This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office] .
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
United States Code U.S. Code: Title 21 - FOOD AND DRUGS U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE
Title 42 published on 03-Aug-2018 03:34
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 10 after this date.
2018-06-05; vol. 83 # 108 - Tuesday, June 5, 2018 83 FR 25943 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration Final rule; further delay of effective date. As of July 1, 2018, the effective date of the final rule published in the Federal Register on January 5, 2017 at 82 FR 1210, delayed March 6, 2017 at 82 FR 12508, March 20, 2017 at 82 FR 14332, May 19, 2017 at 82 FR 22893, and September 29, 2017 at 82 FR 45511, is further delayed until July 1, 2019. 42 CFR Part 10 Summary 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 May 7, 2018, HHS solicited comments on further delaying the effective date of the January 5, 2017, final rule to July 1, 2019. HHS proposed this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for any 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, 2019.
2018-05-07; vol. 83 # 88 - Monday, May 7, 2018 83 FR 20008 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration Notice of proposed rulemaking; further delay of effective date. Submit comments on or before May 22, 2018. 42 CFR Part 10 Summary The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act, referred to as the “340B Drug Pricing Program” or the “340B Program.” HHS is soliciting comments on further delaying the effective date of the January 5, 2017, final rule that sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. HHS proposes to further delay the effective date of the final rule published in the Federal Register from July 1, 2018, to July 1, 2019. HHS proposes this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking.
2017-09-29; vol. 82 # 188 - Friday, September 29, 2017 82 FR 45511 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration Final rule; further delay of effective date. As of September 29, 2017, the effective date of the final rule published in the Federal Register (82 FR 1210, January 5, 2017) is further delayed to July 1, 2018. 42 CFR Part 10 Summary 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.
2017-08-21; vol. 82 # 160 - Monday, August 21, 2017 82 FR 39553 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration Notice of proposed rulemaking; further delay of effective date. Submit comments on or before September 20, 2017. 42 CFR Part 10 Summary 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.” HHS is soliciting comments on delaying the effective date of the January 5, 2017 final rule that sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. HHS proposes to delay the effective date of the final rule published in the Federal Register (82 FR 1210, January 5, 2017) to July 1, 2018. HHS proposes this action in order to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking, as set forth below.
2017-05-19; vol. 82 # 96 - Friday, May 19, 2017 82 FR 22893 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration Final rule; further delay of effective date. As of May 19, 2017, the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) is further delayed to October 1, 2017. 42 CFR Part 10 Summary The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), 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 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. In accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” HRSA issued an interim final rule that delayed the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. HHS invited commenters to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate. After consideration of the comments received on the interim final rule, HHS is delaying the effective date of the January 5, 2017 final rule, to October 1, 2017.
2017-03-20; vol. 82 # 52 - Monday, March 20, 2017 82 FR 14332 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration Interim final rule; further delay of effective date with comment. As of March 20, 2017, the effective date of the final rule published in the Federal Register (82 FR 1210, January 5, 2017) is further delayed to May 22, 2017. Comments on the delay of the effective date to May 22, 2017, as well as comments on alternatively delaying the effective date further to October 1, 2017, must be submitted on or before April 19, 2017. 42 CFR Part 10 Summary 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.” The January 5, 2017 final rule sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This interim final rule delays the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. Commenters are also invited to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate.
2017-03-06; vol. 82 # 42 - Monday, March 6, 2017 82 FR 12508 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties; Delay of Effective Date
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration (HRSA) Final rule; delay of effective date. Effective date: This regulation is effective March 3, 2017. The effective date of the final rule published in the January 5, 2017, Federal Register (82 FR 1210), is delayed until March 21, 2017. Compliance date: HHS recognizes that the effective date falls in the middle of a quarter. As such, HHS plans to begin enforcing the requirements of this final rule at the start of the next quarter, which begins April 1, 2017. 42 CFR Part 10 Summary In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” this action temporarily delays for 60 days from the date of the memorandum the effective date of the final rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation,” published in the January 5, 2017, Federal Register . This document announces that the effective date is delayed until March 21, 2017.
2017-01-05; vol. 82 # 3 - Thursday, January 5, 2017 82 FR 1210 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Health Resources and Services Administration Final rule. This rule is effective March 6, 2017. 42 CFR Part 10 Summary The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the “340B Drug Pricing Program” or the “340B Program.” This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs).
2016-08-12; vol. 81 # 156 - Friday, August 12, 2016 81 FR 53381 - 340B Drug Pricing Program; Administrative Dispute Resolution
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration Notice of proposed rulemaking. Submit written comments on or before October 11, 2016. 42 CFR Part 10 Summary The Health Resources and Services Administration (HRSA) implements section 340B of the Public Health Service Act (PHSA), which is referred to as the “340B Drug Pricing Program” or the “340B Program.” This proposed rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The proposed rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution process.
2016-04-19; vol. 81 # 75 - Tuesday, April 19, 2016 81 FR 22960 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; Reopening of Comment Period
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration (HRSA) Notice; reopening of comment period. The comment period for the proposed rule published on June 17, 2015 (80 FR 34583), is reopened and ends on May 19, 2016. 42 CFR Part 10 Summary This document reopens the comment period for the June 17, 2015, proposed rule entitled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” The comment period for the proposed rule, which ended on August 17, 2015, is reopened for 30 days.
2015-06-17; vol. 80 # 116 - Wednesday, June 17, 2015 80 FR 34583 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration Notice of proposed rulemaking. Submit comments on or before August 17, 2015. 42 CFR Part 10 Summary 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.” This proposed rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. The proposed rule sets forth the calculation of the ceiling price and application of civil monetary penalties.
2013-07-23; vol. 78 # 141 - Tuesday, July 23, 2013 78 FR 44017 - Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Health Resources and Services Administration (HRSA) Final rule. This final rule is effective on October 1, 2013. 42 CFR Part 10 Summary HHS is issuing this final rule to clarify how section 340B(e) of the Public Health Service Act (PHSA) will be implemented. The final rule applies section 340B(e) of the PHSA only to drugs transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the orphan drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FFDCA). The final rule also sets forth that it is the responsibility of the 340B covered entity to maintain auditable records that demonstrate compliance with the terms of the orphan drug exclusion requirements. This rule will provide clarity in the marketplace, maintain the 340B savings for newly-eligible covered entities, and protect the financial incentives for manufacturing orphan drugs designated for a rare disease or condition as indicated in the Affordable Care Act and intended by Congress.
