Archive for NIH Advice

SBIR Woes

An oddly titled (”Start-Ups Say Innovation Doesn’t Grow on Trees”) Washington Post column by Kim Hart laments the absence of a 2.8% set-aside for SBIR/STTR awards in the $10B the NIH received in ARRA funds and notes lobbying efforts for Congressional reauthorization of the small business set-aside program:

Cha-Mei Tang, chief executive of Potomac-based Creatv MicroTech, said she submitted a grant application last week to help hire more employees to gather patient samples and statistics in the development of a tool to detect chronic lymphocytic leukemia. She said past efforts to compete for funds that are not reserved for small businesses have been unsuccessful, so she is concerned that companies will not have much of a shot at stimulus money.

“Everything we sell is based on SBIR funding,” Tang said. She said she plans to visit lawmakers on Capitol Hill this week. The House is scheduled this week to take action to reauthorize the SBIR program, which expires at the end of July. The biggest issue in question is whether venture-backed firms should have access to SBIR grants.

Perhaps Creatv MicroTech should consider why they have been unsuccessful in competing for R&D funding and whether this reflects on the soundness of their science, study design, expertise, facilities, etc.

The Enhancing Small Business Research and Innovation Act of 2009 is being reviewed by the House Committee on Science and Technology, whose Chair Bart Gordon (D-Tenn) calls it “one of the most significant bills the Committee will likely address in this Congress”. Right now, the bill extends the life of SBIR/STTR only until 2011 (corresponding Senate bill, SBIR/STTR Reauthorization Act of 2009 [S. 1233], goes through 2023 and gradually increases the set-aside amount until it reaches 3.5% in 2020). Usually, the program is reauthorized for 8-year cycles.

Both bills increase the award levels, and the House also shortens the application review period. One presumes the NIH will be among those extending the 90-day deadline to 180 days recommended in the House report:

The section also directs Federal agencies to render a final decision on each proposal 90 days after the date a solicitation closes. A clear timeline will allow applicants to better forecast and prepare for receipt of potential SBIR awards. Recognizing that the agencies will not be able to meet with this directive in all cases, the section provides the agencies with the authority to extend the 90-day deadline to a 180-day deadline on a case-by-case basis.

With regard to ARRA small-business funding, apparently the recent RFAs — Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3) ($35M) and Small Business Catalyst Awards for Accelerating Innovative Research (R43) ($5M) — which were not mentioned in the Post article, don’t count.

Regardless, Aprile Pilon of Clarassance, a Rockville-based biopharmaceutical company, “argues that small-business applications get tougher scrutiny than those from academic institutions, and she claims that the board reviewing the applications is largely made up of university representatives.”

What a shocker that the NIH would want to have qualified scientists review the science. Never mind that the paylines for SBIR/STTR grants are much higher than those for the basic biomedical research that will eventually become available for commercialization.

Oh, the Post piece notes that:

Cardin, Van Hollen and Edwards [all D-Md reps] sent a pointed letter to [acting NIH Director] Kington after the hearing [on the SBIR reauthorization bill], saying that his “absence sent a message of indifference.”

Hmm. Wonder what Ray might have on his plate that could possibly be more important than small-business set asides?

Now, not that I am against the NIH Small Business Research programs. Far from it. But when the NIH has to keep raising paylines because there aren’t enough scientifically outstanding and excellent applications competing for these Congressionally designated funds, perhaps industry should put as much effort into evaluating their research practices as lobbying for more federal set-asides.

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Searching-Browsing ARRA Awards from NIH

In case you were not aware, you can browse NIH ARRA-funded awards by state (notice the nice distribution of push pins) or you can search RePORTER (think enhanced CRISP) using the swanky new query form, which includes a check box to “show only projects supported by NIH Recovery Act funds.” Each list of projects by state (scroll down below map) can be sorted by PI or organization name (click on the appropriate column heading) to find those of most interest.

<I’ll pause a moment while feverish fingers check out the success of rivals.>

Notice upon searching RePORTER that you will be given tabs that list award description (abstract), details (including $ amounts), results (publications), history (renewals, supplements – interesting for long-standing awards especially), and subprojects. I’ll add that the new query portal layout and functionality is a very welcome improvement over the CRISP query page.

You can also view an interactive graph to monitor how much of the ARRA monies have been committed to FOAs.

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ARRA Success Stories

As more and more of you become stimulated by ARRA funding, you might consider whether you have a “success story” to share with your funding IC. NIAID has created an ARRA Success Stories Website, and I assume at least some – if not all – other ICs will follow suit. NIAID will eventually have a Web-form through which you can submit your anecdotes, but in the meantime, please send niaidarraimpact@mail.nih.gov the following information:

  • Grant number, project title, PI name
  • How ARRA funding has helped you (1,000 words or fewer)

Another NIAID page suggests what you might report:

Share your successes, both big and small, with us and your community. For example, your personal stories can illustrate how the funds enabled you to keep your lab intact, hire a promising young scientist, expand your research, or advance science.

Maybe even salvage a tenure application. Good luck to you all in getting your sliver (à la mode, of course) of the stimulus pie!

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So, with the new scoring procedure, is an 80 good news?

No.

An impact score of 80 at the 59th percentile means either the study section discussed all proposals, or someone took an interest in your otherwise triage-destined application and advocated for its discussion.

The new scoring range is from 10-90, with impact scores under 20 most likely to be funded … perhaps under 25 since ARRA has relieved the system of some of the backlog of potentially fundable applications. Percentiles issued in this round reflect only the current study section in which the application was reviewed (assuming the study section had 25 or more applications under review … if fewer than 25, then pooled with either all CSR or all IC applications, as appropriate to the review group’s affiliation).

You can find details on the scoring procedure and interpretation as well as reviewer guidelines by mechanism at the Enhancing Peer Review Website.

I’m guessing NIAID will be the first to update their paylines accordingly, and I’ll post updates as the ICs provide them here in the main blog and on the NIH Paylines & Resources page.

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12 h per RC1 Review???

What is Toni Scarpa smoking? He recently told The Chronicle of Higher Education that

The numbers [of RC1s] are causing concern for the present, as each application requires an average of three reviewers working 12 hours apiece, Dr. Scarpa told agency representatives.

Everyone out there who is spending 12 hours reviewing their Challenge Grants, raise your hand. Based on conversations I’ve had with investigators here at BICO (& warmer environs elsewhere) in a wide range of disciplines, they uniformly find these proposals, shall we say, unchallenging, to be kind. I’m sure Comrade PhysioProf can provide the appropriate color commentary. The minimal time needed to assess these is a good thing given that I also know of faculty who just last week unexpectedly found as many as 5 RC1 applications sitting in their eRA Commons account with reviews due June 12. Twelve hours per application? Ooooooh yaaaaaa.

And this apparently is after the NIH removed about 8% of applications that were deemed to be unresponsive/noncompliant … I think noncompliant with the laws of science more than the FOA policies. Many are apparently recycled ideas that weren’t funded the first time as R01s/R21s etc., so novelty will not be a common term used in the truncated summary statements (unless to point out the distinct lack of). It could be that the most novel proposals achieve this distinction due to their basis in woo.

Anyone experiencing review nirvana out there?

But, Toni is most grateful:

“Our scientists and their staff are unsung heroes, managing twice as many applications in a very compressed time with great professionalism and excellence,” said CSR Director Dr. Toni Scarpa. “The response by the scientific community also has been tremendous. The help is particularly gratifying because it shows the value and respect that scientists have for NIH peer review.”

I am glad Toni decided to issue a press release about the number of applications (nearly 21K) and reviewers (18K+) involved. The sheer numbers will hopefully serve as a wake up call that the NIH base appropriation needs to be restored and maintained in a responsible manner – not in irregular spikes guaranteed to stimulate irrational exuberance followed by a musical chairs, survival of the fittest (& richest) scramble for the crumbs that remain after the feast.

Indeed, The Chronicle article concludes:

Mr. Obama’s proposal, if approved by Congress, would set the agency’s baseline budget 4.7% higher than its final budget under President George W. Bush in 2008. But the biology federation said the increase proposed by Mr. Obama for the NIH in fiscal 2010 is only 1.45% higher than the fiscal 2009 level, excluding the stimulus money, raising questions about the federal government’s commitment to sustain biomedical research.

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Job Stimulation – and Study by the NSF

A brief observation. This morning, the Washington Post sent out a news alert that “Obama promises more than 600,000 stimulus jobs” this summer. As if we needed another reminder as to a key review criteria for applications for ARRA funding.

Perhaps this would be a good time to remind you that in the NSF Dear Colleage letter that appeared and then disappeared and then reappeared, the Science of Science & Innovation Policy (SciSIP) Program is accepting 2-5 page proposals for RAPID funding that address the outcome of ARRA, such as:

  • What was the contribution of the science investment to the creation and retention of jobs?
  • What was the contribution of the science investment to science and technology industries?
  • What scientific or technological advances were achieved?
  • What was the impact on the scientific workforce?

In keeping with the Presidential focus on openness and transparency in government, proposals might also examine and evaluate different approaches to building appropriate platforms for tracking and assessing science investments across the federal government as well as ways to visually convey the information to policy makers and the American public.

Edward Tufte, your country needs you.

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ARRA-Funded Human Immunology Profiling Research Groups

NIAID has released its own ARRA funding opportunity with some unique twists (e.g., 5 years of funding, with only the first year covered by ARRA): Protection of Human Health by Immunology and Vaccines (U01, U19).

LOI due: Sept 15
Application due: Oct 15 (full-length applications – not the 12-p jobs sought by most ARRA FOAs)

For U01 applications, requested annual total costs may not exceed $1.5M in year 1 and $1.3M in years 2-5. For U19 applications, requested annual total costs may not exceed $4.5M in year 1 and $4.0M in years 2-5. NIAID anticipates that 6-10 awards will be made for fiscal year 2010.

NOTE: Recovery Act funds will only support the first budget year of the award, and MUST be completely spent by the end of the first budget year, including spending all Infrastructure and Opportunities Funds allocated to support projects and pilot projects. Award recipients must be prepared to initiate their proposed studies upon issuance of the award. Carryover of unobligated funds from the first to subsequent budget years of the award will NOT be allowed. Any unspent first year funds will be returned. Applicants are encouraged to include in their first year budgets any large, one-time costs to support activities that will be carried out during the project period of the award. Examples of such costs include equipment, large peptide or antibody microarrays, microarray analyses, and small molecule libraries.

All applications are required to use bioinformatic, multiplex, and/or systems biology approaches to establish human immune system profiles using samples from well-characterized cohorts obtained (1) after infection, (2) prior to and following challenge with specific vaccines, or (3) prior to and following treatment with an immune adjuvant that targets a known innate immune receptor(s). It is the goal of this initiative to determine how immune profiles are perturbed and eventually return to a new homeostatic state after antigenic challenge. Each Awardee will establish a research infrastructure to collect, characterize and store human samples, and support the complex statistical analysis and informatics needs of the proposed research. All applications are required to include experimental approaches to measure some aspect(s) of the human transcriptome and/or proteome.

Scientific/Research Contacts:

Dr. Matthew J. Fenton
Division of Allergy, Immunology and Transplantation
Telephone: (301) 496-8973
Email: fentonm@niaid.nih.gov

Dr. Helen R. Quill
Division of Allergy, Immunology and Transplantation
Telephone: (301) 435-4416
Email: hquill@niaid.nih.gov

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ARRA Business Funding Opps at NIH

Hmm. Two new business-oriented ARRA funding opps. Hopefully not bridges to nowhere … woo-woo.

Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3)

LOI due: August 3, 2009
Application Due: September 1, 2009

U.S.-owned, for-profit enterprise/commercial organization doing a majority of its business in the United States may apply for RC3 funding. The requested budget is limited to $1 million total costs per year for a maximum of 3 years (up to 10 awards are anticipated).

The RC3 application Research Plan component is limited to a total of 13 pages, including 1 page for the Specific Aims and 12 pages for Research Design and Methods.

The BRDG-SPAN pilot program encourages projects representing, for example, the following:

  • a novel, “first in class” therapy
  • a material improvement over existing technologies
  • a potential substantial reduction in cost over existing technologies/products
  • U.S. alternative to foreign suppliers
  • a product for unmet, under-addressed medical needs (e.g., technologies to produce solid medication dosage forms for children, and therapeutic devices appropriate for children in terms of size and functionality)
  • a significant and demonstrable potential U.S. and/or global markets

Participating ICs list their own program officer and grant administrator contacts.

Small Business Catalyst Awards for Accelerating Innovative Research (R43)

LOI due: August 3, 2009
Application Due: September 1, 2009

Only United States small business concerns are eligible to submit SBIR applications. Budget requests are limited to $200,000 total costs for a maximum project period of 1 year (20-25 awards are anticipated).

The Research Plan is limited to a total of 7 pages, including 1 page for the Specific Aims and 6 pages for Research Design and Methods.

In accord with the funding priority of this initiative to attract applicants without a history of SBIR/STTR support from NIH, the focus of the projects solicited by this FOA is on early stage technology development. High-risk, high reward R&D that is unlikely to be undertaken by ongoing academic efforts or within industrial firms is strongly encouraged.

Again, participating ICs have designated their own program officer and grant administrator contacts.

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ARRA Administration Costs are all Indirect

I had a conversation some time ago with my Division Chief here at BICO explaining why he could not budget (DC) for someone to handle the ARRA reporting and administrative requirements (special admin costs may become direct when the science itself requires them, such as for large survey research – not when the terms of award do). More recently, the NIH has come out with a clear statement for all those other PIs trying to sneak some ARRA reporting support into their grant personnel costs:

Can ARRA grant budgets include direct costs to address ARRA administrative and reporting requirements?

No. It has been determined that ARRA requirements do not provide sufficient justification to support the provision of direct costs for administrative support in addition to the Facilities and Administrative (F&A) costs in the awarded budget.

NIH staff will continue to evaluate direct costs requested for administrate support using the guidance provided in OMB Circular A-21 F.6.b.(2). However, ARRA requirements will not be considered in this determination, because they are incorporated within the core administrative support for the project, which is reimbursed to the institution through the provision of F&A costs.

When direct costs have been requested to address ARRA administrative and reporting requirements in requested budgets, NIH staff will make appropriate adjustments. Revised budgets submitted solely to remove administrative costs will not be accepted.

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NIH ARRA Implementation Plan

I know you’ve been waiting on the edge of your seat for the HHS Agency-Wide Recovery Implementation Plan, and I’m thrilled to say the wait is over.

The section on Strengthening Scientific Research and Facilities includes 4 PDF files laying out how the NIH will spend $8.2B on Scientific Research (only $122M used intramurally); $1B on Extramural Lab Construction & Renovation; $300M on Shared Instrumentation; and $500M on Buildings & Facilities (intramural).

The Scientific Research plan again notes the plan to support Signature Initiatives, the only mechanism (or strategy) not yet announced for funding – and not mentioned in the implementation timeline. On page 4 of the plan, there is an interesting table laying out how the $8.2B will be distributed by grant type. I was puzzled to see, for example, 525 awards totaling $39M going toward institutional training grants. Meritoriously scored pick-ups and supplements?

The table on page 6 is of interest as it gives target quotas for the number of new and competing RPGs, administrative supplements, and competitive revision awards to be made … plus an empty row for number of jobs created/retained. The numbers jump considerably between the original and revised targets for each, especially in FY09, giving a nice incremental change (increase) in performance:

  • 9,842 -> 16,564 RPGs
  • 1,369 -> 3,445 administrative supplements
  • 37 -> 576 competitive revision awards

Oddly, the NIH had no original target for extramural construction awards, despite knowing money had specifically been designated for this purpose. For FY09, their revised award target is 58, with 174 awards to be made in FY10. The Shared Instrumentation plan shows a bigger jump in FY10 (124 -> 544 awards) than in FY09 (123 -> 198).

Intramurally, the NIH’s big projects include the John Edward Porter Neuroscience Research Center Phase II (PNRCII) ($266 million), Building 10 (original clinical research hospital) F Wing Renovations ($134 million), Build-Out of Building 3 (offices) ($21 million), and Conversion of Building 7 (Rocky Mountain Laboratories) ($7 million).

A separate section on Supporting Comparative Effectiveness Research includes 3 very uninformative PDF files: NIH ($400M), AHRQ ($300M), and Office of Secretary. None of them have any original or revised targets in terms of numbers of awards, though the Office of the Secretary plan notes that $1.5M went for a CER study by the IOM and another $1.1M to provide logistical support to the new Federal Coordinating Council for Comparative Effectiveness Research.

Also of interest in the Office of the Secretary plan is a table on page 4 showing output measure targets, which I bring up in consideration of RC2 applicants, who need to provide measurable outcomes to assess whether they are making the most of their grand opportunity. The AHRQ CER plan provides another model for such a table on pp 4-5.

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