Department of Health and Human Services August 11, 2005 – Federal Register Recent Federal Regulation Documents

Provide a clear and concise summary of the proposed goals, major objectives and activities required for achievement of program goals, and amount of funding requested for budget year one of this cooperative agreement. Project Context and Background (Understanding and Need) Project StrategyDescription and Methodologies Project Goals Project Outputs Project Contribution to the Goals and Objectives of the Emergency Plan for AIDS Relief Work Plan and Description of Project Components and Activities Performance Measures Timeline (e.g., GANNT Chart) Management of Project Funds and Reporting. You may include additional information in the application appendices. The appendices will not count toward the narrative page limit. This additional information includes the following: Budget Justification (only for Year 01) Curricula Vitae Organizational Charts Letters of Support You must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access https://www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the HHS/CDC web site at: https://www.cdc.gov/od/pgo/ funding/grantmain.htm. If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter. Additional requirements that could require you to submit additional documentation with your application are listed in section ``VI.2. Administrative and National Policy Requirements.''

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2006. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), authorizes FDA to collect user fees for certain medical device applications. The FY 2006 fee rates are provided in this notice. For all applications submitted on or after October 1, 2005, and through September 30, 2006, fees must be paid at the FY 2006 rates at the time the applications are submitted to FDA. The fee you must pay is the fee that is in effect on the date your application is received by FDA or on the date your check is received, whichever is later. This notice provides details on how fees for FY 2006 were determined and payment procedures for medical device applications subject to user fees.