Department of Health and Human Services December 19, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Impact of Approved Drug Labeling on Chronic Opioid Therapy; Public Hearing; Request for Comments
The Food and Drug Administration (FDA) is announcing a public hearing to obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain.
Silver Nanoparticles (AgNPs); Information and Comment Request
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), as part of its mission to investigate new and emerging hazards, has initiated an evaluation of the scientific data on silver nanoparticles (AgNPs) to ascertain the potential health risks to workers and to identify gaps in knowledge so that appropriate laboratory and field research studies can be conducted. NIOSH has identified a number of relevant publications on AgNPs. This listing (Evaluation of the scientific data on silver nanoparticles (AgNPs) can be found in Docket CDC-2012-0014 at https://www.regulations.gov. NIOSH is requesting additional information on the following: (1) Published and unpublished reports and findings from in vitro and in vivo toxicity studies with AgNPs, (2) information on possible health effects observed in workers exposed to AgNPs, (3) information on workplaces and products in which AgNPs can be found, (4) description of work tasks and scenarios with a potential for exposure, (5) information on measurement methods and, workplace exposure data, and (6) information on control measures (e.g., engineering controls, work practices, PPE) that are being used in workplaces where potential exposures to AgNPs occur.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance: Emergency Use Authorization of Medical Products
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.
Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013-2017. The assessment is described in section V, ``Independent Assessment of Review Process Management'', of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' \1\ (MDUFA III Commitment Letter). The assessment will be conducted by an independent contractor in two phases. FDA is providing a period of 30 days for public comment on the statement of work before requesting proposals for the assessment.
Draft Guidance for Industry on Providing Submissions in Electronic Format-Summary Level Clinical Site Data for Center for Drug Evaluation and Research's Inspection Planning; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Submissions in Electronic FormatSummary Level Clinical Site Data for CDER's Inspection Planning.'' The draft guidance is intended to assist applicants in the voluntary submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the level of the individual study site (summary level clinical site dataset). The summary level clinical site dataset is intended to facilitate use of a risk-based approach to timely identification of clinical investigator sites for onsite inspection by FDA during the review of marketing applications. This draft guidance describes a recommended electronic format for the summary level clinical site dataset to be submitted voluntarily in new drug applications (NDAs), biologics licensing applications (BLAs), and NDA and BLA supplemental applications submitted to FDA's Center for Drug Evaluation and Research (CDER).
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