2017 – Federal Register Recent Federal Regulation Documents

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.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Colorado Advisory Committee to the Commission will by teleconference at 5:00 p.m. (MDT) on Wednesday, October 18, 2017. The purpose of the meeting is to discuss next steps after briefing meeting on the Blaine Amendment in Denver on July 2017.

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB) Chairs. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.

The Food and Drug Administration (FDA or Agency) is establishing a public docket to solicit suggestions, recommendations, and comments from interested parties, including patients and patient representatives, health care professionals, academic institutions, regulated industry, and other interested organizations, on questions relevant to FDA's newly established Opioid Policy Steering Committee (OPSC). Opioid addiction and the resulting overdoses and deaths have created a national crisis, which requires action by federal agencies that may in some instances be unprecedented in order to address the situation and attempt to turn the tide on the crisis. As a public health agency responding to the crisis, FDA seek public input as it considers how its authorities can or should be used to address this crisis. This information will help the Agency understand areas of focus important to the public and identify and address opioid product and policy issues that need clarification. FDA is especially interested in hearing from interested parties in three key areas: What more can FDA do to ensure that the full range of available information, including about possible public health effects, is considered when making opioid-related regulatory decisions; what steps can FDA take with respect to dispensing and packaging (e.g., unit of use) to facilitate consistency of and promote appropriate prescribing practice; and should FDA require some form of mandatory education for health care professionals who prescribe opioid drug products, and if so, how should such a system be implemented?

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the opening of a docket to obtain public comment on two documents; a Systematic Review of the evidence on the diagnosis, prognosis, and management of pediatric mild traumatic brain injury (TBI), and an evidence-based Guideline that offers clinical recommendations for healthcare providers. Public comments will be considered and will inform revisions to the systematic review and guideline.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The FAA is issuing this notice to advise the public of the renewal of the RTCA Charter (FAA Order 1110.77X) for 6 months, effective September 29, 2017. The Federal Aviation Administration (FAA) is authorized to establish the RTCA advisory committee in accordance with the provisions of the Federal Advisory Committee Act (FACA). The current charter agreement requires that the RTCA manage various Federal subcommittees on behalf of the agency. The objective of the advisory committee is to seek resolution of issues and challenges involving air transportation concepts, requirements, operational capabilities, the associated use of technology, and related considerations to aeronautical operations that affect the future of the Air Traffic Management System and the integration of new technologies.

This notice announces the membership of the Defense Nuclear Facilities Safety Board (DNFSB) Senior Executive Service (SES) Performance Review Board (PRB).

The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Investigation Prosecution and Defense of Sexual Assault in the Armed Forces will take place.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning information collection requirements related to additional first year depreciation deduction.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning certain returned magazines, paperbacks, or records.

The Internal Revenue Service (IRS), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning amortizable bond premium.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Agricultural Marketing Service's (AMS) intention to request an extension and revision of a currently approved information collection under the Dairy Product Mandatory Reporting Program. The information collected supports the marketing of dairy products and is used to verify compliance with Federal milk marketing regulations.

The United States and Singapore intend to hold a meeting on implementation of Chapter 18 (Environment) of the United States- Singapore Free Trade Agreement (FTA). The Office of the United States Trade Representative (USTR) requests written comments or suggestions concerning any relevant issues.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Indiana Advisory Committee (Committee) will hold a meeting on Wednesday, October 18, 2017, at 3:00 p.m. EST for the purpose of preparing for its public meeting on voting rights issues in the state.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Alabama Advisory Committee (Committee) will hold a meeting on Thursday, October 12, 2017, at 11:00 a.m. (Central) for the purpose of orientation and a discussion on civil rights topics affecting the state.