alex Kozinski (1996–1997); Justice An- Dirksen Senate Office Building, Wash- cuit Court of Appeals, then clerked for thony M. Kennedy (OT 1997); Mary Ann Todd, ington, DC. Justice Ruth Bader Ginsburg on the Munger, Tolles & Olson LLP, Judge Alex Hon. CHARLES E. GRASSLEY, United States Supreme Court. Kozinski (1993–1994); Eugene Volokh, Gary T. Ranking Member, Senate Judiciary Committee, Schwartz Professor of Law, UCLA School of 224 Dirksen Senate Office Building, Wash- From 1997 through 2000, Mr. Watford Law, Judge Alex Kozinski (1992–1993), Justice ington, DC. served as a federal prosecutor in the Sandra Day O’Connor (OT 1993). DEAR CHAIRMAN LEAHY AND SENATOR United States Attorney’s Office for the GRASSLEY: I write this letter in support of Central District of California, where he THE GENERAL COUNSELS OF the nomination of Paul Watford to the handled a variety of criminal trial and FOUR LARGE BUSINESSES, United States Court of Appeals for the Ninth appellate matters for the office, includ- February 1, 2012. Circuit. I have known Paul on a professional ing major fraud investigations. Re Nomination of Paul J. Watford as Circuit basis for a number of years, and can person- After his tenure as a prosecutor, Mr. Judge of the U.S. Court of Appeals for ally attest to his reputation for being re- Watford entered private practice—first the Ninth Circuit. markably intelligent, insightful and even- with Sidley & Austin, then with his Hon. PATRICK J. LEAHY, handed. He is highly regarded within his Chairman, U.S. Senate, Committee on the Judi- firm, amongst his clients, and within the current law firm, Munger Tolles, where ciary, Washington, DC. wider legal community for his exceptional he is a partner specializing in appellate Hon. CHUCK GRASSLEY, skills as an appellate practitioner. More im- casework and complex commercial liti- Ranking Member, U.S. Senate, Committee on portantly, he is remarkably sincere and gation. the Judiciary, Washington, DC. friendly, and working with him is always a In addition to his record as a lawyer, DEAR CHAIRMAN LEAHY AND RANKING MEM- pleasure. Mr. Watford has served in bar associa- BER GRASSLEY: We write to express our sup- Paul enjoys an exemplary record as an at- tions and professional committees. He torney: UCLA Law Review Editor, clerk to port for the nomination of Paul J. Watford has served as Co-Chair of the American to the U.S. Court of Appeals for the Ninth Judge Alex Kozinski of the Ninth Circuit, Circuit, and urge that the Committee clerk to Justice Ruth Bader Ginsburg of the Bar Association’s Appellate Practice promptly and favorably act to send his nomi- U.S. Supreme Court, Assistant U.S. Attorney Committee, and he is a member of the nation to the floor for confirmation. We are in Los Angeles, and currently, a partner at Central District Court’s Magistrate Se- General Counsels of a broad spectrum of the esteemed firm of Munger, Tolles & Olson. lection Panel. American businesses. Everything we know Paul has had significant, substantive in- The American Bar Association has about Mr. Watford, both from the direct con- volvement in bar association activities; most given him their highest rating—unani- tact some of us have had to others who have notably, he served as the Chair of the ABA mously well qualified. only seen his work, indicates that he would Litigation Section’s Appellate Practice Com- Mr. Watford has earned the respect of be a superb addition to the bench. mittee, and on the ABA’s Amicus Curiae For the last 11 years of private practice at Committee. In addition, Paul shares his tal- attorneys who know his work. For ex- one of the nation’s premier law firms, Mr. ent and time with the broader community, ample, Daniel Collins, who clerked for Watford has represented a broad spectrum of serving on the board of a non-profit legal Justice Scalia and served as an attor- clients, both in private industry as well as in services provider for low income clients and ney in both Bush administrations, said the public sector. In doing so, he has dem- teaching upper-division legal writing at this about Mr. Watford: onstrated an understanding of the legal and USC. Certainly, Paul’s resume is testament He just embodies the definition of judicial economic challenges faced in both spheres, to his stellar qualifications and his dedica- temperament—very level-headed and even- and an appreciation for the importance of tion to the law. keeled. . . . I don’t think he’ll approach the fair, consistent application of the rules of Paul has assisted Mattel with several ap- job with any kind of agenda other than to do law that govern business. The jobs, goods pellate matters. His analysis, reasoning and what is right and consistent with precedent and services that constitute our economy re- writing is of the highest caliber. His per- as he understands it. quire exactly that objective and impartial formance as a ‘‘judge’’ on a moot court approach to deciding the important legal panel, however, is what stands out most in And Jeremy Rosen, a partner at principles that come before a court such as my mind. His questions went right to the Horvitz & Levy and former president of the Ninth Circuit. We have every confidence core issues, his follow-up questioning was the Los Angeles Lawyers Chapter of that Mr. Watford has the right experience, quick and insightful, and his discussion of the Federalist Society, said Mr. intellect and character for such an impor- legal nuances and distinctions came easily Watford is a nominee many conserv- tant role in the judiciary. and naturally. As always, his demeanor was atives could support: It also is noteworthy that Mr. Watford’s thoughtful, attentive and respectful. Paul I know he has the respect of anyone who experiences prior to joining private practice has all the hallmarks of an excellent jurist, has come into contact with him. He is excep- demonstrate the same even-handed perspec- and I highly endorse his appointment to the tionally bright and well qualified. . . . tive. He served as a law clerk on the Ninth Ninth Circuit. Circuit and on the Supreme Court to jurists Sincerely, I ask unanimous consent to have who are known to come at issues from very JILL E. THOMAS. printed in the RECORD letters from

VerDate Mar 15 2010 04:41 May 22, 2012 Jkt 019060 PO 00000 Frm 00017 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.003 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3312 CONGRESSIONAL RECORD — SENATE May 21, 2012 Daniel Collins, Jeremy Rosen, Eugene To my mind, another indication of Paul’s lic, it is vitally important that brilliant, col- Volokh and Henry Weissmann imme- fairmindedness, and of his ability to separate legial, and fair-minded men and women serve diately following my remarks. law and politics, is the wide range of the as appellate judges. Paul Watford is such a The PRESIDING OFFICER. Without matters on which he has worked. Paul has person. gravitated to many of the most interesting Paul graduated with honors from UCLA objection, it is so ordered. legal matters in the firm, and that has Law School and then served as a law clerk to (See exhibit 1.) unsurprisingly led him to work on important two extremely distinguished judges (one Re- Mrs. BOXER. In conclusion, Mr. matters involving controversial issues that publican and one Democrat), Alex Kozinski Watford is a talented lawyer who has may generate strong reactions on one or the and Ruth Bader Ginsberg. Paul then served earned the respect of his peers for his other end of the political spectrum. I do not the public admirably as an assistant United work in the public and private sectors. think that Paul’s work on these or any other States Attorney. Since 2000, Paul has been He will be a great addition to the fed- cases can be viewed as suggesting that he an extremely distinguished appellate lawyer in private practice where he has handled eral bench, and I urge my colleagues to has an ideological agenda that would distort his approach to the law on the bench. Indeed, many complex and sophisticated appeals. join me in voting for him today. one of the more controversial cases that Throughout his career, Paul has shown him- EXHIBIT 1 Paul worked on was Mohamad v. Jeppesen self to possess excellent legal analysis and Los Angeles, CA, May 18, 2012. DataPlan Inc., in which he and I represented judgment. Indeed, there are few lawyers in Re Nomination of Paul J. Watford as Circuit the defendant company, which was accused California (or elsewhere) who are better pre- Judge, United States Court of Appeals by the plaintiffs (who were represented by pared for the intellectual challenges of be- for the Ninth Circuit. the ACLU) of assisting the CIA in carrying coming an appellate judge. out its alleged ‘‘extraordinary rendition’’ Most lawyers who have achieved as much HON. HARRY REID, as Paul tend to be unpleasant egomaniacs. Majority Leader, U.S. Senate, 522 Hart Senate program. That Paul has shown a willingness to work, with great professionalism, on such Not Paul. He is humble, polite and a good lis- Office Building, Washington, DC. tener. I have no doubt that he will have col- HON. PATRICK J. LEAHY, a diverse set of important matters seems to me to dispel any concern that his approach legial relations with the other judges on the Chairman, U.S. Senate, Committee on the Judi- Ninth Circuit. I also have no doubt that Paul ciary, 473 Russell Senate Office Building, to judging would be anything other than evenhanded. Paul has always struck me as a will be fair-minded and will carefully apply Washington, DC. the relevant legal precedent to each case he HON. MITCH MCCONNELL, lawyer’s lawyer and as refreshingly oblivious to ‘‘political’’ concerns. On the bench, he’d decides. Through his clerking experience, Republican Leader, U.S. Senate, 317 Russell and his public and private practice, Paul has Senate Office Building, Washington, DC. be a judge’s judge. Lastly, I would note that Paul has an out- always demonstrated high integrity and eth- HON. CHUCK GRASSLEY, ics. Ranking Member, U.S. Senate, Committee on standing disposition. Anyone who has met him for any length of time cannot fail to be In short, everyone who knows Paul (wheth- the Judiciary, 135 Hart Senate Office Build- er they are conservative or liberal, or some- ing, Washington, DC. impressed by his graciousness and profes- sional demeanor. He is without guile. On the where in between) recognizes that he pos- DEAR SENATORS: I write to express my sesses the qualities that are most needed in strong support for the confirmation of Paul bench, he would epitomize judicial tempera- ment. an appellate judge. Given the urgent need to J. Watford to be a Circuit Judge on the fill vacancies in the Ninth Circuit, I would United States Court of Appeals for the Ninth I recognize the importance of the decision to confirm an individual to a lifetime ap- strongly urge the Senate to swiftly confirm Circuit. Having known and worked with Paul Paul. for more than eight years at Munger, Tolles pointment as a federal appellate judge. I am confident that Paul Watford has the talent, Very truly yours, & Olson LLP in Los Angeles, I am confident JEREMY B. ROSEN. that he has the skills, judgment, tempera- fairness, and integrity to be an excellent ju- rist, and I am pleased to support his con- ment, and integrity to be an outstanding ap- UNIVERSITY OF CALIFORNIA, pellate judge. firmation. Sincerely, SCHOOL OF LAW, Paul and I come from opposite ends of the Los Angeles, CA, January 30, 2012. DANIEL P. COLLINS. political spectrum. I have been a conserv- Hon. PATRICK J. LEAHY, ative Republican for my entire adult life, I Chairman, Senate Judiciary Committee, Wash- HORVITZ & LEVY LLP, am a member and supporter of the Federalist ington, DC. Encino, CA, January 26, 2012. Society, and I served in the Justice Depart- Hon. CHARLES E. GRASSLEY, Re Nomination of Paul Watford. ment in Washington, D.C. during the Admin- Ranking Member, Senate Judiciary Committee, istrations of both George H.W. Bush and Hon. PATRICK J. LEAHY, Washington, DC. George W. Bush. Despite our political dif- Chairman, Senate Judiciary Committee, Dirksen DEAR CHAIRMAN LEAHY AND SENATOR ferences, I can unreservedly support Paul’s Senate Office Building, Washington, DC. GRASSLEY: I am writing this to express my nomination because I believe that he under- Hon. CHARLES E. GRASSLEY, strong support for the nomination of Paul stands and respects the crucial distinction Ranking Member, Senate Judiciary Committee, Watford to the United States Court of Ap- between law and politics. I say that based on Dirksen Senate Office Building, Wash- peals for the Ninth Circuit. I have long been years of having observed how he approaches ington, DC. extremely impressed by Paul, since I first legal precedent and how he analyzes complex DEAR CHAIRMAN LEAHY AND SENATOR met him almost 20 years ago, when my then- legal arguments. GRASSLEY: I write this letter in support of boss Judge Alex Kozinski (now Chief Judge) During our time together at Munger, the nomination of Paul Watford to the was interviewing him as a law clerk. Tolles, I have frequently consulted Paul on United States Court of Appeals for the Ninth As you know, Paul had a stellar academic many difficult legal issues, and he has served Circuit. I have known Paul for over a decade, career, graduating very near the top of his many times as a ‘‘moot court’’ judge helping first as a colleague and then as a friendly class at UCLA School of Law and then clerk- me to prepare for oral arguments. Given competitor in the relatively small California ing for Judge Kozinski and Justice Ruth Paul’s brilliance and honesty, I know that I appellate bar. Bader Ginsburg. He has also earned tremen- can always count on him to quickly spot the By way of background, I am a partner at dous respect as a practicing lawyer, both as weak points in a legal argument and to give Horvitz & Levy LLP, the largest civil appel- a federal prosecutor and an appellate lawyer. me a frank and professional assessment of late law firm in California. My practice pri- He has all the qualities that an appellate the applicable case law. Few traits are more marily focuses on handling appeals in the judge ought to have: intellectual brilliance, important in a Circuit Judge than a willing- Ninth Circuit and California appellate thoughtfulness, fairness, collegiality, an ness to adhere faithfully to precedent, and I courts. At the outset of my career, I had the ability to deal civilly and productively with have always been impressed by the thorough- privilege of serving as a law clerk for a judge colleagues of all ideological stripes, and a ness, objectivity, and candor that Paul on the Ninth Circuit. I am also a member of deep capacity for hard work. If confirmed, brings to bear in his evaluation of the rel- the National Chamber Litigation Center’s he’ll make a superb judge. evant body of law in any given area. California Advisory Committee and past Let me turn then to the question of ide- I strongly agree that judges must respect president of the Los Angeles Chapter of the ology. In the overwhelming majority of cases the proper limits of their office and should Federalist Society. that an appellate judge faces, the judge’s not attempt to implement a personal or ideo- While I find myself in somewhat frequent legal philosophy is entirely or almost en- logical agenda from the bench. I believe that disagreement with the President on many tirely irrelevant: The cases are either Paul understands those limits. While he and issues (and an active supporter of one of his straightforward applications of clear and I may differ on certain jurisprudential opponents), his nomination of Paul to the well-settled law, or, even if less than clear, issues, I have always been impressed by the Ninth Circuit is a home-run and should re- involve highly technical legal questions that even-handed and measured approach he ceive bi-partisan support. As an appellate relate little to high-level philosophical de- brings to bear in analyzing legal problems. I lawyer, I care deeply about our nation’s ap- bates. For those questions Paul’s intellect, feel confident that, on the bench, he would pellate courts and see on a daily basis the care, and legal craftsmanship will yield re- do his level best to fairly reach the correct important role they play in our society. For sults that both liberals and conservatives answer under the law as be sees it. appellate courts to effectively serve the pub- should applaud.

VerDate Mar 15 2010 04:41 May 22, 2012 Jkt 019060 PO 00000 Frm 00018 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.035 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3313 At the same time, there is no doubt that clients. He is brilliant, developing effective cation, we want those pharmaceuticals some small but important fraction of appel- arguments on matters of first impression. He available right away, and we want late cases consists of matters on which lib- is efficient, producing top-quality work prod- them to work as promised. eral judges and conservative judges will uct quickly. He is respectful of his col- One example of the many constitu- reach different results. That is inevitable: leagues, his opponents, and the courts. ents who have contacted me about Law is not mathematics. Some legal ques- Above all, he is a careful lawyer, applying tions are unsettled and not answered by stat- precedent and common sense in a way that PDUFA is Virginia from Newark, DE, utory or constitutional text, or binding leads to moderate arguments. I have never who recently sent a letter to my office. precedent. And in the absence of a clear and seen any hint of politics in Mr. Watford’s She volunteers with the National Brain obvious legal answer, different judges reach lawyering. Tumor Society and is concerned that different results based partly on their phi- Mr. Watford is highly regarded not only without reauthorization of this legisla- losophies. Paul is a moderate liberal; I am a within our firm, but also in the legal com- tion, safe and effective brain tumor moderate libertarianish conservative; I munity at large. Lawyers from private prac- therapies will be slower to be developed therefore expect that, if he is confirmed, tice, his former colleagues in the U.S. Attor- and made available to patients who there would be some future decisions of his ney’s office, clients, academics, and many need them. She wrote: with which I will disagree. others—including those from a wide range of Yet our current President is President political perspectives—hold Mr. Watford in It has been too long since any new thera- Obama, not Senator McCain. The American the highest esteem. pies have become available for brain tumor people spoke, and they elected someone who I have every confidence that, as a judge, patients that significantly extend survival. will not nominate judges with whom Repub- Mr. Watford would apply the law faithfully, Anyone can be diagnosed with a brain tumor, licans like me will always agree. So, respect- objectively, and even-handedly. Mr. Watford and they are the second leading cause of can- ing as I do the voters’ choice in 2008 (though would be an outstanding addition to the cer death in children under twenty. it was not my choice), I do not ask: Is this Ninth Circuit, and I support his nomination I say to the Presiding Officer, I am the sort of judge who shares my legal philos- enthusiastically. sure, like me, in your office, as a Sen- ophy? Rather, I ask: Would he be the sort of Sincerely, ator from Connecticut, you regularly judge whom I could respect intellectually? HENRY WEISSMANN. are visited by folks from around the Would he be the sort of judge whom I could Mr. LEAHY. Mr. President, I ask country or around your State who are trust to be fair-minded and respectful of the unanimous consent that following the deeply concerned about continuing legal rules that he is obligated to follow? Is he likely to be more on the moderate side vote on the Watford nomination, the medical progress, discovery and devel- rather than solidly on the left? For Paul, my motion to reconsider be considered opment of the lifesaving treatments answer to those questions is a definite yes. made and laid upon the table, with no Americans have developed over the last When a Democratic President nominates a intervening action or debate, that no two decades. It is my hope that the judge who is indeed well on the left, Repub- further motions be in order to the nom- Senate will continue to clear the way. licans like me face a difficult question: ination; that any statements related to That is why we need this legislation. Should we resist the nomination, or should the nomination be printed in the This reauthorization helps take care we accept it so long as the judge appears to RECORD; that the President be imme- of innovation and safety so consumers be excellent on the nonideological factors? I diately notified of the Senate’s action, and patients do not have to worry. It have not fully thought through this ques- permanently authorizes programs that tion. and that the Senate then resume legis- But for the reasons I mentioned, that’s a lative session. have helped make medicines safer for question that doesn’t even come up for me in The PRESIDING OFFICER. Is there millions of children. It upgrades the this instance. Paul is the sort of moderate objection? FDA’s tools to police the global supply Democratic nominee that moderates and Without objection, it is so ordered. chain and helps reduce the risk of drug conservatives, as well as liberals, should sol- Mr. LEAHY. Mr. President, I suggest shortages of the kind we saw recently, idly support. the absence of a quorum, but I ask which Senator KLOBUCHAR just spoke Sincerely, to earlier this afternoon, when supplies EUGENE VOLOKH. unanimous consent that the time be- tween now and the vote at 5:30 be even- of critical cancer medications ran low. ly divided. This is a matter of great urgency. HENRY WEISSMANN, The current FDA authorization will ex- Los Angeles, CA, May 3, 2012. The PRESIDING OFFICER. Without pire in a few short months. If we allow Re Nomination of Paul Watford. objection, it is so ordered. that to happen, we put at risk patient Hon. HARRY REID, The clerk will call the roll. access to new medications as well as Majority Leader, U.S. Senate, Hart Senate Of- The legislative clerk proceeded to America’s ongoing global leadership in fice Building, Washington, DC. call the roll. Hon. PATRICK J. LEAHY, biomedical innovation. Mr. COONS. Mr. President, I ask Worst of all, failing to reauthorize Chairman, U.S. Senate, Committee on the Judi- unanimous consent that the order for ciary, Russell Senate Office Building, Wash- would cost us thousands of jobs, and ington, DC. the quorum call be rescinded. more pink slips is not what we need as Hon. MITCH MCCONNELL, The PRESIDING OFFICER. Without our economic recovery gains strength. Republican Leader, U.S. Senate, Russell Senate objection, it is so ordered. If new drug and medical device user fee Office Building, Washington, DC. FDA REAUTHORIZATION agreements are not authorized before Hon. CHUCK GRASSLEY, Mr. COONS. Mr. President, I rise the current ones expire, the FDA must Ranking Member, U.S. Senate, Committee on today in strong support of the bipar- the Judiciary, Hart Senate Office Building, lay off nearly 2,000 employees. Because Washington, DC. tisan legislation to which the Senate that does not happen overnight, layoff DEAR SENATORS REID, MCCONNELL, LEAHY will move to reauthorize the Food and notices would start going out as early AND GRASSLEY: I write in support of the nom- Drug Administration user fees and crit- as July. The good news is we are mov- ination of Paul Watford to the United States ical programs to ensure Americans ing forward with a timely reauthoriza- Court of Appeals for the Ninth Circuit. have access to safe and effective medi- tion to save those jobs, save America’s I am a partner of Mr. Watford’s at Munger, cations. leading role in innovation, and ensure Tolles & Olson LLP. Prior to joining Most of us do not think about the that the FDA continues to make Munger, Tolles, I had the honor of serving as FDA on a regular basis. In fact, we a law clerk to Justice Antonin Scalia of the progress. Supreme Court and Judge James L. Buckley rarely think about where our medi- This is an all-too-rare display of bi- of the United States Court of Appeals for the cines come from, the scientists who in- partisanship across both Chambers. D.C. Circuit. I am also a past President of vented them, the investments required This legislation was unanimously ap- the Los Angeles Chapter of the Federalist to develop them, and the innovative, proved by the House committee and Society and serve on the Executive Com- cutting-edge new treatments that are found strong bipartisan support in the mittee of its national Telecommunications essential to keeping Americans HELP Committee here in the Senate, Practice Group. Although I do not agree healthy and safe or the regulators who ably led by Chairman HARKIN and with President Obama on many issues, I make sure these pharmaceuticals, de- completely agree with his nomination of Mr. Ranking Member ENZI. Watford. vices, and treatments work as they are There is a reason Members of the I have had the pleasure of working with supposed to. But when the moment House and Senate of both parties are in Mr. Watford for over a decade in a variety of comes that we face a health crisis and such strong support of this reauthor- appellate matters involving large corporate our doctors prescribe us essential medi- ization.

VerDate Mar 15 2010 03:25 May 22, 2012 Jkt 019060 PO 00000 Frm 00019 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.013 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3314 CONGRESSIONAL RECORD — SENATE May 21, 2012 The American economy has always This time around, the balance appears to Circuit vacancy a ‘‘judicial emer- been driven by innovation, and some of be tilting slightly toward faster approval. gency.’’ So today we are, in fact, filling our most extraordinary innovations That’s good. one of the seats which is a judicial have come in the biomedical sector. In I agree. Safety is paramount, but emergency. The candidate is Paul the years ahead, it is my faith, my with today’s technology and the FDA’s Watford, a Ninth Circuit nominee with hope, that we will see more and more century of experience, I think we can stellar credentials and support across narrowly targeted drugs created spe- move more quickly to put innovative the political spectrum. I am delighted cifically for certain kinds of patients treatments in the hands of patients that cloture was vitiated so the vote or very specific diseases. In the who desperately need them. The Pre- will be directly on his nomination, and lifecycle of innovation, this is different scription Drug User Fee Act originally it is anticipated that he will be con- than the last few decades when block- passed by Congress in 1992 and reau- firmed without controversy. buster medications were used and then thorized every 5 years since is what al- Mr. Watford earned his bachelor’s de- developed on a very wide scale across lows the FDA to collect user fees from gree from the University of California the country or world. But it is an pharmaceutical manufacturers and Berkeley in 1989 and his law degree equally impressive feat of innovation provide a stable, consistent funding from UCLA in 1994 where he was editor that lies in the years ahead, and one stream that has steadily decreased of the UCLA Law Review and grad- that is only possible because of amaz- drug review times by nearly 60 percent uated Order of the Coif. After finishing ing advances in technology, the map- since it was first enacted. It has pro- law school, Mr. Watford clerked for ping of the human genome, the disasso- vided access on a faster and more pre- Ninth Circuit Judge Alex Kozinski, an ciation across many labs and small dictable timeframe to over 1,500 new appointee of President Reagan’s. He startup businesses, of the machinery, medicines since it was first enacted then clerked for Justice Ruth Bader the mechanics, and the capabilities to and deserves to be reauthorized to help Ginsburg on the U.S. Supreme Court. innovate in the discovery and develop- expedite approval for breakthrough Following his two clerkships, he medications to treat rare and widely ment of pharmaceuticals. spent a year in private practice at the experienced diseases. prestigious firm of Munger, Tolles, and We have to continue to support and In closing, the FDA is the oldest Olson and then moved into public serv- encourage this kind of innovation in comprehensive consumer protection ice as an assistant U.S. attorney in Los order to stay competitive in the global agency in the Federal Government. Its Angeles in 1997. There he prosecuted a economy. At the moment, the FDA relevance has not decreased with age; broad array of crimes, including bank continues to keep pace with many of in fact, quite the opposite. As our re- robberies, firearms offenses, immigra- our global competitors in terms of searchers and scientists have made tion violations, alien smuggling, and their review time for new drug applica- major breakthroughs in care and tech- various types of fraud. tions, but we are at real risk of falling nologies for treatment, the FDA has He later served in the major fraud behind. continued to serve as the conduit be- section of the criminal division, focus- One recent example to which I paid tween innovators, physicians, and pa- ing on white collar crime. Among his close attention, the blood-thinning tients. many cases, he prosecuted the first drug Brilinta, was manufactured by a We face tremendous hurdles in treat- case of an online auction fraud on eBay company—was developed and discov- ing devastating diseases of all kinds. In in California. During his tenure as a ered by a company—in my home State addition to ancient puzzles such as can- Federal prosecutor, Mr. Watford ap- of Delaware, AstraZeneca. It was fi- cer that continue to allude us, there peared in court frequently, typically nally approved by the FDA in July are new challenges cropping up every several times per week. He tried seven 2011. But prior to that approval, 33 day. One example would be the need for cases to verdict, and he worked on nu- other countries, including the EU and new drugs to treat increasing cases of merous Ninth Circuit appeals, arguing Canada, had already approved the drug bacterial infections, greatly resistant four of them. months or years before. This delay in to conventional antibiotics, so-called In one such case, a cocaine dealer had review and approval in some certain superbugs. That is why I have joined already convinced the State court that cases can be bad for patients who rely with the Presiding Officer and Senator a drug seizure had violated his fourth on these medications and bad for the CORKER as a cosponsor of the GAIN amendment rights. Mr. Watford pre- competitiveness of the United States. Act, to spur development of these spe- vailed on appeal in forcing the dealer So I am glad this reauthorization cific types of drugs. This is one of to forfeit over $100,000 in drug traf- clears away some of the conflict in the many examples of the kinds of innova- ficking proceeds. underbrush and will reauthorize and tions that will solve the medical mys- In 2000, Watford rejoined Munger, strengthen and streamline the review teries of the 21st century, ease the suf- Tolles, and Olson where he is currently timeline for new pharmaceuticals. fering of millions of Americans, secure a partner. This is one of the premiere Not only will this provide the kind of high-wage and high-skilled jobs in the appellate law firms in California. Paul predictability and certainty any busi- biomedical research field, and ensure Watford specializes in appellate litiga- ness needs to succeed, but it helps our competitiveness globally. tion at the firm. Like most major law make sure the FDA’s essential regu- So let’s continue working in the bi- firms, Munger’s docket is dominated by latory process keeps pace with sci- partisan spirit that has carried this re- business litigation. Thus the focus of entific innovation. In my home State authorization thus far and proceed to Mr. Watford’s work has been appellate of Delaware, there are more than 20,000 pass it without delay. litigation for business clients. For ex- I yield the floor. ample, he represented Verizon Commu- jobs that directly rely on biomedical The PRESIDING OFFICER. The Sen- research and innovation. But around nications in a consumer class action ator from California. case. He represented the technology the country there are more than 4 mil- Mrs. FEINSTEIN. Mr. President, at company, Rambus, in two complex pat- lion indirectly and more than 675,000 5:30 we will be voting on the nomina- ent infringement cases. He also rep- jobs that directly benefit from this tion of Paul Watford for the Ninth Cir- resented Shell Oil in an antitrust case. area. cuit Court of Appeals. I would like to Mr. Watford and his colleagues at Frankly, it is also one of our strong- say a few words about him at this time. Munger won a 9-to-0 reversal on behalf est export areas of growth for the long But before I do, I think Members might of Shell Oil in the Supreme Court. He term. So we need this reauthorization want to consider the fact that the has also represented numerous other now. In my view, moving forward with Ninth Circuit is by far the busiest U.S. American businesses, such as Coca- this legislation also means finding the circuit in the Nation. It has over 1,400 Cola and Berkshire Hathaway, as well fine balance between speed and safety, appeals pending per three-judge panel. as business executives and municipal between getting treatments to patients That is the most of any circuit. It is government agencies. without delay, and being certain these over two times the average of other In total he has argued 21 cases in the new drugs will be effective and safe. circuits combined. appellate courts, and he has appeared In a recent editorial, the Washington The Judicial Conference of the as counsel in over 20 cases in the U.S. Post noted: United States has declared each Ninth Supreme Court. So he is well equipped.

VerDate Mar 15 2010 03:25 May 22, 2012 Jkt 019060 PO 00000 Frm 00020 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.038 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3315 His extensive experience as a pros- Ninth Circuit, by far the busiest circuit lous or indicate an unacceptable level ecutor and private practitioner, includ- in the Nation, urgently needs him to of professional competence. However, ing his specialty in appellate work, begin his service. in this case, Mr. Watford has not sim- will serve the Ninth Circuit extremely As I said the Ninth Circuit is a judi- ply argued on behalf of a client, he well. Mr. Watford is also regarded by cial emergency. This will fill one va- adopted those legal theories as his very attorneys on both sides of the aisle, in- cancy. So I urge my colleagues to vote own. On July 14, 2010, Mr. Watford gave cluding conservative Republicans who at 5:30, in 15 minutes, for Mr. Watford’s a speech analyzing the constitu- praise him for his keen intellect and nomination. tionality of the Arizona law. His speech fair-minded approach to the law. He I yield the floor. concentrated on ‘‘why S. 1070 is uncon- has been endorsed by two former presi- The PRESIDING OFFICER. The Sen- stitutional,’’ and he recapped many of dents of the Los Angeles chapter of the ator from Iowa. the arguments he made in the Friendly Federalist Society. Mr. GRASSLEY. Mr. President, House case. One, Jeremy Rosen, says Watford is, today we are going to turn to a nomi- Moreover, despite the fact that he ‘‘open-minded and fair,’’ and a ‘‘bril- nation that the Senator from Cali- discussed his views on immigration liant person and a gifted appellate law- fornia has just referred to, Paul publicly, he nonetheless declined to an- yer.’’ The other, Henry Weissman, says Watford, to be circuit judge for the swer many of my questions during his that although he ‘‘do[es] not agree Ninth Circuit. I am disappointed that hearing before the Judiciary Com- with President Obama on issues, [he] the majority leader has brought this mittee. For instance, I asked about an completely agree[s] with his nomina- nomination to the floor. argument in his brief that the Arizona tion of Paul Watford.’’ So that is a The reason I say that is there are at statute prohibiting illegal aliens from good thing. least 10 nominations on the Executive soliciting work somehow violated the Daniel Collins, who clerked for Jus- Calendar that might fall into the cat- first amendment. The nominee re- tice Scalia and served as an Associate egory of consensus nominees. Six nomi- sponded that it would be inappropriate Deputy Attorney General in the Bush nees on the calendar had significant for him to comment on questions re- Justice Department, says Watford opposition in committee and clearly lated to whether illegal immigrants ‘‘embodies the definition of judicial are not consensus nominees. Mr. were entitled to constitutional protec- temperament—very level-headed and Watford falls into this category of not tions other than those contained in the even keeled.’’ being a consensus nominee. fifth, sixth and fourteenth amend- Thirty-two Supreme Court clerks I will oppose Mr. Watford’s nomina- ments. Again, remember, he had al- from the term when Watford clerked tion and ask my colleagues to oppose ready given a speech on this topic, so I for Justice Ginsburg have written in the nomination as well. My opposition was disappointed that he would not support of the nomination. These in- to this nomination is based upon sub- share his views on these important top- clude clerks from every Justice on the stantive concerns that I have regarding ics. Court at that time, including all of Mr. Watford’s views on both immigra- With regard to the death penalty, Mr. Justice Scalia’s clerks from that year, tion and the death penalty. Watford assisted in submitting an ami- as well as several from Justices Mr. Watford partnered with the cus brief to the Supreme Court in Baze Rehnquist, Thomas, and Kennedy. I American Civil Liberties Union and the v. Rees on behalf of a number of groups find that quite amazing. National Immigration Law Center in that opposed Kentucky’s three-drug le- A group of over 40 former clerks for two cases to oppose Arizona’s 2010 im- thal injection protocol. Judge Kozinski have also written in migration bill. In the first case, In its plurality opinion, the Court re- support of Watford’s nomination. This Friendly House, a class action lawsuit, jected the arguments raised in the group includes numerous individuals Mr. Watford served as cocounsel for brief. Ultimately, Kentucky’s three- with unquestionable conservative cre- most of the plaintiffs, including the drug protocol was upheld on a 7-to-2 vote in the Supreme Court. dentials. Many clerked for Justices class action representative Friendly At the hearing we had for Mr. Rehnquist, Scalia, Alito, and Kennedy. House. Watford, in following up questions, Mr. The Friendly House complaint at- Several, such as Steve Engel, Charles Watford gave the standard response tacks the Arizona law on a variety of Duggan, and Ted Ullyot also served in that he would follow Supreme Court grounds. He argued the law violates the the Bush administration, including in precedent regarding the death penalty. Supremacy clause; that it violates the the White House Counsel’s Office and Yet it is very curious to me that he Equal Protection clause by promoting the leadership of the Justice Depart- would go out of his way to provide his racial profiling; that it violates the ment. services to a case that would under- first amendment by chilling the speech Watford also has strong support in mine the death penalty. the business community. The general of non-English speakers; that it vio- Furthermore, his concession that he counsels of leading American corpora- lates the fourth amendment; and that would give consideration to foreign or tions, including Google, Mattel, it violates due process by inviting ra- international law in interpreting the Verizon, and CIRCOR, have also writ- cial profiling and employing vague meaning of the Cruel and Unusual Pun- ten in support of Mr. Watford. They definitions of ‘‘public offense’’ and ishment clause makes me wonder how say Watford ‘‘is exactly the kind of in- other statutory terms. he would approach this issue. dividual that any plaintiff or defend- In the second case, United States v. I have other concerns based on posi- ant—person, business, or government— Arizona, Mr. Watford served as co- tions this nominee has taken in his would welcome deciding their case.’’ counsel on an amicus brief filed by the legal advocacy, as well as some of his In short, Paul Watford is truly both Friendly House plaintiffs. This brief presentations. an excellent and distinguished choice covers most of the arguments raised in I am generally willing to give the for the Ninth Circuit. He is extremely the Friendly House complaint. But in President’s nominees the benefit of the bright. He is experienced at the trial addition, it asserts that Arizona ‘‘fails doubt when the nominee on the surface and appellate level and in both civil to account for the complexities and re- meets the requirements I have pre- and criminal cases. He is uniquely re- alities of Federal immigration law’’ be- viously outlined. But I don’t think this spected for his intellect and judgment, cause individuals lacking immigration nominee meets these requirements. and he has broad support across the po- registration documents are put at risk Finally, Republicans continue to be litical spectrum and in the business of ‘‘constant and repeated criminal accused of obstruction and delay when community. prosecution.’’ it comes to judicial nominations. This Maybe this is the reason cloture was I do not believe an attorney should comes even as we have now confirmed vitiated. He is not filibusterable. I hope be held accountable for the legal posi- 145 of this President’s district and cir- people see the fine and keen intellect tions he advocates on behalf of a client. cuit court nominees. That, of course, is this man is, and he should have a very Of course, there are some exceptions to during a period when we also confirmed large vote. If confirmed, he would be that general rule; for instance, if the two Justices to the Supreme Court. one of just two African-American ac- legal positions are far outside the The last President who had two Su- tive judges on the Ninth Circuit. The mainstream of legal theory, are frivo- preme Court nominees had only 120

VerDate Mar 15 2010 03:25 May 22, 2012 Jkt 019060 PO 00000 Frm 00021 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.039 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3316 CONGRESSIONAL RECORD — SENATE May 21, 2012 confirmations. So this argument of ob- School of Law for three semesters The PRESIDING OFFICER (Mrs. struction, of delay, and of unfairness (2007, 2008, and 2009). HAGAN). Are there any other Senators doesn’t hold up. The ABA Standing Committee on the in the Chamber desiring to vote? I remind my colleagues on the other Federal Judiciary unanimously rated The result was announced—yeas 61, side of the aisle of the obstructionism, him as Well Qualified for this position. nays 34, as follows: delay, and filibusters, which they per- I yield the floor and suggest the ab- [Rollcall Vote No. 104 Ex.] fected. The history of President Bush’s sence of a quorum. YEAS—61 nominees to the ninth circuit provides The PRESIDING OFFICER. The Akaka Graham Murray some very important examples. clerk will call the roll. Alexander Hagan Nelson (NE) President Bush nominated nine indi- The bill clerk proceeded to call the Baucus Harkin Nelson (FL) viduals to the ninth circuit. Three of roll. Begich Inouye Pryor those nominations were filibustered. Mr. REID. Mr. President, I ask unan- Bennet Johnson (SD) Reed Bingaman Kerry Reid Two of those filibusters were success- imous consent that the order for the Blumenthal Klobuchar quorum call be rescinded. Rockefeller ful. The nominations of Carolyn Kuhl Boxer Kohl Sanders Brown (MA) Kyl and William Gerry Myers languished The PRESIDING OFFICER. Without Schumer Brown (OH) Landrieu objection, it is so ordered. Shaheen for years before being returned to the Cantwell Lautenberg President. A fourth nominee, Randy UNANIMOUS CONSENT AGREEMENT—S. 3187 Cardin Leahy Snowe Mr. REID. Mr. President, I ask unan- Carper Levin Stabenow Smith, waited over 14 months before fi- Tester nally being confirmed after his nomi- imous consent that the cloture vote on Casey Lieberman Collins Lugar Udall (CO) nation was blocked and returned to the the motion to proceed to Calendar No. Conrad Manchin Udall (NM) President. After being renominated, he 400, S. 3187, the Food and Drug Admin- Coons McCain Warner was finally confirmed by a unanimous istration Safety and Innovation Act, be Durbin Menendez Webb vitiated; that at 2:15 tomorrow, Tues- Feinstein Merkley Whitehouse vote. Franken Mikulski Wyden President Obama, on the other hand, day, May 22, the motion to proceed be Gillibrand Murkowski has nominated six individuals to the agreed to; that the Harkin-Enzi sub- NAYS—34 ninth circuit. Only one of those nomi- stitute amendment, which is at the nees was subject to a cloture vote. desk, be agreed to, and the bill, as Ayotte Enzi Paul Barrasso Grassley Portman After that vote failed, the nominee amended by the Harkin-Enzi sub- Blunt Hatch Risch withdrew. If confirmed, Mr. Watford stitute, be considered original text for Boozman Hoeven Roberts will be the fourth nominee of President the purposes of further amendment, Burr Hutchison Rubio Chambliss Inhofe Sessions Obama nominated to serve on the and that the majority leader be recog- Coats Isakson nized at that time. Shelby ninth circuit. Those four confirmations Coburn Johanns Thune Cochran Johnson (WI) took an average of about 8 months The PRESIDING OFFICER. Is there Toomey Corker Lee objection? Wicker from the date of nomination. Cornyn McConnell For all of President Obama’s circuit Without objection, it is so ordered. Crapo Moran nominees, the average time for nomi- Mr. REID. Mr. President, based on nation to confirmation is about 242 this, we will have a vote that should NOT VOTING—5 days. For President Bush’s circuit start in 5 minutes, which will be the DeMint Kirk Vitter Heller McCaskill nominees, the average wait for con- only vote of the day. firmation was 350 days. Given this his- I suggest the absence of a quorum. The nomination was confirmed. tory that I have spelled out, one might The PRESIDING OFFICER. The The PRESIDING OFFICER. Under wonder then why President Bush and clerk will call the roll. the previous order, the motions to re- his nominees were treated differently The bill clerk proceeded to call the consider are considered made and laid and so much more unfairly than Presi- role. upon the table, and the President will Mr. REID. Mr. President, I ask unan- dent Obama’s nominees. be immediately notified of the Senate’s Mr. Watford received his B.A. from imous consent that the order for the action. University of California, Berkeley in quorum call be rescinded. The PRESIDING OFFICER. Without f 1989 and his J.D. from the University of objection, it is so ordered. LEGISLATIVE SESSION California, Los Angeles (UCLA) School Mr. REID. Mr. President, I yield back of Law in 1994. Upon graduation, he The PRESIDING OFFICER. The Sen- all time and ask unanimous consent clerked for Judge Alex Kozinski on the ate will resume legislative session. that the vote start now. The majority leader is recognized. Ninth Circuit and then for Justice The PRESIDING OFFICER. Without Ginsburg on the Supreme Court. In objection, it is so ordered. f 1996, he began working as an associate Mr. REID. Mr. President, I ask for in the Litigation Department at the IRAN THREAT REDUCTION ACT OF the yeas and nays. 2011 Los Angeles law firm of Munger, Tolles The PRESIDING OFFICER. Is there a & Olsen. From 1997–2000, Mr. Watford sufficient second? Mr. REID. Madam President, I ask was an Assistant United States Attor- There is a sufficient second. unanimous consent that the Foreign ney in the U.S. Attorney’s Office for The question is, will the Senate ad- Relations Committee be discharged the Central District of California, in vise and consent to the nomination of from further consideration of H.R. 1905, Los Angeles, handling a variety of Paul J. Watford, of California, to be the Iran Threat Reduction Act, and criminal prosecutions, such as immi- United States Circuit Judge for the that the Senate proceed to its consider- gration, narcotics, firearms traf- Ninth Circuit. ation; that the Johnson of South Da- ficking, bank robbery, computer fraud, The clerk will call the roll. kota-Shelby substitute amendment, mail and wire fraud, and securities The bill clerk called the roll. which is at the desk and is the text of fraud. Mr. DURBIN. I announce that the Calendar No. 320, S. 2101, the Iran Sanc- In 2000, Mr. Watford returned to pri- Senator from Missouri (Mrs. MCCAS- tions, Accountability, and Human vate practice as an associate in the ap- KILL) is necessarily absent. Rights Act, as reported by the Banking pellate practice group at Sidley & Aus- Mr. KYL. The following Senators are Committee, be considered; that a John- tin’s Los Angeles office. In 2001, he re- necessarily absent: the Senator from son of South Dakota-Shelby amend- joined Munger, Tolles & Olsen as an as- South Carolina (Mr. DEMINT), the Sen- ment, which is at the desk, be agreed sociate, becoming a partner there in ator from Nevada (Mr. HELLER), the to; that the substitute amendment, as 2003. His practice focuses primarily on Senator from Illinois (Mr. KIRK), and amended, be agreed to; that the bill, as appellate litigation, specifically busi- the Senator from Louisiana (Mr. VIT- amended, be read a third time and the ness and commercial disputes. Mr. TER). Senate proceed to a vote on passage of Watford has also taught a course on Further, if present and voting, the the bill, as amended. Judicial Opinion Writing at the Univer- Senator from South Carolina (Mr. The PRESIDING OFFICER. Is there sity of Southern California’s Gould DEMINT) would have voted ‘‘nay.’’ objection to the consent request?

VerDate Mar 15 2010 04:41 May 22, 2012 Jkt 019060 PO 00000 Frm 00022 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.040 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3317 Mr. MCCAIN. Madam President, re- speak. We cannot leave this debate tough, targeted sanctions against the serving the right to object, and I will without making a very simple un- Iranian Government, making it clear not object, I would like to thank both equivocal statement that the goal is to to the Iranian Government that they leaders for their hard work in getting get it right. And if sanctions can lead must stop their illicit pursuit of nu- what I believe is one of the more im- to getting it right, God bless. If the clear weapons or face increased pres- portant sense-of-the-Senate resolutions sanctions will not get us to where we sure on their economy. achieved here. It is very difficult. I want to go, everything is on the table, Madam President, I ask unanimous think words matter. The fact that this including the use of military force, be- consent that a longer statement of resolution points out that we need a cause this country—Republicans and mine on the bill plus a summary be in- comprehensive policy that includes Democrats—is not going to allow the cluded in the RECORD following my re- economic sanctions, diplomacy in mili- Iranian regime to develop nuclear ca- marks. tary planning, capabilities, and op- pability that will put the world into The PRESIDING OFFICER. Without tions; that this objective is consistent darkness. objection, it is so ordered. with the one stated by President To everybody who negotiated this (See exhibit 1.) Barack Obama in the State of the outcome, thank you very much. Mr. JOHNSON. The bill the Senate Union Address where he said, ‘‘Let I yield the floor. adopted today passed the Banking there be no doubt: America is deter- The PRESIDING OFFICER. Without Committee earlier this year by a unan- mined to prevent Iran from getting a objection, it is so ordered. imous bipartisan vote. Among its other nuclear weapon, and I will take no op- The amendment (No. 2123) in the na- provisions, this legislation will have tions off the table to achieve that ture of a substitute was agreed to. important effects because it requires goal’’—I think this is an important res- (The amendment is printed in today’s intensified targeting of Iran’s Revolu- olution. I thank the majority leader. RECORD under ‘‘Text of Amendments.’’) tionary Guard Corps, sanctioning en- I also point out that the final part of The amendment (No. 2124) was agreed ergy and uranium mining joint ven- it says that nothing in the act shall be to. tures with Iran, and mandating sanc- construed as a declaration of war or an (The amendment is printed in today’s tions for those who supply Iran with authorization of the use of force RECORD under ‘‘Text of Amendments.’’) weapons and other technologies used to against Iran or Syria. The substitute amendment, as commit human abuses, including those First of all, it is not an authoriza- amended, was agreed to. used to impose an electronic curtain of tion. Second of all, I wonder if we The amendment was ordered to be censorship on Iran’s citizens. In addi- ought to include Canada and maybe engrossed and the bill to be read a tion, this legislation gives the Presi- Brazil and other countries along with third time. dent additional authority to sanction that since this resolution contemplates The bill was read the third time. the Asad regime in Syria. in no way anything concerning Syria, The PRESIDING OFFICER. The Today the Senate has shown that we but I guess we could probably throw it question is on passage of the bill as can still act in a bipartisan way on im- in. However, I will not ask for a unani- amended. portant priorities. I thank every Mem- mous consent to amend to add Canada, The bill (H.R. 1905), as amended, was ber for supporting passage of this bill although the Canadians are very upset passed. today. In particular, I thank all the because they have no teams in the Mr. REID. Madam President, I ask members of the Banking Committee finals of the National Hockey League unanimous consent that the motion to for their work, including Ranking Stanley Cup championship series. reconsider be laid upon the table and Member SHELBY and Senators MENEN- Again, I thank both the Senate ma- that any statements related to this DEZ, KIRK, SCHUMER, and BROWN. In ad- jority leader and the Republican leader matter be printed in the RECORD in the dition, I thank Majority Leader REID for the work they did and also our appropriate place as if read. for his determination to get this legis- friend Senator MENENDEZ, who was also The PRESIDING OFFICER. Without lation through the Senate. an important factor in getting this objection, it is so ordered. I look forward to working with my done. Mr. REID. Madam President, before colleagues in the House to quickly I do not object. we leave here this evening, I must men- come together on a final bill the Presi- The PRESIDING OFFICER. The Sen- tion the good work done by the Bank- dent can sign soon. It is important that ator from South Carolina. ing Committee. Senator JOHNSON of the Congress act swiftly so that we can Mr. GRAHAM. Madam President, to South Dakota has been stalwart in this continue to put pressure on the Iranian the majority leader, well done. I think issue. He and Senator SHELBY worked regime to end its illicit and illegal nu- we are going to be able to voice vote a together. It has been very heart- clear activity. resolution that states the policy of our warming. Again, I thank all my colleagues for country and our President very clearly. I appreciate Senator MENENDEZ, who their support on the Iran sanctions bill To the Senator from New Jersey, Mr. has been a loud voice in making sure today. MENENDEZ, great job on the sanctions. we do something on this legislation EXHIBIT 1 I hope the Senator understands why I about which he feels so strongly. TIGHTENING IRAN SANCTIONS wanted to put in all options. I hope the The most important thing for me is Mr. JOHNSON of South Dakota. Mr. Presi- sanctions will work. This is a clear Iranians need to know we mean busi- dent, the prospect of a nuclear-armed Iran is statement by the Senate backing up ness, particularly with the next round the most pressing foreign policy challenge our President that when it comes to of international negotiations taking we face, and we must continue to do all we Iran having nuclear capabilities, there place the day after tomorrow. can—politically, economically, and dip- will be more than sanctions on the I am glad we resolved our differences lomatically—to avoid that result. The meet- table, and the Iranians need to know and everyone realizes how important it ings here in Washington in March between that. is to advance these measures to pre- Israeli Prime Minister Netanyahu and Presi- dent Obama underscored the gravity of these I hope we can end this peacefully for vent Iran from obtaining a nuclear issues, and the importance of an intensified, Israel’s sake, for our sake, and for the weapon. They should be aware that unified effort by the international commu- world’s sake as we approach beefing up there is still more we can do. I am very nity to further isolate Iran’s leaders and the sanctions with the Banking Com- happy with what we have done at this compel them to abandon their illicit nuclear mittee, with Senator MENENDEZ’s and time. activities. Iran’s willingness to sit down Senator KIRK’s leadership, and others, The PRESIDING OFFICER. The Sen- again with the P5 + 1 group—the five perma- who have done a great job. If you are ator from South Dakota. nent members of the UN Security Council on the Banking Committee, you did a Mr. JOHNSON of South Dakota. plus Germany—and begin to re-engage on the Madam President, I rise to discuss to- nuclear issues is a hopeful sign. But even great job. I don’t even know who is on after the first meeting, which both sides it. day’s unanimous, bipartisan approval called ‘‘constructive,’’ it remains to be seen The bottom line is I think the sanc- of the Senate Iran Sanctions, Account- whether Iran will actually be willing to work tions were really well drafted and will ability and Human Rights Act. With towards progress on the central issues at the enhance the President’s hand, so to this action, we are adding additional negotiating sessions planned for Baghdad

VerDate Mar 15 2010 04:41 May 22, 2012 Jkt 019060 PO 00000 Frm 00023 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.043 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3318 CONGRESSIONAL RECORD — SENATE May 21, 2012 later this week, or whether these meetings tracking data. It is clear Iran is losing oil with the House bill and move it forward will simply be another in a series of stalling sales to key customers in Europe, Asia, and quickly into law this year. I look forward to actions to buy time to enrich additional ura- elsewhere, and is having some of its biggest working with my House colleagues, includ- nium and further fortify their nuclear pro- customers demand steep discounts to buy its ing Chairman Ros-Lehtinen and Ranking gram. oil. Some estimate the losses in Iran’s oil Member Berman, who as former Foreign Af- As that process moves forward, today the revenues are approaching 40 percent of daily fairs Committee Chairman has led the sanc- full Senate is finally acting on an important sales. Iran’s oil exports have the potential to tions effort against Iran for many years, and bill to confront this very serious threat to fall another 300,000 to 500,000 barrels a day or played a key role in developing both CISADA our national security, to Israel and to our more when the European Union’s embargo and the House version of this measure, to get other allies in the Middle East and Europe. takes effect in July, according to a report a bill enacted this year. S. 2101, the Iran Sanctions Accountability this week by Barclays. That is a huge im- IRAN SANCTIONS, ACCOUNTABILITY AND HUMAN and Human Rights Act of 2012, was approved pact. A senior IRGC official acknowledged RIGHTS ACT OF 2012 by a unanimous bipartisan vote in the Sen- the effectiveness of sanctions recently, say- ate Banking Committee. I am pleased that, ing: ‘‘The regime is at the height of isolation SECTION-BY-SECTION SUMMARY with the help of ranking member Senator and in the midst of a technological, sci- Sec. 1—Short Title, Table of Contents Shelby and other committee colleagues, we entific and economic siege. We are not in a Sec. 2—Findings are presenting to the full Senate, as we did situation of imaginary threats and sanc- Contains a series of findings about the 2 years ago, this bipartisan bill to expand tions. Threats and sanctions against us are threat posed by Iran, the bipartisan under- and tighten sanctions on Iran, along with a effectively being pursued.’’ These sanctions standing of the implications of its achieving manager’s amendment to address several have had a more powerful effect than many a nuclear weapons capability, steps taken issues that required updating to take into thought possible. thus far by the US, its allies and the United account recent events, and clarifications or Iran is also isolated diplomatically. The Nations Security Council to counter that additions that my colleagues sought to ex- international community is lined up against threat, and the need to intensify those ef- pand the reach and effectiveness of the bill, their nuclear program, with progressively forts to counter that threat and deter Iran’s including changes requested by Senator tougher UN sanctions imposed on them. nuclear ambitions. Menendez to an amendment he offered in Their most important ally, Syria, is col- Sec. 3—Definitions committee, section 503, to narrow its appli- lapsing into civil war. They are, as President cation while preserving his original intent to Obama said, in a ‘‘world of hurt.’’ Many be- Provides that the definitions of key terms enable attachment of assets in which the lieve the recent shift by Iran’s leaders on the (‘‘appropriate congressional committees,’’ government of Iran has an interest, to sat- nuclear issue is the result of that pain, and ‘‘credible information,’’ and ‘‘knowingly,’’) isfy certain terror-related judgments against the intense pressure of heightened sanctions. will be those found in the Iran Sanctions Act Iran. But while it is clear that existing sanctions (ISA) of 1996, as amended, and that the defi- In pressing this bill forward we recognize are biting, they have not yet persuaded nition of ‘‘United States person’’ will be that that economic sanctions are not an end: they Iran’s leaders to drop their nuclear ambi- found in the Comprehensive Iran Sanctions, are a means to an end. That end is to apply tions. We must not let up now, as negotia- Accountability, and Divestment Act of 2010 enough pressure to secure agreement from tions on these issues are continuing. (CISADA). Iran’s leaders to fully, completely and I believe that further progress in those ne- Sec. 101—Statement of Policy verifiably abandon their illicit nuclear pro- gotiations depends on intensifying that pres- Defines US policy to be to prevent Iran gram. The President has made clear that his sure on Iran’s leaders, and that’s what this from (i) acquiring or developing nuclear policy is not to contain Iran once it has a nu- bill is all about. With these new sanctions, weapons and advanced conventional weapons clear weapon: it is to prevent Iran from including those targeted at the IRGC, we are and ballistic missile capabilities, (ii) con- achieving that goal in the first place. He is forcing Iran’s military and political leaders tinuing its support for international ter- deadly serious about that. At the same time, to make a clear choice. They can end the rorism, and (iii) engaging in other activities he is moving forward diplomatically, in con- suppression of their people, come clean on designed to destabilize its neighbors in the sultation with our allies, to test Iran’s will- their nuclear program, suspend enrichment, region. It also outlines the US policy of sup- ingness to come clean on its nuclear pro- and stop supporting terrorist activities port for full implementation of all sanctions gram, and resolve the international commu- around the globe. Or they can continue to against Iran as part of multilateral efforts to nity’s concerns on this front. face sustained multilateral economic and compel Iran to abandon its illicit nuclear Let me describe where we have been on diplomatic pressure, and deepen their inter- program. Iran sanctions, so that Senators may better national isolation. understand where we’re going. This has been Just as then-Chairman Dodd and Ranking Sec. 102—Expansion and Implementation of the subject of heated rhetoric on the Presi- Member Shelby did in 2010, Senator Shelby Multilateral Sanctions Regime dential campaign trail, so I want to describe and I have incorporated ideas from many of States the sense of Congress that expan- clearly the longstanding bipartisan approach our Senate colleagues into one Committee sion and vigorous implementation of bilat- we in Congress have taken. Since here in the bill, including from S. 1048 sponsored by Sen- eral and multilateral sanctions against Iran, Senate we sometimes cannot even agree to ator Menendez. Senator Menendez has been a and vigorous enforcement of all U.S. sanc- cross the street together, in today’s hyper- leader on these issues, along with Senator tions, is an effective way to achieve the goal partisan environment bipartisan agreement Kirk, and we acknowledge their many con- of compelling Iran to abandon its efforts to on this bill is notable. On Iran sanctions we tributions. The bill also borrows and refines achieve a nuclear weapons capability. have always worked in a bipartisan fashion; ideas from legislation developed by Senators Sec. 103—Diplomatic Efforts to Expand Multi- I hope that will continue. Lautenberg, Gillibrand, Schumer, Kyl, Lie- lateral Sanctions Regime In coordination with allies like the Euro- berman, Brown, and others. I will now touch Urges efforts by the US to expand the UN pean Union, Japan, South Korea, Australia, on a few of the highlights of this bill and I sanctions regime to include (i) imposing ad- Canada, and others, the Administration has will insert a more comprehensive and de- ditional travel restrictions on Iranian offi- taken its own steps to increase pressure on tailed summary into the record at the end of cials responsible for human rights violations, Iran’s petrochemical industry, oil and gas in- my remarks. Our legislation will: broaden the development of Iran’s nuclear and bal- dustry, and financial sector. We acted in the the list of available sanctions, require inten- listic missile programs, and Iran’s support Senate 5 months ago on an amendment by sified targeting of Iran’s Revolutionary for terrorism; (ii) withdrawing sea- and air- Senators Menendez and Kirk to sanction the Guard Corps, require firms traded on US port landing rights for Iran Shipping Lines Central Bank of Iran and other banks that stock exchanges to disclose Iran-related ac- and Iran Air, for their role in nuclear pro- deal with Iranian banks involved in nefar- tivity to the Securities and Exchange Com- liferation and illegal arms sales; (iii) expand- ious activities. Shortly thereafter, Europe mission, sanction energy and uranium min- ing the range of sanctions to which Iran is announced it will ban oil imports from Iran, ing joint ventures with Iran, penalize US subject; (iv) expanding sanctions to limit starting in July. This will further increase parent firms for certain Iran-related activi- Iran’s petroleum development, imports of re- pressure on Iran’s economy and cut off other ties of their foreign subsidiaries, mandate fined petroleum products and reduce its rev- key sources of revenue for their nuclear pro- sanctions for those who supply Iran with enue from sale of petrochemical products, gram. Almost $60 billion in energy-related weapons and other technologies used to com- and (v) accelerating US diplomatic and eco- projects in Iran have been put on hold or dis- mit human rights abuses, including those nomic efforts to help allies reduce their de- continued. Oil shipments have sharply de- used to impose an ‘‘Electronic Curtain’’ on pendence on Iranian crude oil and other pe- clined due to sanctions. The Wall Street Iran’s citizens, and provide for other similar troleum products. Requires periodic report- Journal recently reported that Iran’s crude measures designed to increase pressure on ing to Congress. oil output has dropped to its lowest level in Iran’s government. over 20 years, due largely to the tightening All told, when enacted the bill will signifi- Sec. 104—Imposition of Sanctions with regard to squeeze of sanctions. And, in the last few cantly increase pressure on Iran’s leaders, Iran months, about half of the tankers booked and that must be our goal as we move for- Declares the sense of Congress that efforts monthly to load at the country’s largest ter- ward in this process. I hope and expect my should be made to maximize the effects of minal didn’t complete the voyages, accord- colleagues will support this bill enthusiasti- sanctions and to preserve information-shar- ing to brokers, company officials and ship- cally, and that we will be able to reconcile it ing.

VerDate Mar 15 2010 03:25 May 22, 2012 Jkt 019060 PO 00000 Frm 00024 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.045 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3319 Sec. 201—Sanctions with respect to Energy Joint rorism-related activities. The sanctions communications services providers such as Ventures with Iran apply to parents of the persons involved if SWIFT terminate services to Iranian finan- Extends ISA sanctions to persons know- they knew or should have known of the cial institutions designated for the imposi- ingly participating in petroleum resources sanctionable activity and to any of their tion of sanctions pursuant to IEEPA. Re- development joint ventures established on or subsidiaries or affiliates that knowingly par- quires the Comptroller General of the United after January 1, 2002 anywhere in the world, ticipated in the activity. Provides for Presi- States to submit a list, within 60 days of the unless such ventures are terminated within dential national security interest waiver; re- date of enactment, of entities that provide 180 days of enactment, in which Iran’s gov- quires a report to Congress regarding the use financial communications services to or fa- ernment is a substantial partner or investor, of such a waiver. cilitate access to such services for the Cen- or through which Iran could otherwise re- Sec. 212—Imposition of Sanctions on Subsidi- tral Bank of Iran or financial institutions ceive energy sector technology or know-how aries and Agents of UN-sanctioned Persons described in 104(c)(2)(E)(ii) of CISADA (i.e., institutions whose property is blocked in not previously available to its government. Amends CISADA to ensure that US finan- connection with Iran’s proliferation of WMD Sec. 202—Expands Sanctions on Providers of cial sanctions imposed on UN-designated en- or its support for terrorism). Requires re- Goods and Services to Iran’s Energy Sector tities reach those persons acting on behalf porting by the Secretary of the Treasury of, at the direction of, or owned or controlled Requires imposition of ISA sanctions on within 90 days of enactment on the efforts of by, the designated entities. Requires the persons who knowingly sell, lease, or provide SWIFT to terminate the provision of services Treasury Department to revise its regula- to Iran goods, services, technology or sup- to the Central Bank of Iran and Iranian fi- tions within 90 days of enactment to imple- port (including refinery construction or re- nancial institutions designated for sanction. ment the change. pair), or infrastructure predominantly used Authorizes the imposition of sanctions under for the transportation of refined petroleum Sec. 213—Liability of US Companies for Viola- CISADA or IEEPA with respect to a finan- products, that could directly and signifi- tions by their Foreign Subsidiaries cial communications services provider, and cantly contribute to its petroleum resources Requires the imposition of civil penalties the directors of, and shareholders with a sig- development or refining programs, in single under the International Emergency Eco- nificant interest in, a provider, that has not transactions of $1 million or more or mul- nomic Powers Act (IEEPA) of up to twice the terminated such services to the Central tiple transactions aggregating to $5 million amount of the relevant transaction on US Bank of Iran or designated Iranian financial or more in any 12-month period. Requires parent companies for the activities of their institutions. imposition of at least three ISA sanctions to foreign subsidiaries which, if undertaken by Sec. 217—GAO Reports on Iran’s Energy Sector persons who knowingly sell, lease, or provide a US person or in the United States, would Mandates regular reports from GAO on for- to Iran goods, services, technology or sup- violate US sanctions law. Subsidiaries are port for its petrochemical sector in a single eign investment in Iran’s energy sector, ex- defined as those entities in which a US per- porters of refined petroleum products to transaction of $250,000 or more, or multiple son holds more than fifty percent equity in- transactions aggregating to $1,000,000 or Iran, entities providing shipping and insur- terest or a majority of the seats on the ance services to Iran, Iranian energy joint more in any 12-month period. In so doing, board, or that a US person otherwise con- codifies the President’s decision to extend ventures worldwide, and countries where Ira- trols. Covers activities under the current US nian petroleum is produced or refined. US sanctions to Iran’s petrochemical sector, trade embargo with Iran and would apply re- Sec. 218—Expanded Reporting on Iran’s Crude adopting the standards, thresholds and pe- gardless of whether the subsidiary was estab- Oil and Refined Petroleum Products trochemicals list contained in Executive lished to circumvent US sanctions. Order 13590. Amends section 110(b) of CISADA to re- Sec. 214—Securities and Exchange Commission quire additional reporting on the volume of Sec. 203—Sanctions with respect to Uranium Disclosures on Certain Activities in Iran Joint Ventures with Iran crude oil and refined petroleum products im- Amends the Securities and Exchange Act ported to and exported from Iran, the per- Requires ISA sanctions to be imposed on of 1934 to require issuers whose stock is trad- persons who knowingly participate in joint sons selling and transporting crude oil and ed on US exchanges to disclose whether they refined petroleum products, the countries ventures with Iran’s government, Iranian or their affiliates have knowingly engaged in firms, or persons acting for or on behalf of with primary jurisdiction over those persons activities (i) in section 5 of the ISA (energy and the countries in which those products Iran’s government in the mining, production sector activity); (ii) in 104(c)(2) or (d)1 of or transportation of uranium anywhere in were refined, the sources of financing for CISADA (related to foreign financial institu- such imports and the involvement of foreign the world. Exempts such persons from sanc- tions who facilitate WMD/terrorism, money tions if they withdraw from such joint ven- persons in efforts to assist Iran in developing laundering, IRGC activity, and other viola- its oil and gas production capacity, import- tures within 6 months after the date of en- tions); (iii) in 105A(b)(2) of CISADA (related actment. ing advanced technology to upgrade existing to those who transfer weapons and other Iranian refineries, converting existing chem- Sec. 204—Expansion of Sanctions Available technologies to Iran likely to be used for ical plants to petroleum refineries and main- under the Iran Sanctions Act of 1996 human rights abuses); (iv) with persons taining, upgrading or expanding refineries or Expands the current menu of sanctions, whose property is blocked for WMD/ter- constructing new refineries. available to the President under the ISA, to rorism and; (v) persons in the government of Sec. 301—Sanctions on Iran Revolutionary authorize exclusion from the United States Iran. Provides for periodic public disclosure Guard Corps Officials, Agents, and Affili- of aliens who are corporate officers, prin- of such information, and conveyance of that ates cipals or controlling shareholders in a sanc- information by the SEC to Congress and the Requires the President to identify, and tioned firm, and permits applicable ISA President. Requires the President to initiate designate for sanctions, officials, affiliates sanctions to be applied to the CEO or other an investigation into the possible imposition and agents of the IRGC within 90 days of en- principal executive officers (or persons per- of sanctions as specified, and to make a sanc- actment, and periodically thereafter; des- forming similar functions) of a sanctioned tions determination within 6 months. ignation requires exclusion of such persons firm, which could include a freeze of their US Sec. 215—Immigration Restrictions on Senior from the United States, and imposition of assets. Iranian Officials and their Family Members sanctions (related to WMD under IEEPA, in- Sec. 205—Definitions Requires the identification of and denial of cluding freezing their assets and otherwise Defines ‘‘credible information’’ and ‘‘petro- visa requests to senior officials, including isolating them financially). Also, outlines chemical product.’’ ‘‘Credible information’’ the Supreme Leader, the President, members priorities for investigating certain foreign includes public announcements by persons of the Assembly of Experts, senior members persons and transactions in assessing con- that they are engaged in certain activities, of the Intelligence Ministry of Iran, and nections to the IRGC. Requires the President including those made in a report to stock- members of the IRGC with the rank of briga- to report on designations and waivers. holders, and may include announcements by dier general or higher that are involved in Sec. 302—Sanctions on Foreign Persons Sup- the Government of Iran, and reports from nuclear proliferation, support international porting IRGC terrorism or the commission of serious the General Accountability Office (GAO), the Subjects foreign persons to ISA sanctions human rights abuses against citizens of Iran. Energy Information Administration, the if those persons knowingly provide material Also includes their family members. Pro- Congressional Research Service, or other assistance to, or engage in any significant vides for Presidential national security in- reputable governmental organizations. De- transaction—including barter transactions— terest and UN obligations waiver; requires a fines ‘‘petrochemical product’’ consistent with officials of the IRGC, its agents or af- report to Congress regarding the use of such with Executive Order 13590. filiates. Requires imposition of similar sanc- a waiver. Sec. 211—Sanctions for Shipping WMD or Ter- tions against those persons who engage in rorism-related Materials to or from Iran Sec. 216—Sanctions with respect to the Provi- significant transactions with UN-sanctioned Requires the blocking of assets of, and im- sion of Certain Financial Communications persons, those acting for or on their behalf, poses other sanctions on, persons who know- Services to the Central Bank of Iran and or those owned or controlled by them. Pro- ingly provide ships, insurance or reinsur- Sanctioned Iranian Financial Institutions vides for additional sanctions under IEEPA ance, or other shipping services, for trans- States the sense of Congress that the as the President deems appropriate. Requires portation of goods that materially con- President should intensify current diplo- the President to report on designations and tribute to Iran’s WMD program or its ter- matic efforts to ensure that global financial waivers, as applicable.

VerDate Mar 15 2010 04:41 May 22, 2012 Jkt 019060 PO 00000 Frm 00025 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.045 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3320 CONGRESSIONAL RECORD — SENATE May 21, 2012 Sec. 303—Rule of Construction veloping counter-censorship technologies, Sec. 701—Short Title for Title VII Clarifies that section 301 and 302 sanctions expanding access to ‘‘surrogate’’ program- The ‘‘Syria Human Rights Accountability do not limit in any way the President’s au- ming including Voice of America’s Persian Act of 2012.’’ thority to designate persons for sanction News Network, and Radio FARDA inside Sec. 702—Sanctions on Those Responsible for under IEEPA. Iran, and taking other similar measures. Human Rights Abuses of Syria’s Citizens Sec. 311—Extension of US Procurement Ban to Sec. 413—Sense of Congress on Political Pris- Requires the President to identify within Foreign Persons who interact with IRGC oners 90 days, and sanction under IEEPA, officials Requires certification by prospective US Declares that the United States should ex- of the Syrian government or those acting on government contractors (for contract solici- pand efforts to identify, assist, and protect their behalf who are complicit in or respon- tations issued beginning 90 days from the prisoners of conscience in Iran and intensify sible for the commission of serious human date of enactment) that neither they nor work to abolish Iranian human rights viola- rights abuses against Syria’s citizens, re- their subsidiaries have engaged in signifi- tions. Directs the Secretary of State to pub- gardless of whether the abuses occurred in cant economic transactions with designated licly call for the release of political pris- Syria. IRGC officials, agents or affiliates. oners, as appropriate. Sec. 703—Sanctions on those Transferring to Sec. 312—Sanctions Determinations on NIOC Sec. 501—Exclusion of Certain Iranian Students Syria Technologies for Human Rights and NITC from the US Abuses Requires the Secretary of State to deny Requires the President to identify and Amends CISADA to require the Secretary visas and the Secretary of Homeland Secu- sanction persons determined to have engaged of the Treasury to determine and notify Con- rity to exclude certain Iranian university in the transfer of technologies—including gress whether the National Iranian Oil Com- students who may seek to come to the U.S. weapons, rubber bullets, tear gas and other pany and the National Iranian Tanker Com- to study to prepare for work in Iran’s energy riot control equipment, and jamming, moni- pany are agents or affiliates of the IRGC. If sector or in fields related to its nuclear pro- toring and surveillance equipment—which found to be IRGC entities, sanctions apply to gram, including nuclear sciences or nuclear the President determines are likely to be transactions or relevant financial services engineering. used by Syrian officials to commit human for the purchase of petroleum or petroleum rights abuses or restrict the free flow of in- products from the NIOC or NITC only if the Sec. 502—Technical Correction formation in Syria. Provides for exceptions President determines that there exists a suf- Reaffirms longstanding US policy allowing where a person has agreed to stop providing ficient supply of petroleum from countries the sale of certain licensed agricultural com- such technologies, and agreed not to know- other than Iran to permit purchasers to sig- modities to Iran by amending section ingly provide such technologies in the fu- nificantly reduce in volume their purchases 1245(d)2 of the National Defense Authoriza- ture. Requires the President to report on from Iran. Provides for an exception to fi- tion Act to allow for continued payments re- designations and waivers, where applicable, nancial institutions of a country that has lated to such commodities. and to update the list periodically. significantly reduced its purchases of Iranian Sec. 503 Interests in Financial Assets of Iran petroleum or petroleum products within Sec. 704—Sanctions on those Engaging in Cen- Deems blocked assets of Iran seized or fro- sorship and Repression in Syria specified periods which track those provided zen in the US, and property interests of Iran Requires the President to identify and re- for in section 1245 of the FY 2012 National in the United States, to include property port to Congress within 90 days of enactment Defense Authorization Act. held in book entry and related indirect those persons and firms found to have en- Sec. 401—Sanctions on those Transferring to forms, property held by securities clearing gaged in censorship or repression of the Iran Technologies for Human Rights Abuses agencies and other intermediaries, and in- rights of freedom of expression or assembly choate interests in funds transfers in the Imposes sanctions provided for in CISADA, of Syria’s citizens, and impose sanctions payment process through intermediary including a visa ban and property blocking/ under IEEPA on such persons. Requires peri- banks, regardless of federal or state law that asset freeze, on persons and firms which sup- odic updating of the list, and public access might otherwise apply, if that property is an ply Iran with equipment and technologies— via the websites of the Departments of State interest held for the benefit of Iran or if any including weapons, rubber bullets, tear gas and Treasury. and other riot control equipment, and jam- intermediary holds the interest for the ben- Sec. 705—Waiver ming, monitoring and surveillance equip- efit of Iran and the status of the property is ment—which the President determines are relevant to any attachment or proceedings Provides for Presidential national security likely to be used by Iranian officials to com- in aid of execution, whenever issued, on judg- interest waiver for Syria provisions; requires mit human rights abuses. Requires the Presi- ments against Iran for damages for personal a report to Congress on the reasons for the dent to maintain and update lists of such injury or death caused by torture, waiver. persons who commit human rights abuses, extrajudicial killing, aircraft sabotage, or Sec. 706—Termination submit updated lists to Congress, and make hostage taking, or material support for such Provides for termination of the Syria pro- the unclassified portion of those lists public. an act. Defines various terms used for pur- visions if the President certifies that the Requires the President to report on designa- poses of the section, including ‘‘blocked Government of Syria is democratically elect- tions and waivers, as applicable. asset,’’ ‘‘clearing corporation,’’ ‘‘financial ed and representative of the people of Syria, Sec. 402—Sanctions on those Engaging in Cen- asset,’’ ‘‘security,’’ and ‘‘securities Inter- or a legitimate transitional government of sorship and Repression in Iran mediary.’’ Syria is in place. Certification required must Sec. 504—Report on Membership of Iran in stipulate that the government of Syria has Requires imposition of sanctions as in sec- International Organizations released political prisoners, ceased the abuse tion 401 against individuals and firms found of citizens engaged in peaceful political ac- to have engaged in censorship or curtailment Requires the Secretary of State to submit tivity, ceased the practice of procuring sen- of the rights of freedom of expression or as- a report to Congress listing the international sitive technology to restrict the free expres- sembly of Iran’s citizens. organizations of which Iran is a member and detailing the amount the US contributes to sion rights of its citizens, ended support for Sec. 411—Expedited Processing of Human each such organization annually. terrorist organizations, ceased development Rights, Humanitarian, and Democracy Aid of missile programs, is not engaged in the de- Sec. 601—Technical implementation; penalties Requires the Office of Foreign Assets Con- velopment or acquisition of biological, chem- trol (OFAC) of the Treasury Department to Provides the President with the necessary ical or nuclear weapons, and agreed to allow establish a 90-day process to expedite proc- procedural tools to administer the provisions the UN and international observers to verify essing of US Iran-related humanitarian, of this new law, drawing on relevant provi- such claims. Provides for suspension of sanc- human rights and democratization aid by en- sions of IEEPA, including ensuring that the tions for 1 year if a transitional government tities receiving funds from the State Depart- Administration can require recordkeeping of is in place, to provide time to develop the ment; the Broadcasting Board of Governors; certain persons, and has subpoena and en- more detailed certification above. and other federal agencies. Requires the forcement authority for certain specified provisions of the bill. I yield the floor. State Department to conduct a foreign pol- The PRESIDING OFFICER. The Sen- icy review within 30 days of request submis- Sec. 602—Applicability to Authorized Intel- ligence Activities ator from New Jersey. sion. Provides for additional time for proc- Mr. MENENDEZ. Madam President, essing of applications involving certain spec- Provides a general exemption for author- first let me thank the majority leader ified sensitive goods and technology, and re- ized intelligence activities of the U.S. for his doggedness in making sure we quests involving novel or extraordinary cir- Sec. 603—Termination cumstances. could come to an agreement that sends Provides for termination of some provi- a clear message to Iran before the P5+1 Sec. 412—Comprehensive Strategy to Promote sions of the new law if the President certifies Internet Freedom in Iran as required in CISADA that Iran has ceased talks take place this week. His com- Requires the Administration to devise a its support for terrorism and ceased efforts mitment made the difference. comprehensive strategy and report to Con- to pursue, acquire or develop weapons of I would also like to thank the chair- gress on how best to assist Iran’s citizens in mass destruction and ballistic missiles and man of the Banking Committee, Sen- freely and safely accessing the Internet, de- ballistic missile launch technology. ator JOHNSON of South Dakota, who, in

VerDate Mar 15 2010 04:41 May 22, 2012 Jkt 019060 PO 00000 Frm 00026 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.045 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3321 an agenda that is incredibly full with America’s response to their posture We have had a lot of divisions be- all of the challenges the Banking Com- would be. This includes sanctions on tween Democrats and Republicans, but mittee is taking up, made sure the the national Iranian oil and tanker on the issue of making sure that Iran whole effort on Iran sanctions had a companies to terminate a work-around does not have a nuclear weapon, we are priority in the committee and worked to the Central Bank sanctions; sanc- united. The threat, the specter of an to get the strong, bipartisan, unani- tions on satellite companies that pro- Iranian nuclear weapon, will continue mous vote that came out of the com- vide satellite services to the Iranian to bring Democrats and Republicans mittee that gives us the foundation to regime but fail to prevent jamming by together. I hope the Iranian Govern- move forward today. So I thank both of Iran of transmissions by other users of ment recognizes that, because we are them. the same satellite service company; going to continue to tighten and tight- Today the Senate sends a clear mes- sanctions on financial messaging serv- en and tighten restrictions so that Iran sage to Iran as it prepares for the P5+1 ice companies that provide services to realizes that not just the United States talks in Baghdad, and basically that sanctioned Iranian financial institu- but just about all of the civilized world message is: provide a real and tions; imposition of liability on parent is against her gaining a nuclear weap- verifiable plan for completely disman- companies for actions of foreign sub- on. The Iranians can’t talk about why tling your nuclear weapons program or sidiaries; and sanctions on energy joint shouldn’t have it when everyone else Washington will further tighten the ventures with Iran related to the devel- does. With the kind of saber rattling economic noose. The Obama adminis- opment of petroleum resources. Those and verbiage that comes out of that re- tration is moving forward with full im- are just some. gime about what they might do to plementation of the Menendez-Kirk This is perfecting legislation to Israel or other countries, it shows they Central Bank sanctions, and the U.S. CISADA and I am so thrilled we are are not a mature enough nation to be Congress is ready with additional seeing it today. possessing this God-awful power. measures, such as sanctions on the Na- Finally, I wish to also comment on The point I wish to make here to- tional Iranian Oil Company and Ira- one particular section of the bill to en- night is this is another step forward. nian energy joint ventures that will sure there is no ambiguity about its in- We are further tightening the sanc- further isolate the regime. tent. Section 503, as revised in the tions. We will continue to tighten them I think Iran’s Supreme Leader has a managers’ amendment, preempts any so that the answer for Iran, if they per- choice: Either come to Baghdad with a conflicting Federal or State law, but sist with moving forward on producing real plan to terminate Iran’s nuclear only as they pertain to the eligibility a nuclear weapon, is economic chaos program or we will make our own plan for attachment and execution of cer- for the Iranian leadership and, unfortu- through sanctions and other necessary tain blocked assets of the state of Iran, nately, for many of the Iranian people. measures to ensure that Iran fails to identified in the section, for judgments Let Iran beware. This is just another achieve its nuclear ambitions. against Iran for the execution of ter- step. We will not stop. We are united as And lest anyone think this is nec- rorist acts, including the marine corps two parties, we are united as a Nation, essary, Madam President, as nego- barracks bombing in Lebanon in 1983, and we are united as a family of na- tiators head to Baghdad this week for which killed 241 U.S. servicemen, and tions to make sure we do everything the P5+1 talks, this bill is another tool the Khobar Towers bombing in Saudi we can to prevent Iran from becoming that will demonstrate to Iran that the Arabia in 1996 which killed 19 U.S. serv- a nuclear power. That would represent United States is not backing down and icemen. Nothing in this legislation al- a disaster to the nations of the world, that buying time and just thinking ters any other applicable law. and one we cannot tolerate. that you can go and talk without sub- As someone who authored these pro- I yield the floor. stantive, meaningful concessions here visions, I wanted to be sure that there The PRESIDING OFFICER. The Sen- is just not going to work. was understanding on the record that ator from Ohio. In case anyone has doubts as to the Iran, in addition to stopping its nu- Mr. BROWN of Ohio. Madam Presi- need for this legislation, the record is clear weapons program, which is in the dent, I wish to reiterate and underscore pretty clear. In recent weeks the Inter- national interest and security of the the words of my colleague, the senior national Atomic Energy Administra- United States, should not be able to Senator from New York, about how im- tion has been subject to Iranian delays avoid having its assets attached and portant the tightening of the Iran and deception over access to the pursued and executed upon as they sanctions are to Israel, to the United Parchin facility—a facility they claim killed Americans and having been part States of America, and to the stability has no connection to their nuclear pro- of killing Americans abroad. of the world. Allowing nuclear weapons gram but which scientists believe may With that, I yield the floor. in the hands of a country as unstable contain a blast chamber used to test The PRESIDING OFFICER. The Sen- as Iran and which is hostile to so many explosives that can trigger a nuclear ator from New York. of our values and which is hostile to blast. ORDER OF PROCEDURE most people in the world—not just the Combine that information with Mr. SCHUMER. Madam President, I United States, not just Israel, not just Iran’s continued enrichment of ura- ask unanimous consent to speak for 2 the democratic world—how problem- nium to 20 percent, development of new minutes; immediately thereafter, the atic this is for the entire world. That is enrichment facilities, conducting of Senator from Ohio, Senator BROWN, be why I am pleased with the work Chair- high explosives testing and detonator permitted to speak for 5 minutes; and man JOHNSON did, along with Ranking development to set off a nuclear then the Senator from Kansas, Senator Member SHELBY, Senator MENENDEZ, charge, computer modeling of a core of MORAN, be permitted to speak for 5 Senator GRAHAM, and others, so that a nuclear warhead, and the August 2011 minutes. this continues to send an important IAEA inspection that revealed 43.5 The PRESIDING OFFICER. Without message to Iran that we will continue pounds of a component used to arm nu- objection, it is so ordered. to increasingly tighten sanctions clear warheads was unaccounted for in Mr. SCHUMER. I will be brief. First, threatening to Iran and the stability of Iran, and that Iran is working on an in- I wish to thank our chairman, Senator its economy, and helping Iran to under- digenous design for a nuclear payload JOHNSON of South Dakota, for being so stand that this will create difficulties small enough to fit on Iran’s long- steadfast in bringing this bill to the for that regime in having any support range Shahab-3 missile, a missile capa- floor. He worked in tandem with Sen- of its people with the economic con- ble of reaching Israel, capable of reach- ator SHELBY, whom I thank as well. sequences that could happen as we ing some of our allies in Europe which Senator MENENDEZ has been a true tighten sanctions. we are committed to NATO to defend, leader on these issues and has been the As Senator MCCAIN said, we will take there is a pretty clear picture of why lead sponsor of many of the pieces of nothing off the table. We want a diplo- this is in the national interest and se- legislation to tighten the economic matic solution with these sanctions. curity of the United States and what is noose on Iran. I wish to thank my We want Iran to recognize it is in their going on in Iran. friend and colleague Senator GRAHAM interests not to have nuclear weapons. The bill is intended to give Iran a from South Carolina as well for being That is the best thing for all of us, but, pretty clear picture in return of what so instructive on this issue. again, taking nothing off the table.

VerDate Mar 15 2010 04:41 May 22, 2012 Jkt 019060 PO 00000 Frm 00027 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.046 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3322 CONGRESSIONAL RECORD — SENATE May 21, 2012 LEAD SMELTER SITES IN OHIO need to take action to clean up resid- Again, I would say there is nothing Mr. BROWN of Ohio. Madam Presi- ual contamination. political about Bob Bethell. He was re- dent, I rise to bring attention to a Last week the CDC lowered by half spected and someone everybody en- problem plaguing many aging commu- the recommended allowable limit for joyed being around, but it wasn’t be- nities in Ohio and throughout the in- lead exposure to young children, so we cause he as a politician calculated dustrial Midwest. We in this country must ramp up our efforts to address what the right answer was or how to have a rich manufacturing heritage, the problem lingering in our soil. We get along with people or one who took none richer than Ohio. We are the third need to address it now. Too many a poll to discover what the issues were leading manufacturing State in the young lives are depending on our ac- that people supported; it was just that country, trailing only in production, tions. Too many children in too many Bob Bethell, in his love of God, had a and trailing only States two and three urban school districts suffer from be- love of human beings, of citizens of times our size—Texas and California. havior problems, suffer from intel- Kansas. So we would see Bob Bethell We have built an infrastructure in this ligence problems, if you will, because with a smile on his face at every pa- country that defined the landscape of they have had far too high lead levels rade, at every community meeting. the modern world. in their blood which retard growth, re- I think sometimes in our lives, when At Ohio plants in places such as Mid- strict learning, and cause behavioral we see an elected official, we may see dletown and Youngstown, Ohioans problems. It is a serious public health someone walk across the street some- made steel beams that built America’s problem. It is the paint on the walls in times to avoid the political conversa- skyscrapers, railroads, and bridges. these old homes, and it is the lead in tion. But, again, there was nothing po- And at lead smelter sites from Cleve- the paint on the walls. It is the lead in litical about Bob; he was somebody land to Cincinnati, OH, workers proc- the soil of the homes and neighbor- who cared about people and it showed. essed metal to shore up the economic hoods and playgrounds. It does call for He enjoyed being around people; loved foundation of 20th century America. real action from State and Federal the conversation. He worked hard at But as revealed in a disturbing series of Governments and local communities. being a constituent-service-oriented recent reports in USA TODAY, former I yield the floor. member in the Kansas House of Rep- lead smelter plants have left behind a The PRESIDING OFFICER. The Sen- resentatives. It is so sad for us to lose terrible legacy: elevated lead levels in ator from Kansas. such a person. the soil and in the air and surrounding f I hope Lorene and her family and friends in Alden find comfort in the be- playgrounds and schools, especially in HONORING THE LIFE OF BOB lief that God will care for Bob Bethell poorer areas of our cities. Many of BETHELL these potentially contaminated places in the life hereafter. They believe that are in underresourced, aging areas Mr. MORAN. Madam President, I in their lives. They demonstrated that where homes are not necessarily in woke up this morning in Kansas with to the people across Kansas, and their good shape and where neighborhoods some sad news. One of our State legis- focus was a love of others. Bob is a role are plagued with many other problems lators, Bob Bethell, a 13-year member model for all of us to make certain we as well. of the Kansas House of Representa- focus on the things that matter—not Yesterday I met with Angelina and tives, died in a car wreck late last the public opinion polls and not the Ken Shefton in Cleveland at a property night. The Kansas legislature has had a calculation of how to get along with that is within breathing distance of an difficult session and finally concluded, people, but the idea that we in public old lead smelter site. What is even I believe after 100 days of the legisla- service are given an opportunity to more troubling is that they didn’t even tive session, this year’s work in To- make a great difference in the lives of know this existed. They are parents of peka, and one of our central Kansas others, and it ought to be that moti- five. One of their sons was recently di- legislators on the drive home from To- vating factor, the one that Bob Bethell agnosed with elevated blood lead lev- peka back to Alden, KS, was involved exhibited throughout his life, that we els. They fear for the other four chil- in a one-car accident, a fatality. should exemplify. dren also. Parents such as them and I rise tonight to pay respect to my So Robba and I—my wife and I—ex- thousands of Ohioans living in commu- friend and former colleague Bob tend our greatest sympathies and care nities with aging and abandoned indus- Bethell, and express my respect and and concern to the people across Kan- trial sites are worried about the health gratitude for his public service, and my sas, but especially to the family and and safety of their families. care and concern, in fact my love, for the folks who knew Bob so well in his A national newspaper report found his wife Lorene and his family and home district, the 113th House of Rep- that lead levels in soil near this smelt- friends. resentatives District in Kansas. Our er plant in Cleveland exceed 3,400 parts Bob Bethell was, I suppose you could prayers and thoughts are extended to per million. The average lead level in call him, a great politician in the sense them, and we praise God for the life U.S. soils is only 19 parts per million. that his constituents loved and ad- well lived of one of His servants, Bob As a father and grandfather, I am mired him. They respected him. They Bethell. particularly disturbed by these reports. cared about him. He could be called a I yield the floor. We know that lead is not broken down great politician because in Topeka he I suggest the absence of a quorum. when it lingers in the ground. It can was someone whose voice was listened The PRESIDING OFFICER. The enter our groundwater and children to. But nothing about Bob Bethell was clerk will call the roll. can absorb it on the baseball diamond a politician. The legislative clerk proceeded to or while making mud pies in the yard. Bob Bethell was a person who was a call the roll. For too long regulators have over- Baptist minister in his small home- Mr. BROWN of Ohio. Madam Presi- looked or neglected to fully investigate town. He loved God greatly. God was dent, I ask unanimous consent that the toxic sites in our communities. That is the focus of his life. He loved the peo- order for the quorum call be rescinded. why I am urging the Federal Govern- ple God created in his community and The PRESIDING OFFICER. Without ment to take action. I have called on across Kansas. In fact, Bob became the objection, it is so ordered. the Senate Environment and Public administrator of a nursing home be- f Works Committee to hold a hearing on cause of his care for senior citizens. It what we can do to address this issue. was that extension of his care for sen- MORNING BUSINESS We need to prioritize testing our iors that caused him to want to serve Mr. BROWN of Ohio. Madam Presi- schools and playgrounds in those in the legislature. Bob wanted to ex- dent, I ask unanimous consent that the neighborhoods close to abandoned tend that opportunity to make a dif- Senate proceed to a period of morning sites. ference in the lives of the people he business, with Senators permitted to I am asking the EPA to take imme- cared for in his profession with public speak therein for up to 10 minutes diate action to review sites that have policy decisions that were important to each. not yet been tested. But that is not them and their future and their fami- The PRESIDING OFFICER. Without enough. After the results come in, we lies in Topeka, KS. objection, it is so ordered.

VerDate Mar 15 2010 03:25 May 22, 2012 Jkt 019060 PO 00000 Frm 00028 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.047 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3323 RECOGNIZING THE LAS VEGAS Marine Division, known as the Lex- The Lexington Platoon will be honored METROPOLITAN POLICE DEPART- ington Platoon. Mr. Cecil and 69 other again Thursday at the Urban County Council MENT men from the central Kentucky area meeting. This time, Cecil, 88, will be the only formed the Platoon in 1942, 8 months platoon member present. ‘‘As best we can Mr. REID. Madam President, I rise tell, I’m the only one left,’’ he said. today to recognize the Las Vegas Met- after the Japanese bombing of Pearl Mayor Jim Gray will present a proclama- ropolitan Police Department’s His- Harbor. These young men went on to tion declaring James Cecil Day. Councilman panic American Resource Team’s fight in some of the bloodiest battles of Jay McChord will speak about how he met (H.A.R.T.) 10th Academy for their ef- the Pacific, including in Okinawa, Cecil and other World War II veterans while writing and illustrating his 2010 book, A Vet- forts to combat crimes against His- Saipan, Tinian, and Guadalcanal. The Lexington Platoon was honored eran’s Legacy: Field Kit Journal. panic-Americans, while building good on Thursday, May 17 at the Lexington ‘‘We’re losing so many of these guys every will and trust between the city’s police Urban City Council meeting, with Mr. day, it’s good any time we can honor them,’’ department and the Hispanic commu- McChord said. ‘‘We need to remind ourselves Cecil being the only member present. nity. of who they are and what they did.’’ Lexington Mayor Jim Gray proclaimed Cecil and Mitch Alcorn, his Lafayette High For more than a decade, H.A.R.T. has it James Cecil Day, and Councilman fulfilled and exceeded its mission, ‘‘to School buddy and the longtime Midway post- Jay McChord spoke about his inter- master, began tracking down their fellow build and maintain positive relation- views with Mr. Cecil while writing his Lexington Platoon members several years ships between the Hispanic community 2010 book, A Veteran’s Legacy: Field ago, searching the Internet and running ads and the police through compassion and Kit Journal. in veterans magazines. innovative thinking.’’ At its core, the James Cecil grew up on a tobacco By this time last year, the group had dwin- H.A.R.T. program trains and places tal- farm, and chose to join the Marines dled to the two of them and Elwood Watkins, who earned a Silver Star and three Purple ented officers who are fluent in English when the United States entered the and Spanish to work directly with Hearts in battle. Watkins died July 12. war rather than being drafted. He was Alcorn, who earned a Purple Heart and later Spanish-dominant community mem- promoted from private to corporal fought in the Korean and Vietnam wars as an bers. It is through language ability, after killing a Japanese officer and ob- Army officer, died February 18. cultural competence, and dedication taining his map of artillery positions, Cecil grew up on a tobacco farm off that H.A.R.T maintains public safety and received a Purple Heart for injuries Nicholasville Road. ‘‘We didn’t have any for the broader community regardless suffered during the battle of Saipan in money, but we had plenty to eat,’’ he said. of language capability or immigration June 1944. ‘‘We had milk cows, chickens and a big gar- status. den.’’ Although Mr. Cecil was recommended When the war came, he decided to join the A centerpiece of the educational for officer candidate school in August Marines rather than wait to be drafted. After services H.A.R.T. provides is the His- 1945, he never got the chance to attend, training, platoon members were scattered to panic Citizens Academy which offers an as in the weeks following, the United various units of the 2nd Marine Division, al- intensive 12-week training program in States bombed Japan, thus ending though Cecil served alongside Alcorn and a Spanish to non-English speaking com- World War II. few others from Lexington. ‘‘We were just munity members to impart knowledge After his service, Mr. Cecil moved to like a big family,’’ he said. on how to navigate through routine Ohio and became the owner of a suc- As I talked with Cecil last week, he pulled cessful trucking company. He moved out a small envelope. Inside was a portrait of law enforcement protocols, including a Japanese officer he killed, and money and knowing their legal rights and how to back to Lexington after the death of a ration card he found in the officer’s pocket. contact the police in case of an emer- his wife, Janet, in 1988. Today, Mr. That wasn’t all: The officer was carrying a gency. The Hispanic Citizens Academy Cecil is in good health and still often map of artillery positions, a find that got helps strengthen the partnership be- reflects on his wartime experiences. He Cecil promoted from private to corporal. tween the Hispanic immigrant commu- says that he feels ‘‘honored and proud Cecil earned a Purple Heart for wounds suf- nity and the Las Vegas Metropolitan that [he] served [his] country.’’ fered in the battle of Saipan on June 20, 1944. Police Department. In fact, the Na- I would like to ask at this time for He survived several Japanese suicide attacks my colleagues in the U.S. Senate to on his camps at night. tional League of Cities recognized Las ‘‘The next morning you couldn’t walk Vegas and the H.A.R.T. program as one join me in recognizing Mr. James Cecil without walking on a dead Marine or a dead of the top 17 U.S. police departments for his brave service to our Nation dur- Japanese,’’ he said. for good practices in a June 2011 report. ing World War II. There was recently At the battle of Okinawa, a Japanese sui- H.A.R.T.’s work serves as a model for an article published in the Lexington cide pilot hit the USS Hinsdale before Cecil’s other police departments across the Herald-Leader highlighting Mr. Cecil’s unit could land on the beach. Cecil spent 45 Nation to ensure public safety in immi- valorous service and his platoon’s leg- minutes in the cold water, watching for acy. I ask unanimous consent that said sharks, before a Navy destroyer rescued him. grant communities by keeping them ‘‘We had so many killed and wounded,’’ informed and engaged. article be printed in the RECORD. There being no objection, the mate- Cecil said. ‘‘Every battle, you just didn’t On May 23, 2012, H.A.R.T. will be cele- know who was going to be next.’’ brating the graduation of individuals rial was ordered to be printed in the Cecil’s only trip stateside came in August serving in the 10th Hispanic Citizens RECORD as follows: 1945, when he was recommended for officer Academy, a stage shared by more than [From the Lexington Herald-Leader, May 15, candidate school. Before he could begin, 2012] though, U.S. forces dropped atomic bombs on 500 alumni of the program. I am a SOLE SURVIVING MARINES’ LEXINGTON Japan, and World War II ended. proud supporter of the H.A.R.T. pro- PLATOON MEMBER TO BE HONORED After the war, Cecil had a successful career gram, and I applaud the leadership and (By Tom Eblen) as the owner of an Ohio-based trucking com- dedication law enforcement officers pany. He moved back to Lexington after Eight months after the Japanese bombed Janet, his wife of 52 years, died in 1998. In his have demonstrated to the growing His- Pearl Harbor, hundreds of people gathered apartment, he proudly displays photos of panic population of my home State of around the steps of the Fayette County her, their sons and their grandsons. Nevada. I ask my colleagues to please Courthouse to honor James T. Cecil and 69 Cecil’s health is good, his mind sharp. He other local boys. join me in congratulating the Las finds himself thinking a lot these days about Vegas Metropolitan Police Department The recent graduates of Henry Clay, Lafay- ette and other central Kentucky high his wartime experiences, including the occa- and its H.A.RT initiative as they cele- sional nightmare with Japanese soldiers brate the 10th Hispanic Citizens Acad- schools were forming the Lexington Platoon of the United States Marine Corps. Mayor T. ‘‘getting after me.’’ ‘‘I just felt honored and proud that I served emy. I wish H.A.R.T. continued success Ward Havely and other dignitaries spoke at my country,’’ Cecil said. ‘‘Coming off a to- in their future endeavors. the mass-induction ceremony. A young lady bacco patch and going into battle, that was sang the Marine Hymn, and women and chil- f a hell of a change. We were just a bunch of dren wept, the Lexington Herald and Leader brave boys.’’ TRIBUTE TO JAMES CECIL reported in late August 1942. Platoon members left in buses that day for f Mr. MCCONNELL. Madam President, processing in Louisville and training in San ISHRA today I wish to honor Mr. James Cecil, Diego. From there, they joined some of the who is believed to be the last living bloodiest battles of the Pacific Theater: Oki- Mr. JOHNSON of South Dakota. member of the 729th Platoon of the 2nd nawa, Saipan, Tinian and Guadalcanal. Madam President, earlier today the

VerDate Mar 15 2010 04:58 May 22, 2012 Jkt 019060 PO 00000 Frm 00029 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.020 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3324 CONGRESSIONAL RECORD — SENATE May 21, 2012 Senate passed by Unanimous Consent Misinterpretation of U.S. law by for- nity, basic democratic rights, and ac- S. 2101, the Iran Sanctions, Account- eign financial institutions should no cess to economic opportunity is more ability, and Human Rights Acts of 2012 longer deny the people of Iran the ben- perilous than ever to long-term U.S. (ISHRA). The bill significantly in- efit of OFAC-approved humanitarian national security interests. creases pressure on Iran’s leaders and I trade. It is for this reason that I make a few thank my colleagues for their support I want to close by again thanking my points about our reliable partner in the of this important measure. As we begin colleagues for their support of ISHRA. Horn of Africa, Ethiopia. Two weeks negotiations with our counterparts in I think this action sends an important ago at the World Economic Forum, the House, I want to expand on my message to the Iranians and the world Ethiopian Prime Minister Meles comments from my earlier statement. that the U.S. will continue to increase Zenawi made hopeful remarks about I do so in order to provide my col- sanctions until Iran verifiably aban- the virtues of democratic society. I leagues some clarification regarding a dons its illicit nuclear program. As we publically commit my continuing sup- few provisions in the bill. begin our work with the House, I will port for efforts to make such impor- First, section 201 of the Iran Sanc- continue to press for the strongest and tant principles a reality in Ethiopia. It tions, Accountability, and Human most effective sanctions legislation is in the U.S. interest to match Ethio- Rights Acts of 2012 will impose sanc- possible. pia’s progress in economic development tions, for the first time, against enti- I yield the floor. and poverty reduction with movement ties involved in joint ventures to de- f toward economic opportunity, social velop petroleum resources outside of justice and judicial independence. It Iran that are established on or after CUBAN INDEPENDENCE DAY has been said that basic human rights January 1, 2002. Those joint ventures Mr. NELSON of Florida. Madam and free and fair elections are nothing which qualify are joint ventures which President, today I wish to commemo- but dreams for all except for the devel- involve the Government of Iran as a rate the 110th anniversary of Cuba’s oped countries of the world. I do not substantial partner or investor, or independence. On May 20, 1902, after a believe that to be true; Ethiopia is through which Iran could receive tech- series of rebellions against foreign ready to realize that dream. To foster nological knowledge or equipment not rule, Cuba finally gained its freedom the benefits of a diverse citizenry, the previously available to it that could from the Spanish empire. I am honored many political prisoners and journal- contribute to its ability to develop do- to join with Cubans around the world ists should be released, the Charities mestic petroleum resources. Further, in commemorating this day. and Societies Act, as designed and as it even if ancillary agreements to imple- At the same time, we must remember is implemented, should be prevented ment an existing pre–2002 joint venture that the island nation still remains from strangling peaceful civil society are agreed to on or after January 1, under the tyranny of an authoritarian advocacy. 2002, sanctions are not authorized to be Beginning in 1903, President Theo- imposed against any third-party to regime. We can never forget that the Castro regime continues to jail its po- dore Roosevelt and Ethiopian Emperor that joint venture or against persons Menelik II launched a long and mutu- who provide goods, services, tech- litical opponents, and it still holds an American hostage. Once again, I rise ally beneficial history of working to- nology or information to such a joint gether on important geopolitical and venture, as a result of their participa- today to urge the Cuban regime in the strongest possible terms to imme- economic strategic partnerships that tion in or dealings with such venture, last to this day. Our friend and partner, by virtue of such ancillary agreements. diately and unconditionally release Mr. Alan Gross. Ethiopia, has been a champion with the In addition, this legislation seeks to United States during many critical continue the long-standing tradition of Today, we reaffirm our solidarity with the people of Cuba. Now more times for almost 110 years. When Italy ensuring that humanitarian trade, in- invaded Ethiopia, we refused to recog- cluding agricultural commodities, than ever, the United States must con- tinue policies that promote respect for nize the conquest. When the United food, medicine and medical products is States asked for help during the Cold specifically exempted by Congress from the fundamental principles of political freedom, democracy, and human rights, War, Haile Selassie was ready to help. sanctions, on the condition that such When the regime of Mengistu Haile- trade be licensed by the Department of in a manner consistent with the aspira- tions of the people of Cuba. Mariam failed, the United States came the Treasury’s Office of Foreign Assets to Ethiopia’s side with help to prevent Control, or OFAC. It is becoming more f violence in Addis Ababa, by facili- apparent that U.S. financial sanctions CITIZEN ENGAGEMENT BUILDING tating Mengistu’s departure. We gave targeting Iran’s banking sector are IN ETHIOPIA this support for the mutual benefit and causing increased concern among busi- promise of democratization in Ethi- nesses and banks of our allies. The fear Mr. BEGICH. Madam President, to opia. is that engaging in humanitarian trade mark the occasion of President Obama’s Camp David G8 Summit focus- Ethiopia’s macroeconomic successes in the current sanctions environment of rapid growth rates and better than might lead to sanctions for legiti- ing, in part, on the problem of food se- curity in Africa, I want to take this op- average performance in poverty reduc- mately licensed humanitarian trade. tion have been celebrated at this past However, it is not and has not been portunity to address the necessity for week’s G8 Summit, and at the recent the intent of U.S. policy to harm the the United States to help foster stable World Economic Forum. There Prime Iranian people by prohibiting humani- and democratic nations as partners as Minister Meles pondered aloud: tarian trade that is licensed by the we build multilateral coalitions to U.S. Treasury Department. OFAC con- tackle global issues like hunger and What is the substantive political thing poverty. that creates such an environment [of fair sistently issues many licenses, both economic opportunity for all citizens]? The general and specific, for this type of Alaska is a long way from Africa, but one [thing] that creates such an environment trade. The practical financing difficul- the citizens of my State are committed is an engaged citizenry that is able to create ties arising today between banks and to a stable and prosperous Africa. an environment where corruption and loot those engaging in licensed humani- Many Alaskans contribute their time cannot happen at the lower level, at the mid- tarian trade can be best addressed by and resources toward this goal. level, at the higher level, and that goes be- U.S. Government officials, who should A year ago in Deauville, France, yond elections every four and five years. do more to make it clear that no U.S. President Obama joined other leaders On the microeconomic level, aside sanctions will be imposed against of the G8 in reaffirming that ‘‘democ- from the lack of progress on land re- third-country banks that facilitate racy lays the best path to peace, sta- form, this is good news indeed, given OFAC-licensed or exempted humani- bility, prosperity, shared growth and recent complaints about poor state of tarian trade. The Administration must development.’’ As the events in North economic opportunity for all of Ethio- make that clear in public statements, Africa and the Middle East have shown, pia’s citizens. We are hopeful this is a in private meetings with foreign finan- supporting reliable autocrats who are sign that Ethiopia’s federal ministries cial institutions, and elsewhere as ap- helpful on matters of security and eco- are ready to engage and assist the local propriate. nomics at the expense of human dig- citizenry in issues that relate to their

VerDate Mar 15 2010 04:58 May 22, 2012 Jkt 019060 PO 00000 Frm 00030 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.017 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3325 economic interests. Many observers are ganization’s Division III National dent of the Building and Construction pessimistic, but I prefer to think of the Championship on April 29, 2012, in Trades Council of greater New York glass as half full, and ready to be filled Glendale, CO. from 1992 to 2008 and as president of the to the brim. The Salve Regina Seahawks, ranked New York State Building and Con- The Prime Minister’s sentiments number one by the National Small Col- struction Trades Council from 1992 raise many issues, including: the na- lege Rugby Organization, were unde- until his retirement earlier this year. tion’s commitment to an environment feated this season with a record of 11– Prior to his service in these capacities, conducive to free speech and citizen 0. The team earned a spot in the na- Mr. Malloy served as president of the participation; a commitment to build- tional semifinals when it defeated Enterprise Association of Steamfitters ing an informed and engaged citizenry Tufts University on November 13, 2011, Local Union 638, where he began as an as a key to inclusive, long term eco- in the New England Championship and apprentice, rose to journeyman and nomic development; a call for the then went on to defeat Molloy College was a longtime member. He was also a quick and unconditional release of on November 19, 2011, in the Northeast veteran of the U.S. Army. journalists and political prisoners as a Region Championship. Mr. Malloy was a driving force for measure of good faith; and commit- Reestablished in 2007, the Salve Re- private economic development and ment to a diverse and multi-party elec- gina Seahawks men’s rugby team has public infrastructure improvements tion in 2015, free from federal govern- appeared in the final four of the Na- throughout New York State. He was in- ment interference. tional Small College Rugby Organiza- strumental in promoting measures to Hopeful as I am, I urge my Senate tion’s Division III national tournament contain construction costs and maxi- and House colleagues to re-commit to three times in the past five years. The mize employment opportunities for assistance we have offered the people Seahawks’ 21–15 victory over the Cali- workers. His signature achievement in of Ethiopia and their government in fornia Maritime Academy Keelhaulers this regard was the advancement of the past. in the championship match was the project labor agreements for major Let us help build a national con- first national championship victory for public works projects, which are now sensus on the value of the following Salve Regina University in any sport. widely used to deliver construction in a I am especially pleased and proud to goals in Ethiopia: robust public insti- cost-efficient and timely manner. tutions that represent the diversity of share that the members of the Salve Mr. Malloy was also a strong sup- perspectives in Ethiopia; free and fair Regina Seahawks men’s rugby team porter of promoting opportunity and political processes drawing legitimacy demonstrated great sportsmanship and diversity in the construction industry’s from broad citizen participation; an represented both their school and the workforce, helping launch programs to independent judicial system as out- State of Rhode Island with distinction. provide access to careers in the build- I would like to recognize the lined in Ethiopia’s constitution; a press ing and construction trades for youth, Seahawks head coach Michael Martin with institutional independence and veterans of the U.S. Armed Services, and his assistant U.S. Air Force Colo- legal protection to enable it to accom- nel Dan Lockert; team president Rich- minorities and women. In particular, modate and a broad range of perspec- ard Casey; captains Paul Schacter and an organization that Mr. Malloy helped tives and ensure the free flow of infor- Jesse DiTullio; and members Andrew found has to date placed more than mation, ideas and opinions that are Baik, Jeffrey Bouley, Patrick Brown, 1,300 youth, public housing residents necessary in a democratic society, as Chris Buckman, Michael Burlingame, and other city residents into unionized outlined in Ethiopia’s constitution; an Brian Cronin, Christopher Dieselman, apprenticeships, 89 percent of whom environment where each citizen can Matt Dougenik, Zachary Faiella, Brian are African American, Hispanic, Asian take advantage of Ethiopia’s economic Goodridge, James Horn, Martin and other minorities. The results of success; and the security that comes Kelliher, Alfred Knapp, John Kuchac, these efforts are evident today, with with the assurance that universal Shane Lange, Robert LaRiviere- the majority of union apprentices and rights are respected and protected. Tougas, Stephen McEnery, Glen Miles, workers in New York City’s construc- Our international partnerships are Zackary Moreau, Daniel Murphy, Troy tion industry being African American, stronger and more enduring when we Ochoa, Joshua Patterson, Nicholas Hispanic, Asian and other minorities. share values of opportunity and free- Edward J. Malloy was respected by Patti, Nicholas Pesce, Anthony Pesce, dom with our partners. A more demo- all who knew him as not only a tireless Russell Petrucci, Jacob Piazza, Nich- cratic Ethiopia would represent a more advocate for working men and women, olas Pinto, Evan Raiff, Rylan Richard, stable and reliable partner for the but an advocate for our great city and Nathan Rose, Kyle Russell, Justin United States and serve the long-term State. His hard work and wit allowed Ryel, Carlos Santos, David Seguin, interests of peace and security in the him to pass easily from union halls to Colby Sherman, Ryan Shilalis, Connor Horn of Africa. A more democratic business board rooms and the chambers Taub, Grant Thiem, Quinn Turner, Pat- Ethiopia would ease the free flow of in- of government. rick Wendt, and Joseph Zoeller. This dedication and personality formation, which would ease trade and I would also like to acknowledge the served members of organized labor well ensure more informed investments. A contributions of Salve Regina’s presi- for decades as he worked to promote more democratic Ethiopia would en- dent Sister Jane Gerety, RSM, chan- job creation, economic development sure that government policies are the cellor Sister M. Therese Antone, RSM, and fairness. His contributions are im- result of broad national consultation and athletic director Colin Sullivan. measurable and we owe him an enor- with all segments of society. Once again, congratulations to the Such are hallmarks of inclusive and mous debt of gratitude for them. We members of the Salve Regina Sea- sustainable economic growth, and they extend our heartfelt condolences to his hawks men’s rugby team on this out- provide a return of accountability and family on behalf of an entire industry. standing achievement and well-de- transparency to both American tax- Mr. President, today, I ask all mem- served championship. payers and Ethiopian citizens. Let’s do bers of this esteemed body to join me what we can to help our fast and true f in honoring Edward J. Malloy’s life- friend, Ethiopia, extend opportunity ADDITIONAL STATEMENTS time of commitment to improving the and freedom to the majority of its citi- lives of working men and women from zenry. around the country.∑ REMEMBERING EDWARD MALLOY f f ∑ Mrs. GILLIBRAND. Madam Presi- CONGRATULATING THE SALVE RE- dent, today I wish to mourn the pass- CONGRATULATING THE GINA UNIVERSITY MEN’S RUGBY ing of Edward J. Malloy, who dedicated UNIVERSITY OF TEXAS AT AUSTIN TEAM his life as a champion for hard working ∑ Mrs. HUTCHISON. Madam President, Mr. REED. Madam President, today I men and women in New York State and today, I want to congratulate and ac- congratulate the Salve Regina Univer- throughout the country. knowledge the University of Texas at sity men’s rugby team for winning the Mr. Malloy was a tireless advocate Austin’s Department of History for cre- 2012 National Small College Rugby Or- for workers’ rights, serving as presi- ating an interactive website that offers

VerDate Mar 15 2010 04:58 May 22, 2012 Jkt 019060 PO 00000 Frm 00031 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.021 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3326 CONGRESSIONAL RECORD — SENATE May 21, 2012 a unique outlet for promoting informa- driving force behind Lawrence Techno- MESSAGES FROM THE PRESIDENT tion and enhancing understanding logical University’s growth and contin- Messages from the President of the about U.S. and world history. This new ued success. Dr. Walker retires in June United States were communicated to site puts the expertise of the Univer- after 18 years at Lawrence Tech, the the Senate by Mr. Pate, one of his sec- sity of Texas world-renowned faculty last 6 as President and CEO. retaries. at the service of the general citizenry, Ensuring students acquire the skills and provides a public forum for the dis- necessary to meet the challenges of an f cussion of historical and contemporary ever-changing, global workplace has EXECUTIVE MESSAGES REFERRED events. been a central tenet of Dr. Walker’s As in executive session the Presiding The title of the website, work at Lawrence Tech. Since joining Officer laid before the Senate messages www.notevenpast.org, ‘‘Not Even Lawrence Tech in 1994, Dr. Walker has from the President of the United Past,’’ (NEP) derives its name from sought innovative ways to expand the States submitting sundry nominations William Faulkner’s famous line that, university’s academic footprint. A hall- which were referred to the appropriate ‘‘The past is never dead. It’s not even mark of his tenure has been his com- committees. past.’’ It acknowledges the professional mitment to broadening academic op- (The nominations received today are and ethical commitment to under- portunities for students, pursuing printed at the end of the Senate pro- standing history as a public conversa- international partnerships, and ex- ceedings.) tion about the importance of the past panding the university’s technological f for our actions, values, and beliefs in infrastructure. the present, and for the decisions we This work led to the creation of a REPORT ON THE CONTINUATION make today that will affect our lives number of certificate and degree pro- OF THE NATIONAL EMERGENCY tomorrow. grams at Lawrence Tech, from the as- THAT WAS ORIGINALLY DE- I would like to congratulate particu- sociate to the doctoral level, and nota- CLARED IN EXECUTIVE ORDER larly the efforts of Professor Joan bly includes programs in robotics, de- 13303 OF MAY 22, 2003, RECEIVED Neuberger, Chairman Alan Tully, the fense and sustainability. Impressively, DURING ADJOURNMENT OF THE department’s 60-person faculty, and the during his tenure, the number of aca- SENATE ON MAY 18, 2012—PM 50 input of graduate students for estab- demic programs the university offers The PRESIDING OFFICER laid be- lishing this project in 2010. has expanded from 60 to more than 100 fore the Senate the following message NEP brings together a diverse group and more than 40 ‘‘fast track’’ certifi- from the President of the United of historians in every major historical cate programs have been created to States, together with an accompanying field by using modern technology as a help dislocated workers transition to report; which was referred to the Com- vehicle to share their perspectives on new career paths. mittee on Banking, Housing, and topics related to Texas, the United Dr. Walker also emphasized leader- Urban Affairs: States, and world history. The website ship, believing that ‘‘Our aim has been allows people from around the world to imbue in our graduates the ability To the Congress of the United States: with an interest in history and histor- to have confidence in themselves.’’ Section 202(d) of the National Emer- ical events to take advantage of the This focus is truly perceptive. Seeking gencies Act (50 U.S.C. 1622(d)) provides University of Texas’ new resource. This to integrate leadership throughout the for the automatic termination of a na- unique and innovative website offers University experience, Lawrence Tech tional emergency unless, within 90 book and film recommendations, movie now includes leadership training as days prior to the anniversary date of clips, podcasts, links to historical doc- part of its undergraduate experience. its declaration, the President publishes uments and artifacts, as well as a fact- Under Dr. Walker’s leadership Law- in the Federal Register and transmits to checker series and free virtual courses. rence Tech also forged a partnership the Congress a notice stating that the The development of NEP reinforces with the Ferndale Public Schools to es- emergency is to continue in effect be- the reputation of the University of tablish the University High School, a yond the anniversary date. In accord- Texas Department of History. I believe high school designed to challenge its ance with this provision, I have sent this website is an invaluable resource students academically and expose them the enclosed notice to the Federal Reg- of remarkable range and interest, and to the university experience. Its core ister for publication continuing the na- will advance the university’s goal of focus is to prepare public high school tional emergency with respect to the undertaking programs of civil, edu- students for success in college and be- stabilization of Iraq. This notice states cational and social services. yond. that the national emergency with re- Since NEP was launched in January Dr. Walker has a distinguished aca- spect to the stabilization of Iraq de- 2011, the website has enabled hosting demic background. He holds 3 degrees, clared in Executive Order 13303 of May and sponsoring events devoted to the including a Ph.D. in electrical engi- 22, 2003, as modified in scope and relied history curriculum, organization of a neering and has published more than 50 upon for additional steps taken in Ex- book club with award-winning profes- technical papers. Before joining Law- ecutive Order 13315 of August 28, 2003, sors and students of history, accumula- rence Tech, he served at the University Executive Order 13350 of July 29, 2004, tion of an extensive library of podcasts, of Hartford in various capacities, in- Executive Order 13364 of November 29, short articles and recommended mov- cluding dean of engineering and special 2004, and Executive Order 13438 of July ies related to all aspects of history, and assistant to the president. Earlier this 17, 2007, is to continue in effect beyond even virtual history courses that are year, he was awarded the 2012 Gold May 22, 2012. offered through the University of Award from the Affiliate Council of Obstacles to the orderly reconstruc- Texas. In June 2012, NEP will also Engineering Society of Detroit for his tion of Iraq, the restoration and main- begin posting university, high school, outstanding work in science and engi- tenance of peace and security in the and middle school students’ history neering. country, and the development of polit- projects. Throughout his professional career, ical, administrative, and economic in- Congratulations to the University of Dr. Walker has worked tirelessly to stitutions in Iraq continue to pose an Texas Department of History for cre- find solutions to pressing concerns and unusual and extraordinary threat to ating this interactive website.∑ to position Lawrence Tech to meet the the national security and foreign pol- f challenges of tomorrow. The Lawrence icy of the United States. Accordingly, I Tech community is a better place as a have determined that it is necessary to TRIBUTE TO DR. LEWIS N. result of his efforts, and we know his continue the national emergency with WALKER wife, Nancy and their children and respect to this threat and maintain in ∑ Mr. LEVIN. Madam President, today grandchildren are proud of his many force the measures taken to deal with I, along with my Senate colleague from accomplishments over his long and il- that national emergency. Michigan, Senator STABENOW, recog- lustrious career. We wish Dr. Walker Recognizing positive developments in nize Dr. Lewis Walker, a dynamic and and his family the best as he embarks Iraq, my Administration will continue forward thinking leader who has been a on the next chapter of his life.∑ to evaluate Iraq’s progress in resolving

VerDate Mar 15 2010 03:25 May 22, 2012 Jkt 019060 PO 00000 Frm 00032 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.017 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3327 outstanding debts and claims arising Wisconsin, Mr. CRENSHAW of Florida, attle, WA’’ ((RIN1625–AA11) (Docket No. from actions of the previous regime, so Mr. LATTA of Ohio, and Mr. ADERHOLT USCG–2010–1145)) received in the Office of the that I may determine whether to fur- of Alabama. President of the Senate on May 9, 2012; to the ther continue the prohibitions con- The message further announced that Committee on Commerce, Science, and Transportation. tained in Executive Order 13303 of May pursuant to section 703(c) of the Public EC–6166. A communication from the Attor- 22, 2003, as amended by Executive Order Interest Declassification Act of 2000 (50 ney-Advisor, U.S. Coast Guard, Department 13364 of November 29, 2004, on any at- U.S.C. 435 note), and the order of the of Homeland Security, transmitting, pursu- tachment, judgment, decree, lien, exe- House of January 5, 2011, the Speaker ant to law, the report of a rule entitled ‘‘An- cution, garnishment, or other judicial reappoints the following member on chorage Regulations; Wells, ME’’ ((RIN1625– process with respect to the Develop- the part of the House of Representa- AA01) (Docket No. USCG–2011–0231)) received ment Fund for Iraq, the accounts, as- tives to the Public Interest Declas- in the Office of the President of the Senate sets, and property held by the Central sification Board for a term of 3 years: on May 9, 2012; to the Committee on Com- Bank of Iraq, and Iraqi petroleum-re- Admiral William O. Studeman of Great merce, Science, and Transportation. lated products, which are in addition to Falls, VA. EC–6167. A communication from the Attor- ney-Advisor, U.S. Coast Guard, Department the sovereign immunity accorded Iraq f of Homeland Security, transmitting, pursu- under otherwise applicable law. MEASURES PLACED ON THE ant to law, the report of a rule entitled ‘‘An- BARACK OBAMA. chorage Regulations: Subpart A—Special An- THE WHITE HOUSE, May 18, 2012. CALENDAR chorage Regulations, Newport Bay Harbor, f The following bills were read the first CA’’ ((RIN1625–AA01) (Docket No. USCG– 2010–0929)) received in the Office of the Presi- MESSAGE FROM THE HOUSE and second times by unanimous con- sent, and placed on the calendar: dent of the Senate on May 9, 2012; to the RECEIVED DURING ADJOURNMENT Committee on Commerce, Science, and H.R. 4970. An act to reauthorize the Vio- Transportation. Under the authority of the order of lence Against Women Act of 1994. the Senate of January 5, 2011, the Sec- H.R. 5740. An act to extend the National EC–6168. A communication from the Chief retary of the Senate, on May 18, 2012, Flood Insurance Program, and for other pur- of Staff, Media Bureau, Federal Communica- during the adjournment of the Senate, poses. tions Commission, transmitting, pursuant to law, the report of a rule entitled ‘‘Innovation received a message from the House of f in the Broadcast Television Bands: Alloca- Representatives announcing that the EXECUTIVE AND OTHER tions, Channel Sharing and Improvements to Speaker has signed the following en- VHF’’ (ET Docket No. 10–235; FCC 12–45) re- rolled bills: COMMUNICATIONS ceived in the Office of the President of the H.R. 2072. An act to reauthorize the Ex- The following communications were Senate on May 9, 2012; to the Committee on port-Import Bank of the United States, and laid before the Senate, together with Commerce, Science, and Transportation. for other purposes. accompanying papers, reports, and doc- EC–6169. A communication from the Chief H.R. 4045. An act to modify the Depart- uments, and were referred as indicated: of Staff, Media Bureau, Federal Communica- ment of Defense Program Guidance relating tions Commission, transmitting, pursuant to EC–6161. A communication from the Attor- to the award of Post-Deployment/Mobiliza- law, the report of a rule entitled ‘‘Standard- ney-Advisor, U.S. Coast Guard, Department tion Respite Absence administrative absence ized and Enhanced Disclosure Requirements of Homeland Security, transmitting, pursu- days to members of the reserve components for Television Broadcast Licensee Public In- ant to law, the report of a rule entitled to exempt any member whose qualified mo- terest Obligations; Extension of the Filing ‘‘MARPOL Annex V Special Areas: Wider bilization commenced before October 1, 2011, Requirement For Children’s Television Pro- Caribbean Region’’ ((RIN1625–AB76) (Docket and continued on or after that date, from the gramming Report’’ (MB Docket Nos. 00–168 No. USCG–2012–0187)) received in the Office of changes to the program guidance that took and 00–44; FCC 12–44) received in the Office of the President of the Senate on May 9, 2012; to effect on that date. the President of the Senate on May 9, 2012; to the Committee on Commerce, Science, and Under the authority of the order of the Committee on Commerce, Science, and Transportation. Transportation. the Senate of January 5, 2011, the en- EC–6162. A communication from the Attor- EC–6170. A communication from the Senior ney-Advisor, U.S. Coast Guard, Department rolled bills were signed on May 18, 2012, Program Analyst, Federal Aviation Adminis- of Homeland Security, transmitting, pursu- during the adjournment of the Senate, tration, Department of Transportation, ant to law, the report of a rule entitled by the President pro tempore (Mr. transmitting, pursuant to law, the report of ‘‘Changes to Standard Numbering System, INOUYE). a rule entitled ‘‘Airworthiness Directives; Vessel Identification System, and Boating Rolls-Royce plc Turbofan Engines’’ f Accident Report Database’’ ((RIN1625–AB45) ((RIN2120–AA64) (Docket No. FAA–2010–0959)) (Docket No. USCG–2003–14963)) received in MESSAGE FROM THE HOUSE received in the Office of the President of the the Office of the President of the Senate on Senate on May 8, 2012; to the Committee on At 2:04 p.m., a message from the May 9, 2012; to the Committee on Commerce, Commerce, Science, and Transportation. House of Representatives, delivered by Science, and Transportation. Mrs. Cole, one of its reading clerks, an- EC–6163. A communication from the Attor- EC–6171. A communication from the Acting Director, Office of Sustainable Fisheries, De- nounced that the House has passed the ney-Advisor, U.S. Coast Guard, Department of Homeland Security, transmitting, pursu- partment of Commerce, transmitting, pursu- following bills, in which it requests the ant to law, the report of a rule entitled concurrence of the Senate: ant to law, the report of a rule entitled ‘‘Sea- going Barges—Correcting Amendment’’ ‘‘Fisheries of the Northeastern United H.R. 4970. An act to reauthorize the Vio- ((RIN1625–AB71) (Docket No. USCG–2011– States; Atlantic Mackerel, Squid, and lence Against Women Act of 1994. 0363)) received in the Office of the President Butterfish Fisheries; Closure of the Tri- H.R. 5740. An act to extend the National of the Senate on May 9, 2012; to the Com- mester 1 Longfin Squid Fishery’’ (RIN0648– Flood Insurance Program, and for other Pur- mittee on Commerce, Science, and Transpor- XB145) received in the Office of the President poses. tation. of the Senate on May 9, 2012; to the Com- The message further announced that EC–6164. A communication from the Attor- mittee on Commerce, Science, and Transpor- tation. the House agree to the amendment of ney-Advisor, U.S. Coast Guard, Department the Senate to the bill (H.R. 4849) to di- of Homeland Security, transmitting, pursu- EC–6172. A communication from the Acting Director, Office of Sustainable Fisheries, De- rect the Secretary of the Interior to ant to law, the report of a rule entitled ‘‘Regulated Navigation Area; Zidell Water- partment of Commerce, transmitting, pursu- issue commercial use authorizations to front Property, Willamette River, OR’’ ant to law, the report of a rule entitled commercial stock operators for oper- ((RIN1625–AA11) (Docket No. USCG–2011– ‘‘Fisheries of the Exclusive Economic Zone ations in designated wilderness within 0254)) received in the Office of the President Off Alaska; Pacific Cod by Catcher/proc- the Sequoia and Kings Canyon Na- of the Senate on May 9, 2012; to the Com- essors Using Trawl Gear in the Central Regu- tional Parks, and for other purposes. mittee on Commerce, Science, and Transpor- latory Area of the Gulf of Alaska’’ (RIN0648– The message also announced that tation. XB174) received in the Office of the President pursuant to 22 U.S.C. 276I, and the EC–6165. A communication from the Attor- of the Senate on May 9, 2012; to the Com- mittee on Commerce, Science, and Transpor- order of the House of January 5, 2011, ney-Advisor, U.S. Coast Guard, Department of Homeland Security, transmitting, pursu- tation. the Speaker appoints the following ant to law, the report of a rule entitled EC–6173. A communication from the Acting Members of the House of Representa- ‘‘Regulated Navigation Area; Pacific Sound Director, Office of Sustainable Fisheries, De- tives to the British-American Inter- Resources and Lockheed Shipyard EPA partment of Commerce, transmitting, pursu- parliamentary Group: Mr. PETRI of Superfund Cleanup Sites, Elliott Bay, Se- ant to law, the report of a rule entitled

VerDate Mar 15 2010 04:58 May 22, 2012 Jkt 019060 PO 00000 Frm 00033 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.027 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3328 CONGRESSIONAL RECORD — SENATE May 21, 2012 ‘‘Fisheries Off West Coast States; Modifica- EC–6181. A communication from the Acting EC–6190. A communication from the Direc- tions of the West Coast Commercial and Rec- Deputy Assistant Administrator for Regu- tor of Congressional Affairs, Nuclear Reactor reational Salmon Fisheries; Inseason Ac- latory Programs, National Marine Fisheries Regulation, Nuclear Regulatory Commis- tions Nos. 1, 2, and 3’’ (RIN0648–XB120) re- Service, Department of Commerce, transmit- sion, transmitting, pursuant to law, the re- ceived in the Office of the President of the ting, pursuant to law, the report of a rule en- port of a rule entitled ‘‘Filing a Renewed Li- Senate on May 9, 2012; to the Committee on titled ‘‘Fisheries of the Northeastern United cense Application’’ (Docket No. PRM–54–6; Commerce, Science, and Transportation. States; 2012–2013 Northeast Skate Complex NRC–2010–0291) received in the Office of the EC–6174. A communication from the Acting Fishery Specifications’’ (RIN0648–BB83) re- President of the Senate on May 16, 2012; to Director, Office of Sustainable Fisheries, De- ceived in the Office of the President of the the Committee on Environment and Public partment of Commerce, transmitting, pursu- Senate on May 9, 2012; to the Committee on Works. ant to law, the report of a rule entitled Commerce, Science, and Transportation. EC–6191. A communication from the Direc- ‘‘Magnuson-Stevens Act Provisions; Fish- EC–6182. A communication from the Under tor of the Regulatory Management Division, eries Off West Coast States; Biennial Speci- Secretary of Defense (Comptroller), trans- Environmental Protection Agency, transmit- fications and Management Measures; mitting, pursuant to law, a report relative to ting, the Uniform Resource Locator (URL) Inseason Adjustments’’ (RIN0648–BC02) re- a violation of the Antideficiency Act that oc- for a report entitled ‘‘OSRE–RCRA 9003(h) ceived in the Office of the President of the curred within the Procurement, Defense- Corrective Action Model Unilateral Order for Senate on May 9, 2012; to the Committee on Wide, account 97*0300 during fiscal years 2004 LUST Enforcement’’; to the Committee on Commerce, Science, and Transportation. through 2010 and was assigned United States Environment and Public Works. EC–6192. A communication from the Acting EC–6175. A communication from the Acting Special Operations Command case number Fiscal Assistant Secretary, Department of Director, Office of Sustainable Fisheries, De- 09–02; to the Committee on Appropriations. the Treasury, transmitting, pursuant to law, partment of Commerce, transmitting, pursu- EC–6183. A communication from the Assist- the annual reports that appeared in the ant to law, the report of a rule entitled ant Director, Executive and Political Per- March 2012 Treasury Bulletin; to the Com- ‘‘Fisheries of the Northeastern United sonnel, Department of Defense, transmit- States; Summer Flounder Fishery; Quota mittee on Finance. ting, (62) reports relative to vacancies in the EC–6193. A communication from the Direc- Transfer’’ (RIN0648–XC002) received in the Department of Defense, received in the Of- Office of the President of the Senate on May tor of Regulations and Policy Management fice of the President of the Senate on May 16, Staff, Food and Drug Administration, De- 9, 2012; to the Committee on Commerce, 2012; to the Committee on Armed Services. Science, and Transportation. partment of Health and Human Services, EC–6184. A communication from the Assist- transmitting, pursuant to law, the report of EC–6176. A communication from the Acting ant Secretary of Defense (Global Strategic Director, Office of Sustainable Fisheries, De- a rule entitled ‘‘Irradiation in the Produc- Affairs), transmitting, pursuant to law, a re- tion, Processing and Handling of Food’’ partment of Commerce, transmitting, pursu- port entitled ‘‘Cooperative Biological En- ant to law, the report of a rule entitled (Docket No. FDA–1999–F–0021) received in the gagement Program (CBEP) Report to Con- Office of the President of the Senate on May ‘‘Fisheries of the Exclusive Economic Zone gress Pursuant to Section 1303(a) (1) and (2) Off Alaska; Pacific Cod by Catcher Vessels 17, 2012; to the Committee on Health, Edu- of the NDAA for FY 2012’’; to the Committee cation, Labor, and Pensions. Using Trawl Gear in the Bering Sea and on Armed Services. Aleutian Islands Management Area’’ EC–6194. A communication from the Direc- EC–6185. A communication from the Chief tor of Regulations and Policy Management (RIN0648–XB176) received in the Office of the Counsel, Federal Emergency Management Staff, Food and Drug Administration, De- President of the Senate on May 9, 2012; to the Agency, Department of Homeland Security, partment of Health and Human Services, Committee on Commerce, Science, and transmitting, pursuant to law, the report of transmitting, pursuant to law, the report of Transportation. a rule entitled ‘‘Suspension of Community EC–6177. A communication from the Acting a rule entitled ‘‘Labeling and Effectiveness Eligibility’’ ((44 CFR Part 64) (Docket No. Director, Office of Sustainable Fisheries, De- Testing; Sunscreen Drug Products for Over- FEMA–2012–0003)) received in the Office of partment of Commerce, transmitting, pursu- the-Counter Human Use; Delay of Compli- the President of the Senate on May 16, 2012; ance Dates’’ (Docket No. FDA–1978–N–0018) ant to law, the report of a rule entitled to the Committee on Banking, Housing, and received in the Office of the President of the ‘‘Fisheries of the Exclusive Economic Zone Urban Affairs. Senate on May 17, 2012; to the Committee on Off Alaska; Pacific Cod by Catcher Vessels EC–6186. A communication from the Assist- Health, Education, Labor, and Pensions. Using Hook-and-Line Gear in the Western ant General Counsel for Legislation, Regula- EC–6195. A communication from the Sec- Regulatory Area of the Gulf of Alaska’’ tion and Energy Efficiency, Department of retary of Health and Human Services, trans- (RIN0648–XB119) received in the Office of the Energy, transmitting, pursuant to law, the mitting, pursuant to law, the report of a pe- President of the Senate on May 9, 2012; to the report of a rule entitled ‘‘Energy Conserva- tition to add workers from at the Clinton Committee on Commerce, Science, and tion Program for Certain Industrial Equip- Engineer Works in Oakridge, Tennessee, to Transportation. ment: Energy Conservation Standards and the Special Exposure Cohort; to the Com- EC–6178. A communication from the Acting mittee on Health, Education, Labor, and Deputy Assistant Administrator for Regu- Test Procedures for Commercial Heating, Air-Conditioning, and Water-Heating Equip- Pensions. latory Programs, National Marine Fisheries EC–6196. A communication from the Sec- Service, Department of Commerce, transmit- ment’’ (RIN1904–AC47) received in the Office of the President of the Senate on May 17, retary of Health and Human Services, trans- ting, pursuant to law, the report of a rule en- mitting, pursuant to law, the report of a pe- titled ‘‘Fisheries of the Northeastern United 2012; to the Committee on Energy and Nat- ural Resources. tition to add workers from the Electro Met- States; Atlantic Bluefish Fishery; 2012 At- allurgical site in Niagara Falls, New York, lantic Bluefish Specifications’’ (RIN0648– EC–6187. A communication from the Gen- eral Counsel, Federal Energy Regulatory to the Special Exposure Cohort; to the Com- XA904) received in the Office of the President mittee on Health, Education, Labor, and of the Senate on May 9, 2012; to the Com- Commission, transmitting, pursuant to law, the report of a rule entitled ‘‘Transmission Pensions. mittee on Commerce, Science, and Transpor- EC–6197. A communication from the Sec- Planning Reliability Standards’’ (Docket No. tation. retary of Health and Human Services, trans- EC–6179. A communication from the Acting RM11–18–000) received in the Office of the mitting, pursuant to law, the report of a pe- Deputy Assistant Administrator for Regu- President of the Senate on May 16, 2012; to tition to add workers from Hangar 481 on the latory Programs, National Marine Fisheries the Committee on Energy and Natural Re- premises of Kirtland Air Force Base, Albu- Service, Department of Commerce, transmit- sources. querque, New Mexico, to the Special Expo- ting, pursuant to law, the report of a rule en- EC–6188. A communication from the Chair- sure Cohort; to the Committee on Health, titled ‘‘Shrimp Fisheries of the Gulf of Mex- man of the Office of Proceedings, Surface Education, Labor, and Pensions. ico and South Atlantic; Revisions of Bycatch Transportation Board, Department of Trans- EC–6198. A communication from the Sec- Reduction Device Testing Protocols’’ portation, transmitting, pursuant to law, the retary of Health and Human Services, trans- (RIN0648–BB61) received in the Office of the report of a rule entitled ‘‘National Trails mitting, pursuant to law, the report of a pe- President of the Senate on May 9, 2012; to the System Act and Railroad Rights-of-Way’’ tition to add workers from the Brookhaven Committee on Commerce, Science, and (RIN2140–AB04) received in the Office of the National Laboratory in Upton, New York, to Transportation. President of the Senate on May 17, 2012; to the Special Exposure Cohort; to the Com- EC–6180. A communication from the Acting the Committee on Energy and Natural Re- mittee on Health, Education, Labor, and Deputy Assistant Administrator for Regu- sources. Pensions. latory Programs, National Marine Fisheries EC–6189. A communication from the Direc- EC–6199. A communication from the Sec- Service, Department of Commerce, transmit- tor of Congressional Affairs, Nuclear Reactor retary of Health and Human Services, trans- ting, pursuant to law, the report of a rule en- Regulation, Nuclear Regulatory Commis- mitting, pursuant to law, the report of a pe- titled ‘‘Fisheries of the Northeastern United sion, transmitting, pursuant to law, the re- tition to add workers from the Sandia Na- States; Summer Flounder, Scup, and Black port of a rule entitled ‘‘Aging Management tional Laboratories in Albuquerque, New Sea Bass Fisheries; Final 2012 Summer of Stainless Steel Structures and Compo- Mexico, to the Special Exposure Cohort; to Flounder, Scup, and Black Sea Bass Speci- nents in Treated Borated Water’’ (LR–ISG– the Committee on Health, Education, Labor, fications’’ (RIN0648–XA795) received in the 2011–01) received in the Office of the Presi- and Pensions. Office of the President of the Senate on May dent of the Senate on May 16, 2012; to the EC–6200. A communication from the Sec- 9, 2012; to the Committee on Commerce, Committee on Environment and Public retary of Health and Human Services, trans- Science, and Transportation. Works. mitting, pursuant to law, the ninth annual

VerDate Mar 15 2010 03:25 May 22, 2012 Jkt 019060 PO 00000 Frm 00034 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.024 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3329 report for the Temporary Assistance for contracting goals and preferences of the De- SNOWE) was added as a cosponsor of S. Needy Families Program; to the Committee partment of Veterans Affairs for small busi- 1578, a bill to amend the Safe Drinking on Health, Education, Labor, and Pensions. nesses owned by veterans of small businesses Water Act with respect to consumer EC–6201. A communication from the Chair- after the death of a disabled veteran owner, confidence reports by community man and Chief Executive Officer, Farm Cred- and for other purposes; to the Committee on it Administration, transmitting, pursuant to Veterans’ Affairs. water systems. law, the Administration’s Semiannual Re- By Mr. BENNET: S. 1696 port of the Inspector General and the Semi- S. 3211. A bill to authorize the President to At the request of Mr. LEAHY, the annual Management Report on the Status of determine the appropriate export controls of name of the Senator from Connecticut Audits for the period from October 1, 2011 satellites and related items based on the na- (Mr. BLUMENTHAL) was added as a co- through March 31, 2012; to the Committee on tional security and foreign policy objectives sponsor of S. 1696, a bill to improve the Homeland Security and Governmental Af- of the United States, and for other purposes; fairs. to the Committee on Foreign Relations. Public Safety Officers’ Benefits Pro- EC–6202. A communication from the Chair- gram. f man of the National Credit Union Adminis- S. 1749 tration, transmitting, pursuant to law, the SUBMISSION OF CONCURRENT AND At the request of Mr. WARNER, the Semi-Annual Report of the Inspector Gen- SENATE RESOLUTIONS name of the Senator from Pennsyl- eral for the period from October 1, 2011 vania (Mr. CASEY) was added as a co- through March 21, 2012; to the Committee on The following concurrent resolutions Homeland Security and Governmental Af- and Senate resolutions were read, and sponsor of S. 1749, a bill to establish fairs. referred (or acted upon), as indicated: and operate a National Center for Cam- EC–6203. A communication from the Dep- By Mr. BLUMENTHAL (for himself, pus Public Safety. uty General Counsel, Office of Financial As- Mr. CASEY, and Mr. CHAMBLISS): S. 1872 sistance, Small Business Administration, S. Res. 468. A resolution expressing the At the request of Mr. CASEY, the transmitting, pursuant to law, the report of sense of the Senate with respect to childhood names of the Senator from New Jersey a rule entitled ‘‘Disaster Assistance Loan stroke and recognizing May as ‘‘National Pe- (Mr. LAUTENBERG) and the Senator Program; Maximum Term for Disaster Loans diatric Stroke Awareness Month’’; consid- from Michigan (Ms. STABENOW) were to Small Businesses with Credit Available ered and agreed to. Elsewhere’’ (RIN3245–AG42) received in the By Ms. LANDRIEU (for herself, Ms. added as cosponsors of S. 1872, a bill to Office of the President of the Senate on May SNOWE, Mr. PRYOR, Mr. LIEBERMAN, amend the Internal Revenue Code of 17, 2012; to the Committee on Small Business Mr. ENZI, Mr. KERRY, Mr. BROWN of 1986 to provide for the tax treatment of and Entrepreneurship. Massachusetts, Ms. CANTWELL, Ms. ABLE accounts established under EC–6204. A communication from the Dep- AYOTTE, Mr. RISCH, Mr. CARDIN, Mrs. State programs for the care of family uty General Counsel, Office of Size Stand- HAGAN, Mr. RUBIO, and Mr. members with disabilities, and for ards, Small Business Administration, trans- MERKLEY): other purposes. mitting, pursuant to law, the report of a rule S. Res. 469. A resolution honoring the en- entitled ‘‘Small Business Size Standards: trepreneurial spirit of small business con- S. 1878 Transportation and Warehousing’’ (RIN3245– cerns in the United States during National At the request of Mr. MENENDEZ, the AG08) received in the Office of the President Small Business Week, which begins on May name of the Senator from Montana of the Senate on May 17, 2012; to the Com- 20, 2012; considered and agreed to. (Mr. TESTER) was added as a cosponsor mittee on Small Business and Entrepreneur- of S. 1878, a bill to assist low-income ship. f individuals in obtaining recommended ADDITIONAL COSPONSORS f dental care. REPORTS OF COMMITTEES S. 491 S. 1884 The following reports of committees At the request of Mr. PRYOR, the At the request of Mr. DURBIN, the were submitted: names of the Senator from Iowa (Mr. name of the Senator from Missouri By Mr. LEVIN, from the Committee on HARKIN) and the Senator from Min- (Mr. BLUNT) was added as a cosponsor Armed Services: nesota (Mr. FRANKEN) were added as co- of S. 1884, a bill to provide States with Special Report entitled ‘‘Inquiry into sponsors of S. 491, a bill to amend title incentives to require elementary Counterfeit Electronic Parts in the Depart- 38, United States Code, to recognize the schools and secondary schools to main- ment of Defense Supply Chain’’ (Rept. No. service in the reserve components of tain, and permit school personnel to 112–167). the Armed Forces of certain persons by administer, epinephrine at schools. f honoring them with status as veterans S. 1910 INTRODUCTION OF BILLS AND under law, and for other purposes. At the request of Mr. LIEBERMAN, the JOINT RESOLUTIONS S. 507 name of the Senator from New Jersey The following bills and joint resolu- At the request of Mr. ROCKEFELLER, (Mr. MENENDEZ) was added as a cospon- tions were introduced, read the first the name of the Senator from New sor of S. 1910, a bill to provide benefits and second times by unanimous con- York (Mrs. GILLIBRAND) was added as a to domestic partners of Federal em- sent, and referred as indicated: cosponsor of S. 507, a bill to provide for ployees. increased Federal oversight of prescrip- By Mr. BLUMENTHAL: S. 1979 S. 3207. A bill to amend title 10, United tion opioid treatment and assistance to At the request of Mr. CONRAD, the States Code, to provide for relief in civil ac- States in reducing opioid abuse, diver- name of the Senator from South Da- tions for violations of the protections on sion, and deaths. kota (Mr. THUNE) was added as a co- credit extended to members of the Armed S. 1507 sponsor of S. 1979, a bill to provide in- Forces and their dependents; to the Com- At the request of Mr. HATCH, the centives to physicians to practice in mittee on Armed Services. name of the Senator from Nevada (Mr. By Mr. PORTMAN (for himself, Mr. rural and medically underserved com- ELLER UDALL of New Mexico, Ms. SNOWE, H ) was added as a cosponsor of S. munities and for other purposes. and Mr. WHITEHOUSE): 1507, a bill to provide protections from S. 2047 S. 3208. A bill to reauthorize the Multi- workers with respect to their right to At the request of Mr. SCHUMER, the national Species Conservation Funds select or refrain from selecting rep- name of the Senator from New Mexico Semipostal Stamp, and for other purposes; to resentation by a labor organization. (Mr. BINGAMAN) was added as a cospon- the Committee on Homeland Security and S. 1551 Governmental Affairs. sor of S. 2047, a bill to authorize the By Mr. TESTER: At the request of Mr. KIRK, the name Secretary of Education to make dem- S. 3209. A bill to provide for the settlement of the Senator from Wyoming (Mr. onstration grants to eligible local edu- of the water rights claims of the Fort ENZI) was added as a cosponsor of S. cational agencies for the purpose of re- Belknap Indian Community, and for other 1551, a bill to establish a smart card ducing the student-to-school nurse purposes; to the Committee on Indian Af- pilot program under the Medicare pro- ratio in public elementary schools and fairs. gram. secondary schools. By Mr. BROWN of Massachusetts (for S. 1578 S. 2066 himself and Mr. BURR): S. 3210. A bill to amend title 38, United At the request of Mr. TOOMEY, the At the request of Ms. MURKOWSKI, the States Code, to modify the treatment under name of the Senator from Maine (Ms. name of the Senator from Ohio (Mr.

VerDate Mar 15 2010 03:25 May 22, 2012 Jkt 019060 PO 00000 Frm 00035 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.026 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3330 CONGRESSIONAL RECORD — SENATE May 21, 2012 PORTMAN) was added as a cosponsor of land (Mr. WHITEHOUSE) was added as a every community, but especially in S. 2066, a bill to recognize the heritage cosponsor of S. 3048, a bill to provide American Indian Country. Water plays of recreational fishing, hunting, and for a safe, accountable, fair, and effi- a particularly important role in Native shooting on Federal public land and en- cient banking system, and for other American life—past and present—in sure continued opportunities for those purposes. history, culture and religion. That is activities. S. 3188 why I am proud to introduce the Gros S. 2116 At the request of Mrs. GILLIBRAND, Ventre and Assiniboine Tribes of the At the request of Mr. CARPER, the the name of the Senator from New Fort Belknap Indian Community Water names of the Senator from New York York (Mr. SCHUMER) was added as a co- Rights Settlement Act of 2012. (Mrs. GILLIBRAND) and the Senator sponsor of S. 3188, a bill to increase the Not every issue relating to this im- from Rhode Island (Mr. REED) were authorized number of Weapons of Mass portant compact is resolved. I very added as cosponsors of S. 2116, a bill to Destruction Civil Support Teams. much appreciate the perspective of count revenues from military and vet- S. 3199 those who say that changes are still eran education programs toward the At the request of Mr. BEGICH, his needed. My goal in introducing this limit on Federal revenues that certain name was added as a cosponsor of S. legislation is to get all interested par- proprietary institutions of higher edu- 3199, a bill to amend the Immigration ties to negotiate on the issues that cation are allowed to receive for pur- and Nationality Act to stimulate inter- must still be resolved. By introducing poses of section 487 of the Higher Edu- national tourism to the United States this bill today, the Ft. Belknap Indian cation Act of 1965, and for other pur- and for other purposes. community, surrounding counties and the State of Montana indicate to the poses. S. RES. 435 United States that we are ready to ne- S. 2138 At the request of Mr. CASEY, the gotiate in earnest. During that process, At the request of Mr. VITTER, the names of the Senator from Oregon (Mr. Montanans and I will work to gain sup- name of the Senator from Louisiana MERKLEY) and the Senator from Cali- port from the Department of the Inte- (Ms. LANDRIEU) was added as a cospon- fornia (Mrs. BOXER) were added as co- rior, State of Montana, the Tribe, and sor of S. 2138, a bill to establish a pilot sponsors of S. Res. 435, a resolution local communities as we address indi- program to evaluate the cost-effective- calling for democratic change in Syria, vidual concerns. and for other purposes. ness and project delivery efficiency of The current federal policy to deter- non-Federal sponsors as the lead AMENDMENT NO. 2107 mine Indian water rights is to nego- project delivery team for authorized At the request of Mr. MCCAIN, the tiate, rather than litigate. Montana civil works flood control and naviga- names of the Senator from Minnesota has had a similar policy since it cre- tion construction projects of the Corps (Mr. FRANKEN) and the Senator from ated the Montana Reserved Water of Engineers. Maine (Ms. SNOWE) were added as co- Rights Compact Commission in 1979. S. 2165 sponsors of amendment No. 2107 in- Both governments recognize that liti- At the request of Mrs. BOXER, the tended to be proposed to S. 3187, a bill gating every water right on Montana’s names of the Senator from Texas (Mr. to amend the Federal Food, Drug, and vast Indian reservations is cost prohib- CORNYN), the Senator from Virginia Cosmetic Act to revise and extend the itive and time consuming. Negotiated (Mr. WARNER) and the Senator from user-fee programs for prescription settlements are cheaper for everybody. Montana (Mr. BAUCUS) were added as drugs and medical devices, to establish They are much faster than litigation. cosponsors of S. 2165, a bill to enhance user-fee programs for generic drugs and They allow individuals to participate strategic cooperation between the biosimilars, and for other purposes. in the outcome. They provide a greater United States and Israel, and for other AMENDMENT NO. 2108 degree of certainty to everybody in- purposes. At the request of Ms. MURKOWSKI, the volved. Folks working on this settle- S. 2320 names of the Senator from California ment and I intend this legislation to At the request of Ms. AYOTTE, the (Mrs. FEINSTEIN) and the Senator from fulfill the spirit of those policies. name of the Senator from Alaska (Ms. Oregon (Mr. WYDEN) were added as co- Since the Supreme Court’s 1908 deci- MURKOWSKI) was added as a cosponsor sponsors of amendment No. 2108 in- sion in Winters, the United States has of S. 2320, a bill to direct the American tended to be proposed to S. 3187, a bill had a responsibility to provide water to Battle Monuments Commission to pro- to amend the Federal Food, Drug, and the land it reserves for specific pur- vide for the ongoing maintenance of Cosmetic Act to revise and extend the poses, such as reservations for Amer- Clark Veterans Cemetery in the Repub- user-fee programs for prescription ican Indian homelands. This legislation lic of the Philippines, and for other drugs and medical devices, to establish fulfills that responsibility. It will em- purposes. user-fee programs for generic drugs and power the Tribe to create jobs and biosimilars, and for other purposes. S. 2371 stronger communities by improving AMENDMENT NO. 2111 At the request of Mr. RUBIO, the critical infrastructure. name of the Senator from Idaho (Mr. At the request of Mr. BINGAMAN, the More importantly, it strikes the proper balance to achieve a fair, equi- RISCH) was added as a cosponsor of S. name of the Senator from Ohio (Mr. 2371, a bill to amend the National BROWN) was added as a cosponsor of table, and final settlement of claims to Labor Relations Act to permit employ- amendment No. 2111 intended to be pro- water rights in the State of Montana ers to pay higher wages to their em- posed to S. 3187, a bill to amend the between the State, the Tribe, and the ployees. Federal Food, Drug, and Cosmetic Act United States for the benefit for the to revise and extend the user-fee pro- Tribe and allottees. S. 2374 grams for prescription drugs and med- There is more work to do to ensure At the request of Mr. BINGAMAN, the ical devices, to establish user-fee pro- that all interested parties can support name of the Senator from Connecticut grams for generic drugs and a final agreement. I understand that. (Mr. BLUMENTHAL) was added as a co- biosimilars, and for other purposes. However, hundreds of hours of delibera- sponsor of S. 2374, a bill to amend the f tion over more than a decade have been Helium Act to ensure the expedient put into shaping the terms of this Com- and responsible draw-down of the Fed- STATEMENTS ON INTRODUCED pact and Settlement. Although we have eral Helium Reserve in a manner that BILLS AND JOINT RESOLUTIONS made good progress during that time, protects the interests of private indus- By Mr. TESTER: we still have a lot of work left. I look try, the scientific, medical, and indus- S. 3209. A bill to provide for the set- forward to working with my tribal, trial communities, commercial users, tlement of the water rights claims of local, state and federal partners to get and Federal agencies, and for other the Fort Belknap Indian Community, this done. It is the right thing to do for purposes. and for other purposes; to the Com- the United States, the Tribe and the S. 3048 mittee on Indian Affairs. State of Montana. At the request of Mr. BROWN of Ohio, Mr. TESTER. Mr. President, water is In 2001, as a member of the Montana the name of the Senator from Rhode Is- the foundation for life. That is true in legislature, I was happy to support

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00036 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.030 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3331 state ratification of the Fort Belknap (3) supports the work of the National Insti- (1) honors the entrepreneurial spirit of Water Rights Compact. I look forward tutes of Health in pursuit of medical small business concerns in the United States to assisting the parties in moving this progress on the matter of pediatric stroke; during National Small Business Week, which Compact over the next hurdle—con- and begins on May 20, 2012; (4) urges continued coordination and co- (2) applauds the efforts and achievements gressional authorization. operation between government, researchers, of the owners and employees of small busi- f families, and the public to improve treat- ness concerns, whose hard work and commit- SUBMITTED RESOLUTIONS ments and prognoses for children who suffer ment to excellence have made such small strokes. business concerns a key part of the economic vitality of the United States; f (3) recognizes the work of the Small Busi- SENATE RESOLUTION 468—EX- SENATE RESOLUTION 469—HON- ness Administration and its resource part- PRESSING THE SENSE OF THE ORING THE ENTREPRENEURIAL ners in providing assistance to entrepreneurs SENATE WITH RESPECT TO SPIRIT OF SMALL BUSINESS and small business concerns; and CHILDHOOD STROKE AND RECOG- CONCERNS IN THE UNITED (4) recognizes the importance of ensuring NIZING MAY AS ‘‘NATIONAL PE- STATES DURING NATIONAL that— (A) guaranteed loans, including microloans DIATRIC STROKE AWARENESS SMALL BUSINESS WEEK, WHICH MONTH’’ and microloan technical assistance, for BEGINS ON MAY 20, 2012 start-up and growing small business con- Mr. BLUMENTHAL (for himself, Mr. Ms. LANDRIEU (for herself, Ms. cerns, and venture capital, are made avail- CASEY, and Mr. CHAMBLISS) submitted SNOWE, Mr. PRYOR, Mr. LIEBERMAN, Mr. able to all qualified small business concerns; the following resolution; which was ENZI, Mr. KERRY, Mr. BROWN of Massa- (B) the management assistance programs considered and agreed to: delivered by resource partners on behalf of chusetts, Ms. CANTWELL, Ms. AYOTTE, S. RES. 468 the Small Business Administration, such as Mr. RISCH, Mr. CARDIN, Mrs. HAGAN, Small Business Development Centers, Wom- Whereas a stroke, also known as a cerebro- Mr. RUBIO, and Mr. MERKLEY) sub- en’s Business Centers, and the Service Corps vascular accident, is an acute neurologic in- mitted the following resolution; which of Retired Executives, are provided with the jury that occurs when the blood supply to a Federal resources necessary to provide in- part of the brain is interrupted by a clot in was considered and agreed to: valuable counseling services to entre- the artery or a burst of the artery; S. RES. 469 preneurs in the United States; Whereas a stroke is a medical emergency Whereas the approximately 27,500,000 small (C) the Small Business Administration that can cause permanent neurologic damage business concerns in the United States are continues to provide timely and efficient dis- or even death if not promptly diagnosed and the driving force behind the Nation’s econ- aster assistance so that small businesses in treated; omy, creating 2 out of every 3 new jobs and areas struck by natural or manmade disas- Whereas stroke occurs in approximately 1 generating more than 50 percent of the Na- ters can quickly return to business to keep out of every 4,000 live births, and the risk of tion’s non-farm gross domestic product; local economies alive in the aftermath of stroke from birth through age 18 is nearly 11 Whereas small businesses are the driving such disasters; out of every 100,000 children per year; force behind the economic recovery of the (D) affordable broadband Internet access is Whereas an individual can have a stroke United States; available to all people in the United States, before birth; Whereas small businesses represent 99.7 particularly people in rural and underserved Whereas stroke is among the top 10 causes percent of employer firms in the United communities, so that small businesses can of death for children in the United States; States; use the Internet to make their operations Whereas between 20 percent and 40 percent Whereas small business concerns are the more globally competitive while boosting of children who suffer a stroke die as a re- Nation’s innovators, serving to advance local economies; sult; technology and productivity; (E) regulatory relief is provided to small Whereas stroke recurs in 20 percent of chil- Whereas small business concerns represent businesses through the reduction of duplica- dren who have experienced a stroke; 97.5 percent of all exporters and produce 31 tive or unnecessary regulatory requirements Whereas the death rate for children who percent of exported goods; that increase costs for small businesses; and experience a stroke before the age of 1 year Whereas Congress established the Small (F) leveling the playing field for con- is the highest out of all age groups; Business Administration in 1953 to aid, coun- tracting opportunities remains a primary Whereas the average time from onset of sel, assist, and protect the interests of small focus, so that small businesses, particularly symptoms to diagnosis of stroke is 24 hours, business concerns in order to preserve free minority-owned small businesses, can com- putting many affected children outside the and competitive enterprise, to ensure that a pete for and win more of the $400,000,000,000 window of 3 hours for the most successful fair proportion of the total Federal Govern- in contracts that the Federal Government treatment; ment purchases, contracts, and subcontracts enters into each year for goods and services. Whereas between 50 and 85 percent of in- for property and services are placed with fants and children who have a pediatric small business concerns, to ensure that a fair f stroke will have serious, permanent neuro- proportion of the total sales of government AMENDMENTS SUBMITTED AND logical disabilities, including paralysis, sei- property are made to such small business PROPOSED zures, speech and vision problems, and atten- concerns, and to maintain and strengthen tion, learning, and behavioral difficulties; the overall economy of the United States; SA 2113. Mr. INHOFE submitted an amend- Whereas those disabilities may require on- Whereas every year since 1963, the Presi- ment intended to be proposed by him to the going physical therapy and surgeries; dent has designated a ‘‘National Small Busi- resolution S. Res. 466, calling for the release Whereas the permanent health concerns ness Week’’ to recognize the contributions of from prison of former Prime Minister of and treatments resulting from strokes that small businesses to the economic well-being Ukraine Yulia Tymoshenko; which was re- occur during childhood and young adulthood of the United States; ferred to the Committee on Foreign Rela- have a considerable impact on children, fam- Whereas in 2012, National Small Business tions. ilies, and society; Week will honor the estimated 27,200,000 SA 2114. Mr. GRASSLEY (for himself and Whereas very little is known about the small businesses in the United States; Mr. WHITEHOUSE) submitted an amendment cause, treatment, and prevention of pediatric Whereas the Small Business Administra- intended to be proposed by him to the bill S. stroke; tion has helped small business concerns by 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user- Whereas medical research is the only providing access to critical lending opportu- fee programs for prescription drugs and med- means by which the citizens of the United nities, protecting small business concerns ical devices, to establish user-fee programs States can identify and develop effective from excessive Federal regulatory enforce- for generic drugs and biosimilars, and for treatment and prevention strategies for pedi- ment, helping to ensure full and open com- other purposes; which was ordered to lie on petition for government contracts, and im- atric stroke; and the table. Whereas early diagnosis and treatment of proving the economic environment in which SA 2115. Mr. GRASSLEY submitted an pediatric stroke greatly improves the small business concerns compete; amendment intended to be proposed by him chances that the affected child will recover Whereas for more than 50 years, the Small to the bill S. 3187, supra; which was ordered and not experience a recurrence: Now, there- Business Administration has helped millions to lie on the table. fore, be it of entrepreneurs achieve the American SA 2116. Mr. GRASSLEY submitted an Resolved, That the Senate— dream of owning a small business, and has amendment intended to be proposed by him (1) acknowledges May as ‘‘National Pedi- played a key role in fostering economic to the bill S. 3187, supra; which was ordered atric Stroke Awareness Month’’; growth; and to lie on the table. (2) urges the people of the United States to Whereas the President has designated the SA 2117. Mr. ROCKEFELLER submitted an support the efforts, programs, services, and week beginning May 20, 2012, as ‘‘National amendment intended to be proposed by him advocacy of organizations that work to en- Small Business Week’’: Now, therefore, be it to the bill S. 3187, supra; which was ordered hance public awareness of childhood stroke; Resolved, That the Senate— to lie on the table.

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00037 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.003 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3332 CONGRESSIONAL RECORD — SENATE May 21, 2012 SA 2118. Mr. ROCKEFELLER submitted an biosimilars, and for other purposes; which was ordered to lie on the table; amendment intended to be proposed by him which was ordered to lie on the table; as follows: to the bill S. 3187, supra; which was ordered as follows: At the end of title XI, add the following: to lie on the table. SA 2119. Mr. ROCKEFELLER submitted an At the end of title XI, add the following: SEC. 11ll. PROTECTIONS FOR THE COMMIS- SEC. 11ll. SUBPOENA AUTHORITY. SIONED CORPS OF THE PUBLIC amendment intended to be proposed by him HEALTH SERVICE ACT. to the bill S. 3187, supra; which was ordered Section 702 (21 U.S.C. 372) is amended by Section 221(a) of the Public Health Service to lie on the table. adding at the end the following: Act (42 U.S.C. 213a(a)) is amended by adding SA 2120. Mr. GRASSLEY submitted an ‘‘(f)(1) The Secretary may conduct inves- at the end the following: amendment intended to be proposed by him tigations as the Secretary deems necessary— ‘‘(18) Section 1034, Protected Communica- to the bill S. 3187, supra; which was ordered ‘‘(A) to carry out the authority of the Sec- tions; Prohibition of Retaliatory Personnel to lie on the table. retary under this Act or section 351 of the Actions.’’. SA 2121. Mr. GRASSLEY submitted an Public Health Service Act; or ‘‘(B) to determine whether any person has amendment intended to be proposed by him Mr. ROCKEFELLER sub- to the bill S. 3187, supra; which was ordered engaged or is about to engage in any act that SA 2117. to lie on the table. constitutes or will constitute a violation of mitted an amendment intended to be SA 2122. Mr. HARKIN (for himself and Mr. this Act or such section 351. proposed by him to the bill S. 3187, to ‘‘(2) For the purpose of any investigation ENZI) submitted an amendment intended to amend the Federal Food, Drug, and be proposed by him to the bill S. 3187, supra; conducted under paragraph (1), the Secretary Cosmetic Act to revise and extend the which was ordered to lie on the table. may administer oaths and affirmations, sub- user-fee programs for prescription SA 2123. Mr. REID (for Mr. JOHNSON of poena witnesses, compel the attendance of such witnesses, take evidence, and require drugs and medical devices, to establish South Dakota (for himself and Mr. SHELBY)) user-fee programs for generic drugs and proposed an amendment to the bill H.R. 1905, the production of any books, papers, docu- to strengthen Iran sanctions laws for the ments, or other materials that are relevant biosimilars, and for other purposes; purpose of compelling Iran to abandon its to the investigation. which was ordered to lie on the table; pursuit of nuclear weapons and other threat- ‘‘(3)(A) In case of contumacy or refusal to as follows: ening activities, and for other purposes. obey a subpoena issued under paragraph (2), At the end of title XI, add the following: the district court of the United States for SA 2124. Mr. REID (for Mr. JOHNSON of the judicial district in which such investiga- SEC. 11ll. PRACTITIONER EDUCATION. South Dakota (for himself and Mr. SHELBY)) (a) EDUCATION REQUIREMENTS.— proposed an amendment to amendment SA tion or proceeding is conducted, or in which the subpoenaed person resides or conducts (1) REGISTRATION CONSIDERATION.—Section 2123 proposed by Mr. REID (for Mr. JOHNSON 303(f) of the Controlled Substances Act (21 of South Dakota (for himself and Mr. business, may issue an order requiring such person to appear before the Secretary, tes- U.S.C. 823(f)) is amended by inserting after SHELBY)) to the bill H.R. 1905, supra. paragraph (5) the following: SA 2125. Mr. CARDIN submitted an amend- tify, or produce books, papers, documents, or other materials that are relevant to the in- ‘‘(6) The applicant’s compliance with the ment intended to be proposed by him to the training requirements described in sub- bill S. 3187, to amend the Federal Food, vestigation. All process in any such case may be served in the judicial district in section (g)(3) during any previous period in Drug, and Cosmetic Act to revise and extend which the applicant has been subject to such the user-fee programs for prescription drugs which such person resides or may be found. ‘‘(B) Any failure to obey an order issued training requirements.’’. and medical devices, to establish user-fee (2) TRAINING REQUIREMENTS.—Section 303(g) programs for generic drugs and biosimilars, under subparagraph (A) may be punished by the court as contempt of court.’’. of the Controlled Substances Act (21 U.S.C. and for other purposes; which was ordered to 823(g)) is amended by adding at the end the lie on the table. SA 2115. Mr. GRASSLEY submitted following: SA 2126. Mr. REED submitted an amend- ‘‘(3)(A) To be registered to prescribe or oth- ment intended to be proposed by him to the an amendment intended to be proposed by him to the bill S. 3187, to amend the erwise dispense methadone or other opioids, bill S. 3187, supra; which was ordered to lie a practitioner described in paragraph (1) on the table. Federal Food, Drug, and Cosmetic Act shall comply with the 16-hour training re- f to revise and extend the user-fee pro- quirement of subparagraph (B) at least once grams for prescription drugs and med- during each 3-year period. TEXT OF AMENDMENTS ical devices, to establish user-fee pro- ‘‘(B) The training requirement of this sub- SA 2113. Mr. INHOFE submitted an grams for generic drugs and paragraph is that the practitioner has com- amendment intended to be proposed by biosimilars, and for other purposes; pleted not less than 16 hours of training him to the resolution S. Res. 466, call- which was ordered to lie on the table; (through classroom situations, seminars at ing for the release from prison of as follows: professional society meetings, electronic communications, or otherwise) with respect former Prime Minister of Ukraine At the end of title XI, add the following: to— Yulia Tymoshenko; which was referred SEC. 11ll. PROTECTIONS FOR THE COMMIS- ‘‘(i) the treatment and management of to the Committee on Foreign Rela- SIONED CORPS OF THE PUBLIC opioid-dependent patients; tions; as follows: HEALTH SERVICE ACT AND THE NA- ‘‘(ii) pain management treatment guide- TIONAL OCEANIC AND ATMOS- In the preamble, strike the third and PHERIC ADMINISTRATION. lines; and fourth whereas clauses and insert the fol- (a) COMMISSIONED CORPS OF THE PUBLIC ‘‘(iii) early detection of opioid addiction, lowing: HEALTH SERVICE ACT.—Section 221(a) of the including through such methods as Screen- Whereas, as a result of the electoral fraud Public Health Service Act (42 U.S.C. 213a(a)) ing, Brief Intervention, and Referral to by which Prime Minister Viktor is amended by adding at the end the fol- Treatment (SBIRT), Yanukovych was declared the winner of the lowing: that is provided by relevant professional so- 2004 presidential election, the citizens of ‘‘(18) Section 1034, Protected Communica- cieties, as determined by the Secretary.’’. Ukraine organized a series of protests, tions; Prohibition of Retaliatory Personnel (b) REQUIREMENTS FOR PARTICIPATION IN strikes, and sit-ins, which came to be known Actions.’’. OPIOID TREATMENT PROGRAMS.—Effective as ‘‘The Orange Revolution’’; (b) NATIONAL OCEANIC AND ATMOSPHERIC July 1, 2013, a physician practicing in an Whereas the Orange Revolution, in concert ADMINISTRATION.—Section 261 of the Na- opioid treatment program shall comply with with United States and international pres- tional Oceanic and Atmospheric Administra- the requirements of section 303(g)(3) of the sure, forced the Supreme Court of Ukraine to tion Commissioned Officer Corps Act of 2002 Controlled Substances Act (as added by sub- require an unprecedented second run-off (33 U.S.C. 3071(a)) is amended by adding at section (a)) with respect to required min- election, which resulted in opposition leader the end the following: imum training at least once during each 3- Viktor Yushchenko defeating Mr. ‘‘(17) Section 1034, Protected Communica- year period. Yanukovych by a margin of 52 percent to 44 tions; Prohibition of Retaliatory Personnel (c) DEFINITION.—In this section, the term percent; Actions.’’. ‘‘opioid treatment program’’ has the mean- ing given such term in section 8.2 of title 42, SA 2114. Mr. GRASSLEY (for himself SA 2116. Mr. GRASSLEY submitted Code of Federal Regulations (or any suc- and Mr. WHITEHOUSE) submitted an an amendment intended to be proposed cessor regulation). amendment intended to be proposed by by him to the bill S. 3187, to amend the (d) FUNDING.—The Drug Enforcement Ad- him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act ministration shall fund the enforcement of Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee pro- the requirements specified in section 303(g)(3) of the Controlled Substances Act (as to revise and extend the user-fee pro- grams for prescription drugs and med- added by subsection (a)) through the use of a grams for prescription drugs and med- ical devices, to establish user-fee pro- portion of the licensing fees paid by con- ical devices, to establish user-fee pro- grams for generic drugs and trolled substance prescribers under the Con- grams for generic drugs and biosimilars, and for other purposes; trolled Substances Act (21 U.S.C. 801 et seq.).

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00038 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.037 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3333 SA 2118. Mr. ROCKEFELLER sub- (9) According to the Centers for Disease section (g)(3) during any previous period in mitted an amendment intended to be Control and Prevention, the number of poi- which the applicant has been subject to such proposed by him to the bill S. 3187, to soning deaths involving methadone in- training requirements.’’. amend the Federal Food, Drug, and creased nearly 7-fold from almost 790 in 1999 (2) TRAINING REQUIREMENTS.—Section 303(g) to almost 5,420 in 2006, which is the most of the Controlled Substances Act (21 U.S.C. Cosmetic Act to revise and extend the rapid increase among opioid analgesics and 823(g)) is amended by adding at the end the user-fee programs for prescription other narcotics involved in poisoning deaths. following: drugs and medical devices, to establish (10) The age-specific rates of methadone ‘‘(3)(A) To be registered to prescribe or oth- user-fee programs for generic drugs and death are higher for persons age 35 to 44 and erwise dispense methadone or other opioids, biosimilars, and for other purposes; 45 to 54 than for other age groups. However, a practitioner described in paragraph (1) which was ordered to lie on the table; the rate of methadone deaths in younger in- shall comply with the 16-hour training re- as follows: dividuals (age 15 to 24) increased 11-fold from quirement of subparagraph (B) at least once 1999 through 2005. during each 3-year period. At the end of title XI, add the following: (11) Deaths from methadone and other opi- ‘‘(B) The training requirement of this sub- SEC. 11ll. PRESCRIPTION MONITORING PRO- ates may actually be underreported. There is paragraph is that the practitioner has com- GRAM. no comprehensive database of drug-related pleted not less than 16 hours of training Section 399O of the Public Health Service deaths in the United States. (through classroom situations, seminars at Act (42 U.S.C. 280g–3) is amended— (12) The lack of standardized reporting by professional society meetings, electronic (1) in subsection (d)(1), by inserting ‘‘(in- Medical Examiners precludes a uniform defi- communications, or otherwise) with respect cluding prescribers of methadone)’’ after nition of ‘‘cause of death’’ on death certifi- to— ‘‘dispensers’’; and cates. ‘‘(i) the treatment and management of (2) by striking subsection (n) and inserting (13) The Controlled Substances Act (21 opioid-dependent patients; the following: U.S.C. 801 et seq.) requires that every person ‘‘(ii) pain management treatment guide- ‘‘(n) APPROPRIATIONS.—There is authorized who dispenses or who proposes to dispense lines; and to be appropriated to carry out this section controlled narcotics, including methadone, ‘‘(iii) early detection of opioid addiction, $25,000,000 for each of fiscal years 2013 whether for pain management or opioid including through such methods as Screen- through 2017.’’. treatment obtain a registration from the ing, Brief Intervention, and Referral to SA 2119. Mr. ROCKEFELLER sub- Drug Enforcement Administration. Unfortu- Treatment (SBIRT), nately there is no requirement as a condition that is provided by relevant professional so- mitted an amendment intended to be of receiving the registration that these prac- cieties, as determined by the Secretary.’’. proposed by him to the bill S. 3187, to titioners receive any education on the use of (b) REQUIREMENTS FOR PARTICIPATION IN amend the Federal Food, Drug, and these controlled narcotics, including metha- OPIOID TREATMENT PROGRAMS.—Effective Cosmetic Act to revise and extend the done. July 1, 2013, a physician practicing in an user-fee programs for prescription (14) Current Federal oversight of metha- opioid treatment program shall comply with drugs and medical devices, to establish done and other opioids is inadequate to ad- the requirements of section 303(g)(3) of the user-fee programs for generic drugs and dress the growing number of opioid-related Controlled Substances Act (as added by sub- biosimilars, and for other purposes; overdoses and deaths. section (a)) with respect to required min- (15) Federal legislation is needed to avert imum training at least once during each 3- which was ordered to lie on the table; opioid abuse, misuse, and death, without re- year period. as follows: ducing patient access to needed care. (c) DEFINITION.—In this section, the term At the end of title XI, add the following: SEC. 1142. CONSUMER EDUCATION CAMPAIGN. ‘‘opioid treatment program’’ has the mean- Subtitle D—Prescription Drug Abuse Part A of title V of the Public Health Serv- ing given such term in section 8.2 of title 42, Prevention and Treatment ice Act (42 U.S.C. 290aa et seq.) is amended Code of Federal Regulations (or any suc- SEC. 1141. SHORT TITLE; FINDINGS. by adding at the end the following: cessor regulation). (a) SHORT TITLE.—This subtitle may be ‘‘SEC. 506C. CONSUMER EDUCATION CAMPAIGN. (d) FUNDING.—The Drug Enforcement Ad- cited as the ‘‘Prescription Drug Abuse Pre- ‘‘(a) IN GENERAL.—The Administrator shall ministration shall fund the enforcement of vention and Treatment Act of 2012’’. award grants to States and nonprofit enti- the requirements specified in section (b) FINDINGS.—Congress makes the fol- ties for the purpose of conducting culturally 303(g)(3) of the Controlled Substances Act (as lowing findings: sensitive consumer education about opioid added by subsection (a)) through the use of a (1) Nonmedical use of prescription pain re- abuse, including methadone abuse. Such edu- portion of the licensing fees paid by con- lievers is a matter of increasing public cation shall include information on the dan- trolled substance prescribers under the Con- health concern. According to the Substance gers of opioid abuse, how to prevent opioid trolled Substances Act (21 U.S.C. 801 et seq.). Abuse and Mental Health Services Adminis- abuse including through safe disposal of pre- SEC. 1144. MORATORIUM ON METHADONE HY- tration, the proportion of all substance scription medications and other safety pre- DROCHLORIDE TABLETS. abuse treatment admissions aged 12 or older cautions, and detection of early warning (a) IN GENERAL.—Notwithstanding any that reported any pain reliever abuse in- signs of addiction. other provision of law, during the period be- creased more than 400 percent between 1998 ‘‘(b) ELIGIBILITY.—To be eligible to receive ginning on the date of enactment of this Act and 2008, from 2.2 to 9.8 percent. a grant under subsection (a), an entity and ending on the date described in sub- (2) In 2008, among the population of the shall— section (b), no individual or entity may pre- United States aged 12 or older, nonmedical ‘‘(1) be a State or nonprofit entity; and scribe or otherwise dispense a 40-mg diskette use of prescription pain relievers was the ‘‘(2) submit to the Administrator an appli- of methadone unless such prescription or dis- second most prevalent type of illicit drug cation at such time, in such manner, and pensation is consistent with the methadone use, after marijuana use. containing such information as the Adminis- 40-mg diskette policy of the Drug Enforce- (3) When used properly under medical su- trator may require. ment Administration as in effect on the date pervision, prescription opiates enable indi- ‘‘(c) PRIORITY.—In awarding grants under of enactment of this Act, except that such viduals with chronic pain to lead productive this section, the Administrator shall give prohibition shall extend to hospitals unless lives. However, when taken without a physi- priority to applicants that are States or such hospitals provide for direct patient su- cian’s oversight and direction, opiates can communities with a high incidence of abuse pervision with respect to such methadone. cause serious adverse health effects, result- of methadone and other opioids, and opioid- (b) ENDING DATE OF MORATORIUM.—The ing in dependence, abuse, and death. related deaths. moratorium under subsection (a) shall cease (4) As with any controlled substance, there ‘‘(d) EVALUATIONS.—The Administrator to have force and effect— is a risk of abuse of methadone and other shall develop a process to evaluate the effec- (1) on the date that the Controlled Sub- opiates. tiveness of activities carried out by grantees stances Clinical Standards Commission pub- (5) Methadone is an extensively tested, fed- under this section at reducing abuse of meth- lishes in the Federal Register dosing guide- erally approved, and widely accepted method adone and other opioids. lines for all forms of methadone, in accord- of treating addiction to prescription pain re- ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— ance with section 506D(b)(1)(A) of the Public lievers or opiates. There is authorized to be appropriated to Health Service Act (as added by section (6) For more than 30 years, this synthetic carry out this section $15,000,000 for each of 1146); and prescription drug has been used for pain fiscal years 2013 through 2017.’’. (2) if, as part of such dosing guidelines, management and treatment for addiction to SEC. 1143. PRACTITIONER EDUCATION. such Commission finds that 40-mg diskettes heroin, morphine, and other opioid drugs. (a) EDUCATION REQUIREMENTS.— of methadone are safe and clinically appro- (7) The efficacy and lower cost of metha- (1) REGISTRATION CONSIDERATION.—Section priate. done has resulted in its being prescribed for 303(f) of the Controlled Substances Act (21 SEC. 1145. OPERATION OF OPIOID TREATMENT pain management. U.S.C. 823(f)) is amended by inserting after PROGRAMS. (8) Prescriptions for methadone have in- paragraph (5) the following: Section 303 of the Controlled Substances creased by nearly 700 percent from 1998 ‘‘(6) The applicant’s compliance with the Act (21 U.S.C. 823) is amended by adding at through 2006. training requirements described in sub- the end the following:

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00039 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.046 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3334 CONGRESSIONAL RECORD — SENATE May 21, 2012 ‘‘(i)(1) An opioid treatment program that is ‘‘(iv) specific guidelines for initiating pain carry out this section such sums as may be registered under this section, and that closes management with methadone, that pre- necessary for each of fiscal years 2013 for business on any weekday or weekend day, scribing physicians or other clinicians shall through 2017.’’. including a Federal or State holiday, shall comply with in order to meet Drug Enforce- SEC. 1147. PRESCRIPTION MONITORING PRO- comply with the requirements of this sub- ment Administration certification and re- GRAM. section. certification requirements; and Section 399O of the Public Health Service ‘‘(2) The program shall make acceptable ‘‘(v) consensus guidelines for pain manage- Act (42 U.S.C. 280g–3) is amended— arrangements for each patient who is re- ment with prescription opioid drugs. (1) in subsection (d)(1), by inserting ‘‘(in- stricted, by Federal regulation or guideline ‘‘(B) UPDATING OF GUIDELINES.—Not later cluding prescribers of methadone)’’ after or by the determination of the program med- than 3 years after the publication of guide- ‘‘dispensers’’; ical director, from having a take home dose lines under subparagraph (A), and at least (2) in subsection (e), by adding at the end of a controlled substance related to the every 3 years thereafter, the Commission the following: treatment involved, to receive a dose of that shall update such guidelines. ‘‘(5) Subject to the requirements of section substance under appropriate supervision dur- ‘‘(2) PUBLICATION OF BENCHMARK GUIDE- 543, the State shall, at the request of a Fed- ing the closure. LINES.— eral, State, or local officer whose duties in- ‘‘(3) The Administrator of the Substance ‘‘(A) IN GENERAL.—Not later than 3 years clude enforcing laws relating to drugs, pro- Abuse and Mental Health Services Adminis- after the date of enactment of this section, vide to such officer information from the tration shall issue a notice that references database relating to an individual who is the regulations on acceptable arrangements the Commission established under sub- section (a) shall publish in the Federal Reg- subject of an active drug-related investiga- under this subsection, or shall promulgate tion conducted by the officer’s employing regulations on such acceptable arrange- ister— ‘‘(i) the initial benchmark guidelines for government entity.’’; and ments.’’. (3) by striking subsection (n) and inserting SEC. 1146. ESTABLISHMENT OF THE CON- the reduction of methadone abuse to be used— the following: TROLLED SUBSTANCES CLINICAL ‘‘(n) APPROPRIATIONS.—There is authorized ‘‘(I) by opioid treatment programs in pro- STANDARDS COMMISSION. to be appropriated to carry out this section viding methadone therapy; and Part A of title V of the Public Health Serv- $25,000,000 for each of fiscal years 2013 ‘‘(II) by entities in the initial accreditation ice Act (42 U.S.C. 290aa et seq.), as amended through 2017.’’. by section 1142, is further amended by adding or certification, and the re-accreditation and SEC. 1148. MORTALITY REPORTING. at the end the following: re-certification, of such opioid treatment Part A of title V of the Public Health Serv- programs; ‘‘SEC. 506D. ESTABLISHMENT OF THE CON- ice Act (42 U.S.C. 290aa et seq.), as amended TROLLED SUBSTANCES CLINICAL ‘‘(ii) a model policy for dispensing metha- STANDARDS COMMISSION. by section 1146, is further amended by adding done to be used by pharmacists that dispense at the end the following: ‘‘(a) IN GENERAL.—The Secretary shall es- methadone, which should include education ‘‘SEC. 506E. MORTALITY REPORTING. tablish a Controlled Substances Clinical and training guidelines for such pharmacists; ‘‘(a) MODEL OPIOID TREATMENT PROGRAM Standards Commission (referred to in this ‘‘(iii) the continuing education guidelines MORTALITY REPORT.— section as the ‘Commission’), to be composed that all prescribers shall comply with in of representatives from the Administration, ‘‘(1) IN GENERAL.—Not later than July 1, order to meet Drug Enforcement Adminis- 2012, the Secretary, acting through the Ad- the Centers for Disease Control and Preven- tration certification and re-certification re- tion, the Food and Drug Administration, the ministrator, shall require that a Model quirements, as set forth in section 303(g)(3) Opioid Treatment Program Mortality Report Pain Management Consortia of the National of the Controlled Substances Act (21 U.S.C. Institutes of Health, and other agencies that be completed and submitted to the Adminis- 823(g)(3)), which should include a minimum trator for each individual who dies while re- the Secretary may deem necessary, to de- of 16 training hours at least every 3 years velop— ceiving treatment in an opioid treatment that include the integration of both addic- ‘‘(1) appropriate and safe dosing guidelines program. tion and pain management curricula; and for all forms of methadone, including rec- ‘‘(2) REQUIREMENT OF STATES THAT RECEIVE ‘‘(iv) patient education guidelines for both ommendations for maximum daily doses of FUNDING FOR THE CONTROLLED SUBSTANCE opioid treatment programs and pain manage- all forms as provided for in subsection (b)(1); MONITORING PROGRAM.—As a condition for re- ment, including recommendations for pa- ‘‘(2) benchmark guidelines for the reduc- ceiving funds under section 399O, each State tient counseling prior to and during opioid tion of methadone abuse, as provided for in shall require that any individual who signs a addiction treatment or treatment for pain. subsection (b)(2); death certificate where an opioid drug is de- ‘‘(B) UPDATING OF GUIDELINES.—Not later ‘‘(3) appropriate conversion factors for use tected in the body of the deceased, or where than 1 year after the publication of guide- by health care providers in transitioning pa- such drug is otherwise associated with the tients from one opioid to another; lines under subparagraph (A), and at least death, report such death to the Adminis- ‘‘(4) specific guidelines for initiating pain annually thereafter, the Commission shall trator by submitting a Model Opioid Treat- management with methadone that pre- update the guidelines published under ment Program Mortality Report described in scribing practitioners shall comply with in clauses (iii) and (iv) of such subparagraph. paragraph (3). Such report shall be submitted order to meet certification requirements set ‘‘(3) CONSULTATION.—In developing and to the Administrator on or before the later forth in part C of the Controlled Substances publishing the guidelines under this section, of— Act (21 U.S.C. 821 et seq.); and the Commission shall consult with relevant ‘‘(A) 90 days after the date of signing the ‘‘(5) patient and practitioner education professional organizations with expertise in death certificate; or guidelines for both methadone maintenance the area of addiction, relevant professional ‘‘(B) as soon as practicable after the date therapy and pain management that apply to organizations with expertise in the area of on which the necessary postmortem and safe and effective use and include detoxifica- pain management, physician groups, phar- toxicology reports become available to such tion. macy groups (including the National Asso- individual, as required by the Secretary. ‘‘(b) GUIDELINES.— ciation of Boards of Pharmacy), patient rep- ‘‘(3) DEVELOPMENT.—The Administrator, in ‘‘(1) PUBLICATION OF DOSING GUIDELINES.— resentatives, and any other organization consultation with State and local medical ‘‘(A) IN GENERAL.—Not later than 2 years that the Secretary determines is appropriate examiners, prescribing physicians, hospitals, after the date of enactment of this section, for purposes of this section. and any other organization that the Admin- ‘‘(c) WEBSITE.—Not later than 180 days the Commission established under sub- istrator determines appropriate, shall de- after the date of enactment of this section, section (a) shall publish in the Federal Reg- velop a Model Opioid Treatment Program the Commission shall establish and operate a ister— Mortality Report to be used under para- Commission website. ‘‘(i) safe and clinically appropriate dosing graphs (1) and (2). ‘‘(d) METHADONE TOOLKIT.—Not later than 1 guidelines for all forms of methadone used ‘‘(b) NATIONAL OPIOID DEATH REGISTRY.— year after the date of enactment of this sec- for both pain management and opioid treat- tion, the Commission shall establish, and ‘‘(1) IN GENERAL.—Not later than July 1, ment programs, including recommendations distribute to practitioners that are reg- 2012, the Administrator shall establish and for maximum daily doses of all forms, in- istered to prescribe or otherwise dispense implement, through the National Center for cluding recommendations for the induction methadone, a methadone toolkit. The Com- Health Statistics, a National Opioid Death process for patients who are newly pre- mission shall make the components of the Registry (referred to in this subsection as scribed methadone; toolkit that are available in electronic form the ‘Registry’) to track opioid-related deaths ‘‘(ii) requirements for individual patient available on the Commission website. and information related to such deaths. care plans, including initial and follow-up ‘‘(e) PRACTITIONER EDUCATION PROGRAM.— ‘‘(2) CONSULTATION.—In establishing the patient physical examination guidelines, and The Commission shall develop a practitioner uniform reporting criteria for the Registry, recommendations for screening patients for education program that shall be used for the the Director of the Centers for Disease Con- chronic or acute medical conditions that practitioner education described in section trol and Prevention shall consult with the may cause an immediate and adverse reac- 303(g)(3) of the Controlled Substances Act, Administrator, State and local medical ex- tion to methadone; and shall make such program available to aminers, prescribing physicians, hospitals, ‘‘(iii) appropriate conversion factors for providers of such practitioner education. and any other organization that the Director use by health care providers in transitioning ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.— determines is appropriate for purposes of patients from one opioid to another; There is authorized to be appropriated to this subsection.

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00040 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.046 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3335 ‘‘(3) REQUIREMENTS.—The registry shall be SA 2120. Mr. GRASSLEY submitted Strike all after the enacting clause and in- designed as a uniform reporting system for an amendment intended to be proposed sert the following: opioid-related deaths and shall require the by him to the bill S. 3187, to amend the SECTION 1. SHORT TITLE. reporting of information with respect to Federal Food, Drug, and Cosmetic Act This Act may be cited as the ‘‘Food and such deaths, including— to revise and extend the user-fee pro- Drug Administration Safety and Innovation ‘‘(A) the particular drug formulation used grams for prescription drugs and med- Act’’. at the time of death; SEC. 2. TABLE OF CONTENTS; REFERENCES IN ‘‘(B) the dosage level; ical devices, to establish user-fee pro- grams for generic drugs and ACT. ‘‘(C) a description of the circumstances (a) TABLE OF CONTENTS.—The table of con- surrounding the death in relation to the rec- biosimilars, and for other purposes; tents of this Act is as follows: ommended dosage involved; which was ordered to lie on the table; Sec. 1. Short title. ‘‘(D) a disclosure of whether the medica- as follows: Sec. 2. Table of contents; references in Act. tion involved can be traced back to a physi- At the end of title XI, add the following: TITLE I—FEES RELATING TO DRUGS cian’s prescription; SEC. 11ll. PROTECTIONS FOR THE COMMIS- ‘‘(E) a disclosure of whether the individual SIONED CORPS OF THE PUBLIC Sec. 101. Short title; finding. was in an opioid treatment program at the HEALTH SERVICE ACT AND THE NA- Sec. 102. Definitions. time of death; TIONAL OCEANIC AND ATMOS- Sec. 103. Authority to assess and use drug ‘‘(F) the age and sex of the individual; and PHERIC ADMINISTRATION. fees. ‘‘(G) other non-personal information such (a) COMMISSIONED CORPS OF THE PUBLIC Sec. 104. Reauthorization; reporting require- as that included in filed National Associa- HEALTH SERVICE ACT.—Section 221(a) of the ments. tion of Medical Examiners Pediatric Toxi- Public Health Service Act (42 U.S.C. 213a(a)) Sec. 105. Sunset dates. cology Registry case reports as required is amended by adding at the end the fol- Sec. 106. Effective date. under the privacy standard for the de-identi- lowing: Sec. 107. Savings clause. fication of health information pursuant to ‘‘(18) Section 1034, Protected Communica- TITLE II—FEES RELATING TO DEVICES tions; Prohibition of Retaliatory Personnel the regulations contained in part 164 of title Sec. 201. Short title; findings. 45, Code of Federal Regulations. Actions.’’. (b) NATIONAL OCEANIC AND ATMOSPHERIC Sec. 202. Definitions. ‘‘(4) AUTHORIZATION.—There is authorized Sec. 203. Authority to assess and use device to be appropriated $5,000,000 for each of fiscal ADMINISTRATION.—Section 261 of the Na- tional Oceanic and Atmospheric Administra- fees. years 2013 through 2017 to carry out this sub- Sec. 204. Reauthorization; reporting require- section. tion Commissioned Officer Corps Act of 2002 (33 U.S.C. 3071(a)) is amended by adding at ments. ‘‘(c) REPORT ON REGISTRY INFORMATION.— Sec. 205. Savings clause. Not later than the January 1 of the first fis- the end the following: ‘‘(17) Section 1034, Protected Communica- Sec. 206. Effective date. cal year beginning 2 years after the date of Sec. 207. Sunset dates. enactment of this section, and each January tions; Prohibition of Retaliatory Personnel Actions.’’. Sec. 208. Streamlined hiring authority to 1 thereafter, the Director of the Centers for support activities related to the Disease Control and Prevention shall submit (c) CONFORMING AMENDMENT.—Section 221(b) of the Public Health Service Act (42 process for the review of device to the Secretary a report, based on informa- U.S.C. 213a(b)) is amended by adding at the applications. tion contained in the Registry described in end the following: ‘‘For purposes of para- subsection (b), concerning the number of TITLE III—FEES RELATING TO GENERIC graph (18) of subsection (a), the term ‘Inspec- methadone-related deaths in the United DRUGS tor General’ in section 1034 of such title 10 States for the year for which the report is Sec. 301. Short title. shall mean the Inspector General of the De- submitted.’’. Sec. 302. Authority to assess and use human partment of Health and Human Services.’’. SEC. 1149. ADDITIONAL REPORTING. generic drug fees. Sec. 303. Reauthorization; reporting require- Part A of title V of the Public Health Serv- SA 2121. Mr. GRASSLEY submitted ice Act (42 U.S.C. 290aa et seq.), as amended ments. an amendment intended to be proposed Sec. 304. Sunset dates. by section 1148, is further amended by adding by him to the bill S. 3187, to amend the at the end the following: Sec. 305. Effective date. Federal Food, Drug, and Cosmetic Act Sec. 306. Amendment with respect to mis- ‘‘SEC. 506F. ADDITIONAL REPORTING. to revise and extend the user-fee pro- branding. ‘‘(a) REPORT ON METHADONE USAGE.— grams for prescription drugs and med- Sec. 307. Streamlined hiring authority of the ‘‘(1) IN GENERAL.—Not later than January 1 Food and Drug Administration of the first fiscal year beginning 2 years after ical devices, to establish user-fee pro- to support activities related to the date of enactment of this section, and grams for generic drugs and human generic drugs. each January 1 thereafter, the Adminis- biosimilars, and for other purposes; trator and the Commissioner of Food and which was ordered to lie on the table; TITLE IV—FEES RELATING TO Drugs shall submit to the Secretary a report as follows: BIOSIMILAR BIOLOGICAL PRODUCTS containing detailed statistics on methadone At the end of title XI, add the following: Sec. 401. Short title; finding. usage for opioid treatment and pain manage- SEC. 11ll. PROTECTIONS FOR THE COMMIS- Sec. 402. Fees relating to biosimilar biologi- ment. Such statistics shall include— SIONED CORPS OF THE PUBLIC cal products. ‘‘(A) information on the distribution of HEALTH SERVICE ACT. Sec. 403. Reauthorization; reporting require- prescribed doses of methadone at federally (a) IN GENERAL.—Section 221(a) of the Pub- ments. qualified health centers, opioid treatment lic Health Service Act (42 U.S.C. 213a(a)) is Sec. 404. Sunset dates. clinics, other health-related clinics, physi- amended by adding at the end the following: Sec. 405. Effective date. cian offices, pharmacies, and hospitals; and ‘‘(18) Section 1034, Protected Communica- Sec. 406. Savings clause. ‘‘(B) information relating to adverse health tions; Prohibition of Retaliatory Personnel Sec. 407. Conforming amendment. events resulting from such methadone usage. Actions.’’. TITLE V—PEDIATRIC DRUGS AND ‘‘(2) AVAILABILITY OF INFORMATION.—The (b) CONFORMING AMENDMENT.—Section DEVICES Secretary shall make the reports submitted 221(b) of the Public Health Service Act (42 Sec. 501. Permanence. under paragraph (1) available to the general U.S.C. 213a(b)) is amended by adding at the Sec. 502. Written requests. public, including through the use of the end the following: ‘‘For purposes of para- Sec. 503. Communication with Pediatric Re- Internet website of the Department of graph (18) of subsection (a), the term ‘Inspec- view Committee. Health and Human Services. tor General’ in section 1034 of such title 10 Sec. 504. Access to data. ‘‘(b) ANNUAL REPORT ON EFFECTIVENESS.— shall mean the Inspector General of the De- Sec. 505. Ensuring the completion of pedi- Not later than September 30, 2013, and annu- partment of Health and Human Services.’’. atric studies. ally thereafter until September 30, 2017, the Sec. 506. Pediatric study plans. Secretary shall submit to the appropriate SA 2122. Mr. HARKIN (for himself Sec. 507. Reauthorizations. committees of Congress, a report concerning and Mr. ENZI) submitted an amend- Sec. 508. Report. the effectiveness of the methadone mainte- ment intended to be proposed by him Sec. 509. Technical amendments. nance therapy program. Such report shall to the bill S. 3187, to amend the Fed- Sec. 510. Relationship between pediatric la- evaluate the success of efforts to reduce eral Food, Drug, and Cosmetic Act to beling and new clinical inves- opioid addiction and methadone-related revise and extend the user-fee pro- tigation exclusivity. deaths, including the impact of health care grams for prescription drugs and med- Sec. 511. Pediatric rare diseases. provider and patient education. ical devices, to establish user-fee pro- ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.— TITLE VI—MEDICAL DEVICE There is authorized to be appropriated to grams for generic drugs and REGULATORY IMPROVEMENTS carry out this section such sums as may be biosimilars, and for other purposes; Sec. 601. Reclassification procedures. necessary for each of fiscal years 2013 which was ordered to lie on the table; Sec. 602. Condition of approval studies. through 2017.’’. as follows: Sec. 603. Postmarket surveillance.

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00041 Fmt 4624 Sfmt 0655 E:\CR\FM\A21MY6.046 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3336 CONGRESSIONAL RECORD — SENATE May 21, 2012 Sec. 604. Sentinel. TITLE X—DRUG SHORTAGES (c)(5)’’ each place such term appears and in- Sec. 605. Recalls. Sec. 1001. Drug shortages. serting ‘‘subsection (c)(4)’’; Sec. 606. Clinical holds on investigational TITLE XI—OTHER PROVISIONS (C) in the matter following clause (ii) in device exemptions. paragraph (2)(A)— Sec. 607. Unique device identifier. Subtitle A—Reauthorizations (i) by striking ‘‘subsection (c)(5)’’ and in- Sec. 608. Clarification of least burdensome Sec. 1101. Reauthorization of provision re- serting ‘‘subsection (c)(4)’’; and standard. lating to exclusivity of certain (ii) by striking ‘‘payable on or before Octo- Sec. 609. Custom devices. drugs containing single ber 1 of each year’’ and inserting ‘‘due on the Sec. 610. Agency documentation and review enantiomers. later of the first business day on or after Oc- of certain decisions regarding Sec. 1102. Reauthorization of the Critical tober 1 of each fiscal year or the first busi- devices. Path Public-Private Partner- ness day after the enactment of an appro- Sec. 611. Good guidance practices relating to ships. priations Act providing for the collection devices. Subtitle B—Medical Gas Product Regulation and obligation of fees for such fiscal year Sec. 612. Modification of de novo application Sec. 1111. Regulation of medical gas prod- under this section’’; and process. ucts. (D) in paragraph (3)— Sec. 613. Humanitarian device exemptions. Sec. 1112. Regulations. (i) in subparagraph (A)— Sec. 614. Reauthorization of third-party re- Sec. 1113. Applicability. (I) by striking ‘‘subsection (c)(5)’’ and in- view and inspections. serting ‘‘subsection (c)(4)’’; and Sec. 615. 510(k) device modifications. Subtitle C—Miscellaneous Provisions (II) by striking ‘‘payable on or before Octo- Sec. 616. Health information technology. Sec. 1121. Advisory committee conflicts of ber 1 of each year.’’ and inserting ‘‘due on interest. TITLE VII—DRUG SUPPLY CHAIN the later of the first business day on or after Sec. 1122. Guidance document regarding Subtitle A—Drug Supply Chain October 1 of each fiscal year or the first busi- product promotion using the ness day after the enactment of an appro- Sec. 701. Registration of domestic drug es- Internet. tablishments. Sec. 1123. Electronic submission of applica- priations Act providing for the collection Sec. 702. Registration of foreign establish- tions. and obligation of fees for such fiscal year ments. Sec. 1124. Combating prescription drug under this section.’’; and Sec. 703. Identification of drug excipient in- abuse. (ii) by amending subparagraph (B) to read formation with product listing. Sec. 1125. Tanning bed labeling. as follows: Sec. 704. Electronic system for registration Sec. 1126. Optimizing global clinical trials. ‘‘(B) EXCEPTION.—A prescription drug prod- and listing. Sec. 1127. Advancing regulatory science to uct shall not be assessed a fee under subpara- Sec. 705. Risk-based inspection frequency. promote public health innova- graph (A) if such product is— Sec. 706. Records for inspection. tion. ‘‘(i) identified on the list compiled under Sec. 707. Failure to allow foreign inspection. Sec. 1128. Information technology. section 505(j)(7) with a potency described in Sec. 708. Exchange of information. Sec. 1129. Reporting requirements. terms of per 100 mL; Sec. 709. Enhancing the safety and quality Sec. 1130. Strategic integrated management ‘‘(ii) the same product as another product of the drug supply. plan. that— Sec. 710. Accreditation of third-party audi- Sec. 1131. Drug development and testing. ‘‘(I) was approved under an application tors for drug establishments. Sec. 1132. Patient participation in medical filed under section 505(b) or 505(j); and Sec. 711. Standards for admission of im- product discussions. ‘‘(II) is not in the list of discontinued prod- ported drugs. Sec. 1133. Nanotechnology regulatory ucts compiled under section 505(j)(7); Sec. 712. Notification. science program. ‘‘(iii) the same product as another product Sec. 713. Protection against intentional Sec. 1134. Online pharmacy report to Con- that was approved under an abbreviated ap- adulteration. gress. plication filed under section 507 (as in effect Sec. 714. Enhanced criminal penalty for Sec. 1135. Medication and device errors. on the day before the date of enactment of counterfeiting drugs. Sec. 1136. Compliance provision. the Food and Drug Administration Mod- Sec. 715. Extraterritorial jurisdiction. (b) REFERENCES IN ACT.—Except as other- ernization Act of 1997); or Sec. 716. Compliance with international wise specified, amendments made by this Act ‘‘(iv) the same product as another product agreements. to a section or other provision of law are that was approved under an abbreviated new Subtitle B—Pharmaceutical Distribution amendments to such section or other provi- drug application pursuant to regulations in Integrity sion of the Federal Food, Drug, and Cosmetic effect prior to the implementation of the Sec. 721. Short title. Act (21 U.S.C. 301 et seq.). Drug Price Competition and Patent Term Sec. 722. Securing the pharmaceutical dis- TITLE I—FEES RELATING TO DRUGS Restoration Act of 1984.’’; tribution supply chain. (2) in subsection (b)— SEC. 101. SHORT TITLE; FINDING. (A) in paragraph (1)— TITLE VIII—GENERATING ANTIBIOTIC (a) SHORT TITLE.—This title may be cited INCENTIVES NOW (i) in the matter preceding subparagraph as the ‘‘Prescription Drug User Fee Amend- (A), by striking ‘‘fiscal years 2008 through Sec. 801. Extension of exclusivity period for ments of 2012’’. 2012’’ and inserting ‘‘fiscal years 2013 through drugs. (b) FINDING.—The Congress finds that the 2017’’; Sec. 802. Priority review. fees authorized by the amendments made in (ii) in subparagraph (A), by striking Sec. 803. Fast track product. this title will be dedicated toward expediting ‘‘$392,783,000; and’’ and inserting Sec. 804. GAO study. the drug development process and the proc- ‘‘$693,099,000;’’; and Sec. 805. Clinical trials. ess for the review of human drug applica- (iii) by striking subparagraph (B) and in- Sec. 806. Regulatory certainty and predict- tions, including postmarket drug safety ac- serting the following: ability. tivities, as set forth in the goals identified ‘‘(B) the dollar amount equal to the infla- TITLE IX—DRUG APPROVAL AND for purposes of part 2 of subchapter C of tion adjustment for fiscal year 2013 (as deter- PATIENT ACCESS chapter VII of the Federal Food, Drug, and mined under paragraph (3)(A)); and Sec. 901. Enhancement of accelerated pa- Cosmetic Act, in the letters from the Sec- ‘‘(C) the dollar amount equal to the work- tient access to new medical retary of Health and Human Services to the load adjustment for fiscal year 2013 (as deter- treatments. Chairman of the Committee on Health, Edu- mined under paragraph (3)(B)).’’; and Sec. 902. Breakthrough therapies. cation, Labor, and Pensions of the Senate (B) by striking paragraphs (3) and (4) and Sec. 903. Consultation with external experts and the Chairman of the Committee on En- inserting the following: on rare diseases, targeted ergy and Commerce of the House of Rep- ‘‘(3) FISCAL YEAR 2013 INFLATION AND WORK- therapies, and genetic targeting resentatives, as set forth in the Congres- LOAD ADJUSTMENTS.—For purposes of para- of treatments. sional Record. graph (1), the dollar amount of the inflation Sec. 904. Accessibility of information on pre- SEC. 102. DEFINITIONS. and workload adjustments for fiscal year scription drug container labels Paragraph (7) of section 735 (21 U.S.C. 379g) 2013 shall be determined as follows: by visually-impaired and blind is amended, in the matter preceding subpara- ‘‘(A) INFLATION ADJUSTMENT.—The infla- consumers. graph (A), by striking ‘‘incurred’’. tion adjustment for fiscal year 2013 shall be Sec. 905. Risk-benefit framework. SEC. 103. AUTHORITY TO ASSESS AND USE DRUG the sum of— Sec. 906. Independent study on medical inno- FEES. ‘‘(i) $652,709,000 multiplied by the result of vation inducement model. Section 736 (21 U.S.C. 379h) is amended— an inflation adjustment calculation deter- Sec. 907. Orphan product grants program. (1) in subsection (a)— mined using the methodology described in Sec. 908. Reporting of inclusion of demo- (A) in the matter preceding paragraph (1), subsection (c)(1)(B); and graphic subgroups in clinical by striking ‘‘fiscal year 2008’’ and inserting ‘‘(ii) $652,709,000 multiplied by the result of trials and data analysis in ap- ‘‘fiscal year 2013’’; an inflation adjustment calculation deter- plications for drugs, biologics, (B) in paragraph (1), in clauses (i) and (ii) mined using the methodology described in and devices. of subparagraph (A), by striking ‘‘subsection subsection (c)(1)(C).

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‘‘(B) WORKLOAD ADJUSTMENT.—Subject to adjustment and the supporting methodolo- in advance in a prior year appropriations subparagraph (C), the workload adjustment gies. Act.’’; for fiscal 2013 shall be— ‘‘(B) Under no circumstances shall the ad- (C) in paragraph (3), by striking ‘‘fiscal ‘‘(i) $652,709,000 plus the amount of the in- justment result in fee revenues for a fiscal years 2008 through 2012’’ and inserting ‘‘fiscal flation adjustment calculated under subpara- year that are less than the sum of the years 2013 through 2017’’; and graph (A); multiplied by amount under subsection (b)(1)(A) and the (D) in paragraph (4)— ‘‘(ii) the amount (if any) by which a per- amount under subsection (b)(1)(B), as ad- (i) by striking ‘‘fiscal years 2008 through centage workload adjustment for fiscal year justed for inflation under paragraph (1). 2010’’ and inserting ‘‘fiscal years 2013 through 2013, as determined using the methodology ‘‘(C) The Secretary shall contract with an 2015’’; described in subsection (c)(2)(A), would ex- independent accounting or consulting firm (ii) by striking ‘‘fiscal year 2011’’ and in- ceed the percentage workload adjustment (as to periodically review the adequacy of the serting ‘‘fiscal year 2016’’; so determined) for fiscal year 2012, if both adjustment and publish the results of those (iii) by striking ‘‘fiscal years 2008 though such adjustment percentages were calculated reviews. The first review shall be conducted 2011’’ and inserting ‘‘fiscal years 2013 through using the 5-year base period consisting of fis- and published by the end of fiscal year 2013 2016’’; and cal years 2003 through 2007. (to examine the performance of the adjust- (iv) by striking ‘‘fiscal year 2012’’ and in- ‘‘(C) LIMITATION.—Under no circumstances ment since fiscal year 2009), and the second serting ‘‘fiscal year 2017’’. shall the adjustment under subparagraph (B) review shall be conducted and published by SEC. 104. REAUTHORIZATION; REPORTING RE- result in fee revenues for fiscal year 2013 that the end of fiscal year 2015 (to examine the QUIREMENTS. are less than the sum of the amount under continued performance of the adjustment). Section 736B (21 U.S.C. 379h–2) is amend- paragraph (1)(A) and the amount under para- The reports shall evaluate whether the ad- ed— graph (1)(B).’’; justment reasonably represents actual (1) by amending subsection (a) to read as (3) by striking subsection (c) and inserting changes in workload volume and complexity follows: the following: and present options to discontinue, retain, or ‘‘(a) PERFORMANCE REPORT.—Beginning ‘‘(c) ADJUSTMENTS.— modify any elements of the adjustment. The with fiscal year 2013, not later than 120 days ‘‘(1) INFLATION ADJUSTMENT.—For fiscal reports shall be published for public com- after the end of each fiscal year for which year 2014 and subsequent fiscal years, the ment. After review of the reports and receipt fees are collected under this part, the Sec- revenues established in subsection (b) shall of public comments, the Secretary shall, if retary shall prepare and submit to the Com- be adjusted by the Secretary by notice, pub- warranted, adopt appropriate changes to the mittee on Energy and Commerce of the lished in the Federal Register, for a fiscal methodology. If the Secretary adopts House of Representatives and the Committee year by the amount equal to the sum of— changes to the methodology based on the on Health, Education, Labor, and Pensions of ‘‘(A) one; first report, the changes shall be effective for the Senate a report concerning the progress ‘‘(B) the average annual percent change in the first fiscal year for which fees are set of the Food and Drug Administration in the cost, per full-time equivalent position of after the Secretary adopts such changes and achieving the goals identified in the letters the Food and Drug Administration, of all each subsequent fiscal year. described in section 101(b) of the Prescrip- personnel compensation and benefits paid ‘‘(3) FINAL YEAR ADJUSTMENT.—For fiscal tion Drug User Fee Amendments of 2012 dur- with respect to such positions for the first 3 year 2017, the Secretary may, in addition to ing such fiscal year and the future plans of years of the preceding 4 fiscal years, multi- adjustments under this paragraph and para- the Food and Drug Administration for meet- plied by the proportion of personnel com- graphs (1) and (2), further increase the fee ing the goals. The report under this sub- pensation and benefits costs to total costs of revenues and fees established in subsection section for a fiscal year shall include infor- the process for the review of human drug ap- (b) if such an adjustment is necessary to pro- mation on all previous cohorts for which the plications (as defined in section 735(6)) for vide for not more than 3 months of operating Secretary has not given a complete response the first 3 years of the preceding 4 fiscal reserves of carryover user fees for the proc- on all human drug applications and supple- years; and ess for the review of human drug applica- ments in the cohort.’’; ‘‘(C) the average annual percent change tions for the first 3 months of fiscal year (2) in subsection (b), by striking ‘‘2008’’ and that occurred in the Consumer Price Index 2018. If such an adjustment is necessary, the inserting ‘‘2013’’; and for urban consumers (Washington-Baltimore, rationale for the amount of the increase (3) in subsection (d), by striking ‘‘2012’’ DC–MD–VA–WV; Not Seasonally Adjusted; shall be contained in the annual notice es- each place it appears and inserting ‘‘2017’’. All items; Annual Index) for the first 3 years tablishing fee revenues and fees for fiscal SEC. 105. SUNSET DATES. of the preceding 4 years of available data, year 2017. If the Secretary has carryover bal- (a) AUTHORIZATION.—Sections 735 and 736 of multiplied by the proportion of all costs ances for such process in excess of 3 months the Federal Food, Drug, and Cosmetic Act other than personnel compensation and ben- of such operating reserves, the adjustment (21 U.S.C. 379g; 379h) shall cease to be effec- efits costs to total costs of the process for under this paragraph shall not be made. tive October 1, 2017. the review of human drug applications (as ‘‘(4) ANNUAL FEE SETTING.—The Secretary (b) REPORTING REQUIREMENTS.—Section defined in section 735(6)) for the first 3 years shall, not later than 60 days before the start 736B of the Federal Food, Drug, and Cos- of the preceding 4 fiscal years. of each fiscal year that begins after Sep- metic Act (21 U.S.C. 379h–2) shall cease to be The adjustment made each fiscal year under tember 30, 2012, establish, for the next fiscal effective January 31, 2018. this paragraph shall be added on a com- year, application, product, and establish- (c) PREVIOUS SUNSET PROVISION.—Section pounded basis to the sum of all adjustments ment fees under subsection (a), based on the 106 of the Prescription Drug User Fee made each fiscal year after fiscal year 2013 revenue amounts established under sub- Amendments of 2007 (Title I of Public Law under this paragraph. section (b) and the adjustments provided 110–85) is repealed. ‘‘(2) WORKLOAD ADJUSTMENT.—For fiscal under this subsection. (d) TECHNICAL CLARIFICATIONS.— year 2014 and subsequent fiscal years, after ‘‘(5) LIMIT.—The total amount of fees (1) Effective September 30, 2007, section 509 the fee revenues established in subsection (b) charged, as adjusted under this subsection, of the Prescription Drug User Fee Amend- are adjusted for a fiscal year for inflation in for a fiscal year may not exceed the total ments Act of 2002 (Title V of Public Law 107– accordance with paragraph (1), the fee reve- costs for such fiscal year for the resources 188) is repealed. nues shall be adjusted further for such fiscal allocated for the process for the review of (2) Effective September 30, 2002, section 107 year to reflect changes in the workload of human drug applications.’’; and of the Food and Drug Administration Mod- the Secretary for the process for the review (4) in subsection (g)— ernization Act of 1997 (Public Law 105–115) is of human drug applications. With respect to (A) in paragraph (1), by striking ‘‘Fees au- repealed. such adjustment: thorized’’ and inserting ‘‘Subject to para- (3) Effective September 30, 1997, section 105 ‘‘(A) The adjustment shall be determined graph (2)(C), fees authorized’’; of the Prescription Drug User Fee Act of 1992 by the Secretary based on a weighted aver- (B) in paragraph (2)— (Public Law 102–571) is repealed. age of the change in the total number of (i) in subparagraph (A)— SEC. 106. EFFECTIVE DATE. human drug applications (adjusted for (I) in clause (i), by striking ‘‘shall be re- The amendments made by this title shall changes in review activities, as described in tained’’ and inserting ‘‘subject to subpara- take effect on October 1, 2012, or the date of the notice that the Secretary is required to graph (C), shall be collected and available’’; the enactment of this Act, whichever is publish in the Federal Register under this and later, except that fees under part 2 of sub- subparagraph), efficacy supplements, and (II) in clause (ii), by striking ‘‘shall only be chapter C of chapter VII of the Federal Food, manufacturing supplements submitted to the collected and available’’ and inserting ‘‘shall Drug, and Cosmetic Act shall be assessed for Secretary, and the change in the total num- be available’’; and all human drug applications received on or ber of active commercial investigational new (ii) by adding at the end the following new after October 1, 2012, regardless of the date of drug applications (adjusted for changes in re- subparagraph: the enactment of this Act. view activities, as so described) during the ‘‘(C) PROVISION FOR EARLY PAYMENTS.— SEC. 107. SAVINGS CLAUSE. most recent 12-month period for which data Payment of fees authorized under this sec- Notwithstanding the amendments made by on such submissions is available. The Sec- tion for a fiscal year, prior to the due date this title, part 2 of subchapter C of chapter retary shall publish in the Federal Register for such fees, may be accepted by the Sec- VII of the Federal Food, Drug, and Cosmetic the fee revenues and fees resulting from the retary in accordance with authority provided Act, as in effect on the day before the date

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00043 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3338 CONGRESSIONAL RECORD — SENATE May 21, 2012 of the enactment of this title, shall continue SEC. 202. DEFINITIONS. (3) in paragraph (3)— to be in effect with respect to human drug Section 737 (21 U.S.C. 379i) is amended— (A) in subparagraph (A)— applications and supplements (as defined in (1) in paragraph (9), by striking ‘‘incurred’’ (i) by inserting ‘‘and subsection (f)’’ after such part as of such day) that on or after Oc- after ‘‘expenses’’; ‘‘subparagraph (B)’’; and tober 1, 2007, but before October 1, 2012, were (2) in paragraph (10), by striking ‘‘October (ii) by striking ‘‘2008’’ and inserting ‘‘2013’’; accepted by the Food and Drug Administra- 2001’’ and inserting ‘‘October 2011’’; and and tion for filing with respect to assessing and (3) in paragraph (13), by striking ‘‘is re- (B) in subparagraph (C), by striking ‘‘ini- collecting any fee required by such part for quired to register’’ and all that follows tial registration’’ and all that follows a fiscal year prior to fiscal year 2012. through the end of paragraph (13) and insert- through ‘‘section 510.’’ and inserting ‘‘later ing the following: ‘‘is registered (or is re- TITLE II—FEES RELATING TO DEVICES of— quired to register) with the Secretary under ‘‘(i) the initial or annual registration (as SEC. 201. SHORT TITLE; FINDINGS. section 510 because such establishment is en- applicable) of the establishment under sec- (a) SHORT TITLE.—This title may be cited gaged in the manufacture, preparation, prop- tion 510; or as the ‘‘Medical Device User Fee Amend- agation, compounding, or processing of a de- ‘‘(ii) the first business day after the date of ments of 2012’’. vice.’’. enactment of an appropriations Act pro- (b) FINDINGS.—The Congress finds that the SEC. 203. AUTHORITY TO ASSESS AND USE DE- viding for the collection and obligation of fees authorized under the amendments made VICE FEES. fees for such year under this section.’’. by this title will be dedicated toward expe- (a) TYPES OF FEES.—Section 738(a) (21 diting the process for the review of device U.S.C. 379j(a)) is amended— (b) FEE AMOUNTS.—Section 738(b) (21 U.S.C. applications and for assuring the safety and (1) in paragraph (1), by striking ‘‘fiscal 379j(b)) is amended to read as follows: effectiveness of devices, as set forth in the year 2008’’ and inserting ‘‘fiscal year 2013’’; ‘‘(b) FEE AMOUNTS.— goals identified for purposes of part 3 of sub- (2) in paragraph (2)(A)— ‘‘(1) IN GENERAL.—Subject to subsections chapter C of chapter VII of the Federal Food, (A) in the matter preceding clause (i)— (c), (d), (e), (f), and (i), for each of fiscal years Drug, and Cosmetic Act in the letters from (i) by striking ‘‘subsections (d) and (e)’’ 2013 through 2017, fees under subsection (a) the Secretary of Health and Human Services and inserting ‘‘subsections (d), (e), and (f)’’; shall be derived from the base fee amounts to the Chairman of the Committee on (ii) by striking ‘‘October 1, 2002’’ and in- specified in paragraph (2), to generate the Health, Education, Labor, and Pensions of serting ‘‘October 1, 2012’’; and total revenue amounts specified in paragraph the Senate and the Chairman of the Com- (iii) by striking ‘‘subsection (c)(1)’’ and in- (3). mittee on Energy and Commerce of the serting ‘‘subsection (c)’’; and ‘‘(2) BASE FEE AMOUNTS.—For purposes of House of Representatives, as set forth in the (B) in clause (viii), by striking ‘‘1.84’’ and paragraph (1), the base fee amounts specified Congressional Record. inserting ‘‘2’’; and in this paragraph are as follows:

Fiscal Fiscal Fiscal Fiscal Fiscal ‘‘Fee Type Year Year Year Year Year 2013 2014 2015 2016 2017

Premarket Application ...... $248,000 $252,960 $258,019 $263,180 $268,443 Establishment Registration...... $2,575 $3,200 $3,750 $3,872 $3,872

‘‘(3) TOTAL REVENUE AMOUNTS.—For pur- the fiscal years preceding such fiscal year, enue amounts, as adjusted under paragraph poses of paragraph (1), the total revenue beginning with fiscal year 2014. (2).’’. amounts specified in this paragraph are as ‘‘(C) BASE INFLATION ADJUSTMENT TO TOTAL (d) FEE WAIVER OR REDUCTION.—Section 738 follows: REVENUE AMOUNTS.— (21 U.S.C. 379j) is amended by— ‘‘(A) $97,722,301 for fiscal year 2013. ‘‘(i) IN GENERAL.—Subject to further ad- (1) redesignating subsections (f) through ‘‘(B) $112,580,497 for fiscal year 2014. justment under clause (ii), the base inflation (k) as subsections (g) through (l), respec- ‘‘(C) $125,767,107 for fiscal year 2015. adjustment for a fiscal year is the sum of one tively; and ‘‘(D) $129,339,949 for fiscal year 2016. plus— (2) by inserting after subsection (e) the fol- ‘‘(E) $130,184,348 for fiscal year 2017.’’. ‘‘(I) the average annual percent change in lowing new subsection: (c) ANNUAL FEE SETTING; ADJUSTMENTS.— the cost, per full-time equivalent position of ‘‘(f) FEE WAIVER OR REDUCTION.— Section 738(c) (21 U.S.C. 379j(c)) is amended— the Food and Drug Administration, of all ‘‘(1) IN GENERAL.—The Secretary may, at (1) in the subsection heading, by inserting personnel compensation and benefits paid the Secretary’s sole discretion, grant a waiv- ‘‘; ADJUSTMENTS’’ after ‘‘SETTING’’; with respect to such positions for the first 3 er or reduction of fees under subsection (a)(2) (2) by striking paragraphs (1) and (2); years of the preceding 4 fiscal years, multi- or (a)(3) if the Secretary finds that such (3) by redesignating paragraphs (3) and (4) plied by 0.60; and waiver or reduction is in the interest of pub- as paragraphs (4) and (5), respectively; and ‘‘(II) the average annual percent change lic health. (4) by inserting before paragraph (4), as so that occurred in the Consumer Price Index ‘‘(2) LIMITATION.—The sum of all fee waiv- redesignated, the following: for urban consumers (Washington-Baltimore, ers or reductions granted by the Secretary in ‘‘(1) IN GENERAL.—The Secretary shall, 60 DC–MD–VA–WV; Not Seasonally Adjusted; any fiscal year under paragraph (1) shall not days before the start of each fiscal year after All items; Annual Index) for the first 3 years exceed 2 percent of the total fee revenue September 30, 2012, establish fees under sub- of the preceding 4 years of available data amounts established for such year under sub- section (a), based on amounts specified under multiplied by 0.40. section (c). subsection (b) and the adjustments provided ‘‘(ii) LIMITATIONS.—For purposes of sub- ‘‘(3) DURATION.—The authority provided by under this subsection, and publish such fees, paragraph (B), if the base inflation adjust- this subsection terminates October 1, 2017.’’. and the rationale for any adjustments to ment for a fiscal year under clause (i)— such fees, in the Federal Register. ‘‘(I) is less than 1, such adjustment shall be (e) CONDITIONS.—Section 738(h)(1)(A) (21 ‘‘(2) INFLATION ADJUSTMENTS.— considered to be equal to 1; or U.S.C. 379j(h)(1)(A)), as redesignated by sub- ‘‘(A) ADJUSTMENT TO TOTAL REVENUE ‘‘(II) is greater than 1.04, such adjustment section (d)(1), is amended by striking AMOUNTS.—For fiscal year 2014 and each sub- shall be considered to be equal to 1.04. ‘‘$205,720,000’’ and inserting ‘‘$280,587,000’’. sequent fiscal year, the Secretary shall ad- ‘‘(D) ADJUSTMENT TO BASE FEE AMOUNTS.— (f) CREDITING AND AVAILABILITY OF FEES.— just the total revenue amount specified in For each of fiscal years 2014 through 2017, the Section 738(i) (21 U.S.C. 379j(i)), as redesig- subsection (b)(3) for such fiscal year by mul- base fee amounts specified in subsection nated by subsection (d)(1), is amended— tiplying such amount by the applicable infla- (b)(2) shall be adjusted as needed, on a uni- (1) in paragraph (1), by striking ‘‘Fees au- tion adjustment under subparagraph (B) for form proportionate basis, to generate the thorized’’ and inserting ‘‘Subject to para- such year. total revenue amounts under subsection graph (2)(C), fees authorized’’; ‘‘(B) APPLICABLE INFLATION ADJUSTMENT TO (b)(3), as adjusted for inflation under sub- (2) in paragraph (2)— TOTAL REVENUE AMOUNTS.—The applicable in- paragraph (A). (A) in subparagraph (A)— flation adjustment for a fiscal year is— ‘‘(3) VOLUME-BASED ADJUSTMENTS TO ESTAB- (i) in clause (i), by striking ‘‘shall be re- ‘‘(i) for fiscal year 2014, the base inflation LISHMENT REGISTRATION BASE FEES.—For each tained’’ and inserting ‘‘subject to subpara- adjustment under subparagraph (C) for such of fiscal years 2014 through 2017, after the graph (C), shall be collected and available’’; fiscal year; and base fee amounts specified in subsection and ‘‘(ii) for fiscal year 2015 and each subse- (b)(2) are adjusted under paragraph (2)(D), (ii) in clause (ii)— quent fiscal year, the product of— the base establishment registration fee (I) by striking ‘‘collected and’’ after ‘‘shall ‘‘(I) the base inflation adjustment under amounts specified in such subsection shall be only be’’; and subparagraph (C) for such fiscal year; and further adjusted, as the Secretary estimates (II) by striking ‘‘fiscal year 2002’’ and in- ‘‘(II) the product of the base inflation ad- is necessary in order for total fee collections serting ‘‘fiscal year 2009’’; and justment under subparagraph (C) for each of for such fiscal year to generate the total rev- (B) by adding at the end, the following:

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‘‘(C) PROVISION FOR EARLY PAYMENTS.— (b) REPORTING REQUIREMENTS.—Section of the Drug Price Competition and Patent Payment of fees authorized under this sec- 738A (21 U.S.C. 739j–1) shall cease to be effec- Term Restoration Act of 1984; and tion for a fiscal year, prior to the due date tive January 31, 2018. ‘‘(B) does not include an application for a for such fees, may be accepted by the Sec- (c) PREVIOUS SUNSET PROVISION.—Section positron emission tomography drug. retary in accordance with authority provided 217 of the Medical Device User Fee Amend- ‘‘(2) The term ‘active pharmaceutical in- in advance in a prior year appropriations ments of 2007 (Title II of Public Law 110–85) gredient’ means— Act.’’; is repealed. ‘‘(A) a substance, or a mixture when the (3) by amending paragraph (3) to read as (d) TECHNICAL CLARIFICATION.—Effective substance is unstable or cannot be trans- follows: September 30, 2007, section 107 of the Medical ported on its own, intended— ‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.— Device User Fee and Modernization Act of ‘‘(i) to be used as a component of a drug; For each of the fiscal years 2013 through 2017, 2002 (Public Law 107– 250) is repealed. and there is authorized to be appropriated for SEC. 208. STREAMLINED HIRING AUTHORITY TO ‘‘(ii) to furnish pharmacological activity or fees under this section an amount equal to SUPPORT ACTIVITIES RELATED TO other direct effect in the diagnosis, cure, the total revenue amount specified under THE PROCESS FOR THE REVIEW OF mitigation, treatment, or prevention of dis- subsection (b)(3) for the fiscal year, as ad- DEVICE APPLICATIONS. ease, or to affect the structure or any func- justed under subsection (c) and, for fiscal Subchapter A of chapter VII (21 U.S.C. 371 tion of the human body; or year 2017 only, as further adjusted under et seq.) is amended by inserting after section ‘‘(B) a substance intended for final crys- paragraph (4).’’; and 713 the following new section: tallization, purification, or salt formation, (4) in paragraph (4)— ‘‘SEC. 714. STREAMLINED HIRING AUTHORITY. or any combination of those activities, to be- (A) by striking ‘‘fiscal years 2008, 2009, and ‘‘(a) IN GENERAL.—In addition to any other come a substance or mixture described in 2010’’ and inserting ‘‘fiscal years 2013, 2014, personnel authorities under other provisions subparagraph (A). and 2015’’; of law, the Secretary may, without regard to ‘‘(3) The term ‘adjustment factor’ means a (B) by striking ‘‘fiscal year 2011’’ and in- the provisions of title 5, United States Code, factor applicable to a fiscal year that is the serting ‘‘fiscal year 2016’’; governing appointments in the competitive Consumer Price Index for all urban con- (C) by striking ‘‘June 30, 2011’’ and insert- service, appoint employees to positions in sumers (all items; United States city aver- ing ‘‘June 30, 2016’’; the Food and Drug Administration to per- age) for October of the preceding fiscal year (D) by striking ‘‘the amount of fees speci- form, administer, or support activities de- divided by such Index for October 2011. fied in aggregate in’’ and inserting ‘‘the cu- scribed in subsection (b), if the Secretary de- ‘‘(4) The term ‘affiliate’ means a business mulative amount appropriated pursuant to’’; termines that such appointments are needed entity that has a relationship with a second (E) by striking ‘‘aggregate amount in’’ be- to achieve the objectives specified in sub- business entity if, directly or indirectly— fore ‘‘excess shall be credited’’; and section (c). ‘‘(A) one business entity controls, or has the power to control, the other business enti- (F) by striking ‘‘fiscal year 2012’’ and in- ‘‘(b) ACTIVITIES DESCRIBED.—The activities serting ‘‘fiscal year 2017’’. described in this subsection are activities ty; or ‘‘(B) a third party controls, or has power to (g) CONFORMING AMENDMENT.—Section under this Act related to the process for the control, both of the business entities. 515(c)(4)(A) (21 U.S.C. 360e(c)(4)(A)) is amend- review of device applications (as defined in ‘‘(5)(A) The term ‘facility’— ed by striking ‘‘738(g)’’ and inserting section 737(8)). ‘‘(i) means a business or other entity— ‘‘738(h)’’. ‘‘(c) OBJECTIVES SPECIFIED.—The objectives ‘‘(I) under one management, either direct specified in this subsection are with respect SEC. 204. REAUTHORIZATION; REPORTING RE- or indirect; and to the activities under subsection (b), the QUIREMENTS. ‘‘(II) at one geographic location or address goals referred to in section 738A(a)(1). (a) REAUTHORIZATION.—Section 738A(b) (21 engaged in manufacturing or processing an ‘‘(d) INTERNAL CONTROLS.—The Secretary U.S.C. 379j–1(b)) is amended— active pharmaceutical ingredient or a fin- shall institute appropriate internal controls (1) in paragraph (1), by striking ‘‘2012’’ and ished dosage form; and for appointments under this section. inserting ‘‘2017’’; and ‘‘(ii) does not include a business or other ‘‘(e) SUNSET.—The authority to appoint (2) in paragraph (5), by striking ‘‘2012’’ and entity whose only manufacturing or proc- employees under this section shall terminate inserting ‘‘2017’’. essing activities are one or more of the fol- on the date that is three years after the date (b) REPORTS.—Section 738A(a) (21 U.S.C. lowing: repackaging, relabeling, or testing. 379j–1(a)) is amended— of enactment of this section.’’. ‘‘(B) For purposes of subparagraph (A), sep- (1) by striking ‘‘2008 through 2012’’ each TITLE III—FEES RELATING TO GENERIC arate buildings within close proximity are place it appears and inserting ‘‘2013 through DRUGS considered to be at one geographic location 2017’’; and SEC. 301. SHORT TITLE. or address if the activities in them are— (2) by striking ‘‘section 201(c) of the Food (a) SHORT TITLE.—This title may be cited ‘‘(i) closely related to the same business and Drug Administration Amendments Act as the ‘‘Generic Drug User Fee Amendments enterprise; of 2007’’ and inserting ‘‘section 201(b) of the of 2012’’. ‘‘(ii) under the supervision of the same Medical Device User Fee Amendments of (b) FINDING.—The Congress finds that the local management; and 2012’’. fees authorized by the amendments made in ‘‘(iii) capable of being inspected by the SEC. 205. SAVINGS CLAUSE. this title will be dedicated to human generic Food and Drug Administration during a sin- Notwithstanding the amendments made by drug activities, as set forth in the goals iden- gle inspection. this title, part 3 of subchapter C of chapter tified for purposes of part 7 of subchapter C ‘‘(C) If a business or other entity would VII of the Federal Food, Drug, and Cosmetic of chapter VII of the Federal Food, Drug, and meet the definition of a facility under this Act (21 U.S.C. 379i et seq.), as in effect on the Cosmetic Act, in the letters from the Sec- paragraph but for being under multiple man- day before the date of the enactment of this retary of Health and Human Services to the agement, the business or other entity is title, shall continue to be in effect with re- Chairman of the Committee on Health, Edu- deemed to constitute multiple facilities, one spect to submissions described in section cation, Labor, and Pensions of the Senate per management entity, for purposes of this 738(a)(2)(A) of the Federal Food, Drug, and and the Chairman of the Committee on En- paragraph. Cosmetic Act (as in effect as of such day) ergy and Commerce of the House of Rep- ‘‘(6) The term ‘finished dosage form’ that on or after October 1, 2007, but before resentatives, as set forth in the Congres- means— October 1, 2012, were accepted by the Food sional Record. ‘‘(A) a drug product in the form in which it will be administered to a patient, such as a and Drug Administration for filing with re- SEC. 302. AUTHORITY TO ASSESS AND USE spect to assessing and collecting any fee re- HUMAN GENERIC DRUG FEES. tablet, capsule, solution, or topical applica- quired by such part for a fiscal year prior to Subchapter C of chapter VII (21 U.S.C. 379f tion; fiscal year 2013. et seq.) is amended by adding at the end the ‘‘(B) a drug product in a form in which re- following: constitution is necessary prior to adminis- SEC. 206. EFFECTIVE DATE. tration to a patient, such as oral suspensions The amendments made by this title shall ‘‘PART 7—FEES RELATING TO GENERIC or lyophilized powders; or take effect on October 1, 2012, or the date of DRUGS ‘‘(C) any combination of an active pharma- the enactment of this Act, whichever is ‘‘SEC. 744A. DEFINITIONS. ceutical ingredient with another component later, except that fees under part 3 of sub- ‘‘For purposes of this part: of a drug product for purposes of production chapter C of chapter VII of the Federal Food, ‘‘(1) The term ‘abbreviated new drug appli- of a drug product described in subparagraph Drug, and Cosmetic Act shall be assessed for cation’— (A) or (B). submissions described in section 738(a)(2)(A) ‘‘(A) means an application submitted under ‘‘(7) The term ‘generic drug submission’ of the Federal Food, Drug, and Cosmetic Act section 505(j), an abbreviated application means an abbreviated new drug application, received on or after October 1, 2012, regard- submitted under section 507 (as in effect on an amendment to an abbreviated new drug less of the date of the enactment of this Act. the day before the date of enactment of the application, or a prior approval supplement SEC. 207. SUNSET DATES. Food and Drug Administration Moderniza- to an abbreviated new drug application. (a) AUTHORIZATIONS.—Sections 737 and 738 tion Act of 1997), or an abbreviated new drug ‘‘(8) The term ‘human generic drug activi- (21 U.S.C. 739i; 739j) shall cease to be effec- application submitted pursuant to regula- ties’ means the following activities of the tive October 1, 2017. tions in effect prior to the implementation Secretary associated with generic drugs and

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00045 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3340 CONGRESSIONAL RECORD — SENATE May 21, 2012 inspection of facilities associated with ge- entific equipment, and other necessary ma- has paid the fee required under subparagraph neric drugs: terials and supplies; and (A) within 20 calendar days after the applica- ‘‘(A) The activities necessary for the re- ‘‘(D) collecting fees under subsection (a) ble due date under subparagraph (E); and view of generic drug submissions, including and accounting for resources allocated for ‘‘(II) the drug master file has not failed an review of drug master files referenced in the review of abbreviated new drug applica- initial completeness assessment by the Sec- such submissions. tions and supplements and inspection related retary, in accordance with criteria to be pub- ‘‘(B) The issuance of— to generic drugs. lished by the Secretary. ‘‘(i) approval letters which approve abbre- ‘‘(12) The term ‘Type II active pharma- ‘‘(iii) LIST.—The Secretary shall make pub- viated new drug applications or supplements ceutical ingredient drug master file’ means a licly available on the Internet Web site of to such applications; or submission of information to the Secretary the Food and Drug Administration a list of ‘‘(ii) complete response letters which set by a person that intends to authorize the the drug master file numbers that cor- forth in detail the specific deficiencies in Food and Drug Administration to reference respond to drug master files that have suc- such applications and, where appropriate, the information to support approval of a ge- cessfully undergone an initial completeness the actions necessary to place such applica- neric drug submission without the submitter assessment, in accordance with criteria to be tions in condition for approval. having to disclose the information to the ge- published by the Secretary, and are available ‘‘(C) The issuance of letters related to Type neric drug submission applicant. for reference. II active pharmaceutical drug master files ‘‘SEC. 744B. AUTHORITY TO ASSESS AND USE ‘‘(E) FEE DUE DATE.— HUMAN GENERIC DRUG FEES. which— ‘‘(i) IN GENERAL.—Subject to clause (ii), a ‘‘(a) TYPES OF FEES.—Beginning in fiscal ‘‘(i) set forth in detail the specific defi- drug master file fee shall be due no later year 2013, the Secretary shall assess and col- ciencies in such submissions, and where ap- than the date on which the first generic drug lect fees in accordance with this section as propriate, the actions necessary to resolve follows: submission is submitted that references the those deficiencies; or associated Type II active pharmaceutical in- ‘‘(1) ONE-TIME BACKLOG FEE FOR ABBRE- ‘‘(ii) document that no deficiencies need to gredient drug master file. VIATED NEW DRUG APPLICATIONS PENDING ON IMITATION be addressed. OCTOBER 1, 2012.— ‘‘(ii) L .—No fee shall be due under ‘‘(D) Inspections related to generic drugs. ‘‘(A) IN GENERAL.—Each person that owns subparagraph (A) for a fiscal year until the ‘‘(E) Monitoring of research conducted in an abbreviated new drug application that is later of— connection with the review of generic drug pending on October 1, 2012, and that has not ‘‘(I) 30 calendar days after publication of submissions and drug master files. received a tentative approval prior to that the notice provided for in clause (i) or (ii) of ‘‘(F) Postmarket safety activities with re- date, shall be subject to a fee for each such subparagraph (C), as applicable; or spect to drugs approved under abbreviated application, as calculated under subpara- ‘‘(II) 30 calendar days after the date of en- new drug applications or supplements, in- graph (B). actment of an appropriations Act providing cluding the following activities: ‘‘(B) METHOD OF FEE AMOUNT CALCULA- for the collection and obligation of fees ‘‘(i) Collecting, developing, and reviewing TION.—The amount of each one-time backlog under this section. safety information on approved drugs, in- fee shall be calculated by dividing $50,000,000 ‘‘(3) ABBREVIATED NEW DRUG APPLICATION cluding adverse event reports. by the total number of abbreviated new drug AND PRIOR APPROVAL SUPPLEMENT FILING ‘‘(ii) Developing and using improved ad- applications pending on October 1, 2012, that FEE.— verse-event data-collection systems, includ- have not received a tentative approval as of ‘‘(A) IN GENERAL.—Each applicant that sub- ing information technology systems. that date. mits, on or after October 1, 2012, an abbre- ‘‘(iii) Developing and using improved ana- ‘‘(C) NOTICE.—Not later than October 31, viated new drug application or a prior ap- lytical tools to assess potential safety prob- 2012, the Secretary shall publish in the Fed- proval supplement to an abbreviated new lems, including access to external data eral Register a notice announcing the drug application shall be subject to a fee for bases. amount of the fee required by subparagraph each such submission in the amount estab- ‘‘(iv) Implementing and enforcing section (A). lished under subsection (d). 505(o) (relating to postapproval studies and ‘‘(D) FEE DUE DATE.—The fee required by ‘‘(B) NOTICE.— clinical trials and labeling changes) and sec- subparagraph (A) shall be due no later than ‘‘(i) FISCAL YEAR 2013.—Not later than Octo- tion 505(p) (relating to risk evaluation and 30 calendar days after the date of the publi- ber 31, 2012, the Secretary shall publish in mitigation strategies) insofar as those ac- cation of the notice specified in subpara- the Federal Register a notice announcing the tivities relate to abbreviated new drug appli- graph (C). amount of the fees under subparagraph (A) cations. ‘‘(2) DRUG MASTER FILE FEE.— for fiscal year 2013. ‘‘(v) Carrying out section 505(k)(5) (relating ‘‘(A) IN GENERAL.—Each person that owns a ‘‘(ii) FISCAL YEARS 2014 THROUGH 2017.—Not to adverse-event reports and postmarket Type II active pharmaceutical ingredient later than 60 days before the start of each of safety activities). drug master file that is referenced on or fiscal years 2014 through 2017, the Secretary ‘‘(G) Regulatory science activities related after October 1, 2012, in a generic drug sub- shall publish in the Federal Register the to generic drugs. mission by any initial letter of authorization amount of the fees under subparagraph (A) ‘‘(9) The term ‘positron emission tomog- shall be subject to a drug master file fee. for such fiscal year. raphy drug’ has the meaning given to the ‘‘(B) ONE-TIME PAYMENT.—If a person has ‘‘(C) FEE DUE DATE.— term ‘compounded positron emission tomog- paid a drug master file fee for a Type II ac- ‘‘(i) IN GENERAL.—Except as provided in raphy drug’ in section 201(ii), except that tive pharmaceutical ingredient drug master clause (ii), the fees required by subpara- paragraph (1)(B) of such section shall not file, the person shall not be required to pay graphs (A) and (F) shall be due no later than apply. a subsequent drug master file fee when that the date of submission of the abbreviated ‘‘(10) The term ‘prior approval supplement’ Type II active pharmaceutical ingredient new drug application or prior approval sup- means a request to the Secretary to approve drug master file is subsequently referenced plement for which such fee applies. a change in the drug substance, drug prod- in generic drug submissions. ‘‘(ii) SPECIAL RULE FOR 2013.—For fiscal year uct, production process, quality controls, ‘‘(C) NOTICE.— 2013, such fees shall be due on the later of— equipment, or facilities covered by an ap- ‘‘(i) FISCAL YEAR 2013.—Not later than Octo- ‘‘(I) the date on which the fee is due under proved abbreviated new drug application ber 31, 2012, the Secretary shall publish in clause (i); when that change has a substantial potential the Federal Register a notice announcing the ‘‘(II) 30 calendar days after publication of to have an adverse effect on the identity, amount of the drug master file fee for fiscal the notice referred to in subparagraph (B)(i); strength, quality, purity, or potency of the year 2013. or drug product as these factors may relate to ‘‘(ii) FISCAL YEAR 2014 THROUGH 2017.—Not ‘‘(III) if an appropriations Act is not en- the safety or effectiveness of the drug prod- later than 60 days before the start of each of acted providing for the collection and obliga- uct. fiscal years 2014 through 2017, the Secretary tion of fees under this section by the date of ‘‘(11) The term ‘resources allocated for shall publish in the Federal Register the submission of the application or prior ap- human generic drug activities’ means the ex- amount of the drug master file fee estab- proval supplement for which the fees under penses for— lished by this paragraph for such fiscal year. subparagraphs (A) and (F) apply, 30 calendar ‘‘(A) officers and employees of the Food ‘‘(D) AVAILABILITY FOR REFERENCE.— days after the date that such an appropria- and Drug Administration, contractors of the ‘‘(i) IN GENERAL.—Subject to subsection tions Act is enacted. Food and Drug Administration, advisory (g)(2)(C), for a generic drug submission to ‘‘(D) REFUND OF FEE IF ABBREVIATED NEW committees, and costs related to such offi- reference a Type II active pharmaceutical in- DRUG APPLICATION IS NOT CONSIDERED TO HAVE cers and employees and to contracts with gredient drug master file, the drug master BEEN RECEIVED.—The Secretary shall refund such contractors; file must be deemed available for reference 75 percent of the fee paid under subparagraph ‘‘(B) management of information, and the by the Secretary. (A) for any abbreviated new drug application acquisition, maintenance, and repair of com- ‘‘(ii) CONDITIONS.—A drug master file shall or prior approval supplement to an abbre- puter resources; be deemed available for reference by the Sec- viated new drug application that the Sec- ‘‘(C) leasing, maintenance, renovation, and retary if— retary considers not to have been received repair of facilities and acquisition, mainte- ‘‘(I) the person that owns a Type II active within the meaning of section 505(j)(5)(A) for nance, and repair of fixtures, furniture, sci- pharmaceutical ingredient drug master file a cause other than failure to pay fees.

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‘‘(E) FEE FOR AN APPLICATION THE SEC- ‘‘(I) not later than 45 days after the publi- concerning the difference in cost between in- RETARY CONSIDERS NOT TO HAVE BEEN RE- cation of the notice under subparagraph (B); spections of facilities located in the United CEIVED, OR THAT HAS BEEN WITHDRAWN.—An or States, including its territories and posses- abbreviated new drug application or prior ap- ‘‘(II) if an appropriations Act is not en- sions, and those located outside of the proval supplement that was submitted on or acted providing for the collection and obliga- United States and its territories and posses- after October 1, 2012, and that the Secretary tion of fees under this section by the date of sions. considers not to have been received, or that the publication of such notice, 30 days after ‘‘(D) 14 percent shall be derived from fees has been withdrawn, shall, upon resubmis- the date that such an appropriations Act is under subsection (a)(4)(A)(ii) (relating to ac- sion of the application or a subsequent new enacted. tive pharmaceutical ingredient facilities). submission following the applicant’s with- ‘‘(ii) FISCAL YEARS 2014 THROUGH 2017.—For The amount of the fee for a facility located drawal of the application, be subject to a full each of fiscal years 2014 through 2017, the outside the United States and its territories fee under subparagraph (A). fees under subparagraph (A) for such fiscal and possessions shall be not less than $15,000 ‘‘(F) ADDITIONAL FEE FOR ACTIVE PHARMA- year shall be due on the later of— and not more than $30,000 higher than the CEUTICAL INGREDIENT INFORMATION NOT IN- ‘‘(I) the first business day on or after Octo- amount of the fee for a facility located in the CLUDED BY REFERENCE TO TYPE II ACTIVE ber 1 of each such year; or United States, including its territories and PHARMACEUTICAL INGREDIENT DRUG MASTER ‘‘(II) the first business day after the enact- possessions, as determined by the Secretary FILE.—An applicant that submits a generic ment of an appropriations Act providing for on the basis of data concerning the dif- drug submission on or after October 1, 2012, the collection and obligation of fees under ference in cost between inspections of facili- shall pay a fee, in the amount determined this section for such year. ties located in the United States and its ter- under subsection (d)(3), in addition to the fee ‘‘(5) DATE OF SUBMISSION.—For purposes of ritories and possessions and those located required under subparagraph (A), if— this Act, a generic drug submission or Type outside of the United States and its terri- ‘‘(i) such submission contains information II pharmaceutical master file is deemed to tories and possessions. concerning the manufacture of an active be ‘submitted’ to the Food and Drug Admin- ‘‘(c) ADJUSTMENTS.— pharmaceutical ingredient at a facility by istration— ‘‘(1) INFLATION ADJUSTMENT.—For fiscal means other than reference by a letter of au- ‘‘(A) if it is submitted via a Food and Drug year 2014 and subsequent fiscal years, the thorization to a Type II active pharma- Administration electronic gateway, on the revenues established in subsection (b) shall ceutical drug master file; and day when transmission to that electronic be adjusted by the Secretary by notice, pub- ‘‘(ii) a fee in the amount equal to the drug gateway is completed, except that a submis- lished in the Federal Register, for a fiscal master file fee established in paragraph (2) sion or master file that arrives on a week- year, by an amount equal to the sum of— has not been previously paid with respect to end, Federal holiday, or day when the Food ‘‘(A) one; such information. and Drug Administration office that will re- ‘‘(B) the average annual percent change in ‘‘(4) GENERIC DRUG FACILITY FEE AND ACTIVE view that submission is not otherwise open the cost, per full-time equivalent position of PHARMACEUTICAL INGREDIENT FACILITY FEE.— for business shall be deemed to be submitted the Food and Drug Administration, of all ‘‘(A) IN GENERAL.—Facilities identified, or on the next day when that office is open for personnel compensation and benefits paid intended to be identified, in at least one ge- business; or with respect to such positions for the first 3 neric drug submission that is pending or ap- ‘‘(B) if it is submitted in physical media years of the preceding 4 fiscal years multi- proved to produce a finished dosage form of form, on the day it arrives at the appropriate plied by the proportion of personnel com- a human generic drug or an active pharma- designated document room of the Food and pensation and benefits costs to total costs of ceutical ingredient contained in a human ge- Drug Administration. human generic drug activities for the first 3 neric drug shall be subject to fees as follows: ‘‘(b) FEE REVENUE AMOUNTS.— years of the preceding 4 fiscal years; and ‘‘(i) GENERIC DRUG FACILITY.—Each person ‘‘(1) IN GENERAL.— ‘‘(C) the average annual percent change that owns a facility which is identified or in- ‘‘(A) FISCAL YEAR 2013.—For fiscal year 2013, that occurred in the Consumer Price Index tended to be identified in at least one ge- fees under subsection (a) shall be established for urban consumers (Washington-Baltimore, neric drug submission that is pending or ap- to generate a total estimated revenue DC–MD–VA–WV; Not Seasonally Adjusted; proved to produce one or more finished dos- amount under such subsection of $299,000,000. All items; Annual Index) for the first 3 years age forms of a human generic drug shall be Of that amount— of the preceding 4 years of available data assessed an annual fee for each such facility. ‘‘(i) $50,000,000 shall be generated by the multiplied by the proportion of all costs ‘‘(ii) ACTIVE PHARMACEUTICAL INGREDIENT one-time backlog fee for generic drug appli- other than personnel compensation and ben- FACILITY.—Each person that owns a facility cations pending on October 1, 2012, estab- efits costs to total costs of human generic which produces, or which is pending review lished in subsection (a)(1); and drug activities for the first 3 years of the to produce, one or more active pharma- ‘‘(ii) $249,000,000 shall be generated by the preceding 4 fiscal years. ceutical ingredients identified, or intended fees under paragraphs (2) through (4) of sub- The adjustment made each fiscal year under to be identified, in at least one generic drug section (a). this subsection shall be added on a com- submission that is pending or approved or in ‘‘(B) FISCAL YEARS 2014 THROUGH 2017.—For pounded basis to the sum of all adjustments a Type II active pharmaceutical ingredient each of the fiscal years 2014 through 2017, made each fiscal year after fiscal year 2013 drug master file referenced in such a generic fees under paragraphs (2) through (4) of sub- under this subsection. drug submission, shall be assessed an annual section (a) shall be established to generate a ‘‘(2) FINAL YEAR ADJUSTMENT.—For fiscal fee for each such facility. total estimated revenue amount under such year 2017, the Secretary may, in addition to ‘‘(iii) FACILITIES PRODUCING BOTH ACTIVE subsection that is equal to $299,000,000, as ad- adjustments under paragraph (1), further in- PHARMACEUTICAL INGREDIENTS AND FINISHED justed pursuant to subsection (c). crease the fee revenues and fees established DOSAGE FORMS.—Each person that owns a fa- ‘‘(2) TYPES OF FEES.—In establishing fees in subsection (b) if such an adjustment is cility identified, or intended to be identified, under paragraph (1) to generate the revenue necessary to provide for not more than 3 in at least one generic drug submission that amounts specified in paragraph (1)(A)(ii) for months of operating reserves of carryover is pending or approved to produce both one fiscal year 2013 and paragraph (1)(B) for each user fees for human generic drug activities or more finished dosage forms subject to of fiscal years 2014 through 2017, such fees for the first 3 months of fiscal year 2018. clause (i) and one or more active pharma- shall be derived from the fees under para- Such fees may only be used in fiscal year ceutical ingredients subject to clause (ii) graphs (2) through (4) of subsection (a) as fol- 2018. If such an adjustment is necessary, the shall be subject to fees under both such lows: rationale for the amount of the increase clauses for that facility. ‘‘(A) 6 percent shall be derived from fees shall be contained in the annual notice es- ‘‘(B) AMOUNT.—The amount of fees estab- under subsection (a)(2) (relating to drug mas- tablishing fee revenues and fees for fiscal lished under subparagraph (A) shall be estab- ter files). year 2017. If the Secretary has carryover bal- lished under subsection (d). ‘‘(B) 24 percent shall be derived from fees ances for such activities in excess of 3 ‘‘(C) NOTICE.— under subsection (a)(3) (relating to abbre- months of such operating reserves, the ad- ‘‘(i) FISCAL YEAR 2013.—For fiscal year 2013, viated new drug applications and supple- justment under this subparagraph shall not the Secretary shall publish in the Federal ments). The amount of a fee for a prior ap- be made. Register a notice announcing the amount of proval supplement shall be half the amount ‘‘(d) ANNUAL FEE SETTING.— the fees provided for in subparagraph (A) of the fee for an abbreviated new drug appli- ‘‘(1) FISCAL YEAR 2013.—For fiscal year within the timeframe specified in subsection cation. 2013— (d)(1)(B). ‘‘(C) 56 percent shall be derived from fees ‘‘(A) the Secretary shall establish, by Octo- ‘‘(ii) FISCAL YEARS 2014 THROUGH 2017.—With- under subsection (a)(4)(A)(i) (relating to ge- ber 31, 2012, the one-time generic drug back- in the timeframe specified in subsection neric drug facilities). The amount of the fee log fee for generic drug applications pending (d)(2), the Secretary shall publish in the Fed- for a facility located outside the United on October 1, 2012, the drug master file fee, eral Register the amount of the fees under States and its territories and possessions the abbreviated new drug application fee, subparagraph (A) for such fiscal year. shall be not less than $15,000 and not more and the prior approval supplement fee under ‘‘(D) FEE DUE DATE.— than $30,000 higher than the amount of the subsection (a), based on the revenue amounts ‘‘(i) FISCAL YEAR 2013.—For fiscal year 2013, fee for a facility located in the United States established under subsection (b); and the fees under subparagraph (A) shall be due and its territories and possessions, as deter- ‘‘(B) the Secretary shall establish, not on the later of— mined by the Secretary on the basis of data later than 45 days after the date to comply

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with the requirement for identification of fa- ‘‘(A) IN GENERAL.—Any person that owns or paragraph (C) of such subsection shall result cilities in subsection (f)(2), the generic drug operates a site or organization described in in the abbreviated new drug application or facility fee and active pharmaceutical ingre- subparagraph (B) shall submit to the Sec- the prior approval supplement to an abbre- dient facility fee under subsection (a) based retary information concerning the owner- viated new drug application not being re- on the revenue amounts established under ship, name, and address of the site or organi- ceived within the meaning of section subsection (b). zation. 505(j)(5)(A) until such outstanding fee is paid. ‘‘(2) FISCAL YEARS 2014 THROUGH 2017.—Not ‘‘(B) SITES AND ORGANIZATIONS.—A site or ‘‘(4) GENERIC DRUG FACILITY FEE AND ACTIVE more than 60 days before the first day of organization is described in this subpara- PHARMACEUTICAL INGREDIENT FACILITY FEE.— each of fiscal years 2014 through 2017, the graph if it is identified in a generic drug sub- ‘‘(A) IN GENERAL.—Failure to pay the fee Secretary shall establish the drug master mission and is— under subsection (a)(4) within 20 calendar file fee, the abbreviated new drug application ‘‘(i) a site in which a bioanalytical study is days of the due date as specified in subpara- fee, the prior approval supplement fee, the conducted; graph (D) of such subsection shall result in generic drug facility fee, and the active ‘‘(ii) a clinical research organization; the following: pharmaceutical ingredient facility fee under ‘‘(iii) a contract analytical testing site; or ‘‘(i) The Secretary shall place the facility subsection (a) for such fiscal year, based on ‘‘(iv) a contract repackager site. on a publicly available arrears list, such that the revenue amounts established under sub- ‘‘(C) NOTICE.—The Secretary may, by no- no new abbreviated new drug application or section (b) and the adjustments provided tice published in the Federal Register, speci- supplement submitted on or after October 1, under subsection (c). fy the means and format for submission of 2012, from the person that is responsible for ‘‘(3) FEE FOR ACTIVE PHARMACEUTICAL IN- the information under subparagraph (A) and paying such fee, or any affiliate of that per- GREDIENT INFORMATION NOT INCLUDED BY REF- may specify, as necessary for purposes of son, will be received within the meaning of ERENCE TO TYPE II ACTIVE PHARMACEUTICAL this section, any additional information to section 505(j)(5)(A). INGREDIENT DRUG MASTER FILE.—In estab- be submitted. ‘‘(ii) Any new generic drug submission sub- lishing the fees under paragraphs (1) and (2), ‘‘(D) INSPECTION AUTHORITY.—The Sec- mitted on or after October 1, 2012, that ref- the amount of the fee under subsection retary’s inspection authority under section erences such a facility shall not be received, (a)(3)(F) shall be determined by multi- 704(a)(1) shall extend to all such sites and or- within the meaning of section 505(j)(5)(A) if plying— ganizations. the outstanding facility fee is not paid with- ‘‘(A) the sum of— ‘‘(g) EFFECT OF FAILURE TO PAY FEES.— in 20 calendar days of the Secretary pro- ‘‘(i) the total number of such active phar- ‘‘(1) GENERIC DRUG BACKLOG FEE.—Failure viding the notification to the sponsor of the to pay the fee under subsection (a)(1) shall maceutical ingredients in such submission; failure of the owner of the facility to pay the result in the Secretary placing the person and facility fee under subsection (a)(4)(C). that owns the abbreviated new drug applica- ‘‘(ii) for each such ingredient that is manu- ‘‘(iii) All drugs or active pharmaceutical tion subject to that fee on an arrears list, factured at more than one such facility, the ingredients manufactured in such a facility such that no new abbreviated new drug ap- total number of such additional facilities; or containing an ingredient manufactured in plications or supplement submitted on or and such a facility shall be deemed misbranded after October 1, 2012, from that person, or ‘‘(B) the amount equal to the drug master under section 502(aa). any affiliate of that person, will be received file fee established in subsection (a)(2) for ‘‘(B) APPLICATION OF PENALTIES.—The pen- within the meaning of section 505(j)(5)(A) such submission. alties under this paragraph shall apply until until such outstanding fee is paid. the fee established by subsection (a)(4) is ‘‘(e) LIMIT.—The total amount of fees ‘‘(2) DRUG MASTER FILE FEE.— charged, as adjusted under subsection (c), for ‘‘(A) Failure to pay the fee under sub- paid or the facility is removed from all ge- a fiscal year may not exceed the total costs section (a)(2) within 20 calendar days after neric drug submissions that refer to the fa- for such fiscal year for the resources allo- the applicable due date under subparagraph cility. cated for human generic drug activities. (E) of such subsection (as described in sub- ‘‘(C) NONRECEIVAL FOR NONPAYMENT.— ‘‘(f) IDENTIFICATION OF FACILITIES.— section (a)(2)(D)(ii)(I)) shall result in the ‘‘(i) NOTICE.—If an abbreviated new drug ‘‘(1) PUBLICATION OF NOTICE; DEADLINE FOR Type II active pharmaceutical ingredient application or supplement to an abbreviated COMPLIANCE.—Not later than October 1, 2012, drug master file not being deemed available new drug application submitted on or after the Secretary shall publish in the Federal for reference. October 1, 2012, references a facility for Register a notice requiring each person that ‘‘(B)(i) Any generic drug submission sub- which a facility fee has not been paid by the owns a facility described in subsection mitted on or after October 1, 2012, that ref- applicable date under subsection (a)(4)(C), (a)(4)(A), or a site or organization required to erences, by a letter of authorization, a Type the Secretary shall notify the sponsor of the be identified by paragraph (4), to submit to II active pharmaceutical ingredient drug generic drug submission of the failure of the the Secretary information on the identity of master file that has not been deemed avail- owner of the facility to pay the facility fee. each such facility, site, or organization. The able for reference shall not be received with- ‘‘(ii) NONRECEIVAL.—If the facility fee is notice required by this paragraph shall speci- in the meaning of section 505(j)(5)(A) unless not paid within 20 calendar days of the Sec- fy the type of information to be submitted the condition specified in clause (ii) is met. retary providing the notification under and the means and format for submission of ‘‘(ii) The condition specified in this clause clause (i), the abbreviated new drug applica- such information. is that the fee established under subsection tion or supplement to an abbreviated new ‘‘(2) REQUIRED SUBMISSION OF FACILITY IDEN- (a)(2) has been paid within 20 calendar days drug application shall not be received within TIFICATION.—Each person that owns a facility of the Secretary providing the notification the meaning of section 505(j)(5)(A). described in subsection (a)(4)(A) or a site or to the sponsor of the abbreviated new drug ‘‘(h) LIMITATIONS.— organization required to be identified by application or supplement of the failure of ‘‘(1) IN GENERAL.—Fees under subsection (a) paragraph (4) shall submit to the Secretary the owner of the Type II active pharma- shall be refunded for a fiscal year beginning the information required under this sub- ceutical ingredient drug master file to pay after fiscal year 2012, unless appropriations section each year. Such information shall— the drug master file fee as specified in sub- for salaries and expenses of the Food and ‘‘(A) for fiscal year 2013, be submitted not paragraph (C). Drug Administration for such fiscal year (ex- later than 60 days after the publication of ‘‘(C)(i) If an abbreviated new drug applica- cluding the amount of fees appropriated for the notice under paragraph (1); and tion or supplement to an abbreviated new such fiscal year) are equal to or greater than ‘‘(B) for each subsequent fiscal year, be drug application references a Type II active the amount of appropriations for the salaries submitted, updated, or reconfirmed on or be- pharmaceutical ingredient drug master file and expenses of the Food and Drug Adminis- fore June 1 of the previous year. for which a fee under subsection (a)(2)(A) has tration for the fiscal year 2009 (excluding the ‘‘(3) CONTENTS OF NOTICE.—At a minimum, not been paid by the applicable date under amount of fees appropriated for such fiscal the submission required by paragraph (2) subsection (a)(2)(E), the Secretary shall no- year) multiplied by the adjustment factor (as shall include for each such facility— tify the sponsor of the abbreviated new drug defined in section 744A) applicable to the fis- ‘‘(A) identification of a facility identified application or supplement of the failure of cal year involved. or intended to be identified in an approved or the owner of the Type II active pharma- ‘‘(2) AUTHORITY.—If the Secretary does not pending generic drug submission; ceutical ingredient drug master file to pay assess fees under subsection (a) during any ‘‘(B) whether the facility manufactures ac- the applicable fee. portion of a fiscal year and if at a later date tive pharmaceutical ingredients or finished ‘‘(ii) If such fee is not paid within 20 cal- in such fiscal year the Secretary may assess dosage forms, or both; endar days of the Secretary providing the such fees, the Secretary may assess and col- ‘‘(C) whether or not the facility is located notification, the abbreviated new drug appli- lect such fees, without any modification in within the United States and its territories cation or supplement to an abbreviated new the rate, for Type II active pharmaceutical and possessions; drug application shall not be received within ingredient drug master files, abbreviated ‘‘(D) whether the facility manufactures the meaning of 505(j)(5)(A). new drug applications and prior approval positron emission tomography drugs solely, ‘‘(3) ABBREVIATED NEW DRUG APPLICATION supplements, and generic drug facilities and or in addition to other drugs; and FEE AND PRIOR APPROVAL SUPPLEMENT FEE.— active pharmaceutical ingredient facilities ‘‘(E) whether the facility manufactures Failure to pay a fee under subparagraph (A) at any time in such fiscal year notwith- drugs that are not generic drugs. or (F) of subsection (a)(3) within 20 calendar standing the provisions of subsection (a) re- ‘‘(4) CERTAIN SITES AND ORGANIZATIONS.— days of the applicable due date under sub- lating to the date fees are to be paid.

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‘‘(i) CREDITING AND AVAILABILITY OF cers, employees, and advisory committees so ties for the first 5 fiscal years after fiscal FEES.— engaged. year 2017, and for the reauthorization of this ‘‘(1) IN GENERAL.—Fees authorized under ‘‘(l) POSITRON EMISSION TOMOGRAPHY part for such fiscal years, the Secretary shall subsection (a) shall be collected and avail- DRUGS.— consult with— able for obligation only to the extent and in ‘‘(1) EXEMPTION FROM FEES.—Submission of ‘‘(A) the Committee on Energy and Com- the amount provided in advance in appro- an application for a positron emission to- merce of the House of Representatives; priations Acts, subject to paragraph (2). mography drug or active pharmaceutical in- ‘‘(B) the Committee on Health, Education, Such fees are authorized to remain available gredient for a positron emission tomography Labor, and Pensions of the Senate; until expended. Such sums as may be nec- drug shall not require the payment of any ‘‘(C) scientific and academic experts; essary may be transferred from the Food and fee under this section. Facilities that solely ‘‘(D) health care professionals; Drug Administration salaries and expenses produce positron emission tomography drugs ‘‘(E) representatives of patient and con- appropriation account without fiscal year shall not be required to pay a facility fee as sumer advocacy groups; and limitation to such appropriation account for established in subsection (a)(4). ‘‘(F) the generic drug industry. salaries and expenses with such fiscal year ‘‘(2) IDENTIFICATION REQUIREMENT.—Facili- ‘‘(2) PRIOR PUBLIC INPUT.—Prior to begin- limitation. The sums transferred shall be ties that produce positron emission tomog- ning negotiations with the generic drug in- available solely for human generic drug ac- raphy drugs or active pharmaceutical ingre- dustry on the reauthorization of this part, tivities. dients of such drugs are required to be iden- the Secretary shall— ‘‘(2) COLLECTIONS AND APPROPRIATION tified pursuant to subsection (f). ‘‘(A) publish a notice in the Federal Reg- ACTS.— ‘‘(m) DISPUTES CONCERNING FEES.—To qual- ister requesting public input on the reau- ‘‘(A) IN GENERAL.—The fees authorized by ify for the return of a fee claimed to have thorization; this section— been paid in error under this section, a per- ‘‘(B) hold a public meeting at which the ‘‘(i) subject to subparagraphs (C) and (D), son shall submit to the Secretary a written public may present its views on the reau- shall be collected and available in each fiscal request justifying such return within 180 cal- thorization, including specific suggestions year in an amount not to exceed the amount endar days after such fee was paid. for changes to the goals referred to in sub- specified in appropriation Acts, or otherwise ‘‘(n) SUBSTANTIALLY COMPLETE APPLICA- section (a); made available for obligation for such fiscal TIONS.—An abbreviated new drug application ‘‘(C) provide a period of 30 days after the year; and that is not considered to be received within public meeting to obtain written comments ‘‘(ii) shall be available for a fiscal year be- the meaning of section 505(j)(5)(A) because of from the public suggesting changes to this ginning after fiscal year 2012 to defray the failure to pay an applicable fee under this part; and costs of human generic drug activities (in- provision within the time period specified in ‘‘(D) publish the comments on the Food cluding such costs for an additional number subsection (g) shall be deemed not to have and Drug Administration’s Internet Web of full-time equivalent positions in the De- been ‘substantially complete’ on the date of site. partment of Health and Human Services to its submission within the meaning of section ‘‘(3) PERIODIC CONSULTATION.—Not less fre- be engaged in such activities), only if the 505(j)(5)(B)(iv)(II)(cc). An abbreviated new quently than once every month during nego- Secretary allocates for such purpose an drug application that is not substantially tiations with the generic drug industry, the Secretary shall hold discussions with rep- amount for such fiscal year (excluding complete on the date of its submission solely resentatives of patient and consumer advo- amounts from fees collected under this sec- because of failure to pay an applicable fee cacy groups to continue discussions of their tion) no less than $97,000,000 multiplied by under the preceding sentence shall be views on the reauthorization and their sug- the adjustment factor, as defined in section deemed substantially complete and received gestions for changes to this part as expressed 744A(3), applicable to the fiscal year in- within the meaning of section 505(j)(5)(A) as under paragraph (2). volved. of the date such applicable fee is received.’’. OMPLIANCE ‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.— ‘‘(B) C .—The Secretary shall be SEC. 303. REAUTHORIZATION; REPORTING RE- considered to have met the requirements of After negotiations with the generic drug in- QUIREMENTS. dustry, the Secretary shall— subparagraph (A)(ii) in any fiscal year if the Part 7 of subchapter C of chapter VII, as costs funded by appropriations and allocated ‘‘(A) present the recommendations devel- added by section 302 of this Act, is amended oped under paragraph (1) to the congres- for human generic activities are not more by inserting after section 744B the following: than 10 percent below the level specified in sional committees specified in such para- ‘‘SEC. 744C. REAUTHORIZATION; REPORTING RE- such subparagraph. graph; QUIREMENTS. ‘‘(B) publish such recommendations in the ‘‘(C) FEE COLLECTION DURING FIRST PRO- ‘‘(a) PERFORMANCE REPORT.—Beginning Federal Register; GRAM YEAR.—Until the date of enactment of with fiscal year 2013, not later than 120 days an Act making appropriations through Sep- ‘‘(C) provide for a period of 30 days for the after the end of each fiscal year for which tember 30, 2013 for the salaries and expenses public to provide written comments on such fees are collected under this part, the Sec- account of the Food and Drug Administra- recommendations; retary shall prepare and submit to the Com- tion, fees authorized by this section for fiscal ‘‘(D) hold a meeting at which the public mittee on Energy and Commerce of the may present its views on such recommenda- year 2013, may be collected and shall be cred- House of Representatives and the Committee tions; and ited to such account and remain available on Health, Education, Labor, and Pensions of ‘‘(E) after consideration of such public until expended. the Senate a report concerning the progress views and comments, revise such rec- ‘‘(D) PROVISION FOR EARLY PAYMENTS IN of the Food and Drug Administration in ommendations as necessary. SUBSEQUENT YEARS.—Payment of fees author- achieving the goals identified in the letters ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— ized under this section for a fiscal year (after described in section 301(b) of the Generic Not later than January 15, 2017, the Sec- fiscal year 2013), prior to the due date for Drug User Fee Amendments of 2012 during retary shall transmit to the Congress the re- such fees, may be accepted by the Secretary such fiscal year and the future plans of the vised recommendations under paragraph (4), in accordance with authority provided in ad- Food and Drug Administration for meeting a summary of the views and comments re- vance in a prior year appropriations Act. the goals. ceived under such paragraph, and any ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— ‘‘(b) FISCAL REPORT.—Beginning with fiscal changes made to the recommendations in re- For each of the fiscal years 2013 through 2017, year 2013, not later than 120 days after the sponse to such views and comments. there is authorized to be appropriated for end of each fiscal year for which fees are col- ‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— fees under this section an amount equivalent lected under this part, the Secretary shall ‘‘(A) PUBLIC AVAILABILITY.—Before pre- to the total revenue amount determined prepare and submit to the Committee on En- senting the recommendations developed under subsection (b) for the fiscal year, as ergy and Commerce of the House of Rep- under paragraphs (1) through (5) to the Con- adjusted under subsection (c), if applicable, resentatives and the Committee on Health, gress, the Secretary shall make publicly or as otherwise affected under paragraph (2) Education, Labor, and Pensions of the Sen- available, on the Internet Web site of the of this subsection. ate a report on the implementation of the Food and Drug Administration, minutes of ‘‘(j) COLLECTION OF UNPAID FEES.—In any case where the Secretary does not receive authority for such fees during such fiscal all negotiation meetings conducted under payment of a fee assessed under subsection year and the use, by the Food and Drug Ad- this subsection between the Food and Drug (a) within 30 calendar days after it is due, ministration, of the fees collected for such Administration and the generic drug indus- such fee shall be treated as a claim of the fiscal year. try. United States Government subject to sub- ‘‘(c) PUBLIC AVAILABILITY.—The Secretary ‘‘(B) CONTENT.—The minutes described chapter II of chapter 37 of title 31, United shall make the reports required under sub- under subparagraph (A) shall summarize any States Code. sections (a) and (b) available to the public on substantive proposal made by any party to ‘‘(k) CONSTRUCTION.—This section may not the Internet Web site of the Food and Drug the negotiations as well as significant con- be construed to require that the number of Administration. troversies or differences of opinion during full-time equivalent positions in the Depart- ‘‘(d) REAUTHORIZATION.— the negotiations and their resolution.’’. ment of Health and Human Services, for offi- ‘‘(1) CONSULTATION.—In developing rec- SEC. 304. SUNSET DATES. cers, employees, and advisory committees ommendations to present to the Congress (a) AUTHORIZATION.—The amendments not engaged in human generic drug activi- with respect to the goals, and plans for meet- made by section 302 cease to be effective Oc- ties, be reduced to offset the number of offi- ing the goals, for human generic drug activi- tober 1, 2017.

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(b) REPORTING REQUIREMENTS.—The amend- ‘‘PART 8—FEES RELATING TO BIOSIMILAR ‘‘(ii) if so, general advice on the expected ments made by section 303 cease to be effec- BIOLOGICAL PRODUCTS content of the development program; and tive January 31, 2018. ‘‘SEC. 744G. DEFINITIONS. ‘‘(B) does not include any meeting that in- SEC. 305. EFFECTIVE DATE. ‘‘For purposes of this part: volves substantive review of summary data The amendments made by this title shall ‘‘(1) The term ‘adjustment factor’ applica- or full study reports. take effect on October 1, 2012, or the date of ble to a fiscal year that is the Consumer ‘‘(9) The term ‘costs of resources allocated the enactment of this title, whichever is Price Index for all urban consumers (Wash- for the process for the review of biosimilar later, except that fees under section 302 shall ington-Baltimore, DC–MD–VA–WV; Not Sea- biological product applications’ means the be assessed for all human generic drug sub- sonally Adjusted; All items) of the preceding expenses in connection with the process for missions and Type II active pharmaceutical fiscal year divided by such Index for Sep- the review of biosimilar biological product drug master files received on or after Octo- tember 2011. applications for— ber 1, 2012, regardless of the date of enact- ‘‘(2) The term ‘affiliate’ means a business ‘‘(A) officers and employees of the Food and Drug Administration, contractors of the ment of this title. entity that has a relationship with a second business entity if, directly or indirectly— Food and Drug Administration, advisory SEC. 306. AMENDMENT WITH RESPECT TO MIS- committees, and costs related to such offi- BRANDING. ‘‘(A) one business entity controls, or has the power to control, the other business enti- cers employees and committees and to con- Section 502 (21 U.S.C. 352) is amended by tracts with such contractors; ty; or adding at the end the following: ‘‘(B) management of information, and the ‘‘(B) a third party controls, or has power to ‘‘(aa) If it is a drug, or an active pharma- acquisition, maintenance, and repair of com- control, both of the business entities. ceutical ingredient, and it was manufac- puter resources; ‘‘(3) The term ‘biosimilar biological prod- tured, prepared, propagated, compounded, or ‘‘(C) leasing, maintenance, renovation, and uct’ means a product for which a biosimilar processed in a facility for which fees have repair of facilities and acquisition, mainte- biological product application has been ap- not been paid as required by section nance, and repair of fixtures, furniture, sci- proved. 744A(a)(4) or for which identifying informa- entific equipment, and other necessary ma- ‘‘(4)(A) Subject to subparagraph (B), the tion required by section 744B(f) has not been terials and supplies; and term ‘biosimilar biological product applica- submitted, or it contains an active pharma- ‘‘(D) collecting fees under section 744H and ceutical ingredient that was manufactured, tion’ means an application for licensure of a accounting for resources allocated for the re- prepared, propagated, compounded, or proc- biological product under section 351(k) of the view of submissions in connection with bio- essed in such a facility.’’. Public Health Service Act. similar biological product development, bio- ‘‘(B) Such term does not include— SEC. 307. STREAMLINED HIRING AUTHORITY OF similar biological product applications, and THE FOOD AND DRUG ADMINISTRA- ‘‘(i) a supplement to such an application; supplements. TION TO SUPPORT ACTIVITIES RE- ‘‘(ii) an application filed under section ‘‘(10) The term ‘final dosage form’ means, LATED TO HUMAN GENERIC DRUGS. 351(k) of the Public Health Service Act that with respect to a biosimilar biological prod- Section 714 of the Federal Food, Drug, and cites as the reference product a bovine blood uct, a finished dosage form which is approved Cosmetic Act, as added by section 208, is product for topical application licensed be- for administration to a patient without sub- amended— fore September 1, 1992, or a large volume par- stantial further manufacturing (such as (1) in subsection (b)— enteral drug product approved before such lyophilized products before reconstitution). (A) by striking ‘‘are activities’’ and insert- date; ‘‘(11) The term ‘financial hold’— ing ‘‘are— ‘‘(iii) an application filed under section ‘‘(A) means an order issued by the Sec- ‘‘(1) activities’’; 351(k) of the Public Health Service Act with retary to prohibit the sponsor of a clinical (B) by striking the period at the end and respect to— investigation from continuing the investiga- inserting ‘‘; and’’; and ‘‘(I) whole blood or a blood component for tion if the Secretary determines that the in- (C) by adding at the end the following: transfusion; vestigation is intended to support a bio- ‘‘(2) activities under this Act related to ‘‘(II) an allergenic extract product; similar biological product application and human generic drug activities (as defined in ‘‘(III) an in vitro diagnostic biological the sponsor has failed to pay any fee for the section 744A).’’; and product; or product required under subparagraph (A), (2) by amending subsection (c) to read as ‘‘(IV) a biological product for further man- (B), or (D) of section 744H(a)(1); and follows: ufacturing use only; or ‘‘(B) does not mean that any of the bases ‘‘(c) OBJECTIVES SPECIFIED.—The objectives ‘‘(iv) an application for licensure under for a ‘clinical hold’ under section 505(i)(3) specified in this subsection are— section 351(k) of the Public Health Service have been determined by the Secretary to ‘‘(1) with respect to the activities under Act that is submitted by a State or Federal exist concerning the investigation. subsection (b)(1), the goals referred to in sec- Government entity for a product that is not ‘‘(12) The term ‘person’ includes an affil- tion 738A(a)(1); and distributed commercially. iate of such person. ‘‘(2) with respect to the activities under ‘‘(5) The term ‘biosimilar biological prod- ‘‘(13) The term ‘process for the review of subsection (b)(2), the performance goals with uct development meeting’ means any meet- biosimilar biological product applications’ respect to section 744A (regarding assess- ing, other than a biosimilar initial advisory means the following activities of the Sec- ment and use of human generic drug fees), as meeting, regarding the content of a develop- retary with respect to the review of submis- set forth in the letters described in section ment program, including a proposed design sions in connection with biosimilar biologi- 301(b) of the Generic Drug User Fee Amend- for, or data from, a study intended to sup- cal product development, biosimilar biologi- ments of 2012.’’. port a biosimilar biological product applica- cal product applications, and supplements: tion. ‘‘(A) The activities necessary for the re- TITLE IV—FEES RELATING TO ‘‘(6) The term ‘biosimilar biological prod- view of submissions in connection with bio- BIOSIMILAR BIOLOGICAL PRODUCTS uct development program’ means the pro- similar biological product development, bio- SEC. 401. SHORT TITLE; FINDING. gram under this part for expediting the proc- similar biological product applications, and (a) SHORT TITLE.—This title may be cited ess for the review of submissions in connec- supplements. as the ‘‘Biosimilar User Fee Act of 2012’’. tion with biosimilar biological product de- ‘‘(B) Actions related to submissions in con- (b) FINDING.—The Congress finds that the velopment. nection with biosimilar biological product fees authorized by the amendments made in ‘‘(7)(A) The term ‘biosimilar biological development, the issuance of action letters this title will be dedicated to expediting the product establishment’ means a foreign or which approve biosimilar biological product process for the review of biosimilar biologi- domestic place of business— applications or which set forth in detail the cal product applications, including ‘‘(i) that is at one general physical location specific deficiencies in such applications, and postmarket safety activities, as set forth in consisting of one or more buildings, all of where appropriate, the actions necessary to the goals identified for purposes of part 8 of which are within five miles of each other; place such applications in condition for ap- subchapter C of chapter VII of the Federal and proval. Food, Drug, and Cosmetic Act, in the letters ‘‘(ii) at which one or more biosimilar bio- ‘‘(C) The inspection of biosimilar biological from the Secretary of Health and Human logical products are manufactured in final product establishments and other facilities Services to the Chairman of the Committee dosage form. undertaken as part of the Secretary’s review on Health, Education, Labor, and Pensions of ‘‘(B) For purposes of subparagraph (A)(ii), of pending biosimilar biological product ap- the Senate and the Chairman of the Com- the term ‘manufactured’ does not include plications and supplements. mittee on Energy and Commerce of the packaging. ‘‘(D) Activities necessary for the release of House of Representatives, as set forth in the ‘‘(8) The term ‘biosimilar initial advisory lots of biosimilar biological products under Congressional Record. meeting’— section 351(k) of the Public Health Service SEC. 402. FEES RELATING TO BIOSIMILAR BIO- ‘‘(A) means a meeting, if requested, that is Act. LOGICAL PRODUCTS. limited to— ‘‘(E) Monitoring of research conducted in Subchapter C of chapter VII (21 U.S.C. 379f ‘‘(i) a general discussion regarding whether connection with the review of biosimilar bio- et seq.) is amended by inserting after part 7, licensure under section 351(k) of the Public logical product applications. as added by title III of this Act, the fol- Health Service Act may be feasible for a par- ‘‘(F) Postmarket safety activities with re- lowing: ticular product; and spect to biologics approved under biosimilar

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00050 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3345 biological product applications or supple- support a biosimilar biological product ap- under subparagraph (A) or (B), or a reactiva- ments, including the following activities: plication. tion fee as required under subparagraph (D), ‘‘(i) Collecting, developing, and reviewing ‘‘(II) Not later than 5 days after the Sec- the Secretary shall not provide a biosimilar safety information on biosimilar biological retary grants a request for a biosimilar bio- biological product development meeting re- products, including adverse-event reports. logical product development meeting. lating to the product for which fees are ‘‘(ii) Developing and using improved ad- ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL PROD- owed. verse-event data-collection systems, includ- UCT DEVELOPMENT FEE.— ‘‘(ii) NO RECEIPT OF INVESTIGATIONAL NEW ing information technology systems. ‘‘(i) IN GENERAL.—A person that pays an DRUG APPLICATIONS.—Except in extraor- ‘‘(iii) Developing and using improved ana- initial biosimilar biological product develop- dinary circumstances, the Secretary shall lytical tools to assess potential safety prob- ment fee for a product shall pay for such not consider an investigational new drug ap- lems, including access to external data product, beginning in the fiscal year fol- plication to have been received under section bases. lowing the fiscal year in which the initial 505(i)(2) if— ‘‘(iv) Implementing and enforcing section biosimilar biological product development ‘‘(I) the Secretary determines that the in- 505(o) (relating to postapproval studies and fee was paid, an annual fee established under vestigation is intended to support a bio- clinical trials and labeling changes) and sec- subsection (b)(1)(B) for biosimilar biological similar biological product application; and tion 505(p) (relating to risk evaluation and product development (referred to in this sec- ‘‘(II) the sponsor has failed to pay an ini- mitigation strategies). tion as ‘annual biosimilar biological product tial or annual biosimilar biological product ‘‘(v) Carrying out section 505(k)(5) (relating development fee’). development fee for the product as required to adverse-event reports and postmarket ‘‘(ii) DUE DATE.—The annual biosimilar bi- under subparagraph (A) or (B), or a reactiva- safety activities). ological product development program fee tion fee as required under subparagraph (D). ‘‘(14) The term ‘supplement’ means a re- for each fiscal year will be due on the later ‘‘(iii) FINANCIAL HOLD.—Notwithstanding quest to the Secretary to approve a change of— section 505(i)(2), except in extraordinary cir- in a biosimilar biological product applica- ‘‘(I) the first business day on or after Octo- cumstances, the Secretary shall prohibit the tion which has been approved, including a ber 1 of each such year; or sponsor of a clinical investigation from con- supplement requesting that the Secretary ‘‘(II) the first business day after the enact- tinuing the investigation if— determine that the biosimilar biological ment of an appropriations Act providing for product meets the standards for interchange- the collection and obligation of fees for such ‘‘(I) the Secretary determines that the in- ability described in section 351(k)(4) of the year under this section. vestigation is intended to support a bio- similar biological product application; and Public Health Service Act. ‘‘(iii) EXCEPTION.—The annual biosimilar ‘‘(II) the sponsor has failed to pay an ini- ‘‘SEC. 744H. AUTHORITY TO ASSESS AND USE BIO- development program fee for each fiscal year SIMILAR BIOLOGICAL PRODUCT will be due on the date specified in clause tial or annual biosimilar biological product FEES. (ii), unless the person has— development fee for the product as required ‘‘(a) TYPES OF FEES.—Beginning in fiscal ‘‘(I) submitted a marketing application for under subparagraph (A) or (B), or a reactiva- year 2013, the Secretary shall assess and col- the biological product that was accepted for tion fee for the product as required under lect fees in accordance with this section as filing; or subparagraph (D). follows: ‘‘(II) discontinued participation in the bio- ‘‘(iv) NO ACCEPTANCE OF BIOSIMILAR BIO- ‘‘(1) BIOSIMILAR DEVELOPMENT PROGRAM similar biological product development pro- LOGICAL PRODUCT APPLICATIONS OR SUPPLE- FEES.— gram for the product under subparagraph MENTS.—If a person has failed to pay an ini- ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL PROD- (C). tial or annual biosimilar biological product UCT DEVELOPMENT FEE.— ‘‘(C) DISCONTINUATION OF FEE OBLIGATION.— development fee as required under subpara- ‘‘(i) IN GENERAL.—Each person that sub- A person may discontinue participation in graph (A) or (B), or a reactivation fee as re- mits to the Secretary a meeting request de- the biosimilar biological product develop- quired under subparagraph (D), any bio- scribed under clause (ii) or a clinical pro- ment program for a product effective Octo- similar biological product application or tocol for an investigational new drug pro- ber 1 of a fiscal year by, not later than Au- supplement submitted by that person shall tocol described under clause (iii) shall pay gust 1 of the preceding fiscal year— be considered incomplete and shall not be ac- for the product named in the meeting re- ‘‘(i) if no investigational new drug applica- cepted for filing by the Secretary until all quest or the investigational new drug appli- tion concerning the product has been sub- such fees owed by such person have been cation the initial biosimilar biological prod- mitted, submitting to the Secretary a writ- paid. uct development fee established under sub- ten declaration that the person has no ‘‘(F) LIMITS REGARDING BIOSIMILAR DEVEL- section (b)(1)(A). present intention of further developing the OPMENT PROGRAM FEES.— ‘‘(ii) MEETING REQUEST.—The meeting re- product as a biosimilar biological product; or ‘‘(i) NO REFUNDS.—The Secretary shall not quest described in this clause is a request for ‘‘(ii) if an investigational new drug appli- refund any initial or annual biosimilar bio- a biosimilar biological product development cation concerning the product has been sub- logical product development fee paid under meeting for a product. mitted, by withdrawing the investigational subparagraph (A) or (B), or any reactivation ‘‘(iii) CLINICAL PROTOCOL FOR IND.—A clin- new drug application in accordance with part fee paid under subparagraph (D). ical protocol for an investigational new drug 312 of title 21, Code of Federal Regulations ‘‘(ii) NO WAIVERS, EXEMPTIONS, OR REDUC- protocol described in this clause is a clinical (or any successor regulations). TIONS.—The Secretary shall not grant a protocol consistent with the provisions of ‘‘(D) REACTIVATION FEE.— waiver, exemption, or reduction of any ini- section 505(i), including any regulations pro- ‘‘(i) IN GENERAL.—A person that has discon- tial or annual biosimilar biological product mulgated under section 505(i), (referred to in tinued participation in the biosimilar bio- development fee due or payable under sub- this section as ‘investigational new drug ap- logical product development program for a paragraph (A) or (B), or any reactivation fee plication’) describing an investigation that product under subparagraph (C) shall pay a due or payable under subparagraph (D). the Secretary determines is intended to sup- fee (referred to in this section as ‘reactiva- ‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT APPLI- port a biosimilar biological product applica- tion fee’) by the earlier of the following: CATION AND SUPPLEMENT FEE.— tion for a product. ‘‘(I) Not later than 5 days after the Sec- ‘‘(A) IN GENERAL.—Each person that sub- ‘‘(iv) DUE DATE.—The initial biosimilar bio- retary grants a request for a biosimilar bio- mits, on or after October 1, 2012, a biosimilar logical product development fee shall be due logical product development meeting for the biological product application or a supple- by the earlier of the following: product (after the date on which such par- ment shall be subject to the following fees: ‘‘(I) Not later than 5 days after the Sec- ticipation was discontinued). ‘‘(i) A fee for a biosimilar biological prod- retary grants a request for a biosimilar bio- ‘‘(II) Upon the date of submission (after the uct application that is equal to— logical product development meeting. date on which such participation was discon- ‘‘(I) the amount of the fee established ‘‘(II) The date of submission of an inves- tinued) of an investigational new drug appli- under subsection (b)(1)(D) for a biosimilar bi- tigational new drug application describing cation describing an investigation that the ological product application; minus an investigation that the Secretary deter- Secretary determines is intended to support ‘‘(II) the cumulative amount of fees paid, if mines is intended to support a biosimilar bi- a biosimilar biological product application any, under subparagraphs (A), (B), and (D) of ological product application. for that product. paragraph (1) for the product that is the sub- ‘‘(v) TRANSITION RULE.—Each person that ‘‘(ii) APPLICATION OF ANNUAL FEE.—A per- ject of the application. has submitted an investigational new drug son that pays a reactivation fee for a product ‘‘(ii) A fee for a biosimilar biological prod- application prior to the date of enactment of shall pay for such product, beginning in the uct application for which clinical data (other the Biosimilars User Fee Act of 2012 shall next fiscal year, the annual biosimilar bio- than comparative bioavailability studies) pay the initial biosimilar biological product logical product development fee under sub- with respect to safety or effectiveness are development fee by the earlier of the fol- paragraph (B). not required, that is equal to— lowing: ‘‘(E) EFFECT OF FAILURE TO PAY BIOSIMILAR ‘‘(I) half of the amount of the fee estab- ‘‘(I) Not later than 60 days after the date of DEVELOPMENT PROGRAM FEES.— lished under subsection (b)(1)(D) for a bio- the enactment of the Biosimilars User Fee ‘‘(i) NO BIOSIMILAR BIOLOGICAL PRODUCT DE- similar biological product application; minus Act of 2012, if the Secretary determines that VELOPMENT MEETINGS.—If a person has failed ‘‘(II) the cumulative amount of fees paid, if the investigational new drug application de- to pay an initial or annual biosimilar bio- any, under subparagraphs (A), (B), and (D) of scribes an investigation that is intended to logical product development fee as required paragraph (1) for that product.

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‘‘(iii) A fee for a supplement for which clin- ment, notwithstanding the number of bio- ‘‘(E) BIOSIMILAR BIOLOGICAL PRODUCT ES- ical data (other than comparative bio- similar biological products manufactured at TABLISHMENT FEE.—The biosimilar biological availability studies) with respect to safety or the establishment, subject to clause (ii). product establishment fee under subsection effectiveness are required, that is equal to ‘‘(ii) In the event an establishment is listed (a)(3) for a fiscal year shall be equal to the half of the amount of the fee established in a biosimilar biological product applica- amount established under section 736(c)(4) under subsection (b)(1)(D) for a biosimilar bi- tion by more than one applicant, the estab- for a prescription drug establishment for ological product application. lishment fee for the fiscal year shall be di- that fiscal year. ‘‘(B) REDUCTION IN FEES.—Notwithstanding vided equally and assessed among the appli- ‘‘(F) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— section 404 of the Biosimilars User Fee Act of cants whose biosimilar biological products The biosimilar biological product fee under 2012, any person who pays a fee under sub- are manufactured by the establishment dur- subsection (a)(4) for a fiscal year shall be paragraph (A), (B), or (D) of paragraph (1) for ing the fiscal year and assessed biosimilar equal to the amount established under sec- a product before October 1, 2017, but submits biological product fees under paragraph (4). tion 736(c)(4) for a prescription drug product a biosimilar biological product application ‘‘(E) EXCEPTION FOR NEW PRODUCTS.—If, for that fiscal year. for that product after such date, shall be en- during the fiscal year, an applicant initiates ‘‘(2) LIMIT.—The total amount of fees titled to the reduction of any biosimilar bio- or causes to be initiated the manufacture of charged for a fiscal year under this section logical product application fees that may be a biosimilar biological product at an estab- may not exceed the total amount for such assessed at the time when such biosimilar bi- lishment listed in its biosimilar biological fiscal year of the costs of resources allocated ological product application is submitted, by product application— for the process for the review of biosimilar the cumulative amount of fees paid under ‘‘(i) that did not manufacture the bio- biological product applications. subparagraphs (A), (B), and (D) of paragraph similar biological product in the previous ‘‘(c) APPLICATION FEE WAIVER FOR SMALL (1) for that product. fiscal year; and BUSINESS.— ‘‘(C) PAYMENT DUE DATE.—Any fee required ‘‘(ii) for which the full biosimilar biologi- ‘‘(1) WAIVER OF APPLICATION FEE.—The Sec- by subparagraph (A) shall be due upon sub- cal product establishment fee has been as- retary shall grant to a person who is named mission of the application or supplement for sessed in the fiscal year at a time before in a biosimilar biological product applica- which such fee applies. manufacture of the biosimilar biological tion a waiver from the application fee as- ‘‘(D) EXCEPTION FOR PREVIOUSLY FILED AP- product was begun, sessed to that person under subsection PLICATION OR SUPPLEMENT.—If a biosimilar the applicant shall not be assessed a share of (a)(2)(A) for the first biosimilar biological biological product application or supplement the biosimilar biological product establish- product application that a small business or was submitted by a person that paid the fee ment fee for the fiscal year in which the its affiliate submits to the Secretary for re- for such application or supplement, was ac- manufacture of the product began. view. After a small business or its affiliate is cepted for filing, and was not approved or ‘‘(4) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— granted such a waiver, the small business or was withdrawn (without a waiver), the sub- ‘‘(A) IN GENERAL.—Each person who is its affiliate shall pay— mission of a biosimilar biological product named as the applicant in a biosimilar bio- ‘‘(A) application fees for all subsequent application or a supplement for the same logical product application shall pay for biosimilar biological product applications product by the same person (or the person’s each such biosimilar biological product the submitted to the Secretary for review in the licensee, assignee, or successor) shall not be annual fee established under subsection same manner as an entity that is not a small subject to a fee under subparagraph (A). (b)(1)(F). business; and ‘‘(E) REFUND OF APPLICATION FEE IF APPLI- ‘‘(B) DUE DATE.—The biosimilar biological ‘‘(B) all supplement fees for all supple- CATION REFUSED FOR FILING OR WITHDRAWN product fee for a fiscal year shall be due on ments to biosimilar biological product appli- BEFORE FILING.—The Secretary shall refund the later of— 75 percent of the fee paid under this para- ‘‘(i) the first business day on or after Octo- cations submitted to the Secretary for re- graph for any application or supplement ber 1 of each such year; or view in the same manner as an entity that is which is refused for filing or withdrawn ‘‘(ii) the first business day after the enact- not a small business. without a waiver before filing. ment of an appropriations Act providing for ‘‘(2) CONSIDERATIONS.—In determining ‘‘(F) FEES FOR APPLICATIONS PREVIOUSLY the collection and obligation of fees for such whether to grant a waiver of a fee under REFUSED FOR FILING OR WITHDRAWN BEFORE year under this section. paragraph (1), the Secretary shall consider FILING.—A biosimilar biological product ap- ‘‘(C) ONE FEE PER PRODUCT PER YEAR.—The only the circumstances and assets of the ap- plication or supplement that was submitted biosimilar biological product fee shall be plicant involved and any affiliate of the ap- but was refused for filing, or was withdrawn paid only once for each product for each fis- plicant. before being accepted or refused for filing, cal year. ‘‘(3) SMALL BUSINESS DEFINED.—In this sub- shall be subject to the full fee under subpara- ‘‘(b) FEE SETTING AND AMOUNTS.— section, the term ‘small business’ means an graph (A) upon being resubmitted or filed ‘‘(1) IN GENERAL.—Subject to paragraph (2), entity that has fewer than 500 employees, in- over protest, unless the fee is waived under the Secretary shall, 60 days before the start cluding employees of affiliates, and does not subsection (c). of each fiscal year that begins after Sep- have a drug product that has been approved ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT ESTAB- tember 30, 2012, establish, for the next fiscal under a human drug application (as defined LISHMENT FEE.— year, the fees under subsection (a). Except as in section 735) or a biosimilar biological ‘‘(A) IN GENERAL.—Except as provided in provided in subsection (c), such fees shall be product application (as defined in section subparagraph (E), each person that is named in the following amounts: 744G(4)) and introduced or delivered for in- as the applicant in a biosimilar biological ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL PROD- troduction into interstate commerce. product application shall be assessed an an- UCT DEVELOPMENT FEE.—The initial bio- ‘‘(d) EFFECT OF FAILURE TO PAY FEES.—A nual fee established under subsection similar biological product development fee biosimilar biological product application or (b)(1)(E) for each biosimilar biological prod- under subsection (a)(1)(A) for a fiscal year supplement submitted by a person subject to uct establishment that is listed in the ap- shall be equal to 10 percent of the amount es- fees under subsection (a) shall be considered proved biosimilar biological product applica- tablished under section 736(c)(4) for a human incomplete and shall not be accepted for fil- tion as an establishment that manufactures drug application described in section ing by the Secretary until all fees owed by the biosimilar biological product named in 736(a)(1)(A)(i) for that fiscal year. such person have been paid. such application. ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL PROD- ‘‘(e) CREDITING AND AVAILABILITY OF ‘‘(B) ASSESSMENT IN FISCAL YEARS.—The es- UCT DEVELOPMENT FEE.—The annual bio- FEES.— tablishment fee shall be assessed in each fis- similar biological product development fee ‘‘(1) IN GENERAL.—Subject to paragraph (2), cal year for which the biosimilar biological under subsection (a)(1)(B) for a fiscal year fees authorized under subsection (a) shall be product named in the application is assessed shall be equal to 10 percent of the amount es- collected and available for obligation only to a fee under paragraph (4) unless the bio- tablished under section 736(c)(4) for a human the extent and in the amount provided in ad- similar biological product establishment drug application described in section vance in appropriations Acts. Such fees are listed in the application does not engage in 736(a)(1)(A)(i) for that fiscal year. authorized to remain available until ex- the manufacture of the biosimilar biological ‘‘(C) REACTIVATION FEE.—The reactivation pended. Such sums as may be necessary may product during such fiscal year. fee under subsection (a)(1)(D) for a fiscal be transferred from the Food and Drug Ad- ‘‘(C) DUE DATE.—The establishment fee for year shall be equal to 20 percent of the ministration salaries and expenses appro- a fiscal year shall be due on the later of— amount of the fee established under section priation account without fiscal year limita- ‘‘(i) the first business day on or after Octo- 736(c)(4) for a human drug application de- tion to such appropriation account for sala- ber 1 of such fiscal year; or scribed in section 736(a)(1)(A)(i) for that fis- ries and expenses with such fiscal year limi- ‘‘(ii) the first business day after the enact- cal year. tation. The sums transferred shall be avail- ment of an appropriations Act providing for ‘‘(D) BIOSIMILAR BIOLOGICAL PRODUCT APPLI- able solely for the process for the review of the collection and obligation of fees for such CATION FEE.—The biosimilar biological prod- biosimilar biological product applications. fiscal year under this section. uct application fee under subsection (a)(2) ‘‘(2) COLLECTIONS AND APPROPRIATION ‘‘(D) APPLICATION TO ESTABLISHMENT.— for a fiscal year shall be equal to the amount ACTS.— ‘‘(i) Each biosimilar biological product es- established under section 736(c)(4) for a ‘‘(A) IN GENERAL.—Subject to subpara- tablishment shall be assessed only one fee human drug application described in section graphs (C) and (D), the fees authorized by per biosimilar biological product establish- 736(a)(1)(A)(i) for that fiscal year. this section shall be collected and available

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in each fiscal year in an amount not to ex- Administration for meeting such goals. The (b) REPORTING REQUIREMENTS.—The amend- ceed the amount specified in appropriation report for a fiscal year shall include informa- ment made by section 403 shall cease to be Acts, or otherwise made available for obliga- tion on all previous cohorts for which the effective January 31, 2018. tion for such fiscal year. Secretary has not given a complete response SEC. 405. EFFECTIVE DATE. ‘‘(B) USE OF FEES AND LIMITATION.—The on all biosimilar biological product applica- (a) IN GENERAL.—Except as provided under fees authorized by this section shall be avail- tions and supplements in the cohort. subsection (b), the amendments made by this able for a fiscal year beginning after fiscal ‘‘(b) FISCAL REPORT.—Not later than 120 title shall take effect on the later of— year 2012 to defray the costs of the process days after the end of fiscal year 2013 and (1) October 1, 2012; or each subsequent fiscal year for which fees for the review of biosimilar biological prod- (2) the date of the enactment of this title. are collected under this part, the Secretary uct applications (including such costs for an (b) EXCEPTION.—Fees under part 8 of sub- shall prepare and submit to the Committee additional number of full-time equivalent chapter C of chapter VII of the Federal Food, on Energy and Commerce of the House of positions in the Department of Health and Drug, and Cosmetic Act, as added by this Representatives and the Committee on Human Services to be engaged in such proc- title, shall be assessed for all biosimilar bio- Health, Education, Labor, and Pensions of ess), only if the Secretary allocates for such logical product applications received on or the Senate a report on the implementation purpose an amount for such fiscal year (ex- after October 1, 2012, regardless of the date of of the authority for such fees during such fis- cluding amounts from fees collected under the enactment of this title. this section) no less than $20,000,000, multi- cal year and the use, by the Food and Drug Administration, of the fees collected for such SEC. 406. SAVINGS CLAUSE. plied by the adjustment factor applicable to Notwithstanding the amendments made by the fiscal year involved. fiscal year. ‘‘(c) PUBLIC AVAILABILITY.—The Secretary this title, part 2 of subchapter C of chapter ‘‘(C) FEE COLLECTION DURING FIRST PRO- shall make the reports required under sub- VII of the Federal Food, Drug, and Cosmetic GRAM YEAR.—Until the date of enactment of sections (a) and (b) available to the public on Act, as in effect on the day before the date an Act making appropriations through Sep- the Internet Web site of the Food and Drug of the enactment of this title, shall continue tember 30, 2013, for the salaries and expenses Administration. to be in effect with respect to human drug account of the Food and Drug Administra- ‘‘(d) STUDY.— applications and supplements (as defined in tion, fees authorized by this section for fiscal ‘‘(1) IN GENERAL.—The Secretary shall con- such part as of such day) that were accepted year 2013 may be collected and shall be cred- tract with an independent accounting or con- by the Food and Drug Administration for fil- ited to such account and remain available sulting firm to study the workload volume ing on or after October 1, 2007, but before Oc- until expended. and full costs associated with the process for tober 1, 2012, with respect to assessing and ‘‘(D) PROVISION FOR EARLY PAYMENTS IN the review of biosimilar biological product collecting any fee required by such part for SUBSEQUENT YEARS.—Payment of fees author- applications. a fiscal year prior to fiscal year 2013. ized under this section for a fiscal year (after ‘‘(2) INTERIM RESULTS.—Not later than SEC. 407. CONFORMING AMENDMENT. fiscal year 2013), prior to the due date for June 1, 2015, the Secretary shall publish, for Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is such fees, may be accepted by the Secretary public comment, interim results of the study amended by striking ‘‘or (k)’’. in accordance with authority provided in ad- described under paragraph (1). TITLE V—PEDIATRIC DRUGS AND vance in a prior year appropriations Act. ‘‘(3) FINAL RESULTS.—Not later than Sep- DEVICES ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— tember 30, 2016, the Secretary shall publish, For each of fiscal years 2013 through 2017, for public comment, the final results of the SEC. 501. PERMANENCE. there is authorized to be appropriated for study described under paragraph (1). (a) PEDIATRIC STUDIES OF DRUGS.—Sub- fees under this section an amount equivalent ‘‘(e) REAUTHORIZATION.— section (q) of section 505A (21 U.S.C. 355a) is to the total amount of fees assessed for such ‘‘(1) CONSULTATION.—In developing rec- amended— fiscal year under this section. ommendations to present to the Congress (1) in the subsection heading, by striking ‘‘(f) COLLECTION OF UNPAID FEES.—In any with respect to the goals described in sub- ‘‘SUNSET’’ and inserting ‘‘PERMANENCE’’; case where the Secretary does not receive section (a), and plans for meeting the goals, (2) in paragraph (1), by striking ‘‘on or be- payment of a fee assessed under subsection for the process for the review of biosimilar fore October 1, 2012,’’; and (a) within 30 days after it is due, such fee biological product applications for the first 5 (3) in paragraph (2), by striking ‘‘on or be- shall be treated as a claim of the United fiscal years after fiscal year 2017, and for the fore October 1, 2012,’’. States Government subject to subchapter II reauthorization of this part for such fiscal (b) RESEARCH INTO PEDIATRIC USES FOR of chapter 37 of title 31, United States Code. years, the Secretary shall consult with— DRUGS AND BIOLOGICAL PRODUCTS.—Section ‘‘(g) WRITTEN REQUESTS FOR WAIVERS AND ‘‘(A) the Committee on Energy and Com- 505B (21 U.S.C. 355c) is amended— REFUNDS.—To qualify for consideration for a merce of the House of Representatives; (1) by striking subsection (m); and waiver under subsection (c), or for a refund ‘‘(B) the Committee on Health, Education, (2) by redesignating subsection (n) as sub- of any fee collected in accordance with sub- Labor, and Pensions of the Senate; section (m). section (a)(2)(A), a person shall submit to the ‘‘(C) scientific and academic experts; SEC. 502. WRITTEN REQUESTS. Secretary a written request for such waiver ‘‘(D) health care professionals; (a) FEDERAL FOOD, DRUG, AND COSMETIC or refund not later than 180 days after such ‘‘(E) representatives of patient and con- ACT.—Subsection (h) of section 505A (21 fee is due. sumer advocacy groups; and U.S.C. 355a) is amended to read as follows: ‘‘(h) CONSTRUCTION.—This section may not ‘‘(F) the regulated industry. ‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH be construed to require that the number of ‘‘(2) PUBLIC REVIEW OF RECOMMENDATIONS.— REQUIREMENTS.—Exclusivity under this sec- full-time equivalent positions in the Depart- After negotiations with the regulated indus- tion shall only be granted for the completion ment of Health and Human Services, for offi- try, the Secretary shall— of a study or studies that are the subject of cers, employers, and advisory committees ‘‘(A) present the recommendations devel- a written request and for which reports are not engaged in the process of the review of oped under paragraph (1) to the congres- submitted and accepted in accordance with biosimilar biological product applications, sional committees specified in such para- subsection (d)(3). Written requests under this be reduced to offset the number of officers, graph; section may consist of a study or studies re- employees, and advisory committees so en- ‘‘(B) publish such recommendations in the quired under section 505B.’’. gaged.’’. Federal Register; (b) PUBLIC HEALTH SERVICE ACT.—Section SEC. 403. REAUTHORIZATION; REPORTING RE- ‘‘(C) provide for a period of 30 days for the 351(m)(1) of the Public Health Service Act (42 QUIREMENTS. public to provide written comments on such U.S.C. 262(m)(1)) is amended by striking ‘‘(f), Part 8 of subchapter C of chapter VII, as recommendations; (i), (j), (k), (l), (p), and (q)’’ and inserting ‘‘(f), added by section 402, is further amended by ‘‘(D) hold a meeting at which the public (h), (i), (j), (k), (l), (n), and (p)’’. inserting after section 744H the following: may present its views on such recommenda- SEC. 503. COMMUNICATION WITH PEDIATRIC RE- ‘‘SEC. 744I. REAUTHORIZATION; REPORTING RE- tions; and VIEW COMMITTEE. QUIREMENTS. ‘‘(E) after consideration of such public Not later than 1 year after the date of en- ‘‘(a) PERFORMANCE REPORT.—Beginning views and comments, revise such rec- actment of this Act, the Secretary of Health with fiscal year 2013, not later than 120 days ommendations as necessary. and Human Services (referred to in this title after the end of each fiscal year for which ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— as the ‘‘Secretary’’) shall issue internal fees are collected under this part, the Sec- Not later than January 15, 2017, the Sec- standard operating procedures that provide retary shall prepare and submit to the Com- retary shall transmit to the Congress the re- for the review by the internal review com- mittee on Energy and Commerce of the vised recommendations under paragraph (2), mittee established under section 505C of the House of Representatives and the Committee a summary of the views and comments re- Federal Food, Drug, and Cosmetic Act (21 on Health, Education, Labor, and Pensions of ceived under such paragraph, and any U.S.C. 355d) of any significant modifications the Senate a report concerning the progress changes made to the recommendations in re- to initial pediatric study plans, agreed ini- of the Food and Drug Administration in sponse to such views and comments.’’. tial pediatric study plans, and written re- achieving the goals identified in the letters SEC. 404. SUNSET DATES. quests under sections 505A and 505B of the described in section 401(b) of the Biosimilar (a) AUTHORIZATION.—The amendment made Federal Food, Drug, and Cosmetic Act (21 User Fee Act of 2012 during such fiscal year by section 402 shall cease to be effective Oc- U.S.C. 355c). Such internal standard oper- and the future plans of the Food and Drug tober 1, 2017. ating procedures shall be made publicly

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00053 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3348 CONGRESSIONAL RECORD — SENATE May 21, 2012 available on the Internet website of the Food (ii) in clause (ii)— (A) in clause (ii), by striking ‘‘; and’’ and and Drug Administration. (I) by inserting ‘‘, as well as the date of inserting a semicolon; SEC. 504. ACCESS TO DATA. each deferral or deferral extension, as appli- (B) in clause (iii), by adding ‘‘and’’ at the Not later than 3 years after the date of en- cable,’’ after ‘‘clause (i)’’; and end; and actment of this Act, the Secretary shall (II) by inserting ‘‘not later than 90 days (C) by adding at the end the following: make available to the public, including after submission to the Secretary or with ‘‘(iv) the number of postmarket non-com- through posting on the Internet website of the next routine quarterly update’’ after pliance letters issued pursuant to subsection the Food and Drug Administration, the med- ‘‘Administration’’; and (d), and the recipients of such letters;’’. ical, statistical, and clinical pharmacology (2) in subsection (f)— SEC. 506. PEDIATRIC STUDY PLANS. reviews of, and corresponding written re- (A) in the subsection heading, by inserting (a) IN GENERAL.—Subsection (e) of section quests issued to an applicant, sponsor, or ‘‘DEFERRAL EXTENSIONS,’’ after ‘‘DEFER- 505B (21 U.S.C. 355c) is amended to read as holder for, pediatric studies submitted be- RALS,’’; follows: tween January 4, 2002 and September 27, 2007 (B) in paragraph (1), by inserting ‘‘, defer- ‘‘(e) PEDIATRIC STUDY PLANS.— under subsection (b) or (c) of section 505A of ral extension,’’ after ‘‘deferral’’; and ‘‘(1) IN GENERAL.—An applicant subject to the Federal Food, Drug, and Cosmetic Act (C) in paragraph (4)— subsection (a) shall submit to the Secretary (21 U.S.C. 355a) for which 6 months of market (i) in the paragraph heading, by inserting an initial pediatric study plan prior to the exclusivity was granted and that resulted in ‘‘DEFERRAL EXTENSIONS,’’ after ‘‘DEFER- submission of the assessments described a labeling change. The Secretary shall make RALS,’’; and under subsection (a)(2). public the information described in the pre- (ii) by inserting ‘‘, deferral extensions,’’ ‘‘(2) TIMING; CONTENT; MEETING.— ceding sentence in a manner consistent with after ‘‘deferrals’’. ‘‘(A) TIMING.—An applicant shall submit an how the Secretary releases information initial pediatric study plan to the Secretary (b) TRACKING OF EXTENSIONS; ANNUAL IN- under section 505A(k) of the Federal Food, not later than 60 calendar days after the date FORMATION.—Section 505B(f)(6)(D) (21 U.S.C. Drug, and Cosmetic Act (21 U.S.C. 355a(k)). 355c(f)(6)(D)) is amended to read as follows: of the end of phase II meeting or such other SEC. 505. ENSURING THE COMPLETION OF PEDI- equivalent time agreed upon between the ATRIC STUDIES. ‘‘(D) aggregated on an annual basis— ‘‘(i) the total number of deferrals and de- Secretary and the applicant. Nothing in this (a) EXTENSION OF DEADLINE FOR DEFERRED paragraph shall preclude the Secretary from ferral extensions requested and granted STUDIES.—Section 505B (21 U.S.C. 355c) is accepting the submission of an initial pedi- under this section and, if granted, the rea- amended— atric study plan earlier than the date de- sons for each such deferral or deferral exten- (1) in subsection (a)(3)— scribed under the preceding sentence. sion; (A) by redesignating subparagraph (B) as ‘‘(B) CONTENT OF INITIAL PLAN.—The initial ‘‘(ii) the timeline for completion of the as- subparagraph (C); pediatric study plan shall include— sessments; and (B) by inserting after subparagraph (A) the ‘‘(i) an outline of the pediatric study or ‘‘(iii) the number of assessments completed following: studies that the applicant plans to conduct and pending;’’. ‘‘(B) DEFERRAL EXTENSION.— (including, to the extent practicable study ‘‘(i) IN GENERAL.—On the initiative of the (c) ACTION ON FAILURE TO COMPLETE STUD- objectives and design, age groups, relevant Secretary or at the request of the applicant, IES.— endpoints, and statistical approach); the Secretary may grant an extension of a (1) ISSUANCE OF LETTER.—Subsection (d) of ‘‘(ii) any request for a deferral, partial deferral approved under subparagraph (A) for section 505B (21 U.S.C. 355c) is amended to waiver, or waiver under this section, if appli- submission of some or all assessments re- read as follows: cable, along with any supporting informa- quired under paragraph (1) if— ‘‘(d) SUBMISSION OF ASSESSMENTS.—If a per- tion; and ‘‘(I) the Secretary determines that the con- son fails to submit a required assessment de- ‘‘(iii) other information specified in the ditions described in subclause (II) or (III) of scribed in subsection (a)(2), fails to meet the regulations promulgated under paragraph subparagraph (A)(i) continue to be met; and applicable requirements in subsection (a)(3), (4). ‘‘(II) the applicant submits a new timeline or fails to submit a request for approval of a ‘‘(C) MEETING.—The Secretary— under subparagraph (A)(ii)(IV) and any sig- pediatric formulation described in sub- ‘‘(i) shall meet with the applicant to dis- nificant updates to the information required section (a) or (b), in accordance with applica- cuss the initial pediatric study plan as soon under subparagraph (A)(ii). ble provisions of subsections (a) and (b), the as practicable, but not later than 90 calendar ‘‘(ii) TIMING AND INFORMATION.—If the de- following shall apply: days after the receipt of such plan under sub- ferral extension under this subparagraph is ‘‘(1) Beginning 270 days after the date of paragraph (A); requested by the applicant, the applicant enactment of the Food and Drug Administra- ‘‘(ii) may determine that a written re- shall submit the deferral extension request tion Safety and Innovation Act, the Sec- sponse to the initial pediatric study plan is containing the information described in this retary shall issue a non-compliance letter to sufficient to communicate comments on the subparagraph not less than 90 days prior to such person informing them of such failure initial pediatric study plan, and that no the date that the deferral would expire. The to submit or meet the requirements of the meeting is necessary; and Secretary shall respond to such request not applicable subsection. Such letter shall re- ‘‘(iii) if the Secretary determines that no later than 45 days after the receipt of such quire the person to respond in writing within meeting is necessary, shall so notify the ap- letter. If the Secretary grants such an exten- 45 calendar days of issuance of such letter. plicant and provide written comments of the sion, the specified date shall be the extended Such response may include the person’s re- Secretary as soon as practicable, but not date. The sponsor of the required assessment quest for a deferral extension if applicable. later than 90 calendar days after the receipt under paragraph (1) shall not be issued a let- Such letter and the person’s written re- of the initial pediatric study plan. ter described in subsection (d) unless the sponse to such letter shall be made publicly ‘‘(3) AGREED INITIAL PEDIATRIC STUDY specified or extended date of submission for available on the Internet Web site of the PLAN.—Not later than 90 calendar days fol- such required studies has passed or if the re- Food and Drug Administration 60 calendar lowing the meeting under paragraph (2)(C)(i) quest for an extension is pending. For a de- days after issuance, with redactions for any or the receipt of a written response from the ferral that has expired prior to the date of trade secrets and confidential commercial Secretary under paragraph (2)(C)(iii), the ap- enactment of the Food and Drug Administra- information. If the Secretary determines plicant shall document agreement on the ini- tion Safety and Innovation Act or that will that the letter was issued in error, the re- tial pediatric study plan in a submission to expire prior to 270 days after the date of en- quirements of this paragraph shall not apply. the Secretary marked ‘Agreed Initial Pedi- actment of such Act, a deferral extension ‘‘(2) The drug or biological product that is atric Study Plan’, and the Secretary shall shall be requested by an applicant not later the subject of an assessment described in confirm such agreement to the applicant in than 180 days after the date of enactment of subsection (a)(2), applicable requirements in writing not later than 30 calendar days of re- such Act. The Secretary shall respond to any subsection (a)(3), or request for approval of a ceipt of such agreed initial pediatric study such request as soon as practicable, but not pediatric formulation, may be considered plan. later than 1 year after the date of enactment misbranded solely because of that failure and ‘‘(4) DEFERRAL AND WAIVER.—If the agreed of such Act. Nothing in this clause shall pre- subject to relevant enforcement action (ex- initial pediatric study plan contains a re- vent the Secretary from updating the status cept that the drug or biological product shall quest from the applicant for a deferral, par- of a study or studies publicly if components not be subject to action under section 303), tial waiver, or waiver under this section, the of such study or studies are late or de- but such failure shall not be the basis for a written confirmation under paragraph (3) layed.’’; and proceeding— shall include a recommendation from the (C) in subparagraph (C), as so redesig- ‘‘(A) to withdraw approval for a drug under Secretary as to whether such request meets nated— section 505(e); or the standards under paragraphs (3) or (4) of (i) in clause (i), by adding at the end the ‘‘(B) to revoke the license for a biological subsection (a). following: product under section 351 of the Public ‘‘(5) AMENDMENTS TO THE PLAN.—At the ini- ‘‘(III) Projected completion date for pedi- Health Service Act.’’. tiative of the Secretary or the applicant, the atric studies. (2) TRACKING OF LETTERS ISSUED.—Subpara- agreed initial pediatric study plan may be ‘‘(IV) The reason or reasons why a deferral graph (D) of section 505B(f)(6) (21 U.S.C. amended at any time. The requirements of or deferral extension continues to be nec- 355c(f)(6)), as amended by subsection (b), is paragraph (2)(C) shall apply to any such pro- essary.’’; and further amended— posed amendment in the same manner and to

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00054 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3349 the same extent as such requirements apply provement Act (Public Law 110–85; 42 U.S.C. (C) for labeling changes that required such to an initial pediatric study plan under para- 282 note)) is amended by striking ‘‘$6,000,000 dispute resolution process, a description of— graph (1). The requirements of paragraphs (3) for each of fiscal years 2008 through 2012’’ (i) the disputes; and (4) shall apply to any agreement result- and inserting ‘‘$4,500,000 for each of fiscal (ii) the recommendations of the Pediatric ing from such proposed amendment in the years 2013 through 2017’’. Advisory Committee; and same manner and to the same extent as such (e) PROGRAM FOR PEDIATRIC STUDY OF (iii) the outcomes of such process; and requirements apply to an agreed initial pedi- DRUGS IN PHSA.—Section 409I(e)(1) of the (D) an assessment of the effectiveness in atric study plan. Public Health Service Act (42 U.S.C. improving information about pediatric uses ‘‘(6) INTERNAL COMMITTEE.—The Secretary 284m(e)(1)) is amended by striking ‘‘to carry of drugs and biological products; shall consult the internal committee under out this section’’ and all that follows (10)(A) the efforts made by the Secretary section 505C on the review of the initial pedi- through the end of paragraph (1) and insert- to increase the number of studies conducted atric study plan, agreed initial pediatric ing ‘‘to carry out this section $25,000,000 for in the neonatal population (including efforts plan, and any significant amendments to each of fiscal years 2012 through 2017.’’. made to encourage the conduct of appro- such plans. SEC. 508. REPORT. priate studies in neonates by companies with ‘‘(7) REQUIRED RULEMAKING.—Not later (a) IN GENERAL.—Not later than October 31, products that have sufficient safety and than 1 year after the date of enactment of 2016, and at the end of each subsequent 5- other information to make the conduct of the Food and Drug Administration Safety year period, the Secretary shall submit to the studies ethical and safe); and and Innovation Act, the Secretary shall pro- Congress a report that evaluates the effec- (B) the results of such efforts; mulgate proposed regulations and issue pro- tiveness of sections 505A and 505B of the Fed- (11)(A) the number and importance of drugs posed guidance to implement the provisions eral Food, Drug, and Cosmetic Act (21 U.S.C. and biological products for children with of this subsection.’’. 355a, 355c) and section 409I of the Public cancer that are being tested as a result of (b) CONFORMING AMENDMENTS.—Section Health Service Act (42 U.S.C. 284m) in ensur- the programs described in paragraph (7); and 505B (21 U.S.C. 355c)is amended— ing that medicines used by children are test- (B) any recommendations for modifica- (1) by amending subclause (II) of sub- ed in pediatric populations and properly la- tions to such programs that would lead to section (a)(3)(A)(ii) to read as follows: beled for use in children. new and better therapies for children with ‘‘(II) a pediatric study plan as described in (b) CONTENTS.—The report under sub- cancer, including a detailed rationale for subsection (e);’’; and section (a) shall include— each recommendation; (2) in subsection (f)— (1) the number and importance of drugs (12) an assessment of progress made in ad- (A) in the subsection heading, by striking and biological products for children for dressing the recommendations and findings ‘‘PEDIATRIC PLANS,’’ and inserting ‘‘PEDI- which studies have been requested or re- of any prior report issued by the Comptroller ATRIC STUDY PLANS,’’; quired (as of the date of such report) under General, the Institute of Medicine, or the (B) in paragraph (1), by striking ‘‘all pedi- 505A and 505B of the Federal Food, Drug, and Secretary regarding the topics addressed in atric plans’’ and inserting ‘‘initial pediatric Cosmetic Act (21 U.S.C. 355a, 355c) and sec- the report under this section, including with study plans, agreed initial pediatric study tion 409I of the Public Health Service Act (42 respect to— plans,’’; and U.S.C. 284m), including— (A) improving public access to information (C) in paragraph (4)— (A) the number of labeling changes made from pediatric studies conducted under such (i) in the paragraph heading, by striking to drugs and biological products pursuant to sections 505A and 505B; and ‘‘PEDIATRIC PLANS,’’ and inserting ‘‘PEDI- such sections since the date of enactment of (B) improving the timeliness of pediatric ATRIC STUDY PLANS,’’; and this Act; and studies and pediatric study planning under (ii) by striking ‘‘pediatric plans’’ and in- (B) the importance of such drugs and bio- such sections 505A and 505B; serting ‘‘initial pediatric study plans, agreed logical products in the improvement of the (13) any recommendations for modification initial pediatric study plans,’’. health of children; to the programs that would improve pedi- (c) EFFECTIVE DATES.— (2) the number of required studies under atric drug research and increase pediatric la- (1) PEDIATRIC STUDY PLANS.—Subsection (e) such section 505B that have not met the ini- beling of drugs and biological products; and of section 505B of the Federal Food, Drug, tial deadline provided under such section, in- (14) an assessment of the successes of and and Cosmetic Act (other than paragraph (4) cluding— limitations to studying drugs for rare dis- of such subsection), as amended by sub- (A) the number of deferrals and deferral ex- eases under such sections 505A and 505B. section (a), shall take effect 180 days after tensions granted and the reasons such exten- (c) CONSULTATION ON RECOMMENDATIONS.— the date of enactment of this Act, without sions were granted; At least 180 days before the report is due regard to whether the Secretary has promul- (B) the number of waivers and partial under subsection (a), and no sooner than 4 gated final regulations under paragraph (4) waivers granted; and years after the date of enactment of this of such subsection by such date. (C) the number of letters issued under sub- Act, the Secretary shall consult with rep- (2) CONFORMING AMENDMENTS.—The amend- section (d) of such section 505B; resentatives of patient groups, including pe- ments made by subsection (b) shall take ef- (3) the number of written requests issued, diatric patient groups, consumer groups, reg- fect 180 days after the date of enactment of declined, and referred to the National Insti- ulated industry, scientific and medical com- this Act. tutes of Health under such section 505A since munities, academia, and other interested SEC. 507. REAUTHORIZATIONS. the date of enactment of this Act (including parties to obtain any recommendations or (a) PEDIATRIC ADVISORY COMMITTEE.—Sec- the reasons for such declination), and a de- information relevant to the effectiveness of tion 14(d) of the Best Pharmaceuticals for scription and status of referrals made under the programs described in subsection (b)(7), Children Act (42 U.S.C. 284m note) is amend- subsection (n) of such section 505A; including suggestions for modifications to ed by striking ‘‘Notwithstanding section 14 (4) the number of proposed pediatric study such programs. of the Federal Advisory Committee Act, the plans submitted and agreed to as identified SEC. 509. TECHNICAL AMENDMENTS. advisory committee shall continue to oper- in the marketing application under such sec- (a) PEDIATRIC STUDIES OF DRUGS IN ate during the five-year period beginning on tion 505B; FFDCA.—Section 505A (21 U.S.C. 355a) is the date of the enactment of the Best Phar- (5) any labeling changes recommended by amended— maceuticals for Children Act of 2007’’ and in- the Pediatric Advisory Committee as a re- (1) in subsection (k)(2), by striking ‘‘sub- serting ‘‘Section 14 of the Federal Advisory sult of the review by such Committee of ad- section (f)(3)(F)’’ and inserting ‘‘subsection Committee Act shall not apply to the advi- verse events reports; (f)(6)(F)’’; sory committee’’. (6) the number and current status of pedi- (2) in subsection (n)— (b) PEDIATRIC SUBCOMMITTEE OF THE ONCO- atric postmarketing requirements; (A) in the subsection heading, by striking LOGIC DRUGS ADVISORY COMMITTEE.—Section (7) the number and importance of drugs ‘‘COMPLETED’’ and inserting ‘‘SUBMITTED’’; 15(a)(3) of the Best Pharmaceuticals for Chil- and biological products for children that are and dren Act (42 U.S.C. 284m note) is amended by not being tested for use in pediatric popu- (B) in paragraph (1)— striking ‘‘during the five-year period begin- lations, notwithstanding the existence of the (i) in the matter preceding subparagraph ning on the date of the enactment of the programs under such sections 505A and 505B (A), by striking ‘‘have not been completed’’ Best Pharmaceuticals for Children Act of and section 409I of the Public Health Service and inserting ‘‘have not been submitted by 2007’’ and inserting ‘‘for the duration of the Act; the date specified in the written request operation of the Oncologic Drugs Advisory (8) the possible reasons for the lack of test- issued or if the applicant or holder does not Committee’’. ing reported under paragraph (7); agree to the request’’; (c) HUMANITARIAN DEVICE EXEMPTION EX- (9) the number of drugs and biological (ii) in subparagraph (A)— TENSION.—Section 520(m)(6)(A)(iv) of the Fed- products for which testing is being done (as (I) in the first sentence, by inserting ‘‘, or eral Food, Drug, and Cosmetic Act (21 U.S.C. of the date of the report) and for which a la- for which a period of exclusivity eligible for 360j(m)(6)(A)(iv)) is amended by striking beling change is required under the programs extension under subsection (b)(1) or (c)(1) of ‘‘2012’’ and inserting ‘‘2017’’. described in paragraph (7), including— this section or under subsection (m)(2) or (d) DEMONSTRATION GRANTS TO IMPROVE PE- (A) the date labeling changes are made; (m)(3) of section 351 of the Public Health DIATRIC DEVICE AVAILABILITY.—Section 305(e) (B) which labeling changes required the use Service Act has not ended’’ after ‘‘expired’’; of Pediatric Medical Device Safety and Im- of the dispute resolution process; and and

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00055 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3350 CONGRESSIONAL RECORD — SENATE May 21, 2012 (II) by striking ‘‘Prior to’’ and all that fol- year and five-year period referred to in sub- a portion of the 180-day period to which the lows through the period at the end; and section (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), applicant is entitled for the drug, the 180-day (iii) in subparagraph (B), by striking ‘‘no (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of sec- period shall be extended from—’’; listed patents or has 1 or more listed patents tion 505 of the Federal Food, Drug, and Cos- (2) by redesignating paragraphs (1) and (2) that have expired,’’ and inserting ‘‘no unex- metic Act, or applicable twelve-year period as subparagraphs (A) and (B) and moving pired listed patents and for which no unex- referred to in section 351(k)(7) of this Act, such subparagraphs, as so redesignated, 2 pired periods of exclusivity eligible for ex- and any seven-year period referred to in sec- ems to the right; and tension under subsection (b)(1) or (c)(1) of tion 527 of the Federal Food, Drug, and Cos- (3) by adding at the end the following: this section or under subsection (m)(2) or metic Act has ended for at least one form of ‘‘(2) 3-YEAR EXCLUSIVITY PERIOD.—The 3- (m)(3) of section 351 of the Public Health the drug; and’’; and year period of exclusivity under clauses (iii) Service Act apply,’’; and (2) in paragraph (2)— and (iv) of subsection 505(c)(3)(E) and clauses (3) in subsection (o)(2), by amendment sub- (A) in the paragraph heading, by striking (iii) and (iv) of subsection 505(j)(5)(F) are not paragraph (B) to read as follows: ‘‘FOR DRUGS LACKING EXCLUSIVITY’’; and available for approval of applications or sup- ‘‘(B) a statement of any appropriate pedi- (B) by striking ‘‘under section 505 of the plements to applications based on reports of atric contraindications, warnings, pre- Federal Food, Drug, and Cosmetic Act’’; and pediatric studies conducted under sections cautions, or other information that the Sec- (C) by striking ‘‘505A of such Act’’ and in- 505A or 505B that resulted, pursuant to sec- retary considers necessary to assure safe serting ‘‘505A of the Federal Food, Drug, and tion 505A(j) or 505B(g)(2), in the inclusion in use.’’. Cosmetic Act or section 351(m) of this Act’’. the labeling of the product a determination (b) RESEARCH INTO PEDIATRIC USES FOR (e) PEDIATRIC SUBCOMMITTEE OF THE ONCO- that the product is not indicated for use in DRUGS AND BIOLOGICAL PROJECTS IN LOGIC ADVISORY COMMITTEE.—Section 15(a) of pediatric populations or subpopulations or FFDCA.—Section 505B (21 U.S.C. 355c) is the Best Pharmaceuticals for Children Act information indicating that the results of an amended— (Public Law 107–109), as amended by section assessment were inconclusive or did not (1) in subsection (a)— 502(e) of the Food and Drug Administration demonstrate that the product is safe or effec- (A) in paragraph (1)— Amendments Act of 2007 (Public Law 110–85), tive in pediatric populations or subpopula- (i) in the matter preceding subparagraph is amended in paragraph (1)(D), by striking tion.’’. (A), by inserting ‘‘for a drug’’ after ‘‘(or sup- ‘‘section 505B(f)’’ and inserting ‘‘ ‘section (c) PROMPT APPROVAL OF DRUGS.—Section plement to an application)’’; 505C’ ’’. 505A(o) (21 U.S.C. 355a(o)) is amended— (ii) in subparagraph (A), by striking ‘‘for (f) FOUNDATION OF NATIONAL INSTITUTES OF (1) in the heading, by striking ‘‘SECTION a’’ and inserting ‘‘, including, with respect to HEALTH.—Section 499(c)(1)(C) of the Public 505(J)’’ and inserting ‘‘SUBSECTIONS (C) AND a drug, an application (or supplement to an Health Service Act (42 U.S.C. 290b(c)(1)(C)) is (J) OF SECTION 505’’; application) for a’’; amended by striking ‘‘for which the Sec- (2) in paragraph (1), by striking ‘‘under sec- (iii) in subparagraph (B), by striking ‘‘for retary issues a certification in the affirma- tion 505(j)’’ and inserting ‘‘under subsection a’’ and inserting ‘‘, including, with respect to tive under section 505A(n)(1)(A) of the Fed- (b)(2), (c), or (j) of section 505’’; a drug, an application (or supplement to an eral Food, Drug, and Cosmetic Act’’. (3) in paragraph (2), in the matter pre- application) for a’’; and (g) APPLICATION.—Notwithstanding any ceding subparagraph (A), by inserting (iv) in the matter following subparagraph provision of section 505A and 505B of the Fed- ‘‘clauses (iii) and (iv) of section 505(c)(3)(E) (B), by inserting ‘‘(or supplement)’’ after eral Food, Drug, and Cosmetic Act (21 U.S.C. or’’ after ‘‘Notwithstanding’’; and ‘‘application’’; and 355a, 355c) stating that a provision applies (4) in paragraph (3)— (B) in paragraph (4)(C)— beginning on the date of the enactment of (A) in subparagraph (B), by inserting ‘‘that (i) in the first sentence, by inserting ‘‘par- the Best Pharmaceuticals for Children Act of differ from adult formulations’’ before the tial’’ before ‘‘waiver is granted’’; and 2007 or the date of the enactment of the Pedi- semicolon at the end; and (ii) in the second sentence, by striking ‘‘ei- atric Research Equity Act of 2007, any (B) in subparagraph (C)— ther a full or’’ and inserting ‘‘such a’’; amendment made by this title to such a pro- (i) by striking ‘‘under section 505(j)’’ and (2) in subsection (b)(1), in the matter pre- vision applies beginning on the date of the inserting ‘‘under subsection (c) or (j) of sec- ceding subparagraph (A), by striking ‘‘After enactment of this Act. tion 505’’; and providing notice’’ and all that follows SEC. 510. RELATIONSHIP BETWEEN PEDIATRIC (ii) by inserting ‘‘clauses (iii) or (iv) of sec- through ‘‘studies), the’’ and inserting ‘‘The’’; LABELING AND NEW CLINICAL IN- tion 505(c)(3)(E) or’’ after ‘‘exclusivity (3) in subsection (g)— VESTIGATION EXCLUSIVITY. under’’. (A) in paragraph (1)(A), by inserting ‘‘that (a) IN GENERAL.—Section 505 (21 U.S.C. 351) receives a priority review or 330 days after is amended by adding at the end the fol- SEC. 511. PEDIATRIC RARE DISEASES. the date of the submission of an application lowing: (a) PUBLIC MEETING.—Not later than 18 or supplement that receives a standard re- ‘‘(w) RELATIONSHIP BETWEEN PEDIATRIC LA- months after the date of enactment of this view’’ after ‘‘after the date of the submission BELING AND NEW CLINICAL INVESTIGATION EX- Act, the Secretary shall hold a public meet- of the application or supplement’’; and CLUSIVITY.—The period of market exclusivity ing to discuss ways to encourage and accel- (B) in paragraph (2), by striking ‘‘the label described in clauses (iii) and (iv) of sub- erate the development of new therapies for of such product’’ and inserting ‘‘the labeling section (c)(3)(E) and clauses (iii) and (iv) of pediatric rare diseases. of such product’’; and subsection (j)(5)(F) shall not apply to a pedi- (b) REPORT.—Not later than 180 days after (4) in subsection (h)(1)— atric study conducted under section 505A or the date of the public meeting under sub- (A) by inserting ‘‘an application (or supple- 505B that results, pursuant to section section (a), the Secretary shall issue a report ment to an application) that contains’’ after 505B(g)(2), in the inclusion in the labeling of that includes a strategic plan for encour- ‘‘date of submission of’’; and the product a determination that the prod- aging and accelerating the development of (B) by inserting ‘‘, if the application (or uct is not indicated for use in pediatric popu- new therapies for treating pediatric rare dis- supplement) receives a priority review, or lations or subpopulations or information in- eases. not later than 330 days after the date of sub- dicating that the results of a study were in- TITLE VI—MEDICAL DEVICE REGULATORY mission of an application (or supplement to conclusive or did not demonstrate that the IMPROVEMENTS an application) that contains a pediatric as- product is safe or effective in pediatric popu- SEC. 601. RECLASSIFICATION PROCEDURES. sessment under this section, if the applica- lations or subpopulations.’’. tion (or supplement) receives a standard re- (b) PEDIATRIC STUDIES OF DRUGS.—Section (a) CLASSIFICATION CHANGES.— view,’’ after ‘‘under this section,’’. 505A(m) (21 U.S.C. 355a(m)) is amended— (1) IN GENERAL.—Section 513(e)(1) (21 U.S.C. (c) INTERNAL REVIEW COMMITTEE.—The (1) by striking ‘‘(m) CLARIFICATION OF 360c(e)(1)) is amended to read as follows: heading of section 505C (21 U.S.C. 355d) is INTERACTION OF MARKET EXCLUSIVITY UNDER ‘‘(e)(1)(A) Based on new information re- amended by inserting ‘‘and deferral extensions’’ THIS SECTION AND MARKET EXCLUSIVITY specting a device, the Secretary may, upon after ‘‘deferrals’’. AWARDED TO AN APPLICANT FOR APPROVAL OF the initiative of the Secretary or upon peti- (d) PROGRAM FOR PEDIATRIC STUDIES OF A DRUG UNDER SECTION 505(j).—If a’’ and all tion of an interested person, change the clas- DRUGS.—Section 409I(c) of the Public Health that follows through the end of the matter sification of such device, and revoke, on ac- Service Act (42 U.S.C. 284m(c)) is amended— that precedes paragraph (1) and inserting the count of the change in classification, any (1) in paragraph (1)— following: regulation or requirement in effect under (A) in the matter preceding subparagraph ‘‘(m) CLARIFICATION OF INTERACTION OF section 514 or 515 with respect to such device, (A), by inserting ‘‘or section 351(m) of this MARKET EXCLUSIVITY UNDER THIS SECTION by administrative order published in the Act,’’ after ‘‘Cosmetic Act,’’; AND MARKET EXCLUSIVITY AWARDED TO AN Federal Register following publication of a (B) in subparagraph (A)(i), by inserting ‘‘or APPLICATION OR SUPPLEMENT UNDER SUB- proposed reclassification order in the Fed- section 351(k) of this Act’’ after ‘‘Cosmetic SECTION (C) OR (J) OF SECTION 505.— eral Register, a meeting of a device classi- Act’’; and ‘‘(1) 180-DAY EXCLUSIVITY PERIOD.—If a 180- fication panel described in subsection (b), (C) by amending subparagraph (B) to read day period under section 505(j)(5)(B)(iv) over- and consideration of comments to a public as follows: laps with a 6-month exclusivity period under docket, notwithstanding subchapter II of ‘‘(B) there remains no patent listed pursu- this section, so that the applicant for ap- Chapter 5 of title 5 of the United States ant to section 505(b)(1) of the Federal Food, proval of a drug under section 505(j) entitled Code. An order under this subsection chang- Drug, and Cosmetic Act, and every three- to the 180-day period under that section loses ing the classification of a device from class

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00056 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3351 III to class II may provide that such classi- trative order, the Commissioner shall con- (II) by striking ‘‘promulgation of a section fication shall not take effect until the effec- sult with the Office of the Secretary. The 515(b) regulation’’ and inserting ‘‘issuance of tive date of a performance standard estab- Commissioner shall issue such an order as an administrative order under subsection lished under section 514 for such device. proposed by the Director of the Center for (b)’’. ‘‘(B) Authority to issue such administra- Devices and Radiological Health unless the (2) TECHNICAL AND CONFORMING AMEND- tive order shall not be delegated below the Commissioner, in consultation with the Of- MENTS.—Section 501(f) (21 U.S.C. 351(f)) is Commissioner. The Commissioner shall issue fice of the Secretary, concludes that the amended— such an order as proposed by the Director of order exceeds the legal authority of the Food (A) in subparagraph (1)(A)— the Center for Devices and Radiological and Drug Administration or that the order (i) in subclause (i), by striking ‘‘a regula- Health unless the Commissioner, in con- would be lawful, but unlikely to advance the tion promulgated’’ and inserting ‘‘an order sultation with the Office of the Secretary of public health.’’; issued’’; and Health and Human Services, concludes that (ii) in subclause (ii), by striking ‘‘promul- the order exceeds the legal authority of the (ii) in paragraph (2)— gation of such regulation’’ and inserting Food and Drug Administration or that the (I) by striking subparagraph (B); and ‘‘issuance of such order’’; order would be lawful, but unlikely to ad- (II) in subparagraph (A)— (B) in subparagraph (2)(B)— vance the public health.’’. (aa) by striking ‘‘(2)(A) A proceeding for (i) by striking ‘‘a regulation promulgated’’ (2) TECHNICAL AND CONFORMING AMEND- the promulgation of a regulation under para- and inserting ‘‘an order issued’’; and MENTS.— graph (1) respecting a device shall be initi- (ii) by striking ‘‘promulgation of such reg- (A) Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is ated by the publication in the Federal Reg- ulation’’ and inserting ‘‘issuance of such amended by striking ‘‘regulation promul- ister of a notice of proposed rulemaking. order’’; and gated’’ and inserting ‘‘an order issued’’. Such notice shall contain—’’ and inserting (C) by adding at the end the following: (B) Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is ‘‘(2) A proposed order required under para- ‘‘(3) In the case of a device with respect to amended by striking ‘‘under a regulation graph (1) shall contain—’’; which a regulation was promulgated under under section 513(e) but such regulation’’ and (bb) by redesignating clauses (i) through section 515(b) prior to the date of enactment inserting ‘‘under an administrative order (iv) as subparagraphs (A) through (D), re- of the Food and Drug Administration Safety under section 513(e) (or a regulation promul- spectively; and Innovation Act, a reference in this sub- gated under such section prior to the date of (cc) in subparagraph (A), as so redesig- section to an order issued under section enactment of the Food and Drug Administra- nated, by striking ‘‘regulation’’ and insert- 515(b) shall be deemed to include such regu- tion Safety and Innovation Act) but such ing ‘‘order’’; and lation.’’. order (or regulation)’’; (dd) in subparagraph (C), as so redesig- (3) APPROVAL BY REGULATION PRIOR TO THE (C) Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is nated, by striking ‘‘regulation’’ and insert- DATE OF ENACTMENT OF THIS ACT.—The amended by striking ‘‘or changing the classi- ing ‘‘order’’; amendments made by this subsection shall fication of a device to class I’’ and inserting (iii) in paragraph (3)— have no effect on a regulation that was pro- ‘‘, an administrative order changing the clas- (I) by striking ‘‘proposed regulation’’ each mulgated prior to the date of enactment of sification of a device to class I,’’. place such term appears and inserting ‘‘pro- this Act requiring that a device have an ap- (3) DEVICES RECLASSIFIED PRIOR TO THE posed order’’; proval under section 515 of the Federal Food, DATE OF ENACTMENT OF THIS ACT.— (II) by striking ‘‘paragraph (2) and after’’ Drug, and Cosmetic Act (21 U.S.C. 360e) of an (A) IN GENERAL.—The amendments made and inserting ‘‘paragraph (2),’’; application for premarket approval. by this subsection shall have no effect on a (III) by inserting ‘‘and a meeting of a de- (c) REPORTING.—The Secretary of Health regulation promulgated with respect to the vice classification panel described in section and Human Services shall annually post on classification of a device under section 513(e) 513(b),’’ after ‘‘such proposed regulation and the Internet website of the Food and Drug of the Federal Food, Drug, and Cosmetic Act findings,’’; Administration— prior to the date of enactment of this Act. (IV) by striking ‘‘(A) promulgate such reg- (1) the number and type of class I and class (B) APPLICABILITY OF OTHER PROVISIONS.— ulation’’ and inserting ‘‘(A) issue an adminis- II devices reclassified as class II or class III In the case of a device reclassified under sec- trative order under paragraph (1)’’; in the previous calendar year under section tion 513(e) of the Federal Food, Drug, and (V) by striking ‘‘paragraph (2)(A)(ii)’’ and 513(e)(1) of the Federal Food, Drug, and Cos- Cosmetic Act by regulation prior to the date inserting ‘‘paragraph (2)(B)’’; and metic Act (21 U.S.C. 360c(e)(1)); of enactment of this Act, section 517(a)(1) of (VI) by striking ‘‘promulgation of the regu- (2) the number and type of class II and the Federal Food, Drug, and Cosmetic Act lation’’ and inserting ‘‘issuance of the ad- class III devices reclassified as class I or (21 U.S.C. 360g(a)(1)) shall apply to such regu- ministrative order’’; and class II in the previous calendar year under lation promulgated under section 513(e) of (iv) by striking paragraph (4); and such section 513(e)(1); and such Act with respect to such device in the (C) in subsection (i)— (3) the number and type of devices reclassi- same manner such section 517(a)(1) applies to (i) in paragraph (2)— fied in the previous calendar year under sec- an administrative order issued with respect (I) in the matter preceding subparagraph tion 515 of the Federal Food, Drug, and Cos- to a device reclassified after the date of en- (A)— metic Act (21 U.S.C. 360e). actment of this Act. (aa) by striking ‘‘December 1, 1995’’ and in- SEC. 602. CONDITION OF APPROVAL STUDIES. (b) DEVICES MARKETED BEFORE MAY 28, serting ‘‘the date that is 2 years after the Section 515(d)(1)(B)(ii) (21 U.S.C. 1976.— date of enactment of the Food and Drug Ad- 360e(d)(1)(B)(ii)) is amended— (1) PREMARKET APPROVAL.—Section 515 (21 ministration Safety and Innovation Act’’; (1) by striking ‘‘(ii)’’ and inserting ‘‘(ii)(I)’’; U.S.C. 360e) is amended— and and (A) in subsection (a), by striking ‘‘regula- (bb) by striking ‘‘publish a regulation in (2) by adding at the end the following: tion promulgated under subsection (b)’’ and the Federal Register’’ and inserting ‘‘issue ‘‘(II) An order approving an application for inserting ‘‘an order issued under subsection an administrative order following publica- a device may require as a condition to such (b) (or a regulation promulgated under such tion of a proposed order in the Federal Reg- approval that the applicant conduct a subsection prior to the date of enactment of ister, a meeting of a device classification postmarket study regarding the device.’’. the Food and Drug Administration Safety panel described in section 513(b), and consid- SEC. 603. POSTMARKET SURVEILLANCE. and Innovation Act)’’; eration of comments from all affected stake- Section 522 (21 U.S.C. 360l) is amended— (B) in subsection (b)— holders, including patients, payors, and pro- (1) in subsection (a)(1)(A), in the matter (i) in paragraph (1)— viders, notwithstanding subchapter II of preceding clause (i), by inserting ‘‘, at the (I) in the heading, by striking ‘‘Regula- chapter 5 of title 5, United States Code,’’; time of approval or clearance of a device or tion’’ and inserting ‘‘Order’’; and (II) in subparagraph (B), by striking ‘‘final at any time thereafter,’’ after ‘‘by order’’; (II) in the matter following subparagraph regulation has been promulgated under sec- and (B)— tion 515(b)’’ and inserting ‘‘administrative (2) in subsection (b)(1), by inserting ‘‘The (aa) by striking ‘‘by regulation, promul- order has been issued under subsection (b) manufacturer shall commence surveillance gated in accordance with this subsection’’ (or no regulation has been promulgated under this section not later than 15 months and inserting ‘‘by administrative order fol- under such subsection prior to the date of after the day on which the Secretary issues lowing publication of a proposed order in the enactment of the Food and Drug Administra- an order under this section.’’ after the sec- Federal Register, a meeting of a device clas- tion Safety and Innovation Act)’’; ond sentence. sification panel described in section 513(b), (III) in the matter following subparagraph SEC. 604. SENTINEL. and consideration of comments from all af- (B), by striking ‘‘regulation requires’’ and in- Section 519 (21 U.S.C. 360i) is amended by fected stakeholders, including patients, serting ‘‘administrative order issued under adding at the end the following: payors, and providers, notwithstanding sub- this paragraph requires’’; and ‘‘(h) INCLUSION OF DEVICES IN THE chapter II of chapter 5 of title 5, United (IV) by striking the third and fourth sen- POSTMARKET RISK IDENTIFICATION AND ANAL- States Code’’; and tences; and YSIS SYSTEM.— (bb) by adding at the end the following: (ii) in paragraph (3)— ‘‘(1) IN GENERAL.— ‘‘Authority to issue such administrative (I) by striking ‘‘regulation requiring’’ each ‘‘(A) APPLICATION TO DEVICES.—The Sec- order shall not be delegated below the Com- place such term appears and inserting ‘‘order retary shall amend the procedures estab- missioner. Before publishing such adminis- requiring’’; and lished and maintained under clauses (i), (ii),

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00057 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3352 CONGRESSIONAL RECORD — SENATE May 21, 2012 (iii), and (v) of section 505(k)(3)(C) in order to (1) an individual device recall ordered formation that would support a determina- expand the postmarket risk identification under section 518(e) of the Federal Food, tion of substantial equivalence between a and analysis system established under such Drug, and Cosmetic Act (21 U.S.C. 360h(e)); new device and a predicate device. section to include and apply to devices. and ‘‘(iii) Nothing in this subparagraph shall ‘‘(B) EXCEPTION.—Subclause (II) of clause (2) any correction or removal action for alter the standard for determining substan- (i) of section 505(k)(3)(C) shall not apply to which a report is required to be submitted to tial equivalence between a new device and a devices. the Secretary under section 519(g) of such predicate device.’’. ‘‘(C) CLARIFICATION.—With respect to de- Act (21 U.S.C. 360i(g)). SEC. 609. CUSTOM DEVICES. vices, the private sector health-related elec- SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL Section 520(b) (21 U.S.C. 360j(b)) is amended tronic data provided under section DEVICE EXEMPTIONS. to read as follows: 505(k)(3)(C)(i)(III)(bb) may include medical Section 520(g) (21 U.S.C. 360j(g)) is amended ‘‘(b) CUSTOM DEVICES.— device utilization data, health insurance by adding at the end the following: ‘‘(1) IN GENERAL.—The requirements of sec- claims data, and procedure and device reg- ‘‘(8)(A) At any time, the Secretary may tions 514 and 515 shall not apply to a device istries. prohibit the sponsor of an investigation from that— ‘‘(2) DATA.—In expanding the system as de- conducting the investigation (referred to in ‘‘(A) is created or modified in order to com- scribed in paragraph (1)(A), the Secretary this paragraph as a ‘clinical hold’) if the Sec- ply with the order of an individual physician shall use relevant data with respect to de- retary makes a determination described in or dentist (or any other specially qualified vices cleared under section 510(k) or ap- subparagraph (B). The Secretary shall speci- person designated under regulations promul- proved under section 515, including claims fy the basis for the clinical hold, including gated by the Secretary after an opportunity data, patient survey data, and any other the specific information available to the Sec- for an oral hearing); data deemed appropriate by the Secretary. retary which served as the basis for such ‘‘(B) in order to comply with an order de- ‘‘(3) STAKEHOLDER INPUT.—To help ensure clinical hold, and confirm such determina- scribed in subparagraph (A), necessarily de- effective implementation of the system de- tion in writing. viates from an otherwise applicable perform- ‘‘(B) For purposes of subparagraph (A), a scribed in paragraph (1)(A), the Secretary ance standard under section 514 or require- determination described in this subpara- shall engage outside stakeholders in develop- ment under section 515; graph with respect to a clinical hold is a de- ment of the system through a public hearing, ‘‘(C) is not generally available in the termination that— advisory committee meeting, public docket, United States in finished form through label- ‘‘(i) the device involved represents an un- or other like public measures, as appro- ing or advertising by the manufacturer, im- reasonable risk to the safety of the persons priate. porter, or distributor for commercial dis- who are the subjects of the clinical inves- ‘‘(4) VOLUNTARY SURVEYS.—Chapter 35 of tribution; tigation, taking into account the qualifica- title 44, United States Code, shall not apply ‘‘(D) is designed to treat a unique pathol- tions of the clinical investigators, informa- to the collection of voluntary information ogy or physiological condition that no other tion about the device, the design of the clin- from health care providers, such as vol- device is domestically available to treat; ical investigation, the condition for which untary surveys or questionnaires, initiated ‘‘(E)(i) is intended to meet the special the device is to be investigated, and the by the Secretary for purposes of postmarket needs of such physician or dentist (or other health status of the subjects involved; or risk identification for devices.’’. specially qualified person so designated) in ‘‘(ii) the clinical hold should be issued for SEC. 605. RECALLS. the course of the professional practice of such other reasons as the Secretary may by (a) ASSESSMENT OF DEVICE RECALL INFOR- such physician or dentist (or other specially regulation establish. MATION.— ‘‘(C) Any written request to the Secretary qualified person so designated); or (1) IN GENERAL.— from the sponsor of an investigation that a ‘‘(ii) is intended for use by an individual (A) ASSESSMENT PROGRAM.—The Secretary clinical hold be removed shall receive a deci- patient named in such order of such physi- of Health and Human Services (referred to in sion, in writing and specifying the reasons cian or dentist (or other specially qualified this section as the ‘‘Secretary’’) shall en- therefor, within 30 days after receipt of such person so designated); hance the Food and Drug Administration’s request. Any such request shall include suffi- ‘‘(F) is assembled from components or recall program to routinely and systemati- cient information to support the removal of manufactured and finished on a case-by-case cally assess— such clinical hold.’’. basis to accommodate the unique needs de- (i) information submitted to the Secretary scribed in clause (i) or (ii) of subparagraph SEC. 607. UNIQUE DEVICE IDENTIFIER. pursuant to a device recall order under sec- Section 519(f) (21 U.S.C. 360i(f)) is amend- (E); and tion 518(e) of the Federal Food, Drug, and ed— ‘‘(G) may have common, standardized de- Cosmetic Act (21 U.S.C. 360h(e)); and (1) by striking ‘‘The Secretary shall pro- sign characteristics, chemical and material (ii) information required to be reported to mulgate’’ and inserting ‘‘Not later than De- compositions, and manufacturing processes the Secretary regarding a correction or re- cember 31, 2012, the Secretary shall issue as commercially distributed devices. moval of a device under section 519(g) of such proposed’’; and ‘‘(2) LIMITATIONS.—Paragraph (1) shall Act (21 U.S.C. 360i(g)). (2) by adding at the end the following: apply to a device only if— (B) USE.—The Secretary shall use the as- ‘‘The Secretary shall finalize the proposed ‘‘(A) such device is for the purpose of treat- sessment of information described under sub- regulations not later than 6 months after the ing a sufficiently rare condition, such that paragraph (A) to proactively identify strate- close of the comment period and shall imple- conducting clinical investigations on such gies for mitigating health risks presented by ment the final regulations with respect to device would be impractical; defective or unsafe devices. devices that are implantable, life-saving, and ‘‘(B) production of such device under para- (2) DESIGN.—The program under paragraph life sustaining not later than 2 years after graph (1) is limited to no more than 5 units (1) shall, at a minimum, identify— the regulations are finalized.’’. per year of a particular device type, provided (A) trends in the numbers and types of de- that such replication otherwise complies SEC. 608. CLARIFICATION OF LEAST BURDEN- vice recalls; SOME STANDARD. with this section; and (B) the types of devices in each device class (a) PREMARKET APPROVAL.—Section ‘‘(C) the manufacturer of such device cre- that are most frequently recalled; 513(a)(3)(D) (21 U.S.C. 360c(a)(3)(D)) is amend- ated or modified as described in paragraph (C) the causes of device recalls; and ed— (1) notifies the Secretary on an annual basis, (D) any other information as the Secretary (1) by redesignating clause (iii) as clause in a manner prescribed by the Secretary, of determines appropriate. (v); and the manufacture of such device. (b) AUDIT CHECK PROCEDURES.—The Sec- (2) by inserting after clause (ii) the fol- ‘‘(3) EXCEPTION.—Paragraph (1) shall not retary shall clarify procedures for con- lowing: apply to oral facial devices. ducting device recall audit checks to im- ‘‘(iii) For purposes of clause (ii), the term ‘‘(4) GUIDANCE.—Not later than 2 years prove the ability of investigators to perform ‘necessary’ means the minimum required in- after the date of enactment of this section, these checks in a consistent manner. formation that would support a determina- the Secretary shall issue final guidance on (c) ASSESSMENT CRITERIA.—The Secretary tion by the Secretary that an application replication of multiple devices described in shall develop explicit criteria for assessing provides reasonable assurance of the effec- paragraph (2)(B).’’. whether a person subject to a recall order tiveness of the device. SEC. 610. AGENCY DOCUMENTATION AND REVIEW under section 518(e) of the Federal Food, ‘‘(iv) Nothing in this subparagraph shall OF CERTAIN DECISIONS REGARDING Drug, and Cosmetic Act (21 U.S.C. 360h(e)) or alter the criteria for evaluating an applica- DEVICES. to a requirement under section 519(g) of such tion for premarket approval of a device.’’. Chapter V (21 U.S.C. 351 et seq.) is amended Act (21 U.S.C. 360i(g)) has performed an effec- (b) PREMARKET NOTIFICATION UNDER SEC- by inserting after section 517 the following: tive recall under such section 518(e) or an ef- TION 510(K).—Section 513(i)(1)(D) (21 U.S.C. ‘‘SEC. 517A. AGENCY DOCUMENTATION AND RE- fective correction or removal action under 360c(i)(1)(D)) is amended— VIEW OF CERTAIN DECISIONS RE- such section 519(g), respectively. (1) by striking ‘‘(D) Whenever’’ and insert- GARDING DEVICES. (d) TERMINATION OF RECALLS.—The Sec- ing ‘‘(D)(i) Whenever’’; and ‘‘(a) DOCUMENTATION OF RATIONALE FOR DE- retary shall document the basis for the ter- (2) by adding at the end the following: NIAL.—If the Secretary renders a final deci- mination by the Food and Drug Administra- ‘‘(ii) For purposes of clause (i), the term sion to deny clearance of a premarket notifi- tion of— ‘necessary’ means the minimum required in- cation under section 510(k) or approval of a

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00058 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3353 premarket application under section 515, or such request shall describe the device and (ii) by striking clause (ii) and inserting the when the Secretary disapproves an applica- provide detailed information and reasons for following: tion for an investigational exemption under the recommended classification. ‘‘(ii) During any calendar year, the number 520(g), the written correspondence to the ap- ‘‘(ii) Submit a request for initial classifica- of such devices distributed during that year plicant communicating that decision shall tion of the device under this subparagraph, if under each exemption granted under this provide a substantive summary of the sci- the person declares that there is no legally subsection does not exceed the annual dis- entific and regulatory rationale for the deci- marketed device upon which to base a sub- tribution number for such device. In this sion. stantial equivalence determination as that paragraph, the term ‘annual distribution ‘‘(b) REVIEW OF DENIAL.— term is defined in subsection (i). Subject to number’ means the number of such devices ‘‘(1) IN GENERAL.—A person who has sub- subparagraph (B), the Secretary shall clas- reasonably needed to treat, diagnose, or cure mitted a report under section 510(k), an ap- sify the device under the criteria set forth in a population of 4,000 individuals in the plication under section 515, or an application subparagraphs (A) through (C) of subsection United States. The Secretary shall deter- for an exemption under section 520(g) and for (a)(1). The person submitting the request for mine the annual distribution number when whom clearance of the report or approval of classification under this subparagraph may the Secretary grants such exemption.’’; and the application is denied may request a su- recommend to the Secretary a classification (B) by amending subparagraph (C) to read pervisory review of the decision to deny such for the device and shall, if recommending as follows: clearance or approval. Such review shall be classification in class II, include in the re- ‘‘(C) A person may petition the Secretary conducted by an individual at the organiza- quest an initial draft proposal for applicable to modify the annual distribution number tional level above the organization level at special controls, as described in subsection determined by the Secretary under subpara- which the decision to deny the clearance of (a)(1)(B), that are necessary, in conjunction graph (A)(ii) with respect to a device if addi- the report or approval of the application is with general controls, to provide reasonable tional information arises, and the Secretary made. assurance of safety and effectiveness and a may modify such annual distribution num- ber.’’; ‘‘(2) SUBMISSION OF REQUEST.—A person re- description of how the special controls pro- (2) in paragraph (7), by striking ‘‘regarding questing a supervisory review under para- vide such assurance. Requests under this a device’’ and inserting ‘‘regarding a device graph (1) shall submit such request to the clause shall be subject to the electronic copy described in paragraph (6)(A)(i)(I)’’; and Secretary not later than 30 days after such requirements of section 745A(b).’’; (3) in paragraph (8), by striking ‘‘of all de- denial and shall indicate in the request (3) by inserting after subparagraph (A) the vices described in paragraph (6)’’ and insert- whether such person seeks an in-person following: ing ‘‘of all devices described in paragraph meeting or a teleconference review. ‘‘(B) The Secretary may decline to under- (6)(A)(i)(I)’’. ‘‘(3) TIMEFRAME.— take a classification request submitted (b) APPLICABILITY TO EXISTING DEVICES.—A ‘‘(A) IN GENERAL.—Except as provided in under clause (2)(A)(ii) if the Secretary iden- sponsor of a device for which an exemption subparagraph (B), the Secretary shall sched- tifies a legally marketed device that could was approved under paragraph (2) of section ule an in-person or teleconference review, if provide a reasonable basis for review of sub- 520(m) of the Federal Food, Drug, and Cos- so requested, not later than 30 days after stantial equivalence under paragraph (1), or metic Act (21 U.S.C. 360j(m)) before the date such request is made. The Secretary shall when the Secretary determines that the de- of enactment of this Act may seek a deter- issue a decision to the person requesting a vice submitted is not of low-moderate risk or mination under subclause (I) or (II) of sec- review under this subsection not later than that general controls would be inadequate to tion 520(m)(6)(A)(i) (as amended by sub- 45 days after the request is made under para- control the risks and special controls to section (a)). If the Secretary of Health and graph (1), or, in the case of a person who re- mitigate the risks cannot be developed.’’; Human Services determines that such sub- quests an in-person meeting or teleconfer- and clause (I) or (II) applies with respect to a de- ence, 30 days after such meeting or tele- (4) in subparagraph (C), as so redesig- vice, clauses (ii), (iii), and (iv) of subpara- conference. nated— graph (A) and subparagraphs (B), (C), (D), ‘‘(B) EXCEPTION.—Subparagraph (A) shall (A) in clause (i), by striking ‘‘Not later and (E) of paragraph (6) of such section not apply in cases that involve consultation than 60 days after the date of the submission 520(m) shall apply to such device, and the with experts outside of the Food and Drug of the request under subparagraph (A),’’ and Secretary shall determine the annual dis- Administration, or in cases in which the inserting ‘‘Not later than 120 days after the tribution number for purposes of clause (ii) sponsor seeks to introduce evidence not al- date of the submission of the request under of such subparagraph (A) when making the ready in the administrative record at the subparagraph (A)(i) or 150 days after the date determination under this subsection. time the denial decision was made.’’. of the submission of the request under sub- (c) REPORT.—Not later than January 1, SEC. 611. GOOD GUIDANCE PRACTICES RELATING paragraph (A)(ii),’’; and 2017, the Comptroller General of the United TO DEVICES. (B) in clause (ii), by inserting ‘‘or is classi- States shall submit to Congress a report that Subparagraph (C) of section 701(h)(1) (21 fied in’’ after ‘‘remains in’’. evaluates and describes— U.S.C. 371(h)(1)) is amended— (b) GAO REPORT.—Not later than 2 years (1) the effectiveness of the amendments (1) by striking ‘‘(C) For guidance docu- after the date of enactment of this Act, the made by subsection (a) in stimulating inno- ments’’ and inserting ‘‘(C)(i) For guidance Comptroller General of the United States vation with respect to medical devices, in- documents’’; and shall complete a study and submit to Con- cluding any favorable or adverse impact on pediatric device development; (2) by adding at the end the following: gress a report on the effectiveness of the re- (2) the impact of such amendments on pedi- ‘‘(ii) With respect to devices, if a notice to view pathway under section 513(f)(2)(A) of atric device approvals for devices that re- industry guidance letter, a notice to indus- the Federal Food, Drug, and Cosmetic Act, ceived a humanitarian use designation under try advisory letter, or any similar notice as amended by this Act. section 520(m) of the Federal Food, Drug, and sets forth initial interpretations of a regula- (c) CONFORMING AMENDMENT.—Section Cosmetic Act (21 U.S.C. 360j(m)) prior to the tion or policy or sets forth changes in inter- 513(f)(1)(B) (21 U.S.C. 360c(f)(1)(B)) is amended date of enactment of this Act; pretation or policy, such notice shall be by inserting ‘‘a request under paragraph (2) (3) the status of public and private insur- treated as a guidance document for purposes or’’ after ‘‘response to’’. ance coverage of devices granted an exemp- of this subparagraph.’’. SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS. tion under paragraph (2) of such section SEC. 612. MODIFICATION OF DE NOVO APPLICA- (a) IN GENERAL.—Section 520(m) (21 U.S.C. 520(m) (as amended by subsection (a)) and TION PROCESS. 360j(m)) is amended— costs to patients of such devices; (a) IN GENERAL.—Section 513(f)(2) (21 U.S.C. (1) in paragraph (6)— (4) the impact that paragraph (4) of such 360c(f)(2)) is amended— (A) in subparagraph (A)— section 520(m) has had on access to and in- (1) by redesignating subparagraphs (B) and (i) by striking clause (i) and inserting the surance coverage of devices granted an ex- (C) as subparagraphs (C) and (D), respec- following: emption under paragraph (2) of such section tively; ‘‘(i) The device with respect to which the 520(m); and (2) by amending subparagraph (A) to read exemption is granted— (5) the effect of the amendments made by as follows: ‘‘(I) is intended for the treatment or diag- subsection (a) on patients described in such ‘‘(A) In the case of a type of device that nosis of a disease or condition that occurs in section 520(m). has not previously been classified under this pediatric patients or in a pediatric sub- SEC. 614. REAUTHORIZATION OF THIRD-PARTY Act, a person may do one of the following: population, and such device is labeled for use REVIEW AND INSPECTIONS. ‘‘(i) Submit a report under section 510(k), in pediatric patients or in a pediatric sub- (a) THIRD PARTY REVIEW.—Section 523(c) and, if the device is classified into class III population in which the disease or condition (21 U.S.C. 360m(c)) is amended by striking under paragraph (1), such person may re- occurs; or ‘‘2012’’ and inserting ‘‘2017’’. quest, not later than 30 days after receiving ‘‘(II) is intended for the treatment or diag- (b) THIRD PARTY INSPECTIONS.—Section written notice of such a classification, the nosis of a disease or condition that does not 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by Secretary to classify the device under the occur in pediatric patients or that occurs in striking ‘‘2012’’ and inserting ‘‘2017’’. criteria set forth in subparagraphs (A) pediatric patients in such numbers that the SEC. 615. 510(K) DEVICE MODIFICATIONS. through (C) of subsection (a)(1). The person development of the device for such patients Having acknowledged to Congress poten- may, in the request, recommend to the Sec- is impossible, highly impracticable, or un- tial unintended consequences that may re- retary a classification for the device. Any safe.’’; and sult from the implementation of the Food

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00059 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3354 CONGRESSIONAL RECORD — SENATE May 21, 2012 and Drug Administration guidance entitled and supplies a drug (other than an excipient) ‘‘(E) in the case of a drug contained in the ‘‘Guidance for Industry and FDA Staff— to such person, including all establishments applicable list, the name and place of busi- 510(k) Device Modifications: Deciding When of each such drug importer, the unique facil- ness of each manufacturer of an excipient of to Submit a 510(k) for a Change to an Exist- ity identifier of each such drug importer es- the listed drug with which the person listing ing Device’’, the Secretary of Health and tablishment, and a point of contact e-mail the drug conducts business, including all es- Human Services shall withdraw such guid- address for each such drug importer.’’; and tablishments used in the production of such ance promptly and ensure that, before any (B) by adding at the end the following: excipient, the unique facility identifier of future guidance document on this issue is ‘‘(3) The Secretary may specify the unique each such establishment, and a point of con- made final, affected stakeholders are pro- facility identifier system that shall be used tact e-mail address for each such excipient vided with an opportunity to comment. by registrants under paragraph (1).’’; and manufacturer.’’. SEC. 616. HEALTH INFORMATION TECHNOLOGY. (2) in subsection (c), by striking ‘‘with the SEC. 704. ELECTRONIC SYSTEM FOR REGISTRA- (a) LIMITATION.—Notwithstanding any Secretary his name, place of business, and TION AND LISTING. other provision of law, the Secretary of such establishment’’ and inserting ‘‘with the Section 510(p) (21 U.S.C. 360(p)) is amend- Health and Human Services (referred to in Secretary— ed— this section as the ‘‘Secretary’’) may issue ‘‘(1) with respect to drugs, the information (1) by striking ‘‘(p) Registrations and list- final guidance on medical mobile applica- described under subsection (b)(1); and ings’’ and inserting the following: tions only after the requirements under sub- ‘‘(2) with respect to devices, the informa- ‘‘(p) ELECTRONIC REGISTRATION AND LIST- sections (b) and (c) are met. tion described under subsection (b)(2).’’. ING.— (b) REPORT.—Not later than 18 months SEC. 702. REGISTRATION OF FOREIGN ESTAB- ‘‘(1) IN GENERAL.—Registration and list- after the date of enactment of this Act, the LISHMENTS. ing’’; and Secretary, in consultation with the Commis- (a) ENFORCEMENT OF REGISTRATION OF FOR- (2) by adding at the end the following: sioner of Food and Drugs, the National Coor- EIGN ESTABLISHMENTS.—Section 502(o) (21 ‘‘(2) ELECTRONIC DATABASE.—Not later than dinator for Health Information Technology, U.S.C. 352(o)) is amended by striking ‘‘in any 2 years after the Secretary specifies a unique and the Chairman of the Federal Commu- State’’. facility identifier system under subsections nications Commission, shall submit to the (b) REGISTRATION OF FOREIGN DRUG ESTAB- (b) and (i), the Secretary shall maintain an LISHMENTS.—Section 510(i) (U.S.C. 360(i)) is Committee on Health, Education, Labor, and electronic database, which shall not be sub- amended— Pensions of the Senate and the Committee ject to inspection under subsection (f), popu- (1) in paragraph (1)— on Energy and Commerce of the House of lated with the information submitted as de- (A) by amending the matter preceding sub- Representatives a report that contains a pro- scribed under paragraph (1) that— paragraph (A) to read as follows: ‘‘Every per- posed strategy and recommendations on an ‘‘(A) enables personnel of the Food and son who owns or operates any establishment appropriate, risk-based regulatory frame- Drug Administration to search the database within any foreign country engaged in the work pertaining to medical device regulation by any field of information submitted in a manufacture, preparation, propagation, and health information technology software, registration described under paragraph (1), compounding, or processing of a drug or de- including mobile applications, that promotes or combination of such fields; and vice that is imported or offered for import innovation and protects patient safety. ‘‘(B) uses the unique facility identifier sys- into the United States shall, through elec- (c) WORKING GROUP.— tem to link with other relevant databases tronic means in accordance with the criteria (1) IN GENERAL.—In carrying out subsection within the Food and Drug Administration, of the Secretary—’’; (b), the Secretary shall convene a working including the database for submission of in- (B) by amending subparagraph (A) to read group of external stakeholders and experts formation under section 801(r). as follows: to provide appropriate input on the strategy ‘‘(3) RISK-BASED INFORMATION AND COORDI- ‘‘(A) upon first engaging in any such activ- and recommendations required for the report NATION.—The Secretary shall ensure the ac- ity, immediately submit a registration to under subsection (b). curacy and coordination of relevant Food the Secretary that includes— (2) REPRESENTATIVES.—The Secretary shall and Drug Administration databases in order ‘‘(i) with respect to drugs, the name and determine the number of representatives to identify and inform risk-based inspections place of business of such person, all such es- participating in the working group, and shall under section 510(h).’’. tablishments, the unique facility identifier ensure that the working group is geographi- SEC. 705. RISK-BASED INSPECTION FREQUENCY. cally diverse and includes representatives of of each such establishment, a point of con- tact e-mail address, the name of the United Section 510(h) (21 U.S.C. 360(h)) is amended patients, consumers, health care providers, to read as follows: startup companies, health plans or other States agent of each such establishment, the ‘‘(h) INSPECTIONS.— third-party payers, venture capital inves- name and place of business of each drug im- porter with which such person conducts busi- ‘‘(1) IN GENERAL.—Every establishment tors, information technology vendors, small that is required to be registered with the businesses, purchasers, employers, and other ness to import or offer to import drugs into the United States, including all establish- Secretary under this section shall be subject stakeholders with relevant expertise, as de- to inspection pursuant to section 704. termined by the Secretary. ments of each such drug importer, the unique facility identifier of each such estab- ‘‘(2) BIENNIAL INSPECTIONS FOR DEVICES.— (3) OTHER REQUIREMENTS.— Every establishment described in paragraph (A) FACA.—The Federal Advisory Com- lishment, and a point of contact e-mail ad- dress for each such drug importer; and (1), in any State, that is engaged in the man- mittee Act (5 U.S.C. App.) shall apply to the ufacture, propagation, compounding, or proc- working group under this section. ‘‘(ii) with respect to devices, the name and place of business of the establishment, the essing of a device or devices classified in (B) FFDCA ADVISORY COMMITTEES.—The re- class II or III shall be so inspected by one or quirements for advisory committees under name of the United States agent for the es- tablishment, the name of each importer of more officers or employees duly designated section 712 of the Federal Food, Drug, and by the Secretary, or by persons accredited to Cosmetic Act (21 U.S.C. 379d–1), as amended such device in the United States that is known to the establishment, and the name of conduct inspections under section 704(g), at by section 1121, shall not apply to the work- least once in the 2-year period beginning ing group under this section. each person who imports or offers for import such device to the United States for purposes with the date of registration of such estab- TITLE VII—DRUG SUPPLY CHAIN of importation; and’’; and lishment pursuant to this section and at Subtitle A—Drug Supply Chain (C) by amending subparagraph (B) to read least once in every successive 2-year period SEC. 701. REGISTRATION OF DOMESTIC DRUG ES- as follows: thereafter. TABLISHMENTS. ‘‘(B) each establishment subject to the re- ‘‘(3) RISK-BASED SCHEDULE FOR DRUGS.—The Section 510 (21 U.S.C. 360) is amended— quirements of subparagraph (A) shall there- Secretary, acting through one or more offi- (1) in subsection (b)— after register with the Secretary during the cers or employees duly designated by the (A) in paragraph (1), by striking ‘‘On or be- period beginning on October 1 and ending on Secretary, shall inspect establishments de- fore’’ and all that follows through the period December 31 of each year.’’; and scribed in paragraph (1) that are engaged in at the end and inserting the following: ‘‘Dur- (2) by adding at the end the following: the manufacture, preparation, propagation, ing the period beginning on October 1 and ‘‘(4) The Secretary may specify the unique compounding, or processing of a drug or ending on December 31 of each year, every facility identifier system that shall be used drugs (referred to in this subsection as ‘drug person who owns or operates any establish- by registrants under paragraph (1) with re- establishments’) in accordance with a risk- ment in any State engaged in the manufac- spect to drugs.’’. based schedule established by the Secretary. ture, preparation, propagation, SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT ‘‘(4) RISK FACTORS.—In establishing the compounding, or processing of a drug or INFORMATION WITH PRODUCT LIST- risk-based scheduled under paragraph (3), the drugs shall register with the Secretary— ING. Secretary shall inspect establishments ac- ‘‘(A) the name of such person, places of Section 510(j)(1) (21 U.S.C. 360(j)(1)) is cording to the known safety risks of such es- business of such person, all such establish- amended— tablishments, which shall be based on the ments, the unique facility identifier of each (1) in subparagraph (C), by striking ‘‘; and’’ following factors: such establishment, and a point of contact e- and inserting a semicolon; ‘‘(A) The compliance history of the estab- mail address; and (2) in subparagraph (D), by striking the pe- lishment. ‘‘(B) the name and place of business of each riod at the end and inserting ‘‘; and’’; and ‘‘(B) The record, history, and nature of re- importer that takes physical possession of (3) by adding at the end the following: calls linked to the establishment.

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00060 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3355 ‘‘(C) The inherent risk of the drug manu- SEC. 708. EXCHANGE OF INFORMATION. materials, materials used in the manufac- factured, prepared, propagated, compounded, Section 708 (21 U.S.C. 379) is amended— turing of drugs, and finished drug products.’’. or processed at the establishment. (1) by striking ‘‘CONFIDENTIAL INFORMA- SEC. 710. ACCREDITATION OF THIRD-PARTY TION ‘‘(D) The certifications described under ’’ and all that follows through ‘‘The Sec- AUDITORS FOR DRUG ESTABLISH- sections 801(r) and 809 for the establishment. retary’’ and inserting ‘‘confidential information. MENTS. ‘‘(E) Whether the establishment has been ‘‘(a) CONTRACTORS.—The Secretary’’; and (a) IN GENERAL.—Chapter VIII (21 U.S.C. inspected in the preceding 4-year period. (2) by adding at the end the following: 381 et seq.) is amended by adding at the end ‘‘(F) Any other criteria deemed necessary ‘‘(b) ABILITY TO RECEIVE AND PROTECT CON- the following: and appropriate by the Secretary for pur- FIDENTIAL INFORMATION.—The Secretary poses of allocating inspection resources. shall not be required to disclose under sec- ‘‘SEC. 809. ACCREDITATION OF THIRD-PARTY ‘‘(5) EFFECT OF STATUS.—In determining tion 552 of title 5, United States Code, or any AUDITORS FOR DRUG ESTABLISH- the risk associated with an establishment for other provision of law, any information re- MENTS. purposes of establishing a risk-based sched- lating to drugs obtained from a Federal, ‘‘(a) DEFINITIONS.—In this section: State or local government agency, or from a ule under paragraph (3), the Secretary shall ‘‘(1) ACCREDITATION BODY.—The term ‘ac- not consider whether the drugs manufac- foreign government agency, if the agency creditation body’ means an authority that tured, prepared, propagated, compounded, or has requested that the information be kept performs accreditation of third-party audi- processed by such establishment are drugs confidential, except pursuant to an order of tors. a court of the United States. For purposes of described in section 503(b). ‘‘(2) ACCREDITED THIRD-PARTY AUDITOR.— section 552 of title 5, United States Code, ‘‘(6) ANNUAL REPORT ON INSPECTIONS OF ES- The term ‘accredited third-party auditor’ this subsection shall be considered a statute TABLISHMENTS.—Not later than February 1 of means a third-party auditor (which may be described in section 552(b)(3)(B). each year, the Secretary shall submit a re- an individual) accredited by an accreditation ‘‘(c) AUTHORITY TO ENTER INTO MEMORANDA port to Congress regarding— body to conduct drug safety and quality au- OF UNDERSTANDING FOR PURPOSES OF INFOR- ‘‘(A)(i) the number of domestic and foreign dits. MATION EXCHANGE.—The Secretary may establishments registered pursuant to this enter into written agreements regarding the ‘‘(3) AUDIT AGENT.—The term ‘audit agent’ section in the previous fiscal year; and exchange of information referenced in sec- means an individual who is an employee or ‘‘(ii) the number of such domestic estab- tion 301(j) subject to the following criteria: agent of an accredited third-party auditor lishments and the number of such foreign es- and, although not individually accredited, is ‘‘(1) CERTIFICATION.—The Secretary may tablishments that the Secretary inspected in only enter into written agreements under qualified to conduct drug safety and quality the previous fiscal year; this subsection with foreign governments audits on behalf of an accredited third-party ‘‘(B) with respect to establishments that that the Secretary has certified as having auditor. manufacture, prepare, propagate, compound, the authority and demonstrated ability to ‘‘(4) CONSULTATIVE AUDIT.—The term ‘con- or process an active ingredient of a drug, a protect trade secret information from disclo- sultative audit’ means an audit of an eligible finished drug product, or an excipient of a sure. Responsibility for this certification entity intended for internal purposes only to drug, the number of each such type of estab- shall not be delegated to any officer or em- determine whether an establishment is in lishment; and ployee other than the Commissioner. compliance with the provisions of this Act ‘‘(C) the percentage of the budget of the and applicable industry practices, or any ‘‘(2) WRITTEN AGREEMENT.—The written Food and Drug Administration used to fund agreement under this subsection shall in- other such service. the inspections described under subpara- clude a commitment by the foreign govern- ‘‘(5) DRUG SAFETY AND QUALITY AUDIT.—The graph (A). ment to protect information exchanged term ‘drug safety and quality audit’— ‘‘(7) PUBLIC AVAILABILITY OF ANNUAL RE- under this subsection from disclosure unless ‘‘(A) means an audit of an eligible entity to PORTS.—The Secretary shall make the report and until the sponsor gives written permis- certify that the eligible entity meets the re- required under paragraph (6) available to the sion for disclosure or the Secretary makes a quirements of this Act applicable to drugs, public on the Internet Web site of the Food declaration of a public health emergency including the requirements of section 501 and Drug Administration.’’. pursuant to section 319 of the Public Health with respect to drugs; and SEC. 706. RECORDS FOR INSPECTION. Service Act that is relevant to the informa- ‘‘(B) is not a consultative audit. Section 704(a) (21 U.S.C. 374(a)) is amended tion. ‘‘(6) ELIGIBLE ENTITY.—The term ‘eligible entity’ means an entity, including a foreign by adding at the end the following: ‘‘(3) INFORMATION EXCHANGE.—The Sec- ‘‘(4)(A) Any records or other information retary may provide to a foreign government drug establishment registered under section that the Secretary is entitled to inspect that has been certified under paragraph (1) 510(c), in the drug supply chain that chooses under this section from a person that owns and that has executed a written agreement to be audited by an accredited third-party or operates an establishment that is engaged under paragraph (2) information referenced auditor or the audit agent of such accredited in the manufacture, preparation, propaga- in section 301(j) in the following cir- third-party auditor. tion, compounding, or processing of a drug cumstances: ‘‘(7) THIRD-PARTY AUDITOR.—The term shall, upon the request of the Secretary, be ‘‘(A) Information concerning the inspec- ‘third-party auditor’ means a foreign govern- provided to the Secretary by such person tion of a facility may be provided if— ment, agency of a foreign government or any within a reasonable time frame, within rea- ‘‘(i) the Secretary reasonably believes, or other third party (which may be an indi- sonable limits and in a reasonable manner, that the written agreement described in vidual), as the Secretary determines appro- and in electronic form, at the expense of paragraph (2) establishes, that the govern- priate in accordance with the criteria de- such person. The Secretary’s request shall ment has authority to otherwise obtain such scribed in subsection (c)(1), that is eligible to include a clear description of the records re- information; and be considered for accreditation to conduct quested. ‘‘(ii) the written agreement executed under drug safety and quality audits. ‘‘(B) Upon receipt of the records requested paragraph (2) limits the recipient’s use of the ‘‘(b) ACCREDITATION SYSTEM.— under subparagraph (A), the Secretary shall information to the recipient’s civil regu- ‘‘(1) RECOGNITION OF ACCREDITATION BOD- provide to the person confirmation of the re- latory purposes. IES.— ceipt of such records. ‘‘(B) Information not described in subpara- ‘‘(A) IN GENERAL.—Not later than 2 years ‘‘(C) Nothing in this paragraph supplants graph (A) may be provided as part of an in- after date of enactment of the Food and the authority of the Secretary to conduct in- vestigation, or to alert the foreign govern- Drug Administration Safety and Innovation spections otherwise permitted under this Act ment to the potential need for an investiga- Act, the Secretary shall establish a system in order to ensure compliance by an estab- tion, if the Secretary has reasonable grounds for the recognition of accreditation bodies lishment with this Act.’’. to believe that a drug has a reasonable prob- that accredit third-party auditors to conduct SEC. 707. FAILURE TO ALLOW FOREIGN INSPEC- ability of causing serious adverse health con- drug safety and quality audits. TION. sequences or death to humans or animals. ‘‘(B) DIRECT ACCREDITATION.— Section 801(a) (21 U.S.C. 381(a)) is amended ‘‘(4) EFFECT OF SUBSECTION.—Nothing in ‘‘(i) IN GENERAL.—If, by the date that is 2 by adding at the end the following: ‘‘Not- this subsection affects the ability of the Sec- years after the date of establishment of the withstanding any other provision of this sub- retary to enter into any written agreement system described in subparagraph (A), the section, the Secretary of Homeland Security authorized by other provisions of law to Secretary has not identified and recognized shall, upon request from the Secretary of share confidential information.’’. an accreditation body to meet the require- Health and Human Services refuse to admit SEC. 709. ENHANCING THE SAFETY AND QUALITY ments of this section, the Secretary may di- into the United States any article if the arti- OF THE DRUG SUPPLY. rectly accredit third-party auditors. cle was manufactured, prepared, propagated, Section 501 (21 U.S.C. 351) is amended by ‘‘(ii) CERTAIN DIRECT ACCREDITATIONS.— compounded, processed, or held at an estab- adding at the end the following flush text: Notwithstanding subparagraph (A) or clause lishment that has refused to permit the Sec- ‘‘For purposes of subsection (a)(2)(B), the (i), the Secretary may directly accredit any retary of Health and Human Services to term ‘current good manufacturing practice’ foreign government or any agency of a for- enter or inspect the establishment in the includes the implementation of oversight eign government as a third-party auditor at same manner and to the same extent as the and controls over the manufacture of drugs any time after the date of enactment of the Secretary may inspect establishments under to ensure quality, including managing the Food and Drug Administration Safety and section 704.’’. risk of and establishing the safety of raw Innovation Act.

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‘‘(2) NOTIFICATION.—Each accreditation tion body (or, in the case of direct accredita- ‘‘(i) IN GENERAL.—An accredited third- body recognized by the Secretary shall sub- tion under subsection (b)(1)(B), the Sec- party auditor shall issue a drug certification mit to the Secretary— retary) shall perform such reviews and au- described in subparagraph (A) only after con- ‘‘(A) a list of all accredited third-party dits of the training and qualifications of ducting a drug safety and quality audit and auditors accredited by such body (including audit agents used by that party and conduct such other activities that may be necessary the name, contact information, and scope such reviews of internal systems and such to establish compliance with the provisions and duration of accreditation for each such other investigation of the party as the Sec- of section 501. auditor), and the audit agents of such audi- retary deems necessary, including require- ‘‘(ii) PROVISION OF CERTIFICATION.—Only an tors; and ments under the standards developed under accredited third-party auditor or the Sec- ‘‘(B) updated lists as needed to ensure the subsection (b)(5), to determine that the retary may provide a drug certification de- list held by the Secretary is accurate. third-party auditor is capable of adequately scribed in subparagraph (A). ‘‘(3) REVOCATION OF RECOGNITION AS AN AC- ensuring that an eligible entity or drug cer- ‘‘(C) RECORDS.—Following any accredita- CREDITATION BODY.—The Secretary shall tified by such third-party auditor meets the tion of a third-party auditor, the Secretary promptly revoke, after the opportunity for requirements of this Act. may, at any time, require the accredited an informal hearing, the recognition of any ‘‘(2) USE OF AUDIT AGENTS.—An accredited third-party auditor or any audit agent of accreditation body found not to be in com- third-party auditor may conduct drug safety such auditor to submit to the Secretary a pliance with the requirements of this sec- and quality audits and may employ or use drug safety and quality audit report and tion. audit agents to conduct drug safety and such other reports or documents required as ‘‘(4) REINSTATEMENT.—The Secretary shall part of the drug safety and quality audit quality audits, but must ensure that such establish procedures to reinstate recognition process, for any eligible entity for which the audit agents comply with all requirements of an accreditation body if the Secretary de- accredited third-party auditor or audit agent the Secretary deems necessary, including re- termines, based on evidence presented by of such auditor performed a drug safety and quirements under paragraph (1) and sub- such accreditation body, that revocation was quality audit. The Secretary may require section (b)(5). inappropriate or that the body meets the re- documentation that the eligible entity is in ‘‘(3) REVOCATION OF ACCREDITATION.— quirements for recognition under this sec- compliance with any applicable registration ‘‘(A) IN GENERAL.—The Secretary shall tion. requirements. promptly revoke, after the opportunity for ‘‘(5) MODEL ACCREDITATION STANDARDS.— ‘‘(D) LIMITATION.—The requirement under an informal hearing, the accreditation of an ‘‘(A) IN GENERAL.—Not later than 18 subparagraph (C) shall not include any re- months after the date of enactment of the accredited third-party auditor— port or other documents resulting from a Food and Drug Administration Safety and ‘‘(i) if, following an evaluation, the Sec- consultative audit, except that the Secretary Innovation Act, the Secretary shall develop retary finds that the accredited third-party may access the results of a consultative model standards, including standards for auditor is not in compliance with the re- audit in accordance with section 704. drug safety and quality audit results, re- quirements of this section; or ‘‘(E) DECLARATION OF AUDIT TYPE.—Before ports, and certifications, and each recognized ‘‘(ii) following a refusal to allow United an accredited third-party auditor begins any accreditation body shall ensure that third- States officials to conduct such audits and audit or provides any consultative service to party auditors and audit agents of such audi- investigations as may be necessary to deter- an eligible entity, both the accredited third- tors meet such standards in order to qualify mine compliance with the requirements set party auditor and eligible entity shall estab- such third-party auditors as accredited forth in this section. lish in writing whether the audit is intended third-party auditors under this section. ‘‘(B) ADDITIONAL BASIS FOR REVOCATION OF to be a drug safety and quality audit. Any ‘‘(B) CONTENT.—The standards developed ACCREDITATION.—The Secretary may revoke audit, inspection, or consultative service of under subparagraph (A) may— accreditation from an accredited third-party any type provided by an accredited third- ‘‘(i) include a description of required stand- auditor in the case that such third-party party auditor on behalf of an eligible entity ards relating to the training procedures, auditor is accredited by an accreditation shall be presumed to be a drug safety and competency, management responsibilities, body for which recognition as an accredita- quality audit in the absence of such a writ- quality control, and conflict of interest re- tion body under subsection (b)(3) is revoked, ten agreement. Once a drug safety and qual- quirements of accredited third-party audi- if the Secretary determines that there is ity audit is initiated, it shall be subject to tors; and good cause for the revocation of accredita- the requirements of this section, and no per- ‘‘(ii) set forth procedures for the periodic tion. son may withhold from the Secretary any renewal of the accreditation of accredited ‘‘(4) REACCREDITATION.—The Secretary document subject to subparagraph (C) on the third-party auditors. shall establish procedures to reinstate the grounds that the audit was a consultative ‘‘(C) REQUIREMENT TO PROVIDE RESULTS AND accreditation of a third-party auditor for audit or otherwise not a drug safety and REPORTS TO THE SECRETARY.—An accredita- which accreditation has been revoked under quality audit. tion body (or, in the case of direct accredita- paragraph (3)— ‘‘(F) RULE OF CONSTRUCTION.—Nothing in tion under subsection (b)(1)(B), the Sec- ‘‘(A) if the Secretary determines, based on this section shall be construed to limit the retary) may not accredit a third-party audi- evidence presented, that— authority of the Secretary under section 704. tor unless such third-party auditor agrees to ‘‘(i) the third-party auditor satisfies the re- ‘‘(6) REQUIREMENTS REGARDING SERIOUS provide to the Secretary, upon request, the quirements of this section; and RISKS TO THE PUBLIC HEALTH.—If, at any time results and reports of any drug safety and ‘‘(ii) adequate grounds for revocation no during a drug safety and quality audit, an quality audit conducted pursuant to the ac- longer exist; and accredited third-party auditor or an audit creditation provided under this section. ‘‘(B) in the case of a third-party auditor ac- agent of such auditor discovers a condition ‘‘(6) DISCLOSURE.—The Secretary shall credited by an accreditation body for which that could cause or contribute to a serious maintain on the Internet Web site of the recognition as an accreditation body is re- risk to the public health, such auditor shall Food and Drug Administration a list of rec- voked under subsection (b)(3)— immediately notify the Secretary of— ognized accreditation bodies and accredited ‘‘(i) if the third-party auditor becomes ac- ‘‘(A) the identity and location of the eligi- third-party auditors under this section. credited not later than 1 year after revoca- ble entity subject to the drug safety and ‘‘(c) ACCREDITED THIRD-PARTY AUDITORS.— tion of accreditation under paragraph (3), quality audit; and ‘‘(1) REQUIREMENTS FOR ACCREDITATION AS A through direct accreditation under sub- ‘‘(B) such condition. THIRD-PARTY AUDITOR.— section (b)(1)(B), or by an accreditation body ‘‘(7) LIMITATIONS.— ‘‘(A) FOREIGN GOVERNMENTS.—Prior to ac- in good standing; or ‘‘(A) IN GENERAL.—An audit agent of an ac- crediting a foreign government or an agency ‘‘(ii) under such other conditions as the credited third-party auditor may not per- of a foreign government as an accredited Secretary may require. form a drug safety and quality audit of an el- third-party auditor, the accreditation body ‘‘(5) REQUIREMENT TO ISSUE CERTIFICATION igible entity if such audit agent has per- (or, in the case of direct accreditation under OF ELIGIBLE ENTITIES FOR COMPLIANCE WITH formed a drug safety and quality audit or subsection (b)(1)(B), the Secretary) shall per- CURRENT GOOD MANUFACTURING PRACTICE.— consultative audit of such eligible entity form such reviews and audits of drug safety ‘‘(A) IN GENERAL.—An accreditation body during the previous 13-month period. programs, systems, and standards of the gov- (or, in the case of direct accreditation under ‘‘(B) WAIVER.—The Secretary may waive ernment or agency of the government as the subsection (b)(1)(B), the Secretary) may not the application of subparagraph (A) if the Secretary deems necessary, including re- accredit a third-party auditor unless such Secretary determines that there is insuffi- quirements under the standards developed third-party auditor agrees to issue a written cient access to accredited third-party audi- under subsection (b)(5), to determine that and, as appropriate, electronic, document or tors in a country or region or that the use of the foreign government or agency of the for- certification, as the Secretary may require the same audit agent or accredited third- eign government is capable of adequately en- under this Act, regarding compliance with party auditor is otherwise necessary. suring that eligible entities or drugs cer- section 501. The Secretary may consider any ‘‘(8) CONFLICTS OF INTEREST.— tified by such government or agency meet such document or certification to satisfy re- ‘‘(A) ACCREDITATION BODIES.—A recognized the requirements of this Act. quirements under section 801(r) and to target accreditation body shall— ‘‘(B) OTHER THIRD PARTIES.—Prior to ac- inspection resources under section 510(h). ‘‘(i) not be owned, managed, or controlled crediting any other third party to be an ac- ‘‘(B) REQUIREMENTS FOR ISSUING CERTIFI- by any person that owns or operates a third- credited third-party auditor, the accredita- CATION.— party auditor to be accredited by such body;

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00062 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3357 ‘‘(ii) in carrying out accreditation of third- such an amount necessary to establish and such Act (21 U.S.C. 351(a)(2)(B)) and 801(r) of party auditors under this section, have pro- administer the recognition and accreditation such Act (as added by section 711). cedures to ensure against the use of any offi- program under this section. The Secretary (3) Whether the Secretary has been able to cer or employee of such body that has a fi- may require accredited third-party auditors access drug safety and quality audit reports nancial conflict of interest regarding a third- and audit agents to reimburse the Food and completed by accredited third-party auditors party auditor to be accredited by such body; Drug Administration for the work performed under such section 809. and to carry out this section. The Secretary (4) Whether accredited third-party auditors ‘‘(iii) annually make available to the Sec- shall not generate surplus revenue from such accredited under such section 809 have ad- retary disclosures of the extent to which a reimbursement mechanism. Fees author- hered to the conflict of interest provisions such body and the officers and employees of ized under this paragraph shall be collected set forth in such section. such body have maintained compliance with and available for obligation only to the ex- (5) The extent to which the Secretary has clauses (i) and (ii) relating to financial con- tent and in the amount provided in advance audited recognized accreditation bodies or flicts of interest. in appropriation Acts. Such fees are author- accredited third-party auditors to ensure ‘‘(B) ACCREDITED THIRD-PARTY AUDITORS.— ized to remain available until expended. compliance with the requirements of such An accredited third-party auditor shall— ‘‘(2) AUTHORIZED FEES FOR RECOGNIZED AC- section 809. ‘‘(i) not be owned, managed, or controlled CREDITATION BODIES.—An accreditation body (6) The number of waivers under subsection by any person that owns or operates an eligi- recognized by the Secretary under sub- (c)(7)(B) of such section 809 issued during the ble entity to be certified by such auditor; section (b) may assess a reasonable fee to ac- most recent 12-month period and the official ‘‘(ii) in carrying out drug safety and qual- credit third-party auditors. justification by the Secretary for each deter- ity audits of eligible entities under this sec- ‘‘(h) LIMITATIONS.— mination that there was insufficient access tion, have procedures to ensure against the ‘‘(1) NO EFFECT ON SECTION 704 INSPEC- to an accredited third-party auditor. use of any officer or employee of such audi- TIONS.—The drug safety and quality audits (7) The number of times a manufacturer tor that has a financial conflict of interest performed under this section shall not be has used the same accredited third-party regarding an eligible entity to be certified by considered inspections under section 704. auditor for 2 or more consecutive drug safety such auditor; and ‘‘(2) NO EFFECT ON INSPECTION AUTHORITY.— and quality audits under such section 809. ‘‘(iii) annually make available to the Sec- Nothing in this section affects the authority (8) Recommendations to Congress regard- retary disclosures of the extent to which of the Secretary to inspect any eligible enti- ing the accreditation program under such such auditor and the officers and employees ty pursuant to this Act. section 809, including whether Congress of such auditor have maintained compliance ‘‘(i) REGULATIONS.— should continue, modify, or terminate the with clauses (i) and (ii) relating to financial ‘‘(1) IN GENERAL.—Not later than 18 months program. conflicts of interest. after the date of enactment of the Food and SEC. 711. STANDARDS FOR ADMISSION OF IM- ‘‘(C) AUDIT AGENTS.—An audit agent shall— Drug Administration Safety and Innovation PORTED DRUGS. ‘‘(i) not own or operate an eligible entity Act, the Secretary shall adopt final regula- Section 801 (21 U.S.C. 381) is amended— to be audited by such agent; tions implementing this section. (1) in subsection (o), by striking ‘‘drug or’’; ‘‘(ii) in carrying out audits of eligible enti- ‘‘(2) PROCEDURE.—In promulgating the reg- and ties under this section, have procedures to ulations implementing this section, the Sec- (2) by adding at the end the following: ensure that such agent does not have a fi- retary shall— ‘‘(r)(1) The Secretary may require, as a nancial conflict of interest regarding an eli- ‘‘(A) issue a notice of proposed rulemaking condition of granting admission to a drug gible entity to be audited by such agent; and that includes the proposed regulation; imported or offered for import into the United States, that the importer electroni- ‘‘(iii) annually make available to the Sec- ‘‘(B) provide a period of not less than 60 cally submit information demonstrating retary disclosures of the extent to which days for comments on the proposed regula- that the drug complies with applicable re- such agent has maintained compliance with tion; and quirements of this Act. clauses (i) and (ii) relating to financial con- ‘‘(C) publish the final regulation not less than 30 days before the effective date of the ‘‘(2) The information described under para- flicts of interest. graph (1) may include— ‘‘(d) FALSE STATEMENTS.—Any statement regulation. ‘‘(A) information demonstrating the regu- or representation made— ‘‘(3) CONTENT.—Such regulations shall in- latory status of the drug, such as the new ‘‘(1) by an employee or agent of an eligible clude— drug application, abbreviated new drug ap- entity to an accredited third-party auditor ‘‘(A) requirements that, to the extent prac- plication, or investigational new drug or ticable, drug safety and quality audits per- or audit agent; or drug master file number; formed under this section be unannounced; ‘‘(2) by an accreditation body, accredited ‘‘(B) facility information, such as proof of ‘‘(B) a structure to decrease the potential third-party auditor, or audit agent of such registration and the unique facility identi- for conflicts of interest, including timing auditor to the Secretary, shall be subject to fier; and public disclosure, for fees paid by eligi- section 1001 of title 18, United States Code. ‘‘(C) indication of compliance with current ‘‘(e) MONITORING.—To ensure compliance ble entities to accredited third-party audi- good manufacturing practice, testing results, with the requirements of this section, the tors; and certifications relating to satisfactory inspec- Secretary— ‘‘(C) appropriate limits on financial affili- tions, and compliance with the country of ‘‘(1) shall periodically, or at least once ations between an accredited third-party export regulations; and every 4 years, reevaluate the accreditation auditor or audit agents of such auditor and ‘‘(D) any other information deemed nec- bodies described in subsection (b)(1); any person that owns or operates an eligible essary and appropriate by the Secretary to ‘‘(2) shall periodically, or at least once entity to be audited by such auditor, as de- assess compliance of the article being offered every 4 years, evaluate the performance of scribed in subparagraphs (A) and (B). for import. each accredited third-party auditor, through ‘‘(4) RESTRICTIONS.—Notwithstanding any ‘‘(3) Information requirements referred to the review of regulatory audit reports by other provision of law, the Secretary shall in paragraph (2)(C) may, at the discretion of such auditors, the compliance history as promulgate regulations implementing this the Secretary, be satisfied— available of eligible entities certified by such section only as described in paragraph (2).’’. ‘‘(A) by certifications from accredited auditors, and any other measures deemed (b) REPORT ON ACCREDITED THIRD-PARTY third parties, as described under section 809; necessary by the Secretary; AUDITORS.—Not later than January 20, 2017, ‘‘(B) through representation by a foreign ‘‘(3) may at any time, conduct an onsite the Comptroller General of the United States government, if such inspection is conducted audit of any eligible entity certified by an shall submit to Congress a report that ad- using standards and practices as determined accredited third-party auditor, with or with- dresses the following, with respect to the pe- appropriate by the Secretary; or out the auditor present; and riod beginning on the date of implementa- ‘‘(C) other appropriate documentation or tion of section 809 of the Federal Food, Drug, ‘‘(4) shall take any other measures deemed evidence as described by the Secretary. necessary by the Secretary. and Cosmetic Act (as added by subsection ‘‘(4)(A) Not later than 18 months after the ‘‘(f) EFFECT OF AUDIT.—The results of a (a)) and ending on the date of such report: date of enactment of the Food and Drug Ad- drug safety and quality audit by an accred- (1) The extent to which drug safety and ministration Safety and Innovation Act, the ited third-party auditor under this section— quality audits completed by accredited Secretary shall adopt final regulations im- ‘‘(1) may be used by the eligible entity— third-party auditors under such section 809 plementing this subsection. Such require- ‘‘(A) as documentation of compliance with are being used by the Secretary of Health ments shall be appropriate for the type of section 501(a)(2)(B) or section 801(r); and and Human Services (referred to in this sub- import, such as whether the drug is for im- ‘‘(B) for other purposes as determined ap- section as the ‘‘Secretary’’) in establishing port into the United States for use in pre- propriate by the Secretary; and or applying the risk-based inspection sched- clinical research or in a clinical investiga- ‘‘(2) shall be used by the Secretary in es- ules under section 510(h) of such Act (as tion under an investigational new drug ex- tablishing the risk-based inspection sched- amended by section 705). emption under 505(i). ules under section 510(h). (2) The extent to which drug safety and ‘‘(B) In promulgating the regulations im- ‘‘(g) COSTS.— quality audits completed by accredited plementing this subsection, the Secretary ‘‘(1) AUTHORIZED FEES OF SECRETARY.—The third-party auditors or agents are assisting shall— Secretary may assess fees on accreditation the Food and Drug Administration in evalu- ‘‘(i) issue a notice of proposed rulemaking bodies and accredited third-party auditors in ating compliance with sections 501(a)(2)(B) of that includes the proposed regulation;

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‘‘(ii) provide a period of not less than 60 ‘‘(A) IN GENERAL.—Whoever commits an of- 2012’’ or the ‘‘Securing Pharmaceutical Dis- days for comments on the proposed regula- fense under subsection (a) with respect to a tribution Integrity Act of 2012’’. tion; and drug (as defined in section 201 of the Federal SEC. 722. SECURING THE PHARMACEUTICAL DIS- ‘‘(iii) publish the final regulation not less Food, Drug, and Cosmetic Act (21 U.S.C. 321)) TRIBUTION SUPPLY CHAIN. than 30 days before the effective date of the shall— (a) IN GENERAL.—Chapter V (21 U.S.C. 351 regulation. ‘‘(i) if an individual, be fined not more than et seq.) is amended by adding at the end the ‘‘(C) Notwithstanding any other provision $4,000,000, imprisoned not more than 20 years, following: of law, the Secretary shall promulgate regu- or both; and ‘‘Subchapter H—Pharmaceutical Distribution lations implementing this subsection only as ‘‘(ii) if a person other than an individual, Integrity described in subparagraph (B).’’. be fined not more than $10,000,000. ‘‘SEC. 581. DEFINITIONS. SEC. 712. NOTIFICATION. ‘‘(B) MULTIPLE OFFENSES.—In the case of ‘‘In this subchapter: (a) PROHIBITED ACTS.—Section 301 (21 an offense by a person under this paragraph ‘‘(1) DATA CARRIER.—The term ‘data car- U.S.C. 331) is amended by adding at the end that occurs after that person is convicted of rier’ means a machine-readable graphic that the following: another offense under this paragraph, the is intended to be affixed to, or imprinted ‘‘(aaa) The failure to notify the Secretary person convicted— upon, an individual saleable unit and a ho- in violation of section 568.’’. ‘‘(i) if an individual, shall be fined not mogeneous case of product. The data carrier (b) NOTIFICATION.— more than $8,000,000, imprisoned not more shall comply with a form and format devel- (1) IN GENERAL.—Subchapter E of chapter V than 20 years, or both; and oped by a widely recognized international (21 U.S.C. 360bbb et seq.) is amended by add- ‘‘(ii) if other than an individual, shall be standards development organization to en- ing at the end the following: fined not more than $20,000,000.’’. sure interoperability among distribution ‘‘SEC. 568. NOTIFICATION. (c) SENTENCING.— chain participants. ‘‘(a) NOTIFICATION TO SECRETARY.—With re- (1) DIRECTIVE TO SENTENCING COMMISSION.— ‘‘(2) INDIVIDUAL SALEABLE UNIT.—The term spect to a drug, the Secretary may require Pursuant to its authority under section ‘individual saleable unit’ means the smallest notification to the Secretary by a covered 994(p) of title 28, United States Code, and in container of product put into interstate com- person if the covered person knows— accordance with this section, the United merce by the manufacturer that is intended ‘‘(1) of a substantial loss or theft of such States Sentencing Commission shall review by the manufacturer for individual sale to a drug; or and amend, if appropriate, its guidelines and pharmacy or other dispenser of such product. ‘‘(2) that such drug— its policy statements applicable to persons ‘‘(3) PRODUCT.—The term ‘product’ means a ‘‘(A) has been or is being counterfeited; and convicted of an offense described in section finished drug subject to section 503(b)(1). ‘‘(B)(i) is a counterfeit product in com- 2320(b)(2) of title 18, United States Code, as ‘‘(4) PRODUCT TRACING.—The term ‘product merce in the United States; or amended by subsection (b), in order to reflect tracing’ means— ‘‘(ii) is offered for import into the United the intent of Congress that such penalties be ‘‘(A) identifying the immediate previous States. increased in comparison to those currently source and immediate subsequent recipient ‘‘(b) MANNER OF NOTIFICATION.—Notifica- provided by the guidelines and policy state- of a product in wholesale distribution at the tion under this section shall be made in a ments. lot level where a change of ownership of such reasonable time, in such reasonable manner, (2) REQUIREMENTS.—In carrying out this product has occurred between non-affiliated and by such reasonable means as the Sec- subsection, the Commission shall— entities, except as otherwise described in retary may require by regulation or specify (A) ensure that the sentencing guidelines this subchapter; in guidance. and policy statements reflect the intent of ‘‘(B) identifying the immediate subsequent ‘‘(c) DEFINITION.—In this section, the term Congress that the guidelines and policy recipient of the product at the lot level when ‘covered person’ means— statements reflect the serious nature of the a manufacturer or repackager introduces ‘‘(1) a person who is required to register offenses described in paragraph (1) and the such product into interstate commerce; under section 510 with respect to an estab- need for an effective deterrent and appro- ‘‘(C) identifying that manufacturer and lishment engaged in the manufacture, prepa- priate punishment to prevent such offenses; dispenser of a product at the lot level when ration, propagation, compounding, or proc- (B) consider the extent to which the guide- a manufacturer ships a product at the lot essing of a drug; or lines may or may not appropriately account level, without regard to the change in owner- ‘‘(2) a person engaged in the wholesale dis- for the potential and actual harm to the pub- ship involving the wholesale distributor; and tribution (as defined in section 503(e)(3)(B)) lic resulting from the offense; ‘‘(D) identifying the immediate previous of a drug.’’. (C) assure reasonable consistency with source of a product at the lot level for dis- (2) APPLICABILITY.—Notifications under other relevant directives and with other sen- pensers. section 568 of the Federal Food, Drug, and tencing guidelines; ‘‘(5) RXTEC.—The term ‘RxTEC’ means a Cosmetic Act (as added by paragraph (1)) (D) account for any additional aggravating data carrier that includes the standardized apply to losses, thefts, or counterfeiting, as or mitigating circumstances that might jus- numerical identifier (SNI), the lot number, described in subsection (a) of such section tify exceptions to the generally applicable and the expiration date of a product. The 568, that occur on or after the date of enact- sentencing ranges; standard data carrier RxTEC shall be a 2D ment of this Act. (E) make any necessary conforming data matrix barcode affixed to each indi- SEC. 713. PROTECTION AGAINST INTENTIONAL changes to the sentencing guidelines; and vidual saleable unit of a product and a linear ADULTERATION. (F) assure that the guidelines adequately or 2D data matrix barcode on a homogenous Section 303(b) (21 U.S.C. 333(b)) is amended meet the purposes of sentencing as set forth case of a product. Such information shall be by adding at the end the following: in section 3553(a)(2) of title 18, United States both machine readable and human readable. ‘‘(7) Notwithstanding subsection (a)(2), any Code. ‘‘(6) SUSPECT PRODUCT.—The term ‘suspect person that knowingly and intentionally SEC. 715. EXTRATERRITORIAL JURISDICTION. product’ means a product that, based on adulterates a drug such that the drug is Chapter III (21 U.S.C. 331 et seq.) is amend- credible evidence— adulterated under subsection (a)(1), (b), (c), ed by adding at the end the following: ‘‘(A) is potentially counterfeit, diverted, or or (d) of section 501 and has a reasonable ‘‘SEC. 311. EXTRATERRITORIAL JURISDICTION. stolen; probability of causing serious adverse health ‘‘There is extraterritorial jurisdiction over ‘‘(B) is reasonably likely to be inten- consequences or death to humans or animals any violation of this Act relating to any ar- tionally adulterated such that the product shall be imprisoned for not more than 20 ticle regulated under this Act if such article would result in serious adverse health con- years or fined not more than $1,000,000, or was intended for import into the United sequences or death to humans; or both.’’. States or if any act in furtherance of the vio- ‘‘(C) appears otherwise unfit for distribu- SEC. 714. ENHANCED CRIMINAL PENALTY FOR lation was committed in the United States.’’. tion such that the product would result in COUNTERFEITING DRUGS. serious adverse health consequence or death SEC. 716. COMPLIANCE WITH INTERNATIONAL (a) FFDCA.—Section 303(b) (21 U.S.C. AGREEMENTS. to humans. 333(b)), as amended by section 713, is further Nothing in this title (or an amendment ‘‘(7) VERIFICATION.—The term ‘verification’ amended by adding at the end the following: made by this title) shall be construed in a means the process of determining whether a ‘‘(8) Notwithstanding subsection (a)(2), any manner inconsistent with the obligations of product has the standardized numerical iden- person who knowingly and intentionally vio- the United States under the Agreement Es- tifier or lot number, consistent with section lates section 301(i) shall be imprisoned for tablishing the World Trade Organization, or 582, and expiration date assigned by the man- not more than 20 years or fined not more any other treaty or international agreement ufacturer, or the repackager as applicable, than $4,000,000 or both.’’. to which the United States is a party. and identifying whether a product has the (b) TITLE 18.—Section 2320(b) of title 18, appearance of being a counterfeit, diverted, United States Code, is amended— Subtitle B—Pharmaceutical Distribution or stolen product, or a product otherwise (1) by redesignating paragraphs (2) and (3) Integrity unfit for distribution. Verification of the as paragraphs (3) and (4), respectively; and SEC. 721. SHORT TITLE. RxTEC data may occur by using either a (2) by inserting after paragraph (1) the fol- This subtitle may be referred to as the human-readable, machine-readable, or other lowing: ‘‘Securing Pharmaceutical Distribution In- method such as through purchase records or ‘‘(2) COUNTERFEIT DRUGS.— tegrity to Protect the Public Health Act of invoices.

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ENSURING THE SAFETY OF THE PHAR- ‘‘(ii) shall take into consideration— ‘‘(iii) the proprietary or established name MACEUTICAL DISTRIBUTION SUP- ‘‘(I) the likelihood that a particular prod- or names of the product; PLY CHAIN THROUGH THE ESTAB- uct has a high potential risk with respect to ‘‘(iv) the National Drug Code number of LISHMENT OF AN RXTEC SYSTEM. pharmaceutical distribution supply chain se- the product; ‘‘(a) MANUFACTURER REQUIREMENTS.— curity; ‘‘(v) container size; ‘‘(1) PRODUCT TRACING.—A manufacturer, ‘‘(II) the history and severity of incidences ‘‘(vi) number of containers; not later than 41⁄2 years after the date of en- of counterfeit, diversion, and theft of such ‘‘(vii) the lot number or numbers of the actment of the Securing Pharmaceutical product; product; and Distribution Integrity Act of 2012 and in ac- ‘‘(III) the point in the pharmaceutical dis- ‘‘(viii) the date of the transaction; cordance with this section, shall— tribution supply chain where counterfeit, di- ‘‘(E) provide the following change of own- ‘‘(A) apply RxTEC to the individual sale- version, or theft has occurred or is most ership and transaction information to the able units and homogeneous case of all prod- likely to occur; immediate subsequent recipient of such ucts intended to be introduced into inter- ‘‘(IV) the likelihood that such activities product— state commerce; will reduce the possibility of the counterfeit, ‘‘(i) the proprietary or established name or ‘‘(B) maintain change of ownership and diversion, and theft of such product; names of the product; transaction information, including RxTEC ‘‘(V) whether the product could mitigate or ‘‘(ii) the National Drug Code number of the data that associate unit and lot level data prevent a drug shortage as defined in section product; for each individual saleable unit of product 506C; and ‘‘(iii) container size; and homogenous case introduced in inter- ‘‘(VI) any guidance the Secretary issues re- ‘‘(iv) number of containers; state commerce; and garding high-risk scenarios that could in- ‘‘(v) the lot number or numbers of the ‘‘(C) maintain, where a change of owner- crease the risk of a suspect product entering product; and ship has occurred between non-affiliated en- the pharmaceutical distribution supply ‘‘(vi) a signed statement that the repack- tities or, in the case of a return from the im- chain; and ager— mediate previous source, change of owner- ‘‘(B) conduct unit level verification upon ‘‘(I) is licensed or registered; ship and transaction information relating to the request of a licensed or registered re- ‘‘(II) received the product from a manufac- a product, including— packager, wholesale distributor, dispenser, turer that is licensed or registered; ‘‘(i) RxTEC data; or the Secretary, regarding such product. ‘‘(III) received a signed statement from the ‘‘(ii) the business name and address of the ‘‘(3) NOTIFICATION OF PRODUCT REMOVAL.— manufacturer of such product consistent immediate previous source, if applicable, and ‘‘(A) IN GENERAL.—Not later than 41⁄2 years with subsection (a)(1)(D)(vi); and the immediate subsequent recipient of the after the date of enactment of the Securing ‘‘(IV) did not knowingly and intentionally product; Pharmaceutical Distribution Integrity Act adulterate or knowingly and intentionally ‘‘(iii) the proprietary or established name of 2012 and in accordance with this section, a counterfeit such product; and or names of the product; manufacturer, upon confirming that a prod- ‘‘(F) upon request by the Secretary, other ‘‘(iv) the National Drug Code number of uct does not have the standardized numer- appropriate Federal official, or State offi- the product; ical identifier or lot number, consistent with cial, in the event of a recall, or as deter- ‘‘(v) container size; this section, and expiration date assigned by mined necessary by the Secretary or such ‘‘(vi) number of containers; the manufacturer, or has the appearance of other Federal or State official to investigate ‘‘(vii) the lot number or numbers of the being a counterfeit, diverted, or stolen prod- a suspect product, provide in a reasonable product; and uct, or a product otherwise unfit for dis- time and in a reasonable manner— ‘‘(viii) the date of the transaction; tribution such that the product would result ‘‘(i) RxTEC data by lot; and ‘‘(D) provide the following change of own- in serious adverse health consequences or ‘‘(ii) change of ownership and transaction ership and trans action information to the death to humans, shall— information pursuant to subparagraph (C) or immediate subsequent recipient of such ‘‘(i) promptly notify the Secretary and im- (E) necessary to identify the immediate pre- product— pacted trading partners, as applicable and vious source or the immediate subsequent re- ‘‘(i) the proprietary or established name or appropriate; and cipient of such product, as applicable. names of the product; ‘‘(ii) take steps to remove such product ‘‘(2) VERIFICATION REQUIREMENTS.—A re- ‘‘(ii) the National Drug Code number of the from the pharmaceutical distribution supply packager, not later than 51⁄2 years after the product; chain. date of enactment of the Securing Pharma- ‘‘(iii) container size; ‘‘(B) REDISTRIBUTION.—Any product subject ceutical Distribution Integrity Act of 2012 ‘‘(iv) number of containers; to a notification under this subsection may and in accordance with this section, shall— ‘‘(v) the lot number or numbers of the not be redistributed as a saleable product un- ‘‘(A) utilize RxTEC data at the lot level, as product; and less the manufacturer, in consultation with part of ongoing activities to significantly ‘‘(vi) a signed statement that the manufac- the Secretary, determines such product may minimize or prevent the incidences of sus- turer did not knowingly and intentionally reenter the pharmaceutical distribution sup- pect product in the pharmaceutical distribu- adulterate or knowingly and intentionally ply chain. tion supply chain, as applicable and appro- counterfeit such product; and ‘‘(4) LIMITATION.—Nothing in this section priate, which— ‘‘(E) upon request by the Secretary, other shall require a manufacturer to aggregate ‘‘(i) may include— appropriate Federal official, or State offi- unit level data to cases or pallets. ‘‘(I) responding to alerts regarding a sus- cial, in the event of a recall or as determined ‘‘(b) REPACKAGER REQUIREMENTS.— pect product from a trading partner or the necessary by the Secretary, or such other ‘‘(1) PRODUCT TRACING.—A repackager, not Secretary, routine monitoring of a suspect Federal or State official, to investigate a later than 51⁄2 years after the date of enact- product at the lot level while such product is suspect product, provide in a reasonable time ment of the Securing Pharmaceutical Dis- in the possession of the repackager; and and in a reasonable manner— tribution Integrity Act of 2012 and in accord- ‘‘(II) checking inventory for a suspect ‘‘(i) RxTEC data by lot; and ance with this section, shall— product at the request of a trading partner ‘‘(ii) change of ownership and transaction ‘‘(A) apply RxTEC to the individual sale- or the Secretary in the case of returns; and information pursuant to subparagraphs (C) able unit and the homogenous case of all ‘‘(ii) shall take into consideration— and (D) necessary to identify the immediate product intended to be introduced into inter- ‘‘(I) the likelihood that a particular prod- previous source or immediate subsequent re- state commerce; uct has a high potential risk with respect to cipient of such product, as applicable. ‘‘(B) maintain change of ownership and pharmaceutical distribution supply chain se- ‘‘(2) VERIFICATION REQUIREMENTS.—A manu- transaction information, including RxTEC curity; facturer, not later than 41⁄2 years after the data, that associate unit and lot level data ‘‘(II) the history and severity of incidences date of enactment of the Securing Pharma- for each individual saleable unit of product of counterfeit, diversion, and theft of such ceutical Distribution Integrity Act of 2012 and each homogenous case of product intro- product; and in accordance with this section, shall— duced in interstate commerce, including ‘‘(III) the point in the pharmaceutical dis- ‘‘(A) utilize RxTEC data at the lot level, as RxTEC data received for such products and tribution supply chain where counterfeit, di- part of ongoing activities to significantly for which a repackager applies a new RxTEC; version, and theft has occurred or is most minimize or prevent the incidences of a sus- ‘‘(C) receive only products encoded with likely to occur; pect product in the pharmaceutical distribu- RxTEC data from a licensed or registered ‘‘(IV) the likelihood that such activities tion supply chain, as applicable and appro- manufacturer or wholesaler; will reduce the possibility of counterfeit, di- priate, which— ‘‘(D) maintain, where a change of owner- version, and theft of such product; ‘‘(i) may include responding to an alert re- ship has occurred between non-affiliated en- ‘‘(V) whether the product could mitigate or garding a suspect product from a trading tities in wholesale distribution, change of prevent a drug shortage as defined in section partner or the Secretary, routine monitoring ownership and transaction information re- 506C; and of a suspect product at the lot level while lating to a product, including— ‘‘(VI) any guidance the Secretary issues re- such product is in the possession of the man- ‘‘(i) RxTEC data; garding high-risk scenarios that could in- ufacturer, and checking inventory for a sus- ‘‘(ii) the business name and address of the crease the risk of a suspect product entering pect product at the request of a trading part- immediate previous source and the imme- the pharmaceutical distribution supply ner or the Secretary in case of returns; and diate subsequent recipient of the product; chain; and

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‘‘(B) conduct unit level verification upon knowingly and intentionally counterfeit ‘‘(A) IN GENERAL.—Not later than 61⁄2 years the request of a licensed or registered manu- such product; and after the date of enactment of the Securing facturer, wholesale distributor, dispenser, or ‘‘(IV) did not knowingly and intentionally Pharmaceutical Distribution Integrity Act the Secretary, regarding such product. adulterate or knowingly and intentionally of 2012 and in accordance with this section, a ‘‘(3) NOTIFICATION AND PRODUCT REMOVAL.— counterfeit such product; and wholesale distributor, upon confirming that ‘‘(A) IN GENERAL.—Not later than 51⁄2 years ‘‘(D) upon request by the Secretary, other a product does not have the standardized nu- after the date of enactment of the Securing appropriate Federal official, or State offi- merical identifier or lot number, consistent Pharmaceutical Distribution Integrity Act cial, in the event of a recall, return, or as de- with this section, and expiration date as- of 2012 and in accordance with this section, a termined necessary by the Secretary, or such signed by the manufacturer, or has the ap- repackager, upon confirming that a product other Federal or State official, to inves- pearance of being a counterfeit, diverted, or does not have the standardized numerical tigate a suspect product, provide in a reason- stolen product, or a product otherwise unfit identifier or lot number, consistent with this able time and in a reasonable manner— for distribution such that the product would section, and expiration date assigned by the ‘‘(i) RxTEC data by lot; and result in serious adverse health consequences manufacturer, or has the appearance of being ‘‘(ii) change of ownership and transaction or death to humans, shall— a counterfeit, diverted, or stolen product, or information pursuant to subparagraphs (B) ‘‘(i) promptly notify the Secretary and im- a product otherwise unfit for distribution and (C), as necessary to identify the imme- pacted trading partners, as applicable and such that it would result in serious adverse diate previous source or the immediate sub- appropriate; and health consequences or death to humans, sequent recipient of such product. ‘‘(ii) take steps to remove such product from the pharmaceutical distribution supply shall— ‘‘(2) VERIFICATION REQUIREMENTS.— chain. ‘‘(i) promptly notify the Secretary and im- ‘‘(A) IN GENERAL.—A wholesale distributor ‘‘(B) REDISTRIBUTION.—Any product subject pacted trading partners, as applicable and engaged in wholesale distribution, not later to a notification under this subsection may appropriate; and than 61⁄2 years after the date of enactment of not be redistributed as a saleable product un- ‘‘(ii) take steps to remove such product the Securing Pharmaceutical Distribution less the wholesaler, in consultation with the from the pharmaceutical distribution supply Integrity Act of 2012 and in accordance with chain. Secretary, and manufacturer or repackager this section, shall— as applicable, determines such product may ‘‘(B) REDISTRIBUTION.—Any product subject ‘‘(i) utilize RxTEC data at the lot level, as to a notification under this subsection may reenter the pharmaceutical distribution sup- part of ongoing activities to significantly ply chain. not be redistributed as a saleable product un- minimize or prevent the incidence of suspect ‘‘(C) CONFIDENTIAL DATA.—A wholesale dis- less the repackager, in consultation with the product in the pharmaceutical distribution Secretary, and manufacturer as applicable, tributor may confidentially maintain RxTEC supply chain, as applicable and appropriate, data for a direct trading partner and provide determines such product may reenter the which— pharmaceutical distribution supply chain. access to such information to such trading ‘‘(I) may include responding to an alert re- partner in lieu of data transmission, if mutu- ‘‘(4) LIMITATION.—Nothing in this section garding a suspect product from a trading shall require a repackager to aggregate unit ally agreed upon by such trading partners. partner or the Secretary, routine monitoring ‘‘(d) DISPENSER REQUIREMENTS.— level data to cases or pallets. of a suspect product at the lot level while ‘‘(1) PRODUCT TRACING REQUIREMENTS.—A ‘‘(c) WHOLESALE DISTRIBUTOR REQUIRE- such product is in the possession of the dispenser, not later than 71⁄2 years after the MENTS.— wholesale distributor, and checking inven- date of enactment of the Securing Pharma- ‘‘(1) PRODUCT TRACING REQUIREMENTS.—A tory for a suspect product at the request of ceutical Distribution Integrity Act of 2012 wholesale distributor engaged in wholesale a trading partner or the Secretary; and and in accordance with this section, shall— distribution, not later than 61⁄2 years after ‘‘(II) shall take into consideration— ‘‘(A) receive product only from a licensed the date of enactment of the Securing Phar- ‘‘(aa) the likelihood that a particular prod- or registered manufacturer, repackager, or maceutical Distribution Integrity Act of 2012 uct has a high potential risk with respect to wholesale distributor; and in accordance with this section, shall— pharmaceutical distribution supply chain se- ‘‘(B) receive only products encoded with ‘‘(A) receive only products encoded with curity; RxTEC lot level data from a manufacturer, RxTEC from a licensed or registered manu- ‘‘(bb) the history and severity of incidences repackager, or wholesale distributor selling facturer, wholesaler, or repackager; of counterfeit, diversion, and theft of such the drug product to the dispenser; ‘‘(B) maintain, in wholesale distribution product; ‘‘(C) maintain RxTEC lot level data or where a change of ownership has occurred ‘‘(cc) the point in the pharmaceutical dis- allow the wholesale distributor to confiden- between non-affiliated entities, change of tribution supply chain where counterfeit, di- tially maintain and store the RxTEC lot ownership and transaction information, in- version, and theft has occurred or is most level data sufficient to identify the product cluding— likely to occur; provided to the dispenser from the imme- ‘‘(i) RxTEC data by lot; ‘‘(dd) the likelihood that such activities diate previous source where a change of own- ‘‘(ii) the business name and address of the will reduce the possibility of counterfeit, di- ership has occurred between non-affiliated immediate previous source and the imme- version, and theft of such product; entities (if such arrangement is mutually diate subsequent recipient of the product; ‘‘(ee) whether the product could mitigate agreed upon by the dispenser and the whole- ‘‘(iii) the proprietary or established name or prevent a drug shortage as defined in sec- sale distributor); or names of the product; tion 506C; and ‘‘(D) use the RxTEC lot level data main- ‘‘(iv) the National Drug Code number of ‘‘(ff) any guidance the Secretary issues re- tained by the dispenser or maintained by the the product; garding high-risk scenarios that could in- wholesale distributor on behalf of the dis- ‘‘(v) container size; crease the risk of suspect product entering penser (if such arrangement is mutually ‘‘(vi) number of containers; the pharmaceutical distribution supply agreed upon by the dispenser and the whole- ‘‘(vii) the lot number or numbers of the chain; sale distributor), as necessary to respond to product; and ‘‘(ii) conduct lot-level verification in the a request from the Secretary in the event of ‘‘(viii) the date of the transaction; event of a recall, including upon the request a suspect product or recall; ‘‘(C) provide the following change of owner- of a licensed or registered manufacturer, re- ‘‘(E) maintain lot level data upon change ship and transaction information to the im- packager, dispenser, or the Secretary, re- of ownership between non-affiliated entities mediate subsequent recipient of such prod- garding such product and recall; and for recalled product; and uct— ‘‘(iii) conduct verification of a returned ‘‘(F) for investigation purposes only, and ‘‘(i) the proprietary or established name or product to validate the return at the lot upon request by the Secretary, other appro- names of the product; level for a sealed homogenous case of such priate Federal official, or State official, for ‘‘(ii) the National Drug Code number of the product or at the individual saleable unit of the purpose of investigating a suspect or re- product; such product if the unit is not in a sealed ho- called product, provide the RxTEC data by ‘‘(iii) container size; mogenous case; and lot and the immediate previous source or im- ‘‘(iv) number of containers; ‘‘(iv) conduct unit level verification of a mediate subsequent receipt of the suspect or ‘‘(v) the lot number or numbers of the suspect product— recalled product, as applicable. product; ‘‘(I) upon the request of a licensed or reg- ‘‘(2) VERIFICATION REQUIREMENTS.—Not ‘‘(vi) the date of the transaction; and istered manufacturer, repackager, whole- later than 7 1⁄2 years after the date of enact- ‘‘(vii) a signed statement that the whole- saler, dispenser, or the Secretary, regarding ment of the Securing Pharmaceutical Dis- sale distributor— such product; or tribution Integrity Act of 2012 and in accord- ‘‘(I) is licensed or registered; ‘‘(II) upon the determination that a prod- ance with this section, a dispenser shall be ‘‘(II) received the product from a registered uct is a suspect product. required to conduct lot level verification of or licensed manufacturer, repackager, or ‘‘(B) LIMITATION.—Nothing in this para- suspect product only. wholesale distributor, as applicable; graph shall require a wholesale distributor ‘‘(3) NOTIFICATION AND PRODUCT REMOVAL.— ‘‘(III) received a signed statement from the to verify product at the unit level except as ‘‘(A) IN GENERAL.—Not later than 7 1⁄2 years immediate subsequent recipient of such required under clauses (iii) and (iv) of sub- after the date of enactment of the Securing product that such trading partner did not paragraph (A). Pharmaceutical Distribution Integrity Act knowingly and intentionally adulterate or ‘‘(3) NOTIFICATION AND PRODUCT REMOVAL.— of 2012 and in accordance with this section, a

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00066 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3361 dispenser, upon confirming that a product is ‘‘(C) publish the final regulation not less for a change that results in a new indication, a suspect product or a product otherwise than 30 days before the effective date of the route of administration, dosing schedule, unfit for distribution, shall— regulation. dosage form, delivery system, delivery de- ‘‘(i) promptly notify the Secretary and im- ‘‘(3) RESTRICTIONS.—Notwithstanding any vice, or strength; or pacted trading partners, as applicable and other provision of law, the Secretary shall ‘‘(3) an application for a product that is appropriate; and promulgate regulations implementing this not approved for the use for which it re- ‘‘(ii) take steps to remove such product section only as described in paragraph (2). ceived a designation under subsection (d). from the pharmaceutical distribution supply ‘‘(g) STANDARDS.—The Secretary shall, in ‘‘(d) DESIGNATION.— chain. consultation with other appropriate Federal ‘‘(1) IN GENERAL.—The manufacturer or ‘‘(B) REDISTRIBUTION.—Any product subject officials, manufacturers, repackagers, whole- sponsor of a drug may request the Secretary to a notification under this paragraph may sale distributors, dispensers, and other sup- to designate a drug as a qualified infectious not be redistributed as a saleable product un- ply chain stakeholders, prioritize and de- disease product at any time before the sub- less the dispenser, in consultation with the velop standards for the interoperable ex- mission of an application under section Secretary, and manufacturer, repackager, or change of ownership and transaction infor- 505(b) for such drug. The Secretary shall, not wholesaler as applicable, determines such mation for tracking and tracing prescription later than 60 days after the submission of such a request, determine whether the drug product may reenter the pharmaceutical dis- drugs.’’. (b) PROHIBITED ACT.—Section 301 (21 U.S.C. is a qualified infectious disease product. tribution supply chain. 331), as amended by section 712, is further ‘‘(2) LIMITATION.—Except as provided in ‘‘(C) LIMITATIONS.—Nothing in this section amended by inserting at the end the fol- paragraph (3), a designation under this sub- shall— lowing: section shall not be withdrawn for any rea- ‘‘(i) require a dispenser to verify product at ‘‘(bbb) The violation of any requirement son, including modifications to the list of the unit level; or under section 582.’’. qualifying pathogens under subsection ‘‘(ii) require a dispenser to adopt specific (c) SMALL ENTITY COMPLIANCE GUIDE.—Not (f)(2)(C). technologies or business systems for compli- later than 180 days after enactment of this ‘‘(3) REVOCATION OF DESIGNATION.—The Sec- ance with this section. Act, the Secretary of Health and Human retary may revoke a designation of a drug as ‘‘(e) ENSURING FLEXIBILITY.—The require- Services (referred to in this title as the a qualified infectious disease product if the ments under this section shall— ‘‘Secretary’’) shall issue a compliance guide Secretary finds that the request for such des- ‘‘(1) require the maintenance and trans- setting forth in plain language the require- ignation contained an untrue statement of mission only of information that is reason- ments under section 582 of the Federal Food, material fact. ably available and appropriate; Drug, and Cosmetic Act, as added by sub- ‘‘(e) REGULATIONS.— ‘‘(2) be based on current scientific and section (a), in order to assist small entities ‘‘(1) IN GENERAL.—Not later than 2 years technological capabilities and shall neither in complying with such section. after the date of enactment of the Food and require nor restrict the use of additional (d) LIMITATIONS.— Drug Administration Safety and Innovation data carrier technologies; (1) SAVINGS CLAUSE.—Nothing in this sub- Act, the Secretary shall adopt final regula- tions implementing this section. ‘‘(3) not prescribe or proscribe specific title or the amendments made by this sub- ‘‘(2) PROCEDURE.—In promulgating a regu- technologies or systems for the maintenance title shall preempt any State or local law or lation implementing this section, the Sec- and transmission of data other than the regulation. retary shall— standard data carrier for RxTEC or specific (2) EFFECT ON CALIFORNIA LAW.—Notwith- ‘‘(A) issue a notice of proposed rulemaking methods of verification; standing any other provision of Federal or that includes the proposed regulation; ‘‘(4) not require a record of the complete State law, including any provision of this ‘‘(B) provide a period of not less than 60 previous distribution history of the drug subtitle or of subchapter H of chapter V of days for comments on the proposed regula- from the point of origin of such drug; the Federal Food, Drug, and Cosmetic Act, tion; and ‘‘(5) take into consideration whether the as added by subsection (a), such subchapter ‘‘(C) publish the final regulation not less public health benefits of imposing any addi- H shall not trigger California Business and than 30 days before the effective date of the tional regulations outweigh the cost of com- Professions Code, section 4034.1. regulation. pliance with such requirements; (3) EFFECTIVE DATE.—Subsection (c) and ‘‘(3) RESTRICTIONS.—Notwithstanding any ‘‘(6) be scale-appropriate and practicable the amendments made by subsections (a) and other provision of law, the Secretary shall for entities of varying sizes and capabilities; (b) shall take effect on January 1, 2022, or on promulgate regulations implementing this ‘‘(7) with respect to cost and recordkeeping the date on which Congress enacts a law pro- section only as described in paragraph (2), burdens, not require the creation and main- viding for express preemption of any State except that the Secretary may issue interim tenance of duplicative records where the in- law regulating the distribution of drugs, guidance for sponsors seeking designation formation is contained in other company whichever is later. under subsection (d) prior to the promulga- records kept in the normal course of busi- TITLE VIII—GENERATING ANTIBIOTIC tion of such regulations. ness; INCENTIVES NOW ‘‘(4) DESIGNATION PRIOR TO REGULATIONS.— ‘‘(8) to the extent practicable, not require SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD The Secretary may designate drugs as quali- specific business systems for compliance FOR DRUGS. fied infectious disease products under sub- with such requirements; (a) IN GENERAL.—Chapter V (21 U.S.C. 351 section (d) prior to the promulgation of regu- ‘‘(9) include a process by which the Sec- et seq.) is amended by inserting after section lations under this subsection. retary may issue a waiver of such regula- 505D the following: ‘‘(f) QUALIFYING PATHOGEN.— tions for an individual entity if the Sec- ‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD ‘‘(1) DEFINITION.—In this section, the term retary determines that such requirements FOR NEW QUALIFIED INFECTIOUS DISEASE PRODUCTS. ‘qualifying pathogen’ means a pathogen would result in an economic hardship or for identified and listed by the Secretary under emergency medical reasons, including a pub- ‘‘(a) EXTENSION.—If the Secretary approves an application pursuant to section 505 for a paragraph (2) that has the potential to pose lic health emergency declaration pursuant to a serious threat to public health, such as— section 319 of the Public Health Service Act; drug that has been designated as a qualified infectious disease product under subsection ‘‘(A) resistant gram positive pathogens, in- and cluding methicillin-resistant Staphylococcus ‘‘(10) include a process by which the Sec- (d), the 4- and 5-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of aureus, vancomycin-resistant Staphy- retary may determine exceptions to the lococcus aureus, and vancomycin-resistant standard data carrier RxTEC requirement if section 505, the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) enterococcus; a drug is packaged in a container too small ‘‘(B) multi-drug resistant gram negative or otherwise unable to accommodate a label and clauses (iii) and (iv) of subsection (j)(5)(F) of section 505, or the 7-year period bacteria, including Acinetobacter, with sufficient space to bear the information Klebsiella, Pseudomonas, and E. coli species; required for compliance with this section. described in section 527, as applicable, shall be extended by 5 years. ‘‘(C) multi-drug resistant tuberculosis; and ‘‘(f) REGULATIONS AND GUIDANCE.— ‘‘(b) RELATION TO PEDIATRIC EXCLUSIVITY.— ‘‘(D) Clostridium difficile. ‘‘(1) IN GENERAL.—The Secretary may issue Any extension under subsection (a) of a pe- ‘‘(2) LIST OF QUALIFYING PATHOGENS.— guidance consistent with this section regard- riod shall be in addition to any extension of ‘‘(A) IN GENERAL.—The Secretary shall es- ing the circumstances surrounding suspect the period under section 505A with respect to tablish and maintain a list of qualifying product and verification practices. the drug. pathogens, and shall make public the meth- ‘‘(2) PROCEDURE.—The Secretary, in pro- ‘‘(c) LIMITATIONS.—Subsection (a) does not odology for developing such list. mulgating any regulation pursuant to this apply to the approval of— ‘‘(B) CONSIDERATIONS.—In establishing and section, shall— ‘‘(1) a supplement to an application under maintaining the list of pathogens described ‘‘(A) issue a notice of proposed rulemaking section 505(b) for any qualified infectious dis- under this section the Secretary shall— that includes a copy of the proposed regula- ease product for which an extension de- ‘‘(i) consider— tion; scribed in subsection (a) is in effect or has ‘‘(I) the impact on the public health due to ‘‘(B) provide a period of not less than 60 expired; drug-resistant organisms in humans; days for comments on the proposed regula- ‘‘(2) a subsequent application filed with re- ‘‘(II) the rate of growth of drug-resistant tion; and spect to a product approved under section 505 organisms in humans;

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‘‘(III) the increase in resistance rates in (1) an assessment of any underlying regu- (2) RECOMMENDATIONS.—If the Secretary humans; and latory issues related to qualified infectious has reason to believe that a drug for which a ‘‘(IV) the morbidity and mortality in hu- disease products, including qualified infec- request is made under this subsection is a mans; and tious disease biological products; qualified infectious disease product, the Sec- ‘‘(ii) consult with experts in infectious dis- (2) an assessment of the management by retary shall provide the person making the eases and antibiotic resistance, including the the Food and Drug Administration of the re- request written recommendations for the Centers for Disease Control and Prevention, view of qualified infectious disease products, nonclinical and clinical investigations which the Food and Drug Administration, medical including qualified infectious disease bio- the Secretary believes, on the basis of infor- professionals, and the clinical research com- logical products and the regulatory cer- mation available to the Secretary at the munity. tainty of related regulatory pathways for time of the request, would be necessary for ‘‘(C) REVIEW.—Every 5 years, or more often such products; approval under section 505 of the Federal as needed, the Secretary shall review, pro- (3) a description of any regulatory impedi- Food, Drug, and Cosmetic Act (21 U.S.C. 355) vide modifications to, and publish the list of ments to the clinical development of new of such drug for the use described in para- qualifying pathogens under subparagraph (A) qualified infectious disease products, includ- graph (1). and shall by regulation revise the list as nec- ing qualified infectious disease biological (c) GAO STUDY.—Not later than January 1, essary, in accordance with subsection (e). products, and the efforts of the Food and 2016, the Comptroller General of the United ‘‘(g) QUALIFIED INFECTIOUS DISEASE PROD- Drug Administration to address such impedi- States shall submit to Congress a report— UCT.—The term ‘qualified infectious disease ments; and (1) regarding the review and revision of the product’ means an antibacterial or (4) recommendations with respect to— clinical trial guidance documents required antifungal drug for human use intended to (A) improving the review and predict- under subsection (a) and the impact such re- treat serious or life-threatening infections, ability of regulatory pathways for such prod- view and revision has had on the review and including those caused by— ucts; and approval of qualified infectious disease prod- ‘‘(1) an antibacterial or antifungal resist- (B) overcoming any regulatory impedi- ucts; ant pathogen, including novel or emerging ments identified in paragraph (3). (2) assessing— infectious pathogens; or (c) DEFINITIONS.—In this section: (A) the effectiveness of the results-oriented ‘‘(2) qualifying pathogens listed by the Sec- (1) The term ‘‘biological product’’ has the metrics managers employ to ensure that re- retary under subsection (f).’’. meaning given to such term in section 351 of viewers of such products are familiar with, (b) APPLICATION.—Section 505E of the Fed- the Public Health Service Act (42 U.S.C. 262). and consistently applying, clinical trial eral Food, Drug, and Cosmetic Act, as added (2) The term ‘‘qualified infectious disease guidance documents; and by subsection (a), applies only with respect biological product’’ means a biological prod- (B) the predictability of related regulatory to a drug that is first approved under section uct intended to treat a serious or life-threat- pathways and review; 505(c) of such Act (21 U.S.C. 355(c)) on or ening infection described in section 505E(g) (3) identifying any outstanding regulatory after the date of the enactment of this Act. of the Federal Food, Drug, and Cosmetic Act, impediments to the clinical development of SEC. 802. PRIORITY REVIEW. as added by section 801. qualified infectious disease products; (a) AMENDMENT.—Chapter V (21 U.S.C. 351 (3) The term ‘‘qualified infectious disease (4) reporting on the progress the Food and et seq.) is amended by inserting after section product’’ has the meaning given such term in Drug Administration has made in addressing 524 the following: section 505E(g) of the Federal Food, Drug, the impediments identified under paragraph ‘‘SEC. 524A. PRIORITY REVIEW FOR QUALIFIED and Cosmetic Act, as added by section 801. (3); and INFECTIOUS DISEASE PRODUCTS. SEC. 805. CLINICAL TRIALS. (5) containing recommendations regarding ‘‘If the Secretary designates a drug under (a) REVIEW AND REVISION OF GUIDANCE DOC- how to improve the review of, and regulatory section 505E(d) as a qualified infectious dis- UMENTS.— pathway for, such products. ease product, then the Secretary shall give (1) IN GENERAL.—The Secretary of Health (d) QUALIFIED INFECTIOUS DISEASE PROD- priority review to any application submitted and Human Services (referred to in this sec- UCT.—For purposes of this section, the term for approval for such drug under section tion as the ‘‘Secretary’’) shall review and, as ‘‘qualified infectious disease product’’ has 505(b).’’. appropriate, revise not fewer than 3 guidance the meaning given such term in section (b) APPLICATION.—Section 524A of the Fed- documents per year, which shall include— 505E(g) of the Federal Food, Drug, and Cos- eral Food, Drug, and Cosmetic Act, as added (A) reviewing the guidance documents of metic Act, as added by section 801. by subsection (a), applies only with respect the Food and Drug Administration for the SEC. 806. REGULATORY CERTAINTY AND PRE- to an application that is submitted under conduct of clinical trials with respect to DICTABILITY. section 505(b) of such Act (21 U.S.C. 355(b)) on antibacterial and antifungal drugs; and (a) INITIAL STRATEGY AND IMPLEMENTATION or after the date of the enactment of this (B) as appropriate, revising such guidance PLAN.—Not later than 1 year after the date Act. documents to reflect developments in sci- of enactment of this Act, the Secretary of SEC. 803. FAST TRACK PRODUCT. entific and medical information and tech- Health and Human Services (referred to in Section 506(a)(1) (21 U.S.C. 356(a)(1)), as nology and to ensure clarity regarding the this section as the ‘‘Secretary’’) shall submit amended by section 901(b), is amended by in- procedures and requirements for approval of to Congress a strategy and implementation serting ‘‘, or if the Secretary designates the antibacterial and antifungal drugs under plan with respect to the requirements of this drug as a qualified infectious disease product chapter V of the Federal Food, Drug, and Act. The strategy and implementation plan under section 505E(d)’’ before the period at Cosmetic Act (21 U.S.C. 351 et seq.). shall include— the end of the first sentence. (2) ISSUES FOR REVIEW.—At a minimum, the (1) a description of the regulatory chal- SEC. 804. GAO STUDY. review under paragraph (1) shall address the lenges to clinical development, approval, and (a) IN GENERAL.—The Comptroller General appropriate animal models of infection, in licensure of qualified infectious disease prod- of the United States shall— vitro techniques, valid micro-biological sur- ucts; (1) conduct a study— rogate markers, the use of non-inferiority (2) the regulatory and scientific priorities (A) on the need for, and public health im- versus superiority trials, trial enrollment, of the Secretary with respect to such chal- pact of, incentives to encourage the re- data requirements, and appropriate delta lenges; and search, development, and marketing of values for non-inferiority trials. (3) the steps the Secretary will take to en- qualified infectious disease biological prod- (3) RULE OF CONSTRUCTION.—Except to the sure regulatory certainty and predictability ucts and antifungal products; and extent to which the Secretary makes revi- with respect to qualified infectious disease (B) consistent with trade and confiden- sions under paragraph (1)(B), nothing in this products, including steps the Secretary will tiality data protections, assessing, for all section shall be construed to repeal or other- take to ensure managers and reviewers are antibacterial and antifungal drugs, including wise effect the guidance documents of the familiar with related regulatory pathways, biological products, the average or aggre- Food and Drug Administration. requirements of the Food and Drug Adminis- gate— (b) RECOMMENDATIONS FOR INVESTIGA- tration, guidance documents related to such (i) costs of all clinical trials for each TIONS.— products, and applying such requirements phase; (1) REQUEST.—The sponsor of a drug in- consistently. (ii) percentage of success or failure at each tended to be designated as a qualified infec- (b) SUBSEQUENT REPORT.—Not later than 3 phase of clinical trials; and tious disease product may request that the years after the date of enactment of this (iii) public versus private funding levels of Secretary provide written recommendations Act, the Secretary shall submit to Congress the trials for each phase; and for nonclinical and clinical investigations a report on— (2) not later than 1 year after the date of which the Secretary believes may be nec- (1) the progress made toward the priorities enactment of this Act, submit a report to essary to be conducted with the drug before identified under subsection (a)(2); Congress on the results of such study, in- such drug may be approved under section 505 (2) the number of qualified infectious dis- cluding any recommendations of the Comp- of the Federal Food, Drug, and Cosmetic Act ease products that have been submitted for troller General on appropriate incentives for (21 U.S.C. 355) for use in treating, detecting, approval or licensure on or after the date of addressing such need. preventing, or identifying a qualifying enactment of this Act; (b) CONTENTS.—The part of the study de- pathogen, as defined in section 505E of such (3) a list of qualified infectious disease scribed in subsection (a)(1)(A) shall include— Act. products with information on the types of

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00068 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3363 exclusivity granted for each product, con- proval and fast track provisions set forth in the predicted effect on irreversible morbidity sistent with the information published under section 506 of the Federal Food, Drug, and or mortality or other clinical benefit. section 505(j)(7)(A)(iii) of the Federal Food, Cosmetic Act (21 U.S.C. 356), as amended by ‘‘(B) That the sponsor submit copies of all Drug, and Cosmetic Act (21 U.S.C. this section, to help expedite the develop- promotional materials related to the product 355(j)(7)(A)(iii)); ment and availability to patients of treat- during the preapproval review period and, (4) the number of such qualified infectious ments for serious or life-threatening diseases following approval and for such period there- disease products and that have been ap- or conditions while maintaining safety and after as the Secretary determines to be ap- proved or licensed on or after the date of en- effectiveness standards for such treatments. propriate, at least 30 days prior to dissemi- actment of this Act; and (b) EXPEDITED APPROVAL OF DRUGS FOR SE- nation of the materials. (5) the number of calendar days it took for RIOUS OR LIFE-THREATENING DISEASES OR ‘‘(3) EXPEDITED WITHDRAWAL OF AP- the approval or licensure of the qualified in- CONDITIONS.—Section 506 (21 U.S.C. 356) is PROVAL.—The Secretary may withdraw ap- fectious disease products approved or li- amended to read as follows: proval of a product approved under acceler- censed on or after the date of enactment of ‘‘SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR ated approval using expedited procedures (as this Act. SERIOUS OR LIFE-THREATENING prescribed by the Secretary in regulations (c) QUALIFIED INFECTIOUS DISEASE PROD- DISEASES OR CONDITIONS. which shall include an opportunity for an in- UCT.—For purposes of this section, the term ‘‘(a) DESIGNATION OF DRUG AS FAST TRACK formal hearing) if— ‘‘qualified infectious disease product’’ has PRODUCT.— ‘‘(A) the sponsor fails to conduct any re- the meaning given such term in section ‘‘(1) IN GENERAL.—The Secretary shall, at quired post-approval study of the drug with 505E(g) of the Federal Food, Drug, and Cos- the request of the sponsor of a new drug, fa- due diligence; metic Act, as added by section 801. cilitate the development and expedite the re- ‘‘(B) a study required to verify and describe TITLE IX—DRUG APPROVAL AND PATIENT view of such drug if it is intended, whether the predicted effect on irreversible morbidity ACCESS alone or in combination with one or more or mortality or other clinical benefit of the product fails to verify and describe such ef- SEC. 901. ENHANCEMENT OF ACCELERATED PA- other drugs, for the treatment of a serious or TIENT ACCESS TO NEW MEDICAL life-threatening disease or condition, and it fect or benefit; TREATMENTS. demonstrates the potential to address unmet ‘‘(C) other evidence demonstrates that the (a) FINDINGS; SENSE OF CONGRESS.— medical needs for such a disease or condi- product is not safe or effective under the (1) FINDINGS.—Congress finds as follows: tion. (In this section, such a drug is referred conditions of use; or (A) The Food and Drug Administration (re- to as a ‘fast track product’.) ‘‘(D) the sponsor disseminates false or mis- ferred to in this section as the ‘‘FDA’’) ‘‘(2) REQUEST FOR DESIGNATION.—The spon- leading promotional materials with respect serves a critical role in helping to assure sor of a new drug may request the Secretary to the product. that new medicines are safe and effective. to designate the drug as a fast track product. ‘‘(c) REVIEW OF INCOMPLETE APPLICATIONS Regulatory innovation is 1 element of the A request for the designation may be made FOR APPROVAL OF A FAST TRACK PRODUCT.— Nation’s strategy to address serious and life- concurrently with, or at any time after, sub- ‘‘(1) IN GENERAL.—If the Secretary deter- threatening diseases or conditions by pro- mission of an application for the investiga- mines, after preliminary evaluation of clin- moting investment in and development of in- tion of the drug under section 505(i) or sec- ical data submitted by the sponsor, that a novative treatments for unmet medical tion 351(a)(3) of the Public Health Service fast track product may be effective, the Sec- needs. Act. retary shall evaluate for filing, and may (B) During the 2 decades following the es- ‘‘(3) DESIGNATION.—Within 60 calendar days commence review of portions of, an applica- tablishment of the accelerated approval after the receipt of a request under para- tion for the approval of the product before mechanism, advances in medical sciences, graph (2), the Secretary shall determine the sponsor submits a complete application. including genomics, molecular biology, and whether the drug that is the subject of the The Secretary shall commence such review bioinformatics, have provided an unprece- request meets the criteria described in para- only if the applicant— dented understanding of the underlying bio- graph (1). If the Secretary finds that the ‘‘(A) provides a schedule for submission of logical mechanism and pathogenesis of dis- drug meets the criteria, the Secretary shall information necessary to make the applica- ease. A new generation of modern, targeted designate the drug as a fast track product tion complete; and medicines is under development to treat se- and shall take such actions as are appro- ‘‘(B) pays any fee that may be required rious and life-threatening diseases, some ap- priate to expedite the development and re- under section 736. plying drug development strategies based on view of the application for approval of such ‘‘(2) EXCEPTION.—Any time period for re- biomarkers or pharmacogenomics, predictive product. view of human drug applications that has toxicology, clinical trial enrichment tech- ‘‘(b) ACCELERATED APPROVAL OF A DRUG been agreed to by the Secretary and that has niques, and novel clinical trial designs, such FOR A SERIOUS OR LIFE-THREATENING DISEASE been set forth in goals identified in letters of as adaptive clinical trials. OR CONDITION, INCLUDING A FAST TRACK the Secretary (relating to the use of fees col- (C) As a result of these remarkable sci- PRODUCT.— lected under section 736 to expedite the drug entific and medical advances, the FDA ‘‘(1) IN GENERAL.— development process and the review of should be encouraged to implement more ‘‘(A) ACCELERATED APPROVAL.—The Sec- human drug applications) shall not apply to broadly effective processes for the expedited retary may approve an application for ap- an application submitted under paragraph (1) development and review of innovative new proval of a product for a serious or life- until the date on which the application is medicines intended to address unmet med- threatening disease or condition, including a complete. ical needs for serious or life-threatening dis- fast track product, under section 505(c) or ‘‘(d) AWARENESS EFFORTS.—The Secretary eases or conditions, including those for rare section 351(a) of the Public Health Service shall— diseases or conditions, using a broad range of Act upon a determination that the product ‘‘(1) develop and disseminate to physicians, surrogate or clinical endpoints and modern has an effect on a surrogate endpoint that is patient organizations, pharmaceutical and scientific tools earlier in the drug develop- reasonably likely to predict clinical benefit, biotechnology companies, and other appro- ment cycle when appropriate. This may re- or on a clinical endpoint that can be meas- priate persons a description of the provisions sult in fewer, smaller, or shorter clinical ured earlier than irreversible morbidity or of this section applicable to accelerated ap- trials for the intended patient population or mortality, that is reasonably likely to pre- proval and fast track products; and targeted subpopulation without compro- dict an effect on irreversible morbidity or ‘‘(2) establish a program to encourage the mising or altering the high standards of the mortality or other clinical benefit, taking development of surrogate and clinical FDA for the approval of drugs. into account the severity, rarity, or preva- endpoints, including biomarkers, and other (D) Patients benefit from expedited access lence of the condition and the availability or scientific methods and tools that can assist to safe and effective innovative therapies to lack of alternative treatments. The approval the Secretary in determining whether the treat unmet medical needs for serious or life- described in the preceding sentence is re- evidence submitted in an application is rea- threatening diseases or conditions. ferred to in this section as ‘accelerated ap- sonably likely to predict clinical benefit for (E) For these reasons, the statutory au- proval’. serious or life-threatening conditions for thority in effect on the day before the date ‘‘(B) EVIDENCE.—The evidence to support which significant unmet medical needs exist. of enactment of this Act governing expedited that an endpoint is reasonably likely to pre- ‘‘(e) CONSTRUCTION.— approval of drugs for serious or life-threat- dict clinical benefit under subparagraph (A) ‘‘(1) PURPOSE.—The amendments made by ening diseases or conditions should be may include epidemiological, the Food and Drug Administration Safety amended in order to enhance the authority pathophysiological, therapeutic, pharmaco- and Innovation Act to this section are in- of the FDA to consider appropriate scientific logic, or other evidence developed using bio- tended to encourage the Secretary to utilize data, methods, and tools, and to expedite de- markers, for example, or other scientific innovative and flexible approaches to the as- velopment and access to novel treatments methods or tools. sessment of products under accelerated ap- for patients with a broad range of serious or ‘‘(2) LIMITATION.—Approval of a product proval for treatments for patients with seri- life-threatening diseases or conditions. under this subsection may be subject to 1 or ous or life-threatening diseases or conditions (2) SENSE OF CONGRESS.—It is the sense of both of the following requirements: and unmet medical needs. Congress that the Food and Drug Adminis- ‘‘(A) That the sponsor conduct appropriate ‘‘(2) CONSTRUCTION.—Nothing in this sec- tration should apply the accelerated ap- post-approval studies to verify and describe tion shall be construed to alter the standards

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00069 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3364 CONGRESSIONAL RECORD — SENATE May 21, 2012 of evidence under subsection (c) or (d) of sec- or life-threatening disease or condition and the requirements with respect to break- tion 505 (including the substantial evidence preliminary clinical evidence indicates that through therapies, as set forth in section standard in section 505(d)) of this Act or the drug may demonstrate substantial im- 506(a) of the Federal Food, Drug, and Cos- under section 351(a) of the Public Health provement over existing therapies on 1 or metic Act (21 U.S.C. 356(a)), as amended by Service Act. Such sections and standards of more clinically significant endpoints, such this section. The Secretary shall issue final evidence apply to the review and approval of as substantial treatment effects observed guidance not later than 1 year after the close products under this section, including early in clinical development. (In this sec- of the comment period for the draft guid- whether a product is safe and effective. tion, such a drug is referred to as a ‘break- ance. Nothing in this section alters the ability of through therapy’.) (B) AMENDED REGULATIONS.— the Secretary to rely on evidence that does ‘‘(2) REQUEST FOR DESIGNATION.—The spon- (i) IN GENERAL.—If the Secretary deter- not come from adequate and well-controlled sor of a drug may request the Secretary to mines that it is necessary to amend the reg- investigations for the purpose of determining designate the drug as a breakthrough ther- ulations under title 21, Code of Federal Regu- whether an endpoint is reasonably likely to apy. A request for the designation may be lations in order to implement the amend- predict clinical benefit as described in sub- made concurrently with, or at any time ments made by this section to section 506(a) section (b)(1)(B).’’. after, the submission of an application for of the Federal Food, Drug, and Cosmetic Act, (c) GUIDANCE; AMENDED REGULATIONS.— the investigation of the drug under section the Secretary shall amend such regulations (1) DRAFT GUIDANCE.—Not later than 1 year 505(i) or section 351(a)(3) of the Public Health not later than 2 years after the date of enact- after the date of enactment of this Act, the Service Act. ment of this Act. Secretary of Health and Human Services (re- ‘‘(3) DESIGNATION.— (ii) PROCEDURE.—In amending regulations ferred to in this section as the ‘‘Secretary’’) ‘‘(A) IN GENERAL.—Not later than 60 cal- under clause (i), the Secretary shall— shall issue draft guidance to implement the endar days after the receipt of a request (I) issue a notice of proposed rulemaking amendments made by this section. In devel- under paragraph (2), the Secretary shall de- that includes the proposed regulation; oping such guidance, the Secretary shall spe- termine whether the drug that is the subject (II) provide a period of not less than 60 cifically consider issues arising under the ac- of the request meets the criteria described in days for comments on the proposed regula- celerated approval and fast track processes paragraph (1). If the Secretary finds that the tion; and under section 506 of the Federal Food, Drug, drug meets the criteria, the Secretary shall (III) publish the final regulation not less and Cosmetic Act, as amended by subsection designate the drug as a breakthrough ther- than 30 days before the effective date of the (b), for drugs designated for a rare disease or apy and shall take such actions as are appro- regulation. condition under section 526 of such Act (21 priate to expedite the development and re- (iii) RESTRICTIONS.—Notwithstanding any U.S.C. 360bb) and shall also consider any view of the application for approval of such other provision of law, the Secretary shall unique issues associated with very rare dis- drug. promulgate regulations implementing the eases. ‘‘(B) ACTIONS.—The actions to expedite the amendments made by section only as de- development and review of an application (2) FINAL GUIDANCE.—Not later than 1 year scribed in clause (ii). after the issuance of draft guidance under under subparagraph (A) may include, as ap- (2) REQUIREMENTS.—Guidance issued under paragraph (1), and after an opportunity for propriate— this section shall— public comment, the Secretary shall issue ‘‘(i) holding meetings with the sponsor and (A) specify the process and criteria by final guidance. the review team throughout the development which the Secretary makes a designation of the drug; (3) CONFORMING CHANGES.—The Secretary under section 506(a)(3) of the Federal Food, shall issue, as necessary, conforming amend- ‘‘(ii) providing timely advice to, and inter- Drug, and Cosmetic Act; and ments to the applicable regulations under active communication with, the sponsor re- (B) specify the actions the Secretary shall title 21, Code of Federal Regulations, gov- garding the development of the drug to en- take to expedite the development and review erning accelerated approval. sure that the development program to gather of a breakthrough therapy pursuant to such the non-clinical and clinical data necessary (4) NO EFFECT OF INACTION ON REQUESTS.—If designation under such section 506(a)(3), in- the Secretary fails to issue final guidance or for approval is as efficient as practicable; cluding updating good review management amended regulations as required by this sub- ‘‘(iii) involving senior managers and expe- practices to reflect breakthrough therapies. section, such failure shall not preclude the rienced review staff, as appropriate, in a col- (c) INDEPENDENT REVIEW.—Not later than 3 review of, or action on, a request for designa- laborative, cross-disciplinary review; years after the date of enactment of this tion or an application for approval submitted ‘‘(iv) assigning a cross-disciplinary project Act, the Comptroller General of the United pursuant to section 506 of the Federal Food, lead for the Food and Drug Administration States, in consultation with appropriate ex- perts, shall assess the manner by which the Drug, and Cosmetic Act, as amended by sub- review team to facilitate an efficient review Food and Drug Administration has applied section (b). of the development program and to serve as a scientific liaison between the review team the processes described in section 506(a) of (d) INDEPENDENT REVIEW.—The Secretary the Federal Food, Drug, and Cosmetic Act, may, in conjunction with other planned re- and the sponsor; and as amended by this section, and the impact views, contract with an independent entity ‘‘(v) taking steps to ensure that the design of the clinical trials is as efficient as prac- of such processes on the development and with expertise in assessing the quality and timely availability of innovative treatments efficiency of biopharmaceutical development ticable, when scientifically appropriate, such as by minimizing the number of patients ex- for patients affected by serious or life- and regulatory review programs to evaluate threatening conditions. Such assessment the Food and Drug Administration’s applica- posed to a potentially less efficacious treat- ment.’’; shall be made publicly available upon com- tion of the processes described in section 506 pletion. of the Federal Food, Drug, and Cosmetic Act, (4) in subsection (f)(1), as so redesignated, by striking ‘‘applicable to accelerated ap- (d) CONFORMING AMENDMENTS.—Section as amended by subsection (b), and the impact 506B(e) (21 U.S.C. 356b) is amended by strik- proval’’ and inserting ‘‘applicable to break- of such processes on the development and ing ‘‘section 506(b)(2)(A)’’ each place such through therapies, accelerated approval, timely availability of innovative treatments term appears and inserting ‘‘section and’’; and for patients suffering from serious or life- 506(c)(2)(A)’’. (5) by adding at the end the following: threatening conditions. Any such evaluation SEC. 903. CONSULTATION WITH EXTERNAL EX- ‘‘(g) REPORT.—Beginning in fiscal year shall include consultation with regulated in- 2013, the Secretary shall annually prepare PERTS ON RARE DISEASES, TAR- dustries, patient advocacy and disease re- GETED THERAPIES, AND GENETIC and submit to the Committee on Health, search foundations, and relevant academic TARGETING OF TREATMENTS. Education, Labor, and Pensions of the Sen- medical centers. Subchapter E of chapter V (21 U.S.C. 360bbb ate and the Committee on Energy and Com- et seq.), as amended by section 712, is further SEC. 902. BREAKTHROUGH THERAPIES. merce of the House of Representatives, and amended by adding at the end the following: (a) IN GENERAL.—Section 506 (21 U.S.C. 356), make publicly available, with respect to this as amended by section 901, is further amend- ‘‘SEC. 569. CONSULTATION WITH EXTERNAL EX- section for the previous fiscal year— PERTS ON RARE DISEASES, TAR- ed— ‘‘(1) the number of drugs for which a spon- GETED THERAPIES, AND GENETIC (1) by redesignating subsections (a) sor requested designation as a breakthrough TARGETING OF TREATMENTS. through (c) as subsections (b) through (d), re- therapy; ‘‘(a) IN GENERAL.—For the purpose of pro- spectively; ‘‘(2) the number of products designated as moting the efficiency of and informing the (2) by redesignating subsection (d) as sub- a breakthrough therapy; and review by the Food and Drug Administration section (f); ‘‘(3) for each product designated as a of new drugs and biological products for rare (3) by inserting before subsection (b), as so breakthrough therapy, a summary of the ac- diseases and drugs and biological products redesignated, the following: tions taken under subsection (a)(3).’’. that are genetically targeted, the following ‘‘(a) DESIGNATION OF A DRUG AS A BREAK- (b) GUIDANCE; AMENDED REGULATIONS.— shall apply: THROUGH THERAPY.— (1) IN GENERAL.— ‘‘(1) CONSULTATION WITH STAKEHOLDERS.— ‘‘(1) IN GENERAL.—The Secretary shall, at (A) GUIDANCE.—Not later than 18 months Consistent with sections X.C and IX.E.4 of the request of the sponsor of a drug, expedite after the date of enactment of this Act, the the PDUFA Reauthorization Performance the development and review of such drug if Secretary of Health and Human Services (re- Goals and Procedures Fiscal Years 2013 the drug is intended, alone or in combination ferred to in this section as the ‘‘Secretary’’) through 2017, as referenced in the letters de- with 1 or more other drugs, to treat a serious shall issue draft guidance on implementing scribed in section 101(b) of the Prescription

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Drug User Fee Amendments of 2012, the Sec- (referred to in this section as the ‘‘Access (1) IN GENERAL.—Beginning 18 months after retary shall ensure that opportunities exist, Board’’) shall convene a stakeholder working the completion of the development of best at a time the Secretary determines appro- group (referred to in this section as the practices under subsection (a)(3)(A), the priate, for consultations with stakeholders ‘‘working group’’) to develop best practices Comptroller General of the United States on the topics described in subsection (c). on access to information on prescription shall conduct a review of the extent to which ‘‘(2) CONSULTATION WITH EXTERNAL EX- drug container labels for individuals who are pharmacies are utilizing such best practices, PERTS.—The Secretary shall develop and blind or visually impaired. and the extent to which barriers to acces- maintain a list of external experts who, be- (2) MEMBERS.—The working group shall be sible information on prescription drug con- cause of their special expertise, are qualified comprised of representatives of national or- tainer labels for blind and visually-impaired to provide advice on rare disease issues, in- ganizations representing blind and visually- individuals continue. cluding topics described in subsection (c). impaired individuals, national organizations (2) REPORT.—Not later than September 30, The Secretary may, when appropriate to ad- representing the elderly, and industry groups 2016, the Comptroller General of the United dress a specific regulatory question, consult representing stakeholders, including retail, States shall submit to Congress a report on such external experts on issues related to the mail order, and independent community the review conducted under paragraph (1). review of new drugs and biological products pharmacies, who would be impacted by such Such report shall include recommendations for rare diseases and drugs and biological best practices. Representation within the about how best to reduce the barriers experi- products that are genetically targeted, in- working group shall be divided equally be- enced by blind and visually-impaired individ- cluding the topics described in subsection tween consumer and industry advocates. uals to independently accessing information (c), when such consultation is necessary be- (3) BEST PRACTICES.— on prescription drug container labels. cause the Secretary lacks specific scientific, (A) IN GENERAL.—The working group shall (c) DEFINITIONS.—In this section— medical, or technical expertise necessary for develop, not later than 1 year after the date (1) the term ‘‘pharmacy’’ includes a phar- the performance of its regulatory respon- of the enactment of this Act, best practices macy that receives prescriptions and dis- sibilities and the necessary expertise can be for pharmacies to ensure that blind and vis- penses prescription drugs through an Inter- provided by the external experts. ually-impaired individuals have safe, con- net website or by mail; ‘‘(b) EXTERNAL EXPERTS.—For purposes of sistent, reliable, and independent access to (2) the term ‘‘prescription drug’’ means a subsection (a)(2), external experts are those the information on prescription drug con- drug subject to section 503(b)(1) of the Fed- who possess scientific or medical training tainer labels. eral Food, Drug, and Cosmetic Act (21 U.S.C. that the Secretary lacks with respect to one (B) PUBLIC AVAILABILITY.—The best prac- 353(b)(1)); and or more rare diseases. tices developed under subparagraph (A) may (3) the term ‘‘prescription drug container ‘‘(c) TOPICS FOR CONSULTATION.—Topics for be made publicly available, including label’’ means the label with the directions consultation pursuant to this section may through the Internet websites of the working for use that is affixed to the prescription include— group participant organizations, and through drug container by the pharmacist and dis- ‘‘(1) rare diseases; other means, in a manner that provides ac- pensed to the consumer. ‘‘(2) the severity of rare diseases; cess to interested individuals, including indi- SEC. 905. RISK-BENEFIT FRAMEWORK. ‘‘(3) the unmet medical need associated viduals with disabilities. Section 505(d) (21 U.S.C. 355(d)) is amended with rare diseases; (C) LIMITATIONS.—The best practices devel- by adding at the end the following: ‘‘The ‘‘(4) the willingness and ability of individ- oped under subparagraph (A) shall not be Secretary shall implement a structured risk- uals with a rare disease to participate in construed as accessibility guidelines or benefit assessment framework in the new clinical trials; standards of the Access Board, and shall not drug approval process to facilitate the bal- ‘‘(5) an assessment of the benefits and risks confer any rights or impose any obligations anced consideration of benefits and risks, a of therapies to treat rare diseases; on working group participants or other per- consistent and systematic approach to the ‘‘(6) the general design of clinical trials for sons. Nothing in this section shall be con- discussion and regulatory decisionmaking, rare disease populations and subpopulations; strued to limit or condition any right, obli- and the communication of the benefits and and gation, or remedy available under the Amer- risks of new drugs. Nothing in the preceding ‘‘(7) demographics and the clinical descrip- icans with Disabilities Act of 1990 (42 U.S.C. sentence shall alter the criteria for evalu- tion of patient populations. 12101 et seq.) or any other Federal or State ating an application for premarket approval ‘‘(d) CLASSIFICATION AS SPECIAL GOVERN- law requiring effective communication, bar- of a drug.’’. MENT EMPLOYEES.—The external experts who rier removal, or nondiscrimination on the SEC. 906. INDEPENDENT STUDY ON MEDICAL IN- are consulted under this section may be con- basis of disability. NOVATION INDUCEMENT MODEL. sidered special government employees, as de- (4) CONSIDERATIONS.—In developing and (a) IN GENERAL.—The Secretary of Health fined under section 202 of title 18, United issuing the best practices under paragraph and Human Services shall enter into an States Code. (3)(A), the working group shall consider— agreement with the National Academies to ‘‘(e) PROTECTION OF PROPRIETARY INFORMA- (A) the use of— provide expert consultation and conduct a TION.—Nothing in this section shall be con- (i) Braille; study that evaluates the feasibility and pos- strued to alter the protections offered by (ii) auditory means, such as— sible consequences of the use of innovation laws, regulations, and policies governing dis- (I) ‘‘talking bottles’’ that provide audible inducement prizes to reward successful med- closure of confidential commercial or trade container label information; ical innovations. Under the agreement, the secret information, and any other informa- (II) digital voice recorders attached to the National Academies shall submit to the Sec- tion exempt from disclosure pursuant to sec- prescription drug container; and retary a report on such study not later than tion 552(b) of title 5, United States Code, as (III) radio frequency identification tags; 15 months after the date of enactment of this such provisions would be applied to consulta- (iii) enhanced visual means, such as— Act. tion with individuals and organizations prior (I) large font labels or large font ‘‘dupli- (b) REQUIREMENTS.— to the date of enactment of this section. cate’’ labels that are affixed or matched to a (1) IN GENERAL.—The study conducted ‘‘(f) OTHER CONSULTATION.—Nothing in this prescription drug container; under subsection (a) shall model at least 3 section shall be construed to limit the abil- (II) high-contrast printing; and separate segments on the medical tech- ity of the Secretary to consult with individ- (III) sans-serf font; and nologies market as candidate targets for the uals and organizations as authorized prior to (iv) other relevant alternatives as deter- new incentive system and consider different the date of enactment of this section. mined by the working group; medical innovation inducement prize design ‘‘(g) NO RIGHT OR OBLIGATION.—Nothing in (B) whether there are technical, financial, issues, including the challenges presented in this section shall be construed to create a manpower, or other factors unique to phar- the implementation of prizes for end prod- legal right for a consultation on any matter macies with 20 or fewer retail locations ucts, open source dividend prizes, and prizes or require the Secretary to meet with any which may pose significant challenges to the for upstream research. particular expert or stakeholder. Nothing in adoption of the best practices; and (2) MARKET SEGMENTS.—The segments on this section shall be construed to alter (C) such other factors as the working group the medical technologies market that shall agreed upon goals and procedures identified determines to be appropriate. be considered under paragraph (1) include— in the letters described in section 101(b) of (5) INFORMATION CAMPAIGN.—Upon comple- (A) all pharmaceutical and biologic drugs the Prescription Drug User Fee Amendments tion of development of the best practices and vaccines; of 2012. Nothing in this section is intended to under subsection (a)(3), the National Council (B) drugs and vaccines used solely for the increase the number of review cycles as in on Disability, in consultation with the work- treatment of HIV/AIDS; and effect before the date of enactment of this ing group, shall conduct an informational (C) antibiotics. section.’’. and educational campaign designed to in- (c) ELEMENTS.—The study conducted under SEC. 904. ACCESSIBILITY OF INFORMATION ON form individuals with disabilities, phar- subsection (a) shall include consideration of PRESCRIPTION DRUG CONTAINER macists, and the public about such best prac- each of the following: LABELS BY VISUALLY-IMPAIRED tices. (1) Whether a system of large innovation AND BLIND CONSUMERS. (6) FACA WAIVER.—The Federal Advisory inducement prizes could work as a replace- (a) ESTABLISHMENT OF WORKING GROUP.— Committee Act (5 U.S.C. App.) shall not ment for the existing product monopoly/pat- (1) IN GENERAL.—The Architectural and apply to the working group. ent-based system, as in effect on the date of Transportation Barriers Compliance Board (b) GAO STUDY.— enactment of this Act.

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00071 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3366 CONGRESSIONAL RECORD — SENATE May 21, 2012 (2) How large the innovation prize funds 355), in biologics license applications under ‘‘(E) used in emergency medical care or would have to be in order to induce at least section 351 of the Public Health Service Act during surgery; and as much research and development invest- (42 U.S.C. 262), and in premarket approval ap- ‘‘(2) that is not a radio pharmaceutical ment in innovation as is induced under the plications under section 515 of the Federal drug product, a human tissue replaced by a current system of time-limited market ex- Food, Drug, and Cosmetic Act (21 U.S.C. recombinant product, a product derived from clusivity, as in effect on the date of enact- 360e) for products approved or licensed by the human plasma protein, or any other product ment of this Act. Food and Drug Administration, consistent as designated by the Secretary, (3) Whether a system of large innovation with applicable requirements and Guidance shall notify the Secretary, in accordance inducement prizes would be more or less ex- for Industry, and consistent with the regula- with subsection (b), of a permanent dis- pensive than the current system of time-lim- tions of the Food and Drug Administration continuance in the manufacture of the drug ited market exclusivity, as in effect on the pertaining to the protection of sponsors’ con- or an interruption of the manufacture of the date of enactment of this Act, calculated fidential commercial information as of the drug that could lead to a meaningful disrup- over different time periods. date of enactment of this Act. tion in the supply of that drug in the United (4) Whether a system of large innovation (C) An analysis of the extent to which de- States. inducement prizes would expand access to mographic subgroups, including sex, age, ra- ‘‘(b) TIMING.—A notice required under sub- new products and improve health outcomes. cial, and ethnic subgroups, are represented section (a) shall be submitted to the Sec- (5) The type of information and decision- in clinical studies to support applications for retary— making skills that would be necessary to approved or licensed new molecular entities, ‘‘(1) at least 6 months prior to the date of manage end product prizes. biological products, and devices. the discontinuance or interruption; or (6) Whether there would there be major ad- (D) An analysis of the extent to which a ‘‘(2) if compliance with paragraph (1) is not vantages in rewarding the incremental im- summary of product safety and effectiveness possible, as soon as practicable. ‘‘(c) EXPEDITED INSPECTIONS AND RE- pact of innovations, as benchmarked against data by demographic subgroups including VIEWS.—If, based on notifications described existing products. sex, age, race, and ethnicity is readily avail- in subsection (a) or any other relevant infor- (7) How open-source dividend prizes could able to the public in a timely manner by mation, the Secretary concludes that there be managed, and whether such prizes would means of the product labeling or the Food is, or is likely to be, a drug shortage of a increase access to knowledge, materials, and Drug Administration’s Internet website. drug described in subsection (a), the Sec- data and technologies. (b) ACTION PLAN.— retary may— (8) Whether a system of competitive inter- (1) IN GENERAL.—Not later than 1 year after ‘‘(1) expedite the review of a supplement to mediaries for interim research prizes would the publication of the report described in a new drug application submitted under sec- provide an acceptable solution to the valu- subsection (a), the Secretary, acting through tion 505(b), an abbreviated new drug applica- ation challenges for interim prizes. the Commissioner, shall publish an action tion submitted under section 505(j), or a sup- SEC. 907. ORPHAN PRODUCT GRANTS PROGRAM. plan on the Internet website of the Food and plement to such an application submitted (a) REAUTHORIZATION OF PROGRAM.—Sec- Drug Administration, and provide such pub- under section 505(j) that could help mitigate tion 5(c) of the Orphan Drug Act (21 U.S.C. lication to Congress. or prevent such shortage; or 360ee(c)) is amended by striking ‘‘2008 (2) CONTENT OF ACTION PLAN.—The plan de- ‘‘(2) expedite an inspection or reinspection through 2012’’ and inserting ‘‘2013 through scribed in paragraph (1) shall include— of an establishment that could help mitigate 2017’’. (A) recommendations, as appropriate, to or prevent such drug shortage. (b) HUMAN CLINICAL TESTING.—Section improve the completeness and quality of ‘‘(d) COORDINATION.— 5(b)(1)(A)(ii)) of the Orphan Drug Act (21 analyses of data on demographic subgroups ‘‘(1) TASK FORCE AND STRATEGIC PLAN.— U.S.C. 360ee(b)(1)(A)(ii)) is amended by strik- in summaries of product safety and effective- ‘‘(A) IN GENERAL.— ing ‘‘after the date such drug is designated ness data and in labeling; ‘‘(i) TASK FORCE.—As soon as practicable under section 526 of such Act and’’. (B) recommendations, as appropriate, on after the date of enactment of the Food and SEC. 908. REPORTING OF INCLUSION OF DEMO- the inclusion of such data, or the lack of GRAPHIC SUBGROUPS IN CLINICAL Drug Administration Safety and Innovation availability of such data in labeling; Act, the Secretary shall establish a Task TRIALS AND DATA ANALYSIS IN AP- (C) recommendations, as appropriate, to PLICATIONS FOR DRUGS, BIO- Force to develop and implement a strategic LOGICS, AND DEVICES. otherwise improve the public availability of plan for enhancing the Secretary’s response (a) REPORT.— such data to patients, healthcare providers, to preventing and mitigating drug shortages. (1) IN GENERAL.—Not later than 1 year after and researchers; and ‘‘(ii) STRATEGIC PLAN.—The strategic plan the date of enactment of this Act, the Sec- (D) a determination with respect to each described in clause (i) shall include— retary, acting through the Commissioner, recommendation identified in subparagraphs ‘‘(I) plans for enhanced interagency and shall publish on the Internet website of the (A) through (C) that distinguishes between intraagency coordination, communication, Food and Drug Administration a report, con- product types referenced in subsection and decisionmaking; sistent with the regulations of the Food and (a)(2)(B) insofar as the applicability of each ‘‘(II) plans for ensuring that drug shortages Drug Administration pertaining to the pro- such recommendation to each type of prod- are considered when the Secretary initiates tection of sponsors’ confidential commercial uct. a regulatory action that could precipitate a information as of the date of enactment of (c) DEFINITIONS.—In this section: drug shortage or exacerbate an existing drug this Act, addressing the extent to which clin- (1) The term ‘‘Commissioner’’ means the shortage; ical trial participation and the inclusion of Commissioner of Food and Drugs. ‘‘(III) plans for effective communication safety and effectiveness data by demographic (2) The term ‘‘device’’ has the meaning with outside stakeholders, including who the subgroups including sex, age, race, and eth- given such term in section 201(h) of the Fed- Secretary should alert about potential or ac- nicity, is included in applications submitted eral Food, Drug, and Cosmetic Act (21 U.S.C. tual drug shortages, how the communication to the Food and Drug Administration, and 321(h)). should occur, and what types of information shall provide such publication to Congress. (3) The term ‘‘drug’’ has the meaning given should be shared; and such term in section 201(g) of the Federal (2) CONTENTS OF REPORT.—The report de- ‘‘(IV) plans for considering the impact of scribed in paragraph (1) shall contain the fol- Food, Drug, and Cosmetic Act (21 U.S.C. drug shortages on research and clinical lowing: 321(g)). trials. (4) The term ‘‘biological product’’ has the (A) A description of existing tools to en- ‘‘(iii) CONSULTATION.—In carrying out this sure that data to support demographic anal- meaning given such term in section 351(i) of subparagraph, the Task Force shall ensure yses are submitted in applications for drugs, the Public Health Service Act (42 U.S.C. consultation with the appropriate offices biological products, and devices, and that 262(i)). within the Food and Drug Administration, these analyses are conducted by applicants (5) The term ‘‘Secretary’’ means the Sec- including the Office of the Commissioner, consistent with applicable Food and Drug retary of Health and Human Services. the Center for Drug Evaluation and Re- Administration requirements and Guidance TITLE X—DRUG SHORTAGES search, the Office of Regulatory Affairs, and for Industry. The report shall address how SEC. 1001. DRUG SHORTAGES. employees within the Department of Health the Food and Drug Administration makes (a) IN GENERAL.—Section 506C (21 U.S.C. and Human Services with expertise regard- available information about differences in 356c) is amended to read as follows: ing drug shortages. The Secretary shall en- safety and effectiveness of medical products ‘‘SEC. 506C. DISCONTINUANCE OR INTERRUPTION gage external stakeholders and experts as according to demographic subgroups, such as IN THE PRODUCTION OF LIFE-SAV- appropriate. sex, age, racial, and ethnic subgroups, to ING DRUGS. ‘‘(B) TIMING.—Not later than 1 year after healthcare providers, researchers, and pa- ‘‘(a) IN GENERAL.—A manufacturer of a the date of enactment Food and Drug Ad- tients. drug— ministration Safety and Innovation Act, the (B) An analysis of the extent to which de- ‘‘(1) that is— Task Force shall— mographic data subset analyses on sex, age, ‘‘(A) life-supporting; ‘‘(i) publish the strategic plan described in race, and ethnicity is presented in applica- ‘‘(B) life-sustaining; subparagraph (A); and tions for new drug applications for new mo- ‘‘(C) intended for use in the prevention of a ‘‘(ii) submit such plan to Congress. lecular entities under section 505 of the Fed- debilitating disease or condition; ‘‘(2) COMMUNICATION.—The Secretary shall eral Food, Drug, and Cosmetic Act (21 U.S.C. ‘‘(D) a sterile injectable product; or ensure that, prior to any enforcement action

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or issuance of a warning letter that the Sec- ‘‘(2) TREND ANALYSIS.—The Secretary is au- ‘‘(A) issue a notice of proposed rulemaking retary determines could reasonably be an- thorized to retain a third party to conduct a that includes the proposed regulation; ticipated to lead to a meaningful disruption study, if the Secretary believes such a study ‘‘(B) provide a period of not less than 60 in the supply in the United States of a drug would help clarify the causes, trends, or so- days for comments on the proposed regula- described under subsection (a), there is com- lutions related to drug shortages. tion; and munication with the appropriate office of ‘‘(3) ANNUAL SUMMARY.—Not later than 18 ‘‘(C) publish the final regulation not less the Food and Drug Administration with ex- months after the date of enactment of the than 30 days before the regulation’s effective pertise regarding drug shortages regarding Food and Drug Administration Safety and date. whether the action or letter could cause, or Innovation Act, and annually thereafter, the ‘‘(4) RESTRICTIONS.—Notwithstanding any exacerbate, a shortage of the drug. Secretary shall submit to the Committee on other provision of Federal law, in imple- ‘‘(3) ACTION.—If the Secretary determines, Health, Education, Labor, and Pensions of menting this section, the Secretary shall after the communication described in para- the Senate and the Committee on Energy only promulgate regulations as described in graph (2), that an enforcement action or a and Commerce of the House of Representa- paragraph (3).’’. warning letter could reasonably cause or ex- tives a report summarizing, with respect to (b) EFFECT OF NOTIFICATION.—The submis- acerbate a shortage of a drug described under the 1-year period preceding such report, the sion of a notification to the Secretary of subsection (a), then the Secretary shall information described in paragraph (1). Such Health and Human Services (referred to in evaluate the risks associated with the im- report shall not include any information this section as the ‘‘Secretary’’) for purposes pact of such shortage upon patients and that is exempt from disclosure under sub- of complying with the requirement in sec- those risks associated with the violation in- section (a) of section 552 of title 5, United tion 506C(a) of the Federal Food, Drug, and volved before taking such action or issuing States Code, by reason of subsection (b)(4) of Cosmetic Act (as amended by subsection (a)) such letter, unless there is imminent risk of such section. shall not be construed— serious adverse health consequences or death ‘‘(f) DEFINITIONS.—For purposes of this sec- (1) as an admission that any product that to humans. tion— is the subject of such notification violates ‘‘(4) REPORTING BY OTHER ENTITIES.—The ‘‘(1) the term ‘drug’— any provision of the Federal Food, Drug, and Secretary shall identify or establish a mech- ‘‘(A) means a drug (as defined in section Cosmetic Act (21 U.S.C. 301 et seq.); or anism by which healthcare providers and 201(g)) that is intended for human use; and (2) as evidence of an intention to promote other third-party organizations may report ‘‘(B) does not include biological products or market the product for an indication or to the Secretary evidence of a drug shortage. (as defined in section 351 of the Public use for which the product has not been ap- ‘‘(5) REVIEW AND CONSTRUCTION.—No deter- Health Service Act), unless otherwise pro- proved by the Secretary. mination, finding, action, or omission of the vided by the Secretary in the regulations (c) INTERNAL REVIEW.—Not later than 2 Secretary under this subsection shall— promulgated under subsection (h); years after the date of enactment of this ‘‘(A) be subject to judicial review; or ‘‘(2) the term ‘drug shortage’ or ‘shortage’, Act, the Secretary shall— ‘‘(B) be construed to establish a defense to with respect to a drug, means a period of (1) analyze and review the regulations pro- an enforcement action by the Secretary. time when the demand or projected demand mulgated under the Federal Food, Drug, and ‘‘(e) RECORDKEEPING AND REPORTING.— for the drug within the United States ex- Cosmetic Act (21 U.S.C. 301 et seq.), the guid- ‘‘(1) RECORDKEEPING.—The Secretary shall ceeds the supply of the drug; and ances or policies issued under such Act re- maintain records related to drug shortages, ‘‘(3) the term ‘meaningful disruption’— lated to drugs intended for human use, and including with respect to each of the fol- ‘‘(A) means a change in production that is the practices of the Food and Drug Adminis- lowing: reasonably likely to lead to a reduction in tration regarding enforcing such Act related ‘‘(A) The number of manufacturers that the supply of a drug by a manufacturer that to manufacturing of such drugs, to identify submitted a notification to the Secretary is more than negligible and impacts the abil- any such regulations, guidances, policies, or under subsection (a) in each calendar year. ity of the manufacturer to fill orders or meet practices that cause, exacerbate, prevent, or ‘‘(B) The number of drug shortages that oc- expected demand for its product; and mitigate drug shortages (as defined in sec- curred in each calendar year and a list of ‘‘(B) does not include interruptions in man- tion 506C of the Federal Food, Drug, and Cos- drug names, drug types, and classes that ufacturing due to matters such as routine metic Act (as amended by subsection (a)); were the subject of such shortages. maintenance or insignificant changes in and ‘‘(C) A list of the known factors contrib- manufacturing so long as the manufacturer (2) determine how regulations, guidances, uting to the drug shortages described in sub- expects to resume operations in a short pe- policies, or practices identified under para- paragraph (B). riod of time. graph (1) should be modified, streamlined, ‘‘(D)(i) A list of major actions taken by the ‘‘(g) DISTRIBUTION.—To the maximum ex- Secretary to prevent or mitigate the drug tent practicable, the Secretary may dis- expanded, or discontinued in order to reduce shortages described in subparagraph (B). tribute information on drug shortages and or prevent such drug shortages, taking into ‘‘(ii) The Secretary shall include in the list on the permanent discontinuation of the consideration the effect of any changes on under clause (i) the following: drugs described in this section to appropriate the public health. ‘‘(I) The number of applications for which provider and patient organizations, except (d) STUDY ON MARKET FACTORS CONTRIB- the Secretary expedited review under sub- that any such distribution shall not include UTING TO DRUG SHORTAGES AND STOCK- section (c)(1) in each calendar year. any information that is exempt from disclo- PILING.— ‘‘(II) The number of establishment inspec- sure under section 552 of title 5, United (1) IN GENERAL.—Not later than 1 year after tions or reinspections that the Secretary ex- States Code, by reason of subsection (b)(4) of the date of enactment of this Act, the Comp- pedited under subsection (c)(2) in each cal- such section. troller General of the United States, in con- endar year. ‘‘(h) REGULATIONS.— sultation with the Secretary, the Depart- ‘‘(E) The number of notifications sub- ‘‘(1) IN GENERAL.—Not later than 18 months ment of Health and Human Services Office of mitted to the Secretary under subsection (a) after the date of enactment of the Food and the Inspector General, the Attorney General, in each calendar year. Drug Administration Safety and Innovation and Chairman of the Federal Trade Commis- ‘‘(F) The names of manufacturers that the Act, the Secretary shall adopt a final regula- sion, shall publish a report reviewing any Secretary has learned did not comply with tion implementing this section. findings that drug shortages (as so defined) the notification requirement under sub- ‘‘(2) INCLUSION OF BIOLOGICAL PRODUCTS.— have led market participants to stockpile af- section (a) in each calendar year. ‘‘(A) IN GENERAL.—The Secretary may by fected drugs or sell them at significantly in- ‘‘(G) The number of times in each calendar regulation apply this section to biological creased prices, the impact of such activities year that the Secretary determined under products (as defined in section 351 of the on Federal revenue, and any economic fac- subsection (d)(3) that an enforcement action Public Health Service Act) if the Secretary tors that have exacerbated or created a mar- or a warning letter could reasonably cause or determines such inclusion would benefit the ket for such actions. exacerbate a shortage of a drug described public health. (2) CONTENT.—The report under paragraph under subsection (a), but did not evaluate ‘‘(B) RULE FOR VACCINES.—If the Secretary (1) shall include— the risks associated with the impact of such applies this section to vaccines pursuant to (A) an analysis of the incidence of any of shortage upon patients and those risks asso- subparagraph (A), the Secretary shall— the activities described in paragraph (1) and ciated with the violation involved before ‘‘(i) consider whether the notification re- the effect of such activities on the public taking such action or issuing such letter on quirement under subsection (a) may be satis- health; the grounds that there was imminent risk of fied by submitting a notification to the Cen- (B) an evaluation of whether in such cases serious adverse health consequences or death ters for Disease Control and Prevention there is a correlation between drugs in short- to humans, and a summary of the determina- under the vaccine shortage notification pro- age and— tions. gram of such Centers; and (i) the number of manufacturers producing ‘‘(H) A summary of the communications ‘‘(ii) explain the determination made by such drugs; made and actions taken under subsection (d) the Secretary under clause (i) in the regula- (ii) the pricing structure, including Fed- in each calendar year. tion. eral reimbursements, for such drugs before ‘‘(I) Any other information the Secretary ‘‘(3) PROCEDURE.—In promulgating a regu- such drugs were in shortage, and to the ex- deems appropriate to better prevent and lation implementing this section, the Sec- tent possible, revenue received by each such mitigate drug shortages. retary shall— manufacturer of such drugs;

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(iii) pricing structure and revenue, to the ‘‘SEC. 576. REGULATION OF MEDICAL GAS PROD- ‘‘(B) INAPPLICABILITY OF EXCLUSIVITY PRO- extent possible, for the same drugs when sold UCTS. VISIONS.— under the conditions described in paragraph ‘‘(a) CERTIFICATION OF DESIGNATED MEDICAL ‘‘(i) EFFECT ON INELIGIBILITY.—No des- (1); and GAS PRODUCTS.— ignated medical gas product deemed under (iv) the impact of contracting practices by ‘‘(1) SUBMISSION.— paragraph (3)(A)(i) to have in effect an ap- market participants (including manufactur- ‘‘(A) IN GENERAL.—Beginning on the date of proved application shall be eligible for any ers, distributors, group purchasing organiza- enactment of this section, any person may periods of exclusivity under sections 505(c), tions, and providers) on competition, access file with the Secretary a request for a cer- 505(j), or 527, or the extension of any such pe- to drugs, and pricing of drugs; tification of a designated medical gas prod- riod under section 505A, on the basis of such (C) whether the activities described in uct. deemed approval. paragraph (1) are consistent with applicable ‘‘(B) CONTENT.—A request under subpara- ‘‘(ii) EFFECT ON CERTIFICATION.—No period law; and graph (A) shall contain— of exclusivity under sections 505(c), 505(j), or (D) recommendations to Congress on what, ‘‘(i) a description of the medical gas prod- section 527, or the extension of any such pe- if any, additional reporting or enforcement uct; riod under section 505A, with respect to an actions are necessary. ‘‘(ii) the name and address of the sponsor; application for a drug shall prohibit, limit, (3) TRADE SECRET AND CONFIDENTIAL INFOR- ‘‘(iii) the name and address of the facility or otherwise affect the submission, grant, or MATION.—Nothing in this subsection alters or or facilities where the gas product is or will effect of a certification under this section, amends section 1905 of title 18, United States be manufactured; and except as provided in paragraph Code, or section 552(b)(4) of title 5, United ‘‘(iv) any other information deemed appro- (3)(A)(i)(VIII). States Code. priate by the Secretary to determine wheth- ‘‘(4) WITHDRAWAL, SUSPENSION, OR REVOCA- (e) GUIDANCE REGARDING REPACKAGING.— er the medical gas product is a designated TION OF APPROVAL.— Not later than 1 year after the date of enact- medical gas product. ‘‘(A) IN GENERAL.—Nothing in this sub- ment of this Act, the Secretary shall issue ‘‘(2) GRANT OF CERTIFICATION.—A certifi- chapter limits the authority of the Secretary guidance that clarifies the policy of the Food cation described under paragraph (1)(A) shall to withdraw or suspend approval of a drug, and Drug Administration regarding hospital be determined to have been granted unless, including a designated medical gas product pharmacies repackaging and safely transfer- not later than 60 days after the filing of a re- deemed under this section to have in effect ring repackaged drugs among hospitals with- quest under paragraph (1), the Secretary an approved application, under section 505 or in a common health system during a drug finds that— section 512. shortage, as identified by the Secretary. ‘‘(A) the medical gas product subject to the ‘‘(B) REVOCATION.—The Secretary may re- TITLE XI—OTHER PROVISIONS certification is not a designated medical gas voke the grant of a certification under this product; section if the Secretary determines that the Subtitle A—Reauthorizations ‘‘(B) the request does not contain the infor- request for certification contains any mate- SEC. 1101. REAUTHORIZATION OF PROVISION RE- mation required under paragraph (1) or oth- rial omission or falsification. LATING TO EXCLUSIVITY OF CER- erwise lacks sufficient information to permit TAIN DRUGS CONTAINING SINGLE ‘‘(b) PRESCRIPTION REQUIREMENT.— ENANTIOMERS. the Secretary to determine that the gas ‘‘(1) IN GENERAL.—A designated medical gas product is a designated medical gas product; (a) IN GENERAL.—Section 505(u)(4) (21 product shall be subject to section 503(b)(1) or U.S.C. 355(u)(4)) is amended by striking unless the Secretary exercises the authority ‘‘(C) granting the request would be con- ‘‘2012’’ and inserting ‘‘2017’’. provided in section 503(b)(3) to remove such trary to public health. gas product from the requirements of section (b) AMENDMENT.—Section 505(u)(1)(A)(ii)(II) ‘‘(3) EFFECT OF CERTIFICATION.— (21 U.S.C. 355(u)(1)(A)(ii)(II)) is amended by 503(b)(1) or the use in question is authorized ‘‘(A) IN GENERAL.— inserting ‘‘clinical’’ after ‘‘any’’. pursuant to another provision of this Act re- ‘‘(i) APPROVED USES.—A designated medical lating to use of medical products in emer- SEC. 1102. REAUTHORIZATION OF THE CRITICAL gas product for which a certification is gencies. PATH PUBLIC-PRIVATE PARTNER- granted under paragraph (2) is deemed, alone SHIPS. ‘‘(2) EXCEPTION FOR OXYGEN.— or in combination with another designated ‘‘(A) IN GENERAL.—Notwithstanding para- Section 566(f) (21 U.S.C. 360bbb–5(f)) is gas product or products as medically appro- graph (1), oxygen may be provided without a amended by striking ‘‘2012’’ and inserting priate, to have in effect an approved applica- prescription for the following uses: ‘‘2017’’. tion under section 505 or 512, subject to all ‘‘(i) The use in the event of depressuriza- Subtitle B—Medical Gas Product Regulation applicable postapproval requirements, for tion or other environmental oxygen defi- SEC. 1111. REGULATION OF MEDICAL GAS PROD- the following indications for use: ciency. UCTS. ‘‘(I) Oxygen for the treatment or preven- ‘‘(ii) The use in the event of oxygen defi- (a) REGULATION.—Chapter V (21 U.S.C. 351 tion of hypoxemia or hypoxia. ciency or use in emergency resuscitation, et seq.) is amended by adding at the end the ‘‘(II) Nitrogen for use in hypoxic challenge when administered by properly trained per- following: testing. sonnel. ‘‘(III) Nitrous oxide for analgesia. ‘‘(B) LABELING.—For oxygen provided pur- ‘‘Subchapter G—Medical Gas Products ‘‘(IV) Carbon dioxide for use in suant to subparagraph (A), the requirements ‘‘SEC. 575. DEFINITIONS. extracorporeal membrane oxygenation ther- established in section 503(b)(4) shall be ‘‘In this subchapter: apy or respiratory stimulation. deemed to have been met if the labeling of ‘‘(1) The term ‘designated medical gas ‘‘(V) Helium for the treatment of upper air- the oxygen bears a warning that the medical product’ means any of the following: way obstruction or increased airway resist- gas product can be used for emergency use ‘‘(A) Oxygen, that meets the standards set ance. only and for all other medical applications a forth in an official compendium. ‘‘(VI) Medical air to reduce the risk of prescription is required. ‘‘(B) Nitrogen, that meets the standards hyperoxia. ‘‘(c) INAPPLICABILITY OF DRUGS FEES TO set forth in an official compendium. ‘‘(VII) Carbon monoxide for use in lung dif- ‘‘(C) Nitrous oxide, that meets the stand- fusion testing. DESIGNATED MEDICAL GAS PRODUCTS.—A des- ards set forth in an official compendium. ‘‘(VIII) Any other indication for use for a ignated medical gas product deemed under ‘‘(D) Carbon dioxide, that meets the stand- designated medical gas product or combina- this section to have in effect an approved ap- ards set forth in an official compendium. tion of designated medical gas products plication shall not be assessed fees under sec- ‘‘(E) Helium, that meets the standards set deemed appropriate by the Secretary, unless tion 736(a) on the basis of such deemed ap- forth in an official compendium. any period of exclusivity under clause (iii) or proval.’’. ‘‘(F) Carbon monoxide, that meets the (iv) of section 505(c)(3)(E), under clause (iii) SEC. 1112. REGULATIONS. standards set forth in an official compen- or (iv) of section 505(j)(5)(F), or under section dium. 527, or the extension of any such period (a) REVIEW OF REGULATIONS.—Not later ‘‘(G) Medical air, that meets the standards under section 505A, applicable to such indica- than 18 months after the date of enactment set forth in an official compendium. tion for use for such gas product or combina- of this Act, the Secretary of Health and ‘‘(H) Any other medical gas product tion of products has not expired. Human Services (referred to in this section deemed appropriate by the Secretary, unless ‘‘(ii) LABELING.—The requirements estab- as the ‘‘Secretary’’) shall, after obtaining any period of exclusivity under section lished in sections 503(b)(4) and 502(f) shall be input from medical gas product manufactur- 505(c)(3)(E)(ii) or 505(j)(5)(F)(ii), or the exten- deemed to have been met for a designated ers, and any other interested members of the sion of any such period under section 505A, medical gas product if the labeling on final public, submit a report to the Committee on applicable to such medical gas product has use containers of such gas product bears the Health, Education, Labor, and Pensions of not expired. information required by section 503(b)(4) and the Senate and the Committee on Energy ‘‘(2) The term ‘medical gas product’ means a warning statement concerning the use of and Commerce of the House of Representa- a drug that— the gas product, as determined by the Sec- tives regarding any changes to the Federal ‘‘(A) is manufactured or stored in a lique- retary by regulation, as well as appropriate drug regulations in title 21, Code of Federal fied, nonliquefied, or cryogenic state; and directions and warnings concerning storage Regulations that the Secretary determines ‘‘(B) is administered as a gas. and handling. to be necessary.

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(b) AMENDED REGULATIONS.—If the Sec- interest in having the expertise of the mem- tify gaps and opportunities with respect to retary determines that changes to the Fed- ber with respect to the particular matter be- ensuring the safe use and disposal of pre- eral drug regulations in title 21, Code of Fed- fore the advisory committee.’’; scription drugs with the potential for abuse. eral Regulations are necessary under sub- (3) in subsection (e), by inserting ‘‘, and (b) REPORT.—Not later than 1 year after section (a), the Secretary shall issue final shall make publicly available,’’ after ‘‘House the date of enactment of this Act, the Sec- regulations implementing such changes not of Representatives’’; and retary shall post a report on the Internet later than 4 years after the date of enact- (4) by adding at the end the following: website of the Food and Drug Administra- ment of this Act. ‘‘(g) GUIDANCE ON REPORTED FINANCIAL IN- tion on the findings of the review under sub- SEC. 1113. APPLICABILITY. TEREST OR INVOLVEMENT.—The Secretary section (a). Such report shall include find- Nothing in this subtitle or the amend- shall issue guidance that describes how the ings and recommendations on— ments made by this subtitle shall apply to— Secretary reviews the financial interests and (1) how best to leverage and build upon ex- (1) a drug that is covered by an application involvement of advisory committee members isting Federal and federally funded data under section 505 or 512 of the Federal Food, that are reported under subsection (c)(1) but sources, such as prescription drug moni- Drug, and Cosmetic Act (21 U.S.C. 355, 360b) that the Secretary determines not to meet toring program data and the sentinel initia- approved prior to May 1, 2012; or the definition of a disqualifying interest tive of the Food and Drug Administration (2) any of the gases listed in subparagraphs under section 208 of title 18, United States under section 505(k)(3) of the Federal Food, (A) through (G) of section 575(1) of such Act Code for the purposes of participating in a Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), (as added by section 1111), or any mixture of particular matter.’’. as it relates to collection of information rel- any such gases, for an indication that— SEC. 1122. GUIDANCE DOCUMENT REGARDING evant to adverse events, patient safety, and (A) is not included in, or is different from, PRODUCT PROMOTION USING THE patient outcomes, to create a centralized those specified in subclauses (I) through INTERNET. data clearinghouse and early warning tool; (VII) of section 576(a)(3)(i) of such Act (as Not later than 2 years after the date of en- (2) how best to develop and disseminate added by section 1111); and actment this Act, the Secretary of Health widely best practices models and suggested (B) is approved on or after May 1, 2012, pur- and Human Services shall issue guidance standard requirements to States for achiev- suant to an application submitted under sec- that describes Food and Drug Administra- ing greater interoperability and effective- tion 505 or 512 of such Act. tion policy regarding the promotion, using ness of prescription drug monitoring pro- Subtitle C—Miscellaneous Provisions the Internet (including social media), of grams, especially with respect to provider medical products that are regulated by such participation, producing standardized data SEC. 1121. ADVISORY COMMITTEE CONFLICTS OF INTEREST. Administration. on adverse events, patient safety, and pa- Section 712 (21 U.S.C. 379d–1) is amended— SEC. 1123. ELECTRONIC SUBMISSION OF APPLI- tient outcomes; and (1) in subsection (b)— CATIONS. (3) how best to develop provider, phar- (A) by striking paragraph (2); and Subchapter D of chapter VII (21 U.S.C. 379k macist, and patient education tools and a (B) in paragraph (1)— et seq.) is amended by inserting after section strategy to widely disseminate such tools (i) by redesignating subparagraph (B) as 745 the following: and assess the efficacy of such tools. paragraph (2) and moving such paragraph, as ‘‘SEC. 745A. ELECTRONIC FORMAT FOR SUBMIS- (c) GUIDANCE ON ABUSE-DETERRENT PROD- so redesignated, 2 ems to the left; SIONS. UCTS.—Not later than 6 months after the (ii) in subparagraph (A), by redesignating ‘‘(a) DRUGS AND BIOLOGICS.— date of enactment of this Act, the Secretary, clauses (i) through (iii) as subparagraphs (A) ‘‘(1) IN GENERAL.—Beginning no earlier acting through the Commissioner, shall pro- through (C), respectively, and moving such than 24 months after the issuance of a final mulgate guidance on the development of subparagraphs, as so redesignated, 2 ems to guidance issued after public notice and op- abuse-deterrent drug products. the left; portunity for comment, submissions under (d) STUDY AND REPORT ON PRESCRIPTION (iii) in subparagraph (A), as so redesig- subsection (b), (i), or (j) of section 505 of this DRUG ABUSE.—Not later than 1 year after the nated, by inserting ‘‘, including strategies to Act or subsection (a) or (k) of section 351 of date of enactment of this Act, the Secretary increase the number of special Government the Public Health Service Act shall be sub- shall seek to enter into an agreement with employees across medical and scientific spe- mitted in such electronic format as specified the Institute of Medicine to conduct a study cialties in areas where the Secretary would by the Secretary in such guidance. and report on prescription drug abuse. Such benefit from specific scientific, medical, or ‘‘(2) GUIDANCE CONTENTS.—In the guidance report shall evaluate trends in prescription technical expertise necessary for the per- under paragraph (1), the Secretary may— drug abuse, assess opportunities to inform formance of its regulatory responsibilities’’ ‘‘(A) provide a timetable for establishment and educate the public, patients, and health before the semicolon at the end; by the Secretary of further standards for care providers on issues related to prescrip- (iv) by striking ‘‘(1) RECRUITMENT.—’’ and electronic submission as required by such tion drug abuse and misuse, and identify po- inserting ‘‘(1) RECRUITMENT IN GENERAL.— paragraph; and tential barriers, if any, to prescription drug The Secretary shall—’’; ‘‘(B) set forth criteria for waivers of and monitoring program participation and im- (v) by striking ‘‘(A) IN GENERAL.—The Sec- exemptions from the requirements of this plementation. retary shall—’’; subsection. SEC. 1125. TANNING BED LABELING. (vi) by redesignating clauses (i) through ‘‘(3) EXCEPTION.—This subsection shall not Not later than 18 months after the date of (iii) of paragraph (2) (as so redesignated) as apply to submissions described in section 561. enactment of this Act, the Secretary of subparagraphs (A) through (C), respectively, ‘‘(b) DEVICES.— Health and Human Services shall determine and moving such subparagraphs, as so redes- ‘‘(1) IN GENERAL.—Beginning after the whether to amend the warning label require- ignated, 2 ems to the left; issuance of final guidance implementing this ments for sunlamp products to include spe- (vii) in paragraph (2) (as so redesignated), paragraph, pre-submissions and submissions cific requirements to more clearly and effec- in the matter before subparagraph (A) (as so for devices under section 510(k), 513(f)(2)(A), tively convey the risks that such products redesignated), by striking ‘‘subparagraph 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of pose for the development of irreversible dam- (A)’’ and inserting ‘‘paragraph (1)’’; and this Act or section 351 of the Public Health age to the eyes and skin, including skin can- (viii) by adding at the end the following: Service Act, and any supplements to such cer. ‘‘(3) RECRUITMENT THROUGH REFERRALS.—In pre-submissions or submissions, shall include SEC. 1126. OPTIMIZING GLOBAL CLINICAL carrying out paragraph (1), the Secretary an electronic copy of such pre-submissions or TRIALS. shall, in order to further the goal of includ- submissions. Subchapter E of chapter V (21 U.S.C. 360bbb ing in advisory committees highly qualified ‘‘(2) GUIDANCE CONTENTS.—In the guidance et seq.), as amended by section 903, is further and specialized experts in the specific dis- under paragraph (1), the Secretary may— amended by adding at the end the following: eases to be considered by such advisory com- ‘‘(A) provide standards for the electronic ‘‘SEC. 569A. OPTIMIZING GLOBAL CLINICAL mittees, at least every 180 days, request re- copy required under such paragraph; and TRIALS. ferrals from a variety of stakeholders, such ‘‘(B) set forth criteria for waivers of and ‘‘(a) IN GENERAL.—The Secretary shall— as the Institute of Medicine, the National In- exemptions from the requirements of this ‘‘(1) work with other regulatory authori- stitutes of Health, product developers, pa- subsection.’’. ties of similar standing, medical research tient groups, disease advocacy organizations, SEC. 1124. COMBATING PRESCRIPTION DRUG companies, and international organizations professional societies, medical societies, in- ABUSE. to foster and encourage uniform, scientif- cluding the American Academy of Medical (a) IN GENERAL.—To combat the significant ically-driven clinical trial standards with re- Colleges, and other governmental organiza- rise in prescription drug abuse and the con- spect to medical products around the world; tions.’’; sequences of such abuse, the Secretary of and (2) by amending subsection (c)(2)(C) to read Health and Human Services (referred to in ‘‘(2) enhance the commitment to provide as follows: this section as the ‘‘Secretary’’), acting consistent parallel scientific advice to manu- ‘‘(C) CONSIDERATION BY SECRETARY.—The through the Commissioner of Food and facturers seeking simultaneous global devel- Secretary shall ensure that each determina- Drugs (referred to in this section as the opment of new medical products in order tion made under subparagraph (B) considers ‘‘Commissioner’’) and in coordination with to— the type, nature, and magnitude of the finan- other Federal agencies, as appropriate, shall ‘‘(A) enhance medical product develop- cial interests at issue and the public health review current Federal initiatives and iden- ment;

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00075 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3370 CONGRESSIONAL RECORD — SENATE May 21, 2012 ‘‘(B) facilitate the use of foreign data; and (4) identify clear, measurable metrics by systems modernization projects with the ‘‘(C) minimize the need to conduct duplica- which progress on the priorities identified strategic goals of the Food and Drug Admin- tive clinical studies, preclinical studies, or under paragraph (2) and gaps identified under istration, including results-oriented goals, non-clinical studies. paragraph (3) will be measured by the Food strategies, milestones, performance meas- ‘‘(b) MEDICAL PRODUCT.—In this section, and Drug Administration, including metrics ures; the term ‘medical product’ means a drug, as specific to the integration and adoption of (B) efforts to finalize and approve a com- defined in subsection (g) of section 201, a de- advances in regulatory science described in prehensive inventory of the information vice, as defined in subsection (h) of such sec- paragraph (5) and improving medical product technology systems of the Food and Drug tion, or a biological product, as defined in decisionmaking, in a predictable and Administration that includes information section 351(i) of the Public Health Service science-based manner; and describing each system, such as costs, sys- Act. (5) set forth how the Food and Drug Ad- tem function or purpose, and status informa- ‘‘(c) SAVINGS CLAUSE.—Nothing in this sec- ministration will ensure that advances in tion, and incorporate use of the system port- tion shall alter the criteria for evaluating regulatory science for medical products are folio into the information investment man- the safety or effectiveness of a medical prod- adopted, as appropriate, on an ongoing basis agement process of the Food and Drug Ad- uct under this Act. and in an manner integrated across centers, ministration; ‘‘SEC. 569B. USE OF CLINICAL INVESTIGATION divisions, and branches of the Food and Drug (C) the ways in which the Food and Drug DATA FROM OUTSIDE THE UNITED STATES. Administration, including by senior man- Administration uses the plan described in agers and reviewers, including through the— subparagraph (A) to guide and coordinate the ‘‘(a) IN GENERAL.—In determining whether to approve, license, or clear a drug or device (A) development, updating, and consistent modernization projects and activities of the pursuant to an application submitted under application of guidance documents that sup- Food and Drug Administration, including this chapter, the Secretary shall accept data port medical product decisionmaking; and the interdependencies among projects and from clinical investigations conducted out- (B) the adoption of the tools, methods, and activities; and side of the United States, including the Eu- processes under section 566 of the Federal (D) the extent to which the Food and Drug ropean Union, if the applicant demonstrates Food, Drug, and Cosmetic Act (21 U.S.C. Administration has fulfilled or is imple- that such data are adequate under applicable 360bbb–5). menting recommendations of the Govern- standards to support approval, licensure, or (c) ANNUAL PERFORMANCE REPORTS.—As ment Accountability Office with respect to clearance of the drug or device in the United part of the annual performance reports sub- the Food and Drug Administration and infor- States. mitted to Congress under sections 736B(a) (as mation technology; and ‘‘(b) NOTICE TO SPONSOR.—If the Secretary amended by section 104), 738A(a) (as amended (2) develop— finds under subsection (a) that the data from by section 204), 744C(a) (as added by section (A) a documented enterprise architecture clinical investigations conducted outside the 303), and 744I(a) (as added by section 403) of program management plan that includes the United States, including in the European the Federal Food, Drug, and Cosmetic Act tasks, activities, and timeframes associated Union, are inadequate for the purpose of for each of fiscal years 2013 through 2017, the with developing and using the architecture making a determination on approval, clear- Secretary shall annually report on the and addresses how the enterprise architec- ance, or licensure of a drug or device pursu- progress made with respect to— ture program management will be performed ant to an application submitted under this (1) advancing the regulatory science prior- in coordination with other management dis- chapter, the Secretary shall provide written ities identified under paragraph (2) of sub- ciplines, such as organizational strategic notice to the sponsor of the application of section (b) and resolving the gaps identified planning, capital planning and investment such finding and include the rationale for under paragraph (3) of such subsection, in- control, and performance management; and such finding.’’. cluding reporting on specific metrics identi- (B) a skills inventory, needs assessment, SEC. 1127. ADVANCING REGULATORY SCIENCE TO fied under paragraph (4) of such subsection; gap analysis, and initiatives to address skills PROMOTE PUBLIC HEALTH INNOVA- (2) the integration and adoption of ad- gaps as part of a strategic approach to infor- TION. vances in regulatory science as set forth in mation technology human capital planning. (a) IN GENERAL.—Not later than 1 year paragraph (5) of such subsection; and (b) GAO REPORT.—Not later than January after the date of enactment of this Act, the (3) the progress made in advancing the reg- 1, 2016, the Comptroller General of the Secretary of Health and Human Services (re- ulatory science goals outlined in the Pre- United States shall issue a report regarding ferred to in this section as the ‘‘Secretary’’) scription Drug User Fee Agreement commit- the strategic plan described in subsection shall develop a strategy and implementation ment letter, the Generic Drug User Fee (a)(1)(A) and related actions carried out by plan for advancing regulatory science for Agreement commitment letter, and the Bio- the Food and Drug Administration. Such re- medical products in order to promote the similar User Fee Agreement commitment port shall assess the progress the Food and public health and advance innovation in reg- letter transmitted by the Secretary to Con- Drug Administration has made on— ulatory decisionmaking. gress on January 13, 2012, and the Medical (1) the development and implementation of (b) REQUIREMENTS.—The strategy and im- plementation plan developed under sub- Device User Fee Agreement transmitted by a comprehensive information technology section (a) shall be consistent with the user the Secretary to Congress on April 20, 2012. strategic plan, including the results-oriented fee performance goals in the Prescription (d) INDEPENDENT ASSESSMENT.—Not later goals, strategies, milestones, and perform- Drug User Fee Agreement commitment let- than January 1, 2016, the Comptroller Gen- ance measures identified in subsection ter, the Generic Drug User Fee Agreement eral of the United States shall submit to (a)(1)(A); commitment letter, and the Biosimilar User Congress a report— (2) the effectiveness of the comprehensive Fee Agreement commitment letter trans- (1) detailing the progress made by the Food information technology strategic plan de- mitted by the Secretary to Congress on Jan- and Drug Administration in meeting the pri- scribed in subsection (a)(1)(A), including the uary 13, 2012, and the Medical Device User orities and addressing the gaps identified in results-oriented goals and performance Fee Agreement commitment letter trans- subsection (b), including any outstanding measures; and mitted by the Secretary to Congress on April gaps; and (3) the extent to which the Food and Drug 20, 2012, and shall— (2) containing recommendations, as appro- Administration has fulfilled recommenda- (1) identify a clear vision of the funda- priate, on how regulatory science initiatives tions of the Government Accountability Of- mental role of efficient, consistent, and pre- for medical products can be strengthened fice with respect to such agency and infor- dictable, science-based decisions throughout and improved to promote the public health mation technology. regulatory decisionmaking of the Food and and advance innovation in regulatory deci- SEC. 1129. REPORTING REQUIREMENTS. Drug Administration with respect to medical sionmaking. Subchapter A of chapter VII (21 U.S.C. 371 products; (e) MEDICAL PRODUCT.—In this section, the et seq.), as amended by section 208, is further (2) identify the regulatory science prior- term ‘‘medical product’’ means a drug, as de- amended by adding at the end the following: ities of the Food and Drug Administration fined in subsection (g) of section 201 of the ‘‘SEC. 715. REPORTING REQUIREMENTS. directly related to fulfilling the mission of Federal Food, Drug, and Cosmetic Act (21 ‘‘(a) NEW DRUGS.—Beginning with fiscal the agency with respect to decisionmaking U.S.C. 321), a device, as defined in subsection year 2013 and ending with fiscal year 2017, concerning medical products and allocation (h) of such section, or a biological product, not later than 120 days after the end of each of resources towards such regulatory science as defined in section 351(i) of the Public fiscal year for which fees are collected under priorities; Health Service Act. part 2 of subchapter C, the Secretary shall (3) identify regulatory and scientific gaps SEC. 1128. INFORMATION TECHNOLOGY. prepare and submit to the Committee on that impede the timely development and re- (a) HHS REPORT.—Not later than 1 year Health Education, Labor, and Pensions of view of, and regulatory certainty with re- after the date of enactment of this Act, the the Senate and the Committee on Energy spect to, the approval, licensure, or clear- Secretary of Health and Human Services and Commerce of the House of Representa- ance of medical products, including with re- shall— tives a report concerning, for all applica- spect to companion products and new tech- (1) report to Congress on— tions for approval of a new drug under sec- nologies, and facilitating the timely intro- (A) the milestones and a completion date tion 505(b) of this Act or a new biological duction and adoption of new technologies for developing and implementing a com- product under section 351(a) of the Public and methodologies in a safe and effective prehensive information technology strategic Health Service Act filed in the previous fis- manner; plan to align the information technology cal year—

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00076 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3371 ‘‘(1) the number of such applications that ‘‘(A) the number of applications for ap- (4) assess the extent to which performance met the goals identified for purposes of part proval filed under section 351(k) of the Pub- information is collected, analyzed, and acted 2 of subchapter C in the letters from the Sec- lic Health Service Act; and on by managers; and retary of Health and Human Services to the ‘‘(B) the percentage of applications de- (5) make recommendations, as appropriate, Chairman of the Committee on Health, Edu- scribed in subparagraph (A) that were ap- regarding how the strategic management cation, Labor, and Pensions of the Senate proved by the Secretary. plan and related actions of the Center for and the Chairman of the Committee on En- ‘‘(2) ADDITIONAL INFORMATION.—As part of Drug Evaluation and Research, the Center ergy and Commerce of the House of Rep- the performance report described in para- for Biologics Evaluation and Research, and resentatives, as set forth in the Congres- graph (1), the Secretary shall include an ex- the Center for Devices and Radiological sional Record; planation of how the Food and Drug Admin- Health could be improved to fulfill the public ‘‘(2) the percentage of such applications istration is managing the biological product health mission of the Food and Drug Admin- that were approved; review program to ensure that the user fees istration in as efficient and effective manner ‘‘(3) the percentage of such applications collected under part 2 are not used to review as possible. that were issued complete response letters; an application under section 351(k) of the SEC. 1131. DRUG DEVELOPMENT AND TESTING. ‘‘(4) the percentage of such applications Public Health Service Act.’’. that were subject to a refuse-to-file action; SEC. 1130. STRATEGIC INTEGRATED MANAGE- (a) IN GENERAL.—Section 505–1 (21 U.S.C. ‘‘(5) the percentage of such applications MENT PLAN. 355–1) is amended by adding at the end the that were withdrawn; and (a) STRATEGIC INTEGRATED MANAGEMENT following: ‘‘(6) the average total time to decision by PLAN.—Not later than 1 year after the date ‘‘(k) DRUG DEVELOPMENT AND TESTING.— the Secretary for all applications for ap- of enactment of this Act, the Secretary of ‘‘(1) IN GENERAL.—Notwithstanding any proval of a new drug under section 505(b) of Health and Human Services (referred to in other provision of law, if a drug is a covered this Act or a new biological product under this section as the ‘‘Secretary’’) shall submit drug, no elements to ensure safe use shall section 351(a) of the Public Health Service to Congress a strategic integrated manage- prohibit, or be construed or applied to pro- Act filed in the previous fiscal year, includ- ment plan for the Center for Drug Evalua- hibit, supply of such drug to any eligible ing the number of calendar days spent during tion and Research, the Center for Biologics drug developer for the purpose of conducting the review by the Food and Drug Adminis- Evaluation and Research, and the Center for testing necessary to support an application tration and the number of calendar days Devices and Radiological Health. Such stra- under subsection (b)(2) or (j) of section 505 of spent by the sponsor responding to a com- tegic management plan shall— this Act or section 351(k) of the Public plete response letter.’’. (1) identify strategic institutional goals Health Service Act, if the Secretary has ‘‘(b) GENERIC DRUGS.—Beginning with fis- and priorities for the Center for Drug Eval- issued a written notice described in para- cal year 2013 and ending after fiscal year uation and Research, the Center for Bio- graph (2), and the eligible drug developer has 2017, not later than 120 days after the end of logics Evaluation and Research, and the Cen- agreed to comply with the terms of the no- each fiscal year for which fees are collected ter for Devices and Radiological Health; tice. under part 7 of subchapter C, the Secretary (2) describe the actions the Secretary will ‘‘(2) WRITTEN NOTICE.—For purposes of this shall prepare and submit to the Committee take to recruit, retain, train, and continue subsection, the Secretary shall, within a rea- on Health Education, Labor, and Pensions of to develop the workforce at the Center for sonable period of time, consider and respond the Senate and the Committee on Energy Drug Evaluation and Research, the Center to a request by an eligible drug developer for and Commerce of the House of Representa- for Biologics Evaluation and Research, and a written notice authorizing the supply of a tives a report concerning, for all applica- the Center for Devices and Radiological covered drug for purposes of testing as de- tions for approval of a generic drug under Health to fulfill the public health mission of scribed in paragraph (1), and the Secretary section 505(j), amendments to such applica- the Food and Drug Administration; and shall issue a written notice to such eligible tions, and prior approval supplements with (3) identify results-oriented, outcome- drug developer and the holder of an applica- respect to such applications filed in the pre- based measures that the Secretary will use tion for a covered drug authorizing the sup- vious fiscal year— to measure the progress of achieving the ply of such drug to such eligible drug devel- ‘‘(1) the number of such applications that strategic goals and priorities identified oper for purposes of testing if— met the goals identified for purposes of part under paragraph (1) and the effectiveness of ‘‘(A) the eligible drug developer has agreed 7 of subchapter C, in the letters from the the actions identified under paragraph (2), to comply with any conditions the Secretary Secretary of Health and Human Services to including metrics to ensure that managers considers necessary; the Chairman of the Committee on Health, and reviewers of the Center for Drug Evalua- ‘‘(B) in the event the eligible drug devel- Education, Labor, and Pensions of the Sen- tion and Research, the Center for Biologics oper is conducting bioequivalence or other ate and the Chairman of the Committee on Evaluation and Research, and the Center for clinical testing, the eligible drug developer Energy and Commerce of the House of Rep- Devices and Radiological Health are familiar has submitted, and the Secretary has ap- resentatives, as set forth in the Congres- with and appropriately and consistently proved, a protocol that includes protections sional Record; apply the requirements under the Federal that the Secretary finds will provide assur- ‘‘(2) the average total time to decision by Food, Drug, and Cosmetic Act (21 U.S.C. 301 ance of safety comparable to the assurance the Secretary for applications for approval et seq.), including new requirements under of safety provided by the elements to ensure of a generic drug under section 505(j), amend- parts 2, 3, 7, and 8 of subchapter C of title VII safe use in the risk evaluation and mitiga- ments to such applications, and prior ap- of the Federal Food, Drug, and Cosmetic Act tion strategy for the covered drug as applica- proval supplements with respect to such ap- (21 U.S.C. 379f et seq.). ble to such testing; and plications filed in the previous fiscal year, (b) REPORT.—Not later than January 1, ‘‘(C) the eligible drug developer is in com- including the number of calendar days spent 2016, the Comptroller General of the United pliance with applicable laws and regulations during the review by the Food and Drug Ad- States shall issue a report regarding the related to such testing, including any appli- ministration and the number of calendar strategic management plan described in sub- cable requirements related to Investiga- days spent by the sponsor responding to a section (a) and related actions carried out by tional New Drug Applications or informed complete response letter; the Food and Drug Administration. Such re- consent. ‘‘(3) the total number of applications under port shall— ‘‘(3) ADDITIONAL REQUIRED ELEMENT.—The section 505(j), amendments to such applica- (1) assess the effectiveness of the actions Secretary shall require as an element of each tions, and prior approval supplements with described in subsection (a)(2) in recruiting, risk evaluation and mitigation strategy with respect to such applications that were pend- retaining, training, and developing the work- elements to ensure safe use approved by the ing with the Secretary for more than 10 force at the Center for Drug Evaluation and Secretary that the holder of an application months on the date of enactment of the Food Research, the Center for Biologics Evalua- for a covered drug shall not restrict the re- and Drug Administration Safety and Innova- tion and Research, and the Center for De- sale of the covered drug to an eligible drug tion Act; and vices and Radiological Health in fulfilling developer that receives a written notice from ‘‘(4) the number of applications described the public health mission of the Food and the Secretary under paragraph (2) unless, at in paragraph (3) on which the Food and Drug Drug Administration; any time, the Secretary provides written no- Administration took final regulatory action (2) assess the effectiveness of the measures tice to the holder of the application direct- in the previous fiscal year. identified under subsection (a)(3) in gauging ing otherwise based on a shortage of such ‘‘(c) BIOSIMILAR BIOLOGICAL PRODUCTS.— progress against the strategic goals and pri- drug for patients, national security concerns ‘‘(1) IN GENERAL.—Beginning with fiscal orities identified under subsection (a)(1); related to access to such drug, or such other year 2014, not later than 120 days after the (3) assess the extent to which the Center reason as the Secretary may specify. end of each fiscal year for which fees are col- for Drug Evaluation and Research, the Cen- ‘‘(4) VIOLATION AND PENALTIES.—For pur- lected under part 8 of subchapter C, the Sec- ter for Biologics Evaluation and Research, poses of subsection (f)(8) and sections 301, retary shall prepare and submit to the Com- and the Center for Devices and Radiological 303(f)(4), 502(y), and 505(p), it shall be a viola- mittee on Health Education, Labor, and Pen- Health are using the identified results-ori- tion of the risk evaluation and mitigation sions of the Senate and the Committee on ented set of performance measures in track- strategy for the holder of the application for Energy and Commerce of the House of Rep- ing their workload by strategic goals and the a covered drug to violate the element de- resentatives a report concerning— effectiveness of such measures; scribed in paragraph (3), or in the case of a

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00077 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3372 CONGRESSIONAL RECORD — SENATE May 21, 2012 holder of an application that is a sole dis- (1) Section 505–1(c)(2) (21 U.S.C. 355–1(c)(2)) ‘‘(6) building scientific expertise on nano- tributor or supplier of a covered drug, to pre- is amended by striking ‘‘(e) and (f)’’ and in- materials within the Food and Drug Admin- vent the sale thereof after receipt of a writ- serting ‘‘(e), (f), and (k)(3)’’. istration, including field and laboratory ex- ten notice by the Secretary issued under (2) Section 502(y) (21 U.S.C. 352(y)) is pertise, for monitoring the production and paragraph (2). The Secretary shall provide amended by striking ‘‘’’(d), (e), or (f) of sec- presence of nanomaterials in domestic and written notice to the Committee on Health, tion 505–1’’ and inserting ‘‘(d), (e), (f), or imported products regulated under this Act; Education, Labor, and Pensions of the Sen- (k)(3) of section 505–1’’. ‘‘(7) ensuring ongoing training, as well as ate and the Committee on Energy and Com- SEC. 1132. PATIENT PARTICIPATION IN MEDICAL dissemination of new information within the merce of the House of Representatives with- PRODUCT DISCUSSIONS. centers of the Food and Drug Administra- in 30 days of the Secretary becoming aware Subchapter E of chapter V (21 U.S.C. 360bbb tion, and more broadly across the Food and that a holder of an application of a covered et seq.), as amended by section 1126, is fur- Drug Administration, to ensure timely, in- drug has restricted the sale of such a covered ther amended by adding at the end the fol- formed consideration of the most current drug to any eligible drug developer after re- lowing: science pertaining to nanomaterials; ceipt of written notice as provided in para- ‘‘SEC. 569C. PATIENT PARTICIPATION IN MED- ‘‘(8) encouraging the Food and Drug Ad- graph (2). ICAL PRODUCT DISCUSSION. ministration to participate in international ‘‘(a) IN GENERAL.—The Secretary shall de- ‘‘(5) LIABILITY.—Unless the holder of the and national consensus standards activities application for a covered drug and the eligi- velop and implement strategies to solicit the pertaining to nanomaterials; and ble developer are the same entity, the holder views of patients during the medical product ‘‘(9) carrying out other activities that the development process and consider the per- of an application for a covered drug shall not Secretary determines are necessary and con- spectives of patients during regulatory dis- be liable for any claim arising out of the eli- sistent with the purposes described in para- cussions, including by— gible drug developer’s testing necessary to graphs (1) through (8). ‘‘(1) fostering participation of a patient support an application under subsection ‘‘(c) PROGRAM ADMINISTRATION.— representative who may serve as a special (b)(2) or (j) of section 505 of this Act or sec- ‘‘(1) DESIGNATED INDIVIDUAL.—In carrying government employee in appropriate agency tion 351(k) of the Public Health Service Act out the program under this section, the Sec- meetings with medical product sponsors and for a drug obtained under this subsection. retary, acting through the Commissioner of investigators; and Nothing in this subsection shall be construed Food and Drugs, may designate an appro- ‘‘(2) exploring means to provide for identi- priately qualified individual who shall super- to expand or limit the liability of the eligi- fication of patient representatives who do ble drug developer or the holder of an appli- vise the planning, management, and coordi- not have any, or have minimal, financial in- nation of the program. cation for a covered drug for any other terests in the medical products industry. ‘‘(2) DUTIES.—The duties of the individual claim. ‘‘(b) FINANCIAL INTEREST.—In this section, designated under paragraph (1) may in- ‘‘(6) CERTIFICATION.—In any request for the term ‘financial interest’ means a finan- clude— supply of a covered drug for purposes of test- cial interest under section 208(a) of title 18, ‘‘(A) developing a detailed strategic plan ing as described in paragraph (1), an eligible United States Code.’’. for achieving specific short- and long-term drug developer shall certify to the Secretary SEC. 1133. NANOTECHNOLOGY REGULATORY technical goals for the program; that— SCIENCE PROGRAM. ‘‘(B) coordinating and integrating the stra- ‘‘(A) the eligible drug developer will com- (a) IN GENERAL.—Chapter X (21 U.S.C. 391 tegic plan with activities by the Food and ply with all conditions the Secretary con- et seq.) is amended by adding at the end the Drug Administration and other departments siders necessary, any protocol approved by following: and agencies participating in the National the Secretary, and all applicable laws and ‘‘SEC. 1013. NANOTECHNOLOGY REGULATORY Nanotechnology Initiative; and regulations pertaining to such testing; and SCIENCE PROGRAM. ‘‘(C) developing Food and Drug Adminis- ‘‘(a) IN GENERAL.—Not later than 180 days ‘‘(B) the eligible drug developer intends to tration programs, contracts, memoranda of after the date of enactment of the Food and submit an application under subsection (b)(2) agreement, joint funding agreements, and Drug Administration Safety and Innovation or (j) of section 505 of this Act or section other cooperative arrangements necessary Act, the Secretary, in consultation as appro- 351(k) of the Public Health Service Act for for meeting the long-term challenges and priate with the Secretary of Agriculture, the drug for which it is requesting written achieving the specific technical goals of the shall establish within the Food and Drug Ad- notice pursuant to paragraph (2), and will program. ministration a Nanotechnology Regulatory use the covered drug only for the purpose of ‘‘(d) REPORT.—Not later than March 15, conducting testing to support such an appli- Science Program (referred to in this section 2015, the Secretary shall publish on the cation. as the ‘program’) to enhance scientific Internet Web site of the Food and Drug Ad- ‘‘(7) DEFINITIONS.— knowledge regarding nanomaterials included ministration a report on the program carried ‘‘(A) COVERED DRUG.—Notwithstanding sub- or intended for inclusion in products regu- out under this section. Such report shall in- section (b)(2), for purposes of this subsection, lated under this Act or other statutes admin- clude— the term ‘covered drug’ means a drug, in- istered by the Food and Drug Administra- ‘‘(1) a review of the specific short- and cluding a biological product licensed under tion, to address issues relevant to the regula- long-term goals of the program; section 351(a) of the Public Health Service tion of those products, including the poten- ‘‘(2) an assessment of current and proposed Act, that is subject to a risk evaluation and tial toxicology of such materials, the effects funding levels for the program, including an mitigation strategy with elements to ensure of such materials on biological systems, and assessment of the adequacy of such funding safe use under subsection (f), or a drug, in- interaction of such materials with biological levels to support program activities; and cluding a biological product licensed under systems. ‘‘(3) a review of the coordination of activi- ‘‘(b) PROGRAM PURPOSES.—The purposes of section 351(a) of the Public Health Service ties under the program with other depart- the program established under subsection (a) Act, required to have a risk evaluation and ments and agencies participating in the Na- may include— mitigation strategy with elements to ensure tional Nanotechnology Initiative. ‘‘(1) assessing scientific literature and data safe use under section 909(b) of the Food and ‘‘(e) EFFECT OF SECTION.—Nothing in this on general nanomaterials interactions with Drug Administration Amendments Act of section shall affect the authority of the Sec- biological systems and on specific nanomate- 2007. retary under any other provision of this Act rials of concern to the Food and Drug Ad- ‘‘(B) ELIGIBLE DRUG DEVELOPER.—For pur- or other statutes administered by the Food ministration; poses of this subsection, the term ‘eligible and Drug Administration.’’. ‘‘(2) in cooperation with other Federal drug developer’ means a sponsor that has (b) EFFECTIVE DATE; SUNSET.—The Nano- agencies, developing and organizing informa- submitted, or intends to submit, an applica- technology Regulatory Science Program au- tion using databases and models that will fa- tion under subsection (b)(2) or (j) of section thorized under section 1013 of the Federal cilitate the identification of generalized 505 of this Act or section 351(k) of the Public Food, Drug, and Cosmetic Act (as added by principles and characteristics regarding the Health Service Act to market a version of subsection (a)) shall take effect on October 1, behavior of classes of nanomaterials with bi- the covered drug in the United States. 2012, or the date of the enactment of this ological systems; ‘‘(8) EFFECT ON OTHER LAW.—Notwith- Act, whichever is later. Such Program shall ‘‘(3) promoting Food and Drug Administra- standing the provisions of this subsection, cease to be effective October 1, 2017. tion programs and participate in collabo- the antitrust statutes enforced by the Fed- SEC. 1134. ONLINE PHARMACY REPORT TO CON- rative efforts, to further the understanding eral Trade Commission, including the Fed- GRESS. of the science of novel properties of nano- eral Trade Commission Act (15 U.S.C. 41–58), Not later than 1 year after the date of en- materials that might contribute to toxicity; actment of this Act, the Comptroller General the Sherman Act (15 U.S.C. 1–7), and any ‘‘(4) promoting and participating in col- of the United States shall submit to the other statute properly under such Commis- laborative efforts to further the under- Committee on Health, Education, Labor, and sion’s jurisdiction, shall apply to the con- standing of measurement and detection Pensions of the Senate and the Committee duct described in this subsection to the same methods for nanomaterials; on Energy and Commerce of the House of extent as such statutes did on the day before ‘‘(5) collecting, synthesizing, interpreting, Representatives a report that describes any the date of enactment of this subsection.’’. and disseminating scientific information and problems posed by pharmacy Internet (b) TECHNICAL AND CONFORMING AMEND- data related to the interactions of nano- websites that violate Federal or State law, MENTS.— materials with biological systems; including—

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00078 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3373 (1) the methods by which Internet websites TITLE I—EXPANSION OF MULTILATERAL TITLE III—SANCTIONS WITH RESPECT TO are used to sell prescription drugs in viola- SANCTIONS REGIME WITH RESPECT TO IRAN’S REVOLUTIONARY GUARD CORPS tion of Federal or State law or established IRAN Subtitle A—Identification of, and Sanctions industry standards; Sec. 101. Policy of the United States with re- With Respect to, Officials, Agents, Affili- (2) the harmful health effects that patients spect to development of nuclear ates, and Supporters of Iran’s Revolu- experience when they consume prescription weapons capabilities by Iran. tionary Guard Corps and Other Sanctioned drugs purchased through such pharmacy Persons Sec. 102. Sense of Congress on expansion of Internet websites; Sec. 301. Identification of, and imposition of multilateral sanctions regime (3) efforts by the Federal Government and sanctions with respect to, offi- and implementation of sanc- State and local governments to investigate cials, agents, and affiliates of tions laws. and prosecute the owners or operators of Iran’s Revolutionary Guard pharmacy Internet websites, to address the Sec. 103. Diplomatic efforts to expand multi- Corps. threats such websites pose, and to protect lateral sanctions regime. Sec. 302. Identification of, and imposition of patients; Sec. 104. Sense of Congress regarding the im- sanctions with respect to, per- (4) the level of success that Federal, State, position of sanctions with re- sons that support or conduct and local governments have experienced in spect to Iran. certain transactions with Iran’s investigating and prosecuting such cases; Revolutionary Guard Corps or (5) whether the law, as in effect on the date TITLE II—EXPANSION OF SANCTIONS RE- other sanctioned persons. of the report, provides sufficient authorities LATING TO THE ENERGY SECTOR OF Sec. 303. Rule of construction. to Federal, State, and local governments to IRAN AND PROLIFERATION OF WEAP- Subtitle B—Additional Measures Relating to investigate and prosecute the owners and op- ONS OF MASS DESTRUCTION BY IRAN Iran’s Revolutionary Guard Corps erators of pharmacy Internet websites; Subtitle A—Expansion of Iran Sanctions Act Sec. 311. Expansion of procurement prohibi- (6) additional authorities that could assist of 1996 tion to foreign persons that en- Federal, State, and local governments in in- gage in certain transactions vestigating and prosecuting the owners and Sec. 201. Imposition of sanctions with re- with Iran’s Revolutionary operators of pharmacy Internet websites; spect to joint ventures with the Guard Corps. (7) laws, policies, and activities that would Government of Iran relating to Sec. 312. Determinations of whether the Na- educate consumers about how to distinguish developing petroleum re- tional Iranian Oil Company and pharmacy Internet websites that comply sources. the National Iranian Tanker with Federal and State laws and established Sec. 202. Imposition of sanctions with re- Company are agents or affili- industry standards from those pharmacy spect to the provision of goods, ates of Iran’s Revolutionary Internet websites that do not comply with services, technology, or support Guard Corps. such laws and standards; and for the energy or petrochemical TITLE IV—MEASURES RELATING TO (8) laws, policies, and activities that would sectors of Iran. HUMAN RIGHTS ABUSES IN IRAN encourage private sector actors to take steps to address the prevalence of illegitimate Sec. 203. Imposition of sanctions with re- Subtitle A—Expansion of Sanctions Relating pharmacy Internet websites. spect to joint ventures with the to Human Rights Abuses in Iran Government of Iran relating to SEC. 1135. MEDICATION AND DEVICE ERRORS. Sec. 401. Imposition of sanctions with re- mining, production, or trans- spect to the transfer of goods or The Secretary of Health and Human Serv- portation of uranium. ices shall continue and further coordinate technologies to Iran that are activities of the Department of Health and Sec. 204. Expansion of sanctions available likely to be used to commit Human Services related to the prevention of under the Iran Sanctions Act of human rights abuses. Sec. 402. Imposition of sanctions with re- medication and device errors, including con- 1996. spect to persons who engage in sideration of medication and device errors Sec. 205. Expansion of definitions under the censorship or other related ac- that affect the pediatric patient population. Iran Sanctions Act of 1996. tivities against citizens of Iran. In developing initiatives to address medica- Subtitle B—Additional Measures Relating to tion and device errors, the Secretary shall Subtitle B—Additional Measures to Promote Sanctions Against Iran consider the root causes of medication and Human Rights in Iran device errors, including pediatric medication Sec. 211. Imposition of sanctions with re- Sec. 411. Expedited consideration of requests and device errors, in the clinical setting and spect to the provision of vessels for authorization of certain consult with relevant stakeholders on effec- or shipping services to trans- human rights-, humanitarian-, tive strategies to reduce and prevent medica- port certain goods related to and democracy-related activi- tion and device errors in the clinical setting. proliferation or terrorism ac- ties with respect to Iran. Sec. 412. Comprehensive strategy to promote SEC. 1136. COMPLIANCE PROVISION. tivities to Iran. Internet freedom and access to The budgetary effects of this Act, for the Sec. 212. Imposition of sanctions with re- information in Iran. purpose of complying with the Statutory spect to subsidiaries and agents Sec. 413. Sense of Congress on political pris- Pay-As-You-Go-Act of 2010, shall be deter- of persons sanctioned by United oners. mined by reference to the latest statement Nations Security Council reso- TITLE V—MISCELLANEOUS titled ‘‘Budgetary Effects of PAYGO Legisla- lutions. Sec. 501. Exclusion of citizens of Iran seek- tion’’ for this Act, submitted for printing in Sec. 213. Liability of parent companies for the Congressional Record by the Chairman of ing education relating to the violations of sanctions by for- nuclear and energy sectors of the Senate Budget Committee, provided that eign subsidiaries. such statement has been submitted prior to Iran. the vote on passage. Sec. 214. Disclosures to the Securities and Sec. 502. Technical correction. Exchange Commission relating Sec. 503. Interests in financial assets of Iran. to sanctionable activities. Sec. 504. Report on membership of Iran in SA 2123. Mr. REID (for Mr. JOHNSON international organizations. of South Dakota (for himself and Mr. Sec. 215. Identification of, and immigration TITLE VI—GENERAL PROVISIONS SHELBY)) proposed an amendment to restrictions on, senior officials Sec. 601. Technical implementation; pen- the bill H.R. 1905, to strengthen Iran of the Government of Iran and their family members. alties. sanctions laws for the purpose of com- Sec. 602. Applicability to certain intel- Sec. 216. Reports on, and authorization of pelling Iran to abandon its pursuit of ligence activities. imposition of sanctions with re- Sec. 603. Termination. nuclear weapons and other threatening spect to, the provision of finan- activities, and for other purposes; as cial communications services TITLE VII—SANCTIONS WITH RESPECT follows: to the Central Bank of Iran and TO HUMAN RIGHTS ABUSES IN SYRIA Strike all after the enacting clause and in- sanctioned Iranian financial in- Sec. 701. Short title. sert the following: stitutions. Sec. 702. Imposition of sanctions with re- spect to certain persons who SECTION 1. SHORT TITLE; TABLE OF CONTENTS. Sec. 217. Government Accountability Office are responsible for or complicit (a) SHORT TITLE.—This Act may be cited as report on foreign entities that in human rights abuses com- the ‘‘Iran Sanctions, Accountability, and invest in the energy sector of mitted against citizens of Syria Human Rights Act of 2012’’. Iran or export refined petro- or their family members. (b) TABLE OF CONTENTS.—The table of con- leum products to Iran. Sec. 703. Imposition of sanctions with re- tents for this Act is as follows: Sec. 218. Reporting on the importation to spect to the transfer of goods or Sec. 1. Short title; table of contents. and exportation from Iran of technologies to Syria that are Sec. 2. Findings. crude oil and refined petroleum likely to be used to commit Sec. 3. Definitions. products. human rights abuses.

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00079 Fmt 4624 Sfmt 0655 E:\CR\FM\A21MY6.041 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3374 CONGRESSIONAL RECORD — SENATE May 21, 2012 Sec. 704. Imposition of sanctions with re- dermining and destabilizing its neighbors subsection (a) have been successful that in- spect to persons who engage in and other countries; and cludes— censorship or other forms of re- (2) to fully implement all multilateral and (1) an identification of the countries that pression in Syria. bilateral sanctions against Iran, as part of have agreed to impose additional sanctions Sec. 705. Waiver. larger multilateral and bilateral diplomatic or take other measures to further the policy Sec. 706. Termination. efforts, in order to compel the Government set forth in section 101 and a description of SEC. 2. FINDINGS. of Iran— those measures; Congress makes the following findings: (A) to abandon efforts to acquire a nuclear (2) an identification of the countries that (1) Successive Presidents of the United weapons capability; have not agreed to impose such sanctions or States have determined that the pursuit of (B) to abandon and dismantle its ballistic measures; nuclear weapons capabilities by the Govern- missile and unconventional weapons pro- (3) recommendations for additional meas- ment of Iran presents a danger to the United grams; and ures that the United States could take to States, its friends and allies, and to global (C) to cease all support for terrorist orga- further the policy set forth in section 101; security. nizations and other terrorist activities and (2) Successive Congresses have recognized aimed at undermining and destabilizing its (4) a description of any decision by the the threat that the Government of Iran and neighbors and other countries. World Trade Organization with respect to its policies present to the United States, its SEC. 102. SENSE OF CONGRESS ON EXPANSION whether the imposition by any country of friends and allies, and to global security, and OF MULTILATERAL SANCTIONS RE- any sanction with respect to Iran is incon- responded with successive bipartisan legisla- GIME AND IMPLEMENTATION OF sistent with the obligations of that country tive initiatives, including most recently the SANCTIONS LAWS. as a member of the World Trade Organiza- enactment of the Comprehensive Iran Sanc- It is the sense of Congress that the goal of tion or under the General Agreement on Tar- tions, Accountability, and Divestment Act of compelling Iran to abandon efforts to ac- iffs and Trade, done at Geneva October 30, 2010 (22 U.S.C. 8501 et seq.) on July 1, 2010. quire a nuclear weapons capability and other 1947. (3) If the Government of Iran achieves a threatening activities can be effectively nuclear weapons capability, it would pose a achieved through— SEC. 104. SENSE OF CONGRESS REGARDING THE threat to the United States and allies and (1) the prompt expansion, vigorous imple- IMPOSITION OF SANCTIONS WITH RESPECT TO IRAN. friends of the United States, particularly mentation, and intensification of enforce- Israel, destabilize the Middle East, increase ment of the current multilateral sanctions It is the sense of Congress that all efforts the threat of nuclear terrorism, and signifi- regime with respect to Iran; and should be made by the President to maxi- cantly undermine global nonproliferation ef- (2) full and vigorous implementation of all mize the effects of existing sanctions with forts. sanctions enacted into law, including sanc- respect to Iran and the United States should (4) The United States and its allies in the tions imposed or expanded by this Act or take all necessary measures to preserve ro- international community recognize the amendments made by this Act. bust information-sharing activities. threat posed by the pursuit of nuclear weap- SEC. 103. DIPLOMATIC EFFORTS TO EXPAND TITLE II—EXPANSION OF SANCTIONS RE- ons capabilities by the Government of Iran MULTILATERAL SANCTIONS RE- LATING TO THE ENERGY SECTOR OF and have imposed significant sanctions GIME. IRAN AND PROLIFERATION OF WEAP- against the Government of Iran, including (a) MULTILATERAL NEGOTIATIONS.—In order ONS OF MASS DESTRUCTION BY IRAN through the enactment of the Comprehensive to further the policy set forth in section 101, Iran Sanctions, Accountability, and Divest- Congress urges the President to intensify Subtitle A—Expansion of Iran Sanctions Act ment Act of 2010 in the United States and the diplomatic efforts, both in appropriate inter- of 1996 adoption of a series of successive, increas- national fora such as the United Nations and SEC. 201. IMPOSITION OF SANCTIONS WITH RE- ingly stringent United Nations Security bilaterally with allies of the United States, SPECT TO JOINT VENTURES WITH Council resolutions. While such efforts, to- to expand the multilateral sanctions regime THE GOVERNMENT OF IRAN RELAT- gether with others, have served to slow the with respect to Iran, including— ING TO DEVELOPING PETROLEUM development of Iran’s nuclear program, they (1) expanding the United Nations Security RESOURCES. have not yet deterred Iran from its nuclear Council sanctions regime to include— Section 5(a) of the Iran Sanctions Act of ambitions, and international efforts to do so (A) a prohibition on the issuance of visas 1996 (Public Law 104–172; 50 U.S.C. 1701 note) must be intensified. to any official of the Government of Iran is amended— SEC. 3. DEFINITIONS. who is involved in— (1) in the subsection heading, by striking In this Act: (i) human rights violations in or outside of ‘‘WITH RESPECT TO’’ and all that follows (1) APPROPRIATE CONGRESSIONAL COMMIT- Iran; through ‘‘TO IRAN’’ and inserting ‘‘RELATING TEES.—The term ‘‘appropriate congressional (ii) the development of a nuclear weapons TO THE ENERGY SECTOR OF IRAN’’; and committees’’ has the meaning given that program and a ballistic missile capability in (2) by adding at the end the following: term in section 14 of the Iran Sanctions Act Iran; or ‘‘(4) JOINT VENTURES WITH IRAN RELATING TO of 1996 (Public Law 104–172; 50 U.S.C. 1701 (iii) support by the Government of Iran for DEVELOPING PETROLEUM RESOURCES.— note). terrorist organizations, including Hamas and ‘‘(A) IN GENERAL.—Except as provided in (2) CREDIBLE INFORMATION.—The term Hezbollah; and subparagraph (B) and subsection (f), the ‘‘credible information’’ has the meaning (B) a requirement that each member coun- President shall impose 3 or more of the sanc- given that term in section 14 of the Iran try of the United Nations prohibit the Is- tions described in section 6(a) with respect to Sanctions Act of 1996, as amended by section lamic Republic of Iran Shipping Lines from a person if the President determines that the 205 of this Act. landing at seaports, and cargo flights of Iran person knowingly participates, on or after (3) KNOWINGLY.—The term ‘‘knowingly’’ Air from landing at airports, in that country the date of the enactment of the Iran Sanc- has the meaning given that term in section because of the role of those organizations in tions, Accountability, and Human Rights 14 of the Iran Sanctions Act of 1996 (Public proliferation and illegal arms sales; Act of 2012, in a joint venture with respect to Law 104–172; 50 U.S.C. 1701 note). (2) expanding the range of sanctions im- the development of petroleum resources out- (4) UNITED STATES PERSON.—The term posed with respect to Iran by allies of the side of Iran if— ‘‘United States person’’ has the meaning United States; ‘‘(i) the joint venture is established on or given that term in section 101 of the Com- (3) expanding efforts to limit the develop- after January 1, 2002; and prehensive Iran Sanctions, Accountability, ment of petroleum resources and the impor- ‘‘(ii)(I) the Government of Iran is a sub- and Divestment Act of 2010 (22 U.S.C. 8511). tation of refined petroleum products by Iran; stantial partner or investor in the joint ven- TITLE I—EXPANSION OF MULTILATERAL (4) developing additional initiatives to— ture; or SANCTIONS REGIME WITH RESPECT TO (A) increase the production of crude oil in ‘‘(II) Iran could, through a direct oper- IRAN countries other than Iran; and ational role in the joint venture or by other means, receive technological knowledge or SEC. 101. POLICY OF THE UNITED STATES WITH (B) assist countries that purchase or other- RESPECT TO DEVELOPMENT OF NU- wise obtain crude oil or petroleum products equipment not previously available to Iran CLEAR WEAPONS CAPABILITIES BY from Iran to reduce their dependence on that could directly and significantly con- IRAN. crude oil and petroleum products from Iran; tribute to the enhancement of Iran’s ability It shall be the policy of the United and to develop petroleum resources in Iran. States— (5) eliminating the revenue generated by ‘‘(B) APPLICABILITY.—Subparagraph (A) (1) to prevent the Government of Iran the Government of Iran from the sale of pe- shall not apply with respect to participation from— trochemical products produced in Iran to in a joint venture established on or after (A) acquiring or developing nuclear weap- other countries. January 1, 2002, and before the date of the ons; (b) REPORTS TO CONGRESS.—Not later than enactment of the Iran Sanctions, Account- (B) developing its advanced conventional 180 days after the date of the enactment of ability, and Human Rights Act of 2012 if the weapons and ballistic missile capabilities; this Act, and every 180 days thereafter, the person participating in the joint venture ter- and President shall submit to the appropriate minates that participation not later than (C) continuing its support for terrorist or- congressional committees a report on the ex- the date that is 180 days after such date of ganizations and other activities aimed at un- tent to which diplomatic efforts described in enactment.’’.

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00080 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.044 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3375 SEC. 202. IMPOSITION OF SANCTIONS WITH RE- (D) by adding at the end the following: ‘‘(ii) information set forth in a report to SPECT TO THE PROVISION OF ‘‘(B) except as provided in paragraph (3), stockholders of the person indicating that GOODS, SERVICES, TECHNOLOGY, knowingly participated, on or after the date the person has engaged in such an activity; OR SUPPORT FOR THE ENERGY OR PETROCHEMICAL SECTORS OF IRAN. of the enactment of the Iran Sanctions, Ac- and Section 5(a) of the Iran Sanctions Act of countability, and Human Rights Act of 2012, ‘‘(B) may include, in the discretion of the 1996 (Public Law 104–172; 50 U.S.C. 1701 note), in a joint venture— President— as amended by section 201, is further amend- ‘‘(i) with— ‘‘(i) an announcement by the Government ed by adding at the end the following: ‘‘(I) the Government of Iran; of Iran that the person has engaged in such ‘‘(5) SUPPORT FOR THE DEVELOPMENT OF PE- ‘‘(II) an entity incorporated in Iran or sub- an activity; or TROLEUM RESOURCES AND REFINED PETROLEUM ject to the jurisdiction of the Government of ‘‘(ii) information indicating that the per- PRODUCTS IN IRAN.— Iran; or son has engaged in such an activity that is ‘‘(A) IN GENERAL.—Except as provided in ‘‘(III) a person acting on behalf of or at the set forth in— subsection (f), the President shall impose 3 direction of, or owned or controlled by, the ‘‘(I) a report of the Government Account- or more of the sanctions described in section Government of Iran or an entity described in ability Office, the Energy Information Ad- 6(a) with respect to a person if the President subclause (II); and ministration, or the Congressional Research determines that the person knowingly, on or ‘‘(ii) that involves any activity relating to Service; or after the date of the enactment of the Iran the mining, production, or transportation of ‘‘(II) a report or publication of a similarly Sanctions, Accountability, and Human uranium.’’; and reputable governmental organization. Rights Act of 2012, sells, leases, or provides (2) by adding at the end the following: ‘‘(20) PETROCHEMICAL PRODUCT.—The term to Iran goods, services, technology, or sup- ‘‘(3) APPLICABILITY OF SANCTIONS WITH RE- ‘petrochemical product’ includes any aro- port described in subparagraph (B)— SPECT TO JOINT VENTURES RELATING TO THE matic, olefin, or synthesis gas, and any de- ‘‘(i) any of which has a fair market value of MINING, PRODUCTION, OR TRANSPORTATION OF rivative of such a gas, including ethylene, $1,000,000 or more; or URANIUM.— propylene, butadiene, benzene, toluene, xy- ‘‘(ii) that, during a 12-month period, have ‘‘(A) IN GENERAL.—Paragraph (1)(B) shall lene, ammonia, methanol, and urea.’’. an aggregate fair market value of $5,000,000 apply with respect to participation, on or (b) EFFECTIVE DATE.—The amendment or more. after the date of the enactment of the Iran made by subsection (a) shall take effect on ‘‘(B) GOODS, SERVICES, TECHNOLOGY, OR SUP- Sanctions, Accountability, and Human the date of the enactment of this Act and PORT DESCRIBED.—Goods, services, tech- Rights Act of 2012, in— apply with respect to activities described in nology, or support described in this subpara- ‘‘(i) a joint venture established on or after section 5 of the Iran Sanctions Act of 1996, as graph are goods, services, technology, or sup- such date of enactment; and amended by this Act, commenced on or after port that could directly and significantly ‘‘(ii) except as provided in subparagraph such date of enactment. contribute to the maintenance or enhance- (B), a joint venture established before such Subtitle B—Additional Measures Relating to ment of Iran’s— date of enactment. Sanctions Against Iran ‘‘(i) ability to develop petroleum resources ‘‘(B) EXCEPTION.—Paragraph (1)(B) shall SEC. 211. IMPOSITION OF SANCTIONS WITH RE- located in Iran; or not apply with respect to participation in a SPECT TO THE PROVISION OF VES- ‘‘(ii) domestic production of refined petro- joint venture described in subparagraph SELS OR SHIPPING SERVICES TO leum products, including any direct and sig- (A)(ii) if the person participating in the joint TRANSPORT CERTAIN GOODS RE- nificant assistance with respect to the con- venture terminates that participation not LATED TO PROLIFERATION OR TER- struction, modernization, or repair of petro- later than the date that is 180 days after the RORISM ACTIVITIES TO IRAN. (a) IN GENERAL.—Except as provided in leum refineries or directly associated infra- date of the enactment of the Iran Sanctions, subsection (c), if the President determines structure, including port facilities, railroads, Accountability, and Human Rights Act of that a person, on or after the date of the en- or roads, if the predominant use of those fa- 2012.’’. actment of this Act, knowingly provides a cilities, railroads, or roads is for the trans- SEC. 204. EXPANSION OF SANCTIONS AVAILABLE portation of refined petroleum products. vessel, insurance or reinsurance, or any UNDER THE IRAN SANCTIONS ACT other shipping service for the transportation ‘‘(6) DEVELOPMENT AND PURCHASE OF PETRO- OF 1996. to or from Iran of goods that could materi- CHEMICAL PRODUCTS FROM IRAN.— (a) IN GENERAL.—Section 6(a) of the Iran ‘‘(A) IN GENERAL.—Except as provided in ally contribute to the activities of the Gov- Sanctions Act of 1996 (Public Law 104–172; 50 ernment of Iran with respect to the pro- subsection (f), the President shall impose 3 U.S.C. 1701 note) is amended— or more of the sanctions described in section liferation of weapons of mass destruction or (1) by redesignating paragraph (9) as para- support for acts of international terrorism, 6(a) with respect to a person if the President graph (11); and determines that the person knowingly, on or the President shall, pursuant to Executive (2) by inserting after paragraph (8) the fol- Order 13382 (70 Fed. Reg. 38567; relating to after the date of the enactment of Iran Sanc- lowing: tions, Accountability, and Human Rights blocking of property of weapons of mass de- ‘‘(9) EXCLUSION OF CORPORATE OFFICERS.— struction proliferators and their supporters) Act of 2012, sells, leases, or provides to Iran The President may direct the Secretary of goods, services, technology, or support de- or Executive Order 13224 (66 Fed. Reg. 49079; State to deny a visa to, and the Secretary of relating to blocking property and prohib- scribed in subparagraph (B)— Homeland Security to exclude from the ‘‘(i) any of which has a fair market value of iting transactions with persons who commit, United States, any alien that the President threaten to commit, or support terrorism), $250,000 or more; or determines is a corporate officer or principal ‘‘(ii) that, during a 12-month period, have or otherwise pursuant to the International of, or a shareholder with a controlling inter- Emergency Economic Powers Act (50 U.S.C. an aggregate fair market value of $1,000,000 est in, a sanctioned person. or more. 1701 et seq.), block and prohibit all trans- ‘‘(10) SANCTIONS ON PRINCIPAL EXECUTIVE actions in all property and interests in prop- ‘‘(B) GOODS, SERVICES, TECHNOLOGY, OR SUP- OFFICERS.—The President may impose on the erty of the persons specified in subsection (b) PORT DESCRIBED.—Goods, services, tech- principal executive officer or officers of any if such property and interests in property are nology, or support described in this subpara- sanctioned person, or on persons performing graph are goods, services, technology, or sup- in the United States, come within the United similar functions and with similar authori- States, or are or come within the possession port that could directly and significantly ties as such officer or officers, any of the contribute to the maintenance or expansion or control of a United States person. sanctions under this subsection.’’. (b) PERSONS SPECIFIED.—The persons speci- of Iran’s domestic production of petro- (b) EFFECTIVE DATE.—The amendments fied in this subsection are— chemical products.’’. made by subsection (a) shall take effect on (1) the person that provided a vessel, insur- SEC. 203. IMPOSITION OF SANCTIONS WITH RE- the date of the enactment of this Act and ance or reinsurance, or other shipping serv- SPECT TO JOINT VENTURES WITH apply with respect to activities described in THE GOVERNMENT OF IRAN RELAT- ice described in subsection (a); and ING TO MINING, PRODUCTION, OR section 5 of the Iran Sanctions Act of 1996, as (2) any person that— TRANSPORTATION OF URANIUM. amended by this Act, commenced on or after (A) is a successor entity to the person re- Section 5(b) of the Iran Sanctions Act of such date of enactment. ferred to in paragraph (1); 1996 (Public Law 104–172; 50 U.S.C. 1701 note) SEC. 205. EXPANSION OF DEFINITIONS UNDER (B) owns or controls the person referred to is amended— THE IRAN SANCTIONS ACT OF 1996. in paragraph (1), if the person that owns or (1) in paragraph (1)— (a) IN GENERAL.—Section 14 of the Iran controls the person referred to in paragraph (A) by redesignating subparagraphs (A) and Sanctions Act of 1996 (Public Law 104–172; 50 (1) had actual knowledge or should have (B) as clauses (i) and (ii), respectively, and U.S.C. 1701 note) is amended by adding at the known that the person referred to in para- moving such clauses, as so redesignated, 2 end the following: graph (1) provided the vessel, insurance or ems to the right; ‘‘(19) CREDIBLE INFORMATION.—The term reinsurance, or other shipping service; or (B) by striking ‘‘a person has, on or after’’ ‘credible information’, with respect to a per- (C) is owned or controlled by, or under and inserting the following: ‘‘a person has— son— common ownership or control with, the per- ‘‘(A) on or after’’; ‘‘(A) includes— son referred to in paragraph (1), if the person (C) in subparagraph (A)(ii), as redesig- ‘‘(i) a public announcement by the person owned or controlled by, or under common nated, by striking the period and inserting ‘‘; that the person has engaged in an activity ownership or control with (as the case may or’’; and described in section 5; and be), the person referred to in paragraph (1)

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knowingly engaged in the provision of the States person to the same extent that such ‘‘(4) PUBLIC DISCLOSURE OF INFORMATION.— vessel, insurance or reinsurance, or other penalties apply to a person that commits an Upon receiving a notice under paragraph (3) shipping service. unlawful act described in section 206(a) of that an annual or quarterly report includes a (c) WAIVER.—The President may waive the that Act if an entity owned or controlled by disclosure of an activity described in para- requirement to impose sanctions with re- the United States person and established or graph (1), the Commission shall promptly— spect to a person under subsection (a) on or maintained outside the United States vio- ‘‘(A) transmit the report to— after the date that is 30 days after the Presi- lates, attempts to violate, conspires to vio- ‘‘(i) the President; dent— late, or causes a violation of any order or ‘‘(ii) the Committee on Foreign Affairs and (1) determines that such a waiver is in the regulation issued to implement subsection the Committee on Financial Services of the national security interests of the United (b). House of Representatives; and States; and (d) APPLICABILITY.—Subsection (c) shall ‘‘(iii) the Committee on Foreign Relations (2) submits to the appropriate congres- not apply with respect to a transaction de- and the Committee on Banking, Housing, sional committees a report that contains the scribed in subsection (b) by an entity owned and Urban Affairs of the Senate; and reasons for that determination. or controlled by a United States person and ‘‘(B) make the information provided in the (d) RULE OF CONSTRUCTION.—Nothing in established or maintained outside the United disclosure and the notice available to the this section shall be construed to limit the States if the United States person divests or public by posting the information on the authority of the President to designate per- terminates its business with the entity not Internet website of the Commission. sons for the imposition of sanctions pursuant later than the date that is 180 days after the ‘‘(5) INVESTIGATIONS.—Upon receiving a re- to Executive Order 13382 (70 Fed. Reg. 38567; date of the enactment of this Act. port under paragraph (4), the President relating to the blocking of property of weap- SEC. 214. DISCLOSURES TO THE SECURITIES AND shall— ons of mass destruction proliferators and EXCHANGE COMMISSION RELATING ‘‘(A) initiate an investigation into the pos- their supporters) or Executive Order 13224 (66 TO SANCTIONABLE ACTIVITIES. sible imposition of sanctions under the Iran Fed. Reg. 49079; relating to blocking property (a) IN GENERAL.—Section 13 of the Securi- Sanctions Act of 1996 (Public Law 104–172; 50 and prohibiting transactions with persons ties Exchange Act of 1934 (15 U.S.C. 78m) is U.S.C. 1701 note), section 104 or 105A of the who commit, threaten to commit, or support amended by adding at the end the following Comprehensive Iran Sanctions, Account- terrorism), or otherwise pursuant to the new subsection: ability, and Divestment Act of 2010, an Exec- International Emergency Economic Powers ‘‘(r) DISCLOSURE OF CERTAIN ACTIVITIES RE- utive Order specified in clause (i) or (ii) of Act (50 U.S.C. 1701 et seq.). LATING TO IRAN.— paragraph (1)(D), or any other provision of SEC. 212. IMPOSITION OF SANCTIONS WITH RE- ‘‘(1) IN GENERAL.—Each issuer required to law relating to the imposition of sanctions SPECT TO SUBSIDIARIES AND file an annual or quarterly report under sub- with respect to Iran, as applicable; and AGENTS OF PERSONS SANCTIONED section (a) shall disclose in that report the ‘‘(B) not later than 180 days after initiating BY UNITED NATIONS SECURITY such an investigation, make a determination COUNCIL RESOLUTIONS. information required by paragraph (2) if, dur- with respect to whether sanctions should be (a) IN GENERAL.—Section 104(c)(2)(B) of the ing the period covered by the report, the imposed with respect to the issuer or the af- Comprehensive Iran Sanctions, Account- issuer or any affiliate of the issuer— filiate of the issuer (as the case may be). ability, and Divestment Act of 2010 (22 U.S.C. ‘‘(A) knowingly engaged in an activity de- ‘‘(6) SUNSET.—The provisions of this sub- 8513(c)(2)(B)) is amended— scribed in section 5 of the Iran Sanctions Act section shall terminate on the date that is 30 (1) by striking ‘‘of a person subject’’ and of 1996 (Public Law 104–172; 50 U.S.C. 1701 days after the date on which the President inserting the following: ‘‘of— note); makes the certification described in section ‘‘(i) a person subject’’; ‘‘(B) knowingly engaged in an activity de- 401(a) of the Comprehensive Iran Sanctions, (2) in clause (i), as redesignated, by strik- scribed in subsection (c)(2) of section 104 of Accountability, and Divestment Act of 2010 ing the semicolon and inserting ‘‘; or’’; and the Comprehensive Iran Sanctions, Account- (22 U.S.C. 8551(a)).’’. (3) by adding at the end the following: ability, and Divestment Act of 2010 (22 U.S.C. ‘‘(ii) a person acting on behalf of or at the 8513) or a transaction described in subsection (b) EFFECTIVE DATE.—The amendment direction of, or owned or controlled by, a (d)(1) of that section; made by subsection (a) shall take effect with person described in clause (i);’’. ‘‘(C) knowingly engaged in an activity de- respect to reports required to be filed with (b) REGULATIONS.—Not later than 90 days scribed in section 105A(b)(2) of that Act; or the Securities and Exchange Commission after the date of the enactment of this Act, ‘‘(D) knowingly conducted any transaction after the date that is 180 days after the date the Secretary of the Treasury shall make or dealing with— of the enactment of this Act. such revisions to the regulations prescribed ‘‘(i) any person the property and interests SEC. 215. IDENTIFICATION OF, AND IMMIGRA- under section 104 of the Comprehensive Iran in property of which are blocked pursuant to TION RESTRICTIONS ON, SENIOR OF- Sanctions, Accountability, and Divestment Executive Order 13224 (66 Fed. Reg. 49079; re- FICIALS OF THE GOVERNMENT OF Act of 2010 (22 U.S.C. 8513) as are necessary to lating to blocking property and prohibiting IRAN AND THEIR FAMILY MEMBERS. carry out the amendments made by sub- transactions with persons who commit, (a) IDENTIFICATION.—Not later than 180 section (a). threaten to commit, or support terrorism); days after the date of the enactment of this Act, and annually thereafter, the President SEC. 213. LIABILITY OF PARENT COMPANIES FOR ‘‘(ii) any person the property and interests VIOLATIONS OF SANCTIONS BY FOR- in property of which are blocked pursuant to shall publish a list of each individual the EIGN SUBSIDIARIES. Executive Order 13382 (70 Fed. Reg. 38567; re- President determines is— (a) DEFINITIONS.—In this section: lating to blocking of property of weapons of (1) a senior official of the Government of (1) ENTITY.—The term ‘‘entity’’ means a mass destruction proliferators and their sup- Iran described in subsection (b) that is in- partnership, association, trust, joint ven- porters); or volved in Iran’s— ture, corporation, or other organization. ‘‘(iii) any person identified under section (A) illicit nuclear activities or prolifera- (2) OWN OR CONTROL.—The term ‘‘own or 560.304 of title 31, Code of Federal Regula- tion of weapons of mass destruction or deliv- control’’ means, with respect to an entity— tions (relating to the definition of the Gov- ery systems for weapons of mass destruction; (A) to hold more than 50 percent of the eq- ernment of Iran). (B) support for international terrorism; or uity interest by vote or value in the entity; ‘‘(2) INFORMATION REQUIRED.—If an issuer or (C) commission of serious human rights (B) to hold a majority of seats on the board an affiliate of the issuer has engaged in any abuses against citizens of Iran or their fam- of directors of the entity; or activity described in paragraph (1), the ily members; or (C) to otherwise control the actions, poli- issuer shall disclose a detailed description of (2) a family member of such an official. cies, or personnel decisions of the entity. each such activity, including— (b) SENIOR OFFICIALS OF THE GOVERNMENT (b) PROHIBITION.—Not later than 60 days ‘‘(A) the nature and extent of the activity; OF IRAN DESCRIBED.—A senior official of the after the date of the enactment of this Act, ‘‘(B) the gross revenues and net profits, if Government of Iran described in this sub- the President shall prohibit an entity owned any, attributable to the activity; and section is any senior official of that Govern- or controlled by a United States person and ‘‘(C) whether the issuer or the affiliate of ment, including— established or maintained outside the United the issuer (as the case may be) intends to (1) the Supreme Leader of Iran, Ali States from engaging in any transaction di- continue the activity. Khamenei; rectly or indirectly with the Government of ‘‘(3) NOTICE OF DISCLOSURES.—If an issuer (2) the President of Iran, Mahmoud Iran or any person subject to the jurisdiction reports under paragraph (1) that the issuer or Ahmadinejad; of that Government that would be prohibited an affiliate of the issuer has knowingly en- (3) a member of the Cabinet of the Govern- by an order or regulation issued pursuant to gaged in any activity described in that para- ment of Iran; the International Emergency Economic Pow- graph, the issuer shall separately file with (4) a member of the Assembly of Experts; ers Act (50 U.S.C. 1701 et seq.) if the trans- the Commission, concurrently with the an- (5) a senior member of the Intelligence action were engaged in by a United States nual or quarterly report under subsection Ministry of Iran; or person or in the United States. (a), a notice that the disclosure of that activ- (6) a member of Iran’s Revolutionary (c) CIVIL PENALTY.—The civil penalties ity has been included in that annual or quar- Guard Corps with the rank of brigadier gen- provided for in section 206(b) of the Inter- terly report that identifies the issuer and eral or higher, including a member of a para- national Emergency Economic Powers Act contains the information required by para- military organization such as Ansar-e- (50 U.S.C. 1705(b)) shall apply to a United graph (2). Hezbollah or Basij-e Motaz’afin.

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(c) RESTRICTIONS ON VISAS AND ADJUST- Treasury shall submit to the appropriate on the date that is 30 days before the date on MENTS IN IMMIGRATION STATUS.—The Sec- congressional committees a report on the which the preceding report was required to retary of State and the Secretary of Home- status of efforts to ensure that SWIFT has be submitted by this section, that— land Security may not grant an individual terminated the provision of financial com- ‘‘(1) contains the matters required in the on the list required by subsection (a) immi- munications services to, and the enabling report under subsection (a)(1); and gration status in, or admit the individual to, and facilitation of access to such services ‘‘(2) identifies— the United States. for, the Central Bank of Iran and Iranian fi- ‘‘(A) the volume of crude oil and refined pe- (d) WAIVER.—The President may waive the nancial institutions designated for the impo- troleum products imported to and exported application of subsection (a) or (c) with re- sition of sanctions pursuant to the Inter- from Iran (including through swaps and simi- spect to an individual if the President— national Emergency Economic Powers Act lar arrangements); (1) determines that such a waiver is— (50 U.S.C. 1701 et seq.). ‘‘(B) the persons selling and transporting (A) in the national interests of the United (d) AUTHORIZATION FOR THE IMPOSITION OF crude oil and refined petroleum products de- States; or SANCTIONS.—If, on or after the date that is 90 scribed in subparagraph (A), the countries (B) necessary to permit the United States days after the date of the enactment of this with primary jurisdiction over those persons, to comply with the Agreement between the Act, a global financial communications serv- and the countries in which those products United Nations and the United States of ices provider has not terminated the provi- were refined; America regarding the Headquarters of the sion of financial communications services to, ‘‘(C) the sources of financing for imports to United Nations, signed June 26, 1947, and en- and the enabling and facilitation of access to Iran of crude oil and refined petroleum prod- tered into force November 21, 1947; and such services for, the Central Bank of Iran ucts described in subparagraph (A); and (2) not less than 7 days before the waiver and any financial institution described in ‘‘(D) the involvement of foreign persons in takes effect, notifies Congress of the waiver paragraph (2)(E)(ii) of section 104(c) of the efforts to assist Iran in— and the reason for the waiver. Comprehensive Iran Sanctions, Account- ‘‘(i) developing upstream oil and gas pro- SEC. 216. REPORTS ON, AND AUTHORIZATION OF ability, and Divestment Act of 2010 (22 U.S.C. duction capacity; IMPOSITION OF SANCTIONS WITH 8513(c)), the President may impose sanctions ‘‘(ii) importing advanced technology to up- RESPECT TO, THE PROVISION OF FI- pursuant to that section or the International grade existing Iranian refineries; NANCIAL COMMUNICATIONS SERV- Emergency Economic Powers Act (50 U.S.C. ‘‘(iii) converting existing chemical plants ICES TO THE CENTRAL BANK OF 1701 et seq.) with respect to the financial to petroleum refineries; or IRAN AND SANCTIONED IRANIAN FI- NANCIAL INSTITUTIONS. communications services provider and the ‘‘(iv) maintaining, upgrading, or expanding directors of, and shareholders with a signifi- (a) SENSE OF CONGRESS.—It is the sense of refineries or constructing new refineries.’’. Congress that— cant interest in, the provider. TITLE III—SANCTIONS WITH RESPECT TO (1) the President has been engaged in diplo- SEC. 217. GOVERNMENT ACCOUNTABILITY OF- IRAN’S REVOLUTIONARY GUARD CORPS matic efforts to multilateralize sanctions FICE REPORT ON FOREIGN ENTITIES THAT INVEST IN THE ENERGY SEC- Subtitle A—Identification of, and Sanctions against Iran to restrict the access of the TOR OF IRAN OR EXPORT REFINED With Respect to, Officials, Agents, Affili- Government of Iran to the global financial PETROLEUM PRODUCTS TO IRAN. ates, and Supporters of Iran’s Revolu- system; (a) INITIAL REPORT.— tionary Guard Corps and Other Sanctioned (2) the President should intensify those ef- (1) IN GENERAL.—Not later than 180 days Persons forts and, in particular, efforts to ensure after the date of the enactment of this Act, SEC. 301. IDENTIFICATION OF, AND IMPOSITION that global financial communications serv- the Comptroller General of the United States OF SANCTIONS WITH RESPECT TO, ices providers, such as the Society for World- shall submit to the appropriate congres- OFFICIALS, AGENTS, AND AFFILI- wide Interbank Financial Telecommuni- sional committees a report— ATES OF IRAN’S REVOLUTIONARY cation (in this section referred to as (A) listing all foreign investors in the en- GUARD CORPS. ‘‘SWIFT’’), cut off services to Iranian finan- ergy sector of Iran during the period speci- (a) IN GENERAL.—Not later than 90 days cial institutions designated for the imposi- fied in paragraph (2), including— after the date of the enactment of this Act, tion of sanctions pursuant to the Inter- (i) all entities that exported gasoline and and as appropriate thereafter, the President national Emergency Economic Powers Act other refined petroleum products to Iran; shall— (50 U.S.C. 1701 et seq.); and (ii) all entities involved in providing re- (1) identify foreign persons that are offi- (3) at a time when financial institutions fined petroleum products to Iran, including— cials, agents, or affiliates of Iran’s Revolu- around the world are severing their ties with (I) entities that provided ships to transport tionary Guard Corps; and such Iranian financial institutions, it is in- refined petroleum products to Iran; and (2) for each foreign person identified under consistent and troubling that financial com- (II) entities that provided insurance or re- paragraph (1) that is not already designated munications services providers continue to insurance for shipments of refined petroleum for the imposition of sanctions pursuant to service those financial institutions, particu- products to Iran; and the International Emergency Economic Pow- larly with respect to the Belgian cooperative (iii) all entities involved in commercial ers Act (50 U.S.C. 1701 et seq.)— SWIFT, which— transactions of any kind, including joint (A) designate that foreign person for the (A) is subject to the prohibition of the Eu- ventures anywhere in the world, with Ira- imposition of sanctions pursuant to that ropean Union on providing economic re- nian energy companies; and Act; and sources to financial institutions designated (B) identifying the countries in which gas- (B) block and prohibit all transactions in for the imposition of sanctions by the Euro- oline and other refined petroleum products all property and interests in property of that pean Union; and exported to Iran during the period specified foreign person if such property and interests (B) notes in its own corporate rules that it in paragraph (2) were produced or refined. in property are in the United States, come reserves the right to expel a SWIFT cus- (2) PERIOD SPECIFIED.—The period specified within the United States, or are or come tomer that may adversely affect SWIFT’s in this paragraph is the period beginning on within the possession or control of a United ‘‘reputation, brand, or goodwill’’, for in- January 1, 2006, and ending on the date that States person. stance if the SWIFT customer is subject to is 150 days after the date of the enactment of (b) PRIORITY FOR INVESTIGATION.—In identi- sanctions (such as by the United Nations or this Act. fying foreign persons pursuant to subsection the European Union), as is the case with Ira- (b) UPDATED REPORTS.—Not later than one (a)(1) as officials, agents, or affiliates of nian financial institutions. year after submitting the report required by Iran’s Revolutionary Guard Corps, the Presi- (b) REPORT ON THE PROVISION OF FINANCIAL subsection (a), and annually thereafter, the dent shall give priority to investigating— COMMUNICATIONS SERVICES TO SANCTIONED Comptroller General of the United States (1) foreign persons identified under section IRANIAN FINANCIAL INSTITUTIONS.—Not later shall submit to the appropriate congres- 560.304 of title 31, Code of Federal Regula- than 60 days after the date of the enactment sional committees a report containing the tions (relating to the definition of the Gov- of this Act, the Comptroller General of the matters required in the report under sub- ernment of Iran); and United States shall submit to the appro- section (a)(1) for the one-year period begin- (2) foreign persons for which there is a rea- priate congressional committees a list of all ning on the date that is 30 days before the sonable basis to find that the person has con- known entities (including SWIFT) that pro- date on which the preceding report was re- ducted or attempted to conduct one or more vide financial communications services to, quired to be submitted by this section. sensitive transactions or activities described or that enable or facilitate access to such SEC. 218. REPORTING ON THE IMPORTATION TO in subsection (c). services for, the Central Bank of Iran or a fi- AND EXPORTATION FROM IRAN OF (c) SENSITIVE TRANSACTIONS AND ACTIVITIES nancial institution described in section CRUDE OIL AND REFINED PETRO- DESCRIBED.—A sensitive transaction or ac- 104(c)(2)(E)(ii) of the Comprehensive Iran LEUM PRODUCTS. tivity described in this subsection is— Sanctions, Accountability, and Divestment Section 110(b) of the Comprehensive Iran (1) a financial transaction or series of Act of 2010 (22 U.S.C. 8513(c)(2)(E)(ii)). Sanctions, Accountability, and Divestment transactions valued at more than $1,000,000 (c) REPORT ON EFFORTS TO TERMINATE THE Act of 2010 (22 U.S.C. 8518(b)) is amended by in the aggregate in any 12-month period in- PROVISION BY SWIFT OF SERVICES FOR SANC- striking ‘‘a report containing the matters’’ volving a non-Iranian financial institution; TIONED IRANIAN FINANCIAL INSTITUTIONS.— and all that follows through the period at (2) a transaction to facilitate the manufac- Not later than 90 days after the date of the the end and inserting the following: ‘‘a re- ture, importation, exportation, or transfer of enactment of this Act, the Secretary of the port, covering the 180-day period beginning items needed for the development by Iran of

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Sanctions, Accountability, and Divestment direction of, or owned or controlled by, a (4) Section 9. Act of 2010 (22 U.S.C. 8515(c))). person described in clause (i). (5) Section 11. (d) EXCLUSION FROM UNITED STATES.— (2) FORM OF REPORT.—A report submitted (6) Section 12. (1) IN GENERAL.—Subject to paragraph (2), under paragraph (1) shall be submitted in un- (7) Subsection (b) of section 13. the Secretary of State shall deny a visa to, classified form but may contain a classified (8) Section 14. and the Secretary of Homeland Security annex. SEC. 303. RULE OF CONSTRUCTION. shall exclude from the United States, any (3) BARTER TRANSACTIONS.—For purposes of Nothing in this subtitle shall be construed alien who, on or after the date of the enact- paragraph (1), the term ‘‘transaction’’ in- to limit the authority of the President to ment of this Act, is a foreign person des- cludes a barter transaction. designate foreign persons for the imposition ignated pursuant to subsection (a) for the (b) IMPOSITION OF SANCTIONS.—If the Presi- of sanctions pursuant to the International imposition of sanctions pursuant to the dent determines under subsection (a)(1) that Emergency Economic Powers Act (50 U.S.C. International Emergency Economic Powers a foreign person has knowingly engaged in 1701 et seq.). Act (50 U.S.C. 1701 et seq.). an activity described in that subsection, the Subtitle B—Additional Measures Relating to (2) REGULATORY EXCEPTIONS TO COMPLY President— Iran’s Revolutionary Guard Corps WITH INTERNATIONAL OBLIGATIONS.—The re- (1) shall impose 3 or more of the sanctions SEC. 311. EXPANSION OF PROCUREMENT PROHI- quirement to deny visas to and exclude described in section 6(a) of the Iran Sanc- BITION TO FOREIGN PERSONS THAT aliens from the United States pursuant to tions Act of 1996, as amended by section 204 ENGAGE IN CERTAIN TRANSACTIONS paragraph (1) shall be subject to such regula- of this Act; and WITH IRAN’S REVOLUTIONARY GUARD CORPS. tions as the President may prescribe, includ- (2) may impose additional sanctions pursu- (a) IN GENERAL.—Section 6(b)(1) of the Iran ing regulatory exceptions to permit the ant to the International Emergency Eco- nomic Powers Act (50 U.S.C. 1701 et seq.) Sanctions Act of 1996 (Public Law 104–172; 50 United States to comply with the Agreement U.S.C. 1701 note) is amended— between the United Nations and the United with respect to the person. (c) TERMINATION.—The President may ter- (1) by striking ‘‘Not later than 90 days’’ States of America regarding the Head- and inserting the following: quarters of the United Nations, signed June minate a sanction imposed with respect to a ‘‘(A) CERTIFICATIONS RELATING TO ACTIVI- 26, 1947, and entered into force November 21, foreign person pursuant to subsection (b) if TIES DESCRIBED IN SECTION 5.—Not later than 1947, and other applicable international obli- the President determines that the person— (1) no longer engages in the activity for 90 days’’; and gations. (2) by adding at the end the following: (e) WAIVER OF IMPOSITION OF SANCTIONS.— which the sanction was imposed; and ‘‘(B) CERTIFICATIONS RELATING TO TRANS- (1) IN GENERAL.—The President may waive (2) has provided assurances to the Presi- ACTIONS WITH IRAN’S REVOLUTIONARY GUARD the application of subsection (a)(2) or (d) dent that the person will not engage in any CORPS.—Not later than 90 days after the date with respect to a foreign person if the Presi- activity described in subsection (a)(1) in the of the enactment of the Iran Sanctions, Ac- dent— future. countability, and Human Rights Act of 2012, (A) determines that it is in the national se- (d) WAIVER OF IMPOSITION OF SANCTIONS.— the Federal Acquisition Regulation shall be curity interests of the United States to do (1) IN GENERAL.—The President may waive revised to require a certification from each so; and the imposition of sanctions under subsection person that is a prospective contractor that (B) submits to the appropriate congres- (b) with respect to a foreign person if the the person, and any person owned or con- sional committees a report that— President— trolled by the person, does not knowingly en- (i) identifies the foreign person with re- (A)(i) determines that the person has gage in a significant transaction or trans- spect to which the waiver applies; and ceased the activity for which sanctions actions with Iran’s Revolutionary Guard (ii) sets forth the reasons for the deter- would otherwise be imposed and has taken Corps or any of its officials, agents, or affili- mination. measures to prevent a recurrence of the ac- tivity; or ates the property and interests in property (2) FORM OF REPORT.—A report submitted of which are blocked pursuant to the Inter- under paragraph (1)(B) shall be submitted in (ii) determines that it is in the national se- national Emergency Economic Powers Act unclassified form but may contain a classi- curity interests of the United States to do (50 U.S.C. 1701 et seq.).’’. fied annex. so; and (b) TECHNICAL AND CONFORMING AMEND- (f) RULE OF CONSTRUCTION.—Nothing in this (B) submits to the appropriate congres- sional committees a report that— MENTS.— section shall be construed to remove any (1) Section 6(b) of the Iran Sanctions Act of sanction of the United States in force with (i) identifies the foreign person with re- spect to which the waiver applies; 1996, as amended by subsection (a), is further respect to Iran’s Revolutionary Guard Corps amended— as of the date of the enactment of this Act. (ii) describes the activity that would other- wise subject the foreign person to the impo- (A) in paragraph (1)(A), as redesignated, by SEC. 302. IDENTIFICATION OF, AND IMPOSITION sition of sanctions under subsection (b); and striking ‘‘issued pursuant to section 25 of the OF SANCTIONS WITH RESPECT TO, Office of Federal Procurement Policy Act (41 PERSONS THAT SUPPORT OR CON- (iii) sets forth the reasons for the deter- DUCT CERTAIN TRANSACTIONS mination. U.S.C. 421)’’; WITH IRAN’S REVOLUTIONARY (2) FORM OF REPORT.—A report submitted (B) in paragraph (2)— GUARD CORPS OR OTHER SANC- under paragraph (1)(B) shall be submitted in (i) in subparagraph (A), by striking ‘‘the TIONED PERSONS. unclassified form but may contain a classi- revision’’ and inserting ‘‘the applicable revi- (a) IDENTIFICATION.— fied annex. sion’’; and (1) IN GENERAL.—Not later than 90 days (e) WAIVER OF IDENTIFICATIONS AND DES- (ii) in subparagraph (B), by striking after the date of the enactment of this Act, IGNATIONS.—Notwithstanding any other pro- ‘‘issued pursuant to section 25 of the Office and every 180 days thereafter, the President vision of this subtitle and subject to para- of Federal Procurement Policy Act (41 U.S.C. shall submit to the appropriate congres- graph (2), the President shall not be required 421)’’; sional committees a report identifying for- to make any identification of a foreign per- (C) by striking paragraph (6) and inserting eign persons that the President determines, son under subsection (a) or any identifica- the following: on or after the date of the enactment of this tion or designation of a foreign person under ‘‘(6) DEFINITIONS.—In this subsection: Act, knowingly— section 301(a) if the President— ‘‘(A) EXECUTIVE AGENCY.—The term ‘execu- (A) materially assist, sponsor, or provide (1) determines that doing so would cause tive agency’ has the meaning given that financial, material, or technological support damage to the national security of the term in section 133 of title 41, United States for, or goods or services in support of, Iran’s United States, including through the divul- Code.

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‘‘(B) FEDERAL ACQUISITION REGULATION.— the NITC if the President determines and re- United States Code), rubber bullets, police The term ‘Federal Acquisition Regulation’ ports to Congress, not later than 90 days batons, pepper or chemical sprays, stun gre- means the regulation issued pursuant to sec- after the date on which the President makes nades, electroshock weapons, tear gas, water tion 1303(a)(1) of title 41, United States the determination required by section cannons, or surveillance technology; or Code.’’; and 1245(d)(4)(B) of the National Defense Author- ‘‘(ii) sensitive technology (as defined in (D) in paragraph (7)— ization Act for Fiscal Year 2012, and every section 106(c)). (i) by striking ‘‘The revisions to the Fed- 180 days thereafter, that the country with ‘‘(3) SPECIAL RULE TO ALLOW FOR TERMI- eral Acquisition Regulation required under primary jurisdiction over the foreign finan- NATION OF SANCTIONABLE ACTIVITY.—The paragraph (1)’’ and inserting the following: cial institution has significantly reduced its President shall not be required to include a ‘‘(A) CERTIFICATIONS RELATING TO ACTIVI- volume of crude oil purchases from Iran dur- person on the list required by paragraph (1) TIES DESCRIBED IN SECTION 5.—The revisions ing the period beginning on the date on if the President certifies in writing to the to the Federal Acquisition Regulation re- which the President submitted the last re- appropriate congressional committees that— quired under paragraph (1)(A)’’; and port with respect to the country under this ‘‘(A) the person is no longer engaging in, or (ii) by adding at the end the following: clause. has taken significant verifiable steps toward ‘‘(B) CERTIFICATIONS RELATING TO TRANS- ‘‘(D) DEFINITIONS.—In this paragraph: stopping, the activity described in paragraph ACTIONS WITH IRAN’S REVOLUTIONARY GUARD ‘‘(i) NIOC.—The term ‘NIOC’ means the Na- (2) for which the President would otherwise CORPS.—The revisions to the Federal Acqui- tional Iranian Oil Company. have included the person on the list; and sition Regulation required under paragraph ‘‘(ii) NITC.—The term ‘NITC’ means the ‘‘(B) the President has received reliable as- (1)(B) shall apply with respect to contracts National Iranian Tanker Company.’’. surances that the person will not knowingly for which solicitations are issued on or after (b) CONFORMING AMENDMENTS.—Section engage in any activity described in para- the date that is 90 days after the date of the 104(g) of the Comprehensive Iran Sanctions, graph (2) in the future. enactment of the Iran Sanctions, Account- Accountability, and Divestment Act of 2010 ‘‘(4) UPDATES OF LIST.—The President shall ability, and Human Rights Act of 2012.’’. (22 U.S.C. 8513(g)) is amended by striking submit to the appropriate congressional (2) Section 101(3) of the Comprehensive ‘‘subsection (c)(1)’’ each place it appears and committees an updated list under paragraph Iran Sanctions, Accountability, and Divest- inserting ‘‘paragraph (1) or (4) of subsection (1)— ment Act of 2010 (22 U.S.C. 8511(3)) is amend- (c)’’. ‘‘(A) each time the President is required to ed by striking ‘‘section 4 of the Office of Fed- TITLE IV—MEASURES RELATING TO submit an updated list to those committees eral Procurement Policy Act (41 U.S.C. 403)’’ HUMAN RIGHTS ABUSES IN IRAN under section 105(b)(2)(A); and ‘‘(B) as new information becomes avail- and inserting ‘‘section 133 of title 41, United Subtitle A—Expansion of Sanctions Relating able. States Code’’. to Human Rights Abuses in Iran SEC. 312. DETERMINATIONS OF WHETHER THE ‘‘(5) FORM OF REPORT; PUBLIC AVAIL- SEC. 401. IMPOSITION OF SANCTIONS WITH RE- ABILITY.— NATIONAL IRANIAN OIL COMPANY SPECT TO THE TRANSFER OF GOODS ‘‘(A) FORM.—The list required by paragraph AND THE NATIONAL IRANIAN TANK- OR TECHNOLOGIES TO IRAN THAT ER COMPANY ARE AGENTS OR AF- ARE LIKELY TO BE USED TO COMMIT (1) shall be submitted in unclassified form FILIATES OF IRAN’S REVOLU- HUMAN RIGHTS ABUSES. but may contain a classified annex. TIONARY GUARD CORPS. (a) IN GENERAL.—The Comprehensive Iran ‘‘(B) PUBLIC AVAILABILITY.—The unclassi- (a) IN GENERAL.—Section 104(c) of the Com- Sanctions, Accountability, and Divestment fied portion of the list required by paragraph prehensive Iran Sanctions, Accountability, Act of 2010 (22 U.S.C. 8501 et seq.) is amended (1) shall be made available to the public and and Divestment Act of 2010 (22 U.S.C. 8513(c)) by inserting after section 105 the following: posted on the websites of the Department of is amended by adding at the end the fol- the Treasury and the Department of State. lowing: ‘‘SEC. 105A. IMPOSITION OF SANCTIONS WITH RE- SPECT TO THE TRANSFER OF GOODS ‘‘(c) APPLICATION OF SANCTIONS.— ‘‘(4) DETERMINATIONS REGARDING NIOC AND OR TECHNOLOGIES TO IRAN THAT ‘‘(1) IN GENERAL.—Subject to paragraph (2), NITC.— ARE LIKELY TO BE USED TO COMMIT the President shall impose sanctions de- ‘‘(A) DETERMINATIONS.—For purposes of HUMAN RIGHTS ABUSES. scribed in section 105(c) with respect to a paragraph (2)(E)(i), the Secretary of the ‘‘(a) IN GENERAL.—The President shall im- person on the list required by subsection (b). Treasury shall, not later than 60 days after pose sanctions in accordance with subsection ‘‘(2) TRANSFERS TO IRAN’S REVOLUTIONARY the date of the enactment of the Iran Sanc- (c) with respect to each person on the list re- GUARD CORPS.—In the case of a person on the tions, Accountability, and Human Rights quired by subsection (b). list required by subsection (b) for transfer- Act of 2012— ‘‘(b) LIST.— ring, or facilitating the transfer of, goods or ‘‘(i) determine whether the NIOC or the ‘‘(1) IN GENERAL.—Not later than 90 days technologies described in subsection (b)(2)(C) NITC is an agent or affiliate of Iran’s Revo- after the date of the enactment of the Iran to Iran’s Revolutionary Guard Corps, or pro- lutionary Guard Corps; and Sanctions, Accountability, and Human viding services with respect to such goods or ‘‘(ii) submit to the appropriate congres- Rights Act of 2012, the President shall sub- technologies after such goods or tech- sional committees a report on the deter- mit to the appropriate congressional com- nologies are transferred to Iran’s Revolu- minations made under clause (i), together mittees a list of persons that the President tionary Guard Corps, the President shall— with the reasons for those determinations. determines have knowingly engaged in an ‘‘(A) impose sanctions described in section ‘‘(B) FORM OF REPORT.—A report submitted activity described in paragraph (2) on or 105(c) with respect to the person; and under subparagraph (A)(ii) shall be sub- after such date of enactment. ‘‘(B) impose such other sanctions from mitted in unclassified form but may contain ‘‘(2) ACTIVITY DESCRIBED.— among the sanctions described in section 6(a) a classified annex. ‘‘(A) IN GENERAL.—A person engages in an of the Iran Sanctions Act of 1996 (Public Law ‘‘(C) APPLICABILITY WITH RESPECT TO PETRO- activity described in this paragraph if the 104–172; 50 U.S.C. 1701 note) as the President LEUM TRANSACTIONS.— person— determines appropriate.’’. ‘‘(i) APPLICATION OF SANCTIONS.—Except as ‘‘(i) transfers, or facilitates the transfer of, (b) CLERICAL AMENDMENT.—The table of provided in clause (ii), the regulations pre- goods or technologies described in subpara- contents for the Comprehensive Iran Sanc- scribed under paragraph (1) shall apply to a graph (C) to Iran; or tions, Accountability, and Divestment Act of transaction for the purchase of petroleum or ‘‘(ii) provides services with respect to 2010 is amended by inserting after the item petroleum products from, or to financial goods or technologies described in subpara- relating to section 105 the following: services relating to such a transaction for, graph (C) after such goods or technologies ‘‘Sec. 105A. Imposition of sanctions with re- the NIOC or the NITC on or after the date are transferred to Iran. spect to the transfer of goods or that is 180 days after the date of the enact- ‘‘(B) APPLICABILITY TO CONTRACTS AND technologies to Iran that are ment of the National Defense Authorization OTHER AGREEMENTS.—A person engages in an likely to be used to commit Act for Fiscal Year 2012 (Public Law 112–81) activity described in subparagraph (A) with- human rights abuses.’’. only if the President has determined, pursu- out regard to whether the activity is carried SEC. 402. IMPOSITION OF SANCTIONS WITH RE- ant to section 1245(d)(4)(B) of that Act, that out pursuant to a contract or other agree- SPECT TO PERSONS WHO ENGAGE IN there is a sufficient supply of petroleum and ment entered into before, on, or after the CENSORSHIP OR OTHER RELATED petroleum products produced in countries date of the enactment of the Iran Sanctions, ACTIVITIES AGAINST CITIZENS OF other than Iran to permit purchasers of pe- Accountability, and Human Rights Act of IRAN. troleum and petroleum products from Iran to 2012. (a) IN GENERAL.—The Comprehensive Iran Sanctions, Accountability, and Divestment reduce significantly in volume their pur- ‘‘(C) GOODS OR TECHNOLOGIES DESCRIBED.— Act of 2010 (22 U.S.C. 8501 et seq.), as amend- chases from Iran. Goods or technologies described in this sub- ed by section 401, is further amended by in- ‘‘(ii) EXCEPTION FOR CERTAIN COUNTRIES.— paragraph are goods or technologies that the serting after section 105A the following: The regulations prescribed under paragraph President determines are likely to be used by (1) shall not apply to a foreign financial in- the Government of Iran or any of its agen- ‘‘SEC. 105B. IMPOSITION OF SANCTIONS WITH RE- SPECT TO PERSONS WHO ENGAGE IN stitution that facilitates a significant trans- cies or instrumentalities to commit serious CENSORSHIP OR OTHER RELATED action or transactions for the purchase of pe- human rights abuses against the people of ACTIVITIES AGAINST CITIZENS OF troleum or petroleum products from, or that Iran, including— IRAN. provides significant financial services relat- ‘‘(i) firearms or ammunition (as those ‘‘(a) IN GENERAL.—The President shall im- ing to such a transaction for, the NIOC or terms are defined in section 921 of title 18, pose sanctions described in section 105(c)

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00085 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.044 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3380 CONGRESSIONAL RECORD — SENATE May 21, 2012 with respect to each person on the list re- including section 501.801 of title 31, Code of (10) expand worldwide United States em- quired by subsection (b). Federal Regulations (commonly known as bassy and consulate programming for and ‘‘(b) LIST OF PERSONS WHO ENGAGE IN CEN- the Reporting, Procedures and Penalties outreach to Iranian dissident communities. SORSHIP.— Regulations). Applicants must fully disclose SEC. 413. SENSE OF CONGRESS ON POLITICAL ‘‘(1) IN GENERAL.—Not later than 90 days the parties to the transactions as well as de- PRISONERS. after the date of the enactment of the Iran scribe the activities to be undertaken. Li- It is the sense of Congress that— Sanctions, Accountability, and Human cense applications involving the exportation (1) the Secretary of State should support Rights Act of 2012, the President shall sub- or reexportation of goods, technology, or efforts to research and identify prisoners of mit to the appropriate congressional com- software to Iran must provide a copy of an conscience and cases of human rights abuses mittees a list of persons that the President official Commodity Classification issued by in Iran; determines have engaged in censorship or the Department of Commerce, Bureau of In- (2) the United States Government should— other activities that prohibit, limit, or pe- dustry and Security, as part of the license (A) offer refugee status or political asylum nalize the exercise of freedom of expression application. in the United States to political dissidents in or assembly by citizens of Iran. (c) FOREIGN POLICY REVIEW.—The Depart- Iran if requested and consistent with the ‘‘(2) APPLICABILITY.—Paragraph (1) applies ment of State shall complete a foreign policy laws and national security interests of the with respect to censorship or other activities review of a request for authorization under United States; and described in that paragraph that are— subsection (a) not later than 30 days after (B) offer to assist, through the United Na- ‘‘(A) commenced on or after the date of the the request is referred to the Department by tions High Commissioner for Refugees, with enactment of the Iran Sanctions, Account- the Office of Foreign Assets Control. the relocation of such political prisoners to (d) LICENSE DETERMINATIONS.—License de- ability, and Human Rights Act of 2012; or other countries if requested, as appropriate terminations for complete requests for au- ‘‘(B) commenced before such date of enact- and with appropriate consideration for thorization under subsection (a) shall be ment, if such activities continue on or after United States national security interests; made not later than 90 days after receipt by such date of enactment. and the Office of Foreign Assets Control, with ‘‘(3) UPDATES OF LIST.—The President shall (3) the Secretary of State should publicly the following exceptions: submit to the appropriate congressional call for the release of Iranian dissidents by (1) Any requests involving the exportation committees an updated list under paragraph name and raise awareness with respect to in- or reexportation to Iran of goods, tech- (1)— dividual cases of Iranian dissidents and pris- nology, or software listed on the Commerce ‘‘(A) each time the President is required to oners of conscience, as appropriate and if re- Control List maintained pursuant to part 774 submit an updated list to those committees quested by the dissidents or prisoners them- of the Export Administration Regulations under section 105(b)(2)(A); and selves or their families. shall be processed in a manner consistent ‘‘(B) as new information becomes avail- TITLE V—MISCELLANEOUS able. with the Iran-Iraq Arms Non-Proliferation Act of 1992 (title XVI of Public Law 102–484) SEC. 501. EXCLUSION OF CITIZENS OF IRAN SEEK- ‘‘(4) FORM OF REPORT; PUBLIC AVAIL- and other applicable provisions of law. ING EDUCATION RELATING TO THE ABILITY.— (2) Any other requests presenting novel or NUCLEAR AND ENERGY SECTORS OF ‘‘(A) FORM.—The list required by paragraph IRAN. (1) shall be submitted in unclassified form extraordinary circumstances. (e) REGULATIONS.—The Secretary of the (a) IN GENERAL.—The Secretary of State but may contain a classified annex. Treasury may prescribe such regulations as shall deny a visa to, and the Secretary of ‘‘(B) PUBLIC AVAILABILITY.—The unclassi- are appropriate to carry out this section. Homeland Security shall exclude from the fied portion of the list required by paragraph United States, any alien who is a citizen of (1) shall be made available to the public and SEC. 412. COMPREHENSIVE STRATEGY TO PRO- MOTE INTERNET FREEDOM AND AC- Iran that the Secretary of State determines posted on the websites of the Department of CESS TO INFORMATION IN IRAN. seeks to enter the United States to partici- the Treasury and the Department of State.’’. Not later than 90 days after the date of the pate in coursework at an institution of high- (b) CLERICAL AMENDMENT.—The table of enactment of this Act, the President shall er education (as defined in section 101(a) of contents for the Comprehensive Iran Sanc- submit to the appropriate congressional the Higher Education Act of 1965 (20 U.S.C. tions, Accountability, and Divestment Act of committees a comprehensive strategy devel- 1001(a))) to prepare the alien for a career in 2010, as amended by section 401, is further oped in consultation with the Department of the energy sector of Iran or in nuclear amended by inserting after the item relating State, the Department of the Treasury, and science or nuclear engineering or a related to section 105A the following: other Federal agencies, as appropriate, to— field in Iran. ‘‘Sec. 105B. Imposition of sanctions with re- (1) assist the people of Iran to produce, ac- (b) APPLICABILITY.—Subsection (a) applies spect to persons who engage in cess, and share information freely and safely with respect to visa applications filed on or censorship or other related ac- via the Internet, including in Farsi and re- after the date of the enactment of this Act. tivities against citizens of gional languages; SEC. 502. TECHNICAL CORRECTION. Iran.’’. (2) support the development of counter- (a) IN GENERAL.—Section 1245(d)(2) of the (c) CONFORMING AMENDMENTS.—Section censorship technologies that enable the citi- National Defense Authorization Act for Fis- 401(b)(1) of the Comprehensive Iran Sanc- zens of Iran to undertake Internet activities cal Year 2012 (Public Law 112–81) is amend- tions, Accountability, and Divestment Act of without interference from the Government ed— 2010 (22 U.S.C. 8551(b)(1)) is amended— of Iran; (1) in the paragraph heading, by inserting (1) by inserting ‘‘, 105A(a), or 105B(a)’’ after (3) increase the capabilities and avail- ‘‘AGRICULTURAL COMMODITIES,’’ after ‘‘SALES ‘‘105(a)’’; and ability of secure communications through OF’’; and (2) by inserting ‘‘, 105A(b), or 105B(b)’’ after connective technology among human rights (2) in the text, by inserting ‘‘agricultural ‘‘105(b)’’. and democracy activists in Iran; commodities,’’ after ‘‘sale of’’. Subtitle B—Additional Measures to Promote (4) provide resources for digital safety (b) EFFECTIVE DATE.—The amendments Human Rights in Iran training for media and academic and civil so- made by subsection (a) shall take effect as if ciety organizations in Iran; included in the National Defense Authoriza- SEC. 411. EXPEDITED CONSIDERATION OF RE- QUESTS FOR AUTHORIZATION OF (5) provide accurate and substantive Inter- tion Act for Fiscal Year 2012 (Public Law CERTAIN HUMAN RIGHTS-, HUMANI- net content in local languages in Iran; 112–81). TARIAN-, AND DEMOCRACY-RELATED (6) increase emergency resources for the SEC. 503. INTERESTS IN FINANCIAL ASSETS OF ACTIVITIES WITH RESPECT TO IRAN. most vulnerable human rights advocates IRAN. (a) REQUIREMENT.—The Office of Foreign seeking to organize, share information, and (a) INTERESTS IN BLOCKED ASSETS.—Not- Assets Control, in consultation with the De- support human rights in Iran; withstanding any other provision of law, and partment of State, shall establish an expe- (7) expand surrogate radio, television, live preempting any inconsistent provision of dited process for the consideration of com- stream, and social network communications State law, the property interest of Iran in a plete requests for authorization to engage in inside Iran, including Voice of America’s blocked asset shall include an interest in human rights-, humanitarian-, or democ- Persian News Network and Radio Free Eu- property of any nature whatsoever, direct or racy-related activities relating to Iran that rope/Radio Liberty’s Radio Farda, to provide indirect, including any direct or indirect in- are submitted by— hourly live news update programming and terest in securities or other financial assets (1) entities receiving funds from the De- breaking news coverage capability 24 hours a immobilized or in any other manner held in partment of State to engage in the proposed day and 7 days a week; book entry form and credited to a securities activity; (8) expand activities to safely assist and account in the United States and the pro- (2) the Broadcasting Board of Governors; train human rights, civil society, and democ- ceeds thereof, or in any funds transfers held and racy activists in Iran to operate effectively in a United States financial institution. The (3) other appropriate agencies of the and securely; property interest of Iran in securities or United States Government. (9) identify and utilize all available re- other financial assets immobilized or in any (b) PROCEDURES.—Requests for authoriza- sources to overcome attempts by the Gov- other manner held in book entry form and tion under subsection (a) shall be submitted ernment of Iran to jam or otherwise deny credited to a securities account in the to the Office of Foreign Assets Control in international satellite broadcasting signals; United States and proceeds thereof shall be conformance with the agency’s regulations, and deemed to exist at every tier of securities

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00086 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.044 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3381 intermediary necessary to hold an interest (ii) is property subject to the Vienna Con- that violates, attempts to violate, conspires in any such securities or other financial as- vention on Diplomatic Relations or the Vi- to violate, or causes a violation of a provi- sets. The property interest of Iran in a funds enna Convention on Consular Relations, or sion specified in paragraph (2) of this sub- transfer shall exist at any intermediary that enjoys equivalent privileges and immu- section, or an order or regulation prescribed bank necessary to complete such funds nities under the laws of the United States, under such a provision, to the same extent transfer. and is being used exclusively for diplomatic that such penalties apply to a person that (b) PROPERTY IN THE UNITED STATES OF or consular purposes. commits an unlawful act described in section IRAN.—Notwithstanding any other provision (2) CLEARING CORPORATION.—The term 206(a) of that Act. of law, and preempting any inconsistent pro- ‘‘clearing corporation’’ means— (2) PROVISIONS SPECIFIED.—The provisions vision of State law, the property, including (A) a clearing agency (as defined in section specified in this paragraph are the following: any interest in the property, of Iran shall be 3(a)(23) of the Securities Exchange Act of (A) Sections 211 and 216, subtitle A of title deemed to be property in the United States 1934 (15 U.S.C. 78c(a)(23))); III, and title VII of this Act. of Iran if— (B) a Federal reserve bank; or (B) Sections 105A and 105B of the Com- (1) that property is an interest, held di- (C) any other person that provides clear- prehensive Iran Sanctions, Accountability, rectly or indirectly for the benefit of Iran or ance or settlement services with respect to and Divestment Act of 2010, as added by sub- for the benefit of any securities inter- financial assets that would require it to reg- title A of title IV of this Act. mediary that directly or indirectly holds the ister as a clearing agency under the Federal SEC. 602. APPLICABILITY TO CERTAIN INTEL- interest for the benefit of Iran, in securities securities laws but for an exclusion or ex- LIGENCE ACTIVITIES. or other financial assets that are represented emption from the registration requirement Nothing in this Act or the amendments by certificates or are in other physical form under section 3(a)(23)(B) of the Securities Ex- made by this Act shall apply to the author- and are immobilized, custodized, or held for change Act of 1934, if its activities as a clear- ized intelligence activities of the United safekeeping or any other reason in the ing corporation, including promulgation of States. United States; or rules, are subject to regulation by a Federal SEC. 603. TERMINATION. (2) that property is an interest in securi- or State governmental authority. The provisions of sections 211, 213, 215, 216, ties or other financial assets held in book (3) FINANCIAL ASSET; SECURITY.—The terms 217, and 501, title I, and subtitle A of title III entry form or otherwise, and credited to a ‘‘financial asset’’ and ‘‘security’’ have the shall terminate on the date that is 30 days securities account in the United States by meanings given those terms in the Uniform after the date on which the President makes any securities intermediary directly or indi- Commercial Code. the certification described in section 401(a) rectly for the benefit of Iran or for the ben- (4) IRAN.—The term ‘‘Iran’’ means the Gov- of the Comprehensive Iran Sanctions, Ac- efit of any other securities intermediary ernment of Iran, including the central bank countability, and Divestment Act of 2010 (22 that directly or indirectly holds the interest or monetary authority of that Government U.S.C. 8551(a)). for the benefit of Iran. and any agency or instrumentality of that TITLE VII—SANCTIONS WITH RESPECT TO (c) DETERMINATION OF WHETHER SECURITIES Government. HUMAN RIGHTS ABUSES IN SYRIA OR OTHER ASSETS ARE HELD OR CREDITED TO (5) PROPERTY SUBJECT TO THE VIENNA CON- SEC. 701. SHORT TITLE. A SECURITIES ACCOUNT IN THE UNITED VENTION ON DIPLOMATIC RELATIONS OR THE VI- This title may be cited as the ‘‘Syria STATES.—For purposes of this section, an in- ENNA CONVENTION ON CONSULAR RELATIONS.— Human Rights Accountability Act of 2012’’. terest in securities or other financial assets The term ‘‘property subject to the Vienna is held and credited to a securities account SEC. 702. IMPOSITION OF SANCTIONS WITH RE- Convention on Diplomatic Relations or the SPECT TO CERTAIN PERSONS WHO in the United States by a securities inter- Vienna Convention on Consular Relations’’ ARE RESPONSIBLE FOR OR mediary if the securities intermediary is lo- means any property the attachment in aid of COMPLICIT IN HUMAN RIGHTS cated in the United States. A securities execution or execution of which would result ABUSES COMMITTED AGAINST CITI- intermediary is conclusively presumed to be ZENS OF SYRIA OR THEIR FAMILY in a violation of an obligation of the United located in the United States if it is regulated MEMBERS. States under the Vienna Convention on Dip- in its capacity as a securities intermediary (a) IN GENERAL.—The President shall im- lomatic Relations, done at Vienna April 18, under the laws of the United States. pose sanctions described in subsection (c) 1961, or the Convention on Consular Rela- (d) COMMERCIAL ACTIVITY IN THE UNITED with respect to each person on the list re- tions, done at Vienna April 24, 1963. STATES.—Notwithstanding any other provi- quired by subsection (b). (6) SECURITIES INTERMEDIARY.—The term sion of law, the ownership by Iran, or its cen- (b) LIST OF PERSONS WHO ARE RESPONSIBLE ‘‘securities intermediary’’ means— tral bank or monetary authority, of any FOR OR COMPLICIT IN CERTAIN HUMAN RIGHTS (A) a clearing corporation; or property, including the interest in property ABUSES.— (B) a person, including a bank or broker, described in paragraphs (1) and (2) of sub- (1) IN GENERAL.—Not later than 90 days that in the ordinary course of its business section (b), or any other interest in property, after the date of the enactment of this Act, maintains securities accounts for others and shall be deemed to be commercial activity in the President shall submit to the appro- is acting in that capacity. the United States and that property, includ- priate congressional committees a list of (7) UNITED STATES.—The terms ‘‘United ing any interest in that property, shall be persons who are officials of the Government States’’ includes all territory and waters, deemed not to be held for the central bank’s of Syria or persons acting on behalf of that continental or insular, subject to the juris- or monetary authority’s own account. Government that the President determines, (e) APPLICABILITY.—This section applies to diction of the United States. based on credible evidence, are responsible all attachments and proceedings in aid of SEC. 504. REPORT ON MEMBERSHIP OF IRAN IN for or complicit in, or responsible for order- execution issued or obtained before, on, or INTERNATIONAL ORGANIZATIONS. ing, controlling, or otherwise directing, the after the date of the enactment of this Act Not later than 180 days after the date of commission of serious human rights abuses with respect to judgments entered against the enactment of this Act, and annually against citizens of Syria or their family Iran for damages for personal injury or death thereafter not later than September 1, the members, regardless of whether such abuses caused by an act of torture, extrajudicial Secretary of State shall submit to Congress occurred in Syria. killing, aircraft sabotage, or hostage-taking, a report listing the international organiza- (2) UPDATES OF LIST.—The President shall or the provision of material support or re- tions of which Iran is a member and detail- submit to the appropriate congressional sources for such an act. ing the amount that the United States con- committees an updated list under paragraph (f) DEFINITIONS.—In this section: tributes to each such organization on an an- (1)— (1) BLOCKED ASSET.—The term ‘‘blocked nual basis. (A) not later than 270 days after the date of asset’’— TITLE VI—GENERAL PROVISIONS the enactment of this Act and every 180 days (A) means any asset seized or frozen by the SEC. 601. TECHNICAL IMPLEMENTATION; PEN- thereafter; and United States under section 5(b) of the Trad- ALTIES. (B) as new information becomes available. ing With the Enemy Act (50 U.S.C. App. 5(b)) (a) IMPLEMENTATION.—The President may (3) FORM OF REPORT; PUBLIC AVAILABILITY.— or under section 202 or 203 of the Inter- exercise all authorities provided under sec- (A) FORM.—The list required by paragraph national Emergency Economic Powers Act tions 203 and 205 of the International Emer- (1) shall be submitted in unclassified form (50 U.S.C. 1701 and 1702); and gency Economic Powers Act (50 U.S.C. 1702 but may contain a classified annex. (B) does not include property that— and 1704) to carry out— (B) PUBLIC AVAILABILITY.—The unclassified (i) is subject to a license issued by the (1) sections 211, 213, and 216, subtitle A of portion of the list required by paragraph (1) United States Government for final pay- title III, and title VII of this Act; and shall be made available to the public and ment, transfer, or disposition by or to a per- (2) sections 105A and 105B of the Com- posted on the websites of the Department of son subject to the jurisdiction of the United prehensive Iran Sanctions, Accountability, the Treasury and the Department of State. States in connection with a transaction for and Divestment Act of 2010, as added by sub- (4) CONSIDERATION OF DATA FROM OTHER which the issuance of the license has been title A of title IV of this Act. COUNTRIES AND NONGOVERNMENTAL ORGANIZA- specifically required by a provision of law (b) PENALTIES.— TIONS.—In preparing the list required by other than the International Emergency (1) IN GENERAL.—The penalties provided for paragraph (1), the President shall consider Economic Powers Act (50 U.S.C. 1701 et seq.) in subsections (b) and (c) of section 206 of the credible data already obtained by other or the United Nations Participation Act of International Emergency Economic Powers countries and nongovernmental organiza- 1945 (22 U.S.C. 287 et seq.); or Act (50 U.S.C. 1705) shall apply to a person tions, including organizations in Syria, that

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00087 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.044 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3382 CONGRESSIONAL RECORD — SENATE May 21, 2012 monitor the human rights abuses of the Gov- (I) to restrict the free flow of unbiased in- (1) determines that such a waiver is in the ernment of Syria. formation in Syria; or national security interests of the United (c) SANCTIONS DESCRIBED.—The sanctions (II) to disrupt, monitor, or otherwise re- States; and described in this subsection are sanctions strict speech of the people of Syria. (2) submits to the appropriate congres- pursuant to the International Emergency (ii) EXCEPTION.—The term ‘‘sensitive tech- sional committees a report on the reasons Economic Powers Act (50 U.S.C. 1701 et seq.), nology’’ does not include information or in- for that determination. including blocking of property and restric- formational materials the exportation of SEC. 706. TERMINATION. tions or prohibitions on financial trans- which the President does not have the au- actions and the exportation and importation thority to regulate or prohibit pursuant to (a) IN GENERAL.—The provisions of this of property, subject to such regulations as section 203(b)(3) of the International Emer- title and any sanctions imposed pursuant to the President may prescribe. gency Economic Powers Act (50 U.S.C. this title shall terminate on the date on SEC. 703. IMPOSITION OF SANCTIONS WITH RE- 1702(b)(3)). which the President submits to the appro- SPECT TO THE TRANSFER OF GOODS (3) SPECIAL RULE TO ALLOW FOR TERMI- priate congressional committees— OR TECHNOLOGIES TO SYRIA THAT NATION OF SANCTIONABLE ACTIVITY.—The (1) the certification described in subsection ARE LIKELY TO BE USED TO COMMIT (b); and HUMAN RIGHTS ABUSES. President shall not be required to include a (2) a certification that— (a) IN GENERAL.—The President shall im- person on the list required by paragraph (1) pose sanctions described in section 702(c) if the President certifies in writing to the (A) the Government of Syria is democrat- with respect to— appropriate congressional committees that— ically elected and representative of the peo- (1) each person on the list required by sub- (A) the person is no longer engaging in, or ple of Syria; or section (b); and has taken significant verifiable steps toward (B) a legitimate transitional government (2) any person that— stopping, the activity described in paragraph of Syria is in place. (A) is a successor entity to a person on the (2) for which the President would otherwise (b) CERTIFICATION DESCRIBED.—A certifi- list; have included the person on the list; and cation described in this subsection is a cer- (B) owns or controls a person on the list, if (B) the President has received reliable as- tification by the President that the Govern- the person that owns or controls the person surances that the person will not knowingly ment of Syria— on the list had actual knowledge or should engage in any activity described in para- (1) has unconditionally released all polit- have known that the person on the list en- graph (2) in the future. ical prisoners; gaged in the activity described in subsection (4) UPDATES OF LIST.—The President shall (2) has ceased its practices of violence, un- (b)(2) for which the person was included in submit to the appropriate congressional lawful detention, torture, and abuse of citi- the list; or committees an updated list under paragraph zens of Syria engaged in peaceful political (C) is owned or controlled by, or under (1)— activity; common ownership or control with, the per- (A) not later than 270 days after the date of (3) has ceased its practice of procuring sen- son on the list, if the person owned or con- the enactment of this Act and every 180 days sitive technology designed to restrict the trolled by, or under common ownership or thereafter; and free flow of unbiased information in Syria, or control with (as the case may be), the person (B) as new information becomes available. to disrupt, monitor, or otherwise restrict the on the list knowingly engaged in the activity (5) FORM OF REPORT; PUBLIC AVAILABILITY.— right of citizens of Syria to freedom of ex- described in subsection (b)(2) for which the (A) FORM.—The list required by paragraph pression; person was included in the list. (1) shall be submitted in unclassified form (4) has ceased providing support for foreign (b) LIST.— but may contain a classified annex. terrorist organizations and no longer allows (1) IN GENERAL.—Not later than 90 days (B) PUBLIC AVAILABILITY.—The unclassified such organizations, including Hamas, after the date of the enactment of this Act, portion of the list required by paragraph (1) Hezbollah, and Palestinian Islamic Jihad, to the President shall submit to the appro- shall be made available to the public and maintain facilities in territory under the priate congressional committees a list of posted on the websites of the Department of control of the Government of Syria; and persons that the President determines have the Treasury and the Department of State. (5) has ceased the development and deploy- knowingly engaged in an activity described SEC. 704. IMPOSITION OF SANCTIONS WITH RE- ment of medium- and long-range surface-to- in paragraph (2) on or after such date of en- SPECT TO PERSONS WHO ENGAGE IN surface ballistic missiles; actment. CENSORSHIP OR OTHER FORMS OF (6) is not pursuing or engaged in the re- (2) ACTIVITY DESCRIBED.— REPRESSION IN SYRIA. search, development, acquisition, produc- (A) IN GENERAL.—A person engages in an (a) IN GENERAL.—The President shall im- tion, transfer, or deployment of biological, activity described in this paragraph if the pose sanctions described in section 702(c) chemical, or nuclear weapons, and has pro- person— with respect to each person on the list re- vided credible assurances that it will not en- (i) transfers, or facilitates the transfer of, quired by subsection (b). gage in such activities in the future; and goods or technologies described in subpara- (b) LIST OF PERSONS WHO ENGAGE IN CEN- (7) has agreed to allow the United Nations graph (C) to Syria; or SORSHIP.— and other international observers to verify (ii) provides services with respect to goods (1) IN GENERAL.—Not later than 90 days that the Government of Syria is not engag- or technologies described in subparagraph after the date of the enactment of this Act, ing in such activities and to assess the credi- (C) after such goods or technologies are the President shall submit to the appro- bility of the assurances provided by that transferred to Syria. priate congressional committees a list of Government. (B) APPLICABILITY TO CONTRACTS AND OTHER persons that the President determines have (c) SUSPENSION OF SANCTIONS AFTER ELEC- AGREEMENTS.—A person engages in an activ- engaged in censorship, or activities relating TION OF DEMOCRATIC GOVERNMENT.—If the ity described in subparagraph (A) without re- to censorship, in a manner that prohibits, President submits to the appropriate con- gard to whether the activity is carried out limits, or penalizes the legitimate exercise of gressional committees the certification de- pursuant to a contract or other agreement freedom of expression by citizens of Syria. scribed in subsection (a)(2), the President entered into before, on, or after the date of (2) UPDATES OF LIST.—The President shall may suspend the provisions of this title and the enactment of this Act. submit to the appropriate congressional any sanctions imposed under this title for (C) GOODS OR TECHNOLOGIES DESCRIBED.— committees an updated list under paragraph not more than one year to allow time for a Goods or technologies described in this sub- (1)— certification described in subsection (b) to be paragraph are goods or technologies that the (A) not later than 270 days after the date of submitted. President determines are likely to be used by the enactment of this Act and every 180 days the Government of Syria or any of its agen- thereafter; and cies or instrumentalities to commit human (B) as new information becomes available. SA 2124. Mr. REID (for Mr. JOHNSON rights abuses against the people of Syria, in- (3) FORM OF REPORT; PUBLIC AVAILABILITY.— of South Dakota (for himself and Mr. cluding— (A) FORM.—The list required by paragraph SHELBY)) proposed an amendment to (i) firearms or ammunition (as those terms (1) shall be submitted in unclassified form amendment SA 2123 proposed by Mr. are defined in section 921 of title 18, United but may contain a classified annex. REID (for Mr. JOHNSON of South Dakota States Code), rubber bullets, police batons, (B) PUBLIC AVAILABILITY.—The unclassified pepper or chemical sprays, stun grenades, (for himself and Mr. SHELBY)) to the portion of the list required by paragraph (1) bill H.R. 1905, to strengthen Iran sanc- electroshock weapons, tear gas, water can- shall be made available to the public and nons, or surveillance technology; or posted on the websites of the Department of tions laws for the purpose of compel- (ii) sensitive technology. the Treasury and the Department of State. ling Iran to abandon its pursuit of nu- (D) SENSITIVE TECHNOLOGY DEFINED.— clear weapons and other threatening SEC. 705. WAIVER. (i) IN GENERAL.—For purposes of subpara- activities, and for other purposes; as graph (C), the term ‘‘sensitive technology’’ The President may waive the requirement follows: means hardware, software, telecommuni- to include a person on a list required by sec- cations equipment, or any other technology, tion 702, 703, or 704 or to impose sanctions Beginning on page 7, strike line 18, and all that the President determines is to be used pursuant to any such section if the Presi- that follows through page 8, line 8, and insert specifically— dent— the following:

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SEC. 102. SENSE OF CONGRESS ON ENFORCE- (c) RESTRICTIONS ON VISAS AND ADJUST- Iran or a financial institution described in MENT OF MULTILATERAL SANC- MENTS IN IMMIGRATION STATUS.—Except as section 104(c)(2)(E)(ii) of the Comprehensive TIONS REGIME AND EXPANSION AND provided in subsection (d), the Secretary of Iran Sanctions, Accountability, and Divest- IMPLEMENTATION OF SANCTIONS LAWS. State and the Secretary of Homeland Secu- ment Act of 2010 (22 U.S.C. 8513(c)(2)(E)(ii)) It is the sense of Congress that the goal of rity may not grant an individual on the list includes doing so by serving as an inter- compelling Iran to abandon efforts to ac- required by subsection (a) immigration sta- mediary financial institution with access to quire a nuclear weapons capability and other tus in, or admit the individual to, the United such messaging services. threatening activities can be effectively States. (3) FORM OF REPORT.—A report submitted achieved through a comprehensive policy (d) EXCEPTION TO COMPLY WITH UNITED NA- under paragraph (1) shall be submitted in un- that includes economic sanctions, diplo- TIONS HEADQUARTERS AGREEMENT.—Sub- classified form but may contain a classified macy, and military planning, capabilities section (c) shall not apply to an individual if annex. and options, and that this objective is con- admitting the individual to the United (c) AUTHORIZATION OF THE IMPOSITION OF sistent with the one stated by President States is necessary to permit the United SANCTIONS.— Barack Obama in the 2012 State of the Union States to comply with the Agreement be- (1) IN GENERAL.—Except as provided in Address: ‘‘Let there be no doubt: America is tween the United Nations and the United paragraph (2), if, on or after the date that is determined to prevent Iran from getting a States of America regarding the Head- 90 days after the date of the enactment of nuclear weapon, and I will take no options quarters of the United Nations, signed June this Act, a person continues to knowingly off the table to achieve that goal’’. Among 26, 1947, and entered into force November 21, and directly provide specialized financial these economic sanctions are— 1947. messaging services to, or knowingly enable (1) prompt enforcement of the current mul- (e) WAIVER.—The President may waive the or facilitate direct or indirect access to such tilateral sanctions regime with respect to application of subsection (a) or (c) with re- messaging services for, the Central Bank of Iran; spect to an individual if the President— Iran or a financial institution described in (2) full, timely, and vigorous implementa- (1) determines that such a waiver is in the paragraph (2)(E)(ii) of section 104(c) of the tion of all sanctions enacted into law, in- national interest of the United States; and Comprehensive Iran Sanctions, Account- cluding sanctions imposed or expanded by (2) not less than 7 days before the waiver ability, and Divestment Act of 2010 (22 U.S.C. this Act or amendments made by this Act, takes effect, notifies Congress of the waiver 8513(c)), the President may impose sanctions through— and the reason for the waiver. pursuant to that section or the International (A) intensified monitoring by the President Beginning on page 34, strike line 1 and all Emergency Economic Powers Act (50 U.S.C. and his designees, including the Secretary of that follows through page 37, line 5, and in- 1701 et seq.) with respect to the person. the Treasury and the Secretary of State, sert the following: (2) EXCEPTION.—The President may not im- along with senior officials in the intelligence SEC. 216. REPORTS ON, AND AUTHORIZATION OF pose sanctions pursuant to paragraph (1) community, as appropriate; IMPOSITION OF SANCTIONS WITH with respect to a person for directly pro- (B) more extensive use of extraordinary au- RESPECT TO, THE PROVISION OF viding specialized financial messaging serv- thorities provided for under the Inter- SPECIALIZED FINANCIAL MES- ices to, or enabling or facilitating direct or national Emergency Economic Powers Act SAGING SERVICES TO THE CENTRAL indirect access to such messaging services BANK OF IRAN AND OTHER SANC- (50 U.S.C. 1701 et seq.) and other sanctions for, the Central Bank of Iran or a financial laws; TIONED IRANIAN FINANCIAL INSTI- TUTIONS. institution described in section (C) reallocation of resources to provide the (a) SENSE OF CONGRESS.—It is the sense of 104(c)(2)(E)(ii) of the Comprehensive Iran personnel necessary, within the Department Congress that— Sanctions, Accountability, and Divestment of the Treasury, the Department of State, (1) providers of specialized financial mes- Act of 2010 (22 U.S.C. 8513(c)(2)(E)(ii)) if— and the Department of Defense, and, where saging services are a critical link to the (A) the person is subject to a sanctions re- appropriate, the intelligence community, to international financial system; gime under its governing foreign law that re- apply and enforce sanctions; and quires it to eliminate the knowing provision (D) expanded cooperation with inter- (2) the European Union is to be commended for strengthening the multilateral sanctions of such messaging services to, and the know- national sanctions enforcement efforts; ing enabling and facilitation of direct or in- (3) urgent consideration of the expansion of regime against Iran by deciding that special- ized financial messaging services may not be direct access to such messaging services existing sanctions with respect to such areas for— as— provided to the Central Bank of Iran and other sanctioned Iranian financial institu- (i) the Central Bank of Iran; and (A) the provision of energy-related services (ii) a group of Iranian financial institu- to Iran; tions by persons subject to the jurisdiction of the European Union; and tions identified under such governing foreign (B) the provision of insurance and reinsur- law for purposes of that sanctions regime if ance services to Iran; (3) the loss of access by sanctioned Iranian financial institutions to specialized financial the President determines that— (C) the provision of shipping services to (I) the group is substantially similar to the Iran; messaging services must be maintained. (b) REPORTS REQUIRED.— group of financial institutions described in (D) those Iranian financial institutions not section 104(c)(2)(E)(ii) of the Comprehensive currently designated for the imposition of (1) IN GENERAL.—Not later than 60 days after the date of the enactment of this Act, Iran Sanctions, Accountability, and Divest- sanctions that may be acting as inter- ment Act of 2010 (22 U.S.C. 8513(c)(2)(E)(ii)); mediaries for Iranian financial institutions and every 90 days thereafter, the Secretary of the Treasury shall submit to the appro- and that are designated for the imposition of (II) the differences between those groups of sanctions; and priate congressional committees a report that contains— financial institutions do not adversely affect (4) a focus on countering Iran’s efforts to the national interest of the United States; evade sanctions, including— (A) a list of all persons that the Secretary has identified that directly provide special- and (A) the activities of telecommunications, (B) the person has, pursuant to that sanc- Internet, and satellite service providers, ized financial messaging services to, or en- able or facilitate direct or indirect access to tions regime, terminated the knowing provi- within and outside of Iran, to ensure that sion of such messaging services to, and the such providers are not participating in or fa- such messaging services for, the Central Bank of Iran or a financial institution de- knowing enabling and facilitation of direct cilitating, directly or indirectly, the evasion or indirect access to such messaging services of the sanctions regime with respect to Iran scribed in section 104(c)(2)(E)(ii) of the Com- prehensive Iran Sanctions, Accountability, for, the Central Bank of Iran and each Ira- or violations of the human rights of the peo- nian financial institution identified under ple of Iran; and Divestment Act of 2010 (22 U.S.C. 8513(c)(2)(E)(ii)); and such governing foreign law for purposes of (B) the activities of financial institutions that sanctions regime. or other businesses or government agencies, (B) a detailed assessment of the status of efforts by the Secretary to end the direct On page 58, between lines 6 and 7, insert within or outside of Iran, not yet designated the following: for the imposition of sanctions; and provision of such messaging services to, and (C) urgent and ongoing evaluation of Iran’s the enabling or facilitation of direct or indi- SEC. 401. FINDINGS. energy, national security, financial, and rect access to such messaging services for, Congress makes the following findings: telecommunications sectors, to gauge the ef- the Central Bank of Iran or a financial insti- (1) The Government of Iran continues to fects of, and possible defects in, particular tution described in section 104(c)(2)(E)(ii) of violate systematically the basic human sanctions, with prompt efforts to correct any the Comprehensive Iran Sanctions, Account- rights of citizens of Iran, including by cut- gaps in the existing sanctions regime with ability, and Divestment Act of 2010 (22 U.S.C. ting off their access to information and tech- respect to Iran. 8513(c)(2)(E)(ii)). nology, suppressing their freedom of expres- On page 30, line 12, insert ‘‘that includes a (2) ENABLING OR FACILITATION OF ACCESS TO sion, and punishing severely, and sometimes disclosure of an activity described in para- SPECIALIZED FINANCIAL MESSAGING SERVICES brutally, their attempts to exercise political graph (1) (other than an activity described in THROUGH INTERMEDIARY FINANCIAL INSTITU- rights. subparagraph (D)(iii) of that paragraph)’’ TIONS.—For purposes of paragraph (1) and (2) In a March 20, 2012, speech celebrating after ‘‘paragraph (4)’’. subsection (c), enabling or facilitating direct Nowruz, the Iranian New Year, President On page 33, strike lines 1 through 20, and or indirect access to specialized financial Barack Obama described censorship of the insert the following: messaging services for the Central Bank of Internet and monitoring of computers and

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00089 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.045 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3384 CONGRESSIONAL RECORD — SENATE May 21, 2012 cell phones by the Government of Iran as de- mit to the appropriate congressional com- Economic Powers Act (50 U.S.C. 1701 et seq.) priving the people of Iran of ‘‘the informa- mittees a list of persons that the President or the United Nations Participation Act of tion they want [and] stopping the free flow determines have, on or after June 12, 2009, 1945 (22 U.S.C. 287 et seq.); or of information and ideas into the country’’. engaged in censorship or other activities (ii) is property subject to the Vienna Con- The President concluded that ‘‘in recent that— vention on Diplomatic Relations or the Vi- weeks, Internet restrictions have become so ‘‘(A) prohibit, limit, or penalize the exer- enna Convention on Consular Relations, or severe that Iranians cannot communicate cise of freedom of expression or assembly by that enjoys equivalent privileges and immu- freely with their loved ones within Iran, or citizens of Iran; or nities under the laws of the United States, beyond its borders, [so that] an electronic ‘‘(B) limit access to print or broadcast and is being used exclusively for diplomatic curtain has fallen around Iran.’’. media, including the facilitation or support or consular purposes. (3) At a time when growing numbers of Ira- of intentional frequency manipulation by the (2) FINANCIAL ASSET; SECURITIES INTER- nians turn to the Internet as a source for Government of Iran that would jam or re- MEDIARY.—The terms ‘‘financial asset’’ and news and political debate, the response of strict an international signal or the failure ‘‘securities intermediary’’ have the mean- the Government of Iran has combined in- to prohibit intentional frequency manipula- ings given those terms in the Uniform Com- creasingly pervasive jamming and filtering tion by the Government of Iran that would mercial Code, but the former includes cash. of the Internet, blocking of email, social net- jam or restrict an international signal by (3) IRAN.—The term ‘‘Iran’’ means the Gov- working and other websites, and interception satellite service providers that provide sat- ernment of Iran, including the central bank of Internet, telephonic, and mail commu- ellite services to the Government of Iran or or monetary authority of that Government nications. an entity owned or controlled by the Govern- and any agency or instrumentality of that (4) The March 2012 Report of the United ment of Iran. Government. Nations Human Rights Council Special On page 64, line 13, strike ‘‘(3)’’ and insert (4) PERSON.— Rapporteur on Iran details the Government ‘‘(2)’’. (A) IN GENERAL.—The term ‘‘person’’ means of Iran’s widespread human rights abuses On page 64, line 21, strike ‘‘(4)’’ and insert an individual or entity. and censorship, its chronic disregard of due ‘‘(3)’’. (B) ENTITY.—The term ‘‘entity’’ means a process, and its equally chronic harassment, Beginning on page 72, strike line 7 and all partnership, association, trust, joint ven- abuse, and intimidation of the people of Iran. that follows through page 78, line 6, and in- ture, corporation, group, subgroup, or other (5) There has been no independent inves- sert the following: organization. tigation into the months of violence that fol- SEC. 503. INTERESTS IN CERTAIN FINANCIAL AS- (5) TERRORIST PARTY.—The term ‘‘terrorist lowed Iran’s fraudulent 2009 presidential SETS OF IRAN. party’’ has the meaning given that term in election, violence that included the beatings (a) INTERESTS IN BLOCKED ASSETS.—Not- section 201(d) of the Terrorism Risk Insur- of scores of Tehran University students by withstanding any other provision of law, in- ance Act of 2002 (28 U.S.C. 1610 note). cluding any provision of law relating to sov- security forces using weapons, such as (6) UNITED STATES.—The term ‘‘United chains, metal rods, and electrified batons, ereign immunity, and preempting any incon- States’’ includes all territory and waters, and the subsequent imprisonment of many sistent provision of State law, a financial continental, or insular, subject to the juris- students, some of whom died in captivity. asset that is— diction of the United States. (6) The Government of Iran has failed to (1) property in the United States of a for- On page 78, between lines 15 and 16, insert cooperate with human rights investigations eign securities intermediary doing business the following: by the Special Rapporteur, and its failure to in the United States, SEC. 505. INCREASED CAPACITY FOR EFFORTS TO cooperate in those and similar investigations (2) a blocked asset (whether or not subse- COMBAT UNLAWFUL OR TERRORIST has been criticized in reports of the United quently unblocked) that is property de- FINANCING. Nations Secretary-General, General Assem- scribed in subsection (b), and (a) AUTHORIZATION OF APPROPRIATIONS FOR bly, and Human Rights Council, even as (3) equal in value to a financial asset of OFFICE OF TERRORISM AND FINANCIAL INTEL- human rights abuses continue. Iran, including an asset of the central bank LIGENCE AND BUREAU OF INDUSTRY AND SECU- or monetary authority of the Government of RITY SEC. 402. SENSE OF CONGRESS. .—Section 109 of the Comprehensive Iran Iran or any agency or instrumentality of Sanctions, Accountability, and Divestment It is the sense of Congress that— that Government, that such foreign securi- Act of 2010 (22 U.S.C. 8517) is amended— (1) the Government of Iran, especially ties intermediary or a related intermediary (1) in subsection (b)(2), by striking ‘‘and Iran’s Revolutionary Guard Corps, continues holds abroad, 2013’’ and inserting ‘‘through 2016’’; and to engage in serious, systematic, and ongo- shall be available for all attachments and (2) in subsection (d)(2), by striking ‘‘and ing violations of human rights and the rise other proceedings in aid of execution, with 2013’’ and inserting ‘‘through 2016’’. in the level of such violations after the 2009 respect to judgments entered against Iran (b) AUTHORIZATION OF APPROPRIATIONS FOR presidential elections has not abated; for damages for personal injury or death FINANCIAL CRIMES ENFORCEMENT NETWORK.— (2) the Government of Iran is engaging in a caused by an act of torture, extrajudicial Section 310(d)(1) of title 31, United States systematic campaign to prevent news, enter- killing, aircraft sabotage, or hostage-taking, Code, is amended by striking ‘‘and 2013’’ and tainment, and opinions from reaching media or the provision of material support or re- inserting ‘‘through 2016’’. that are not subject to government control sources for such an act. On page 80, between lines 5 and 6, insert and to eliminate any free Internet or other (b) PROPERTY DESCRIBED.—Property de- the following: electronic media discussion among the peo- scribed in this subsection is property that is SEC. 603. RULE OF CONSTRUCTION WITH RE- ple of Iran; and identified in and the subject of proceedings SPECT TO USE OF FORCE AGAINST (3) the Government of Iran has refused to in the United States District Court for the IRAN AND SYRIA. cooperate with international organizations, Southern District of New York in Peterson et Nothing in this Act or the amendments including the United Nations, seeking to in- al. v. Islamic Republic of Iran et al., Case No. made by this Act shall be construed as a dec- vestigate or to alleviate those conditions. 10 Civ. 4518 (BSJ) (GWG). laration of war or an authorization of the use On page 58, line 7, strike ‘‘401’’ and insert (c) RULE OF CONSTRUCTION.—Nothing in of force against Iran or Syria. ‘‘403’’. this section shall be construed to affect the On page 80, line 6, strike ‘‘603’’ and insert On page 59, line 12, insert ‘‘, any entity or- availability, or lack thereof, of a right to ‘‘604’’. ganized under the laws of Iran or otherwise satisfy a judgment in any other action subject to the jurisdiction of the Govern- against a terrorist party in any proceedings SA 2125. Mr. CARDIN submitted an ment of Iran, or any national of Iran, for use other than proceedings referred to in sub- amendment intended to be proposed by in or with respect to Iran’’ after ‘‘Iran’’. section (b). him to the bill S. 3187, to amend the On page 59, line 13, insert ‘‘(including serv- (d) DEFINITIONS.—In this section: Federal Food, Drug, and Cosmetic Act ices relating to hardware, software, and spe- (1) BLOCKED ASSET.—The term ‘‘blocked cialized information, and professional con- asset’’— to revise and extend the user-fee pro- sulting, engineering, and support services)’’ (A) means any asset seized or frozen by the grams for prescription drugs and med- after ‘‘services’’. United States under section 5(b) of the Trad- ical devices, to establish user-fee pro- On page 60, line 6, insert ‘‘(or by any other ing With the Enemy Act (50 U.S.C. App. 5(b)) grams for generic drugs and person on behalf of the Government of Iran or under section 202 or 203 of the Inter- biosimilars, and for other purposes; or any of such agencies or instrumental- national Emergency Economic Powers Act which was ordered to lie on the table; ities)’’ after ‘‘instrumentalities’’. (50 U.S.C. 1701 and 1702); and as follows: On page 63, line 1, strike ‘‘402’’ and insert (B) does not include property that— At the end of title XI, add the following: ‘‘404’’. (i) is subject to a license issued by the On page 63, strike line 19 and all that fol- United States Government for final pay- SEC. 11ll. ENSURING ADEQUATE INFORMATION REGARDING PHARMACEUTICALS lows through page 64, line 12, and insert the ment, transfer, or disposition by or to a per- FOR ALL POPULATIONS, PARTICU- following: son subject to the jurisdiction of the United LARLY UNDERREPRESENTED SUB- ‘‘(1) IN GENERAL.—Not later than 90 days States in connection with a transaction for POPULATIONS, INCLUDING RACIAL after the date of the enactment of the Iran which the issuance of the license has been SUBGROUPS. Sanctions, Accountability, and Human specifically required by a provision of law (a) COMMUNICATION PLAN.—The Secretary Rights Act of 2012, the President shall sub- other than the International Emergency of Health and Human Services (referred to in

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00090 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.045 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3385 this section as the ‘‘Secretary’’), acting (1) December 17, 2013, for products subject The PRESIDING OFFICER. Without through the Commissioner of Food and to such rule with annual sales of less than objection, it is so ordered. Drugs, shall review and modify, as necessary, $25,000 and the Food and Drug Administration’s commu- (2) December 17, 2012, for all other products The resolution (S. Res. 468) was nication plan to inform and educate health subject to such rule. agreed to. care providers, patients, and payors on the f benefits and risks of medical products, with The preamble was agreed to. particular focus on underrepresented sub- NOTICE OF HEARING The resolution, with its preamble, populations, including racial subgroups. COMMITTEE ON INDIAN AFFAIRS reads as follows: (b) CONTENT.—The communication plan de- Mr. AKAKA. Mr. President, I would S. RES. 468 scribed under subsection (a)— like to announce that the Committee (1) shall take into account— Whereas a stroke, also known as a cerebro- (A) the goals and principles set forth in the on Indian Affairs will meet on May 24, 2012, in room SD–628 of the Dirksen vascular accident, is an acute neurologic in- Strategic Action Plan to Reduce Racial and jury that occurs when the blood supply to a Ethnic Health Disparities issued by the De- Senate Office Building, at 2:15 p.m., to part of the brain is interrupted by a clot in partment of Health and Human Services; conduct a hearing entitled ‘‘Programs the artery or a burst of the artery; (B) the nature of the medical product; and and Services for Native Veterans.’’ Whereas a stroke is a medical emergency (C) health and disease information avail- Those wishing additional information that can cause permanent neurologic damage able from other agencies within such Depart- may contact the Indian Affairs Com- or even death if not promptly diagnosed and ment, as well as any new means of commu- mittee at (202) 224–2251. nicating health and safety benefits and risks treated; related to medical products; f Whereas stroke occurs in approximately 1 (2) taking into account the nature of the out of every 4,000 live births, and the risk of AUTHORITY FOR COMMITTEES TO stroke from birth through age 18 is nearly 11 medical product, shall address the best strat- MEET egy for communicating safety alerts, labeled out of every 100,000 children per year; indications for the medical products, SUBCOMMITTEE ON OVERSIGHT OF GOVERNMENT Whereas an individual can have a stroke changes to the label or labeling of medical MANAGEMENT, THE FEDERAL WORKFORCE, before birth; products (including black box warnings, AND THE DISTRICT OF COLUMBIA Whereas stroke is among the top 10 causes health advisories, health and safety benefits Ms. LANDRIEU. Mr. President, I ask of death for children in the United States; and risks), particular actions to be taken by unanimous consent that the Com- Whereas between 20 percent and 40 percent healthcare professionals and patients, any mittee on Homeland Security and Gov- of children who suffer a stroke die as a re- information identifying particular sub- ernmental Affairs’ Subcommittee on sult; populations, and any other relevant informa- Whereas stroke recurs in 20 percent of chil- tion as determined appropriate to enhance Oversight of Government Management, the Federal Workforce, and the Dis- dren who have experienced a stroke; communication, including varied means of Whereas the death rate for children who electronic communication; and trict of Columbia be authorized to experience a stroke before the age of 1 year (3) shall include a process for implementa- meet during the session of the Senate is the highest out of all age groups; tion of any improvements or other modifica- on May 21, 2012, at 2:30 p.m. to conduct Whereas the average time from onset of tions determined to be necessary. a hearing entitled, ‘‘A National Secu- symptoms to diagnosis of stroke is 24 hours, (c) ISSUANCE AND POSTING OF COMMUNICA- rity Crisis: Foreign Language Capabili- putting many affected children outside the TION PLAN.— ties in the Federal Government.’’ window of 3 hours for the most successful (1) COMMUNICATION PLAN.—Not later than 1 The PRESIDING OFFICER. Without treatment; year after the date of enactment of this Act, the Secretary, acting through the Commis- objection, it is so ordered. Whereas between 50 and 85 percent of in- sioner of Food and Drugs, shall issue the f fants and children who have a pediatric stroke will have serious, permanent neuro- communication plan described under this PRIVILEGES OF THE FLOOR section. logical disabilities, including paralysis, sei- (2) POSTING OF COMMUNICATION PLAN ON THE Mr. HARKIN. Mr. President, I ask zures, speech and vision problems, and atten- OFFICE OF MINORITY HEALTH WEBSITE.—The unanimous consent that William tion, learning, and behavioral difficulties; Secretary, acting through the Commissioner McConagha and Kathleen Wise be Whereas those disabilities may require on- of Food and Drugs, shall publicly post the granted the privilege of the floor for going physical therapy and surgeries; communication plan on the Internet website the duration of consideration of S. 3187, Whereas the permanent health concerns of the Office of Minority Health of the Food and treatments resulting from strokes that the Food and Drug Administration and Drug Administration, and provide links occur during childhood and young adulthood to any other appropriate webpage, and seek Safety and Innovation Act. have a considerable impact on children, fam- public comment on the communication plan. The PRESIDING OFFICER. Without ilies, and society; objection, it is so ordered. Whereas very little is known about the SA 2126. Mr. REED submitted an f cause, treatment, and prevention of pediatric amendment intended to be proposed by NATIONAL PEDIATRIC STROKE stroke; him to the bill S. 3187, to amend the AWARENESS MONTH Whereas medical research is the only Federal Food, Drug, and Cosmetic Act means by which the citizens of the United to revise and extend the user-fee pro- Mr. BROWN of Ohio. Madam Presi- States can identify and develop effective grams for prescription drugs and med- dent, I ask unanimous consent that the treatment and prevention strategies for pedi- ical devices, to establish user-fee pro- Senate proceed to the consideration of atric stroke; and grams for generic drugs and S. Res. 468, which was submitted ear- Whereas early diagnosis and treatment of pediatric stroke greatly improves the biosimilars, and for other purposes; lier today by Senator BLUMENTHAL. The PRESIDING OFFICER. The chances that the affected child will recover which was ordered to lie on the table; and not experience a recurrence: Now, there- as follows: clerk will report the resolution by title. fore, be it At the end of title XI, add the following: The legislative clerk read as follows: Resolved, That the Senate— SEC. 11ll. COMPLIANCE DATE FOR RULE RE- A resolution (S. Res. 468) expressing the (1) acknowledges May as ‘‘National Pedi- LATING TO SUNSCREEN DRUG sense of the Senate with respect to childhood atric Stroke Awareness Month’’; PRODUCTS FOR OVER-THE- (2) urges the people of the United States to COUNTER HUMAN USE. stroke and recognizing May as ‘‘National Pe- diatric Stroke Awareness Month.’’ support the efforts, programs, services, and In accordance with the final rule issued by advocacy of organizations that work to en- the Commissioner of Food and Drug entitled There being no objection, the Senate hance public awareness of childhood stroke; ‘‘Labeling and Effectiveness Testing; Sun- proceeded to consider the resolution. (3) supports the work of the National Insti- screen Drug Products for Over-the-Counter Mr. BROWN of Ohio. Madam Presi- tutes of Health in pursuit of medical Human Use; Delay of Compliance Dates’’ (77 dent, I ask unanimous consent that the Fed. Reg. 27591 (May 11, 2012)), a product sub- progress on the matter of pediatric stroke; resolution be agreed to, the preamble and ject to the final rule issued by the Commis- be agreed to, the motions to reconsider sioner entitled ‘‘Labeling and Effectiveness (4) urges continued coordination and co- Testing; Sunscreen Drug Products for Over- be laid upon the table, with no inter- operation between government, researchers, the-Counter Human Use’’ (76 Fed. Reg. 35620 vening action or debate, and any re- families, and the public to improve treat- (June 17, 2011)), shall comply with such rule lated statements be printed in the ments and prognoses for children who suffer not later than— RECORD. strokes.

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00091 Fmt 4624 Sfmt 0634 E:\CR\FM\A21MY6.047 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3386 CONGRESSIONAL RECORD — SENATE May 21, 2012 HONORING THE ENTREPRE- America; we foster that entrepreneur- those opportunities. Access to govern- NEURIAL SPIRIT OF SMALL ship, free but fair markets, well regu- ment contracting—you know, the Fed- BUSINESS lated, not too lightly, not too heavily. eral Government, state governments, Mr. BROWN of Ohio. Madam Presi- Sometimes we go a little overboard and local governments are some of the dent, I ask unanimous consent that the and we need to pull back. Sometimes biggest spenders and biggest busi- Senate proceed to the consideration of we do not regulate enough and we need nesses—if they were businesses, which S. Res. 469, submitted earlier today. to step up. But that is what we have they are not; there are clear dif- The PRESIDING OFFICER. The been exploring. ferences—but if we were a business, the clerk will report the resolution by In fact, we have broken our Federal Government would be the larg- title. roundtables into domains: Do our small est business in the world. It buys more The legislative clerk read as follows: businesses have enough access to cap- goods and services than others. We do A resolution (S. Res. 469) honoring the en- ital? Do our small businesses truly not have to do all of that just with the trepreneurial spirit of small business con- have access to grow global markets? big businesses such as IBM, GE, cerns in the United States during National What did we learn this year? We ExxonMobil. We can contract with Small Business Week, which begins on May learned that less than 12 percent of all small businesses. It takes a little more 20, 2012. small businesses in America export. time, takes a little more energy, takes There being no objection, the Senate With the market growing overseas and a little bit different approach, but we proceeded to consider the resolution. only the small percentage of the world most certainly can buy some of the Ms. LANDRIEU. We have submitted market being now in the United things we need from the small business a resolution, because it is Small Busi- States—we were at one time the big- right down the street. ness Week, on behalf of myself and gest market, when China was closed, So we are shaping policies to do that. Senator SNOWE, Senator PRYOR, Sen- when communism was reigning in the Senator CARDIN from Maryland has been particularly aggressive when it ator LIEBERMAN, Senator ENZI, Senator Soviet Union, and the Arab world was comes to contracting with minority KERRY, Senator BROWN, Senator CANT- in darkness. I mean the market was in and women-owned businesses, which WELL, Senator AYOTTE, Senator RISCH, the United States. Senator CARDIN, and Senator HAGAN, a But that is no longer the case, as make up a significant and growing very good representation of our Small these countries and areas have emerged area. It is very exiting as more women Business Committee and others that and created markets and opportunities enter not just the workforce but decide they want their flexibility. They want submitted a resolution this week, of their own. again, as we have done every year since So one thing we learned is that the to set their own hours. They want to be 1953. We have done so every year since ecosystem needs to be stronger by their own bosses. They want to estab- 1953 to recognize this week, or 1 week helping small businesses to export. lish businesses that allow them to also in the year, as Small Business Week. They do not have the back office or the raise children at home, to be there So that is what our resolution, which expertise of 10 accountants and a Chi- when their kids need them. So they find that small businesses operating was submitted earlier today, does. nese specialist and a South American out of their homes are the answer to I hope Leaders MCCONNELL and REID specialist. But we can, by being smart, that dilemma. We want to give them will take up this resolution and pass it help. Through the Commerce Depart- access to government contracting so we can honor the 28 million small ment, the Small Business Administra- when, of course, they are capable and businesses that exist today in America. tion, or maybe even through some of We have been doing everything we can, provide the right price. our research and development arms of One of the big areas that we looked and I am very proud, as the chairman some of our departments, we can be the at is access to human capital. I think of the Small Business Committee, that back office for small businesses. you probably heard, Madam President, we have worked in a bipartisan fashion We are excited about what is hap- many of our businesses saying: Why is for the most part trying to give our pening there. So access to capital, ac- it that we are bringing in some of the businesses, first of all, the recognition cess to global markets, access to coun- smartest people in the world, educating that 9 out of 10 new jobs created were seling, mentoring, technical assistance them at our universities, to where they created by a small number, a very and education. I have had so many are getting master’s degrees and Ph.D.s small number, of small businesses that small businesses come before our com- in engineering, math, and science, and are fast growing. They are the new job mittee and say: You know, Senator, then we send them back to the country creators. These are the businesses that getting the loan from the bank was the they came from so they can create are going to be putting this recession first step. But if so-and-so had not businesses to compete against us? Why behind us. These are the businesses shown up in my office from the Score don’t we extend visa privileges to these that are innovating and adapting and Chapter or if I could not have reached master’s and Ph.D. candidates? changing and being more strategic and out to my local university or my small That is a good question, and we have smarter, looking for those opportuni- business center there, I would never bills to answer that. We also want to ties in all areas and in all geographic have been able to make it because they develop a skilled workforce in Amer- parts of our Nation. told me what to do to save me from ica. Access to human capital is what Over the past few months my com- making a fatal mistake and got me on small businesses need to grow and to mittee has held three very special my way or helped me to rethink my expand. roundtables to explore strategies, market during the recession. Finally, we need access to flexible tools, and methods to strengthen what How one lady put it before our com- regulation and smart tax policy. We I like to call the ecosystem of entre- mittee, they helped her remarket her are never going to live in a world where preneurship. Much like a rain forest or business so now it is growing faster we do not pay taxes. It is just the na- desert or much like the ocean itself, than ever. I think also access to stra- ture of what we have to do to keep our that is an environment where many tegic partnerships is important. No government running and operating, creatures or organisms have to live and man is an island. We do not accomplish with a government that serves the peo- interact. The same is true of our finan- anything by ourselves in the world. ple—by the people, for the people. cial ecosystem, the political eco- That is true of individuals, that is true But our taxes should not be too system. Society itself is an ecosystem of small businesses. So we asked our- heavy, too burdensome, and our regu- where small businesses have to func- selves: Who are the partners, strategic latory regime should not be either too tion. partners for small businesses? Cities light or too onerous. It should be just In order for them to be healthy, there are doing some creative things. right. But it is hard to get that just- have to be the right nutrients, if you Madam President, you were a county right approach. We are working at it will, present. So we have explored in executive. You know the things you did every day. Senator SNOWE has been our committee what—we know the as a county executive. Your reputation working on regulatory reform. Senator United States does this well. We do it is well known in that regard. WARNER has been working very hard on better than any country on Earth. States can be strategic partners to regulatory reform—and other Members That is one of the great strengths of their small businesses. We explored of this body.

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00092 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.051 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE May 21, 2012 CONGRESSIONAL RECORD — SENATE S3387 The bottom line is that this is Small on a Saturday—and it was very quiet— sel, assist, and protect the interests of small Business Week. We want to honor the I could feel the energy in that building, business concerns in order to preserve free small businesses that are helping us although it was virtually empty. and competitive enterprise, to ensure that a put this recession in the rearview mir- I have walked through incubators in fair proportion of the total Federal Govern- New Orleans, and I hope the occupant ment purchases, contracts, and subcontracts ror. I want to ask the leadership to for property and services are placed with pass this resolution—a very straight- of the chair did, and helped to create small business concerns, to ensure that a fair forward, noncontroversial resolution them in Delaware. That is what it is proportion of the total sales of government by both Democrats and Republicans, going to take, a strategic partnership property are made to such small business recognizing this is Small Business between government and the private concerns, and to maintain and strengthen Week. sector, letting the private sector do the overall economy of the United States; I also wanted to bring to the atten- what they do best, but letting govern- Whereas every year since 1963, the Presi- tion of the body the conclusion, basi- ment do what it does best. That was a dent has designated a ‘‘National Small Busi- perfect example of what I saw in terms ness Week’’ to recognize the contributions of cally, of the three roundtables we have small businesses to the economic well-being held and thank the Members who at- of taking research dollars that are of the United States; tended. We had good attendance, and spent at MIT, moving them out to the Whereas in 2012, National Small Business we gleaned some excellent ideas about universities, and then on to these Week will honor the estimated 27,200,000 the brackets I have outlined today, and ideas, where they are literally being small businesses in the United States; have been in the process of filing over tested and commercialized to get out Whereas the Small Business Administra- the last week, and throughout this into the market to create wealth and tion has helped small business concerns by week, individual bills that reflect what opportunity for the United States and providing access to critical lending opportu- the world. nities, protecting small business concerns we have learned in these roundtables. from excessive Federal regulatory enforce- We have taken those ideas and turned I am happy to be chair of the Small ment, helping to ensure full and open com- them into legislation. Business Committee. For small busi- petition for government contracts, and im- I am happy to say there is not going ness and economic growth, it is Na- proving the economic environment in which to be a big pricetag on this legislation. tional Small Business Week. I thank small business concerns compete; It is not just throwing money at the all the groups helping us to celebrate Whereas for more than 50 years, the Small problem, but we do need additional re- this week and, most important, I thank Business Administration has helped millions sources. It is sharpening things, re- the entrepreneurs who literally risk ev- of entrepreneurs achieve the American erything to create their dreams and dream of owning a small business, and has forming some of our strategies, laws, played a key role in fostering economic rules, and regulations on the books, bring economic prosperity not just to growth; and and encouraging, by granting some themselves and their family business Whereas the President has designated the competitive grants, some of these stra- but to a Nation that relies on them week beginning May 20, 2012, as ‘‘National tegic partnerships with counties, cit- every day. We want to make that bur- Small Business Week’’: Now, therefore, be it ies, and States. I look forward to see- den lighter. I want to help them in Resolved, That the Senate— ing how this body responds to some of every way we can in our committee in (1) honors the entrepreneurial spirit of Washington and throughout our States, small business concerns in the United States the new pieces of legislation we put during National Small Business Week, which out. I look forward to working with my counties, and cities, and be the partner begins on May 20, 2012; colleagues through this week and the they can rely on to get the job done. (2) applauds the efforts and achievements month of May, through the summer, Madam President, I don’t see anyone of the owners and employees of small busi- and into the election, to keep focused else on the floor. I urge my colleagues ness concerns, whose hard work and commit- on the No. 1 issue on the minds of the to adopt our resolution. I thank all of ment to excellence have made such small American people, which is jobs, eco- us who will be speaking today and this business concerns a key part of the economic vitality of the United States; nomic hope, and economic opportunity week on Small Business Week. Mr. BROWN of Ohio. Madam Presi- (3) recognizes the work of the Small Busi- for themselves and their families. Tom dent, it is my understanding we are ness Administration and its resource part- Friedman has been saying all over the ready to act on this resolution. ners in providing assistance to entrepreneurs and small business concerns; and world that when kids graduate from The PRESIDING OFFICER. If there college, it is not a job they are looking (4) recognizes the importance of ensuring is no further debate, the question is on that— for. They may not be able to find the agreeing to the resolution. job they are looking for. They need to (A) guaranteed loans, including microloans The resolution (S. Res. 469) was and microloan technical assistance, for create the job they want. They need to agreed to. start-up and growing small business con- build a business, build a better mouse- Mr. BROWN of Ohio. Madam Presi- cerns, and venture capital, are made avail- trap, think about a different way of de- dent, I now ask that we act on the pre- able to all qualified small business concerns; livering a product or a service or think amble. (B) the management assistance programs about a business that is selling to a do- The PRESIDING OFFICER. If there delivered by resource partners on behalf of mestic market and taking it global. is no further debate, the question is on the Small Business Administration, such as With technology and opportunities, agreeing to the preamble. Small Business Development Centers, Wom- many young people are doing just that. The preamble was agreed to. en’s Business Centers, and the Service Corps In conclusion, I had the wonderful The resolution, with its preamble, of Retired Executives, are provided with the Federal resources necessary to provide in- opportunity on Friday to be involved reads as follows: valuable counseling services to entre- and took the opportunity Saturday S. RES. 469 preneurs in the United States; morning to stop in at the Cambridge Whereas the approximately 27,500,000 small (C) the Small Business Administration Innovation Center, the granddaddy of business concerns in the United States are continues to provide timely and efficient dis- all small business incubators. It is the driving force behind the Nation’s econ- aster assistance so that small businesses in across the street from MIT, Microsoft, omy, creating 2 out of every 3 new jobs and areas struck by natural or manmade disas- and Google. There were some young generating more than 50 percent of the Na- ters can quickly return to business to keep and exciting college students in the tion’s non-farm gross domestic product; local economies alive in the aftermath of Whereas small businesses are the driving such disasters; building. You could either rent a cubi- force behind the economic recovery of the (D) affordable broadband Internet access is cle that looked like a kindergarten United States; available to all people in the United States, with your name on it to get in the Whereas small businesses represent 99.7 particularly people in rural and underserved building or you could rent a space such percent of employer firms in the United communities, so that small businesses can as a bullpen where you could work or States; use the Internet to make their operations rent your own cubicle or private office; Whereas small business concerns are the more globally competitive while boosting and thousands, literally, of young peo- Nation’s innovators, serving to advance local economies; ple were moving into that building—ac- technology and productivity; (E) regulatory relief is provided to small Whereas small business concerns represent businesses through the reduction of duplica- tually people of all ages, even retired 97.5 percent of all exporters and produce 31 tive or unnecessary regulatory requirements executives who decided, I have always percent of exported goods; that increase costs for small businesses; and wanted to try out my idea, so let’s see Whereas Congress established the Small (F) leveling the playing field for con- if I can get my business started. Even Business Administration in 1953 to aid, coun- tracting opportunities remains a primary

VerDate Mar 15 2010 03:30 May 22, 2012 Jkt 019060 PO 00000 Frm 00093 Fmt 4624 Sfmt 0634 E:\CR\FM\G21MY6.053 S21MYPT1 jbell on DSK7SPTVN1PROD with SENATE S3388 CONGRESSIONAL RECORD — SENATE May 21, 2012 focus, so that small businesses, particularly leaders be reserved for their use later There being no objection, the Senate, minority-owned small businesses, can com- in the day, and that the majority lead- at 6:53 p.m., adjourned until Tuesday, pete for and win more of the $400,000,000,000 er be recognized; that the first hour May 22, 2012, at 10 a.m. in contracts that the Federal Government following the remarks of the majority enters into each year for goods and services. f Mr. BROWN of Ohio. Madam Presi- leader and Republican leader be equal- dent, I ask unanimous consent that the ly divided and controlled between the NOMINATIONS motions to reconsider be laid upon the two sides, with the majority control- Executive nominations received by table, and any statements related to ling the first half and the Republicans the Senate: controlling the second half; further, the resolution be printed in the THE JUDICIARY that the Senate recess from 12:30 until RECORD. 2:15 p.m. to allow for the weekly caucus THOMAS M. DURKIN, OF ILLINOIS, TO BE UNITED The PRESIDING OFFICER. Without STATES DISTRICT JUDGE FOR THE NORTHERN DISTRICT objection, it is so ordered. meetings. OF ILLINOIS, VICE WAYNE R. ANDERSEN, RETIRED. The PRESIDING OFFICER. Without NATIONAL INSTITUTE OF BUILDING SCIENCES f objection, it is so ordered. JOSEPH BYRNE DONOVAN, OF VIRGINIA, TO BE A MEM- APPOINTMENTS BER OF THE BOARD OF DIRECTORS OF THE NATIONAL IN- f STITUTE OF BUILDING SCIENCES FOR A TERM EXPECT- The PRESIDING OFFICER. The ING SEPTEMBER 7, 2013, VICE LANE CARSON, RESIGNED. Chair, on behalf of the Republican PROGRAM NATIONAL FOUNDATION ON THE ARTS AND THE Leader, pursuant to Public Law 96–114, Mr. BROWN of Ohio. Madam Presi- HUMANITIES as amended, appoints the following in- dent, it is the majority leader’s inten- BRUCE R. SIEVERS, OF CALIFORNIA, TO BE A MEMBER dividuals to the Congressional Award OF THE NATIONAL COUNCIL ON THE HUMANITIES FOR A tion to resume the motion to proceed TERM EXPIRING JANUARY 26, 2018, VICE KENNETH R. Board: to Calendar No. 400, S. 3187, the Food WEINSTEIN, TERM EXPIRED. Michael Schmid of Wyoming, and Drug Administration user fees leg- IN THE ARMY Cheryl D. Maddox of Kentucky, and islation, when the Senate convenes to- THE FOLLOWING NAMED OFFICER FOR APPOINTMENT Charmaine Yoest of Virginia. morrow. At 2:15 the Senate will begin IN THE UNITED STATES ARMY TO THE GRADE INDICATED WHILE ASSIGNED TO A POSITION OF IMPORTANCE AND f consideration of the bill. Senators will RESPONSIBILITY UNDER TITLE 10, U.S.C., SECTION 601: ORDERS FOR TUESDAY, MAY 22, be notified when votes are scheduled. To be lieutenant general 2012 f MAJ. GEN. WILLIAM B. GARRETT III Mr. BROWN of Ohio. Madam Presi- f dent, I ask unanimous consent that ADJOURNMENT UNTIL 10 A.M. when the Senate completes its business TOMORROW CONFIRMATION today, it adjourn until 10 am on Tues- Mr. BROWN of Ohio. Madam Presi- Executive nomination confirmed by day, May 22; that following the prayer dent, if there is no further business to the Senate May 21, 2012: and pledge, the Journal of proceedings come before the Senate, I ask unani- THE JUDICIARY be approved to date, the morning hour mous consent that it adjourn under the PAUL J. WATFORD, OF CALIFORNIA, TO BE UNITED be deemed expired, the time for the two previous order. STATES CIRCUIT JUDGE FOR THE NINTH CIRCUIT.

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SENATE COMMITTEE MEETINGS Veterans’ Affairs courthouses, S. 2370, to amend title 11, To hold hearings to examine seamless United States Code, to make bank- Title IV of Senate Resolution 4, transition, focusing on a review of the ruptcy organization more efficient for agreed to by the Senate on February 4, Integrated Disability Evaluation Sys- small business debtors, the nomina- 1977, calls for establishment of a sys- tem. tions of Robert E. Bacharach, of Okla- tem for a computerized schedule of all SD–562 homa, to be United States Circuit meetings and hearings of Senate com- 10:30 a.m. Judge for the Tenth Circuit, Paul Wil- mittees, subcommittees, joint commit- Homeland Security and Governmental Af- liam Grimm, to be United States Dis- tees, and committees of conference. fairs trict Judge for the District of Mary- To hold hearings to examine the Secret This title requires all such committees land, John E. Dowdell, to be United Service, focusing on trust and con- States District Judge for the Northern to notify the Office of the Senate Daily fidence. District of Oklahoma, Mark E. Walker, Digest—designated by the Rules Com- SD–G50 to be United States District Judge for mittee—of the time, place, and purpose 2 p.m. the Northern District of Florida, Brian of the meetings, when scheduled, and Banking, Housing, and Urban Affairs J. Davis, of Florida, to be United any cancellations or changes in the Security and International Trade and Fi- States District Judge for the Middle meetings as they occur. nance Subcommittee District of Florida, and Charles Thom- To hold hearings to examine reviewing as Massarone, of Kentucky, to be a As an additional procedure along the United States-China strategic and with the computerization of this infor- Commissioner of the United States Pa- economic dialogue. role Commission. mation, the Office of the Senate Daily SD–538 SD–226 Digest will prepare this information for Commission on Security and Cooperation 10:30 a.m. printing in the Extensions of Remarks in Europe Foreign Relations section of the CONGRESSIONAL RECORD To hold hearings to examine democra- To hold hearings to examine the global on Monday and Wednesday of each tization in the Caucasus, focusing on implications of poaching in Africa, fo- elections in Armenia, Azerbaijan, and week. cusing on ivory and insecurity. Georgia, and how far free and fair elec- SD–419 Meetings scheduled for Tuesday, May tions have come in the Caucasus, and 22, 2012 may be found in the Daily Di- 2:15 p.m. what the United States can do to pro- Indian Affairs gest of today’s RECORD. mote progress in upcoming elections. To hold an oversight hearing to examine 2203, Rayburn Building programs and services for native vet- MEETINGS SCHEDULED 2:30 p.m. erans. Armed Services SD–628 MAY 23 Closed business meeting to markup the 9:30 a.m. proposed National Defense Authoriza- MAY 25 Armed Services tion Act for fiscal year 2013. Strategic Forces Subcommittee SR–222 9:30 a.m. Closed business meeting to markup those Armed Services provisions which fall under the sub- MAY 24 Closed business meeting to continue markup of the proposed National De- committee’s jurisdiction of the pro- 9 a.m. fense Authorization Act for fiscal year posed National Defense Authorization Intelligence 2013. Act for fiscal year 2013. To hold closed hearings to examine cer- SR–222 SR–232A tain intelligence matters. 10 a.m. SH–219 JUNE 7 Judiciary 9:30 a.m. Administrative Oversight and the Courts Armed Services 2:15 p.m. Subcommittee Closed business meeting to continue Indian Affairs To hold hearings to examine protecting markup of the proposed National De- To hold an oversight hearing to examine our children, focusing on the impor- fense Authorization Act for fiscal year Universal Service Fund Reform, focus- tance of training child protection pro- 2013. ing on ensuring a sustainable and con- fessionals. SR–222 nected future for native communities. SD–226 10 a.m. SD–628 Appropriations Banking, Housing, and Urban Affairs Department of Defense Subcommittee To hold hearings to examine ‘‘The Re- JUNE 28 To hold hearings to examine the fiscal sponsible Homeowner Refinancing Act 10 a.m. year 2013 Guard and Reserve budget of 2012’’. Health, Education, Labor, and Pensions overview. SD–538 To hold hearings to examine creating SD–192 Homeland Security and Governmental Af- positive learning environments for all Finance fairs students. To hold hearings to examine progress in Federal Financial Management, Govern- Room to be announced health care delivery, focusing on inno- ment Information, Federal Services, vations from the field. and International Security Sub- POSTPONEMENTS SD–215 committee Foreign Relations To hold hearings to examine efforts to To hold hearings to examine The Law of reform information technology spend- MAY 23 the Sea Convention (Treaty Doc. 103– ing, focusing on innovating with less. 2:30 p.m. 39), focusing on the United States Na- SD–342 Judiciary tional Security and Strategic Impera- Judiciary To hold hearings to examine certain tives for Ratification. Business meeting to consider S. 2076, to nominations. SH–216 improve security at State and local SD–226

∑ 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 Mar 15 2010 01:11 May 22, 2012 Jkt 019060 PO 00000 Frm 00001 Fmt 0626 Sfmt 0634 E:\CR\FM\M21MY8.000 E21MYPT1 tjames on DSK6SPTVN1PROD with REMARKS Monday, May 21, 2012 Daily Digest Senate A unanimous-consent agreement was reached pro- Chamber Action viding that the motion to invoke cloture on the mo- Routine Proceedings, pages S3295–S3388 tion to proceed to consideration of the bill, be with- Measures Introduced: Five bills and two resolu- drawn; that at 2:15 p.m., Tuesday, May 22, 2012, tions were introduced, as follows: S. 3207–3211, and the motion to proceed be agreed to; that a Harkin- S. Res. 468–469. Page S3329 Enzi substitute amendment, which is at the desk, be agreed to; and the bill, as amended, by the Harkin- Measures Reported: Enzi substitute be considered original text for the Special Report entitled ‘‘Inquiry into Counterfeit purposes of further amendment; and that the Major- Electronic Parts in the Department of Defense Sup- ity Leader be recognized. Page S3316 ply Chain’’. (S. Rept. No. 112–167) Page S3329 Appointments: Measures Passed: Congressional Award Board: The Chair, on be- Iran Threat Reduction Act: Committee on For- eign Relations was discharged from further consider- half of the Republican Leader, pursuant to Public ation of H.R. 1905, to strengthen Iran sanctions Law 96–114, as amended, appointed the following laws for the purpose of compelling Iran to abandon individuals to the Congressional Award Board: Mi- its pursuit of nuclear weapons and other threatening chael Schmid of Wyoming, Cheryl D. Maddox of activities, and the bill was then passed, after agree- Kentucky, and Charmaine Yoest of Virginia. ing to the following amendments proposed thereto: Page S3388 Pages S3316–22 Message from the President: Senate received the Reid (for Johnson (SD)/Shelby) Amendment No. following message from the President of the United 2124 (to the language proposed by Amendment No. States: 2123), to improve the bill. Page S3317 Transmitting, pursuant to law, a report on the Reid (for Johnson (SD)/Shelby) Amendment No. continuation of the national emergency that was 2123, in the nature of a substitute. Page S3317 originally declared in Executive Order 13303 of May National Pediatric Stroke Awareness Month: 22, 2003, received during adjournment of the Senate Senate agreed to S. Res. 468, expressing the sense of on May 18, 2012; which was referred to the Com- the Senate with respect to childhood stroke and rec- mittee on Banking, Housing, and Urban Affairs. ognizing May as ‘‘National Pediatric Stroke Aware- (PM–50) Pages S3326–27 ness Month’’. Page S3385 Nomination Confirmed: Senate confirmed the fol- National Small Business Week: Senate agreed to lowing nomination: S. Res. 469, honoring the entrepreneurial spirit of By 61 yeas to 34 nays (Vote No. EX. 104), Paul small business concerns in the United States during J. Watford, of California, to be United States Circuit National Small Business Week, which begins on Judge for the Ninth Circuit. Pages S3307–16 May 20, 2012. Pages S3386–88 A unanimous-consent agreement was reached pro- viding that the motion to invoke cloture on the Measures Considered: nomination, be withdrawn. Page S3296 FDA User Fee—Agreement: Senate resumed con- Nominations Received: Senate received the fol- sideration of the motion to proceed to consideration lowing nominations: of S. 3187, to amend the Federal Food, Drug, and Thomas M. Durkin, of Illinois, to be United Cosmetic Act to revise and extend the user-fee pro- States District Judge for the Northern District of Il- grams for prescription drugs and medical devices, to linois. establish user-fee programs for generic drugs and biosimilars. Pages S3295–S3307 D503

VerDate Mar 15 2010 04:44 May 22, 2012 Jkt 019060 PO 00000 Frm 00001 Fmt 0627 Sfmt 0627 E:\CR\FM\D21MY2.REC D21MYPT1 tjames on DSK6SPTVN1PROD with DIGEST D504 CONGRESSIONAL RECORD — DAILY DIGEST May 21, 2012 Joseph Byrne Donovan, of Virginia, to be a Mem- ber of the Board of Directors of the National Insti- Committee Meetings tute of Building Sciences for a term expiring Sep- (Committees not listed did not meet) tember 7, 2013. Bruce R. Sievers, of California, to be a Member of FOREIGN LANGUAGE CAPABILITIES IN the National Council on the Humanities for a term THE FEDERAL GOVERNMENT expiring January 26, 2018. Committee on Homeland Security and Governmental Af- 1 Army nomination in the rank of general. fairs: Subcommittee on Oversight of Government Page S3388 Management, the Federal Workforce, and the Dis- Messages from the House: Page S3327 trict of Columbia concluded a hearing to examine national security, focusing on foreign language capa- Measures Placed on the Calendar: Pages S3327 bilities in the Federal government, after receiving Executive Communications: Pages S3327–29 testimony from Eduardo Ochoa, Assistant Secretary of Education for Postsecondary Education; Linda Additional Cosponsors: Pages S3329–30 Thomas-Greenfield, Director General of the Foreign Statements on Introduced Bills/Resolutions: Service and Director of Human Resources, Depart- Pages S3330–31 ment of State; Laura J. Junor, Assistant Secretary for Additional Statements: Pages S3325–26 Readiness, Glenn Nordin, Principal Foreign Lan- guage and Area Advisor, Office of the Under Sec- Amendments Submitted: Pages S3331–85 retary for Intelligence, and Major Gregory Mitchell, Notices of Hearings/Meetings: Page S3385 G–3/5/7 Training Directorate, United States Army, Authorities for Committees to Meet: Page S3385 all of the Department of Defense; Tracey North, Deputy Assistant Director, Intelligence Operations Privileges of the Floor: Page S3385 Branch, Directorate of Intelligence, Federal Bureau Record Votes: One record vote was taken today. of Investigation, Department of Justice; Andrew (Total—104) Page S3316 Lawless, Dig-IT Globalization Consulting, Andover, Adjournment: Senate convened at 2 p.m. and ad- Massachusetts; Allan E. Goodman, Institute of Inter- journed at 6:53 p.m., until 10 a.m. on Tuesday, May national Education, and Dan E. Davidson, American 22, 2012. (For Senate’s program, see the remarks of Councils for International Education, both of Wash- the Acting Majority Leader in today’s Record on ington, D.C.; and Paula Patrick, Fairfax County Public Schools, Shauna Kaplan, Michelle Dressner, page S3388.) and Jeffrey Wood, all of Fairfax, Virginia. h House of Representatives COMMITTEE MEETINGS FOR TUESDAY, Chamber Action MAY 22, 2012 The House was not in session today. The House is scheduled to meet at 10 a.m. on Tuesday, May (Committee meetings are open unless otherwise indicated) 22, 2012 in pro forma session. Senate Committee on Appropriations: business meeting to mark up proposed budget estimates for fiscal year 2013 for Committee Meetings Military Construction and Veterans Affairs, and Related No hearings were held. Agencies and Department of Homeland Security, 10:30 a.m., SD–106. Subcommittee on State, Foreign Operations, and Re- Joint Meetings lated Programs, business meeting to mark up proposed No joint committee meetings were held. budget estimates for fiscal year 2013 for Department of State, Foreign Operations, and Related Programs, 2:30 p.m., SD–138. Committee on Armed Services: Subcommittee on SeaPower, closed business meeting to mark up those provisions which fall under the subcommittee’s jurisdiction of the

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proposed National Defense Authorization Act for fiscal committee’s jurisdiction of the proposed National Defense year 2013, 9:30 a.m., SR–232A. Authorization Act for fiscal year 2013, 5 p.m., SR–232A. Subcommittee on Readiness and Management Support, Committee on Banking, Housing, and Urban Affairs: to business meeting to mark up those provisions which fall hold hearings to examine implementing derivatives re- under the subcommittee’s jurisdiction of the proposed form, focusing on reducing systemic risk and improving National Defense Authorization Act for fiscal year 2013, market oversight, 10 a.m., SD–538. 11 a.m., SD–G50. Committee on Energy and Natural Resources: to hold hear- Subcommittee on Emerging Threats and Capabilities, ings to examine the report produced by the American En- closed business meeting to mark up those provisions ergy Innovation Council titled ‘‘Catalyzing American In- which fall under the subcommittee’s jurisdiction of the genuity: The Role of Government in Energy Innovation’’ proposed National Defense Authorization Act for fiscal and related issues, 10 a.m., SD–366. year 2013, 2 p.m., SR–232A. Subcommittee on Airland, closed business meeting to Select Committee on Intelligence: closed business meeting mark up those provisions which fall under the sub- to mark up expiring provisions of the ‘‘FISA Amendment committee’s jurisdiction of the proposed National Defense Act’’, 2:30 p.m., SH–219. Authorization Act for fiscal year 2013, 3:30 p.m., SR–232A. House Subcommittee on Personnel, closed business meeting to No hearings are scheduled. mark up those provisions which fall under the sub-

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Next Meeting of the SENATE Next Meeting of the HOUSE OF REPRESENTATIVES 10 a.m., Tuesday, May 22 10 a.m., Tuesday, May 22

Senate Chamber House Chamber Program for Tuesday: The Majority Leader will be rec- Program for Tuesday: The House will meet in pro ognized. The Majority Leader intends to continue consid- forma session at 10 a.m. eration of the motion to proceed to consideration of S. 3187, FDA User Fee, and at 2:15 p.m. the motion to proceed will be agreed to. (Senate will recess from 12:30 p.m. until 2:15 p.m. for their respective party conferences.)

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