Department of Health and Human Services April 27, 2021 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Application by Association of Diabetes Care and Education Specialists (ADCES) for Continued CMS Approval of Its Diabetes Outpatient Self-Management Training Program
This proposed notice acknowledges the receipt of an application from the Association of Diabetes Care and Education Specialists for continued recognition as a national accrediting organization (AO) for accrediting entities that wish to furnish diabetes outpatient self-management training services to Medicare beneficiaries.
Medicare Program; Application by American Diabetes Association (ADA) for Continued CMS Approval of Its Diabetes Outpatient Self-Management Training Program
This proposed notice acknowledges the receipt of an application from the American Diabetes Association (ADA) for continued recognition as a national accrediting organization (AO) for accrediting entities that wish to furnish diabetes outpatient self-management training services to Medicare beneficiaries.
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.
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases; Draft Guidance for Sponsor-Investigators; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases.'' FDA is publishing this draft guidance to help sponsor-investigators (hereafter referred to as sponsors) with developing the nonclinical information that FDA recommends to support an investigational new drug application (IND) for certain individualized antisense oligonucleotide (ASO) drug products. ASO drug products that are the focus of this draft guidance are those being developed to treat rapidly progressing, severely debilitating or life-threatening (SDLT) disease attributable to a unique genetic variant or variants that may be amenable to RNA- directed treatment.
Request for Information (RFI): Developing the National Public Health Strategy for the Prevention and Control of Vector-Borne Diseases in Humans
The development of a national strategy on vector-borne diseases including tickborne diseases was mandated by Congress. To inform development of the national strategy to address vector-borne diseases, HHS is issuing this Request for Information (RFI). The RFI solicits specific input regarding strategic goals, benchmarks, gaps, duplicative federally funded programs, and opportunities to enhance coordination data collection, research, and the development of diagnostics, treatments, vaccines and other related activities across HHS and other federal departments. The set of questions is available in the SUPPLEMENTARY INFORMATION section below.
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