June 2006 COGR Meeting Agenda -1- June 2006 COGR Meeting Agenda

COUNCIL ON GOVERNMENTAL RELATIONS

1200 New York Avenue, N.W., Suite 320, Washington, D.C.20005

(202) 289-6655/(202) 289-6698 (FAX)

May 25, 2006

AGENDA

MEETING OF THE COUNCIL ON GOVERNMENTAL RELATIONS

WASHINGTON MARRIOTT HOTEL

June 8 and 9, 2006

Planning information for the upcoming meeting of the Council on Governmental Relations was sent to the COGR Listserve in late March 2006. Those planning to attend should make hotel reservations at the Washington Marriott Hotel at 1221 22nd Street, N.W., Washington, D.C. and should send registration notices along with registration fees to the COGR office. Changes should be made by telephone to the hotel (202-872-1500) and by FAX to the COGR office (202-289-6698). Meeting registration cancellations must be received in writing, via fax or mail, no later than Thursday, June 1, 2006 to receive a refund of the registration fee.

Thursday, June 8, 2006

  • 8:30 a.m. Registration
  • 10:00 a.m. – 11:45 a.m. – Discussion Groups

There will be three discussions groups this meeting. The groups are:

Complex Costing – Staying Clean in Tricky Circumstances - Many costing situations require critical analysis to assure the institution is properly charging costs to the federal government. Each of the following topics is discussed in the form of a mini case study, using an interactive dialogue between the panel and the audience.

  • Clinical Trials and Medicare
  • Recharge Centers (e.g. Computing/Information Technology)
  • University / State “joint” programs
  • Administrative personnel and the DCE
  • Depreciation on a “cost shared” asset

Panelists will include Mary Ellen Sheridan, University of Chicago, Lisa Murtha, The Huron Consulting Group, John Shipley, PurdueUniversity and Gary Talesnik, Bearing Point.

[Special Note: We are considering starting a regular, formal presentation of F&A Rate Negotiation Recaps either during the Thursday morning session, or during the Friday morning Committee Reports. If you want to share results of a recent negotiation experience (you will not asked to be the presenter), please contact David Kennedy at , or at 202.289.6655.]

Implications of the CREATE Act for University Sponsored Research and Technology Transfer Offices - The Research and Technology Enhancement (CREATE) Act of 2003 requires university sponsored research and technology transfer offices both to be aware of the Act’s implications in drafting and reviewing a wide range of agreements. Issues raised by the Act and the advantages/disadvantages of its application will be discussed. Draft COGR Q&As on CREATE will be previewed at this session.

Electronic Grant Applications and Administration - The implementation of the Grants.gov electronic submission process by the National Institutes of Health has drawn significant attention from the research community. But other agencies are slowly and systematically preparing for the use of Grants.gov. Some have electronic application systems in place; others do not. Patricia Modrow (US Army’s Congressionally Directed Medical Research Program), Paul Brundage (NASA) and Frank O’Day (DOD Office of Naval Research) will discuss electronic grant submission at their agencies and how the implementation of Grants.gov may affect their approach to grants management.

  • 12:00 Noon – 1:00 p.m. – Buffet Lunch
  • 1:00 p.m. – 1:45 p.m. – Guest Speaker

Ms. Karen Evans, Administrator for E-government and Information Technology, Office of Management and Budget will address the membership.

  • 1:45 p.m. – 2:00 p.m. - Break
  • 2:00 p.m. – 3:30 p.m.University Forum

COGR Topics for Discussion - There are a number of issues and topics that the COGR Committees and staff are following, and it would be both helpful to the Committees and informative for the membership if we had a discussion of these topics. This forum will be moderated by COGR Board members, assisted by COGR staff, and cover topics such as:

  • Science and Security issues, including Export Controls, and FBI/University cooperative efforts.
  • Center for Medicare and Medicaid Services (CMS) letter regarding Medicare coverage of complications resulting from investigational procedures - if an institution billed Medicare for services requited for a trial-related injury, the claim could be a false claim under the Medicare Second Payor rules.
  • Proposal by NIH to reduce graduate student tuition payment under the National Research Service Award program.
  • Changes to the OMB Circular A-133 Compliance Supplement.
  • Proposed guidance from the National Cancer Institute on Biorepositories.
  • Agency and Congressional proposals to develop publicly available repositories of publications resulting from federally-funded research.
  • Implications of Court ruling overturning the Agency for International Development requirement for awardees to pledge their “opposition to prostitution”.
  • 3:30 p.m. – 3:45 p.m. Break
  • 3:45 p.m. – 5:30 p.m. Federal Forum

OSTP/NIH Guidance on Multiple Principal Investigators: Financial, Research and IP Implications - In January, 2004, the Office of Science and Technology Policy (OSTP) Research Business Models Subcommittee called on Federal agencies to formally recognize the contribution of multiple principal investigators (PI) on research awards. To assist the agencies in implementing this policy, OSTP sought information from the community in July 2005 on key elements, including what constitutes a PI; how to manage communication with the agency; how to provide access to award information, etc. The National Institutes of Health consulted the community at the same time and in February 2006 began to implement its plan through a pilot program of Multiple PI awards.

This discussion will provide some background and various perspectives on the Federal initiatives and how research institutions can acknowledge the efforts of investigators who work together as peers on research projects, whether within the same institution or at different institutions. The questions of who gets the credit and how to acknowledge investigators’ involvement and contribution for consideration in tenure and promotion decisions without the formal allocation of funds is key to fostering interdisciplinary and multidisciplinary research. How does the institution and research team meet the compliance and administrative responsibility?

Jane Youngers, University of Texas Health Sciences Center at San Antonio, will moderate the discussion with Joe Ellis, NIH Office of Policy for Extramural Research Administration, Connie Atwell, NIH and Task Group Leader, Multiple PIs and formerly Research Business Models Subcommittee [invited]; Jay Moskowitz, Milton S. Hershey Medical Center, PennsylvaniaState College of Medicine [invited] and other research institution representatives.

  • 5:30 p.m. – 8:00 p.m. – Reception and Dinner

Friday, June 9, 2006

  • 7:30 a.m. – Buffet Breakfast
  • 8:30 a.m. – 10:00 a.m. – Committee Reports
  • 10:00 a.m. – 10:30 a.m. Association Update – National Association of StateUniversities and Land-GrantColleges (NASULGC)
  • 10:30 a.m. - Break
  • 10:45 a.m. – 12:00Noon – Committee Reports continue
  • 12:00Noon – Adjournment

Attendance at COGR meetings is limited to employees of member universities, their governing boards and research foundations, affiliated hospitals and affiliated research institutes.

TABLE OF CONTENTS

GENERAL DEVELOPMENTS

DHHS OIG Compliance Program Guidance Will be Withdrawn

Cost Sharing on Department of Energy Research Awards

Prospects for Fix for Tax Exempt Bond/Bayh-Dole Act Conflict

AID Prostitution Clause Violates First Amendment

CONTRACTS AND INTELLECTUAL PROPERTY

Progress Made on Export Control Issues

Department of Commerce Deemed Export Advisory Committee

Department of Defense Proposed Rule on Export Controls

GAO Reviewing Intangible Exports and Electronic Exports

COGR Guide and Thursday Session on CREATE

Developments in Patent Law Continue

Patent Reform Legislation Still Pending

Supreme Court Patent Activity Continues

COGR Comments on Proposed PTO Rule Changes

University-Industry Summit Meeting at NationalAcademy

COGR Planning to Revise Current Technology Transfer Materials

COSTING POLICIES

Effort Reporting Policies and Practices

Effort Reporting – “Urban Myth”Clarified

Ruth Kirschstein, National Research Service Award Program

OMB Circular A-133 Compliance Supplement

Inspector General Reports

RESEARCH COMPLIANCE AND ADMINISTRATION

NIH Recognition of Multiple PIs

Available only in Pilot Programs

COGR Comment in Implementation Plan

Federal Forum Focus

NIH Changes in Business Processes

NCI Proposes Guidelines for Biorepositories

FDA Guidance

FDA Withdraws Good Manufacturing Practices Exemption for INDs

Centralized IRBs in Multicenter Trials

Clinical Trial Data Monitoring

Informed Consent in Studies Using Excess Human Specimens

IRB Referrals of Studies with Children

USDA Policy Changes

GENERAL DEVELOPMENTS

1.DHHS OIG Compliance Program Guidance Will be Withdrawn

It is our understanding, based on discussion with the Office of Science and Technology Policy and OMB officials, that the proposed Compliance Program Guidance for Recipients of PHS Research Awards, published in the Federal Register of November 28, 2005, will be withdrawn. More details will be provided during the COGR Meeting.

2.Cost Sharing on Department of Energy Research Awards

We have heard from several COGR members that some recent Department of Energy (DOE) funding announcements and/or awards have indicated a cost sharing requirement of at least 20%. In following up on this with Senate Finance Committee staff, we found that the Department of Energy Re-authorization Act – called the Energy Policy Act of 2005, Public Law 109-58 – has the following provision:

“Sec. 988. COST SHARING.

“(a) Applicability.--Notwithstanding any other provision of law, in carrying out a research, development, demonstration, or commercial application program or activity that is initiated after the date of enactment of this section, the Secretary shall require cost-sharing in accordance with this section.

“(b) Research and Development.--

“(1) IN GENERAL.--Except as provided in paragraphs (2) and (3) and subsection (f), the Secretary shall require not less than 20 percent of the cost of a research or development activity described in subsection (a) to be provided by a non-Federal source.

“(2) EXCLUSION.--Paragraph (1) shall not apply to a research or development activity described in subsection (a) that is of a basic or fundamental nature, as determined by the appropriate officer of the Department.

“(3) REDUCTION.--The Secretary may reduce or eliminate the requirement of paragraph (1) for a research and development activity of an applied nature if the Secretary determines that the reduction is necessary and appropriate.”

As stated in the Act, no cost sharing is required for basic research, and the requirement can be waived or reduced for applied research. Since most if not all of the research performed at universities and research institutes is categorized as basic, attempts by DOE grant or contracting officers to require cost sharing on awards should be resisted, citing the above provision.

3.Prospects for Legislative/Administrative Fix for Tax Exempt Bond-Bayh Dole Act Conflict

As we have been reporting, there have been at least two universities that, based on advice from Bond Counsel, have had to issue taxable rather than tax exempt bonds to finance construction of research facilities that will house federally-funded research. The advice from Counsel was based on an apparent conflict between the private use provision in the Tax Code and the Bayh-Dole Act provisions that provide the federal government with certain rights to inventions. To summarize, under the tax-exempt bond provisions of the Tax Code, the federal government is a private user; for bonds to qualify for tax-exempt status, a private user sponsor must not receive preferential treatment over any other potential user with respect to research results; under Bayh-Dole, the government receive a royalty free non-exclusive license to federally-funded research, thus receiving what appears to be preferential treatment, and thus disqualifying the bonds from tax-exempt status.

In discussing this over the past year with federal officials, congressional staff, and experts in the bond community, there is general agreement that Congress did not intend for this conflict to occur. There are two main paths to resolving this conflict - legislation amending the Tax Code to specifically exempt federally-funded research from the definition of private use, or seeking a clarification from the Treasury Department. COGR has been pursuing both options, and we will report on further developments during the COGR meeting.

4.USAID Prostitution Clause Violates First Amendment

COGR has reported several times on the U.S. Agency for International Development (USAID) and HHS-related agencies including the Center for Disease Control (CDC) prohibition of the use of federal funds to promote or advocate prostitution or sex trafficking and for the requirement for all U.S. and foreign prime subaward recipients to have an explicit policy opposing prostitution and sex trafficking to. These requirements are linked to provisions in the U.S. Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, PL 108-25 (the AIDS Authorization)

The requirement for explicit policies opposing prostitution and sex trafficking raised serious concerns among organizations and agencies providing direct service to HIV/AIDS sufferers. The provisions were challenged in court as an unconstitutional infringement of speech that undermines efforts to stem the spread of HIV/AIDS.

On May 9, 2006, the U.S. District Court for the Southern District of New York ruled that the USAID requirement violates the First Amendment.

COGR will be reviewing the impact of this decision on the recently proposed Federal Acquisition Regulation (FAR) clause to Combat Trafficking in Persons. The FAR interim rule and request for comments appeared in the April 19, 2006 Federal Register (71FR 20301). Comments are due June 19, 2006 and COGR is preparing a comment on the proposed rule. This rule will be discussed at the June COGR meeting during the University Forum.

CONTRACTS AND INTELLECTUAL PROPERTY

Committee: James A. Severson, University of Washington, Chairman; Susan Burkett, Carnegie Mellon University; Kathleen Irwin, University of Wisconsin-Madison; Marvin Parnes, University of Michigan; Wendy Streitz, University of California; Jilda Diehl Garton, Georgia Institute of Technology; Ann Hammersla, Massachusetts Institute of Technology; Fred Reinhart, Wayne State University; John Ritter, Princeton University; Thomas Sharpe, University of Missouri; Patricia Harsche Weeks, Fox Chase Cancer Center

1.Progress Made on Export Control Issues

a) Department of Commerce to Issue Formal Noticeof Establishment of Deemed Export Advisory Committee

Press reports indicate that a formal Federal Register notice concerning deemed exports will be issued shortly by the Department of Commerce Bureau of Industry and Security (BIS). The notice will not be a Notice of Proposed Rule Making (NPRM), but instead is expected to announce the Department of Commerce’s intent to create a new federal Deemed Export Advisory Committee. As we understand it, this advisory committee will be charged with helping the Department consider what deemed export control policies make sense and will be effective in the future and within this broader context, how best to address the issues raised by the Commerce Department Inspector General’s March 2004 report.

We view this as a very positive development that reflects the intensive dialogue over the past year between Commerce officials and senior academic leadership. The Association of American Universities (AAU) has issued statements (available on the AAU website: praising BIS for stepping back from the Department of Commerce Inspector General’s recommendations and instead setting the goal of ensuring national security without disrupting vital research taking place on the nation’s university campuses.

Language announcing the proposed establishment of a Deemed Export Advisory Committee (DEAC) appeared in the April 24 Federal Register as a part of the Department of Commerce’s Semiannual Regulatory Agenda. We have clarified that while this provides a glimpse of Commerce’s intent, it is not the formal Federal Register announcement which we expect will provide more details.

b)2) ease Revised Proposed Rule in Last June sen to take on this matter. statement as soon as we have an opporunity e next weeDOD Revised Proposed Rule Concerning Export Controls Expected in June

In response to the many comments and concerns the Department of Defense (DOD) received regarding the proposed rule on export controls that it published in July of 2005, the Department has drafted a new, significantly revised proposed rule. The specifics of the revised proposed rule remain unknown. Based on conversations with DOD officials, hopefully it will be largely responsive to the concerns raised by the higher education and research communities. We understand that the revised proposed rule has been approved by the Defense Federal Acquisitions Council (DFARS). It now is being reviewed by the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA). DOD officials have said they do not expect the proposed rule to appear in the Federal Register until late June.

c)Government Accountability Office (GAO) Reviewing “Intangible” Exports and Electronic Exports

At the request of the House Judiciary Committee, the GAO is conducting a review of “intangible” and electronic exports, including deemed export issues related to universities. The GAO team recently met with COGR and AAU staff and has visited two local universities. GAO appears to be at the scoping stage of its review. While it remains unclear why the Judiciary Committee requested the study, at this point we believe that it is primarily informational in nature.

2.COGR Plans New Guide and Thursday Morning Session on CREATE

Previous COGR meeting reports have discussed the Cooperative Research and Technology Enhancement Act (P.L. 108-453); “CREATE”). They also have discussed our plans to develop materials to assist member institutions in addressing the issues raised by CREATE (see February 2006 Meeting Report).

Our thinking has continued to evolve on what type of materials might most helpful to COGR members. It also has been informed by discussions at recent sessions on the CREATE Act at a number of meetings of other higher education associations (i.e. NCURA, AUTM).

We now plan to develop a COGR guide to the CREATE Act in a “Question and Answer” format. The “Qs and As” will provide a summary of relevant information about the Act, its implications and its use in academic research programs, including the benefits and potential hazards. It is not planned to be a comprehensive analysis of the Act nor intended to provide legal advice as to its interpretation. The CREATE Act raises complex issues in its application, and it is important that both university sponsored research offices and technology transfer offices be aware of these issues and work together to resolve them.

COGR understands that member institutions are receiving an increasing number of agreements that reference the CREATE Act. These include sponsored research agreements, materials transfer agreements, and others. Because of the growing concerns and questions, we have scheduled a Thursday morning session on the CREATE Act at the June COGR meeting. At this session the issues raised by CREATE and the draft COGR Qs and As will be discussed.