Department of Health and Human Services March 19, 2009 – Federal Register Recent Federal Regulation Documents
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Proposed Collection; Comment Request; Survey of NHLBI Constituents' Health Information Needs and Preferred Formats
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 Heart, Lung and Blood Institute (NHLBI), the 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. Proposed Collection: Title: Survey of NHLBI Constituents' Health Information Needs and Preferred Formats. Type of Information Collection Request: NEW. Need and Use of Information Collection: The purpose of this survey is to obtain information from NHLBI constituents (health professionals, patients and their families, and the general public) for the purpose of evaluating their health information and education needs and format preferences. The Consumer Services Team (CST) will use the data collected in this survey to create a 3-year Strategic Plan. The findings from the survey, described in the Strategic Plan, will be used to develop new health information materials for NHLBI constituents and to revise materials currently in the Institute's portfolio. Frequency of Response: Once every 3 years. Affected Public: Individuals. Type of Respondents: Individuals who have been consumers of NHLBI information within the past 3 years. The annual reporting burden is as follows: Estimated Number of Respondents: 2,450; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.2; and Estimated Total Annual Burden Hours Requested: 162. The annualized cost to respondents is estimated at: $3,518.62. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Proposed Collection; Comment Request; Simulations for Drug Related Science Education
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), 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 June 26, 2008, (Vol. 73 No. 124, page 36337) 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 November 15, 2008, unless it displays a currently valid OMB control number. Proposed Collection: Title: Simulations for Drug Related Science Education. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module Archie MD: The Science of Drugs (1) Increases students' knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforce or instill negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre and post test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. Frequency of Response: 4. Affected Public: High school students engaged with the ArchieMD: The Science of Drugs program. Type of Respondent: Participants will include high school students enrolled in the tenth and eleventh grade. Estimated Total Annual Number of Respondents: 360. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: One high school period lasting 50 minutes. Estimated Total Annual Burden Hours Requested: 1199.95. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.
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.
Implantation or Injectable Dosage Form New Animal Drugs; Tylosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for tylosin injectable solution.
Secretary's Advisory Committee on Genetics, Health, and Society; Request for Public Comment
The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comments on a Draft Report to the Secretary of Health and Human Services, ``Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests'' (available at https://oba.od.nih.gov/ SACGHS/sacghspubliccomments.html). A copy can also be obtained from the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) by e-mailing faunteroytd@od.nih.gov or calling 301-496-9838.
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