Department of Health and Human Services December 6, 2018 – Federal Register Recent Federal Regulation Documents
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Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS (Secretary). HRSA is seeking nominations of qualified candidates to fill up to five positions on the Committee.
Medicare Program: Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures, Correction
This document corrects technical and typographical errors in the proposed rule that appeared in the Federal Register on October 2, 2018 entitled ``Medicare Program: Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures.''
Notice of Hearing: Reconsideration of Disapproval Washington Medicaid State Plan Amendment (SPA) 17-0002
This notice announces an administrative hearing to be held on January 15, 2019, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid and Children's Health, Seattle Regional Office, 701 Fifth Avenue, Suite 1600, Seattle, WA 98104 to reconsider CMS' decision to disapprove Washington's Medicaid SPA 17-0002.
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.'' The draft guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. The guidance provides recommendations for all platelet products, including platelets manufactured by automated methods (apheresis platelets), whole blood derived (WBD) platelets, pooled platelets (pre-storage and post- storage) and platelets stored in additive solutions. The draft guidance replaces the draft guidance of the same title dated March 2016.
Proposed Information Collection Activity; Strengthening Relationship Education and Marriage Services (STREAMS) Evaluation (OMB#0970-0481)
The Office of Family Assistance (OFA) within the Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services has issued grants to organizations to provide healthy marriage and relationship education (HMRE) services. Under a previously approved data collection activity (OMB#0970-0481), the Office of Planning, Research, and Evaluation (OPRE) within ACF is conducting the Strengthening Relationship Education and Marriage Services (STREAMS) evaluation with five HMRE grantees. The purpose of STREAMS is to measure the effectiveness and quality of HMRE programs designed to strengthen intimate relationships. This data collection request is for an extension of previously approved data collection instruments and for two additional data collection instruments.
Findings of Research Misconduct
Findings of research misconduct have been made on the part of Rajendra Kadam, former Ph.D. student in pharmaceutical sciences, University of Colorado, Denver (UCD) (Respondent). Mr. Kadam engaged in research misconduct in research supported by National Eye Institute (NEI), National Institutes of Health (NIH), grants R01 EY018940, R01 EY017533, R24 EY017045, and RC1 EY020361. The administrative actions, including debarment for a period of three (3) years, were implemented beginning on November 13, 2018, and are detailed below.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Asthma Information Reporting System (AIRS)'' (OMB Control No. 0920-0853, expiration date 6/30/2019). The purpose of AIRS 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
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Surveillance of Community Water Systems and Corresponding Populations with the Recommended Fluoridation Level. This surveillance collects the fluoridation status of the nation's approximately 52,000 community water systems (CWS) which serve the 50 states and the District of Columbia. It also collects fluoride level testing data for those CWS which adjust naturally occurring fluoride levels. The data are analyzed and published to inform the public and to support state and local governments' efforts to monitor community water fluoridation levels relative to the US Public Health Service recommended level to prevent tooth decay.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Web-based approaches to reach black or African American and Hispanic/Latino MSM for HIV Testing and Prevention Services.''
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