Generic Drug Substitution in Special Populations (U01) | Apply Online

Frequently Asked Questions (FAQs)

1) What is the title and identifier of this funding opportunity?

The opportunity is titled "Generic Drug Substitution in Special Populations (U01)" and is identified by Funding Opportunity Number RFA FD 16 011.

2) What type of funding mechanism is being used?

This opportunity uses a discretionary cooperative agreement mechanism (U01). A cooperative agreement generally involves substantial federal involvement or collaboration during the project compared with a standard grant.

3) Which federal department issued this opportunity?

The opportunity was issued by HHS (listed in the source data as HHS-NIH11).

4) What is the CFDA number associated with this opportunity?

The CFDA number listed is 93.103.

5) What is the main purpose of the project?

The project is intended to understand how generic drug substitution works in real-world care settings when patients are part of "special populations" where medication use can be more complicated. The goal is to generate practical evidence about when and why generic substitution may be difficult to implement, and whether certain common clinical behaviors could create safety or effectiveness concerns when switching from a brand product to a generic in higher-risk or less-studied groups.

6) What does "special populations" mean in the context of this opportunity?

Within the information provided, "special populations" refers to patient groups where medication use and administration are less standardized and can be more complicated, such as pediatrics, geriatrics, patients with swallowing difficulties, and individuals receiving enteral nutrition (for example, via feeding tubes).

7) What are the three main study goals?

The study has three main goals that build on each other:

• Collect information on practice patterns in special populations to identify barriers to generic substitution.
• Compare real clinical practice with labeled administration instructions, focusing on common deviations such as drug manipulation and co-administration with food or other drugs.
• Analyze how product-level, patient-level, and provider-level factors interact to affect generic substitution.

8) What kinds of real-world practice patterns or barriers is the project trying to identify?

The project is aimed at understanding what clinicians and care teams actually do in practice and what gets in the way of straightforward substitution. Barriers may relate to workflow, patient needs, caregiver capabilities, dosage form limitations, and provider habits, rather than being driven only by formularies or regulations.

9) What does the opportunity mean by comparing clinical practice to "labeled administration instructions"?

It means examining how medications are actually administered in special populations versus how the product labeling instructs the drug should be administered. The intent is to identify where everyday clinical use deviates from labeling and whether those deviations create concerns for safety or effectiveness when substituting a brand product with a generic.

10) What administration deviations are specifically highlighted?

The announcement highlights examples such as drug product manipulation prior to administration and co-administration with food or another drug. It also describes common adaptations including crushing tablets, splitting doses, opening capsules, compounding liquids from solid dosage forms, administering through feeding tubes, or mixing medicines with foods to improve acceptance.

11) Why do administration deviations matter for generic substitution?

In special populations, altering how a drug is administered can change how the drug performs compared to labeled conditions. The opportunity notes that small differences in formulation characteristics could matter more when administration is altered, which could raise safety or effectiveness concerns during brand-to-generic switching.

12) What factors will be analyzed in the multi-level assessment of substitution?

The opportunity calls for analyzing factors at multiple levels:

• Product-level factors (for example: dosage form, excipients, release characteristics, packaging, or ease of manipulation).
• Patient-level factors (for example: age, comorbidities, swallowing function, feeding tube use, adherence challenges, and concomitant medications).
• Provider-level factors (for example: prescribing habits, comfort with substitution, institutional policies, perceptions about generics, and communication patterns with pharmacies and caregivers).

13) What is the expected outcome or deliverable of the project?

The expected outcome is actionable knowledge that informs FDA regulatory science and supports successful generic substitution. The results are intended to identify research needs (such as gaps where more bioequivalence, formulation, or administration-related studies may be warranted), support FDA efforts to monitor and evaluate substitution in practice, and strengthen the evidence base used to reassure the public about the safety and effectiveness of generic drugs.

14) Is the project meant to be descriptive only?

No. The opportunity states that the outcome is not simply descriptive. It is intended to produce practical, actionable evidence that can guide future research priorities and regulatory attention, especially where current labeling and typical clinical use may not align.

15) What is the award ceiling for this opportunity?

The award ceiling is listed as $200,000.

16) Who is eligible to apply?

Eligibility is broad and includes:

• Various levels of government entities
• Public and private institutions of higher education
• Federally recognized tribal governments and other tribal organizations
• Public housing authorities/Indian housing authorities
• Nonprofit organizations (both 501(c)(3) and non-501(c)(3))
• For-profit organizations other than small businesses
• Small businesses
• An additional catch-all category referencing further eligibility clarification in the full announcement

17) What are the posting, creation, and closing dates?

The posting date and creation date are March 28, 2016. The closing date is June 3, 2016. The solicitation is described as time-limited, with the same original and current deadline.

18) What settings does the opportunity emphasize for the research?

The opportunity emphasizes real-world care settings, particularly where patients are part of special populations and where medication administration may be adapted in ways that differ from labeling.

19) What kinds of concerns is the project specifically trying to detect?

The focus is on identifying when and why generic substitution may be difficult to implement and whether common clinical behaviors (such as altering dosage forms or co-administering with food/other drugs) could create safety or effectiveness concerns when switching from a brand product to a generic in special populations.

20) How does this work support FDA priorities?

The information provided states that the results are intended to inform FDA regulatory science, help FDA monitor and evaluate substitution in practice, and identify research needs that could shape future studies and regulatory attention related to generic substitution in special populations.