Sebelius: NCRR Must Go

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

10 Comments »

  1. AH said

    There are few things that do not fit at all. Among those

    1. NIH Directors, presently Collins, are expected to have priorities in their vision of the agency’s mission at anytime point in history and best respond to the needs of the nation. If Collins’s impetus was to move forward the therapeutic aspect of translational sciences at NIH and he wanted to do it effectively, WITHIN THE BUDGETARY AND STATUTORY LIMITATIONS we are in, why he did not think on implementing that at NCRR in the first place ?. Why?. WHY, WHY?.

    I am under the impression that this is about what goes on sometimes, unfortunately, in the academic world: there are people who steal ideas, scoop data from papers, grants in review: SCOOPING. This is what is all about. And the irony is that the whole process is legal and protected by statutory limitations.

    There is very little, if any, novelty on the SMRB discussions of what NCATS should be (both in concepts and possibilities) that is not already flourishing at NCRR. Oh yes. I forgot. There is one novelty at NCATS and that is: “the fast-track quick drug pipeline”.

    2. If in the impetus for moving forward therapeutics development at NIH , there was ever a thought on the necessity or possibility to downgrade or eliminate an institute, how come the Director of that Institute or her designated person has not been a member of SMRB since the very first moment in the whole procedure?. My initial answer has been: perhaps because the Committee needed absolute freedom to discuss without constrains all the possibilities. That sounds like a very rational criterion. What is not consistent, perhaps legal but unethical is to recuse NCRR Director from the Committee and designate Arthur Rubenstein as Chair of the TMAT Subcommittee. He is well known for being in at least 5 or 6 Pharmaceutical Boards and has been receiving moneys for his service. He could have certainly had a valuable presentation on his experience at SMRB but giving him an organizing/decision-making voice in an initiative to move forward therapeutics at NIH is wrong.

    Finally, I am sorry that John Bartrum “felt disheartened” that NIH and HHS has initiated a discussion with the stakeholders before Congress’s decision. My consolation is that Bartrum is a Lawyer and he knows or should know better.

    Mr Bartrum, how do you think we are feeling about the dictatorial procedure followed to eliminate NCRR from NIH, which is supported by the taxpayers?. We have made an investment and are proud and confident on their achievements ! We should have our word on it!!.

  2. Verdeluz said

    It seems that Congress is not all too happy with the proposal. From the questions in the email you can see that they’re wondering if NIH has really thought this through and has considered all impacts. And they gave NIH only two days to respond!? I wonder if they were able to meet the deadline…

  3. drugmonkey said

    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

    This is the most hilarious part of the whole thing. Veiled threat?

    • writedit said

      I’d say the not especially veiled threat with the most teeth can be found here:

      “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.”

      Apparently no one thought about the possibility of Congress accepting the abolishment of NCRR (reduce the deficit!), separate from any other proposed changes. Poof – NCRR and all its programs are gone (“no longer required”), with the funds restored to the Treasury. Now what, FC?

      • PKC said

        I am not sure it is fair to ask ” now what, FC?” and put all the blame on him. A huge share is to be put on whoever decided to give AR a seat on that TMAT. He and his supporters have been trying to set a foot inside NIH in multiple ways. They have screwed a lot of programs now and many investigators.

  4. Verdeluz said

    And among all this recent controversy, one person who has been the voice of reason and caution, Jeremy Berg, has just announced he will be resigning in June…
    http://news.sciencemag.org/scienceinsider/2010/12/nigms-director-berg-steps-down.html?ref=hp

  5. Victoria said

    Yes indeed, this has been a “ true accident” (hopefully not fatal) that should be avoided for the future. It can happen to inexperienced drivers. The Scientific Management Review Board (SMRB) for Periodic Organizational Reviews got his/her driver license by PUBLIC LAW 109–482—JAN. 15, 2007 but their actual driving started only in 2008. SMRB is a young, inexperienced driver.

    In San Diego (California), a very tolerant community, if you get lost driving in the middle of the night and you get very confused, avoid yielding, miss a stop sign and a police happens to see you, he will give you a reprimand and a huge ticket. No matter how hard you try to explain that you were lost and frightened not being able to find your home, the police will have you keeping the ticket. But if you go to the pertinent office and explain the situation, the authority will wave the fine for you BUT you have to take a one-week DRIVING COURSE at their school. (This is a true story).

    The take home message is that SMRB, but also all of us, have to re-read the NIH Reform Act 2006 and ask relevant lawmakers about the interpretation and implementation of the law.

    I just went through my first reading:

    In section “(e) SCIENTIFIC MANAGEMENT REVIEW BOARD FOR PERIODIC ORGANIZATIONAL REVIEWS:

    DUTIES:
    ‘‘(A) REPORTS ON ORGANIZATIONAL ISSUES.-The Board shall provide ADVICE to the appropriate officials under subsection (d)

    “(B) CERTAIN RESPONSIBILITIES REGARDING REPORTS (Most of them have been addressed in Mr Braum’s letter).

    ‘‘(C) CONSULTATION. In carrying out subparagraph (A), the Board shall consult with‘‘(i) the heads of national research institutes and national centers whose directors are not members of the Board; ‘‘(ii) other scientific leaders who are officers or employees of NIH and are not members of the Board; ‘‘(iii) advisory councils of the national research institutes and national centers; ‘‘(iv) organizations representing the scientific community; and ‘‘(v) organizations representing patients.

    The language of the law, consultation-wise, does not appear restrictive. Extensive participatory consultation could have been efficiently done, after Rubenstein’s Presentation on TMAT Charges July 26, 2010 by releasing an NIH Notice- REQUEST FOR INPUT (RFI) with a time frame of 12 weeks for responding and processing the information…… But yes, inexperienced drivers can be forgetful about driving precautions.

    ‘‘COMPOSITION OF BOARD.—The Board shall consist of the Director of NIH, who shall be a permanent nonvoting member on an ex officio basis, and an odd number of additional members, not to exceed 21, all of whom shall be voting members. The voting members of the Board shall be the following: ‘‘(A) Not fewer than 9 officials who are directors of national research institutes or national centers. The Secretary shall designate such officials for membership and shall ensure that the group of officials so designated includes directors of— ‘‘(i) national research institutes whose budgets are substantial relative to a majority of the other institutes; ‘‘(ii) national research institutes whose budgets are small relative to a majority of the other institutes; ‘‘(iii) national research institutes that have been in existence for a substantial period of time without significant organizational change under subsection (d); ‘‘(iv) as applicable, national research institutes that have undergone significant organization changes under such subsection, or that have been established under such subsection, other than national research institutes for which such changes have been in place for a substantial period of time; and ‘‘(v) national centers.
    ‘‘(B) Members appointed by the Secretary from among individuals who are not officers or employees of the United States. Such members shall include ‘‘(i) individuals representing the interests of public or private institutions of higher education that have historically received funds from NIH to conduct research; and ‘‘(ii) individuals representing the interests of private entities that have received funds from NIH to conduct research or that have broad expertise regarding how the National Institutes of Health functions, exclusive of private entities to which private entities to which clause (i) applies.

    WHAT I AM MISSING HERE IS IF APPOINTMENT TO THE BOARD REQUIRES FINANCIAL DISCLOSURE AND/OR AFFIDAVIT ON CONFLICT OF INTERESTS. AT A MINIMUM, APPOINTEES SHOULD CONSULT IF THEIR PAST OR PRESENT ACTIVITIES COULD POTENTIALLY CONSTITUTE A COI. THIS IS A PROCEDURE, REGULARLY DONE, AT NIH FOR GRANT REVIEW PURPOSES.
    SMRB IS A REVIEW COMMITTEE.

    One of the conclusions is that the SMRB has done a rather poor job in managing their review assignment. Metrics should have to be applied to evaluate it as to improve it.

  6. […] 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. […]

  7. […] 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 […]

  8. […] What sort of information is Rep. Rehberg looking for? The sort requested last January by John Bartrum. […]

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