340B Drug Pricing Program; Administrative Dispute Resolution

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services 42 CFR Part 10 [Docket No. 2021-0004] RIN 0906-AB28 AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of proposed rulemaking. SUMMARY: The Health Resources and Services Administration implements section 340B of the Public Health Service (PHS) Act, which is referred to as the “340B Drug Pricing Program” or the “340B Program.” This notice of proposed rulemaking (NPRM) proposes to revise the current 340B administrative dispute resolution (ADR) final rule (Dec. 14, 2020) with a new process and solicits comment on the proposal. DATES: Written comments and related material to this proposed rule must be received on or before January 30, 2023. ADDRESSES: You may submit written comments electronically by the following method: Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions on the website for submitting comments. Include the HHS Docket No. “HRSA-2021-000X” in your comments. All comments received will be posted without change to https://www.regulations.gov . Please do not include any personally identifiable or confidential business information you do not want publicly disclosed. FOR FURTHER INFORMATION CONTACT: Michelle Herzog, Deputy Director, Office of Pharmacy Affairs, HRSA, 5600 Fishers Lane, Mail Stop 08W12, Rockville, MD 20857; email: 340badr@hrsa.gov ; telephone: 301-594-4353. SUPPLEMENTARY INFORMATI…