Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has 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.
Announcement of Requirements and Registration for the Predict the Influenza Season Challenge
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Predict the Influenza Season Challenge. Each year annual epidemics of influenza occur in the United States. However, variations in the timing and intensity of the season occur each year. Early insights into the timing of the beginning, the peak, and the intensity of the influenza season would be very useful in planning vaccination campaigns, targeting resources and therefore reducing costs associated with influenza prevention and control, and communicating prevention messages to the public. Mathematical and statistical models can be useful in predicting the timing and impact of the influenza season, but no models published to date have successfully predicted key influenza season milestones with sufficient accuracy. The Influenza Division, National Center for Immunization and Respiratory Diseases, CDC would like to invest in innovation through the research and development of mathematical and statistical models that use digital surveillance data (e.g. Twitter, internet search data, web surveys, etc.) to predict the timing, peak, and intensity of the upcoming influenza season. By hosting this challenge, the Influenza Division is able to garner the technical innovation required to accurately forecast the influenza season for less resources than would be required through more traditional mechanisms. Furthermore, this challenge will allow the Influenza Division to foster competition and receive and evaluate multiple influenza season forecasts from a number of scientists using a variety of different methodologies, which would not be possible if a single entity were funded. Accurate influenza forecasts have the potential to reduce long-term costs by more efficiently utilizing resources that are available to track influenza and implement control measures during the influenza season. The challenge could be solved by applying any mathematical, statistical, or other approach to predictive modeling. This challenge will provide the Influenza Division with methods that advance the science of prediction modeling, enhance the understanding of influenza modeling and the use of digital data for influenza surveillance, and improve the implementation of prevention and control measures for seasonal influenza. The historical national surveillance data that could be used to enable training and correlation model development by competitors are available at http://gis.cdc.gov/grasp/fluview/fluportaldashboard.html and are updated every Friday at noon. The competitors' predictions and methodology describing their models will comprise their initial challenge entry. Eight subsequent bi-weekly submissions of predictions based on the submitted methodology are also required. Predictions must be national in scope but may also include HHS region predictions; all predictions must be scaled to ILINet. Competitors' models will be evaluated based on the methodology and how well the predictions match the 2013-14 influenza season as measured by the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet: http:// www.cdc.gov/flu/weekly/overview.htm#Outpatient). The competition will award a $75,000 prize and singular recognition to the person or team that most closely predicts the influenza season.
Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products'' dated November 2013. The guidance document provides sponsors and individuals that design and implement preclinical studies with recommendations on the substance and scope of preclinical information needed to support clinical trials for investigational products reviewed by the Office of Cellular, Tissue and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, xenotransplantation, and certain biologic-device combination products, which OCTGT reviews. The guidance clarifies current expectations regarding the preclinical information that would support an investigational new drug application (IND) and a biologics license application (BLA) for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2012, and supersedes the recommendations in Section VIII in the guidance entitled ``Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy'' dated March 1998.
Prospective Grant of Exclusive License: Development of Chitosan/IL-12 Conjugate as Immunotherapeutic Products for Human Cancers
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Scion Cardio-vascular (``Scion'') located in Miami, FL, USA.
Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only.'' This guidance document is intended for manufacturers and distributors of ``for research use only'' (RUO) and ``for investigational use only'' (IUO) in vitro diagnostic (IVD) products and any other entities who label IVD products, as well as FDA staff.
Medical Gas Regulation Review; Announcement of Public Meeting; Correction
The Food and Drug Administration is correcting a document that appeared in the Federal Register of November 1, 2013 (78 FR 65588). The document announced a public meeting entitled ``Medical Gas Regulation Review.'' The document was published with an incorrect Web site. This document corrects that error.