Burden Statement to Include in OPAIS

Public Burden Statement: The purpose of this information collection is to provide a mechanism for covered entities and manufacturers to file an Alternative Dispute Resolution (ADR) claim for certain disputes arising under the 340B Drug Pricing Program. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0915/0906-XXXX and it is valid until XX/XX/202X. This information collection is required to file a 340B ADR Claim. The 340B statute (42 U.S.C. § 256b(d)(1)(B)(iii)) requires protection of privileged pricing data from unauthorized re-disclosure. Public reporting burden for this collection of information is estimated to average 2 hours, 30 minutes per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Information Collection Clearance Officer, 5600 Fishers Lane, Room 14NWH04, Rockville, Maryland, 20857 or [email protected].  Please see https://www.hrsa.gov/about/508-resources for the HRSA digital accessibility statement.