RFA-FD-22-013: Development of advanced analytical methods for the characterization of complex generics
Closed
This grant is closed. A newer notice from the same program is open now: Flexible Funding Model - Advancing Domestic Mutual Reliance Through Strengthened Infrastructure Development and Maintenance for Manufactured Food Regulatory Programs (PAR-27-017). Status: Rolling or no fixed deadline. It is in our archive of Food and Drug Administration notices from 2022.
Food and Drug Administration offered grants of up to $300,000 (at least $50,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make $300,000 in total. Applications closed on March 7, 2022.
From the official notice on Grants.gov, last changed January 12, 2022. Checked November 7, 2026.
- Award ceiling$300,000
- Award floor$50,000
- Total funding$300,000
- Cost sharingNot required
- Funding typeCooperative Agreement
Key dates
| Posted | January 12, 2022 |
|---|---|
| Deadline | March 7, 2022 |
| Archived by Grants.gov | April 6, 2022 |
Who can apply
This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.
All 15 applicant types the notice lists
- 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
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
Section III. Eligibility Information1. Eligible ApplicantsEligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs)o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Is this a realistic fit?
- Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $300,000 per award.
- Most of the program's money (35% over five years) went to nonprofits.
- No cost sharing or match is required.
What the grant funds
Advanced analytical methods for characterization and comparative analysis of complex products, which help to link product attributes to product quality, safety and efficacy, are useful for facilitating the development of generic complex products. The purpose of this study is to develop advanced analytical methods for analyzing the diastereomer compositions in phosphorothioate (PS) oligonucleotides using either TEGSEDI (inotersen) or SPINRAZA (Nusinersen) as the model product. The proposed studies will focus on 1) understanding the diastereomer composition in TEGSEDI or SPINRAZA (Nusinersen), and 2) determining whether and how the manufacturing process may affect the diastereomeric distributions in the drug product. Methods developed through this research may also be applied in cases of other synthetic oligonucleotides, and could greatly facilitate the development and assessment of generic oligonucleotide drug products. Knowledge gained from this research may also contribute to quality control of oligonucleotide drugs.
Who has won Food and Drug Administration Research grants before
From fiscal 2021 to 2025, Food and Drug Administration Research (93.103) awarded $1.2 billion across 940 grant awards, an average of $1.3 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The Critical Path Institute | Arizona | 13 | $94.0 million |
| National Environmental Health Association | Colorado | 9 | $55.4 million |
| Association of Food & Drug Officials | Pennsylvania | 14 | $50.3 million |
| The Medical Device Innovation Consortium | Virginia | 1 | $48.6 million |
| Duke University | North Carolina | 11 | $35.6 million |
Applying now
This notice no longer takes applications. Apply under the newer notice, PAR-27-017, which is open now.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
Questions people ask
Is RFA-FD-22-013 still open?
No. It closed on March 7, 2022. A newer notice is open: PAR-27-017, rolling or no fixed deadline.
Who can apply for Development of advanced analytical methods for the characterization of complex generics?
Food and Drug Administration accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.
What is the deadline for Development of advanced analytical methods for the characterization of complex generics?
Closed March 7, 2022. Applications are no longer accepted; the program's newer notices are on this page when there are any.
How much funding is available?
Awards of up to $300,000 each. About $300,000 in total.
Who has won Food and Drug Administration Research grants before?
The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.
Similar open grants
- Single Source for the Continuation of the Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Scientific and Data Research Center (U01 Clinical Trial Required)
- Single Source for the Continuation of the Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Center (Collaborative U01 Clinical Trial Not Allowed)
- Data Coordinating Center for the Aging and Alzheimer’s Disease Mouse Brain Atlas (AD-MBA) (U24 Clinical Trial Not Allowed)
- Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
- Advanced Development and Validation of Emerging Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)
- Early-Stage Innovative Technology Development for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed)