Your Candidates Your Health 2012

2012 is upon us, which means that election season is in full swing. Now is a great time to become familiar with candidates’ thoughts on the role of the federal government in biomedical research. AADR is supporting the Research!America initiative “Your Candidates-Your Health 2012,” which is designed to educated the electorate on candidates -as related to health and research. Candidates for the presidency and Congress are provided a brief questionnaire and their responses are made available online. Responses have already been provided by the campaigns of Former House Speaker Newt Gingrich and President Barack Obama. AADR is pleased to join many national and state-based organizations in sponsoring this important project and encourages its members to visit the site regularly to view new responses from candidates.

OSTP Extends Deadline for Response to Open Access RFI

The White House Office of Science and Technology Policy has announced an extension of the deadline for response to its Request for Information on expanding open access to scholarly publications that draw from federally funded research. The new deadline is January 12th. AADR will provide a response to the RFI. Members wishing to offer thoughts for consideration are encouraged to e-mail jnurse@aadronline.org by January 4th.

OSTP RFI On Scholarly Publications

Purpose

In accordance with Section 103(b)(6) of the America COMPETES Reauthorization Act of 2010 (ACRA; Pub. L. 111-358), this Request for Information (RFI) offers the opportunity for interested individuals and organizations to provide recommendations on approaches for ensuring long-term stewardship and broad public access to the peer-reviewed scholarly publications that result from federally funded scientific research. The public input provided through this Notice will inform deliberations of the National Science and Technology Council’s Task Force on Public Access to Scholarly Publications.

NCATS Leadership Announced

**Updated 12/23** Additional Details on NCATS

Moments after the passage of the FY12 omnibus appropriations bill on Saturday, NIH Director Francis Collins made the following announcement to staff:

“…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.”

FY12 Budget Finalized, NIH Up Slightly and NCATS OK’d

In a demonstration of “better late than never,” the House and Senate joined late last week to approve Fiscal Year 2012 spending for the nine appropriations bills that remained. The end of the FY12 appropriations process came roughly 11 weeks late, as the fiscal year began on October 1st. However, some are commending Congress for passage of all of its spending bills in mid-December, since in recent years the annual appropriations process lasted several months -well into the next calendar year. President Obama is expected to sign the package into law by December 23rd -when temporary spending expires.

Provisions of Note in Final FY12 “Omnibus/Megabus” Spending Bill:

[*Note: The Labor-HHS-Education section of the omnibus FY12 spending bill contains a 0.189% across-the-board (ATB) reduction]

National Institutes of Health– Provided $30.7 billion or $299 million (approximately 1%) above FY11. [$30.6 billion after ATB reduction]

NIH is strongly urged to ensure its policies continue to support a robust extramural community and make certain sufficient research resources are available to the more than 300,000 NIH-supported scientists at over 3,100 institutions across the country. The conferees affirm the critical importance of new and competing research project grants (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. The conferees expect NIH to evaluate its new grant-estimating methodology to improve its accuracy and support as many scientifically meritorious new and competing RPGs as possible, at a reasonable award level, with the funding provided in this Act.

In recent years, extramural research has accounted for nearly 90 percent of NIH’s budget. The conferees strongly urge NIH to maintain at least that level in fiscal year 2012. NIH should also establish safeguards to ensure the percentage of funds used to support basic research across NIH is maintained.

National Institute of Dental and Craniofacial Research- $411.5 million or $1.9 million (0.46%) above FY11. [$410.7 million after ATB reduction]

National Center for Advancing Translational Sciences (NCATS)- $576.5 million. [$575.4 million after ATB reduction]

The conference agreement includes language to eliminate the National Center for Research Resources (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).

Lessons learned with NCATS should guide NIH as it considers another proposed restructuring, one that would involve consolidating NIDA, NIAAA and components of other Institutes and Centers (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.

Centers for Disease Control and Prevention, Oral Health- $14.7 million or $276,000 (1.8%) less than FY11. [$14.67 million after ATB reduction]

The conferees are pleased to learn that CDC has decided to retain the Division of Oral Health. This action is supported by a recent Institute of Medicine (IOM) report titled “Advancing Oral Health in America” that recommends oral health be given a high priority within HHS. This decision will allow CDC to focus on the prevention and elimination of oral disease, support state oral health infrastructure programs, and improve the coordination of oral health activities with other chronic disease prevention activities.

Agency for Healthcare Research and Quality- $369 million or $3 million (0.8%) below FY11. [$368 million after ATB reduction]

Human Subjects Protection Report Out

After news reports that the U.S. government supported research from 1946-48 that exposed human subjects in Guatemala to sexually transmitted diseases, President Obama ordered the Presidential Commission for the Study of Bioethics to complete an assessment of research standards. The Commission has completed its work and a report is now available that finds that in general current regulations are sufficient to protect human subjects in research, and notably that the harm to human subjects experienced decades ago in Guatemala could not happen today. However, the Commission also found that many federal agencies that conduct research involving human subjects lack sufficient tracking mechanisms; “In assessing the current regulations that protect human subjects, the Commission learned that there is no central source with information about the overall size, scope, and cost of the government’s research involving human subjects.” Several other findings and recommendations are contained in the report.

Summary and Full Report

NIH Slated for 1% FY12 Increase, But Not Really

Late last night, the House of Representatives filed its Fiscal Year 2012 omnibus appropriations bill -as worked out in a conference committee with members of the Senate. The bill indicates that the two chambers have agreed to fund the National Institutes of Health at $30.7 billion, an increase of $299 million or roughly 1% above FY11. The bill conveys the assumption that NIH would fund the same number of meritorious grants as last year.

The 1% increase for NIH is more than negated by two across-the-board cuts proposed by the House. The first is a 0.189% cut to the components of the Labor-HHS-Education bill -which funds NIH. The second is a 1.83% cut to all appropriations bills in order to provide disaster assistance.

House Summary

The House release of the funding bill is likely to be viewed as an attempt to force the hand of Senate Majority Leader Harry Reid (D-NV) and President Obama, as both have indicated that the FY12 omnibus bill must wait until an agreement on a tax relief bill is reached. If the Senate and White House hold firm, and a temporary spending measure is not passed in the next day, a government shutdown would become a reality.

Following the House budget release, the White House issued a statement calling on Congress to pass another short-term continuing resolution in order to avoid a government shutdown.

White House Statement

Additional details on other budget lines of interest will be made available when the House and Senate formally agree on the spending bill.

The Clock Ticks on FY12 Budget and Taxes

This Friday, December 16th, temporary funding for federal government operations will expire. It’s a similar situation to that which has played out repeatedly this year. Spending decisions are now agreed to in the final minutes before the government is forced to close its doors and turn off its lights.

Since Fiscal Year 2012 officially began back on October 1st, Congress has passed a series of temporary funding measures known as continuing resolutions (CRs) in order to buy itself more time to agree on permanent spending levels for federal agencies and programs. With the current CR expiring on Friday and the winter holidays quickly approaching, Congress has moved permanent FY12 spending decisions to the final stages. The unfinished bills, including the one that funds NIH, have been packaged together into a single bill that has been referred to as a “megabus,” and “omnibus.” However, it appears that the bus is not quite ready to leave the station.

Senate Majority Leader Harry Reid (D-NV) has indicated that he will not allow the final FY12 spending bill to come to a vote without a decision on expiring tax reductions for the middle-class, and unless controversial policy provisions are left out of the package. With just two days left, we may see another temporary extension or what has been somewhat uncommon this year -compromise leading to a final product.

In related news, the National Journal is reporting that Senator Tom Harkin (D-IA)  — who chairs the subcommittee that largely determines NIH funding — has indicated that NIH will see a small budget increase this year. If the comment proves accurate, NIH and the National Science Foundation would have weathered the ongoing budget storm to eek out inflationary increases. Much more advocacy will be necessary in the coming year, but it is clear that the efforts of the health and research communities have contributed to sustained federal investments in science.

FY12 Appropriations in Sight

The House and Senate are apparently nearing the end of the FY12 appropriations process. This week, selected Members (known as conferees) of both chambers continue to meet to finalize spending levels for the current fiscal year. Nine spending bills, including the Labor-HHS-Education bill that funds NIH, remain undone. Once an agreement is developed by the conferees, the legislation returns back to each chamber for a final vote. Details on FY12 spending levels are likely to surface any day now. Stay tuned for details on research funding in the legislation and what will likely be the final opportunity for advocacy this year.