Department of Health and Human Services July 9, 2013 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Notice of Single-Case Deviation from Competition Requirements: Transfer of Grantee Request for the Detroit Healthy Start Program, Detroit, MI
HRSA will be issuing a grantee transfer without competition for the Detroit Michigan Healthy Start program to the Institute for Population Health (IPH). The IPH will assume responsibility for the Healthy Start program and receive year 5 funding in the amount of $1,575,000, from Grant Number H49MC00147, during the budget period of 6/1/2013-5/31/2014 to support the objectives of the Eliminating Disparities in Perinatal Health Healthy Start Program. The Eliminating Disparities in Perinatal Health Healthy Start Program (H49), CFDA No. 93.926, is authorized by the Public Health Service Act, Title III, Part D, Section 330H (42 USC 254c-8). The purpose of the Eliminating Disparities in Perinatal Health Healthy Start Program is to address significant disparities in perinatal health. Differences in perinatal health indicators may occur by virtue of education, income, disability, or living in rural/isolated areas. To address disparities and the factors contributing to them, project services have been designed to cover the pregnancy and interconceptional phases for women and infants residing in the proposed project area. In order to promote longer interconceptional periods and prevent relapses of risk behaviors, the women and infants are to be followed through the infant's second year of life and/or two years following delivery.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Discretionary Grant Program
HRSA will be transferring the Michigan Family-to-Family Health Information Center (F2F HIC) grant (H84MC09365) from the Family Center for Children and Youth with Special Health Care Needs (FCCYSHCN) in Detroit, Michigan, to the Michigan Public Health Institute (MPHI) in Okemos, Michigan, to ensure the continued provision of health resources, financing, related services, and parent-to-parent support for families with children and youth with special health care needs (CYSHCN) in the state of Michigan.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act
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 associated with medical devices third-party review under the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products
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 communication studies involving medical devices and radiation-emitting products regulated by FDA. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission to protect the public health.
Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Reporting for Manufacturers.'' This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance is intended to update FDA's policy and to further clarify FDA's interpretations of the regulation requirements and, when final, will supersede the previous manufacturer guidances issued in 1988 and 1997. This draft guidance also provides answers to frequently asked questions and includes a section on common reporting errors. This draft guidance is not final nor is it in effect at this time.
Medicare and Medicaid Programs; Home Health Prospective Payment System Rate Update for CY 2014, Home Health Quality Reporting Requirements, and Cost Allocation of Home Health Survey Expenses Correction
This document corrects technical errors that appeared in the proposed rule with comment period titled ``Medicare and Medicaid Programs; Home Health Prospective Payment System Rate Update for CY 2014, Home Health Quality Reporting Requirements, and Cost Allocation of Home Health Survey Expenses'' published on July 3, 2013.
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