Foa_Content_of_RFA-DP-22-002 Revised.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH

PROMOTION

Epidemiology of Lupus: Longitudinal Studies in Population-Based Cohorts

RFA-DP-22-002

01/19/2022

Table of Contents 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

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for Chronic Disease Prevention and Health Promotion Notice of Funding Opportunity (NOFO) Title Epidemiology of Lupus: Longitudinal Studies in Population-Based Cohorts Activity Code Cooperative agreement: U01

Amendment 1 (12-02-21):

Section I, Background and Purpose, paragraph 3, sentence 1. Added "and/or skin lupus".

Section I, Relevant Work, Paragraph 1, sentence 2, Changed "University of Utah" to "Mayo Clinic".

Section I, Relevant Work, Paragraph 1, sentence 3, Added "University of Utah".

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

RFA-DP-22-002

Assistance Listings Number(s) 93.068 Category of Funding Activity HL - Health

NOFO Purpose The purpose of this funding opportunity is to better understand the epidemiology of lupus and improve understanding of how lupus impacts morbidity and mortality over time. To do that the applicants will need access to an existing adult or pediatric lupus population with a minimum of 5 years of follow-up for the adult population and 3 years of follow-up for the pediatric population. The study populations consist of (1) adults with diagnosed lupus aged 18 years or older, and (2) pediatric cases diagnosed with lupus aged <18 years.

The NOFO purpose will be accomplished through two components:

Component A: Epidemiology of Lupus Among Adults, using population registries to study adult lupus patients.

Component B: Epidemiology of Lupus in the Pediatric Population, using an existing cohort of pediatric lupus patients to study and advance existing knowledge of lupus in pediatric populations.

During the proposed 5-year funding period, it is anticipated that applicants for both Components A and B will carry out observational, longitudinal research of established, population-based cohorts in addition to collecting data for analysis and follow-up using a variety of proposed approaches such as recurrent surveys, personal contacts, medical examination, medical records, genetic analysis, and other laboratory testing.

Key Dates Publication Date:

To receive notification of any changes to RFA-DP-22-002, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

12/20/2021 Publication Date: 11/05/21 LOI Date: 12/20/21

Application Due Date:

01/19/2022 1/19/2022

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.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

E-mail: commons@od.nih.gov Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

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:

03/17/2022 Secondary Review:

05/11/2022 Estimated Start Date:

09/30/2022 Expiration Date:

01/20/2022 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - 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.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

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

Executive Summary Purpose. The purpose of this funding opportunity is to better understand the epidemiology of lupus and improve understanding of how lupus impacts morbidity and mortality over time. Because lupus is a rare condition, applicants should already have access to an established, well characterized and on-going cohort of adults or youth with lupus of sufficient sample size for extrapolation to national estimates. Applicants will need existing access to an adult or pediatric lupus population with a minimum of 5 years of follow-up for the adult population and 3 years of follow-up for the pediatric population. The study populations consist of (1) adults with a lupus diagnosis aged 18 years or older and (2) children diagnosed with lupus aged 18 years or younger.

Mechanism of Support. Cooperative Agreement

Funds Available and Anticipated Number of Awards. The estimated total funding (direct and indirect) for the entire period of performance is $26,400,000 to support up to 6 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.

Budget and Period of Performance. Applicants are eligible to apply for both components A and B. For both components A and B, the estimated average award is $880,000, annually. The estimated total funding (direct and indirect) for the first budget period (9/30/2022 to 9/29/2023) for Component A is $4,400,000 (5 awards) and for Component B is $880,000 (1 award). The estimated total funding (direct and indirect) for the entire Period of Performance (9/30/2022 to 9/29/2027) for Component A is $22,000,000 (5 awards) and for Component B is $4,400,000 (1 award).

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 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.

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

Number of Applications. One application per eligible institution (normally identified by having a unique DUNS number) is allowed for each Component. Separate applications are required for each Component.

Application Type. New Special Date(s). None Application Materials. See Section IV.1 for application materials.

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

A link to this NOFO on Grants.gov is available at https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm

Section I. Funding Opportunity Description Statutory Authority This program is authorized under 317(k) (2) of the Public Health Service Act (PHS Act), 42 U.S.C. 247b(k)(2) and 301(a) of the PHS Act, 42 U.S.C. 241(a).

1. Background and Purpose Lupus is an autoimmune disease with a wide spectrum of illness that can affect almost any tissue and organ in the body and cause severe morbidity and premature mortality. Systemic lupus erythematous (SLE) is the most common and serious form of lupus. Recent estimates suggest that around 200,000 US adults have SLE though prior estimates ranged as high as 1.5 million.

Disparities in SLE incidence and prevalence are noted, affecting women far more than men and minorities more than whites. The causes of SLE are unknown but likely linked to genetic, environmental, and hormonal factors. Data regarding SLE in pediatric populations are very limited, and Congress directed CDC to continue working with existing childhood lupus registries to generate more robust information about the impact of the disease in children in the FY21 Appropriations Act.

There is continued need for a basic epidemiologic understanding of lupus to elucidate the full clinical spectrum and population impact of the disease. CDC has funded adult population-based registries up to 18 years, and pediatric population-based registries for over 2 years, from a diverse geographic distribution across the United States allowing for epidemiological estimates to not only be generalizable to the United States, but also to different unique and underserved populations with varying degrees of lupus burden. A pediatric registry was added in the last funding period (CDC-RFA-DP19-003). A wealth of information is emerging from these registries, but more is needed to understand the epidemiology of lupus to inform public health action. Published studies include the first population-based estimates of lupus incidence and prevalence in whites, blacks, Hispanics, Asians, American Indians/Alaska Natives, Arabs, and Chaldeans, but estimates for other groups have yet to be obtained.1-6 Previous registry research has found that 1 in 3 adults with lupus use prescription opioids and have lower adherence to prescription medications and lower health care access than controls.7 More research is needed to understand why this is happening. Furthermore, lower socioeconomic status has been shown to be associated with more severe lupus outcomes and lower adherence to lupus medication.8,9 Additional research can help identify what can be done to lower these risk factors for poorer outcomes in lower SES lupus populations.

This NOFO will support research designed to better understand the epidemiology of lupus by determining treatment patterns and impacts, health care access, disparities, and long-term natural history (severity, morbidity, mortality) of lupus (systemic lupus erythematosus and/or skin lupus). This observational, longitudinal research will solicit established, population-based cohorts to collect data over 5 years using a variety of methods such as recurrent surveys, personal contacts, medical examination, medical records, genetic analysis as well as analysis of existing longitudinal data. Up to five adult population registries (Component A: Epidemiology of Lupus Among Adults) and one pediatric registry (Component B: Epidemiology of Lupus in the Pediatric Population) will be funded.

Extended follow up of long-term cohorts will allow data collection that adds unique knowledge and insight into the epidemiology of lupus and its impacts on morbidity and mortality, such as the contributions of genetic and social factors as well as patterns of care in lupus outcomes, and transitions to adulthood and continuity of care.

Healthy People 2030 and other National Strategic Priorities Analyses from this NOFO address all four arthritis Healthy People 2030 objectives on doctor-diagnosed arthritis because lupus is included in the definition of doctor-diagnosed arthritis, which includes more than 100 different conditions. The four arthritis objectives are A- 01 (moderate or severe joint pain), A-02 (activity limitations), A-03 (work limitations), and A-

04 (counseling for physical activity). These objectives are available at https://health.gov/healthypeople the Healthy People 2030 website.10

Public Health Impact The results from this study will provide a better understanding of the epidemiology, clinical patterns, treatment of the disease, and lupus-related morbidity and mortality. 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 lupus and lupus comorbidities. With this information, clinical and public health approaches can be enhanced to help improve the quality of life and health outcomes of adults with lupus. Findings will be used to target interventions, inform best practices, improve health equity among populations heavily impacted by lupus, and educate providers, researchers, and patients.

Relevant Work CDC has funded population-based lupus registries for up to 18 years with an earlier focus on incidence/prevalence of lupus. The current NOFO (CDC-RFA-DP19-003) funds 4 adult lupus registries at the University of Michigan, Mayo Clinic, Emory University, and the University of California San Francisco. A pediatric registry (University of Utah) was added in the current NOFO (Epidemiology of Lupus: Longitudinal Studies in Population-Based Cohorts, CDC-RFA-

DP19-003).

2. Approach The NOFO has two components. Component A: Epidemiology of Lupus Among Adults is intended to support applicants with access to an existing adult lupus patient population and at least 5 years of follow-up from baseline. Component B: Epidemiology of Lupus in the Pediatric Population is aimed at supporting a pediatric registry with at least 3 years of follow-up from baseline to extend existing knowledge of lupus in pediatric populations. Because lupus is a rare condition, it is efficient to obtain new information from existing lupus cohorts to reduce costs and recruitment times, except where new lupus population cohorts may be warranted to answer new scientific or public health questions. In any longitudinal cohort study the greatest new knowledge and value comes from continued follow-up. Further, longer-term follow-up of an existing lupus cohort is critical to achieving the objectives of epidemiologic research and addressing current gaps in the literature on lupus and longitudinal outcomes such as quality of life, disability, and mortality. Numerous longitudinal studies of other chronic diseases demonstrate that longer-term follow-up of specific people with the disease provides greater understanding of disease natural history as well as clinical and treatment features impacting quality of life and medical management of disease.

During the proposed 5-year funding period, it is anticipated that applicants for both Components A and B will carry out observational, longitudinal research of established, population-based cohorts in addition to collecting data for follow-up using a variety of proposed approaches such as recurrent surveys, personal contacts, medical examination, medical records, genetic analysis, and other laboratory testing. While earlier CDC funding periods focused on incidence and prevalence, the focus of this NOFO is on collection of data related to the course of lupus and its consequences for people with lupus (e.g., function, quality of life, disability, and mortality). Topics of consideration for data collection and/or data analysis may include but are not limited to disease severity; genetic linkages; health care practices; social, behavioral, and psychosocial factors; laboratory markers, and others suggested by applicants. Because of reliance on existing registries, extending prior information for longitudinal studies and new information collection will both be beneficial.

Applicants may apply for Component A and/or Component B. Separate applications are required for each Component.

Objectives/Outcomes Component A: Epidemiology of Lupus Among Adults

Outcomes and Objectives

Examine the treatment (e.g., medications including opioid; type; appropriateness; etc.) of people with lupus.

Determine health care access and gaps that people 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; transition from pediatric to adult healthcare for people diagnosed as children).

Determine longer term natural history (severity, chronic pain, progression, morbidity, mortality, disability and quality of life, work/ school/activity interference, etc.) of people with lupus, including assessing potential genetic factors.

Examine other factors related to disparities in lupus outcomes (e.g., age, sex, race/ethnic group, and socioeconomic status).

Examine lupus comorbidities.

Translate findings to influence public health practice via the dissemination of findings for education, outreach and awareness to scientific researchers, clinical practitioners, and the affected population.

Component B: Epidemiology of Lupus in the Pediatric Population

Outcomes and Objectives

Examine the treatment (e.g., medications including opioid; type; appropriateness; etc.) of people with lupus.

Determine health care access and gaps that people 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; transition from pediatric to adult healthcare for people diagnosed as children).

Determine longer term natural history (severity, chronic pain, progression, morbidity, mortality, disability and quality of life, work/ school/activity interference, etc.) of people with lupus, including assessing potential genetic factors.

Examine other factors related to disparities in lupus outcomes (e.g., age, sex, race/ethnic group, and socioeconomic status).

Examine lupus comorbidities.

Translate findings to influence public health practice via the dissemination of findings for education, outreach and awareness to scientific researchers, clinical practitioners, and the affected population. Findings should be documented through presentations and peer-reviewed publications and any media should be documented as well. Findings should be disseminated to deliver education and awareness to appropriate target audiences, including providers, care givers, and people living with lupus.

Target Population Component A: Epidemiology of Lupus Among Adults: Applicants are expected to target adults (≥18 years) impacted by lupus, identified from an existing and ongoing registry, and followed up for at least 5-years. The study population chosen should be as representative of the US population as possible and include ethnic/racial minorities, urban/rural populations, individuals of low socioeconomic status, those with disabilities, and sexual and gender minority populations. The results from the study population chosen should be extrapolated to the entire US population, so the study design must be capable of generating national estimates.

Component B: Epidemiology of Lupus in the Pediatric Population: The target population includes pediatric patients (aged <18 years) impacted by lupus, identified from a registry, and followed up for at least 3-years. The study population chosen should be as representative of the US pediatric population as possible and include ethnic/racial minorities, urban/rural populations, individuals of low socioeconomic status, those with disabilities, and sexual and gender minority populations. The results from the study population chosen should be extrapolated to the entire US population, so the study design must be amenable to generating national estimates.

Collaboration/Partnerships Component A: Epidemiology of Lupus Among Adults and Component B: Epidemiology of Lupus in the Pediatric Population

Applicants are expected to collaborate with stakeholders that will promote increased lupus education, outreach, and provider and patient awareness. Furthermore, collaborating with outside subject matter experts in the field of lupus epidemiology is encouraged. Finally, collaborations with organizations focused on social determinants of health, health equity, and health disparities is highly encouraged.

Evaluation/Performance Measurement The awardees are expected to develop an evaluation plan by the 6th month post award. This plan should align with the stated purpose and outcomes of the NOFO, which includes participant follow-up, and progress towards meeting study objectives. Evaluation plan should be used to monitor data collection, analysis, and publication status of proposed research articles. Recipient should specify details related to scale, staffing, or resources in the evaluation plan.

Evaluation plans can be refined with CDC post-award. Specific information regarding evaluation can be found at: https://www.cdc.gov/eval/index.htm

Translation Plan For both Component A: Epidemiology of Lupus Among Adults and Component B:

Epidemiology of Lupus in the Pediatric Population, the funded applicants are expected to include a plan for translation of the findings to influence public health practice and disseminate findings for education, outreach and awareness to scientific researchers, clinical practitioners, and the affected population.

OMB/PRA is not expected to apply.

References

1. 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. doi: 10.1002/art.38238. PubMed:24504809.

2. 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. doi: 10.1002/art.38239. PubMed: 24504808.

3. Ferucci ED, Johnston JM, Gaddy JR, et al. Prevalence and incidence of systemic lupus erythematosus in a population-based registry of American Indian and Alaska Native people, 2007-2009. Arthritis Rheumatol. 2014;66(9):2492-2502. doi: 10.1002/art.38720.PubMed:

24891315.

4. Housey M, Deguire P, Lyon-callo S, et al. Incidence and prevalence of systemic lupus erythematosus among Arab and Chaldean Americans in southeastern Michigan: the Michigan Lupus Epidemiology and Surveillance Program. Am J Public Health. 2015;105(5):e74-9. doi:

10.2105/AJPH.2014.302423. PubMed: 25790387.

5. Izmirly PM, Wan I, Sahl S, et al. The incidence and prevalence of systemic lupus erythematosus in New York County (Manhattan), New York: The Manhattan Lupus Surveillance Program. Arthritis Rheumatol. 2017;69(10):2006-2017. doi: 10.1002/art.40192.

6. 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.

7. Somers EC, Lee J, Hassett AL, Zick SM, Harlow SD, Helmick CG, Barbour KE, Gordon C, Brummett CM, Minhas D, Padda A, Wang L, McCune WJ, Marder W. Prescription opioid use in patients with and without systemic lupus erythematosus—Michigan Lupus Epidemiology and Surveillance Program 2014-2015. Morb Mortal Wkly Rep. 2019;68(38):819-824.

8. Courtney Hoge; C. Barrett Bowling, S. Sam Lim, Cristina Drenkard, and Laura Plantinga.

Association of Poverty Income Ratio with Physical Functioning in a Cohort of Patients with Systemic Lupus Erythematosus. J Rheumatol. 2020 Jul 1; 47 (7):983:990

9. DeQuattro K, Trupin L, Li J, Katz PP, Murphy LB, Yelin EH, Rush S, Lanata C, Criswell LA, Dall’Era M, Yazdany J. Relationships Between Adverse Childhood Experiences and Health Status in Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2020 Apr; 72 (4): 525- 533.

10. Healthy People 2030 Arthritis Objectives: https//healthypeople/objectives-and-data/browse-objectives/arthritis

3. Funding Strategy N/A

Section II. Award Information Funding Instrument Type:

CA (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:

$26,400,000 Estimated total funding (direct and indirect) for the first budget period (9/30/2022 to 9/29/2023)

Component A: $4,400,000 Component B: $880,000

Estimated total funding (direct and indirect) for the period of performance (9/30/2022 to 9/29/2027)

Component A is $22,000,000 Component B is $4,400,000

The award ceiling for both Components A and B is $900,000

Anticipated Number of Awards:

Component A : 5 awards (average award amount per budget period $880,000) Component B: 1 award (average award amount per budget period $880,000)

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

Award Ceiling:

$900,000 Per Budget Period

Award Floor:

$870,000 Per Budget Period

Total Period of Performance Length:

5 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

(https://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.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

20 (Private institutions of higher education)

04 (Special district governments)

22 (For profit organizations other than small businesses)

08 (Public housing authorities/Indian housing authorities)

99 (Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility")

00 (State governments)

07 (Native American tribal governments (Federally recognized))

02 (City or township governments)

01 (County governments)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

23 (Small businesses)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other:

Faith-based or Community-based Organizations

Regional Organizations

Foreign Organizations: a Foreign Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms."

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR.

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. Additional Information on Eligibility Special Eligibility. For an application to be considered, the application must be responsive to these Special Eligibility Requirements. 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.

Component A: Epidemiology of Lupus Among the Adults

Applicants must have access to an existing and established baseline cohort of lupus patients that has been followed for at least 5 years.

The sample size of the cohort to be used for this study should include a minimum of 400 lupus participants.

If an applicant requests a funding amount greater than the ceiling of $900,000 (Section II.

Award Information) for either Component (A or B) as indicated in Section II of this NOFO, 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 requirement.

Applicants must have access to an existing and established baseline cohort of lupus patients that has been followed for at least 3 years.

The sample size of the cohort to be used for this study should include a minimum of 400 lupus participants.

If an applicant requests a funding amount greater than the ceiling of $900,000 (Section II.

Award Information) for either Component (A or B) as indicated in Section II of this NOFO, 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 requirement.

4. Justification for Less than Maximum Competition

NA

5. Responsiveness If the Responsiveness information requested below is incomplete or non-responsive to these requirements, the application will not enter into the review process.

Component A: Epidemiology of Lupus Among in the Adults

Evidence of access to an established cohort followed for at least 5 years - Applicants must provide a letter of support, memorandum of agreement, or other required documentation showing this. This documentation should be placed in Appendix A of the application.

Evidence of at least 400 lupus patients in the cohort study - Applicants must provide a letter of support, memorandum of agreement, or other required documentation showing this. This documentation should be placed in Appendix A of the application.

Evidence of access to an established cohort followed for at least 3 years - Applicants must provide a letter of support, memorandum of agreement, or other required documentation showing this. This documentation should be placed in Appendix A of the application.

Evidence of at least 400 lupus patients in the cohort study - Applicants must provide a letter of support, memorandum of agreement, or other required documentation showing this. This documentation should be placed in Appendix A of the application.

Ceiling - If an applicant requests a funding amount greater than the ceiling for Component A ($900,000) and Component B ($900,000), 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.

PLEASE NOTE: For applications due on or after January 25, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. Grant application forms and instructions will be updated to reflect and require UEI instead of DUNS. If already registered in SAM.gov, a UEI was automatically generated for your entity and is visible in both SAM.gov and Grants.gov. Entities registering in SAM.gov prior to April 2022 must still obtain a DUNS number before registering in SAM and a UEI will be assigned during SAM.gov registration.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code:

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

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

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 Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal 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 an 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.

PLEASE NOTE: For applications due on or after January 25, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. Grant application forms and instructions will be updated to reflect and require UEI instead of DUNS. If already registered in SAM.gov, a UEI was automatically generated for your entity and is visible in both SAM.gov and Grants.gov. Entities registering in SAM.gov prior to April 2022 must still obtain a DUNS number before registering in SAM and a UEI will be assigned during SAM.gov registration.

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 SAM.gov and the SAM.gov Knowledge Base.

If an award is granted, the recipient 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 recipient organization.

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

9. Cost Sharing This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement,(https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity 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 NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

One application per eligible institution (normally identified by having a unique DUNS number) is allowed for each Component. Separate applications are required for each Component.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

To use ASSIST, applicants must visit https://public.era.nih.gov where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via: http://grants.nih.gov/support/index.html

Email: commons@od.nih.gov Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

2. Content and Form of Application Submission Applicants must use FORMS-G application packages for due dates on or after January 25, 2022 and must use FORMS-F application packages for due dates on or before January 24, 2022.

Application guides for FORMS-G application packages will be posted to the How to Apply - Application Guide page no later than October 25, 2021.

It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide How to Apply - Application Guide except where instructed in this Notice of Funding Opportunity 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 package associated with this NOFO includes all applicable mandatory and optional forms. Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Please use the form and instructions for SF424 (R&R) Form F. Applicants must use FORMS-F application packages for due dates on or before January 24, 2022.

3. Letter of Intent Due Date for Letter Of Intent 12/20/2021

12/20/2021 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information it contains allows CDC staff to plan for the review.

By December 20, 2021, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Institution Descriptive title of proposed research, including Component 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 should be emailed to:

Sue Shaw, MPH Scientific Program Official Telephone: 770.488.6142 Email: researchnofo@cdc.gov Note: Include NOFO number in the email subject line.

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

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 components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide at How to Apply

- Application Guide for additional information. Please attach applicable sections of the following

Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the NOFO. As applicable to and specified in the NOFO, 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 NOFO.

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 time line.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide at How to Apply - Application Guide must be followed along with any additional instructions provided in the NOFO.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application.

A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

A description of the data to be collected or generated in the proposed project;

Standards to be used for the collected or generated data;

Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data);

Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and

Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data).

CDC OMB approved templates may be used (e.g. NCCDPHP template https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx)

Other examples of DMPs may be found here: USGS, http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans

Applicants must use FORMS-G application packages for due dates on or after January 25, 2022 and must use FORMS-F application packages for due dates on or before January 24, 2022.

Application guides for FORMS-G application packages will be posted to the How to Apply - Application Guide page no later than October 25, 2021.

Research Plan

Applicants may apply for Component A: Epidemiology of Lupus Among Adults and/or Component B: Epidemiology of Lupus in the Pediatric Population.

The application should clearly indicate the name of the Component (Component A: Epidemiology of Lupus Among Adults or Component B: Epidemiology of Lupus in the Pediatric Population).

A separate application must be submitted for each Component.

Use form and instructions for SF424 (R&R) Form F. Applicants must use FORMS-F application packages for due dates on or before January 24, 2022.

The following research plan components are applicable for both Component A: Epidemiology of Lupus Among Adults and Component B: Epidemiology of Lupus in the Pediatric Population:

The applicant's research plan should address activities that will be performed over the entire performance period and should include the following items:

1. Describe the existing prospective cohort study (e.g., duration of follow-up, location) and the outcomes to be achieved.

2. Describe sampling plan to demonstrate how obtained estimates from a sufficient sample size will be extrapolated and generalized to the US population.

3. Describe the proposed study population (e.g., age, sex, race).

4. Describe the proposed data collection methods (e.g., over the phone, mail, in-person).

5. Describe the variables, in alignment with the NOFO purpose, and how they are measured using self-reports or other methods such as those used to examine sociodemographic patterns, healthcare access, quality of life, chronic conditions, or mortality.

6. Describe the process of recruiting participants, their follow-up and data collection frequency over the five-year funding period. Also describe how often participants are contacted for each visit.

7. Describe the proposed analytic or statistical methods for…