Department of Health and Human Services October 10, 2007 – Federal Register Recent Federal Regulation Documents
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Submission for OMB Review; Comment Request; Graduate Student Training Program Applications
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Graduate Partnerships Program/OIR/ OD/, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on Monday, June 25, 2007/Vol. 72, No. 121/Pages 34692-34693 and allowed 60-days for public comment. No public comments were received. 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: Graduate Student Training Programs Application. Type of Information Collection Request: Revision. Need and Use of Information Collection: The information gathered in the Graduate Student Training Programs application will enable the identification and evaluation of graduate students interested in performing their dissertation research in the NIH Intramural Research Program laboratories (NIH-IRP). The GSTP application models graduate university applications by containing the sections that will aid in the NIH Admission Committee's evaluation of an applicant: Contact information, citizenship, education history and transcripts, standardized examination scores, research interests, personal statement research proposal, references and letters of recommendation, and partnership selection. Ethnicity and gender are additional optional information used to evaluate the GPP recruiting abilities and compliance with federal regulations. Feedback questions forwarded to interviewed applicants will assist in modifying interview day schedules and identification of factors used when deciding to accept or decline the admission offer. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Students pursuing an advanced degree and wish to perform dissertation research in the NIH Intramural Research Program laboratories. The annual reporting burden is displayed in the following table:
Notice of meeting of the Advisory Committee on Organ Transplantation
Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the thirteenth meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on November 15, 2007, and from 9 a.m. to 3 p.m. on November 16, 2007, at the Crowne Plaza Hotel Washington, DCSilver Spring, 8777 Georgia Avenue, Silver Spring, MD 20910. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).
Prospective Grant of Exclusive License: Devices for Countercurrent Chromatography
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: HHS Ref. No. E-321-2007 ``Second Generation Improved Spiral Tube Support for Countercurrent Chromatography'' to CC Biotech LLC, a company incorporated under the laws of the State of Maryland having its headquarters in Rockville, Maryland. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to devices and components for centrifugal or countercurrent chromatographic purification, isolation, or preparation of biomolecules and macromolecules.
Administration on Children, Youth and Families; Award Announcement
The Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), herein announces the awarding of fifty supplemental awards in the amount of $5,733,115 to Fiscal Year (FY) 2006 Mentoring of Children of Prisoners (MCP) grantees. Section 439 of the Social Security Act, as amended by the Child and Family Services Improvement Act of 2006 (Pub. L. 109-288) authorizes the Secretary of Health and Human Services (HHS) to award grants for the purpose of supporting the establishment or expansion and operation of community-based programs to provide one-on-one mentoring relationships between a child of incarcerated parent(s) and a caring, supportive adult mentor under the Mentoring Children of Prisoners Program (MCP). The program is designed to reach the President's goal of establishing 100,000 mentor/mentee relationships between a caring adult and a young person whose parent(s) is incarcerated in a correctional facility by the end of FY 2008. This funding is requested for those grantees that have demonstrated the capacity to make quality matches and currently making significant process in reaching their match goal. One-third of the grantees have made over 50% of their three-year match goal within their first year. The fifty supplemental awards are important to helping our grantees reach more youth who are in need of a mentor. The following agencies are receiving grant funds for a twelve month project period:
Award Announcement; Administration on Children, Youth and Families
The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) announces the approval of a deviation to supplement the National Runaway Switchboard for the purpose of expanding their services. Congress authorized the establishment of a ``national communications system to assist runaway and homeless youth in making contact with their families and service providers'' through the Runaway and Homeless Youth Act (RHYA) of the Juvenile Justice and Delinquency Prevention Act of 1974, as amended. Funding for the system was first authorized in fiscal year 1980. (The system currently is authorized through Part C, section 331, of the ``Runaway, Homeless, and Missing Children Protection Act,'' Pub. L. 108-96.) The Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), herein announces an expansion supplement award to the National Runaway Switchboard (NRS) for two initiatives; a comprehensive research project on runaway and at-risk youth and a comprehensive database conversion. The results of the comprehensive research project will enable NRS to better understand how to communicate with youth and develop strategies to connect with them and them with the NRS. The comprehensive database conversion will enhance the Switchboard's capability to download and manage information. This project will provide the NRS with the internal controls necessary to query and analyze data collected in their crisis logs. It is anticipated that the enhanced internal controls will result in a significant improvement in the way needs of runaway, homeless and other youth in at-risk situations are met. This expansion supplement is for a nine month project period for the amount of $162,637.
Administration fon Children, Youth and Families; Award Announcement
The Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), herein announces the awarding of ten supplemental awards in the amount of $1,932,300 to fund Fiscal Year (FY) 2007 Runaway and Homeless Youth Training and Technical Assistance cooperative agreements. The average amount per grantee would be $192,230. Section 439 of the Social Security Act, as amended by the Child and Family Services Improvement Act of 2006 (Pub. L. 109-288) authorizes the Secretary of Health and Human Services (HHS) to award grants for the purpose of supporting the establishment or expansion and operation of community-based programs to provide one-on-one mentoring relationships between a child of incarcerated parent(s) and a caring, supportive adult mentor under the Mentoring Children of Prisoners Program (MCP). This supplemental funding will be used to access the capacity building expertise of the ten Runaway and Homeless Youth Training and Technical Assistance Providers for the purpose of enhancing the capacity of newly awarded lower scoring community and faith-based MCP grantees. It is expected that the supplementing of the ten RHY Training and Technical Assistance Providers will result in the reduction in program start-up issues and other barriers to high performance. It is critical that these MCP grantees receive the best possible services as it relates to enhancing their capacity to develop and maintain a quality mentoring program. The following agencies are receiving grant funds for a twelve month project period:
Menley & James Laboratories, Inc. et al.; Withdrawal of Approval of Six New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of six new drug applications (NDAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for the applications.
Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2008 Proposed Guidance Development; Establishment of a Public Docket
The Food and Drug Administration (FDA) is announcing the Web location where it will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA is establishing a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates; Correction
This document corrects technical errors that appeared in the final rule with comment period entitled ``Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates'' that appeared in the August 22, 2007 Federal Register.
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