Regulatory Letters & Comments
SHEA expertise is routinely sought by regulatory and legislative entities. This section showcases regulatory letters and comments.
SHEA responds to CMS' Life Safety Code proposal
On June 13, 2014, SHEA submitted comments to CMS in response to the proposed rule for fire safety requirements for certain health care facilities. The Society’s comments address the topics of anesthetizing locations and alcohol based hand rubs.
SHEA comments on FDA’s Draft Guidance for Industry on Allowable Excess Volume and Labeled Vial Fill Size
SHEA, APIC and HONOReform submitted comments in response to the FDA’s Draft Guidance for industry addressing appropriate packaging sizes for injectable drug and biological products in order to prevent medication errors and misuse or pooling of leftover drug products.
Coalition letter to U.S. House and Senate Appropriators on FY 2015 CDC funding
SHEA joined with coalition of health care organizations in support of FY 2015 CDC funding for National Healthcare Safety Network, Prevention Epicenters Program, Detect and Protect Against Antibiotic Resistance Initiative and Advanced Molecular Detection Initiative.
View letter sent to Appropriations Committees PDF (127 KB)
View letter sent to Appropriations Subcommittees PDF (127 KB)
SHEA/IDSA letter to NIOSH regarding Respiratory Protective Devices
SHEA and IDSA submitted joint comments to NIOSH in response to its request for information on Respiratory Protective Devices used in health care.
SHEA letter to HHS regarding National HAI Action Plan 2020 Targets
SHEA provided comments in response to HHS’ National HAI Action Plan proposed new five-year 2020 targets.
SHEA letter to FDA regarding fecal microbiota for transplantation (FMT) guidance
SHEA submitted comments to FDA on its Guidance for industry regarding enforcement policy for use of FMT to treat Clostridium difficile infection not responsive to standard therapies.
SHEA/IDSA letter to CMS advancing Antimicrobial Stewardship as a Condition of Participation
SHEA and IDSA submitted a joint letter to CMS on March 4 advancing Antimicrobial Stewardship as a Condition of Participation.