Department of Health and Human Services August 17, 2023 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
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.
Optimizing the Use of Postapproval Pregnancy Safety Studies; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Optimizing the Use of Postapproval Pregnancy Safety Studies'' convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis. This workshop will include discussions of designs of postapproval pregnancy safety studies for drug and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and experiences with implementing these studies. The workshop also will include discussion of considerations for further development of a framework that describes how data from different types of postapproval pregnancy safety studies might optimally be used when it has been determined that this data should be collected.
Notice; Licensing and Collaboration Opportunity
The invention listed below is directed to potential peptidyl therapeutics that counteract with amyloid forming IAPP and amyloid- [beta] in treatments of diabetes and Alzheimer's disease and serve as blood-based biomarkers for Alzheimer's disease. This technology was discovered and is being developed by the National Institute on Aging (NIA). The NIA is currently seeking a licensee and/or collaborator to further develop this technology.
Collaboration Opportunity To Develop a Vaccine Against Nicotine or Arecoline
The Cancer Prevention Program of the National Cancer Institute (NCI) is seeking a partner in the private sector to develop a vaccine directed against nicotine or a related molecule called arecoline, with the goal of reducing or eliminating the craving of such substance(s) in smokers or betel nut users.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment; Biographical Sketch Form for Use With Applications to the Maternal and Child Health Bureau Research Grants OMB No. 0906-Reinstatement
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.
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