Department of Health and Human Services August 31, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Submission for OMB Review; Temporary Assistance for Needy Families (TANF) Data Reporting for Work Participation (OMB #0970-0338)
The Administration for Children and Families (ACF) is requesting a 3-year extension of the Temporary Assistance for Needy Families (TANF) Data Reporting for Work Participation (formerly titled the Deficit Reduction Act of 2005 TANF Final Rule; OMB #0970-0338). Information collections include the TANF data verification procedures, the TANF Data Report, the Separate State Program (SSP)Maintenance of Effort (MOE) Data Report, the Caseload Reduction Documentation Process, and the Reasonable Cause/Corrective Compliance Documentation Process. We are proposing to continue these information collections without change.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.'' The FDA encourages the collection, analysis, and integration of patient perspectives in the development, evaluation, and surveillance of medical devices, including digital health technologies. Patient-reported outcome (PRO) instruments facilitate the systematic collection of patient perspectives as scientific evidence to support the regulatory and healthcare decision-making process. This draft guidance describes principles that should be considered when using PRO instruments in the evaluation of medical devices and provides recommendations about the importance of ensuring the measures are ``fit-for-purpose.'' This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Identifying and Testing Strategies for Management of Opioid Use and Misuse in Older Adults in Primary Care Practices.'' This proposed information collection was previously published in the Federal Register on June 8, 202020 and allowed 60 days for public comment. No comments were received by AHRQ. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; ELZONRIS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELZONRIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Submission for OMB Review; Cost Study of Trauma-Specific Evidence-Based Programs Used in the Regional Partnership Grants Program (New Collection)
The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new descriptive studythe Cost Study of Trauma-Specific Evidence-Based Programs used in the Regional Partnership Grants (RPG) Program.
Determination of Regulatory Review Period for Purposes of Patent Extension; POTELIGEO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for POTELIGEO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Medicare Program; FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements; Correcting Amendment
In the August 6, 2015 issue of the Federal Register, we published a final rule that provided hospice quality reporting program updates, including finalizing the proposal to codify the Hospice Quality Reporting Program Submission Extension and Exemption Requirements. The effective date of the final rule was October 1, 2015. This correcting amendment corrects an omission identified in the August 6, 2015 final rule.
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