Department of Health and Human Services March 24, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Fiscal Year 2021 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2021 Generic Drug Science and Research Initiatives Workshop.'' The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholdersindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its Fiscal Year (FY) 2022 GDUFA science and research initiatives.
List of Bulk Drug Substances for Which There Is a Clinical Need Under the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies one bulk drug substance that FDA has considered and proposes to include on the 503B Bulks List: Quinacrine hydrochloride (``quinacrine''). This notice identifies four bulk drug substances that FDA has considered and proposes not to include on the list: Bromfenac sodium, mitomycin-C, nepafenac, and hydroxychloroquine sulfate. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and may be the subject of future notices.
Determination That Folic Acid, Oral Tablets, 1 Milligram, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled ``The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; Request for Comments'' that appeared in the Federal Register of October 28, 2020. The Agency is taking this action to allow interested persons additional time to submit comments.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved from October 1, 2018, through December 31, 2020. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.
Submission for OMB Review; Child Care and Development Fund (CCDF) ACF-696T Financial Report (OMB #0970-0195)
The Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF-696T: Child Care and Development Fund Annual Financial Report. This form is currently approved under the ACF Generic Clearance for Financial Reports (OMB #0970-0510; expiration May 31, 2021), and ACF is proposing to reinstate the previous OMB number under which this form had been approved. There are no changes requested to the form.
Submission for OMB Review; Child Care and Development Fund (CCDF) ACF-696 Financial Report (OMB #0970-0163)
The Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF-696: Child Care and Development Fund (CCDF) Quarterly Financial Report. This form is currently approved under the ACF Generic Clearance for Financial Reports (OMB #0970-0510; expiration May 31, 2021), and ACF is proposing to reinstate the previous OMB number under which this form had been approved. There are no changes requested to the form.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
