Department of Health and Human Services June 24, 2020 – Federal Register Recent Federal Regulation Documents

Determination That TENEX (Guanfacine Hydrochloride) Tablets, 1 Milligram, 2 Milligrams, and 3 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2020-13594
Type: Notice
Date: 2020-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that TENEX (guanfacine hydrochloride) tablets, 1 milligram (mg), 2 mg, and 3 mg, was not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
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30 Grams/100 Milliliters, 40 Grams/100 Milliliters, 60 Grams/100 Milliliters, and 70 Grams/100 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2020-13593
Type: Notice
Date: 2020-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
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CONTAINER (dextrose) injectable, 30 grams (g)/100 milliliters (mL), 40 g/100 mL, 60 g/100 mL, and 70 g/100 mL, were not withdrawn from sale for reasons of safety or effectiveness.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
Document Number: 2020-13578
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services
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
Document Number: 2020-13576
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services
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]
Document Number: 2020-13575
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services
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
Document Number: 2020-13574
Type: Notice
Date: 2020-06-24
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2020-13553
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2020-13552
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-13551
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2020-13550
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-13549
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-13548
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-13547
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-13546
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-13545
Type: Notice
Date: 2020-06-24
Agency: Department of Health and Human Services, National Institutes of Health
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