Department of Health and Human Services July 8, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Proposed Collection; 60-Day Comment Request; Assessment of Oncology Nursing Education and Training in Low and Middle Income Countries (NCI)
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 Cancer Institute (NCI), 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 instruments or request more information on the proposed project, contact: Annette Galassi, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W250, Rockville, MD 20850 or call non-toll-free number 240-276-6632 or Email your request, including your address to: agalassi@mail.nih.gov. Formal requests for additional plans and instruments 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: Assessment of Oncology Nursing Education and Training in Low and Middle Income Countries, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a request for OMB to approve the Assessment of Oncology Nursing Education and Training in Low and Middle Income Countries (LMICs). NCI-Designated Cancer Centers have a range of international activities, some of which are funded by NCI, but many of which are not. These international activities may include oncology nursing education and training in LMICs, but the extent of these activities across cancer centers is unknown. The proposed assessment requests information about oncology nursing education and training projects including: Descriptions of projects, partner organizations, types of activities, cost, and impact. NCI's Center for Global Health (CGH) is in the process of developing its strategic plan for oncology nursing education in LMICs. This information will help inform this strategic planning process and provide evidence to inform decisions on potential investments in grants for oncology nursing education in LMICs. Additionally, this information will be used in an online, interactive map that is being developed by CGH which will allow external organizations, such as cancer centers, to explore what projects are being done in which countries, which will facilitate collaborations and minimize duplication. The frequency of the data collection will be once per year although respondents may have more than one response if they have up to three projects. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 51.
Submission for OMB Review; 30-Day Comment Request; Specimen Resource Locator (NCI)
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 April 8, 2014 (Vol. 79, P. 19345) 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 Cancer Institute (NCI), 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 October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache
The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcranial magnetic stimulator for headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Patient-Focused Drug Development for Idiopathic Pulmonary Fibrosis; Public Meeting; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for idiopathic pulmonary fibrosis. Patient- Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of idiopathic pulmonary fibrosis on daily life as well as patient views on treatment approaches for idiopathic pulmonary fibrosis.
Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas
The Food and Drug Administration (FDA), Office of International Programs (OIP) is announcing the availability of grant funds for the support of a single source cooperative agreement to the Pan American Health Organization (PAHO) for fostering cooperation and strengthening medical product regulatory systems in the Americas. The goal of the cooperative agreement is to build upon existing cooperation between OIP/FDA and PAHO to foster regulatory collaboration and strengthen regulatory capacity throughout the Americas.
Center for Drug Evaluation and Research; Use of Innovative Packaging, Storage, and/or Disposal Systems To Address the Misuse and Abuse of Opioid Analgesics; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the notice entitled ``Center for Drug Evaluation and Research; Use of Innovative Packaging, Storage, and/or Disposal Systems to Address the Misuse and Abuse of Opioid Analgesics,'' which published in the Federal Register of April 9, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments.
Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use); Correction
The Food and Drug Administration (FDA) published a document in the Federal Register of March 10, 2014 (79 FR 13263), providing notice of a petition filed by Kemin Industries, Inc., that proposed the food additive regulations be amended to provide for the safe use of chromium propionate as a source of chromium in broiler feed. That petition included an environmental assessment which was not noted in the March 10 notice of petition.
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