DP-19-003.pdf

Centers for Disease Control

National Center for Chronic Disease Prevention and Health Promotion Extramural Research

Program Office

Epidemiology of Lupus: Longitudinal Studies in Population-Based Cohorts

RFA-DP-19-003

Application Due Date: 03/08/2019

Epidemiology of Lupus: Longitudinal Studies in Population-Based Cohorts

RFA-DP-19-003

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 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) Notice of Funding Opportunity (NOFO) Title Epidemiology of Lupus: Longitudinal Studies in Population-Based Cohorts Activity Code U01

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-DP-19-003

Assistance Listings (CFDA) Number(s) 93.283 Category of Funding Activity:

Health NOFO Purpose This NOFO is intended to support research on lupus through a 2-component cooperative agreement:

Component A (Longitudinal Studies of Lupus in Population-based Cohorts of Adults with Lupus: 3 Year Followup):

This is a longitudinal followup study designed to support an established, US-based, population-based cohort of adults age 18 and older with diagnosed lupus (systemic lupus erythematosus {SLE} and skin lupus) that includes followup data collected at least once since 2015. The intent of this study is to conduct data collection, building upon the cohort and initial followup activities. This data collection should include four content areas:

1. The natural history (e.g., severity, morbidity, mortality, disability, comorbidity, work interference, etc.) of cohort members, and

2. Treatment (e.g., medications, therapy, self-management, etc.) of lupus including the treatment of chronic pain and opioid use, and

3. Health care access and gaps that adults with lupus experience, and

4. Disparities (e.g., age, race/ethnicity, sex) and other factors associated with lupus outcomes.

Component B: (A Pediatric Lupus Registry with Longitudinal Followup):

This is a project that will support an existing US-based registry of children age 0-17 years with diagnosed lupus (SLE and skin lupus). The intent of this study is to gather baseline for children age 0-17 years and followup data for this cohort for three additional years. The baseline and followup data should include these 4 content areas:

1. The natural history (e.g., severity, morbidity, mortality, disability, comorbidity, work interference, etc.) of cohort members, and

2. Treatment (e.g., medications, therapy, self-management, etc.) of lupus including the treatment of chronic pain and opioid use, and

3. Health care access and gaps that children with lupus experience, and

4. Disparities (e.g., age, race/ethnicity, sex) and other factors associated with lupus outcomes.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-19-003, 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: 02/08/2019

Application Due Date: 03/08/2019

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

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time 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: 04/18/2019

Secondary Review: 05/19/2019 https://www.grants.gov

Estimated Start Date: 09/01/2019

Expiration Date: 03/09/2019 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) 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

1. Purpose. This NOFO is intended to support research on lupus through a 2-component cooperative agreement:

Component A (Longitudinal Studies in Population-based Cohorts of Adults with Lupus: 3 Year Followup):

This is a longitudinal followup study designed to follow an established, US-based, population-based cohort of adults age 18 and older with diagnosed lupus (systemic lupus erythematosus {SLE} and skin lupus) that includes followup data collected at least once since 2015. The intent of this study is to conduct data collection, building upon the cohort and initial followup activities. This data collection should include four content areas:

1. The natural history (e.g., severity, morbidity, mortality, disability, comorbidity, work interference, etc.) of cohort members, and

2. Treatment (e.g., medications, therapy, self-management, etc.) of lupus including the treatment of chronic pain and opioid use, and

3. Health care access and gaps that adults with lupus experience, and http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

4. Disparities (e.g., age, race/ethnicity, sex) and other factors associated with lupus outcomes.

Component B (A Pediatric Lupus Registry with Longitudinal Followup):

This is a project that will support an existing US-based registry of children age 0-17 years with diagnosed lupus (SLE and skin lupus). The intent of this study is to gather baseline data for children age 0-17 years and follow up data for this cohort for three additional years. The baseline and follow up data should include these 4 content areas:

1. The natural history (e.g., severity, morbidity, mortality, disability, comorbidity, work interference, etc.) of cohort members, and

2. Treatment (e.g., medications, therapy, self-management, etc.) of lupus including the treatment of chronic pain and opioid use, and

3. Health care access and gaps that children with lupus experience, and

4. Disparities (e.g., age, race/ethnicity, sex) and other factors associated with lupus outcomes.

Applicants can apply for Component A, Component B or both but there must be separate applications if applying for both.

2. Mechanism of Support. Cooperative Agreement

3. Funds Available and Anticipated Number of Awards. Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications.

Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Component A: 9/1/19 - 8/31/20, is $2,700,000 for 3 awards. The average award amount is $900,000 per award in year one.The estimated total funding (direct and indirect) for the entire period of performance, 9/1/19 - 8/31/22, is $8,100,000 for 3 awards.

Component B: 9/1/19 - 8/31/20, is $800,000 for 1 award. The estimated total funding (direct and indirect) for the entire period of performance, 9/1/19 - 8/31/22, is $2,400,000.

4. Budget and Period of Performance. The estimated total funding (direct and indirect) for the first budget period:

Component A: The estimated total funding (direct and indirect) for the entire period of performance is $8,100,000, to fund up to 3 awards. Average award will be $2,700,000 at $900,000 per year per award.

Component B: The estimated total funding (direct and indirect) for the entire period of performance is $2,400,000, to fund 1 award at $800,000 per year.

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

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV

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

7. 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.

8. Number of PDs/PIs. Applications may include more than one PI; however, the first PI listed on the application will be the ?contact PI? for all correspondence. Any additional PIs are permitted, but would be referred to as Co-PIs.

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

10. Application Type. New.

11. Special Date(s). Not applicable.

12. Application Materials. See Section IV.1 for application materials. Please note that Form E is to be used when downloading the application package

13. Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: 1- 888-232-6348.

A link to this NOFO will be available at Notice of Funding Opportunities | Our Programs | National Center for Chronic Disease Prevention and Health Promotion | CDC

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 Lupus is the prototypical autoimmune disease, having 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 at all ages. 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 http://era.nih.gov/commons/index.cfm#SectionIII1A http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm population burden of the disease. This need is described in the 2015 National Public Health Agenda for Lupus (1), and is a priority for the CDC Arthritis Program.

Knowledge of such information on the full spectrum of disease for lupus, which is associated with strong age/sex/race disparities and has had little public health research, can help identify missed opportunities for better treatment, help identify new disease phenotypes based on progression of disease, and help identify factors associated with progression that may play a role in secondary and tertiary prevention.

Component A (Longitudinal Studies in Population-based Cohorts of Adults with Lupus: 3 Year Followup):

Population-based cohorts that include the full spectrum of diagnosed disease provide an opportunity to conduct extended followup studies that address the many unanswered questions that clinicians and researchers have about these relatively uncommon but serious conditions.

These questions can only be addressed by examining the same people over the course of the illness. Such lupus followup research studies were funded in 2011 and 2016 in Michigan (University of Michigan) and in 2014 in Georgia (Emory University) and California (University of California - San Francisco) and have provided important followup information for five (Georgia, California) and eight (Michigan) years of followup. The public health need is for additional followup information beyond what has been collected already.

The purpose of Component A is to support research on lupus through a longitudinal followup study designed to follow an established, US-based, population-based cohort of adults age 18 and older with diagnosed lupus (systemic lupus erythematosus {SLE} and skin lupus) that includes followup data collected at least once since 2015. The intent of this study is to conduct data collection, building upon the cohort and initial followup activities.

1. The natural history (e.g., severity, morbidity, mortality, disability, co-morbidity, work interference, etc.) of cohort members.

a. Natural history pertains to the severity of disease (e.g., end-stage renal disease), disease progression (including predictors of progression), morbidity (especially the effects of co-morbid conditions), and mortality.

2. Treatment (e.g., medications, therapy, self-management, etc.) of lupus including the treatment of chronic pain and opioid use.

a. Lupus is characterized by chronic pain which may be treated with opioid analgesics. Given the current guidelines for prescribing of opioids for chronic pain (https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm), data on opioid use among lupus patients will help inform clinical guidelines for the treatment of pain in lupus.

3. Health care access and gaps that adults with lupus experience.

a. Lupus affects disparate populations (e.g., women, especially African American women; African Americans; Hispanics) who may have problems accessing the necessary health care, particularly specialty care such as for lupus nephritis.

Evaluating factors that influence disparities in access to care can help inform interventions to improve care for all lupus patients.

4. Disparities (e.g., age, race/ethnicity, sex) and other factors associated with lupus outcomes.

a. Data collected with these population-based cohorts will inform potential https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm culturally-relevant interventions to address disparities.

Such information, if available at all, has generally been available only for hospital-based, specialist-based, or other convenience samples that may not be representative of the full clinical spectrum of lupus. This observational, followup research of established, population-based cohorts will collect data multiple times over 3 years using recurrent surveys, personal contacts, clinical examination, medical records, and genetic and other laboratory testing.

Component B: (A Pediatric Lupus Registry with Longitudinal Followup):

Population-based cohorts of children that include the full spectrum of diagnosed disease provide an opportunity to conduct extended followup studies that address the many unanswered questions that clinicians and researchers have about these relatively uncommon but serious conditions. These questions can only be addressed by examining the same children over the course of the illness, including beyond childhood.

The purpose of this Component B is to support an existing U.S. based registry of children age 0- 17 years with diagnosed lupus (SLE and skin lupus). The intent of this study is to gather baseline data for children age 0-17 years and follow up data for this cohort for three additional years. The baseline and follow up data should include these 4 content areas:

1. The natural history (e.g., severity, morbidity, mortality, disability, co-morbidity, school or work interference, etc.) of cohort members.

a. Natural history pertains to the severity of disease (e.g., end-stage renal disease), disease progression (including predictors of progression), morbidity (especially the effects of co-morbid conditions), and mortality.

2. Treatment (e.g., medications, therapy, self-management, etc.) of lupus including the treatment of chronic pain and opioid use.

a. Lupus is characterized by chronic pain which may be treated with opioid analgesics. Given the current guidelines for prescribing of opioids for chronic pain (https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm), data on opioid use among lupus patients will help inform clinical guidelines for the treatment of pain in lupus.

3. Health care access and gaps that children with lupus experience.

a. Lupus affects disparate populations (e.g., women, especially African American women; African Americans; Hispanics) who may have problems accessing the necessary health care, particularly specialty care such as for lupus nephritis.

Evaluating factors that influence disparities in access to care can help inform interventions to improve care for all lupus patients.

4. Disparities (e.g., age, race/ethnicity, sex) and other factors associated with lupus outcomes.

a. Data collected with these population-based cohorts will inform potential culturally-relevant interventions to address disparities.

Such information, if available at all, has generally been available only for hospital-based, specialist-based, or other convenience samples that may not be representative of the full clinical spectrum of lupus. This observational, followup research will support a baseline registry (as population-based as possible) and collect data multiple times over the 3-year project period using recurrent surveys, personal contacts, clinical examination, medical records, and genetic and other laboratory testing.

Healthy People 2020 and other National Strategic Priorities Lupus is classified as a type of arthritis for public health purposes, so it relates to several national priorities.

This NOFO addresses the Healthy People 2020 focus areas of 1) Arthritis, Osteoporosis, and Chronic Back Conditions; 2) Access to Health Services, 3) Disability and Health; 4) Health Communication and Health Information Technology; 5) Social Determinants of Health and 6) Health-related Quality of Life & Well-being. Analyses from this NOFO may address all nine arthritis objectives on doctor diagnosed arthritis because they address lupus, a condition which is included in the definition of arthritis and other rheumatic conditions. 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 NOFO 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). (1) This NOFO aligns with epidemiology and surveillance strategies and recommendations of the 2015 National Public Health Agenda for Lupus (2):

Strategy 1-1: Monitor long-term trends in the burden of lupus Strategy 1-2: Assess and monitor the quality and timeliness of care for people living with lupus Strategy 1-3: Assess and monitor quality of life among people living with lupus Strategy 1-5: Expand research in lupus, including epidemiologic, surveillance and public health research By addressing gender and race disparities in lupus, this NOFO addresses the fourth strategic direction of the National Prevention Strategy (Elimination of Health Disparities). (3) Also, this NOFO addresses the CDC Strategic Framework Strategy #2: Better prevent the leading causes of illness, injury, disability, and death, by collecting accurate, timely and comprehensive surveillance information on a condition that has been not previously been captured by other population-based data systems. (4)

Public Health Impact Component A (Longitudinal Studies in Population-based Cohorts of Adults with Lupus: 3 Year Followup):

This research will have a public health impact by identifying strengths and challenges of existing clinical and public health approaches to managing lupus, a clinically complicated disease, by addressing research questions on natural history, treatment, health care access, and disparities. This research addresses a public health gap by advancing epidemiologic understanding of lupus, a disease that is difficult to diagnose; confirming the burden and outcomes of lupus; and providing direction for the interventions to address identified problems.

With this information, clinical and public health approaches can be enhanced to help improve the quality of life of adults with lupus. Also, by examining categories of research interest (e.g., age, sex, race/ethnicity), more culturally relevant interventions can be produced.

Component B (A Pediatric Lupus Registry with Longitudinal Followup):

This research will have a public health impact by identifying strengths and challenges of existing clinical and public health approaches to managing lupus, a particularly clinically complicated disease in children. It will address research questions on natural history, treatment, health care access, and disparities. This research addresses a public health gap for children by advancing epidemiologic understanding of lupus, a disease that is difficult to diagnose;

confirming the burden and outcomes of lupus; and providing direction for the interventions to address identified problems. With this information, clinical and public health approaches can be enhanced to help improve the quality of life of children with lupus. Also, by examining categories of research interest (e.g., age, sex, race/ethnicity), 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 research (i.e., adult lupus registries and followup studies) and non-research (partnerships, raising awareness, etc.), and in 2015 published a National Public Health Agenda for Lupus, the first-ever such public health agenda (5).

Previous funding (some as early as FY 2003) created five, population-based lupus registries of >400 lupus patients designed to develop credible estimates of the incidence and prevalence of lupus for five race/ethnic groups (Blacks, Whites, Hispanics, Asians, and American Indian/Alaska Natives). These include:

The Georgia Lupus Registry (Blacks, Whites) Michigan Lupus Epidemiology and Surveillance (MILES) Program (Blacks, Whites) California Lupus Surveillance Program (Hispanics, Asians) Manhattan Lupus Surveillance Program (Hispanics, Asians) Indian Health Service Lupus Project (American Indians/Alaska Natives)

From these initial registries, CDC has since funded three studies of established population-based lupus cohorts to determine natural history, treatment, health care access, and disparities over 5+ years. These currently funded projects are being completed by University of Michigan, Emory University, and University of California, San Francisco. These projects have collected data and published findings on the incidence and prevalence of lupus, morbidity (renal disease, health-related quality of life, etc.), health care (diagnosis and management) and disparities (e.g., age, race/ethnicity, sex). (5-11) The CDC Arthritis Program also funds the Lupus Foundation of America (LFA) and the

American College of Rheumatology (ACR) through a DP15-1511 cooperative agreement to improve the health of individuals with lupus by providing tools to improve overall well-being.

Through key stakeholders, awardees are empowering the individual to take action by providing practical resources and skills to achieve increased knowledge of lupus signs and symptoms, to establish lupus patient centered care, and to improve lupus self-management. This work is important to address the limited availability and access to lupus education and resources among these targeted audiences. The ultimate impact can reduce hospitalization rates and improve kidney disease health outcomes.

2. Approach Intent of this NOFO is to use an existing population based registry and subsequent cohort to collect followup data on 4 important content areas. A population based registry is important because, to date, information has generally only been available for hospital-based, specialist-based, or other convenience samples that may not be representative of the full clinical spectrum of lupus.

Component A (Longitudinal Studies in Population-based Cohorts of Adults with Lupus: 3 Year Followup):

By the end of the performance period the applicant must collect data on a population based, established cohort of patients with lupus over 3 years.

Study should involve an existing population-based cohort of >400 adults that includes the full spectrum of disease, SLE and skin lupus, and has been followed for the following content areas for at least 4 years at the time of application.

o The natural history (e.g., severity, morbidity, mortality, disability, comorbidity, work interference, etc.) of cohort members, and o Treatment (e.g., medications, therapy, self-management, etc.) of lupus including the treatment of chronic pain and opioid use, and o Health care access and gaps that adults with lupus experience, and o Disparities (e.g., age, race/ethnicity, sex) and other factors associated with lupus outcomes.

Data collection should include the four content areas listed above: natural history, treatment, health care access, and disparities.

Participate in 1-on-1 bi-monthly conference calls with CDC Project Officer.

Participate in quarterly conference calls with all sites and CDC Staff.

Particpate in site visit/reverse site visit with CDC Project Officer as scheduled to discuss project.

Publish study results (conference abstracts, peer-reviewed manuscripts, etc.).

Component B (A Pediatric Lupus Registry with Longitudinal Followup):

Study should support a registry of >200 children ages 0-17 years with diagnosed lupus (as population-based as possible) that includes the full spectrum of disease (SLE and skin lupus) with baseline data needed to follow the resulting cohort for the duration of the project period for the following content areas.

o The natural history (e.g., severity, morbidity, mortality, disability, comorbidity, school or work interference, etc.) of cohort members, and o Treatment (e.g., medications, therapy, self-management, etc.) of lupus including the treatment of chronic pain and opioid use, and o Health care access and gaps that children with lupus experience, and o Disparities (e.g., age, race/ethnicity, sex) and other factors associated with lupus outcomes.

By the end of the performance period the applicant must establish baseline data collection, collect at least 1 year of followup data and publish results.

Data collection during the period of performance (baseline and followup) should include the four content areas listed above: natural history, treatment, health care access, and disparities.

Participate in 1-on-1 bi-monthly conference calls with CDC Project Officer.

Participate in quarterly conference calls with Component A sites and CDC Staff.

Participate in site visit/reverse site visit with CDC Project Officer as scheduled to discuss project.

Publish study results (conference abstracts, peer-reviewed manuscripts, etc.).(12-17)

Applicants can apply for Component A, Component B or both but there must be separate applications if applying for both.

Objectives/Outcomes Component A (Longitudinal Studies in Population-based Cohorts of Adults with Lupus: 3 Year Followup):

Objective 1: Determine longer term natural history (e.g., severity, morbidity, mortality, disability, comorbidity, work interference, etc.) of adults with lupus.

Outcomes: Collect, analyze and publish data on the long-term (8+ years of followup) natural history of lupus among a population-based cohort of adult lupus patients.

Objective 2: Document the treatment (e.g., type, appropriateness, medications, physical therapies, mental health, self-management, etc.) of adults with lupus including chronic pain and opioid use.

Outcomes: Presentations (e.g., conferences) and publications providing descriptive analyses of type and extent of clinical treatment (e.g., blood testing, physical examination, pharmacologics, non-pharmacologic interventions) among a population-based cohort of lupus patients and identifying disparities in treatment by age, sex, race/ethnicity.

Objective 3: Determine the health care access (e.g., ambulatory care, hospitalizations, emergency room visits, insurance status, access to specialists such as rheumatologists, nephrologists, etc.) and gaps that adults with lupus experience in addressing their varied health problems (e.g., general health problems as well as those for specific lupus outcomes such as nephritis).

Outcomes: Presentations (e.g., conferences) and publications providing descriptive analyses of health care access and gaps in health care access that adults with lupus experience.

Objective 4: Assess disparities and other factors associated with lupus outcomes by categories of interest (e.g., age, sex, and race/ethnicity group).

Outcomes: Presentations and publications on lupus outcomes by age, sex, and race/ethnicity.

Objective 5: Presentations (e.g., conferences) and publications of study results to various audiences (health professionals, public health practitioners, persons with lupus, etc.) including publication in peer reviewed journals, presentations at conferences and disseminate findings using health communications though partnerships with patient disease associations (e.g., Lupus Foundation of America).

Component B (A Pediatric Lupus Registry with Longitudinal Followup):

Objective 1: Determine the natural history (e.g., severity, morbidity, mortality, disability, comorbidity, school or work interference, etc.) of children with lupus.

Outcomes: Collect, analyze and publish data on the baseline registry and followup cohort for natural history of lupus among children.

Objective 2: Document the treatment (e.g., type, appropriateness, medications, physical therapies, mental health, self-management, etc.) of children with lupus including chronic pain and opioid use.

Outcomes: Presentations (e.g., conferences) and publications providing descriptive analyses of type and extent of clinical treatment (e.g., blood testing, physical examination, pharmacologics, non-pharmacologic interventions) among a population-based cohort of lupus patients and identify disparities in treatment by age, sex, race/ethnicity.

Objective 3: Determine the health care access (e.g., ambulatory care, hospitalizations, emergency room visits, insurance status, access to specialists such as rheumatologists, nephrologists, etc.) and gaps that children with lupus experience in addressing their varied health problems (e.g., general health problems as well as those for specific lupus outcomes such as nephritis).

Outcomes: Presentations (e.g., conferences) and publications providing descriptive analyses of health care access and gaps in health care access that adults with lupus experience.

Objective 4: Assess disparities and other factors associated with lupus outcomes by categories of interest (e.g., age, sex, and race/ethnicity group).

Outcomes: Presentations and publications on lupus outcomes by age, sex, and race/ethnicity.

Objective 5: Presentations (e.g., conferences) and publications of study results to various audiences (health professionals, public health practitioners, persons with lupus, etc.) including publication in peer reviewed journals, presentations at conferences and disseminate findings using health communications though partnerships with patient disease associations (e.g., Lupus Foundation of America).

Target Population Component A (Longitudinal Studies in Population-based Cohorts of Adults with Lupus: 3 Year Followup):

The target population is adults aged 18 and older with SLE and/or skin lupus who were identified through a U.S, population-based registry and have 4 years of followup at time of application for the four content areas listed above under Approach.

Component B (A Pediatric Lupus Registry with Longitudinal Followup):

The target population is children age 0-17 years with diagnosed lupus (SLE and/or skin lupus) for a registry as geographically population-based as possible.

Collaboration/Partnerships Components A and B:

Collaboration or partnerships may be needed to guarantee access to the required data (both existing and followup data), and to those with the requisite expertise in lupus (e.g., international lupus experts), data management, and longitudinal data analysis needed to achieve the objectives of this NOFO. For example, the applicant may partner with the state Health Department and the vital statistics system to match mortality data to the the lupus cohort. The applicant will work with CDC collaborators and other grantees to design, implement, and analyze data across sites as needed.

Evaluation/Performance Measurement Components A and B:

Awardees will be expected to provide a timeline of key milestones (matched cohort with vital statistics, followup of cardiovascular events, etc.), plans for data assurance, confidentiality and quality, and plans for conference calls/site visits and drafting related minutes and reports.

Translation Plan Component A (Longitudinal Studies in Population-based Cohorts of Adults with Lupus: 3 Year Followup):

Awardees will be expected to provide a plan to submit and present abstracts at relevant professional meetings (e.g., the American College of Rheumatology, biannual Armonk (NY) Lupus Meeting) and to publish full-length manuscripts in peer reviewed journals. It is expected that 3-5 manuscripts per year will be submitted to peer reviewed journals by each awardee.

Priority findings to be disseminated should include natural history, treatment, health care access and disparities in these outcomes.

Component B (A Pediatric Lupus Registry with Longitudinal Followup):

Awardees will be expected to provide a plan to submit and present abstracts at relevant professional meetings (e.g., the American College of Rheumatology, biannual Armonk (NY) Lupus Meeting, pediatric meetings) and to publish full-length manuscripts in peer reviewed journals. It is expected that at least an average of 2 manuscripts per year will be submitted to peer reviewed journals by the awardee during the project period. Priority findings to be disseminated should include natural history, treatment, health care access and disparities in these outcomes.

OMB/PRA is expected to apply.

References:

1. Healthy People 2020 available at https://www.healthypeople.gov/2020/topics-objectives/topic/Arthritis-Osteoporosis-and-Chronic-Back-Conditions/objectives

2. The National Prevention Strategy can be found at:

http://www.surgeongeneral.gov/priorities/prevention/strategy/report.pdf.

3. CDC Strategic Framework Strategy #2 can be found at https://www.cdc.gov/about/organization/strategic-framework/index.html#B2

4. 2015 National Public Health Agenda for Lupus is available at https://www.lupus.org/general-news/entry/national-lupus-public-health-agenda-provides-roadmap.

5. Lim SS, Bayakly AR, Helmick CG, Gordon C, Easley KA, Drenkard C. The incidence and prevalence of systemic lupus erythematosus, 2002?2004: The Georgia Lupus Registry.

Arthritis Rheumatol. 2014;66(2):357?368.

6. Somers EC, Marder W, Cagnoli P, et al. Population-based incidence and prevalence of systemic lupus erythematosus: the Michigan Lupus Epidemiology and Surveillance Program.

Arthritis Rheumatol. 2014;66(2):369?378.

7. Dall?era M, Cisternas MG, Snipes K, et al. The incidence and prevalence of systemic lupus erythematosus in San Francisco County, California: The California Lupus Surveillance Project.

Arthritis Rheumatol. 2017;69(10):1996-2005. doi: 10.1002/art.40191

8. Lim S, Drenkard C, McCune WJ, et al. Population-based lupus registries: Advancing our epidemiologic understanding. Arthritis Rheum. 2009;61(10):1462?1466.

9. Plantinga L, Lim SS, Patzer R, et al. Incidence of end-stage renal disease among newly diagnosed systemic lupus erythematosus patients: The Georgia Lupus Registry. Arthritis Care Res (Hoboken). 2015;68:357-365.

10. Plantinga L, Lim SS, Bowling CB, Drenkard C. Association of age with health-related quality of life in a cohort of patients with systemic lupus erythematosus: the Georgians Organized Against Lupus study. Lupus Sci Med. 2016:3e000161.

11. McDougall JA, Helmick CG, Lim SS, et al. Differences in the diagnosis and management of systemic lupus erythematosus by primary care and specialist providers in the American Indian/Alaska Native population. Lupus. [published online March 19, 2018]. doi:

10.1177/0961203318763529

12. Demirkaya E, Concolaro A, Sonmez HE, Giancane G, Simsek D, Ravelli A. Current Research in Outcomes Measures for Pediatric Rheumatic and Autoimflammatory Diseases.

Curr Rheumatol Repo 2016;18(8):DOI 10.1007/s11926-015-0558-4.13.Hersh AO, Case SM, Son MB. Predictors of Disability in a Childhood-onset Systemic Lupus Erythematosus Cohort:

Results from the CARRA Legacy Registry. Lupus 2018;27:494-500.

Borgia RE, Silverman ED. Childhood-onset Systemic Lupus Erythematosus: An Update. Curr Opin Rheumatol. 2015;27(5):483-92. doi: 10.1097/BOR.0000000000000208.

13. Aggarwal A, Srivastava P. Childhood Onset Systemic Lupus Erythematosus: How is it different from adult SLE? International Journal of Rheumatic Diseases 2015;18:182-191.

14. Thakral A, Klein-Gitelman MS. An Update on Treatment and Management of Pediatric Systemic Lupus Erythematosus. Rheumatol Ther. 2016 Dec;3(2):209-219. Epub 2016 Sep 30.

15. Beukelman T, Kimura Y, Ilowite NT, Mieszkalski K, Natter MD, Burrell G, Best B, Jones J, Schanberg LE. The new Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry: design, rationale, and characteristics of patients enrolled in the first 12 months. Pediatric Rheumatology201715:30 https://doi.org/10.1186/s12969-017-0160-6

16. Luca NJC, Feldman BM. Health Outcomes of Pediatric Rheumatic Diseases. Best Practice & Research Clinical Rheumatology 2014;28:331-350.

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:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $10,500,000 Component A: 9/1/19 – 8/31/20, is $2,700,000 for 3 awards. The average award amount is $900,000 per award in year one.The estimated total funding (direct and indirect) for the entire period of performance, 9/1/19 – 8/31/22, is $8,100,000 for 3 awards.

Component B: 9/1/19 – 8/31/20, is $800,000 for 1 award. The estimated total funding (direct and indirect) for the entire period of performance, 9/1/19 – 8/31/22, is $2,400,000.

Anticipated Number of Awards: 4 Component A: 3 awards Component B: 1 award

Awards issued under this NOFO 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: $700,000 Per Budget Period Total Period of Performance Length: 3 year(s)

Throughout the Period of Performance, 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/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

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 include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements Eligibility applicants must meet the following criteria:

Component A: (Longitudinal Studies of Lupus in Population-based cohorts of Adults with Lupus: 3 Year Followup):

Criteria 1. Applicant must have an existing U.S. population-based cohort with > 400 adults ages 18 and greater at baseline, with SLE and/or skin lupus.

Criteria 2. Applicant must have at least 4 years of followup at time of application for the four content areas listed in the Approach section above (natural history, treatment, health care access, and disparities).

Component B: (A Pediatric Lupus Registry with Longitudinal Followup):

Criteria 1. Applicant must have access to an existing cohort with 200+ diagnosed U.S. lupus patients ages 0-17 years at baseline in an area that is geographically population-based.

If your application is incomplete or non-responsive to the special eligibility requirements listed in this section, it will not enter into the review process.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Evidence for the special eligibility criteria listed in number 3 above documentation must be presented in Appendix A of the application. If your application is incomplete or non-responsive to these requirements, it will not enter into the review process.

Component A (Longitudinal Studies in Population-based Cohorts of Adults with Lupus: 3 Year Followup):

Criteria 1: Existing population-based cohort with > 400 adults ages 18 and greater at baseline, with SLE and/or skin lupus.

Provide a letter stating they have access to a cohort with the stated requirements.

Criteria 2: Applicant must have at least 4 years of followup at time of application for the four content areas:

1. Natural history (e.g., severity, morbidity, mortality, disability, comorbidity, work interference, etc.) of cohort members,

2. Treatment (e.g., medications, therapy, self-management, etc.) of lupus including the treatment of chronic pain and opioid use,

3. Health care access and gaps that adults with lupus experience, and

4. Disparities (e.g., age, race/ethnicity, sex) associated with lupus outcomes.

Provide one or more figures, tables, diagrams or publications demonstrating data collection related to the four content areas over at least a 4 year period.

Component B: (A Pediatric Lupus Registry with Longitudinal Followup):

Criteria 1. Existing population-based cohort of at least 200+ diagnosed U.S. lupus patients ages 0-17 years at baseline in areas that are geographically population-based.

Provide a letter stating they have access to a cohort with the stated 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/.

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 Principle Investigator (PD/PI) 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 eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process. During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

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 https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf…