Latest Federal Register Notices

BIOLOGICS

Guidance on Reducing Creutzfeldt-Jakob Disease
Federal Register Notice: FDA is making available a guidance entitled Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry. It provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive recommendations intended to minimize the possible risk of transmission of the diseases from blood and blood products. The guidance amends a guidance of the same name dated 5/2010 by finalizing and incorporating the recommendations from the draft document entitled Draft Guidance for Industry: Amendment to 'Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products dated 6/2012. To download the guidance, click here. To view this notice, click here.

Vaccines Panel Renewed
Federal Register Notice: The FDA commissioner is renewing the Vaccines and Related Biological Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 12/31/17. To view this notice, click here.

DEVICES

Comments Sought on Humanitarian Device Info
Federal Register Notice: FDA is seeking public comment on the information to accompany humanitarian device exemption (HDE) applications and the collection of information on the annual distribution number. Comments should be submitted by 3/15. To view this notice, click here.

HUMAN DRUGS

Workshop on Next Generation Sequencing Oncology Panels
Federal Register Notice: FDA will hold a public workshop 2/25 entitled “Next Generation Sequencing-Based Oncology Panels.” Its purpose is to obtain feedback on analytical and clinical validation approaches for next generation sequencing (NGS)-based oncology panels. Comments and suggestions generated through this workshop will help guide the development of appropriate regulatory standards for evaluation of NGS-based oncology panels in cancer patient management. The workshop will be held from 8:30 a.m. to 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 B and C (the Great Room), Silver Spring, MD. Contact Jennifer Dickey, (301) 796-5028, Jennifer.Dickey@fda.hhs.gov. To view this notice, click here.

Workshop on Engaging CDER
Federal Register Notice: CDER is sponsoring a public workshop 3/31 entitled “Navigating CDER: What You Should Know for Effective Engagement.” It aims to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER. The workshop will be held from 8:30 a.m. to 5 p.m. at FDA’s White Oak campus, 10903 New Hampshire Ave., Building 31 (The Great Room A, B, and C), Silver Spring, MD. Contact Shawn Brooks, (240) 402-6509, email: NAV-CDER@fda.hhs.gov. To view this notice, click here.

Conference on Evaluating Drug Liver Injuries
Federal Register Notice: FDA will hold a public conference 3/23-24 entitled “How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?” This conference will be co-sponsored with the Critical Path Institute and will discuss, debate, and share views among stakeholders. It will be held 3/23, from 8 a.m. to 6 p.m., and 3/24, from 8 a.m. to 4 p.m. at the College Park Marriott Hotel & Conference Center, 3501 University Blvd., East Hyattsville, MD. Contact Lana L. Pauls, (301) 796-0518, lana.pauls@fda.hhs.gov. To view this notice, click here.

TOBACCO

Comments Sought on Tobacco Restrictions
Federal Register Notice: FDA is seeking public comment on regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. Comments should be submitted by 3/14. To view this notice, click here.

GENERAL

Docket Established on Clinical Outcomes Pilot
Federal Register Notice: FDA is establishing a docket to receive suggestions, recommendations, and comments from interested parties (including academic institutions, regulated industry, and patient groups) on its pilot “Clinical Outcome Assessment Compendium” (COA). Comments received on the pilot during its pilot phase will help FDA determine its utility, and may assist FDA in developing future iterations of the COA Compendium and identifying best methods for conveying COA Compendium information on FDA's Web site. Comments should be submitted by 3/14. To view this notice, click here.

Public Workshop on Genetic Test Results
Federal Register Notice: FDA will hold a public workshop 3/2: “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.” Its purpose is to understand patient and provider perspectives on receiving potentially medically relevant genetic test results. The topic(s) to be discussed will focus on better defining the specific information patients and providers prefer to receive, with an emphasis on the type(s) and amount of evidence available to interpret the results for medical purposes, how those results should be returned, and what information is needed to understand the results in the event that they could effectively aid in medical decision making. The workshop will be held from 8 a.m. to 4 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact Cara Tenenbaum, (301) 796-8456, cara.tenenbaum@fda.hhs.gov. To view this notice, click here.