Department of Health and Human Services August 11, 2014 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing
Document Number: 2014-18945
Type: Notice
Date: 2014-08-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the blood establishment registration and product listing requirements in the Agency's regulations and on Form FDA 2830.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
Document Number: 2014-18944
Type: Notice
Date: 2014-08-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the guidance which discusses FDA's approach to enforcement of adverse event reporting requirements during an influenza pandemic.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
Document Number: 2014-18943
Type: Notice
Date: 2014-08-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed collection of information resulting from the guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP).
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-18940
Type: Notice
Date: 2014-08-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2014-18903
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-18902
Type: Notice
Date: 2014-08-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Evaluation Criteria and Standards for Quality Improvement Networks Quality Improvement Program Contracts [Base and Task Order(s)]
Document Number: 2014-18901
Type: Notice
Date: 2014-08-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice with comment period describes the general criteria we intend to use to evaluate the effectiveness and efficiency of the Quality Innovation Network (QIN) Quality Improvement Organizations (QIOs) that will enter into contracts with CMS under the Quality Innovation Network Quality Improvement Organizations (Solicitation Number: HHSM-500-2014-RFP-QIN-QIO) Statement of Work (SOW) on August 1, 2014. The evaluation of a QIN-QIO's performance related to their SOW will be based on evaluation criteria specified for the tasks and subtasks set forth in Sections C.5, G.22 and G.29 of the QIN-QIO Base Contract and Attachment J-1(b) of the Base Contract; Attachment J-1 is QIN-QIO Task Order No. 001.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2014-18898
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of Requirements and Registration for “Follow that Cell” Challenge
Document Number: 2014-18870
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, National Institutes of Health
Through the ``Follow that Cell'' Challenge (the ``Challenge''), the Single Cell Analysis Program (SCAP)http:// commonfund.nih.gov/Singlecell/index, a component of the National Institutes of Health Common Fundhttp://commonfund.nih.gov/about, is searching for novel methods for analyzing dynamic states of individual cells that can serve as the basis for predicting alterations in cell behavior and function over time. The goal of the Challenge is to develop new tools and methods that allow time-dependent measurements at the single-cell level in a complex tissue environment in order to assess functional changes, provide information on the health status of a given cell, and help guide diagnosis and therapeutic treatments related to human disease states. Technological breakthroughs in this arena could allow researchers and physicians to identify rare cells in a mixed population, such as individual cells that can transform and become cancerous, cells that are latently infected with a pathogenic virus, or cells that develop resistance to drugs over time. The NIH Common Fund currently supports SCAP grants, the majority of which are associated with academic institutions. This Challenge, structured in two phases, will strengthen and complement the existing SCAP grant portfolio by reaching out to a more diverse population of innovators and solvers, including not only those who are from academic institutions but also those who are from research and development communities in the private sector and those who are outside biomedical disciplines. The NIH believes this Challenge will stimulate investment from both public and private sectors in single-cell analysis research and product development, which, in turn, could lead to the development of more sensitive, robust, and cost-effective assay approaches, reagents, tools, and devices for basic research and clinical diagnosis.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-18857
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-18856
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2014-18853
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Neurological Disorders and Stroke Notice of Closed Meeting
Document Number: 2014-18852
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2014-18851
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services
National Institute on Alcohol Abuse and Alcoholism Notice of Meeting
Document Number: 2014-18850
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke
Document Number: 2014-18849
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering Notice of Closed Meetings
Document Number: 2014-18848
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Notice of Closed Meeting
Document Number: 2014-18847
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2014-18846
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-18845
Type: Notice
Date: 2014-08-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-18844
Type: Notice
Date: 2014-08-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Justification for a Single Source Cooperative Agreement Award for the World Health Organization
Document Number: 2014-18836
Type: Notice
Date: 2014-08-11
Agency: Department of Health and Human Services
A natural re-emergence of smallpox is not deemed possible, but if it were to occur as a result of a terrorist or deliberate event, it would be a potentially devastating threat to public health worldwide and would constitute a public health emergency of international concern (PHEIC) under the International Health Regulations (IHR) (2005). A case of smallpox detected by a member state requires notification to World Health Organization (WHO) as soon as possible, and any confirmed smallpox case would generate an immediate global public health response. WHO must rely on fast and reliable laboratory diagnostic capacity worldwide to be able to identify a re-emergence of smallpox, particularly in countries where systemic orthopoxvirus infections such as monkeypox, vaccinia virus infection or cowpox, and other non-pox viral rash illnesses, such as chicken pox, may cause clinical diagnostic confusion. Over the past 10 years, clinical virology laboratory diagnostics has been evolving and increasingly rely on molecular techniques. This is also true with laboratory diagnoses of poxvirus infections. Precise and consistent identification of orthopoxviruses, in particular variola viruses, is now achievable using such molecular techniques as real-time Polymerase Chain Reaction (unlike earlier techniques that may have relied on direct virus isolation and identification). Additionally, the U.S. Government supports the development of other medical products, including vaccines and drugs, for use within the U.S. upon verification of a smallpox case. The U.S. Government, through the Office of the Assistant Secretary for Preparedness and Response (ASPR), has successfully developed vaccine products, and is actively engaged in the development of several drug candidates for smallpox therapies which require access to the Variola virus to satisfy regulatory requirements for product approvals. Period of Performance: September 30, 2014 to September 29, 2015.