Department of Health and Human Services May 22, 2024 – Federal Register Recent Federal Regulation Documents
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Privacy Act of 1974; System of Records; Correction
The Department of Health and Human Services (HHS) published a system of records notice in the Federal Register on May 16, 2024, for new system of records "OCSS Research Platform" maintained by HHS' Administration for Children and Families (ACF), Office of Child Support Services (OCSS). The notice contained an incorrect system number, 09-80-0391; the correct number is 09-80- 0390.
Submission for OMB Review; 30-Day Comment Request; Application and Impact of Clinical Research Training on Healthcare Professionals in Academia and Clinical Research (Office of the Director)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD)
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD)
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Vaccines and Related Biological Products Advisory Committee; Amendment of Notice-Selection of the 2024 to 2025 Formula for COVID-19 Vaccines
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological Products Advisory Committee. This meeting was announced in the Federal Register of March 4, 2024. The amendment is being made to reflect a change in the meeting date in the SUMMARY and DATES portions of the document from May 16, 2024, to June 5, 2024. There are no other changes.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request: National Survey of Organ Donation Attitudes and Practices, OMB No. 0915-0290
In compliance with the Paperwork Reduction Act of 1995, HRSA 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
The Food and Drug Administration (FDA, Agency, or we) 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information concerning class II special controls for an automated blood cell separator device operating by centrifugal or filtration separation principle.
Agency Information Collection Activities; Proposed Collection; Comment Request; Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey
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, including each proposed reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collections associated with the "Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI) B12 Pediatric Device Survey."
Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule entitled "Labeling Requirements for Approved or Conditionally Approved New Animal Drugs" published in the Federal Register of March 12, 2024, by 60 days. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products; Public Workshop
The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products." The purpose of the public workshop is to discuss transplacental transfer of drug and biological products with immunosuppressive properties and the potential clinical impact on the developing fetus and newborn infant, understand the gaps in knowledge, and consider innovative approaches to improve collection of relevant data.
Meeting of the National Advisory Council for Healthcare Research and Quality
This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
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 "Implementation and Testing of Diagnostic Safety Resources." This proposed information collection was previously published in the Federal Register on March 7th, 2024 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Supplemental Evidence and Data Request on Digestible Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Digestible Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Supplemental Evidence and Data Request on Management of Suicidal Thoughts and Behaviors in Youth
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Management of Suicidal Thoughts and Behaviors in Youth, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
National Institutes of Health (NIH) Office of Science Policy (OSP): Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity Through Access Planning
The National Institutes of Health (NIH) is proposing to develop and implement a new policy within its Intramural Research Program (IRP) to promote access to products stemming from taxpayer- funded inventions. NIH seeks input on this draft policy and accompanying draft license agreement language that incorporates patient access in the commercialization process for NIH-owned inventions.
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.
Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee
The Food and Drug Administration (FDA or the Agency) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC or the Committee) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice.
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