Medical Writing, Editing & Grantsmanship

NCRR is not quite dead yet … but on Saturday, Collins jumped the gun in trumpeting this “signal moment for NIH”:

From: Exec Sec1 (NIH/OD)
To: NIH-STAFF@LIST.NIH.GOV
Sent: Sat Dec 17 18:56:52 2011
Subject: Message from the NIH Director – Changes at NIH

To: All NIH Staff
From: Director, NIH
Date: December 17, 2011
Subject: Changes at NIH

The omnibus appropriations bill for FY2012 passed by Congress and signed into law by President Obama today includes provisions that formally establish the National Center for Advancing Translational Sciences (NCATS) as a new component of the NIH. This is an important step forward in our efforts to speed the delivery of new drugs, diagnostics, and medical devices to patients. It was just over a year ago that the Scientific Management Review Board recommended the establishment of this new component of NIH, and the achievement of this complex outcome in this time frame is a testimony to the remarkable diligence of many dedicated individuals, both within and outside of NIH, who have worked together to achieve this goal.

This is a signal moment for NIH. I want to take this opportunity to recognize the rich history of the National Center for Research Resources (NCRR) and pay tribute to the important contributions of its dedicated employees and grantees. Over more than two decades, NCRR has established and administered a remarkably diverse portfolio of research programs, most recently including the re-invention of our nation’s academic clinical research network in the form of the Clinical and Translational Sciences Awards (CTSAs). I am grateful to Acting Director Dr. Louise Ramm and all of the dedicated staff of NCRR, for their devotion to the cause of excellence in NIH research. Although NCRR is now disbanded, its scientific legacy will live on. As former NCRR employees and their programs transition into new homes within NCATS and other Institutes and Centers, please welcome them with open arms and embrace their wealth of expertise and experience.

Change is never easy; however, it often opens doors to unexpected opportunities for personal growth and scientific collaboration. So, even as we look back at the many accomplishments of NCRR, let us also look ahead to NCATS and realizing its vision of transforming translational research.

In this vein of change, I am pleased to designate Thomas Insel, M.D., as the Acting Director of NCATS and Kathy L. Hudson, Ph.D., as Acting Deputy Director of NCATS. Drs. Insel and Hudson will lead the many activities of bringing the Center into being and getting its programs underway, while we conduct a nationwide search for the first NCATS Director. Drs. Insel and Hudson have already been deeply involved in establishing the Center and are natural choices to implement our plans for NCATS. Both of them will continue to serve in their current roles, at NIMH and in the Director’s Office respectively, while serving in these Acting leadership positions.

I very much appreciate Tom’s and Kathy’s willingness to take on these exciting but challenging additional roles, and I know I can count on all of you to join me in giving them as much support as possible.

Francis S. Collins, M.D., Ph.D.

***

From: “Exec Sec1 (NIH/OD)” <EXECSEC1@od.nih.gov>
Date: December 17, 2011 7:59:57 PM EST
To: “NIH-STAFF@LIST.NIH.GOV” <NIH-STAFF@LIST.NIH.GOV>
Subject: Message from the NIH Director — Correction: Please disregard the previous message.
Reply-To: “Exec Sec1 (NIH/OD)” <EXECSEC1@od.nih.gov>

To: All NIH Staff
From: Director, NIH
Date: December 17, 2011
Subject: Correction: Please disregard the previous message.

The President signed a Continuing Resolution until December 23, so nothing is finalized until we have a signed bill. We apologize for any confusion.

Francis S. Collins, M.D., Ph.D.

I hope he was not suggesting we disregard the polite praise for NCRR … which, according to the NIH Almanac, has been serving the biomedical research community quite well for closer to five decades (though only formally as NCRR since 1990).

The FY12 appropriations bill Conference Report includes its own assessment of the process by which NCRR was replaced by NCATS:

The conference agreement includes language to eliminate the NCRR and create the National Center for Advancing Translational Sciences (NCATS).

NCATS will study steps in the therapeutics development and implementation process, consult with experts in academia and the biotechnology and pharmaceutical industries to identify bottlenecks in the processes that are amenable to re-engineering, and develop new technologies and innovative methods for streamlining the processes. In order to evaluate these innovations and new approaches, NCATS will undertake targeted therapeutics development and implementation projects. In all of these efforts, the conferees expect that NCATS will complement, not compete with, the efforts of the private sector.

While the conferees welcome the creation of NCATS, they were disappointed by the way the administration requested it. The President’s proposed budget for fiscal year 2012 included a vague description of NCATS but did not formally request funding for the restructuring or provide any details about which components of NIH would be consolidated into the new Center. The failure to do so caused unnecessary uncertainty about the proposal and contributed to the impression that it was being rushed. The conferees are also aware of concerns that the NIH process for evaluating the merits of the NCATS reorganization did not comply with the NIH Reform Act of 2006 with respect to the role of the Scientific Management Review Board (SMRB).

The decision to create NCATS might have been rushed?

With an agreement finally reached on an appropriations bill, the news for the NIH is better than if we had continued the CR with its 1.5% cut all year. Looking at the House Appropriations Committee’s marked up bill (H.R. 3671, see pp 50-56) and FY11 appropriation levels, I initially read slight decreases (except where NCRR funds move to new ICs), with any new money earmarked for specific programs (see notes below). Science and The Chronicle of Higher Education highlighted a slight overall increase for the NIH, which is true but relative (more below). Either way, not much change, up or down.

Biggest bonus surprise: anyone who applied to an IDeA FOA this past year certainly hit the jackpot: this program will have an extra ~$46M+ to hand out by September 30th … not sure if they’ll just reach farther down their payline or whip up a new solicitation in time for review & funding by the end of the FY. This is now NIGMS’ call, with the unfortunate dissolution of NCRR in the same appropriations bill.

I originally used dollar amounts from the marked up HR 3671 and the FY11 $s from what was signed into law. However, the Conference Report (see table at pp 31-34) helpfully provides $s for FY11 enacted that take into account Public Law 112-10‘s 0.2% across-the-board cut in discretionary spending plus an extra $210M cut to the NIH (spread across the ICs) … so the NIH is getting a small increase, though it does not quite offset what was lost last year (i.e., by the 0.2% + $210M additional cuts). I’ll leave all the numbers up as a reminder of how complicated this can get …

NCI: $5,103,388,000 FY11 (PL)/$5,058,577 (Conf) vs $5,081,788,000 FY12

NHLBI: $3,096,916,000 FY11 (PL)/$3,069,723 (Conf) vs $3,084,851,000 FY12

NIDCR: $413,236,000 FY11 (PL)/$409,608,000 (Conf) vs $411,488,000 FY12

NIDDK: $1,808,100,000 FY11 (PL)/$1,792,224,000 (Conf) vs $1,800,447,000 FY12

NINDS: $1,636,371,000 FY11 (PL)/$1,622,003,000 (Conf) vs $1,629,445,000 FY12

NIAID: $4,518,275,000 (after $300M to global fund) FY11/$4,478,668,000 (Conf) vs $4,499,215,000 FY12 (no global fund transfer)

NIGMS: $2,051,798,000 FY11 (PL)/$2,033,782,000 (Conf) vs $2,434,637,000 FY12 (includes $ for NCRR programs transferred to NIGMS … and “provided that not less than $276,480,000 is provided for the IDeA program”)

NICHD: $1,329,528,000 FY11 (PL)/$1,317,854,000 (Conf) vs $1,323,900,000 FY12

NEI: $707,036,000 FY11 (PL)/$700,828,000 (Conf) vs $704,043,000 FY12

NIEHS: $689,781,000 FY11 (PL)/$683,724,000 (Conf) vs $686,869,000 FY12

NIA: $1,110,229,000 FY11 (PL)/$1,100,481,000 (Conf) vs $1,105,530,000 FY12

NIAMS: $539,082,000 FY11 (PL)/$534,349,000 (Conf) vs $536,801,000 FY12

NIDCD: $418,833,000 FY11 (PL)/$415,155,000 (Conf) vs $417,061,000 FY12

NINR: $145,660,000 FY11 (PL)/$144,381,000 (Conf) vs $145,043,000 FY12

NIAAA: $462,346,000 FY11 (PL)/$458,286,000 (Conf) vs $460,389,000 FY12

NIDA: $1,059,848,000 FY11 (PL)/$1,050,542,000 (Conf) vs $1,055,362,000 FY12

NIMH: $1,489,372,000 FY11 (PL)/$1,476,294 (Conf) vs $1,483,068,000 FY12

NHGRI: $516,028,000 FY11 (PL)/$511,497,000 (Conf) vs $513,844,000 FY12

NIBIB: $316,582,000 FY11 (PL)/$313,802,000 (Conf) vs $338,998,000 FY12 (includes $ for NCRR programs transferred to NIBIB)

NCRR: $1,268,896,000 FY11 (PL)/$1,257,754,000 (Conf) vs $0 FY12 (these $ are all redistributed to other ICs & OD)

NCCAM: $128,844,000 FY11 (PL)/$127,713,000 (Conf) vs $128,299,000 FY12

NIMHD: $211,572,000 FY11 (PL)/$209,714,000 (Conf) vs $276,963,000 FY12 (includes $ for NCRR programs transferred to NIMHD)

FIC: $70,051,000 FY11 (PL)/$69,436,000 (Conf) vs $69,754,000 FY12

NLM: $339,716,000 FY11 (PL)/$336,733,000 (Conf) vs $338,278,000 FY12

NCATS: $0 FY11 vs $576,456,000 FY12 ($10M for CAN, $487,767,000 for CTSA, rest for other NCRR programs)

OD: $1,177,300,000 FY11 (PL)/$1,166,963,000 (Conf) ($544,109,000 for Common Fund) vs $1,461,880,000 ($545,962,000 for Common Fund)

Buildings and facilities: $100,000,000 FY11 vs $125,581,000 FY12

If anything changes in the language of the final bill signed into law, I will update this post accordingly.

In the meantime, the Conference Report includes a few other items of interest:

• The conferees affirm the critical importance o f new and competing RPGs to the mission of NIH and are concerned that in the past few years, NIH has failed to support the number of new, competing RPGs that it estimated
  would be awarded in its annual congressional budget justifications.
• NIH should also establish safeguards to ensure the percentage of funds used to support basic research across NIH is maintained.
• While the conferees welcome the creation of NCATS, they were disappointed by the way the administration requested it. The President’s proposed budget for fiscal year 2012 included a vague description of NCATS but did not formally request funding for the restructuring or provide any details about which components of NIH would be consolidated into the new Center. The failure to do so caused unnecessary uncertainty about the proposal and contributed to the impression that it was being rushed. The conferees are also aware of concerns that the NIH process for evaluating the merits ofthe NCATS reorganization did not comply with the NIH Reform Act of 2006 with respect to the role of the Scientific SMRB.
• Lessons learned with NCATS should guide NIH as it considers another proposed restructuring, one that would involve consolidating NIDA, NIAAA and components of other ICs into a new Institute devoted to research on substance use, abuse and addiction. The conferees understand that NIH plans to adopt a more deliberate approach in evaluating the need for this Institute. The conferees strongly recommend that this approach should include full consideration by the SMRB and that if the administration ultimately decides to seek such a restructuring, it should provide sufficient details in a formal budget request to Congress.