Friday, April 25, 2014

READOUT: PRESIDENT OBAMA'S CALL WITH GERMAN, ITALIAN, FRENCH AND BRITISH LEADERS

FROM:  THE WHITE HOUSE 
Readout of the President’s Call with President Hollande, Chancellor Merkel, Prime Minister Renzi, and Prime Minister Cameron

Today the President spoke with President Hollande of France, Chancellor Merkel of Germany, Prime Minister Renzi of Italy, and Prime Minister Cameron of the UK to consult about the alarming situation in eastern Ukraine.  The leaders noted the positive steps that Ukraine had taken to move forward on the actions to which it committed in the April 17 joint statement by Ukraine, Russia, the European Union, and the United States – including proposing an amnesty law for those who will peacefully leave the buildings they have seized in eastern Ukraine, supporting the work of the Organization for Security and Cooperation in Europe (OSCE), and committing themselves once again to a process of constitutional reform and decentralization.  The leaders also agreed that Russia had not reciprocated – including by not publicly supporting the Geneva accord, nor calling on armed militant groups to lay down their arms and leave the government buildings they’ve occupied – and had in fact continued to escalate the situation through its increasingly concerning rhetoric and threatening military exercises on Ukraine’s border.

The President noted that the United States is prepared to impose targeted sanctions to respond to Russia's latest actions. The leaders agreed to work closely together, and through the G7 and European Union, to coordinate additional steps to impose costs on Russia. The leaders underscored that Russia could still choose a peaceful resolution to the crisis, including by implementing the Geneva accord.

SECRETARY HAGEL WAITS TO HEAR FROM RUSSIAN COUNTERPARTS ON DE-ESCALATING TENSIONS

FROM:  DEFENSE DEPARTMENT 
Hagel Waits to Hear From Russian Counterparts
By Claudette Roulo
American Forces Press Service

WASHINGTON, April 25, 2014 – Defense Department officials are still waiting to hear back from their Russian counterparts after reaching out to them via phone yesterday to discuss tensions in Ukraine, Pentagon spokesman Army Col. Steve Warren said today.

The department has made it clear to the Russians that Defense Secretary Chuck Hagel is available for a phone call at any time, Warren said.

"He wants to continue calling on the Russians to de-escalate the situation in Ukraine," the colonel said. "Their continued destabilizing activities along the Ukrainian border are unhelpful, and they need to withdraw their troops from the Ukrainian border and place them back into their garrisons and go about working to a peaceful resolution to this crisis."

Tens of thousands of Russian troops were mobilized to the region in late February and early March. While some of those troops seized control of the Crimean Peninsula, others established cantonment areas along Russia’s border with Ukraine. Russian President Vladimir Putin told the international community that the troops in the border region were staging exercises. Until recently, defense officials have said there was no evidence the Russian military was conducting the type of exercises they had described.

Warren said reports from multiple sources indicate that the movements by thousands of troops in the region are now consistent with the exercises recently announced by Russia.

“Troops are moving out of their cantonment areas into exercise areas,” he said.
Russia has a broad array of forces aligned along the Ukrainian border, Warren said, including mechanized infantry, light infantry, armor and airborne troops and fixed- and rotary-wing aerial assets.

“We're seeing all flavors of the Russian combined arms force,” he said.
The U.S. message to Russia has been very clear since the start of tensions with Ukraine, Warren said.

“Our message remains, 'Deescalate. Live up to commitments both in Geneva and international norms. Help bring this crisis to an end,'" he said.

U.S. CONGRATULATES PEOPLE OF TOGO ON THEIR INDEPENDENCE DAY

FROM:  U.S. STATE DEPARTMENT 
On the Occasion of the Republic of Togo's National Day
Press Statement
John Kerry
Secretary of State
Washington, DC
April 25, 2014

On behalf of President Obama and the American people, I congratulate the people of Togo as you celebrate your independence on April 27.

Our two countries enjoy a strong partnership. The United States appreciates Togo’s efforts to promote regional peace, expand economic opportunity, and fight transnational crime.

We look forward to continuing to work together in the years to come.

U.S. DEFENSE DEPARTMENT CONTRACTS FOR APRIL 25, 2014

FROM:  U.S. DEFENSE DEPARTMENT 
CONTRACTS

NAVY

Charles Stark Draper Laboratory Inc., Cambridge, Mass, is being awarded a maximum $283,126,264 firm-fixed-price, fixed-price-incentive, and cost-plus-incentive-fee contract for the ongoing acquisition of Trident (D5) MK 6 Guidance System Repair Program with failure verification, test, repair and recertification of inertial measurement units, electronic assemblies, and electronic modules. Work will be performed in Pittsfield, Mass. (42 percent); Minneapolis, Minn. (29 percent); Clearwater, Fla. (22 percent); Cambridge, Mass. (6 percent); and Terrytown, N.Y. (1 percent), with an expected completion date of April 30, 2017. Fiscal 2014 weapons procurement, Navy contract funds in the amount of $243,150,264 and fiscal 2014 United Kingdom contract funds in the amount of $39,976,000 are being obligated at time of award. The contract funds will not expire at the end of the current fiscal year. This contract is a sole source acquisition pursuant to 10 U.S.C. 2304(c)(1). Strategic Systems Program, Washington, D.C., is the contracting activity (N00030-14-C-0001).

AIR FORCE

SOS International LLC, Reston, Va., (FA5641-14-D-0001); Mission Essential Personnel LLC, Columbus, Ohio, (FA5641-14-D-0002); Digital Management Inc., Bethesda, Md., (FA5641-14-D-0003); L-3 National Security Solutions, Reston, Va., (FA5641-14-D-0004); General Dynamics Information Technology, Herndon, Va., (FA5641-14-D-0005); and Decypher Technologies, San Antonio, Texas, (FA5641-14-D-0006), have been awarded a $33,000,000 multiple-award, indefinite-delivery/indefinite-quantity contract for advisory and assistance services. The contract shall serve as a vehicle to provide broad technical and analytical services to support and improve policy development, decision making, and management and administration, as well as improve the operation of systems within the primary using activities' areas of responsibility. Outputs may take the form of information, advice, alternatives, analyses, evaluations, recommendations, training and the day-to-day aid of support personnel needed to complement the government's technical expertise. In addition, the contract serves as a vehicle for non-advisory and assistance service support that is incidental to the advisory and assistance services. Work will be performed in Germany, Italy, United Kingdom, United States and other in-scope locations, and is expected to be complete by April 30, 2015. This award is the result of a competitive acquisition, and nine offers were received. Fiscal 2014 and fiscal 2015 operations and maintenance funds will be obligated on individual task orders as they are issued. This is not a multiyear contract. Air Force Installation Contracting Agency's 764th Specialized Contracting Squadron, Kaiserslautern, Germany, is the contracting activity.
Lockheed Martin Aeronautics Co., Marietta, Ga., has been awarded a $27,370,337 firm-fixed-price contract for C-130-J center wing box. The contractor will provide an extended service life center wing box on five C-130J aircraft initially. Work will be performed at Marietta, Ga., and is expected to be completed Dec. 30, 2016. This award is the result of a sole-source acquisition. Fiscal 2013 procurement funds in the amount of $27,370,337 are being obligated at time of award. Air Force Life Cycle Management Center/WLKCA, Robins Air Force Base., Ga., is the contracting activity (FA8504-14-C-0003).

ARMY

Cherokee General Corporation*, Federal Way, Wash. (W912DW-14-D-1002); Pease Construction, Inc.*, Lakewood, Wash. (W912DW-14-D-1003); Performance Systems, Inc.*, Fruitland, Idaho (W912DW-14-D-1004); Alutiiq-Mele, LLC*, Anchorage, Alaska (W912DW-D-14-1005); and Pease & Sons, Inc*, Tacoma, Wash. (W912DW-14-D-1006) will share in an award of a $100,000,000 firm-fixed-price, indefinite-delivery/indefinite-quantity, multiple-award contract. The contract requirement is for multi-disciplinary maintenance, repair, construction, and incidental design work for Joint Base Lewis-McChord, Wash., and its sub-installations and other customers supported by the Seattle District Corps of Engineers. Funding and performance locations will be determined with each order. The estimated completion date is April 24, 2019. Bids were solicited via the Web with 27 received. This is a small business set-aside contract. The U.S. Army Corps of Engineers Seattle District, Seattle, Wash., is the contracting activity.

Midland Surveying, Inc.*, Maryville, Mo. (W9128F-14-D-0002), was awarded a $9,000,000 firm-fixed-price, indefinite-delivery/indefinite-quantity contract for architect-engineer surveying and mapping of shallow water habitat, floodplain changes and vegetation cover at various nationwide locations. Funding and performance locations will be determined with each order. Estimated completion date is April 24, 2019. Bids were solicited via the Web with 27 received. The U.S. Army Corps of Engineers Omaha District, Omaha, Neb., is the contracting activity.

L-3 Communications Corp., Muskegon, Mich., was awarded an $8,746,150 modification (P00110) to cost-plus-fixed-fee contract W56HZV-09-C-0098 to exercise an option for 37,948 hours for systems technical support on a cost-plus-fixed-fee level of effort basis for the Bradley transmission. Work will be performed in Muskegon, Mich., with an estimated completion date of June 30, 2015. Fiscal 2014 other procurement funds in the amount of $8,746,150 will be obligated at award. The U.S. Army Contracting Command, Tank and Automotive (Warren), Warren, Mich., is the contracting activity.

DEFENSE LOGISTICS AGENCY

Raytheon Co., El Segundo, Calif., has been awarded a maximum $14,393,119 firm-fixed-price contract for aircraft radar receivers, circuit card assemblies, electric synthesizers, and electronic components. This is a sole-source acquisition. This contract is a stand-alone delivery order on a basic delivery order agreement. This is a three-year base contract with no options. Location of performance is California, Mississippi, and Malaysia with an April 2018 performance completion date. Using service is Navy. Type of appropriation is fiscal 2014 through fiscal 2017 Navy working capital funds. The contracting activity is the Defense Logistics Agency Aviation, Philadelphia, Pa., (SPRPA1-11-G-003X-5008).
* Small Business

REMARKS BY SECRETARY OF STATE KERRY AND NORWEGIAN FOREIGN MINISTER BRENDE

FROM:  U.S. STATE DEPARTMENT 

Remarks With Norwegian Foreign Minister Borge Brende Before Their Meeting

Remarks
John Kerry
Secretary of State
Treaty Room
Washington, DC
April 24, 2014


SECRETARY KERRY: Good afternoon, everybody. It’s a great pleasure for me to welcome my friend and collaborator, a partner in so many efforts on some of the challenges that we face, the Foreign Minister of Norway Borge Brende. Borge has been very much involved with us in any number of initiatives. He’s a strong NATO partner, a strong ally. Norway has been one of the leaders in standing up for democracy in Ukraine, standing up for the sovereignty and the territorial integrity of Ukraine.

Norway also is one of the leading countries helping the challenges – meet the challenges of Syria. We’ve had Norway’s great help in removing chemical weapons. With the movement today, providing it took place from Homs, we are over 90 percent now of all the chemical weapons being removed. So already, it’s a very significant effort, and I’m grateful for Norway’s help in it. In addition, Norway has been particularly helpful in meeting the challenge of refugees – some 2.7 million registered refugees now, and over six million people displaced within the country. It is the largest displacement of a population of any nation on the planet, and a very serious humanitarian challenge for all of us.

And also, we are working closely on other issues – climate change, the environment. I hope Norway is going to be a key participant with us in the oceans conference that we will be holding here in June.

So altogether, we couldn’t have, honestly, a better partnership. And for me, it’s very special because I once lived in Norway, my father worked there. I have a special affection for Norway and for Norwegians, and I’m very, very happy to welcome Borge here today.

FOREIGN MINISTER BRENDE: Thank you, John. Thank you, Secretary Kerry, for those very warm, welcoming remarks. America, under your leadership and President Obama, is definitely Norway’s closest ally. We have a common border with Russia. As the Secretary notes, we are very clear, as the U.S. and the rest of NATO is, on the importance of respecting Ukraine’s territorial integrity. Russia has accepted the borders of Ukraine very clearly. Back in Budapest in 1994, Ukraine gave all its nuclear weapons to Russia, and the borders have to be respected. There is no alternative. And the elections the 25th of May should go forward, so Ukraine will have then a permanent political leadership to take the country forward.
We will also continue to collaborate under Secretary Kerry’s leadership on bringing the chemical weapons out of Syria, making sure that those weapons never can be used against the civilians of Syria again. I’m happy that we’re now close to 90 percent.

Also, thank you for your personal courage and leadership in the Middle East, on Israel and the Palestinian situation – very difficult these days, but sometimes we really can show leadership when times are difficult. And there is no alternative to finding a permanent solution between the Israelis and the Palestinians. So we will also support your work on the private sector in Palestine.

Also, our work in South Sudan is now in the top of our agenda and the troika work there. The UN Security Council will hopefully make clear statements on this, because it’s unacceptable what we’re seeing of the humanitarian catastrophe unfolding. So thank you.

SECRETARY KERRY: Well said. I forgot – I’ll be there next week, as a matter of fact.
FOREIGN MINISTER BRENDE: Me too. (Laughter.)

SECRETARY KERRY: So we’ll talk about it. (Laughter.) See?

QUESTION: Mr. Secretary, is there a way to get past this impasse in the Middle East peace talks? Do you see a way forward?

SECRETARY KERRY: Well, there’s always a way forward, but leaders have to make the compromises necessary to do that. We may see a way forward, but if they’re not willing to make the compromises necessary, it becomes very elusive. We will never give up our hope or our commitment for the possibilities of peace. We believe it is the only way to go. But right now, obviously, it’s at a very difficult point. And the leaders themselves have to make decisions. It’s up to them. Thank you.

U.S. EXTENDS WARMEST REGARDS, BEST WISHES TO PEOPLE OF AUSTRALIA AND NEW ZEALAND ON ANZAC DAY

FROM:  U.S. STATE DEPARTMENT 
Secretary's Remarks: Australian and New Zealand Army Corps (ANZAC) Day
04/24/2014 04:23 PM EDT
Australian and New Zealand Army Corps (ANZAC) Day
Press Statement
John Kerry
Secretary of State
Washington, DC
April 24, 2014

On behalf of President Obama and the people of the United States, it gives me great pleasure to extend our warmest regards and best wishes to the people of Australia and New Zealand on ANZAC Day this April 25.

This year marks the 100th anniversary of the start of World War I and begins the ANZAC Centenary. This milestone not only honors and remembers the original soldiers of the Australian and New Zealand Army Corps who courageously served at Gallipoli and the Western Front in The Great War, but also highlights and commemorates a century of commitment and dedication from the servicemen and women to the nations of Australia and New Zealand.

The legacy of these brave and determined individuals and their families is extraordinary and enduring. They continue to represent your countries proudly at home and around the world in support of peace, democracy, and freedom.

We will never forget those who have made the ultimate sacrifice.

Today, as all members, past and present, of the defense forces of Australia and New Zealand are honored, know that the United States stands with you in unwavering support as a true friend and partner.

U.S. DEFENSE DEPARTMENT CONTRACTS FOR APRIL 24, 2014

FROM:  U.S. DEFENSE DEPARTMENT 
CONTRACTS

ARMY

The Boeing Co., Mesa, Ariz., was awarded a $103,800,000 firm-fixed-price contract for advance procurement funding for the purchase of long lead items as part of the AH-64E Apache Full Rate Production Lot 5 aircraft requirement. Fiscal 2014 other procurement funds in the amount of $103,800,000 were obligated at the time of the award. Estimated completion date is Dec. 31, 2014. Bids were solicited via the Internet with one received. Work will be performed in Mesa, Ariz. Army Contracting Command, Redstone Arsenal, Ala., is the contracting activity (W58RGZ-14-C-0018).

Bers-Weston Services JVA LLC,* Anchorage, Alaska, was awarded a $95,000,000 indefinite-delivery/indefinite-quantity, multi-year rapid response/immediate response contract for remediation of various hazardous waste sites within the United States and territories. Funding and work performance location will be determined with each order. Estimated completion date is April 23, 2019. Bids were solicited via the Internet with six received. U.S. Army Corps of Engineers, Omaha, Neb., is the contracting activity (W9128F-14-D-0009).
Bates Engineers/Contractors Inc.,* Bainbridge, Ga., was awarded a $46,000,000 firm-fixed-price indefinite-delivery/indefinite-quantity single award task order contract for the U.S. Army Corps of Engineers Mobile District's North Alabama Regional Construction Program. Funding and work performance location will be determined with each order. Estimated completion date is April 23, 2019. Bids were solicited via the Internet with 36 received. U.S. Army Corps of Engineers, Mobile, Ala., is the contracting activity (W91278-14-D-0039).

EMCOR Government Services Inc., Arlington, Va., was awarded a $45,000,000 firm-fixed-price contract for operations, maintenance, repair and minor construction for the Fort Belvoir Community Hospital, Fort Belvoir, Va. Funding and work performance locations will be determined with each order. Estimated completion date is April 16, 2019. Bids were solicited via the Internet with three received. U.S. Army Corps of Engineers, Mobile, Ala., is the contracting activity (W91278-14-D-0021).

Jacobs Technology, Tullahoma, Tenn., was awarded a $20,689,631 modification (P00024) to contract W91CRB-08-D-0001 to extend support services to the Aberdeen Test Center, Aberdeen Proving Ground, Md., through July 31, 2014. Funding and work performance location will be determined with each order. Estimated completion date is July 31, 2014. Army Contracting Command, Aberdeen, Md., is the contracting activity.

Truetech,* Riverhead, N.Y., was awarded an $8,071,865 firm-fixed-price, multi-year, indefinite-delivery/indefinite-quantity contract for the procurement of M256A2 chemical agent detector kits. Funding and work performance location will be determined with each order. Estimated completion date is April 24, 2019. Bids were solicited via the Internet with one received. Army Contracting Command, Warren, Mich., is the contracting activity (W56HZV-14-D-0061).
CORRECTION: The contract W58RGZ-14-D-0077 to Overhaul Support Services announced April 23, 2014 was not awarded.

DEFENSE LOGISTICS AGENCY

Sylvan Forest Products Inc.,* Portland, Ore., (SPM8E6-11-D-0004/P00102); S&S Forest Products LLC,** Boerne, Texas, (SPM8E6-11-D-0005/P00101); R.D. Buie Enterprises,* Boerne, Texas, (SPM8E6-11-D-0006/P00101); Forest Products Distributors Inc.,* Rapid City, S.D., (SPM8E6-11-D-0007/P00101), have been awarded maximum $60,796,669 modifications exercising the second option period on a two-year base contract with three one-year option periods. This is a firm-fixed-price contract to provide wood products. Locations of performance are Oregon, Texas, and South Dakota with a May 24, 2015 performance completion date. Using military services are Army, Navy, Air Force, Marine Corps, and federal civilian agencies. Type of appropriation is fiscal 2014 through fiscal 2015 defense working capital funds. The contracting activity is the Defense Logistics Agency Troop Support, Philadelphia, Pa.

Sysco Northern New England, Inc., Westbrook, Maine, has been awarded a maximum $12,000,000 fixed-price with economic-price-adjustment contract for prime vendor food and beverage support. This is a sole-source acquisition. This is a four-year base contract with no options. Location of performance is Maine with a Mar. 23, 2018 performance completion date. Using services are Army, Navy, Air Force, and Marine Corps. Type of appropriation is fiscal year 2014 defense working capital funds. The contracting activity is the Defense Logistics Agency Troop Support, Philadelphia, Pa., (SPE300-14-D-3005). (Awarded March 24, 2014)

PerkinElmer Genetrics, Inc., Bridgeville, Pa., has been awarded a maximum $9,700,000 modification (P0012) exercising the third option period on a one-year base contract (SPM2DE-11-D-7229) with four one-year option periods. This is a fixed-price with economic-price-adjustment, indefinite-delivery/indefinite-quantity contract for shipping of various laboratory and pharmaceutical supplies. Location of performance is Pennsylvania with a May 6, 2015 performance completion date. Using military services are Army, Navy, Air Force, and Marine Corps. Type of appropriation is fiscal 2014 through fiscal 2015 defense working capital funds. The contracting activity is the Defense Logistics Agency Troop Support, Philadelphia, Pa

AIR FORCE

Sonoran Technology and Professional Services LLC, Goodyear, Ariz., has been awarded a $49,000,000 max value firm-fixed-price, indefinite-delivery/indefinite-quantity contract for F-16 weapons system support for F-16 academic instruction, F-16 aircrew training devices (ATD) instruction/console operations, and ATD cockpit operations, comprehensive courseware development, and training support. Work will be performed at Luke Air Force Base, Ariz. and Holloman AFB, N.M., and is estimated to be completed by April 30, 2019. This award is the result of a competitive, small business set-aside acquisition solicited through Federal Business Opportunities, and five offers were received. The current action includes less than one percent unclassified foreign military sale to the Republic of Singapore. Fiscal 2014 operations and maintenance funds in the amount of $5,923,515 will be obligated upon availability of funds. The 338th Specialized Contracting Squadron, Randolph AFB, Texas, is the contracting activity (FA3002-14-D-0005).

1st American Systems and Services, Falls Church, Va., has been awarded a maximum $42,000,000 firm-fixed-price, indefinite-delivery/indefinite-quantity contract for Family Advocacy Program and Domestic Violence Counseling in the Pacific Region. The Family Advocacy Program promotes family health, welfare, and morale by preventing or treating cases of maltreatment and by supporting family members who have special medical or educational needs. Work will be performed at Eielson Air Force Base, Alaska; Elmendorf AFB, Alaska; Kadena Air Base, Japan; Misawa AB, Japan; Yokota AB, Japan; and Osan AB, Republic of Korea, and will be completed by April 26, 2019. This award is the result of a competitive 8(a) set-aside acquisition solicited through Federal Business Opportunities, and five offers were received. Fiscal 2014 Office of the Secretary of Defense operations and maintenance funds in the amount of $4,752,833 will be obligated at time of award. Air Force Installation Contracting Agency, San Antonio, Texas, is the contracting activity (FA8052-14-D-0003).

NAVY

Raytheon Co., Intelligence, Information and Services, Dulles, Va., is being awarded a $15,844,476 cost-plus-incentive-fee, cost-plus-fixed-fee, cost contract for non-recurring research and development support for the Tactical Control System (TCS). This effort continues the transition from the TCS baseline into the Unmanned Aerial System Control Segment architecture, integrates modern intuitive controls as identified during testing with fleet operators, Automates testing procedures in support of future integration & production, and it supports the software baseline operating in the field. Work will be performed in Sterling, Va. (80 percent); Dahlgren, Va. (9 percent); Carson, Calif. (6 percent); and Garland, Texas (5 percent), and is expected to be completed in April 2016. Fiscal 2014 research, development, test and evaluation and fiscal 2014 operations and maintenance, Navy funds in the amount of $4,214,507 will be obligated at time of award, $100,000 of which will expire at the end of the current fiscal year. This contract was not competitively procured pursuant to FAR 6.302-1. The Naval Air Systems Command, Patuxent River, Md., is the contracting activity (N00019-14-C-0049).

Aegisound LLC,* Christiansburg, Va., is being awarded a $10,135,882 firm-fixed-price, delivery order (0008) against a previously issued basic ordering agreement (N68335-11-G-0019) to procure flight deck cranial double hearing protection headsets. This order will include 4215 DC2; 458 Argonaut CEP-generic fit communication earplugs standard replacement tips; 1068 Argonaut CEP-generic fit communication earplugs slim replacement tips; 1236 Argonaut Boom Headset-Harris P71000 Radio; 1415 Argonaut Boom Headset- F-18 ICS; 401Argonaut muzzle headset-sound powered phone; 401 battery pack; 301 Two Gang battery charger; 3052 Argonaut generic fit communication earplugs; 33 production lot testings, and 14 production status reports. Work will be performed in Christiansburg, Va., and is expected to be completed in May 2016. Fiscal 2013 and 2014 other procurement, Navy funds in the amount of $10,135,882 will be obligated at time of award, none of which will expire at the end of the current fiscal year. The Naval Air Warfare Center Aircraft Division, Lakehurst, N.J., is the contracting activity.

The Boeing Co., Seattle, Wash., is being awarded $8,747,003 for cost-plus-fixed-fee, delivery order 3008 against a previously issued basic ordering agreement (N00019-11-G-0001) for software updates in support of the P-8A Poseidon aircraft. Work will be performed in Seattle, Wash. (27.6 percent); Huntington Beach, Calif. (18.9 percent); McKinney, Texas (18.4 percent); Grand Rapids, Mich. (13.4 percent); Baltimore, Md. (7.8 percent); Rolling Meadows, Ill. (4.2 percent); El Segundo, Calif. (3.9 percent); Farmingdale, N.Y. (3 percent); St. Louis, Mo. (1.5 percent); and Amityville, N.Y. (1.3 percent), and is expected to be completed in August 2015.  Fiscal 2014 aircraft procurement and fiscal 2014 operations and maintenance, Navy funds in the amount of $8,446,018 will be obligated at time of award, $300,000 of which will expire at the end of the current fiscal year. The Naval Air Systems Command, Patuxent River, Md., is the contracting activity.
*Small Business

**Service-Disabled Veteran Owned Small Business

SECRETARY KERRY'S REMARKS ON UKRAINE

FROM:  U.S. STATE DEPARTMENT 
Remarks on Ukraine
Remarks
John Kerry
Secretary of State
State Department Press Briefing Room
Washington, DC
April 24, 2014

It has now been a week since the United States, the European Union, Russia, and Ukraine met in Geneva.  We did so after a phone call between President Putin and President Obama, in which both leaders expressed a desire to avoid further escalation in Ukraine.  We met in Geneva with a clear mission: to improve security conditions and find political solutions to the conflict threatening the sovereignty and unity of Ukraine.  And right there in Geneva, EU High Representative Ashton and I made clear that both Russia and Ukraine had to demonstrate more than good faith.  They needed to take concrete actions in order to meet their commitments.

The simple reality is you can’t resolve a crisis when only one side is willing to do what is necessary to avoid a confrontation.  Every day since we left Geneva – every day, even up to today, when Russia sent armored battalions right up the Luhansk Oblast border – the world has witnessed a tale of two countries, two countries with vastly different understandings of what it means to uphold an international agreement.

One week later, it is clear that only one side, one country, is keeping its word.  And for anyone who wants to create gray areas out of black, or find in the fine print crude ways to justify crude actions, let’s get real – the Geneva agreement is not open to interpretation.  It is not vague.  It is not subjective.  It is not optional.  What we agreed to in Geneva is as simple as it is specific.

We agreed that all sides would refrain from violence, intimidation, and taking provocative actions.  We agreed that illegal groups would lay down their arms and that, in exchange for amnesty, they would hand over the public buildings and spaces that they occupied.  We agreed that to implement these objectives – and this is important, to implement this – monitors from the Organization for Security and Cooperation in Europe would have unfettered access to parts of Ukraine where they were needed most.  And we agreed that all parties would work to create that access and to provide help to the OSCE in order to do this.  We agreed that the OSCE would report from the ground whether the rights, security, and dignity of Ukrainian citizens was being protected.

From day one, the Government of Ukraine started making good on its commitments – from day one.  From day one, Prime Minister Yatsenyuk has kept his word.  He immediately agreed to help vacate buildings.  He suspended Ukraine’s counterterrorism initiative over Easter, choosing de-escalation, despite Ukraine’s legitimate, fundamental right to defend its own territory and its own people.  From day one, the Ukrainian Government sent senior officials to work with the OSCE, in keeping with the agreement, to send them to work in regions where Russia had voiced its most urgent concerns about the security of Russian speakers and ethnic Russians.  And on day one, Prime Minister Yatsenyuk went on live television and committed his government publicly to all of the people of Ukraine that – and these are his words – committed them to undertake comprehensive constitutional reform that will strengthen the powers of the regions.  He directly addressed the concerns expressed by the Russians, and he did so on day one.

He also made a personal appeal to Russian-speaking Ukrainians, pledging to support – and again, these are his words – a special status to the Russian language and the protection of the language.  And in keeping with his Geneva commitments, Prime Minister Yatsenyuk has publicly announced amnesty legislation – once more, in his words – for all those who surrender arms, come out of the premises and will begin with the Ukrainian people to build a sovereign and independent Ukraine.  That is a promise made by the interim government to the people of Ukraine.

And by complying with actions requested by Russia, like removing the barricades in the Maidan and cleaning up the square and ensuring that all ongoing demonstrations in Kyiv are actually government-approved and peaceful, Ukraine is thereby taking tangible, concrete steps to move beyond the division of the last months.  That is how a government defines keeping your word.  That is leadership that upholds both the spirit and the letter of a Geneva agreement.

The world has rightly judged that Prime Minister Yatsenyuk and the Government of Ukraine are working in good faith.  And the world, sadly, has rightly judged that Russia has put its faith in distraction, deception, and destabilization.  For seven days, Russia has refused to take a single concrete step in the right direction.  Not a single Russian official, not one, has publicly gone on television in Ukraine and called on the separatists to support the Geneva agreement, to support the stand-down, to give up their weapons, and get out of the Ukrainian buildings.  They have not called on them to engage in that activity.

In fact, the propaganda bullhorn that is the state-sponsored Russia Today program, has been deployed to promote – actually, Russia Today network – has deployed to promote President Putin’s fantasy about what is playing out on the ground.  They almost spend full time devoted to this effort to propagandize and to distort what is happening or not happening in Ukraine.  Instead, in plain sight, Russia continues to fund, coordinate, and fuel a heavily armed separatist movement in Donetsk.

Meanwhile, Russian leaders are making increasingly outrageous claims to justify their action – that the CIA invented the internet in order to control the world or that the forces occupying buildings, armed to the teeth, wearing brand new matching uniforms and moving in disciplined military formation, are merely local activists seeking to exercise their legitimate rights.  That is absurd, and there is no other word to describe it.

But in the 21st century, where every citizen can broadcast messages, images, and video from the palm of their hand, no amount of propaganda is capable of hiding such actions.  No amount of propaganda will hide the truth, and the truth is there in the social media and across the pages of newspapers and in the video of televisions for all of the world to see.  No amount of propaganda can withstand that kind of scrutiny today.

The world knows that peaceful protesters don’t come armed with grenade launchers and automatic weapons, the latest issue from the Russian arsenal, hiding the insignias on their brand new matching military uniforms, and speaking in dialects that every local knows comes from thousands of miles away.  The world knows that the Russian intelligence operatives arrested in Ukraine didn’t just take a wrong turn on the highway.  In fact, we have seen soldiers wearing uniforms identical to the ones Russian soldiers wore in Crimea last month.

As international observers on the ground have borne witness, prior to Russia’s escalation, there was no violence.  There was no broad-scale assault on the rights of people in the east.  Ukraine was largely stable and peaceful, including in the south and the east.  Even as we were preparing to meet in Geneva, we know that the Russian intelligence services were involved in organizing local pro-Russian militias.  And during the week leading up to the Geneva meetings, separatists seized at least 29 buildings.  This is one more example of how Russia is stoking the very instability that they say they want to quell.

And in the weeks since this agreement, we have seen even more violence visited upon Ukrainians.  Right after we left Geneva, separatists seized TV and radio stations that broadcast in the Ukrainian language.  The mayor of Slovyansk was kidnapped the very day after the parties committed to end the violence and intimidations.  Two days ago, one journalist was kidnapped and another went missing, bringing the total number of kidnapped journalists into the double digits.  That same day, two dead bodies were found near Slovyansk.  One of them was a city councilmember who had been knocked unconscious and thrown in a river with a weighted backpack strapped to him.

The Government of Ukraine has reported the arrest of Russian intelligence agents, including one yesterday who it says was responsible for establishing secure communications allowing Russia to coordinate destabilizing activities in Ukraine.  And then, just this morning, separatist forces tried to overrun another arms depot.

Having failed to postpone Ukraine’s elections, having failed to halt a legitimate political process, Russia has instead chosen an illegitimate course of armed violence to try and achieve with the barrel of a gun and the force of a mob what couldn’t be achieved any other way.  They’ve tried to create enough chaos in the east to delay or delegitimize the elections, or to force Ukraine to accept a federalism that gives Russia control over its domestic and foreign policies, or even force Ukraine to overreact and create an excuse for military intervention.  This is a full-throated effort to actively sabotage the democratic process through gross external intimidation that has brought inside Ukraine, and it is worse even.

We have seen this movie before.  We saw it most recently in Crimea, where similar subterfuge and sabotage by Russia was followed by a full invasion – an invasion, by the way, for which President Putin recently decorated Russian special forces at the Kremlin.

Now Russia claims that all of this is exaggerated, or even orchestrated, that Ukrainians can’t possibly be calling for a government free of corruption and coercion.  Russia is actually mystified to see Ukraine’s neighbors and likeminded free people all over the world united with Ukrainians who want to build a better life and choose their leaders for themselves, by themselves.

Nobody should doubt Russia’s hand in this.  As NATO’s Supreme Allied Commander in Europe wrote this week, “What is happening in eastern Ukraine is a military operation that is well planned and organized and we assess that it is being carried out at the direction of Russia.”  Our intelligence community tells me that Russia’s intelligence and military intelligence services and special operators are playing an active role in destabilizing eastern Ukraine with personnel, weapons, money, operational planning, and coordination.  The Ukrainians have intercepted and publicized command-and-control conversations from known Russian agents with their separatist clients in Ukraine.  Some of the individual special operations personnel, who were active on Russia’s behalf in Chechnya, Georgia, and Crimea have been photographed in Slovyansk, Donetsk, and Luhansk.  Some are even bragging about it by themselves on their Russian social media sites.  And we’ve seen weapons and gear on the separatists that matches those worn and used by Russian special forces.

So following today’s threatening movement of Russian troops right up to Ukraine’s border, let me be clear:  If Russia continues in this direction, it will not just be a grave mistake, it will be an expensive mistake.  Already the international response to the choices made by Russia’s leaders is taking its toll on Russia’s economy.  Prime Minister Medvedev has alluded to the cost Russia is already paying.  Even President Putin has acknowledged it.

As investors’ confidence dwindles, some $70 billion in capital has fled the Russian financial system in the first quarter of 2014, more than all of last year.  Growth estimates for 2014 have been revised downward by two to three percentage points.  And this follows a year in which GDP growth was already the lowest since 2009.  Meanwhile, the Russian Central Bank has had to spend more than $20 billion to defend the ruble, eroding Russia’s buffers against external shocks.  Make no mistake that what I’ve just described is really just a snapshot and is also, regrettably, a preview of how the free world will respond if Russia continues to escalate what they had promised to de-escalate.

Seven days, two opposite responses, and one truth that cannot be ignored:  The world will remain united for Ukraine.  So I will say it again.  The window to change course is closing.  President Putin and Russia face a choice.  If Russia chooses the path of de-escalation, the international community – all of us – will welcome it.  If Russia does not, the world will make sure that the cost for Russia will only grow.  And as President Obama reiterated earlier today, we are ready to act.

DEFENSE SECRETARY HAGEL WANTS TO STRENGTHEN TIES WITH CANADA AND MEXICO

FROM:  THE DEFENSE DEPARTMENT 

Defense Secretary Chuck Hagel, left, greets Canadian Defense Minister Robert Nicholson before meeting in Mexico City, April 23, 2014. Hagel will attend a defense ministerial conference with Mexico, Canada and the United States before traveling to Guatemala. 

Hagel Looks to Strengthen Ties With Canada, Mexico.
By Cheryl Pellerin
American Forces Press Service

MEXICO CITY, April 24, 2014 – Defense Secretary Chuck Hagel met here last night with Canadian Defense Minister Rob Nicholson, ahead of today’s North American Defense Ministerial conference, which brings together the defense leaders from the United States, Canada and Mexico.

The conference is the second since 2012, when Canada hosted the first North American defense ministers meeting, and on the flight here, Hagel told reporters traveling with him that it’s important to keep the momentum going.
“Every time we meet,” he said, “we add muscle and sinew --substance -- to what we’re doing and what we could be doing.”

Hagel said the defense ministerial arose from President Barack Obama’s attendance in February in Toluca, Mexico, with Mexican President Pena Nieto and Canadian Prime Minister Stephen Harper at the North American Leaders Summit. There, the leaders discussed their vision for a prosperous and secure future for North American citizens and a shared commitment to work together to realize that vision. The leaders announced initiatives by the three countries to enhance competitiveness in the global economy, expand opportunities for North American citizens, and promote peace, security and development through multilateral action.
The secretary said his visit here would focus on the importance of the region and specific relationships within the region -- in particular, the trilateral relationship among the United States, Mexico and Canada.

“I don't think over the years we've done enough to reach out to our Latin American partners, partly because we suffer from a pretty good relationship,” Hagel said. “The places that get most of the attention around the world are the trouble spots.”
A senior defense official traveling with the secretary said the focus on the North American trilateral relationship “is the defense component of what we're trying to do in the [Western] Hemisphere -- drawing the United States, Mexico and Canada closer together as three partners.”

“We've always had very strong bilateral relationships with both countries, and it's not meant to supplant those … relationships, but we're trying to leverage the capabilities of all three countries,” the official added.

And because the three nations share threat perceptions and interests in so many places in the region and increasingly around the world, the defense official said, the focus on the trilateral partnership is an effort to build on those shared interests.
The official said the defense ministers would meet in several different kinds of meetings, large and small. Though the trilateral conference involves three countries, four ministers will attend the meetings, because in Mexico, two government ministries are directly responsible for national defense: the Mexican National Defense Secretariat, shortened as SEDENA in its Spanish acronym, and the Navy Secretariat, SEMAR.

Hagel’s counterparts in Mexico are Secretary of National Defense Gen. Salvador Zepeda Cienfuegos and Naval Secretary Adm. Vidal Francisco Soberon Sanz, and the secretary will meet with them for the first time today.

These military officers hold Cabinet rank and have regular and direct access to the Mexican president, who also is supreme commander of the armed forces.
Hagel has met with his Canadian counterpart several times, the defense official said, most recently in February during a NATO defense ministers meeting in Brussels.

When the two leaders met here today, Pentagon Press Secretary Navy Rear Adm. John Kirby said, they discussed a range of issues of mutual concern, including the situation in Ukraine, recent developments in the Asia-Pacific region, and common security challenges in the Western Hemisphere.

During the 30-minute meeting, Kirby added, both Hagel and Nicholson “expressed eagerness to discuss in more detail ways in which all three nations can work more closely together to deal with the threats posed by criminal networks, cyberattacks and natural disasters.”

Hagel also thanked Nicholson for his leadership and for Canada's strong contributions to the NATO alliance, the press secretary said, including the International Security Assistance Force mission in Afghanistan.

The senior defense official characterized Hagel’s visit here as a great opportunity to establish relationships with partners in the Western Hemisphere and to continue to work with Mexico on the bilateral relationship with the United States.
“The Mexicans are our regional partners, regional leaders, and increasingly, in the world they're becoming more of a global player,” the defense official said.
“The relatively new president of Mexico made quite a splash on the world scene, and he's got big challenges at home with the economy,” he added, “but he's an impressive leader, and President Obama had a good meeting with him a couple of months ago.”

As indicated by the potential sale of 18 Black Hawk helicopters by the United States to Mexico, as announced this week by the State Department, the Mexicans are interested in acquiring a range of U.S. capabilities, the official said.
The potential Black Hawk sale is a high-visibility request by Mexico, he added, “but we are talking to them about a range of capabilities that they are interested in, … like our assistance in their own security.”

“There are partnership things we can do and things we can do together,” he added, “but they also want to acquire their own capabilities, and we're interested in helping.”

When Hagel leaves Mexico, he’ll travel to Guatemala to meet with defense and government leaders.

CHIEF OFFICER AND HIS FIRM CHARGED WITH ILLEGALLY SHIPPING MACHINERY TO IRAN

FROM:  U.S JUSTICE DEPARTMENT 
Wednesday, April 23, 2014
Pennsylvania Firm and Chief Officer Charged with Shipping Machinery to Iran in Violation of U.S. Export License Requirements

A criminal information has been filed against a Pennsylvania firm and its chief officer, charging them with conspiracy to evade export reporting requirements and with attempting to smuggle to Iran a lathe machine in violation of U.S. export regulations.   The announcement was made today by the U.S. Attorney Peter J. Smith for the Middle District of Pennsylvania.

Charged in the Criminal Information were Hetran Inc., an engineering and manufacturing plant in Orwigsburg, Pa., and its chief executive officer, Helmut Oertmann.   At the same time, an indictment was unsealed that had previously been voted by a federal grand jury in Harrisburg in December 2012 against three Iranians and two Iranian firms connected with the criminal scheme: Mujahid Ali, Khosrow Kasraei, Reza Ghoreishi, FIMCO FZE, and Crescent International Trade and Services FZE.

Also charged was Suniel Malhotra, an Indian national, an overseas sales representative for Hetran Inc.

According to U.S. Attorney Peter Smith, Hetran allegedly manufactured a horizontal lathe, also described as a bar peeling machine (peeler), valued at more than $800,000 and weighing in excess of 50,000 pounds.   A horizontal lathe, or peeling machine, is used in the production of high grade steel or bright steel,” a product used, among other things, in the manufacture of automobile and aircraft parts.

On or about June 2009, Hetran was allegedly contacted by representatives of FIMCO, an Iranian company with offices in Iran and the United Arab Emirates, and Crescent International, an affiliated company based in Dubai in the United Arab Emirates.  FIMCO allegedly wanted to purchase the peeler.  During negotiations, it became apparent that the peeler was intended for shipment to Iran.  American companies are forbidden to ship “dual use” items (such as the peeler) to Iran without first obtaining a license from the U.S. Department of Commerce.  Aware that it was unlikely that such a license would be granted, Hetran, Helmut Oertmann and other co-conspirators agreed to falsely state on the shipping documents that the end-user of the peeler was Crescent International in Dubai.

On June 17, 2012, Hetran allegedly caused the peeling machine to be shipped to Dubai in the United Arab Emirates, fraudulently listing Crescent International in Dubai as the end-user, knowing that the shipment was ultimately being sent to Iran in violation of federal law.

Hetran is charged with conspiring to violate the export laws of the United States, and is subject to a sentence of up to $1,000,000.  Helmut Oertmann, charged with attempting to smuggle goods from the United States to Iran, faces a potential penalty of up to 10 years imprisonment, a fine of up to $250,000 and up to 5 years supervised release.  The Iranian and Indian defendants are charged with conspiring to violate and with attempting to violate the export laws of the United States, each carrying potential penalties of up to 10 years imprisonment, a fine of up to $250,000 and up to 5 years supervised release for the individual defendants and a $1,000,000 fine for each corporate defendant.

The case was investigated by the Office of Export Enforcement of the U.S. Department of Commerce.  The prosecution is being coordinated by Assistant U.S. Attorney Christy Fawcett and Senior Litigation Counsel Gordon Zubrod and is being overseen by the National Security Division of the U.S. Department of Justice.

Indictments and criminal informations are only allegations. All persons charged are presumed to be innocent unless and until found guilty in court.

A sentence following a finding of guilty is imposed by the Judge after consideration of the applicable federal sentencing statutes and the Federal Sentencing Guidelines.

In this case, the maximum penalty under the federal statute is 10 years imprisonment, a term of supervised release following imprisonment and a fine. Under the Federal Sentencing Guidelines, the Judge is also required to consider and weigh a number of factors, including the nature, circumstances and seriousness of the offense; the history and characteristics of the defendant; and the need to punish the defendant, protect the public and provide for the defendant’s educational, vocational and medical needs.  For these reasons, the statutory maximum penalty for the offense is not an accurate indicator of the potential sentence for a specific defendant.

FDA POINTS OUT SEVERAL TYPES OF TOBACCO PRODUCTS

FROM:  FEDERAL FOOD AND DRUG ADMINISTRATION 
Recognize Tobacco in its Many Forms

Tobacco use is the single largest preventable cause of disease and death in the United States, but can you recognize all the different forms of a tobacco product? The marketplace includes an array of new products, with many looking very different from the traditional tobacco products you may know about.
To attract users, tobacco companies regularly modify their products and introduce novel tobacco products to the market. “Parents should stay updated on the various products available and, discuss the dangers of tobacco use with their children,” says Ii-Lun Chen, M.D., a pediatrician and medical branch chief in the Office of Science at FDA’s Center for Tobacco Products.

The basic components of most cigarettes are tobacco, a filter, and paper wrapping. Although smokers use cigarettes to get nicotine, they are exposed to toxic and cancer-causing chemicals that are created when the cigarette is burned.

Cigars, Little Cigars, Cigarillos

Generally, cigars are cured tobacco wrapped in leaf tobacco or a substance containing tobacco. Cigars vary in size — with smaller sizes sometimes referred to as little cigars or cigarillos. Large cigars can deliver as much as 10 times the nicotine, 2 times more tar, and more than 5 times the carbon monoxide than a filtered cigarette. Although cigarettes with characterizing flavors are illegal, there are products available on the market that look like cigarettes but are labeled as “little cigars,” and some include candy and fruit flavors that appeal to adolescents and youth adults. Cigars also may appeal to youth because they may be less expensive than cigarettes. In addition, young adults may think that cigars are less addictive and present fewer health risks than cigarettes.

Dissolvable Products

In the past, smokeless tobacco products have required spitting or discarding the product remains. There are new tobacco products that are not smoked and are often called “dissolvables.” These products can be more easily concealed as no product disposal is needed. They are sold as lozenges, strips, or sticks, and may look like candy. The advertised appealing flavor and discreet forms of these products may encourage young people to take them up, but the nicotine content can lead to addiction and may also present an accidental poisoning risk for children.


Electronic Cigarettes (Also Referred to as: Vape Pen, e-Hookah, Hookah Pen)

Electronic cigarettes often resemble traditional cigarettes but they use a heat source, usually powered by a battery, to turn “e-liquid,” a liquid that usually contains nicotine from tobacco and flavorings, into an aerosol that is inhaled by the user. The amount of nicotine in the aerosol may vary by brand. Little information about the safety of electronic cigarettes exists.

Traditional Smokeless Tobacco Products

There are two main types of smokeless tobacco that have been traditionally marketed in the United States: chewing tobacco and moist snuff. Chewing tobacco is cured tobacco in the form of loose leaf, plug, or twist. Snuff is finely cut or powdered, cured tobacco that can be dry, moist, or packaged in sachets. Snus is a finely ground moist snuff that can be loose or packaged. Most smokeless tobacco use involves placing the product between the cheek or lip and the gum.

The availability of flavored, lower-nicotine, smokeless tobacco products lacking harsh attributes promoted by manufacturers may allow for experimentation by new users, but may also lead to nicotine addiction and continued use of smokeless or other tobacco products. Over time, smokeless tobacco users may switch from lower-nicotine smokeless tobacco products to products that deliver more nicotine.

Waterpipes (Also Referred to as: Hookah, Shisha, Narghile, Argileh)

Waterpipes (also known as hookah, shisha, narghile, or argileh) are used to smoke specially made tobacco that comes in a variety of flavors like mint, cherry and licorice. Waterpipe smoking delivers the addictive drug nicotine and the smoke from a waterpipe is at least as toxic as, or more toxic than cigarette smoke. In fact, research shows that waterpipe smokers may absorb even more of the harmful components found in cigarette smoke because smoking sessions are longer. A typical one-hour hookah session involves inhaling 100–200 times the volume of smoke from a single cigarette. Waterpipe tobacco flavoring, exotic paraphernalia, and social use at hookah bars have increased its popularity with people who don’t already smoke cigarettes and younger people in the United States.

What FDA Currently Regulates

Currently, FDA regulates the manufacture, marketing and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, FDA has recently issued a proposed rule to bring additional products that meet the Tobacco Control Act’s definition of a tobacco product under FDA’s regulatory authority, including electronic cigarettes, some or all cigars, pipe tobacco, dissolvables, and waterpipe tobacco. The proposed rule will be available for public comment for 75 days and FDA encourages the public to submit comments, data, research, or other information related to the proposed rule.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

April 24, 2014

PRESIDENT OBAMA MARKES REMARKS TO MIRAIKAN SCIENCE AND YOUTH EXPO IN TOKYO, JAPAN

FROM:  THE WHITE HOUSE PRESIDENT 
Remarks by President Obama to Miraikan Science and Youth Expo
Miraikan Museum
Tokyo, Japan

3:27 P.M. JST

PRESIDENT OBAMA:  Konnichiwa.  Please sit down.  Thank you so much.  Well, I want to thank Dr. Mohri and everyone at The Miraikan for welcoming me here today.  And it is wonderful to see all of these outstanding students.  Dr. Mohri is a veteran of two space shuttle missions, embodies the spirit that brings us here together —- the incredible cooperation in science and technology between Japan and the United States.

I want to thank all the students that I had a chance to meet with as we went around the various exhibits.  We heard a message from the international space station.  We saw some truly amazing robots -- although I have to say the robots were a little scary. They were too lifelike.  They were amazing.  And these students showed me some of their experiments, including some soccer-playing robots that we just saw.  And all of the exhibits I think showed the incredible breakthroughs in technology and science that are happening every single day.

And historically, Japan and the United States have been at the cutting-edge of innovation.  From some of the first modern calculators decades ago to the devices that we hold in our hands today -- the smartphones that I’m sure every young person here uses -- Japan and the United States have often led the way in the innovations that change our lives and improve our lives.

And that’s why I’m so pleased that the United States and Japan are renewing the 10-year agreement that makes so much of our science and technology cooperation possible.  Both of our societies celebrate innovation, celebrate science, celebrate technology.  We’re close partners in the industries of tomorrow. And it reminds us why it’s so important for us to continue to invest in science, technology, math, engineering.  These are the schools -- these are the skills that students like all of you are going to need for the global economy, and that includes our talented young women.

Historically, sometimes young women have been less represented in the sciences, and one of the things that I’ve really been pushing for is to make sure that young women, just like young men, are getting trained in these fields, because we need all the talent and brainpower to solve some of the challenges that we’re going to face in the future.

Earlier today, Prime Minister Abe and I announced a new initiative to increase student exchanges, including bringing more Japanese students to the United States.  So I hope you’ll come.  Welcome.  And it’s part of our effort to double students exchanges in the coming years.  As we saw today, young people like you have at your fingertips more technology and more power than even the greatest innovators in previous generations. So there’s no limit to what you can achieve, and the United States of America wants to be your partner.

So I’m very proud to have been here today.  I was so excited by what I saw.  The young people here were incredibly impressive.  And as one of our outstanding astronauts described, as we just are a few days after Earth Day, it’s important when we look at this globe and we think about how technology has allowed us to understand the planet that we share, and to understand not only the great possibilities but also the challenges and dangers from things like climate change -- that your generation is going to help us to find answers to some of the questions that we have to answer.  Whether it’s:  How do we feed more people in an environment in which it’s getting warmer? How do we make sure that we’re coming up with new energy sources that are less polluting and can save our environment?  How do we find new medicines that can cure diseases that take so many lives around the globe?  To the robots that we saw that can save people’s lives after a disaster because they can go into places like Fukushima that it may be very dangerous for live human beings to enter into.  These are all applications, but it starts with the imaginations and the vision of young people like you.

So I’m very proud of all of you and glad to see that you’re doing such great work.  You have counterparts in the United States who share your excitement about technology and science.  I hope you get a chance to meet them.  I hope you get a chance to visit the United States.  As far as I know, we don’t have one of those cool globes, but we have some other pretty neat things in the United States as well.  And I hope we can share those with you if and when you come.

Thank you very much.  And I just want you to know in closing that I really believe that each of you can make a difference.  Gambatte kudasai.  You can do this thing if you apply yourselves.  Thank you.  (Applause.)

END

Thursday, April 24, 2014

FORMER ARMY SGT. WILL ACCEPT MEDAL OF HONOR IN HONOR OF SIX WHO GAVE THEIR LIVES

FROM:  THE DEFENSE DEPARTMENT 
White to Accept Medal of Honor in Memory of Comrades
By J.D. Leipold
Army News Service

WASHINGTON, April 24, 2014 – Former Army Sgt. Kyle J. White said that when he accepts the Medal of Honor from President Barack Obama at the White House on May 13, he will do so in honor of the five soldiers and one Marine "who gave their lives in the defense of freedom and the American way of life."
White spoke at a press conference yesterday at the National Guard Center in Charlotte, N.C., near where he now lives. White was just 20 when he was deployed to Afghanistan. On Nov. 9, 2007, his 14-man unit and squad of Afghan soldiers were brutally ambushed on three sides by Taliban fighters on a path descending from the village of Aranas into a valley.

"On May 13th when I'm awarded the Medal of Honor, I will tell their stories and preserve their memories… they will not be forgotten," the now-27-year-old Seattle native told the press and bloggers. "Their sacrifice and the sacrifices of so many others are what motivate me to wake up each and every day to be the best I can. Everything I do in my life is done to make them proud."
White was asked how strong the memory of the battle is now, after almost seven years, during which time he attained a bachelor's degree and became an investment analyst for a major bank.

"I would say for the first couple of years, memories were more vivid than today. As time goes on certain things you think about less and less, but at any given moment I can close my eyes and hear the sounds and smell the gunpowder in the air; but six and a half years later, I don't think about it as much as I used to," he said.

He did share that there were two things he can always visualize as if it were yesterday -- when he looked up from applying a tourniquet to wounded Marine Sgt. Phillip Bocks to see then-Spc. Kain Schilling take an enemy round to his left leg. White rushed to his buddy and for the second time that day applied a second tourniquet to Schilling, the only one he had left, his own belt.
White will receive the Medal of Honor for his disregard of his own life while trying to save the lives of a Marine and two fellow soldiers after his team of 14 U.S. soldiers and squad of Afghan National Army soldiers were set up and ambushed by a much larger and more heavily armed Taliban force, who engaged in a three-prong attack from elevated ground.

He will become the seventh living recipient of the nation's highest military decoration for conspicuous gallantry and valor during actions in Iraq or Afghanistan.

PRESIDENT OBAMA'S STATEMENT ON ARMENIAN REMEMBRANCE DAY

FROM:  THE WHITE HOUSE 

Statement by the President on Armenian Remembrance Day

Today we commemorate the Meds Yeghern and honor those who perished in one of the worst atrocities of the 20th century.  We recall the horror of what happened ninety-nine years ago, when 1.5 million Armenians were massacred or marched to their deaths in the final days of the Ottoman Empire, and we grieve for the lives lost and the suffering endured by those men, women, and children.   We are joined in solemn commemoration by millions in the United States and across the world.   In so doing, we remind ourselves of our shared commitment to ensure that such dark chapters of human history are never again repeated.
 
I have consistently stated my own view of what occurred in 1915, and my view has not changed.  A full, frank, and just acknowledgement of the facts is in all of our interests.  Peoples and nations grow stronger, and build a foundation for a more just and tolerant future, by acknowledging and reckoning with painful elements of the past.  We continue to learn this lesson in the United States, as we strive to reconcile some of the darkest moments in our own history.   We recognize and commend the growing number of courageous Armenians and Turks who have already taken this path, and encourage more to do so, with the backing of their governments, and mine.  And we recall with pride the humanitarian efforts undertaken by the American Committee for Syrian and Armenian Relief, funded by donations from Americans, which saved the lives of countless Armenians and others from vulnerable communities displaced in 1915.
 
As we honor through remembrance those Armenian lives that were unjustly taken in 1915, we are inspired by the extraordinary courage and great resiliency of the Armenian people in the face of such tremendous adversity and suffering.  I applaud the countless contributions that Armenian-Americans have made to American society, culture, and communities.  We share a common commitment to supporting the Armenian people as they work to build a democratic, peaceful, and prosperous nation. 
 
Today, our thoughts and prayers are with Armenians everywhere, as we recall the horror of the Meds Yeghern, honor the memory of those lost, and reaffirm our enduring commitment to the people of Armenia and to the principle that such atrocities must always be remembered if we are to prevent them from occurring ever again.

CO. AND AFFILIATES TO PAY $150 MILLION FOR ALLEGEDLY BILLING MEDICARE FOR INELIGIBLE PATIENTS AND SERVICES

FROM:  U.S. JUSTICE DEPARTMENT 
Wednesday, April 23, 2014

Amedisys Home Health Companies Agree to Pay $150 Million to Resolve False Claims Act Allegations

Amedisys Inc. and its affiliates (Amedisys) have agreed to pay $150 million to the federal government to resolve allegations that they violated the False Claims Act by submitting false home healthcare billings to the Medicare program, the Department of Justice announced today.  Amedisys, a Louisiana-based for-profit company, is one of the nation’s largest providers of home health services and operates in 37 states, the District of Columbia and Puerto Rico.  
“It is critical that scarce Medicare home health dollars flow only to those who provide qualified services,” said Stuart F. Delery, Assistant Attorney General for the Civil Division.  “This settlement demonstrates the department’s commitment to ensuring that home health providers, like other providers, comply with the rules and don’t misuse taxpayer dollars.”

The settlement announced today resolves allegations that, between 2008 and 2010, certain Amedisys offices improperly billed Medicare for ineligible patients and services.  Amedisys allegedly billed Medicare for nursing and therapy services that were medically unnecessary or provided to patients who were not homebound, and otherwise misrepresented patients’ conditions to increase its Medicare payments.  These billing violations were the alleged result of management pressure on nurses and therapists to provide care based on the financial benefits to Amedisys, rather than the needs of patients.  

Additionally, this settlement resolves certain allegations that Amedisys maintained improper financial relationships with referring physicians.  The Anti-Kickback Statute and the Stark Statute restrict the financial relationships that home healthcare providers may have with doctors who refer patients to them.  The United States alleged that Amedisys’ financial relationship with a private oncology practice in Georgia – whereby Amedisys employees provided patient care coordination services to the oncology practice at below-market prices – violated statutory requirements.

“Combating Medicare fraud and overbilling is a priority for my office, other components of the Department of Justice, and United States Attorneys’ Offices across the country,” said Zane David Memeger, United States Attorney for the Eastern District of Pennsylvania.  “We have recovered billions of dollars in federal health care funds from schemes such as the one alleged in this case.  Those are health care dollars that should be spent on legitimate medical needs.”
“Home health services are a large and growing part of our federal health care system,” said Sally Quillian Yates, United States Attorney for the Northern District of Georgia.  “Health care dollars must be reserved to pay for services needed by patients, not to enrich providers who are bilking the system.”
  “Amedisys made false Medicare claims, depriving the American taxpayer of millions of dollars and unlawfully enriching Amedisys,” said Joyce White Vance, U.S. Attorney for the Northern District of Alabama.  “The vigorous enforcement work by assistant U.S. attorneys in my office, along with their colleagues in North Georgia, Eastern Pennsylvania, Eastern Kentucky and the Civil Division of the Justice Department, has secured the return of $150 million to the taxpayers and stands as a warning to future wrongdoers that we will aggressively pursue them.”
“This settlement represents a significant recovery of public funds and an important victory for the taxpayers,” said Kerry B. Harvey, United States Attorney for the Eastern District of Kentucky.  “Fighting health care fraud and recovering tax payer dollars that fund our vital health care programs is one of the highest priorities for our district.”

Amedisys also agreed to be bound by the terms of a Corporate Integrity Agreement with the Department of Health and Human Services – Office of Inspector General that requires the companies to implement compliance measures designed to avoid or promptly detect conduct similar to that which gave rise to the settlement.  
“Improper financial relationships and false billing, as alleged in this case, can shortchange taxpayers and patients,” said Daniel R. Levinson, Inspector General for the U.S. Department of Health and Human Services.  “Our compliance agreement with Amedisys contains strong monitoring and reporting provisions to help ensure that people in Federal health programs will be protected.”  
This settlement resolves seven lawsuits pending against Amedisys in federal court – six in the Eastern District of Pennsylvania and one in the Northern District of Georgia – that were filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery.  As part of today’s settlement, the whistleblowers – primarily former Amedisys employees – will collectively split over $26 million.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $19.2 billion through False Claims Act cases, with more than $13.6 billion of that amount recovered in cases involving fraud against federal health care programs.

The United States’ investigation was conducted by the Justice Department’s Commercial Litigation Branch of the Civil Division; the United States Attorneys’ Offices for the Eastern District of Pennsylvania, Northern District of Alabama, Northern District of Georgia, Eastern District of Kentucky, District of South Carolina, and Western District of New York; the Department of Health and Human Services’ Office of Inspector General; the Federal Bureau of Investigation; the Office of Personnel Management’s Office of Inspector General; the Defense Criminal Investigative Service of the Department of Defense; and the Railroad Retirement Board’s Office of Inspector General.

The lawsuits are captioned United States ex rel. CAF Partners et al. v. Amedisys, Inc. et al. 10-cv-2323 (E.D. Pa.); United States ex rel. Brown v. Amedisys, Inc. et al., 13-cv-2803 (E.D. Pa.); United States ex rel. Umberhandt  v. Amedisys, Inc., 13-cv-2789 (E.D. Pa.); United States ex rel. Doe et al. v. Amedisys, Inc., 13-cv-3187 (E.D. Pa.); United States ex rel. Ognen et al. v. Amedisys, Inc. et al. 13-cv-4232 (E.D. Pa.); United States ex rel. Lewis v. Amedisys, Inc., 13-cv-3359 (E.D. Pa.); and United States ex rel. Natalie Raven et al. v. Amedisys, Inc. et al., 11-cv-0994 (N.D. Ga.).  The claims settled by the agreement are allegations only, and there has been no determination of liability.

ECOLOGISTS LOOK AT RELATIONSHIP BETWEEN YELLOWSTONE'S WILLOWS AND STREAMS

Photo:  Yellowstone Stream.  From: Wikimedia.
FROM:  NATIONAL SCIENCE FOUNDATION 
Earth Week: Whither Yellowstone's willows and the streams they shade?

Yellowstone's water table dropping below riverbank willow trees
Willows and streams. In Yellowstone, where there's one, the other isn't far behind.

On Earth Week, scientists are asking: How far do such connections reach?

New research on water-dependent willows shows that streams and willows may be conducting the music on Yellowstone's ecological dance floor.

Ecologists Tom Hobbs, Kristin Marshall and David Cooper published the results in a recent issue of the Journal of Ecology. Hobbs and Cooper are with Colorado State University (CSU) in Fort Collins, Marshall is at NOAA.

After wolves were extirpated from Yellowstone almost 100 years ago, elk multiplied, says Hobbs. The herbivores roamed across the landscape, nibbling willows to nubbins.

But the story doesn't end there.

With fewer willows to gnaw on, beavers began to decline. Crucially for willows, without the dams beavers build, which slow the flow of water, streams ran faster. Brooks soon became deeply carved into their banks from the force of rapidly-moving water.

Before long, the water table fell below the reach of streamside willows' roots.

Wolves and elk, beavers and willows: carefully choreographed parts

"All the possible interactions among plants and animals in nature are impossible to separately identify and measure," says Henry Gholz, program director in the National Science Foundation's (NSF) Division of Environmental Biology, which funds the Yellowstone willow research through its Long Term Research in Environmental Biology (LTREB) Program.

"Yet scientists know these links are critical to the maintenance of functional ecosystems."

Over a 30-year-period, Hobbs and colleagues studied riparian willow (Salix spp.) establishment and stem growth. In Yellowstone's northern range, the scientists reconstructed willows' history from tree rings. The three-decade time-frame covered the reintroduction of wolves in 1995.

"What happens to willows is shaped more by how high the water table is," says Hobbs, "than by any other factor."

The finding shows how complicated ecosystem links can be, says Gholz. "The effects of elk browsing on streamside willows in Yellowstone over the past 30 years are related more to variations in year-to-year climate, age of the willow trees, and changes in streams due to declining numbers of beavers."

The scientists used climate variables such as annual precipitation, stream flow and growing season length; the abundance of herbivores (elk); and landscape elevation and an index of "topographic wetness" (how soggy the ground is) to predict willow growth before and after the reintroduction of wolves.

"Explaining variability in [willow] establishment required models with stream flow, annual precipitation and elk abundance," write the ecologists in their paper.

"The results show that changes in the growth of willows after the reintroduction of wolves," says Marshall, "can't be understood without considering all the variables."

Life as a willow: water required

Picture a willow as it leans over a river or stream. Willows, sallows and osiers form the genus Salix, made up of some 400 species of deciduous trees and shrubs. All are found on moist soils in cold and temperate regions of the Northern Hemisphere.

Most are known as willows, but some narrow-leaved shrub species are called osiers, and broader-leaved species are referred to as sallows, from an Old English word derived from the Latin term salix.

Willows are the dominant riparian, or riverside, woody vegetation in Yellowstone and across the Rocky Mountains, according to Hobbs.

In Yellowstone, willows are found along rivers and streams, as well as near springs, seeps and anywhere water is available.

"As long as willows' roots can reach groundwater," says Hobbs, "the trees can survive--and withstand very high levels of browsing by elk. It all comes down to water."

On Earth Week and every week, the dance of life needs all the partners

Restoring an ecologically complete ecosystem in Yellowstone requires the return of willows--and with them, beavers, says Hobbs.

Once willows have returned, beavers will gnaw down a certain number of the trees to build dams. The dams will slow stream flow, allowing yet more willows to grow.

Willows, streams and beavers; wolves and elk. Willows and streams may have the first dance. But without them all, Yellowstone's ecological music will eventually fade away.

-- Cheryl Dybas
Investigators
Fred Watson
David Cooper
Jennifer Hoeting
Matthew Kauffman
N. Thompson Hobbs
Related Institutions/Organizations
Colorado State University

JAPANESE AUTO PARTS MANUFACTURER PLEADS GUILTY IN PRICE FIXING/BID RIGGING CASE

FROM:  U.S. JUSTICE DEPARTMENT 
Wednesday, April 23, 2014
Japanese Automotive Parts Manufacturer Agrees to Plead Guilty to Price Fixing and Bid Rigging on Automobile Parts Installed in U.S. Cars
Company Agrees to Pay $19.9 Million Criminal Fine

Showa Corp., an automotive parts manufacturer based in Saitama, Japan, has agreed to plead guilty and to pay a $19.9 million criminal fine for its role in a conspiracy to fix prices and rig bids for pinion-assist type electric powered steering assemblies installed in cars sold in the United States and elsewhere, the Department of Justice announced today.

According to a one-count felony charge filed today in the U.S. District Court for the Southern District of Ohio in Cincinnati, Showa engaged in a conspiracy to suppress and eliminate competition in the automotive parts industry by agreeing to rig bids for, and to fix, stabilize and maintain the prices of, certain pinion-assist type electric powered steering assemblies sold to Honda Motor Co. Ltd. and certain of its subsidiaries in the United States and elsewhere.  In addition to the criminal fine, Showa has agreed to cooperate with the department’s ongoing investigation.  The plea agreement will be subject to court approval.

“Today’s guilty plea marks the 27th time a company has been held accountable for fixing prices on parts used to manufacture cars in the United States,” said Bill Baer, Assistant Attorney General in charge of the Department of Justice’s Antitrust Division.  “The Antitrust Division and its law enforcement partners remain committed to prosecuting illegal cartels that harm U.S. consumers and businesses.”

According to the charge, Showa and its co-conspirators carried out the conspiracy through meetings, conversations and communications in which they discussed and agreed upon bids and price quotations on pinion-assist type electric powered steering assemblies to be submitted to Honda.  Showa then submitted quotations in accordance with those agreements and sold pinion-assist type electric powered steering assemblies at collusive and noncompetitive prices.  Showa and its co-conspirators monitored adherence to the agreed-upon bid-rigging and price-fixing scheme.  The conspirators kept their conduct secret by using code names and meeting at remote locations, among other things.  Showa’s involvement in the conspiracy lasted from at least as early as 2007 until as late as September 2012.

Showa manufactures and sells pinion-assist type electric powered steering assemblies.  These devices provide power to the steering gear pinion shaft from electric motors to assist the driver to more easily steer the automobile.  Pinion-assist type electric powered steering assemblies include an electronic control unit and link the steering wheel to the tires but do not include the column, intermediate shaft, steering wheel or tires.

Including Showa, 27 companies and 24 executives have pleaded guilty or agreed to plead guilty in the division’s ongoing investigation into price fixing and bid rigging in the auto parts industry and have agreed to pay a total of $2.3 billion in criminal fines.

Showa Corp. is charged with price fixing and bid rigging in violation of the Sherman Act, which carries maximum penalties of a $100 million criminal fine for corporations.  The maximum fine may be increased to twice the gain derived from the crime or twice the loss suffered by the victims of the crime, if either of those amounts is greater than the statutory maximum fine.

Today’s charge is the result of an ongoing federal antitrust investigation into price fixing, bid rigging and other anticompetitive conduct in the automotive parts industry, which is being conducted by the Antitrust Division’s criminal enforcement sections and the FBI.  Today’s charge was brought by the Antitrust Division’s Chicago Office and the FBI’s Cincinnati Field Office with assistance from the U.S. Attorney’s Office for the Southern District of Ohio.

FDA TOUTS ADULT STEM CELL RESEARCH

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
Adult Stem Cell Research Shows Promise
So What Are Stem Cells?
Why Is FDA Studying These Cells?
What's Being Done?

Scientists sporting white coats and safety gloves are working in a bright Food and Drug Administration (FDA) lab on an incredible project.

They are part of FDA’s MSC Consortium, a large team of FDA scientists studying adult mesenchymal stem cells (MSCs)—cells that could eventually be used to repair, replace, restore or regenerate cells in the body, including those needed for heart and bone repair.

The scientists’ investigational work is unprecedented: Seven labs at FDA's Center for Biologics Evaluation and Research formed the consortium to fill in gaps in knowledge about how stem cells function.

“This research aims to facilitate development of this important class of innovative medical products,” explains Carolyn A. Wilson, Ph.D., associate director for research at the center. “It’s the first time we’ve done anything like this, and it’s proven to be a very useful approach. It’s worked so well because this is a huge, complicated project that requires expertise in many different technologies and methods.”

The research could ultimately be key to the advancement of personalized medicine, the practice in which medical treatment is tailored to the needs of an individual patient. “It’s not science fiction,” says Steven R. Bauer, Ph.D., chief of the Cellular and Tissue Therapy Branch in FDA’s Office of Cellular Tissue and Gene Therapies. “For me, regenerative medicine is the most exciting part of what we regulate in our office.”

So What Are Stem Cells?
There are two basic kinds of stem cells that are currently useful in the field of regenerative medicine: multipotent and pluripotent stem cells. Multipotent stem cells are generally taken from adults and can divide and develop into many different cell types. Pluripotent stem cells can develop into any type of cell in the body. Both types could divide to replenish cells damaged by injury, illness or normal wear. When stem cells divide, the new cells can either remain stem cells or develop into a new type of cell with a more specific function.
Two types of pluripotent stem cells exist: human embryonic stem cells and induced pluripotent stem cells, which are created by reprogramming adult cells that had already changed into a mature type of cell.

FDA’s MSC Consortium is not studying stem cells taken from embryos. “We’re looking at a particular kind of multipotent adult stem cell—the MSC—which is being used in a lot of regenerative medicine clinical trials,” adds Bauer.

The group is currently studying eight unique cell lines, each acquired from commercial sources and sourced to one of eight distinct, adult donors. (Males and females age 22 to 47 donated stem cells from bone marrow.)

The cells under study are multipotent: “They can differentiate (mature into) at least three cell types: bone, fat and cartilage, primarily,” Bauer explains. “They can also differentiate into nerve cells, liver cells and a kind of cell called ‘stroma’ that is in the bone marrow and supports blood forming cells. Then, for investigational clinical uses, they’ve been used for repairing hearts, repairing bone and repairing cartilage.”

Why Is FDA Studying These Cells?
In addition to differentiating into a variety of replacement cell types, MSCs can limit a patient’s immune response. So they can potentially be taken from one human donor and placed into a different recipient with less possibility of rejection.

But growing stem cells and making sure they are safe and effective is challenging, which is one reason why stem-cell based clinical trials have not yet resulted in a marketed product.

“The major challenge is that cells are much more complex than traditional products that FDA regulates. And they have the ability to respond to their environment,” Bauer explains. “Taking them out of the body and manufacturing them—that is, growing large numbers of them—or isolating them can change their biology. And it can change the way they behave if they are put back into the patient.”

For instance, if cells are manufactured in large quantities outside their natural environment, they may become ineffective or develop harmful characteristics. For example, they can produce tumors, severe immune reactions or growth of unwanted tissue. So FDA is trying to develop methods that would predict with more certainty how manufactured or isolated adult stem cells will behave in patients.

What's Being Done?
In the labs, cells are suspended in a nutrient liquid solution and grown in sterile containers called tissue culture flasks. Cells then multiply and go through three, five or seven generations of growth.
FDA scientists are using a variety of cutting-edge methods to characterize cells and then determine if any of these characteristics can predict the behavior of the cells in biological assays or in animal models. The next step will be to determine if any characteristics they measure will predict the safety or effectiveness of stem-cell based products in patients.

Specifically, scientists will continue studying whether factors such as different methods of growing the cells, donor age or gender affects the cells’ quality and performance. This research will ultimately provide new tools to the community of academic and private industry scientists who are interested in evaluating and developing stem cells into new clinical treatments.

“The consortium has shown that widely accepted ways to identify and characterize MSCs do not reveal some important biological differences between batches of these cells,” Bauer says. So the consortium seeks to demonstrate ways to better characterize MSCs that will be used in clinical trials. That’s important because, if investigators can improve the tools used to characterize MSCs used for clinical trials, the data generated from their studies could also improve because their MSC products will be more predictable, he adds.

And the improved predictability of their products will, in turn, allow FDA scientists to more easily evaluate the safety and effectiveness of new stem cell technologies—a key part of the regulatory science that is the foundation of FDA decisions.

Agency scientists already have published six papers in scientific journals such as Tissue Engineering and Cytotherapy. “We’re hoping this project will inspire people to do more research in this area,” Bauer says.

Stem cells, like other medical products intended to treat, cure or prevent disease, require FDA approval before they can be marketed. “It is important for FDA to maintain a sound regulatory science research program to promote the development of safe and effective products in emerging areas that hold great promise,” Bauer says.

“My colleagues and I hope our scientific findings will be helpful in the field of regenerative medicine, including the ability to repair or even replace organs and tissues more safely and effectively than traditional means,” he adds. “Although there are many scientific hurdles to overcome before the use of stem cells reaches its full potential, I think this medicine will eventually have the capacity to do that.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

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