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FASEB Comments on Extramural Conflict of Interest ANPRM
This week, FASEB submitted
comments to the National Institutes of Health (NIH) in response to an Advance Notice of Proposed Rulemaking
(ANPRM) on the subject of conflict of interest (COI) regulations for extramural researchers funded through the Public Health Service. FASEB’s comments underscore the need for maintaining public trust in medical research and preventing the introduction of bias through
stricter disclosure requirements, and, where appropriate, management or reduction of COI. FASEB also recommends enhanced outreach and
training to prevent unintentional noncompliance. Finally, the comments recommend that NIH encourage institutions, journals, industry
contractors and professional societies to adopt and enforce clearer and uniform standards for COI and use monitoring to ensure
compliance, while not diverting responsibility from institutions for managing financial conflicts of interest of their employees.
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FASEB Meets With White House Staff to Discuss Funding for NIH
On June 11th, Jennifer Zeitzer, FASEB Director of Legislative Relations, and Howard Garrison, Director of FASEB’s Office of Public
Affairs, met with budget examiners from the Office of Management and Budget (OMB). OMB, a part of the Executive Office of the
President, has a critical oversight role for federal programs in addition to responsibility for coordinating the President’s annual
budget request and long term spending plans.
The meeting, organized by the Ad Hoc Group for Medical Research, included individuals representing scientists, research institutions,
and patients. FASEB staff used this opportunity to raise a key concern for the research community: what will happen to researchers
and research programs when the “stimulus” funds from the American Recovery and Reinvestment Act (ARRA) are exhausted? Following up
on a discussion with OMB initiated by FASEB President Richard Marchase in March, FASEB presented an analysis of the potential damage
that could be caused by a steep funding shortfall. An alterative model was also presented by FASEB. Additional funding plus a
relaxation of spending guidelines so that the research expenditures could occur over a three year period would substantially mitigate
negative consequences of the “boom and bust” funding scenario. OMB staff appreciated the FASEB model and requested copies for their
analysis. The representatives of the research community concluded the meeting by emphasizing that progress in research would be
maximized by predictable, sustained growth in research investments.
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Inside (The Beltway) Scoop – Jennifer Zeitzer
The race to complete the fiscal year 2010 bills went in to overdrive in the last two weeks as the House Appropriations Committee moved five
bills (Agriculture, Commerce/Justice/Science, Homeland Security, Interior-Environment and Legislative Branch) through full committee and
two bills (Military Construction/Veterans and State/Foreign Operations) through subcommittee mark-up’s. The House also adopted the final
Commerce/Justice/Science (CJS) bill after a contentious debate and two days of marathon voting on amendments (see summary below). The House
was also expected to take final votes on the Legislative Branch appropriations bill on the evening of June 19th.
Not to be outdone, the Senate Appropriations Committee finished work on its version of the Homeland Security and Legislative Branch bills
and adopted their 302(b) allocations, which provided slightly more funding for the Agriculture, CJS, Energy & Water, and Military
Construction/Veterans bills and approximately $300 million less than the House for the Labor/HHS/Education (LHHS) bill (see summary table
below).
|
Fiscal Year 2010 302(b) Allocations |
| |
Senate
Allocation |
House
Allocation |
President's
Budget |
Fiscal Year 2009
Allocation |
|
Agriculture |
$23 million |
$22.9 million |
$23 million |
$20.6 million |
|
CJS |
$64.8 million |
$64.3 million |
$64.5 million |
$57.6 million |
|
Energy & Water |
$33.7 million |
$33.3 million |
$34.3 million |
$33.2 million |
|
LHHS |
$161.1 billion |
$163.4 billion |
$161.5 billion |
$152.2 billion |
|
Mil-Con/Veterans |
$76.7 million |
$76.5 million |
$76.2 million |
$72.8 million |
| * As approved by House Appropriations Committee June 9, 2009 and Senate Appropriations Committee June 18, 2009. |
The frenetic pace of activity on the spending bills will continue through the week of June 22nd, the final five days of legislative
business until the Independence Day recess (June 29 – July 3). The Homeland Security and Interior-Environment bills are scheduled for
floor consideration in the House and the Senate is also expected to bring up its version of the Homeland Security bill. In addition, the
Energy & Water and Financial Services bills are scheduled for House subcommittee action while the Military Construction/Veterans and
State/Foreign Operations bills are expected to be marked-up by the full Committee (see schedule below).
|
2010 House & Senate Appropriations Bills Mark-Up Schedule |
|
|
House
Subcom.* |
House
Full Com.* |
House
Floor* |
Senate
Subcom. |
Senate
Full Com. |
Senate
Floor |
|
Agriculture |
June 11 |
June 18 |
July 8-9 |
July 7 |
July 9 |
TBD |
|
CJS |
June 4 |
June 9 |
July 17-18 |
June 23 |
June 25 |
TBD |
|
Energy & Water |
June 25 |
July 7 |
July 15-16 |
July 14 |
July 16 |
TBD |
|
LHHS |
July 8 |
July 14 |
July 22-23 |
End of July |
End of July |
TBD |
|
Mil-Con/VA |
June 16 |
June 24 |
July 13 |
TBD |
TBD |
TBD |
| * Per schedule released by House Appropriations Committee, June 9, 2009. |
Thus far, the federal science agencies and programs of interest to the FASEB community have fared well in early appropriations action,
including:
Agriculture and Food Research Initiative (AFRI), U.S. Department of Agriculture (USDA)
On June 18th, the House Appropriations Committee approved the 2010 Agriculture Appropriations bill (no bill number yet) by voice vote.
The bill provides $20.4 billion for the USDA, a $2 billion increase over the fiscal year 2009 funding level. The committee recommended
that AFRI receive $210 million, an increase of $10 million over 2009 funding levels (but less than FASEB’s recommendation of $300 million).
Subcommittee chairwoman, Representative Rosa DeLauro (CT-03) noted the AFRI increase in her opening statement commenting that the bill
would also “make significant investments in agricultural research by providing total funding levels of nearly $1.2 billion for the
Agricultural Research Service (ARS) and nearly $1.25 billion for the Cooperative State Research, Education and Extension Service
(CSREES), nearly $82 billion above the President’s budget request, including increases in key program such as Hatch Act, Evans-Allen,
the new competitive Agriculture and Food Research Initiative, Smith Lever, the 1890 programs, and the Veterinary Medical Services Act.”
The Agriculture Appropriations bill is tentatively set to be considered on the House floor July 8th – 9th.
National Science Foundation (NSF)
On June 9th, the House Appropriations Committee approved the 2010 CJS bill (HR 2847) by voice vote. The bill provides $64.3 billion in
discretionary spending for the Commerce and Justice departments, science programs and related agencies – 12 percent more than in fiscal
2009 and slightly less than the President’s request. NSF received $6.9 billion, $108 million below the President’s request (and slightly below
FASEB’s recommended funding level of $7 billion) but that amount is $446 million above 2009 levels. The funding is intended to advance the most
promising scientific research at America’s colleges and universities, and support scientists with cutting edge labs and equipment. The bill also
endorses the President’s commitment to double funding for basic research in key agencies over 10 years. The House adopted the CJS bill on a 259-157
vote the evening of June 18th. The Senate CJS Appropriations Subcommittee is scheduled to mark-up the bill on June 23rd followed by full
committee consideration on June 25th.
Medical and Prosthetics Research Program, U.S. Department of Veterans Affairs
On June 16th, the House Military Construction/Veterans Affairs Appropriations Subcommittee approved a draft measure by voice vote that provides
approximately $109 billion for the Veterans Administration, including $580 million ($5 million above FASEB’s recommended funding level and $70
million above 2009 funding) for the Veterans Affairs (VA) Medical and Prosthetic Research program. Subcommittee Chairman, Representative Chet
Edwards (TX-17) noted the increase in funding for the Medical and Prosthetic Research program in his opening statement during the subcommittee
mark-up session. The bill now moves forward to the full House Appropriations Committee which is expecting to mark-up the bill on June 24th.
In other news, the House overwhelmingly passed the International Science and Technology Cooperation Act (H.R. 1736), which would form a committee
under the National Science and Technology Council to coordinate activities in international research and science training activities across the
federal agencies. “Science diplomacy presents a unique and essential opportunity to develop and sustain friendships and collaborations into the
future,” said Rep. Brian Baird (D-Wash.), the bill’s author and chairman of the Science and Technology Committee's Energy and Environment
Subcommittee. The legislation provides the new committee with the authority to plan and coordinate cooperative research and training partnerships,
establish federal policies for aligning research and training with partners from other countries, identify opportunities for new partnerships,
solicit input from non-federal stakeholders, report to Congress, and address broad issues that affect collaboration. A Senate version of the bill
has not yet been introduced.
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FASEB and ASN Discuss Ag Research With Senate Appropriators
FASEB has been working with member society, the American Society for Nutrition (ASN) to advocate on behalf of competitive agricultural
research at the USDA. Jennifer Zeitzer, of FASEB's Office of Public Affairs, and Mary Lee Watts, of ASN, met with the offices of Senators
Durbin (IL), Bond (MO), and Dorgan (ND) to recommend a funding level of $300 million for the Agriculture and Food Research Initiative
(AFRI) in FY 2010.
AFRI is a new program, created by last year's Farm Bill, which replaces the National Research Initiative, USDA's previous competitive
research program. Unfortunately, competitive research has historically fared poorly at USDA. While many Senators have been generally
supportive of agricultural research, the low allocation given to the Agriculture Appropriations subcommittees limits the pool available
for research. The House Appropriations Subcommittee recommended a level of $210 million for AFRI, an increase above the President's
recommendation of $202 million. The Senate has not yet developed a funding bill for agricultural research.
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