Department of Health and Human Services September 18, 2014 – Federal Register Recent Federal Regulation Documents

Applications for New Awards; Preschool Development Grants-Expansion Grants; Correction
Document Number: 2014-22320
Type: Notice
Date: 2014-09-18
Agency: Department of Education, Department of Health and Human Services
On August 18, 2014, the Departments of Education and Health and Human Services published in the Federal Register (79 FR 48874) a notice inviting applications for new awards for fiscal year 2014 for the Preschool Development GrantsExpansion Grants program. This notice corrects the Executive Summary Selection Criterion (A)(7)(b).
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-22298
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Amended; Notice of Meeting
Document Number: 2014-22297
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
Issuance of Final Guidance Publication
Document Number: 2014-22275
Type: Notice
Date: 2014-09-18
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) announces the publication of the following document entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014.''
Dental Devices; Reclassification of Salivary Stimulatory System, To Be Renamed Electrical Salivary Stimulator System
Document Number: 2014-22255
Type: Proposed Rule
Date: 2014-09-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to reclassify salivary stimulatory system, a class III device, into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes will provide a reasonable assurance of safety and effectiveness of the device. The Agency is proposing to rename the device ``electrical salivary stimulatory system.''
Medical Devices; Immunology and Microbiology Devices; Classification of Tryptase Test System
Document Number: 2014-22254
Type: Rule
Date: 2014-09-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying tryptase test system devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public Webcast
Document Number: 2014-22253
Type: Notice
Date: 2014-09-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The HHS Centers for Disease Control and Prevention's Division of Select Agents and Toxins (DSAT) and the USDA Animal and Plant Health Inspection Service (APHIS), Agriculture Select Agent Services (AgSAS) are jointly charged with the oversight of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. The purpose of the Webcast is to provide guidance related to the Federal Select Agent Program for interested individuals.
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2014-22213
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-22212
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 2014-22211
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive License: Therapeutics for the Treatment of Lysosomal Storage Disorders
Document Number: 2014-22210
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the following invention as embodied in the following patent applications:
Findings of Research Misconduct
Document Number: 2014-22192
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Makoto Suzuki, M.D., University of Texas Southwestern Medical Center: Based on the report of an investigation conducted by the University of Texas Southwestern Medical Center (UT Southwestern) and analysis conducted by ORI in its oversight review, ORI found that Dr. Makoto Suzuki, currently a Professor in the Department of Thoracic Surgery, Kumamoto University Hospital, Kumamoto, Japan, and formerly a Visiting Scientist in the Hamon Center for Therapeutic Oncology Research, UT Southwestern, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants P50 CA070907 and U01 CA084971. ORI found that Respondent knowingly, intentionally, and recklessly falsified data reported in six (6) publications:
Findings of Research Misconduct
Document Number: 2014-22191
Type: Notice
Date: 2014-09-18
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Takao Takahashi, M.D., Ph.D., University of Texas Southwestern Medical Center: Based on the report of an investigation conducted by the University of Texas Southwestern Medical Center (UT Southwestern) and analysis conducted by ORI in its oversight review, ORI found that Dr. Takao Takahashi, currently a faculty member in the Department of Surgical Oncology, Gifu University, Graduate School of Medicine, Gifu, Japan, and formerly a Visiting Scientist in the Hamon Center for Therapeutic Oncology Research, UT Southwestern, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant U01 CA084971. ORI found that Respondent knowingly, intentionally, and recklessly falsified data reported in four (4) publications: