federal_register: 2018-24057
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2018-24057 | 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation | Proposed Rule | The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the "340B Drug Pricing Program" or the "340B Program." HRSA published a final rule on January 5, 2017, that set forth the calculation of the 340B ceiling price and application of civil monetary penalties. On June 5, 2018, HRSA published a final rule that delayed the effective date of the 340B ceiling price and civil monetary rule until July 1, 2019, to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After further consideration of the issue, the Department of Health and Human Services (HHS or Department) proposes to cease any further delay of the rule and change the effective date from July 1, 2019, to January 1, 2019. | 2018-11-02 | 2018 | 11 | https://www.federalregister.gov/documents/2018/11/02/2018-24057/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulation | https://www.govinfo.gov/content/pkg/FR-2018-11-02/pdf/2018-24057.pdf | Health and Human Services Department | 221 | The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the "340B Drug Pricing Program" or the "340B Program." HRSA published a final rule on January 5, 2017,... |