HRSA-14-139 - Severe Combined Immunodeficiency (SCID) Newborn Screening Implementation Program Review Criteria / Application and Comparison This does not replace the FOA. Please remember to review the FOA. Information that responds to the review criterion may not be contained in the Application Section identified below. The Panel cannot reduce their score because information is not in right place. Be sure to review all parts of the application. If information that responds to a review criterion is contained in another part of the application, then it must be considered. Remember the 3 C’s: Continuity ~ Consistency ~ Clarity o Continuity – Does the application and attachments make logical connections? o Consistency – Does the application and documents present consistent information? o Clarity – Does the application and attachments present a clear project and objects? PROJECT NARRATIVE INTRODUCTION -- Corresponds to Section V’s Review Criterion #1 NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criterion #1 METHODOLOGY -- Corresponds to Section V’s Review Criteria #2 & #4 Applicants must propose methods that will be used to address the stated needs and meet each of the 6 program requirements and listed under Purpose. Applicants must address how they will: Develop and implement a plan that will identify , select and support state and local public health agencies that have not fully implemented SCID as part of their newborn screening program. The plan must include how the applicant will assess the state or public health agency’s ability to implement SCID testing and follow-up, including availability of laboratory space, staff, and technical capacity to expand their newborn screening program to include newborn screening for SCID. Enter into sub-award agreements with state and local public health agencies, or other entities that will: a) Expand the capacity of existing newborn screening programs to incorporate the addition of SCID screening; counseling; and/or follow-up health 1 HRSA-14-139 - Severe Combined Immunodeficiency (SCID) Newborn Screening Implementation Program Review Criteria / Application and Comparison care services; and b) Assist in providing the public health and healthcare professional community (laboratory scientists, healthcare providers, newborn screening program officials, primary care physicians) needed knowledge, skills and training. Develop and deliver national, regional, or state educational and awareness programs (at appropriate literacy levels) to parents, families, and patient advocacy and support groups. Facilitate communication between subawardees and collaboration with: states that have fully implemented newborn screening for SCID; other relevant Federal programs and entities facilitating SCID newborn screening and data collection; and MCHB-funded programs including, but not limited to the Regional Genetics and Newborn Screening Collaboratives, the National Coordinating Center for the Collaboratives, the Newborn Screening Data Repository and Technical Assistance Center, and the Clearinghouse of Newborn Screening Information. Evaluate the progress towards achieving newborn screening for SCID in all states and territories. WORK PLAN AND LOGIC MODEL -- Corresponds to Section V’s Review Criteria #2 & #4 Describe the activities or steps that will be used to achieve each of the activities proposed during the entire project period. Use a time line that includes each activity (month-over-month) and identifies responsible staff. As appropriate, identify meaningful support and collaboration with key stakeholders. RESOLUTION OF CHALLENGES -- Corresponds to Section V’s Review Criterion #2 EVALUATION AND TECHNICAL SUPPORT CAPACITY -- Corresponds to Section V’s Review Criteria #3 & #5 ORGANIZATIONAL INFORMATION -- Corresponds to Section V’s Review Criterion #5 2 HRSA-14-139 - Severe Combined Immunodeficiency (SCID) Newborn Screening Implementation Program Review Criteria / Application and Comparison Budget and Budget Justification Narrative Corresponds to Section IV’s Budget Justification Narrative The budget forms along with the Budget Justification components of the itemized budget and budget narrative together should provide reviewers with the information to determine the reasonableness of the requested support. The budget must clearly demonstrate how support will be provided to state and local public health agencies or other entities to increase SCID newborn screening activities. Reminder: The awardee is expected to set aside at least 85% of the budget to directly support state newborn programs’, or other appropriate entities’’ efforts to expand the capacity to screen, treat, and educate about SCID newborn screening 3 HRSA-14-139 - Severe Combined Immunodeficiency (SCID) Newborn Screening Implementation Program Review Criteria / Application and Comparison Criterion 1: Need (5 points) 1) The extent to which the application demonstrates the problem and associated contributing factors to the problem. Application Project Narrative Introduction Needs Assessment Criterion 2: Response (40 points) 1) The extent to which the activities described in the application are capable of addressing the problem and attaining the project objectives. 2) The extent to which the applicant provides a description of a sustainability strategy for SCID testing and follow-up without the use of HRSA funding. 3) The extent to which the proposed approach is likely to produce an active SCID newborn screening program by the end of the project period. 4) The extent to which the work plan includes a logical, stepwise process to validate and implement SCID screening. 5) The extent to which the proposed activities are consistent with the program strategy. 6) The extent to which the timeline seems reasonable 7) The extent to which the appropriate state-wide and/or regional partnerships and collaborations (including clinical referral networks) are indicated and supported. 8) The extent to which the challenges that are likely to be encountered in designing and implementing the activities described in the Work Plan are identified and addressed Application Project Narrative Methodology Work Plan and Logic Model Resolution of Challenges Attachment 1 – Work Plan Attachment 4 – Letters of Agreement, Memoranda of Understanding and/or Descriptions of proposed/existing contracts Attachments 7-5 – Other Relevant Documents (letters of support) 4 HRSA-14-139 - Severe Combined Immunodeficiency (SCID) Newborn Screening Implementation Program Review Criteria / Application and Comparison Criterion 3: Evaluative Measures (10 points) 1) The extent to which the program objectives have been met. 2) The extent to which these can be attributed to the project; 3) The extent to which the applicant presents a reasonable plan to evaluate the process to implement screening. 4) The extent to which the applicant presents a reasonable plan to evaluate the implemented screening program. 5) The extent to which the applicant presents a plan to continuously measure performance against the proposed timeline. Application Project Narrative Evaluation and Technical Support Capacity Criterion 4: Impact (5 points) 1) The feasibility and effectiveness of plans for dissemination of project results, and 2) The extent to which project results may be national in scope, and 3) The degree to which the project activities are replicable, and 4) The sustainability of the program beyond the Federal funding. Application Project Narrative Methodology Work Plan and Logic Model 5 HRSA-14-139 - Severe Combined Immunodeficiency (SCID) Newborn Screening Implementation Program Review Criteria / Application and Comparison Criterion 5: Resources/Capabilities (30 points) 1) The extent to which the applicant demonstrates national expertise in SCID and related disorders, experience in developing and implementing national, regional, or state SCID newborn screening education and awareness campaigns, and experience collaborating with public health and community programs, professional organizations, and State and Federal agencies, as well as other programs and organizations to improve and provide newborn screening for SCID. 2) The extent to which the applicant demonstrates it can serve in a national capacity to coordinate activities among multiple state newborn screening programs and other stakeholders. Criterion 6: Support Requested (10 points) 1) The extent to which the proposed budget seems sufficient to manage all proposed activities. 2) The extent to which the proposed budget is reasonable for each year of the project period in relation to the objectives, the complexity of the projects activities, and the anticipated results. 3) The extent to which costs, as outlined in the budget and required resources sections, are reasonable given the scope of work. 4) The extent to which key personnel have adequate time devoted to the project to achieve project objectives. 5) The extent to which the budget justification logically documents how and why equipment purchases support the goals and activities of the project. Application Project Narrative Evaluation and Technical Support Capacity Organizational Information Attachment 2 – Staffing Plan and Job Descriptions Attachment 3 – Biographical Sketches of Key Personnel Attachment 4 – Letters of Agreement, Memoranda of Understanding and/or Descriptions of proposed/existing contracts Attachment 5 – Project Organizational Chart Attachments 7-5 – Other Relevant Documents (letters of support) Application Budget and Budget Justification Narrative Attachments 7-5 – Other Relevant Documents (letters of Support indicating a commitment to the project (in-kind services, dollars, staff, space, equipment, etc.) 6