Department of Health and Human Services June 2020 – Federal Register Recent Federal Regulation Documents
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Determination That DEXTROSE IN PLASTIC CONTAINER (Dextrose) Injectable, 30 Grams/100 Milliliters, 40 Grams/100 Milliliters, 60 Grams/100 Milliliters, and 70 Grams/100 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that DEXTROSE IN PLASTIC CONTAINER (dextrose) injectable, 30 grams (g)/100 milliliters (mL), 40 g/100 mL, 60 g/100 mL, and 70 g/100 mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dextrose injectable, 30 g/100 mL, 40 g/100 mL, 60 g/100 mL, and 70 g/100 mL, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; National Beneficiary Survey of State Health Insurance Assistance Program (SHIP) OMB# 0985-0057
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the Proposed Revision and solicits comments on the information collection requirements related to the National Beneficiary Survey of State Health Insurance Assistance Program (SHIP) OMB# 0985-0057.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; SHIP-SMP Survey of Group Outreach and Education Events, Formerly the “Senior Medicare Program National Beneficiary Survey”, OMB #0985-0056
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the Proposed Revision and solicits comments on the information collection requirements related to the ``National SHIP- SMP Beneficiary Survey of Group Outreach and Education Events''.
Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of Participants of an Annual SMP/SHIP National Training Conference Hosted by the Office of Healthcare Information and Counseling [OMB #0985-New]
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to Proposed new information collection requirements related to Evaluation of participants of an Annual SMP/SHIP National Training Conference hosted by the Office of Healthcare Information and Counseling.
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: ``Patient-Centered Outcomes Research Clinical Decision Support: Current State and Future Directions.'' This proposed information collection was previously published in the Federal Register on March 25, 2020. AHRQ received no comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Proposed Information Collection Activity; 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.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
National Healthcare Preparedness Programs (NHPP); Single Source Cooperative Agreement to the American Red Cross
The National Healthcare Preparedness Programs (NHPP) Branch of the Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services intends to provide a Single Source Cooperative Agreement to the American Red Cross. The Cooperative Agreement will support the stability of the American Red Cross blood operations and humanitarian services during the COVID-19 pandemic. The total proposed cost of the Single Source Cooperative Agreement is not to exceed $118,000,000 for a total of 12 months.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Operational Readiness Review (ORR) 2.0. The Operational Readiness Review is a rigorous, evidence- based assessment used to evaluate PHEP recipients' planning and operational functions.
Submission for OMB Review; National Child Abuse and Neglect Data System (OMB #0970-0424)
The Administration for Children and Families (ACF) in the U.S. Department of Health and Human Services (HHS) is requesting a 3-year extension of the National Child Abuse and Neglect Data System (NCANDS) collection (OMB #0970-0424, expiration 02/28/2021). There are no changes requested to this data collection.
Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 12, 2019. The document announced the withdrawal of approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The document erroneously included ANDA 077736 for Polyethylene Glycol 3350 Powder for Oral Solution, 17 grams/scoopful, held by Breckenridge Pharmaceutical, Inc. (Breckenridge). This document corrects that error.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Notice of a Supplemental Award to Education Development Center for the Home Visiting Collaborative Improvement and Innovation Network 2.0 Cooperative Agreement
HRSA announces the award of a supplemental award of approximately $330,000 per year to the Education Development Center (EDC) for the Home Visiting Collaborative Improvement and Innovation Network 2.0 (HV CoIIN 2.0) for fiscal years (FY) 2020, 2021 and 2022. The supplement will allow the recipient to build a continuous quality improvement (CQI) health equity framework for the Maternal, Infant and Early Childhood Home Visiting Program (MIECHV).
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Fenoterol and Certain Fenoterol Analogues for the Treatment of Cancer
The National Institute on Aging, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Paz Pharmaceuticals, LLC of the State of Delaware.
Prospective Grant of an Exclusive Patent License: Ointment for the Topical Administration to Ischemic Treat and/or Neuropathic Ulcers in Humans
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Emmaus Medical Inc. located in 21250 Hawthorne Boulevard, Suite 800, Torrance, CA, 90503.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
In accordance with the Federal Advisory Committee Act, the CDC announces the following virtual meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This meeting is open to the public, limited only by the availability of telephone ports and webinar capacity. Time will be available for public comment. If you wish to attend by webcast or teleconference, please register at the NIOSH website https:// www.cdc.gov/niosh/bsc/ or call (404-498-2581) at least five business days in advance of the meeting.
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.
Indian Health; Removal of Suspended Regulations
The Indian Health Service (IHS) of the Department of Health and Human Services (HHS or ``the Department'') is issuing this notice of proposed rulemaking (NPRM) proposing the removal of regulations appearing in the Code of Federal Regulations. These regulations have never been implemented and were referred to as ``suspended'' in a 1999 Federal Register Notice.
Hazardous Drugs: Draft NIOSH List of Hazardous Drugs in Healthcare Settings, 2020; Procedures; and Risk Management Information; Extension of Comment Period
On May 1, 2020, the National Institute for Occupational Safety and Health (NIOSH), within the Center for Disease Control and Prevention (CDC), opened a docket to obtain public input on the following draft documents: (1) NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures); (2) NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 (List), and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. Comments were to be received by June 30, 2020. NIOSH is extending the comment period to close on July 30, 2020, to allow stakeholders and other interested parties additional time to respond.
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