Department of Health and Human Services February 8, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Prospective Grant of Exclusive License: Purified Inactivated Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in the 3′-UTR of Dengue Types 1,2,3, and 4
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications:
Proposed Collection; Comment Request; Web Based Training for Pain Management Providers
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. The purpose of this notice is to allow 60 days for public comment.
Proposed Collection; Comment Request; Lost People Finder System
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Contents of a Complete Submission for the Evaluation of Proprietary Names'' (proprietary names submission guidance). This guidance provides recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary names for drugs, including biological products, and other factors that, in association with the name, can contribute to medication errors. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications
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.
Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials.'' This guidance summarizes FDA's current thoughts on the appropriate use of Bayesian statistical methods in the design and analysis of medical device clinical trials.
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