federal_register: 2017-20911

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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
2017-20911 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation Rule The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known 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 ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. On August 21, 2017, HHS solicited comments on further delaying the effective date of the January 5, 2017, final rule to July 1, 2018 (82 FR 39553). HHS proposed this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After consideration of the comments received on the proposed rule, HHS is delaying the effective date of the January 5, 2017, final rule, to July 1, 2018. 2017-09-29 2017 9 https://www.federalregister.gov/documents/2017/09/29/2017-20911/340b-drug-pricing-program-ceiling-price-and-manufacturer-civil-monetary-penalties-regulation https://www.govinfo.gov/content/pkg/FR-2017-09-29/pdf/2017-20911.pdf Health and Human Services Department 221 The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known as the "340B Drug Pricing Program" or the "340B Program." HRSA published a final rule on January 5, 2017, that set forth the... 0906-AB11

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