Department of Health and Human Services January 13, 2009 – Federal Register Recent Federal Regulation Documents

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on November 3, 2008 (Volume 73, No. 213, p. 65387) and allowed 60 days for public comment. There was one public comment received which questioned why U.S. tax dollars are being spent on a study located in Europe. The investigator responded directly to the comment on 12/19/08 stating that this study costs less money to conduct in central Europe than in the U.S. since previous data has already been collected. Additionally, since this region has the highest rates of kidney cancer in the world a study in this area would provide a wealth of data in terms of the causes of kidney cancer. 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: Follow-up of Kidney Cancer Patients from the Central European Multicenter Case-Control Study (NCI). Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this questionnaire is to obtain information on the 5-year survival status of kidney cancer patients that were previously enrolled in a Central European Case-Control Study of Kidney Cancer that was conducted from 2001 to 2004. The aim is to assess survival, the prevalence of recurrent disease and progression, and to investigate patient, tumor and genetic determinants of survival among cases. The questionnaire will collect information on patient related factors, tumor related factors that were not collected during the initial study, and the type of treatment(s) received since the patients were last contacted for the case-control study. This questionnaire adheres to The Public Health Service Act, section 412 (42 U.S.C. 285a- 1) and section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Individuals that participated in the Central European Renal Cancer Case-Control Study between 2001-2004 and physician abstractors. The estimated total annual burden hours requested is 296. The annualized cost to respondents is estimated at $5174. The data will be collected within a two-year period. There are no additional capital costs, operating costs, and/or maintenance costs to report.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.'' The guidance provides drug, biologics, and device manufacturers with the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses for FDA- approved drugs or biologics or FDA-approved or cleared medical devices to healthcare professionals and healthcare entities.

The Food and Drug Administration (FDA) is seeking information and comments on issues related to the enrollment of certain populations in clinical drug trials. Particularly, we are requesting information and comments from medical product manufacturers, institutional review boards (IRBs), patient groups, universities, researchers, community groups, and other interested parties. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA) section 901, which requires recommendations be included in a report to Congress addressing best practice approaches on increasing the participation of elderly populations, children, racially and ethnically diverse communities, and medically underserved populations in clinical drug trials. FDA requests that those with information on possible approaches to increase participation of these groups in clinical drug trials submit comments.