Department of Health and Human Services February 20, 2009 – Federal Register Recent Federal Regulation Documents

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 Office of the Director, 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: A Process Evaluation of the NIH Director's New Innovator Award (NIA) Program. Type of Information Collection Request: New collection. Need and Use of Information Collection: This study will assess the NIA Program operations and the outputs of the identification, evaluation and selection process. The primary objectives of the study are to: (1) Assess the NIA award selection process; (2) determine if the program was implemented as planned; and (3) determine if the process was conducted in accordance with the overall mission of the NIA program. The findings will provide valuable information concerning: (1) The characteristics of applicants and reviewers; (2) the criteria used to evaluate and select awardees; and (3) aspects of the process that could be revised or improved. Frequency of Response: Once. Affected Public: none. Type of Respondents: Applicants, Reviewers. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimated Number of Respondents: 662; Estimated Number of Responses per Respondent: 1: Average Burden Hours Per Response: .28 (15 minutes for applicants and 30 minutes for Extramural Reviewers), and Estimated Total Annual Burden Hours Requested: 188.5 and the annualized cost to respondents is estimated at $12,199.72. Table l and Table 2 respectively present data concerning the burden hours and cost burdens for this data collection.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Influenza: Developing Drugs for Treatment and/or Prophylaxis.'' Recent concerns about the possibility of pandemic spread of novel influenza strains have increased interest in influenza drug development for both seasonal and pandemic settings. The purpose of this guidance is to assist sponsors in all phases of influenza drug development and to address questions FDA often receives regarding the potential for emergency use of influenza drugs for the treatment and/or prophylaxis of influenza.