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COGRUPDATE

2016 NCURA Annual Conference

1An association of research universities, affiliated medical centers, and independent research institutes

Presented by Jackie Bendall, Director RCACouncil on Governmental Relations

August 9, 2016

Overview

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Council on Governmental Relations (www.cogr.edu), established in 1948

190+ Member Institutions

Staff of 6 and 4 Committees:

1) Costing, 2) RCA, 3) CIP, and

4) Research & Regulatory Reform

Active Board and Committees, comprised of 25 individuals from Member institutions

Regular Collaboration with other Partners

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Mission Statement

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COGR is an association of leading universities and research institutions.

We provide information, analyses, advice, policy perspective, and historical context to our members in the areas of research administration and compliance, financial oversight, and intellectual property.

COGR communicates the viewpoint and concerns of its members and fosters productive relationshipsbetween the research community and federal policymakers, advocating for innovation and change that avoid unnecessary regulatory burden.

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Costing Policies

Committee

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Uniform Guidance: Procurement

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COGR and The Association of Independent Research Institutes (AIRI) submit letter to OMB on June 1st on results of COGR/AIRI surveys on the administrative and cost impact of $3,500 micro purchase threshold;

OMB is reviewing survey data and may plan to formally reopen the Rulemaking process. Look for Federal Register notice in September/October 2016 timeframe. Rulemaking will invite comments specific to 2 CFR 200.320(a), Procurement by micro-purchase.

Extension of grace period expected to be approved to FY 2019 (i.e., 7/1/18 for most institutions) for implementation of 200.317-326, Procurement Standards.

Uniform Guidance: Open Items Beyond Procurement

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F&A: Request to OMB to adjust the 1.3% Utility Cost Adjustment and Relative Energy Use Index (REUI) methodology to update the weighting factor for research square footage. (see COGR letter of 11/13/15). OMB and COFAR will review with determination to be made this fall.

• F&A: New DS-2 Form still not available from CASB. Timing remains uncertain. COGR will continue to push for not having to file amendments to the DS-2 to cognizant agency 6 months in advance of disclosed practice being changed. See 200.419(b)(2) for more info..

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Open Items, Cont.

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• Subrecipient Monitoring (implement/confirm the “Safe Harbor” exists when the subrecipient is a peer institution and is subject to the single audit) OMB willing to explore ways to use Single Audit and its current audit resolution process to adequately and efficiently monitor the performance of subrecipients; OMB to provide clarifications on current requirements. Look for more in the fall.

• For-Profits/10% De minimus (confirm applicability to for-profits or allow budget approval by the agency to constitute rate acceptability, also address small entities that have a provisional rate or have had a rate in the past, but no longer have a negotiated rate). OMB to provide update in fall.

Open Items Cont.• Cost Share and F&A deviations (pursue creative

solutions such as targeting selected funding announcements and organizing an email outreach to OMB, seek agency compliance via the agency IGs, etc.). OMB asks that we continue to send examples and they will work with us and the Federal agencies for a uniform application of the Guidance.

• Foreign Entity Subrecipients (clarify applicability of the single audit to foreign entities)

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NIH Closeout Policy

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120 days as new standard in section 8.6, CLOSEOUT, per the NIH Grants Policy Statement.

Payment Management System (PMS) has been configured by HHS to allow for 120 days (NIH only)

The Challenge: FFR (NIH Commons) and the FCTR (PMS) are required to be reconciled, and due to complexities and timing issues, the reconciliation often extends beyond 180 days after project end.

AND … New NIH Unilateral Closeout policy suggests that unilateral closeout actions should take place at 180 days after project end.

COGR is engaging with NIH and HHS to fix

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RRR

Committee

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Human Subjects – Common Rule

• Comments on the Common Rule NPRM were due Jan. 6.

• COGR supported measures such as eliminating continuing review for minimal risk studies; enforcing compliance directly against unaffiliated IRBs not operated by an assured institution; and updating and expanding the Secretary’s list of research eligible for expedited review.

• COGR Opposed measures such as expanding the definition of a “human subject” to include all biospecimens regardless of identifiability; mandatory reliance on a single IRB for multi-site studies; and the inclusion of non-regulated, unfunded trials under the regulations for organizations which receive federal grants.

Human Subjects –Common Rule

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• COGR and APLU analyzed the 2,186 NPRM comments.

• 76% of all comments addressed proposed changes to the treatment of biospecimens with 74% indicating opposition. 96% of responses from patients and members of the research community (i.e., researchers, universities, medical centers and industry) opposed the changes.

• Consistent with OHRP findings that a “strong majority of commenters oppose these proposals” and that there was “opposition across all subgroups.”

• National Academies committee has called for the NPRM to be withdrawn. Indications are that HHS will move forward.

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Human Subjects – sIRB Policy

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• The final policy was published on June 21 and will take effect on May 25, 2017.

• Guidance on the use of direct and indirect costs for single IRB review under the policy and general FAQs were also published on June 21. Additional guidance is forthcoming.

• Applicants will submit a plan identifying the IRB of record.

• Institutions are assessing options. COGR may assess which options (i.e., conducting an internal or commercial review or ceding to another institutional IRB) result in the shortest time to study initiation and greatest cost recovery.

Research Regulatory Reform

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• Part 2 of the National Academies report, Optimizing the Nation’s Investment in Academic Research; A New Regulatory Framework for the 21st Century was released June 29.

• Addresses the Common Rule NPRM; export controls; select agents and toxins; intellectual property/technology transfer reporting; and operationalizing the Research Policy Board.

• The Government Accountability Office released the report Federal Research Grants: Opportunities Remain for Agencies to Streamline Administrative Requirements on July 22. Addresses budgets; documenting personnel expenses; micropurchases; subrecipient monitoring; biosketches; pre-award requirements; PHS COI; data access and mentoring plans.

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Research Regulatory Reform

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• University Regulations Streamlining and Harmonization Act of 2016 – Congressman Lipinski

• Promoting Biomedical Research and Public Health for Patients Act –Senators Alexander and Murray

• Both bills would create a Research Policy Board and address additional recommendations made in Part 1 of the National Academies report.

• Data Act Section 5 Pilot – standardized notice of award; consolidating forms and financial reporting

• COGR checklist – actions for reducing institutional burden associated with federal research awards

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CIP

Committee

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New DOD Information Security Rules

• New DFARS Safeguarding Requirements for DoD contracts (Revised DFARS 7012 and 7008 clauses)

• Applies to new category of “covered defense information,” which includes CUI

• Makes the information subject to NIST IT Security Requirements which includes 111controls

• Implementation deadline extended to 12/31/17 but compliance by then must be certified at time of award

• Separate new DoD rule mandates reporting of cyber incidents affecting covered defense info

• New requirements will result in significant compliance costs for institutions subject to them

• Some institutions already have walked away from or terminated DoD contracts with these requirements

• COGR/AAU seeking to get fundamental research specifically exempted

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New Service Contract Reporting Requirements

• Institutions are receiving new requirements from multiple agencies to report direct labor hours expended in performance of service contracts

• New FAR reporting clauses (52.204-14 & 15)were supposed to be included in contracts beginning Jan. ‘14 but many agencies only now are adding

• Labor hours information is to be included in annual agency “FAIR” Act inventories

• Requirement stems from legislation to report FTEs (govt. will convert labor hours reported to FTEs)

• Numbers should not be considered binding for audit

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DoED Proposed Open Licensing Requirement

• Ed. Dept. NPRM in November proposed open licensing requirement for copyrightable IP created under Ed grants (except research grants)

• “One size fits all” mandatory approach with no flexibility• Calls into question ability to commercialize IP on Ed-funded

technologies and materials• Many unanswered questions: relationship to background IP, treatment

of derivatives, reputational risks to creators (and institutions), and potential conflict with Bayh-Dole on software (although patenting relatively rare)

• COGR/AAU and other higher ed. associations objected; 140 public comments submitted evenly divided between pro and con (even within same institution)

• COGR February panel session with ARI and other stakeholders; need to seek balance; general recognition that flexibility is important

• Final rule submitted to OMB; COGR meeting with OIRA 8/9• Rule to be published in September

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Patent Troll Legislation• Bills introduced in both House and Senate last year but

no Congressional action taken

• Would significantly complicate ability to enforce patents against infringers

• Strongly pushed by IT sector; universities and biotech sectors strongly opposed

• Prospects uncertain; proponents intend to continue pushing for it

• Courts have taken recent actions to reduce frivolous infringement claims and troll-like behavior

• One big issue is the new interpartes review procedure permitting challenges of granted patents at PTO; has led to abuses (e.g. hedge funds threatening to file challenges and “shorting” companies stock); both court cases and legislation pending to address problem 20

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March-In Rights Raised Again

• 50 House Democrats co-sign letter to HHS/NIH in January urging NIH to issue guidelines for the exercise of march-in rights under the Bayh-Dole Act to address drug price gouging

• Petition filed with NIH (and DoD) requesting march-in on a prostate cancer drug (Xtandi) developed with NIH/DOD co-funding on grounds that U.S. price is 2—4 times greater than other advanced countries

• NIH has consistently held that march-in is not appropriately used to address drug pricing issues; reiterated that view in June letter rejecting march-in

• HHS also declined House request

• Issue not going away; proponents plan to appeal; upcoming UN Secretary General’s Report expected to place primary blame on IP for lack of access to essential medicines by people in poorer countries.

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RCA

Committee

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Effective Practices Guide• Guide for university community on effective financial,

compliance, and administrative practices in research administration

• Incorporates 2 CFR 200 (UG) and other updated regulations

• Last revised July 2009, new version is posted online with hyperlinks throughout to relevant info and cross cutting sections

• Online version will be updated regularly

• 7 hard copies mailed to member institutions in July.

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Research Terms & Conditions• Appendices to RTCs have not been released. Unknown at t his time

if research community will be able to provide a response.

• COGR continues to push with OMB that all agencies adopt RTCs.

• Participating Agencies: U. S. Department of Commerce/National Oceanic and Atmospheric Administration and National Institute of Standards and Technology; U.S. Department of Energy; U.S. Environmental Protection Agency; National Aeronautics and Space Administration; National Science Foundation; U.S. Department of Health and Human Services/National Institutes of Health; U.S. Department of Agriculture/National Institute of Food and Agriculture; U.S. Department of Transportation/Federal Aviation Administration; and U.S. Department of Homeland Security.

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DOL Overtime Rule• DOL released NPRM July 2015

• New rule to take effect December 1, 2016

• Raises the salary threshold indicating eligibility from $455/week to $913 ($47,476 per year)

• 3 year automatic updates to threshold based on wage growth over time.

• Impacts Post Docs and other certain positions.

• May require re-classifications from exempt to non-exempt causing the tracking of hours during 40hr work weeks (incongruent with post doc schedules/responsibilities)

• COGR reaching out to membership with FLSA survey focused on post docs.

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Public Access• Public Access - RCA to comment and monitor public

access plans of federal agencies as a result of 2013 OSTP directive.

• Approximately 17 federal department and agencies have released their plans. Others are phasing in.

• COGR, AAU, APLU post statement to the National Dialogue recommending that OMB require federal agencies to harmonize public access procedures and submission requirements.

• COGR continues to seek feedback on issues/burden from research community.

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Questions

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