cdc-rfa-ps15-150102cont16 07 01 15 final.docx

Centers for Disease Control and Prevention (CDC) Procurement and Grants Office Instructions for Preparing an Annual Performance Report (APR) Catalog of Federal Domestic Assistance (CFDA): 93.116 Funding Opportunity Announcement (FOA) Number: CDC-RFA-PS15-150102CONT16

Tuberculosis Elimination and Laboratory Cooperative Agreement National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Eligibility:

This award will be a continuation of funds intended only for grantees previously awarded under PS15-1501, Tuberculosis Elimination and Laboratory Cooperative Agreement.

Application Submission:

CDC requires grantees to submit their Annual Performance Reports (APR), which serves as the continuation application, through www.Grants.gov NLT 120 days prior to the end of the budget period.

If you encounter any difficulties submitting your annual performance report through www.Grants.gov, please contact CDC’s Technical Information Management Section at 770-488-2700 prior to the submission deadline. If you need further information regarding the annual performance report process, please contact Edna Green, Grants Management Specialist, at 770-488-2858. For programmatic information, please contact Glen Christie, Project Officer, at 404-639-8133.

Reports must be submitted by August 31, 2015, 11:59pm Eastern Standard Time on www.Grants.gov for Reporting Period 1/1/2015- 6/30/2015. Late or incomplete reports could result in an enforcement action such as a delay in the award or a reduction in funds. CDC will accept requests for a deadline extension on rare occasions and after adequate justification has been provided.

General Application Packet Tips:

· Properly label each item of the application packet

· Each section should use 1.5 spacing with one-inch margins

· Number all narrative pages only

· This report must not exceed 45 pages excluding administrative reporting; allowed, but web links are allowed

· Where the instructions on the forms conflict with these instructions, follow these instructions

1. CDC requires the use of PDF format for ALL attachments.

2. Use of file formats other than PDF may result in the file being unreadable by CDC staff.

3. Directions for creating PDF files can be found on www.Grants.gov

Checklist of required contents of application packet:

1. SF-424 Application for Federal Domestic Assistance-Short Organizational Form

2. SF-424A Budget Information-Non-Construction Programs

3. Budget Justification

4. Indirect Cost Rate Agreement

5. Project Narrative

Instructions for accessing and completing required contents of the application package:

a) Go to: www.Grants.gov

b) Select: “Apply for Grants”

c) Select: “Step 1: Download a Grant Application”

d) Insert the PS15-150102CONT16 only

e) Download application package and complete all sections.

1. SF-424 Application for Federal Domestic Assistance-Short Organizational Form:

Complete all sections:

A. In addition to inserting the legal name of your organization in Block #5a, insert the CDC Award Number provided in the CDC Notice of Award. Failure to provide your award number could cause delay in processing your application.

B. Please insert your organization’s Business Official information in Block #8.

SPECIAL NOTE: Items 2, 3, and 4 should be attached to the application through the “Mandatory Documents” section of the “Grant Application” page. Select “Other Attachments Form” and attach as a PDF file.

2. SF-424A Budget Information and Justification:

A. Download the form from www.grants.gov.

B. Complete all applicable sections.

C. Estimated Un-obligated

1. Awardees may request up to 75% of anticipated unobligated funds at the end of the current budget period.

2. If use of estimated un-obligated funds is requested in addition to funding for the next year, complete all columns in Section A of SF-424A and submit an interim Federal Financial Report (FFR), Standard Form-425, available on the CDC internet at http://grants.nih.gov/grants/forms.htm#closeout.

D. The estimated un-obligated balance should be realistic in order to be consistent with the annual FFR to be submitted via eRA Commons following the end of the budget period.

E. Based on the current rate of obligation, if it appears there will be un-obligated funds at the end of the current budget period, provide detailed actions that will be taken to obligate this amount.

F. If it appears there will be insufficient funds

1. Provide detailed justification of the shortfall

2. List the actions taken to bring the obligations in line with the authorized funding level.

3. Provide a “true needs budget” to include activities planned in the event there are supplemental funds (e.g., outbreak investigations, surveillance, contracted services lost due to budget cuts, other special needs).

G. The proposed budget should be based on the federal funding level stated in the letter from CDC.

H. In a separate narrative, provide a detailed, line-item budget justification of the funding amount requested to support the activities to be carried out with those funds. Attach in the “Mandatory Documents” box under “Budget Narrative Attachment Form.” Document needs to be in the PDF format.

I. The budget justification must be prepared in the general form, format, and to the level of detail as described in the CDC Budget Guidance. The sample budget guidance is provided on CDC’s internet at: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm.

J. For any new proposed subcontracts provide the information specified in the Budget Guidance.

K. When non-federal matching is required, provide a line-item list of non-federal contributions including source, amount, and/or value of third party contributions proposed to meet a matching requirement.

3. Indirect Cost Rate Agreement (This is not applicable to grantees subject to OMB Guidance A-21 – Educational Institutions. The rates stay the same as the first year award.):

A. If indirect costs are requested, include a copy of the current negotiated federal indirect cost rate agreement or a cost allocation plan approval letter for those Grantees under such a plan.

B. Clearly describe the method used to calculate indirect costs. Make sure the method is consistent with the Indirect Cost Rate Agreement.

C. To be entitled to use indirect cost rates, a rate agreement must be in effect at the start of the budget period.

D. If an Indirect Cost Rate Agreement is not in effect, indirect costs may be charged as direct if (1) this practice is consist with the grantee’s/applicant’s approved accounting practices; and (2) if the costs are adequately supported and justified. Please see the Budget Guidelines (http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm) for additional information.

E. If applicable, attach in the “Mandatory Documents” box under “Other Attachments Form”. Name document “Indirect Cost Rate.”

4. Project Narrative:

Within the 45-page limit of the APR, awardees should use a maximum of 30 pages for P&C; 5 pages for HRD; and 10 pages for Laboratory Strengthening to cover performance reporting and continuation funding application.

Section I. Current Budget Period Progress:

The annual performance report must include the following:

· Performance Measures (including outcomes)–Awardees must report on performance measures for each budget period and update measures, if needed.

· Evaluation Results–Awardees must report evaluation results for the work completed to date (including any data about the effects of the program).

· Work Plan –Awardees must update work plan each budget period.

· Successes

· Awardees must report progress on completing activities outlined in the work plan.

· Awardees must describe any additional successes (e.g., identified through evaluation results or lessons learned) achieved in the past year.

· Awardees must describe success stories.

· Challenges

· Awardees must describe any challenges that might affect their ability to achieve annual and project-period outcomes, conduct performance measures, or complete the activities in the work plan.

· Awardees must describe any additional challenges (e.g., identified through evaluation results or lessons learned) encountered in the past year.

· CDC Program Support to Awardees

· Awardees must describe how CDC could help them overcome challenges to achieving annual and project-period outcomes and performance measures, and completing activities outlined in the work plan.

· Administrative Reporting (No page limit)

· SF-424A Budget Information-Non-Construction Programs.

· Budget Narrative–must use the format outlined in “Content and Form of Application

· Submission, Budget Narrative” section.

· Indirect Cost-Rate Agreement.

Performance and outcome reporting requirements specific to each component are as follows:

Prevention and Control (P&C):

a. One-page summary report on National TB Program Objectives using NTIP system including a description of which objectives were met and what the impediments were to meeting the objectives.

b. Report on the priority level activities highlighting successful outcomes, including developing benchmarks for specific activities.

c. Report of an integrated approach, such as PCSI, which was undertaken to foster collaboration and coordination of proposed activities in the work plan.

d. Report describing barriers and challenges to program implementation of the proposed priority level strategies/activities that were encountered; how was the planned program modified to accommodate them?

e. PE annual report must have the followings four sections (i–iv) and address the relevant components:

i. Introduction: Description of the Evaluation Objectives

1. Describe the purpose of your evaluation

2. Provide rationale for selecting evaluation focus area

3. State how NTIP and/or other data sources were used to select evaluation focus area

4. Define the evaluation objectives and key evaluation questions to be answered that are consistent with the activities and outcomes in the work plan

5. Identify expected outcomes (short, medium, long)

ii. Description of Data Collection and Analyses for Each Evaluation Objective.

1. Describe the type of evaluation (process and outcome)

2. Describe how and when the evaluation was conducted (list activities and timeline)

3. Describe data sources

4. Describe methodology for data collection and analysis

iii. Conclusion and Discussion of Results.

1. Provide results of the proposed evaluation objectives/key questions. If not achieved, why not? Discuss barriers to and facilitators of achieving the objective(s).

2. Provide an interpretation of results for each evaluation objective/key questions.

3. Provide a statement of findings with respect to evaluation in attaining the National TB Program Objectives (how evaluation findings can be linked with the objectives).

4. Discuss limitations that may have affected the evaluation's findings.

iv. Recommendations to Program Administrators for Future Program Focus and Evaluation Efforts.

1. Describe the emerging, promising, and best and/or evidence-based practices.

2. List the lessons learned and program recommendations based on the evaluation findings.

3. Identify the next focus area for evaluation.

4. Identify plans to share lessons learned (i.e. webinars, conferences, publications).

f. Cohort Review Reports: Grantees should report the progress on conducting cohort reviews, including the number of cases discussed, key issues identified during the reviews and recommendations provided.

Format for Cohort Review Reporting:

Date(s) of Cohort Review(s)

Number of cases discussed (per review/total)

Summary of review process

Key Issues Identified and resolved

Recommendations

New tools or trainings

The Designated Evaluation Focal Point:

Name:

Job title:

Mailing address:

Telephone:

FAX number:

Email:

Human Resources Development:

Grantees should report on progress of HRD activities and achievements for the previous year. The report should include, but not limited to, description of utilization of funds; training courses conducted or attended; educational resources purchased or leased; attendance at TB ETN conference and focal point meeting; and salary for training and education personnel.

The Annual HRD Progress Report should also include a description of how identified needs were addressed, as well as barriers and opportunities identified in the area of TB HRD.

Please list objectives and activities to

1. Establish and improve existing in-service TB training and human resource development.

2. Establish evaluation strategies to improve existing systems and to identify ongoing training and HRD needs.

3. Establish and improve patient education and communications capacity within the program.

4. Coordinate training related to TB control with training for other disease control interventions, such as HIV/AIDS, viral hepatitis, and STD.

5. Target other health care providers or organizations serving high-risk populations.

Public Health Laboratory Strengthening:

a. Update work plan (i.e., organizational charts, laboratory contact, methods, and TAT and workload data).

b. Report on success and challenges for strategies and activities in meeting proposed outcomes for each laboratory element based on level of service and workload.

· Element 1: Ensuring availability of high-quality and prompt core laboratory services that meet CDC and Healthy People 2020 recommended TATs.

· Element 2: Promoting continual advancement of laboratory efficiency and quality assurance through use of local data.

· Element 3: Collaborating with partners to ensure optimal use of laboratory services.

Propose new activities for next budget year to continue progress toward meeting stated outcomes. The following instructions should be used as guide in providing the information that will serve as the application for the next budget year funding.

Section II. New Budget Period Proposed Objectives and Activities:

A. List proposed objectives for the upcoming budget period. These objectives must support the intent of the original Funding Opportunity Announcement (FOA) or Program Announcement (PA).

B. Each objective and activity must contain a performance or outcome measure that assesses the effectiveness of the project.

C. For each objective:

1. List activities that will be implemented;

2. Provide a timeline for accomplishment;

3. Identify and justify any redirection of activities; and

4. Explain the methods you will use to implement the new, redirected activities.

D. In addition to this information, include comments pertaining to budgetary issues that might hamper the success or completion of the project as originally proposed and approved. Please utilize the work plan format in the original work plan, if applicable.

For budget period 02 and beyond of the award, awardees may request up to 75% of their estimated unobligated funds be carried over into the next budget period.

The carryover request must:

· Express a bona fide need for permission to use an unobligated balance;

· Include a signed, dated, and accurate Federal Financial Report (FFR) for the budget period from which funds will be transferred (NTE 75% of unobligated balances); and

· Include a list of proposed activities, an itemized budget, and a narrative justification for those activities.]

5. Additional Program Requirements (If applicable)

Program should include guidance for any additional requirements of the recipient for the upcoming budget period. Changes in programmatic priorities must be within the scope of the approved funding opportunity announcement and Notice of Award.

As stipulated in the original FOA for the current project period the Aggregate Report for Program Evaluation (ARPE) is due on August 15. The Final ARPE report is due for the current year minus two (for example, in 2015, the Final report is due for year 2013). The Preliminary ARPE report is due for the current year minus one (for example, in 2015, the Preliminary report is due for year 2014). In year 2015, the Final 2013 and Preliminary 2014 will be due.

Note: The National TB Indicators Project (NTIP) has performance outcome reports for each project area. You may use these reports in your analysis, and for comparison with state and local data. Access can be found at ntip@cdc.gov, or contacting the helpdesk at 404-639-8444; Hours: 8 a.m.–5 p.m. (EST), Monday–Friday.

Performance Measure Reporting: CDC programs must require awardees to submit performance measures annually as a minimum, and may require reporting more frequently. Performance measure reporting must be limited to data collection. When funding is awarded initially, CDC programs must specify required reporting frequency, data fields, and format.

Awardees will meet this annual requirement to report on performance measures with the submission of an Annual Performance Report. However, CDC may request an additional report, the Performance Measure Report, in certain instances such as a jurisdiction’s response to a large TB outbreak.

Performance Measure Reports should at minimum include:

Report on the activities completed Outcomes achieved Challenges experienced Program improvements as applicable Additional support (if any) requested from CDC

Awardees submitting Performance Measure Reports for response to large TB outbreaks should provide a report 90 days following the response and quarterly thereafter for the first year of outbreak response, and at least semiannually thereafter until the outbreak subsides.

Below are additional guidance provided to assist in completing the laboratory component for the Annual Performance Report:

The annual performance review for the Laboratory Component should include the following information and address Laboratory Elements 1, 2, and 3 as described below.

Provide an organizational chart of personnel performing laboratory testing for TB. Include a designated laboratory contact with contact information. Provide a brief description of the methods used in the laboratory, including those for specimen processing, direct detection, acid-fast bacilli (AFB) smear, culture, identification, and drug-susceptibility testing (DST) as well as a brief overview of testing algorithm. The concise description should include information on overall flow of specimens in the laboratory, how testing is reflected, referral practices, reporting protocols, electronic test ordering and reporting, and number of days per week testing is performed.

Laboratory Element 1: Ensure availability of high-quality and prompt core laboratory services for TB. All laboratories, regardless of volume, should describe anticipated outcomes and the specific strategies and activities for achieving these outcomes based on your laboratory-specific baseline for each indicator, and describe annual, incremental goals for improving turnaround time (TAT).

Laboratory-specific benchmarks should be established in an effort to meet or exceed national benchmarks. If currently meeting national benchmarks, focus activities on continued improvement or sustained efforts. Describe any potential obstacles to meeting outcomes. Application may include plans to increase access to molecular testing in-line with local and national guidelines as well as plans for referral (e.g., first-line DST).

In tabular form, report the laboratory’s data for each of the following workload and TAT indicators for the previous calendar year and year-to-date (January–June). These data should reflect testing for your jurisdiction only. (Refer to Glossary for an explanation of laboratory terms.)

1) Total number of clinical specimens that were processed for smear and culture. Do not include isolates referred from another laboratory.

2) Number of individual patients for whom a clinical specimen was processed for smear and culture

a. Of these, report the number of individual patients for whom at least one culture was positive for M. tuberculosis complex (MTBC).

b. Of these individuals positive for MTBC by culture, how many individual patients were initially positive by nucleic acid amplification testing (NAAT) of a clinical specimen in your laboratory? Note: This number should not include specimens referred for NAAT only (i.e., no culture performed in your laboratory). (Allows assessment of Healthy People 2020 goal)

3) Number of individual patients for whom a reference isolate was received to rule out or confirm the identification of MTBC. This should not include known nontuberculous mycobacteria.

a. Of these, report the number of individual patients that had at least one reference isolate identified as MTBC.

4) Number of individual patients for whom growth-based MTBC first-line DST was performed and/or, if was not performed in-house, for whom an isolate was referred to another laboratory for DST.

5) Number of individual patients for whom a clinical specimen or processed referred sediment was tested directly with a NAAT. (This includes testing performed in-house and referred testing.) This does not refer to rapid species identification tests performed on isolates (e.g., ACCUPROBE).

a. Of these, report the number of individual patients for whom a NAAT result was positive for MTBC. Note: For labs that accept referred specimens or sediments for NAAT-only, this number may be higher than data reported for 2b above.

6) Number of individual patients for whom the laboratory referred an isolate of MTBC for genotyping.

7) If applicable, provide the total number of interferon gamma release assays (IGRA) performed by your public health laboratory.

Report the calculated TAT for each recommendation as described below. Calculations should include weekends and holidays. Current performance targets can be found at http://www.aphl.org/aphlprograms/infectious/tuberculosis/pages/tb-cooperative-agreement.aspx

· Promote rapid delivery of specimens to the laboratory. Benchmark is receipt within 1 day of specimen collection. Report cumulative percent received within 1, 2, and 3 calendar days.

Volume Considerations for Addressing Laboratory Elements 2 and 3 Laboratories receiving < 2,000 clinical specimens each year should provide at least one measureable outcome for both components 2 and 3 as described below. Those laboratories receiving 2001–6,000 clinical specimens each year should provide at least two measurable outcomes, and those receiving > 6,000 clinical specimens each year should provide at least three measurable outcomes for each element 2 and 3.

Laboratory Element 2: Promote continual advancement of laboratory efficiency and quality assurance through use of local data. Set measurable outcomes specific for your laboratory volume and services. Specific strategies and activities to include in evaluation plans should be described and progress updated in all subsequent progress reports. As an example, laboratories might consider assessing testing algorithms and workload trends for potential redundancies, sources of delay, and efficient use of CDC or reference laboratory services.

Progress and evaluation may include an overview of any written policies to eliminate redundant testing. Additionally, applicants might examine business practices (e.g., electronic test ordering and reporting, cost recovery, referral systems, or data management) for process improvements. Laboratories may also consider use of the Association of Public Health Laboratories (APHL) tool, “Mycobacterium tuberculosis: Assessing your laboratory” as another means to examine local practices to potentially identify areas for improvements: http://www.aphl.org/aphlprograms/infectious/tuberculosis/Pages/TB-Self-Assessment-Tool.aspx It is anticipated that laboratories will implement process improvements during the 5-year project period. Gained efficiencies due to changes in practices should be monitored and documented.

Laboratory Element 3: Collaborate with partners (e.g., healthcare providers, TB control, and laboratory network) to ensure optimal use of laboratory services and timely flow of information. Set measurable outcomes appropriate for your laboratory volume and level of service. Describe strategies and activities to achieve outcomes and how progress will be evaluated. As an example, laboratories might initiate plans for educational opportunities/consultation for TB control and laboratory network, find opportunities to integrate evidence-based local practices with broader public health laboratory system and national strategies, and collaborate with TB control to improve awareness and understanding of laboratory services (e.g., development of specimen collection guidelines or promotion of laboratory services including NAAT). Evaluable feedback from both the laboratory, TB control, and other partners should be included as part of future reports to assess progress.

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