March 20, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments
The Food and Drug Administration (FDA or we) is further delaying the effective date of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until March 21, 2017, the effective date of the final rule. This action further delays the effective date of the rule until March 19, 2018. FDA has received a petition from affected parties which raises questions about the amendments to the regulations regarding ``intended uses'' and requests that FDA reconsider these amendments. FDA is further delaying the effective date to invite public comment on the important substantive issues raised by the petition and to allow additional time to fully evaluate these issues and any other issues raised in response to this request for comments. FDA is seeking input on some specific questions, and is also interested in any other pertinent information or comments stakeholders would like to provide regarding any aspect of the final rule, or with respect to issues relating to ``intended uses'' generally.
Homeland Security Acquisition Regulation (HSAR); Safeguarding of Controlled Unclassified Information (HSAR Case 2015-001); Information Technology Security Awareness Training (HSAR Case 2015-002); Privacy Training (HSAR Case 2015-003)-Extension of Comment Periods
DHS is extending the comment periods for the following three notices of proposed rulemaking (proposed rules) published on January 19, 2017: ``Safeguarding of Controlled Unclassified Information,'' ``Information Technology Security Awareness Training,'' and ``Privacy Training.'' DHS is extending the comment period by 30 days to ensure the public has sufficient time to review and provide comment on these proposed rules.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
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.
Technical Correction to the National Ambient Air Quality Standards for Particulate Matter
The Environmental Protection Agency (EPA) is taking final action to make a technical correction to equation 2 in appendix N to part 50, section 4.4(b) of the National Ambient Air Quality Standards (NAAQS) for Particulate Matter. Equation 2 in appendix N describes an intermediate step in the calculation of the design value for the annual PM2.5 (particles with an aerodynamic diameter less than or equal to a nominal 2.5 micrometers) NAAQS. This action corrects Equation 2 to properly account for cases where a site has quarters without daily values and passes the minimum quarterly value data substitution test. This change accurately reflects the intended calculation of the annual PM2.5 design value and is consistent with the text of section 4.1 in appendix N to part 50.
Alabama: Final Authorization of State Hazardous Waste Management Program Revisions
Alabama has applied to the Environmental Protection Agency (EPA) for final authorization of changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). These changes correspond to certain Federal rules promulgated between July 1, 2006 through June 30, 2008, and July 1, 2011 through June, 30, 2014 (also known as RCRA Clusters XVII through XVIII, and XXII through XXIII). With this proposed rule, EPA is proposing to grant final authorization to Alabama for these changes.
Alabama: Final Authorization of State Hazardous Waste Management Program Revisions
Alabama has applied to the United States Environmental Protection Agency (EPA) for final authorization of changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA has determined that these changes satisfy all requirements needed to qualify for final authorization, and is authorizing the State's changes through this direct final rule. In the ``Proposed Rules'' section of today's Federal Register, EPA is also publishing a separate document that serves as the proposal to authorize these changes. EPA believes this action is not controversial and does not expect comments that oppose it. Unless EPA receives written comments that oppose this authorization during the comment period, the decision to authorize Alabama's changes to its hazardous waste program will take effect. If EPA receives comments that oppose this action, EPA will publish a document in the Federal Register withdrawing today's direct final rule before it takes effect, and the separate document published in today's ``Proposed Rules'' section of this Federal Register will serve as the proposal to authorize the changes.
Further Delay of Effective Dates for Five Final Regulations Published by the Environmental Protection Agency Between December 12, 2016 and January 17, 2017
In accordance with the Presidential directive as expressed in the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' and the Federal Register document published by EPA on January 26, 2017, EPA is further delaying the effective dates for the five regulations listed in the table below.
Final Flood Elevation Determinations
Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Final Flood Elevation Determinations
Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Connect America Fund, ETC Annual Reports and Certifications, Developing a Unified Intercarrier Compensation Regime
This document corrects errors in the supplementary information and final rules portions of a Federal Register document adopting significant reforms to place the universal service program on solid footing for the next decade to ``preserve and advance'' voice and broadband service in areas served by rate-of-return carriers. The summary was published in the Federal Register on April 25, 2016.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
