Section 160.204 would require States to: 1) submit a written request, that meets the requirements of this section, to the Secretary to except a provision of State law from preemption under 160.203; 2) submit a new request to the Secretary, should there be any changes to the standard, requirement, or implementation specification or provision of State law upon which an exception previously was granted, and 3) submit a written request for an extension of the exception prior to the end of the three-year approval period for a given exception. In addition, section 160.204 would require a State to submit a written request for an advisory opinion to the Secretary that meets the requirements of 160.204.
The burden associated with these requirements is the time and effort necessary for a State to prepare and submit the written request for preemption or advisory opinion to HCFA for approval. On an annual basis it is estimated that it will take 10 States 16 hours each to prepare and submit a request. The total annual burden associated with this requirement is 160 hours.