Department of Health and Human Services June 21, 2018 – Federal Register Recent Federal Regulation Documents
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Availability of Draft Toxicological Profile: Perfluoroalkyls
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS) announces the availability of the Draft Toxicological Profile for Perfluoroalkyls for review and comment. All toxicological profiles issued as ``Drafts for Public Comment'' represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information, reports, and studies about the health effects of these substances. Although ATSDR considers key studies for this substance during the profile development process, this document solicits any relevant, additional studies. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR remains committed to providing a comment period for this document as a means to best serve public health.
Draft-National Occupational Research Agenda for Healthcare and Social Assistance
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Healthcare and Social Assistance (HCSA) for public comment. To view the notice and related materials, visit https:// www.regulations.gov and enter CDC-2018-0050 in the search field and click ``Search.''
Major Depressive Disorder: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Major Depressive Disorder: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the monotherapeutic, combination, and adjunctive treatment of major depressive disorder (MDD). Specifically, this draft guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for antidepressant drug products. This draft guidance is intended to serve as a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public. This draft guidance revises the guidance for industry entitled ``Guidelines for the Clinical Evaluation of Antidepressant Drugs'' issued in September 1977.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This revised draft guidance provides recommendations to applicants planning to request a waiver or reduction in user fees. This draft guidance is a revision of the guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products,'' issued in September 2011.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA or 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 adverse event reporting for outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of five new drug applications (NDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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