Department of Health and Human Services July 30, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
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. 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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. This is necessary to ensure compliance with an initiative of the Administration. We are requesting an emergency review under 5 CFR Part 1320(a)(2)(i) because public harm is reasonably likely to result if the normal clearance procedures are followed. We are seeking emergency approval for modifications to the information collection request (ICR) currently approved under Office of Management and Budget (OMB) control number 0938-1187 to include account registration elements associated with submitting data through the Amazon Cloud EDGE Server or the On-Premise EDGE server. As a result of contractor changes and technical design changes to our distributed data collection (DDC) approach for implementing the risk adjustment and reinsurance programs, we must change the data elements that issuers will submit as part of the DDC information collection requirements. These modifications will permit us to register EDGE servers with the appropriate issuer accounts, permitting CMS to make risk adjustment and reinsurance payments to issuers.
Proposed Collection; 60-Day Comment Request; The NIH/NCATS GRDRSM
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instuments, submit comments in writing, or request more information on the proposed project, contact Yaffa Rubinstein, Ph.D., Office of Rare Diseases Research (ORDR), National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), 6701 Democracy Boulevard, Room 1004, Bethesda, Maryland 20892, or call non-toll free number (301) 402-4338, or Email your request including your address to yaffa.rubinstein@nih.gov. Formal requests for additional plans and instuments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The NIH/NCATS GRDR\SM\ Program, 0925-NEW GRDR, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH). Need and Use of Information Collection: The NIH created the GRDR program https://grdr.ncats.nih.gov an informatics system and central data repository, housed at the NCATS/NIH Center to support and accelerate research in the cause, diagnosis, and treatment of rare diseases. The GRDR program collects a wide range of data types, including phenotypic, clinical, and genomic, as well as medical images, derived from individuals who participate in rare disease patient registries, regardless of the source of funding. The GRDR program provides the infrastructure to store, search across, retrieve, and analyze these varied types of data. This valuable information will help NIH understand and evaluate the use of repositories/datasets in the research community. The GRDR program will support: (1) Mapping data to standards; (2) increased visibility for participating registries; (3) opportunity for cross-disease research; (4) better and faster RD clinical research. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 100.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Payment Policies Related to Patient Status; Correcting Amendment
This document corrects technical errors in the final rule that appeared in the August 19, 2013 Federal Register, entitled ``Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Payment Policies Related to Patient Status.''
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Care Coordination Quality Measure for Patients in the Primary Care Setting.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Medical Device User Fee Rates for Fiscal Year 2015
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2015, which apply from October 1, 2014, through September 30, 2015. To avoid delay in the review of your application, you should pay the standard fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2015, you should not submit a FY 2015 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2015 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A; Guidance for Industry and Food and Drug Administration Staff
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.'' This document provides CDRH's interpretation of key provisions of section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which were added by the FDA Safety and Innovation Act (FDASIA), as these provisions pertain to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by CDRH.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; FDA Safety Communication Readership Survey
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``FDA Safety Communication Readership Survey'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Zhihua Zou, Ph.D., Harvard Medical School and Fred Hutchinson Cancer Research Center: Based on the reports of investigations conducted by Harvard Medical School (HMS) and Fred Hutchinson Cancer Research Center (FHCRC) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Zhihua Zou, former Postdoctoral Fellow, Department of Neurobiology, HMS, and former Staff Scientist, Division of Basic Sciences, FHCRC, engaged in research misconduct in research supported by National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH), grants R01 DC001622 and R01 DC004842. ORI found that Respondent engaged in research misconduct by falsifying data that were included in two (2) publications:
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
