Department of Health and Human Services March 1, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Meunerie Sawyerville, Inc.; Denial of Hearing; Final Debarment Order
The Food and Drug Administration (FDA or the Agency) is denying a request for a hearing submitted by Meunerie Sawyerville, Inc. (Meunerie Sawyerville) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Meunerie Sawyerville for 5 years from importing articles of food or offering such articles for import into the United States. FDA bases this order on a finding that Meunerie Sawyerville was convicted of felony offenses for conduct relating to the importation of food into the United States. In determining the appropriateness and period of Meunerie Sawyerville's debarment, FDA has considered the relevant factors listed in the FD&C Act. Meunerie Sawyerville has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Susceptibility Test Interpretive Criteria Recognized and Listed on the Susceptibility Test Interpretive Web Page; Reopening of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or the Agency) is reopening a docket for public comment on the susceptibility test interpretive criteria for antibacterial and antifungal drugs provided by FDA on its Susceptibility Test Interpretive Criteria web page (Interpretive Criteria web page) established on December 13, 2017. On the Interpretive Criteria web page, FDA recognizes, in whole or in part, susceptibility test interpretive criteria standards established by Standard Development Organizations (SDOs) and lists other susceptibility test interpretive criteria identified by FDA outside of the SDO process.
Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1); International Council for Harmonisation; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1).'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance amends the guidance entitled ``E6 Good Clinical Practice: Consolidated Guidance (E6(R1))'' to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The guidance is intended to improve clinical trial quality and efficiency, while maintaining human subject protection and reliability of trial results.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Proposed Data Collections Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER), formerly the Questionnaire Design Research Laboratory (QDRL), generic clearance request, which encompasses general questionnaire development, pre- testing, and measurement-error reduction activities to be carried out in 2018-2020.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the information collection project titled ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.''
Clinical Laboratory Improvement Advisory Committee (CLIAC); Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Clinical Laboratory Improvement Advisory Committee (CLIAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through February 19, 2020.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC): Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services, has been renewed for a 2-year period through February 1, 2020.
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