Department of Health and Human Services January 2016 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 233
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-00940
Type: Notice
Date: 2016-01-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the information collection entitled ``Division of Community Health (DCH) Training and Technical Assistance: Needs Assessment and Satisfaction Surveys''.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-00939
Type: Notice
Date: 2016-01-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the information collection project entitled ``Colorectal Cancer Control Program CRCCP) Monitoring Activities''. CDC is requesting a reinstatement with change of OMB No. 0920-1074 to include a redesigned survey and a new clinic- level data collection.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-00938
Type: Notice
Date: 2016-01-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Behavioral Risk Factor Surveillance System (BRFSS), a state-level survey of health risk behaviors and chronic health conditions. Survey questions are updated each year. The information collection is being revised to incorporate an annual field test of proposed changes prior to their implementation on a broad scale.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-00937
Type: Notice
Date: 2016-01-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the revision of the ``Asthma Information Reporting System (AIRS)'' information collection plan. The purpose of AIRS is to collect performance measure and surveillance data spreadsheets designed to increase the efficiency and effectiveness of state asthma programs and to monitor the impact of the state and national programs.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-00936
Type: Notice
Date: 2016-01-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collect project entitled ``The Pregnancy Risk Assessment Surveillance System''.
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2016-00908
Type: Notice
Date: 2016-01-20
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2016-00889
Type: Notice
Date: 2016-01-20
Agency: Department of Health and Human Services, Administration for Children and Families
Announcement of the Award a Single-Source Program Expansion Supplement Grant to BCFS Health and Human Services in San Antonio, TX
Document Number: 2016-00886
Type: Notice
Date: 2016-01-20
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), announces the award of a single-source program expansion supplement grant for $12,860,855 to BCFS Health and Human Services (BCFS) in San Antonio, TX, under the Unaccompanied Children's (UC) Program to support a program expansion supplement. The expansion supplement grant will support the need to increase shelter capacity to accommodate the increasing numbers of UCs being referred by DHS. BCFS has a network of trained, qualified emergency staff able to bring on board and operate emergency beds in short timeframe. BCFS provides residential services to UC in the care and custody of ORR, as well as services to include counseling, case management, and additional support services to the family or to the UC and their sponsor when a UC is released from ORR's care and custody.
Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Technical Amendments
Document Number: 2015-32101
Type: Rule
Date: 2016-01-20
Agency: Department of Health and Human Services
This document contains technical amendments to HHS regulations regarding Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. The regulatory content is being amended to add information that was erroneously omitted, to include updated cross-references within HHS' regulations, and to make grammatical corrections.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-00867
Type: Notice
Date: 2016-01-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-00866
Type: Notice
Date: 2016-01-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-00844
Type: Notice
Date: 2016-01-19
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 (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.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-00840
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, Administration for Children and Families
Request for Information on Psychosocial Predictors of Uptake of Tobacco and Other Products
Document Number: 2016-00836
Type: Notice
Date: 2016-01-19
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2016-00828
Type: Notice
Date: 2016-01-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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
Document Number: 2016-00827
Type: Notice
Date: 2016-01-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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
Document Number: 2016-00825
Type: Notice
Date: 2016-01-19
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2016-00824
Type: Notice
Date: 2016-01-19
Agency: Food and Drug Administration, Department of Health and Human Services
Arthritis Advisory Committee; Notice of Meeting
Document Number: 2016-00823
Type: Notice
Date: 2016-01-19
Agency: Food and Drug Administration, Department of Health and Human Services
Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Draft Guidance for Industry; Availability
Document Number: 2016-00822
Type: Notice
Date: 2016-01-19
Agency: Food and Drug Administration, Department of Health and Human Services
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.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-00802
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meetings
Document Number: 2016-00801
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-00800
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2016-00799
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2016-00798
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-00797
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-00796
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-00795
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-00794
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-00793
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2016-00792
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2016-00791
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of Requirements and Registration for “Pill Image Recognition Challenge”
Document Number: 2016-00777
Type: Notice
Date: 2016-01-19
Agency: Department of Health and Human Services, National Institutes of Health
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
Document Number: 2016-00758
Type: Proposed Rule
Date: 2016-01-19
Agency: Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Semi-Annual and Final Reporting Requirements for the Older Americans Act Title IV Discretionary Grants Program
Document Number: 2016-00762
Type: Notice
Date: 2016-01-15
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Navigating the Center for Drug Evaluation and Research: What You Should Know for Effective Engagement; Public Workshop
Document Number: 2016-00694
Type: Notice
Date: 2016-01-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administrations (FDA) Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled ``Navigating CDER: What You Should Know for Effective Engagement.'' The purpose of this public workshop is to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER.
Agency Information Collection Activities; Proposed Collection; Comment Request; Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
Document Number: 2016-00691
Type: Notice
Date: 2016-01-15
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 to accompany humanitarian device exemption (HDE) applications and the collection of information regarding the annual distribution number (ADN).
How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?
Document Number: 2016-00690
Type: Notice
Date: 2016-01-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public conference entitled ``How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?'' This conference will be cosponsored with the Critical Path Institute (C- Path). The purpose of the conference is to discuss, debate, and share views among stakeholders in academia, patient groups, regulatory bodies, and the health care and pharmaceutical industries on how best to measure, evaluate, and act upon liver injury and dysfunction caused by drugs used during clinical trials.
Advisory Committee: Vaccines and Related Biological Products Advisory Committee, Renewal
Document Number: 2016-00675
Type: Notice
Date: 2016-01-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Vaccines and Related Biological Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Vaccines and Related Biological Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until December 31, 2017.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-00652
Type: Notice
Date: 2016-01-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2016-00651
Type: Notice
Date: 2016-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-00650
Type: Notice
Date: 2016-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-00649
Type: Notice
Date: 2016-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-00648
Type: Notice
Date: 2016-01-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke Notice of Closed Meeting
Document Number: 2016-00647
Type: Notice
Date: 2016-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Temporary Assistance for Needy Families (TANF) Program, State Reporting On Policies and Practices To Prevent Use of TANF Funds in Electronic Benefit Transfer Transactions in Specified Locations
Document Number: 2016-00608
Type: Rule
Date: 2016-01-15
Agency: Department of Health and Human Services, Administration for Children and Families
This final rule makes regulatory changes to the Temporary Assistance for Needy Families (TANF) regulations to require states, subject to penalty, to maintain policies and practices that prevent TANF funded assistance from being used in any electronic benefit transfer transaction in any liquor store; any casino, gambling casino, or gaming establishment; or any retail establishment that provides adult-oriented entertainment in which performers disrobe or perform in an unclothed state for entertainment. This rule implements provisions of Section 4004 of the Middle Class Tax Relief and Job Creation Act of 2012.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-00595
Type: Notice
Date: 2016-01-14
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-00564
Type: Notice
Date: 2016-01-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection entitled ``Young Men who have Sex with Men (YMSM) Study Thailand''. CDC is requesting a three-year approval for this new project.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-00563
Type: Notice
Date: 2016-01-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services