Excerpt: In 2013, FDA adopted labeling changes affecting Extended Release and Long-Acting (ER/LA) opioid analgesics, requiring manufacturers to adopt the most restrictive language that can be found in drug labeling, a ‘black box’ warning about their potential for abuse, the risk of fatal overdose, and a warning that maternal use of these products during pregnancy can result in neonatal opioid w
Excerpt: We are writing to obtain baseline information about enforcement of the federal select agent program (FSAP).
Excerpt: For fiscal year 2014, CMS reported an estimated improper payment rate for the Medicaid program of 6.7 percent, or $17.5 billion. This was an increase over its 2013 estimate of 5.8 percent, or $14.4 billion. Rather than looking to improve its improper payment rate, CMS raised its target rate for the Medicaid program from 5.6 percent to 6.7 percent for 2015.
Excerpt: In February 2015, the NRC staff reported that the agency received feedback from stakeholders stating that the NRC's process for setting fees is "opaque and difficult to understand." The staff recommended that the NRC take actions to improve transparency and simplify how it calculates and accounts for fees, and improve thetimeliness of when the NRC communicates fee changes.
Excerpt: Influenza has the ability to mutate and potentially threaten public health. On June 2, 2015, the CDC issued a health advisory stating that it ‘considers these newly-identified HPAI H5 viruses as having the potential to cause sever disease in humans’ and made recommendations to clinicians, state health departments, and the public. ...
Excerpt: The May 19, 2015, failure of Plains Pipeline, LP’s Line 901 pipeline and subsequent crude oil spill along the Gaviota Coast of California raises questions about PHMSA’s oversight of pipeline safety. The incident also raises questions about the delayed implementation of the Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011 (P.L.