OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed | RFA FD 23 005

Opportunity Information: Apply for RFA FD 23 005

The OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed (RFA-FD-23-005) is a discretionary federal grant from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), specifically tied to the FDA Office of Minority Health and Health Equity (OMHHE). It is structured as a cooperative agreement (U01), which generally means the FDA expects to have substantial involvement with awardees during the project period, such as collaborating on priorities, reviewing progress, and helping align outreach materials and activities with FDA public health objectives. The overall aim is not to fund clinical trials, but to support education, outreach, and public awareness work focused on the use of skin lightening products and the potential health risks associated with them, including products containing ingredients such as hydroquinone.

At its core, the opportunity is designed to expand and strengthen OMHHEs ongoing work with community stakeholders and partner organizations to improve public understanding of skin lightening products. The grant emphasizes education that is grounded in science and public health practice, with an explicit interest in innovative and community-based strategies. In practical terms, applicants are expected to design and carry out outreach approaches that meet people where they are, taking into account cultural context, language access, community trust, and the real-world channels through which these products are marketed, discussed, and purchased. The emphasis on strengthening the science base for education suggests that projects should not only disseminate information, but also use thoughtful methods to develop, refine, and evaluate messages and educational tools so that future public health communication can be better informed by evidence about what works.

The subject matter focus is skin lightening products and their potential risks. While the notice mentions hydroquinone as an example, the broader category includes a wide range of products and formulations that consumers may use for skin lightening, brightening, bleaching, or tone-evening. Education efforts under this award are intended to improve awareness of potential harms and encourage safer decision-making, particularly in communities that may be disproportionately targeted by marketing, face higher exposures due to product use patterns, or experience misinformation about safety. Because this is an OMHHE effort, the underlying health equity dimension is important: the initiative aligns with improving outreach to minority and underserved populations and ensuring that public health education is accessible, credible, and responsive to community needs.

The program falls under the Science and Technology and other Research and Development funding activity category and is associated with CFDA number 93.103. Although it is categorized within research and development, the description signals that the funded work is expected to be applied and translational, meaning it should convert scientific and regulatory understanding into real-world educational practice. Typical deliverables for this kind of cooperative agreement often include educational materials, toolkits, outreach campaigns, community engagement events, training sessions for community educators or health workers, and evaluation results showing reach and impact. Since clinical trials are not allowed, the work should avoid interventional clinical research in humans and instead focus on education, communication strategies, stakeholder engagement, and possibly non-clinical research or evaluation methods to assess the effectiveness of outreach.

Eligibility is broad and includes many types of public and private entities. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments as well as other tribal organizations; public housing authorities and Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. This wide eligibility suggests the FDA is open to partnerships across academia, community-based organizations, local governments, tribal entities, schools, and private-sector groups, as long as the proposed work is credible, mission-aligned, and capable of delivering education and outreach at community level.

Funding parameters indicate an award ceiling of $250,000, with an expectation of making two awards. This points to a relatively focused, targeted initiative rather than a large multi-site program, and it places a premium on well-scoped projects with clear objectives and efficient implementation plans. Applicants would likely need to prioritize activities with measurable outputs, such as the number of people reached, materials distributed, trainings completed, or community organizations engaged, alongside outcomes such as improved knowledge, improved risk awareness, or increased ability to identify potentially unsafe products or misleading claims. Because it is a cooperative agreement, applicants should also expect ongoing coordination with the FDA/OMHHE and should propose management and communication plans that make collaboration straightforward.

Key administrative details from the source information include the creation date of October 4, 2022 and an original closing date of December 5, 2022. While those dates reflect the specific cycle captured in the notice, the content still provides a useful blueprint for what the FDA sought to fund: community-centered, innovative, evidence-informed education and outreach that raises public awareness about skin lightening products and potential risks, strengthens the broader foundation for public health communication on the issue, and advances OMHHEs health equity mission through stakeholder and partner engagement.

• The Department of Health and Human Services, Food and Drug Administration in the science and technology and other research and development sector is offering a public funding opportunity titled "OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
• This funding opportunity was created on Oct 04, 2022.
• Applicants must submit their applications by Dec 05, 2022. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $250,000.00 in funding.
• The number of recipients for this funding is limited to 2 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions 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 that do not have a 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.

Apply for RFA FD 23 005

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