Washington Update: Omnibus Appropriations Bill; HEA Reauthorization; HHS Clinical Trials Regulations; and More

With funding for the government due to run out next week, APLU is pressing Congress to pass an omnibus bill for fiscal year 2015. APLU also released a statement on Senator Tom Harkin’s proposal for the reauthorization of the Higher Education Act.

The association joined in sending a letter to Congress on the importance of the National Institutes of Health peer review process. In addition, the Department of Health and Human Services has issued two proposals regarding clinical trials and the National Science Foundation issued a revised Proposal and Award Policies and Procedures Guide. Also, Rush Holt has been named CEO of the American Association for the Advancement of Science and Auburn University is seeking participants for its Presidents United to Solve Hunger Initiative.

APLU Signs Onto Several Community Letters Urging Passage of an Omnibus for FY15

With a looming federal government shutdown on the horizon, APLU helped organize and signed onto several community letters requesting Congress pass a FY15 Omnibus Appropriations bill with robust funding for our priorities. APLU signed onto letters from the Task Force on American Innovation; the Coalition for National Science Funding; NASA/NOAA FY15 Omnibus Letter; Ad Hoc Group for Medical Research; Close the Innovation Deficit Campaign; Student Aid Alliance; and United for Medical Research.

APLU Statement on Senator Harkin’s HEAA Bill Introduction

APLU released a statement on the introduction of Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Tom Harkin’s (D-IA), bill to reauthorize the Higher Education Act, the Higher Education Affordability Act (HEAA).

HHS Issues Two Proposals Regarding Clinical Trials

The Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM), clarifying the requirements for registering clinical trials and submitting results to ClinicalTrials.gov, established by the Food and Drug Administration Amendments Act (FDAAA) of 2007. There are three major changes to current practice. First, the NPRM expands the scope of clinical trials to include trials of unapproved, unlicensed, and uncleared products. Second, the NPRM calls for additional data elements to be provided at the time of registration. And lastly, the NPRM calls for more rapid updating of several data elements, at least once a year. Comments on the NPRM can be submitted to docket number NIH-2011-0003 at www.regulations.gov and must be made before February 19.

The second HHS proposal is a draft National Institute of Health policy intended to complement the NPRM. The policy applies to all NIH-funded awardees and investigators conducting clinical trials. It would require all NIH-funded clinical trials be registered at ClinicalTrials.gov and the summary results be posted in a timely matter. Comments on the draft NIH policy can be made before February 19. Instructions for submission are available here.

Both proposals are intended to ensure that the public has access to the most up-to-date and comprehensive information regarding clinical trials and results. A summary of the NPRM and NIH policy can be found here.

APLU Joins Letter to Members of Congress on the NIH Competitive Peer Review Process

APLU joined in signing a letter circulated by the Coalition to Promote Research to Members of Congress expressing strong support for the competitive peer review process used by the National Institutes of Health (NIH). The letter highlights the importance of the peer review process. It further goes on to note that while Congress does have an oversight role, we have concerns about recent criticism of NIH funding decisions. The letter was sent to all Members of the House and Senate.

NSF Issues a Revised Proposal and Award Policies and Procedures Guide

The National Science Foundation (NSF) issued a revision of its Proposal and Award Policies and Procedures Guide (PAPPG, NSF 15-1). The update includes implementation of Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance). The Uniform Guidance incorporates eight Office of Management and Budget (OMB) circulars into one. The PAPPG will be effective December 26, 2014. If you have further questions, please direct them to the Policy Office in the Division of Institution and Award Support at policy@nsf.gov.

Rush Holt Named CEO of AAAS

The American Association for the Advancement of Science announced Congressman Rush Holt (D-NJ), who is retiring from Congress at the end of the year, will be succeeding Alan Leshner as CEO of AAAS and executive publisher of Science in February. Holt, a physicist, formerly served as Assistant Director of the Princeton Plasma Physics Laboratory, Princeton’s largest research facility. He also taught physics and public policy courses at Swarthmore College. Throughout his tenure in Congress Holt has been a strong proponent of science.

Presidents United to Solve Hunger Initiative Seeking Additional University Participation

APLU is helping to spread the word on the Presidents United to Solver Hunger (PUSH) initiative, led by Auburn University. PUSH is seeking additional participation of universities contributing to food security. Information can be found at http://www.pushtosign.org/ on joining more than 40 university presidents from U.S. and international institutes of higher education in a commitment to fighting hunger. The presidents’ statement outlines a number of activities where university leaders will make food and nutrition security a campus priority by encouraging assessment and acceleration of teaching, research, outreach and student engagement in these areas on their respective campuses. The first step in making this commitment is to contribute to an international inventory and mapping of existing activities to facilitate collaboration across universities and to minimize redundancies.