The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) is announcing its intent to accept and consider a single source application for the award of a grant to the Duke University’s Duke Translational Medicine Institute (DTMI) to support increasing the quality and efficiency of clinical trials. Funding Opportunity Number: RFA-FD-14-017. Assistance Listing: 93.103. Funding Instrument: G. Category: FN,HL. Award Amount: Up to $7.5M per award.

The Center for Drug Evaluation and Research (CDER) receives a vast and growing amount of data in a variety of regulatory submissions from a multitude of sources and in a variety of formats. This wealth of data holds great potential to advance CDER’s regulatory and scientific work, but the present lack of standardized data creates significant challenges to realizing that potential.The volume and complexity of drug-related information submitted to CDER for regulatory review is creating significant challenges to the Center’s ability to efficiently and effectively perform its critical public health mission.The lack of standardized data affects CDER’s review processes by curtailing a reviewer’s ability to perform integral tasks such as rapid acquisition, analysis, storage and reporting of regulatory data. Improved data quality, accessibility and predictability will give reviewers more time to carry out complex analyses, ask in-depth questions and address late-emerging issues. Standardized data will allow reviewers to increase review consistency and perform evaluations across the drug lifecycle. This will enhance the Center’s performance across key drug regulatory functions and ongoing business operations, including pre-market review, post-market safety, oversight of drug quality, and oversight of drug promotion.In accordance with the Office of Management and Budget (OMB) Circular A-119, the FDA will: use voluntary, consensus-based standards development processes in place of government unique standards unless such standards are inconsistent with law or otherwise impractical; advocate to align these standards with existing health information technology initiatives, laws, regulations, and mandates; and promote coordination with other standards currently in use. The projects selected under this funding opportunity must adhere to these principles. Funding Opportunity Number: RFA-FD-15-033. Assistance Listing: 93.103. Funding Instrument: CA. Category: FN,IS. Award Amount: $50K – $225K per award.

The goal of these cooperative agreements is to facilitate long-term improvements to the national integrated food safety system by unifying and coordinating federal/state/local food/feed emergency response efforts including: 1) Strengthening the link among epidemiology, lab and environmental health/regulatory components; 2) Improving States' regulatory and surveillance food/feed protection programs to include using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to conduct integrated responses to all-hazards food/feed emergencies, rapidly identifying and removing tainted food from commerce, and conducting root cause investigations to inform future prevention efforts; and 3) Addressing supporting components, such as training, data sharing, data analysis, communications, continuous process improvement, and development of best practices and other resources to support national capacity/capability development. This will be accomplished through the provision of funding to support development of multi-jurisdictional, multi-disciplinary Rapid Response Teams (RRTs) and will require extensive cooperation and coordination with FDA District Offices and other FDA program offices. Funding Opportunity Number: RFA-FD-16-032. Assistance Listing: 93.103. Funding Instrument: CA. Category: CP,FN,HL. Award Amount: Up to $300K per award.

Program Announcement No. OSBDC-2010-02. Note: Program Announcements No. OSBDC-2010-01 (for FY applicants) and No. OSBDC-2010-02 (for CY applicants) are identical in content. U.S. Small Business Administration / Office of Small Business Development Centers (OSBDC) OPENING DATE: June 1, 2009 CLOSING DATE: August 27, 2009 The U.S. Small Business Administration (SBA) plans to issue Program Announcement No.OSBDC-2010-02 to invite applications to renew funding for existing recipient organizations currently funded under the Small Business Development Center (SBDC) program as authorized by Section 21 of the Small Business Act, (15 USC Section 648). Applicants will provide business management and technical assistance, including short and long-term counseling, training to clients who want to start or expand a small business. The SBDC program is the SBA’s largest matching grant-funded service delivery network providing high quality business and economic development assistance to small businesses and nascent entrepreneurs in order to promote growth, expansion, innovation, increased productivity and management improvement. The SBDCs, in partnership with SBA’s Office of Small Business Development Centers (OSBDC) and SBA District Offices, develop programs and provide business management and other services that enhance the economic development goals and objectives of SBA and their other respective state and local funding partners. The SBDC program is a broad-based system of assistance for the small business community that links the resources of Federal, state, and local governments with those of the educational community and the private sector. Although SBA is responsible for the general management and oversight of the SBDC program, a partnership exists between SBA and the recipient organization to effectuate the delivery of assistance to the small business community. Award recipients must provide non-Federal matching funds at the rate of one non-Federal dollar for each Federal dollar. Up to one-half of the non-Federal match funds may be in the form of in-kind contributions but at least 50% of match must be in cash. Questions about this program announcement should be directed to the Office of Small Business Development Centers at the SBA, at (202)205-6766. Note: Program Announcements No. OSBDC-2010-01 (for FY applicants) and No. OSBDC-2010-02 (for CY applicants) are identical in content. Funding Opportunity Number: OSBDC-2010-02. Assistance Listing: 59.037. Funding Instrument: CA. Category: BC. Award Amount: $611K – $6.6M per award.

Program Announcement No. OSBDC-2011-01. Note: Program Announcements No. OSBDC-2011-01 (for FY applicants) and No. OSBDC-2011-02 (for CY applicants) are identical in content. U.S. Small Business Administration / Office of Small Business Development Centers (OSBDC) OPENING DATE: May 21, 2010 CLOSING DATE: see above The U.S. Small Business Administration (SBA) plans to issue Program Announcement No.OSBDC-2011-01 to invite applications to renew funding for existing recipient organizations currently funded under the Small Business Development Center (SBDC) program as authorized by Section 21 of the Small Business Act, (15 USC Section 648). Applicants will provide business management and technical assistance, including short and long-term counseling, training to clients who want to start or expand a small business. The SBDC program is the SBA’s largest matching grant-funded service delivery network providing high quality business and economic development assistance to small businesses and nascent entrepreneurs in order to promote growth, expansion, innovation, increased productivity and management improvement. The SBDCs, in partnership with SBA’s Office of Small Business Development Centers (OSBDC) and SBA District Offices, develop programs and provide business management and other services that enhance the economic development goals and objectives of SBA and their other respective state and local funding partners. The SBDC program is a broad-based system of assistance for the small business community that links the resources of Federal, state, and local governments with those of the educational community and the private sector. Although SBA is responsible for the general management and oversight of the SBDC program, a partnership exists between SBA and the recipient organization to effectuate the delivery of assistance to the small business community. Award recipients must provide non-Federal matching funds at the rate of one non-Federal dollar for each Federal dollar. Up to one-half of the non-Federal match funds may be in the form of in-kind contributions but at least 50% of match must be in cash. Questions about this program announcement should be directed to the Office of Small Business Development Centers, at (202)205-6766. Note: Program Announcements No. OSBDC-2011-01 (for FY applicants) and No. OSBDC-2011-02 (for CY applicants) are identical in content. Funding Opportunity Number: OSBDC-2011-01. Assistance Listing: 59.037. Funding Instrument: CA. Category: BC. Award Amount: $628K – $6.8M per award.

The purpose of this agreement is to allow the Service and the Cooperators to jointly sponsor environmental and cultural education programming serving children in communities within or adjacent to Alaska's 16 National Wildlife Refuges. All environmental education programming's purpose is to bring together science and traditional knowledge and experience, and to help young people understand, appreciate, and practice stewardship. Program Objectives: 1.Increased awareness and understanding of Alaska National Wildlife Refuges and regional natural and cultural history among school children and participating in adults in communities neighboring refuges. 2.Increased skills among children related to scientific inquiry and traditional cultural practices. 3.Participants and the host community will have a positive experience interacting with Service staff and volunteers. Content and Form of Application Submission A complete application package will include the following: 1.A project proposal (4 pages maximum) including: *Statement demonstrating established partnership with one or more of Alaska National Wildlife Refuge including: (contact information of local refuge staff, a description of past successful partnership(s) *Statement demonstrating community (physical, economic, social, financial, institutional) need for the program. The results or benefits expected ones that solution has been achieved. *Statement demonstrating that environmental education programming will provide a quality environmental education experience. In other words, the environmental education opportunity must offer learning opportunities which support behavioral objectives that compliment management and outreach objectives of the refuge. *Statement demonstrating a partnership with other Fish and Wildlife Service programs or private partners to not only leverage dollars to maximize impacts but to, where possible, combine staff efforts to achieve common goals and remove duplicative efforts in communities. Science camps are encouraged to demonstrate at least a 25 percent nonfederal match. Budget Narrative A.Applicant's contribution (Include both monetary and in-kind services. Please indicate whether the funds are federal or non-federal). B.Other partners' contributions (Include monetary and in-kind services. Please indicate whether the funds are federal or non-federal) C.Funds requested from the Fish and Wildlife Service D.Total Project Cost (Sum of A, B, and C) E.Total value of non-federal contribution F.Total value of federal contribution G.Non-federal percent of total project cost [calculated as (E/E+F)*100] Contact Include name, agency or organization, address, phone, FAX, e-mail. Submission Dates and Times, effect of missing a deadline Application must be postmarked, faxed, transmitted through Grants.govAPPLY by 4:00 p.m. Alaska Time, February 29, 2012. It is the applicant's responsibility to confirm receipt of their proposal with the designated Agency Contact. Funding Restrictions Projects may not involve political advocacy or litigation. Reasonable indirect/administrative costs are allowable. Limited reimbursement of pre-award costs is allowable; such costs are incurred at the risk of the applicant should the grant application not be selected for funding. Application Review Proposals will be evaluated by a regional visitor services panel. Panel members will review each proposal and judge the project's ability to: 1.Science camp funding will first be distributed to long standing camps with committed partners, measureable behavioral objectives and demonstrated successes. 2.Strong partnerships are greatly encouraged and will be given priority. Please be advised that the ratio of federal to nonfederal dollars is one of the criteria the panel will review when analyzing proposals. 3.New or expanded camps will be funded through this program unless the request for funding exceeds the dollars available. If requests for proposals exceed the funding amount then the Service will rank the proposals. Funding priority will be based on the following criteria: a.Population size of communities based on the 2010 Census data (e.g. Camps serving communities with less than 5,000 people will be given more consideration than larger communities - based on the premise that large communities have more opportunities and resources available to them); b.Number of students the camp will reach; c.Demonstration of a benefit to a refuge's purpose; d.Number of partners involved in the camp. Top rank proposals will be funded using the science camp allocation. The remaining proposals will be considered and ranked with the general CCS projects by the CCS panel if they propose a 50 percent or greater nonfederal match. Funding Opportunity Number: F12AS00053. Assistance Listing: 15.649. Funding Instrument: CA. Category: ED. Award Amount: $3K – $25K per award.