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.
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