Contractor_Q&A.pdf

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For the CDC application, information is needed regarding the responsible POC for packaging and shipping of the specimens. In particular we are in need of pertains information as related to the following countries: Japan, South Korea, Germany, Iraq and Afghanistan 9if needed).

All samples should be packaged IAW applicable regulatory guidelines [e.g., Code of Federal Regulations (CFR), International Air Transport Association (IATA), etc], hazard classification/categorization, and host nation rules and regulations. Both the US and IATA classify HIV diagnostics samples as Category B, Diagnostic/Clinical Samples, and requirements for training, packaging, shipping and documentation are commensurate with that categorization.

As HIV screening samples do not fall under Select Agent or Toxin rules CDC registration is not required to ship these samples into the United States based upon current CFR or IATA regulations and guidelines. Additionally, according to the CDC's IPP FAQ an import permit is not required for a diagnostic specimen (see attachment). Please provide clarification on which form/application is being submitted to the CDC.

It should be noted that IAW the PWS this is a contingency requirement only.

This requirement has not been exercised during the life of the current or two previous contracts, however it is included due to the nature of the Government's requirement and operational impact. All European and Central Command specimens (Germany, Iraq and Afghanistan) would route through Landstuhl AMC and all Pacific Command specimens (Japan and South Korea) would route through Tripler AMC.

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