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News & Press: National News

Impact of Federal Government Shutdown on Biomedical R&D

Tuesday, October 08, 2013  
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Because biomedical R&D is so dependent on federal support and regulation, we are all concerned about the impact of the Federal Government shutdown.  Following are links to the shutdown operational plans of key federal agencies.


Food and Drug Administration.  The FDA has prepared a detailed document summarizing the anticipated scope of FDA’s activities beginning on October 1, 2013, and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution for FDA (the "lapse period”).  Some operations will continue due to existing authority to use fiscal year carryover money and user fees to fund operations.  Generally, many activities with respect to the review of pending applications for which PDUFA, GDUFA and MDUFA fees were authorized and collected will continue, but new applications requiring payment of a fee will not be accepted.


National Institutes of Health. HHS provided an overview of staffing and activities at NIH during the shutdown at  In addition, NIH has provided Information for the NIH Extramural Grantee Community During the Lapse of Federal Government Funding  The impact on intramural research, maintenance of online resources and other NIH activities have been reported widely, including, for example, in Nature News at


USPTO.   During the general government shutdown that began October 1, 2013 the United States Patent and Trademark Office has announced it will remain open, using prior year reserve fee collections to operate as usual for approximately four weeks.  The PTO states it will continue to assess fee collections compared to operating requirements to determine how long it will be able to operate in this capacity, and provide updates as more definitive information becomes available.  The PTO has suggested categories of activities it would have to curtail if the shutdown continues for an extended period.


Securities and Exchange Commission.   The SEC, which also receives user fees, has stated in the short run it intends to remain open and operational, but has issued a contingency plan as well.


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