Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement with change of a previously-approved information collection assigned OMB control number 0990-0324, which expired on 03/31/2011. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Vaccines and Related Biological Products Advisory Committee; Cancellation
The meeting of the Vaccines and Related Biological Products Advisory Committee scheduled for November 16, 2016, is cancelled. This meeting was announced in the Federal Register of August 30, 2016 (81 FR 59634).
Possession, Use, and Transfer of Select Agents and Toxins-Addition of Bacillus Cereus Biovar Anthracis to the HHS List of Select Agents and Toxins
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is adding Bacillus cereus Biovar anthracis to the list of HHS select agents and toxins as a Tier 1 select agent. We are taking this action to regulate this agent that is similar to B. anthracis to prevent its misuse, which could cause a biological threat to public health and/or national security.
New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a 3-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for production indications in swine and to reflect the reformulation of the Type A medicated article as a 2- way, fixed-ratio, combination drug product without penicillin.
Withdrawal of Approval of Part of a New Animal Drug Application; Chlortetracycline, Procaine Penicillin, and Sulfamethazine
The Food and Drug Administration (FDA) is withdrawing approval of those parts of a new animal drug application (NADA) for a 3-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for production indications in swine. This action is being taken at the sponsor's request because the 3-way Type A medicated article is no longer manufactured.
The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Establishing Appropriate Durations of Therapeutic Administration; Request for Comments
The Food and Drug Administration (FDA, the Agency, we) is soliciting comments regarding the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine (i.e., medically important antimicrobial drugs) when they are administered in the feed or water of food-producing animals for therapeutic purposes. This activity is consistent with previous efforts by FDA to protect public health by promoting the judicious use of these drugs in food-producing animals.