Department of Health and Human Services May 10, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Proposed Information Collection; Request for Public Comment: Indian Health Service Loan Repayment Program (LRP)
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was previously published in the Federal Register (77 FR 11558) on February 27, 2012 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program.'' Type of Information Collection Request: Revision of currently approved information collection, 0917-0014, ``Indian Health Service Loan Repayment Program.'' The LRP application has been revised so that it is now available in an electronically fillable and fileable format. Form(s): The IHS LRP Information Booklet contains the instructions and the application formats. Need and Use of Information Collection: The IHS LRP identifies health professionals with pre- existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract through which the IHS agrees to repay part or all of their indebtedness for professional training time in IHS health care facilities. This program is necessary to augment the critically low health professional staff at IHS health care facilities. Any health professional wishing to have their health education loans repaid may apply to the IHS LRP. A two-year contract obligation is signed by both parties, and the individual agrees to work at an IHS location and provide health services to American Indian and Alaska Native individuals. The information collected via the on-line application from individuals is analyzed and a score is given to each applicant. This score will determine which applicants will be awarded each fiscal year. The administrative scoring system assigns a score to the geographic location according to vacancy rates for that fiscal year and also considers whether the location is in an isolated area. When an applicant accepts employment at a location, they in turn ``pick-up'' the score of that location. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).
Device Improvements for Pediatric X-Ray Imaging; Public Meeting; Request for Comments
FDA is announcing the following public meeting on the draft guidance ``Pediatric Information for X-ray Imaging Device Premarket Notifications.'' This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and interventional fluoroscopy devices. FDA has organized this meeting to solicit public feedback on the draft guidance and to help identify issues relevant to radiation safety in pediatric x-ray imaging that may benefit from standards development or further research.
Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Pediatric Information for X-ray Imaging Device Premarket Notifications.'' This draft guidance document outlines FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations on information to support such indications. This draft guidance applies only to complete x-ray imaging devices that could be used on pediatric patients. This draft guidance is not final nor is it in effect at this time.
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