Department of Health and Human Services July 7, 2020 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Sickle Cell Disease Treatment Demonstration Regional Collaborative Program, OMB No. 0906-xxxx-New
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention to Participate
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholdersincluding patient and consumer advocacy groups, healthcare professionals, and scientific and academic expertsnotify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Notice of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Change in Information Contact, Removal of Chloroquine Phosphate and Hydroxychloroquine HCl; Correction
This document updates the March 30, 2020, Federal Register Notice entitled ``Notice of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures,'' by replacing the named contact and updating the ``Notice of Designation of Scarce Materials or Threatened Materials'' section.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Data to Support Cross-Center Collaboration for Social Behavioral Sciences Associated With Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of Food and Drug Administration Regulated Products
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a new collection of information to collect entitled ``Generic Clearance for Data to Support Cross-Center Collaboration for Social Behavioral Sciences Associated with Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of FDA Regulated Products.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health Care Providers' Understanding of Opioid Analgesic Abuse Deterrent Formulations
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 (PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials.''
Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.7 Implementation Guide 3.3 and for Define-Extensible Markup Language Version 2.1; Requirement Ends for Study Data Tabulation Model Version 1.3 Implementation Guide 3.1.3
The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the dates that support and requirement will begin for version 1.7 of the Clinical Data Interchange Standards Consortium (CDISC) for Study Data Tabulation Model (SDTM) Implementation Guide (IG) 3.3, as well as for version 2.1 of the Define-Extensible Markup Language (Define-XML). CBER and CDER are also announcing the date that support and requirement will end for version 1.3 of the CDISC SDTM IG 3.1.3. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes.
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