Department of Health and Human Services November 5, 2010 – Federal Register Recent Federal Regulation Documents
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Recruitment of Sites for Assignment of Corps Personnel Obligated Under the National Health Service Corps Loan Repayment Program (FY 2011)
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) Loan Repayors (Corps Personnel, Corps members) during the period October 1, 2010, through September 30, 2011, is posted on the HRSA Web site at https:// datawarehouse.hrsa.gov/HGDWReports/ OneClickRptFilter.aspx?rptName=NHSCAppSiteList&rptFormat=HTML 3.2. This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Loan Repayment Program (LRP), and Corps members who have become Corps members other than pursuant to contractual obligations under the LRP. Please note that not all vacancies associated with sites on this list will be for Corps members, but could be for individuals serving an obligation to the NHSC LRP through the Private Practice Option.
Submission for OMB Review; Comment Request; Request; OMB No. 0925-0177 “Special Volunteer and Guest Researcher Assignment,” Form 590
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 25, 2010, page 52351 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after July 31, 2005, unless it displays a currently valid OMB control number. Proposed Collection: Title: Special Volunteer and Guest Researcher Assignment for use in NIH facilities. Type of Information Collection Request: Reinstatement, OMB 0925-0177, Expiration Date July 31, 2005. Need and Use of Information Collection Request: Form Number: NIH-590. A single Form NIH-590 is completed by an NIH official for each Guest Researcher or Special Volunteer prior to his/her arrival at NIH. The information on the form is necessary for the approving official to reach a decision on whether to allow a Guest Researcher to use NIH facilities, or whether to accept volunteer services offered by a Special Volunteer. If the original assignment is extended, another form notating the extension is completed to update the file. Frequency of Response: once. Affected Public: Individuals Type of Respondents: Non- federal scientific professionals and/or individuals. The annual Reporting burden is as follows: Estimated Number of Respondents: 1660; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 0.1; and Estimated Total Annual Burden Hours Requested: 166. The estimated annualized cost to respondents is $2,275. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Restaurant Menu and Vending Machine Labeling: Recordkeeping and Mandatory Third Party Disclosure Under Section 4205 of the Patient Protection and Affordable Care Act of 2010
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 recordkeeping and mandatory third party disclosure provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010 (ACA).
Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System
The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Full-Field Digital Mammography System.'' FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Full-Field Digital Mammography System.'' This guidance document describes a means by which a full-field digital mammography (FFDM) system may comply with special controls that apply to these class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify these device types from class III into class II (special controls).
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