Department of Health and Human Services December 4, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Secondary Direct Food Additives Permitted in Food for Human Consumption; Sodium Dodecylbenzenesulfonate
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of sodium dodecylbenzenesulfonate (CAS No. 25155-30-0) as an antimicrobial agent for use in wash water for fruits and vegetables without the requirement of a potable water rinse. This action is in response to a petition filed by Ecolab, Inc.
DSM Nutritional Products; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA) is announcing that DSM Nutritional Products has filed a petition proposing that the food additive regulations be amended to provide for the safe use of benzoic acid as a feed acidifier in swine feed.
Artificially Sweetened Fruit Jelly and Artificially Sweetened Fruit Preserves and Jams; Proposed Revocation of Standards of Identity
The Food and Drug Administration (FDA or we) is proposing to revoke the standards of identity for artificially sweetened jelly, preserves, and jams. We are taking this action primarily in response to a citizen petition submitted by the International Jelly and Preserve Association (IJPA). We are taking this action because we tentatively conclude that these standards are both obsolete and unnecessary in light of our regulations for foods named by use of a nutrient content claim and a standardized term. We also tentatively conclude that this action will promote honesty and fair dealing in the interest of consumers.
Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Request for Comments; Correction
The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of November 21, 2012 (77 FR 69863). The document announced a public hearing entitled ``Antiseptic Patient Preoperative Skin Preparation Products.'' The document was published with an incorrect email address. This document corrects that error. Due to this error, FDA is extending the Requests for Oral Presentations registration date from November 27, 2012, to December 7, 2012.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Device Good Manufacturing Practice Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.'' The guidance is intended to assist manufacturers of PET drugs in submitting investigational new drug applications (INDs).
Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``FDA Oversight of PET Drug ProductsQuestions and Answers.'' This guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees.
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review
The Department of Health and Human Services is correcting a final rule that appeared in the Federal Register on October 5, 2012 (77 FR 61084). The document updated the list of HHS and overlap biological agents and toxins and designated certain select agents and toxins as Tier 1 agents.
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