CDC-RFA-DP-16-003PUBLICATION.pdf

Centers for Disease Control and Prevention

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

Johnston County Osteoarthritis Project: Arthritis, Disability, and Other Chronic Diseases

RFA-DP-16-003

Application Due Date: 02/10/2016

Johnston County Osteoarthritis Project: Arthritis, Disability, and Other Chronic Diseases

RFA-DP-16-003

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 Johnston County Osteoarthritis Project: Arthritis, Disability, and Other Chronic Diseases Activity Code U01

Funding Opportunity Announcement Type Reissue of DP11-005 Funding Opportunity Announcement Number

RFA-DP-16-003

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) refine population-based estimates of the prevalence, incidence, and progression of hip and knee osteoarthritis (OA) and related outcomes; (2) gather information on and investigate possible factors (both risk and protective, including other chronic conditions) associated with hip and knee OA; and (3) determine racial or ethnic differences in outcomes and in the role of comorbid conditions and the effect of risk factors upon OA outcomes.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-16-003, 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: 01/11/2016

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: 02/11/2016 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

Executive Summary Purpose. This funding opportunity announcement is intended to support a population-based longitudinal study, which is designed to: (1) refine population-based estimates of the prevalence, incidence, and progression of hip and knee osteoarthritis (OA) and related outcomes; (2) gather information on and investigate possible factors (both risk and protective, including other chronic conditions) associated with hip and knee OA; and (3) determine racial or ethnic differences in outcomes and in the role of comorbid conditions and the effect of risk factors upon OA outcomes.

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 $1,500,000 (direct and indirect) each year, for the 5-year project period, to fund one award. The award issued under this FOA is contingent upon the 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 $1,500,000. The estimated total funding (direct and indirect) for the 5-year project period, 09/30/2016 to 09/29/2021, is $7,500,000.

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.

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

(770) 488-2783.

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 http://era.nih.gov/commons/index.cfm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm http://www.cdc.gov/chronicdisease/about/foa.htm

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, 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 Arthritis affects 52.5 million adults and is the most common cause of disability in the United States, yet it is relatively understudied given its large burden, especially in the African-American population. Osteoarthritis (OA) of the hip and knee are the most common causes of arthritis disability. As OA continues to grow in prevalence and burden, much more remains to be learned from a public health perspective about its incidence, prevalence, progression, and the factors associated with each. This need has been described in documents such as the 1999 National Arthritis Action Plan - A Public Health Strategy1, and is a priority for the CDC Arthritis Program. The need is also documented in the recommendations of the 2010 National Public Health Agenda for Osteoarthritis2.

For 25 years, the University of North Carolina at Chapel Hill has conducted a unique, population-based, longitudinal study of approximately 3200 rural white and black residents aged 45 and older. The Johnston County Osteoarthritis Project cohort study is the only population-based longitudinal study of OA that includes both Caucasians and African-Americans, and is designed to determine the prevalence, incidence, and risk factors associated with the occurrence and progression of hip and knee OA—the most common and disabling types of arthritis. This project was initially supported by CDC’s National Center for Environmental Health’s Office of Disability and Health and is currently supported by the CDC Arthritis Program.

Supplemental analyses of the Johnston County Osteoarthritis Project cohort study have been funded by the National Institutes of Health's National Institute of Arthritis and Musculoskeletal and Skin Diseases and National Institute of Mental Health. Results of this study have already led to a better understanding of how and why these conditions occur and what modifiable risk factors can be targeted to reduce their impact.

There is much more to be done from a public health perspective.

The Johnston County Osteoarthritis Project cohort study has also facilitated the development of additional spinoff projects funded by multiple federal agencies, foundations, private philanthropic sources, and industry groups. The scope of these studies ranges from the biomedical (e.g., development and validation of serum and urine biomarkers of joint metabolism, proteomics, metabolomics, and, most recently, genome-wide association studies) to the psychosocial (e.g., the role of psychiatric comorbidity in the pain and disability of arthritis, individual and community social determinants of arthritis outcome, and spirituality). The Johnston County Osteoarthritis Project has been a part of research studies with investigators throughout the nation and the world.

The goal of this FOA is to support continuation of observational research for the longitudinal, population-based Johnston County Osteoarthritis Project cohort study. The aims of this FOA are to determine the prevalence, incidence, and progression of hip and knee OA and related outcomes; to investigate possible risk and protective factors associated with hip and knee OA; and to determine racial or ethnic differences in outcomes and in the role of comorbid conditions.

Healthy People 2020 and other National Strategic Priorities This FOA addresses the Healthy People 2020 focus area of Arthritis, Osteoporosis, and Chronic Back http://www.cdc.gov/chronicdisease/about/foa.htm

This FOA addresses the Healthy People 2020 focus area of Arthritis, Osteoporosis, and Chronic Back Conditions. The nine 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 http://www.healthypeople.gov/2020/topic s-objectives/topic/arthritis-osteoporosis-and-chronic-back-conditions.

This FOA complements the following national initiatives/activities:

1999 National Arthritis Action Plan surveillance, epidemiology and prevention research objective to establish a solid scientific base of knowledge on the prevention of arthritis and related disability.

2010 National Public Health Agenda for Osteoarthritis recommendation to pursue research and evaluation which can help enhance surveillance, better understand risk factors, refine recommended intervention strategies, evaluate workplace interventions, and examine emerging evidence on additional promising interventions.

National Prevention Strategy fourth strategic direction aimed at the elimination of health disparities.

This report is available at http://www.surgeongeneral.gov/priorities/prevention/strategy/report.pdf.

CDC’s Four Domains of Chronic Disease Prevention epidemiology and surveillance domain, which focuses on the provision of data to define and prioritize public health problems. This report is available at: http://www.cdc.gov/chronicdisease/pdf/four-domains-factsheet-2015.pdf .

Public Health Impact Population-based investigations are crucial to the understanding of disease epidemiology, natural history and pathogenesis.This research will have a public health impact by continuing to allow investigators to build and refine population-based estimates of the prevalence, incidence, and progression of hip and knee OA and related outcomes for older, long-established members of the initial cohort and for additional cohort members added at the various follow-up periods. This information can be used to develop an in-depth understanding of hip and knee OA, as well as the other related outcomes, which can be used to develop effective interventions for the prevention and management of OA. Results from the baseline (T0) and three follow-up (T1, T2, T3) studies have already led to a better understanding of how and why these conditions occur in both whites and blacks, and what modifiable risk factors can be targeted to reduce their impact.

Relevant Work CDC’s Arthritis Program, guided by recommendations in National Arthritis Action Plan: A Public Health Strategy (NAAP), has been funding Arthritis Programs at state health departments since 1999, with as many as 36 state health departments receiving CDC arthritis funding from 2003-2008. Currently, 12 state health departments are receiving funding to improve the quality of life among persons affected by arthritis. States use funding to strengthen partnerships with other chronic disease programs, state Arthritis Foundation chapters/regions and other partners; improve their ability to monitor the burden of arthritis; coordinate activities; increase States’ work to increase awareness that something can be done to address the burden and impact of arthritis; and to promote self-management education and physical activity.

2. Approach This FOA supports continuation of observational research of the longitudinal, population-based Johnston County Osteoarthritis Project cohort study, which aims to determine the prevalence, incidence, and progression of hip and knee OA and related outcomes; to investigate possible risk and protective factors associated with hip and knee OA; and to determine racial or ethnic differences in outcomes and in the role of comorbid conditions. Johnston County is one of only 3 well-established population-based longitudinal studies of OA (Framingham Osteoarthritis Study; Rochester Minnesota studies) and the only one to include African Americans. The study has collected data multiple times using recurrent surveys, clinical examinations, radiographs, specimens, genetic testing and other laboratory testing. This FOA will support follow-up activities for the fourth follow-up phase (T4) of the study. A future T5 phase may occur if there is http://www.healthypeople.gov/2020/topics-objectives/topic/arthritis-osteoporosis-and-chronic-back-conditions http://www.healthypeople.gov/2020/topics-objectives/topic/arthritis-osteoporosis-and-chronic-back-conditions http://www.surgeongeneral.gov/priorities/prevention/strategy/report.pdf http://www.cdc.gov/chronicdisease/pdf/four-domains-factsheet-2015.pdf http://www.arthritis.org/about-us/naap/ http://www.arthritis.org/about-us/naap/ http://www.arthritis.org/about-us/naap/ 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 the protocol, methods, and quality assurances to be used for the study.

Identifies the data to be collected and the 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, including project staff at UNC and elsewhere. The staffing plan should discuss how staff local to Johnston County will be used for the project. This has been a particular strength of this longitudinal study for the past 25 years.

Specifies how the applicant will collaborate with other public health and arthritis 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, clinical examinations, radiographs, genetic testing and other laboratory testing over the five-year period to characterize the cohort for hip and knee OA. The research objectives are to:

Utilize the existing cohort and methodology to extend the follow-up time for examination of the slowly developing conditions of hip and knee OA. This will allow investigators to refine population-based estimates of the prevalence, incidence, and progression of hip and knee OA and related outcomes for older, long-established members of the initial cohort and for additional cohort members added at the various follow-up periods. Such “later onset” disease may be dissimilar from earlier onset disease, and may well differ between Caucasians and African Americans, who already have demonstrated variability in radiographic and symptomatic disease.

Gather information on and investigate possible factors (both risk and protective) associated with the above outcomes, especially modifiable risk factors that have implications for clinical or public health practice. Only a few such factors have been analyzed so far, and these were analyzed over a relatively short time horizon (e.g., 5-year average). It may be that factors associated with earlier onset disease (e.g., sports joint injury) may be different from those with later onset disease (e.g. occupational tasks, obesity). Clarifying factors such as the timing and role of comorbid conditions (e.g., obesity, heart disease, diabetes), which are frequent in cross-sectional studies of arthritis, should be examined, All these factors may vary between whites and blacks, as we have seen with radiographic and symptomatic studies previously done. Information determining the role of the above factors in OA has direct implications for public health and clinical interventions aimed at reducing OA burden, which is increasing rapidly as the population is aging. Current public health interventions focus only on self-management education and physical activity, but will expand as we learn more about risk/protective factors.

Determine racial or ethnic differences in outcomes and in the role of comorbid conditions and the effect of risk factors upon OA outcomes.

Outcomes

Provide data which has been collected multiple times over the five-year period which characterizes hip and knee osteoarthritis (OA) and other related outcomes among an established cohort;

Provide refined population-based estimates of prevalence, incidence and progression of hip and knee OA and other related outcomes;

Identify factors (both risk and protective) associated with hip and knee OA, especially modifiable risk factors that have implications for clinical or public health practice;

Clarify factors such as the timing and role of comorbid conditions (e.g., obesity, heart disease, diabetes) on hip and knee OA outcomes;

Determine racial or ethnic differences in outcomes and in the role of comorbid conditions and the effect of risk factors upon OA outcomes; and Results are shared with the public health and clinical community.

Target Population This FOA continues to target the general population of 6 townships in Johnston County, North Carolina.

Collaboration/Partnerships The 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 those with requisite expertise in OA, data management, and longitudinal data analysis to achieve the objectives of this FOA.

Collaboration/partnerships with other funding sources to supplement this award may prove 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 OA interventions.

Evaluation/Performance Measurement The applicant is expected to develop an evaluation plan that includes process evaluation of key milestones of the project.

Translation Plan The applicant is expected to conduct analyses related to the listed objectives/outcomes and publish the results in relevant professional journals.

OMB/PRA is not expected to apply.

References

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.

1.

Centers for Disease Control and Prevention & Arthritis Foundation. A National Public Health Agenda for Osteoarthritis: 2010. http://www.cdc.gov/arthritis/docs/oaagenda.pdf. Published 2010.

2.

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: $7,500,000 http://www.ncbi.nlm.nih.gov/pubmed/10513494 http://www.cdc.gov/arthritis/docs/oaagenda.pdf

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: $1,500,000 Per Budget Period Award Floor: $600,000 Per Budget Period Total Project Period Length: 5 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 is the University of North Carolina at Chapel Hill.

4. Justification for Less than Maximum Competition The University of North Carolina at Chapel Hill is the only institution that has the ability to continue to follow this 25-year cohort and to leverage other federal and private resources to create a rich data set and conduct a variety of analyses to further public health goals. The use of staff local to Johnston County for the past 25 years and their special relationship with the community are special methodological strengths of this particular longitudinal study. No other institution in the United States has the resources in place and is positioned to conduct a fourth follow-up study that address the research questions. Continued, uninterrupted support for this research will allow CDC to expand its efforts and ability to address the public health problem of OA and its related conditions.

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

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 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.

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 https://www.sam.gov/index.html

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 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 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 http://grants.nih.gov/grants/forms.htm

3. Letter of Intent Due Date for Letter of Intent: 01/11/2016 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 IC 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 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 mailto:Zgx7@cdc.gov

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 entire five-year project period and should include the following items:

Introduction/Background

Describe how the study addresses hip and knee OA.

Describe the demographics of the study population.

Specific Aims

Specify overall aims or objectives for the study.

Describe expected outcomes by the end of the project period.

Research Strategy

Describe the design, methodology and protocol for the study.

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

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 include previously obtained data (T0, T1, T2, T3 and T4). Description should include plans to maintain clarity, quality and consistency of analyses and publications that result from these and earlier data.

Describe expected contributions to the field.

Staffing and Milestones

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

Identify key milestones 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. Plan should discuss strategy for using staff local to Johnston County, which has been a strength of the study for the past 25 years.

Describe the 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 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 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 mailto:support@grants.gov mailto:www.pgotim@cdc.gov 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 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

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 mailto:www.pgotim@cdc.gov http://www.whitehouse.gov/omb/grants_spoc http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144 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

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 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 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, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?