Opportunity Information: Apply for RFA FD 15 013
Apply for RFA FD 15 013
- The Food Drug Administration in the consumer protection education food and nutrition health sector is offering a public funding opportunity titled "Educating Groups Influencing Generic Drug Use (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Mar 25, 2015 and posted on Mar 25, 2015.
- Applicants must submit their applications by Jun 3, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $250,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: For profit organizations other than small businesses Public housing authorities/Indian housing authorities County governments State governments Private institutions of higher education Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Special district governments.
- Non 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.
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Opportunity Summary:
The funding opportunity titled "Educating Groups Influencing Generic Drug Use (U01)" (Funding Opportunity Number RFA FD 15 013) is a Food and Drug Administration (FDA) cooperative agreement focused on consumer protection education in the health arena. The central aim is to improve understanding and communication around generic drugs by first figuring out which groups most strongly shape whether and how generics are used, then identifying what those groups actually need to know, and finally developing and refining messages that can address those needs. A key feature of the project is that it is not meant to treat generic drugs as one uniform topic; instead, it specifically calls for capturing how attitudes, concerns, and informational gaps may differ depending on the drug class, recognizing that perceptions of generics can vary widely between, for example, maintenance medications and drugs used for more acute or high-risk conditions.
In practical terms, the work supported under this opportunity would involve research to map the "influencer" landscape around generic drug use and then gather evidence about what different audiences believe, misunderstand, distrust, or feel uncertain about. "Groups influencing use" can reasonably include prescribers, pharmacists, patients and caregivers, insurers and pharmacy benefit managers, health system decision-makers, and other parties that affect prescribing, dispensing, substitution, adherence, and acceptance of generics. The project is expected to move beyond simple description and into message testing: drafting educational messages targeted to these groups, evaluating whether the messages are understandable, credible, and persuasive, and revising them based on what the research shows. Because the mechanism is a cooperative agreement (U01), applicants should generally expect substantial involvement from the FDA during the project, such as collaboration on study approach, alignment with FDA priorities, and review or input during key stages of message development and testing.
The opportunity was posted on March 25, 2015, with an application closing date of June 3, 2015, and it was archived on July 3, 2015. The program anticipated making one award, with an estimated total funding amount of $250,000 and an award ceiling of $250,000. There was no cost-sharing or matching requirement. The CFDA listing associated with the announcement is 93.103, under the FDA.
Eligibility was broad and included many organization types: for-profit entities (including small businesses), nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) nonprofits), public and private institutions of higher education, and a wide range of government entities (state, county, city or township, special district governments, public housing authorities/Indian housing authorities, and independent school districts), as well as Native American tribal governments (federally recognized) and other Native American tribal organizations. Importantly, foreign institutions and other non-U.S. entities were eligible to apply, and foreign components of U.S. organizations were allowed under the HHS Grants Policy Statement rules.
For applicants or stakeholders seeking the official details, the announcement pointed to the full posting on the NIH Guide for Grants and Contracts. For access issues, the listed grants management contact was Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Educating Groups Influencing Generic Drug Use (U01)" and the Funding Opportunity Number is RFA FD 15 013.
Which agency is offering this opportunity?
This is a Food and Drug Administration (FDA) funding opportunity.
What type of award mechanism is being used?
The mechanism is a cooperative agreement (U01).
What does a cooperative agreement (U01) imply for how the project will be run?
Because it is a cooperative agreement, applicants should expect substantial FDA involvement during the project. This can include collaboration on the study approach, alignment with FDA priorities, and FDA review or input at key stages of message development and testing.
What is the main purpose of this project?
The central aim is to improve understanding and communication around generic drugs by (1) identifying which groups most strongly influence whether and how generics are used, (2) determining what those groups need to know, and (3) developing and refining educational messages that address those needs.
Is the project focused on generic drugs as one general topic?
No. A key feature is that the project should not treat generic drugs as a single uniform topic. It specifically calls for capturing how attitudes, concerns, and information gaps may vary by drug class, recognizing that perceptions can differ across types of medications (for example, maintenance medicines versus drugs used for more acute or higher-risk conditions).
What kind of activities does the opportunity expect applicants to carry out?
The work is expected to include research to map the "influencer" landscape around generic drug use, gather evidence on what different audiences believe or misunderstand, and then develop, test, and refine targeted educational messages based on that evidence.
What does "mapping the influencer landscape" mean in this context?
It means identifying and characterizing the groups that shape generic drug use decisions and behaviors, including how those groups affect prescribing, dispensing, substitution, adherence, and acceptance of generics.
Which groups could be considered "groups influencing use" of generic drugs?
The announcement indicates that relevant groups can reasonably include prescribers, pharmacists, patients and caregivers, insurers and pharmacy benefit managers, health system decision-makers, and other parties that influence prescribing, dispensing, substitution, adherence, and acceptance of generic drugs.
Is the project limited to describing beliefs and attitudes, or does it include message development?
It is expected to go beyond simple description. The project is expected to include message testing, such as drafting educational messages targeted to specific groups, evaluating whether messages are understandable, credible, and persuasive, and revising messages based on research findings.
What aspects of messages are expected to be tested?
The announcement highlights testing whether messages are understandable, credible, and persuasive, followed by revision based on results.
What is the total estimated funding amount for this opportunity?
The estimated total funding amount is $250,000.
What is the award ceiling?
The award ceiling is $250,000.
How many awards did the program anticipate making?
The program anticipated making one award.
Is cost sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement.
When was the opportunity posted?
The opportunity was posted on March 25, 2015.
What was the application closing date?
The application closing date was June 3, 2015.
Was this opportunity archived, and if so when?
Yes. It was archived on July 3, 2015.
What CFDA listing is associated with this announcement?
The CFDA listing associated with the announcement is 93.103.
Who is eligible to apply?
Eligibility is broad and includes for-profit organizations (including small businesses), nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits), public and private institutions of higher education, and multiple types of government entities (state, county, city or township, special district governments, public housing authorities/Indian housing authorities, and independent school districts), as well as Native American tribal governments (federally recognized) and other Native American tribal organizations.
Are foreign organizations eligible to apply?
Yes. Foreign institutions and other non-U.S. entities were eligible to apply.
Are foreign components of U.S. organizations allowed?
Yes. Foreign components of U.S. organizations were allowed under the HHS Grants Policy Statement rules.
Where can applicants find the official full posting for this opportunity?
The announcement pointed to the full posting on the NIH Guide for Grants and Contracts.
Who is the grants management contact for access issues or official questions?
The listed grants management contact is Lisa Ko, Grants Management Specialist. The provided email is lisa.ko@fda.hhs.gov.
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