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2006 proposed fee schedule - American Society of Clinical Oncology

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eporting requirements are discussed in further detail in<br />

the interim final rule with comment, Medicare Program;<br />

Manufacturer Submission <strong>of</strong> Manufacturer’s Average Sales<br />

313<br />

Price (ASP) Data for Medicare Part B Drugs and Biologicals,<br />

that published on April 2, 2004 in the Federal Register<br />

(69FR17935-17941).<br />

The burden associated with these requirements is the<br />

time and effort required by manufacturers <strong>of</strong> Medicare Part B<br />

Drugs and biologicals to prepare and submit to the required<br />

ASP data to CMS.<br />

While these requirements are subject to the PRA, the<br />

requirements are currently approved in OMB No. 0938-0921,<br />

with a current expiration date <strong>of</strong> September 30, 2007.<br />

We intend to revise this information collection to<br />

include adequate instructions for manufacturers to report<br />

the ASP, the WAC, and other data elements. These revisions<br />

will be addressed in detail in a revised information<br />

collection request in accordance with the Paperwork<br />

Reduction Act <strong>of</strong> 1995.<br />

We have submitted a copy <strong>of</strong> this <strong>proposed</strong> rule to OMB<br />

for its review <strong>of</strong> the information collection requirements<br />

described above. These requirements are not effective until<br />

they have been approved by OMB.

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