Department of Health and Human Services October 28, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Proposed Collection; Comment Request; A Generic Submission for Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources (NCI)
Under the provisions 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 Cancer Institute (NCI), 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.
Draft Guidance for Industry and Reviewers on Structured Product Labeling Standard for Content of Labeling Technical Questions and Answers, Revision; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for industry and reviewers entitled ``SPL Standard for Content of Labeling Technical Qs & As.'' This draft guidance is intended to assist sponsors who submit the content of their product labeling to the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) using the Structured Product Labeling standard (SPL) in extensible markup language (XML). The draft guidance also provides information to CDER and CBER staff who review and manage that product information using electronic systems. This draft guidance is being revised to reflect technological changes and changes resulting from the requirement in the Food and Drug Administration Amendments Act of 2007 to submit drug establishment registration and drug listing information electronically.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
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.
Office of Biotechnology Activities; Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
A proposal by Dr. Harlan Caldwell at the Rocky Mountain Laboratories (RML) involving the deliberate transfer of a tetracycline resistance trait to non-ocular strains of Chlamydia trachomatis has been submitted to the NIH Office of Biotechnology Activities (OBA). The introduction of tetracycline resistance could compromise the ability to treat disease caused by Chlamydia trachomatis as doxycycline is currently used to treat disease caused by this organism. Under Section III-A-1 of the NIH Guidelines, if the deliberate transfer of a drug resistance trait to microorganisms could compromise the use of the drug to control disease in humans, veterinary medicine, or agriculture the experiment must be reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the medicated feed mill licensing applications.
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