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

The Food and Drug Administration (FDA) is extending to December 31, 2010, the comment period for a notice of availability of a draft compliance policy guide (CPG) that appeared in the Federal Register of August 2, 2010 (75 FR 45130). In the document, FDA requested comments on its proposal that certain criteria should be considered in recommending enforcement action against animal feed or feed ingredients that are adulterated due to the presence of Salmonella. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

This notice provides the adjusted Federal Medical Assistance Percentage (FMAP) rate for the fourth quarter of Fiscal Year 2010 (FY10) as required under Section 5001 of the American Recovery and Reinvestment Act of 2009 (ARRA). Section 5001 of the ARRA provides for temporary increases in the FMAP rates to provide fiscal relief to States and to protect and maintain State Medicaid and certain other assistance programs in a period of economic downturn. The increased FMAP rates apply during a recession adjustment period that was originally defined in ARRA as the period beginning October 1, 2008 and ending December 31, 2010. Public Law 111-226 amended ARRA to extend the recession adjustment period to June 30, 2011 and to extend the hold harmless provision that prevents a State's FMAP rate from decreasing due to a lower unemployment rate from the calendar quarter ending before July 1, 2010 to the calendar quarter ending before January 1, 2011. Public Law 111-226 also provided for a phase-down of the general FMAP increase in the last two quarters of the extended recession adjustment period, and changed the methodology for calculating the unemployment adjustment for those quarters.

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 July 13, 2010 (75 FR 39950) and allowed 60-days for public comment. There have been no public comments. Additionally, the 30-day Federal Register was published on September 13, 2010. The purpose of this notice is to allow an additional 30 days for public comment to the revisions. 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: Cancer Trial Support Unit (CTSU). Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: CTSU collects annual surveys of customer satisfaction for clinical site staff using the CTSU Help Desk and the CTSU Web site. An ongoing user satisfaction survey is in place for the Oncology Patient Enrollment Network (OPEN). User satisfaction surveys are compiled as part of the project quality assurance activities and used to direct improvements to processes and technology. In addition, the CTSU collects standardized forms to process site regulatory information, changes to membership, patient enrollment data, and routing information for case report forms. This questionnaire adheres to The Public Health Service Act, Section 413 (42 U.S.C. 285a-2) authorizes CTEP to establish and support programs to facilitate the participation of qualified investigators on CTEP- supported studies, and to institute programs that minimize redundancy among grant and contract holders, thereby reducing overall cost of maintaining a robust treatment trials program. Based on a conversation with the Office of Management and Budget on October 17, 2010, the burden table has been revised to take into account future submissions of a generic data transmittal forms (see Attachment 1gg in the Table below). It was agreed that the generic forms will be finalized and submitted in the future as non-substantive change requests for OMB clearance as needed. Frequency of Response: The help desk and Web site survey are collected annually. The OPEN survey is ongoing. The form submissions vary depending on the purpose of the form and the activity of the local site. Affected Public: CTSU's target audience is staff members at clinical sites and CTEP-supported programs. Respondent and burden estimates are listed in the Table below. The annualized burden is estimated to be 34,802 hours and the annualized cost to respondents is estimated to be $946, 601. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Presidential Commission for the Study of Bioethical Issues (PCSBI) will conduct its third meeting in November. At this meeting, the Commission will continue discussing the emerging science of synthetic biology, including its potential benefits and risks, and appropriate ethical boundaries and principles. The Commission will develop and finalize recommendations concerning any actions that the Federal Government should take to ensure that America reaps the benefits of this developing field of science while identifying appropriate ethical boundaries and minimizing risks. It will also identify suggestions for future study, if any.

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).

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of eight new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.