Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Request for Information on Psychosocial Predictors of Uptake of Tobacco and Other Products
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is opening a docket to obtain data and information related to psychosocial predictors of uptake and continued use of tobacco products, including specific categories of tobacco products and specific individual tobacco products, as well as other products from which predictors may be adapted for or extrapolated to tobacco products. FDA is seeking data and information in the form of reports and manuscripts that are unpublished or not available through indexed bibliographic databases. The purpose of this request for information (RFI) is to gather additional information that could help identify and evaluate predictors of consumer initiation, uptake, and use of tobacco products. FDA has already searched the publicly available scientific literature and is now seeking to supplement that with information that is not included in the published scientific literature.
Request for Information on NIOSH Center for Direct Reading and Sensor Technologies: Sensors for Emergency Response Activities
The National Institute for Occupational Safety and Health (NIOSH), part of the Centers for Disease Control and Prevention (CDC), requests information to enhance the value of the NIOSH Center for Direct Reading and Sensor Technologies and is seeking input regarding specific issues on the availability, capability, suitability, barriers, limitations, and opportunities for current or future direct reading devices and sensor technologies that can be utilized for emergency response. This RFI is intended to inform the planning of a document to evaluate current and future sensor technologies used in emergency response.
Request for Information on Development of a Performance Test Protocol for Closed System Transfer Devices That Incorporate Air-Cleaning Technology To Provide Worker Protection During Pharmacy Compounding and Administration of Hazardous Drugs
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) requests information for the development of a test protocol to evaluate the performance of closed system drug-transfer devices (CSTDs) that adopt air-cleaning technologies. CSTDs are generally available in two design types: (1) One that uses a physical barrier to block the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway and (2) one that uses air cleaning or filtration technologies to prevent the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway. A draft protocol titled, ``A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs,'' was developed by NIOSH to evaluate how protective the physical barrier-type CSTD devices were as an indicator of how effective they would be at preventing hazardous drug escape from the closed system. This RFI seeks information from the public regarding the feasibility of developing a protocol applicable to CSTDs using air cleaning or filtration technologies and to request information from stakeholders on this topic.
Request for Nominations on the Technical Electronic Product Radiation Safety Standards Committee
The Food and Drug Administration (FDA) is requesting any industry organizations interested in participating in the selection of voting industry representatives to serve on the Technical Electronic Product Radiation Safety Standards Committee for the Center for Devices and Radiological Health to notify FDA in writing. FDA is also requesting nominations for voting industry representatives to serve on the Technical Electronic Product Radiation Safety Standards Committee. A nominee may either be self-nominated or nominated by an organization to serve as a voting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #238 entitled ``Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications.'' This draft guidance provides recommendations on the submission of chemistry, manufacturing, and controls (CMC) and pharmacokinetic information, as well as procedures to follow, to support the approval of modified release parenteral drug products intended for use in veterinary species. This draft guidance is applicable to both new animal drug applications (NADAs) and abbreviated new animal drug application (ANADAs) products.
Announcement of Requirements and Registration for “Pill Image Recognition Challenge”
The Pill Image Recognition Challenge is a National Institutes of Health (NIH) Challenge under the America COMPETES (Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science) Reauthorization Act of 2010 (Pub. L. 111-358). Through this Challenge, the National Library of Medicine (NLM), part of NIH, seeks algorithms and software to match images of prescription oral solid-dose pharmaceutical medications (pills, including capsules and tablets). The objective of the Challenge is the development and discovery of high-quality algorithms and software that rank how well consumer images of prescription pills match reference images of pills in the authoritative NLM RxIMAGE database. NLM may use all or part of any Challenge entry (i.e., algorithm and software) to create a future software system and a future API (Application Programming Interface) for pill image recognition; the system will be freely usable and the API will be freely accessible.
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements
In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and proposes to amend and republish the list. Specifically, we are proposing to remove six biological agents; add provisions to address the inactivation of select agents; add specific provisions to the section of the regulations addressing biosafety; and clarify regulatory language concerning security, training, incident response, and records.