Department of Health and Human Services December 10, 2010 – Federal Register Recent Federal Regulation Documents
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Office of the National Coordinator for Health Information Technology; Health Information Technology; Request for Information Regarding the President's Council of Advisors on Science and Technology (PCAST) Report Entitled “Realizing the Full Potential of Health Information Technology To Improve Healthcare for Americans: The Path Forward”
This document is a request for comments regarding the recently released PCAST report and its implications for the nation's health information technology (HIT) agenda and ONC's implementation of the Health Information Technology for Economic and Clinical Health Act (HITECH Act).
Determination of Regulatory Review Period for Purposes of Patent Extension; COARTEM
The Food and Drug Administration (FDA) has determined the regulatory review period for COARTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; MULTAQ
The Food and Drug Administration (FDA) has determined the regulatory review period for MULTAQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
Public Consultation on Personnel Reliability and Culture of Responsibility Issues
The National Science Advisory Board for Biosecurity (NSABB), an advisory committee to the Federal Government, is hosting a public consultation to obtain input from the scientific community and general public regarding strategies for enhancing personnel reliability and strengthening the culture of responsibility at facilities that conduct research with dangerous pathogens. The discussion will inform NSABB deliberations and ultimately the development of an NSABB report on the topic.
Submission for OMB Review; Comment Request; Generic Clearance for Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of Extramural Research (OER), 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 September 13, 2010 (Volume 75, Number 176, page 55585) and allowed 60 days for public comment. One public comment was 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 October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Generic Clearance for Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of Health. Type of Information Collection Request: NEW. Need and Use of Information Collection: OER develops, coordinates the implementation of, and evaluates NIH-wide policies and procedures for the award of extramural funds . To move forward with our initiatives to ensure success in accomplishing the NIH mission, input from partners and customers is essential. Quality management principles have been integrated into OER's culture and these surveys will provide customer satisfaction input on various elements of OER's business processes. The approximately 14 (10 quantitative and 4 qualitative) customer satisfaction surveys that will be conducted under this generic clearance will gather and measure customer and partner satisfaction with OER processes and operations. The data collected from these surveys will provide the feedback to track and gauge satisfaction with NIH's statutorily mandated operations and processes. OER/OD/NIH will present data and outcomes from these surveys to inform the NIH staff, officers, leadership, advisory committees, and other decision-making bodies as appropriate. Based on feedback from these stakeholders, OER/ OD/NIH will formulate improvement plans and take action when necessary. Frequency of Response: 1 response. Affected Public: Individuals. Type of Respondents: Science professionals (applicants, reviewers, Institutional Officials), adult science trainees, and the general public. The annual reporting burden is as follows: Quantitative surveys: Estimated Number of Respondents per Survey: 9,820; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.25; Estimated Total Annual Burden Hours Requested per Quantitative Survey: 2,455; Estimated Total Annual Burden Hours Requested for 10 Quantitative Surveys: 24,550. Qualitative surveys: Estimated Number of Respondents per Survey: 30; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 1.0; Estimated Total Annual Burden Hours Requested per Qualitative Survey: 30; Estimated Total Annual Burden Hours Requested for 4 Qualitative Surveys: 120. Based on an estimated 10 quantitative and 4 qualitative surveys per year: Estimated Total Combined Annual Hours of Burden Requested in Each of 3 Years: 24,670. Estimated Total Combined Cost to Respondents: $728,326. Based on an estimated 10 quantitative and 4 qualitative surveys per year over 3 years: Estimated Total Hours of Burden to Respondents for 2011, 2012, and 2013 Combined: 74,010. Estimated Total Cost to Respondents for 2011, 2012, and 2013 Combined: $2,184,978. 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. 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: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Gwynne L. Jenkins, Special Assistant to the Director, Office of Extramural Programs, OER, NIH, 6705 Rockledge Drive, Suite 350, Bethesda, MD 20892, or call non-toll-free number (301) 496-9232 or e-mail your request, including your address to: OEPMailbox@mail.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); NTP Workshop: Role of Environmental Chemicals in the Development of Diabetes and Obesity
The NTP announces a workshop on January 11-13, 2011, to evaluate the science associating exposure to certain chemicals or chemical classes with the development of diabetes and obesity in humans. The NTP invites the submission of public comments and relevant data for consideration at the workshop. Registration to attend the workshop is closed; however, slides presented during the plenary sessions will be webcast over the Internet. Information about the workshop may be found at https://cerhr.niehs.nih.gov/evals/ diabetesobesity/.
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings.'' We are issuing the guidance to provide information on how the public may participate at the open public hearing (OPH) portion of FDA advisory committee meetings. The guidance also provides recommendations regarding financial disclosure by persons participating in the OPH portion of advisory committee meetings.
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