Congressional Record, Volume 153 Issue 75 (Tuesday, May 8, 2007)

[Congressional Record Volume 153, Number 75 (Tuesday, May 8, 2007)]
[Senate]
[Pages S5689-S5707]
From the Congressional Record Online through the 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
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

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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 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

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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.
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

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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 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

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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 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

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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 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

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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.
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

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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 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.

[[Page S5697]]

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
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

[[Page S5698]]

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 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

[[Page S5699]]

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 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

[[Page S5700]]

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).
``(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

[[Page S5701]]

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.
(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.

[[Page S5702]]

``(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 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).'';

[[Page S5703]]

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''.

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.

[[Page S5704]]

(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 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,

[[Page S5705]]

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
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

[[Page S5706]]

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 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.

[[Page S5707]]

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
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.

____________________