Department of Health and Human Services October 2019 – Federal Register Recent Federal Regulation Documents

Results 251 - 261 of 261
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry; Availability
Document Number: 2019-21228
Type: Notice
Date: 2019-10-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry.'' The guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. The recommendations in the guidance apply to all platelet products stored at room temperature in plasma or additive solutions, including platelets manufactured by automated methods (apheresis platelets), and Whole Blood derived (WBD) single and pooled (pre-storage and post-storage) platelets. Additionally, the guidance provides licensed blood establishments with recommendations on how to report implementation of manufacturing and labeling changes. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2018.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2019-21255
Type: Notice
Date: 2019-10-01
Agency: Department of Health and Human Services
Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: https://www.dhhs.gov/ohrp/sachrp- committee/meetings/.
Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-21248
Type: Notice
Date: 2019-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on scientific issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-21239
Type: Notice
Date: 2019-10-01
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: ``Embedded Research in Care Delivery Systems.'' In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 29, 2019 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Patient-Focused Drug Development: Methods To Identify What Is Important to Patients; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
Document Number: 2019-21226
Type: Notice
Date: 2019-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, FDA staff, and other stakeholders entitled ``Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.'' This guidance (Guidance 2) is the second in a series of four methodological guidance documents that FDA committed to develop to describe how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision-making.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2019-21224
Type: Notice
Date: 2019-10-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-21223
Type: Notice
Date: 2019-10-01
Agency: Department of Health and Human Services, National Institutes of Health
Determination That KENALOG (Triamcinolone Acetonide) Ointment, 0.025% and 0.1%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-21201
Type: Notice
Date: 2019-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were 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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2019-21176
Type: Notice
Date: 2019-10-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https://www.samhsa.gov/workplace.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-21167
Type: Notice
Date: 2019-10-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Evonik Corp.; Filing of Food Additive Petition (Animal Use)
Document Number: 2019-20958
Type: Proposed Rule
Date: 2019-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that Evonik Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of silicon dioxide as an anticaking agent, grinding aid, antifoaming agent, or carrier in animal feed components (ingredients, intermediate premixes, premixes, supplements, or concentrates).
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