rfa-ps-13-00104cont16 amendment i final 02 02 16.docx

AMENDMENT I

Page 1: Application Submission: Removed submit application to Grants.gov, all application are to be FEDEX to Technical Information Management Section

Centers for Disease Control and Prevention (CDC) Office of Financial Resources, Office of Grants Services (OGS) Catalog of Federal Domestic Assistance (CFDA): 93.270 Funding Opportunity Announcement (FOA) Number: RFA-PS-13-00104CONT16 RFA-PS13-001: Centers for Disease Control and Prevention Natural History and Prevention of Viral Hepatitis among Alaska Natives Project National Center for HIV/AIDS, STD, and TB Prevention, Division of Viral Hepatitis (NCHHSTP/DVH/ESB)

Eligibility:

This award will be a continuation of funds intended only for grantees previously awarded under RFA-PS-13-001: Centers for Disease Control and Prevention Natural History and Prevention of Viral Hepatitis among Alaska Natives Project.

Application Submission:

CDC requires grantees to submit their Annual Performance Reports (APR), which serves as the continuation application, to be submitted 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 Constance Jarvis, Grants Management Officer, at (404) 488-5859. For programmatic information, please contact Paul Smutz, Project Officer, at (404) 718-8830.

Reports must be submitted by March 01, 2016, retrieve your applications from Grants.gov, all applications will be mailed to the following address:

All applications are to be FEDEX to the below address:

Technical Information Management Section – RFA-PS-13-00104CONT16 ATTN: L.C. Browning 2920 Brandywine Road Mail Stop K-98 Atlanta GA 30341 770-488-2700

For Reporting Period 7/1/2015- 6/30/2016. 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.

The Continuation Application/Progress Report should include:

1. Description of Progress during Annual Budget Period: Current Budget Period Progress reported on the PHS 2590 (http://grants1.nih.gov/grants/funding/2590/2590.htm): Detailed narrative report for the current budget period (07/01/15 – 06/30/16) that directly addresses progress towards the Measures of Effectiveness included in the current budget period proposal.

· Research Aims: list each research aim/project

a) Research Aim/Project: purpose, status (met, ongoing, and unmet), challenges, successes, and lessons learned

b) Leadership/Partnership: list project collaborations and describe the role of external partners.

2. Translation of Research (1 page maximum----topic required by OADS). When relevant to the goals of the research project, the PI should describe how the research significant findings may be used to promote, enhance, or advance translation of the research to practice or may be used to inform policy. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The PI should identify the research findings that were translated into public health policy or practice and how the findings have been or may be adopted in public health settings. Or, if they cannot be applied yet, this section should address which research findings may be translated, how these findings can guide future or related activities, and recommendations for translation. If relevant, describe how the results of this project could be generalized to populations and communities outside of the study.

Questions to consider in preparing this section include:

· How will the scientific findings be translated into public health practice or inform policy?

· How will the project improve or affect the translation of research findings into public health practice or inform policy?

· How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs or practices?

· How will the findings advance or guide future research efforts or related activities?

3. Public Health Relevance and Impact (1 page maximum----topic required by OADS). This section should address improvements in public health as measured by documented or anticipated outcomes from the project. The PI should consider how the findings of the project relate beyond the immediate study to improved practices, prevention or intervention techniques, legislation, policy, or use of technology in public health.

Questions to consider in preparing this section include:

· How will this project lead to improvements in public health?

· How will the findings, results, or recommendations been used to influence practices, legislation, procedures, methodologies, etc?

· How will the findings, results, or recommendations contributed to documented or projected reductions in morbidity, mortality, injury, disability, or disease?

4. Current Budget Period Financial Progress: Status of obligation of current budget period funds and an estimate of unobligated funds projected as of 06/30/16 provided on an estimated FFR.

5. New Budget Period Proposal (07/01/16 through 06/30/17):

· Detailed operational plan for continuing activities in the upcoming budget period, including updated Measures of Effectiveness for evaluating progress during the upcoming budget period. Report listed by Research Aim/Project.

· Project Timeline: Include planned milestones for the upcoming year (be specific and provide deadlines).

6. New Budget Period Budget: Detailed line-item budget and budget justification for new budget period (07/01/16 – 06/30/17). Use the CDC budget guideline format.

7. Human Subject Research Institutional Review Board (IRB) Approvals: Include all current IRB approvals to avoid a funding restriction on your award. If the research does not involve human subjects, then please state so. Please provide a copy of the most recent local IRB protocol and, if applicable, CDC IRB protocol. If any approval is still pending at time of annual progress report due date, indicate the status in your narrative.

8. Publications/Presentations: Include publications/presentations resulting from this CDC grant only during this budget period. If no publication or presentations have been made at this stage in the project, simply indicate “Not applicable: No publications or presentations have been made.

Please note: On September 24, 2014, the Federal government issued a policy for the oversight of life sciences “Dual Use Research of Concern” (DURC) and required this policy to be implemented by September 24, 2015. This policy applies to all New and Renewal awards issued on applications submitted on or after September 24, 2015, and to all non-competing continuation awards issued on or after that date. CDC grantee institutions and their investigators conducting life sciences research subject to the Policy have a number of responsibilities that they must fulfill. This Notice does not recapitulate all of them, but highlights a few. Institutions should reference the actual policy, available at http://www.phe.gov/s3/dualuse, for a comprehensive listing of those requirements.

Notably, principal investigators at funded institutions must identify projects involving one or more of 15 agents or toxins listed in the Policy. These projects must be reviewed by an Institutional Review Entity (IRE) identified by the institution. IRE’s are required to identify DURC as described by the scope of the USG Policy and assess such research for the benefits and risks associated with its conduct and communication.

If research funded by CDC is assessed by the IRE for DURC potential, the institution will be required to notify the Grants Management Specialist listed on the Notice of Award of the results of the IRE review process within 30 days. In instances when the research is determined to be DURC, CDC will work with the institutions and investigators conducting the research to develop an appropriate risk mitigation plan to minimize the risk of misuse of the knowledge, information, products, or technologies generated by the research. If, during the course of conducting research, the research becomes DURC, the grantee will be required to inform CDC immediately of the change in DURC status and to develop a risk mitigation plan as outlined above. The institution will be responsible for ensuring that DURC is conducted in accordance with the approved risk mitigation plan. In the case that the institution discovers non-compliance, the institution will have to report it to CDC, as well as corrective actions undertaken to prevent future recurrences.

Please contact Paul Smutz at (404) 718-8830 or pos1@cdc.gov if you have any questions.

Rev. 5/22/14 image1.tiff