+---+---------+---------------------------------------------------------+
|   | **COMM  | **EXCERPTS of COMMENT**                                 |
|   | ENTER** |                                                         |
+===+=========+=========================================================+
| * |         |                                                         |
| * |         |                                                         |
| G |         |                                                         |
| E |         |                                                         |
| N |         |                                                         |
| E |         |                                                         |
| R |         |                                                         |
| A |         |                                                         |
| L |         |                                                         |
| C |         |                                                         |
| O |         |                                                         |
| M |         |                                                         |
| M |         |                                                         |
| E |         |                                                         |
| N |         |                                                         |
| T |         |                                                         |
| S |         |                                                         |
| O |         |                                                         |
| N |         |                                                         |
| O |         |                                                         |
| V |         |                                                         |
| E |         |                                                         |
| R |         |                                                         |
| V |         |                                                         |
| I |         |                                                         |
| E |         |                                                         |
| W |         |                                                         |
| I |         |                                                         |
| N |         |                                                         |
| F |         |                                                         |
| O |         |                                                         |
| R |         |                                                         |
| M |         |                                                         |
| A |         |                                                         |
| T |         |                                                         |
| I |         |                                                         |
| O |         |                                                         |
| N |         |                                                         |
| A |         |                                                         |
| N |         |                                                         |
| D |         |                                                         |
| F |         |                                                         |
| U |         |                                                         |
| L |         |                                                         |
| L |         |                                                         |
| A |         |                                                         |
| N |         |                                                         |
| N |         |                                                         |
| O |         |                                                         |
| U |         |                                                         |
| N |         |                                                         |
| C |         |                                                         |
| E |         |                                                         |
| M |         |                                                         |
| E |         |                                                         |
| N |         |                                                         |
| T |         |                                                         |
| * |         |                                                         |
| * |         |                                                         |
+---+---------+---------------------------------------------------------+
|   |         |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Assn. | AIRI institutions are distinct from other organizations |
|   | of      | involved in research, such as universities, hospitals,  |
|   | Inde    | and for-profit laboratories, in their organization,     |
|   | pendent | mission, and size.  Their flexibility provides an       |
|   | Res.    | environment that is particularly conducive to           |
|   | Insti   | creativity and innovation in research.                  |
|   | tutes** |                                                         |
|   |         | AIRI believes it is vitally important to keep in mind   |
|   |         | some important principles regarding this Nation's       |
|   |         | research enterprise.  Any policy changes that could     |
|   |         | affect the output of the research enterprise must be    |
|   |         | carefully considered so as to not have unintended       |
|   |         | adverse consequences on the productivity and diversity  |
|   |         | of the Nation's research enterprise.                    |
+---+---------+---------------------------------------------------------+
|   | *       | As with any partnership, stability, transparency, and a |
|   | *Assoc. | reasonable level of predictability in expectations and  |
|   | of      | behaviors are necessary for success. Progressive,       |
|   | Amer.   | incremental changes in grants policy, regulations, and  |
|   | Medical | other federal actions have increasingly moved the       |
|   | Col     | federal-academic partnership away from an "investment   |
|   | leges** | model" and closer to a "procurement model" of           |
|   |         | government funding for science that, while perhaps more |
|   |         | comforting to and protective of some federal            |
|   |         | administrators and auditors, nevertheless threatened to |
|   |         | impede scientific creativity and productivity and       |
|   |         | ultimately diminish the long-term financial stability   |
|   |         | of academic research institutions.3 We called for a     |
|   |         | reaffirmation of the fundamental principles and         |
|   |         | assumptions underlying the federal sponsorship of       |
|   |         | university research, stabilizing the terms of the       |
|   |         | partnership, and strengthening mechanisms for collegial |
|   |         | consultation and dialogue.                              |
|   |         |                                                         |
|   |         | The AAMC continues to have concerns that a mostly       |
|   |         | piecemeal accumulation of directives, restrictions,     |
|   |         | mandates, and alterations in policy and budgeting       |
|   |         | seriously threaten the partnership. These actions are   |
|   |         | typically taken unilaterally within agencies, and       |
|   |         | seemingly without due regard for the sustainability of  |
|   |         | scientific institutions or the federal-academic         |
|   |         | partnership itself, core values that lie at the heart   |
|   |         | of the cost-reimbursement model for academic research.  |
|   |         |                                                         |
|   |         | Seek models that correctly identify the real "products" |
|   |         | of academic research (e.g., new knowledge, a cadre of   |
|   |         | trained personnel), the requirements and challenges of  |
|   |         | this research (e.g., adequate facilities,               |
|   |         | instrumentation, and cross-disciplinary support), and   |
|   |         | above all that "strive to return to a costing and       |
|   |         | regulatory system that is equitable, effective and that |
|   |         | appropriately reflects the diversity and needs of the   |
|   |         | individual research providers."5 *The AAMC strongly     |
|   |         | supports COGR's view of the NSTC subcommittee's request |
|   |         | for comments as an initial invitation to participate in |
|   |         | a constructive and ongoing dialogue, and with this      |
|   |         | expectation, we focus here on an initial, exemplary,    |
|   |         | but by no means exhaustive, enumeration of issues and   |
|   |         | potential data sources:*                                |
+---+---------+---------------------------------------------------------+
|   | *       | We share your goal of improving the performance and     |
|   | *Assoc. | management of federally-sponsored research. Indeed, AAU |
|   | of      | research universities value the long-standing           |
|   | Amer.   | partnership between research universities and the       |
|   | Univ.   | federal government.                                     |
|   | (AAU),  |                                                         |
|   | S       |                                                         |
|   | ubcomm. |                                                         |
|   | on      |                                                         |
|   | A-21**  |                                                         |
+---+---------+---------------------------------------------------------+
|   | **C     | \(1\) **Basic Research Remains Critical to the          |
|   | olumbia | Long-Range Scientific Enterprise** Agencies target      |
|   | Univ.** | different kinds of research, ranging from NSF\'s focus  |
|   |         | on basic research to much more applied research at      |
|   |         | DARPA. While the benefits of applied research often are |
|   |         | more immediately apparent, we cannot forget that it is  |
|   |         | basic research that provides the new knowledge on which |
|   |         | applied research and development must build. (2)        |
|   |         | **Limits on Cost Recovery Threaten the Research         |
|   |         | Enterprise** - In 1991,                                 |
|   |         |                                                         |
|   |         | the Office of Management and Budget placed a cap on the |
|   |         | administrative costs for which universities can be      |
|   |         | reimbursed. Unfortunately the government has not        |
|   |         | stopped adding regulatory burdens that add to these     |
|   |         | costs - making it harder for universities to meet the   |
|   |         | costs of conducting high-quality research.              |
+---+---------+---------------------------------------------------------+
|   | **      | The term "business model", although prevalent in        |
|   | Council | commercial enterprises, could be misleading in the      |
|   | on      | context of federally funded, not-for-profit academic    |
|   | Govt.   | research. This new discussion must remain framed by the |
|   | Re      | recognition that the unique "products" of universities  |
|   | lations | are new knowledge, trained students and research        |
|   | (       | investigators.                                          |
|   | COGR)** |                                                         |
|   |         | Even though at times the parties may have different     |
|   |         | short-term interests, it is important to maintain the   |
|   |         | vibrancy and the ability of universities to be research |
|   |         | performers. Changes to "business models" should         |
|   |         | carefully weigh potential consequences.                 |
|   |         |                                                         |
|   |         | A look at the government's role in this business        |
|   |         | relationship, might suggest that a sound business model |
|   |         | would require that the federal agencies become more     |
|   |         | willing to manage their R&D as a portfolio of           |
|   |         | interconnected activities to optimize scientific        |
|   |         | discovery. As projects grow larger and reach across     |
|   |         | disciplinary boundaries, interagency coordination       |
|   |         | becomes more urgent and should be part of the           |
|   |         | discussion. We note that, looking ahead to FY 2005, the |
|   |         | Science Advisor has supported this concept in his       |
|   |         | message to agencies.                                    |
|   |         |                                                         |
|   |         | A good business model also needs to include a fair      |
|   |         | assessment of instrumentation and facilities needs.     |
|   |         | Over the past decades, the universities have witnessed  |
|   |         | a painful decrease in federal programs to support these |
|   |         | needs. The consequences of such developments and        |
|   |         | potential remedies should be on your agenda.            |
|   |         |                                                         |
|   |         | Most importantly, a good business model cannot tolerate |
|   |         | a hybrid of conflicting goals. The government appears   |
|   |         | to follow different, conflicting models in funding      |
|   |         | university research. In a model based on cost           |
|   |         | reimbursement principles, the key question becomes what |
|   |         | the country can afford to fund to assure the best       |
|   |         | science is supported. By contrast, models based on      |
|   |         | straight procurement principles seek to buy more        |
|   |         | products at the lowest bid. We believe that many of the |
|   |         | recent disagreements between universities and federal   |
|   |         | agencies about cost reimbursement stem from a blurring  |
|   |         | of the distinctions between these different models for  |
|   |         | government support of university research. We believe   |
|   |         | that both parties must strive to return to a costing    |
|   |         | and regulatory system that is equitable, consistent,    |
|   |         | effective, and that appropriately reflects the          |
|   |         | diversity and the needs of the individual research      |
|   |         | providers.                                              |
|   |         |                                                         |
|   |         | With regard to the government-university business       |
|   |         | relationship, the two central considerations for        |
|   |         | universities are *cost*s, including how they are        |
|   |         | charged and compensated, - and *administrative          |
|   |         | regulations*, including how they are imposed and        |
|   |         | complied with. For most university research, the        |
|   |         | current regulatory models for costs and administrative  |
|   |         | compliance are based on the respective OMB Circulars.   |
|   |         | In their original form they reflected much discussion   |
|   |         | with the university community, were well designed,      |
|   |         | capable of providing adequate accountability and        |
|   |         | demonstrating responsible use of public funds. As such, |
|   |         | they could continue to be a solid basis for the         |
|   |         | interaction between universities and the federal        |
|   |         | government. However, lack of uniform implementation by  |
|   |         | federal agencies and several seemingly arbitrary        |
|   |         | changes made by the government call for review of       |
|   |         | Circulars A-21 and A-110.                               |
|   |         |                                                         |
|   |         | These developments in the government's implementation   |
|   |         | of the existing circulars may be a more serious source  |
|   |         | of the problems universities face today rather than the |
|   |         | inability to adjust to changes in research. In effect,  |
|   |         | the government has inappropriately shifted cost         |
|   |         | burdens, creating stresses in the academic              |
|   |         | infrastructure, both in terms of facilities as well as  |
|   |         | administrative costs. Consequently, the universities    |
|   |         | have to draw funds from a number of unrelated sources   |
|   |         | of revenue to cover these costs, which is detrimental   |
|   |         | to the overall health of universities in the long run.  |
|   |         | The government should recognize that such cost shifting |
|   |         | ultimately increases the burden on other university     |
|   |         | stakeholders.                                           |
|   |         |                                                         |
|   |         | While clarification of some definitions in OMB Circular |
|   |         | A-21 has been useful over the years, that document is   |
|   |         | now changed from its original design far beyond simply  |
|   |         | eliminating these "gray areas". A combination of        |
|   |         | changes now prevents universities from charging some    |
|   |         | costs directly, while at the same time, restricting the |
|   |         | recovery of administrative costs. The government        |
|   |         | expects universities to adhere faithfully to the cost   |
|   |         | principles, but its facilities and administrative rate  |
|   |         | negotiation process seems to reflect the government's   |
|   |         | short term financial needs rather than the long-term    |
|   |         | health of the research infrastructure. The Appendix to  |
|   |         | this letter provides comments, illustrations and data   |
|   |         | on this issue.                                          |
|   |         |                                                         |
|   |         | OMB Circular A-110 establishes principles that provide  |
|   |         | a reasonable approach to the management of research,    |
|   |         | but the circular's guidance has not been implemented    |
|   |         | uniformly by the agencies. Moreover, the agency         |
|   |         | implementing regulations have remained inconsistent in  |
|   |         | spite of experience demonstrating no increased risk     |
|   |         | from simplification of administrative requirements      |
|   |         | permitted by the circular. In an environment where      |
|   |         | available resources are limited, both partners in the   |
|   |         | research enterprise should agree to simplify procedures |
|   |         | that can save administrative costs. Such                |
|   |         | inconsistencies have expanded exponentially and have    |
|   |         | become a tremendous administrative burden, especially   |
|   |         | with the addition of unfunded mandates (e.g. HIPAA      |
|   |         | provisions and select agent rules)                      |
|   |         |                                                         |
|   |         | We agree with OSTP that research needs have changed. At |
|   |         | the same time, societal expectations on universities    |
|   |         | are growing. A reconsideration of, and improvements in, |
|   |         | the current hybrid cost and regulatory structure for    |
|   |         | the business relationship between the government and    |
|   |         | universities in research is essential. COGR has         |
|   |         | longstanding concerns about some of the areas singled   |
|   |         | out in the notice. We believe that significant          |
|   |         | improvements are needed in the federal management of    |
|   |         | the business relationship between federal agencies and  |
|   |         | university research performers.                         |
+---+---------+---------------------------------------------------------+
|   | **      | Research universities are unique as recipients of       |
|   | Federal | funding from the federal government. Not only does      |
|   | Demons  | research done at universities push the frontiers of     |
|   | tration | knowledge, it also provides training and education to   |
|   | Project | the next generation of researchers, whether they remain |
|   | (FDP)** | at universities or move into the private sector. OMB    |
|   |         | A-21, when originally drafted, recognized this duality  |
|   |         | of research and instruction and helped solidify this    |
|   |         | duality as a strength of the higher education research  |
|   |         | enterprise. This supports the contention that research  |
|   |         | at institutions of higher education is not a "business" |
|   |         | as suggested in the request for comment. Most           |
|   |         | universities do not see the research undertaken by our  |
|   |         | faculty, researchers, and students as a "business" in   |
|   |         | the classic, corporate sense. As important as the       |
|   |         | enterprise is, and as critical as funding to the        |
|   |         | nation's universities is, one cannot see the            |
|   |         | partnership *first* as a business. Nonetheless,         |
|   |         | universities recognize that efficiency, streamlining,   |
|   |         | and considering new and more effective ways to carry    |
|   |         | out the enterprise is of value to both parties.         |
|   |         |                                                         |
|   |         | In looking at the relationship between the parties, two |
|   |         | specific areas are of particular concern to             |
|   |         | universities: (i) the increasing regulatory             |
|   |         | requirements that are being imposed on the higher       |
|   |         | education community without regard to the collective    |
|   |         | burden that this places on the institutions, and (ii)   |
|   |         | the costs associated with these increased requirements. |
|   |         | Specifically, we are concerned about                    |
|   |         |                                                         |
|   |         | -   the problem of unfunded mandates (for many          |
|   |         |     institutions the 26% cap on the "A" part of "F&A"   |
|   |         |     is extremely burdensome. This cap hasn't been       |
|   |         |     changed in a decade, but costs have spiraled during |
|   |         |     that time)                                          |
|   |         |                                                         |
|   |         | -   the shifting of direct costs from the federal       |
|   |         |     government to the university recipients of awards   |
|   |         |     (cost sharing; addressed in specific comments)      |
|   |         |                                                         |
|   |         | -   the increasing cost of multi- and interdisciplinary |
|   |         |     research (addressed in specific comments)           |
+---+---------+---------------------------------------------------------+
|   | **Fred  | Dr. Grinnell submitted the first chapter ("Practicing   |
|   | Gri     | Science") of the book, *Everyday Practice of Science*,  |
|   | nnell** | he is currently writing. The chapter places the         |
|   |         | individual researcher at the center of the practice of  |
|   | UT-S.W. | science and seeks to differentiate between              |
|   | Med Ctr | classifications of research (e.g., basic or applied)    |
|   |         | from the process of conducting research. Issues related |
|   |         | to the Federal Register notice include the role of      |
|   |         | ambiguity in the everyday practice of research, the     |
|   |         | enhancement of scientific exploration arising from a    |
|   |         | diversity of researchers, and thee fact that science    |
|   |         | policy affects every aspect of research. On this final  |
|   |         | note, substitution of a linear model of science by      |
|   |         | science policy makers for the everyday practice of      |
|   |         | science can undermine and distort research.             |
+---+---------+---------------------------------------------------------+
|   | **      | Effective mechanisms for managing such research have    |
|   | Harvard | been well developed in connection with NSF Materials    |
|   | Unive   | Research Science and Engineering Centers and Centers of |
|   | rsity** | Excellence, and with user facilities at National        |
|   |         | Laboratories. It is the mix that is changing, and       |
|   |         | overarching policies and procedures must be flexible    |
|   |         | enough to accommodate and deal appropriately with       |
|   |         | diverse ingredients.                                    |
|   |         |                                                         |
|   |         | Three manifestations of the change in the research      |
|   |         | enterprise in the last several years are identified in  |
|   |         | the request for information -- items F, G, and H -- an  |
|   |         | increased reliance on multidisciplinary/collaborative   |
|   |         | research, on research infrastructure, and on            |
|   |         | information technology. On the one hand, they tend to   |
|   |         | add to the difficulties posed by inconsistent policies  |
|   |         | and regulations. On the other hand, they lend           |
|   |         | themselves to funding mechanisms that can encourage     |
|   |         | interaction, promote innovation, and assure             |
|   |         | accountability more efficiently than some of the        |
|   |         | long-standing mechanisms for supporting and assessing   |
|   |         | single investigators.                                   |
|   |         |                                                         |
|   |         | It is important to recognize that                       |
|   |         | collaborative/multidisciplinary research, and research  |
|   |         | that relies heavily on infrastructure and on            |
|   |         | information technology is not new. Effective mechanisms |
|   |         | for managing such research have been well developed in  |
|   |         | connection with NSF Materials Research Science and      |
|   |         | Engineering Centers and Centers of Excellence, and with |
|   |         | user facilities at National Laboratories. It is the mix |
|   |         | that is changing, and overarching policies and          |
|   |         | procedures must be flexible enough to accommodate and   |
|   |         | deal appropriately with diverse ingredients.            |
+---+---------+---------------------------------------------------------+
|   | **Inde  | The NSTC subcommittee is surely concerned with          |
|   | pendent | increasing the innovativeness, interdisciplinarity and  |
|   | College | strength of the U.S. scientific and technological       |
|   | Office  | enterprise. One way to do this is to simplify the       |
|   | &       | business model that is used on the Federal side of the  |
|   | Project | government/academic partnership. Another way to foster  |
|   | Kaleido | innovation over the long-term is to recognize that one  |
|   | scope** | size does not fit all. Federal programs must be         |
|   |         | thoughtfully designed to encourage desired outcomes in  |
|   |         | a variety of ways. These must be appropriate to         |
|   |         | different kinds of institutions that fulfill somewhat   |
|   |         | different, but complementary, functions critical for    |
|   |         | the national welfare. Therefore, we offer the following |
|   |         | insights.                                               |
|   |         |                                                         |
|   |         | -   *Continue to explore innovative business models,    |
|   |         |     considering the impact on a wider range of          |
|   |         |     institutions.*                                      |
|   |         |                                                         |
|   |         |     A federal demonstration project (FDP) has been      |
|   |         |     established to work with research universities to   |
|   |         |     examine, streamline, and reduce the burdens of      |
|   |         |     grant administration. To the degree that this       |
|   |         |     activity has been found to be useful in simplifying |
|   |         |     compliance and accountability in such universities, |
|   |         |     could this model be adapted to provide similar      |
|   |         |     services to colleges with a lesser level of         |
|   |         |     involvement with Federal awards? The key, as with   |
|   |         |     the current FDP, would be to respect both the       |
|   |         |     demand for accountability and the stewardship       |
|   |         |     required for the prudent use of taxpayer dollars    |
|   |         |     and the substantial policies already in place to    |
|   |         |     ensure fiscal responsibility of academic officers   |
|   |         |     and faculty.                                        |
|   |         |                                                         |
|   |         | -   *Consider other steps to promote innovation, by     |
|   |         |     tailoring programs to take advantage of the unique  |
|   |         |     potential contributions of institutions of          |
|   |         |     different size and mission.*                        |
|   |         |                                                         |
|   |         |     It is widely understood that the future of great    |
|   |         |     innovations in science and technology in our        |
|   |         |     country is closely related to the development of    |
|   |         |     interdisciplinary communities of scientists and     |
|   |         |     engineers. In many respects the liberal arts        |
|   |         |     colleges model this kind of community now. Their    |
|   |         |     goal is to foster the community of scientific       |
|   |         |     professionals in much the same manner that the      |
|   |         |     Federally-funded, interdisciplinary Centers at      |
|   |         |     larger institutions are designed to establish.      |
|   |         |     Grants to individual colleges to build sustainable  |
|   |         |     interdisciplinary science/technology                |
|   |         |     research/learning centers, consonant with their     |
|   |         |     size and mission, should be explored. As the source |
|   |         |     of 20% of the nation's graduate students,           |
|   |         |     strengthening the capacity of these institutions to |
|   |         |     produce graduate students prepared to operate in    |
|   |         |     such interdisciplinary collaborations could         |
|   |         |     significantly improve graduate education and        |
|   |         |     advance the building of an innovative,              |
|   |         |     interdisciplinary 21^st^ century community of       |
|   |         |     scientific and technological professionals in our   |
|   |         |     country.                                            |
|   |         |                                                         |
|   |         | -   *Foster innovation by targeting programs to faculty |
|   |         |     at different career stages, at different types of   |
|   |         |     institutions.*                                      |
|   |         |                                                         |
|   |         |     At many liberal arts institutions, nearly 50% of    |
|   |         |     the STEM faculty are recent hires, replacing        |
|   |         |     retiring colleagues whose careers were enhanced by  |
|   |         |     post-Sputnik investments this nation made in its    |
|   |         |     scientific infrastructure-- investments that have   |
|   |         |     realized a remarkable return. Making similar,       |
|   |         |     well-thought through investments in current         |
|   |         |     faculty-- particularly those with decades of        |
|   |         |     service yet ahead of them-- will produce a similar  |
|   |         |     rate of return. A better balance of Federal awards  |
|   |         |     to junior and senior faculty needs to be explored   |
|   |         |     as we contemplate the future of the scientific and  |
|   |         |     technological enterprise in this country. Pilot,    |
|   |         |     planning and exploratory grants would address the   |
|   |         |     need for more innovation, as well as provide        |
|   |         |     important sources of support for new researchers    |
|   |         |     who may well be more adventurous in exploring       |
|   |         |     "out-of-the-box" interdisciplinary ideas. A more    |
|   |         |     intentional mix of faculty at different career      |
|   |         |     stages on peer review panels could also bring new   |
|   |         |     ideas to the table, as well as help integrate       |
|   |         |     early-career scholars into the larger community of  |
|   |         |     their peers.                                        |
|   |         |                                                         |
|   |         | ```{=html}                                              |
|   |         | <!-- -->                                                |
|   |         | ```                                                     |
|   |         | -   *Continue the process of gathering informative      |
|   |         |     data*.                                              |
|   |         |                                                         |
|   |         |     From anecdotal reports from these liberal arts      |
|   |         |     colleges and the other institutions involved with   |
|   |         |     Project Kaleidoscope (a national alliance working   |
|   |         |     to strengthen undergraduate STEM), it is clear that |
|   |         |     first-rate facilities are critical to the continued |
|   |         |     capacity of these institutions to prepare           |
|   |         |     significant numbers of graduate students and to     |
|   |         |     motivate all students to pursue careers in STEM     |
|   |         |     fields. In setting national priorities, precise     |
|   |         |     data must be gathered on the relationship between   |
|   |         |     the quality of the space and the capacity of the    |
|   |         |     institution to serve national needs in S&T fields.  |
|   |         |     Equally, data on faculty demographics-- current     |
|   |         |     age, expertise, etc.-- would help inform shaping of |
|   |         |     policies and programs.                              |
+---+---------+---------------------------------------------------------+
|   | **      | Here is the comment that I just sent to Dr Zehrouni,    |
|   | Jacques | Director of the NIH. To me the only question to ask is: |
|   | Benve   | \"why is it that, in spite of the billions spent, no    |
|   | niste** | major improvement in major diseases (cancer,            |
|   |         | degenerative diseases, infectious and parasitic         |
|   |         | diseases, immune disorders) has stemmed from            |
|   |         | fundamental research since a half century?\" A lot of   |
|   |         | progresses have been achieved, but only from empirical  |
|   |         | or technological advances. I believe the answer is that |
|   |         | the theoretical basis of current biology are wrong.     |
|   |         | Thus mechanisms must be found to allow non-mainstream   |
|   |         | provocative ideas to be supported. 99% of them will     |
|   |         | fail but the only hope is in the remaining 1%.          |
+---+---------+---------------------------------------------------------+
|   | **Joint | **Use of the phrase "Research Business Models"** - We   |
|   | AAU-    | are concerned about the use of the term "research       |
|   | NASULGC | business models" by the NSTC. We prefer looking at our  |
|   | L       | relationship with the federal government as a mutually  |
|   | etter** | beneficial partnership rather than a traditional        |
|   |         | business relationship. **Research and Education are     |
|   |         | Intertwined** - Federal research funding not only       |
|   |         | advances the frontiers of knowledge but also educates   |
|   |         | and trains the next generation of researchers and       |
|   |         | societal leaders. The fact that teaching and research   |
|   |         | are so inextricably linked also complicates accounting  |
|   |         | and accountability, a fact that should be recognized    |
|   |         | and carefully considered in your review. **Federal      |
|   |         | Investment in Basic Research and Core Academic          |
|   |         | Disciplines Remains Critical to the Long-Range          |
|   |         | Scientific Enterprise** - It is important to remember   |
|   |         | that non-mission- and mission-based basic research      |
|   |         | forms the foundation on which applied research and      |
|   |         | development are built. As agencies review the ways they |
|   |         | use research to accomplish their missions, the benefits |
|   |         | of investing in fundamental research need to be kept in |
|   |         | mind, lest immediate research needs crowd out research  |
|   |         | that is more likely to produce fundamental              |
|   |         | breakthroughs over time. **Limitations on Cost          |
|   |         | Recovery** -- In 1991, the Office of Management and     |
|   |         | Budget placed a cap on the administrative costs for     |
|   |         | which universities can be reimbursed. However, as noted |
|   |         | earlier, the government has not stopped adding          |
|   |         | regulatory burdens that increase these expenses, making |
|   |         | it harder for universities to meet the costs of         |
|   |         | conducting high-quality research. At the same time the  |
|   |         | universities recognize the need for compliance programs |
|   |         | that address valid societal concerns. To balance these  |
|   |         | competing demands, a new, comprehensive strategy for    |
|   |         | dealing with compliance costs is necessary.             |
+---+---------+---------------------------------------------------------+
|   | **M     |                                                         |
|   | .I.T.** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Sarah | It isn\'t a good idea to invest in R&D without          |
|   | Ma      | assessing the effectiveness and net impact of that      |
|   | rston** | investment; conceivably, the current federally funded   |
|   |         | R&D programs deliver a net negative as opposed to a net |
|   | StatSc  | positive impact. The specific areas of concerns are     |
|   | i/Degge | listed below followed by suggestions: (1) Excessive     |
|   | Group   | Overhead at the NIH. (2) Absence of Basic Performance   |
|   |         | Assessments. (3) Absence of Balance Across Disciplines  |
|   |         | in R&D Funding. (4) Disruptions of the S&E Workforce    |
|   |         | Due to Graduate Student-Postdoc Issues.                 |
+---+---------+---------------------------------------------------------+
|   | *       |                                                         |
|   | *Senior |                                                         |
|   | R       |                                                         |
|   | esearch |                                                         |
|   | Off     |                                                         |
|   | icers** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **S     | Overall, much of the feedback provided by the Stanford  |
|   | tanford | Research community echo recommendations found in the    |
|   | Unive   | Presidential Review Directive -- 4 report. While some   |
|   | rsity** | recommendations from that report have already been      |
|   |         | implemented, many remain to be fully achieved. We       |
|   |         | suggest that the PRD-4 serve as a key resource for the  |
|   |         | Subcommittee to identify those principles and action    |
|   |         | items of critical importance to the university research |
|   |         | community. We also suggest that the subcommittee take   |
|   |         | advantage of the work of the Federal Demonstration      |
|   |         | Partnership (FDP) and, in particular, the FDP           |
|   |         | Initiative to Reduce Administrative Burden (IRAB) Task  |
|   |         | Force.                                                  |
|   |         |                                                         |
|   |         | (1) **Create Articulated Principles for Research        |
|   |         |     Partnership**                                       |
|   |         |                                                         |
|   |         | While recognizing the value of a diverse funding        |
|   |         | community, we nonetheless see the lack of underlying    |
|   |         | business principles as a significant obstacle to an     |
|   |         | effective partnership. At the present time, no common   |
|   |         | underlying agreement exists among federal agencies, the |
|   |         | audit community, and the university research community  |
|   |         | defining the acceptable principles and business         |
|   |         | standards for the conduct of research.                  |
|   |         |                                                         |
|   |         | This lack of agreement results both in tremendous       |
|   |         | effort for investigators, program officers and grant    |
|   |         | and contract officials to track and enforce the myriad  |
|   |         | of requirements, and results in uncertainty on the part |
|   |         | of researchers and university administrative officials  |
|   |         | about what constitutes an appropriate level of          |
|   |         | compliance. Faculty can feel they are personally at     |
|   |         | risk as they try to decide the appropriate level of     |
|   |         | compliance, which results in their spending significant |
|   |         | time on identifying (often small) alternative fund      |
|   |         | sources to cover less routine research costs, or in     |
|   |         | moving their research portfolio to the private sector   |
|   |         | as a way to avoid perceived financial or other risk.    |
|   |         | The lack of clarity makes it profoundly difficult for   |
|   |         | an institution to accurately analyze and correct areas  |
|   |         | of deficiency, and to foster an appropriate balance     |
|   |         | between meaningful and material compliance and a        |
|   |         | responsive, flexible research enterprise.               |
|   |         |                                                         |
|   |         | To address this core issue, we recommend:               |
|   |         |                                                         |
|   |         | A.  The federal government, working in close            |
|   |         |     collaboration with the University research          |
|   |         |     community, should formalize the key underlying      |
|   |         |     principles governing the federal government/        |
|   |         |     university research partnership (e.g, in a new OMB  |
|   |         |     Circular, "A1- The Principles of Research           |
|   |         |     Partnership.) This document should leverage the     |
|   |         |     excellent work contained in the PRD-4 and its       |
|   |         |     successor clarifications to OMB A-21.               |
|   |         |                                                         |
|   |         | B.  Federal and inter-university research policies,     |
|   |         |     practices, and standards should be aligned with     |
|   |         |     these principles. New federal policies or standards |
|   |         |     should be reviewed before they are adopted to       |
|   |         |     ensure that they are in conformance with these      |
|   |         |     principles. Existing federal circulars, policies    |
|   |         |     and practices should be reviewed and adjusted       |
|   |         |     within a reasonable period of time. This effort     |
|   |         |     should leverage the work of the FDP, particularly   |
|   |         |     its "Initiative to Reduce Administrative Burden"    |
|   |         |     Task Force, COGR, and as the national research      |
|   |         |     professional organizations (NCURA, SRA, NPMA,       |
|   |         |     etc.), who are well positioned to provide           |
|   |         |     leadership in the area of development and           |
|   |         |     assessment of inter-organizational standards.       |
|   |         |                                                         |
|   |         | C.  Agency and institutional best practices, norms and  |
|   |         |     standard interpretations built on these principles  |
|   |         |     should be developed by federal agencies, university |
|   |         |     business partners, national research administration |
|   |         |     organizations (e.g., FDP, COGR, NCURA, SRA) and the |
|   |         |     audit community, and broadly disseminated.          |
+---+---------+---------------------------------------------------------+
|   | **Univ. |                                                         |
|   | of      |                                                         |
|   | Washi   |                                                         |
|   | ngton** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Many of the questions posed in OSTP's Federal Register  |
|   | versity | notice are extremely broad and not susceptible to       |
|   | of      | simple, easy answers. Even within the academic          |
|   | Calif   | community, there are a variety of viewpoints from       |
|   | ornia** | researchers in different disciplines. Recognizing that  |
|   |         | OSTP's notice was published during the summer when many |
|   |         | academic researchers were away from campus, our hope is |
|   |         | that OSTP will continue its efforts throughout the      |
|   |         | coming year to engage the research community in         |
|   |         | substantive discussion about these issues. We also hope |
|   |         | that OSTP will consider suggestions regarding improving |
|   |         | the management of the federally-funded research process |
|   |         | that have been made in recent years through related     |
|   |         | federal projects -- e.g., the Federal Demonstration     |
|   |         | Project, responses to the last Presidential Review      |
|   |         | Directive, and responses to federal grants streamlining |
|   |         | activities related to Public Law (P.L.) 106-107, the    |
|   |         | Federal Financial Assistance Management Improvement Act |
|   |         |                                                         |
|   |         | Finally, I want to echo the caution expressed by the    |
|   |         | Council on Governmental Relations (COGR) about the      |
|   |         | application of the term "business model" to the         |
|   |         | relationship between universities and federal funding   |
|   |         | agencies.                                               |
|   |         |                                                         |
|   |         | While we agree that it is useful to examine the         |
|   |         | adequacy of existing research funding mechanisms, we    |
|   |         | believe it is important to recognize that universities  |
|   |         | serve a unique role and that it is not necessarily      |
|   |         | appropriate to apply to universities models and         |
|   |         | assumptions taken from the for-profit business world.   |
+---+---------+---------------------------------------------------------+
|   | **Uni   | We recommend that the Federal Demonstration Partnership |
|   | versity | (FDP) continue to be expanded and enhanced to enroll    |
|   | of      | more institutions and heighten the visibility of this   |
|   | Cali    | valuable initiative. FDP is both a policy tool and      |
|   | fornia, | delivery mechanism that has streamlined the efficiency  |
|   | Davis** | of sponsored research delivery by standardizing terms   |
|   |         | and conditions across Federal agencies, simplifying the |
|   |         | prior approval process, and streamlining the award      |
|   |         | distribution process. In summary, FDP has made          |
|   |         | federally sponsored research more accessible to the     |
|   |         | researcher and easier to manage for the administrator.  |
+---+---------+---------------------------------------------------------+
|   | **Uni   | A defined set of principles and procedures that achieve |
|   | versity | a true partnership between granting agencies and        |
|   | of      | research institutions are needed. Actions are often     |
|   | Idaho** | taken unilaterally by granting agencies without regard  |
|   |         | for the sustainability of scientific institutions. We   |
|   |         | need to move toward one of two possible management      |
|   |         | models: a broad consultation arrangement where the      |
|   |         | agencies operate under guidance and recommendations of  |
|   |         | an advisory/steering committee that is the keeper of    |
|   |         | principles, or a true partnership arrangement where the |
|   |         | agencies and grantee institutions jointly manage and    |
|   |         | govern the process.                                     |
|   |         |                                                         |
|   |         | Collaboration between the federal government and        |
|   |         | non-federal research providers should be a performance  |
|   |         | metric for the federal agencies, particularly those     |
|   |         | with federal research laboratories (DOE, EPA, NASA,     |
|   |         | DOD, USDA, DOC). If this metric existed, in periods of  |
|   |         | reduced research funding, the federal agency would not  |
|   |         | be as inclined to protect its laboratory operations at  |
|   |         | the expense of its extramural partner. Sustained        |
|   |         | collaboration should strengthen federal-partner         |
|   |         | relationships, encourage more multi-disciplinary        |
|   |         | federal-partner research, and simplify the contracting  |
|   |         | language and terms used in these activities. In turn,   |
|   |         | the business processes are streamlined and more         |
|   |         | research is accomplished.                               |
|   |         |                                                         |
|   |         | A clearly understood role of the partners is important. |
|   |         | A university's key role is providing scholarship and    |
|   |         | educating the next generation of researchers. Since     |
|   |         | universities promote the unencumbered distribution of   |
|   |         | knowledge, restrictions on publication or persons       |
|   |         | associated with research are problematic.               |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Let me begin with two concerns I have about the         |
|   | versity | fundamental process. The first is the decision to have  |
|   | of      | the committee comprised of just federal employees and   |
|   | Ken     | to bring in the institutional viewpoint through         |
|   | tucky** | comments and "town meetings". The relationship between  |
|   |         | the universities and the government really is a         |
|   |         | partnership and that partnership would be furthered if  |
|   |         | the ongoing committee reflects both of the key sectors  |
|   |         | involved. While I understand the constraints OSTP was   |
|   |         | under in establishing this committee, I do feel that it |
|   |         | represents a missed opportunity to have both sides of   |
|   |         | the partnership better appreciate the needs, concerns   |
|   |         | and constraints the other faces. When different parties |
|   |         | sit across the table from each other and must thrash    |
|   |         | out issues together it creates valuable dynamics.       |
|   |         |                                                         |
|   |         | Second, the charge to the committee and the community   |
|   |         | is to review the "business practices". While there is   |
|   |         | clearly a business element to the interactions between  |
|   |         | the federal agencies and the universities, this         |
|   |         | relationship is not primarily one of a business nature. |
|   |         | For the most part, federal agencies are not             |
|   |         | "purchasing" a commodity, but are in a partnership with |
|   |         | universities to support shared goals such as the        |
|   |         | furtherance of research. There are excellent concepts   |
|   |         | from business that can help both the universities and   |
|   |         | the federal agencies work better, but that is not the   |
|   |         | same as construing the relationship as a business       |
|   |         | relationship.                                           |
+---+---------+---------------------------------------------------------+
|   | **Uni   | We are concerned with the language in the NSTC request  |
|   | versity | for information as the term \"research business model\" |
|   | of      | has not been defined. Academic research funded by the   |
|   | Pitts   | federal government does not conform to more traditional |
|   | burgh** | definitions of \"business\" and we firmly believe that  |
|   |         | conventional \"business\" processes and terminology     |
|   |         | should not and cannot be reliably and appropriately     |
|   |         | applied to the academic context.                        |
+---+---------+---------------------------------------------------------+
|   | **Uni   | We remain optimistic that this Administration is        |
|   | versity | committed to finding efficiencies and improvements, yet |
|   | of      | at the same time strengthening the partnership between  |
|   | Roch    | the university research community and federal agencies  |
|   | ester** | that is vital to the nation's improvements and          |
|   |         | discoveries in science and technology.                  |
|   |         |                                                         |
|   |         | As an AAU and COGR member institution, we heartily      |
|   |         | endorse the message that COGR's correspondence conveyed |
|   |         | -- in summary, 1) advocating an increased flexibility   |
|   |         | of the award mechanisms supporting R&D, 2) a            |
|   |         | reexamination of the reimbursement of costs associated  |
|   |         | with University research inclusive of facility          |
|   |         | requirements that support federally funded research and |
|   |         | 3) an assessment of the divergent and contradictory     |
|   |         | interpretations of the regulatory and administrative    |
|   |         | requirements imposed by funding agencies.               |
+---+---------+---------------------------------------------------------+
|   | **Uni   | There are many complex and interlocking arrangements    |
|   | versity | that have evolved over the years in response to federal |
|   | of      | practices. While we welcome reform, it is also          |
|   | Washi   | important to recognize that major steps in such a       |
|   | ngton** | complex system will have many unintended consequences   |
|   |         | and should be approached in a very deliberate and       |
|   |         | careful way: "first do not harm". The meetings are      |
|   |         | good, but should be a prelude to a detailed             |
|   |         | collaborative design period for any proposed reforms. I |
|   |         | would suggest that active research institutions such as |
|   |         | ours be included in the detailed design, either         |
|   |         | individually or through organizations such as the AAU.  |
|   |         |                                                         |
|   |         | The tradition of competitive peer-reviewed science      |
|   |         | funding at research universities has served our country |
|   |         | well by advancing excellent research in many areas. It  |
|   |         | is important that this quality not be sacrificed to     |
|   |         | efficiency.                                             |
|   |         |                                                         |
|   |         | One critical deficiency of the current system, as       |
|   |         | pointed out in the COGR letter, is that administrative  |
|   |         | overhead rates for universities are arbitrarily capped  |
|   |         | at 26% of modified total direct costs. This limit       |
|   |         | requires universities (but not other types of           |
|   |         | organizations doing the same kinds of research) to find |
|   |         | nonfederal funds to support many costs of doing federal |
|   |         | research, including rapidly rising, federally mandated  |
|   |         | regulatory expenses. At universities, the only other    |
|   |         | sources of funds are those for education, so this       |
|   |         | practice has the effect of draining the educational     |
|   |         | resource of the nation's top higher-education           |
|   |         | institutions. In the long run, it is not sustainable;   |
|   |         | universities will have to stop those research           |
|   |         | activities where the costs are not recoverable from     |
|   |         | some source.                                            |
|   |         |                                                         |
|   |         | The cap has contributed to a community response that    |
|   |         | has actually spawned a new set of administrative        |
|   |         | inefficiencies. Because full indirect costs can be      |
|   |         | recovered by non-university organizations, there is an  |
|   |         | incentive for university researchers to take their      |
|   |         | research work outside universities, where a better      |
|   |         | research environment can be sustained. For example,     |
|   |         | university researchers affiliated with certain Veterans |
|   |         | Administration hospitals across the country (who cannot |
|   |         | apply for NIH funding through their VA affiliation) are |
|   |         | running their grant funding through new, independent    |
|   |         | VA-allied foundations created solely to act as hosts    |
|   |         | for their grants.                                       |
+---+---------+---------------------------------------------------------+
|   | **Uni   | We strongly encourage the return to a partnership of    |
|   | versity | trust and cooperation, rather than an "arms length"     |
|   | R       | procurement-based relationship. A true partnership      |
|   | esearch | increases the fruits of scientific research at a        |
|   | A       | reasonable expenditure of taxpayers' money.             |
|   | ssoc.** |                                                         |
+---+---------+---------------------------------------------------------+
|   | *       | My observation is that the face of research is          |
|   | *Victor | changing. Especially in computational and grand         |
|   | Pinks** | challenge areas due in part to the dramatic reduction   |
|   |         | in cost for computer clustering. I have a 9-node        |
|   | Inst.   | Beowulf supercomputer that cost me \$10K that would     |
|   | of      | have cost \$100K 10 years ago for the same performance. |
|   | Liquid  | Technological advances such as low cost clustering,     |
|   | D       | open source coding and the internet (to name just a     |
|   | ynamics | few) have empowered the individual. In areas of         |
|   | Simul.  | computer science, IT IS possible to compete             |
|   |         | scientifically with federal labs and universities right |
|   |         | out of your home. The face of scientific research is    |
|   |         | changing - first and foremost, it is changing in areas  |
|   |         | touched by grand challenge computations.                |
+---+---------+---------------------------------------------------------+
| * |         |                                                         |
| * |         |                                                         |
| A |         |                                                         |
| . |         |                                                         |
| A |         |                                                         |
| C |         |                                                         |
| C |         |                                                         |
| O |         |                                                         |
| U |         |                                                         |
| N |         |                                                         |
| T |         |                                                         |
| A |         |                                                         |
| B |         |                                                         |
| I |         |                                                         |
| L |         |                                                         |
| I |         |                                                         |
| T |         |                                                         |
| Y |         |                                                         |
| * |         |                                                         |
| * |         |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Al    | The ultimate accountability of the research enterprise  |
|   | exander | is to the society as a whole i.e. to the training of a  |
|   | Sche    | technically-skilled workforce, the generation of new    |
|   | eline** | ideas that will power the economy, and the improvement  |
|   |         | of quality of life (a concept difficult to quantify).   |
|   | Uni     | How can one show accountability in the short run, when  |
|   | versity | the goal is long-run? Current practices show            |
|   | of      | accountability that is easy to measure (bidding         |
|   | I       | practices, rationalized decisions on funding), but have |
|   | llinois | no way to show that the decisions are better than       |
|   | at      | alternatives would have been \[*subsequent* *text       |
|   | Ur      | omitted*\]                                              |
|   | bana-Ch |                                                         |
|   | ampaign | Vast amounts of time and energy are spent just trying   |
|   |         | to keep one\'s students in lab with even minimal        |
|   |         | resources. Wouldn\'t we be better off with less         |
|   |         | oversight and less short-term accountability, even with |
|   |         | a few boondoggles, if, as a result, we had a            |
|   |         | demographically better balanced workforce and greater   |
|   |         | creativity in an atmosphere of free                     |
+---+---------+---------------------------------------------------------+
|   | *       | The doubling of the NIH budget has heightened the       |
|   | *Assoc. | obligations of the NIH and the biomedical research      |
|   | of      | community to demonstrate their accountability in the    |
|   | Amer.   | use of federal funds in discovery-oriented research. We |
|   | Medical | urge the NSTC to examine the NIH's most recent GPRA     |
|   | Col     | report. The AAMC was disappointed to learn that the     |
|   | leges** | Office of Management and Budget opted not to accept     |
|   |         | NIH's "GPRA goals" in implementing its own management   |
|   |         | performance tool, but has sought to mandate yet a new   |
|   |         | set of performance measures.                            |
+---+---------+---------------------------------------------------------+
|   | **      | The OSTP notice asks how performers can best            |
|   | Council | demonstrate results or returns on federal research      |
|   | on      | investments. However, federally supported fundamental   |
|   | Govt.   | research projects, by definition, may produce results   |
|   | Re      | with no apparent immediate benefits, or even "negative" |
|   | lations | findings. Yet, negative results often are vitally       |
|   | (       | important for the progress of science. Efforts to       |
|   | COGR)** | quantify returns at the individual research project     |
|   |         | level are inherently misguided. There needs to be a     |
|   |         | tolerance for research "failures" and a greater         |
|   |         | understanding of the nature of basic research on the    |
|   |         | part of public decision makers.                         |
|   |         |                                                         |
|   |         | The notice rightly calls for comment on accountability  |
|   |         | by the parties involved in the business interaction.    |
|   |         | Unfortunately, the government appears to define         |
|   |         | accountability primarily in terms of                    |
|   |         | financial/administrative compliance rather than         |
|   |         | scientific outcomes. This compliance focus raises the   |
|   |         | issue of the appropriate level of risk in federal audit |
|   |         | and oversight activities (e.g. effort reporting and     |
|   |         | subrecipient monitoring) as well as the acceptable      |
|   |         | risk/benefit ratio. The issue of subrecipient           |
|   |         | monitoring is of particular concern in this context,    |
|   |         | since collaborative research has increased markedly     |
|   |         | during the past five years. Management and audit issues |
|   |         | all feed back to the central question of costs in       |
|   |         | relation to benefits.                                   |
|   |         |                                                         |
|   |         | Universities fully subscribe to the single audit        |
|   |         | concept embodied in the Single Audit Act and OMB        |
|   |         | Circular A-133. Under these provisions, the current     |
|   |         | system clearly provides adequate accountability and     |
|   |         | permits demonstration of responsible use of public      |
|   |         | funds. However, a number of federal agencies            |
|   |         | increasingly are insisting on performing their own      |
|   |         | audits. As a result, the government may spend more on   |
|   |         | audits than it is likely to recover from findings of    |
|   |         | deviations from requirements. Government data indicate  |
|   |         | that the findings in university audits have not         |
|   |         | skyrocketed, but in fact have declined. For example,    |
|   |         | audits by the NSF Inspector General have identified     |
|   |         | questioned costs of \$8.7 million in FY 2000, \$7.0     |
|   |         | million on 2001, and \$5.7 million in 2002, with        |
|   |         | corresponding sustained findings through the audit      |
|   |         | resolution process of \$2.4 million, \$1.9 million and  |
|   |         | \$1.4 million.                                          |
|   |         |                                                         |
|   |         | The revised Circular A-133 guidance moves the oversight |
|   |         | of subrecipients in a direction diametrically opposed   |
|   |         | to the goals of the Single Audit Act by requiring prime |
|   |         | recipients to join the government and audit firms as an |
|   |         | additional auditor of their sister institutions.        |
|   |         | Subjecting subrecipients to additional audit in this    |
|   |         | manner is an unnecessary waste of resources in the case |
|   |         | of all those subrecipients that have already            |
|   |         | demonstrated the adequacy of their systems through      |
|   |         | their Circular A-133 audits. Such additional reviews    |
|   |         | are duplicative, costly, and disruptive, particularly   |
|   |         | since the vast majority of subawards issued by          |
|   |         | universities are made to other universities for         |
|   |         | collaborative research projects where the funding       |
|   |         | agency has already approved the participation of the    |
|   |         | collaborating university.                               |
|   |         |                                                         |
|   |         | As reported by NSF in InfoBrief 03-327, 7.2% of         |
|   |         | federally-funded university research is passed through  |
|   |         | to subrecipients, an increase from the 5.2% passed      |
|   |         | through in 1998. Another example of redundant and       |
|   |         | costly government rules with respect to financial       |
|   |         | accountability is the imposition of Cost Accounting     |
|   |         | Standards on universities, finalized in 1996.           |
|   |         | Imposition of CAS and the Disclosure Statement (DS-2)   |
|   |         | resulted in an estimated \$20 million in start-up costs |
|   |         | for the top 100 universities, and in the seven years    |
|   |         | since that time, only 25 universities have received     |
|   |         | audited and approved DS-2s from their cognizant federal |
|   |         | agency.[^1] The other 125 remain in limbo, unsure of    |
|   |         | how to proceed when changes in accounting practices are |
|   |         | needed.                                                 |
|   |         |                                                         |
|   |         | Even the few universities with an approved DS-2, as     |
|   |         | predicted in the referenced paper, received             |
|   |         | inconsistent interpretations by federal auditors and    |
|   |         | rate negotiators with respect to cost items such as     |
|   |         | clerical and administrative salaries, employee          |
|   |         | benefits, and administrative computing.                 |
+---+---------+---------------------------------------------------------+
|   | **      | As the PRD-4 report stated "Accounting and              |
|   | Federal | accountability are not the same." This is the principle |
|   | Demons  | that the NSTC should uphold. There are numerous         |
|   | tration | examples of quality research being performed but which  |
|   | Project | resulted in a lengthy interchange between the           |
|   | (FDP)** | university and the government on the accounting for the |
|   |         | expenses supporting that research project.              |
|   |         |                                                         |
|   |         | How should research accountability be recognized? There |
|   |         | are currently in place numerous ways to judge the       |
|   |         | merits and appropriate expenditure on a research        |
|   |         | project. First and foremost, the investigator is        |
|   |         | required to submit technical reports to the sponsor     |
|   |         | describing accomplishments (both positive and           |
|   |         | negative). In addition, referred papers appear in       |
|   |         | journals citing research results, making those results  |
|   |         | open to the public. Finally, if a research project is   |
|   |         | not achieving its goals, the project simply isn't       |
|   |         | refunded. In this way, quality of the research becomes  |
|   |         | the prime determinant of accountability. Additional     |
|   |         | approaches to determining accountability of the         |
|   |         | research itself would be oral presentations at          |
|   |         | meetings, public seminars, creation and protection of   |
|   |         | intellectual property through the transfer of           |
|   |         | technology to the public.                               |
|   |         |                                                         |
|   |         | What, then, about the accounting? Remember that         |
|   |         | accounting is different from accountability. The        |
|   |         | government has a right to be assured that the           |
|   |         | accounting for any funds its provides to a recipient is |
|   |         | appropriately spent. Financial reports should be        |
|   |         | submitted in summary form; auditors should review       |
|   |         | through the single audit concept those reports to       |
|   |         | determine that no unallowable costs were claimed, and   |
|   |         | financial reports should support the technical          |
|   |         | activities described in the progress reports. The       |
|   |         | regulations that appear in OMB Circulars A-21 and       |
|   |         | A-110, as well as in the Federal Acquisition            |
|   |         | Regulations, supplemented by the audit requirements of  |
|   |         | OMB Circular A-133 provide adequate review and          |
|   |         | assurance to the government of the accounting for       |
|   |         | research awards.                                        |
|   |         |                                                         |
|   |         | In summary, the question should be asked, "Did the      |
|   |         | government receive the research that it paid for?"      |
|   |         | Whether the research had spectacularly good results     |
|   |         | pointing to a new area of study or the research merely  |
|   |         | confirmed that a particular approach was not feasible,  |
|   |         | the outcomes were of benefit. That should be the basic  |
|   |         | issue and should be the way to demonstrate the return   |
|   |         | on federal investment.                                  |
+---+---------+---------------------------------------------------------+
|   | **Fr    | If we knew what was to pay off, we would only do that   |
|   | ederick | kind of work. To paraphrase Einstein, \"If we knew what |
|   | Sachs** | we were doing, it wouldn\'t be science\". There is a    |
|   |         | terrible hazard of coming up with criteria to evaluate  |
|   | SUNY--  | the significance of research. Nearly all important      |
|   | Buffalo | ideas have been off-the-wall findings. These are        |
|   |         | approaches and ideas that no one would fund. It is      |
|   |         | generally agreed among scientists that their most       |
|   |         | important results are those obtained without explicit   |
|   |         | funding; results obtained by using the money from       |
|   |         | funded projects to try things that were not included.   |
+---+---------+---------------------------------------------------------+
|   | **      | In our view, there are already more than enough         |
|   | Harvard | mechanisms in place to demonstrate to scientists, to    |
|   | Unive   | agencies, and to the knowledgeable public that federal  |
|   | rsity** | funds have been appropriately and effectively spent.    |
|   |         | These include technical reports by investigators        |
|   |         | describing progress and accomplishments (including      |
|   |         | lists of publications in peer reviewed journals) and    |
|   |         | financial reports that match expenditures to budgets.   |
|   |         | Accomplishment on current grants and contracts also     |
|   |         | plays an important role in award renewal processes.     |
|   |         | Here, not only the quantity, but also the quality and   |
|   |         | promise come into play.                                 |
+---+---------+---------------------------------------------------------+
|   | *       | USDA Policy #12 is essential to replacement, reduction  |
|   | *Humane | and refinement in animal research and should not be     |
|   | S       | eliminated as a legal requirement. Specific suggestions |
|   | ociety\ | for improvement include: (1) Training: Literature       |
|   | **      | searches that are properly conducted can lead to        |
|   |         | decreased animal suffering and, given the expense of    |
|   |         | conducting animal research, could decrease costs of     |
|   |         | research as well. However, too often alternatives       |
|   |         | searches are not properly conducted, and this prevents  |
|   |         | researchers from finding useful information, (2) The    |
|   |         | current Policy #12 requires that researchers            |
|   |         | ***consider*** alternatives and justify why available   |
|   |         | alternatives are not used, if they are not. The         |
|   |         | Institutional Animal Care and Use Committee and the     |
|   |         | USDA should closely examine the justification and       |
|   |         | strongly recommend ***adoption*** of alternatives when  |
|   |         | possible, and (3) The USDA should increase enforcement  |
|   |         | to ensure that alternatives searches are being          |
|   |         | conducted properly and that justification for not       |
|   |         | adopting alternatives is valid.                         |
+---+---------+---------------------------------------------------------+
|   | **James | I think it would save huge effort and avoid wasted time |
|   | Clegg** | if scientists were evaluated on the basis of **what     |
|   |         | they\'ve published (ie provide reprints) during the     |
|   | U       | previous grant period** (not just write about it in the |
|   | C-Davis | current brief Results From Previous Support section).   |
|   |         | Then the proposal itself  would just outline the        |
|   |         | direction of research for the next grant period, and    |
|   |         | include vitae, personnel, budget and so on. Of course,  |
|   |         | a system would have to be developed for first- time     |
|   |         | applicants (young scientists).  I think there is        |
|   |         | uniform agreement amongst scientists that the current   |
|   |         | system involves gigantic effort & time.                 |
+---+---------+---------------------------------------------------------+
|   | **John  | I applaud the objectives of this effort, but have one   |
|   | C .     | major criticism of the above feedback categories from   |
|   | Pet     | the perspective of improving the quality and            |
|   | ura**,\ | cost-effectiveness of the funds expended and efforts    |
|   | Council | exerted in the name of engineering research. My         |
|   | of      | criticism is this. In far too many cases ..., the       |
|   | Engi    | quality of the work performed fails to meet             |
|   | neering | expectations, is excessive in cost, or covers ground    |
|   | and     | that has already been trod because the                  |
|   | Sci     | **[qualifications and experience]{.underline}** of the  |
|   | entific | persons leading the effort are                          |
|   | Spec    | **[deficient]{.underline}** with regard to their        |
|   | ialties | comprehension of the study design, the findings of the  |
|   | Boards  | study, or the \"big picture\" applicability of the      |
|   |         | proposed remediation technology. Two subsets of this    |
|   | Applied | observation are \"scientific defensibility\" and        |
|   | Enviro  | \"engineering feasibility\". The former of these is     |
|   | nmental | generally discussed in the lay media as \"good          |
|   | Mana    | science\". The latter rarely gets any press at all,     |
|   | gement, | because the definition and practice of engineering are  |
|   | Inc.    | not understood by the lay media.                        |
|   |         |                                                         |
|   |         | For any review program of the Business Model to be      |
|   |         | complete, it needs to have a component that addresses   |
|   |         | the qualifications and experience of the basic or       |
|   |         | applied researchers who request grant funding for the   |
|   |         | proposed studies, including a review component that     |
|   |         | asks such questions as \"Has this technology or a       |
|   |         | variation on a theme been studied before?\", \"Has a    |
|   |         | clear set of objectives been set to determine whether   |
|   |         | the technology performs successfully, not in a test     |
|   |         | tube or column study, but in real site settings?\", and |
|   |         | \"Will the unit cost \[\$/cubic yard or \$/ton or       |
|   |         | \$/acre\] for application be determined based on        |
|   |         | consideration of all applicable capital and operating   |
|   |         | costs over the life of a project?\" This last item      |
|   |         | relates to the term **[feasibility]{.underline}**, as   |
|   |         | defined in the National Contingency Plan, which is      |
|   |         | supposed to be the oversight guideline for Superfund    |
|   |         | site remediation assessments.                           |
+---+---------+---------------------------------------------------------+
|   | **M     |                                                         |
|   | .I.T.** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Roger | Accountability should be defined in terms that are      |
|   | A.      | quantitative and, therefore, measurable.... The         |
|   | Fa      | following quantitative measures may be applied          |
|   | rrell** |                                                         |
|   |         | **Pre-award**                                           |
|   | Supe    |                                                         |
|   | rPower, | • Is the research effort something an enterprise would  |
|   | I       | do on its own or is the technical/financial risk too    |
|   | nc**.** | high? Federal support should be provided for the        |
|   |         | latter.                                                 |
|   |         |                                                         |
|   |         | • Are the research objectives realistic given the       |
|   |         | schedule and budget?                                    |
|   |         |                                                         |
|   |         | • Is the organization proposing the research capable    |
|   |         | (personnel and facilities) or doing it?                 |
|   |         |                                                         |
|   |         | **During/immediately after program**                    |
|   |         |                                                         |
|   |         | • How successful was the enterprise in meeting the      |
|   |         | research objectives? Not at all, partially, mostly or   |
|   |         | totally?                                                |
|   |         |                                                         |
|   |         | • How much intellectual property was developed? Patent  |
|   |         | disclosures/awards are the most measurable of these but |
|   |         | this should also include trade secrets and know-how.    |
|   |         |                                                         |
|   |         | • Were the results encouraging enough that additional   |
|   |         | Federal or private funds were granted?                  |
|   |         |                                                         |
|   |         | **Long term**                                           |
|   |         |                                                         |
|   |         | • Did the research lead to products which the           |
|   |         | enterprise commercialized or had commercialized? The    |
|   |         | number of small business innovation research (SBIR)     |
|   |         | phase III successes is a measure of this.               |
|   |         |                                                         |
|   |         | • What additional revenue was generated as a result of  |
|   |         | this research and what payments of Federal and State    |
|   |         | taxes?                                                  |
|   |         |                                                         |
|   |         | • How much additional employment did this research lead |
|   |         | to?                                                     |
|   |         |                                                         |
|   |         | • Did this research result in a leading position for    |
|   |         | United States industry or recouping the lead from a     |
|   |         | foreign country?                                        |
|   |         |                                                         |
|   |         | • Is the research applicable to both the commercial and |
|   |         | government needs?                                       |
|   |         |                                                         |
|   |         | To be successful a detailed scope of work with time     |
|   |         | specific milestones is a necessity, along with regular  |
|   |         | reporting and the willingness to pull the plug if       |
|   |         | milestones are missed. DOE has recently adopted Program |
|   |         | Readiness Reviews for its' SPI programs which is a      |
|   |         | major step in the right direction of avoiding money     |
|   |         | wasted on programs that are in trouble. Relative to     |
|   |         | transparency, use of a peer review process is excellent |
|   |         | because it introduces objectivity into the review       |
|   |         | process and the results, while not publicly available,  |
|   |         | can be used by government to gauge the effectiveness of |
|   |         | the research endeavor.                                  |
+---+---------+---------------------------------------------------------+
|   | **Sarah | \(1\) Before we can evaluate the performance and assess |
|   | Ma      | the overall impact, we need to know how the tax dollars |
|   | rston** | are invested. To that end, as a first step towards      |
|   |         | improving accountability, I suggest development of an   |
|   | StatSc  | \"analyzable\" publicly accessible funding database.    |
|   | i/Degge | (2) Research on research initiatives could include      |
|   | Group   | development of R&D performance metrics, reviews of      |
|   |         | funding performance and process, etc (3) Introducing    |
|   |         | transparency and inviting comments from an inclusive    |
|   |         | and diverse group can substantially increase            |
|   |         | performance and accountability, but introducing         |
|   |         | competition can potentially drive the funding towards   |
|   |         | even higher levels of effectiveness. Competition can be |
|   |         | introduced by decentralizing the funding decision       |
|   |         | process, perhaps by shifting the dollars back to the    |
|   |         | states. Alternatively, establishing a competitive       |
|   |         | environment across federal agencies, associated with    |
|   |         | break-up of the NIH into smaller, more focused research |
|   |         | centers could represent another mechanism for           |
|   |         | introducing competition.                                |
+---+---------+---------------------------------------------------------+
|   | **S     | Federal agencies and universities should work together  |
|   | tanford | to become more sophisticated and science-focused in     |
|   | Unive   | their research administration practices. A "stable" of  |
|   | rsity** | administrative mechanisms and expectations should be    |
|   |         | developed and deployed based on the unique needs        |
|   |         | present in each type of project (e.g., individual       |
|   |         | investigator-led project; individual investigator with  |
|   |         | a portfolio of projects; multiple investigators working |
|   |         | on a single project, joint funding of a project by      |
|   |         | multiple funding sources (including non-federal)        |
|   |         | funding a single initiative, or "big-science").         |
|   |         |                                                         |
|   |         | Revise Agency/University Business Relationship to       |
|   |         | Recognize Accountability and Trust                      |
|   |         |                                                         |
|   |         | Despite a plethora of experience working with one       |
|   |         | another, current business models between the federal    |
|   |         | funding agencies and universities remain almost         |
|   |         | entirely "transaction" based (e.g., proposals, awards,  |
|   |         | reports, etc. ). This business model is expensive,      |
|   |         | labor-intensive (of particular concern given the        |
|   |         | administrative cap on F&A), and takes little account of |
|   |         | the technological advantages that are now available. We |
|   |         | recommend that: Federal agencies and universities       |
|   |         | should consider the viability of "business-to-business" |
|   |         | models for working together. For example, if common     |
|   |         | standards for conducting business are adopted and best  |
|   |         | business practices implemented, institutional research  |
|   |         | oversight systems deploying these standards and         |
|   |         | practices could potentially be accredited to do         |
|   |         | business with the federal government, allowing business |
|   |         | to be conducted on a "business-to-business" basis       |
|   |         | rather than on a per-transaction basis.                 |
+---+---------+---------------------------------------------------------+
|   | **The** | Accountability algorithms are endlessly appealing to    |
|   | **San   | \"research managers\" and their political masters, and  |
|   | Diego   | endlessly chimerical. The big payoffs, at least in      |
|   | Science | basic research, come in serendipitous ways, not ROI     |
|   | and     | calculations. Attempts to fine-tune the outcomes and    |
|   | Tech.   | measure some sort of ROI are a great deal of wasted     |
|   | Co      | effort at best, obstructive at worst. Broad-based       |
|   | uncil** | support of research that is highly rated by experts who |
|   |         | are in a position to make critical scientific judgments |
|   |         | is the best course; let brains, hard work and           |
|   |         | serendipity take over from there. The record of past    |
|   |         | decades shows how today\'s \"returns on investments\"   |
|   |         | are traceable, in ways unforeseen at the time, to that  |
|   |         | sort of support given long ago. But detailed forward    |
|   |         | predictions are likely to be a fool\'s errand by and    |
|   |         | large.                                                  |
|   |         |                                                         |
|   |         | Of course it is quixotic to say such things in an era   |
|   |         | when the \"business model\" is idolized as the proper   |
|   |         | way to organize all things, including scientific        |
|   |         | imagination.                                            |
+---+---------+---------------------------------------------------------+
|   | **Uni   | It would be a mistake                                   |
|   | versity |                                                         |
|   | of      | , to equate the appropriate measures of such public     |
|   | Calif   | returns with those used in the private sector to        |
|   | ornia** | measure commercial "returns on investment." For the     |
|   |         | most part, universities are not vendors and university  |
|   |         | support for research is not a procurement activity.     |
|   |         | Much federally funded research is basic research for    |
|   |         | which there are no pre-determined results or measurable |
|   |         | "deliverables."                                         |
|   |         |                                                         |
|   |         | The benefits of basic research are real and             |
|   |         | significant, if sometimes less susceptible to easy      |
|   |         | measurement than the "returns" realized on more applied |
|   |         | research. Many of the benefits of more fundamental      |
|   |         | research accrue incrementally through subsequent        |
|   |         | developments and through uses of the results by those   |
|   |         | who did not invest directly in the research.            |
|   |         |                                                         |
|   |         | The University of California is engaged actively in an  |
|   |         | effort to develop some such measures through the        |
|   |         | Economic Research Unit of its Industry-University       |
|   |         | Cooperative Research Program. This program has piloted  |
|   |         | studies that have yielded valuable insights into the    |
|   |         | direct economic contributions stemming from federally   |
|   |         | funded basic research, and has defined several specific |
|   |         | measures, which include creation of new businesses and  |
|   |         | production of R&D leaders, among others, that may be    |
|   |         | broadly applicable to federal investments in university |
|   |         | science and engineering research activities.            |
|   |         |                                                         |
|   |         | Additional research is needed to determine how and      |
|   |         | whether it is possible to make these analyses           |
|   |         | practicable at a federal level.                         |
|   |         |                                                         |
|   |         | Peer review administered by federal agencies is an      |
|   |         | essential part of the accountability for public         |
|   |         | investments in research, and the University of          |
|   |         | California strongly supports participation by its       |
|   |         | faculty in the peer review process.                     |
|   |         |                                                         |
|   |         | In addition, the myriad of federal compliance rules     |
|   |         | such as those for human subjects, animal welfare,       |
|   |         | conflict of interest, and costing and administrative    |
|   |         | rules, and restrictions found in Office of Management   |
|   |         | and Budget (OMB) Circulars, audits, Cost Accounting     |
|   |         | Standards, agency-specific requirements, and indirect   |
|   |         | cost rate proposals provide significant financial and   |
|   |         | compliance accountability measurements and restrictions |
|   |         | within which the research enterprise must operate.      |
|   |         | Universities take seriously their obligation to comply  |
|   |         | with these measures. Compliance is audited annually as  |
|   |         | well as in some cases, on a project basis. Such audits  |
|   |         | provide the federal government with continuous          |
|   |         | "accountability for the Federally-supported research    |
|   |         | enterprise."                                            |
+---+---------+---------------------------------------------------------+
|   | **Uni   | \(1\) The principal measure of accountability must      |
|   | versity | remain focused on the research activities and outcomes. |
|   | of      | We advocate for open scientific communication. The      |
|   | Fl      | federal government must continue to support this open   |
|   | orida** | and free ability for Investigators to exchange          |
|   |         | information and publish their findings. (2) Annual and  |
|   |         | Final technical reports delivered to program officers   |
|   |         | is an effective means by which grant performance can be |
|   |         | measured. (3) Fiscal accountability is also very        |
|   |         | important and current practices of reporting            |
|   |         | expenditure information through the quarterly and final |
|   |         | Federal Cash Transaction Report, SF 272. works well.    |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Several people at the Berkeley workshop testified that  |
|   | versity | changes in rules by various agencies have resulted in   |
|   | of      | massive administrative cost-shifting to universities.   |
|   | Idaho** | Dr. Parrish testified that, in ESPCoR states, this      |
|   |         | cost-shifting is even more damaging because the small   |
|   |         | universities in these states do not have the same       |
|   |         | levels of financial flow-through and the flexibility    |
|   |         | that results from that. Moreover, in times when         |
|   |         | legislatures are reducing funding for higher education  |
|   |         | and research, universities in small states can be       |
|   |         | impacted disproportionately. This situation is          |
|   |         | aggravated further by the very large matching           |
|   |         | requirements of many agencies that operate under        |
|   |         | EPSCoR. Some agencies require such large matching that  |
|   |         | the only way to meet the matching is to forego all      |
|   |         | indirect cost recovery and summer salaries. This means  |
|   |         | that not only must the universities bear the burden of  |
|   |         | the same kind of administrative cost-shifting that all  |
|   |         | states are experiencing, but have their administrative  |
|   |         | flexibility reduced even further. As Dean of Science at |
|   |         | UI, I have had to consider not allowing faculty to      |
|   |         | apply for EPSCoR grants from some agencies because I    |
|   |         | cannot afford to support a large research effort that   |
|   |         | brings in no overhead; these grants often include       |
|   |         | building or renovating space, hiring, and other costs   |
|   |         | that require substantial administrative input. This     |
|   |         | completely subverts the purpose of the EPSCoR program,  |
|   |         | which is to increase the diversity of the research      |
|   |         | effort (and therefore the research might) of the        |
|   |         | country.                                                |
|   |         |                                                         |
|   |         | Accountability should be defined in terms of scientific |
|   |         | outcomes, not just financial and administrative         |
|   |         | compliance. Allow PIs to report on outcomes and         |
|   |         | impacts, rather than just inputs and outputs. Encourage |
|   |         | PIs to produce scientific publications as well as       |
|   |         | reports on the application of products derived from     |
|   |         | scientific inquiry.                                     |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Grantees who have subawards to institutions that are    |
|   | versity | A133 compliant could probably be relieved of the need   |
|   | of      | to oversee their fiscal accountability (other than      |
|   | Ken     | items directly part of their subaward). On the other    |
|   | tucky** | hand, subawardees who are not covered under A133 audits |
|   |         | might deserve greater scrutiny. The committee could     |
|   |         | help identify -- and sanction -- activities that could  |
|   |         | have less regulation because it is difficult for        |
|   |         | individual institutions or agencies to make those       |
|   |         | determinations. OSTP could lead any such changes with   |
|   |         | OMB, representing both multiple agencies and            |
|   |         | institutions.                                           |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Universities are significantly engaged in               |
|   | versity | accountability through accreditation and reporting      |
|   | of      |                                                         |
|   | Pitts   |                                                         |
|   | burgh** |                                                         |
+---+---------+---------------------------------------------------------+
|   | *       | Establish a robust and timely value-added evaluation    |
|   | *Victor | system. A value-added evaluation system would weigh     |
|   | Pinks** | each invention on its own merits, by comparing each new |
|   |         | idea to current practice within its respective          |
|   | Inst.   | discipline and judging its chances for commercial       |
|   | of      | success. This approach contrasts sharply with other     |
|   | Liquid  | methods that toss all inventions submitted into a       |
|   | D       | single "bucket," then rank order them, and fund only    |
|   | ynamics | the top few.                                            |
|   | Sim     |                                                         |
|   | ulation |                                                         |
+---+---------+---------------------------------------------------------+
|   | **      | Researchers should be encouraged to communicate their   |
|   | Timothy | successes directly with the public. Many professional   |
|   | D.      | organizations are facilitating these activities and     |
|   | Usher** | educating members on the importance of these            |
|   |         | activities. More needs to be done along these lines.    |
|   | Pro     | Accountability is often used in a very negative way. It |
|   | fessor, | is often used to punish rather than seek direction.     |
|   | Cal     | Also, lengthy and time consuming assessment often       |
|   | ifornia | detracts from the primary research and the outcomes of  |
|   | State   | the assessment are not very clear. The very nature of   |
|   | Univ    | research requires that researchers explore unknown      |
|   | ersity, | areas. Strict assessment procedures stifle this         |
|   | San     | important aspect of research.                           |
|   | Ber     |                                                         |
|   | nardino | Students are perhaps the most important outcome of      |
|   |         | research activities. Lord Kelvin once said that chance  |
|   |         | favors the prepared mind. It is often impossible to     |
|   |         | predict what discoveries will be made. However, it is   |
|   |         | certain that these potential discoveries will go        |
|   |         | unnoticed if investigators are not properly prepared.   |
|   |         | Publications, and inventions are certainly important    |
|   |         | outcomes for research activities. However, at least as  |
|   |         | important is the training that is provided for future   |
|   |         | scientist, mathematicians, engineers,                   |
|   |         |                                                         |
|   |         | and technicians. Well educated and trained individuals  |
|   |         | can quickly adapt to meet the rapidly changing needs of |
|   |         | society and industry.                                   |
+---+---------+---------------------------------------------------------+
| * |         |                                                         |
| * |         |                                                         |
| B |         |                                                         |
| . |         |                                                         |
| I |         |                                                         |
| N |         |                                                         |
| C |         |                                                         |
| O |         |                                                         |
| N |         |                                                         |
| S |         |                                                         |
| I |         |                                                         |
| S |         |                                                         |
| T |         |                                                         |
| E |         |                                                         |
| N |         |                                                         |
| C |         |                                                         |
| Y |         |                                                         |
| O |         |                                                         |
| F |         |                                                         |
| P |         |                                                         |
| O |         |                                                         |
| L |         |                                                         |
| I |         |                                                         |
| C |         |                                                         |
| I |         |                                                         |
| E |         |                                                         |
| S |         |                                                         |
| A |         |                                                         |
| N |         |                                                         |
| D |         |                                                         |
| P |         |                                                         |
| R |         |                                                         |
| A |         |                                                         |
| C |         |                                                         |
| T |         |                                                         |
| I |         |                                                         |
| C |         |                                                         |
| E |         |                                                         |
| S |         |                                                         |
| A |         |                                                         |
| M |         |                                                         |
| O |         |                                                         |
| N |         |                                                         |
| G |         |                                                         |
| F |         |                                                         |
| E |         |                                                         |
| D |         |                                                         |
| E |         |                                                         |
| R |         |                                                         |
| A |         |                                                         |
| L |         |                                                         |
| A |         |                                                         |
| G |         |                                                         |
| E |         |                                                         |
| N |         |                                                         |
| C |         |                                                         |
| I |         |                                                         |
| E |         |                                                         |
| S |         |                                                         |
| * |         |                                                         |
| * |         |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Al    | The modular budget procedure at NIH acknowledges that   |
|   | exander | the typical proposal (80% of new proposals) will not be |
|   | Sche    | funded, and it is thus a waste of time for researchers  |
|   | eline** | to justify a budget in detail that has only 1 chance in |
|   |         | 5 of ever having tangible effect. An approximate        |
|   | Uni     | indication of budget is necessary to adequately         |
|   | versity | evaluate a proposal, but detailed budgeting is          |
|   | of      | typically not a significant factor in a funding         |
|   | I       | decision (in fact, do we want errors of a few dollars   |
|   | llinois | here or there to be decisive in funding decisions? I    |
|   | at      | think not.). The NSF model for electronic submission of |
|   | Ur      | proposals, coupled to the NIH model of only approximate |
|   | bana-Ch | budgeting until funds are likely to be forthcoming      |
|   | ampaign | would be a winning combination. Matching forms for      |
|   |         | Current and Pending Support, Curriculum Vita and        |
|   |         | budgets among agencies would help, since it is common   |
|   |         | for similar numbers and forms to apply to many          |
|   |         | simultaneous proposals                                  |
+---+---------+---------------------------------------------------------+
|   | **A     | **(Bundled comments on B. & C.)**                       |
|   | merican |                                                         |
|   | An      |                                                         |
|   | ti-Vivi |                                                         |
|   | section |                                                         |
|   | Soc.**  |                                                         |
+---+---------+---------------------------------------------------------+
|   | **A     | The U.S. Department of Agriculture (USDA) does not      |
|   | merican | cover birds, mice, and rats (among other species)       |
|   | An      | through law enforcement of the Animal Welfare Act, but  |
|   | ti-Vivi | these animals are covered under Public Health Service   |
|   | section | Policy. Therefore, if projects involving these animals  |
|   | So      | are conducted and not funded by the federal government, |
|   | ciety** | the investigators may not have to abide by basic        |
|   |         | standards of humane care and use, including review of   |
|   |         | the research protocol by an Institutional Care and Use  |
|   |         | Committee (IACUC). This giant loophole not only leads   |
|   |         | to significant animal welfare concerns, but also puts   |
|   |         | the scientific rigor and standardization of such        |
|   |         | projects into question. It is important that animals    |
|   |         | commonly used in laboratories---such as birds, mice,    |
|   |         | and rats who represent over 95% of warm-blooded animals |
|   |         | used--- receive basic protections and that all          |
|   |         | researchers using these animals adhere to the same      |
|   |         | basic standards.                                        |
+---+---------+---------------------------------------------------------+
|   | *       | It appears that a long-standing effort by a segment of  |
|   | *Animal | the research industry opposed to proper consideration   |
|   | Welfare | of alternatives, specifically the USDA-mandated         |
|   | Inst    | literature search, is continuing in this forum.         |
|   | itute** | Attached and below are my comments on this subject      |
|   |         | submitted to NIH in May of 1999.                        |
+---+---------+---------------------------------------------------------+
|   | *       | Recent decades are replete with examples of the federal |
|   | *Assoc. | government\'s unilateral shifting of the terms of the   |
|   | of      | government-university relationship, often under the     |
|   | Amer.   | guise of cost accounting. The most notable of many      |
|   | Medical | changes has been OMB's ex cathedra revision to Circular |
|   | Col     | A-21 establishing an arbitrary 26-percent cap on the    |
|   | leges** | recovery of administrative expenses for academic        |
|   |         | institutions (but not for independent research          |
|   |         | institutions, which are subject to Circular A-122). At  |
|   |         | the same time, universities labor under a steadily      |
|   |         | increasing administrative burden of meeting ever        |
|   |         | expanding and ever more demanding regulatory and        |
|   |         | reporting requirements.                                 |
|   |         |                                                         |
|   |         | Other chafing federal actions include a legislated cap  |
|   |         | on salary levels reimbursable by NIH grants; caps on    |
|   |         | stipends for pre- and post-doctoral fellowships and     |
|   |         | training grants that are below the competitive levels   |
|   |         | many institutions must provide; limitations on recovery |
|   |         | from federal grants of graduate student tuition costs   |
|   |         | at levels below that charged by many institutions, and  |
|   |         | eliminating funding for the NIH's Biomedical Research   |
|   |         | Support Grant mechanism. The net effect of these        |
|   |         | actions has been the cumulative transfer of legitimate  |
|   |         | costs of federal research to awardee institutions.      |
|   |         |                                                         |
|   |         | The AAMC believes that the cap on the reimbursement of  |
|   |         | administrative costs and related cost-shifting actions  |
|   |         | are central issues that must be addressed in any        |
|   |         | contemporary discussion of federal-academic business    |
|   |         | models. COGR, the Association of American Universities, |
|   |         | and their member organizations have monitored the       |
|   |         | cost-reimbursement issues closely and we urge the NSTC  |
|   |         | to engage in dialogue with the academic community on    |
|   |         | this urgent topic. We also cite RAND's excellent study, |
|   |         | Paying for University Research Facilities and           |
|   |         | Administration, which provides further data.            |
+---+---------+---------------------------------------------------------+
|   | **C     | Agency Practices Should Be Consistent. This variation   |
|   | olumbia | exacerbates the problems universities confront in       |
|   | Univ.** | providing effective, efficient reporting. A case in     |
|   |         | point is electronic grant applications, which hold      |
|   |         | promise for administrative simplification but have yet  |
|   |         | to be implemented in a common fashion. Indeed, while    |
|   |         | \<grants.gov\> is working towards electronic submission |
|   |         | of proposals both the NIH (through the "Commons") and   |
|   |         | NSF (through FastLane) are continuing on their own      |
|   |         | paths, continuing to enhance their proprietary systems  |
|   |         | "until \<grants.gov\> has all the capabilities          |
|   |         | currently in" their systems.                            |
+---+---------+---------------------------------------------------------+
|   | **      | (Bundled responses on B & E) OMB Circular A-110 is      |
|   | Council | based on principles that provide a reasonable approach  |
|   | on      | to the management of research supported by federal      |
|   | Govt.   | grants and agreements at universities, but the OMB      |
|   | Re      | guidance has not been implemented uniformly by the      |
|   | lations | agencies.                                               |
|   | (       |                                                         |
|   | COGR)** | Users now require three sources of information: the OMB |
|   |         | basic A-110 guidance on the core principles; a diverse  |
|   |         | array of inconsistent agency implementing regulations,  |
|   |         | and a further layer of expanded authorities granted by  |
|   |         | the ten FDP member agencies to only a select group of   |
|   |         | university participants, engaged in federally approved  |
|   |         | demonstrations under the auspices of the Federal        |
|   |         | Demonstration Partnership (FDP). It is time that these  |
|   |         | "demonstrations" (begun under the Florida Demonstration |
|   |         | Project in the early 1980's) be brought to a close and  |
|   |         | that Circular A-110 be implemented uniformly and on a   |
|   |         | government-wide basis for all research.                 |
|   |         |                                                         |
|   |         | At present, inconsistencies exist not only between FDP  |
|   |         | member and non-member research funding agencies, but    |
|   |         | variances exist even among the FDP agencies. The FDP    |
|   |         | General Terms and Conditions implement the "expanded    |
|   |         | authorities" contained in OMB Circular A-110 (.25(e)).  |
|   |         | However, the agency-specific requirements vary in their |
|   |         | implementation of these prior approvals (e.g. EPA,      |
|   |         | ONR). Review of the individual agency terms and         |
|   |         | conditions indicates a wide variety of other            |
|   |         | agency-specific requirements.[^2] The situation is      |
|   |         | similar with regard to the Federal Acquisition          |
|   |         | Regulations (FAR) used by government agencies in        |
|   |         | research contracts with universities. While there are   |
|   |         | standardized FAR clauses, a great number of individual  |
|   |         | agency supplements exist.                               |
|   |         |                                                         |
|   |         | For example, only two agencies (NIH and NSF) have       |
|   |         | implemented financial disclosure requirements with      |
|   |         | regard to investigator conflicts of interest. While     |
|   |         | COGR generally supports the NSF/NIH regulations, they   |
|   |         | are not fully consistent with each other. We have       |
|   |         | consistently expressed a strong preference for a        |
|   |         | government-wide policy.[^3] A similar example is        |
|   |         | research misconduct. We support both OSTP's approach as |
|   |         | set forth in the December, 2000 Federal Policy on       |
|   |         | Research Misconduct and NSF's implementation (45 CFR    |
|   |         | Part 689) . However, NSF is the only major research     |
|   |         | funding agency to date that has issued final            |
|   |         | regulations, and we are concerned about the potential   |
|   |         | inability to achieve uniform government-wide            |
|   |         | implementation.[^4]                                     |
|   |         |                                                         |
|   |         | The streamlining and simplification process initiated   |
|   |         | by the Federal Financial Assistance Management          |
|   |         | Improvement Act of 1999 (P.L. 106-107) also seems to be |
|   |         | moving slowly.  While the initiatives undertaken by the |
|   |         | interagency groups established under the Act have       |
|   |         | laudable goals, we are concerned that some of the       |
|   |         | proposed new approaches may increase, rather than       |
|   |         | decrease, administrative burdens on universities.       |
+---+---------+---------------------------------------------------------+
|   | **F.    | Like most, I feel the scientific merit review process   |
|   | David   | is central to R&D resource utilization. My suggestion   |
|   | Doty,   | is quite simple: try to make the grant review processes |
|   | Ph.D.** | at DOD and DOE function more like those at NIH and NSF, |
|   |         | where one can at least be assured a worthy proposal     |
|   | Doty    | will be given a serious review by a qualified scientist |
|   | Scie    | or engineer \[*subsequent* *text omitted*\]. Obviously, |
|   | ntific, | I am quite happy with the scientific review processes   |
|   | Inc     | at NIH and NSF.                                         |
+---+---------+---------------------------------------------------------+
|   | **      | Before identifying areas where practices and policies   |
|   | Federal | are inconsistent, it is important to mention one place  |
|   | Demons  | where they are consistent: the Federal Demonstration    |
|   | tration | Partnership (FDP). Through this cooperative             |
|   | Pr      | government-higher education effort, some 12 federal     |
|   | oject** | agencies and more than 90 institutions of higher        |
|   |         | learning have joined to utilize (for the most part)     |
|   |         | common terms and conditions for grants (and some        |
|   |         | cooperative agreements) across the agencies and         |
|   |         | institutions. This type of effort is essential in       |
|   |         | reducing costs and promoting appropriate efficiencies.  |
|   |         | The difficulty most universities see is that the FDP    |
|   |         | terms and conditions are not applied to all assistance  |
|   |         | (grants and cooperative agreements) awards and are not  |
|   |         | applied at all to contracts. We urge that a long range  |
|   |         | goal of the NSTC is to broaden the application of the   |
|   |         | FDP terms to other awards.                              |
|   |         |                                                         |
|   |         | You will be provided with ample evidence of specific    |
|   |         | places where policies and practices are inconsistent    |
|   |         | among federal agencies. Because the lists you receive   |
|   |         | will be extensive, we decided to provide a partial list |
|   |         | here, with limited comments, but are ready to provide   |
|   |         | more information if you would like:                     |
|   |         |                                                         |
|   |         | 1.  Marking awards and BAAs and RFPs sensitive but      |
|   |         |     unclassified. As you may know, this is a specific   |
|   |         |     area of concern for universities. It raises the     |
|   |         |     issue of openness in research and the viability and |
|   |         |     applicability of NSDD 189.                          |
|   |         |                                                         |
|   |         | 2.  Conflict of Interest regulations. NIH and NSF have  |
|   |         |     adopted financial conflict of interest policies,    |
|   |         |     but they differ in small but significant points     |
|   |         |     which causes administrative issues for universities |
|   |         |     who either have to adopt two sets of implementing   |
|   |         |     policies or the most restrictive parts of each.     |
|   |         |     More importantly, other agencies have not issued    |
|   |         |     regulations in this area.                           |
|   |         |                                                         |
|   |         | 3.  Misconduct in Science regulations. Again, NSF and   |
|   |         |     NIH are the only two agencies which have            |
|   |         |     implemented formal regulations. Further, since the  |
|   |         |     federal wide change in the definition of misconduct |
|   |         |     in science, only one agency (NSF) has issued        |
|   |         |     regulations implementing the new definition. This   |
|   |         |     is extremely difficult and troublesome for          |
|   |         |     universities as they manage their institutional     |
|   |         |     programs in this extremely sensitive area.          |
|   |         |                                                         |
|   |         | 4.  Exclusions/changes from standard A-110 terms on FDP |
|   |         |     awards. Although the standard FDP terms are         |
|   |         |     extremely useful to universities, there are even    |
|   |         |     places within these terms where agencies have taken |
|   |         |     exception to selected "standard" FDP terms and      |
|   |         |     conditions. Although we recognize the need in       |
|   |         |     certain places, a move toward more uniformity would |
|   |         |     be welcome.                                         |
|   |         |                                                         |
|   |         | 5.  Payment of academic year salary to faculty. Again,  |
|   |         |     the policy varies widely among agencies and, more   |
|   |         |     importantly, can vary even within one agency.       |
|   |         |                                                         |
|   |         | 6.  Limitation on salary levels. Although these         |
|   |         |     limitations are generally statutorily based (such   |
|   |         |     as the NIH limitation), it creates disincentives    |
|   |         |     for faculty to seek certain types of funding, or it |
|   |         |     creates a financial burden on an institution to     |
|   |         |     supplement what the agency pays to bring an         |
|   |         |     investigator to full salary.                        |
|   |         |                                                         |
|   |         | 7.  Audits. When OMB A-133 was adopted, it regularized  |
|   |         |     what was known as the "single audit." This was a    |
|   |         |     positive step, but subsequent changes in the        |
|   |         |     administration of that circular is beginning to     |
|   |         |     create problems. The latest difficulty is the       |
|   |         |     requirement of institutions of higher education to  |
|   |         |     be responsible to do site visits and other more     |
|   |         |     extensive audits of other institutions of higher    |
|   |         |     education who serve as subrecipients on federal     |
|   |         |     awards. \[This issue is being addressed by the FDP  |
|   |         |     currently and we are attaching information on this  |
|   |         |     effort.\]                                           |
|   |         |                                                         |
|   |         | 8.  Cost sharing. Agencies differ substantially in      |
|   |         |     their requirement for cost sharing on research      |
|   |         |     awards. Universities welcomed the NSF position on   |
|   |         |     cost sharing as described most recently in its      |
|   |         |     Important Notice 123 and we urge that the clarity   |
|   |         |     of the NSF position be carried into other agencies  |
|   |         |     as a standard policy and procedure.                 |
|   |         |                                                         |
|   |         | 9.  The issue of the OMB circulars**.** Written         |
|   |         |     originally as policy documents, the circulars have  |
|   |         |     become more precise and transaction oriented. For   |
|   |         |     example, the A-21 requirements for payroll          |
|   |         |     distribution ("effort reporting") are               |
|   |         |     excruciatingly detailed and subject to any          |
|   |         |     different interpretations. Perhaps the most         |
|   |         |     emotional of the more recent changes is the issue   |
|   |         |     of the payment of administrative and clerical       |
|   |         |     salaries, but it is by no means the only issue of   |
|   |         |     concern. With regard on OMB CircularA-21, a major   |
|   |         |     issue for higher education is the increasing        |
|   |         |     limitation on reimbursement through the F&A process |
|   |         |     of costs incurred for legitimate research purposes. |
|   |         |     Equally importantly, many universities believe the  |
|   |         |     inconsistent application of the requirements of OMB |
|   |         |     Circular A-110 have created problems. As cited      |
|   |         |     above, the use of the FDP standard terms and        |
|   |         |     conditions would be an asset, we believe, to both   |
|   |         |     the government and the university community.        |
|   |         |                                                         |
|   |         | In regard to specific examples, we call your attention  |
|   |         | to the COGR document recently submitted to OSTP on the  |
|   |         | increase in recent years of regulatory burdens -- both  |
|   |         | in terms of time requirements and financial burdens,    |
|   |         | many of which are not value added for colleges and      |
|   |         | universities.                                           |
|   |         |                                                         |
|   |         | In addition, the Federal Demonstration Partnership is   |
|   |         | in the process of a long-term study of institutional    |
|   |         | burdens (IRAB, Initiative to Reduce Administrative      |
|   |         | Burdens) related to the OMB circulars. We are attaching |
|   |         | to this letter the white papers which have been         |
|   |         | produced describing a number of on-going initiatives.   |
+---+---------+---------------------------------------------------------+
|   | **      | Cross-disciplinary research efforts (and oversight of   |
|   | Harvard | research by university-wide administrators and          |
|   | Unive   | designated cognizant agencies) make differences in      |
|   | rsity** | agency policies evident. Two examples of different      |
|   |         | mores in disciplines that the policies and practices of |
|   |         | different agencies display are associated with: (i) the |
|   |         | "transition point" from student to employee in a        |
|   |         | researcher's career trajectory; and (ii) payment of     |
|   |         | academic year salaries by grants and contracts.         |
|   |         |                                                         |
|   |         | Notwithstanding the difference in mores that may        |
|   |         | explain some of the inconsistencies that are so evident |
|   |         | in multidisciplinary initiatives, and that burden       |
|   |         | administrators and auditors, we are convinced that some |
|   |         | simplifications are possible. For example:              |
|   |         |                                                         |
|   |         | -   Cost sharing policies. NSF cost-sharing policies    |
|   |         |     are clear and unambiguous. Research managers must   |
|   |         |     account for time committed to projects, not for all |
|   |         |     of their time (since, in general, none of that time |
|   |         |     is charged to contracts)                            |
|   |         |                                                         |
|   |         | -   Teaching by federally compensated students and      |
|   |         |     staff. Most agencies allow students and             |
|   |         |     postdoctoral fellows to teach. Here too, the NSF    |
|   |         |     has issued an agency-wide guideline. By contrast,   |
|   |         |     our request to HHS for an agency-wide guideline has |
|   |         |     elicited a response that individual institutes      |
|   |         |     within the NIH wish to reserve the authority to     |
|   |         |     make such judgments on a case-by-case basis. In     |
|   |         |     addition to inconsistency, such an approach is      |
|   |         |     needlessly cumbersome.                              |
|   |         |                                                         |
|   |         | -   The ambiguities produced by classifying some life   |
|   |         |     science federally-funded post doctoral fellows as   |
|   |         |     \"employees\" and others as \"students\" has made   |
|   |         |     the administration of benefits and other            |
|   |         |     administrative functions more difficult for         |
|   |         |     universities, with no apparent compensating         |
|   |         |     benefits                                            |
|   |         |                                                         |
|   |         | -   Sometimes we find that various arms *within a       |
|   |         |     single federal agency* are not in close             |
|   |         |     communication or aligned. Members of the audit arm  |
|   |         |     of an agency have on occasion disallowed precisely  |
|   |         |     the same costing practice that program officers     |
|   |         |     have approved. This causes many internal problems,  |
|   |         |     misunderstandings and ultimately, audit findings    |
|   |         |     when many believe they are following the rules!     |
|   |         |                                                         |
|   |         | -   Under the *Cost Accounting Standards,* Harvard      |
|   |         |     University consists of three "segments" with three  |
|   |         |     indirect cost rates. One of our segments has an     |
|   |         |     approved The Disclosure Statement of one of our     |
|   |         |     segments has been reviewed and approved by DCA and  |
|   |         |     audited by the Inspector General\'s office. There   |
|   |         |     has been no contact to follow up on the other two   |
|   |         |     segments submitted DS-2s for review in 1998. Our    |
|   |         |     external auditors want to write a finding about     |
|   |         |     this annually when in fact, the finding should be   |
|   |         |     about the federal agencies not coordinating their   |
|   |         |     practices. If HHS does not have the staffing        |
|   |         |     available to read and opine on the Disclosure       |
|   |         |     Statements, should we be held accountable for       |
|   |         |     writing them and keeping them current? One wonders  |
|   |         |     if HHS still believes in the usefulness of the DS-2 |
|   |         |     to manage grantees?                                 |
|   |         |                                                         |
|   |         | -   A last example is the Single Audit. Our             |
|   |         |     understanding is that all federal audits of direct  |
|   |         |     costs fall within the OMB Circular A-133 audit. It  |
|   |         |     seems duplicative when certain federal agencies     |
|   |         |     require that certain awards be selected for A-133   |
|   |         |     audit, or insist on conducting their own similar,   |
|   |         |     but independent audits.                             |
+---+---------+---------------------------------------------------------+
|   | *       | There should be a mechanism in place in order to        |
|   | *Humane | increase communication between the USDA and the         |
|   | S       | National Institutes of Health funding and grants        |
|   | ociety\ | offices regarding Animal Welfare Act violators. The     |
|   | **      | current funding system provides millions of federal     |
|   |         | dollars to some institutions, and these funds continue  |
|   |         | even if the institution is fined for Animal Welfare Act |
|   |         | violations. Additionally, these funds could actually be |
|   |         | used to pay for the violations. An improved system      |
|   |         | would involve funding consequences for those            |
|   |         | institutions that are fined for Animal Welfare Act      |
|   |         | violations; such a system would improve animal welfare  |
|   |         | as well as accountability.                              |
+---+---------+---------------------------------------------------------+
|   | **Joint | Inconsistent agency reporting requirements exacerbate   |
|   | AAU-    | the problems universities confront in providing         |
|   | NASULGC | effective, efficient reporting. A case in point is      |
|   | L       | electronic grant applications, which hold promise for   |
|   | etter** | administrative simplification but have yet to be        |
|   |         | implemented in a common fashion. We also note the need  |
|   |         | for more consistency and uniformity in grant sizes,     |
|   |         | durations and success rates across federal agencies.    |
+---+---------+---------------------------------------------------------+
|   | **Roger | One of the inconsistencies in Federal policies has been |
|   | A.      | the distinction made between basic and applied          |
|   | Fa      | research. The point is that the distinction should be   |
|   | rrell** | (and actually is) between Science - curiosity driven    |
|   |         | research - and Technology (use driven research). Not    |
|   | Supe    | between Basic and Applied - which are ill defined terms |
|   | rPower, | at best. This is important because Technology research  |
|   | I       | must contain a basic component - where new technology   |
|   | nc**.** | is created - or the greatest opportunities are missed.  |
|   |         | It is very difficult to get federal funding for basic   |
|   |         | technology research for a couple of reasons: policy     |
|   |         | makers haven\'t heard of it, and more importantly,      |
|   |         | think this type of research should be done under        |
|   |         | federal science funding. We need continued federal      |
|   |         | support of science - but we also have to solve the      |
|   |         | problem of there not being a place for basic technology |
|   |         | research. A key difference between science and          |
|   |         | technology is that technology research is almost always |
|   |         | multidisciplinary, making strong management of research |
|   |         | teams essential.                                        |
|   |         |                                                         |
|   |         | Another inconsistency is the definition of "small       |
|   |         | business" as used for Federal government agency SBIR    |
|   |         | programs. The Small Business Administration has         |
|   |         | established standards on an industry by industry basis. |
|   |         | For example, one SBA standard for "small" is less than  |
|   |         | 750 employees. Various Federal agencies such as DOE and |
|   |         | DOD use there own: 500 employees. There should be one   |
|   |         | standard that applies to all SBIR programs. SuperPower  |
|   |         | believes this standard should be 750 employees.         |
+---+---------+---------------------------------------------------------+
|   | **S     | Federal agencies should work to eliminate barriers      |
|   | tanford | caused by artificial distinctions between research and  |
|   | Unive   | education (and public service). In the current research |
|   | rsity** | environment, a student receiving a stipend on a         |
|   |         | fellowship may perform identical work to the salaried   |
|   |         | student sitting at the bench next to her, but receive   |
|   |         | very different levels of compensation (including        |
|   |         | benefits and eligibility for tuition remission) and be  |
|   |         | treated differently for tax purposes, VISA eligibility, |
|   |         | and health care benefits. It is essential that the      |
|   |         | "dual role" of research and education for graduate      |
|   |         | students and postdoctoral scholars be recognized and    |
|   |         | artificial barriers removed.                            |
|   |         |                                                         |
|   |         | Federal agencies should promote the use of business     |
|   |         | models that limit data collection to information that   |
|   |         | is critical and timely to decision-making, and that     |
|   |         | recognizes existing roles and responsibilities in the   |
|   |         | research enterprise. Excellent examples of this model   |
|   |         | are NIH's Modular Grant and Just-in-Time mechanisms,    |
|   |         | both of which warrant extension to other agencies.      |
+---+---------+---------------------------------------------------------+
|   | **The   | For sheer counterproductiveness, the DOD insistence on  |
|   | San     | spending rates, such that PIs have had to skew their    |
|   | Diego   | work in order to spend money at some more or less       |
|   | Science | canonical pace instead of spending at programmatically  |
|   | and     | sensible times, takes first place. NOAA\'s apparent     |
|   | Tech.   | inability to cope with the fiscal year boundary         |
|   | Co      | contrasts sharply with, say, NSF, and threatens to      |
|   | uncil** | torpedo NOAA projects that require funds early in the   |
|   |         | new FY. It\'s in second place, right behind DOD. For    |
|   |         | ease of managing funds to suit projects, NSF seems to   |
|   |         | be the best one to emulate. Not perfect, but better     |
|   |         | than others                                             |
+---+---------+---------------------------------------------------------+
|   | **Uni   | The implementation of more common policies, practices   |
|   | versity | and administrative systems across all federal agencies  |
|   | of      | would improve the efficiency and the cost effectiveness |
|   | Calif   | of recipients' research administration. Among the many  |
|   | ornia** | federal requirements of which recipients must be        |
|   |         | knowledgeable and capable of administering multiple     |
|   |         | systems and rules are:                                  |
|   |         |                                                         |
|   |         | • Invoicing and payment systems: Currently, our         |
|   |         | institution is required to use over 15 different        |
|   |         | federal invoicing and payment procedures/systems,       |
|   |         | despite the federal Treasury Department rule to require |
|   |         | government agencies to use only one of two or three     |
|   |         | payment systems.                                        |
|   |         |                                                         |
|   |         | • Indirect cost rate and base exceptions: Federal       |
|   |         | agencies limit the proper use of federally negotiated   |
|   |         | indirect cost rates on hundreds of individual programs, |
|   |         | continually making exceptions to standard approved      |
|   |         | rates and well as creating a variety of bases against   |
|   |         | which these restrictive rates must be charged.          |
|   |         |                                                         |
|   |         | • Cost Principles: Federal agencies do not uniformly    |
|   |         | implement the federal cost principals set forth in OMB  |
|   |         | Circular A-21. Agencies disallow a variety of allowable |
|   |         | costs such as tuition, benefits, or travel in           |
|   |         | individual programs.                                    |
|   |         |                                                         |
|   |         | • Inconsistent definitions for cost sharing: Some       |
|   |         | agencies restrict what is allowable cost sharing, such  |
|   |         | as unrecovered indirect costs.                          |
|   |         |                                                         |
|   |         | • Multiple electronic proposal submission, award        |
|   |         | administration and reporting systems: Universities are  |
|   |         | required to have the expertise, software, and hardware  |
|   |         | to use more than ten different federal electronic       |
|   |         | proposal, award, and reporting systems. The continuous  |
|   |         | development of these systems adds to the university's   |
|   |         | research infrastructure expense burden.                 |
|   |         |                                                         |
|   |         | • Inconsistent terms regarding treatment of data.       |
|   |         | Federal agreement terms applying to the treatment of    |
|   |         | data are becoming increasingly inconsistent with and    |
|   |         | contradictory to the essential federal premise that     |
|   |         | research is either classified or unclassified. We are   |
|   |         | concerned about some federal agencies' insertion of     |
|   |         | publication restrictions into grants and contracts for  |
|   |         | unclassified fundamental research deemed to be          |
|   |         | "sensitive."                                            |
|   |         |                                                         |
|   |         | Adding to this problem is the improper application of   |
|   |         | export control regulations to basic research.           |
|   |         |                                                         |
|   |         | • Inconsistent terms regarding treatment of inventions. |
|   |         | Federal agreement terms applying to the treatment of    |
|   |         | inventions are becoming increasingly inconsistent with  |
|   |         | and contradictory to the tenets of the federal          |
|   |         | Bayh-Dole Act (35 U.S.C. 200-212).                      |
|   |         |                                                         |
|   |         | • Lack of government-wide adoption of common rules as   |
|   |         | applied to such compliance requirements as misconduct   |
|   |         | in science and disclosure of financial conflict of      |
|   |         | interest adds unnecessary complexity and cost to        |
|   |         | recipients.                                             |
|   |         |                                                         |
|   |         | [Recommendations]{.underline}:                          |
|   |         |                                                         |
|   |         | \-- We recommend that electronic proposal and progress  |
|   |         | report submission systems continue to be developed and, |
|   |         | most importantly, standardized as much as possible. The |
|   |         | NSF FastLane system is a prime example of an efficient  |
|   |         | electronic submission system; it is accessible to       |
|   |         | principal investigators, staff support personnel, and   |
|   |         | administrators. We caution against the development of   |
|   |         | numerous, competing electronic submissions systems that |
|   |         | may create significant confusion and jeopardize timely  |
|   |         | submission.                                             |
|   |         |                                                         |
|   |         | \-- Examine best practices, where agencies have adopted |
|   |         | consistent approaches, such as:                         |
|   |         |                                                         |
|   |         | \- Department of Health and Human Services (DHHS) Human |
|   |         | Subjects regulations, which have been adopted by all    |
|   |         | agencies as a common rule.                              |
|   |         |                                                         |
|   |         | \- Adherence to standardized invention terms under the  |
|   |         | Bayh-Dole Act across all agencies for all Federal       |
|   |         | awards to universities at the prime and subrecipient    |
|   |         | levels.                                                 |
+---+---------+---------------------------------------------------------+
|   | **Uni   | \(1\) For consistent management of grants, OMB should   |
|   | versity | re-state section 25 and require all agencies to         |
|   | of      | re-codify. One example of a clearly written section 25  |
|   | Fl      | was accomplished by the EPA, which could be used as the |
|   | orida** | standard. (2) Lack of clarity about cost sharing and    |
|   |         | expectations is still a problem as many agency issue    |
|   |         | request for proposals or program guidelines that make   |
|   |         | ambiguous statements such as "cost sharing is highly    |
|   |         | recommended" or "cost sharing is strongly encouraged"   |
|   |         | with no further explanation as to how such cost sharing |
|   |         | will be used in the award selection process. (3) We see |
|   |         | a growing number of special indirect cost rates that    |
|   |         | are being imposed upon grantees through special         |
|   |         | programs announcements. It would be preferred that all  |
|   |         | programs should use the Federal negotiated rates of an  |
|   |         | institution and not have selective programs with        |
|   |         | special rates. (4) The University of Florida uses       |
|   |         | multiple payment systems deployed by various federal    |
|   |         | agencies. A description of each is provided below.      |
|   |         | Having multiple payment systems has increased costs.    |
|   |         | (see included table for details). To promote cost       |
|   |         | efficiencies one payment system should be deployed for  |
|   |         | use by all federal agencies                             |
+---+---------+---------------------------------------------------------+
|   | **Uni   | The lack of consistency in guidelines for proposals to  |
|   | versity | different agencies not only imposes an additional       |
|   | of      | administrative burden but also requires a tremendous    |
|   | Idaho** | amount of time and attention to detail on the part of   |
|   |         | everyone from the PI to the Dean. This adds to the      |
|   |         | administrative costs, but it is a "hidden" cost in that |
|   |         | it mostly takes up a large amount of a lot of people's  |
|   |         | time. Time is the most undervalued resource, but it has |
|   |         | real costs to the research enterprise, in two ways.     |
|   |         | First, at the level of the PI, it takes time away from  |
|   |         | research. Second, at all levels, it is expensive in     |
|   |         | that the extra time required to make sure that          |
|   |         | proposals have followed the proper guidelines for a     |
|   |         | particular agency costs between \$15-75/hour, with an   |
|   |         | emphasis in the middle of the range (where most PIs     |
|   |         | sit; this is including benefits).                       |
|   |         |                                                         |
|   |         | Reduce or eliminate multiple and overlapping agency     |
|   |         | audit requirements.                                     |
|   |         |                                                         |
|   |         | Agencies have implemented conflict of interest and      |
|   |         | misconduct/ethics policies that are not entirely        |
|   |         | consistent. There should be a set of policies           |
|   |         | consistent across government agencies.                  |
|   |         |                                                         |
|   |         | With the variations in the application of cost-sharing, |
|   |         | facility & administrative cost recovery, publication,   |
|   |         | and other grant & contract terms by the funding         |
|   |         | agencies, universities may be incited to shop for the   |
|   |         | best deal. This results in shifts in research focus or  |
|   |         | capacity that could deplete, in time, the nation's      |
|   |         | ability to respond to certain urgent needs. We are      |
|   |         | presently making strategic decisions based, in part, on |
|   |         | issues such as cost-sharing and administrative burden.  |
|   |         | A consistent application of rules and regulations       |
|   |         | across all federal agencies would remove this barrier.  |
|   |         |                                                         |
|   |         | Research administration costs should not be capped.     |
|   |         | Properly managed and audited, these are legitimate      |
|   |         | research costs.                                         |
|   |         |                                                         |
|   |         | Consistent application of the negotiated F&A rate is    |
|   |         | critical. Institutions must be able to recover          |
|   |         | legitimate research costs. For example, the Utility     |
|   |         | Cost Adjustment should be expanded to include all       |
|   |         | institutions.                                           |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Applications:                                           |
|   | versity |                                                         |
|   | of      | -   establish standard data elements for required       |
|   | Iowa**  |     general and budgetary information;                  |
|   |         |                                                         |
|   |         | -   eliminate burdensome and ambiguous cost-sharing     |
|   |         |     requirements;                                       |
|   |         |                                                         |
|   |         | -   eliminate unnecessary certifications and            |
|   |         |     assurances;                                         |
|   |         |                                                         |
|   |         | -   establish common language for assurances;           |
|   |         |                                                         |
|   |         | -   improve the process for sharing information about   |
|   |         |     certifications and assurances among federal         |
|   |         |     agencies; and                                       |
|   |         |                                                         |
|   |         | -   state clearly any cost-sharing or matching          |
|   |         |     requirements and avoid vague references to          |
|   |         |     expectations of institutional contributions.        |
|   |         |                                                         |
|   |         | Awards:                                                 |
|   |         |                                                         |
|   |         | -   establish standard data elements for information on |
|   |         |     award documents;                                    |
|   |         |                                                         |
|   |         | -   eliminate agency-specific terms and conditions      |
|   |         |     found to be unnecessary;                            |
|   |         |                                                         |
|   |         | -   state explicitly whether or not expanded            |
|   |         |     authorities apply or not;                           |
|   |         |                                                         |
|   |         | -   state explicitly both mandatory and voluntary       |
|   |         |     committed cost-sharing expectations;                |
|   |         |                                                         |
|   |         | -   develop common language for award terms and         |
|   |         |     conditions, including administrative and public     |
|   |         |     policy requirements; and                            |
|   |         |                                                         |
|   |         | -   achieve greater uniformity in placement of terms    |
|   |         |     and conditions within award documents.              |
|   |         |                                                         |
|   |         | Reporting:                                              |
|   |         |                                                         |
|   |         | -   develop standards, including standard data          |
|   |         |     elements, for property, invention, and              |
|   |         |     environmental reporting;                            |
|   |         |                                                         |
|   |         | -   eliminate unnecessary differences in the required   |
|   |         |     number of report copies and frequency of reporting; |
|   |         |     and                                                 |
|   |         |                                                         |
|   |         | -   provide technical assistance and training for award |
|   |         |     recipients and identify federal agency best         |
|   |         |     practices.                                          |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Perhaps it would be beneficial if the activities of the |
|   | versity | committee focused on clarifying grant, cooperative      |
|   | of      | agreement and contract. It seems that over the years    |
|   | Ken     | some agencies have allowed procurement "behavior" to    |
|   | tucky** | slip into assistance mechanisms and that such blurring  |
|   |         | may create tensions in the oversight of awards. This    |
|   |         | could help agencies clearly stake out areas that are    |
|   |         | assistance and mechanism and then disengage from some   |
|   |         | of the detailed reporting (either in application,       |
|   |         | progress or final reports) with a clear understanding   |
|   |         | that the goal is to support the science and the outcome |
|   |         | of interest is the science. The institution itself will |
|   |         | adhere to typical financial oversight, but it will not  |
|   |         | be central to the agency oversight. If the perception   |
|   |         | -- and the reality -- is that the funding agencies are  |
|   |         | overly focused on administrative overview it will erode |
|   |         | their role of partner in the ultimate purpose of the    |
|   |         | support, the advancement of the science. When their     |
|   |         | oversight is duplicative of the institutional oversight |
|   |         | it risks being an activity with very low return for the |
|   |         | agency.                                                 |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Consistent agency practices among all agencies funding  |
|   | versity | extramural research would be an improvement and quite   |
|   | of      | helpful                                                 |
|   | Pitts   |                                                         |
|   | burgh** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Another area of improving performance and management of |
|   | versity | federally funded research is in the cost principles     |
|   | R       | applied to contracts for research. While improvements   |
|   | esearch | have been made such as the greater use of FAR cost      |
|   | A       | principles, there should be more use of common and      |
|   | ssoc.** | consistent Government cost principles, particularly as  |
|   |         | it regards contract overhead costs and Bid & Proposal   |
|   |         | (B&P) costs. For example, some federal agencies limit   |
|   |         | the reimbursement of overhead by applying caps or       |
|   |         | ceilings. If overhead costs meet the test of            |
|   |         | allowability they are a real expense and should be      |
|   |         | reimbursed in full.                                     |
+---+---------+---------------------------------------------------------+
|   |         |                                                         |
+---+---------+---------------------------------------------------------+
|   |         |                                                         |
+---+---------+---------------------------------------------------------+
| * |         |                                                         |
| * |         |                                                         |
| C |         |                                                         |
| . |         |                                                         |
| I |         |                                                         |
| N |         |                                                         |
| C |         |                                                         |
| O |         |                                                         |
| N |         |                                                         |
| S |         |                                                         |
| I |         |                                                         |
| S |         |                                                         |
| T |         |                                                         |
| E |         |                                                         |
| N |         |                                                         |
| C |         |                                                         |
| Y |         |                                                         |
| O |         |                                                         |
| F |         |                                                         |
| P |         |                                                         |
| O |         |                                                         |
| L |         |                                                         |
| I |         |                                                         |
| C |         |                                                         |
| I |         |                                                         |
| E |         |                                                         |
| S |         |                                                         |
| A |         |                                                         |
| N |         |                                                         |
| D |         |                                                         |
| P |         |                                                         |
| R |         |                                                         |
| A |         |                                                         |
| C |         |                                                         |
| T |         |                                                         |
| I |         |                                                         |
| C |         |                                                         |
| E |         |                                                         |
| S |         |                                                         |
| A |         |                                                         |
| M |         |                                                         |
| O |         |                                                         |
| N |         |                                                         |
| G |         |                                                         |
| U |         |                                                         |
| N |         |                                                         |
| I |         |                                                         |
| V |         |                                                         |
| E |         |                                                         |
| R |         |                                                         |
| S |         |                                                         |
| I |         |                                                         |
| T |         |                                                         |
| I |         |                                                         |
| E |         |                                                         |
| S |         |                                                         |
| * |         |                                                         |
| * |         |                                                         |
+---+---------+---------------------------------------------------------+
|   | **A     | **See entry under B. Inconsistency of policies and      |
|   | merican | practices among Federal Agencies**                      |
|   | An      |                                                         |
|   | ti-Vivi |                                                         |
|   | section |                                                         |
|   | Soc.**  |                                                         |
+---+---------+---------------------------------------------------------+
|   | *       | I wish to express my strong endorsement of the          |
|   | *Viktor | requirement for biomedical investigators to do a        |
|   | Rein    | thorough literature search for Alternatives. The        |
|   | hardt** | literature search for Alternatives - Refinement,        |
|   |         | Reduction and Replacement - can be accomplished         |
|   | Animal  | nowadays without much effort and time input and with no |
|   | Welfare | or little expenses. The databases are comprehensive and |
|   | Inst.   | available to every scientist who has access to the      |
|   |         | Internet. This literature search should be a basic      |
|   |         | requirement for any biomedical scientist BEFORE he/she  |
|   |         | drafts a research proposal. It will be one fundamental  |
|   |         | warranty that research will be conducted following      |
|   |         | fundamental principles of reliable scientific           |
|   |         | methodology - minimizing data variation - and that      |
|   |         | excessive numbers of animals will not be used in        |
|   |         | research. This not only reduces research costs but also |
|   |         | eliminates unnecessary animal suffering.                |
+---+---------+---------------------------------------------------------+
|   | **Roger | The cost effectiveness of a research enterprise would   |
|   | A.      | be improved if the patent policies of universities were |
|   | Fa      | more favorable to commercialization by industry. The    |
|   | rrell** | Bayh/Dole Act grants universities the rights to         |
|   |         | intellectual property for federally funded programs but |
|   | Supe    | does not restrict what universities do with it. Some    |
|   | rPower, | universities and states, however, have policies that,   |
|   | I       | in effect, prevent collaboration with industry.         |
|   | nc**.** |                                                         |
|   |         | In other instances royalty payments or licensing fees   |
|   |         | are initially too high discouraging industry            |
|   |         | evaluation. A policy whereby initial payments to the    |
|   |         | university are lower during the merit evaluation        |
|   |         | (through prototype demonstration) and increase only if  |
|   |         | production is reached would encourage                   |
|   |         | commercialization.                                      |
+---+---------+---------------------------------------------------------+
|   | **      | F&A waivers or reductions. Some institutions do not     |
|   | Federal | waive or reduce the collection of F&A on research       |
|   | Demons  | awards. If not paid by the sponsor (federal or          |
|   | tration | non-federal), the department/laboratory/center must     |
|   | Pr      | provide the funding or the proposal will not be         |
|   | oject** | processed. This is not standard across the university   |
|   |         | community. Although we do not argue that every          |
|   |         | institution must respond in exactly the same fashion    |
|   |         | and there may be differences among institutions (not    |
|   |         | dissimilar from the statutory differences that are      |
|   |         | imposed on selected programs or agencies, it is fair to |
|   |         | point out that this is an area of institutional         |
|   |         | inconsistency.                                          |
|   |         |                                                         |
|   |         | Acceptance of certain terms/conditions of awards.       |
|   |         | Institutions have a variety of policies and practices;  |
|   |         | in many instances, what one university will accept (for |
|   |         | example, restrictions on publications), another will    |
|   |         | not. This creates differences between institutions and  |
|   |         | can lead to difficulties for both sponsors and          |
|   |         | recipients of funding. We suspect it is difficult for a |
|   |         | federal sponsor to understand why---in placing awards   |
|   |         | at a number of institutions under one program           |
|   |         | announcement---the terms and conditions must often be   |
|   |         | negotiated individually.                                |
+---+---------+---------------------------------------------------------+
|   | **      | -   Some of our peer institutions treat "trainee post   |
|   | Harvard |     docs" as students and others as employees           |
|   | Unive   |                                                         |
|   | rsity** | -   Effort reporting/salary distribution reporting is   |
|   |         |     accomplished differently at our peer institutions.  |
|   |         |     This difference reflects different interpretations  |
|   |         |     of rules that should be clarified and simplified in |
|   |         |     A-21 (in a joint effort with FDP)                   |
|   |         |                                                         |
|   |         | -   Public and private universities have different      |
|   |         |     accounting standards, i.e., GASB and FASB,          |
|   |         |     respectively. In making comparisons, Federal        |
|   |         |     agencies should recognize different accounting      |
|   |         |     standards might result in inconsistent costing      |
|   |         |     methods and reimbursement levels for similar        |
|   |         |     research activities.                                |
+---+---------+---------------------------------------------------------+
|   | **Mass. | Some scientists have resorted to going through the      |
|   | SPCA**  | motions of making data base searches simply to fulfill  |
|   |         | the Animal Welfare Act requirement, knowing in advance  |
|   |         | that the effort will accomplish little or no meaningful |
|   |         | results. This approach has furthered the opinion among  |
|   |         | some researchers that this regulation is a burden and   |
|   |         | should be eliminated, because it is not accomplishing   |
|   |         | any improvement in animal welfare. Institutions should  |
|   |         | be focused on the importance of pain relief and should  |
|   |         | be developing methods to identify all possible          |
|   |         | approaches to accomplish this important goal. It is not |
|   |         | the lack of ability to properly search for alternative  |
|   |         | methods to painful procedures that is the problem,      |
|   |         | after all, these are research institutions with many of |
|   |         | the world\'s most capable scientists. The problem is    |
|   |         | institutional commitment to developing a culture that   |
|   |         | places a priority on pain relief in research animals.   |
+---+---------+---------------------------------------------------------+
|   | **Uni   | FDP identified inconsistent policies and practices      |
|   | versity | between institutions when sub-awarding or               |
|   | of      | subcontracting effort under a prime grant agreements    |
|   | Fl      | was to occur. 768 sub-awards using the model sub-award  |
|   | orida** | agreement form have been issued. 746 of these were      |
|   |         | issued without changes, 11 cases required major changes |
|   |         | to be negotiated prior to signature. On average,        |
|   |         | institutions saved 21 pages per sub-award issued, 73%   |
|   |         | of those responding reported time savings               |
+---+---------+---------------------------------------------------------+
|   | **Univ. | University policies and practices dealing with research |
|   | of      | issues are often reactive to agency interpretations of  |
|   | Roch    | federal requirements. As an example, our misconduct     |
|   | ester** | policy was revised several years ago at the request of  |
|   |         | PHS to ensure that PHS was specifically identified as a |
|   |         | stakeholder and that the policy aligned to its own      |
|   |         | research misconduct policy. The university community    |
|   |         | welcomed OSTP's federal-wide misconduct policy, yet PHS |
|   |         | has not yet implemented the federal standards. It does  |
|   |         | beg the question of what is expected of the university  |
|   |         | community? This is only one small example. As noted by  |
|   |         | COGR, the inconsistency of agency implementations of    |
|   |         | the administrative requirements of OMB Circular A-110   |
|   |         | leave faculty and department administrators baffled at  |
|   |         | best. Universities must and should uphold regulatory    |
|   |         | and administrative requirements, but they must be       |
|   |         | applied by the federal agencies in a consistent manner  |
|   |         | and allow for sufficient flexibility to incorporate     |
|   |         | these into the University's management and              |
|   |         | administrative structure.                               |
+---+---------+---------------------------------------------------------+
|   | **Uni   | • Use of model subagreements and subcontracts: The      |
|   | versity | Federal Demonstration Partnership has produced model    |
|   | of      | subagreements and subcontracts for educational          |
|   | Calif   | institutions and nonprofit organizations to use when    |
|   | ornia** | subawarding federal funds to one other. Wide-spread     |
|   |         | adoption and use of these models would streamline the   |
|   |         | subaward process for these recipients.                  |
|   |         |                                                         |
|   |         | • Consistent application of federal indirect cost rates |
|   |         | on federally funded subawards: Too often, prime         |
|   |         | recipients of federal awards refuse to allow their      |
|   |         | subrecipients to charge their applicable federal        |
|   |         | indirect cost rates.                                    |
|   |         |                                                         |
|   |         | • Subrecipient monitoring: The A-133 Audit Compliance   |
|   |         | Guide needs to make clear that subrecipients are not    |
|   |         | required to provide a copy of their A-133 audits to     |
|   |         | prime institutions. What is required is that the prime  |
|   |         | recipient verify on the Federal Audit Clearinghouse     |
|   |         | website that there are no audit findings in relation to |
|   |         | a specific subaward. Clarifying this procedure would    |
|   |         | help reduce the need for the subrecipient to produce    |
|   |         | addition and unnecessary paperwork.                     |
+---+---------+---------------------------------------------------------+
|   | **A     | The U.S. Department of Agriculture (USDA) does not      |
|   | merican | cover birds, mice, and rats (among other species)       |
|   | An      | through law enforcement of the Animal Welfare Act, but  |
|   | ti-Vivi | these animals are covered under Public Health Service   |
|   | section | Policy. Therefore, if projects involving these animals  |
|   | So      | are conducted and not funded by the federal government, |
|   | ciety** | the investigators may not have to abide by basic        |
|   |         | standards of humane care and use, including review of   |
|   |         | the research protocol by an Institutional Care and Use  |
|   |         | Committee (IACUC). This giant loophole not only leads   |
|   |         | to significant animal welfare concerns, but also puts   |
|   |         | the scientific rigor and standardization of such        |
|   |         | projects into question. It is important that animals    |
|   |         | commonly used in laboratories---such as birds, mice,    |
|   |         | and rats who represent over 95% of warm-blooded animals |
|   |         | used--- receive basic protections and that all          |
|   |         | researchers using these animals adhere to the same      |
|   |         | basic standards.                                        |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Collaborations or consortia of grantee institutions     |
|   | versity | have become commonplace and will increase since NIH     |
|   | of      | places interdisciplinary research as a high priority,   |
|   | Iowa**  | but the subcontracting process is more burdensome than  |
|   |         | it ought to be. Universities and state agencies put     |
|   |         | into their subagreements with collaborating             |
|   |         | universities terms and conditions that they themselves  |
|   |         | would strongly object to if the agreements were coming  |
|   |         | directly from federal agencies. Examples include        |
|   |         | unacceptable indemnification and insurance clauses,     |
|   |         | publication restrictions, and prior approval            |
|   |         | requirements that exceed minimum requirements of A-110  |
|   |         | and similar circulars. Subagreements between            |
|   |         | universities generally require months to negotiate,     |
|   |         | severely hampering the research process. The entire     |
|   |         | subcontracting process, including the requirements for  |
|   |         | monitoring and audit, needs to be streamlined. The      |
|   |         | Federal Demonstration Project is making great strides   |
|   |         | at simplifying the process, but the federal government  |
|   |         | should initiate a study of the problems and develop     |
|   |         | recommendations on ways to simplify the process even    |
|   |         | further, at least for subagreements under grants.       |
|   |         |                                                         |
|   |         | Similar problems occur to an even greater extent with   |
|   |         | Material Transfer Agreements, or MTAs. Providers of     |
|   |         | research materials impose excessive indemnification     |
|   |         | requirements and intellectual property stipulations     |
|   |         | that virtually make it impossible for public            |
|   |         | institutions to have easy access to these important     |
|   |         | research materials. The simplified form that NIH        |
|   |         | developed and promoted several years ago needs to be    |
|   |         | streamlined further and made mandatory for MTAs         |
|   |         | associated with NIH grants. NIH consistently violates   |
|   |         | its own best practices guidelines in this area by       |
|   |         | issuing MTAs with objectionable language and being      |
|   |         | unwilling to accept modifications.                      |
+---+---------+---------------------------------------------------------+
|   |         |                                                         |
+---+---------+---------------------------------------------------------+
| * |         |                                                         |
| * |         |                                                         |
| D |         |                                                         |
| . |         |                                                         |
| S |         |                                                         |
| T |         |                                                         |
| A |         |                                                         |
| T |         |                                                         |
| E |         |                                                         |
| A |         |                                                         |
| N |         |                                                         |
| D |         |                                                         |
| I |         |                                                         |
| N |         |                                                         |
| S |         |                                                         |
| T |         |                                                         |
| I |         |                                                         |
| T |         |                                                         |
| U |         |                                                         |
| T |         |                                                         |
| I |         |                                                         |
| O |         |                                                         |
| N |         |                                                         |
| A |         |                                                         |
| L |         |                                                         |
| R |         |                                                         |
| E |         |                                                         |
| Q |         |                                                         |
| U |         |                                                         |
| I |         |                                                         |
| R |         |                                                         |
| E |         |                                                         |
| M |         |                                                         |
| E |         |                                                         |
| N |         |                                                         |
| T |         |                                                         |
| S |         |                                                         |
| * |         |                                                         |
| * |         |                                                         |
+---+---------+---------------------------------------------------------+
|   | **      | The objectives of state audits are similar to those of  |
|   | Harvard | OMB Circular A-133. The practices of financial          |
|   | Unive   | accountability for Federal expenditures, as audited     |
|   | rsity** | under A-133, are no different than the practices used   |
|   |         | for state grants and contracts. Nonetheless, the        |
|   | (Tab    | Commonwealth of Massachusetts requires its grantees,    |
|   | #16)    | and the recipients of its Federal pass-through funding, |
|   |         | to submit annually an externally audited "Uniform       |
|   |         | Financial Statements and Independent Auditor's Report"  |
|   |         | (UFR). Grantees must also assure that sub-recipients    |
|   |         | comply with state UFR audit requirements.               |
|   |         |                                                         |
|   |         | Corroboration by this study of the duplicative nature   |
|   |         | of state audits of this type could be helpful in        |
|   |         | convincing states to eliminate them.                    |
+---+---------+---------------------------------------------------------+
|   | **Roger | New York State Research and Development Authority       |
|   | A.      | (NYSERDA) procedures and requirements are complementary |
|   | Fa      | to those of the Federal government. For example, U.S.   |
|   | rrell** | government overhead and G&A rates are used and U.S.     |
|   |         | Defense Contract Audit Agency (DCAA) audits are         |
|   | Supe    | accepted. NYSERDA has also accepted Federal government  |
|   | rPower, | agency reports, statements of works and milestones in   |
|   | I       | lieu of its own requirements in some cases. This        |
|   | nc**.** | reduces the administrative burden for industry and      |
|   |         | allows more funds to be spent on research. One of the   |
|   | (Tab    | most beneficial aspects of DOE and NYSERDA policy is    |
|   | #14)    | with respect to cost shared programs. For programs      |
|   |         | where both a Federal government agency and NYSERDA are  |
|   |         | contributing, Federal funds are considered to be part   |
|   |         | of industry cost share by NYSERDA and State funds are   |
|   |         | considered to be part of industry cost share by the     |
|   |         | Federal government.                                     |
|   |         |                                                         |
|   |         | SuperPower has also entered into research programs with |
|   |         | the Electric Power Research Institute (EPRI) and,       |
|   |         | again, found acceptance of Federal government rates and |
|   |         | audits. In summary, based on SuperPower's experience,   |
|   |         | States and institutional organizations make an effort   |
|   |         | to apply Federal requirements to their research         |
|   |         | programs. This reduces both industry and institutional  |
|   |         | administrative burden.                                  |
+---+---------+---------------------------------------------------------+
|   | **The   | Largely reactive. Most of the infuriating state and     |
|   | San     | university rules and restrictions would not exist if    |
|   | Diego   | not driven by federal requirements. And the             |
|   | Science | university\'s necessary overhead to administer funds in |
|   | and     | compliance with rules would be much less. Further, it   |
|   | Tech.   | is much easier to attack, and sometimes defeat,         |
|   | Co      | counterproductive rules that are self-inflicted at the  |
|   | uncil** | state or university level than it is to attack such     |
|   |         | rules with roots in federal requirements                |
|   | (Tab    |                                                         |
|   | #9)     |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Uni   | • States do not consistently "flow down" federal        |
|   | versity | regulations and OMB Circulars with federal funds.       |
|   | of      | Rather, they often apply more restrictive and in some   |
|   | Calif   | cases contradictory state rules to federal funds.       |
|   | ornia** |                                                         |
|   |         | Specific examples include: Restrictions on overhead     |
|   |         | recovery; restrictions on use of data, copyrights, and  |
|   |         | publications; additional audit requirements; lower      |
|   |         | equipment definition thresholds; re-budgeting           |
|   |         | restrictions; and invoicing documentation.              |
|   |         |                                                         |
|   |         | • Many state invoicing and payment systems require      |
|   |         | additional university administrative staffing for       |
|   |         | manual implementation. California state agencies, for   |
|   |         | example, do not have electronic invoicing/payment       |
|   |         | systems; require extensive detail and documentation;    |
|   |         | and are not consistent with OMB Circular A-21.          |
|   |         |                                                         |
|   |         | [Recommendation]{.underline}: Require states to "flow   |
|   |         | down" applicable federal rules in their federally       |
|   |         | funded subawards.                                       |
+---+---------+---------------------------------------------------------+
| * |         |                                                         |
| * |         |                                                         |
| E |         |                                                         |
| . |         |                                                         |
| R |         |                                                         |
| E |         |                                                         |
| G |         |                                                         |
| U |         |                                                         |
| L |         |                                                         |
| A |         |                                                         |
| T |         |                                                         |
| O |         |                                                         |
| R |         |                                                         |
| Y |         |                                                         |
| R |         |                                                         |
| E |         |                                                         |
| Q |         |                                                         |
| U |         |                                                         |
| I |         |                                                         |
| R |         |                                                         |
| E |         |                                                         |
| M |         |                                                         |
| E |         |                                                         |
| N |         |                                                         |
| T |         |                                                         |
| S |         |                                                         |
| * |         |                                                         |
| * |         |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Al    | Rather than requiring institutional certification of    |
|   | exander | compliance to be included with every proposal and a     |
|   | Sche    | presumption of non-compliance made of every principal   |
|   | eline** | investigator (lacking a signature to the contrary), why |
|   |         | not maintain a list of complying organizations and      |
|   | Uni     | electronically stamp \"in compliance\" on all proposals |
|   | versity | from that institution? A strong audit of actual         |
|   | of      | performance rather than signatures that simply slow     |
|   | I       | down proposal routing should insure accountability      |
|   | llinois | while cutting bureaucracy.                              |
|   | at      |                                                         |
|   | Ur      |                                                         |
|   | bana-Ch |                                                         |
|   | ampaign |                                                         |
+---+---------+---------------------------------------------------------+
|   | **A     | We feel strongly that requirements stating that Primary |
|   | merican | Investigators conduct proper searches into reduction,   |
|   | An      | refinement, and replacement of the use of animals in    |
|   | ti-Vivi | protocols for research, testing, and education remain   |
|   | section | intact and enforced.                                    |
|   | So      |                                                         |
|   | ciety** | We urge the Subcommittee on Research Business Models to |
|   |         | consider investigating new regulatory requirements      |
|   |         | related to genetically-engineered animals---many of     |
|   |         | whom have special care needs due to genetic alteration. |
|   |         |                                                         |
|   |         | USDA's Animal Care Division oversight and expansion is  |
|   |         | also vital to improving animal welfare and ensuring     |
|   |         | 'humane' science, and we urge additional funding for    |
|   |         | the addition of USDA Inspectors.                        |
+---+---------+---------------------------------------------------------+
|   | *       | Unless modified, the HIPAA privacy rule threatens major |
|   | *Assoc. | impedance of biomedical and health sciences research    |
|   | of      | that is already subject to significant oversight. In    |
|   | Amer.   | the view of the AAMC, the privacy rule excessively      |
|   | Medical | intrudes upon the established Institutional Review      |
|   | Col     | Board (IRB) system of human research oversight,         |
|   | leges** | burdening biomedical and behavioral researchers, their  |
|   |         | institutions, and research participants with onerous    |
|   |         | procedural requirements, ambiguous regulatory           |
|   |         | standards, and extensive new liability concerns         |
|   |         | destined to breed cautionary behavior and vexing        |
|   |         | delays. The new liability under the rule is above and   |
|   |         | beyond the legal consequences that flow from an         |
|   |         | entity\'s failure to observe federal research           |
|   |         | regulations or applicable state laws. Increased         |
|   |         | liability, when coupled with the compliance burden      |
|   |         | imposed by the rule\'s procedural requirements, creates |
|   |         | a substantial disincentive for covered entities to      |
|   |         | accommodate the needs of biomedical and health          |
|   |         | researchers. The threat is most severe to               |
|   |         | population-based research requiring access to large     |
|   |         | numbers of archival medical records, such as public     |
|   |         | health and epidemiological studies, health services     |
|   |         | research, post-marketing assessment of the safety and   |
|   |         | effectiveness of drugs and medical devices, and         |
|   |         | retrospective studies required to understand and        |
|   |         | eliminate the systemic causes of medical errors.        |
|   |         |                                                         |
|   |         | The Association has initiated a web-based survey to try |
|   |         | to document the extent of the rule's impact on research |
|   |         | and research institutions, and intends to make the      |
|   |         | findings of this study available.                       |
|   |         |                                                         |
|   |         | The AAMC itself has joined the Federation of American   |
|   |         | Societies for Experimental Biology (FASEB) in calling   |
|   |         | for rationalization of hazardous waste regulations as   |
|   |         | they apply to university research, and we endorse       |
|   |         | FASEB's insightful comments to the NSTC in this         |
|   |         | regard.15 The Environmental Protection Agency has       |
|   |         | expressed willingness to reconsider provisions of the   |
|   |         | Resource Conservation and Recovery Act (RCRA) that      |
|   |         | while arguably appropriate for industry often apply     |
|   |         | inappropriately to academic institutions.               |
|   |         | Rationalization of RCRA regulations should allow        |
|   |         | universities to meet tailored, performance-based        |
|   |         | standards developed in cooperation with state and local |
|   |         | authorities that often also regulate waste disposal.    |
+---+---------+---------------------------------------------------------+
|   | **Asso  | An important aspect of this partnership is the shared   |
|   | ciation | responsibility for supporting the costs of university   |
|   | of      | infrastructure utilized for federally sponsored         |
|   | A       | research. Universities believe that the principle of    |
|   | merican | full cost reimbursement is vital for this partnership   |
|   | Univers | to be successful, and that the time has come for        |
|   | ities - | research cost reimbursement policies to be brought into |
|   | AAU     | alignment with this sound business principle -- since   |
|   | Subco   | OMB and agency practices have deviated from it in       |
|   | mmittee | recent years.                                           |
|   | on      |                                                         |
|   | A-21**  | When federal agencies do not adequately reimburse       |
|   |         | universities for the F&A expenses attributable to       |
|   |         | research, universities must pay for them by taking      |
|   |         | resources away from other research and education        |
|   |         | obligations. The RAND study entitled "Paying for        |
|   |         | University Research Facilities and Administration,"     |
|   |         | released in the spring of 2000, showed that based upon  |
|   |         | negotiated rates, universities are only reimbursed for  |
|   |         | between 70 and 90 percent of the F&A costs associated   |
|   |         | with federally sponsored research.                      |
|   |         |                                                         |
|   |         | Recent evidence indicates that the under-recovery       |
|   |         | situation is getting worse, not better. A new COGR      |
|   |         | study (which we have attached to this letter) concludes |
|   |         | that universities' costs of complying with federal      |
|   |         | requirements are escalating rapidly over time -- the    |
|   |         | average increase in these expenditures ranges from      |
|   |         | approximately \$1.8 million per campus in 2000 to an    |
|   |         | estimated \$4.1 million in 2005. These compliance cost  |
|   |         | increases are for such things as human subjects         |
|   |         | protection, conflict of interest reviews, disposal of   |
|   |         | hazardous waste, monitoring of health and safety        |
|   |         | requirements in labs, Medicare billing, and more        |
|   |         | recently, HIPAA and SEVIS. As these costs have          |
|   |         | increased, the gap between F&A reimbursements, which    |
|   |         | are limited by Circular A-21's 26% cap on               |
|   |         | administrative costs, and actual campus administrative  |
|   |         | expenses, has grown wider. As COGR's study concludes,   |
|   |         | "continued increases in these substantial compliance    |
|   |         | costs cannot be borne by the universities without       |
|   |         | impairing the research enterprise."                     |
|   |         |                                                         |
|   |         | Within the context of the principle of full cost        |
|   |         | reimbursement, universities therefore seek: a) relief   |
|   |         | from the 26% cap on reimbursement of administrative     |
|   |         | expenses; b) access to increased reimbursement of       |
|   |         | university utility expenses under the Utility Cost      |
|   |         | Adjustment for all institutions; c) the removal of      |
|   |         | agency policies which result in reimbursement at less   |
|   |         | than negotiated rates; and d) F&A rates that are        |
|   |         | negotiated fairly, with due attention paid to the       |
|   |         | documented, audited costs incurred by universities.     |
+---+---------+---------------------------------------------------------+
|   | **C     | Regulatory Requirements are Increasing, Without         |
|   | olumbia | Reimbursements - A RAND report in 2000 concluded that   |
|   | Univ.** | the federal government could reduce its own payments    |
|   |         | for university facilities and administrative costs if   |
|   |         | it streamlined regulatory requirements, which would     |
|   |         | enable universities to lower their costs. But instead   |
|   |         | of reducing regulations, the federal government has     |
|   |         | added new regulatory and other requirements in such     |
|   |         | areas as the privacy of health information, the         |
|   |         | protection of biological agents and toxins, the         |
|   |         | protection of human subjects, and more. Many of these   |
|   |         | requirements serve important public purposes. But when  |
|   |         | the government adds responsibilities without providing  |
|   |         | additional funds to pay for their implementation,       |
|   |         | productivity suffers, as does the partnership.          |
+---+---------+---------------------------------------------------------+
|   | **      | **See response under B. Inconsistency of policies and   |
|   | Council | practices among Federal agencies.**                     |
|   | on      |                                                         |
|   | Govt.   |                                                         |
|   | Re      |                                                         |
|   | lations |                                                         |
|   | (       |                                                         |
|   | COGR)** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **      | 1.  Conflict of Interest regulations. As mentioned      |
|   | Federal |     earlier, this is an area where we strongly believe  |
|   | Demons  |     that the financial conflict of interest regulations |
|   | tration |     should be standardized across agencies.             |
|   | Pr      |                                                         |
|   | oject** | 2.  Misconduct in science. Same comments as earlier. As |
|   |         |     a specific example, the government-wide definition  |
|   |         |     of misconduct in science has been formally issued   |
|   |         |     for 2 years, but only one agency (NSF) has revised  |
|   |         |     its internal regulations to adopt the new           |
|   |         |     definition.                                         |
|   |         |                                                         |
|   |         | 3.  Notices of Grant Awards. Currently, award notices   |
|   |         |     come to us in a variety of ways (electronic award,  |
|   |         |     electronic notification of award, paper).           |
|   |         |     Furthermore, there is no                            |
|   |         |     standardization/consistency on the format or        |
|   |         |     structure of the award. To standardize the formal   |
|   |         |     award itself (perhaps one form for assistance       |
|   |         |     awards and another for procurement awards) would be |
|   |         |     a step in the right direction and allow             |
|   |         |     institutions to develop templates to put the award  |
|   |         |     information into their institutional databases in a |
|   |         |     consistent manner.                                  |
|   |         |                                                         |
|   |         | 4.  Single Letter of Credit System. Although we had     |
|   |         |     understood that there would be only two systems     |
|   |         |     which institutions needed to comply with, most      |
|   |         |     institutions currently have multiple letter of      |
|   |         |     credit (LOC) systems. Additionally, it would be     |
|   |         |     beneficial to the higher education community (and   |
|   |         |     to other institutions who carry out research for    |
|   |         |     the DoD agencies) to be able to draw down funds     |
|   |         |     through LOC for DoD awards, rather than the current |
|   |         |     systems which we now use.                           |
|   |         |                                                         |
|   |         | 5.  Reporting of Balances, current or cumulative.       |
|   |         |     Different agencies now require reporting of         |
|   |         |     cumulative expense balances in different ways (for  |
|   |         |     example, the difference between NIH, NSF, and EPA). |
|   |         |     Standardization in this area would be welcome.      |
|   |         |                                                         |
|   |         | 6.  Web Based Reporting System. All agencies require    |
|   |         |     reporting---technical, financial, administrative.   |
|   |         |     There has been much effort devoted at some agencies |
|   |         |     to electronic reporting (the NSF FastLane system    |
|   |         |     and NIH's i-Edison are but two examples), but a     |
|   |         |     standardized system for reporting all required data |
|   |         |     is critical.                                        |
+---+---------+---------------------------------------------------------+
|   | **      | Although not exhaustive, some examples of where         |
|   | Harvard | efficiencies could be achieved include:                 |
|   | Unive   |                                                         |
|   | rsity** | 1.  Standardize method for reporting expense balances - |
|   |         |     current or cumulative. Different agencies, NIH,     |
|   |         |     EPA, CDC, now require different methods. Both the   |
|   |         |     NIH and the NSF method are reasonable; we ask that  |
|   |         |     one of the two be selected as the standard for all  |
|   |         |     federal agencies to adopt.                          |
|   |         |                                                         |
|   |         | 2.  Standardize Notices of Grant Award (NGOA). The fact |
|   |         |     that different agencies include different data      |
|   |         |     elements causes confusion and mishaps in managing   |
|   |         |     the award throughout its course. The FDP is willing |
|   |         |     to work with OSTP to arrive at a standard set of    |
|   |         |     data elements for all agencies to adopt.            |
|   |         |                                                         |
|   |         | 3.  Develop a unified Letter of Credit system for all   |
|   |         |     granting agencies (we currently have 18 LOC         |
|   |         |     systems); again, the HHS Payment Management System  |
|   |         |     is one with which we are familiar, makes sense and  |
|   |         |     could be adopted by others.                         |
|   |         |                                                         |
|   |         | 4.  Standardize financial reporting requirements; some  |
|   |         |     agencies require monthly invoicing while others     |
|   |         |     require quarterly reports (269's); clearly we are   |
|   |         |     in favor of the quarterly mechanism.                |
|   |         |                                                         |
|   |         | 5\. Development of a web-based reporting and inquiry    |
|   |         | system for all granting agencies                        |
+---+---------+---------------------------------------------------------+
|   | *       | If researchers learn how to conduct searches properly   |
|   | *Humane | through the Animal Welfare Information Center           |
|   | S       | resources, or some equally useful means, time will not  |
|   | ociety\ | be wasted and animal suffering will be decreased.       |
|   | **      |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Joint | A RAND report in 2000 concluded that the federal        |
|   | AAU-    | government could reduce its own payments for university |
|   | NASULGC | facilities and administrative costs if it streamlined   |
|   | L       | regulatory requirements, which would enable             |
|   | etter** | universities to lower their costs. But instead of       |
|   |         | reducing regulations, the federal government has added  |
|   |         | new regulatory and other requirements in such important |
|   |         | areas as the privacy of health information, the         |
|   |         | protection of biological agents and toxins, and the     |
|   |         | protection of human subjects. Many of these             |
|   |         | requirements serve important public purposes. But when  |
|   |         | the government adds responsibilities without providing  |
|   |         | additional resources to pay for their implementation,   |
|   |         | productivity suffers, as does the partnership.          |
+---+---------+---------------------------------------------------------+
|   | **Roger | SuperPower has sought to enter into partnerships with   |
|   | A.      | other companies that have refused to do so because      |
|   | Fa      | Federal funds were going to be utilized and they did    |
|   | rrell** | not want to deal with requirements which they consider  |
|   |         | burdensome or have no experience with.                  |
|   | Supe    |                                                         |
|   | rPower, | Although the government must be protected, the          |
|   | I       | requirements at first glance can appear overwhelming.   |
|   | nc**.** | Typically an Federal Agreement will directly list a     |
|   |         | number of requirements and also reference many more     |
|   |         | from the Federal Acquisition Regulations (FAR), leaving |
|   |         | it to the contractor to sort through all of the         |
|   |         | referenced items. Often one FAR article references      |
|   |         | another so the list grows. One suggestion would be to   |
|   |         | include all requirements/regulations in the body of the |
|   |         | Agreement. This will lead to a bigger document but is   |
|   |         | all inclusive and takes away the recipients concern of  |
|   |         | what happens when the referenced FAR articles are       |
|   |         | amended during the course of the Agreement?             |
|   |         |                                                         |
|   |         | For a novice the rules could lead to a missed           |
|   |         | opportunity. Hence the government ought to provide more |
|   |         | guidance in such cases and seek to make the rules more  |
|   |         | user friendly.                                          |
|   |         |                                                         |
|   |         | The Contractor should be granted ownership of the       |
|   |         | patents, subject to march in rights and other           |
|   |         | provisions that protect the interests of the government |
|   |         | if the Contractor doesn't pursue the invention, rather  |
|   |         | than have to petition the government for ownership. In  |
|   |         | SuperPower's experience, we have received contracts     |
|   |         | from the Air Force citing FAR52.227-12 "Patent Rights   |
|   |         | -- Retention by the Contractor" which already confers   |
|   |         | patent ownership to SuperPower. In others, awarded by   |
|   |         | the DOE, FAR 52.227-13 "Acquisition by the Government"  |
|   |         | is cited requiring us to submit a waiver request to     |
|   |         | have ownership. This is an additional administrative    |
|   |         | burden.                                                 |
+---+---------+---------------------------------------------------------+
|   | **S     | Institutional Review Boards (IRBs) and Institutional    |
|   | tanford | Animal Care and Use Committees (IACUCs) play critical   |
|   | Unive   | and demanding roles in modern biomedical and social     |
|   | rsity** | science research. They are central to the nation\'s     |
|   |         | efforts towards protecting human and animal subjects    |
|   |         | while ensuring that the research moves forward. Yet,    |
|   |         | there is considerable evidence that they are            |
|   |         | under-funded and over-worked. Because the federal       |
|   |         | reimbursement for administrative expenses is capped and |
|   |         | insufficient to cover university administrative         |
|   |         | expenses associated with federally-funded research, IRB |
|   |         | and IACUC members carry on their responsibilities on    |
|   |         | top of those for which they are paid.                   |
|   |         |                                                         |
|   |         | To alleviate this problem, we recommend that:           |
|   |         |                                                         |
|   |         | A. The federal government recognize the importance of   |
|   |         | the IRBs and IACUCs by fully funding that portion of    |
|   |         | their endeavors that is attributable to                 |
|   |         | federally-funded research. The funding should be        |
|   |         | sufficiently large so that it compensates all those who |
|   |         | participate in, and staff, these compliance committees. |
|   |         | Such funding would free up time for the committee       |
|   |         | members to focus on their compliance responsibilities.  |
+---+---------+---------------------------------------------------------+
|   | **The   | The solution, obtainable only at the federal level, is  |
|   | San     | to rely less on regulations to ensure good use of       |
|   | Diego   | public funds, and more on the strong intrinsic          |
|   | Science | feedback: that PIs who waste funds end up not producing |
|   | and     | good research, and are therefore subject to being       |
|   | Tech.   | unfunded in the future if critically reviewed           |
|   | Co      | \[*subsequent* *text omitted*\]                         |
|   | uncil** |                                                         |
|   |         | To rebalance, get rid of a lot of the micromanagement   |
|   |         | rules; just wipe them out. Retain severe penalties for  |
|   |         | GENUINE fiddling - diversion of public funds to private |
|   |         | use, etc. - and retain enough checking/enforcement to   |
|   |         | make this credible. But beyond that, allow considerable |
|   |         | latitude for use of funds. Then the real check: use     |
|   |         | programmatic - not accounting - reviews to weed out     |
|   |         | investigators who have accomplished little with         |
|   |         | previous funding. Given the enormous competition for    |
|   |         | grants, the huge ratio of proposals submitted to        |
|   |         | proposals funded, etc., there is tremendous pressure on |
|   |         | every PI to use funds wisely and get results. Those who |
|   |         | fritter away money on ill-advised purchases or even on  |
|   |         | personal items won\'t last long under such reviews. I   |
|   |         | submit that this intrinsic pressure is far more         |
|   |         | effective than any number of fiscal control volumes and |
|   |         | rooms full of auditors.                                 |
+---+---------+---------------------------------------------------------+
|   | **Uni   | • [Eliminate limit on cost recovery that threatens the  |
|   | versity | research enterprise:]{.underline} Because the Office of |
|   | of      | Management and Budget has placed a cap on the           |
|   | Calif   | administrative costs for which universities can be      |
|   | ornia** | reimbursed, institutions have no way to recover the     |
|   |         | rising costs of new and increasing unfunded federal     |
|   |         | mandates such as:                                       |
|   |         |                                                         |
|   |         | \- The rising cost of annual A-133 audits due to        |
|   |         | increasing scope and requirements;                      |
|   |         |                                                         |
|   |         | \- Implementation of the requirements of the new        |
|   |         | federal Health Insurance Portability and Accountability |
|   |         | Act (HIPAA);                                            |
|   |         |                                                         |
|   |         | \- Training requirements for investigators engaged in   |
|   |         | research projects involving human subjects;             |
|   |         |                                                         |
|   |         | \- CDC and APHIS select agent record-keeping and        |
|   |         | screening rules.                                        |
|   |         |                                                         |
|   |         | [Recommendation:]{.underline} Remove the cap on the     |
|   |         | administrative component of the negotiated indirect     |
|   |         | cost rate to permit institutions to recover the funds   |
|   |         | required to pay for proper and timely implementation of |
|   |         | federal mandates.                                       |
|   |         |                                                         |
|   |         | • [Agency Program Audits:]{.underline} Federal agency   |
|   |         | program staff and their auditors should coordinate to   |
|   |         | make final closeout reports available internally within |
|   |         | the agency so that the reports are not requested        |
|   |         | several more times from the grantees by different parts |
|   |         | of the agency.                                          |
|   |         |                                                         |
|   |         | • [Single Audit Clearinghouse:]{.underline} OMB         |
|   |         | Circular A-133 should state clearly that all federal    |
|   |         | agencies should obtain institutions' A-133 audits       |
|   |         | through the Single Audit Clearinghouse and *not*        |
|   |         | request them from the grantee institution.              |
|   |         |                                                         |
|   |         | • [Subrecipient Monitoring:]{.underline} The single     |
|   |         | audit process leaves prime grantees vulnerable to any   |
|   |         | problems found in subsequent audits of their            |
|   |         | subrecipients.                                          |
|   |         |                                                         |
|   |         | As such, the administrative burden posed by this        |
|   |         | inappropriate subrecipient monitoring requirement       |
|   |         | outweighs the costs of any real value such a monitoring |
|   |         | system could provide. No matter how responsible the     |
|   |         | prime is, the subrecipient's A-133 audit results will   |
|   |         | always be published long after the subaward is closed   |
|   |         | out.                                                    |
|   |         |                                                         |
|   |         | [Recommendations:]{.underline}                          |
|   |         |                                                         |
|   |         | \-- Limit prime grantee responsibility for subrecipient |
|   |         | monitoring to information provided by progress reports  |
|   |         | and invoices available during the period of performance |
|   |         | of the project. Disallowed costs found in subsequent    |
|   |         | audits should be addressed directly by the federal      |
|   |         | agency to the subrecipient.                             |
|   |         |                                                         |
|   |         | • [Cost Accounting Standards:]{.underline} It is very   |
|   |         | costly to implement and maintain the Cost Accounting    |
|   |         | Standards Disclosure (CAS) Statements. Much of the      |
|   |         | Disclosure Statement (DS-2) is duplicative of the       |
|   |         | requirements for developing an indirect cost rate       |
|   |         | proposal. The CAS Disclosure Statement adds nothing to  |
|   |         | the information provided to our federal cognizant       |
|   |         | agency in our indirect cost rate agreement proposals.   |
|   |         |                                                         |
|   |         | [Recommendation:]{.underline} Eliminate the DS-2        |
|   |         | requirement for educational institutions.               |
+---+---------+---------------------------------------------------------+
|   | **Uni   | In 1996 Universities were required to submit a          |
|   | versity | description of its cost accounting practices to the     |
|   | of      | cognizant federal agency for approval. The document     |
|   | Fl      | submitted is known as the DS-2. To date only a few      |
|   | orida** | schools have received an approval of their DS-2. The    |
|   |         | rest of us have been put on hold. A more efficient      |
|   |         | approach would have been to keep this as a disclosure   |
|   |         | document with no approval process. Cost savings and the |
|   |         | burden of having to audit and approve the DS-2's would  |
|   |         | have been relieved. Cognizant federal agencies are then |
|   |         | free to audit the DS-2 of any institution when needed.  |
+---+---------+---------------------------------------------------------+
|   | **Uni   | An example of extreme over-regulation has to do with    |
|   | versity | cost sharing. In an effort to force grantee             |
|   | of      | institutions to document cost sharing in order to drive |
|   | Iowa**  | down facilities and administrative costs, researchers   |
|   |         | are now required to document and differentiate their    |
|   |         | research effort by recording how they spend their time  |
|   |         | in terms of the time that they were paid for by the     |
|   |         | grant, the time that they said they would spend on the  |
|   |         | grant and not get paid for, and the time that they      |
|   |         | decided they spend on the research project in addition  |
|   |         | to the other ways they reported. This is extending      |
|   |         | accountability to unreasonable extremes and, like other |
|   |         | inconsistencies and inadequacies evident in the current |
|   |         | federal granting policies, procedures, and regulations  |
|   |         | discussed in this report, is a serious distraction from |
|   |         | the main purpose of the funds: performing high-quality  |
|   |         | research.                                               |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Regulatory requirements are increasing, without         |
|   | versity | commensurate reimbursement, as indicated in the 2000    |
|   | of      | report from RAND, necessitating improvements in cost    |
|   | Pitts   | recovery                                                |
|   | burgh** |                                                         |
+---+---------+---------------------------------------------------------+
|   |         |                                                         |
+---+---------+---------------------------------------------------------+
| * |         |                                                         |
| * |         |                                                         |
| F |         |                                                         |
| . |         |                                                         |
| R |         |                                                         |
| E |         |                                                         |
| S |         |                                                         |
| E |         |                                                         |
| A |         |                                                         |
| R |         |                                                         |
| C |         |                                                         |
| H |         |                                                         |
| S |         |                                                         |
| U |         |                                                         |
| P |         |                                                         |
| P |         |                                                         |
| O |         |                                                         |
| R |         |                                                         |
| T |         |                                                         |
| * |         |                                                         |
| * |         |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Al    | ....\[If\] there is insufficient preliminary data       |
|   | exander | (despite the strong track record in closely related     |
|   | Sche    | areas), therefore don\'t fund \[it\]. How is one        |
|   | eline** | supposed to get preliminary data without funds? One     |
|   |         | frequently gets the feeling that the proposal/funding   |
|   | Uni     | game is Russian roulette, where one is trying to hit a  |
|   | versity | moving pinhole....                                      |
|   | of      |                                                         |
|   | I       | A large group can stay funded if 25% of the students    |
|   | llinois | are productive. A small group with any gap in           |
|   | at      | productivity can become de-funded and then, lacking     |
|   | Ur      | \"preliminary data\" have no way to restart. The        |
|   | bana-Ch | typical research budget, in the absence of a grant, is  |
|   | ampaign | ZERO. One can do a lot with a little, but nothing with  |
|   |         | nothing. Federal support should encourage scientists to |
|   |         | continually push back scientific and technical          |
|   |         | frontiers. Current policies encourage them to write     |
|   |         | nearly unlimited numbers of proposals. The toughest     |
|   |         | problem in science is NOT the science. It is probably   |
|   |         | not the interpersonal issues of disparate               |
|   |         | collaborators. It is keeping enough funds in the kitty  |
|   |         | to allow any work to happen. So long as this is the     |
|   |         | case, only the super-aggressive will be attracted to    |
|   |         | academic science....                                    |
|   |         |                                                         |
|   |         | If we funded people and institutions, not projects,     |
|   |         | scientists would feel free to move from area to area    |
|   |         | quickly and flexibly. The current system funds          |
|   |         | incrementalism well, but makes field changes for        |
|   |         | mid-career scientists or mid-degree students nearly     |
|   |         | impossible                                              |
+---+---------+---------------------------------------------------------+
|   | **A     | We encourage additional activity through the            |
|   | merican | Interagency Coordinating Committee for Validation of    |
|   | An      | Alternative Methods (ICCVAM), including a provision for |
|   | ti-Vivi | making grants available to scientists conducting        |
|   | section | research into alternatives that reduce, refine, or      |
|   | So      | replace methods of using animals. This encourages       |
|   | ciety** | innovative research that could benefit many in the      |
|   |         | scientific community.                                   |
+---+---------+---------------------------------------------------------+
|   | **Asso  | For the enterprise to contribute to the Nation's        |
|   | ciation | health, environment, economic and national security, it |
|   | of      | must be well supported financially on a continuing      |
|   | Inde    | basis.  The system must be flexible, competitive,       |
|   | pendent | responsive and supportive of the individual             |
|   | R       | investigator, with decisions based on merit, and the    |
|   | esearch | financial investment must be diverse in terms of the    |
|   | Insti   | fields supported and the modes of support utilized.     |
|   | tutes** | Finally, the process must be open and receptive to new  |
|   |         | ideas and investigators from all research institutions  |
|   |         | -- regardless of size.                                  |
+---+---------+---------------------------------------------------------+
|   | **C     | Longer, Larger Grants Are More Efficient - NSF\'s       |
|   | olumbia | relatively small grant size and short duration forces   |
|   | Univ.** | principal investigators to spend more time writing      |
|   |         | grants, leaving them less time to conduct research, in  |
|   |         | contrast to researchers supported by larger grants      |
|   |         | through some other agencies, including NIH. NSF\'s      |
|   |         | efforts to increase the size of grants, and lengthen    |
|   |         | their duration, deserve continued support.              |
+---+---------+---------------------------------------------------------+
|   | **      | **(Bundled comments for F, G, & H)**.                   |
|   | Federal |                                                         |
|   | Demons  | 1.  High risk research is essential to maintaining a    |
|   | tration |     cutting edge superiority at our colleges and        |
|   | Pr      |     universities. Often this type of research does not  |
|   | oject** |     have a "quick" turnaround and the benefits may not  |
|   |         |     be seen for years. However, the federal government  |
|   |         |     should consider at all agencies some funding for    |
|   |         |     high risk, high payoff research.                    |
|   |         |                                                         |
|   |         | 2.  With the growth of large multi-disciplinary         |
|   |         |     programs for large-scale integrated research, there |
|   |         |     is a critical need both for infrastructure support  |
|   |         |     (which is often lacking) and for long term          |
|   |         |     commitments for such undertakings. Programs such as |
|   |         |     the Material Science programs and the Centers of    |
|   |         |     Excellence and Engineering Research Centers         |
|   |         |     programs have demonstrated the value of such        |
|   |         |     integrated research. Awards which guarantee (with   |
|   |         |     adequate progress) multiyear funding for large      |
|   |         |     centers encourage institutions to commit            |
|   |         |     significant resources for these awards because they |
|   |         |     have reasonable assurance that the centers will     |
|   |         |     remain in place. This should be expanded.           |
|   |         |                                                         |
|   |         | 3.  Even individual awards (such as the NSF awards to   |
|   |         |     individual investigators and the NIH RO1 awards)    |
|   |         |     should be increased in size and duration. It is not |
|   |         |     efficient for principal investigators to spend      |
|   |         |     their time writing renewal applications for         |
|   |         |     continuing work, when the research has been         |
|   |         |     extremely productive. Agencies such as NSF have     |
|   |         |     been working to increase their award size and       |
|   |         |     duration and they, as well as others, deserve       |
|   |         |     support here.                                       |
|   |         |                                                         |
|   |         | 4.  Research infrastructure needs are critical. Over    |
|   |         |     the years studies have been performed about the     |
|   |         |     need for infrastructure, especially (but not        |
|   |         |     limited to) bricks and mortar. The recent study     |
|   |         |     completed for the NIH on the financing of research  |
|   |         |     facilities (the Richardson report) is just one of a |
|   |         |     number of projects which demonstrate the need for   |
|   |         |     such support. Not only are there needs for          |
|   |         |     facilities (the "F" part of F&A) but there is an    |
|   |         |     equal need for support for the "A" part. An         |
|   |         |     increasing concern to universities is the "unfunded |
|   |         |     mandate"--- compliance requirements imposed on the  |
|   |         |     research enterprise but not funded by the           |
|   |         |     government. As these costs continue to rise, it     |
|   |         |     becomes more critical for universities to have      |
|   |         |     sufficient funding for this infrastructure. We are  |
|   |         |     aware of the constraints under which federal        |
|   |         |     agencies also operate, but this is an area we       |
|   |         |     believe should be jointly addressed by both         |
|   |         |     communities.                                        |
+---+---------+---------------------------------------------------------+
|   | **Fr    | There are too many grants being funded because          |
|   | ederick | applicants fear a gap in funding, and hence become      |
|   | Sachs** | application writers instead of full time scientists. If |
|   |         | the number of grants/PI was limited (perhaps to two),   |
|   | SUNY--  | then no one would spend time writing additional         |
|   | Buffalo | proposals, and hence would get down to work. If the     |
|   |         | funding rate was higher then scientists would not feel  |
|   |         | the necessity to keep writing applications to avoid     |
|   |         | academic death due to a lack of research funds.... This |
|   |         | does not make for creative science. It rewards the      |
|   |         | least interesting and hence the safest research. Young  |
|   |         | people are the ones with the new ideas, and they need   |
|   |         | to be supported.... To my knowledge, there has never    |
|   |         | been a study of the value of research/\$ in large and   |
|   |         | small labs. My prediction is that small labs where the  |
|   |         | PIs are intimately involved with the ongoing research   |
|   |         | are much more efficient. I suggest such a study of      |
|   |         | efficiency of labs size vs. productivity/\$ is in order |
|   |         | before changing priorities                              |
+---+---------+---------------------------------------------------------+
|   | *       | I work in private chemical industry for metal forming.  |
|   | *Henkel | It seems that Europe and Japan have accelerated their   |
|   | Surface | R&D and patent efforts in metal manufacturing for       |
|   | Technol | years. Our manufacturing sector is suffering a blow to  |
|   | ogies** | overseas competition. Some of our most skilled and      |
|   |         | brightest manufacturing scientists are working not in   |
|   |         | academia, but in industry. I suggest that the OSTP      |
|   |         | provide (more) funding to private industry to boost our |
|   |         | manufacturing efficiency and productivity. I am not     |
|   |         | against academic funding in this area, as we need basic |
|   |         | research in nanotechnology, etc. But, we are            |
|   |         | overlooking the needs of existing technologies that     |
|   |         | could be improved greatly                               |
+---+---------+---------------------------------------------------------+
|   | **      | One is the model that has been used by the NSF for      |
|   | Harvard | three decades in Materials Research Laboratories and    |
|   | Unive   | Materials Research Science and Engineering Centers. It  |
|   | rsity** | places the responsibility and incentives for            |
|   |         | innovating, working together within and across          |
|   |         | disciplines, and sharing facilities in the hands of     |
|   |         | local management, which is then reviewed by Agency      |
|   |         | project managers and peer review committees that        |
|   |         | consider these factors. Over the years, we believe that |
|   |         | the NSF has gathered much data about the effectiveness  |
|   |         | of these Centers that should be of interest for the     |
|   |         | current study.                                          |
+---+---------+---------------------------------------------------------+
|   | **M     | **(Bundled comments for F, G, & H)**.                   |
|   | .I.T.** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Roger | Many government contracts today require 50% cost share  |
|   | A.      | by the Contractor \[, but that\] does not recognize     |
|   | Fa      | varying levels of risk. Perhaps, the amount of          |
|   | rrell** | government support could be varied between 50% and 100% |
|   |         | based on level of risk, potential benefit to the U.S.   |
|   | Supe    | or other combination of criteria? This could be         |
|   | rPower, | addressed perhaps by including a separate set of        |
|   | I       | \"stretch\" goals beyond the basic program, such that   |
|   | nc**.** | if the goals are in fact met a higher level of funding  |
|   |         | (say more than 50% cost share) would be possible. It    |
|   |         | would also be helpful for the government to recognize   |
|   |         | that there is a high degree of cost uncertainty for     |
|   |         | innovation.                                             |
|   |         |                                                         |
|   |         | A major discouragement arises from the delay            |
|   |         | encountered between proposal submission and award. In   |
|   |         | our experience, the government (DOD, DOE and NIST)      |
|   |         | rarely, if ever, meets the published award date. This   |
|   |         | is particularly difficult for small companies but is    |
|   |         | burdensome to all. Another discouraging factor is the   |
|   |         | specialized accounting procedures and number of reports |
|   |         | required.                                               |
+---+---------+---------------------------------------------------------+
|   | **Sarah | The current system, allocation of research dollars      |
|   | Ma      | essentially via one agency (the NIH), clearly stifles   |
|   | rston** | innovation. This relatively homogenous group tends to   |
|   |         | jump on one \"hot\" area and funds that to the          |
|   | StatSc  | exclusion of anything else. Transparency, performance,  |
|   | i/Degge | and accountability, with a focus on meeting clearly     |
|   | Group   | stated goals, are key to promoting innovation. For the  |
|   |         | short run, it is particularly important to address the  |
|   |         | NIH post-doc issues                                     |
+---+---------+---------------------------------------------------------+
|   | **S     | The cap on recovery of indirect administrative costs,   |
|   | tanford | coupled with the prohibition on direct charging of      |
|   | Univ.** | administrative costs that are directly related to the   |
|   |         | research, is causing faculty and other researchers to   |
|   |         | spend considerable time on administrative tasks. Most   |
|   |         | of these tasks could be performed better by             |
|   |         | administrative assistants trained to perform them. This |
|   |         | would leave the researchers more time for research and  |
|   |         | enhance the productivity of the research enterprise.    |
|   |         |                                                         |
|   |         | Our recommendations are as follows:                     |
|   |         |                                                         |
|   |         | A. OMB Circular A-21 should be modified to allow the    |
|   |         | direct charging of administrative services directly     |
|   |         | linked to the performance of the research. The research |
|   |         | enterprise is best served when researchers are          |
|   |         | conducting research, and administrators are providing   |
|   |         | skilled project oversight support for their             |
|   |         | researchers.                                            |
+---+---------+---------------------------------------------------------+
|   | **      | There are some speculative, apparently purely           |
|   | Stephen | hypothetical ideas, or apparently irrelevant            |
|   | Gould** | research that originates from mainstream scientists and |
|   |         | mainstream science that turn out to be valuable either  |
|   |         | to advance theory or in much later applications. Of all |
|   |         | these now useful or relevant ideas, how many would have |
|   |         | been granted funding under the current environment, or  |
|   |         | indeed under many of the submissions you will received? |
|   |         | \[Gould suggests that\] 5% (or some other appropriate   |
|   |         | figure) of the total research budget should go on       |
|   |         | projects that either appear probably unfeasible or lack |
|   |         | any observable practical applications.  The committee   |
|   |         | to oversee and approve these projects should            |
|   |         | be established mainstream scientists who are known for  |
|   |         | their multi-disciplinary contributions - generalists    |
|   |         | tend to be better at identifying and assessing the      |
|   |         | long-term potential, I think, and tend to be less       |
|   |         | orthodox in their approach.                             |
+---+---------+---------------------------------------------------------+
|   | **SUNY  |                                                         |
|   | --      |                                                         |
|   | R       |                                                         |
|   | esearch |                                                         |
|   | Found   |                                                         |
|   | ation** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **The   | In general terms, the more open and flexible the        |
|   | San     | mechanisms and policies, the more likely they are to    |
|   | Diego   | ignite really novel research. There\'s a reason, after  |
|   | Science | all, why REALLY flexible pieces of funding such as      |
|   | and     | those attached to major prizes or endowed chairs flow   |
|   | Tech.   | to the cream of the crop.                               |
|   | Co      |                                                         |
|   | uncil** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Short time-lines for targeted initiatives, sometimes as |
|   | versity | little as 5 years (NSF), mean that we get research on   |
|   | of      | the topics only by the people who are already working   |
|   | Idaho** | on those topics. The ramp-up time for new contributions |
|   |         | is such that, at best, PIs who are new to a topic can   |
|   |         | do only one or two years' worth of research before the  |
|   |         | initiative ends---if they can even get funded in the    |
|   |         | first place---and this might not be enough to lead to   |
|   |         | the breakthroughs that might be made by "new blood".    |
|   |         |                                                         |
|   |         | How the RFP is written very much determines the kind of |
|   |         | science that is done. RFPs are increasingly narrow in   |
|   |         | focus, so the research focus is narrow, and we are      |
|   |         | concerned that it is too much so, lessening the         |
|   |         | opportunity for serendipity. There is a perception that |
|   |         | RFPs are written with the answer already in mind, which |
|   |         | will lead to the expected results; RFPs are sometimes   |
|   |         | virtually work-for-hire, not aimed at developing new    |
|   |         | knowledge. The research-funding process focuses on      |
|   |         | outputs, not on inputs. The concern about having to     |
|   |         | know the answer ahead of time is enhanced by the GPRA   |
|   |         | process.                                                |
|   |         |                                                         |
|   |         | There is a widespread perception that research is now   |
|   |         | required to have immediate societal impact. This may be |
|   |         | inhibiting PIs from pursuing fundamental science.       |
|   |         |                                                         |
|   |         | Big science is commonly less than the sum of its parts. |
|   |         | In other words, less is produced than would have been   |
|   |         | produced if the PIs were individually funded and        |
|   |         | collaborated on their own without a formal structure.   |
|   |         | Money sometimes evaporates in large, multi-PI projects; |
|   |         | an evaluation of "bang-for-the-buck" needs to be done.  |
|   |         | While it depends partly on the culture in which the     |
|   |         | scientists are working, in general large block grants   |
|   |         | don't work well. Forced collaboration often fails.      |
|   |         |                                                         |
|   |         | The perception persists that new ideas are not being    |
|   |         | funded, and we are concerned that this is affecting how |
|   |         | graduate students are trained.                          |
|   |         |                                                         |
|   |         | As a percentage of GDP, research funding during WWII    |
|   |         | was high, and all directed toward a single goal         |
|   |         | (winning the war). Scientists and engineers seemingly   |
|   |         | were relatively unconstrained, however, in how they     |
|   |         | could solve that problem. The same is true with the     |
|   |         | "War on Cancer". Perhaps it would be better to focus on |
|   |         | a few overarching problems, invest a lot of money in    |
|   |         | them, but not constrain how scientists go about solving |
|   |         | them. The lack of constraint would allow for            |
|   |         | serendipity, while still answering society's need for   |
|   |         | accountability and societal impact.                     |
|   |         |                                                         |
|   |         | All of us who have sat on review panels have            |
|   |         | encountered proposals that the panels considered to be  |
|   |         | somewhat exceptional but a poor fit. These proposals    |
|   |         | tend to be dismissed because the panel is unable to     |
|   |         | assess them in the context of the other proposals that  |
|   |         | the panel is reviewing. We suggest that any proposal    |
|   |         | that gets such a reaction be sent to a second panel for |
|   |         | review, where such proposals could be reviewed against  |
|   |         | each other. It is our feeling that a few such proposals |
|   |         | deserve to be funded because of the potential for       |
|   |         | yielding interesting, new results.                      |
|   |         |                                                         |
|   |         | We also suggest that there should be an RFP for         |
|   |         | proposals to do research on the fundamentals of         |
|   |         | science, questioning the sorts of basic assumptions on  |
|   |         | which other research is built. Breakthroughs commonly   |
|   |         | occur when someone goes back to the basic assumptions,  |
|   |         | questions them, and goes off in a different direction   |
|   |         | with the research. We are concerned that the scientific |
|   |         | community is driven along certain paths that keep       |
|   |         | building on previous research in a way that propagates  |
|   |         | assumptions that turn out later to be erroneous. While  |
|   |         | science has always had such propagation, it is our      |
|   |         | concern that this is going much farther than before. We |
|   |         | are also concerned that people who question are         |
|   |         | increasingly marginalized because so much of science    |
|   |         | seems to have taken on political overtones (global      |
|   |         | warming research is one such example).                  |
|   |         |                                                         |
|   |         | As faculty progress and establish their research        |
|   |         | reputations, they are obligated by their institutions   |
|   |         | to take on heavier workloads in teaching and service,   |
|   |         | and because of the time pressures, may get out of synch |
|   |         | with the rapid changes in funding trends. They may also |
|   |         | become trapped by their successes -- there is strong    |
|   |         | pressure from reviewers that actually discourages       |
|   |         | scientists from trying to enter new fields, even when   |
|   |         | the fields in which they established themselves are no  |
|   |         | longer being adequately funded. That they have already  |
|   |         | proven themselves as researchers is not recognized when |
|   |         | they try to change fields to keep up with funding       |
|   |         | trends. This is in contrast to younger researchers who  |
|   |         | have no previous reputation in any particular field and |
|   |         | thus are given the benefit of the doubt when entering   |
|   |         | the professions. Thus, quite a lot of experienced,      |
|   |         | proven intellectual power embodied in senior faculty is |
|   |         | potentially being wasted. Some faculty members may have |
|   |         | as much as 10-15 years of their research lifetime       |
|   |         | remaining. This has repercussions for the future        |
|   |         | workforce as well. Students who observe previously      |
|   |         | highly successful faculty struggling to get funding     |
|   |         | become very discouraged, not only by the lack of        |
|   |         | funding success but by the increasing workloads they    |
|   |         | see their advisors taking on.                           |
|   |         |                                                         |
|   |         | The principle of full cost reimbursement is vital for   |
|   |         | partnerships to be successful.                          |
|   |         |                                                         |
|   |         | Making awards sensitive, but unclassified is            |
|   |         | problematic.                                            |
|   |         |                                                         |
|   |         | The proportion of total US GNP in support of research   |
|   |         | has declined. The balance of investment between         |
|   |         | defense, health and biological/physical/ecological      |
|   |         | sciences needs to be evaluated. Determine the portion   |
|   |         | of total research funding that should be obligated to   |
|   |         | each federal agency. Develop policies that will insure  |
|   |         | the competitive allocation of funds to priority         |
|   |         | research initiatives within each agency.                |
+---+---------+---------------------------------------------------------+
|   | **Univ  | Our faculty have expressed concern with current funding |
|   | of      | models if our goal is to promote innovative and         |
|   | Roch    | interdisciplinary research. With respect to the former, |
|   | ester** | current federal review mechanisms do not promote        |
|   |         | high-risk research. The review process winnows out      |
|   |         | anything with a chance of failure, and thus becomes     |
|   |         | largely derivative. In addition, an acceleration of the |
|   |         | review process is warranted for the rapid funding of    |
|   |         | truly innovative research. With respect to              |
|   |         | collaborative research, limitation of funding of        |
|   |         | current award mechanisms (such as the NIH R01) limits   |
|   |         | overall scope and discourages extensive, and often      |
|   |         | expensive, multi-disciplinary collaborations. A larger  |
|   |         | funding ceiling, such as in the NIH SCOR or Center      |
|   |         | grants (which may require clinical or population-based  |
|   |         | components) would encourage multidisciplinary research. |
|   |         | We do note that NIH has made some recent progress with  |
|   |         | the development of "the NIH Roadmap", however, there    |
|   |         | are foundation programs (e.g., Huntington's Disease     |
|   |         | Foundation, Doris Duke Foundation, Reynolds Foundation) |
|   |         | that may provide models for stimulating                 |
|   |         | federally-supported multidisciplinary research through  |
|   |         | targeted programs.                                      |
|   |         |                                                         |
|   |         | Current requirements and administrative regulations     |
|   |         | have diverted the current business relationship away    |
|   |         | from the outcome of the research, but rather to the     |
|   |         | minutia of rigid and inflexible rules. As noted as a    |
|   |         | guiding principle in the NSTC Presidential Review       |
|   |         | Directive -- 4, we need to return to the fact that      |
|   |         | "accountability and accounting are not the same". We    |
|   |         | are not advocating a lessening of responsibility on     |
|   |         | behalf of the University partner, but a return to       |
|   |         | outcomes-based performance metrics in conjunction with  |
|   |         | a tolerable flexibility for administrative and          |
|   |         | regulatory oversight.                                   |
+---+---------+---------------------------------------------------------+
|   | **Uni   | • [Increase size and duration of federal                |
|   | versity | awards:]{.underline} The dollar amount and duration of  |
|   | of      | many federal awards is too small and too short to allow |
|   | Calif   | for efficient development of a research idea, direction |
|   | ornia** | and program.                                            |
|   |         |                                                         |
|   |         | For a more detailed explanation of this issue, see the  |
|   |         | National Science Foundation Report on Efficiency of     |
|   |         | Grant Size and Duration at:                             |
|   |         | <http://www.nsf.gov                                     |
|   |         | /od/gpra/grantsize/mathematica_NSFRptFinal6.htm#S5HEAD> |
|   |         |                                                         |
|   |         | [Recommendation]{.underline}: Federal support for       |
|   |         | research should incorporate the concept of funding of   |
|   |         | large, basic assistance awards, that provide funding    |
|   |         | for general research programs (program/project grants)  |
|   |         | rather than continuing to require investigators to seek |
|   |         | additional funding for multiple, project-specific       |
|   |         | awards.                                                 |
|   |         |                                                         |
|   |         | • [Fund administrative support:]{.underline} The        |
|   |         | combination of the cap on the administrative component  |
|   |         | of the indirect cost recovery rate and the restriction  |
|   |         | on federal support for departmental administration in   |
|   |         | OMB Circular A-21, section F. 6. J., means that federal |
|   |         | agencies are not permitted to reimburse recipient       |
|   |         | institutions for the administrative support costs borne |
|   |         | by those institutions. As a result, investigators are   |
|   |         | forced to spend more and more of their time on          |
|   |         | administrative details. This is a costly and            |
|   |         | inefficient use of the investigator's time that         |
|   |         | negatively affects research.                            |
|   |         |                                                         |
|   |         | [Recommendation]{.underline}: Revise OMB Circular A-21  |
|   |         | section F. 6. J. to permit agencies to support          |
|   |         | administrative needs of researchers and pooled support  |
|   |         | in their departments.                                   |
|   |         |                                                         |
|   |         | • [Expand Federal Demonstration                         |
|   |         | Partnership:]{.underline} We recommend that the Federal |
|   |         | Demonstration Partnership (FDP) continue to be expanded |
|   |         | and enhanced to enroll more institutions and heighten   |
|   |         | the visibility of this valuable initiative.             |
|   |         |                                                         |
|   |         | [Recommendations:]{.underline}                          |
|   |         |                                                         |
|   |         | \-- Expand successful electronic submission systems     |
|   |         | (e.g., NSF FastLane) to other sponsoring agencies;      |
|   |         |                                                         |
|   |         | \-- Improve and expand centralized repositories that    |
|   |         | list available funding opportunities.                   |
|   |         |                                                         |
|   |         | • [Support for cross-disciplinary                       |
|   |         | research:]{.underline} Though care should be taken to   |
|   |         | ensure a balance between funding for individual and     |
|   |         | multidisciplinary projects (with neither type being     |
|   |         | funded to the exclusion of the other), we applaud the   |
|   |         | Subcommittee's focus on exploring ways to encourage     |
|   |         | multidisciplinary research.                             |
|   |         |                                                         |
|   |         | [Recommendation:]{.underline}                           |
|   |         |                                                         |
|   |         | \-- [Consider expanding collaborative Center-based      |
|   |         | research:]{.underline} Explore expanded funding for     |
|   |         | Research Center-based efforts as one way of encouraging |
|   |         | cross-disciplinary and collaborative research. Examples |
|   |         | of existing Center-based efforts include the NSF        |
|   |         | Science and Technology Center (STC) and Engineering     |
|   |         | Research Center (ERC) programs, which are centered on   |
|   |         | the idea of conducting research (and complementary      |
|   |         | educational efforts) in a collaborative Center setting. |
|   |         |                                                         |
|   |         | \-- [Support related infrastructure needs]{.underline}. |
|   |         | In considering how best to expand Center-based          |
|   |         | research, consideration should be given to providing    |
|   |         | expanded federal support for related infrastructure     |
|   |         | needs.                                                  |
|   |         |                                                         |
|   |         | We suggest more federal funding mechanisms and programs |
|   |         | be made available to provide more academic institutions |
|   |         | with access to funding dedicated to supporting          |
|   |         | infrastructure needs of such large-scale efforts.       |
|   |         |                                                         |
|   |         | • [Review agency research funding                       |
|   |         | priorities:]{.underline} Agencies and researchers need  |
|   |         | to work together to continually review and adjust       |
|   |         | federal research funding priorities.                    |
|   |         |                                                         |
|   |         | [Recommendation:]{.underline} Provide for an            |
|   |         | undesignated fund in agency budgets to address new      |
|   |         | research areas. Establish mechanisms to encourage       |
|   |         | continuous exchanges between federal agencies and       |
|   |         | researchers from various disciplines to help agencies   |
|   |         | select new funding directions.                          |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Partnerships can be corrupted by a shift away from      |
|   | versity | investments in science and research and toward the      |
|   | of      | purchasing and procurement of specific, tangible        |
|   | Idaho** | products. This shift can interrupt and corrupt the      |
|   |         | tried-and-true scientific method, stifle creativity in  |
|   |         | the research community and act as a deterrent to        |
|   |         | involvement by scientists who feel demoralized by the   |
|   |         | process. Commonly this happen in more "local" RFP       |
|   |         | processes directly influenced by political and          |
|   |         | corporate agendas. When it occurs, ironically it        |
|   |         | diminishes the long-term financial stability of         |
|   |         | research institutions.                                  |
|   |         |                                                         |
|   |         | Smaller institutions often have special challenges that |
|   |         | should be addressed in principles. Cost-shifting        |
|   |         | creates disadvantages for smaller institutions that     |
|   |         | have proportionately less unrestricted resources to     |
|   |         | cover cost sharing on the purchase of equipment,        |
|   |         | building of facilities and augmentation of research     |
|   |         | assistantships. Even hiring decisions can be affected   |
|   |         | by unrealistic cost sharing requirements.               |
+---+---------+---------------------------------------------------------+
|   | **Uni   | It is quite common to espouse one goal but allow        |
|   | versity | practices to frankly work against that goal. A simple   |
|   | of      | example, easily fixed, would be the practice of capping |
|   | Ken     | direct costs on grant applications that are seeking to  |
|   | tucky** | support complex interdisciplinary activities. Such      |
|   |         | activities frequently involve partners in different     |
|   |         | sectors and their costs -- direct and indirect -- are   |
|   |         | embedded in the applicant's direct costs. This means    |
|   |         | that the indirect costs on a sub-award are now part of  |
|   |         | the applicant's direct costs and are constrained by the |
|   |         | cap on the direct costs. This would seem to work        |
|   |         | against a desire to see applicants build                |
|   |         | collaborations! This can be easily addressed by human   |
|   |         | intervention...no special forms, no redefinition of     |
|   |         | what is a direct or indirect cost, no new guidance from |
|   |         | OMB. All the agency has to do is either not cap direct  |
|   |         | costs (cap total costs or do not apply a cap) or exert  |
|   |         | human intervention to back out the indirects when       |
|   |         | deciding if an application is eligible. I would suggest |
|   |         | that new policies should be developed as a last resort; |
|   |         | the first step should be to see that existing policies  |
|   |         | are used effectively to achieve stated goals.           |
+---+---------+---------------------------------------------------------+
|   | **Uni   | The government should continue to support basic         |
|   | versity | research as well as applied and even high-risk          |
|   | of      | research. Longer and larger grants would be more        |
|   | Pitts   | efficient since investigators would be able to spend    |
|   | burgh** | more time on research and less time on proposal writing |
+---+---------+---------------------------------------------------------+
|   | *       | Create a foundation that will collect the best          |
|   | *Victor | attributes of multiple Federal agencies. An advocacy    |
|   | Pinks** | center for independent inventors needs to be created in |
|   |         | a single, centralized locale, rather than being         |
|   | Inst.   | distributed across a number of agencies. Centralizing   |
|   | of      | this function and broadening its mission beyond just    |
|   | Liquid  | energy strengthens its profile and allows the more      |
|   | D       | efficient exchange among multiple disciplines, rather   |
|   | ynamics | than limiting consideration only to inventions that fit |
|   | Simul.  | an agency's mission.                                    |
|   |         |                                                         |
|   |         | **Fast Track Concept Evaluation**: To pre-qualify an    |
|   |         | SBIR grant solely on the existence of business          |
|   |         | infrastructure is not prudent. A fast track concept     |
|   |         | evaluation, possibly handled by the military, should be |
|   |         | ready to look at the accomplishments of individual      |
|   |         | researchers where business infrastructure is not        |
|   |         | necessary. **(with other extensive comments on SBIR)**  |
+---+---------+---------------------------------------------------------+
|   |         |                                                         |
+---+---------+---------------------------------------------------------+
| * |         |                                                         |
| * |         |                                                         |
| G |         |                                                         |
| . |         |                                                         |
| M |         |                                                         |
| U |         |                                                         |
| L |         |                                                         |
| T |         |                                                         |
| I |         |                                                         |
| D |         |                                                         |
| I |         |                                                         |
| S |         |                                                         |
| C |         |                                                         |
| I |         |                                                         |
| P |         |                                                         |
| L |         |                                                         |
| I |         |                                                         |
| N |         |                                                         |
| A |         |                                                         |
| R |         |                                                         |
| Y |         |                                                         |
| / |         |                                                         |
| C |         |                                                         |
| O |         |                                                         |
| L |         |                                                         |
| L |         |                                                         |
| A |         |                                                         |
| B |         |                                                         |
| O |         |                                                         |
| R |         |                                                         |
| A |         |                                                         |
| T |         |                                                         |
| I |         |                                                         |
| V |         |                                                         |
| E |         |                                                         |
| R |         |                                                         |
| E |         |                                                         |
| S |         |                                                         |
| E |         |                                                         |
| A |         |                                                         |
| R |         |                                                         |
| C |         |                                                         |
| H |         |                                                         |
| * |         |                                                         |
| * |         |                                                         |
+---+---------+---------------------------------------------------------+
|   | **A     | Much of the current federal funding increase for        |
|   | merican | mathematics has been directed towards interdisciplinary |
|   | Mathe   | collaborations. We feel that these collaborations       |
|   | matical | strengthen the mathematical disciplines by emphasizing  |
|   | So      | the versatility of mathematics in modern day discovery  |
|   | ciety** | and innovation. We embrace the dissoluton of barriers   |
|   |         | among the sciences this entails, and welcome the        |
|   |         | recognition that true progress in technology relevant   |
|   |         | to today\'s needs requires ideas and techniques from    |
|   |         | often very diverse points of view.                      |
|   |         |                                                         |
|   |         | What then, is the right model for funding in the        |
|   |         | mathematical sciences? We propose that it be based on   |
|   |         | balance: a balance which recognizes the importance of   |
|   |         | timely response to emerging technologies, the necessity |
|   |         | of collaboration across disciplines, and the            |
|   |         | essentiality of basic investigation. We are concerned   |
|   |         | that this balance not be eroded. Mathematics is a       |
|   |         | \"small science\" in the sense that the discipline, for |
|   |         | the most part, does not require large facilities or     |
|   |         | laboratories; but mathematics collaborates with the     |
|   |         | \"big science\" disciplines. Small science is the       |
|   |         | riskiest research investment, but often with the        |
|   |         | highest potential in all of science. Federal support,   |
|   |         | broadly across the mathematical areas, is critical for  |
|   |         | the discipline to remain healthy, to grow, and to be a  |
|   |         | contributor to innovation twenty to thirty years from   |
|   |         | now. We need support for all of mathematics, not just   |
|   |         | for the mathematics that we currently see as useful to  |
|   |         | applications. Over time, neglect of basic inquiry will  |
|   |         | lead to a dearth of fresh ideas, as yet untapped, but   |
|   |         | suddenly readily available for application.             |
+---+---------+---------------------------------------------------------+
|   | *       | The growth of multi-disciplinary research across the    |
|   | *Assoc. | biomedical sciences underscores the opportunity for     |
|   | of      | further efforts to coordinate support of infrastructure |
|   | Amer.   | across NIH and with other federal agencies. NIH's use   |
|   | Medical | of DOE-funded synchrotron radiation facilities to       |
|   | Col     | support biological investigations is a successful and   |
|   | leges** | instructive model. Clearly, identification of           |
|   |         | appropriate mechanisms for review and support of        |
|   |         | infrastructure across agencies is a challenging task,   |
|   |         | but pilot projects might be used to test the            |
|   |         | feasibility of alternative approaches. Efforts should   |
|   |         | be made to develop proposals or options to strengthen   |
|   |         | coordination of investment in merit-reviewed,           |
|   |         | cross-disciplinary research infrastructure. NIH could   |
|   |         | initiate such efforts, and should also encourage        |
|   |         | academic institutions to identify opportunities for     |
|   |         | regional research resources that can be shared among    |
|   |         | multiple institutions.                                  |
+---+---------+---------------------------------------------------------+
|   | **      | **See entry under F. Research Support**                 |
|   | Federal |                                                         |
|   | Demons  |                                                         |
|   | tration |                                                         |
|   | Pr      |                                                         |
|   | oject** |                                                         |
+---+---------+---------------------------------------------------------+
|   | *       | There is currently no database or other system in place |
|   | *Humane | in order to network information between the National    |
|   | S       | Primate Research Centers (NPRCs). This lack of          |
|   | ociety\ | communication can result in duplication of efforts and, |
|   | **      | given the invasiveness of the research conducted at the |
|   |         | centers (e.g. infectious disease and cancer) can cause  |
|   |         | unnecessary suffering of an unknown number of nonhuman  |
|   |         | primates. Duplication of effort can significantly waste |
|   |         | federal dollars as well. The NPRCs should be required   |
|   |         | to share information and streamline efforts in order to |
|   |         | decrease the number of animals used, the amount of      |
|   |         | animal suffering and waste of federal funding.          |
+---+---------+---------------------------------------------------------+
|   | **Jeri  | I suggest that policy relevant, outcome driven          |
|   | L.      | research, with performance measures geared towards      |
|   | Berc,   | evaluating sustainable development, \"triple bottom     |
|   | Ph.D.** | line\" impacts - meaning economic, environmental and    |
|   |         | social impacts are integrated and optimized - is a way  |
|   | Special | to stimulate the innovation and the \"multi\" - should  |
|   | Asst.   | be \"inter\" (to encourage integrated, not just         |
|   | to the  | multifaceted) - disciplinary approaches sought. I also  |
|   | Dep.    | suggest participatory/community based research projects |
|   | Chief   | need to be encouraged, as well as stakeholder/community |
|   |         | involvement in defining research agendas and funding to |
|   | Soil    | ensure research relevance to sustainable development    |
|   | Survey  | policy goals                                            |
|   | and     |                                                         |
|   | Re      |                                                         |
|   | sources |                                                         |
|   | Ass     |                                                         |
|   | essment |                                                         |
|   |         |                                                         |
|   | USDA    |                                                         |
|   | Natural |                                                         |
|   | Re      |                                                         |
|   | sources |                                                         |
|   | Conse   |                                                         |
|   | rvation |                                                         |
|   | Service |                                                         |
+---+---------+---------------------------------------------------------+
|   | **M     | **See entry under F. Research Support**                 |
|   | .I.T.** |                                                         |
|   |         |                                                         |
|   | (Tab    |                                                         |
|   | #17)    |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Roger | SuperPower believes that there are funding              |
|   | A.      | organizations that are effective in encouraging         |
|   | Fa      | multidisciplinary work and collaborations. The DOE      |
|   | rrell** | Superconductivity Partnership Initiative which entails  |
|   |         | the design, development and demonstration of high       |
|   | Supe    | temperature superconducting devices entail multiple     |
|   | rPower, | disciplines such as material science, mechanical and    |
|   | I       | electrical engineering, computer science, physics,      |
|   | nc**.** | cryogenics, superconductivity, manufacturing and        |
|   |         | quality assurance. This same program requires           |
|   |         | collaborations through requiring teams consisting of    |
|   |         | superconductor companies, device manufacturers and      |
|   |         | utilities or other end users. The NIST Advanced         |
|   |         | Technology Program also does this in the area of        |
|   |         | collaborations by encouraging "joint ventures" formed   |
|   |         | for the purpose of conducting the program. Data on this |
|   |         | is available via the listings of awards made by these   |
|   |         | two agencies.                                           |
+---+---------+---------------------------------------------------------+
|   | **Sarah | The most substantial changes can come from              |
|   | Ma      | restructuring the peer-review process and broadening    |
|   | rston** | the pool of applicants by increasing the probability of |
|   |         | obtaining funding for new investigators with new ideas. |
|   | StatSc  |                                                         |
|   | i/Degge |                                                         |
|   | Group   |                                                         |
+---+---------+---------------------------------------------------------+
|   | *       |                                                         |
|   | *Senior |                                                         |
|   | R       |                                                         |
|   | esearch |                                                         |
|   | Off     |                                                         |
|   | icers** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **S     | Some of the most important and exciting modern research |
|   | tanford | is at the borders of the disciplines and of the         |
|   | Univ.** | individual agencies\' responsibilities. Investigators   |
|   |         | seeking to acquire federal funding for such endeavors   |
|   |         | must be knowledgeable about a host of different         |
|   |         | individual agency missions and business practices, peer |
|   |         | review preferences, and funding parameters (often tied  |
|   |         | to single-investigator/single-project and "big science" |
|   |         | projects.) They find, in addition, that the             |
|   |         | sophistication of the peer review process varies among  |
|   |         | agencies tremendously, as well. Both the federal        |
|   |         | government and the universities must continue to refine |
|   |         | their methods of dealing with this, while recognizing   |
|   |         | the importance of keeping the disciplines strong and    |
|   |         | that some agencies funding research have specific       |
|   |         | missions.                                               |
|   |         |                                                         |
|   |         | Consequently, we recommend that:                        |
|   |         |                                                         |
|   |         | A.  Federal agencies should re-examine and eliminate    |
|   |         |     existing barriers (political and practical) for     |
|   |         |     projects that transcend disciplines and specific    |
|   |         |     agency missions. Business models should be          |
|   |         |     developed that would facilitate cross-agency        |
|   |         |     support and minimize the amount of time that        |
|   |         |     researchers are required to devote to               |
|   |         |     administrative activities (e.g., implementation of  |
|   |         |     common proposal submission requirements across      |
|   |         |     agencies, development of common expectations about  |
|   |         |     co-PIs, implementation of a single set of terms and |
|   |         |     conditions governing a portfolio of awards, common  |
|   |         |     reporting requirements, etc.)                       |
|   |         |                                                         |
|   |         | B.  Federal agencies and universities should consider   |
|   |         |     whether "mid-size" science (usually                 |
|   |         |     multi-investigator) is adequately supported.        |
|   |         |     Funding for mid-size projects (\$500K - \$1M/year)  |
|   |         |     either involving several investigators in a single  |
|   |         |     area or cross-disciplines, or projects involving    |
|   |         |     two or several investigators in complementary but   |
|   |         |     connected areas is difficult to find, and agency    |
|   |         |     personnel seem hesitant to engage in funding        |
|   |         |     allocations that cross directorates, institutes, or |
|   |         |     agencies.                                           |
|   |         |                                                         |
|   |         | C.  Federal agencies should improve peer review         |
|   |         |     oversight and inter-agency communication about      |
|   |         |     project funding. The degree to which peer review is |
|   |         |     utilized varies tremendously among federal          |
|   |         |     agencies, as well as there being a significant      |
|   |         |     variance in the degree of sophistication and rigor  |
|   |         |     in peer review systems. It would be extremely       |
|   |         |     helpful if peer review was extended more broadly,   |
|   |         |     utilizing well-understood and articulated review    |
|   |         |     criteria and processes, and identifying and         |
|   |         |     deploying the best practices of the leading peer    |
|   |         |     review agencies, NIH and NSF. A common approach to  |
|   |         |     peer review will be essential to the success of     |
|   |         |     inter-disciplinary and cross-agency funding.        |
+---+---------+---------------------------------------------------------+
|   | **Uni   | • [Explore funding mechanisms that encourage            |
|   | versity | collaborative work:]{.underline} Examples worth         |
|   | of      | considering include:                                    |
|   | Calif   |                                                         |
|   | ornia** | [\-- NSF Collaborative Proposal Mechanisms]{.underline} |
|   |         | -- NSF's collaborative research opportunities and       |
|   |         | FastLane system make the collaborative submission       |
|   |         | process simple. Prior to linking proposals from various |
|   |         | institutions for a collaborative project, NSF requires  |
|   |         | that the approval of the relevant program officer be    |
|   |         | secured. Once such approval is granted, the             |
|   |         | collaborating institutions are allowed to submit their  |
|   |         | respective proposals, which are electronically linked   |
|   |         | through the FastLane system. The collaborating          |
|   |         | institutions each receive separate research funds,      |
|   |         | i.e., no subcontracting is involving. However the       |
|   |         | projects remain programmatically linked. Under this     |
|   |         | system, the administrative burden is significantly      |
|   |         | lighter for the participating institutions, while the   |
|   |         | investigators/institutions clearly benefit from the     |
|   |         | collaboration.                                          |
|   |         |                                                         |
|   |         | [\-- University of California's Industry-University     |
|   |         | Collaborative Research Program]{.underline} -- This is  |
|   |         | an example of a successful funding mechanism that       |
|   |         | encourages university-industry collaboration. This      |
|   |         | University of California program awards hundreds of UC  |
|   |         | Discovery Grants each year in five fields of science    |
|   |         | and engineering, in addition to offering a              |
|   |         | Microelectronics grants.                                |
|   |         |                                                         |
|   |         | [\-- University of California's MEXUS                   |
|   |         | Program]{.underline} -- This is an example of a         |
|   |         | successful funding mechanism that encourages            |
|   |         | international collaboration. The University of          |
|   |         | California Institute for Mexico and the United States   |
|   |         | (UC MEXUS) and Mexico's El Consejo Nacional de Ciencia  |
|   |         | y Tecnologia (CONACYT) partner to fund collaborative    |
|   |         | research between U.S. and Mexican researchers. The      |
|   |         | program funds collaborative projects co-directed by UC  |
|   |         | investigators and investigators from a Mexican          |
|   |         | institution, and encourages proposals that include      |
|   |         | participants from multiple institutions. The program    |
|   |         | funds projects expected to lead to the development of   |
|   |         | major, long-term collaborations, and favors projects    |
|   |         | that enhance institutional infrastructure in terms of   |
|   |         | graduate student training and researcher exchange. If a |
|   |         | project is selected, the MEXUS program issues an award  |
|   |         | to the Mexican and UC institution, separately, with     |
|   |         | common and uncomplicated terms and conditions. Similar  |
|   |         | to the NSF Collaborative projects, the MEXUS program    |
|   |         | provides administrative ease and straightforward terms  |
|   |         | and conditions, and facilitates collaboration.          |
|   |         |                                                         |
|   |         | • [Concern: Restrictive terms and lack of support for   |
|   |         | administrative workload:]{.underline} One of the few    |
|   |         | troublesome issues encountered with large               |
|   |         | multidisciplinary and collaborative awards has been     |
|   |         | restrictive federal agency terms inserted in RFAs for   |
|   |         | cooperative projects or in amendments to grants and     |
|   |         | cooperative agreements for collaborations which         |
|   |         | conflict with university and federal agency policies.   |
|   |         | These include: requirements to delay publications or    |
|   |         | restrict use and distribution of data; split indirect   |
|   |         | cost rates; and terms providing collaborative steering  |
|   |         | committees with authority to approve or prevent actions |
|   |         | that are rightfully the domain only of the recipient    |
|   |         | institutions.                                           |
|   |         |                                                         |
|   |         | A secondary concern is that federal agencies are        |
|   |         | transferring the workload without providing the         |
|   |         | financial support for the administrative staff needed   |
|   |         | for large collaborative or multidisciplinary programs.  |
|   |         | This problem occurs in cases where prime recipients     |
|   |         | write and administer multiple subawards rather than     |
|   |         | having the federal agency provide multiple prime        |
|   |         | awards. In addition, some prime recipients do not use   |
|   |         | appropriate subaward models and terms such as the FDP   |
|   |         | model and others limit the indirect cost rate that      |
|   |         | subrecipients can use.                                  |
|   |         |                                                         |
|   |         | [Recommendation]{.underline}: These matters can be      |
|   |         | addressed with guidance, training and infrastructure    |
|   |         | support. They do not detract from maintaining the       |
|   |         | system for funding large program, multiple awards       |
|   |         | currently is place. Inserting an independent            |
|   |         | administrative prime recipient between the federal      |
|   |         | agency and the collaborating institutions only creates  |
|   |         | more bureaucracy, expense, and improper application of  |
|   |         | federal regulations. Particularly where the prime       |
|   |         | recipient is a non-profit or for-profit organization    |
|   |         | administering awards to educational institutions, there |
|   |         | are more issues created with inappropriate terms and    |
|   |         | conditions and indirect cost restrictions than when     |
|   |         | educational institutions manage these collaborations    |
|   |         | themselves.                                             |
+---+---------+---------------------------------------------------------+
|   | **Uni   | The FDP and electronic submissions systems have         |
|   | versity | encouraged researchers from various fields, backgrounds |
|   | of      | and institutions to pursue collaborative sponsored      |
|   | Cali    | research because these systems make the administrative  |
|   | fornia, | aspect of research uniform. Expansion of successful     |
|   | Davis** | electronic systems (e.g., NSF FastLane) to other        |
|   |         | sponsoring agencies should enhance these types of       |
|   |         | collaborations. Another potential way to encourage      |
|   |         | collaboration of a broader mix of researchers is to     |
|   |         | improve upon centralized repositories that list         |
|   |         | available funding opportunities. Heightening the        |
|   |         | visibility of Requests for Proposals and Applications   |
|   |         | will encourage those who do not have an established     |
|   |         | relationship with program officers from various funding |
|   |         | agencies to be exposed to, and to apply for additional  |
|   |         | funding opportunities.                                  |
|   |         |                                                         |
|   |         | Creating a highly visible, centralized repository of    |
|   |         | funding opportunities may encourage those in the social |
|   |         | sciences, as well as the less experienced researchers   |
|   |         | to apply for federal funds.                             |
|   |         |                                                         |
|   |         | The NSF Science and Technology Center (STC) and         |
|   |         | Engineering Research Center (ERC) programs are centered |
|   |         | on the idea of conducting research (and complementary   |
|   |         | educational efforts) in a collaborative Center setting. |
|   |         | Typically, diverse faculty teams and collaborators from |
|   |         | industry and national laboratories from multiple        |
|   |         | disciplines work jointly with graduate students,        |
|   |         | post-docs, and researchers to investigate inherently    |
|   |         | complicated problems. Research Center environments      |
|   |         | emphasize co-supervision of students and researchers,   |
|   |         | active visitors and exchange programs and, typically,   |
|   |         | application-driven research. Science and technology     |
|   |         | policy should consider the various benefits that arise  |
|   |         | from such Center-based efforts, and increase further    |
|   |         | funding for research Centers, especially in             |
|   |         | society-relevant areas.                                 |
|   |         |                                                         |
|   |         | Research Center-based efforts are becoming increasingly |
|   |         | important components of the research and education      |
|   |         | focuses of science and engineering departments.         |
|   |         | Recognizing this trend, science and technology policy   |
|   |         | must take into consideration that larger research       |
|   |         | centers are more likely to be owned by a university at  |
|   |         | large, where Centers report to a central oversight      |
|   |         | unit, not just one department. Considering the desired  |
|   |         | broad definition of Center-based research, in many      |
|   |         | cases maximal research prosperity can be achieved only  |
|   |         | if reporting and oversight issues are treated           |
|   |         | centrally, and not, for example, within the boundaries  |
|   |         | of a specific college or department.                    |
|   |         |                                                         |
|   |         | Large-scale computing-centered research requires        |
|   |         | substantial investments in basic supporting             |
|   |         | infrastructure, including costs for maintenance and     |
|   |         | administrative staff. Academic institutions are         |
|   |         | typically not in a position to support large-scale      |
|   |         | multi-investigator Center-like efforts with sufficient  |
|   |         | base support, concerning equipment and administrative   |
|   |         | needs. It is desirable to increase the number of        |
|   |         | funding mechanisms and programs that would provide a    |
|   |         | relatively larger number academic institutions access   |
|   |         | to funding dedicated to supporting infrastructure needs |
|   |         | of campus-wide, cross-disciplinary computing-centered   |
|   |         | efforts.                                                |
|   |         |                                                         |
|   |         | Science and technology policy must fully recognize the  |
|   |         | basic paradigm shift affecting the very essence of the  |
|   |         | discovery and design process in science, engineering,   |
|   |         | and medicine; funding policy must recognize the need    |
|   |         | for a \"digital cyber-infrastructure\" that scientists  |
|   |         | will have to rely on to effectively utilize vast,       |
|   |         | rapidly expanding digital data repositories. It is      |
|   |         | paramount to recognize that the needed technology has   |
|   |         | to be defined, implemented, and tested in close         |
|   |         | collaborations involving domain scientists and          |
|   |         | technologists.                                          |
|   |         |                                                         |
|   |         | Science and technology policy can play a significant    |
|   |         | role in fostering the establishment of \"integration    |
|   |         | centers\" whose mission would be to identify and        |
|   |         | integrate the latest and most powerful in computer and  |
|   |         | computational science and engineering technology.       |
|   |         | Ideally, such centers would be co-funded and            |
|   |         | co-administered by industry partners or consortia, with |
|   |         | a main objective being rapid technology transfer into   |
|   |         | the private sector.                                     |
|   |         |                                                         |
|   |         | Effective \"knowledge and technology transfer\" is      |
|   |         | needed. Science and technology policy can support this  |
|   |         | goal by mandating and supporting at a much-increased    |
|   |         | level technology transfer-driven components in          |
|   |         | federally funded research. Novel mechanisms must be     |
|   |         | defined that will allow scientists and engineers from   |
|   |         | academia to communicate findings to non-traditional     |
|   |         | groups, especially the industrial and policy sectors.   |
|   |         | For example, designated conference centers or national  |
|   |         | laboratories could serve the purpose of communicating   |
|   |         | our scientists\' latest findings to the broad potential |
|   |         | user communities.                                       |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Adequately fund interdisciplinary, team activity.       |
|   | versity | Acknowledge that team efforts and interdisciplinary     |
|   | of      | work are more expensive (require higher inputs), but    |
|   | Idaho** | that they are justified by higher order outputs and     |
|   |         | impacts.                                                |
|   |         |                                                         |
|   |         | Improve interdisciplinary peer review oversight, extend |
|   |         | its use more broadly, and coordinate inter-agency       |
|   |         | communication on project funding.                       |
|   |         |                                                         |
|   |         | Eliminate artificial distinctions between research,     |
|   |         | education, outreach and public service. Integration of  |
|   |         | functions results in more powerful outcomes and impacts |
|   |         | and ought to be explicitly invited and rewarded.        |
|   |         |                                                         |
|   |         | Government funding agencies do not foster interagency   |
|   |         | or agency-university research. This is especially true  |
|   |         | for agencies that have funding authority and their own  |
|   |         | research functions.                                     |
|   |         |                                                         |
|   |         | Congress often raids agency budgets by earmarks to      |
|   |         | universities. This does not foster cooperative          |
|   |         | relations between research entities and generates       |
|   |         | costly competition between institutions. Provide models |
|   |         | and incentives for joint research agendas by            |
|   |         | universities, agencies and national labs.               |
+---+---------+---------------------------------------------------------+
|   | **Uni   | There is a concern about how "credit" is given to those |
|   | versity | receiving funding. Both NIH and NSF have data systems   |
|   | of      | that allow anyone to see what they are funding. These   |
|   | Ken     | data systems are highly valued by the community and the |
|   | tucky** | committee might want to consider exhorting all agencies |
|   |         | to make similar data available. The NIH system is more  |
|   |         | flexible and rich, but there is one addition that would |
|   |         | be valuable. As research becomes more complex there are |
|   |         | frequently teams of researchers even on R01s. It would  |
|   |         | be helpful to the community if                          |
|   |         |                                                         |
|   |         | they could see how different individuals were involved  |
|   |         | in research projects.                                   |
|   |         |                                                         |
|   |         | There is an elegant solution to this problem that could |
|   |         | be effected simply and quickly, if the institutions     |
|   |         | take responsibility for identifying key personnel.      |
|   |         |                                                         |
|   |         | This is a specific case of a general issue; how can the |
|   |         | OSTP committee serve as a broker between the agencies   |
|   |         | and the universities?                                   |
+---+---------+---------------------------------------------------------+
|   | *       | A key approach should be to develop policies and        |
|   | *Vernon | practices to integrate today\'s relatively independent  |
|   | C.      | science activities into systems that more effectively   |
|   | Gi      | address the needs of society....In 1979 OSTP and OMB    |
|   | lbert** | recognized the value of the U.S. Man and the Biosphere  |
|   |         | Program as an effective integrating mechanism for       |
|   | U.S.    | federal agency science and natural resource management  |
|   | Bi      | programs. In a memorandum to key federal agencies OSTP  |
|   | osphere | and OMB called for the development of a national plan,  |
|   | R       | which included \"Cooperative Regional Demonstration     |
|   | eserves | Projects.\" These projects were requested especially by |
|   | Asso    | officials in OSTP. The Southern Appalachian Man and the |
|   | ciation | Biosphere (SAMAB) Program resulted from this imitative, |
|   |         | and SAMAB has benefited this region in spite of its     |
|   |         | modest and unpredictable funding....If responsible use  |
|   |         | of public resources is to be demonstrated, it will have |
|   |         | to be through agencies\' planning and working together  |
|   |         | on issues of common concern. SAMAB would be a good case |
|   |         | study                                                   |
+---+---------+---------------------------------------------------------+
|   |         |                                                         |
+---+---------+---------------------------------------------------------+
| * |         |                                                         |
| * |         |                                                         |
| H |         |                                                         |
| . |         |                                                         |
| R |         |                                                         |
| E |         |                                                         |
| S |         |                                                         |
| E |         |                                                         |
| A |         |                                                         |
| R |         |                                                         |
| C |         |                                                         |
| H |         |                                                         |
| I |         |                                                         |
| N |         |                                                         |
| F |         |                                                         |
| R |         |                                                         |
| A |         |                                                         |
| S |         |                                                         |
| T |         |                                                         |
| R |         |                                                         |
| U |         |                                                         |
| C |         |                                                         |
| T |         |                                                         |
| U |         |                                                         |
| R |         |                                                         |
| E |         |                                                         |
| * |         |                                                         |
| * |         |                                                         |
+---+---------+---------------------------------------------------------+
|   | **C     | More Funding is Needed for Research Infrastructure - As |
|   | olumbia | reports for NIH and NSF have recently documented,       |
|   | Univ.** | research infrastructure needs additional funding if the |
|   |         | federal government\'s investments in research are to be |
|   |         | optimally utilized. Cutting-edge facilities and         |
|   |         | equipment are necessary to advance the frontiers of     |
|   |         | knowledge. As research becomes increasingly complex and |
|   |         | interconnected across disciplines, the tools and        |
|   |         | support systems necessary to conduct cutting-edge       |
|   |         | research become ever more complex - and expensive.      |
|   |         | Meeting our growing infrastructure requirements and the |
|   |         | accompanying costs will require innovative new federal  |
|   |         | programs and mechanisms through which to support        |
|   |         | cutting-edge scientific infrastructure.                 |
+---+---------+---------------------------------------------------------+
|   | **      | Currently we estimate that underrecovery by             |
|   | Council | universities of legitimate administrative costs amounts |
|   | on      | to \$200 million annually. More importantly, the        |
|   | Govt.   | government has not restrained the agencies from         |
|   | Re      | refusing to fully fund the government negotiated rate.  |
|   | lations | As a result, the underrecovery of F&A costs by          |
|   | (       | universities due to arbitrary agency limitations far    |
|   | COGR)** | exceeds their loss of funds due to the cap, and is      |
|   |         | estimated to be \$1 billion. These data were gathered   |
|   |         | in a 2003 COGR study on the Cost of Doing               |
|   |         | Business.[^5]1 Its findings are consistent with a 2000  |
|   |         | RAND report done for OSTP                               |
|   |         |                                                         |
|   |         | We believe that over the past 10-15 years, short term   |
|   |         | political and budget considerations have resulted in    |
|   |         | changes to Circular A-21 that have trumped the          |
|   |         | government's stated goals of providing the best science |
|   |         | the country can afford.  A pressing issue is the cap on |
|   |         | the administrative portion of the F&A cost rate. The    |
|   |         | government has not imposed such a restriction on any    |
|   |         | other class of research providers and has not reviewed  |
|   |         | the cap in over a decade.                               |
|   |         |                                                         |
|   |         | Universities cannot and should not bear the burden of   |
|   |         | unfair cost shifting.                                   |
|   |         |                                                         |
|   |         | With respect to facilities, a report to the NIH         |
|   |         | Director, issued in 2001, provides an analysis of the   |
|   |         | current insufficiency of biomedical research            |
|   |         | facilities, estimates of needed expansion of facilities |
|   |         | to support research, and the financial roadblocks to    |
|   |         | facilities renewal. The report is entitled, "NIH        |
|   |         | Working Group on Construction of Research Facilities: A |
|   |         | Report to the Advisory Committee of the Director, NIH". |
|   |         |                                                         |
|   |         | In a further blow to the research infrastructure, the   |
|   |         | government has prohibited special cost studies, which   |
|   |         | are intended to illustrate special needs, such as for   |
|   |         | the use of energy required in high tech laboratories.   |
|   |         | COGR has repeatedly reminded OMB of its promise to      |
|   |         | issue a fair and equitable policy for utility cost      |
|   |         | recovery.                                               |
+---+---------+---------------------------------------------------------+
|   | **Roger | In our experience, Federal programs do not allow the    |
|   | A.      | construction of research facilities to be an allowable  |
|   | Fa      | program cost. Capital equipment for research is an      |
|   | rrell** | allowable cost but is sometimes limited to a maximum    |
|   |         | percent of the overall program budget. Operating the    |
|   | Supe    | equipment for the purposes of performing research on    |
|   | rPower, | the program is also an allowable cost. The cost of      |
|   | I       | maintaining the equipment would be covered through      |
|   | nc**.** | labor overhead calculated according to government       |
|   |         | (DCAA) requirements. In New York State, NYSERDA follows |
|   |         | Federal requirements in determining what costs are      |
|   |         | allowable and how they are allocated. Locally, there    |
|   |         | are mechanisms such as "Economic Development Zones". If |
|   |         | a company is located in such a zone, financial          |
|   |         | assistance is provided for infrastructure, job          |
|   |         | training, electricity rates and, possibly, capital      |
|   |         | equipment.                                              |
|   |         |                                                         |
|   |         | SuperPower considers these factors when deciding        |
|   |         | whether to perform a specific research program or not.  |
|   |         | For example a capital equipment item may be too         |
|   |         | expensive for us alone but if there is a Federal        |
|   |         | contribution it becomes tenable. In our field, research |
|   |         | equipment is very expensive and this is important. We   |
|   |         | do not believe there is data on research infrastructure |
|   |         | investment that is readily obtainable.                  |
+---+---------+---------------------------------------------------------+
|   | **      | **See entry under F. Research Support**                 |
|   | Federal |                                                         |
|   | Demons  |                                                         |
|   | tration |                                                         |
|   | Pr      |                                                         |
|   | oject** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Joint | The research infrastructure requires additional funding |
|   | AAU-    | to ensure that the federal government's investments in  |
|   | NASULGC | research are utilized as effectively as possible.       |
|   | L       | Cutting-edge facilities and equipment are necessary to  |
|   | etter** | advance the frontiers of knowledge. Moreover, as        |
|   |         | research becomes increasingly complex and               |
|   |         | interconnected across disciplines, the tools and        |
|   |         | support systems necessary to conduct cutting-edge       |
|   |         | research become ever more complex and expensive.        |
|   |         | Meeting our growing infrastructure requirements and the |
|   |         | accompanying costs will require innovative new federal  |
|   |         | programs and mechanisms through which to support        |
|   |         | cutting-edge scientific infrastructure.                 |
+---+---------+---------------------------------------------------------+
|   | **M     | **See entry under F. Research Support**                 |
|   | .I.T.** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **S     | In the performance of research, scientists are          |
|   | tanford | increasingly dependent on complex, multimillion dollar  |
|   | Univ.** | instrumentation that is smaller than the neutron,       |
|   |         | synchrotron radiation or high energy facilities. This   |
|   |         | instrumentation is usually shared by many investigators |
|   |         | from a broad range of scientific fields who are         |
|   |         | supported by several different federal agencies. They   |
|   |         | are aided by scientists and/or technicians who are      |
|   |         | dedicated to maintaining and improving these            |
|   |         | experimental systems in an effort to assure that they   |
|   |         | are used well, well maintained, constantly at the       |
|   |         | state-of-the art.                                       |
|   |         |                                                         |
|   |         | Existing research business models for such major        |
|   |         | instrumentation, joint-use facilities, and laboratory   |
|   |         | renewal are limited and, at times, serve as a deterrent |
|   |         | for collaboration and sharing of vital research         |
|   |         | resources. "Service Center" models for major facilities |
|   |         | do not allow for adequate fiscal planning for           |
|   |         | stability, evolution or replacement, and audit-worthy   |
|   |         | business models for allocating acquisition, use, and    |
|   |         | ongoing maintenance costs among multiple investigators  |
|   |         | have proven to be impractical in all but the most       |
|   |         | simple sorts of cases.                                  |
|   |         |                                                         |
|   |         | Our recommendations are as follows:                     |
|   |         |                                                         |
|   |         | Federal funding agencies, and university business       |
|   |         | partners should work together to create new policies,   |
|   |         | practices and business arrangements that will foster    |
|   |         | the development, use and continuous improvement of      |
|   |         | shared facilities/equipment (rather than focusing on    |
|   |         | accounting for their use).                              |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Administrative caps on salary, stipends and tuition     |
|   | versity | costs often shift legitimate research costs to          |
|   | of      | awardees. This is particularly true in smaller          |
|   | Idaho** | institutions.                                           |
|   |         |                                                         |
|   |         | Administrative costs at universities are not adequately |
|   |         | funded. As a result, faculty members spend time on      |
|   |         | administrative tasks when others could do these tasks   |
|   |         | better and at a lower salary. Universities need help    |
|   |         | with administrative costs -- both in additional funding |
|   |         | and in helping to reduce those costs. Administrative    |
|   |         | costs can be reduced by having more consistent policies |
|   |         | and practices across agencies and by eliminating        |
|   |         | unnecessary tasks.                                      |
|   |         |                                                         |
|   |         | Formulate more incentives for infrastructure requests   |
|   |         | that support multi-disciplinary research. Foster more   |
|   |         | cross-disciplinary support for special facilities, lab  |
|   |         | buildings and certain types of shared equipment (e.g.,  |
|   |         | mass spectrometers). It is increasingly difficult to    |
|   |         | secure funding for high quality laboratory staff that   |
|   |         | run equipment in multidisciplinary research facilities. |
|   |         | Funding of core facilities and their technical support  |
|   |         | personnel is a critical needed infrastructure component |
|   |         | given the increased specialization in scientific        |
|   |         | equipment.                                              |
|   |         |                                                         |
|   |         | Set higher allowable indirect cost recovery rates and   |
|   |         | be consistent with indirect cost recovery guidelines    |
|   |         | across agencies and RFPs. Institutions must recover     |
|   |         | more indirect costs to pay for the rising costs in:     |
|   |         | a-maintenance of current operations including           |
|   |         | specialized scientific equipment depreciation and       |
|   |         | library electronic databases, b-health benefits,        |
|   |         | c-insurance premiums, d-management of collaborative     |
|   |         | research programs, e-grants and contracts staff needed  |
|   |         | to manage increasing forms of compliance (e.g..         |
|   |         | hazardous chemical tracking, management of paperwork    |
|   |         | for foreign workers), etc.                              |
|   |         |                                                         |
|   |         | Academic institutions have assumed the predominant      |
|   |         | burden for construction of new facilities. The federal  |
|   |         | government should create incentives for state and       |
|   |         | private organizations to partner with it to construct   |
|   |         | new facilities on university campuses.                  |
|   |         |                                                         |
|   |         | Capacity has been increasing at the University of       |
|   |         | Idaho; research expenditures have grown 84% over the    |
|   |         | last five (5) years with grants and contracts awards    |
|   |         | rising 79%. However, the facility and administrative    |
|   |         | costs have outpaced our ability to recover those costs. |
|   |         | Incentive programs have helped us recover a greater     |
|   |         | proportion of the negotiated rate. However, we still    |
|   |         | recover less than a third of the federally negotiated   |
|   |         | rate from federal grants and contracts in part because  |
|   |         | of the differential treatment of these costs between    |
|   |         | federal agencies. This is further compounded by         |
|   |         | cost-sharing requirements, rapidly increasing           |
|   |         | compliance costs, escalating costs associated with      |
|   |         | multi-disciplinary research, less than full             |
|   |         | reimbursement of project costs, and other unfunded      |
|   |         | mandates. As a relatively small institution in a        |
|   |         | predominantly rural state, these costs cannot be        |
|   |         | absorbed on a sustained basis. We have been coping by   |
|   |         | reducing our effective capacity through (1) very        |
|   |         | selective participation in RFPs that have long-term     |
|   |         | personnel implications, (2) having research faculty     |
|   |         | spend time on administrative duties that could be       |
|   |         | better handled by experienced, lower paid staff, and    |
|   |         | (3) not submitting proposals on RFPs that have          |
|   |         | cost-shifting components we cannot fund. This is        |
|   |         | reducing our competitiveness as an institution and      |
|   |         | precluding our involvement in certain RFPs.             |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Over the past decade there has been considerable growth |
|   | versity | in support for research, for which universities are     |
|   | of      | very grateful. There has been far less attention to the |
|   | Ken     | process for ensuring that there are adequate facilities |
|   | tucky** | in which to conduct that research. Despite NSF surveys  |
|   |         | that show the need for research space, direct funding   |
|   |         | levels are low and recovery through F/A is              |
|   |         | retrospective and limited.                              |
|   |         |                                                         |
|   |         | Since the ability to obtain funding is influenced by    |
|   |         | the nature of the university -- public vs. private,     |
|   |         | wealthy vs. struggling -- there will be increasing      |
|   |         | disparities in institutional ability to compete for     |
|   |         | research dollars.                                       |
|   |         |                                                         |
|   |         | Such a concentration would not be good for the overall  |
|   |         | research enterprise because students are widely         |
|   |         | dispersed. One of the strengths of the US model for     |
|   |         | research funding is the close linkage between research  |
|   |         | and graduate education. I urge the committee to revisit |
|   |         | the issue of how funding for research facilities        |
|   |         | influences the overall research enterprise and to       |
|   |         | consider new models for such support.                   |
|   |         |                                                         |
|   |         | The location of this activity in the OSTP, the          |
|   |         | involvement of multiple agencies and the high level     |
|   |         | attention being accorded this activity are critically   |
|   |         | important and should be applauded.                      |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Even in tight financial times that additional funding   |
|   | versity | be found to improve and increase the research           |
|   | of      | infrastructure to remedy deficiencies.                  |
|   | Pitts   |                                                         |
|   | burgh** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Please see our comments in Section F, above, pertaining |
|   | versity | to funding of infrastructure needs.                     |
|   | of      |                                                         |
|   | Calif   | With the rising costs of complying with new and         |
|   | ornia** | increasing federal regulatory mandates, the inability   |
|   |         | of universities to recover legitimate administrative    |
|   |         | costs has become a serious issue. Please see our        |
|   |         | comments in Sections E and F, above.                    |
+---+---------+---------------------------------------------------------+
|   | **Asso  | AAMC's constituents indicate that facilities and        |
|   | ciation | research space remain a significant constraint for new  |
|   | of      | research, and academic institutions have assumed the    |
|   | A       | predominant burden for construction of new              |
|   | merican | facilities.16 The Association and other organizations   |
|   | Medical | have asked that support for renovation and construction |
|   | Col     | of research facilities in general, and for research     |
|   | leges** | facilities for non-human primates, recombinant rodents, |
|   |         | and other animals in particular, be a priority of the   |
|   |         | NIH and its National Center for Research Resources.17   |
|   |         | An NIH advisory group, the Working Group on Research    |
|   |         | Facilities, has innovatively proposed to create a       |
|   |         | federal loan guarantee program for new facility         |
|   |         | construction.18 Such a program would, with minimal cost |
|   |         | to federal partners, improve opportunities for          |
|   |         | financing new facilities at PHS grantee institutions. A |
|   |         | major impediment in biomedical research---incredibly,   |
|   |         | in spite of the growth of the NIH budget---has been     |
|   |         | limited access to commercially available, state-of-art  |
|   |         | instrumentation, and particularly so-called high-end    |
|   |         | instruments, such as high-field MRIs, PET scanners, or  |
|   |         | certain types of mass spectrometers. NIH's central      |
|   |         | program for shared instrumentation (i.e., used by three |
|   |         | or more investigators) has received relatively little   |
|   |         | increased funding, adjusted for inflation, from the     |
|   |         | early 1990s. A new program to support purchase of       |
|   |         | high-end instrumentation has been implemented at NIH,   |
|   |         | though it has been grossly insufficient to address a    |
|   |         | significant share of the meritorious applications       |
|   |         | submitted. There may be opportunities for creating      |
|   |         | programs that establish especially expensive and        |
|   |         | complicated instruments, which require dedicated        |
|   |         | full-time staff, as regional resources, to be shared    |
|   |         | among institutions.                                     |
+---+---------+---------------------------------------------------------+
|   | **      | A few years ago, the Rand Corporation conducted a       |
|   | Harvard | careful and thorough study of building costs throughout |
|   | Unive   | the nation that indicated, in general, that the costs   |
|   | rsity** | were appropriate given regional variability, and that   |
|   |         | non-federal parties were paying a very large fraction   |
|   |         | of these costs. Recent calculations of Harvard F&A      |
|   |         | rates have demonstrated once again an under-recovery of |
|   |         | space costs associated with research.                   |
|   |         |                                                         |
|   |         | Research administration and the provision of facilities |
|   |         | and tools, access to information in libraries and       |
|   |         | digital resources are also essential elements of        |
|   |         | research infrastructure -- elements that cannot be      |
|   |         | overlooked in any meaningful business model. Suffice it |
|   |         | to say that the costs of administration pose a heavy    |
|   |         | burden.                                                 |
|   |         |                                                         |
|   |         | The situation with respect to library costs is          |
|   |         | problematic in two ways. First, there appears to be a   |
|   |         | de facto cap on library facility costs at the level of  |
|   |         | a few percent of the recovered indirect costs of        |
|   |         | research. Second, A-21 sanctions a wide variety of      |
|   |         | inconsistent methods for determining these costs, many  |
|   |         | of which bear little relation to actual library costs   |
|   |         | related to organized research. Library cost allocation  |
|   |         | should be based on library costs including the costs of |
|   |         | on-line journals and databases**.**                     |
+---+---------+---------------------------------------------------------+
|   |         |                                                         |
+---+---------+---------------------------------------------------------+
| * |         |                                                         |
| * |         |                                                         |
| I |         |                                                         |
| . |         |                                                         |
| I |         |                                                         |
| N |         |                                                         |
| F |         |                                                         |
| O |         |                                                         |
| R |         |                                                         |
| M |         |                                                         |
| A |         |                                                         |
| T |         |                                                         |
| I |         |                                                         |
| O |         |                                                         |
| N |         |                                                         |
| T |         |                                                         |
| E |         |                                                         |
| C |         |                                                         |
| H |         |                                                         |
| N |         |                                                         |
| O |         |                                                         |
| L |         |                                                         |
| O |         |                                                         |
| G |         |                                                         |
| Y |         |                                                         |
| * |         |                                                         |
| * |         |                                                         |
+---+---------+---------------------------------------------------------+
|   | *       | The need for a national, uniform, inter-operative       |
|   | *Assoc. | clinical information system to support patient-centered |
|   | of      | clinical research has become an urgent priority in the  |
|   | Amer.   | age of human genomics. The AAMC, with support from the  |
|   | Medical | National Science Foundation, has completed a study of   |
|   | Col     | clinical informatics, recommending, among other         |
|   | leges** | initiatives, that academic health centers take the lead |
|   |         | in developing and adopting a common set of              |
|   |         | specifications, while allowing commercial vendors to    |
|   |         | focus on systems development.                           |
|   |         |                                                         |
|   |         | The development and implementation of clinical          |
|   |         | information systems *designed for support of clinical   |
|   |         | research* is a daunting undertaking of national scope   |
|   |         | that AAMC believes will only be accomplished through a  |
|   |         | public-private partnership catalyzed by federal         |
|   |         | leadership and challenge funding.                       |
+---+---------+---------------------------------------------------------+
|   | **      | Two other areas of concern to COGR involve forces that  |
|   | Council | undeniably impact the way modern research is conducted, |
|   | on      | and about which the notice invites comment. One is the  |
|   | Govt.   | rapid development of computational power. Although      |
|   | Re      | anxious to engage in electronic administration,         |
|   | lations | universities have been hampered by the slow movement of |
|   | (       | agencies in developing a common interface that would    |
|   | COGR)** | allow easy access to the agencies for proposal          |
|   |         | submission, notification of awards and post award       |
|   |         | administrative reporting. In fact, the proliferation of |
|   |         | dissimilar systems implemented by funding agencies,     |
|   |         | tends to increase the cost and complexity of research   |
|   |         | administration.                                         |
|   |         |                                                         |
|   |         | We fully support government-wide initiatives to improve |
|   |         | business relationships through use of electronic        |
|   |         | systems.  However, after having raised the issue with   |
|   |         | federal agencies individually, COGR expressed concerns  |
|   |         | to OMB several months ago about the proliferation of    |
|   |         | federal electronic grant application programs.          |
|   |         |                                                         |
|   |         | This is an area of great concern to COGR and its member |
|   |         | universities. As stated by COGR Board member Marvin     |
|   |         | Parnes of the University of Michigan in recent          |
|   |         | testimony before the House Energy and Commerce          |
|   |         | Subcommittee on Technology, Information Policy,         |
|   |         | Intergovernmental Relations and the Census, "...It is   |
|   |         | our opinion that much harm has been, and is being done, |
|   |         | in the current research environment.                    |
|   |         |                                                         |
|   |         | Without efficient and effective communication between   |
|   |         | the granting agency, the researcher, and the university |
|   |         | administrators charged with fiduciary and               |
|   |         | administrative oversight, the introduction of new       |
|   |         | systems might do more harm than good".                  |
+---+---------+---------------------------------------------------------+
|   | **      | We believe this is an area of both greatest promise     |
|   | Federal | and, at the same time, greatest challenge. It has been  |
|   | Demons  | almost a decade now that federal agencies have been     |
|   | tration | describing electronic research administration as the    |
|   | Partne  | way the research enterprise will be conducted. Through  |
|   | rship** | the years, perhaps the most successful of the agencies  |
|   |         | in implementing eRA has been NSF, with its FastLane     |
|   |         | program. Other agencies have made significant strides   |
|   |         | -- NIH and ONR to name just two -- and other agencies   |
|   |         | are utilizing a variety of electronic systems to carry  |
|   |         | out their business. The problem from our perspective is |
|   |         | the number of these systems -- each of which is         |
|   |         | basically individualized and unique. The NIH Commons    |
|   |         | which became the Federal Commons and is now becoming    |
|   |         | eGov is a step in the right direction. However, there   |
|   |         | are serious issues which still need to be resolved for  |
|   |         | eGov to become the standard across the government. Not  |
|   |         | only must all agencies support eGov, but the number of  |
|   |         | individualized supplemental information which agencies  |
|   |         | might require needs to be restricted. The TS194         |
|   |         | (transaction set for research proposals) provides a     |
|   |         | mechanism for standardization, and it (or its successor |
|   |         | process) should be explored for adoption government     |
|   |         | wide. Not until the federal agencies can settle on one  |
|   |         | process and require its use as a standard (rather than  |
|   |         | just for selected programs in selected agencies) will   |
|   |         | all universities be able to invest in the resources     |
|   |         | necessary to comply. For eGov to become the *de facto*  |
|   |         | standard will require a significant investment by the   |
|   |         | government and the higher education community. We do    |
|   |         | believe that significant steps have been taken and we   |
|   |         | encourage continued development in this area. As an     |
|   |         | institution which is supporting the work of the Federal |
|   |         | Demonstration Partnership, we support the FDP           |
|   |         | initiatives in this area and urge OSTP to work closely  |
|   |         | with the FDP in this critical area.                     |
+---+---------+---------------------------------------------------------+
|   | **      | Administrative. Electronic processing should eventually |
|   | Harvard | make it possible to dispense and gather information in  |
|   | Unive   | a more uniform fashion on or via the Web. We favor      |
|   | rsity** | building a Federal Commons that serves all Federal      |
|   |         | Agencies and meets the needs of most recipients is      |
|   | (Tab    | essential, and believe that this goal will be more      |
|   | #16)    | readily accomplished if it is viewed as joint           |
|   |         | government-university endeavor. To this end, we         |
|   |         | recommend that mechanisms be developed to increase the  |
|   |         | involvement of university research community (including |
|   |         | the business and technical perspectives) through, for   |
|   |         | example, university pilot sites and increased           |
|   |         | university participation on task forces and work        |
|   |         | groups. We understand that Fastlane may be replaced by  |
|   |         | something new from ***EGOV***. We wonder why anyone     |
|   |         | would want to remove a system that is proven and start  |
|   |         | over.                                                   |
|   |         |                                                         |
|   |         | Research. As noted earlier, information technology has  |
|   |         | vastly extended the range of information available, and |
|   |         | the need for IT hardware and software to access,        |
|   |         | process, and store this information. Without these      |
|   |         | tools, research suffers. Yet, there is currently little |
|   |         | place for the inclusion of many of these expenditures   |
|   |         | in either direct or indirect costs.                     |
+---+---------+---------------------------------------------------------+
|   | **Roger | It is believed that \[information technology\] has led  |
|   | A.      | to a reduction in the number of hours doing technical   |
|   | Fa      | due diligence research but there is no data to confirm  |
|   | rrell** | this. Also it is probable that the cost of reporting    |
|   |         | and compliance is reduced because of the productivity   |
|   | Supe    | inherent in automation. Software tools make it possible |
|   | rPower, | to also improve program management, tracking schedule   |
|   | I       | and cost to budget                                      |
|   | nc**.** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Sarah | The NIH could streamline the submission-funding process |
|   | Ma      | and also facilitate execution of clinical trials via    |
|   | rston** | effective application of information technology.        |
|   |         | Pharmaceutical industry already relies on document      |
|   | StatSc  | management and clinical trial software applications to  |
|   | i/Degge | streamline processing, the NIH has failed to            |
|   | Group   | successfully contract and install these types of        |
|   |         | applications. Review of the NIH overhead and            |
|   |         | establishment of performance metrics can encourage the  |
|   |         | NIH to move more aggressively towards delivering        |
|   |         | successful IT solutions to reduce overhead.             |
+---+---------+---------------------------------------------------------+
|   | **Uni   | While research institutions can control their internal  |
|   | versity | selection and development of information technology     |
|   | of      | systems, they are forced to respond to a growing number |
|   | Calif   | of external systems that require costly multiple        |
|   | ornia** | platforms, staff training and technical expertise. In   |
|   |         | the worst case scenario, these various agency systems   |
|   |         | are not responsive to the internal needs of recipient   |
|   |         | institutions' procedures and requirements. Within a     |
|   |         | given research institution or agency, the thoughtful    |
|   |         | development of appropriate information technology is    |
|   |         | reducing paper and increasing efficiency. However, the  |
|   |         | uncontrolled growth of systems and platforms among      |
|   |         | agencies is making complicating implementation of these |
|   |         | changes. Also see comments in Section B, above.         |
+---+---------+---------------------------------------------------------+
|   | **Uni   | We recommend that electronic proposal and progress      |
|   | versity | report submission systems continue to be developed and, |
|   | of      | most importantly, standardized as much as possible. The |
|   | Cali    | NSF Fastlane system is the prime example of an          |
|   | fornia, | efficient electronic submission system; it is           |
|   | Davis** | accessible to principal investigators, staff support    |
|   |         | personnel, and administrators. We must caution against  |
|   |         | the development of numerous, competing electronic       |
|   |         | submissions systems that may create significant         |
|   |         | confusion and jeopardize timely submission.             |
+---+---------+---------------------------------------------------------+
|   | **Uni   | In response to PL 106-107, agencies have independently  |
|   | versity | developed electronic grant application systems that     |
|   | of      | have resulted in inefficiencies and chaos. Many of      |
|   | Fl      | these systems by-pass the institutions sponsored        |
|   | orida** | research offices where Institutional Approval is        |
|   |         | obtained prior to submission of a grant application.    |
|   |         | Provide a common system, which takes advantage of the   |
|   |         | best aspects of systems, such as NSF's FastLane. Allow  |
|   |         | continuous input for both the users and the             |
|   |         | participating agencies to continually improve the       |
|   |         | system. Stagger deadlines so as to not overload the     |
|   |         | systems and, if overload occurs, provide for some       |
|   |         | flexibility to avoid penalizing the users. Do not allow |
|   |         | grant application deadlines to be published that are    |
|   |         | beyond the close of business (normally 5PM). It appears |
|   |         | that the concepts of the Federal Commons now know as    |
|   |         | Grants.gov is still not being fulfilled. There are a    |
|   |         | multitude of committees at various levels working on    |
|   |         | policy and oversight, business practices and standards  |
|   |         | and various demonstration projects. It is not clear how |
|   |         | all the information and the results are being developed |
|   |         | so that there is no confusion in the user community     |
|   |         | about the various approaches to electronic research     |
|   |         | administration, there are fewer independent systems,    |
|   |         | there are uniform data standards, and costs are not     |
|   |         | prohibitive.                                            |
+---+---------+---------------------------------------------------------+
|   | **Uni   | RFPs, reporting of expense balances, reporting of       |
|   | versity | procedures, and notifications of awards are issued in a |
|   | of      | variety of electronic and hard copy formats without     |
|   | Idaho** | standard formatting or terminology. Provide a standard  |
|   |         | template/interface/portals and database. Agencies claim |
|   |         | they cannot overcome their differences, yet they insist |
|   |         | on conformity among institutions responding to their    |
|   |         | RFPs.                                                   |
|   |         |                                                         |
|   |         | Information technology should allow us to have research |
|   |         | program managers for agencies located out around the    |
|   |         | country rather than just in central offices in WDC.     |
|   |         | This might result in better partnering relationships    |
|   |         | and better review processes.                            |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Now, more than ever, with the advent of electronic      |
|   | versity | means of applying for grants, receiving notification of |
|   | of      | grant awards, drawing down funds, and providing         |
|   | Iowa**  | technical and financial reports, it is essential that   |
|   |         | uniform processes be developed and put to use. With     |
|   |         | federal granting agencies going in different directions |
|   |         | with their electronic systems it is becoming even more  |
|   |         | difficult for grantee institutions to apply for and     |
|   |         | accept federal funding. The costs of maintaining highly |
|   |         | trained staff and technology are driving up the costs   |
|   |         | of doing business with the federal government. Smaller  |
|   |         | institutions lacking the resources to adapt to the      |
|   |         | increasing complexity of doing business risk exclusion  |
|   |         | from the process. These electronic processes go by many |
|   |         | different names: FastLane, E-SNAP, NIH Commons, IIPS,   |
|   |         | CDMRP E-Submission, SGMS, e-grants, etc., requiring a   |
|   |         | myriad of passwords and user IDs to keep track of. The  |
|   |         | electronic procedures that some agencies have developed |
|   |         | by-pass internal institutional review requirements or   |
|   |         | are becoming so complex that ingenious applicants are   |
|   |         | able to circumvent internal procedures.                 |
|   |         |                                                         |
|   |         | Attention needs to be focused on Public Law 106-107,    |
|   |         | the Federal Financial Assistance Management Improvement |
|   |         | Act of 1999. Implementation of this law needs to get on |
|   |         | a faster track before federal agencies invest too much  |
|   |         | time and money developing their own systems and thereby |
|   |         | increase their stakes in them. The initial OMB notice   |
|   |         | implementing this law dealt with streamlining the grant |
|   |         | announcement mechanisms by developing standard formats  |
|   |         | and common datasets to be used under the E-Grants       |
|   |         | initiative. Revisions are also proposed to clarify      |
|   |         | ambiguous language in the Federal Cost Principles       |
|   |         | contained in A-21, A-87, and A-122, thereby preventing  |
|   |         | inconsistent interpretations of similar cost items      |
|   |         | across the three circulars. These are excellent steps   |
|   |         | in the right direction, but similar efforts need to be  |
|   |         | made in the grant administration regulations that       |
|   |         | regulate the application, award and postaward           |
|   |         | procedures.                                             |
+---+---------+---------------------------------------------------------+
|   |         |                                                         |
+---+---------+---------------------------------------------------------+
| * |         |                                                         |
| * |         |                                                         |
| J |         |                                                         |
| . |         |                                                         |
| T |         |                                                         |
| E |         |                                                         |
| C |         |                                                         |
| H |         |                                                         |
| N |         |                                                         |
| O |         |                                                         |
| L |         |                                                         |
| O |         |                                                         |
| G |         |                                                         |
| Y |         |                                                         |
| T |         |                                                         |
| R |         |                                                         |
| A |         |                                                         |
| N |         |                                                         |
| S |         |                                                         |
| F |         |                                                         |
| E |         |                                                         |
| R |         |                                                         |
| O |         |                                                         |
| P |         |                                                         |
| T |         |                                                         |
| I |         |                                                         |
| M |         |                                                         |
| I |         |                                                         |
| Z |         |                                                         |
| A |         |                                                         |
| T |         |                                                         |
| I |         |                                                         |
| O |         |                                                         |
| N |         |                                                         |
| * |         |                                                         |
| * |         |                                                         |
+---+---------+---------------------------------------------------------+
|   | **      | The other topic area is university-industry interaction |
|   | Council | and technology transfer. The value of these             |
|   | on      | collaborations and the required oversight is firmly     |
|   | Govt.   | grounded in the conduct of research as a primary        |
|   | Re      | objective, with technology transfer principally         |
|   | lations | embedded in the university's role of research and       |
|   | (       | education rather than commercialization of research     |
|   | COGR)** | outcomes.                                               |
|   |         |                                                         |
|   |         | COGR has worked closely with federal agencies and other |
|   |         | higher education associations to prepare reports that   |
|   |         | provide data and information on intellectual property   |
|   |         | management. One example is the July 2001 NIH Report to  |
|   |         | the U.S. Congress, entitled \"A Plan to Ensure          |
|   |         | Taxpayers\'  Interests Are Protected\",  that discussed |
|   |         | the returns on public investment in biomedical          |
|   |         | research. Another example is the April, 2003 report of  |
|   |         | the President's Council of Advisors on S&T (PCAST) on   |
|   |         | Technology Transfer of Federally Funded R&D. These      |
|   |         | reports provide a wealth of data and information on     |
|   |         | federal technology transfer and the university          |
|   |         | technology transfer activities resulting from the       |
|   |         | Bayh-Dole Act of 1980 (P.L. 96-517) and related         |
|   |         | legislation. Both of these reports concluded that the   |
|   |         | existing technology transfer framework under Bayh-Dole  |
|   |         | works well and should not be changed. Statistical data  |
|   |         | on university technology transfer activities can be     |
|   |         | found in the annual licensing surveys of the            |
|   |         | Association of University Technology Transfer Managers  |
|   |         | (AUTM).                                                 |
|   |         |                                                         |
|   |         | COGR historically has strongly supported the goals and  |
|   |         | policy objectives of the Bayh-Dole Act.  Therefore, we  |
|   |         | are concerned that recent initiatives on the part of a  |
|   |         | number of government agencies have departed from the    |
|   |         | uniform federal framework provided by the Act and its   |
|   |         | implementing regulations (37 CFR Part 401). We also are |
|   |         | concerned about the expansion of the previously unique  |
|   |         | DOD authority to fund "transactions other than          |
|   |         | contracts, grants and cooperative agreements" for       |
|   |         | basic, applied and advanced R&D projects and            |
|   |         | prototypes.                                             |
|   |         |                                                         |
|   |         | "Other transactions (OTs)" are not subject to the       |
|   |         | normal federal contract (i.e. FAR) or grant (i.e.       |
|   |         | OMB/agency grant regulations) requirements.  Of         |
|   |         | particular significance, OTs do not require Bayh-Dole   |
|   |         | Act patent rights or obligations to be applied to       |
|   |         | either prime or sub awardees.  They also are not        |
|   |         | subject to standard government administrative and       |
|   |         | financial compliance requirements.  While some aspects  |
|   |         | of the flexibility provided by OTs might be beneficial  |
|   |         | both for the government and research performers, we     |
|   |         | believe a further trend away from Bayh-Dole patent      |
|   |         | rights is neither in the national interest nor in the   |
|   |         | interests of universities.                              |
+---+---------+---------------------------------------------------------+
|   | **      | The primary source of data on technology transfer       |
|   | Harvard | activity is the annual AUTM survey. That data would     |
|   | Unive   | certainly indicate that over the years since the Bayh   |
|   | rsity** | Dole Act was passed there has been increasing patenting |
|   |         | by universities and an increasing number of licenses    |
|   |         | granted to industry.                                    |
+---+---------+---------------------------------------------------------+
|   | **John  | I am aware of other grants of like and large magnitude  |
|   | C .     | that have been provided to universities by state and    |
|   | Pe      | federal agencies that continued to completion to        |
|   | tura**, | develop and endorse proposed technologies that resulted |
|   |         | in technology transfer reports that overstate the       |
|   | Council | capabilities of the technologies and substantially      |
|   | of      | understate the cost for its full scale application.     |
|   | Engi    | This is not an infrequent occurrence, yet those in      |
|   | neering | charge of such programs as the USEPA SITE program, as   |
|   | and     | an example, do not have the expertise to recognize this |
|   | Sci     | continuing problem. Suffice it to say that there are    |
|   | entific | dozens of published Technology Transfer reports on      |
|   | Spec    | innovative remedial technologies in the archives of     |
|   | ialties | USEPA and elsewhere that have never been implemented in |
|   | Boards  | full scale because the technology is not performance or |
|   |         | cost-effective when taken to the field for full scale   |
|   | Applied | application                                             |
|   | Enviro  |                                                         |
|   | nmental |                                                         |
|   | Mana    |                                                         |
|   | gement, |                                                         |
|   | Inc.    |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Roger | In any collaboration, intellectual property rights are  |
|   | A.      | always a major focus. Generally, the Federal government |
|   | Fa      | laboratories and NYSERDA are very flexible in allowing  |
|   | rrell** | industry to retain rights. For industry the formula is  |
|   |         | generally sole and background intellectual property     |
|   | Supe    | remains with the party who conceived and developed them |
|   | rPower, | and jointly developed intellectual property is shared.  |
|   | I       | In the case of universities and EPRI there can be       |
|   | nc**.** | conflicting views on who should have the rights to      |
|   |         | intellectual property that may inhibit joint            |
|   |         | development or even prevent it. In those cases where    |
|   |         | the government is providing funding, it is possible to  |
|   |         | influence the relationship among parties. For example,  |
|   |         | government policy can serve to modify the university    |
|   |         | licensing process so that U.S. industry and             |
|   |         | commercialization is promoted rather than providing     |
|   |         | near term licensing fees to universities. The latter    |
|   |         | can discourage industry involvement and, hence,         |
|   |         | commercialization which ultimately will benefit         |
|   |         | industry, the university and the government.            |
|   |         |                                                         |
|   |         | In summary, it is fair to say that intellectual         |
|   |         | property has a major impact on relationships.           |
|   |         | Quantitative data probably does not exist.              |
+---+---------+---------------------------------------------------------+
|   | **Uni   | The Bayh-Dole Act (35 U.S.C. 200-212) created a new     |
|   | versity | business model for federally funded research results    |
|   | of      | that supported the transfer of technology to commercial |
|   | Calif   | partners so that research results can be further        |
|   | ornia** | developed and made available to the general public. In  |
|   |         | so doing, it led to the development of a technology     |
|   |         | transfer infrastructure within research universities    |
|   |         | across the nation that is now showing significant       |
|   |         | results. At the University of California alone, more    |
|   |         | than 180 companies have been founded on the basis of    |
|   |         | technology licensing agreements, and in the last        |
|   |         | decade, campuses reported more than 6,000 inventions,   |
|   |         | including many that led to new technologies and         |
|   |         | products.                                               |
|   |         |                                                         |
|   |         | Even as the government-university-industry relationship |
|   |         | becomes increasingly complex, Bayh-Dole continues to    |
|   |         | serve this multi-faceted relationship well. We have     |
|   |         | noticed and are concerned, however, that certain        |
|   |         | Federal agencies are starting to issue awards that are  |
|   |         | inconsistent with the standard Bayh-Dole provisions,    |
|   |         | through more frequent use of Determinations of          |
|   |         | Exceptional Circumstances without accommodating the     |
|   |         | special circumstances as required under 37 CFR 401.3(b) |
|   |         | or consulting with the university community on more     |
|   |         | appropriate approaches. There are also concerns about   |
|   |         | expanding use of the Other Transaction Authority by the |
|   |         | new Department of Homeland Security and other Federal   |
|   |         | agencies.                                               |
+---+---------+---------------------------------------------------------+
|   | **      | One of the major obstacles to successful technology     |
|   | Timothy | transfer is the legal expenses.                         |
|   | D.      |                                                         |
|   | Usher** |                                                         |
|   |         |                                                         |
|   | Pro     |                                                         |
|   | fessor, |                                                         |
|   | Cal     |                                                         |
|   | ifornia |                                                         |
|   | State   |                                                         |
|   | Univ    |                                                         |
|   | ersity, |                                                         |
|   | San     |                                                         |
|   | Ber     |                                                         |
|   | nardino |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Uni   | We would recommend use of the Association of University |
|   | versity | Technology Manager (AUTM), which collects and publishes |
|   | of      | annual statistical reports that provide this            |
|   | Fl      | information and much more.                              |
|   | orida** |                                                         |
+---+---------+---------------------------------------------------------+
|   | **Uni   | Acknowledge that iterative processes between researcher |
|   | versity | and potential end user are more expensive in time and   |
|   | of      | effort, but result in higher levels of ownership and    |
|   | Idaho** | utility for final research and development products.    |
|   |         | Adequately fund integrated research and outreach        |
|   |         | activity when proposed.                                 |
|   |         |                                                         |
|   |         | Reaffirm Bayh-Dole technical transfer principles and    |
|   |         | minimize agency specific limitations of rights.         |
|   |         |                                                         |
|   |         | Promote exchange of tools among investigators while     |
|   |         | protecting proprietary rights.                          |
+---+---------+---------------------------------------------------------+
|   | *       | See comments under A. and F.                            |
|   | *Victor |                                                         |
|   | Pinks** |                                                         |
|   |         |                                                         |
|   | Inst.   |                                                         |
|   | of      |                                                         |
|   | Liquid  |                                                         |
|   | D       |                                                         |
|   | ynamics |                                                         |
|   | Simul.  |                                                         |
+---+---------+---------------------------------------------------------+

[^1]: ^4^

    ^4^ DHHS IG Staff Presentation at February 2003 COGR Meeting [Click
    here to view.](http://206.151.87.67/docs/DHHS IG Presentation.ppt)

[^2]: ^6^

    ^6^ FDP Terms and Conditions [Click here to
    view.](http://www.nsf.gov/home/grants/grants_fdp.htm)

[^3]: ^8^

    ^8^ COGR letters to NSF and NIH on conflicts of interest [Click here
    to view NSF letter](http://206.151.87.67/docs/Leder.doc) and [Click
    here to view NIH letter](http://206.151.87.67/docs/Galasso.doc)

[^4]: ^9^

    ^9^ COGR letter to OSTP on misconduct in science [Click here to
    view](http://206.151.87.67/docs/Francis.doc)

[^5]: ^1^

    ^11^ COGR Cost of Doing Business [Click here to
    view](http://206.151.87.67/docs/WhatsNew.htm)