Jeremy Berg introduced the concept of correlating overall impact score with the individual criterion scores, first using NIGMS and then NIH-wide data.

Based on the 32,546 applications (of 54,727 submitted) that received overall impact scores in FY10, OER played with the numbers a bit more but came up with the same conclusions: Approach and then Significance drive Overall Impact scores.

For applications receiving numerical impact scores (about 60% of the total), we used multiple regression to create a descriptive model to predict impact scores using the applications’ criterion scores, while attempting to control for ten different “institutional” factors (e.g., whether the application was new, a renewal, or a resubmission). In the model, scores for the approach criterion had the largest regression weight, followed by criterion scores for significance, innovation, investigator, and environment. The same pattern of results was observed across multiple rounds of peer review and institute funding decisions.

She also notes, as can be seen in her figure, that scores for Approach showed the widest range, followed by Significance.

So, the work you propose doing better be important … and, more importantly, better be done right.

… and the planned transfer of NCRR programs to NIGMS by Jeremy Berg at the Feedback Loop. Congress still has time to recognize this might not be the best use of taxpayer dollars, but in the absence of a sudden burst of clear thinking, the reorganization will move forward, and Director Berg would genuinely appreciate feedback from the key constituency (namely, the extramural research community the NCRR serves … served). Reflections on the whole process and what this might portend for the NIH more broadly would likely be welcome as well.

The NIGMS Feedback Loop and Rock Talk both have current posts on OER survey data on Enhancing Peer Review. The Feedback Loop pulls out respondent assessment of the value of the individual criterion scores, a topic of recent interest to Director Berg both at the NIGMS and NIH-wide level. Seems less than half of you feel the criterion scores are particularly helpful …

Or not.

According to the agenda posted for the SMRB meeting tomorrow (800-779-1545, pass code “NIH), we’ll get a 15-min update on what’s happening with NCRR, a 15-min update on what’s happening with NCATS, a 15-min discussion among SMRB members, and 20 min of public comment. Just that quickly, we will learn the results of the “extensive and detailed analysis through a transparent process to evaluate the impact of the new Center on other relevant extant programs at NIH, including NCRR”.

A hint of what this transparent process has wrought can be found on the NCATS feedback page, where Larry Tabak has posted an NCRR Task Force recommendations (aka updated straw model) for where NCRR programs will be redistributed. Perhaps most important is the name change from “Interim Infrastructure Unit” to “Infrastructure Entity”, which I am sure will reassure many concerned constituencies.

Former SMRB member and not-yet-former NIGMS Director Jeremy Berg has submitted a public comment urging his former fellow Board members to:

recommend to the NIH Director, to the Secretary of Health and Human Services, and to Congress that NCRR not be abolished at this time, pending an appropriately transparent process, following the principles outlined in the SMRB report, Deliberating Organizational Change and Effectiveness.

Bold typeface is used in the submitted comment. He goes on to explain and cross reference his case for this recommendation and includes an e-mail he sent in advance of the December 7th SMRB meeting raising critical questions about what might happen to NCRR and the need to consider these issues before voting on any proposal to create a new center for translational science and therapeutics.

One wonders if the 15-min presentations to be made this teleconference will address the many questions raised by House staffer John Bartrum. Well, at least it won’t take long to find out.

News updates in Science and Nature highlight the pushback the NIH is getting for its hasty plans to abolish NCRR.

Update: The teleconference was very short on detail (no detailed analysis certainly), and the comments reflected concerns from specific NCRR constituencies for their programs (everyone wants to be put in the OD rather than an IC) as well as patient/disease advocacy groups telling the NIH to hurry up and deliver cures. SMRB member Tom Kelly (Sloan-Kettering) asked why the rest of NCRR wasn’t just left intact after taking out the CTSA program (which only began in 2006, whereas NCRR has been around since 1962). Larry Tabak talked about being left with an IC that looked like a coat of many colors and perhaps the time was right to consider whether better places – better adjacencies – could be found for all these programs.

Of course, the SMRB has been considering the merger of NIAAA and NIDA since its inception in 2009, and in September 2010 recommended the creation of a single new IC devoted to substance use, abuse and addiction. However, after nearly two years of deliberation, Collins has indicated the need for more thoughtful analysis and has not (apparently) transmitted this request to Sebelius, whereas, in the absence of even a cursory impact study, he transmitted the request to both create a new Center (as recommended by the SMRB) and to abolish NCRR (which was not recommended by the SMRB) less than two weeks after the December 7th meeting.

What’s next? Jocelyn Kaiser’s recap in Science suggests it’s all over but the shoutin’.

Hopefully members of the House and Senate will do a little shoutin’ of their own if there is any hope for this precedent-setting reorganization of the NIH to follow a reasonable, deliberative, transparent process.

NATIONAL CENTER FOR RESEARCH RESOURCES
For carrying out section 301 and title IV of the Public Health Service Act with respect to research resources and general research support grants, $1,297,900,000.

and no mention of specific funding for NCATS in the budget tables (no doubt too late) or the Cures Acceleration Network (which was authorized by the Patient Protection and Affordable Care Act, CAN starts on p 978 of PDF), but Obama does acknowledge the new Center in his budget overview for HHS:

Invests in Science for a Healthy Economy
Supports Biomedical Research at the National Institutes of Health (NIH). Biomedical research is essential to the health of the American people and the health of our economy. Innovation in this field creates and sustains companies, products, and jobs. The Budget includes $32 billion for basic and applied biomedical research supported by NIH both on-campus and at academic and independent research institutions across the country. Through implementation of the National Center for Advancing Translational Sciences and the Cures Acceleration Network, NIH will increase its focus on bridging the translational divide between basic science and therapeutic applications. By fostering novel collaborations among government, academia, and industry, NIH will accelerate the development of treatments for diseases and disorders that affect millions of Americans. NIH will continue to pursue the leading edge of discovery in basic cancer science, development of new cancer treatments, and prevention and early detection of cancer, focusing on recent discoveries regarding cancer genomes. For Alzheimer’s disease, NIH is partnering with the private sector to find new methods for early diagnosis and to support early drug discovery and preclinical drug development. Ongoing research into environmental factors, early detection, and novel treatments will transform our understanding and care for those with autism spectrum disorders.

So, we’ll see how this all shakes out, particularly with the rest of the FY11 budget (well, CR) debate ahead of us still.

Nature has a nice summary of where the NIH currently stands on the Republican cutting block (a cut of $1.629 B from vs Obama’s increase of $740 M over FY10 levels), as does Science, and I’ll post their reviews of the Obama budget blueprint as the dust settles.

Every member of Congress will be getting an earful about just about every proposed cut, but that doesn’t mean you shouldn’t contact your Congress person and Senators to voice your concerns about protecting biomedical and other scientific research in the US.

Pursuant to P.L. 109-482, the NIH Reform Act, Congress has 180 days to act on Kathleen Sebelius’ request to abolish the NCRR. It only took Senators Inouye (Hawaii) and Begich (Alaska) 18 days to voice their firm opposition to “the changes currently under deliberation” via a letter to Sebelius and Collins.

Ouch.

As Nature, which released the Senators’ letter notes, Inouye chairs the Senate Appropriations Committee.

Having worked with the exceptional staff at NCRR, I completely concur with the Senators regarding their concern that “disruption of the placement and expertise at NCRR will only serve to dismantle the laudable work that has been accomplished.” NCRR folks will not be rushing to help Collins with his “Interim Infrastructure Unit“, which means these very special and complex (and currently well-managed) programs will at best stall until a more permanent home is found again, whether at an IC or in the OD or in … hmmm … perhaps a new (novel!) freestanding center to again manage such infrastructure programs in the extramural research community.

Of course, in her letters to Congress, Sebelius was acting on “information provided to me by the NIH Director” … which clearly included absolutely no detailed (or even cursory) assessment of the impact of either the abolition of NCRR or the establishment of NCATS on the rest of the NIH (or the extramural research community). Perhaps, given a bit more information after the February 23 SMRB meeting, she will realize that her determinations were premature and that more careful examination of the repercussions of both actions is needed prior to their recommendation to Congress and implementation at the NIH.

Perhaps. One can hope. And one can submit comments on the Feedback page and in advance of the SMRB meeting.

Agenda: Presentation and discussion will focus on NIH activities related to the Board’s recommendations to create a new center for advancing translational medicine and therapeutics development. As requested by the Board in its Report on Translational Medicine and Therapeutics, NIH will provide an update on the proposed creation of a new center and its evaluation of the impact of such a center on other relevant extant programs at NIH, including the National Centerfor Research Resources. The Board will also discuss next steps regarding future SMRB activities. Time will be allotted on the agenda for public comment. To sign up for public comment, please submit your name and affiliation to the contact person listed below by February 22, 2011. Sign up will be restricted to one sign up per e-mail. In the event that time does not allow for all those interested to present oral comments, anyone may file written comments using the contact person address below.

Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

Contact Person: Lyric Jorgenson, Office of Science Policy, Office of the Director, NIH, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, smrb@mail.nih.gov, (301) 496-6837.

Should be a fun 2 hours filled with a lot of fast talking, unless they do not anticipate any impact on the rest of the NIH that will merit discussion or many public comments. Lunchtime no less. No talking with your mouths full.

In the meantime, you can also continue to leave comments at the NCATS feedback page, including your thoughts on the NCRR redistribution straw model and about NCATS itself. I’m not sure why this page does not include the notices sent to Congress about the proposed formation of NCATS and abolition of NCRR or the list of questions from staffer John Bartrum, but you can find all of these items here.

Anyhoo, Collins has charged an ACD subcommittee to develop a workforce model to “help inform NIH in implementing policies to facilitate a vibrant and diverse future biomedical research workforce.” I didn’t realize such a thing could be facilitated, but there you go.

Fortunately, our man Jeremy Berg is all over this one. Last year at this time, he sought input on the planning process for their strategic plan for training and career development … and you all indeed did put out. He now seeks input – by February 15th – on the draft of the NIGMS Strategic Plan for Biomedical and Behavioral Research Training. Perhaps his draft report (which is truly a pleasant read) and your comments could help inform facilitation on a larger scale. Jeremy presents you with a usable document. Clear action bullets. Nice quotes and sidebars. For example,

We all know that being a professional scientist is more than simply doing experiments.”

I’m sure he can’t wait to hear from you about it. I’m sure you can’t wait to read and comment on it. Just do it! Hey, we’re all WTF – together!

I think we’ve all emphasized the need for maintaining close contact with your PO to ensure you have a cheerleader at your IC (you also want to inspire one or more advocates among your reviewers at study section, but you do that with an exciting application rather than direct contact). Dr. Berg makes this role even more clear in describing how “paylist meetings”, which occur after Council meets, go among the 5 units at NIGMS:

For each application, the responsible program director presents the scientific topic as well as factors such as whether the applicant is an ESI or new investigator, how much other support the applicant has (particularly if the application represents the only support available to the investigator), whether the Council has given us specific advice on the application, whether the scientific area is perceived to be particularly exciting, and how much other research we already support in the general area of the application. The other members of the unit listen to these presentations, and the group then produces a prioritized list of applications.

Getting your application toward the top of the funding priority list is critical, particularly when the appropriation is still up in the air:

When it is reasonably clear what level of funds is available at a particular point in the fiscal year, the funds are allocated to different mechanisms and programs (research project grants, training grants, various programs within the Division of Minority Opportunities in Research, and so on) based on our previously established budget. …

Paylists are then developed using the prioritized lists, with budget adjustments for each application based on NIH and NIGMS-wide policies as well as considerations specific to the application provided by the responsible program director. Applications are paid until the available funds are exhausted.

Right now, ICs are working with FY10 funding levels. Come March, we’ll see. If your PO says your application is at least on the list, you need not necessarily abandon all hope if not funded on the first cut …

Applications that are relatively high on the priority list but could not be funded with a given allocation are flagged for consideration later in the fiscal year, when more funds may become available.

So you might still become part of the black bar in his FY funding chart …

Hearty thanks again to Dr. Berg for providing this exceptional service to the extramural community (and for firmly voicing his concerns about recent SMRB and NIH actions on the creation of NCATS and the abolishment of NCRR). His departure from NIGMS will be an incredible loss to the NIH.

Short, for authorization purposes, as sent to the Chairman and Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (Tom Harkin); and to the Chairman and Ranking Member of the House Committee on Energy and Commerce (Tom Harkin letter used for both links, but the text is the same):

Pursuant to section 401 (d)(2) of the Public Health Service (PHS) Act, as amended, I am notifying you that I have determined it necessary to establish the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). The new center is being established to enhance the therapeutic development process and will encompass multiple programs at NIH. I have further determined that the National Center for Research Resources (NCRR) is no longer required, and I am further notifying you of the transfer of relevant NCRR functions and programs to the new center in FY 2012. Any functions currently at NCRR that do not involve translational sciences will be transferred to other existing Institutes and Centers at NIH, as appropriate. To make these assessments, NIH will undertake a thorough scientific review of NCRR programs. I am making this determination based on information provided to me by the NIH Director.

And long, for appropriations purposes, as sent to Chairman, House Subcommittee on Labor, Health and Human Services, Education and Related Agencies, Committee on Appropriations (Dennis Rehberg); the Ranking Member, House Committee on Appropriations (Norman Dicks); the Chairman, Senate Subcommittee on Labor, Health and Human Services, Education and Related Agencies, Committee on Appropriations (Tom Harkin); and the Ranking Member, Senate Committee on Appropriations (Thad Cochran) (again, text is the same for each letter, with the version sent to Tom Harkin standing in for the other three):

I am writing to inform you of the National Institutes of Health (NIH) plan to establish the National Center for Advancing Translational Sciences (NCATS) and to abolish the National Center for Research Resources (NCRR).

NIH has the potential to play a critical and catalytic role in advancing the translational sciences. The agency is expertly equipped to leverage its extant and emerging programs and resources to promote progress in this area. With the passage of the Affordable Care Act, NIH is even better poised to deploy these resources. The provisions of the Act that authorize the NIH to establish a Cures Acceleration Network (CAN) equip the agency with flexibility to carry out therapeutic development projects. This underscores the expectation by Congress and the American public that NIH is to play a leading role in realizing the promise of translational medicine and advancing human health.

NCATS would encompass several extant NIH programs, such as the Molecular Libraries Program, Therapeutics for Rare and Neglected Diseases Program, NIH Rapid Access to Interventional Development Program, the Clinical and Translational Science Awards (CTSA), and the NIH-FDA Regulatory Science Initiative. These programs, which are currently located across NIH, are ideally suited to the goals of translating basic discoveries into therapeutics. Reorganizing these components within a single Center will propel translational science more swiftly. CAN would also be located in the new Center.

Any functions at NCRR that do not involve translational science will be transferred to other Institutes or Centers, as appropriate, resulting in the abolishment of NCRR. To make these assessments, NIH will undertake a thorough scientific review of NCRR programs.

Funding for this new organization is intended to come from existing resources of the programs that would move to NCATS. NIH will provide details of this reorganization once they have been finalized. NIH seeks to implement its plan at the beginning of FY 2012 in October 2011.

Thank you for your continued interest and support of NIH’s activities. I have sent a similar letter to Ranking Member Cochran, Chairman Rehberg, and Ranking Member Dicks. Concurrent with this letter, we are also notifying the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions, as required by section 401 of the Public Health Service Act regarding the reorganization of institutes.

One wonders if Congress might consider the two requests separately and not necessarily concurrently. What if they took Sebelius at her word that NCRR could be abolished and did that first, eliminating all NCRR programs (and the funding for these apparently non-mission-critical programs) … and then took up the matter of whether to approve NCATS, which would in turn need to come up with funding for its proposed mission-critical programs. What if.

What if indeed … as suggested by Congressional staffer and former “NIH Budget Master” John Bartrum (as obtained and posted by Jocelyn Kaiser):

From: Bartrum, John
Sent: Wednesday, January 19, 2011 9:57 AM
Subject: House Questions on Notification of NIH reorganization

All,

We received the notification letter to for two proposed reorganization actions by HHS at NIH, January 14, 2011 letter—emailed at 7:58pm. We appreciate the follow-on note that this is based on SMRB review; therefore, we assume that all the requested information is from below is readily available — if you have all this information ready so if you can send it over on Thursday morning — I will try to find time to meet this Friday. I prefer to have briefing on both at one time. We will expect that at a minimum, Dr. Alving participate in this meeting as we have specific questions on the impact to NCRR programs and the community response; plus Dr. Tabak who is according to the web site is leading the effort for the re-organization.

Also, given the bill— GP that requires advance notice prior to discussion this with the outside — it is disheartening to see that HHS and NIH established a web-site for comments prior to talking or providing full notice on the proposal. In addition, the web-site notes another new organization that was not in the notice—I assume the notice is forth coming and the appropriate action will occur.

(Please note, we would appreciate all answers in word or excel files and not pdf format)

John

The letter proposes two separate actions to be evaluated independently:

1) Establish National Center for Advancing Translational Sciences (NCATS); and

2) Abolish the National Center for Research Resources (NCRR)

We have not taken any position on the two separate proposals at this point and request the following information for each proposal:

A) Specific justification and rational for each proposal

B) Budgetary consequences for FY 2011 and beyond for each proposal to all NIH Institute and Center (IC)—by IC

C) Operational consequences of each proposed change, to include impact on each IC

D) Historical funding and support for research activities NCRR

E) Historical funding and support for research activities NCATS that is conducted by each IC

F) Estimate the level of resources needed to implement each proposed change independently for each NIH IC in FY 2011 and FY 2012

G) Assume the proposed changes are made — provide the SMPR recommendation for the allocation of the resources of NIH IC at the FY 2010 CR level for FY 2011

H) For each proposed change, identify the consequences for the progress of research in the areas affected by the proposed changes for each NIH IC.

On the establishment of the new IC:

A) What would the specific mission of the new IC be and under what authorities?

B) Please provide the pending scientific opportunities and public health need and other criteria used to by the NIH Director.

C) Identify other pending scientific opportunities and public health needs by NIH ICs and the justification as to how this was ranked as a higher priority.

D) The letter notes an assumption about the non-funded health reform provisions, Cures Acceleration Network, as a significant justification for this new IC — please provide specific details on if funded how it would operate under this structure as compared to the request from NIH earlier in the FY 2011 process for it to be located within OD?

E) Please provide specific on the intent of the new IC with respect to — equip the agency with flexibility to carry out therapeutic development projects.—

F) Please provide a budget authority by program table for all the existing and new programs envisioned in the new IC and best guess full mechanism table.

G) Please provide specific on the impact to intellectual rights within this new organization.

H) The letter notes the establishment is out of existing resources, please identify the specific sources — given the separate decisions to abolish NCRR — please do not assume those resources are necessarily available for this purpose.

On the abolishing of NCRR — Please provide

A) What criteria or evaluation was used to determine the need to abolish NCRR and how do the other NIH ICs rank when applied to this criteria

B) Given the abolishment as of the end of FY 2011, what is the revised non-competing level to support current awards and how will the awards be handled in the future?

C) What is the impact on FTE and programs — please provide specific planning details

D) Please confirm that new competing awards will not be made during FY 2011, if not please explain.

According to the NIH website that is solicitation on aspects of the more, indicates another new organizations was established call the interim structure unit:

A) When was notification for this provided to the Committee?

B) What is the long-term plan?

C) How is it funded?

D) How many FTE — contract, loan, etc.?

E) Please provide details on the operational and scientific impact of this organization?

John J. Bartrum
House Committee on Appropriations
Subcommittee on Labor, Health and Human Services,
Education, and Related Agencies
2358 Rayburn House Office Building
Washington, DC 20515

Update: The “General Call” was not especially enlightening, at least what I heard. Others are welcome to chime in with their 2 cents (contributions go toward the interim infrastructure unit payline).

Second, the NCRR Advisory Council Meeting is tomorrow (Tues, Jan 25). The open portion will be videocast, and the agenda item of most interest will likely be from 8:30-9:30 a.m., when Larry Tabak presents the SMRB recommendation to create NCATS. Oddly, there is no agenda item about the dissolution of NCRR. Perhaps that is reserved for the closed portion fireworks display.

Considering Collins’ interview with Jocelyn Kaiser, the solicitation for input seems more than a tad disingenuous:

Q: What do the letters to Congress say? [Jan 14]
F.C.: That there is a proposal to create a new entity at NIH, the National Center for Advancing Translational Sciences (NCATS), and also a proposal to take the existing programs within the [NCRR] and distribute them around to other parts of NIH.

Q: So you’re going to no longer have an NCRR?
F.C.: That’s right.

Okee dokee, Francis. I guess none of the other possibilities you hinted at last month panned out:

Asked if the NCRR would be dissolved under the new proposal, Collins told Nature: “That is a possibility, but it’s not the only possibility.”

And what were the other possibilities, exactly? Well, clearly a moot point now in any case.

Somehow, I missed the part where SMRB recommended redistributing the rest of NCRR programs throughout the NIH. Or, wait, I guess there wasn’t one after all:

As far as the NCRR implications, the SMRB did not get engaged at any level of detail in considering that other than, of course, they recommended that the CTSAs [Clinical and Translational Science Awards], the largest program within NCRR, should move into the new center. …

Collins insists he could not seek public input on the elimination of NCRR until after he proposed it to Congress (but he could seek input on creating a new Center in advance of Congressional notification … not to mention the SMRB-approved merger of NIAAA and NIDA):

Q: It’s not making sense to me that you cannot consult on it until you’ve notified [Congress], but that means you’ve made the decision without consulting with the community first.
F.C.: Well [laughs], this is the government, remember. It is very clear in the legislation that we can’t actually make announcements or seek public input until Congress has been notified.

I grant you, that is a somewhat unfortunate circumstance. In my best of all worlds, I would have wanted to have the chance to have a lot more discussion about this before that kind of announcement.

Oh yes … giggle giggle … a most unfortunate circumstance. Collins goes on:

Q: Some people seem to think you need to keep all these things together. Why not just keep them within a smaller NCRR?
F.C.: I think you would tend to have gotten awfully small and maybe not even to the point of making a lot of sense. … You begin to wonder why have we created that kind of administration support structure for such a small number of programs.

Hello? Before the Great Zerhouni, NCRR staff had enough to do to keep them off the streets and out of the pool halls. In fact, IMHO, they are one of the best-run shops at the NIH. I wish more ICs looked to NCRR in modeling their administrative support structure. Willie McCullough and Esmail Torashvan ran incredibly helpful C06 and G20 application workshops and were unfailing in their support of the extramural community in getting these right.

Q: But if you kept them all together [except for the CTSAs], it wouldn’t be that small.
F.C.: I think even if the CTSAs were not driving this process, you could make a strong argument. For instance, the RCMI [a resource program for minority institutions] would belong more appropriately in the National Institute on Minority Health and Health Disparities than it does in NCRR.

Can I just say my experience in working on EXPORT applications and dealing with NCMHD (now NIMHD) was at the other end of the spectrum from working on NCRR applications? Not that NIMHD does not have good intentions and folks who work hard to address health disparities, but good intentions do not represent the best management plan for hundreds of millions of dollars. (I did feel better when Joyce Hunter moved over there from NIDDK though.) Looking at their Website and logo, I am unclear even when their transition to an Institute will become final.

Anyway, according to Collins, it will be all over but the shouting by the end of February:

Q: You said last month that you thought you might be able to get some special permission from Congress to have 28 institutes for 1 year.
F.C.: And I didn’t even ask, because I don’t think it’s the right thing to do.

Q: What’s the timetable for all this?
F.C.: We need to present the straw model to the SMRB, which is going to be on February 23. There is within NIH a plan to have final recommendations about how to restructure by the end of February.

Wow. Redistributing NCRR. Apparently the right thing to do.

And so, according to Collins’ quotes in an NYT article on NCATS, is redistributing IC funds:

Republicans in the House have promised to cut the kind of discretionary domestic spending that supports the health institutes, and officials are already bracing for significant cuts this year. But Dr. Collins has hinted that he is willing to cannibalize other parts of the health institutes to bring more resources to the new center.

“There are some people that would say this is not the time to do something bold and ambitious because the budget is so tight,” he said. “But we would be irresponsible not to take advantage of scientific opportunity, even if it means tightening in other places.”

No, we would not want to be irresponsible.

They call it a straw model, which dredges up memories of mucking out barn stalls. Maybe that’s just me.

Unfortunately, it is a static PDF, so you cannot click on programs to learn more about what they entail and whether the re-assignment seems appropriate.

Also, there is a puzzlingly named column head (and this column has the most programs listed) with no additional explanation: Interim Infrastructure Unit.

Perhaps this IIU is how Collins will avoid having one too many ICs on the org chart for FY12.

Comments on NCRR programs can be left via the form at the bottom of the page, below the table and links to the NCATS “documentation” and FAQ.

Speaking of which, not surprisingly, they have had to archive the 1105 comments on NCATS received in the first month. Keep those cards and letters coming, too. I like the “a-fresh-start-2″ part of this new NCATS Comments page address … oh, if only it were so easy.

Of course, the real question is, if this is so important and the NIH wants everyone’s input on NCATS and the fate of NCRR, why haven’t any RFI notices been issued in the Guide?

Update: Jeremy Berg posted on the NIGMS Feedback Loop notice of conference calls with various NCRR stakeholder constituencies. Of course, they only announced these calls, which are scheduled for Jan 19-21, on Jan 18. Plenty of notice.

The SMRB was authorized by the Great Zerhouni-era NIH Reform Act of 2006 (signed into law in January 2007), was chartered in Aug 2007, had its membership announced in 2008, and met for the first time in April 2009. According to its charter:

The purpose of the SMRB is to advise the NIH Director and other appropriate agency officials, through reports to the NIH Director, on the use of these organizational authorities and identify the reasons underlying the recommendations.

… Not less than once each 7 years, … the Board will (1) determine whether and to what extent the organizational authorities should be used; and (2) issue a report providing the recommendations of the Board regarding the use of the authorities and the reasons underlying the recommendations.

So the SMRB issues reports. How are they told to discharge this duty, at least with regard to recommended organizational changes?

… the Board will (a) analyze the budgetary and operational consequences of the proposed change(s); (b) take into account historical funding and support for research activities at national research institutes and centers that have been established recently relative to national research institutes and centers that have been in existence for more than two decades; (c) estimate the level of resources needed to implement the proposed changes; (d) assume the proposed changes will be made and make a recommendation for the allocation of the resources of NIH among the national research institutes and national centers; and (e) analyze the consequences for the progress of research in the areas affected by the proposed changes.

In issuing a report on one or more specific contemplated organizational issues, the Board will consult with (1) the heads of national research institutes and national centers whose directors are not members of the Board; (2) other scientific leaders who are officers or employees of NIH and are not members of the Board; (3) advisory councils of the national institutes and national centers; (4) organizations representing the scientific community; and (5) organizations representing patients.

The SMRB has even issued a report on its report-generating process, which itself notes the importance of conducting risk-benefit analyses and examining the broader impacts (not in the NSF sense) of each option for change. So, of course this is how they approached the ginormous responsibility of proposing an entirely new Center.

Or not.

At the Dec 7 meeting, Collins explained that the TMAT working group was charged to assess only the potential value of a new IC focused on translational medicine – not the potential consequences of creating this new entity. He and Arthur Rubenstein emphasized the need for further deliberation of the potential consequences should a new IC be proposed. Indeed, during the public comment period and in its submitted letter, FASEB urged that the potential consequences be examined before any recommendation be made to establish a new IC (the bureaucratic process of which could in fact delay progress on translational research).

Then what to make of the next agenda item, presciently titled, “The NIH Clinical Center and the Proposed New Center: Opportunities for Partnership” by Director John Gallin. Opportunities for partnership with a Center that had not yet been formally proposed?

Well, not to worry. Just prior to Gallin’s presentation, a motion was introduced that:

1. A new translational medicine and therapeutics center be created as recommended in the TMAT Working Group Report;
2. The Board endorse and support the NIH’s commitment to undertake a more extensive and detailed analysis through a transparent process to evaluate the impact of the new Center on other relevant extant programs at NIH, including NCRR; and
3. The NIH report their findings to the SMRB at its next meeting in approximately 3 months.

With this motion on the table and the clear intention to rapidly approve it, Jeremy Berg quickly asked the obvious question: did the TMAT Working Group consider simply restructuring NCRR to accomplish the desired scientific goals?

Rubenstein indicated that “I think almost by default we did that” and suggested the group quickly came to consensus that a new organization was needed to overcome pharmaceutical company problems and Congressional interest in the CAN. Stephen Katz confirmed the group held no in-depth discussion of such an option. How reassuring.

End of discussion. No one else on the SMRB had any questions or concerns. The motion was brought up for a vote … only Jeremy Berg’s hand went up as opposed (and I got the impression that Augustine almost forgot to ask if there were any “nays”).

In a conference call less than 48 h later, CTSA PI James Heubi (U Cinn) found it “unfortunate” that he, as an NCRR Advisory Council Member, had not been part of the TMAT Working Group discussions. Considering again their charter and operating guidelines, one wonders with which stakeholders the SMRB consulted, if not the likes of NCRR Advisory Council members, particularly one who is also a CTSA PI.

Nonetheless, in his interview with Nature, Collins reports that:

The SMRB took a comprehensive look at the situation and concluded that the scientific opportunities are here now.

A comprehensive look? Based on some global concepts presented in September (where the focus was on the NIAAA-NIDA merger) plus one working group PowerPoint presentation by Rubenstein in late November? How many of you out there were consulted for stakeholder input on such a major (and abrupt) change at the NIH?

(With only 3 months allocated to study potential impacts, you should not delay in registering any comments you have on the new center and/or the fate of NCRR.)

And how much deliberation on the potential consequences can realistically be expected if NCATS is already a ~$650M line item in the FY12 budget?

These questions are important not only for this situation but also for the future operation of the NIH. If such major changes can be implemented so quickly with such little input beyond “working” group members, what else might the SMRB do on behalf of NIH Directors seeking to push through special initiatives?

Of course, if NIDA and NIAAA are merged and NCRR is mothballed (its programs scattered among other ICs), Collins will have an extra slot to fill. Nominations for the next IC anyone?

No doubt of most interest to all of you is Jeremy’s comment on what might be in store for FY11:

What do we anticipate for the current fiscal year (Fiscal Year 2011)? At this point, no appropriation bill has passed and we are operating under a continuing resolution through March 4, 2011, that funds NIH at Fiscal Year 2010 levels. Because we do not know the final appropriation level, we are not able at this time to estimate reliably the number of competing grants that we will be able to support. We can, however, estimate that the number of research project grant applications in the success rate base (correcting for applications that are reviewed twice in the same fiscal year). We predict that this number will be approximately 3,875, an increase of 17% over Fiscal Year 2010.

No surprise there. Hopefully Congress won’t have too many unpleasant surprises for the NIH appropriation either.

The Center, recommended by the SMRB within a month of the Nov 10th TMAT Working Group presentation on how to advance translational research and therapeutics development, is projected to be online by October 1, 2011 with a budget (based on an initial estimate of $650M) exceeding that of NIAMS, NHGRI, NIAAA, NIDCD, NIDCR, NLM, NIBIB, NCMHD, NINR, NCCAM, and FIC.

The solicitation of comments suggests input is being sought on both the Center and the future of NCRR, though with regard to the latter, Collins has showed his cards in an interview with Nature:

What happens to the rest of the NCRR’s programmes?

Again, the strong assurance is that these programmes are valued, that they will be supported, that the people involved in them are doing great work. There is no intention here to dismantle them. But if there are opportunities to reorganize and reassign these programmes in ways that make them more interactive with what we are trying to do in this new centre, well, that seems like a good thing to consider.

Hopefully the NIH will take more than a month to consider this course of action.

Damn, I cannot wait to work on applications for research that fulfill these priorities … time to kick my creative writing skills up a notch.

This recap from Science reflects concerns raised about the concept and the rapid time frame involved, which does not permit stakeholders to think things through well:

Debate over the proposal flared at an NIH advisory board meeting this morning. Nearly 20 groups and investigators supported by the National Center for Research Resources, which would be partly absorbed by the new center, sent letters or gave testimony expressing concern that existing NCRR programs might be lost. “It’s a very large organization being done on a very fast time scale, and the community that will be affected needs more time to provide input,” said biochemist Mark Lively of Wake Forest University School of Medicine in Winston-Salem, North Carolina, a member of NCRR’s advisory council, before the meeting. NCRR Director Barbara Alving urged the board instead to expand NCRR into the new translational center.

My thoughts exactly, Dr. Alving. Let’s just rename/rebrand/expand a perfectly functional NCRR … a well-functioning NCRR – I’ve always liked my dealings with NCRR and want to see them do well (big shout out of support for yinz from BICO) – but no:

Despite such concerns, the board voted 12-1 to create the new center. Only Jeremy Berg, director of the National Institute of General Medical Sciences, voted no; he is “concerned that the implications for the rest of NIH hadn’t been adequately discussed,” he said afterward.

So, even with all the promised deliberations and assessments, does Collins just go ahead and combine NIAAA and NIDA (at the same speed with which this Center was created), since he cannot increase the total number of ICs, or will NCRR be cut into programmatic pieces to be dispersed (or discarded) like the victim of some hostile takeover? What I really, really don’t understand is Collins’ crowing comment:

Collins called the decision to go ahead “a momentous occasion” because the center is being created “on the basis of scientific arguments” and not politics, which has “rarely” happened at NIH.

Let’s see … the Center was created in no small part to house the Cures Acceleration Network, which was spontaneously generated by that outstanding scientist, Arlen Specter (who is now standing out of the Senate and unable to garner any support for this Center or the rest of the NIH). CAN as a vote-buying line item in health care reform. Nah, of course there were no politics involved here.

What happens next?

This week, Collins expects to send his recommendation for the new translational center to Health and Human Services Secretary Kathleen Sebelius, who will forward it to legislators. Congress will have 180 days to object; otherwise, the new institute will move forward.

Poof – just like that. If only cures were so easy.

Update: FASEB has included this nice recap of what happens next in their latest update:

Immediately following the SMRB decision to recommend a reorganization (reprogramming), NIH likely notified Congress, starting the clock for the 15 day period before the Director can publically accept the SMRB recommendations. It also started the 180 day period that Congress has to object to the recommendation. Concurrently, NIH has begun to develop a more detailed draft implementation plan in consultation with NCRR Staff, NCRR grantees, and CTSA institutions. After the 15 day period, the NIH Director may issue a statement of acceptance of the recommendations. Assuming acceptance of the recommendations and the development of the more detailed draft plan, broader public input would then be sought. A “final” plan would be presented at the next SMRB meeting and submitted to the Secretary of the Department of Health and Human Services. The Secretary would then have 30 days to accept or reject the final plan. FASEB will continue to monitor this issue closely.

First, another Continuing Resolution continues FY10 funding levels until Dec 18th. According to the AAMC, seems most likely these CRs will be the high-point of FY11:

During debate on the measure, Rep. Jerry Lewis (Calif.), the ranking Republican on the House Appropriations Committee, again expressed opposition to “any potential omnibus spending bill the Democratic leadership may be planning to bring to the House floor before the end of the year.” He also opposed extending the CR for the balance of FY 2011 at current level, which he described as “frankly, too darn high.”

Second, see the opening line of the post below. On Dec 7, the Scientific Management Review Board, which has issued a report recommending the merger of NIAAA and NIDA (under consideration by Collins, with a decision likely by summer 2011), will discuss the possible creation of a new center on translational medicine and therapeutics.

In November, Arthur Rubinstein, in a presentation on workings of the Translational Medicine and Therapeutics (TMAT) Working Group, proposed that:

a new TMAT program be established at NIH in the form of a new IC to:

• Establish new and innovative approaches to conducting research to advance the science of process engineering of the therapeutics development pipeline, in the context of strengthening and streamlining the process itself; and
• Serve as a catalyst, resource, and convener for collaborative interactions, capitalizing on the relative strengths of the extra-and intramural communities, private sector, government, and academia, to promote quick-win, fast-fail paradigms and further develop the pre-competitive space.

Let’s see … “process engineering of the therapeutics development pipeline” … “quick-win, fast-fail paradigms” … “pre-competitive space.”

What happened to the mission “to seek fundamental knowledge about the nature and behavior of living systems”?

Why not just say, we need a place (other than NCRR apparently) to house CAN (Cures Acceleration Network), the CTSAs, NIH-FDA projects (regulatory science), perhaps comparative effectiveness research, and some other big Roadmap initiatives in partnership with the NIH Clinical Center (to enhance its own use & sustainability)? Of course, the next question is what happens to funding levels at the 25 ICs that currently support translational research and therapeutics development (see first news bulletin above).

An NAS Research Universities “blue-ribbon committee” has been asked to write a report on “the top ten actions that Congress, the federal government, state governments, research universities, and others could take to assure the ability of the American research university to maintain … excellence in research and doctoral education…” The commmittee met in late November to address concerns about shrinking federal investment in academic research. As Science reports,

At the top of the list, university leaders want changes in the formula used to reimburse universities for the ancillary costs of conducting federally funded research on campus.

You might think, wow, they finallly recognize that they need to stop floating their research enterprises on soft money and instead ask “universities to use existing resources in the most efficient manner,” as Science reported when the committee was first announced. Maybe a consistent but modest level of F&A reimbursement for all institutions, not individually negotiated rates.

Um, not quite.

The negotiated reimbursement rate is too low … What if, he [James Duderstadt, UMich] said, the community abandoned its perennial request for more … and accepted flat funding in return for the government allowing universities to be reimbursed fully for what they consider the true cost of hosting federally funded research?

“Hosting federally funded research”? Sounds like a damn Tupperware party.

But in other words, universities want all the $ they consider necessary for building new buildings, running their research administration machine, and keeping the lights on, even if it means less money for actual research and training. And they seem to think their faculty will be pleased as punch about all this:

At the same time, Duderstadt acknowledged that increasing reimbursement for overhead costs, in a flat budget, would leave agencies with less money for research grants. That would increase competition among faculty members already bemoaning low success rates on their applications. “Would your faculty support that approach?” wondered panelist Walter Massey, president of Morehouse College in Atlanta and a former director of the National Science Foundation. “They want a grant with lower, not higher, indirect costs. Could you bring them around?”

Several university administrators thought they could, provided the changes were explained properly. “The challenge is to be consistent and understandable,” said Kim Wilcox, provost and vice president for academic affairs at Michigan State University in East Lansing. “If we can do that, then it’s up to us to explain it to the faculty.”

Like I said, what are they smoking?

The current Continuing Resolution will keep the federal government operating at FY10 levels through December 3rd. Last year, a non-election year, the omnibus FY10 appropriations bills were passed by Congress and signed by the President in December. However, the CR could well be extended through the start of the new Congress next January. Keep in mind, though, that FY07, which encompassed the 2006 mid-terms, was managed under a CR all year. Not surprisingly, the ICs must be conservative in making funding decisions until they know how much money they have to play with … and will be especially conservative this year with even more unknowns in the equation.

Where do things stand? The Labor/HHS/Education Appropriation Bill, which funds the NIH budget, includes $1B increase for the NIH … but came out of Committee last July along partisan lines (18-12 vote) and has not been considered by the House. The Senate Committee report is of interest in that it lays out Senate interest in specific areas of research at each IC, such as a request to fund liver cancer SPOREs, an increase in funding for stroke research (“The Committee is concerned that the NIH continues to invests only 1% of its budget on stroke research”), and a “networked pediatric research consortia model”. The Report includes only one item under NIGMS that probably would not immediately come to mind for most of us:

The Committee applauds the Institute’s leadership role in the OppNet initiative, which will support basic behavioral science throughout the NIH. The Committee encourages the NIGMS to support basic behavioral research to its fullest potential, and to incorporate basic behavioral training in its forthcoming training plan.

Nature News prepared a series of pieces about the loss of NIH champions in Congress, the threat posed by the deficit on science funding, and the potential ideological (and budgetary) challenges science could face after the mid-term elections. The loss of NIH champions such as Arlen Specter and David Obey, make the NIH appropriation situation even more precarious.

So what about everyone with scored Cycle 1 applications? For applications scored outside the FY10 payline, my advice is to start working on a resubmission (if an A0). For those near or just inside the FY10 payline, decisions will be a long way off in all likelihood, so you might want to discuss a resubmission strategy with your PO (who won’t know about funding either until an appropriation is passed). For those with clearly fundable scores and an encouraging word from your PO, notices will be slow trickling out, so please be patient. And for those of you looking to ICs with no prior payline benchmarks, please be patient with your PO … unless your score is obviously competitive or not, he or she will not know about funding strategies until the NIH appropriation passes, and the advice will likely be to plan on resubmission (assuming you still have your A1 left) or reworking the research for a (legal) new submission.

Update: Oof … from Bloomberg News:

Republicans taking control of the House next year would roll back funding to agencies including NIH to fiscal 2008 levels, according to a proposal by Rep. Eric Cantor, R-Va., who is likely to become the chamber’s majority leader. That would equate to a 4.3% , or $1.3 billion, cut to the agency’s $30.8 billion annual budget.

But then a glimmer of hope …

Some Republican lawmakers in the House and Senate may defy the budget cuts and defend NIH, Zeitzer said. One ally may be Sen.-elect Mark Kirk of Illinois, who now serves on the House Appropriations Committee, which controls discretionary spending. … Other potential Republican supporters include Reps. Brian Bilbray of California and Dave Reichert of Washington and Sen. Richard Shelby of Alabama.

Probably not entirely what you might expect, but still an interesting thought exercise with plenty of opportunity to enter free-text comments and input.

The project is also creating a digital repository for the aforementioned science agencies (the sorts of program & policy documents not easily found in one place) and examining the broader impacts criteria for NSF-funded research (other than their own).

And, speaking of peer review & broader impacts, for those of you familiar with the Rocket Boys story (and even more so for those of you who are not familiar with it!), I think you’ll enjoy this adorable little (3’32″) video from the NIH.

Correlation coefficients between the overall impact score and the five criterion scores for 32,608 NIH applications from the Fiscal Year 2010 October, January and May Council rounds

As he notes, the trends across the ICs mirror what he found at NIGMS. The NIH-wide data also include more mechanisms … whereas Jeremy analyzed 654 R01s from one cycle, these data include all RPG, research center, and SBIR/STTR applications over 3 cycles (Oct-Jan-May Councils). Not sure if we’ll get all his other lovely data at the NIH level, but we can dream. In the meantime, thanks so much for your leadership in disseminating the NIGMS and now these NIH-wide data, Dr. Berg.

NIGMS Director Jeremy Berg continues to anticipate the sorts of questions NIH-funded investigators would like to have answered. In his latest Feedback Loop post, he analyzes data on publications from 2007-2010 linked to NIGMS funding and the impact factor of the journals involved according to annual direct costs.

So what do the data show? Among the 2,938 investigators who held at least one NIGMS R01 or P01 grant in Fiscal Year 2006:

Median number of grant-linked publications, 6 (2007-2010)
Median journal impact factor, 5.5
Median annual direct costs of funding received, $220K

Please note (at the original post) the ranges in each category, though, and that funding totals are by PI vs award. PI productivity peaks at about $700K per year in annual DC. Anyone surprised? Jeremy notes this supports the NIGMS threshold of $750K in defining (and limiting addtional funding to) “well-funded laboratories.”

Anyone have specific sorts of peer review/grant funding/research productivity data they would like to see analyzed?

One hopes OER has recognized the scientific community’s interest in these types of data … perhaps they could cover NIH-wide and IC-specific trends on their RePORT site down the road.

Separately, he adds a line graph of the cumulative fraction of applications by percentile in four classes: ESI, new, established Type 1 (new application), and established Type 2 (competing renewal). The latter two symbols are a bit tricky to discern on the graph, but the Type 2s are the clear winners, as expected.

And as PP points out in his comment, how did a new investigator with a 3rd percentile/impact score 11 application not get funded? Or the ESI at the 20th percentile with a 19? Hopefully neither of these symbols actually represent more than one unfunded applicant in that status with that score.

Jeremy adds a note explaining that most of the black squares in the lower left quadrant (i.e., competitively scored but unfunded applications) represent Type 1 R01s submitted by PIs with more than $750K DC (including the submitted application). For those of you who weren’t aware, many ICs have policies that limit the number or dollar total of grant awards to any one lab … though exceptions can be made.

The Extramural Nexus from OER this month indicates that “help is on the way” … (that does not involve making Madame Zelda an allowable consultant cost):

NIH will begin requiring reviewers to include a paragraph in their written critiques to explain the factors that informed his or her overall impact score … [to] provide applicants with greater insight into how each reviewer assessed scientific merit of the grant application and determined his/her overall impact score. … You will see the additional information in summary statements for applications reviewed this fall.

Well then, something to look forward to. One wonders if reviewers will be required to remember verbatim the drunken comment made by the applicant at a Gordon conference …