Key Dates

Related Announcements

• July 31, 2023 - Notice  of Special Interest (NOSI): Accelerating Research in Understudied Skin Types. See Notice NOT-AR-24-009.
•  October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272.

Issued by

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

Purpose

The purpose of this announcement is to notify the research community that the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in receiving administrative supplements to grants focused on skin research uncovering the basis for inferior diagnosis, increased prevalence, elevated clinical severity, and altered treatment response in Black Americans and African Americans, Hispanics and Latinos, American Indians and Alaskan Natives, Asians and Asian Americans, and Native Hawaiians and Pacific Islanders with skin diseases.

Background

Existing under studied skin types in biomedical research and ongoing rapid demographic changes in the United States both require better understanding of biological mechanisms and improved prevention and treatment of skin diseases in patients with understudied skin types. Compared to European ancestry populations, Black American and African American, Hispanic and Latinos, American Indian and Alaskan Native, Asian and Asian American, and Native Hawaiian and Pacific Islander populations, experience increased prevalence, elevated severity of clinical features, and altered treatment response in multiple skin diseases. As such, much higher prevalence of hidradenitis suppurativa, atopic dermatitis, acne and vitiligo was described in the populations of African American and Hispanic and Latinos genetic ancestry. Further, increased prevalence of oculocutaneous albinism type 2, keloids and prurigo nodularis is characteristic for African American populations, while cutaneous discoid lupus erythematosus is both significantly more prevalent and more often leads to skin dyspigmentation and scarring alopecia in African Americans. Also, exacerbated clinical course is more often observed in African American patients affected by psoriasis and in Asian, Asian American, Native Hawaiian and Pacific Islander patients experiencing Stevens-Johnson syndrome and toxic epidermolysis necrolysis. Despite this accumulating knowledge and known differences in skin anatomy and physiology among groups that may partly explain disparities in cutaneous disorders based on genetic ancestry, the cellular and molecular mechanisms underpinning higher disease prevalence and severity in the populations remain to be defined. Finally, a difficulty in diagnosis of common conditions such as acne, atopic dermatitis and psoriasis in patients with pigmented skin stems from a paucity of ethnic skin images in core dermatology educational resources and the research setting, often resulting in delays, misdiagnoses, and higher frequency of skin biopsies.

Starting to address this knowledge gap, a recent global transcriptome analysis of healthy African American skin revealed 570 differentially expressed genes, with only four among them being related to melanogenesis and skin pigmentation. The identified set included genes encoding proinflammatory cytokines such as TNF-alpha and IL-32; Igs and their receptors such as FCER1G; as well as epidermal differentiation complex and keratins. Of note, enrichment of the components of IL-13 and IL-4 signaling pathways in healthy African American skin overlapped with the molecular signature of atopic dermatitis. Moreover, a greater dermal infiltration of dendritic cells bearing high affinity IgE receptor FCER1, higher serum IgE levels, increased Th2 and Th22 induction, and upregulation of Th17 axis in the skin were all observed in the initial studies of African American patients with atopic dermatitis, indicating that aggravated course of the disease may be associated with a broader immune activation. Finally, statistically significant variation in the levels of systemic inflammation markers such as C-reactive protein, ferritin, and eosinophils was found in African American patients with prurigo nodularis. Larger subsequent studies utilizing ancestry informative markers should allow for appropriate analyses of more admixed populations and provide rationale for stratified clinical trials based on genetic ancestry. In turn, this approach may help to determine how distinct molecular phenotypes in patients with under studied skin types translate into differential clinical course and treatment strategies for skin diseases.

Currently,some genetic ancestry populations are significantly underrepresented in genome sequencing projects as the percentages of individuals included in genome-wide association studies (GWAS) based on genetic ancestry are 78% European, 10% Asian, 2% African, 1% Hispanic, whereas all others represent less than 1%. While the patterns of genetic variation can affect both disease risk and treatment efficacy and safety, a majority of studies still occur in European ancestry populations, thus limiting the utility of the results across a variety of human populations. Crucially, this bias effectively translates into poorer disease prediction and treatment for individuals of under-represented genetic ancestries. Importantly, studying diverse populations increases our ability to broadly understand genetic disease architectures that will ultimately lead to increased precision in medical care. Likewise, the Black American and African American, Hispanic and Latinos, American Indian and Alsakan Native, Asian and Asian American, and Native Hawaiian and Pacific Islander populations are grossly underrepresented in basic, translational, and clinical NIAMS-funded studies focusing on the skin. This fundamental research gap has created a significant unmet need for better prevention and improved therapeutic approaches in under studied skin types.

Research Objectives

This NOSI invites administrative supplements to active grants  on improving the understanding of skin diseases and conditions within the NIAMS mission in patients with under studied skin types. The generated knowledge should yield basic, translational, and clinical insights to improve health pertinent to disorders of skin and specifically benefit Black Americans and African Americans, Hispanics and Latinos, American Indians and Alaskan Natives, Asians and Asian Americans, and Native Hawaiians and Pacific Islanders as populations with under-studied skin types. It may also gather evidence towards a future innovative study or new scientific direction to accelerate research in these under studied skin types.

Examples of research topics include, but are not limited to:

• Using functional genomics, epigenomics and transcriptomics, to identify lead candidate genes and transcripts associated with increased prevalence and severity of skin diseases in patients with under studied skin types.  
• Combining multi-omics approaches with functional validation, to establish molecular signatures associated with increased prevalence, severity of skin diseases and altered treatment response in patients with under studied skin types  
• Defining the cellular and molecular mechanisms underpinning higher skin disease prevalence, severity and altered treatment response in patients with under studied skin types  
• Identifying biomarkers to predict higher skin disease prevalence, severity and altered treatment response in patients with under studied skin types  
• Exploring interactions between the pigmentation and cutaneous immune systems in understudied skin types 
• Identifying and comparing early biomarkers of inflammation in healthy skin of under studied types
• Improving methodologies for diagnosis of common and rare skin diseases in patients with under studied skin types  
• Improving clinical outcomes for patients with under studied skin types and skin diseases through gaining new mechanistic insights and increased recruitment 

Other considerations:

• Only applications with a patient population of greater than 50% of the total planned enrollment that has an under studied skin type is appropriate for this NOSI.
• Studies focusing on animal models should be excluded unless they are directly relevant to mechanistic analysis of the identified skin disease relevant cellular and molecular pathways.

Budget

NIAMS intends to make multiple awards based on available funds. Application budgets are limited to $150,000 direct costs per year for up to two years, exclusive of consortium F&A costs. The direct costs for supplements should not exceed those for the parent award. The budget must reflect the actual needs of the proposed project. The grants in its final year or in a terminal no-cost extension are not eligible for this administrative supplement.

Active awards with project end dates in FY 2025 or later are eligible. All grant awards made by NIAMS are eligible for this initiative except for the following mechanisms: F30, F31, F32, F33, T32, K01, K08, K23, K24, K99/R00, P30, R03, R13, R15, and R34.

Application and Submission Information

Applications in response to this NOSI must be submitted using the following targeted funding opportunity, or its subsequent reissued equivalent:

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements ( Parent Admin Supp Clinical Trial Optional)

Applications that expand the scope of the parent grant are not responsive to this NOSI.

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide  and PA-20-272 must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-AR-24 -008 ” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be for one year of support, or for two years with strong justification.
• Individual requests cannot exceed the current year direct costs, up to $150,000 in direct costs exclusive of Facilities and Administrative costs on sub-contracts.
• Applicants may only apply to no more than one supplement to a given parent grant/award.
• The Research Strategy section of the application is limited to 6 pages.
• The parent award must be active when the application is submitted (e.g., within the originally reviewed and approved project period) and the proposed work must be completed within the currently approved project period for the existing parent award.  
• The development of resources and data are expected to be shared consistent with plans in the parent award and consistent with NIH policy.

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-AR-24-008 ” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with the program contact listed on this NOSI.

Applications nonresponsive to terms of this NOSI will not be considered for this initiative.

Review Process

Applications will be evaluated for scientific and technical merit by an appropriate internal review panel convened by NIAMS staff, in accordance with the review criteria specified in this NOSI as well as these additional review criteria:

• Does the work proposed clearly address at least one of the research topics defined in this notice?
• If the administrative supplement is focused on an area of scientific interest not included in the NOSI, is there a strong justification?  
• Is the project likely to stimulate substantial innovations in research on under studied skin types?  
• Is the parent award progressing satisfactorily/according to planned timeline and milestones?
• Is the proposed project technically feasible within the proposed budget and funding period?
• Is the overall strategy, methodology, and analyses proposed in the application well-reasoned and appropriate to accomplish the activities in the proposed project period?

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) – October 2, 2023, April 2, 2024 , October 2, 2024, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-AR-24-008 ” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Most  requests may be for one year of support. The option of two years of support should be explicitly discussed with the program contacts before the application submission.
• The Research Strategy section of the application is limited to 6 pages.
• Only existing awardees of R01, R21, R37 and U01 grants are eligible to apply.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this NOFO in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Scientific/Research Contact(s)

Skin Biology and Diseases Group:

Alexey Belkin, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 240-755-3031
Email:  alexey.belkin@nih.gov

Ricardo Cibotti, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-792-4871
Email: cibottirr@mail.nih.gov

Financial/Grants Management Contact(s)

Erik Edgerton
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-7760
Email: edgertont@mail.nih.gov