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

Results 201 - 250 of 325
National Cancer Institute; Notice of Closed Meeting
Document Number: 2014-18997
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2014-18996
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2014-18995
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services
National Institute on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2014-18993
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2014-18992
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2014-18991
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2014-18990
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting
Document Number: 2014-18989
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2014-18988
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2014-18987
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2014-18986
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-18985
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2014-18984
Type: Notice
Date: 2014-08-12
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-18972
Type: Notice
Date: 2014-08-12
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the AHRQ Healthcare Horizon Scanning System.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104- 13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
Document Number: 2014-18969
Type: Rule
Date: 2014-08-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and for use in foods that are sole sources of nutrition for enteral feedings. We are taking this action in response to a petition filed by Abbott Laboratories (Abbott).
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-18808
Type: Notice
Date: 2014-08-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Submission for OMB Review; 30-Day Comment Request
Document Number: 2014-18777
Type: Notice
Date: 2014-08-08
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 22, 2014, page 22507 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Clinical Center, National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_ submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
60-Day Notice Template for Extension of Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
Document Number: 2014-18771
Type: Notice
Date: 2014-08-08
Agency: Department of Health and Human Services
HHS, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection.
Discretionary Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: 2014-18737
Type: Notice
Date: 2014-08-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2014-18736
Type: Notice
Date: 2014-08-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Advisory Committee on Rural Health and Human Services; Notice of Meeting
Document Number: 2014-18735
Type: Notice
Date: 2014-08-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: 2014-18687
Type: Notice
Date: 2014-08-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Reallotment of FY 2013 Funds for the Low Income Home Energy Assistance Program (LIHEAP)
Document Number: 2014-18672
Type: Notice
Date: 2014-08-07
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Community Services (OCS), Division of Energy Assistance (DEA) announces the reallotment of $10,880,543 of FFY 2013 funds for the Low Income Home Energy Assistance Program (LIHEAP).
Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations
Document Number: 2014-18665
Type: Notice
Date: 2014-08-07
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 information collection provisions in FDA's infant formula recall regulations.
Center for Devices and Radiological Health: Experiential Learning Program; General Training Program
Document Number: 2014-18662
Type: Notice
Date: 2014-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH or Center) is announcing a new component of the Experiential Learning Program (ELP) identified as the ELP General Training Program. This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to apply to participate in this formal training program for FDA's medical device review staff, or to contact CDRH for more information regarding the ELP General Training Program.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
Document Number: 2014-18640
Type: Notice
Date: 2014-08-07
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 our proposed collection of certain information. 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 invites comments on the information collection provisions of our reporting requirements contained in existing FDA regulations governing state petitions for exemption from preemption.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Radioactive Drug Research Committees
Document Number: 2014-18609
Type: Notice
Date: 2014-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Radioactive Drug Research Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.