💼Proposed Data Collection on HIV Testing by CDC
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The Greater Access and Impact with NAT (GAIN) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point- of-Care Nucleic Acid Tests (NATs). This study will identify facilitators and barriers with implementation of HIV point-of-care (POC) nucleic acid tests (NATs) in clinical settings, estimate the sensitivity and specificity of the HIV POC NAT, and assess the impact of the test in decreased time to receipt of HIV prevention and care.
Learn More🩺FDA Draft Guidance on Developing Drugs for Optical Imaging
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing Drugs for Optical Imaging." The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that support development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for the detection of pathology such as tumors or to enhance the conspicuity of normal anatomical structures.
Learn More🏥CDC Proposes Data Collection on Antimicrobial Resistance Efforts
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Combating Antimicrobial Resistant Gonorrhea and Other STIs (CARGOS). CARGOS is a comprehensive strategy designed to streamline and improve the coordination of Antimicrobial Resistance (AR) surveillance and preparedness and response activities focused on Neisseria gonorrhoeae (GC) and expand capacity to include other STIs with emerging AR in the United States.
Learn More🏥Proposed Data Collection Notice by CDC on Cancer Registry
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Program of Cancer Registries Cancer Surveillance System. This information collection creates a Cancer Registry that provides useful data on cancer incidence, trends, and outcomes.
Learn More🩺CDC's Road Map for Accelerated HCV Diagnosis
The Centers for Disease Control and Prevention (CDC) announces a two-day convening hosted and facilitated by the Association of Public Health Laboratories (APHL) to discuss hepatitis C diagnostics. Leaders from public health, laboratory, medical, academic, and industry sectors will have the opportunity to provide individual input, without building a consensus, on accelerating the diagnosis of current hepatitis C virus (HCV) infection. Members of the public with interest and expertise in diagnosing HCV infection are also invited to provide individual input. Specifically, the convening will focus on how to leverage the following hepatitis C diagnostic methods: same-day diagnosis and treatment, and viral-first testing. The goal of the convening will be for each person to give their individual input, and not to build consensus. No discussions, recommendations, or advice to CDC will occur or be provided at the meeting. Day 1 will focus on the utility of point-of- care (POC) testing for accelerating same-day HCV diagnosis and rapid treatment i.nitiation. Day 2 will focus on the utility of viral-first testing strategies for accelerating HCV diagnosis and treatment initiation in the United States. Following the meeting, APHL will prepare a meeting report summarizing the discussion and public comment received through regulations.gov, developed and documented as individual input to ensure thorough and complete input from partners. CDC and APHL will disseminate the APHL-prepared report as a reference for partners and industry to follow in developing and implementing future hepatitis C testing strategies. The final report will be added to docket CDC-2025-0002 once it is available.
Learn More🧬FDA Guidance on Tissue Biopsies in Clinical Trials for Businesses
The Food and Drug Administration (FDA or Agency) and the Office for Human Research Protections (OHRP) are announcing the availability of a draft guidance for industry, clinical investigators, institutions, and institutional review boards (IRBs) entitled "Considerations for Including Tissue Biopsies in Clinical Trials." This guidance provides recommendations regarding considerations for tissue biopsies that may be conducted in adults and in children as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services (HHS).
Learn More🏛️Request for Nominations for Medicare Payment Advisory Commission (MedPAC)
The Balanced Budget Act of 1997 established the Medicare Payment Advisory Commission (MedPAC) and gave the Comptroller General of the United States responsibility for appointing its members. The Government Accountability Office (GAO) is now accepting nominations for MedPAC appointments that will be effective in May 2025. Nominations should be sent to the email address listed below. Acknowledgement of receipt will be provided within a week of submission.
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