Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hydroxy Analogue
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of selenomethionine hydroxy analogue as a source of selenium in feed for beef and dairy cattle. This action is in response to a food additive petition filed by Adisseo France S.A.S.
Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of guanidinoacetic acid as a precursor of creatine in poultry feeds. This action is in response to a food additive petition filed by Alzchem Trostberg GmbH.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
On Friday, July 9, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice entitled, ``Agency Information Collection Activities: Submission for OMB Review; Comment Request.'' That notice invited public comments on three separate information collection requests specific to document identifiers: CMS-10215, CMS- 10249, and CMS-10341. Through the publication of this document, we are withdrawing the portion of the notice requesting public comment on the information collection request titled ``Section 1115 Demonstration Projects Regulations at 42 CFR 431.408, 431.412, 431.420, 431.424, and 431.428.'' Form number CMS-10341 (OMB control number 0938-1162). The withdrawn information collection request will be replaced by another 30-day notice in July or August of this year.
Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of final guidance for industry (GFI) #261 entitled ``Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.'' This guidance is intended for sponsors and potential sponsors who may be interested in pursuing conditional approval of new animal drugs for certain major uses in major species. Eligibility for conditional approval has been expanded beyond minor uses in major species and use in minor species (MUMS) to include certain major uses in major species. The Center for Veterinary Medicine (CVM or we) refers to the process for conditionally approving new animal drugs that are not intended for MUMS indications as ``expanded conditional approval.'' The purpose of expanded conditional approval is to incentivize development of new animal drugs for serious or life-threatening conditions or unmet animal or human health needs under circumstances where a demonstration of effectiveness would require a complex or particularly difficult study or studies. This guidance defines certain terms, clarifies the eligibility criteria for expanded conditional approval, and describes the criteria CVM intends to consider when determining expanded conditional approval eligibility.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Conference Attendees' Observations About Prescription Drug Promotion
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.
Determination That STROMECTOL (Ivermectin) Tablets, 6 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that STROMECTOL (ivermectin) tablets, 6 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for STROMECTOL (ivermectin) tablets, 6 mg, if all other legal and regulatory requirements are met.
Approaches to Effective Therapeutic Management of Pain for People With Sickle Cell Disease
This NCCIH/NHLBI-led Trans-NIH workshop on Sickle Cell Disease Pain aims to explore critical gaps and research challenges, as well as to brainstorm potential solutions for this understudied pain condition in a highly underserved population. This fits into the NIH mission of seeking fundamental knowledge to enhance health.