Department of Health and Human Services June 24, 2010 – Federal Register Recent Federal Regulation Documents
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Recruitment of Sites for Assignment of National Health Service Corps (NHSC) Personnel Obligated Under the NHSC Scholarship Program
The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) scholarship recipients (NHSC Personnel, NHSC members) during the period July 1, 2010, through June 30, 2011, is posted on the NHSC Web site at https://nhscjobs.hrsa.gov/. This list specifies which entities are eligible to receive assignment of NHSC members who are participating in the NHSC Scholarship Program. Please note that not all vacancies associated with sites on the list described below will be for NHSC members, but could be for NHSC Scholarship Program participants serving their obligation through the Private Practice Option.
Legislative Changes to Primary Care Loan Program Authorized Under Title VII of the Public Health Service Act
On March 23, 2010, President Obama signed into law the Affordable Care Act (ACA), Public Law 111-148. Section 5201 of the ACA changes the Primary Care Loan (PCL) program by: (1) Reducing the number of years for the primary health care service requirement; (2) lowering the interest rate for service default; and (3) eliminating the HHS requirement that parental financial information be submitted for independent students.
Dermatologic and Ophthalmic Drugs Advisory Committee; Cancellation
The meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for June 28, 2010, is cancelled. This meeting was announced in the Federal Register of May 11, 2010 (75 FR 26264). The meeting was to discuss new drug application (NDA) 22-340, voclosporin 10-milligram capsules, by Lux Biosciences Inc. This meeting has been cancelled to allow time for the resolution of several outstanding issues. The agency intends to continue evaluating NDA 22-340 and, as needed, may schedule an advisory committee meeting in the future.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations
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 recordkeeping requirements related to the medical devices current good manufacturing practice (CGMP) quality system (QS) regulation (CGMP/QS regulation).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adoption of the Food and Drug Administration Food Code by Local, State, and Tribal Governments
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; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
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.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Establishment of the Temporary Certification Program for Health Information Technology
This final rule establishes a temporary certification program for the purposes of testing and certifying health information technology. This final rule is established under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The National Coordinator will utilize the temporary certification program to authorize organizations to test and certify Complete Electronic Health Records (EHRs) and/or EHR Modules, thereby making Certified EHR Technology available prior to the date on which health care providers seeking incentive payments available under the Medicare and Medicaid EHR Incentive Programs may begin demonstrating meaningful use of Certified EHR Technology.
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