Department of Health and Human Services April 18, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Aurolife Pharma, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 31 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of December 4, 2018, for the final rule that appeared in the Federal Register of November 1, 2018, and that amended the color additive regulations to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules.
Determination That TRISENOX (Arsenic Trioxide) Injection, 1 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that TRISENOX (arsenic trioxide) injection, 1 milligram (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of abbreviated new animal drug applications.
The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels: Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.'' The draft guidance, when finalized, will provide guidance on the declaration of allulose on Nutrition Facts and Supplement Facts labels as well as on the caloric content of allulose. The draft guidance, when finalized, also would advise manufacturers of our intent to exercise enforcement discretion for the exclusion of allulose from the amount of Total Sugars and Added Sugars declared on the Nutrition Facts and Supplement Facts label and use of a general factor of 0.4 calories per gram (kcal/g) for allulose.
Sunscreen Drug Products for Over-the-Counter Human Use; Correction
The Food and Drug Administration (FDA) is correcting a proposed rule relating to the regulation of over-the-counter (OTC) sunscreen monograph products that appeared in the Federal Register of February 26, 2019. The document was published with formulas that were illegible. These corrections are being made to improve the accuracy of the proposed rule.
Sunscreen Drug Products for Over-the-Counter Human Use; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of February 26, 2019. In the proposed rule, FDA requested comments on its proposals relating to the regulation of over- the-counter (OTC) sunscreen monograph products. These proposals described the conditions under which the Agency proposes that OTC sunscreen monograph products are generally recognized as safe and effective and not misbranded. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
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