Department of Health and Human Services October 31, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Request for Information on Effective, Large-Scale, Sustainable Approaches To Help People Quit Using Tobacco by Employing Evidence-Based Treatment Options
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is requesting information from the public to inform future activities regarding how to efficiently and cost effectively help people quit using tobacco using evidence-based treatment options.
Notice of Availability of the Final Environmental Assessment and Finding of No Significant Impact for HHS/CDC Chamblee Campus 2025 Master Plan, Chamblee, Georgia
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) announces the availability of the Final Environmental Assessment (EA) and a Finding of No Significant Impact (FONSI) for the CDC Chamblee Campus 2025 Master Plan.
Final Immediately Dangerous to Life or Health (IDLH) Value Profiles
NIOSH announces the availability of the following four Immediately Dangerous to Life or Health (IDLH) Value Profile documents: Acetonitrile [CAS No. 75-05-8], Chloroacetonitrile [CAS No. 107-14-2], Methacrylonitrile [CAS No. 126-98-7], and Nitrogen dioxide [CAS No. 10102-44-0].
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
The Food and Drug Administration (FDA or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection in the guidance on ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.''
Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease
The Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. We are taking this action based on our review of the totality of publicly available scientific evidence currently available and our tentative conclusion that such evidence does not support our previous determination that there is significant scientific agreement (SSA) among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease.
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance clarifies, updates, and extends the earlier ``E9 Statistical Principles for Clinical Trials'' in two main areas. Concerning estimands, it provides a framework for discussion of how the aims of a trial relate to the proposed statistical analysis. Concerning sensitivity analysis, it discusses how to use additional analyses to address concerns about the validity of assumptions underlying the main analysis. The draft guidance is intended to better align the choice of statistical methods with questions of regulatory importance and to improve the reliability of decisions about and representations of the effects of medical products.
National Advisory Committee on Rural Health and Human Services
HHS is hereby giving notice that the charter for the National Advisory Committee on Rural Health and Human Services (NACRHHS) has been renewed. The effective date of the renewed charter is October 31, 2017.
Packaging, Storage, and Disposal Options To Enhance Opioid Safety-Exploring the Path Forward; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Packaging, Storage, and Disposal Options To Enhance Opioid SafetyExploring the Path Forward.'' The purpose of this 2-day public workshop is to host a scientific discussion with experts and seek input from interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products (opioids); guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; integrating packaging, storage, and disposal options into existing health care and pharmacy systems, including both open and closed health care systems (e.g., a closed system such as the U.S. Department of Veterans Affairs); data needs and how to address challenges in assessing the impact of packaging, storage, and disposal options in both the premarket and postmarket settings; and ways in which FDA could encourage the development and assessment of packaging, storage, and disposal options for opioids that have the potential to enhance opioid safety.
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