Department of Health and Human Services March 1, 2006 – Federal Register Recent Federal Regulation Documents

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collection of information, the National Institute on Drug Abuse (NIDA), 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: The NIDA International Program Research Training Modules for International Application Needs Assessment Survey. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to undertake an educational needs assessment survey of NIDA's collaborating international drug abuse researchers. The purpose of this survey is to more precisely define the educational needs of the international drug abuse research community before proceeding with the development of formal distance learning programs. Reviews of distance education programs in the developing world often reveal that, ``systematically organized learning needs assessments are continually absent.'' (USAID 2001: The Use and Effect of Distance Education in Healthcare: What Do We Know? Operations Research Issue Paper 2) This survey will address that issue. The survey is based on recommendations received from current international drug abuse researchers and NIDA grantees. It is designed to be brief (2 pages) and succinct, asking respondents to prioritize their educational needs. The questions have been previously tested with persons who speak English as a second language. Total time to complete the survey is less than five minutes. The survey will cover the following elements: (1) Respondent background, including availability of educational technologies, (2) Educational needs, including a ranking of 10 proposed topics in drug abuse education, and (3) Collaborative needs, including an estimate of the value of online tools for research collaboration. The survey will not collect name, address, or other identifying information. Frequency of Response: This project will be conducted once. Affected Public: International drug abuse researchers who are currently affiliated with or wish to be affiliated with the U.S. drug abuse research community. Type of Respondents/Drug Abuse Researchers: physicians, scientists, mental health workers, and scientists-in-training. The reporting burden is as follows: Estimated Total Annual Number of Respondents: 250; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.09. Estimated Total Annual Burden Hours Requested: 22.5. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of February 9, 2006 (71 FR 6677). That document reclassified hepatitis A virus (HAV) serological assays from class III (premarket approval) into class II (special controls). That document inadvertently published with an error. This document corrects the error.