By Matthew Bin Han Ong
Sixteen days after hardline GOP lawmakers forced the U.S. government into a shutdown, a frenzied Congress voted late Wednesday night to reopen federal agencies and raise the $16.7 trillion debt limit—barely meeting a critical deadline set by the Treasury Department.
President Barack Obama signed the bill shortly after midnight, restoring government services and putting hundred of thousands of furloughed civil servants back to work Thursday morning, many of them in the Washington, D.C. region.
The measure only guarantees current-level funding through Jan. 15. Federal agencies might face another shutdown unless Congress resolves a continuing dispute on the deep automatic spending cuts known as the sequester.
The bill also raises the debt limit to a level the Treasury expects will last until Feb. 7, setting up a second confrontation over the national debt. Economists estimate the shutdown cost the U.S. economy $24 billion, as well as 0.6 percent from the country’s fourth-quarter growth of its gross domestic product, according to Standard & Poor’s.
“One of the things I’ve said in this process is we’ve got to get out of the habit of governing by crisis,” Obama said Wednesday night. “Hopefully next time it won’t be in the eleventh hour.”
NIH staff is reporting to work on their regular schedules, and NIH is ramping up to full operation as quickly as possible to recover from the impact of the shutdown.
The NIH Clinical Center, which was forced to turn away patients during the shutdown, including children with cancer, is now fully operational—initiating new clinical protocols and resuming its normal patient admission process.
While the government was shut down, only a small number of new patients with life-threatening illnesses were admitted, and only one new clinical trial involving such patients was begun. Nearly 75 percent of NIH employees were furloughed (The Cancer Letter, Oct. 4).
The shutdown resulted in a profound loss of momentum, NIH officials said in a statement.
“While some basic and translational research projects involving large or unique investments of resources continued at a greatly reduced pace to protect these investments, the majority of research projects were placed on hold,” the statement said.
“Hundreds of experiments will require starting over, which may take many months.
“While researchers with existing grants were able to draw down funds during the shutdown, NIH was not able to process new grant applications or make any new or continuing grant awards.
“All submission deadlines for grant applications that were scheduled in October are being rescheduled for November so that applicants can have access to NIH staff to assist with the application process.
“Hundreds of peer review meetings that had been scheduled in October must now be rescheduled, and there will be some delays in grant awards. Specific dates will be shared with the research community through the NIH Guide for Grants and Contracts.”
In an email to staff and grantees Oct. 11, NCI Director Harold Varmus said the shutdown was felt most acutely by staff and investigators in the intramural program, but the effects on the extramural research community would worsen if the shutdown persisted.
“NCI’s Division of Extramural Activities has postponed until undetermined dates several site visits to evaluate re-competing centers and large grant applications, and it has postponed more than a dozen meetings to review grant applications,” Varmus wrote.
“Thus, the NCI’s grant review cycle could be significantly delayed, threatening a smooth restart of NCI’s support of extramural research, even if the NIH reopens relatively soon.
“This situation could have serious effects on the review and funding of virtually all NCI programs, including NCI-designated Cancer Centers, program project and SPORE grants, training awards, and individual research project grants.”
Professional Societies: No More Shutdowns, Please
Congress must avoid a repeat of this debacle at the end of the short-term deal, said Jon Retzlaff, managing director of office of science policy and government affairs at the American Association for Cancer Research.
“While we are relieved that the shutdown is finally over and that many of our nation’s talented and dedicated scientists and clinicians are back conducting the research that so many patients are dependent on, we are concerned that we may see this indefensible situation repeat itself in three months,” Retzlaff said to The Cancer Letter.
“If our policymakers are going to be able to move beyond this latest fiasco and begin supporting some of our nation’s priorities, such as the medical research that is funded by the NIH, it is going to require that Congress work in a constructive, bipartisan fashion to find a more balanced approach to address the federal deficit and prevent sequestration from occurring again in January 2014.
“Congress cannot continue to look at the domestic discretionary pot to come up with their deficit reduction,” Retzlaff said.
The government shutdown brought into focus the importance of funding for biomedical research, said Clifford Hudis, president of the American Society of Clinical Oncology.
“Now, our colleagues at NIH and the FDA can continue with their critical life-saving medical research and the advancement of safe and effective drugs into practice,” Hudis said in a statement to The Cancer Letter. “Patients can again enroll in clinical trials at the NIH Clinical Center.
“NIH grant administrators can continue to schedule reviews of grant applications submitted by researchers around the country who are finding ways for all of us to lead healthier and longer lives.
“NIH programs to train the next generation of researchers can continue. FDA staff can resume monitoring drug shortages and drug safety, and reviewing new drug applications.
“Clearly, federal funding for biomedical research pays for a lot of work that improves the health of Americans and contributes to economic growth for the U.S.,” Hudis said. “Now, it’s time for Congress and the Administration to work together to pass a budget that will enhance our country’s commitment to individuals with cancer.”
In the short term, the biggest impact of the shutdown will be the disruption to the grant funding cycle, said Carrie Wolinetz, president of United for Medical Research.
“Rescheduling cancelled study sections and Council meetings, and getting grants reviewed by the new deadlines will be a monumental undertaking, and it’s hard to see how there will not be some delay in the next round of extramural funding,” Wolinetz said in a statement to The Cancer Letter.
“But the aftermath of the shutdown is minute in comparison with the continuing impact of sequestration and the prospect of further cuts to come when the current continuing resolution expires in January.”
In a statement to research advocates, Research!America President Mary Woolley wrote:
“After 16 costly, wasteful days, the government has been funded through Jan. 15 at post-sequestration, FY13 levels—hardly adequate for providing the solutions the American public awaits.
“A bicameral, bipartisan budget committee has been charged to develop a long-term deficit reduction plan by Dec. 13. If these marching orders sound familiar, they should: We’ve been down this road before, only this time sequestration isn’t the threat at the end, it’s embedded in the negotiations.
“As tempting as it is to give in to brinksmanship fatigue and just tune out the process, advocates must seize the opportunity to make sure our issue remains front and center, that it becomes impossible for lawmakers to ignore.
“Sequestration must go; research and innovation must be an immutable national priority, supported at the level of scientific opportunity that will allow us to overcome health challenges and continue to drive the economy.”
The text of Varmus’s Oct. 11 email follows:
To NCI staff, grantees, advisors, reviewers and others:
I am writing to keep you abreast of the ways in which the National Cancer Institute (NCI) and its extramural and intramural research programs have been—and are likely to be—affected by the current shutdown of the federal government.
And I am also writing to ask for your help in responding to the difficult situation that we are likely to face when the government is reopened.
As you have doubtless seen in the media, if not experienced directly, the NCI, along with the rest of the NIH, has been obliged to place on furlough many valuable employees, presently about 80 percent of our staff.
While all components of the NCI have furloughed many personnel, most of those we have been able to exempt from furlough are in our intramural programs and needed to preserve ongoing research protocols, ensure laboratory safety, care for experimental animals, and, especially, serve our patients at the Clinical Research Center.
This situation has been hard for everyone, particularly for many of our trainees, who have been told to limit their activities on campus to those permitted during the shutdown. They, like regular staff members, are unable to travel to scientific meetings or to perform much of the research they came to NCI to do.
Although the shutdown has been felt most acutely by our staff and investigators in the intramural program, the effects on the extramural research community are likely to become progressively greater as the situation persists.
Presently, the vast majority of NCI’s extramural staff is furloughed, which means that many NCI staff members are unable to provide their usual administrative and programmatic support services to extramural grantees.
Furthermore, many grantees, especially those responsible for planning collaborative work, including clinical trials, have been limited in their abilities to conduct important meetings that require NCI staff and support.
Still, we have been able to exempt from furlough some program officers who provide oversight and guidance for clinical trials that were initiated prior to the shutdown. Moreover, the length of the shutdown has not been great enough to affect most ongoing research activities at extramural sites.
Since the Payment Management System has remained operational, we also continue to process requests to obtain expected funds for most of the grants awarded to our extramural investigators. However, that may not be possible if an award was made with restrictive terms or if a request triggers a need for additional interactions.
Now that the shutdown is nearing the end of its second week, however, further consequences are coming into view. While grant applications can be accepted and stored at grants.gov, the NIH Office of Extramural Research has discouraged submissions, and applications will not be processed further until normal business operations are restored through Congressional appropriations. (See the OER’s message).
Furthermore, NCI’s Division of Extramural Activities (DEA) has postponed until undetermined dates several site visits to evaluate re-competing centers and large grant applications, and it has postponed more than a dozen meetings to review grant applications. Thus, the NCI’s grant review cycle could be significantly delayed, threatening a smooth restart of NCI’s support of extramural research, even if the NIH reopens relatively soon.
This situation could have serious effects on the review and funding of virtually all NCI programs, including NCI-designated Cancer Centers, program project and SPORE grants, training awards, and individual research project grants.
Questions or concerns about these matters should be sent to John Czajkowski, NCI Deputy Director for Management, or to Dr. Paulette Gray, Director of the Division of Extramural Activities.
Part of the reason I am writing at this time is to prepare you for the possibility that we at the NCI (and presumably others at the NIH) will be asking reviewers and advisors to adapt to abrupt and inconvenient changes in the scheduling of meetings to review grant applications and oversee programs.
These changes may require you to alter long-standing plans to attend worthwhile events. But avoiding a major crisis in grant-making and program development this year may be possible only if all members of the NCI communities are willing to help alleviate the consequences of the shutdown.
Needless to say, all of us at the NCI hope that the current situation is resolved quickly, but we have no way to know when the shutdown will end. In the meantime, I encourage all of you to monitor major media outlets regularly, as we do, for updates on the status of federal operations.
As long as the shutdown continues, the NCI will remain committed to advancing our common cause—research to control cancer—as best we can within the limits of the law. Your patience, persistence, and flexibility are very much appreciated during this unhappy and uncertain time.
Sixteen days after hardline GOP lawmakers forced the U.S. government into a shutdown, a frenzied Congress voted late Wednesday night to reopen federal agencies and raise the $16.7 trillion debt limit—barely meeting a critical deadline set by the Treasury Department.
President Barack Obama signed the bill shortly after midnight, restoring government services and putting hundred of thousands of furloughed civil servants back to work Thursday morning, many of them in the Washington, D.C. region.
The measure only guarantees current-level funding through Jan. 15. Federal agencies might face another shutdown unless Congress resolves a continuing dispute on the deep automatic spending cuts known as the sequester.
The bill also raises the debt limit to a level the Treasury expects will last until Feb. 7, setting up a second confrontation over the national debt. Economists estimate the shutdown cost the U.S. economy $24 billion, as well as 0.6 percent from the country’s fourth-quarter growth of its gross domestic product, according to Standard & Poor’s.
“One of the things I’ve said in this process is we’ve got to get out of the habit of governing by crisis,” Obama said Wednesday night. “Hopefully next time it won’t be in the eleventh hour.”
NIH staff is reporting to work on their regular schedules, and NIH is ramping up to full operation as quickly as possible to recover from the impact of the shutdown.
The NIH Clinical Center, which was forced to turn away patients during the shutdown, including children with cancer, is now fully operational—initiating new clinical protocols and resuming its normal patient admission process.
While the government was shut down, only a small number of new patients with life-threatening illnesses were admitted, and only one new clinical trial involving such patients was begun. Nearly 75 percent of NIH employees were furloughed (The Cancer Letter, Oct. 4).
The shutdown resulted in a profound loss of momentum, NIH officials said in a statement.
“While some basic and translational research projects involving large or unique investments of resources continued at a greatly reduced pace to protect these investments, the majority of research projects were placed on hold,” the statement said.
“Hundreds of experiments will require starting over, which may take many months.
“While researchers with existing grants were able to draw down funds during the shutdown, NIH was not able to process new grant applications or make any new or continuing grant awards.
“All submission deadlines for grant applications that were scheduled in October are being rescheduled for November so that applicants can have access to NIH staff to assist with the application process.
“Hundreds of peer review meetings that had been scheduled in October must now be rescheduled, and there will be some delays in grant awards. Specific dates will be shared with the research community through the NIH Guide for Grants and Contracts.”
In an email to staff and grantees Oct. 11, NCI Director Harold Varmus said the shutdown was felt most acutely by staff and investigators in the intramural program, but the effects on the extramural research community would worsen if the shutdown persisted.
“NCI’s Division of Extramural Activities has postponed until undetermined dates several site visits to evaluate re-competing centers and large grant applications, and it has postponed more than a dozen meetings to review grant applications,” Varmus wrote.
“Thus, the NCI’s grant review cycle could be significantly delayed, threatening a smooth restart of NCI’s support of extramural research, even if the NIH reopens relatively soon.
“This situation could have serious effects on the review and funding of virtually all NCI programs, including NCI-designated Cancer Centers, program project and SPORE grants, training awards, and individual research project grants.”
Professional Societies: No More Shutdowns, Please
Congress must avoid a repeat of this debacle at the end of the short-term deal, said Jon Retzlaff, managing director of office of science policy and government affairs at the American Association for Cancer Research.
“While we are relieved that the shutdown is finally over and that many of our nation’s talented and dedicated scientists and clinicians are back conducting the research that so many patients are dependent on, we are concerned that we may see this indefensible situation repeat itself in three months,” Retzlaff said to The Cancer Letter.
“If our policymakers are going to be able to move beyond this latest fiasco and begin supporting some of our nation’s priorities, such as the medical research that is funded by the NIH, it is going to require that Congress work in a constructive, bipartisan fashion to find a more balanced approach to address the federal deficit and prevent sequestration from occurring again in January 2014.
“Congress cannot continue to look at the domestic discretionary pot to come up with their deficit reduction,” Retzlaff said.
The government shutdown brought into focus the importance of funding for biomedical research, said Clifford Hudis, president of the American Society of Clinical Oncology.
“Now, our colleagues at NIH and the FDA can continue with their critical life-saving medical research and the advancement of safe and effective drugs into practice,” Hudis said in a statement to The Cancer Letter. “Patients can again enroll in clinical trials at the NIH Clinical Center.
“NIH grant administrators can continue to schedule reviews of grant applications submitted by researchers around the country who are finding ways for all of us to lead healthier and longer lives.
“NIH programs to train the next generation of researchers can continue. FDA staff can resume monitoring drug shortages and drug safety, and reviewing new drug applications.
“Clearly, federal funding for biomedical research pays for a lot of work that improves the health of Americans and contributes to economic growth for the U.S.,” Hudis said. “Now, it’s time for Congress and the Administration to work together to pass a budget that will enhance our country’s commitment to individuals with cancer.”
In the short term, the biggest impact of the shutdown will be the disruption to the grant funding cycle, said Carrie Wolinetz, president of United for Medical Research.
“Rescheduling cancelled study sections and Council meetings, and getting grants reviewed by the new deadlines will be a monumental undertaking, and it’s hard to see how there will not be some delay in the next round of extramural funding,” Wolinetz said in a statement to The Cancer Letter.
“But the aftermath of the shutdown is minute in comparison with the continuing impact of sequestration and the prospect of further cuts to come when the current continuing resolution expires in January.”
In a statement to research advocates, Research!America President Mary Woolley wrote:
“After 16 costly, wasteful days, the government has been funded through Jan. 15 at post-sequestration, FY13 levels—hardly adequate for providing the solutions the American public awaits.
“A bicameral, bipartisan budget committee has been charged to develop a long-term deficit reduction plan by Dec. 13. If these marching orders sound familiar, they should: We’ve been down this road before, only this time sequestration isn’t the threat at the end, it’s embedded in the negotiations.
“As tempting as it is to give in to brinksmanship fatigue and just tune out the process, advocates must seize the opportunity to make sure our issue remains front and center, that it becomes impossible for lawmakers to ignore.
“Sequestration must go; research and innovation must be an immutable national priority, supported at the level of scientific opportunity that will allow us to overcome health challenges and continue to drive the economy.”
The text of Varmus’s Oct. 11 email follows:
To NCI staff, grantees, advisors, reviewers and others:
I am writing to keep you abreast of the ways in which the National Cancer Institute (NCI) and its extramural and intramural research programs have been—and are likely to be—affected by the current shutdown of the federal government.
And I am also writing to ask for your help in responding to the difficult situation that we are likely to face when the government is reopened.
As you have doubtless seen in the media, if not experienced directly, the NCI, along with the rest of the NIH, has been obliged to place on furlough many valuable employees, presently about 80 percent of our staff.
While all components of the NCI have furloughed many personnel, most of those we have been able to exempt from furlough are in our intramural programs and needed to preserve ongoing research protocols, ensure laboratory safety, care for experimental animals, and, especially, serve our patients at the Clinical Research Center.
This situation has been hard for everyone, particularly for many of our trainees, who have been told to limit their activities on campus to those permitted during the shutdown. They, like regular staff members, are unable to travel to scientific meetings or to perform much of the research they came to NCI to do.
Although the shutdown has been felt most acutely by our staff and investigators in the intramural program, the effects on the extramural research community are likely to become progressively greater as the situation persists.
Presently, the vast majority of NCI’s extramural staff is furloughed, which means that many NCI staff members are unable to provide their usual administrative and programmatic support services to extramural grantees.
Furthermore, many grantees, especially those responsible for planning collaborative work, including clinical trials, have been limited in their abilities to conduct important meetings that require NCI staff and support.
Still, we have been able to exempt from furlough some program officers who provide oversight and guidance for clinical trials that were initiated prior to the shutdown. Moreover, the length of the shutdown has not been great enough to affect most ongoing research activities at extramural sites.
Since the Payment Management System has remained operational, we also continue to process requests to obtain expected funds for most of the grants awarded to our extramural investigators. However, that may not be possible if an award was made with restrictive terms or if a request triggers a need for additional interactions.
Now that the shutdown is nearing the end of its second week, however, further consequences are coming into view. While grant applications can be accepted and stored at grants.gov, the NIH Office of Extramural Research has discouraged submissions, and applications will not be processed further until normal business operations are restored through Congressional appropriations. (See the OER’s message).
Furthermore, NCI’s Division of Extramural Activities (DEA) has postponed until undetermined dates several site visits to evaluate re-competing centers and large grant applications, and it has postponed more than a dozen meetings to review grant applications. Thus, the NCI’s grant review cycle could be significantly delayed, threatening a smooth restart of NCI’s support of extramural research, even if the NIH reopens relatively soon.
This situation could have serious effects on the review and funding of virtually all NCI programs, including NCI-designated Cancer Centers, program project and SPORE grants, training awards, and individual research project grants.
Questions or concerns about these matters should be sent to John Czajkowski, NCI Deputy Director for Management, or to Dr. Paulette Gray, Director of the Division of Extramural Activities.
Part of the reason I am writing at this time is to prepare you for the possibility that we at the NCI (and presumably others at the NIH) will be asking reviewers and advisors to adapt to abrupt and inconvenient changes in the scheduling of meetings to review grant applications and oversee programs.
These changes may require you to alter long-standing plans to attend worthwhile events. But avoiding a major crisis in grant-making and program development this year may be possible only if all members of the NCI communities are willing to help alleviate the consequences of the shutdown.
Needless to say, all of us at the NCI hope that the current situation is resolved quickly, but we have no way to know when the shutdown will end. In the meantime, I encourage all of you to monitor major media outlets regularly, as we do, for updates on the status of federal operations.
As long as the shutdown continues, the NCI will remain committed to advancing our common cause—research to control cancer—as best we can within the limits of the law. Your patience, persistence, and flexibility are very much appreciated during this unhappy and uncertain time.
