Department of Health and Human Services October 27, 2010 – Federal Register Recent Federal Regulation Documents

The Division of Epidemiology, Statistics and Prevention Research (hereafter, Division) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) maintains an extensive repository of datasets from completed studies, biospecimens, and ancillary data. The Division intends to make datasets and biospecimens more widely available to the research community for use by qualified researchers and to establish procedures for access consistent with the National Institutes of Health (NIH) Data Sharing Policy. The Division has established an internal committee, the Biospecimen Repository Access and Data Sharing Committee (BRADSC), to oversee the repository access and data sharing program. The purpose of this notice is to request comments on this program and present the initial proposed cost schedule. After full consideration of comments submitted in response to this notice, the BRADSC will finalize proposal guidelines and procedures, publish the cost schedule to the Division Web site, and begin to accept proposals for use of the stored biologic samples and for access to ancillary data that may not be available electronically. The first specimens and ancillary data that will be made available under this program are those from the national Collaborative Perinatal Project (CPP). The CPP is a large, prospective cohort study, conducted by the National Institute of Neurological Diseases and Stroke (NINDS) of the National Institutes of Health (NIH), which recruited and enrolled 48,197 women who contributed 54,390 pregnancies that were prospectively followed from 1959-1966 at twelve academic medical centers across the United States. Custody for disposition of the CPP serum specimens was transferred to the Division from the NINDS in 1993 and for the microfiche archives in 1999. However, under the Federal Privacy Act of 1974 the samples and archive still belong to NINDS. Since 1992, the specimens have had limited public availability through Division investigators. Going forward, the Biospecimen Repository Access and Data Sharing Committee (BRADSC) will oversee the repository access and data sharing program. Access to other Division resources will be announced on the Division Web site. The BRADSC reserves the right to amend the procedures and costs schedules as necessary to maintain the integrity of the program and to suit the conditions under which other specimens were collected. Announcements and current proposal guidelines will be available under the Research link at https:// despr.nichd.nih.gov, and interested researchers should consult the Division Web site for resources available, the most recent guidelines for proposal submission and evaluation, and cost schedules. Procedures may vary depending on the age and nature of the samples and original institutional review board (IRB) approval, although the general outline of the procedures should remain the same. Cost schedules may vary depending on the nature and complexity of the request. No funding is provided as part of this notice nor will any be available as part of the program either to support laboratory analyses or data management. Samples will only be provided to approved projects upon receipt of evidence of necessary IRB approval(s), funding and payment of repository costs and shipping. Approved projects that do not obtain funding will be canceled within one year of their approval date. A more complete description of this program follows. Comments or requests for clarification on all aspects of the program are welcome.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Draft Guidance, Emergency Use Authorization of Medical Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the application for participation in the Medical Device Fellowship Program (MDFP).