Department of Health and Human Services June 6, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 27 of 27
Submission for OMB Review; 30-Day Comment Request; Office of Minority Health Research Coordination (OMHRC) Research Training and Mentor Programs Applications (National Institute of Diabetes and Digestive and Kidney Diseases)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that VYJUVEK (beremagene geperpavec-svdt), manufactured by Krystal Biotech, Inc., meets the criteria for a priority review voucher.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Vintage Pharmaceuticals; Withdrawal of Approval of Abbreviated New Drug Application for Pemoline Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 075328 for pemoline tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811 (Vintage). Vintage requested that approval of this application be withdrawn and has waived its opportunity for a hearing.
Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on July 19, 2013. The document announced the withdrawal of approval of 52 new drug applications (NDAs) and 77 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of August 19, 2013. The document erroneously included the withdrawal of ANDA 075328 for Pemoline tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811. This notice corrects that error.
Proposed Information Collection Activity; Replication of Recovery and Reunification Interventions for Families-Impact Study (New Collection)
The Administration for Children and Families (ACF) is proposing a data collection activity as part of the Replication of Recovery and Reunification Interventions for Families-Impact Study (R3- Impact). The R3-Impact Study aims to satisfy the legislative requirements called for by the 2018 SUPPORT for Patients and Communities Act by replicating and testing the efficacy of two recovery coaching interventions for families engaged in the child welfare system due to parental substance use disorders.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Cover Letter Attachments for Controlled Correspondence and Abbreviated New Drug Application Submissions; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.'' This guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence, original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA. This guidance finalizes the draft guidance of the same title issued on December 13, 2021.
Notice of Purchased/Referred Care Delivery Area Redesignation for the Hoh Indian Tribe in the State of Washington
Notice is hereby given that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Hoh Indian Tribe in the State of Washington to include the county of Clallam in the State of Washington. The final PRCDA for the Hoh Indian Tribe is now the Washington counties of Jefferson and Clallam. The sole purpose of this expansion is to authorize additional Hoh Indian Tribe members and beneficiaries to receive Purchased/Referred Care (PRC) services.
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