Medical Writing, Editing & Grantsmanship

On the NIGMS Feedback Loop, Jeremy Berg has provided another peek behind the curtain, this time about how funding decisions are made.

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.

Through a FOIA request, the January 14th letters submitted by DHHS Secretary Kathleen Sebelius to appropriate members of Congress have been posted online. They come in two flavors.

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: Collins et al. have added a post to the NCATS comment page entitled, Separating Fact & Fiction: News about the proposed National Center for Advancing Translational Sciences (full text included below).

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.

Larry Tabak and Alan Guttmacher have posted a grid laying out the proposed re-distribution of NCRR programs (thanks to Jeremy Berg for alerting us to this under the SMRB post).

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.

Last month, the Scientific Management Review Board (SMRB) recommended the creation of a new National Center for the Advancement of Translational Sciences (NCATS). They have also recommended merging programs from NIAAA and NIDA into a new IC focused on addiction research. Pretty powerful stuff from the new kid on the block.

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?