[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 11581-11600]
[From the U.S. Government Publishing Office, www.gpo.gov]




      PRESCRIPTION DRUG USER FEE AMENDMENTS ACT OF 2007--Continued

  The PRESIDING OFFICER. The Senator from Maine is recognized.
  Ms. COLLINS. Mr. President, I ask unanimous consent that I be 
permitted to speak as in morning business for not to exceed 10 minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered. The 
Senator from Maine is recognized.
  Ms. COLLINS. I thank the Chair.
  (The remarks of Ms. Collins pertaining to the introduction of S. 1329 
are located in today's Record under ``Statements on Introduced Bills 
and Joint Resolutions.'')
  The PRESIDING OFFICER. The Senator from New York is recognized.


                                  Iraq

  Mr. SCHUMER. Mr. President, this week we in Congress are continuing 
to work toward a solution in Iraq that both supports our troops and 
changes our mission away from policing a civil war to more narrowly 
focusing on what should be our first and foremost goal--fighting 
terrorism, counterterrorism, to make sure al-Qaida cannot set up a camp 
and strike at us.
  I rise today because we are beginning. We have said all along that 
this is going to be a long battle. Because we do not have 61 votes in 
the Senate, because the President has the veto power and we certainly 
do not have 68 votes to override a veto in the Senate, we are going to 
have to continue to bring up resolution and amendment after resolution 
and amendment until we persuade our colleagues on the other side of the 
aisle to do what the American people want, to do what the American 
people asked for in November of 2006; that is, dramatically change the 
course in Iraq, the mission--greatly reduce the number of troops so we 
can keep some troops there who can fight terrorism, but that will be 
many fewer. Most will be out of harm's way.
  We are getting good signs. First, 6 months ago President Bush said he 
wouldn't accept any benchmarks or any limitation. Now the word from the 
White House seems to be that they will accept some types of benchmarks 
or other types of language that would not just be a simple funding the 
troops without our other goal, changing the mission. But second and 
more significant, what I and my colleague from Washington--and I 
believe my colleague from Illinois will be speaking about--are seeing 
is our Republican colleagues begin to set their own timetables, their 
own deadlines. This weekend, House minority leader John Boehner 
signaled that, as this debate wears on, the President will continue to 
lose support among the members of his own party.

       By the time we get to September or October, members are 
     going to want to know how well this is working and, if it 
     isn't, what is plan B?

  That sure seems similar to what we are trying to do, although we want 
to do it now.
  Mr. Boehner's comments are echoed by a number of other Republicans 
who are hearing back in their States and districts that we must change 
the mission in Iraq. There are many comments.
  Trent Lott:

       I do think this fall we have to see some significant 
     changes on the ground in Baghdad and other surrounding areas.

  There are many more. One of those is Jim Walsh, from my home State of

[[Page 11582]]

New York. Today, the New York Times reports that Mr. Walsh is replying 
to his constituents that he could soon be prepared to reassess our 
policy and begin withdrawing our troops.
  Republican Congressman Ray LaHood is indicating he expects Republican 
members will grow increasingly ``nervous'' about the President's 
strategy.
  Asked about the President's demand for a funding bill with no 
benchmarks, no conditions, and no reports, says Senator Collins, who 
just spoke here:

       Many of us on both sides of the aisle don't see that as 
     viable.

  We are going to try to come up with a very strong resolution that 
both supports our troops and changes the mission. But we know we are 
making progress because our Republican colleagues themselves have been 
setting timetables, benchmarks, and other types of goals--limitations 
that are not terribly dissimilar from ours.
  We will continue this battle, this struggle to require the President 
to change course in Iraq. We eagerly await our Republican colleagues 
joining us.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Washington.
  Mrs. MURRAY. Mr. President, I thank my colleague from New York. I 
know my colleague from Illinois, Senator Durbin, will be here shortly 
as well to talk about a critical juncture at which we are now in terms 
of the war in Iraq.
  Last week, both the House and Senate sent a very strongly worded bill 
to the President of the United States supporting our troops, saying we 
are there for them when they need us, but we also said it is time for a 
change of course in Iraq, that we can no longer leave our troops in the 
middle of a civil war. It is disappointing to all of us that the 
President chose to veto that bill and sent it back to us. But I think 
it is very important for us to set the context of where we are now as 
we look at what we are going to send back to the President.
  These are the facts. There is increased violence in Baghdad as we 
speak. There is increased violence outside Baghdad today. In fact, over 
100 American soldiers died last month alone, and at least 27 more 
American troops have been killed this month. In my home State of 
Washington, we got the sad news yesterday morning that six of our Fort 
Lewis soldiers were killed over the weekend. These are families--
husbands, children, grandchildren--who will be impacted forever and who 
will not forget.
  Months ago, the President said to the American people that he was 
going to change his course by having a surge of American troops--
25,000, 30,000, 40,000 new troops. They are now on the ground in Iraq. 
What we are seeing is increased violence inside and outside of Baghdad, 
more American soldiers losing their lives. And what are we looking at? 
An Iraqi Government that has not changed, has not stood up to the mark 
to care for their own country and make the tough decisions they need to 
make. The bill we sent to the President was designed to give him the 
tools to turn to Iraq and say: You need to take on your own battles and 
make these tough decisions. It is time for Iraqis to stand up. Four 
years after removing Saddam from Iraq, the Iraqis have still not made 
the political compromises necessary to bring peace to their own 
country. In fact, they are on pretty shaky ground today, even as we 
speak, as we hear of factions that may pull out.
  Most important, what is happening here in our country? Mr. President, 
64 percent of Americans and 65 percent of independents support setting 
a timetable for redeployment.
  That is the ground we are now on, as the President vetoed that very 
important piece of legislation which funded our troops. We had funding 
for our veterans as they came home and important, critical funding for 
Katrina and other important causes.
  Despite all the facts I just laid out--the increased violence, the 
soldiers being killed, the Iraqis not standing up for their own 
Government--we have seen Republicans on the other side of this aisle 
stubbornly stand with President Bush and refuse to set a timetable for 
our troops to come home, refuse to set a timeline to force Iraqis to 
take responsibility for their own future, and refuse to set a timetable 
to let Iraqis know we are not going to be there endlessly, month after 
month, year after year, for decades.
  Mr. President, what is heartening to me today, after the President's 
veto, is we now are hearing from many of our Republican colleagues that 
they, too, believe we cannot continue to send a message that we will 
continue to be there forever.
  Senator Schumer was just here on the Senate floor and spoke of some 
of our Republican colleagues who have been speaking out. House Minority 
Leader Boehner said:

       Over the course of the next 3 to 4 months, we'll have some 
     idea how well the plan is working. Early signs are indicating 
     there is clearly some success on a number of fronts. But, by 
     the time we get to September or October, Members are going to 
     want to know how well this is working, and if it isn't, 
     what's Plan B.

  We are now hearing, thankfully, our Republican colleagues set forth 
time tables of their own. I think it is important we listen to what 
they are saying because despite the fact they said no time tables in 
the bill, we are hearing them say there is a timeline; that this 
country cannot continue to send our troops to Iraq without Iraqis 
standing up.
  Importantly, as well, we are hearing our Republican colleagues talk 
about benchmarks. We know benchmarks without consequences are 
pointless. But unlike the President, our Republican colleagues are 
starting to realize this and are breaking with the White House.
  Senator Susan Collins said:

       Obviously, the President would prefer a straight funding 
     bill with no benchmarks, no conditions, no reports . . . Many 
     of us, on both sides of the aisle, don't see that as viable.

  I hear that as very promising language from our colleagues on the 
other side. We are hearing from many others--Senator Voinovich, who 
spoke out this weekend. We are hearing from House minority whip Roy 
Blunt, who says he ``can support binding benchmarks on the Iraqi 
Government tied to a `consequences package,' so long as it would not 
put restrictions on the military.''
  Mr. President, we support our troops. The bill we sent to the 
President last week supports our troops. Our troops have done 
everything we have asked them to do and more, and they have done it 
courageously. It is time now for us to give them the tools they need so 
the Iraqis will stand up and take control of their own government.
  We can no longer simply say: We will stand down when you stand up to 
the Iraqi people. I hope our Republican colleagues will join with us in 
standing up as well, now, to send a strong message to the Iraqi people 
that it is time for our troops to get the support they need and to know 
that they will be brought home in a timely manner.
  It is encouraging to hear the comments we are hearing. I hope they 
are met by the courage of our colleagues on the other side to stand 
with us, find some language we can agree on, and send the supplemental 
to the President. I hope that is what we can do over the next several 
days. I encourage our colleagues to work with us to do so.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Illinois is recognized.
  Mr. DURBIN. Mr. President, I ask unanimous consent that I be 
recognized to speak as in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Iraq Supplemental

  Mr. DURBIN. Mr. President, for a long time in Washington, if you 
talked about a deadline or a timetable, the response from the 
President, from the administration, even from the Republican side of 
the aisle, was the same. When you talked about a specific end to this 
war, they argued: It endangers our troops.
  I did not agree with that premise. In fact, I believed this was the 
only way to convince the Iraqis we were not going to stay forever. If 
they think the

[[Page 11583]]

very best military in the world, the American military forces, will 
stay there indefinitely, there is no incentive for them to make the 
right decisions, the hard decisions to govern their own country.
  Well, time has passed at great cost to our Nation. As of this 
morning, we have lost 3,361 of our best and brightest soldiers--3,361. 
The month of April was the deadliest month this year in Iraq: 104 
American soldiers lost their lives. I think we all understand now that 
as each day passes, more American soldiers are in danger and, sadly, 
more will give their lives. So to wait for a month, two or three or 
four, is, sadly, to extend that period of time of danger.
  Now we find from Republican leaders a new approach. No longer are 
they rejecting the idea of deadlines or timetables. In fact, they are 
starting to speak in more specific terms.
  This is a quote from the Republican leader of the House, John 
Boehner, who said:

       By the time we get to September or October, members are 
     going to want to know how well this is working, and if it 
     isn't, what's Plan B?

  That, to me, sounds like a deadline of September or October.
  Then, of course, our colleague from Mississippi, Senator Lott, said:

       I do think this fall we have to see some significant 
     changes on the ground, in Baghdad and other surrounding 
     areas.

  I think it is an indication that our colleagues on the other side of 
the aisle are hearing the same thing we hear when we go home: First, an 
immense pride in our men and women in uniform, pride as well in their 
families who have stood by them through this long struggle; an 
understanding of the sacrifices that are being made by our soldiers as 
well as those who love them so very much but, secondly, an 
understanding that this is a failed policy that the President is 
pursuing in Iraq.
  This is the fifth year of this war. This war has lasted longer than 
World War II. It is now only exceeded in cost by the cost of World War 
II in today's dollars. It is an extremely expensive undertaking, first, 
in human life, with over 3,000 Americans dying, and then with thousands 
coming home injured, some very seriously injured, with traumatic brain 
injury and amputations.
  Senator Murray of Washington has been a leader when it comes to the 
care for our returning soldiers and veterans. We know our system is 
breaking down and falling behind, increasing the sense of urgency I 
feel and many feel in Illinois, as I see them on the streets of Chicago 
and Springfield and all around my State. They understand this is a 
heavy cost we are paying.
  When our friends on the Republican side of the aisle say all we need 
is maybe 4 or 5 more months, I hope they understand that time they are 
asking for is time that will have a heavy price. They want us to buy 
some time for political purposes but at a heavy price.
  We think, and I hope they will come to understand, we need to tell 
the Iraqis now they have the responsibility to govern and lead. If they 
fail, then American troops are not going to stay there indefinitely. 
Some worry when American troops leave, there may be an unstable 
situation in Iraq. That is entirely possible. That can happen if we 
leave in 10 months, 10 years, or 15 years.
  They have to understand the responsibility of the future of Iraq lies 
in the hands of the Iraqis. We cannot put that burden on American 
soldiers and their families any longer. I am heartened by these 
statements from the Republican side that finally they understand we 
cannot stay there forever, that the policy of this administration has 
not succeeded, that we owe it to soldiers and their families to treat 
them humanely, to let them know they will be coming home to a hero's 
welcome soon.
  Our colleagues, Senator Jim Webb and Carl Levin, as well as Jack 
Reed, have spoken out about the readiness of our troops, too. I worry 
about that. As the President has extended this war, far beyond what 
anyone ever dreamed of, those who voted for that authorization of 
force, as he has extended this war, have put pressure on our soldiers 
beyond anything we could have imagined.
  We have extended the tours of duty for National Guard members to the 
longest period of time since World War II. We now know many of our 
soldiers are asked to stay on an additional 3 months after they have 
served 12. We know when they come home, they do not receive the rest 
they were promised, the time with their family. They are quickly 
reactivated and sent into battle.
  This has to have an impact on morale. It certainly has a negative 
impact on their families. So I believe as we talk about how this war is 
to be waged and what the next stage will be, regardless of what our 
plan may be, it has to include readiness and a commitment to these 
troops. I think it is important that we say to the President: Don't 
send a single soldier into harm's way or into combat unless they have 
had the time to rest, unless they have been retrained and equipped, 
unless they are prepared to go to battle with all of the forces they 
need to come home safely.
  Shortchanging our soldiers is not a strategy that we should follow in 
Iraq. Let's come up with a plan to start bringing these troops home. We 
sent one to the President last week. He, in a press conference, told 
the American people he was going to reject it. We haven't heard 
anything back from him since then. But, in the meantime, many members 
of his own party have decided it is time for them to finally speak up. 
We welcome them. We need them. We need them particularly on this 
supplemental bill.
  Mr. President, if a handful of Republican Senators will now cross the 
aisle and join us, we can have a positive impact on changing this 
failed policy in Iraq. We can finally stand as one in a bipartisan way 
and say there is a better way; that the Iraqis cannot take long 
vacations while the members of their parliament relax as our soldiers 
risk their lives. We have to tell the Iraqis we are not going to stay 
indefinitely.
  When leaders such as Mr. Boehner of Ohio speak of plan B, just 
remember what the B stands for. The B stands for bring our soldiers 
home. That is what we need to start doing in an orderly, sensible way 
as soon as possible.
  Mr. President, I yield the floor, and I suggest the absence of a 
quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. SESSIONS. I ask unanimous consent that the order for the quorum 
call be rescinded.
  The PRESIDING OFFICER (Mrs. McCaskill). Without objection, it is so 
ordered.
  Mr. SESSIONS. I ask unanimous consent to speak as in morning 
business.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                              Immigration

  Mr. SESSIONS. Madam President, I want to take a few moments this 
afternoon to follow up on my remarks of last evening about concerns I 
have involving the immigration process that is ongoing in the Senate 
and what Senator Reid, the Democratic leader, has indicated he plans to 
do.
  I absolutely believe a framework exists for us to develop 
comprehensive immigration reform that can be worthy of the American 
people, to create a lawful system of immigration that will work. It 
will be difficult in a number of areas, but we can do that. A framework 
is being discussed, I know, because I have seen the PowerPoint 
presentations and some of the other discussions about it. A framework 
exists that could lead to effective immigration reform. There is no 
doubt that this Nation needs comprehensive immigration reform. The 
whole system is broken. Nothing about it works. The legal system is an 
embarrassment to us as a nation and a source of frustration to the 
American people. They rightly are concerned about it, and politicians 
don't seem to be. That is why we have had a problem for so long, and 
frustration and anger gets built up. People sometimes call in to radio 
stations and say things they shouldn't say that are unkind. A lot of it 
is a direct response to a failure of the Congress and the executive 
branch to do what is required to create a lawful system of immigration.

[[Page 11584]]

For Heaven's sake, don't we all agree with that concept, a lawful 
system of immigration?
  What interests should it serve? It should serve the national 
interest, the American interest. I asked Secretary Chertoff of Homeland 
Security and Secretary Gutierrez of Commerce at a hearing of the 
Judiciary Committee not long ago, what should a lawful system of 
immigration do? Should it not serve the national interest? They said: 
Yes, sir.
  Professor Borjas, a Cuban refugee, at Harvard has written a book on 
immigration. He said: If you tell me what interest you wish to serve, I 
can help you draft an immigration policy that will work. For example, 
if you say it should be the national interest, I can help you achieve 
that. If you want to serve the interest of poor people around the 
world, I can help achieve that. He basically said in his book 
``Heaven's Door,'' we could serve poor people around the world by just 
letting them all in. That would be in their interest. We know that. In 
2000, we had 11 million people apply for 50,000 lottery slots. The 
names are drawn out of a hat randomly. Only 50,000 are drawn out a 
year. We had 11 million apply for those slots.
  We have to look at the basics. More people want to come to this 
country than we can accept, and those whom we accept should be based on 
what is in our interest. How much more simple can it be than that? I 
submit that is a moral and legitimate basis.
  We always have a humanitarian component to immigration. I would not 
reduce that. About 16 percent of those who come, thereabouts, are for 
humanitarian reasons. I think we will always want to have that 
available for people who are persecuted or otherwise need humanitarian 
relief. Fundamentally, the rest of our program ought to serve the 
national interest.
  This is what has happened. There are supposedly bipartisan 
discussions going on--and I know they are going on--to try to take the 
framework that has been agreed on by the President, Cabinet members, 
and some Members and to flesh that out and develop an immigration 
policy. That hasn't reached fruition. I understand some of the leaders 
on the Democratic side have walked away. They are not prepared to 
follow through on the overall agenda item for a given area, this 
framework. When you start writing down the words that will actually 
effectuate what you promise to do, then people start backing off.
  I have said a number of times on the floor that we have a great deal 
of interest in immigration reform, except that we need a lawful system 
which will work. If it is a system that will actually work, we find 
immediately people start objecting.
  Senator Reid has said these negotiators--I sometimes want to call 
them masters of the universe; I don't know who selected them--are 
meeting here and they are deciding the fate of American immigration. I 
want to say, well, let's see what they produce. I have told my 
constituents I hope they will discuss it, and maybe some agreement can 
be reached, one I could support. But I promised my constituents--and 
every Senator ought to make this commitment--that I am going to read 
that bill. Just because people have great sounding words, if you don't 
read the words carefully and what they will actually mean in the effort 
to enforce immigration law, then you don't know what you are going to 
get. You are going to end up as we did in 1986, with a program that was 
an utter failure. The one we had last year would never have worked. It 
would have been a disastrous failure. It had no chance of being 
successful or ever achieving the ideas it purported.
  Senator Reid apparently is unhappy. He has the power, as the 
Democratic leader, to call up any piece of legislation he wants to call 
up. He has said: I am not happy with the speed of this. He has said he 
is going to call up, under the power of the majority leader under rule 
XIV, last year's bill, and that this will be on the floor. Then he will 
want the negotiators to continue to negotiate, and maybe they will 
figure out what would be better. Then he might substitute this newly 
negotiated bill that hasn't been written yet--nobody has seen a word of 
it--and then we will vote. That will make everybody happy.
  Let me say this, with all sincerity: The American people know 
immigration is a big issue. It is an important issue; it really is. It 
says a lot about the nature of this country. Are we going to be a 
country that the world knows has laws that are never enforced, that our 
immigration policies make a mockery of the law, as they do today? Will 
we continue to see people all over the world get the idea in their 
heads--correct today, basically--that if they can just get into 
America, sooner or later we will make them citizens and give them 
everything, even if they came illegally? Is that the kind of message we 
want to send?
  Senator Reid has said he is going to bring up last year's bill. He 
also indicated that after last year's bill is introduced and maybe a 
compromise would be reached. Maybe they would substitute this 
compromise as a new bill which we have never seen before, nor the words 
in it.
  Let me tell my colleagues, an immigration bill is not an itty-bitty 
thing. An immigration bill consists of a lot of pages. A group of us, 
about 15 of us, wrote to the majority leader and asked that we have 7 
days--I thought that was way too short--to read the bill. Isn't that 
pathetic? The immigration bill last year was 700-plus pages. Seven 
hundred pages. This never before seen compromise version may be longer. 
At least last year's bill came out of the Judiciary Committee, and we 
had a chance to argue over it in there, although the train ran right 
through the Judiciary Committee and it ran through--basically through 
the floor of the Senate. But we began to read it before it was over, 
and I remember making a speech down here, several speeches, pointing 
out 17 loopholes in that bill, fatal flaws in the legislation. But 
anyway, it passed, but the House refused to even consider it.
  Based on what was in the New York Times and Rollcall or The Hill or 
one of the publications, the plan would then presumably be for Senator 
Reid to bring up last year's bill, which is unthinkable, in my view. It 
was fatally flawed. We will stay on that bill for some time, and then 
perhaps they will plop on it a substitute and take out all or parts of 
last year's bill and substitute an entirely new bill, 600, 700 or 800 
pages, and then we will vote on it. That will be good for the masters 
of the universe, you see, because when you do that, there would not be 
time for the American people or for Lou Dobbs or Rush Limbaugh to find 
out what is in it and to tell the American people what is in it so they 
can get mad about it. That is basically what it is about. They want to 
slide it through with the least possible time to discuss it. I think 
that is irresponsible. It is wrong.
  We should spend plenty of time on this legislation. We should go to 
the American people with honesty and integrity and tell them: Some of 
the things you want to do, Mr. and Mrs. America, we can't do. We are 
not going to be able to make immigration come out exactly like you 
would want it or exactly like I would want it. We are going to have to 
reach a compromise, but we understand we have a commitment to you, and 
that commitment is to create a system that will work in the future.
  But I am worried about it because from what I am hearing, the system 
seems to be moving in a way that is going to create an opportunity to 
vote on a completely unseen immigration bill--nobody has read it except 
a little group--and move it through this Senate. Now, remember, the 
bill that passed last year was a bad piece of legislation, but it did 
pass this Senate. People thought it would die in the House, and sure 
enough, it did die in the House and it was never considered. They 
wouldn't even look at it. But I am not sure that is going to happen 
this time.
  So we may have this plan in the works, and it will work something 
akin to this: Well, we spend 2 or 3 days talking about immigration, 
burning time and filibustering, filing cloture on a motion to proceed, 
and we get on the

[[Page 11585]]

bill for a day or two and then all of a sudden a new bill comes on and 
in a day or two, it is passed. Hardly anybody knows what is in it or 
has had a chance to read it. Then it goes to the House of 
Representatives, where the Democratic majority now has a 15 seat, 16 
seat or so majority over there; some of the Republicans would clearly 
be in favor of whatever passed out of the Senate. They don't have any 
way to delay votes over there, so the bill could be brought up and 
passed, the same bill, without any amendment. That could happen. Then 
it goes to the President and he signs it and then we will find out 2, 3 
or 4 years from now whether it works.
  I don't think it is going to work. I am worried about it. I am 
worried about it. I am worried there is not a commitment among the 
executive branch to enforce the immigration laws.
  Anybody who would like to be elected President--the new executive 
branch leader has a commitment to ensuring a lawful system of 
immigration. That is all the American people want. They are not saying 
they don't want any immigrants in America.
  So I am saying this because I am concerned this is where we are 
headed. I think it is unhealthy for the Senate. If we do that, we would 
have failed in an august responsibility. This is the body that is 
supposed to let the passions cool, where Senators look over important 
issues, think them through, and then make a decision on them. Also, the 
delay and the slowdown that goes on in the Senate is helpful so the 
American people can be advised on what their representatives are 
actually doing. So I am worried about it, and Senator Reid's strategy 
is frightening to me.
  So let me repeat: I believe the framework that has been mentioned for 
the drafting of a comprehensive immigration reform bill actually has 
the potential to be successful. But based on my experience in the 10 
years I have been in the Senate and the debate we have seen on 
immigration, I am inclined to believe they will have positive-sounding 
words on the headlines in big print, but the real language will not 
effectuate the promises they make or the goals they set. We could end 
up with no progress whatsoever. We could end up with amnesty and no 
enforcement in the future.
  That is what happened in 1986. If you remember, in 1986, they said 
there are probably a million people in the country illegally. The 
system was not working. We had to do something, so we should grant 
amnesty to the people who came illegally, contrary to law, and then we 
would develop a new system in the future so that this would be the 
amnesty to end all amnesties. There would be no more amnesties. Well, 3 
million people showed up to take advantage of it rather than 1 million 
people, and in the 20-plus years--21 years--since, we now have found in 
our country an estimated 12 million to 20 million people here 
illegally. So now we want to, I guess, give amnesty again on a promise 
that we will have a system that will work in the future. But the 
American people, you see, are cynical about it. They are not 
comfortable with us anymore on this subject, and frankly they are right 
to be cynical. Because there are a lot of special interests out there 
who are asking for what is in their interests but not what is in the 
national interests. It is time for us to consider what is in the 
national interests and do the right thing on immigration. I firmly 
believe we will do a better job of writing a bill that will work, a 
bill that will serve our national interests, that will create a lawful 
immigration system, if the American people know what is going on, 
because that is what they want.
  The American people have been consistently right on this issue. Their 
instincts have been right consistently. Oh, there are some nutty folks 
out here who are mean spirited, there is no doubt about that, but they 
represent a very small number. The basic feeling of the American people 
is sound on immigration and has been. It is the Congress and the 
executive branches that have failed them for 50 years. We don't have to 
continue to fail the American people. We have a responsibility to make 
it work, and I am hopeful that in the discussions for the first time 
with Secretary Chertoff and Secretary Gutierrez helping behind the 
scenes to develop some plans that would actually work, we might even 
get this thing done. There is some possibility. I wouldn't have 
believed it, but now I am beginning to think it is possible.
  But if at the last minute the special interest groups who seem to 
have dominated last year get their way, we would not be able to pass 
the bill we can be proud of. We would not pass a bill that will work, 
and we will be back in 10 years, 15 years, 20 years from now, dealing 
with another crisis.
  So I will not go on anymore about it. I will mention what the 
framework, as I understood it, contained, that these PowerPoint 
presentations that were shown around and got leaked to the press, it 
has real improvement in border enforcement. We need that. That is 
essential. If you are serious about immigration, you want border 
enforcement. It set up as a goal a very effective job workplace 
enforcement, something that could actually work, using biometric 
identifying cards, helping the businesses and telling them exactly what 
they need to do so they can't be prosecuted or sued for doing something 
wrong. They are told exactly what to do and what will work. We can make 
the workplace cease to be the magnet for illegal jobs. That is very 
important, and it can be done. We need to deal compassionately and 
realistically with the people who are here illegally, but I don't 
believe that someone who broke the law in our country should be given 
every single benefit that we give to those who come lawfully. We will 
have to wrestle with that, and nobody is going to be happy, I am sure, 
with the way that comes out. That is the way it is with any big piece 
of legislation.
  We need a genuine temporary seasonal worker program that is separate 
and apart from the program that would allow people to come into the 
country on a citizenship track. On the basic entry, citizenship entry 
into the United States, we need to be far more similar to Canada, which 
has a merit-based, skill-based system that evaluates applicants on what 
they bring to Canada: Do you speak English? Do you have an education? 
Do you have skills that Canada needs? It is a skill-based point system. 
It is objective and fair, and it serves the Canadian interests, and 
they are very happy with it. So is Australia, so is New Zealand, and I 
think the United Kingdom is also moving forward in this direction. A 
merit-based point system can actually be a framework for success. I 
understand that is being discussed. We do not need to promote such a 
framework, and then vote on a bill that doesn't create the merit-based 
point system when you read the fine print. That would be a failure.
  So those are my concerns, and I will object with every ability I 
have, I will utilize every tool I have to ensure that whatever bill 
hits this floor, that Senators and the American people have time to 
evaluate it and an opportunity to know what is in it. But there are 
ways that this time and opportunity can be denied if the leadership is 
determined and can get the support. We could deny the American people 
that right, and it would be wrong to do so.
  I thank the Chair, and I yield the floor.
  The PRESIDING OFFICER. The Senator from Kansas is recognized.
  Mr. BROWNBACK. I ask unanimous consent to speak as in morning 
business for up to 15 minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                     Tornado in Greensburg, Kansas

  Mr. BROWNBACK. Madam President, I just returned from Greensburg, KS, 
yesterday, where we had a horrific tornado hit late Friday evening. I 
want to share with my colleagues some of the damage assessments, some 
of the pictures of what has taken place, and some of the needs we have 
for this community. It is a community I have been to a number of times 
while serving in different positions in Kansas. It is a wonderful 
community, full of community spirit, with people who have been there 
for a number of years. They have a celebration around a hand-dug well 
that is kind of an unusual event. It is

[[Page 11586]]

the world's largest hand-dug well. You can go to the bottom of it, and 
I have done that.
  Greensburg is a community with a lot of spirit in the middle of the 
State and in the middle of our country. Now it is experiencing this 
tremendous devastation. The tornado covered 40 miles in 90 minutes. It 
was first spotted at 8:24 p.m. last Friday 3 miles south of Sitka, KS, 
in Clark County.
  The tornado tracked through six counties: Comanche, Kiowa, Edwards, 
Stafford, Pratt, and Barton. At 9:45 p.m., the tornado demolished 
Greensburg before wrapping north and dissipating before 10 p.m. 
Fortunately, the National Weather Service and a weather man out of 
Dodge City spotted it and warned the community, and the community had 
about a 20-minute warning that a tornado was coming and that it was a 
big one.
  When Greensburg was struck, the tornado's wind forces exceeded 205 
miles per hour, falling into the highest category on the Enhanced 
Fujita Scale, EF-5. The size of the tornado was 1.7 miles in diameter, 
which, if you know anything about tornadoes, is enormous. Twelve people 
have died as a result of this storm cell. They found another two 
individuals yesterday.
  When a tornado hits--and you will see pictures here--often the houses 
will blow up in the process because of the air pressure outside of the 
house that is much reduced from the air pressure in the house, and 
there will be a blowing up of the house, or the wind comes in and hits 
it. It can be destroyed by the wind.
  Thirteen people are still in the hospital, with four of them in 
critical condition today. There was some good news on Sunday. We found 
a person still alive underneath the rubble.
  Ninety percent of the town has been destroyed, from Greensburg to the 
Northeast, which was hit by multiple tornadoes that were spawned by the 
same supercell thunderstorm. It is an older community. More than 50 
percent of the population is 45 years of age or older, and 25 percent 
of the population is 65 years of age or older. Primarily, the economic 
drivers of the community are farming and oil and gas production.
  We will need substantial assistance. I want to show pictures from the 
wreckage I toured yesterday. I am pleased to note that the President is 
coming tomorrow. I was there yesterday with the Governor and several 
members of the congressional delegation. Senator Roberts was there on 
Saturday. It is devastating to see.
  Here you see a structure left standing there, which is a grain 
elevator. That is really the only structure left standing in the town. 
The courthouse is standing, but its roof has been ripped off. It is 
amazing people can actually survive something like this. Most people 
have storm shelters or basements they can go into, and they did with 
the warning, and some called other people in the community. All of 
these trees were denuded in the area, and the whole place was ripped 
and torn into shreds in the county and in this particular community.
  This is one of the main structures in the downtown area of 
Greensburg. All of the brick around it is damaged.
  They were able to keep the Greensburg sign still posted in this 
picture. These were taken when the storm system was still in the area. 
There was a tornado the next day within a mile of Greensburg, from the 
same supercell system. It dumped 10, 12 inches of rain in northeast 
Kansas.
  You can still see ominous-looking clouds in this photo. It was very 
dicey over the entire weekend.
  This was one of the more stable houses that remains standing in the 
area. I went into a house that was somewhat like this, which was built 
almost 100 years ago. I talked with the owner. They were going to 
celebrate the 100-year anniversary for the house, which was built in 
1908. He said, ``We didn't quite make it.'' The house is going to be 
demolished now. It will not survive.
  This is a view of some of the damage to vehicles. This is a blank 
landscape in the backdrop. I wanted to give some views of what has 
taken place in the community. It has been completely and utterly 
destroyed.
  I would like to note that FEMA has been questioned by me and by a 
number of my colleagues. Prior to Katrina, it had done a lot of good 
work that people had respected and appreciated. They felt there was a 
good group on the job. But then Katrina happened and you looked and 
said: Where is the FEMA that I knew that would go in and respond in 
these situations? We are watching carefully to see how FEMA responds to 
our situation, to our devastation.
  I am pleased to state--and I talked with a number of individuals in 
the community--they are meeting the needs. The needs of the community 
are being met. They are there on the grounds, being aggressive in 
dealing with it. The people appreciate they are there. We are going to 
watch and make sure all of their needs are met.
  I will ask my colleagues for assistance as well. This is a small, 
older community. It lacks much in the way of resources. We need help in 
this particular situation. We are going to be pushing--Senator Roberts 
and I--for 100-percent coverage on public assistance and on matters 
such as debris removal and repair and rebuilding public facilities: 
city hall, fire stations, hospitals, water/wastewater, city powerplant, 
and gas and diesel generators. The community lacks the resources to 
meet these needs. We will look to remove the 25-percent local match for 
FEMA funds. The entire town and their economy was destroyed. There is 
no way Greensburg can come up with the match of funds that is necessary 
in this community.
  I also want to try something innovative. This is a community in the 
High Plains. The New Homestead Act is a bill that Senator Dorgan from 
North Dakota and I have been pushing for some time. I have been a lead 
cosponsor. As I said, it is a bill called the New Homestead Act. We 
have had many communities drained in the High Plains, particularly in 
the Midwest, because of a consolidation in agriculture primarily, but 
also other features, to where we have had out-migration in huge areas. 
This is a county that has experienced a lot of out-migration. I would 
like to see us use Kiowa County--Greensburg is the county seat--as a 
pilot project for the New Homestead Act.
  The biggest concern, once we complete cleanup, is getting the people 
and their businesses back up and going. Here is a chance for us, given 
the level of public commitment in place and the desire to rebuild this 
community, to try this New Homestead Act that can work as a magnet to 
attract people back into these communities that have had difficulty 
transitioning from an agricultural economy to something else. This bill 
is to encourage people to move to rural areas that have depopulated. 
This bill will help repay college tuition loans for people who move 
back into the community, help folks buy their first home and set up 
individual homestead accounts to help people save for the future. Also, 
this bill will help pump capital to Main Street America through a rural 
venture capital fund.
  I think these are things we can look at and say let's try this here 
and let's see it work. Let's see what we can model off of to help many 
places in the High Plains that have experienced this depopulation. We 
will be pushing also for an enhanced USDA rural development package.
  There has been a controversy coming up that I think is unfortunate. 
That has been the question about whether there has been enough 
equipment from the National Guard--the Kansas National Guard, on the 
ground in Greensburg to take care of this atrocity, this disaster, or 
has too much been diverted to the war on terrorism and in Iraq. 
Yesterday, I asked specifically the Kansas adjutant general--the head 
of the Kansas National Guard: Do you have enough equipment on the 
ground to take care of Greensburg? He said: Yes, we have enough 
equipment.
  I made the point: If you don't, we are going to push Fort Riley and 
other places to come up with this equipment.
  He said: No, we have enough equipment.
  Unfortunately, this has grown into a bit of a controversy as to 
whether

[[Page 11587]]

there is sufficient equipment or if too much has been diverted to Iraq. 
The specific statement by Kansas' head of the National Guard--the 
adjutant general--says there is sufficient equipment on the ground to 
meet this need. I think it is important that be stated and that be 
clear because these needs are existing, but they are being met and the 
equipment is there.
  I want to make sure that we can respond. I want to note, finally, to 
anybody who is interested, fortunately, because of the nature of the 
country and generous people in the United States, they want to help. 
They want to know what they can do for the people of Greensburg.
  There are three places that I suggest they look to contribute: the 
American Red Cross, Salvation Army, and the United Way of the Plains in 
Wichita, KS. Those three groups are ones that are receiving and 
funneling funds into Greensburg. Being a small community, it didn't 
have these sorts of organizations there. But these groups do work. Cash 
donations are being accepted. There is no current need for donations 
in-kind, but I hope people will look back and come back in the future 
and consider that on in-kind items. Those groups would be helpful. The 
United Way of the Plains established a Greensburg disaster fund to 
which people can contribute. I hope people will consider contributing 
to those three entities.
  We have a number of different groups that are stepping up, including 
Pizza Huts through Kansas, which are donating 20 percent of their 
profits on Thursday, May 10, to go to this United Way of the Plains--
the Greensburg disaster fund. I hope other groups will also do that so 
Greensburg can rebuild and renew itself and grow into the future. These 
are tough times for this community, but it is a resilient community.
  It impresses me when you see horrific disasters such as this, just a 
complete devastation, and you talk to the people and they want to 
rebuild and dig out and they want to go on. That is the resilience of 
the human spirit in the face of a horrendous disaster, loss of life and 
property, and a loss of almost an entire community. The people there 
were talking about how to rebuild. It is beautiful to see that.
  We mourn their losses. The people of Greensburg and Kansas are 
thankful for all the prayers people have given for that community, in 
all of their tragedy and difficulty. They will be back and they will 
rebuild and they will go forward and raise the next generation of 
families in Greensburg and Kiowa County.
  The country is going to help out, and I think the country will help 
in a powerful, positive way, and we will celebrate as Greensburg comes 
back.
  I yield the floor and suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. REID. Madam President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                                  Iraq

  Mr. REID. Madam President, today is a somber day in Nevada. Last 
night, a helicopter crashed in Austin, NV, killing all five crew 
members on board. It is believed the flight was from Fallon Naval Air 
Station.
  Also yesterday, Nevada lost another soldier in Iraq--25-year-old SGT 
Coby Schwab--to an improvised explosive device.
  Our State and our Nation mourn the loss of all six servicemembers who 
served with honor and courage. Our hearts and our prayers are with the 
families.
  No one wants success in Iraq more than we in the Senate. I can think 
of no greater tribute we can pay to those six servicemembers and the 
more than 3,300 others who have lost their lives in Iraq than to reach 
a responsible and successful end to the war which has cost so much in 
so many different ways.
  The Washington Post this morning ran an article entitled ``The Cost 
of War, Unnoticed.'' It tells us that the war in Iraq is about to 
become the most expensive conflict in United States history, after 
World War II. But unlike World War II, which was fought all over the 
world--in faraway Japan, Africa, all the islands in the South Seas, all 
over Europe--the Iraq conflict is taking place in a country the size of 
the State of California.
  Also unlike past wars, President Bush is putting the costs squarely 
on the shoulders of our children and grandchildren by financing it 
entirely through borrowing and raising the national debt.
  Robert Hormats, a former Republican administration official, says:

       They tried to do this on the cheap and without a candid 
     conversation with the American people about the cost. But the 
     irony is the great wartime leaders have seen it in the 
     opposite way.

  From the beginning, President Bush has called this war a great 
challenge of our time. Yet his actions don't match his rhetoric. He has 
expected sacrifice from our troops now, but has pushed the sacrifice of 
American taxpayers years and years into the future and long past his 
term in office.
  In 18 months, there will be a new election--18 months--to select a 
President. All Americans will continue to bear the financial burden of 
this war in the future, long past a new President assuming office. But 
right now, we are seeing the toll it is taking on our security at home.
  In the wake of the tragic tornadoes that ripped through Kansas this 
past weekend, our National Guard did the best job it could there, a 
fantastic job, and we are grateful for their work, of course, but the 
toll of the war in Iraq crippled the ability of our National Guard to 
do the dangerous and heroic jobs they are charged with doing.
  According to the Governor of Kansas, Kathleen Sebelius:

       Fifty percent of our trucks are gone. Our front loaders are 
     gone. We are missing humvees that move people. We can't 
     borrow them from other States because their equipment is 
     gone. It's a huge issue for States across the country to 
     respond to a disaster like this.

  We can't expect our first responders to keep America safe if they 
don't have the supplies and the equipment to get the job done.
  Our men and women in uniform, both active and in the Guard and 
Reserve, are bearing the bulk of the burden of this war. But we all pay 
a price, whether in death and injury to troops, or whether tremendous 
financial burden not yet fully realized, or whether in the inability of 
the Kansas National Guard to rescue and recover more quickly. That is 
why it is crucial and well past time to change course toward a 
successful and responsible end to the war.
  We continue to negotiate with the White House and our Republican 
colleagues in Congress. We continue to stand firm in our belief that 
the time for a new direction has come. Even some of our Republican 
colleagues who have long supported the President on the war now seem to 
agree it can no longer be open-ended.
  Yesterday my colleague Senator Lott said:

       This fall we have to see some significant changes on the 
     ground.

  Over the weekend, House Minority Leader Boehner said:

       By the time we get to September or October, members are 
     going to want to know how well this is working, and if it 
     isn't, what's Plan B.

  Just yesterday, my colleague Republican Leader McConnell echoed 
Leader Boehner's sentiments.

       I am glad to hear them move to our view, to set their own 
     timeline. But we can't wait until fall. We have to have a 
     responsible plan B right now.

  Plan B gradually reduces combat operations and refocuses our troops 
on protecting America's security throughout the world.
  Our plan B begins to bring troops and equipment home, where they can 
protect American lives in Kansas and across the country.
  Our plan B begins to reduce the financial burden that this war is 
weighing on our shoulders and the shoulders of future generations.
  And our plan B puts the pressure on the Iraqi Government that will 
ultimately lead them to take responsibility for their own future.

[[Page 11588]]

  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. REID. Madam President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. REID. Madam President, there will be no more votes today. The 
managers are working to try to come up with a package that can be 
accepted. As I have indicated, the time on postcloture will run out 
sometime tonight about 10 or 11 o'clock. We hope it is not necessary to 
run the clock that long, but we are going to finish this bill in the 
morning, and we will see how many votes we have. We will try to be 
aware of people's schedules, but the Senate itself has a schedule we 
have to deal with. So we are going to do our best to finish this bill 
tomorrow and move on to other business.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. INHOFE. I ask unanimous consent that the order for the quorum 
call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The remarks of Mr. Inhofe pertaining to the introduction of S. 1335 
are located in today's Record under ``Statements on Introduced Bills 
and Joint Resolutions.'')
  Mr. INHOFE. Madam President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. ISAKSON. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER (Mr. Salazar). Without objection, it is so 
ordered.


                        Tribute to Susan Gordon

  Mr. ISAKSON. Mr. President, I will address the Senate as in morning 
business for a few minutes on two points of great personal privilege 
for me.
  The first is, I read last week of the retirement of Susan Gordon, 
executive secretary and office manager of the Office of Legislative 
Counsel in the Georgia General Assembly. That might seem an odd thing 
for me to come to the Senate floor and talk about, but for me Susan is 
emblematic of all of the people who make us look good in this job of 
public service.
  For 31 years, she served the people of Georgia and the Office of 
Legislative Counsel for the Georgia General Assembly. In my 17 years in 
that assembly, I can think of hundreds of times where Susan stayed late 
or went the extra mile to see to it that legislation was drafted, 
perfected, and got to the floor within the constraints of the general 
assembly. She never played Republicans over Democrats or Democrats over 
Republicans, and she loves the State of Georgia.
  When I learned of Susan's retirement, it only seemed appropriate for 
me to memorialize on the Senate floor to her my appreciation for all 
she has done for me, and countless other legislators who have gone 
before me in Georgia would say precisely the same thing.
  I say for all those others who work in our offices, in legislative 
counsel, and in the departments of government, the unsung heroes of 
this great thing we call democracy and public service, to all the 
``Susan Gordons,'' thank you very much.
  In particular, I thank the Susan Gordon I know in Atlanta, GA. I 
memorialize my thanks and appreciation for her 31 great years of 
service to me and the people of Georgia.


                     Birth of Cecilia Gay Mitchell

  Mr. President, on a second point of personal privilege, at 4:33 p.m. 
on Sunday afternoon, my daughter, Julie, gave birth to Cecilia Gay 
Mitchell, my seventh grandchild.
  With Mother's Day coming up on Sunday, I was struck while on the 
plane flying here on Monday by the generations of people before us, 
what they have done and the importance of family and the importance of 
motherhood.
  You see, Gay is a family name on my wife's side: My wife's great-
grandmother Gay Deam, my wife's mother Gay Davison, my wife Dianne Gay, 
my daughter Julie Gay, and now Cecilia Gay--a fifth generation of Gays, 
all ladies, all but one a mother, all close and treasured by me.
  I will never claim to be the equal of Robert Byrd in terms of his 
great Mother's Day speech, which I think we will all hear on Friday, 
but for me on the celebratory day where I celebrate the birth of a 
seventh grandchild and the fifth-generation Gay in our family and the 
Davison family and the Isakson family, I pay tribute to my daughter 
Julie, her husband Jay, and my expression of thanks to them on behalf 
of Dianne and me for the greatest present that could ever be given to a 
parent--that is the gift of a grandchild, especially a fifth-generation 
Gay.
  I yield the floor. Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. DURBIN. I ask unanimous consent that the order for the quorum 
call be rescinded.
  The PRESIDING OFFICER (Mr. Menendez). Without objection, it is so 
ordered.
  Mr. DURBIN. I ask unanimous consent to speak in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                           Immigration Reform

  Mr. DURBIN. Mr. President, in the coming weeks the Senate will again 
consider legislation to reform our broken immigration system. The 
Presiding Officer has been personally and deeply involved in this issue 
since coming to the Senate. I thank him for his leadership.
  I think we all understand the challenge is substantial. If we want to 
solve the problem, we need a comprehensive approach that is tough but 
fair. We should improve border security by increasing manpower and 
deploying new technology. We should enforce the law against employers 
who are hiring millions of undocumented workers. And we need a 
realistic, honest approach to the 12 million undocumented immigrants 
who live and work in our country illegally.
  Most importantly, we must ensure that immigration reform legislation 
protects the American economy and American workers as well.
  I am concerned about the H-1B visa program as it is currently 
structured. I am afraid it is being abused by foreign companies to 
deprive qualified Americans of good jobs.
  To address this problem, Senator Grassley and I have introduced S. 
1035, the H-1B and L-1 Visa Fraud Abuse Prevention Act of 2007. This is 
a bipartisan bill. It would overhaul the H-1B and L-1 visa programs to 
protect American workers and crack down on unscrupulous employers.
  The H-1B visa program was designed to allow employers to attract and 
hire high-skilled foreign workers with specialized knowledge. H-1B 
visas are probably best known for their use in technology to import 
computer engineers and programmers.
  I can't tell you how many leaders in industry, including one this 
afternoon, come into my office and say: We absolutely need H-1B visas. 
We can't find enough people with specialized education for our 
businesses. If you won't allow us to bring these workers in from 
overseas, we are going to be facing the possibility of taking our 
production facilities overseas where they live.
  It is a compelling argument. I understand it on its face. But let me 
explain some of the problems with the current system and why Senator 
Grassley and I believe the system needs to be changed.
  Supporters claim the goal of the H-1B program is to help the American 
economy by allowing U.S. companies to hire needed foreign workers. The 
reality is that H-1B visas are being used to facilitate the outsourcing 
of American jobs to other countries. It seems counterintuitive that a 
visa that allows people to come into the United States could lead to 
jobs being outsourced overseas, but when you

[[Page 11589]]

hear my illustrations, you will understand the conclusion.
  A recent expose in the International Herald Tribune disclosed that 8 
of the top 10 H-1B visa applicants last year were outsourcing firms 
with major operations in one country--India. So in many cases it wasn't 
the American high tech company using the H-1B visa that was given this 
opportunity but, rather, a firm, more likely in India than any other 
country, that was given the authority to use H-1B visas to send workers 
into the United States. The Herald Tribune concluded:

       As Indian outsourcing companies have become the leading 
     consumers of the [H-1B] visa, they have used to it further 
     their primary mission, which is to gain the expertise 
     necessary to take on critical tasks performed by companies in 
     the United States and perform them in India at a fraction of 
     the cost.

  According to this report, the Indian Government has been lobbying 
hard for the United States Government to increase the number of H-1B 
visas. Kamal Nath, the Indian Commerce Minister, was very blunt when he 
said recently that the H-1B visa ``has become the outsourcing visa.'' 
He concluded:

       If at one point you had X amount of outsourcing and now you 
     have a much higher quantum of outsourcing, you need that many 
     more visas.

  That is a very candid statement by this commerce minister in India. 
It should give us pause as we think about this program, what it was 
designed to do and what it is actually doing.
  In other words, the Indian Government wants more H-1B visas so Indian 
companies can outsource more American jobs to India.
  Let me be clear. India is a valuable American partner in commerce, 
diplomacy, and many other endeavors. Indians who have come to the 
United States have made immeasurable contributions to the benefit of 
our country in so many ways. I trust them as great friends. But some in 
India today understand that we have a weakness in our visa system and 
are using it for their own economic advantage.
  It is not surprising the Indian Government is advocating on behalf of 
Indian companies. The American Government should advocate on behalf of 
American companies. I don't criticize the Indian Government for doing 
that. But we should expect the same from our Government for our 
workers. We need to stand up to make sure American workers don't lose 
their jobs to outsourcing because of H-1B visas.
  H-1B supporters claim we need more H-1B visas to stop American jobs 
from being outsourced. That was the logic behind H-1B visas. It appears 
the opposite is true. Under the current system, more H-1B visas will 
mean more outsourcing.
  Let me give an example. Indian outsourcing company Wipro was No. 2 on 
the list of top applicants for H-1B visas in the year 2006. Wipro has 
more than 4,000 employees in the United States, and approximately 2,500 
of them are here on H-1B visas. It is pretty clear that when it comes 
to Wipro's American operation, the majority of the workers are here on 
H-1B visas. Every year Wipro brings 1,000 new temporary workers here 
from India, while they send another 1,000 U.S. trained workers back to 
India. This is essentially an outsourcing factory.
  Here is what the Herald Tribune concluded:

       Rather than building a thriving community of experts and 
     innovators in the United States, the Indian firms seek to 
     funnel work--and expertise--away from the country.

  It is hard to believe, but it is perfectly legal to use the H-1B visa 
program for outsourcing. A foreign outsourcing company with a U.S. 
office can use H-1B visas to import workers from their home country, 
train the workers in the United States, and then outsource them back to 
their home country to populate businesses competing with the United 
States. They are not required to make any efforts to recruit American 
workers for these jobs. In fact, they can explicitly discriminate 
against American workers who apply for the same jobs by recruiting and 
hiring only workers from their home country.
  Here is what the Labor Department says about the current law:

       H-1B workers may be hired even when a qualified U.S. worker 
     wants the job, and a U.S. worker can be displaced from the 
     job in favor of a foreign worker.

  Is that what we had in mind with H-1B visas? That certainly wasn't 
the way it was explained to me. In fact, under current law, only 
employers who employ H-1B visa holders as a large percentage of their 
U.S. workforce are required to attempt to recruit American workers 
before bringing in foreign workers.
  Senator Grassley and I have taken a look at this system. We both 
reject the notion that what is wrong with the H-1B program is that we 
need more visas. We have to look at the system that generates these 
visas and the way they are used. The legislation we have introduced 
would overhaul the H-1B program, protecting American workers first, and 
stopping H-1Bs from being exploited as outsourcing visas.
  Here are the highlights. First and foremost, we would require all 
employers who want to hire an H-1B worker to attempt to hire an 
American worker first. Employers would also be prohibited from using H-
1B visas to displace American workers. You can't fire an American and 
turn around and appeal to our Government for an H-1B visa to bring 
someone in from overseas to replace that worker.
  This is an important principle. We have to make it clear that 
companies doing business in the United States have to give first 
priority to American workers.
  Our bill would require that before an employer may hire an H-1B 
worker, the employer must first advertise the job opening to American 
workers for 30 days on the Department of Labor Web site.
  Some companies that abuse the H-1B visa program are so brazen, they 
say ``no Americans need apply'' in their job advertisements. Hundreds 
of such ads have been posted on line. They say things such as ``H-1B 
visa holders only'' or ``we require candidates for H-1B from India.''
  Is that what we have in mind, to create this perverse discrimination 
against American workers? That isn't the way it was explained to me. 
Our H-1B reform bill would prohibit this blatant discriminatory 
practice.
  There is another serious problem with the H-1B visa program. Federal 
oversight is virtually nonexistent. Under current law there are many 
roadblocks to effective Government enforcement. For example, the 
Department of Labor does not have the authority to open an 
investigation of an employer suspected of abusing the H-1B program 
unless the Department receives a formal complaint, even if the 
employer's application is clearly fraudulent. Even if there is a 
complaint, the Labor Secretary--and this is something that is almost 
unique in our law--must personally authorize the opening of an 
investigation.
  These restrictions in the law are aggravated by lax Government 
enforcement. According to the Department of Homeland Security's own 
Inspector General, Homeland Security has violated the law by approving 
thousands of H-1B applications in excess of the annual cap of 65,000. 
The Government Accountability Office found that the Labor Department 
approves over 99.5 percent of H-1B petitions it receives, including 
those that on their face clearly violate the law.
  There is virtually no Government oversight of potential abuse in this 
system. The Labor Department's inspector general has concluded that the 
H-1B program is ``highly susceptible to fraud.'' Remember, this program 
was designed to help the American economy, to help create jobs and 
prosperity in our country. Our Government is not even watching it 
closely to make sure that fraud isn't being perpetrated.
  The bill Senator Grassley and I are proposing would give the 
Government more authority to conduct employer investigations and 
streamline the investigative process. Currently, the Labor Department 
is only authorized to review applications for ``completeness and 
obvious inaccuracies.'' Our bill would give the Labor Department more 
authority to review employers' H-1B applications for ``clear indicators

[[Page 11590]]

of fraud or misrepresentation of material fact.''
  Our bill would authorize the Labor Department to conduct random 
audits of any company that uses the H-1B program and require the 
Department of Labor to conduct annual audits of companies that employ 
large numbers of H-1B workers. We would also increase the penalties for 
companies that violate H-1B visa rules and authorize the hiring of 200 
additional Government investigators to oversee and enforce the H-1B 
program.
  Last month, the government began accepting H-1B visa petitions for 
Fiscal Year 2008. In the first 24 hours, the government received 
150,000 petitions for 65,000 slots, supposedly for the whole year. 
Based on last year's statistics, it is likely that the top petitioners 
for visas were companies from India. They understand the system. They 
understand how to make this profitable. But this is not the way it has 
been described to most Members of Congress. It certainly isn't 
consistent with our intent.
  There is another program I wish to mention, the L-1 visa. The L-1 
visa allows companies to transfer certain employees from foreign 
facilities to the United States for up to 7 years.
  Experts have concluded that some employers use the L-1 program to 
evade restrictions on the H-1B program, because the L-1 program doesn't 
have an annual cap and doesn't include even minimal protections for 
American workers. As a result, efforts to reform the H-1B program are 
unlikely to succeed if the L-1 program is not overhauled at the same 
time.
  The bill Senator Grassley and I have prepared would reform the L-1 
program. We would establish for the first time whistleblower 
protections for those who call attention to employer abuses of L-1 
programs, and for the first time we would authorize the Government to 
investigate and audit L-1 employers suspected of violating the law.
  Before we are persuaded to increase the number of H-1B visas, we have 
to reform the program to protect American workers first and to stop H-
1Bs from being used as outsourcing visas that send jobs and business 
away from America. That is what our bill would do, and that is what 
Senator Grassley and I will be pushing for as the Senate considers 
comprehensive immigration reform legislation.
  I know this immigration debate is contentious, controversial, and 
some think it is politically dangerous, but it is long overdue. The 
current immigration system in America has failed us.
  We now have upwards of 800,000 undocumented immigrants who come 
across the borders each year. That has to change. We have to reach a 
point where we have control of our borders. Some of the measures that 
have been suggested during the course of the debate I think are 
extreme. We don't have to move in that direction.
  I recently met with Senators from Mexico who were visiting the 
Capital last week and encouraged them to join with us in a joint effort 
between the United States and Mexico to police the border, to try to 
make sure there is less exploitation of people who are coming across 
for jobs or for moving drugs or contraband--whatever the reason may be. 
I think more cooperation would go a long way between our two countries.
  We also need to be sensitive and cognizant of the burden facing many 
employers in this country. If someone presents themselves, in downstate 
Illinois in a meat-packing plant, with a name and a Social Security 
number and a local address, what is the responsibility of the employer 
today? It certainly isn't to launch a full-scale investigation. If the 
papers presented to that employer appear to be legal on their face, 
most employers will hire the person. They may learn later on that the 
documents were fraudulent.
  How can we change that system? I think we need to move toward some 
form of identification that is reliable so the person carrying the card 
who is here in a legal and temporary employment status can prove their 
identity to the employer, so that the system is able to police itself 
more.
  We also need to deal with the reality of 12 million undocumented 
people currently here. I know all about these folks because almost 90 
percent of our casework in our Senate office deals with immigration. I 
have met many of them and their families. We need to find a fair way to 
hold them accountable, to make certain that over a period of time they 
can earn their way into legal status. They have to have a job and no 
criminal record; they have to pay a fine, pay their taxes, learn 
English, whatever it takes, to make sure that over a period of time, it 
is clear they have every intention to be a citizen of this country, and 
a good one. In that way, they can earn their way, over many years, into 
a position of citizenship or permanent legal status.
  This country is great because of the immigrants who came here. My 
mother was one of them. I am very proud of that fact and happy to serve 
in a State that would elect me and in a State that has so many 
immigrants who can tell the same story I have to tell.
  I think the immigrant spirit is something that has made America a 
unique country. I think of people who, in their foreign lands, get up 
one day and say: We are not going to take it anymore. We are coming to 
America. We have a better chance. That is the kind of get-up-and-go we 
like to see that has made this a much better country.
  I think we can capture that spirit in real, comprehensive immigration 
reform and avoid abuses such as those I have just described with the H-
1B program and at the end of the day have a program and a law supported 
by both political parties that will really move us forward as a Nation.
  Mr. DURBIN. Mr. President, I yield the floor, and I suggest the 
absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. NELSON of Florida. Mr. President, I ask unanimous consent that 
the order for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                        Automobile Sensor Device

  Mr. NELSON of Florida. Mr. President, in the month of April, 16 
children in this country have been backed over and killed by an 
automobile backing out of the driveway. Each of us can visualize what I 
am saying right now because we have a car in the garage or in our home 
driveway, we walk around to make sure there are no obstructions and 
then get into our car, and we really don't know that a small child may, 
in fact, have gotten in the way.
  Last year, over 200 children in this country--in the United States 
alone--over 200 children were killed by these kinds of accidents. Last 
month, of the 16 who were killed nationwide, 3 of them were in Florida. 
I have had come to me moms and dads who have agonized and who have gone 
through the grieving of losing a child. A couple from Boca Raton, FL, 
who have spurred a national effort, came to me. Their child was only 5 
feet in front of the mom, and out backs a car as they are walking down 
the sidewalk and it was too late; that child is gone.
  It is so easily fixable with our technology. If you rent an Avis 
rent-a-car and it is a high-end car, it already has a built-in device 
that has a sensor in the back. Higher end automobiles such as the Lexus 
have a television screen with a little camera mounted in the rear. The 
sensor emits a beep, and the frequency of the beep increases as you get 
closer and closer to an object. It is estimated that such a device may 
cost in the range of $50.
  So the question is, Are we going to encourage the automobile 
manufacturers to include this to stop these kinds of needless deaths? 
Increasingly, the Members of the Senate are going to hear from moms and 
dads who have gone through the grief of losing a child that could have 
been prevented. So it is my hope we will get some action.
  I now bring to the attention of the Senate that it is my 
understanding this is getting ready to be put on the consent calendar 
in the House of Representatives, and it is my understanding we would 
consider this under unanimous consent here in the Senate, and we could 
then save some children's

[[Page 11591]]

lives; otherwise, their parents will grieve forever.
  Mr. President, I yield the floor, and I suggest the absence of a 
quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. BROWN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                                 Trade

  Mr. BROWN. Mr. President, our trade policy is fundamentally flawed. 
Years of wrongheaded trade pacts have sent millions of jobs overseas 
and have devastated far too many of our communities and have opened our 
Nation to new and serious homeland security concerns.
  When we open our borders to trade, as we should, we open them to 
national security threats. Congress must assure the American people 
that we have done everything within our power to protect their safety, 
health, and welfare while promoting trade.
  It is estimated that less than 10 percent of foreign cargo is 
inspected before entering our country--only 10 percent.
  We must both ensure our ports are operating securely and with clear 
lines of accountability--unlike the deal to transfer ownership of six 
U.S. ports to a State-owned company controlled by the United Arab 
Emirates that this administration approved about a year ago.
  The decision to allow a UAE-controlled company had significant 
national security implications, including warnings that the UAE was a 
financial and travel outlet for known terrorists. It took leaders of 
both political parties, here and in the House of Representatives, to 
call attention to this enormous blunder.
  Something else may be happening. This administration has recently 
signed a free-trade deal with South Korea and will soon ask this 
Congress to approve it under fast track, or trade promotion authority. 
One of the major goals South Korea sought in these negotiations was 
securing special treatment for products made in the Kaesong Industrial 
Complex, located in North Korea.
  In Kaesong, South Korea, companies employ more than 11,000 North 
Korean workers. South Korea intends to expand the complex over the next 
few years and will employ close to 70,000--70,000--North Koreans by the 
end of this year, according to a Congressional Research Service report. 
U.S. negotiators had vehemently opposed including the Kaesong complex 
in the trade deal. But then, in a rush to sign a deal, our trade 
negotiators backed off--as they too often do when it comes to 
representing our national interests--and allowed room for future 
negotiations on the Kaesong complex.
  This is a dangerous precedent, and it opens this agreement to a 
series of national security questions:
  How much income, for example, does this Kaesong complex currently 
provide the North Korean Government? How much income can we anticipate 
it providing North Korea under its expansion plans? How are these North 
Korean workers treated? Under a fair trade agreement, would our 
government's actions be no different than the repressive North Korean 
Government?
  Free-trade agreements, as currently written, live well beyond 
political administrations. We can't predict the future decisions and 
intentions of the South Korean Government, nor any other trading 
partners. As national security concerns continue to accompany efforts 
to promote trade, Congress must take proactive steps to ensure our 
homeland security needs are secured every bit as much as our economic 
well-being.
  Last week, Senator Dorgan of North Dakota and I introduced the Trade-
Related American National Security Enhancement and Accountability--
TRANSEA--Act. This act requires the Office of U.S. Trade 
Representative, in collaboration with the Department of State, the 
Department of Justice, the Department of Homeland Security, and the 
Department of Agriculture to submit a report to Congress detailing the 
national security considerations of proposed trade agreements prior to 
commencing negotiations and the trade agreement again after concluding 
the trade negotiations.
  The bill also requires future trade agreements negotiated by the 
administration to include a national security waiver that allows the 
President to suspend any terms of the agreement should it be required 
in the interests of United States national security.
  Lastly, as a final safeguard, the legislation creates a new 
Congressional Executive Commission on Trade Security, which requires 
the appointment of Commissioners by both political parties in both 
Chambers of this Congress. The Commissioners will be charged with 
annually certifying that the terms of the free-trade agreement do not 
pose a threat to U.S. national security interests.
  Should the Commission find that compliance with the agreement would 
pose a threat, the President would be obligated to exercise his or her 
waiver to the extent necessary to ensure the safety and security of the 
United States.
  In a post-9/11 world, U.S. economic policy can no longer be simply 
viewed in a vacuum of bottom lines and profit margins. Homeland 
Security Secretary Michael Chertoff said in 2006:

       We have to balance the paramount urgency of security 
     against the fact that we still want to have a robust global 
     trading system.

  It is the responsibility of our Government to ensure that while 
opening markets for our exporters--again, as we should--our first 
priority remains the safety and the security of the American people.
  Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. BROWN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. BROWN. Mr. President, I, first, thank Senator Enzi, the 
distinguished Senator from Wyoming, for his terrific work, both as the 
ranking member of the Health, Education, Labor and Pension Committee, 
but more precisely today and yesterday for the work he has done on this 
legislation in working out agreements on a set of very complicated 
issues.
  His staff has been terrific in explaining some of the more archaic 
parts of this legislation, and I am very appreciative. I know Senator 
Kennedy is very appreciative, and I know Members on both sides of the 
aisle are as well. So I thank him for his leadership and his 
reasonableness in helping us to move forward in a particularly 
important way on this very important bill.


                      Unanimous-Consent Agreement

  Mr. President, I ask unanimous consent that it be in order for the 
Senate to consider, en bloc, the following list of amendments that has 
been cleared by both managers; that the amendments, as modified, if 
modified, be considered and agreed to, the motions to reconsider be 
laid upon the table:
  Amendments Nos. 985, 1011, 1009, 1026, 987, 1006, 1005, 1004, 1041, 
1019, 1053, 1050, 1049, 1047 and 1056; and that amendments Nos. 983 and 
988 be withdrawn; that a colloquy between Senators Gregg and Kennedy be 
entered into the Congressional Record and then amendment No. 993 be 
withdrawn; further that any statements relating to amendments in this 
agreement be inserted in the Record; that when the Senate resumes 
consideration of S. 1082 tomorrow, Wednesday, May 9, the only 
amendments remaining in order be the following:
  Grassley amendment No. 1039, a Grassley amendment No. 998, and a 
Durbin amendment No. 1034; that at the close of morning business, the 
Senate resume S. 1082, and there be a total of 60 minutes of debate 
remaining, to run concurrently on the bill and remaining amendments; 
with 10 minutes under the control of Senator Grassley or his designee; 
5 minutes under the control of Senator Durbin or his designee; and the 
remaining time equally divided and controlled between the chairman and 
ranking member or their

[[Page 11592]]

designees; that upon the use or yielding back of that time, there be 2 
minutes of debate equally divided and controlled prior to a vote in 
relation to the Grassley amendment No. 1039; that upon disposition of 
that amendment, there be 2 minutes of debate prior to a vote in 
relation to the Grassley amendment No. 998; that upon disposition of 
that amendment, there be 2 minutes of debate prior to a vote in 
relation to the Durbin amendment No. 1034; that upon disposition of 
that amendment, the committee substitute, as modified and amended, be 
agreed to, and the motion to reconsider be laid upon the table; the 
bill be read for a third time; the Senate proceed to vote on passage of 
the bill; with the above occurring without further intervening action 
or debate; that upon passage the motion to reconsider be laid upon the 
table, and the title amendment, which is at the desk, be agreed to and 
the motion to reconsider be laid upon the table; further, that the 
cloture motion on the bill be withdrawn.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendments were agreed to, as follows:


                     amendment no. 985, as modified

       At the appropriate place, insert the following:

     SEC. __. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL 
                   DISEASES.

       Subchapter A of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR 
                   TROPICAL DISEASES.

       ``(a) Definitions.--In this section:
       ``(1) AIDS.--The term `AIDS' means the acquired immune 
     deficiency syndrome.
       ``(2) AIDS drug.--The term `AIDS drug' means a drug 
     indicated for treating HIV.
       ``(3) HIV.--The term `HIV' means the human immunodeficiency 
     virus, the pathogen that causes AIDS.
       ``(4) Neglected or tropical disease.--The term `neglected 
     or tropical disease' means--
       ``(A) HIV, malaria, tuberculosis, and related diseases; or
       ``(B) any other infectious disease that disproportionately 
     affects poor and marginalized populations, including those 
     diseases targeted by the Special Programme for Research and 
     Training in Tropical Diseases cosponsored by the United 
     Nations Development Program, UNICEF, the World Bank, and the 
     World Health Organization.
       ``(5) Priority review.--The term `priority review', with 
     respect to a new drug application described in paragraph (6), 
     means review and action by the Secretary on such application 
     not later than 180 days after receipt by the Secretary of 
     such application, pursuant to the Manual of Policies and 
     Procedures of the Food and Drug Administration.
       ``(6) Priority review voucher.--The term `priority review 
     voucher' means a voucher issued by the Secretary to the 
     sponsor of a tropical disease product that entitles such 
     sponsor, or a person described under subsection (b)(2), to 
     priority review of a new drug application submitted under 
     section 505(b)(1) after the date of approval of the tropical 
     disease product.
       ``(7) Tropical disease product.--The term `tropical disease 
     product' means a product that--
       ``(A) is a new drug, antibiotic drug, biological product, 
     vaccine, device, diagnostic, or other tool for treatment of a 
     neglected or tropical disease; and
       ``(B) is approved by the Secretary for use in the treatment 
     of a neglected or tropical disease.
       ``(b) Priority Review Voucher.--
       ``(1) In general.--The Secretary shall award a priority 
     review voucher to the sponsor of a tropical disease product 
     upon approval by the Secretary of such tropical disease 
     product.
       ``(2) Transferability.--The sponsor of a tropical disease 
     product that receives a priority review voucher under this 
     section may transfer (including by sale) the entitlement to 
     such voucher to a sponsor of a new drug for which an 
     application under section 505(b)(1) will be submitted after 
     the date of the approval of the tropical disease product.
       ``(3) Limitation.--A sponsor of a tropical disease product 
     may not receive a priority review voucher under this section 
     if the tropical disease product was approved by the Secretary 
     prior to the date of enactment of this section.
       ``(c) Priority Review User Fee.--
       ``(1) In general.--The Secretary shall establish a user fee 
     program under which a sponsor of a drug that is the subject 
     of a priority review voucher shall pay to the Secretary a fee 
     determined under paragraph (2). Such fee shall be in addition 
     to any fee required to be submitted by the sponsor under 
     chapter VII.
       ``(2) Fee amount.--The amount of the priority review user 
     fee shall be determined each fiscal year by the Secretary and 
     based on the anticipated costs to the Secretary of 
     implementing this section.
       ``(3) Annual fee setting.--The Secretary shall establish, 
     before the beginning of each fiscal year beginning after 
     September 30, 2007, for that fiscal year, the amount of the 
     priority review user fee.
       ``(4) Payment.--
       ``(A) In general.--The fee required by this subsection 
     shall be due upon the filing of the new drug application 
     under section 505(b)(1) for which the voucher is used.
       ``(B) Complete application.--An application described under 
     subparagraph (A) for which the sponsor requests the use of a 
     priority review voucher shall be considered incomplete if the 
     fee required by this subsection is not included in such 
     application.
       ``(5) Offsetting collections.--Fees collected pursuant to 
     this subsection for any fiscal year--
       ``(A) shall be deposited and credited as offsetting 
     collections to the account providing appropriations to the 
     Food and Drug Administration; and
       ``(B) shall not be collected for any fiscal year except to 
     the extent provided in advance in appropriation Acts.''.


                    amendment no. 1011, as modified

       At the appropriate place, insert the following:

     SEC. __. CITIZENS PETITIONS AND PETITIONS FOR STAY OF AGENCY 
                   ACTION.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), as amended by this Act, is amended by adding at 
     the end the following:
       ``(s) Citizen Petitions and Petitions for Stay of Agency 
     Action.--
       ``(1) In general.--
       ``(A) No delay of consideration or approval.--
       ``(i) In general.--With respect to a pending application 
     submitted under subsection (b)(2) or (j), if a petition is 
     submitted to the Secretary that seeks to have the Secretary 
     take, or refrain from taking, any form of action relating to 
     the approval of the application, including a delay in the 
     effective date of the application, clauses (ii) and (iii) 
     shall apply.
       ``(ii) No delay of consideration or approval.--Except as 
     provided in clause (iii), the receipt and consideration of a 
     petition described in clause (i) shall not delay 
     consideration or approval of an application submitted under 
     subsection (b)(2) or (j).
       ``(iii) No delay of approval without determination.--The 
     Secretary shall not delay approval of an application 
     submitted under subsection (b)(2) or (j) while a petition 
     described in clause (i) is reviewed and considered unless the 
     Secretary determines, not later than 25 business days after 
     the submission of the petition, that a delay is necessary to 
     protect the public health.
       ``(B) Determination of delay.--With respect to a 
     determination by the Secretary under subparagraph (A)(iii) 
     that a delay is necessary to protect the public health the 
     following shall apply:
       ``(i) Not later than 5 days after making such 
     determination, the Secretary shall publish on the Internet 
     website of the Food and Drug Administration a detailed 
     statement providing the reasons underlying the determination. 
     The detailed statement shall include a summary of the 
     petition and comments and supplements, the specific 
     substantive issues that the petition raises which need to be 
     considered prior to approving a pending application submitted 
     under subsection (b)(2) or (j), and any clarifications and 
     additional data that is needed by the Secretary to promptly 
     review the petition.
       ``(ii) Not later than 10 days after making such 
     determination, the Secretary shall provide notice to the 
     sponsor of the pending application submitted under subsection 
     (b)(2) or (j) and provide an opportunity for a meeting with 
     appropriate staff as determined by the Commissioner to 
     discuss the determination.
       ``(2) Timing of final agency action on petitions.--
       ``(A) In general.--Notwithstanding a determination made by 
     the Secretary under paragraph (1)(A)(iii), the Secretary 
     shall take final agency action with respect to a petition not 
     later than 180 days of submission of that petition unless the 
     Secretary determines, prior to the date that is 180 days 
     after the date of submission of the petition, that a delay is 
     necessary to protect the public health.
       ``(B) Determination of delay.--With respect to a 
     determination by the Secretary under subparagraph (A) that a 
     delay is necessary to protect the public health the following 
     shall apply:
       ``(i) Not later than 5 days after making the determination 
     under subparagraph (A), the Secretary shall publish on the 
     Internet website of the Food and Drug Administration a 
     detailed statement providing the reasons underlying the 
     determination. The detailed statement should include the 
     state of the review of the petition, the specific outstanding 
     issues that still need to be resolved, a proposed timeframe 
     to resolve the issues, and any additional information that 
     has been requested by the Secretary of the petitioner or 
     needed by the Secretary in order to resolve the petition and 
     not further delay an application filed under subsection 
     (b)(2) or (j).

[[Page 11593]]

       ``(ii) Not later than 10 days after making the 
     determination under subparagraph (A), the Secretary shall 
     provide notice to the sponsor of the pending application 
     submitted under subsection (b)(2) or (j) and provide an 
     opportunity for a meeting with appropriate staff as 
     determined by the Commissioner to discuss the determination.
       ``(3) Verifications.--
       ``(A) Petitions for review.--The Secretary shall not accept 
     a petition for review unless it is signed and contains the 
     following verification: `I certify that, to my best knowledge 
     and belief: (a) this petition includes all information and 
     views upon which the petition relies; (b) this petition 
     includes representative data and/or information known to the 
     petitioner which are unfavorable to the petition; and (c) 
     information upon which I have based the action requested 
     herein first became known to the party on whose behalf this 
     petition is filed on or about __________. I received or 
     expect to receive payments, including cash and other forms of 
     consideration, from the following persons or organizations to 
     file this petition: ________. I verify under penalty of 
     perjury that the foregoing is true and correct.', with the 
     date of the filing of such petition and the signature of the 
     petitioner inserted in the first and second blank space, 
     respectively.
       ``(B) Supplemental information.--The Secretary shall not 
     accept for review any supplemental information or comments on 
     a petition unless the party submitting such information or 
     comments does so in written form and that the subject 
     document is signed and contains the following verification: 
     `I certify that, to my best knowledge and belief: (a) I have 
     not intentionally delayed submission of this document or its 
     contents; and (b) the information upon which I have based the 
     action requested herein first became known to me on or about 
     __________. I received or expect to receive payments, 
     including cash and other forms of consideration, from the 
     following persons or organizations to submit this information 
     or its contents: _____. I verify under penalty of perjury 
     that the foregoing is true and correct.', with the date of 
     the submission of such document and the signature of the 
     petitioner inserted in the first and second blank space, 
     respectively.
       ``(4) Annual report on delays in approvals per petition.--
     The Secretary shall annually submit to the Congress a report 
     that specifies--
       ``(A) the number of applications under subsection (b)(2) 
     and (j) that were approved during the preceding 1-year 
     period;
       ``(B) the number of petitions that were submitted during 
     such period;
       ``(C) the number of applications whose effective dates were 
     delayed by petitions during such period and the number of 
     days by which the applications were so delayed; and
       ``(D) the number of petitions that were filed under this 
     subsection that were deemed by the Secretary under paragraph 
     (1)(A)(iii) to require delaying an application under 
     subsection (b)(2) or (j) and the number of days by which the 
     applications were so delayed.
       ``(5) Exception.--This subsection does not apply to a 
     petition that is made by the sponsor of the application under 
     subsection (b)(2) or (j) and that seeks only to have the 
     Secretary take or refrain from taking any form of action with 
     respect to that application.
       ``(6) Report by inspector general.--The Office of Inspector 
     General of the Department of Health and Human Services shall 
     issue a report not later than 2 years after the date of 
     enactment of this subsection evaluating evidence of the 
     compliance of the Food and Drug Administration with the 
     requirement that the consideration by the Secretary of 
     petitions that do not raise public health concerns remain 
     separate and apart from the review and approval of an 
     application submitted under subsection (b)(2) or (j).
       ``(7) Definition.--For purposes of this subsection, the 
     term `petition' includes any request for an action described 
     in paragraph (1)(A)(i) to the Secretary, without regard to 
     whether the request is characterized as a petition.''.


                    amendment no. 1009, as modified

       At the end of title II, insert the following:

             Subtitle __--Antibiotic Access and Innovation

     SEC. 2__. INCENTIVES FOR THE DEVELOPMENT OF, AND ACCESS TO, 
                   CERTAIN ANTIBIOTICS.

       (a) In General.--Section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355), as amended by this Act, is 
     further amended by adding at the end the following:
       ``(s) Antibiotic Drugs Submitted Before November 21, 
     1997.--
       ``(1) Antibiotic drugs approved before november 21, 1997.--
       ``(A) In general.--Notwithstanding any provision of the 
     Food and Drug Administration Modernization Act of 1997 or any 
     other provision of law, a sponsor of a drug that is the 
     subject of an application described in subparagraph (B)(i) 
     shall be eligible for, with respect to the drug, the 3-year 
     exclusivity period referred to under clauses (iii) and (iv) 
     of subsection (c)(3)(E) and under clauses (iii) and (iv) of 
     subsection (j)(5)(F), subject to the requirements of such 
     clauses, as applicable.
       ``(B) Application; antibiotic drug described.--
       ``(i) Application.--An application described in this clause 
     is an application for marketing submitted under this section 
     after the date of enactment of this subsection in which the 
     drug that is the subject of the application contains an 
     antibiotic drug described in clause (ii).
       ``(ii) Antibiotic drug.--An antibiotic drug described in 
     this clause is an antibiotic drug that was the subject of an 
     application approved by the Secretary under section 507 of 
     this Act (as in effect before November 21, 1997).
       ``(2) Antibiotic drugs submitted before november 21, 1997, 
     but not approved.--
       ``(A) In general.--Notwithstanding any provision of the 
     Food and Drug Administration Modernization Act of 1997 or any 
     other provision of law, a sponsor of a drug that is the 
     subject of an application described in subparagraph (B)(i) 
     may elect to be eligible for, with respect to the drug--
       ``(i)(I) the 3-year exclusivity period referred to under 
     clauses (iii) and (iv) of subsection (c)(3)(E) and under 
     clauses (iii) and (iv) of subsection (j)(5)(F), subject to 
     the requirements of such clauses, as applicable; and
       ``(II) the 5-year exclusivity period referred to under 
     clause (ii) of subsection (c)(3)(E) and under clause (ii) of 
     subsection (j)(5)(F), subject to the requirements of such 
     clauses, as applicable; or
       ``(ii) a patent term extension under section 156 of title 
     35, United States Code, subject to the requirements of such 
     section.
       ``(B) Application; antibiotic drug described.--
       ``(i) Application.--An application described in this clause 
     is an application for marketing submitted under this section 
     after the date of enactment of this subsection in which the 
     drug that is the subject of the application contains an 
     antibiotic drug described in clause (ii).
       ``(ii) Antibiotic drug.--An antibiotic drug described in 
     this clause is an antibiotic drug that was the subject of 1 
     or more applications received by the Secretary under section 
     507 of this Act (as in effect before November 21, 1997), none 
     of which was approved by the Secretary under such section.
       ``(3) Limitations.--
       ``(A) Exclusivities and extensions.--Paragraphs (1)(A) and 
     (2)(A) shall not be construed to entitle a drug that is the 
     subject of an approved application described in subparagraphs 
     (1)(B)(i) or (2)(B)(i), as applicable, to any market 
     exclusivities or patent extensions other than those 
     exclusivities or extensions described in paragraph (1)(A) or 
     (2)(A).
       ``(B) Conditions of use.--Paragraphs (1)(A) and (2)(A)(i) 
     shall not apply to any condition of use for which the drug 
     referred to in subparagraph (1)(B)(i) or (2)(B)(i), as 
     applicable, was approved before the date of enactment of this 
     subsection.
       ``(4) Application of certain provisions.--Notwithstanding 
     section 125, or any other provision, of the Food and Drug 
     Administration Modernization Act of 1997, or any other 
     provision of law, and subject to the limitations in 
     paragraphs (1), (2), and (3), the provisions of the Drug 
     Price Competition and Patent Term Restoration Act of 1984 
     shall apply to any drug subject to paragraph (1) or any drug 
     with respect to which an election is made under paragraph 
     (2)(A).''.
       (b) Transition Rule.--With respect to a patent issued on or 
     before the date of enactment of this Act, any patent 
     information required to be filed with the Secretary under 
     subsection (b)(1) or (c)(2) of section 505 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355) to be listed on 
     a drug to which subsection (s)(1) of such section 505 (as 
     added by this section) applies shall be filed with such 
     Secretary not later than 60 days after the date of enactment 
     of this Act.

     SEC. 2__. ANTIBIOTICS AS ORPHAN PRODUCTS.

       (a) Public Meeting.--The Commissioner of Food and Drugs 
     shall convene a public meeting and, if appropriate, issue 
     guidance, regarding which serious and life-threatening 
     infectious diseases, such as diseases due to gram-negative 
     bacteria and other diseases due to antibiotic-resistant 
     bacteria, potentially qualify for available grants and 
     contracts under subsection (a) of section 5 of the Orphan 
     Drug Act (21 U.S.C. 360ee(a)) or other incentives for 
     development.
       (b) Grants and Contracts for the Development of Orphan 
     Drugs.--Subsection (c) of section 5 of the Orphan Drug Act 
     (21 U.S.C. 360ee(c)) is amended to read as follows:
       ``(c) For grants and contracts under subsection (a) there 
     are authorized to be appropriated--
       ``(1) such sums as already have been appropriated for 
     fiscal year 2007; and
       ``(2) $35,000,000 for each of fiscal years 2008 through 
     2012.''.

     SEC. 2__. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE 
                   CONCENTRATIONS OF ANTIMICROBIALS.

       (a) Definition.--In this section, the term ``clinically 
     susceptible concentrations'' means specific values which 
     characterize bacteria as clinically susceptible, 
     intermediate, or resistant to the drug (or drugs) tested.
       (b) Identification.--The Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary''), 
     through the Commissioner of Food and Drugs, shall identify 
     and periodically update clinically susceptible 
     concentrations.

[[Page 11594]]

       (c) Public Availability.--The Secretary, through the 
     Commissioner of Food and Drugs, shall make such clinically 
     susceptible concentrations publicly available within 30 days 
     of the date of identification and any update under this 
     section.
       (d) Effect.--Nothing in this section shall be construed to 
     restrict, in any manner, the prescribing of antibiotics by 
     physicians, or to limit the practice of medicine, including 
     for diseases such as Lyme and tick-borne diseases.

     SEC. 2__. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE 
                   ENANTIOMERS.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S. C. 355), as amended by this subtitle, is amended by 
     adding at the end the following:
       ``(t) Certain Drugs Containing Single Enantiomers.--
       ``(1) In general.--For purposes of subsections 
     (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is 
     submitted under subsection (b) for a non-racemic drug 
     containing as an active ingredient a single enantiomer that 
     is contained in a racemic drug approved in another 
     application under subsection (b), the applicant may, in the 
     application for such non-racemic drug, elect to have the 
     single enantiomer not be considered the same active 
     ingredient as that contained in the approved racemic drug, 
     if--
       ``(A)(i) the single enantiomer has not been previously 
     approved except in the approved racemic drug; and
       ``(ii) the application submitted under subsection (b) for 
     such non-racemic drug--
       ``(I) includes full reports of new clinical investigations 
     (other than bioavailability studies)--

       ``(aa) necessary for the approval of the application under 
     subsections (c) and (d); and
       ``(bb) conducted or sponsored by the applicant; and

       ``(II) does not rely on any investigations that are part of 
     an application submitted under subsection (b) for approval of 
     the approved racemic drug; and
       ``(B) the application submitted under subsection (b) for 
     such non-racemic drug is not submitted for approval of a 
     condition of use--
       ``(i) in a therapeutic category in which the approved 
     racemic drug has been approved; or
       ``(ii) for which any other enantiomer of the racemic drug 
     has been approved.
       ``(2) Limitation.--
       ``(A) No approval in certain therapeutic categories.--Until 
     the date that is 10 years after the date of approval of a 
     non-racemic drug described in paragraph (1) and with respect 
     to which the applicant has made the election provided for by 
     such paragraph, the Secretary shall not approve such non-
     racemic drug for any condition of use in the therapeutic 
     category in which the racemic drug has been approved.
       ``(B) Labeling.--If applicable, the labeling of a non-
     racemic drug described in paragraph (1) and with respect to 
     which the applicant has made the election provided for by 
     such paragraph shall include a statement that the non-racemic 
     drug is not approved, and has not been shown to be safe and 
     effective, for any condition of use of the racemic drug.
       ``(3) Definition.--
       ``(A) In general.--For purposes of this subsection, the 
     term `therapeutic category' means a therapeutic category 
     identified in the list developed by the United States 
     Pharmacopeia pursuant to section 1860D-4(b)(3)(C)(ii) of the 
     Social Security Act and as in effect on the date of enactment 
     of this subsection.
       ``(B) Publication by secretary.--The Secretary shall 
     publish the list described in subparagraph (A) and may amend 
     such list by regulation.
       ``(4) Availability.--The election referred to in paragraph 
     (1) may be made only in an application that is submitted to 
     the Secretary after the date of enactment of this subsection 
     and before October 1, 2012.''.

     SEC. 2__. REPORT.

       Not later than January 1, 2012, the Comptroller General of 
     the United States shall submit a report to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives that examines whether and how this subtitle 
     has--
       (1) encouraged the development of new antibiotics and other 
     drugs; and
       (2) prevented or delayed timely generic drug entry into the 
     market.


                    amendment no. 1026, as modified

       At the appropriate place, insert the following:

     SEC. __. PUBLICATION OF ANNUAL REPORTS.

       (a) In General.--The Commissioner on Food and Drugs shall 
     annually submit to Congress and publish on the Internet 
     website of the Food and Drug Administration, a report 
     concerning the results of the Administration's pesticide 
     residue monitoring program, that includes--
       (1) information and analysis similar to that contained in 
     the report entitled ``Food and Drug Administration Pesticide 
     Program Residue Monitoring 2003'' as released in June of 
     2005;
       (2) based on an analysis of previous samples, an 
     identification of products or countries (for imports) that 
     require special attention and additional study based on a 
     comparison with equivalent products manufactured, 
     distributed, or sold in the U.S. (including details on the 
     plans for such additional studies), including in the initial 
     report (and subsequent reports as determined necessary) the 
     results and analysis of the Ginseng Dietary Supplements 
     Special Survey as described on page 13 of the report entitled 
     ``Food and Drug Administration Pesticide Program Residue 
     Monitoring 2003'';
       (3) information on the relative number of interstate and 
     imported shipments of each tested commodity that were 
     sampled, including recommendations on whether sampling is 
     statistically significant, provides confidence intervals or 
     other related statistical information, and whether the number 
     of samples should be increased and the details of any plans 
     to provide for such increase; and
       (4) a description of whether certain commodities are being 
     improperly imported as another commodity, including a 
     description of additional steps that are being planned to 
     prevent such smuggling.
       (b) Initial Reports.--Annual reports under subsection (a) 
     for fiscal years 2004 through 2006 may be combined into a 
     single report, by not later than June 1, 2008, for purposes 
     of publication under subsection (a). Thereafter such reports 
     shall be completed by June 1 of each year for the data 
     collected for the year that was 2-years prior to the year in 
     which the report is published.
       (c) Memorandum of Understanding.--The Commissioner of Food 
     and Drugs, the Administrator of the Food Safety and 
     Inspection Service, the Department of Commerce, and the head 
     of the Agricultural Marketing Service shall enter into a 
     memorandum of understanding to permit inclusion of data in 
     the reports under subsection (a) relating to testing carried 
     out by the Food Safety and Inspection Service and the 
     Agricultural Marketing Service on meat, poultry, eggs, and 
     certain raw agricultural products, respectively.


                     amendment no. 987, as modified

       At the appropriate place, insert the following:

     SEC. __. HEAD START ACT AMENDMENT IMPOSING PARENTAL CONSENT 
                   REQUIREMENT FOR NONEMERGENCY INTRUSIVE PHYSICAL 
                   EXAMINATIONS.

       The Head Start Act (42 U.S.C. 9831 et seq.) is amended by 
     adding at the end the following:

     ``SEC. 657A. PARENTAL CONSENT REQUIREMENT FOR NONEMERGENCY 
                   INTRUSIVE PHYSICAL EXAMINATIONS.

       ``(a) In General.--A Head Start agency shall obtain written 
     parental consent before administration of any nonemergency 
     intrusive physical examination of a child in connection with 
     participation in a program under this subchapter.
       ``(b) Definition.--The term `nonemergency intrusive 
     physical examination' means, with respect to a child, a 
     physical examination that--
       ``(1) is not immediately necessary to protect the health or 
     safety of the child involved or the health or safety of 
     another individual; and
       ``(2) requires incision or is otherwise invasive, or 
     involves exposure of private body parts.''.
       ``(c) Rule of construction.--Nothing in this section shall 
     be construed to prohibit agencies from using established 
     methods, for handling cases of suspected or known child abuse 
     and neglect, that are in compliance with applicable Federal, 
     State, or tribal law.


                    amendment no. 1006, as modified

       Strike section 505(o)(6)(C)(i) of the Federal Food, Drug, 
     and Cosmetic Act, as added by this Act, and insert the 
     following:
       ``(i) health care providers who prescribe the drug have 
     particular training or experience, or are specially certified 
     (which training or certification with respect to the drug 
     shall be available to any willing provider from a frontier 
     area in a widely available training or certification method 
     (including an on-line course or via mail) as approved by the 
     Secretary at minimal cost to the provider);''.
       Add at the end of section 505(o)(6)(F) of the Federal Food, 
     Drug, and Cosmetic Act, as added by this Act, the following: 
     ``The Secretary shall promulgate regulations for how a 
     physician may provide the drug under the mechanisms of 
     section 561.''.


                    amendment no. 1005, as modified

       At the appropriate place, insert the following:

     SEC. __. SAFETY OF FOOD ADDITIVES.

       Not later than 90 days after the date of enactment of this 
     Act, the Food and Drug Administration shall issue a report on 
     the question of whether substances used to preserve the 
     appearance of fresh meat may create any health risks, or 
     mislead consumers.


                    amendment no. 1004, as modified

       At the end of the bill, add the following:

              TITLE __--DOMESTIC PET TURTLE MARKET ACCESS

     SEC. __. SHORT TITLE.

       This title may be cited as the ``Domestic Pet Turtle Market 
     Access Act of 2007''.

     SEC. __. FINDINGS.

       Congress makes the following findings:
       (1) Pet turtles less than 10.2 centimeters in diameter have 
     been banned for sale in the

[[Page 11595]]

     United States by the Food and Drug Administration since 1975 
     due to health concerns.
       (2) The Food and Drug Administration does not ban the sale 
     of iguanas or other lizards, snakes, frogs, or other 
     amphibians or reptiles that are sold as pets in the United 
     States that also carry salmonella bacteria. The Food and Drug 
     Administration also does not require that these animals be 
     treated for salmonella bacteria before being sold as pets.
       (3) The technology to treat turtles for salmonella, and 
     make them safe for sale, has greatly advanced since 1975. 
     Treatments exist that can nearly eradicate salmonella from 
     turtles, and individuals are more aware of the causes of 
     salmonella, how to treat salmonella poisoning, and the 
     seriousness associated with salmonella poisoning.
       (4) University research has shown that these turtles can be 
     treated in such a way that they can be raised, shipped, and 
     distributed without having a recolonization of salmonella.
       (5) University research has also shown that pet owners can 
     be equipped with a treatment regimen that allows the turtle 
     to be maintained safe from salmonella.
       (6) The Food and Drug Administration should allow the sale 
     of turtles less than 10.2 centimeters in diameter as pets as 
     long as the sellers are required to use proven methods to 
     treat these turtles for salmonella.

     SEC. __. SALE OF BABY TURTLES.

       Notwithstanding any other provision of law, the Food and 
     Drug Administration shall not restrict the sale by a turtle 
     farmer, wholesaler, or commercial retail seller of a turtle 
     that is less than 10.2 centimeters in diameter as a pet if--
       (1) the State or territory in which such farmer is located 
     has developed a regulatory process by which pet turtle 
     farmers are required to have a State license to breed, hatch, 
     propagate, raise, grow, receive, ship, transport, export, or 
     sell pet turtles or pet turtle eggs;
       (2) such State or territory requires certification of 
     sanitization that is signed by a veterinarian who is licensed 
     in the State or territory, and approved by the State or 
     territory agency in charge of regulating the sale of pet 
     turtles;
       (3) the certification of sanitization requires each turtle 
     to be sanitized or treated for diseases, including 
     salmonella, and is dependant upon using the Siebeling method, 
     or other such proven non-antibiotic method, to make the 
     turtle salmonella-free; and
       (4) the turtle farmer or commercial retail seller includes, 
     with the sale of such a turtle, a disclosure to the buyer 
     that includes--
       (A) information regarding--
       (i) the possibility that salmonella can re-colonize in 
     turtles;
       (ii) the dangers, including possible severe illness or 
     death, especially for at-risk people who may be susceptible 
     to salmonella poisoning, such as children, pregnant women, 
     and others who may have weak immune systems, that could 
     result if the turtle is not properly handled and safely 
     maintained;
       (iii) the proper handling of the turtle, including an 
     explanation of proper hygiene such as handwashing after 
     handling a turtle; and
       (iv) the proven methods of treatment that, if properly 
     applied, keep the turtle safe from salmonella;
       (B) a detailed explanation of how to properly treat the 
     turtle to keep it safe from salmonella, using the proven 
     methods of treatment referred to under subparagraph (A), and 
     how the buyer can continue to purchase the tools, treatments, 
     or any other required item to continually treat the turtle; 
     and
       (C) a statement that buyers of pet turtles should not 
     abandon the turtle or abandon it outside, as the turtle may 
     become an invasive species to the local community, but should 
     instead return them to a commercial retail pet seller or 
     other organization that would accept turtles no longer wanted 
     as pets.

     SEC. __. FDA REVIEW OF STATE PROTECTIONS.

       The Commissioner of Food and Drugs may, after providing an 
     opportunity for the affected State to respond, restrict the 
     sale of a turtle only if the Secretary of Health and Human 
     Services determines that the actual implementation of State 
     health protections described in this title are insufficient 
     to protect consumers against infectious diseases acquired 
     from such turtle at the time of sale.

                    amendment no. 1041, as modified

       At the appropriate place, insert the following:

     SEC. __. IMPROVING GENETIC TEST SAFETY AND QUALITY.

       Not later than 30 days after the date of enactment of this 
     Act, the Secretary shall enter into a contract with the 
     Institute of Medicine to conduct a study to assess the 
     overall safety and quality of genetic tests and prepare a 
     report that includes recommendations to improve Federal 
     oversight and regulation of genetic tests. Such study shall 
     take into consideration relevant reports by the Secretary's 
     Advisory Committee on Genetic Testing and other groups and 
     shall be completed not later than 1 year after the date on 
     which the Secretary entered into such contract.

                           amendment no. 1019

(Purpose: To express the sense of the Senate concerning orphan disease 
                         treatment in children)

       At the appropriate place, insert the following:

     SEC. __. ORPHAN DISEASE TREATMENT IN CHILDREN.

       (a) Finding.--The Senate finds that parents of children 
     suffering from rare genetic diseases known as orphan diseases 
     face multiple obstacles in obtaining safe and effective 
     treatment for their children due mainly to the fact that many 
     Food and Drug Administration-approved drugs used in the 
     treatment of orphan diseases in children may not be approved 
     for pediatric indications.
       (b) Sense of the Senate.--It is the sense of the Senate 
     that the Food and Drug Administration should enter into a 
     contract with the Institute of Medicine for the conduct of a 
     study concerning measures that may be taken to improve the 
     likelihood that Food and Drug Administration-approved drugs 
     that are safe and effective in treating children with orphan 
     diseases are made available and affordable for pediatric 
     indications.

                           AMENDMENT NO. 1053

(Purpose: To modify provisions related to pediatric testing and medical 
                               products)

       On page 226, line 4, strike ``later'' and insert ``if the 
     determination made under subsection (d)(3) is made less''.
       On page 228, line 3, strike ``later'' and insert ``if the 
     determination made under subsection (d)(3) is made less''.
       On page 233, line 12, insert ``, such as expertise in child 
     and adolescent psychiatry,'' after ``expertise''.
       On page 233, line 15, strike ``including'' and insert 
     ``which may include''.
       On page 233, between lines 18 and 19, insert the following:
       ``(C) Action by committee.--The committee established under 
     this paragraph may perform a function under this section 
     using appropriate members of the committee under subparagraph 
     (B) and need not convene all members of the committee under 
     subparagraph (B) in order to perform a function under this 
     section.
       ``(D) Documentation of committee action.--The committee 
     established under this paragraph shall document for each 
     function under paragraphs (2) and (3), which members of the 
     committee participated in such function.
       On page 234, line 1, strike ``determine'' and insert ``make 
     a recommendation to the Secretary''.
       On page 235, line 2, strike ``and''.
       On page 235, line 6, strike ``.'';'' and insert ``; and''
       On page 235, between lines 6 and 7, insert the following:
       ``(H) the number of times the committee established under 
     paragraph (1) made a recommendation to the Secretary under 
     paragraph (3), the number of times the Secretary did not 
     follow such a recommendation to accept reports under 
     subsection (d)(3), and the number of times the Secretary did 
     not follow such a recommendation to reject such reports under 
     section (d)(3).
       ``(5) Committee.--The committee established under paragraph 
     (1) is the committee established under section 505B(f)(1).'';
       On page 260, lines 17 through 19, strike ``of a letter, or 
     a written request under section 505A that was declined by the 
     sponsor or holder'' and insert ``of a written request under 
     section 505A that was declined by the sponsor or holder, or a 
     letter referencing such declined written request,''.
       On page 261, line 3, strike ``appropriate'' and insert 
     ``appropriate, for the labeled indication or indications,''.
       On page 263, line 14, insert ``, such as expertise in child 
     and adolescent psychiatry,'' after ``expertise''
       On page 263, between lines 19 and 20, insert the following 
     and redesignate the remaining paragraphs accordingly:
       ``(2) Action by the committee.--The committee established 
     under paragraph (1) may perform a function under this section 
     using appropriate members of the committee under paragraph 
     (1) and need not convene all members of the committee under 
     paragraph (1) in order to perform a function under this 
     section.
       ``(3) Documentation of committee action.--For each drug or 
     biological product, the committee established under this 
     paragraph shall document for each function under paragraph 
     (4) or (5), which members of the committee participated in 
     such function.
       On page 265, between lines 18 and 19, insert the following:
       ``(7) Committee.--The committee established under paragraph 
     (1) is the committee established under section 505A(f)(1).
       On page 289, line 16, strike ``SURVEILLANCES'' and insert 
     ``POSTMARKET SURVEILLANCE''.
       On page 289, line 17, strike ``Surveillances'' and insert 
     ``Surveillance''.
       On page 290, strike lines 9 through 12 and insert the 
     following:
       ``(iii) that is intended to be--

       ``(I) implanted in the human body for more than 1 year; or
       ``(II) a life-sustaining or life-supporting device used 
     outside a device user facility.

       On page 290, line 15, strike ``of an'' and all that follows 
     through ``section 510(k) only for'' on line 19, and insert 
     ``or clearance of''.

[[Page 11596]]




                           amendment no. 1050

         (Purpose: To provide for color certification reports)

       At the end of the bill, add the following:

     SEC. __. COLOR CERTIFICATION REPORTS.

       Section 721 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379e) is amended by adding at the end the following:
       ``(g) Color Certification Reports.--Not later than--
       ``(1) 90 days after the close of a fiscal year in which 
     color certification fees are collected, the Secretary shall 
     submit to Congress a performance report for such fiscal year 
     on the number of batches of color additives approved, the 
     average turn around time for approval, and quantifiable goals 
     for improving laboratory efficiencies; and
       ``(2) 120 days after the close of a fiscal year in which 
     color certification fees are collected, the Secretary shall 
     submit to Congress a financial report for such fiscal year 
     that includes all fees and expenses of the color 
     certification program, the balance remaining in the fund at 
     the end of the fiscal year, and anticipated costs during the 
     next fiscal year for equipment needs and laboratory 
     improvements of such program.''.

                    amendment no. 1049, as modified

       Beginning on page 104, strike line 23 and all that follows 
     through line 14 on page 105 and insert the following:
       ``(II) the amount equal to one-fifth of the excess amount 
     in item (bb), provided that--

       ``(aa) the amount of the total appropriation for the Food 
     and Drug Administration for such fiscal year (excluding the 
     amount of fees appropriated for such fiscal year) exceeds the 
     amount of the total appropriation for the Food and Drug 
     Administration for fiscal year 2007 (excluding the amount of 
     fees appropriated for such fiscal year), adjusted as provided 
     under subsection (c)(1); and
       ``(bb) the amount of the total appropriations for the 
     process of human drug review at the Food and Drug 
     Administration for such fiscal year (excluding the amount of 
     fees appropriated for such fiscal year) exceeds the amount of 
     appropriations for the process of human drug review at the 
     Food and Drug Administration for fiscal year 2007 (excluding 
     the amount of fees appropriated for such fiscal year), 
     adjusted as provided under subsection (c)(1).

     In making the adjustment under subclause (II) for any fiscal 
     year 2008 through 2012, subsection (c)(1) shall be applied by 
     substituting `2007' for `2008.'''.
       At the appropriate place, insert the following:

     SEC. __. PROHIBITION ON IMPORTATION FROM A FOREIGN FOOD 
                   FACILITY THAT DENIES ACCESS TO FOOD INSPECTORS.

       Notwithstanding any other provision of law, no food product 
     may be imported into the United States that is the product of 
     a foreign facility registered under section 415 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) that 
     refuses to permit United States inspectors, upon request, to 
     inspect such facility or that unduly delays access to United 
     States inspectors.
       At the appropriate place, insert the following:

     SEC. __. COUNTERFEIT-RESISTANT TECHNOLOGIES.

       Notwithstanding any other provision of this Act, the 
     requirement that the Secretary of Health and Human Services 
     certify that the implementation of the title of this Act 
     relating to the Importation of Prescription Drugs will pose 
     no additional risk to the public's health and safety and will 
     result in a significant reduction in the cost of covered 
     products to the American consumer shall not apply to the 
     requirement that the Secretary require that the packaging of 
     any prescription drug incorporates--
       (1) not later than 18 months after the date of enactment of 
     this Act, a standardized numerical identifier (which, to the 
     extent practicable, shall be harmonized with international 
     consensus standards for such an identifier) unique to each 
     package of such drug, applied at the point of manufacturing 
     and repackaging (in which case the numerical identifier shall 
     be linked to the numerical identifier applied at the point of 
     manufacturing); and
       (2) not later than 24 months after the date of enactment of 
     this Act for the 50 prescription drugs with the highest 
     dollar volume of sales in the United States, based on the 
     calendar year that ends of December 31, 2007, and, not later 
     than 30 months after the date of enactment of this Act for 
     all other prescription drugs--
       (A) overt optically variable counterfeit-resistant 
     technologies that--
       (i) are visible to the naked eye, providing for visual 
     identification of product authenticity without the need for 
     readers, microscopes, lighting devices, or scanners;
       (ii) are similar to that used by the Bureau of Engraving 
     and Printing to secure United States currency;
       (iii) are manufactured and distributed in a highly secure, 
     tightly controlled environment; and
       (iv) incorporate additional layers of nonvisible convert 
     security features up to and including forensic capability; or
       (B) technologies that have a function of security 
     comparable to that described in subparagraph (A), as 
     determined by the Secretary.
       At the appropriate place, insert the following:

     SEC. __. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION.

       (a) Findings.--Congress finds the following:
       (1) In 2007, there has been an overwhelming increase in the 
     volume of aquaculture and seafood that has been found to 
     contain substances that are not approved for use in food in 
     the United States.
       (2) As of May 2007, inspection programs are not able to 
     satisfactorily accomplish the goals of ensuring the food 
     safety of the United States.
       (3) To protect the health and safety of consumers in the 
     United States, the ability of the Secretary of Health and 
     Human Services to perform inspection functions must be 
     enhanced.
       (b) Heightened Inspections.--The Secretary of Health and 
     Human Services (referred to in this section as the 
     ``Secretary'') is authorized to, by regulation, enhance, as 
     necessary, the inspection regime of the Food and Drug 
     Administration for aquaculture and seafood, consistent with 
     obligations of the United States under international 
     agreements and United States law.
       (c) Report to Congress.--Not later than 90 days after the 
     date of enactment of this Act, the Secretary shall submit to 
     Congress a report that--
       (1) describes the specifics of the aquaculture and seafood 
     inspection program;
       (2) describes the feasibility of developing a traceability 
     system for all catfish and seafood products, both domestic 
     and imported, for the purpose of identifying the processing 
     plant of origin of such products; and
       (3) provides for an assessment of the risks associated with 
     particular contaminants and banned substances.
       (d) Partnerships With States.--Upon the request by any 
     State, the Secretary may enter into partnership agreements, 
     as soon as practicable after the request is made, to 
     implement inspection programs regarding the importation of 
     aquaculture and seafood.
       (e) Authorization of Appropriations.--There are authorized 
     to be appropriated such sums as may be necessary to carry out 
     this section.
       At the appropriate place, insert the following:

     SEC. __. SENSE OF THE SENATE REGARDING CERTAIN PATENT 
                   INFRINGEMENTS.

       (a) Findings.--The Senate makes the following findings:
       (1) Innovation in developing life-saving prescription drugs 
     saves millions of lives around the world each year.
       (2) The responsible protection of intellectual property is 
     vital to the continued development of new and life-saving 
     drugs and future growth of the United States economy.
       (3) In order to maintain the global competitiveness of the 
     United States, the United States Trade Representative's 
     Office of Intellectual Property and Innovation develops and 
     implements trade policy in support of vital American 
     innovations, including innovation in the pharmaceutical and 
     medical technology industries.
       (4) The United States Trade Representative also provides 
     trade policy leadership and expertise across the full range 
     of interagency initiatives to enhance protection and 
     enforcement of intellectual property rights.
       (5) Strong and fair intellectual property protection, 
     including patent, copyright, trademark, and data protection 
     plays an integral role in fostering economic growth and 
     development and ensuring patient access to the most effective 
     medicines around the world.
       (6) There are concerns that certain countries have engaged 
     in unfair price manipulation and abuse of compulsory 
     licensing. Americans bear the majority of research and 
     development costs for the world, which could undermine the 
     value of existing United States pharmaceutical patents and 
     could impede access to important therapies.
       (7) There is a growing global threat of counterfeit 
     medicines and increased need for the United States Trade 
     Representative and other United States agencies to use 
     available trade policy measures to strengthen laws and 
     enforcement abroad to prevent harm to United States patients 
     and patients around the world.
       (b) Sense of the Senate.--It is the sense of the Senate 
     that--
       (1) the United States Trade Representative should use all 
     the tools at the disposal of the Trade Representative to 
     address violations and other concerns with intellectual 
     property, including through--
       (A) bilateral engagement with United States trading 
     partners;
       (B) transparency and balance of the annual ``Special 301'' 
     review and reviews of compliance with the intellectual 
     property requirements of countries with respect to which the 
     United States grants trade preferences;
       (C) negotiation of responsible and fair intellectual 
     property provisions as part of bilateral and regional trade 
     agreements; and
       (D) multilateral engagement through the World Trade 
     Organization (WTO); and
       (2) the United States Trade Representative should develop 
     and submit to Congress a strategic plan to address the 
     problem of

[[Page 11597]]

     countries that infringe upon American pharmaceutical 
     intellectual property rights and the problem of countries 
     that engage in price manipulation.
       At the appropriate place, insert the following:

     SEC. __. CONSULTATION REGARDING GENETICALLY ENGINEERED 
                   SEAFOOD PRODUCTS.

       The Commissioner of Food and Drugs shall consult with the 
     Assistant Administrator of the National Marine Fisheries 
     Service of the National Oceanic and Atmospheric 
     Administration to produce a report on any environmental risks 
     associated with genetically engineered seafood products, 
     including the impact on wild fish stocks.
       At the appropriate place, insert the following:

     SEC. __. REPORT ON THE MARKETING OF CERTAIN CRUSTACEANS.

       Not later than 30 days after the date of enactment of this 
     Act, the Secretary of Health and Human Services, in 
     consultation with the Secretary of Commerce, shall submit to 
     the Health, Education, Labor, and Pensions Committee and the 
     Committee on Commerce, Science, and Transportation of the 
     Senate, a report on the differences between taxonomy of 
     species of lobster in the subfamily Nephropinae, and species 
     of langostino, specifically from the infraorder Caridea or 
     Anomura. This report shall also describe the differences in 
     consumer perception of such species, including such factors 
     as taste, quality, and value of the species.

                           AMENDMENT NO. 1047

     (Purpose: To modify provisions relating to direct-to-consumer 
                            advertisements)

         Strike subparagraphs (E) and (F) of section 505(o)(5) of 
     the Federal Food, Drug, and Cosmetic Act, as added by this 
     Act, and insert the following:
         ``(E) Specific disclosures.--
         ``(i) Serious risk; safety protocol.--If the Secretary 
     determines that advertisements lacking a specific disclosure 
     about a serious risk listed in the labeling of a drug or 
     about a protocol to ensure safe use described in the labeling 
     of the drug would be false or misleading, the risk evaluation 
     and mitigation strategy for the drug may require that the 
     applicant include in advertisements of the drug such 
     disclosure.
         ``(ii) Date of approval.--If the Secretary determines 
     that advertisements lacking a specific disclosure of the date 
     a drug was approved and disclosure of a serious risk would be 
     false or misleading, the risk evaluation and mitigation 
     strategy for the drug may require that the applicant include 
     in advertisements of the drug such disclosure.
         ``(iii) Specification of advertisements.--The Secretary 
     may specify the advertisements required to include a specific 
     disclosure under clause (i) or (ii).
         ``(iv) Required safety surveillance.--If the approved 
     risk evaluation and mitigation strategy for a drug requires 
     the specific disclosure under clause (ii), the Secretary 
     shall--

         ``(I) consider identifying and assessing all serious 
     risks of using the drug to be a priority safety question 
     under subsection (k)(3)(B);
         ``(II) not less frequently than every 3 months, evaluate 
     the reports under subsection (k)(1) and the routine active 
     surveillance as available under subsection (k)(3) with 
     respect to such priority drug safety question to determine 
     whether serious risks that might occur among patients 
     expected to be treated with the drug have been adequately 
     identified and assessed;
         ``(III) remove such specific disclosure requirement as an 
     element of such strategy if such serious risks have been 
     adequately identified and assessed; and
         ``(IV) consider whether a specific disclosure under 
     clause (i) should be required.

         On page 101, strike lines 7 through 9.
         At the end of the bill, add the following:

     SEC. __. CIVIL PENALTIES; DIRECT-TO-CONSUMER ADVERTISEMENT.

         (a) Civil Penalties.--Section 303 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding 
     at the end the following:
         ``(g)(1) Any applicant (as such term is used in section 
     505(o)) who disseminates a direct-to-consumer advertisement 
     for a prescription drug that is false or misleading and a 
     violation of section 502(n) shall be liable to the United 
     States for a civil penalty in an amount not to exceed 
     $150,000 for the first such violation in any 3-year period, 
     and not to exceed $300,000 for each subsequent violation 
     committed after the applicant has been penalized under this 
     paragraph any time in the preceding 3-year period. For the 
     purposes of this paragraph, repeated dissemination of the 
     same or similar advertisement prior to the receipt of the 
     written notice referred to in paragraph (2) for such 
     advertisements shall be considered as 1 violation.
         ``(2) A civil penalty under paragraph (1) shall be 
     assessed by the Secretary by an order made on the record 
     after providing written notice to the applicant to be 
     assessed a civil penalty and an opportunity for a hearing in 
     accordance with this paragraph and section 554 of title 5, 
     United States Code. If upon receipt of the written notice, 
     the applicant to be assessed a civil penalty objects and 
     requests a hearing, then in the course of any investigation 
     related to such hearing, the Secretary may issue subpoenas 
     requiring the attendance and testimony of witnesses and the 
     production of evidence that relates to the matter under 
     investigation, including information pertaining to the 
     factors described in paragraph (3).
         ``(3) Upon the request of the applicant to be assessed a 
     civil penalty, the Secretary, in determining the amount of a 
     civil penalty, shall take into account the nature, 
     circumstances, extent, and gravity of the violation or 
     violations, including the following factors:
         ``(A) Whether the applicant submitted the advertisement 
     or a similar advertisement for review under section 736A.
         ``(B) Whether the applicant submitted the advertisement 
     for prereview if required under section 505(o)(5)(D).
         ``(C) Whether, after submission of the advertisement as 
     described in subparagraph (A) or (B), the applicant 
     disseminated the advertisement before the end of the 45-day 
     comment period.
         ``(D) Whether the applicant failed to incorporate any 
     comments made by the Secretary with regard to the 
     advertisement or a similar advertisement into the 
     advertisement prior to its dissemination.
         ``(E) Whether the applicant ceased distribution of the 
     advertisement upon receipt of the written notice referred to 
     in paragraph (2) for such advertisement.
         ``(F) Whether the applicant had the advertisement 
     reviewed by qualified medical, regulatory, and legal 
     reviewers prior to its dissemination.
         ``(G) Whether the violations were material.
         ``(H) Whether the applicant who created the advertisement 
     acted in good faith.
         ``(I) Whether the applicant who created the advertisement 
     has been assessed a civil penalty under this provision within 
     the previous 1-year period.
         ``(J) The scope and extent of any voluntary, subsequent 
     remedial action by the applicant.
         ``(K) Such other matters, as justice may require.
         ``(4)(A) Subject to subparagraph (B), no applicant shall 
     be required to pay a civil penalty under paragraph (1) if the 
     applicant submitted the advertisement to the Secretary and 
     disseminated such advertisement after incorporating any 
     comment received from the Secretary.
         ``(B) The Secretary may retract or modify any prior 
     comments the Secretary has provided to an advertisement 
     submitted to the Secretary based on new information or 
     changed circumstances, so long as the Secretary provides 
     written notice to the applicant of the new views of the 
     Secretary on the advertisement and provides a reasonable time 
     for modification or correction of the advertisement prior to 
     seeking any civil penalty under paragraph (1).
         ``(5) The Secretary may compromise, modify, remit, with 
     or without conditions, any civil penalty which may be 
     assessed under paragraph (1). The amount of such penalty, 
     when finally determined, or the amount charged upon in 
     compromise, may be deducted from any sums owned by the United 
     States to the applicant charged.
         ``(6) Any applicant who requested, in accordance with 
     paragraph (2), a hearing with respect to the assessment of a 
     civil penalty and who is aggrieved by an order assessing a 
     civil penalty, may file a petition for de novo judicial 
     review of such order with the United States Court of Appeals 
     for the District of Columbia Circuit or for any other circuit 
     in which such applicant resides or transacts business. Such a 
     petition may only be filed within the 60-day period beginning 
     on the date the order making such assessments was issued.
         ``(7) If any applicant fails to pay an assessment of a 
     civil penalty--
         ``(A) after the order making the assessment becomes 
     final, and if such applicant does not file a petition for 
     judicial review of the order in accordance with paragraph 
     (6); or
         ``(B) after a court in an action brought under paragraph 
     (6) has entered a final judgment in favor of the Secretary,

     the Attorney General shall recover the amount assessed (plus 
     interest at currently prevailing rates from the date of the 
     expiration of the 60-day period referred to in paragraph (6) 
     or date of such final judgment, as the case may be) in an 
     action brought in any appropriate district court of the 
     United States. In such an action, the validity, amount, and 
     appropriateness of such penalty shall not be subject to 
     review.''.
         (b) Direct-to-Consumer Advertisement.--
         (1) In general.--Section 502(n) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by 
     inserting after the first sentence the following: ``In the 
     case of an advertisement for a prescription drug presented 
     directly to consumers in television or radio format that 
     states the name of the drug and its conditions of use, the 
     major statement relating to side effects, contraindications, 
     and effectiveness referred to in the previous sentence shall 
     be stated in a clear and conspicuous (neutral) manner.''.
         (2) Regulations to determine neutral manner.--The 
     Secretary of Health and Human Services shall by regulation 
     establish standards for determining whether a major

[[Page 11598]]

     statement, relating to side effects, contraindications, and 
     effectiveness of a drug, described in section 502(n) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as 
     amended by paragraph (1)) is presented in the manner required 
     under such section.


                           amendment no. 1056

 (Purpose: To require the FDA to conduct consumer testing to determine 
  the appropriateness of the labeling requirements for indoor tanning 
                                devices)

       At the appropriate place, insert the following:

     SEC. __. REPORT BY THE FOOD AND DRUG ADMINISTRATION REGARDING 
                   LABELING INFORMATION ON THE RELATIONSHIP 
                   BETWEEN THE USE OF INDOOR TANNING DEVICES AND 
                   DEVELOPMENT OF SKIN CANCER OR OTHER SKIN 
                   DAMAGE.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary''), acting 
     through the Commissioner of Food and Drugs, shall determine--
       (1) whether the labeling requirements for indoor tanning 
     devices, including the positioning requirements, provide 
     sufficient information to consumers regarding the risks that 
     the use of such devices pose for the development of 
     irreversible damage to the eyes and skin, including skin 
     cancer; and
       (2)(A) whether modifying the warning label required on 
     tanning beds to read, ``Ultraviolet radiation can cause skin 
     cancer'', or any other additional warning, would communicate 
     the risks of indoor tanning more effectively; or
       (B) whether there is no warning that would be capable of 
     adequately communicating such risks.
       (b) Consumer Testing.--In making the determinations under 
     subsection (a), the Secretary shall conduct appropriate 
     consumer testing, using the best available methods for 
     determining consumer understanding of label warnings.
       (c) Public Hearings; Public Comment.--The Secretary shall 
     hold public hearings and solicit comments from the public in 
     making the determinations under subsection (a).
       (d) Report.--Not later than 1 year after the date of the 
     enactment of this Act, the Secretary shall submit to the 
     Congress a report that provides the determinations under 
     subsection (a). In addition, the Secretary shall include in 
     the report the measures being implemented by the Secretary to 
     significantly reduce the risks associated with indoor tanning 
     devices.


              Amendments Nos. 1039, 998, and 1034, En Bloc

  Mr. BROWN. I now call up amendments Nos. 1039, 998 and 1034, en bloc, 
and ask that once they are reported by number they be set aside.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The legislative clerk read as follows:

       The Senator from Ohio [Mr. Brown], for Mr. Grassley and for 
     Mr. Durbin, proposes amendments Nos. 1039, 998, 1034, en 
     bloc.

  The amendments are as follows:


                           amendment no. 1039

 (Purpose: To clarify the authority of the Office of Surveillance and 
    Epidemiology with respect to postmarket drug safety pursuant to 
             recommendations by the Institute of Medicine).

       At the end of subtitle E of title II, insert the following:

     SEC. 2_. AUTHORITY OF THE OFFICE OF SURVEILLANCE AND 
                   EPIDEMIOLOGY.

       With respect to all actions of the Food and Drug 
     Administration related to postmarketing drug safety, 
     including labeling changes, postapproval studies, and 
     restrictions on distribution or use of drugs with serious 
     risks, the Office of Surveillance and Epidemiology (or 
     successor office) of such Administration and the Office of 
     New Drugs (or successor office) of such Administration shall 
     make decisions jointly. In the event of a disagreement with 
     respect to an action related to postmarketing drug safety, 
     including labeling changes, postapproval studies, and 
     restrictions on distribution or use of drugs with serious 
     risks, between such 2 offices, the Commissioner of Food and 
     Drugs shall make the decision with respect to such action.


                           amendment no. 998

 (Purpose: To provide for the application of stronger civil penalties 
 for violations of approved risk evaluation and mitigation strategies)

       At the appropriate place in section 505(o) of the Federal, 
     Food, Drug, and Cosmetic, as added by section 202, insert the 
     following:
       ``(9) Civil monetary penalty.--Notwithstanding any other 
     provision of this Act, an applicant (as such term is defined 
     for purposes of this section) that knowingly fails to comply 
     with a requirement of an approved risk evaluation and 
     mitigation strategy under this subsection shall be subject to 
     a civil money penalty of $250,000 for the first 30-day period 
     that the applicant is in noncompliance, and such amount shall 
     double for every 30-day period thereafter that the 
     requirement is not complied with, not to exceed 
     $2,000,000.''.


                           amendment no. 1034

  (Purpose: To reduce financial conflict of interest in FDA Advisory 
                                Panels)

       In title II, strike subtitle D and insert the following:

                   Subtitle D--Conflicts of Interest

     SEC. 241. CONFLICTS OF INTEREST.

       (a) In General.--Subchapter A of chapter VII of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is 
     amended by inserting at the end the following:

     ``SEC. 712. CONFLICTS OF INTEREST.

       ``(a) Definitions.--For purposes of this section:
       ``(1) Advisory committee.--The term `advisory committee' 
     means an advisory committee under the Federal Advisory 
     Committee Act that provides advice or recommendations to the 
     Secretary regarding activities of the Food and Drug 
     Administration.
       ``(2) Financial interest.--The term `financial interest' 
     means a financial interest under section 208(a) of title 18, 
     United States Code.
       ``(b) Appointments to Advisory Committees.--
       ``(1) Recruitment.--
       ``(A) In general.--Given the importance of advisory 
     committees to the review process at the Food and Drug 
     Administration, the Secretary, through the Office of Women's 
     Health, the Office of Orphan Product Development, the Office 
     of Pediatric Therapeutics, and other offices within the Food 
     and Drug Administration with relevant expertise, shall 
     develop and implement strategies on effective outreach to 
     potential members of advisory committees at universities, 
     colleges, other academic research centers, professional and 
     medical societies, and patient and consumer groups. The 
     Secretary shall seek input from professional medical and 
     scientific societies to determine the most effective 
     informational and recruitment activities. The Secretary shall 
     also take into account the advisory committees with the 
     greatest number of vacancies.
       ``(B) Recruitment activities.--The recruitment activities 
     under subparagraph (A) may include--
       ``(i) advertising the process for becoming an advisory 
     committee member at medical and scientific society 
     conferences;
       ``(ii) making widely available, including by using existing 
     electronic communications channels, the contact information 
     for the Food and Drug Administration point of contact 
     regarding advisory committee nominations; and
       ``(iii) developing a method through which an entity 
     receiving funding from the National Institutes of Health, the 
     Agency for Healthcare Research and Quality, the Centers for 
     Disease Control and Prevention, or the Veterans Health 
     Administration can identify a person who the Food and Drug 
     Administration can contact regarding the nomination of 
     individuals to serve on advisory committees.
       ``(2) Evaluation and criteria.--When considering a term 
     appointment to an advisory committee, the Secretary shall 
     review the expertise of the individual and the financial 
     disclosure report filed by the individual pursuant to the 
     Ethics in Government Act of 1978 for each individual under 
     consideration for the appointment, so as to reduce the 
     likelihood that an appointed individual will later require a 
     written determination as referred to in section 208(b)(1) of 
     title 18, United States Code, a written certification as 
     referred to in section 208(b)(3) of title 18, United States 
     Code, or a waiver as referred to in subsection (c)(3) of this 
     section for service on the committee at a meeting of the 
     committee.
       ``(3) Participation of guest expert with financial 
     interest.--Notwithstanding any other provision of this 
     section, an individual with a financial interest with respect 
     to any matter considered by an advisory committee may be 
     allowed to participate in a meeting of an advisory committee 
     as a guest expert if the Secretary determines that the 
     individual has particular expertise required for the meeting. 
     An individual participating as a guest expert may provide 
     information and expert opinion, but shall not participate in 
     the discussion or voting by the members of the advisory 
     committee.
       ``(c) Granting and Disclosure of Waivers.--
       ``(1) In general.--Prior to a meeting of an advisory 
     committee regarding a `particular matter' (as that term is 
     used in section 208 of title 18, United States Code), each 
     member of the committee who is a full-time Government 
     employee or special Government employee shall disclose to the 
     Secretary financial interests in accordance with subsection 
     (b) of such section 208.
       ``(2) Financial interest of advisory committee member or 
     family member.--No member of an advisory committee may vote 
     with respect to any matter considered by the advisory 
     committee if such member (or an immediate family member of 
     such member) has a financial interest that could be affected 
     by the advice given to the Secretary with respect to such 
     matter, excluding interests exempted in regulations issued by 
     the Director of the Office of Government Ethics as too remote 
     or inconsequential to affect the integrity of the services of 
     the Government officers or employees to which such 
     regulations apply.
       ``(3) Waiver.--The Secretary may grant a waiver of the 
     prohibition in paragraph (2) if

[[Page 11599]]

     such waiver is necessary to afford the advisory committee 
     essential expertise.
       ``(4) Limitations.--
       ``(A) One waiver per committee meeting.--Notwithstanding 
     any other provision of this section, with respect to each 
     advisory committee, the Secretary shall not grant more than 1 
     waiver under paragraph (3) per committee meeting.
       ``(B) Scientific work.--The Secretary may not grant a 
     waiver under paragraph (3) for a member of an advisory 
     committee when the member's own scientific work is involved.
       ``(5) Disclosure of waiver.--Notwithstanding section 
     107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), 
     the following shall apply:
       ``(A) 15 or more days in advance.--As soon as practicable, 
     but in no case later than 15 days prior to a meeting of an 
     advisory committee to which a written determination as 
     referred to in section 208(b)(1) of title 18, United States 
     Code, a written certification as referred to in section 
     208(b)(3) of title 18, United States Code, or a waiver as 
     referred to in paragraph (3) applies, the Secretary shall 
     disclose (other than information exempted from disclosure 
     under section 552 of title 5, United States Code, and section 
     552a of title 5, United States Code (popularly known as the 
     Freedom of Information Act and the Privacy Act of 1974, 
     respectively)) on the Internet website of the Food and Drug 
     Administration--
       ``(i) the type, nature, and magnitude of the financial 
     interests of the advisory committee member to which such 
     determination, certification, or waiver applies; and
       ``(ii) the reasons of the Secretary for such determination, 
     certification, or waiver.
       ``(B) Less than 30 days in advance.--In the case of a 
     financial interest that becomes known to the Secretary less 
     than 30 days prior to a meeting of an advisory committee to 
     which a written determination as referred to in section 
     208(b)(1) of title 18, United States Code, a written 
     certification as referred to in section 208(b)(3) of title 
     18, United States Code, or a waiver as referred to in 
     paragraph (3) applies, the Secretary shall disclose (other 
     than information exempted from disclosure under section 552 
     of title 5, United States Code, and section 552a of title 5, 
     United States Code) on the Internet website of the Food and 
     Drug Administration, the information described in clauses (i) 
     and (ii) of subparagraph (A) as soon as practicable after the 
     Secretary makes such determination, certification, or waiver, 
     but in no case later than the date of such meeting.
       ``(d) Public Record.--The Secretary shall ensure that the 
     public record and transcript of each meeting of an advisory 
     committee includes the disclosure required under subsection 
     (c)(5) (other than information exempted from disclosure under 
     section 552 of title 5, United States Code, and section 552a 
     of title 5, United States Code).
       ``(e) Annual Report.--Not later than February 1 of each 
     year, the Secretary shall submit to the Committee on 
     Appropriations and the Committee on Health, Education, Labor, 
     and Pensions of the Senate, and the Committee on 
     Appropriations and the Committee on Energy and Commerce of 
     the House of Representatives a report that describes--
       ``(1) with respect to the fiscal year that ended on 
     September 30 of the previous year, the number of vacancies on 
     each advisory committee, the number of nominees received for 
     each committee, and the number of such nominees willing to 
     serve;
       ``(2) with respect to such year, the aggregate number of 
     disclosures required under subsection (c)(5) for each meeting 
     of each advisory committee and the percentage of individuals 
     to whom such disclosures did not apply who served on such 
     committee for each such meeting;
       ``(3) with respect to such year, the number of times the 
     disclosures required under subsection (c)(5) occurred under 
     subparagraph (B) of such subsection; and
       ``(4) how the Secretary plans to reduce the number of 
     vacancies reported under paragraph (1) during the fiscal year 
     following such year, and mechanisms to encourage the 
     nomination of individuals for service on an advisory 
     committee, including those who are classified by the Food and 
     Drug Administration as academicians or practitioners.
       ``(f) Periodic Review of Guidance.--Not less than once 
     every 5 years, the Secretary shall review guidance of the 
     Food and Drug Administration regarding conflict of interest 
     waiver determinations with respect to advisory committees and 
     update such guidance as necessary.''.
       (b) Conforming Amendment.--Section 505(n) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended 
     by--
       (1) striking paragraph (4); and
       (2) redesignating paragraphs (5), (6), (7), and (8) as 
     paragraphs (4), (5), (6), and (7), respectively.
       (c) Effective Date.--The amendments made by this section 
     shall take effect on October 1, 2007.

  The PRESIDING OFFICER. The amendments are set aside.
  The Senator from Wyoming is recognized.
  Mr. ENZI. Mr. President, I congratulate everybody on reaching the 
point we just reached with the unanimous consent agreement that was 
done. I thank the Senator from Ohio for his tremendous work on the 
committee and then on the floor, and on working through some of these 
amendments.
  I particularly thank Senator Kennedy for his efforts. He is having a 
spectacular day. I am sure actually he is probably on a plane again 
now. He represented the United States at the unification treaty signing 
in Ireland today. He left as soon as we finished voting last night, 
traveled through the night, attended that ceremony, and will travel 
virtually through the night tonight to get back again so he will be 
here for tomorrow morning's votes.
  That is just the kind of tireless dedication that he puts in on 
international issues, as well as the issues that come before our 
committee. I am very impressed with the stamina he has and the 
capability he has to do all these things.
  This has been a long road and it has had a few lumps in it, but there 
has been cooperation on both sides. The staff people who have worked on 
this have gone into excruciating detail on every amendment to make sure 
it would do what people said it would do and that it would work, both 
in a United States context and in an international context.
  I think we have progressed to a point where we can do three votes and 
then final passage tomorrow and have this on the way to having the Food 
and Drug Administration reformed so they have more tools in the toolbox 
and can get the job done that we have always been expecting, and have 
more confidence that our food and drug supply in the United States will 
be safe.
  Everybody has been tremendously cooperative. We look forward to 
finishing in the morning.
  I yield the floor.
  Mr. KOHL. Mr. President, I rise to elaborate on a food safety 
amendment that has been accepted on both sides.
  Under current law, the FDA's most decisive legal recourse for dealing 
with suspect food imports is to stop them at our boarder. My amendment 
strengthens the FDA's hand by providing explicit authority under 
section 415 of the Federal Food, Drug and Cosmetics Act, to proactively 
deny entry of all food products from questionable suppliers if they 
fail to cooperate and allow timely inspection of their facilities.
  Events of recent weeks have made clear that the FDA's ability to 
inspect foreign food is inadequate. In the case of melamine tainted 
wheat gluten from China, FDA inspectors were forced to wait more than 2 
weeks before the Chinese Government would grant them access. Two weeks 
is unacceptable. There is simply no excuse for such delays if you want 
to ship food into this country. FDA must be able to respond quickly to 
identify threats and protect public health and safety.
  My amendment provides a succinct and direct legal basis for the FDA 
to seek access and inspect foreign food facilities on demand. If a 
foreign exporter to the United States delays access for FDA inspectors 
unnecessarily, the FDA can stop all food imports from that firm 
immediately thereby denying them access to our markets. If an exporter 
does not want to let the FDA inspect its firm--on FDA's schedule--that 
exporter can't ship to this country. It is that simple. For the vast 
majority of firms and countries, this is not a problem. But for those 
times it is needed, it will be an important tool.
  This amendment will not fix all of the problems that are out there. 
This Congress needs to do some thorough oversight and develop a 
comprehensive plan to improve food safety and security. I intend to 
participate in that process and will exercise my prerogatives as 
chairman of the Agriculture Appropriations Subcommittee to see that the 
FDA follows through.
  Again, I appreciate the help of Senators Kennedy and Enzi and their 
talented staff in getting this amendment included in this bill. They 
have been very helpful, and I look forward to providing them any 
assistance they need in order to keep this in conference.


                           amendment no. 993

  Mr. GREGG. Mr. President, last week, the FDA just sent out a warning 
to American consumers regarding purchasing medications from certain

[[Page 11600]]

Internet sites because the FDA cannot verify that the drugs purchased 
over those sites are going to be safe or that they won't be 
counterfeit. We need to give the FDA the authority and the resources to 
address the issue of unsafe Internet pharmacies and the Gregg Internet 
pharmacy amendment does just that. It creates a comprehensive framework 
to assure consumers that they can shop with confidence, knowing that 
the drugs they purchase online will be safe and effective. Hopefully, 
we will address this important and timely drug safety issue, if not 
now, at least before this bill completes the whole process and comes 
back from the conference committee
  Mr. KENNEDY. I thank the Senator from New Hampshire for his interest 
and work on this important issue. Ensuring that people have access to 
safe and effective medications when purchasing prescription drugs 
online is an important part of our efforts in the area of drug safety. 
The Dorgan legislation in this bill includes some provisions on the 
issue of Internet pharmacies, but I am willing to work with my 
colleague and our colleagues in the Senate to enhance these provisions 
to address the important issues he has raised over the course of this 
debate.
  Mr. ENZI. I would also like to take the opportunity to express my 
support for the need to address the issue of unsafe Internet 
pharmacies. We have worked very hard in other portions of this bill to 
ensure the safety of prescription drugs on the market, and as this bill 
advances, I look forward to working with you both to enhance the 
provisions in this bill relating to the safety of Internet pharmacies.
  The PRESIDING OFFICER. The Senator from Ohio is recognized.

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