ACLA ISA comment re: typo, header titles, harmonization status

Please clarify the term “harmonization status”.  We suggest this term be removed until it can be further clarified for expected implementation, clearly measured, etc.  It is too nebulous as currently stated.  For example, can it be measured and if so, how is it validated and how does it relate to the laboratory or provider’s EHR system Exchanging InVitro Diagnostics (IVD) Test Orders & Results?   Correct typo in last bullet.  “OMB Circular A-1195” should be “OMB Circular A–119”.   The 2nd column ‘header’ is titled “Applicable Value Set(s) and Starter Set(s)” but the comments are not related to value sets; Suggest you retitle; these seem like general comments