Department of Health and Human Services August 29, 2018 – Federal Register Recent Federal Regulation Documents
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DHL Laboratories Inc.; Proposal To Withdraw Approval of a New Drug Application for Dextrose 5% Injection in Plastic Container; Opportunity for a Hearing
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of a new drug application (NDA) for Dextrose 5% Injection in Plastic Container, 5 grams (g)/100 milliliters (mL), held by DHL Laboratories Inc., 155 Medical Science Dr., Union, SC 23979, and is announcing an opportunity for the holder of the NDA to request a hearing on this proposal. The basis for the proposal is that the holder of the NDA has repeatedly failed to file required annual reports for the NDA.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Epidemiologic Study of Health Effects Associated With Low Pressure Events in Drinking Water Distribution Systems.
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