CMS-367c Product Data

Online Product Data Entry Screen in DDR (CMS-367c)

Form CMS-367c (02/28/2023) is used by manufacturers to report a new drug to CMS either electronically or via file transfer, or when the manufacturer has to report a change to the product data
of an existing drug electronically or via file transfer. When needed, the use of Form CMS-367c by manufacturers is considered mandatory under the authority of Section 1927 of the Social
Security Act and the National Drug Rebate Agreement. Under the Privacy Act of 1974 any personally identifying information obtained will be kept private to the extent of the law. According to
the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this
information collection is 0938-0578. The time required to complete this information collection is estimated to average 43.5 hours per response, including the time to review instructions, gather
the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or suggestions for improving this form, please write
to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore, Maryland 21244-1850.