RFA-PS-13-00105CONT17 FINAL 01 09 17.docx

Centers for Disease Control and Prevention (CDC) Office of Grants Services Instructions for Preparing an Annual Performance Report (APR) Catalog of Federal Domestic Assistance (CFDA): 93.270 Funding Opportunity Announcement (FOA) Number: RFA-PS-13-00105CONT17

Centers for Disease Control and Prevention Natural History and Prevention of Viral Hepatitis among Alaska Natives

NCHHSTP

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

Application Submission:

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

If you encounter any difficulties submitting your annual performance report through please contact CDC’s Technical Information Management Section at 770-488-2700 prior to the submission deadline. If you need information regarding the annual performance report process, please contact Constance Jarvis, Grants Management Specialist, at 770-488-5859. For programmatic information, please contact Paul Smutz, Ph.D., Project Officer, at 404-718-8830.

Required Application Instructions:

It is critical that applicants follow the instructions to complete their application http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.100-how-to-use-the-application-instructions.htm except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions in this FOA deviate from those in the Application Guide, follow the program-specific instructions.

Applications and Submission Information:

It is critical that applicants follow the instructions in the Form D Instruction Guide to complete their Application http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.100-how-to-use-the-application-instructions.htm, except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components.

All page limitations described in this individual FOA must be followed. For this FOA, the Research Strategy section is limited to 12 pages. https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/table-of-page-limits.htm

Required Application Instructions:

RESEARCH CONTINUATION/SUPPLEMENT APPLICATIONS:

All application packages (3 hard copies) should sent via FEDEX to the address below:

Please note that your application must arrive to the OGS office with a stamped date no later than March 20, 2017.

Technical Information Management Section – RFA-PS-13-001 ATTN: L.C. Browning 2920 Brandywine Road Mail Stop K-98 Atlanta GA 30341 770-488-2756

FEDEX to CDC OGSTIMS by: March 20, 2017

Retrieve your applications from www.Grants.gov.

The reporting Period is 7/1/2016- 6/30/2017. 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

· The grantee’s continuation application/progress report should include:

1. Description of Progress during Annual Budget Period: Current Budget Period Progress reported on reported on the PHS 2590 (http://grants1.nih.gov/grants/funding/2590/2590.htm): Detailed narrative report for the current budget period (7/1/2016 – 6/30/2017) that directly address progress towards the Objectives 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 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 research 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 effect 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?

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 06/30/17 provided on an estimated FFR.

5. New Budget Period Proposal (Year 05: 7/1/2017 through 6/30/2018):

· 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 (7/1/2017 – 6/30/2018). Use the CDC budget guideline format.

7. Human Subject Research Institutional Review Board (IRB) Protocols: Include copies of all IRB approved protocols that are necessary to support new budget period activities. Absence of approved IRB protocols will result in prohibitions and financial restrictions on federally funded research activities.

8. IRB Approval Certification: Include all current IRB approval letters 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 approval letter (and CDC IRB approval letter, if applicable). If any approval is still pending at the time of annual progress report due date, indicate the status in your narrative.

9. 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”.

10. CDC Grants Assurances and Certifications: http://wwwn.cdc.gov/grantassurances/(S(pna1punvk0ebz0sfijqmuqtt))/Homepage.aspx

11. 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.”

PHS 398 Research Plan Component

The Form D Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only.

Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health. All instructions for Form D must be followed, with the following additional instructions:

The following sections all must be included in the Research Strategy section and are part of the page limit for that section.

Component 3 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the Form D Instruction Guide http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.100-how-to-use-the-application-instructions.htm must be followed along with any additional instructions provided in the FOA.

Appendix

Do not use the appendix to circumvent page limits. A maximum of 5 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publicly available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Page Limitations

All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 12 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 25 pages for all appendices.

Format for Attachments

Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the Form D Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.100-how-to-use-the-application-instructions.htm.

Organizations must submit three (3) hardcopy continuation supplemental applications to the CDC the Office of Grant Services Technical Information Section (OGSTIMS). All application packages must be submitted to OGSTIMS via FEDEX to at the address stated in Section IV. Application and Submission Information, 4. Required and Optional Components in this FOA. Please note that your application must arrive at the OGSTIMS office with a stamped date no later than March 20, 2017.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date to correct any error or warning notices of noncompliance with application instructions that are identified.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free.

Unsuccessful Submissions

If an application submission was unsuccessful, the applicant must:

1. Track his/her submission via FEDEX and verify the submission status.

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (ogstim@cdc.gov) explaining why the submission failed.

b. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 03/20/2017

Other Submission Requirements and Information

Application Submission Continuation supplemental applications must be submitted in hard copy. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in this FOA. When the program-specific instructions in this FOA deviate from those in the Application Guide, follow the program-specific instructions. ELECTRONIC APPLICATIONS WILL NOT BE ACCEPTED.

Applicants must complete all required registrations before the application due date. Section III.6 "Required Registrations" contains information about registration.

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful grant action on an application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

Plain Writing Act

The Plain Writing Act of 2010 was signed into law on October 13, 2010. The law requires that federal agencies use "clear Government communication that the public can understand and use" and requires the federal government to write all new publications, forms, and publicly distributed documents in a "clear, concise, well-organized" manner. For more information on this law, go to: http:// www.plainlanguage.gov/plLaw/index.cfm.

Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration, downloading or navigating forms) Contact Center Phone: 800-518-4726 Email: support@grants.gov Hours: 24 hours a day, 7 days a week; closed on Federal holidays eRA Commons Help Desk (Questions regarding eRA Commons registration, FFR submission) Phone: 301-402-7469 or 866-504-9552 (Toll Free)

TTY: 301-451-5939

Email: commons@od.nih.gov Hours: Monday - Friday, 7am - 8pm U.S. Eastern Time

CDC Technical Information Management Section (TIMS) Office of Grants Services (OGS) Telephone: 770-488-2700 Email: ogstims@cdc.gov Hours: Monday – Friday. 7am – 3:30PM EDT

Please contact Paul Smutz, Ph.D., Project Officer, at 404-718-8830 or wsmutz@cdc.gov if you have any questions.

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 US Government 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.

Additional note (Data Management): On January 27, 2016, the “Policy on Public Health Research and Non-Research Data Management and Access” was implemented by CDC/ATSDR to supersede the “Policy on Releasing and Sharing Data (09/07/2005)” and the guidance based upon it. The purpose of the new policy is to ensure that CDC/ATSDR, hereafter referred to as CDC, and all agencies or organizations funded or co-funded by CDC, are in compliance with applicable laws, regulations, directives, and guidelines regarding the management of public health data and providing access to such data for public use. New awards, as of the date of issue of this policy, and all continuations thereafter, are subject to this policy. Previously established public health data collection systems that continue to collect data after the policy became effective should become compliant within three years of the effective date of the policy, or when the data system undergoes substantial revision—whichever comes first. Applicants for project funding that involve collection or generation of data are required to develop a Data Management Plan (DMP). CDC requires that the cost of public health data sharing be included in grants, cooperative agreements, and contracts. The cost of archiving and long-term preservation of public health data may also be included as part of the total budget requested for first-time or continuation awards.

The DMP must describe the data to be collected or generated in the proposed project; standards to be used for collected or generated data; mechanisms for providing access to and sharing of the data (including provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights); use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and plans for archival and long-term preservation of the data, or explaining why long-term preservation and access are not justified. Awardees who fail to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance (for example, reduction in funding, restriction of funds, or award termination) consistent with applicable regulations and policies or other authorities as appropriate. Future awards will depend on compliance with this requirement. This Notice summarizes key elements of the policy but grantees should reference Additional Requirement – 25 (AR-25) available at: http://www.cdc.gov/grants/additionalrequirements/index.html for a more comprehensive listing of requirements.

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