Justification of a Single Source Cooperative Agreement Award for the World Health Organization
The U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR) intends to fund an unsolicited proposal submitted by the World Health Organization (WHO) to support work towards establishing a regulatory pathway at WHO for prequalification of medical countermeasures to be deployed internationally in an emergency, which includes supporting WHO and potential recipient countries to build regulatory capacity for the import, registration, and emergency use of medical countermeasures. The goals of this Cooperative Agreement are to: (1) Using smallpox vaccines as a case study, complete product review and prequalification of smallpox vaccines included in or pledged to the WHO Smallpox Vaccine Emergency Stockpile for emergency use; (2) Establish general regulatory pathways for emergency use authorization and/or a process for emergency prequalification of emergency medical countermeasures and; (3) Support potential recipient WHO member states in building capacities for the import, registration, and emergency use of medical countermeasures. This Cooperative Agreement directly supports several federal initiatives focused on strengthening national and international health security, including HHS's ongoing work within the Global Health Security Initiative (GHSI) to develop an operational framework for the international deployment of medical countermeasures which contemplates the legal, regulatory, and logistical issues to be considered during such a deployment as noted in the 2013 GHSI Ministerial communique.\1\ Additionally, it supports Objective 9 of the Global Health Security Agenda \2\ which calls for improving global access to medical and non- medical countermeasures during health emergencies and the improvement of international deployment capabilities. It also aligns with the HHS Global Health Strategy priority to ``develop policy frameworks, agreements and operational plans to facilitate HHS decision-making in response to both single and multiple international requests for emergency assistance, including for the deployment of medical countermeasures and HHS personnel.'' \3\
Performance Review Board Members
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2014.
Custom Device Exemption; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Custom Device Exemption.'' FDA has developed this document to provide guidance to industry and FDA staff about implementation of the custom device exemption contained in the Food, Drug, and Cosmetic Act (the FD&C Act). The intent of this guidance is to define terms used in the custom device exemption, explain how to interpret the ``five units per year of a particular device type'' language contained in the FD&C Act, describe information that FDA proposes manufacturers should submit in the custom device annual report, and provide recommendations on how to submit an annual report for devices distributed under the custom device exemption.
Announcement of Requirements and Registration for the 2014 Food and Drug Administration Food Safety Challenge
The Food and Drug Administration (FDA) is announcing the 2014 FDA Food Safety Challenge, a prize competition under the America COMPETES Reauthorization Act of 2010. The 2014 FDA Food Safety Challenge is an effort to advance breakthroughs in foodborne pathogen detection, specifically with the goal of accelerating the detection of Salmonella in fresh produce. As FDA's food safety program incorporates preventive control measures through the implementation of the FDA Food Safety Modernization Act, quicker detection of these harmful bacteria will help to prevent foodborne illnesses.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL52); Draft Guidance for Industry on Bioequivalence: Blood Level Bioequivalence Study; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI 224) entitled ``Draft Guidance for Industry, Bioequivalence: Blood Level Bioequivalence Study'' (VICH GL52). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to harmonize the data recommendations associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products.