Department of Health and Human Services September 19, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Potential Privatization of the Journal “Environmental Health Perspectives;” Request for Comment
For several decades, NIEHS has published Environmental Health Perspectives (EHP), a leading biomedical publication in the field of environmental health science, to provide a forum for research in environmental health science. EHP has well fulfilled this purpose, but NIEHS is now considering new channels to inform scientists, clinicians, patients, families, and the general public about environmental health research findings. NIEHS is exploring web-based and other methods to disseminate such information and anticipates development of a new system to communicate important recent findings in a timely and efficient manner. NIEHS conducts ongoing review of all its research, training, and communications programs and has recently determined that it is now appropriate to consider phasing out Institute sponsorship of this journal. NIEHS has not reached a final decision about potential privatization of EHP nor has an implementation plan for carrying out such a decision been developed. Should such a decision be reached, it is our goal to implement it in a manner that will be least disruptive to the field and to authors, reviewers, editorial board, staff, and subscribers. The current request for comment poses a series of questions around core elements that may comprise an implementation plan for privatization of EHP. These elements include: (1) Feasibility of privatizing EHP, (2) a business plan for continuation of the journal, (3) a timeline and plan for transfer of responsibility, (4) an editorial policy plan, and (5) continued online access.
Guidance for Industry on the Collection of Race and Ethnicity Data in Clinical Trials; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Collection of Race and Ethnicity Data in Clinical Trials.'' This guidance provides recommendations on a standardized approach for collecting and reporting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products. This document provides guidance on meeting the requirements in the 1998 final rule on Investigational New Drug Applications and New Drug Applications (Demographic Rule) (63 FR 6854, February 11, 1998).
Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Extension of Application and Comment Deadlines
The Food and Drug Administration (FDA) is announcing an extension in the deadlines for submitting requests to participate in and comment on a pilot program involving the submission of chemistry, manufacturing, and controls (CMC) information consistent with the new pharmaceutical quality assessment system.
Memorandum of Understanding Between the Food and Drug Administration, Center for Biologics Evaluation and Research, and the National Institutes of Health, National Institute of Neurological Disorders and Stroke
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration, Center for Biologics Evaluation and Research (FDA/ CBER), and the National Institutes of Health, National Institute of Neurological Disorders and Stroke (NIH/NINDS). The purpose of this MOU is to provide a framework for coordination and collaborative efforts between these two entities, which are both components of the Department of Health and Human Services. This MOU also provides the principles and procedures by which information sharing between FDA/CBER and NIH/NINDS units shall take place.
Memorandum of Understanding Between the Food and Drug Administration and the Veterans Health Administration
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Veterans Health Administration (VHA). The purpose of this MOU is to extend an existing formal collaboration between FDA and VHA for the purpose of developing and implementing terminology standards for medication information.
Draft Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Acne Vulgaris: Developing Drugs for Treatment.'' This document has been developed to provide guidance on the development of drug products for the treatment of acne vulgaris other than nodulocystic acne.
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