Author: Roger Wood

In a memorandum issued on Tuesday, March 20, 2012, OMB directed Federal agencies to consider the cumulative effects of new regulatory requirments and take active steps to avoid them. Sunstein calls on agencies to follow several steps to identify cumulative effects and reduce redundant, overlapping and inconsisten requirements. Among the steps suggested are:

• Early consultation, advance notice, and close engagement with affected stakeholders.
• Use of Requests for Information and Advance Notices of Proposed Rulemaking to gather public input.
• Identification of opportunities to increase the net benefits of regulations and to reduce administrative and other costs, while meeting policy goals and legal requirements.
• Careful consideraion, in the analysis of costs and benefits, of the relationship between new regulations and regulations that are already in effect.

“Where appropriate and feasible, agencies should consider cumulative effects and opportunities for regulatory harmonization as part of their analysis of particular rules, and should carefully assess the appropriate content and timing of rules in light of those effects and opportunities.” Agencies should avoid unintentional burdens that could result from exclusive focus on the most recent regulatory activites and should “select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits.”

The large number of Requests for Information and Advance Notices from NIH, NSF and other agencies heavily vested in funding research is clearly consistent with these guidelines from OMB.

Registration is open for the 2012 NIH Regional Seminars. Roger Wood, InfoEd Global Sr. Product Manager will be in Indianapolis and Washington, DC for these meetings. If you would like to learn more about InfoEd Global’s Grants and Contracts solutions during one of these meetings, please contact support@infoedglobal.com.

2012 NIH Regional Seminars
April 16-18 Indianapolis, Indiana
June 20-22 Washington, DC

The NIH Regional Seminar involves approximately 35 NIH and HHS staff who are brought to a central location in order to educate, share, and listen to attendees over the course of two days. This seminar is your opportunity to make direct contact with NIH policy officials, grants management, program and review staff, eRA Commons experts, as well as representatives from the Office for Human Research Protections (OHRP), and Office of Research Integrity (ORI). In addition, take advantage of networking opportunities to learn from fellow attendees from around the world.

The seminar and optional eRA workshops are appropriate for grants administrators, new and early stage investigators, researchers, graduate students, and anyone interested in the grants administration process. This year we are offering more networking opportunities than ever before…additional Institute/Center representation with one-on-one meeting opportunities and inclusion of sessions on NIH niche programs such as the AREA/R15 program.

The Office of Management and Budget and Office of Science and Technology Policy issued a policy memorandum to the heads of executive departments and agencies on April 21, 2010, establishing the uniform RPPR for use by agencies supporting research and research-related activities.  The uniform RPPR will replace other interim performance reporting formats used by agencies.

The RPPR was developed by the Research Business Models (RBM) Subcommittee of the Committee on Science, National Science and Technology Council.  The RBM published the proposed draft RPPR format for public comment in the Federal Register November 9, 2007, and the final format on January 13, 2010.  Additional information about this process and the RPPR Final Format are available on the federal-wide RPPR website hosted by the National Science Foundation.

The RPPR will replace:
PHS Non-competing Continuation Progress Report (PHS 2590)
eSNAP module in the eRA Commons
NIH and AHRQ Ruth L. Kirschstein National Research Service Award Individual Fellowship Progress Report for Continuation Support (PHS 416-9)

Pilot testing of the RPPR for NIH awards will begin in late April 2012 with a limited number of institutions, and will include most awards not requiring submission of an annual detailed budget.  NIH anticipates expanding this pilot to all Federal Demonstration Partnership institutions during the summer of 2012.  Full implementation for fellowships and all awards issued under the Streamlined Non-competing Award Process (SNAP) is scheduled for awards made in Calendar Year 2013.  Implementation for complex mechanisms and non-SNAP awards has not been determined and further guidance will be provided at a later date.

NIH will implement the RPPR as a new module in the eRA Commons.  NIH implementation also includes the following PHS agencies that use existing progress reports maintained by NIH:  
Food and Drug Administration (FDA)
Agency for Healthcare Research and Quality (AHRQ)
Centers for Disease Control and Prevention (CDC)

System-to-system submission of the RPPR is anticipated as a future option, however it will not be an option initially. No specific timeframe has been established for S2S submission availability. 

Information and training materials will be available on the NIH RPPR website.

The US Government Accountability Office (GAO) launched a new iPhone/iPad app this week, that links to mobile versions of its reports, congressional testimony, podcasts and videos.

For research administrators who like to keep up with new GAO activity, this app may be just the thing you need. It presents reports and other information in a chronological format and also includes a nice search utility. The app does not utilize notification services to alert users to new postings.

Just when you thought you were getting a handle on National Institutes of Health’s new FCOI policy… The US National Science Foundation (NSF) is soliciting comment on their proposal to carry out a survey to better understand how NSF grantees identify, oversee, and manage financial conflicts of interest in research funded by NSF.  NSF posted the second notice of a 30 day comment period seeking input on their planned survey, specifically on  the necessity, accuracy of their burden estimate, ways to enhance  the survey’s quality , or ways to minimize the burden on respondents.

Today’s Federal Register includes the Advance Notice of Proposed Guidance from the Office of Management and Budget requesting public input on the ideas proposed to make the oversight of Federal funds more effective and efficient, Reform of Federal Policies Relating to Grants and Cooperative Agreements; Cost Principles and Administrative Requirements (Including Single Audit Act). I provided a summary of the points on which comments are solicited in a recent post.

Comments may be submitted electronically via the newly updated Regulations.gov website. You can search by Agency and use “OMB” to find the Notice.

In the US today, publishing powerhouse Elsevier changed course and withdrew its support of HR 3699, the Research Works Act, introduced by Reps. Darrell Issa (R-CA) and Carolyn Maloney (D-NY) on Dec. 16th. Elsevier said, “While we continue to oppose government mandates in this area, Elsevier is withdrawing support for the Research Work Act itself.” The Elsevier announcement did not directly refer to the more than 7,500 researchers who have signed The Cost of Knowledge boycott of Elsevier.

Hours later, Reps. Issa and Maloney issued a statement in which they announced that they will not be pursuing further legislative action on HR 3699, according to the Chronicle of Higher Education.

Both Elsevier and Reps. Issa and Maloney referenced open access journals as a bit of a wave of the future. In the UK, the government has recently jumped on the open access band wagon as well, in the Dec. 2011 publication Innovation and Research Strategy for Growth. The Wellcome Trust requires research papers funding in whole or in part with its awards to be deposited with PubMed Central and UK PubMed Central within 6 months. In Australia, the National Health and Medical Research Council (NHMRC) recently announced their support for public access to the results of NHMRC-funded research.

Publication policies of an array of government and foundation funders with respect to open access is documented in Sherpa Juliet, maintained by the SHERPA Partnership, based at the University of Nottingham.

Early next week, OMB is expected to publish an Advance Notice of Proposed Guidance in the Federal Register to solicit public comment on several ideas focused on increasing the effectiveness and efficiency of Federal programs by eliminating unnecessary and duplicative requirements, and strengthen oversight of Federal grant dollars. The document is available for review now here.

In the document, a number of ideas for reform are put forth for consideration. T Broadly, three areas are considered in this Notice: reforms to audit requirements, cost principles, and administrative requirements, which could ultimately result in wide ranging reforms affecting OMB Circulars A-21, A-87, A-110, and A-122 (which have been placed in 2 C.F.R. Parts 220, 225, 215, and 230); Circulars A-89, A-102, and A-133; the guidance in Circular A-50 on Single Audit Act follow-up; and the Cost Principles for Hospitals at 45 C.F.R. Part 74, Appendix E. Based on feedback to this Notice, OMB will propose formal adjustments as to some or all of those documents in coming months.

The specific ideas proposed include:

Audit Reforms

• Raising the threshold for requiring a Single Audit from $500,000 to $1 million in Federal awards.
• Reducing the scope of Single Audit requirements for entities with Federal awards between $1 million and $3 million
• Full Single Audit would still be required for entities with over $3 million in Federal awards, however modifications are considered that would: (1) streamline requirements to focus on stewardship of Federal funds specifically focusing on improper payments, waste, fraud, abuse, and program performance; (2) strengthen guidance to Federal agencies on audit followup; (3) reduce burden on pass-through entities and subrecipients through cross-agency coordination and having audit followup by agencies directly with subrecipients who receive most of their Federal funds as direct awards except in cases where the issues were with program delivery.

Cost Principle Reforms

• Consolidate cost principles for all recipient types into a single document, still allowing for variation by entity type where appropriate.
• Move to flat rates in lieu of negotiated rates for indirect costs. Two options are described for implementing this: establish a mandatory flat rate lower than the recipient’s in place negotiated rate, or allow institutions to choose between a flat rate and a negotiated rate. The goal is to reduce Federal indirect cost commitments and reduce the burden on entities for documenting their indirect costs for a negotiation process.
• Explore alternatives to time-and-effort reporting, including consideration of the project certification pilot currently in process with the Federal Demonstration Partnership, other ongoing pilots, or through new pilots to explore alternative methods to adequately document the allowability and allocability of salaries and wages charged to Federal awards.
• Extending the Utility Cost Adjustment to other institutions to make access to this option more equitable. This would likely come with a requirement for recipients to develop a plan to reduce utility costs over time for the adjustment to be approved.
• Allow directly allocable administrative support costs to be charged to direct costs on awards. This would include such costs as project-specific activities such as managing substances/chemicals, data and image management, complex project management, and security.
• Allow certain computing devices to be direct-charged to awards. This would allow computer equipment below the institution’s equipment threshold to be direct-charged to awards rather than managed as indirect costs.
• Harmonizing cost principles to clarify that $5,000 is the threshold for an allowable maximum inventory of unused supplies that may be retained for use on other Federal awards at no cost.
• Eliminate requirement for conducting studies of cost reasonableness for large research facilities.
• Eliminate restrictions on use of indirect costs recovered for depreciation or use allowances.
• Eliminate lease-purchase analyses to justify interest costs prior to relocating federally  sponsored research programs from a debt-financed facility.
• Eliminate specific requirements for printed ‘help wanted’ advertising to reflect appropriate alternative media in use today.
• Allow for budgeting of contingency funds for certain awards.
• Request that the Cost Accounting Standards Board increase the minimum threshold to file a disclosure statement of cost accounting standards from $25 million to $50 million.
• Allow for excess capacity in anticipation of increased usage for certain facilities such as data centers.
• Allow costs for efforts to collect improper payment recoveries.
• Specify that gains and/or losses due to speculative financing arrangements are unallowable.
• Provide non-profit organizations with an example of the Certificate of Indirect Costs similar to that provided for state, local, and tribal governments.
• Provide non-profit organizations with an example of indirect cost proposal documentation requirements similar to that provided for state, local, and tribal governments.

Administrative Requirements Reforms

• Create a uniform set of administrative requirements for all grant recipients through consolidating the requirements in OMB Circulars A-102 and A110.
• Require agency consideration of each applicant’s financial risk in addition to the merit of the proposal prior to making an award. Agencies would be required to consider factors such as: financial stability, quality of management and internal control systems, history of performance, Federal award Single Audit reports and findings for previous awards, and other factors that might affect the applicant’s ability to comply with statutory, regulatory, or other requirements imposed on recipients.
• Require agencies to provide 90-day notice of funding opportunities to ensure applicants have sufficient time to prepare applications.
• Establish a standard format for funding opportunity announcements.
• Reiterate that information collection actives are subject to the Paperwork Reduction Act.

Specifically, OMB seeks responses to a list of provided questions derived from the ideas outlined above, although they welcome suggestion of additional ideas from the community as well. Comments will be accepted for 30 days after the Notice is published in the Federal Register.

The National Institutes of Health (NIH) awarded a construction grant to Boston University Medical Campus to partly fund the design and construction of one of two National Biocontainment Laboratories. These advanced biomedical research laboratories are essential to the civilian biodefense initiative, providing critically needed Biosafety Levels 2, 3 and 4 research space. The basic and translational research to be conducted in these laboratories over the next 20 years would result in development of new rapid diagnostic assays, vaccines and therapeutics for protection of the American public against intentional misuse or release of harmful biological agents or toxins and naturally emerging and re-emerging infectious diseases.

Today, NIH published the Draft Supplementary Risk Assessment for the National Emerging Infectious Diseases Laboratory under contraction at the BioSquare Research Park, Boston. Comments on the Draft Supplementary Risk Assessment must be postmarked no later then May 1, 2012. A public hearing to solicit public input will be held on April 19, 2012. Copies of the Draft Supplementary Risk Assessment and a companion reader’s guide document is available here: http://nihblueribbonpanel-bumc-neidl.od.nih.gov/default.asp

In the US and many other nations, programmatic overlap of awards is generally to be avoided. This is clearly articulated by the NIH in their Grants Policy Statement description of Other Support associated with their Just-in-Time procedures. It is perfectly fine to submit funding applications to multiple sponsors for the same body of work, however, it is important to recognize that if your wildest dreams come true and multiple funders want to offer awards – you can only accept one of them. While it is tempting to submit the same body of work to multiple funders to get around the problem that the work to be done will cost more that is practical to ask for from a single sponsor, that needs to be done by figuring out how to divide the work into smaller definable components and then seeking support for discrete portions of the work from each sponsor. 

Craig Grimes, who was a professor of electrical engineering at Pennsylvania State University until 2010, pleaded guilty to fraud charges stemming from accepting grants from the Department of Energy and the National Science Foundation to fund the same research. Additional details of this case were published in Nature on Februay 7, 2012. apparently, the charges again him also include misappropriation of NIH funds. Other similar cases related to scientific overlap have also generated penalties. Predictably, Congress is getting in on the action; the House held a hearing on Jan 24th in which representatives questioned whether agencies were sufficiently evaluating applications for potential overlap prior to making awards. 

This is the kind of thing that could easily work its way into agency OIG work plans in future years and result in additional requirements beyond the current expectation that investigators disclose any overlaps and that institutions do not accept multiple awards for the same body of work.