rfa-dp16-002 final 02 08 16.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

Michigan Lupus Epidemiology and Surveillance (MILES) Program Longitudinal Cohort Study

RFA-DP-16-002

Application Due Date: 02/10/2016

Signature Date

Michigan Lupus Epidemiology and Surveillance (MILES) Program Longitudinal Cohort Study

RFA-DP-16-002

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

(NCCDPHP ERPO)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Funding Opportunity Announcement (FOA) Title Michigan Lupus Epidemiology and Surveillance (MILES) Program Longitudinal Cohort Study Activity Code U01

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-16-002

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.283 Category of Funding Activity:

Health FOA Purpose This FOA is intended to support research designed to: 1) determine treatment, health care access, and natural history (severity, morbidity, mortality, etc.) of lupus (systemic lupus erythematosus) and related outcomes; 2) identify factors (including genetic and other biological factors such as antibody levels) associated with outcomes of treatment, health care access and natural history; and 3) examine potential disparities and other factors associated with outcomes by categories of interest (e.g., gender and race/ethnic group).

Key Dates Publication Date: To receive notification of any changes to RFA-DP-16-002, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/05/2016

Application Due Date: 02/10/2016

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 04/11/2016 http://www.grants.gov

Secondary Review: 05/22/2016

Estimated Start Date: 09/30/2016

Expiration Date: 03/06/2016 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide 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 deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Supporting materials for the research plan narrative included as appendices may not exceed 10 pdf files with a maximum of 35 pages for all appendices.

Executive Summary Purpose. This funding opportunity announcement is intended to support a population-based longitudinal study to: 1) determine treatment, health care access, and natural history (severity, morbidity, mortality, etc.) of lupus (systemic lupus erythematosus) and related outcomes; 2) identify factors (including genetic and other biological factors such as antibody levels) associated with outcomes of treatment, health care access and natural history; and 3) examine potential disparities and other factors associated with outcomes by categories of interest (e.g., gender and race/ethnic group).

Mechanism of Support. Cooperative Agreement.

Funds Available and Anticipated Number of Awards. The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), intends to commit up to $1,000,000 per year to fund one award. The award issued under this FOA is contingent upon availability of funds and a sufficient number of meritorious applications.

Budget and Project Period. The estimated total funding (direct and indirect) for the first budget period, 09/30/2016 to 09/29/2017, is $1,000,000. The estimated total funding (direct and indirect) for the 3-year project period, 09/30/2016 to 09/29/2019, is $3,000,000.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply through their organization.

Number of PDs/PIs. Applications may contain more than one PI; however, the first PI listed will be the “contact PI” for all correspondence.

Number of Applications. Eligible applicant institutions may not submit more than one application.

Application Type. Renewal Special Date(s). N/A Application Materials. See Section IV.1 for application materials.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV https://era.nih.gov/commons/index.cfm https://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY:

(770) 488-2783.

This funding opportunity announcement will be posted at http://www.cdc.gov/chronicdisease/about/foa.htm

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Section 301(a) of the Public Health Service Act, 42 U.S.C. 241(a), 317(k)(2) of the Public Health Service Act, 42 U.S.C. 247b(k)(2)

1. Background and Purpose Lupus is a prototypical autoimmune disease with a wide spectrum of illness that can be limited to the skin or can affect almost any tissue and organ in the body and cause severe morbidity and premature mortality.

While there are several forms of lupus, systemic lupus erythematous (SLE) is the most common and serious form of lupus and has a variety of clinical manifestations. SLE affects from 320,000 to 1.5 million Americans and has strong disparities in incidence and prevalence, affecting women far more than men and minorities more than whites. The causes of SLE are unknown but are believed to be linked to genetic, environmental, and hormonal factors. Much of what is known about SLE comes from convenience samples and tertiary care centers that are not population-based and therefore biased toward the severe end of the disease spectrum. As a result there is a need for a basic epidemiologic understanding of SLE in order to understand the full clinical spectrum and population burden of the disease. This need is a priority for the CDC Arthritis Program and is described in the 2015 National Public Health Agenda for Lupus1.

Through RFA-DP08-806 the Michigan Department of Community Health conducted a comprehensive surveillance program in collaboration with the University of Michigan to ascertain and validate diagnosed cases of SLE in persons residing in the sociodemographically diverse population of southeastern Michigan (~2.4 million persons) in 2002-2004. This first part of a two-part Michigan Lupus Epidemiology and Surveillance Program (MILES) proposal was designed to create a population-based surveillance cohort by generating better incidence and prevalence estimates of diagnosed SLE in blacks and whites, the two racial/ethnic groups that comprise the most cases of SLE. Subsequently, the CDC Lupus Program conducted an open competition in which MILES was funded through RFA-DP11-004, “Longitudinal Study of a Population-based Cohort of People with Lupus” to conduct the second part of the MILES proposal, namely, a longitudinal study on the epidemiology of SLE using cases from the expensively-created, population-based surveillance cohort. The goals of the latter were to begin to: 1) determine outcomes of treatment, health care access, and natural history (severity, morbidity, mortality, etc.) of SLE; 2) identify factors (including genetic and other biological factors such as antibody levels) associated with the above outcomes; and 3) examine potential disparities and other factors associated with outcomes by categories of interest (e.g., gender and race/ethnic group).

MILES is a part of CDC’s comprehensive approach to better understand SLE and its associated outcomes. As such, the FOA complements other projects being conducted in Georgia and California that were funded in 2014. MILES also contributes to other existing Lupus Program projects that are creating a National Public Health Agenda for Lupus and exploring additional self-management needs among those with lupus. Finally, MILES complements a new FY15 FOA, “Developing and Disseminating Programs to Build Sustainable Lupus Awareness, Knowledge, Skills and Partnerships” and aligns with the National Arthritis Action Plan – A Public Health Strategy2 in which one specific strategy is to improve surveillance of arthritis in general, specific types of arthritis, and related rheumatic conditions such as lupus at national and state levels.

The goal of this FOA is to support continuation of observational research for the longitudinal, population-based MILES registry of persons with lupus in southeastern Michigan to determine the natural https://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm http://www.cdc.gov/chronicdisease/about/foa.htm population-based MILES registry of persons with lupus in southeastern Michigan to determine the natural history, access to health care, nature of treatment, disparities and other related issues.

Healthy People 2020 and other National Strategic Priorities This FOA addresses the Healthy People 2020 focus areas of Arthritis, Osteoporosis, and Chronic Back Conditions; Access to Health Services, Disability, and Health; Health Communication and Health Information Technology; and Health-related Quality of Life & Well-being. Analyses from this FOA may indirectly address all nine arthritis objectives on doctor diagnosed arthritis because they address lupus, a condition which is included in the definition of doctor diagnosed-arthritis. The nine arthritis objectives relate to pain, activity limitations, performing specific joint–related activities, performing personal activities, psychological distress, work, provider counseling, evidence-based education and seeing a health care provider. This site is available at https://www.healthypeople.gov/.

National Prevention Strategy (Elimination of Health Disparities). This FOA aligns with national health objectives aimed at improving the health and well-being of individuals, families and communities by creating social and physical environments that promote good health. This site is available at http://www .surgeongeneral.gov/priorities/prevention/strategy/report.pdf.

NCCDPHP Four Domains of Chronic Disease Prevention. Domain 1 (Epidemiology and Surveillance), focuses on the provision of essential data to define and prioritize public health problems; identify populations most affected; guide solutions, and monitor progress. This site is available at http://www.cdc.gov/chronicdis ease/pdf/four-domains-factsheet-2015.pdf.

This FOA also implements epidemiology strategies from the 1999 National Arthritis Action Plan – A Public Health Strategy, which are a priority for the CDC Arthritis Program. These strategies include: 1) develop population-based, longitudinal data systems to track the occurrence, progress, and impact of arthritis (lupus);

2) identify modifiable risk factors to reduce the incidence of and disability from arthritis (lupus); and 3) study the personal effects of arthritis (lupus).

Public Health Impact This research will have a public health impact by identifying strengths and challenges of existing clinical and public health approaches to managing lupus by addressing research questions on natural history, access to health care, nature of treatment, and other related issues. This research addresses a public health gap by advancing epidemiologic understanding of SLE, a disease that is difficult to diagnose, confirming the burden and outcomes of SLE, and providing direction for interventions to address identified problems. With this information, improvements can be made to approaches to help improve quality of life of people with lupus.

Also, by examining categories of research interest (e.g., age, gender, and race/ethnic group), more culturally relevant interventions can be produced.

Relevant Work CDC has previously funded and is currently funding work on a variety of SLE-relevant activities, including lupus registries, follow-up studies, formative research, and creating a public health agenda (currently under development).

Since 2003, CDC has funded five Lupus Registries which were designed to create credible estimates of the incidence and prevalence of lupus in various ethnic groups by creating population-based cohorts. These include:

https://www.healthypeople.gov/ http://www.surgeongeneral.gov/priorities/prevention/strategy/report.pdf http://www.surgeongeneral.gov/priorities/prevention/strategy/report.pdf http://www.cdc.gov/chronicdisease/pdf/four-domains-factsheet-2015.pdf http://www.cdc.gov/chronicdisease/pdf/four-domains-factsheet-2015.pdf

• Developing and Implementing the Georgia Lupus Registry

• Michigan Lupus Epidemiology and Surveillance (MILES) Program

• California Lupus Surveillance Program

• Manhattan Lupus Surveillance Program

• Indian Health Service Lupus Project

Three longitudinal follow-up studies of established population-based lupus cohorts will determine natural history, access to care, current treatment, and other outcomes. This FOA supports the longitudinal follow-up study for Michigan Lupus Epidemiology and Surveillance (MILES) Program at University of Michigan. The other longitudinal follow-up studies are being completed by, Emory University and University of California, San Francisco.

Formative research on SLE self-management is being completed through a two-year Interagency Agreement with Oak Ridge Associated Universities titled “Filling a Gap: Creating Educational Program/Tools/Materials to Enhance Self-Management in Systemic Lupus Erythematosus (SLE).”

2. Approach This FOA supports continuation of observational research for the longitudinal, population-based MILES registry of persons with lupus to determine the natural history, access to health care, nature of treatment, potential disparities and other related issues. MILES is one of only 3 population-based longitudinal studies of SLE and discoid lupus and has collected data multiple times using recurrent surveys, personal contacts, medical records, genetic testing, and other laboratory tests. This FOA will support follow-up activities for the first follow-up phase (T1) of the study. A future T2 phase may occur if there is minor loss to follow and therefore sufficient statistical power to address research questions.

The applicant is expected to outline an approach that:

Specifies a process for monitoring and updating the protocol, methods, and quality assurances to be used for the study that includes an Advisory Committee.

Identifies the data to be collected and the related hypotheses relevant to the data.

Specifies how the study will be implemented, including plans for acquiring the needed data, the number and type of project staff that would be involved, and potential barriers (e.g., IRB, patient consent, resistance/inability of primary care and other providers to share needed data) to be addressed.

Specifies analyses to be undertaken, including, where possible, the responsible analyst.

Specifies a staffing plan for the study.

Specifies how the applicant will collaborate with other public health and lupus stakeholders to design, implement and analyze data.

Objectives/Outcomes

Objectives

This observational, longitudinal research of an established, population-based cohort will collect data multiple times using recurrent surveys, personal contacts, medical records, genetic testing and other laboratory testing over a three-year period. The research objectives are to:

Objective 1: Examine the treatment (e.g., type; appropriateness) of people with lupus.

Objective 2: Determine the health care access that people with lupus have to address their varied health problems (e.g., general health problems as well as those for specific lupus outcomes such as nephritis).

Objective 3: Determine the natural history (severity, morbidity, mortality, etc.) of persons with lupus as it is treated today.

Objective 4: Identify factors (including genetic and other biological factors such as antibody levels) associated with outcomes of treatment, health care access and natural history.

Objective 5: Examine potential disparities and other factors associated with outcomes by categories of interest (e.g., gender and race/ethnic group).

Outcomes

Description of the research protocol, data analyses plan and a process evaluation of key milestones of the study;

Description of a data collection plan which includes the process to document and track study participation; and Development of a dissemination plan for the results and findings, including publishing results in peer-reviewed journals.

Description of expected outcomes at the end of the project period.

Target Population This FOA continues to target a representative population-based sample of the general population in the region of southeastern Michigan .

Collaboration/Partnerships An applicant is expected to maintain or develop partnerships that are needed to achieve the goals and objectives of the project. Collaboration with partners is required to guarantee access to the required data and to those with requisite expertise in lupus, data management, and longitudinal data analysis to achieve the objectives of this FOA. Collaboration/partnerships with other funding sources to supplement this award may be helpful in achieving the core objectives of the FOA in more detail or more quickly and in achieving additional objectives relevant to a better understanding of lupus and lupus interventions.

Evaluation/Performance Measurement The applicant is expected to monitor and annually document in progress reports key milestones, including the success of various stages of follow-up activities; the quantity and quality of follow-up data obtained; gaps in measures; and limitations or challenges to accomplishing the study.

Translation Plan The applicant is expected to conduct analyses related to the listed objectives/outcomes and publish the results in relevant professional journals. Applicants should describe plans to collaborate when objectives align with other CDC funded lupus registries in combined, more statistically robust data sets for analyses of objectives/outcomes important to this FOA and to possible other research questions.

OMB/PRA is not expected to apply.

References

National Association of Chronic Disease Directions. A National Public Health Agenda for Lupus:

Creating a Blueprint for Action. http://chronicdisease.site-ym.com/?LupusHome . Published Date October 29, 2015.

1.

Meenan, RF, Callahan LF, Helmick CG. The National Arthritis Action Plan: a public health strategy for a looming epidemic. Arthritis Care Res. 1999; 12(2):79-81.

2.

http://chronicdisease.site-ym.com/?LupusHome

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

Renewal (formerly Competing Continuation) - Previous years of funding for the project have elapsed.

Competing for additional years of funding to continue original project.

Estimated Total Funding: $3,000,000

Anticipated Number of Awards: 1

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling: $1,000,000 Per Budget Period Award Floor: $750,000 Per Budget Period Total Project Period Length: 3 year(s)

Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements Additional Information on Eligibility - The only organization eligible to apply for this funding opportunity annoucement is the University of Michigan.

http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

4. Justification for Less than Maximum Competition The University of Michigan is the only institution that has the appropriate resources in place to continue this population-based longitudinal study, including having an established baseline cohort well-characterized for SLE, existing IRB approval and project infrastructure (staffing, collaborations, enhanced recruitment strategies, etc.).

5. Responsiveness If an applicant requests a funding amount greater than the ceiling of the award range for the first year, HHS/CDC will consider the application non-responsive and it will not enter into the review process.

HHS/CDC will notify the applicant that the application did not meet the submission requirements.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM).

Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov http://fedgov.dnb.com/webform

Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http: //www.hhs.gov /asfr /ogapa /aboutog /hhsgps107.

pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/ 424/SF424_RR_Guide_General_VerC.pdf), 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 https://www.sam.gov/index.html http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded from http://grants.nih.gov/grants/forms.htm

3. Letter of Intent Due Date for Letter of Intent: 01/05/2016 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Sue Shaw, MPH National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Operations and Services Centers for Disease Control and Prevention 4770 Buford Highway, NE M/S F-80 Atlanta, GA 30341 zgx7@cdc.gov 770-488-6142

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) 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. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. 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. 3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed http://grants.nih.gov/grants/forms.htm mailto:zgx7@cdc.gov research plan, including staffing and timeline. 4. Inclusion Enrollment Report (Renewal and Revision applications ONLY) 5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects 7. Inclusion of Women and Minorities 8. Targeted/Planned Enrollment Table (for New Application ONLY) 9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals 11. Select Agent Research 12. Multiple PD/PI Leadership Plan. 13.

Consortium/Contractual Arrangements 14. Letters of Support 15. Resource Sharing Plan(s) 16.

Appendix

Component 4 (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 SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

Research Plan

The applicant’s research plan should address activities that will be conducted over the three-year project period and should include the following items:

Introduction/Background

Describe how the study addresses the issues of SLE.

Describe the demographics (age, race/ethnicity, insurance status) of the study population.

Describe the sites from which subjects will be recruited.

Specific Aims

Specify overall aims or objectives for the study.

Describe expected outcomes by the end of the project period.

Research Strategy

Address activities that will be conducted over the entire 3-year project period.

Describe the design, methodology and protocol for the study.

Describe the method for data collection, management, analyses, quality assurance and security.

Describe the plan for maintaining appropriate Institutional Review Board approvals for all institutions or individuals participating in research involving human subjects.

Describe information technology (equipment, software, expertise) to be used.

Describe the plan for analyses and publications addressing the research objectives that use previously obtained data (T0 and T1).

Describe plans to collaborate with other public health and lupus stakeholders to design, implement and analyze data. The plan should also specify how the project will collaborate other CDC funded lupus registries when objectives align to access data and expertise in lupus, data management, and longitudinal data analysis.

Describe a communication plan for CDC funded registries which maintains clarity, quality and consistency of analyses and publications that result from these and earlier data, include communication strategies for analysts.

Describe expected contributions to the field.

Staffing and Milestones

Provide a list of study tasks and a timeline for the study.

Identify key milestones, including stages of follow-up activities; quality and quantity of follow-up data; and performance measures.

Identify and staff needs for study implementation (e.g., recruitment and enrollment, data collection, data management, data analysis, manuscript preparation).

Describe the proposed management and staffing plan for the study.

Describe experience and expertise of key proposed staff, include ability to conduct the study.

Include any potential study limitations or challenges to accomplishing the study.

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

7. 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 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 35 pages for all appendices.

8. 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 SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/ grants/funding/424/ SF424_RR_Guide_General_VerC.pdf).

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http:// grants.nih. gov/grants /guide/url_redirect .htm? id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://www.grants.gov/ http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e. error correction window).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center ( 1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact TIMS at 770-488-2700; pgotim@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

Unsuccessful Submissions: If an application submission was unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status (tracking should be done initially regardless of rejection or success).

a. If the status states “rejected,” do #2a or #2b.

2. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (pgotim@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: 02/10/2016

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

10. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review (http:// www. whitehouse.gov/ omb/ grants_spoc).

11. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

Applicants are advised that any activities involving standard information collection (i.e., surveys, questionnaires, data requests, etc.) from 10 or more non-federal individual/entities are subject to Paperwork Reduction Act (PRA) requirements and may require the CDC to coordinate an OMB/PRA approval request.

Funds will be restricted until:

IRB and OMB/PRA (if needed) approvals are obtained.

Human Subjects Education Requirement documentation is provided.

12. Other Submission Requirements and Information mailto:support@grants.gov mailto:www.pgotim@cdc.gov http://www.whitehouse.gov/omb/grants_spoc http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf

Application Submission Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. PAPER 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.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide /url_ redirect.htm? id=11144).

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 submission of an electronic 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.

If the applicant has an FWA number, enter the 8-digit number. Do not enter the letters “FWA” before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of the SF 424 (R&R) Application Guide and in the HHS Grants Policy Statement.

See more resources to avoid common errors and submitting, tracking, and viewing applications: http:// grants.nih. gov/grants/ Electronic Receipt /avoiding _errors.htm or http:// grants. nih.gov/grants/ Electronic Receipt/submit _app.htm Upon receipt, applications will be evaluated for completeness by the CDC Office of Grants Services (OGS) and responsiveness by OGS and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

Section V. Application Review Information

1. Criteria Only the review criteria described below will be considered in the review process. As part of the CDC mission (http:// www.cdc.gov/ about/ organization/ mission.htm), all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system.

Overall Impact Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144 http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm http://www.cdc.gov/about/organization/mission.htm

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are there plans for 1) protection of human subjects from research risks,…