NIH Director Dr. Francis Collins announced this week the selection of Michael S. Lauer, MD, as the new Deputy Director for Extramural Research. Dr. Lauer started at the NIH in 2007 as the Director of the Division of Prevention and Population Science at the National Heart, Lung, and Blood Institute (NHLBI) and from 2009 to the present he has served as the Director of the Division of …

  The Department of Health and Human Services (HHS) has posted contingency plans for agency operations in the absence of appropriations. NIH would continue patient care for current NIH Clinical Center patients, minimal support for ongoing protocols, animal care services to protect the health of NIH animals, and minimal staff to safeguard NIH facilities an infrastructure. NIH would not admit n…

  The Department of Health and Human Services (HHS) recently announced plans to significantly update the regulations protecting human research subjects. The current regulations that protect individuals who participate in research, which have been in place since 1991, are followed by 18 federal agencies and are often referred to as the Common Rule. They were developed at a time when research was pr…

  Senators Tammy Baldwin (D-WI) and Susan Collins (R-ME) last week introduced the Next Generation Research Act (S.2014) to support the “next generation” of researchers and young scientists supported by the National Institutes of Health (NIH). Provisions in the bill include: Authorizes the creation of an NIH initiative to coordinate polices aimed at promoting new researchers; Strives to implemen…

  The Health Resources and Services Administration (HRSA) issued its proposed omnibus guidance on the 340B Drug Pricing Program in the Aug. 28 Federal Register in the form of a notice with a 60-day comment period. The proposed guidance seeks “to provide increased clarity in the marketplace for all 340B Program stakeholders and strengthen the [Department of Health and Human Services’] ability to a…

  Congress returned to Capitol Hill last week to confront a series of high priority domestic and international policy issues that will dominate the fall legislative agenda. Funding government agencies beyond the end of the fiscal year on September 30 is at the top of the list, as Senate Majority Leader Mitch McConnell (R-KY) acknowledged in an interview on a Kentucky television program on Aug…

On August 24th, the FDA held a public meeting to discuss its plan to request quality metrics from drug manufacturers. The meeting was the first opportunity for the agency and industry to publicly discuss the plan since FDA released its draft guidance in July. The draft guidance, Request for Quality Metrics, details plans to use quality metrics data to further develop the FDA's risk-based inspecti…

  The White House Office of Management and Budget (OMB) recently announced that it is seeking feedback on ways to reduce unnecessary reporting burden for recipients of federal grants and contracts. Information will be collected through the “National Dialogue website” and used to inform a two-year pilot study and other activities. The Federation of American Societies for Experimental Biology (FA…

  Countdown to a showdown; Lawmakers return to Washington in just a few days with next year’s budget resting on the actions taken in the first legislative days. The House is up first and will have to pass a short-term funding bill to avoid a government shutdown. The Senate, scheduled to be in session for 17 days in September, will have a few more days to address any House-passed continuing resolu…

  On July 20, the National Institutes of Health (NIH) issued a draft framework for a five-year strategic plan. The new framework identifies three crosscutting areas of opportunity across biomedicine: promoting fundamental science, improving health promotion and disease prevention, and advancing treatments and cures. The plan also details two unifying principles or “mission priority focus area…