cdc-rfa-ps13-130104cont16.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-PS13-130104CONT16

Accelerating the Prevention and Control of HIV/AIDS, Viral Hepatitis, STDs and TB in the U.S. Affiliated Pacific Islands

Eligibility:

This award will be a continuation of funds intended only for grantees previously awarded under PS13-1301-Accelerating the Prevention and Control of HIV/AIDS, Viral Hepatitis, STDs and TB in the U.S. Affiliated Pacific Islands.

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 Andrew (Andy) Heetderks, Project Officer, at (404) 639-8130.

Reports must be submitted by August 27, 2015, Eastern Standard Time on www.Grants.gov for Reporting Period 7/1/2014- 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 Funding Announcement Number only, formatted as:

CDC-RFA-PS13-130104CONT16

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.

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:

Section I. Current Budget Period Progress

1. For each of the INDICATORS listed in Attachment 1, reporting annual data for 2013 & 2014 and report current budget period progress (January 1, 2015 through June 30, 2015) in tabular form.

2. For each of the OBJECTIVES listed in Attachment 1, provide a brief report addressing the following elements:

a. Status (met, ongoing, or unmet). Objectives may be unmet, but a status update on progress should be provided.

b. Major findings, significance of those findings (a description of how the findings impact or contribute to the public health goal of accelerating the prevention and control of HIV/AIDS, Viral Hepatitis, STD, and TB in the U.S. Affiliated Pacific Islands.

c. Barriers encountered, and how the barriers were addressed.

d. If applicable, include the reasons that goals were not met and a discussion of assistance needed to resolve the situation.

e. Attach in the “Mandatory Documents” box under “Project Narrative Attachment Form.” Document needs to be in the PDF format.

Section II. New Budget Period Objectives and Activities

1. For each of the OBJECTIVES listed in Attachment 1:

a. List activities that will be implemented;

b. Provide a timeline for accomplishment;

c. Identify and justify any redirection of activities; and

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

2. 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 04 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 Requirements (See Attachments 2 and 3)

Grantees shall follow the instructions in Attachments 2 and 3 to provide an update on laboratory and cross-cutting activities.

Attachment 1

Indicators and Objectives for Reporting Current Budget Period Progress FY16 Annual Performance Report

· Number and percentage of TB cases screened for HIV.

· Number and percentage of persons diagnosed with chlamydia tested for HIV.

· Number and percentage of pregnant women screened for HIV and syphilis.

Objectives:

a) Increase the proportion of TB cases who are tested for HIV by 2% per year.

b) Increase the proportion of persons with chlamydia who are tested for HIV by 3% per year.

c) Increase the proportion of pregnant women screened for HIV and syphilis by 2% per year.

· Number of at risk individuals tested for HIV on an annual basis within each jurisdiction.

· Number of newly diagnosed HIV infections.

· Percentage of persons diagnosed with HIV who receive their test results.

· Percentage of people newly-diagnosed with HIV linked to medical care within three months of their diagnosis.

· Percentage of people diagnosed with HIV referred to partner services.

Objectives:

d) Increase the number of at-risk individuals tested for HIV within each jurisdiction by at least 3% per year.

e) Monitor the number of newly diagnosed HIV infections each year.

f) Each year ensure that 90% of persons who test positive for HIV receive their test results.

g) Each year ensure at least 80% of persons who receive their HIV positive test results are linked to medical care and attend their first appointment.

h) Each year ensure at least 75% of persons who receive their HIV positive test results are referred and linked to Partner Services.

· Number of sexually active females 25 years of age and under who are screened for chlamydia.

· Number of symptomatic males cultured for Neisseria gonorrhea (GC) and conduct drug susceptibility testing (DST).

· Number of pregnant women tested for syphilis.

· Number of pregnant women diagnosed with syphilis treated with penicillin.

Objectives:

i) Increase the proportion of sexually active females 25 years of age and under who are screened for chlamydia by 3% per year.

j) Increase the proportion of symptomatic males cultured for GC and DST by 2% per year.

k) Increase the proportion of pregnant women tested for syphilis by 1% per year.

l) Increase the proportion of pregnant women diagnosed with syphilis who are treated with penicillin by 2% per year.

· Proportion of TB patients who complete treatment.

· Proportion of culture positive TB patients who receive DST.

· Percentage of TB patients with reporting completeness for all variables on the RVCT.

Objectives:

m) Increase the proportion of TB patients who complete treatment by 2% per year.

n) Increase the proportion of culture positive TB patients receiving DST by 2% per year.

o) Maintain at least 95 % reporting completeness for all variables on the RVCT.

· Status of hepatitis surveillance system and a chronic hepatitis B and C registry.

Objective:

p) By the end of the project period establish a hepatitis surveillance system and a chronic hepatitis B and C registry.

Attachment 2

Additional Reporting Requirements for Laboratory Activities FY16 Annual Performance Report

Grantees must provide a brief description of progress towards meeting each of the laboratory activities listed below. Report the following for each activity that has not been completed:

a. List activities that will be implemented;

b. Provide a timeline for accomplishment;

c. Identify and justify any redirection of activities; and

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

1. Develop goals for the laboratory to enhance quality and performance. Grantees are encouraged to set time-phased, realistic, achievable goals and describe appropriate milestones toward achieving the ultimate goals. Performance measures should be described that will allow assessment of progress towards each of the goals and/or milestones set by the applicant’s program.

2. Develop a description of laboratory specific goals and objectives, any obstacles encountered and/or reasons for failing to meet established objectives, future plans and objectives to meet goals, and other pertinent information. This narrative should include the following items in the order listed:

a.) Program needs b.) Objectives c.) Methods d.) Evaluation e.) Budget justification

3. Establish a laboratory quality assurance program including use of appropriate laboratory controls and participation in an external quality assurance program. (For further details see: https://www.cms.gov/CLIA/downloads/6066bk.pdf.)

4. Develop standard operating procedure manuals for laboratory tests and review annually and amend, if necessary.

a) For TB testing use recommended Acid Fast Bacilli (AFB) -staining methods for direct smear microscopy and report accurate and reliable results within 24 hours of specimen receipt in the laboratory.

5. Develop procedures for test kits that are approved by the relevant CDC program. (Ensure test kits are not expired and maintain a testing log with results and test kit expiration date.)

6. Develop and institute annual laboratory training for technicians including assessment of basic and test-specific laboratory procedures, and shipping of infectious and diagnostic specimens per International Air Transportation Association (IATA) standards.

7. Develop procedures to annually assess progress towards meeting CDC recommended and laboratory specific turnaround times, identify obstacles, and take corrective action to ensure rapid and reliable laboratory results.

8. Develop an inventory procedure to ensure an adequate supply of all necessary test reagents.

9. Develop procedures to maintain laboratory equipment to ensure accurate test results.

10. Develop procedures to ensure referred specimens are stored, packaged, and shipped in a timely manner to the associated reference laboratory according to appropriate shipping protocols and international regulations.

11. Develop and maintain an accurate and complete laboratory register that includes local and reference laboratory results.

12. Develop procedures to collate and review quarterly laboratory statistics.

13. Develop procedures to report notifiable diseases to the CDC.

14. Develop procedures to perform TB testing and provide data for the following:

a) Total number of individual patients for whom a sputum specimen was received for diagnosis

b) Total number of individual patients for whom a sputum specimen was received for treatment follow-up

c) Total number of AFB smears examined

d) Percentage of positive smears

e) Percentage of patients with positive AFB smears

f) Percentage of AFB smear microscopy results reported within 24 hours of specimen receipt

g) If applicable, the number of molecular tests performed for rapid detection of Mycobacterium tuberculosis complex that might include rapid detection of mutations associated with drug resistance directly from a clinical specimen:

h) Of these, report the number of positive tests for Mycobacterium tuberculosis complex and the number of tests indicating potential resistance (e.g., rifampin resistance).

15. Develop procedures to test for chlamydia, gonorrhea and syphilis and provide data for the following: include the following; in addition, please provide data for the following:

a.) Total number of patients tested for chlamydia, gonorrhea and syphilis

16. Based on availability of programmatic funding, include standard operating procedures and protocol for antimicrobial susceptibility testing on Neisseria gonorrhea (GC) and culture specimens in addition to testing and reporting on GC culture specimens.

Attachment 3

Additional Reporting Requirements for Cross-Cutting Activities FY16 Annual Performance Report

Grantees must provide a brief description of progress towards meeting each of the cross-cutting activities listed below that were explained in detail in the funding opportunity announcement. Report the following for each activity that has not been completed:

a. List activities that will be implemented;

b. Provide a timeline for accomplishment;

c. Identify and justify any redirection of activities; and

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

1. Provide contact information for the individual to serve as the Program Collaboration Service Integration (PCSI) point of contact, and provide contact information for those serving on the PCSI steering committee.

2. Ensure the availability and access to treatment services for HIV, viral hepatitis, STDs, and TB.

3. Conduct and/or facilitate screening, testing, and linkage to care in public and private settings; and when appropriate, integrate screening and testing for populations at risk for multiple infections.

4. Promote comprehensive care and treatment to improve the health outcomes of the populations served.

5. Provide partner services and/or contact investigations.

6. Provide contact information for the responsible person or panel to design, implement and promote health education and social marketing activities for individuals and communities with single and multiple risk for HIV, viral hepatitis, STD and TB.

7. Establish referral services, including a list of partners for referrals for medical, educational, behavioral, and/or social services.

8. Provide contact information for responsible person or panel to establish, maintain, align, and/or improve information systems to identify all newly diagnosed and prevalent cases of HIV, viral hepatitis, reportable STDs and TB.

a. Include an update on data security and developing new integrated security and confidentiality policies based on the CDC Security and Confidentiality Guidelines for HIV, Viral Hepatitis, STD, and TB Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action.

9. Provide contact information for responsible person or panel to securely share aggregate and individual level data to maximize opportunities for public health action and ensure collaboration between surveillance and program units.

10. Provide contact information of responsible person or panel to ensure the availability of laboratory services as well as develop operating procedures and/or protocols for proper specimen collection, handling, storage, processing, and reporting of HIV, viral hepatitis, STD and TB test results.

11. Assess and develop program policies and plans that support individual and community health efforts.

12. Provide contact information for responsible person or panel to develop a detailed evaluation plan.

13. Assure prevention and care services for HIV-positive pregnant women

14. Ensure HIV prevention planning and include the development of a jurisdictional HIV prevention plan and the establishment of a HIV planning group as outlined in the HIV Planning Guidance.

15. Condom distribution activities.

16. HIV surveillance activities, including: identifying and reporting persons with HIV, conducting death ascertainment, conducting intrastate de-duplication of cases, participating in routine interstate de-duplicative review, risk factor ascertainment and collecting HIV laboratory reports.

17. Collect and report HIV testing data.

18. Provide contact information for the individual who will serve as the viral hepatitis point of contact.

19. Collaborate with immunization program to support an increase in viral hepatitis B vaccination coverage.

20. Conduct viral hepatitis surveillance activities, including the registry or database of acute Hepatitis B and C cases.

21. STD Surveillance and Data Management: Describe your current use of EpiAnywhere web-based system for surveillance and data management. Include a description on your efforts to enter data into the system, use of analysis tools to guide programs, and efforts to report case data to CDC. Also, describe any barriers encountered, and plan to address barriers.

22. Coordinate STD prevention services focusing on vulnerable and/or at-risk populations.

23. Conduct STD surveillance activities, including the registry or database of unique persons and unduplicated STD cases.

24. Provide contact information for the individual who will ensure the purchase, distribution and availability of appropriate STD commodities. Provide an update on the development and maintenance of a distribution system of critical commodities.

25. Collaborate with immunization programs to increase human papilloma virus vaccination coverage.

26. Provide appropriate TB case management and directly observed therapy.

27. Conduct TB cohort review.

28. Targeted TB testing for persons with HIV and/or diabetes.

29. Conduct TB surveillance activities, including a log of total morbidity for the Report of Verified Case of Tuberculosis (RVCT), reporting all new cases of TB with Follow Up 1 and 2, and quarterly reporting to CDC.

30. Create, maintain, and/or utilize an outbreak response plan for TB.

31. Use the regional TB reference laboratory and participate in local and regional laboratory training.

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