Biomedical scientists aren't alone in questioning a plan by National Institutes of Health (NIH) Director Francis Collins to create a new center to spur drug development. Last week, a staffer for a key congressional committee asked NIH and the Department of Health and Human Services (HHS) for a long list of details about the reorganization, which also entails dissolving an existing center.
On 14 January, HHS submitted a letter to several committees describing NIH's plan to "establish" a National Center for Advancing Translational Sciences (NCATS) and "abolish" the National Center for Research Resources (NCRR). (By law, HHS must notify Congress of any plan to create or dissolve an NIH center or institute; Congress has 180 days to respond.) The brief letter explains that folding several existing programs at NCRR and other institutes into the new center "will propel translational science more swiftly." NCRR programs not involving translational research will move to other institutes, it says. (An even shorter letter went to the committees that oversee NIH's programs.)
Researchers have flooded NIH with concerns about the reorganization. And Congress is concerned, too. On 19 January, John Bartrum, a staffer on the House of Representatives appropriations subcommittee that oversees the HHS budget, e-mailed several HHS and NIH officials. While Bartrum says the subcommittee has not taken a position on the changes, he asks 25 questions about the new center's mission, its budget, and how NIH decided to dismantle NCRR.
The scrutiny casts doubt on NIH's plan to include NCATS in its 2012 budget request so it can be launched in October. At a meeting of NCCR's advisory council meeting this week, where council members grilled NIH Deputy Director Larry Tabak about the plan, Tabak acknowledged the uncertainty. For the first time he used the acronym "pNCATS" for the new center, with the "p" standing for "proposed."
Meanwhile, an effort by Collins last week to drum up support for NCATS with press interviews may have backfired. An article in The New York Times drew an unusual statement titled "Separating Fact & Fiction" in which NIH officials assure the community that "NCATS is not intended to be a drug company" and that "there are no plans to "cannibalize" the budgets or programs of other NIH Institutes and Centers to form NCATS."
See the full e-mail from the congressional staffer below. For more about the uproar over NCATS, see the 28 January issue of Science.
From: Bartrum, John
Sent: Wednesday, January 19, 2011 9:57 AM
Subject: House Questions on Notification of NIH reorganization
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)
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