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HRSA Requests Comments on 340B Reporting Requirements

Input Requested on Audits and Dispute Resolution Burdens, Due by Dec. 25
 

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October 26, 2012—HRSA has issued a request for comment on proposed forms relating to audits and dispute resolution. Earlier this year, HRSA launched a number of audits of covered entities to determine if they are in compliance with program requirements.[ms-protect-content id=”2799″] The agency has also discussed the possibility of auditing manufacturers. The dispute resolution process is an opportunity for covered entities and manufacturers to resolve disputes over perceived program violations.

HRSA is interested in stakeholder thoughts on the necessity and utility of the proposed forms, the amount of time it will stake for stakeholders to complete the proposed forms, how to improve the proposed collection and the type of information collected. The Monitor will provide more information when it becomes available.

Stakeholders may request copies of the proposed forms from HRSA by emailing paperwork@hrsa.gov or calling the HRSA Reports Clearance Officer at (301) 443-1984. Comments are due to HRSA by Dec. 25 and can be submitted to paperwork@hrsa.gov or by mail to the HRSA Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.[/ms-protect-content]

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