Department of Health and Human Services July 22, 2011 – 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 Center for Scientific Review (CSR), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget for review and approval. Proposed Collection: Title: Generic Clearance for Voluntary Partners and Customers Satisfaction Surveys: Extension. The information collected in these surveys will be used by the Center for Scientific Review management and personnel: (1) To assess the quality of the modified operations and processes now used by CSR to review grant applications; (2) To assess the quality of service provided by CSR to our customers; (3) To enable identification of the most promising biomedical research that will have the greatest impact on improving public health by using a peer review process that is fair, unbiased from outside influence, timely, and (4) To develop new modes of operation based on customer need and customer feedback about the efficacy of implemented modifications. These surveys, which will be both quantitative and qualitative, are designed to assess the quality of services we provide to our major external customers. Customers include the research scientists who submit applications for grant funding to NIH. Those grant applications are reviewed and ranked by the grant scientific peer review study groups' members and chairs. These surveys will almost certainly lead to quality improvement activities that will enhance and/or streamline CSR's operations. Our partners include current grant scientific peer review study groups' members and chairs. Frequency of Response: On occasion. Affected Public: Scientific peer review study groups' members and chairs, grant applicants, other members of the research community. Type of Respondents: Adult scientific professionals.

The Negotiated Rulemaking (NR) Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas establishes criteria and a comprehensive methodology for designation of Medically Underserved Populations (MUPs) and Primary Care Health Professional Shortage Areas (HPSAs).

The National Cancer Institute (NCI), Division of Cancer Control and Population Sciences (DCCPS), is announcing the launch of the Using Public Data for Cancer Prevention and Control: From Innovation to Impact Developer Challenge. This Challenge is sponsored by the NCI and is presented as part of the Office of the National Coordinator for Health Information Technology's Investing in Innovation (i2) program. This contest addresses the NCI DCCPS mission to disseminate information towards the prevention, early detection, diagnosis, and treatment and control of cancer. Specifically, the contest supports the detection, diagnosis, prevention, and treatment of cancer through the demonstration of new methods for the dissemination of information to the general public concerning the prevention, early detection, diagnosis, and treatment and control of cancer.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma'' dated July 2011. The draft guidance document recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 1.0.1 dated December 2010, as an acceptable mechanism that is consistent with FDA's requirements and recommendations for collecting Source Plasma donor history information. The Plasma Protein Therapeutics Association (PPTA) Source Plasma donor history questionnaires and accompanying materials (SPDHQ documents) will provide blood establishments that collect Source Plasma with a specific process for administering questions to Source Plasma donors to determine their eligibility to donate.