Opportunity Information: Apply for RFA DE 16 001
Apply for RFA DE 16 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pharmacogenomics of Orofacial Pain Management (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121 Oral Diseases and Disorders Research.
- This funding opportunity was created on Jan 8, 2015 and posted on Jan 8, 2015.
- Applicants must submit their applications by Jun 24, 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 $2,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities County governments Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Private institutions of higher education State governments Special district governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The Pharmacogenomics of Orofacial Pain Management (R01) funding opportunity (RFA-DE-16-001) was issued by the National Institutes of Health to support research that explains why people with dental and orofacial pain often respond differently to the same analgesic drugs. The core idea is that genetic differences can shape both how a drug is handled by the body and how the body responds to it, which in turn affects pain relief, side effects, and overall treatment success. By funding studies in this area, the program aims to strengthen the scientific basis for more personalized, precision approaches to managing acute and chronic pain conditions in the orofacial region.
A central focus of the announcement is understanding genetic contributions to pharmacokinetics, pharmacodynamics, and toxicity. On the pharmacokinetics side, projects might investigate how genetic variation influences absorption, distribution, metabolism, and elimination of analgesics commonly used in dental or orofacial pain. On the pharmacodynamics side, the FOA emphasizes the need to study how genetic differences alter drug targets and downstream responses, such as variation in receptors, enzymes, and other target molecules that analgesics interact with. The toxicity component highlights adverse events and drug-related harms, encouraging applicants to determine how genetic factors can predict risk of side effects or other negative outcomes during pain treatment.
The FOA specifically calls for delineating genetic variation in several biologically important categories: drug- and neurotransmitter-metabolizing enzymes, transporters that move drugs or signaling molecules across membranes, drug target molecules (including enzymes and receptors), and post-receptor intracellular signaling pathway components that help translate receptor binding into changes in neural activity and pain perception. In addition to cataloging relevant genetic differences, a second major objective is to identify key molecular signatures that can predict therapeutic response. In practice, that means looking beyond single genes when appropriate and developing more informative biomarker patterns, signatures, or profiles that correlate with who will benefit from a particular analgesic regimen and who is more likely to have poor response or unacceptable adverse effects.
Because the goals span clinical outcomes, molecular mechanisms, and advanced genetics, the program strongly encourages multidisciplinary teams that bring together clinical researchers and basic scientists. This team-based emphasis is meant to help applicants connect real-world pain outcomes and treatment responses with underlying biological pathways and genetic factors, ultimately producing findings that can translate into clinical decision-making. The long-term value highlighted in the announcement is the ability to categorize patients into meaningful response groups, so providers can choose the most effective and safest analgesic strategies for each individual rather than relying on trial-and-error prescribing.
Although the announcement is centered on dental and orofacial pain, it also notes that the research could stimulate broader pharmacogenomics work in chronic pain conditions that overlap with temporomandibular joint disorder. In other words, the orofacial focus is both a defined clinical area of need and a potential launching point for insights that extend to related chronic pain syndromes.
From an administrative standpoint, this was a discretionary NIH grant opportunity using the R01 mechanism, with an estimated total funding level of $2,000,000. It fell under CFDA 93.121 (Oral Diseases and Disorders Research) and did not require cost sharing or matching. The opportunity was posted January 8, 2015, with an application due date of June 24, 2015, and it was later archived July 25, 2015. Eligibility was broad and included many types of organizations, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit entities (including small businesses), state and local governments, tribal governments and tribal organizations, U.S. territories, and certain foreign organizations, along with a range of designated serving institutions and community-based or faith-based organizations as described in the eligibility text.
FAQs: Pharmacogenomics of Orofacial Pain Management (R01) - RFA-DE-16-001
What is this funding opportunity?
This is an NIH research funding opportunity titled "The Pharmacogenomics of Orofacial Pain Management (R01)" (RFA-DE-16-001). It supports studies that explain why patients with dental and orofacial pain can respond differently to the same analgesic drugs, with an emphasis on genetic contributors to those differences.
What is the main goal of the program?
The program aims to build a stronger scientific foundation for precision, personalized approaches to managing acute and chronic pain in the orofacial region by connecting genetic differences to pain relief, side effects, and overall treatment success.
Why does the FOA focus on genetics in pain treatment?
The FOA is based on the idea that genetic differences can influence how the body handles a drug (pharmacokinetics) and how the body responds to it (pharmacodynamics), which can change effectiveness and risk of adverse effects.
What kinds of pain are in scope?
The primary clinical focus is dental and orofacial pain conditions. The announcement also notes that the work could stimulate broader pharmacogenomics research in chronic pain conditions that overlap with temporomandibular joint disorder.
What does the FOA mean by pharmacokinetics (PK) in this context?
In this FOA, pharmacokinetics refers to how genetic variation may influence the absorption, distribution, metabolism, and elimination of analgesics commonly used for dental or orofacial pain.
What does the FOA mean by pharmacodynamics (PD) in this context?
Here, pharmacodynamics refers to how genetic differences can alter drug targets and downstream responses, including variation in receptors, enzymes, and other molecules that analgesics interact with, ultimately affecting pain perception and relief.
What does the FOA mean by toxicity?
Toxicity in this FOA refers to adverse events and drug-related harms during pain treatment. The FOA encourages applicants to determine how genetic factors can help predict the risk of side effects or other negative outcomes.
What types of genetic variation does the FOA specifically call out?
The FOA specifically highlights genetic variation in: (1) drug- and neurotransmitter-metabolizing enzymes, (2) transporters that move drugs or signaling molecules across membranes, (3) drug target molecules (including enzymes and receptors), and (4) post-receptor intracellular signaling pathway components that translate receptor binding into changes in neural activity and pain perception.
Is the focus only on single genes, or can studies look at broader biomarkers?
The FOA includes a major objective to identify key molecular signatures that can predict therapeutic response. This supports looking beyond single genes when appropriate and developing biomarker patterns, signatures, or profiles that correlate with benefit, poor response, or unacceptable adverse effects.
What is meant by "molecular signatures" in the FOA?
In this announcement, molecular signatures are combinations or profiles of molecular or genetic indicators intended to predict therapeutic response, including who is more likely to benefit from a specific analgesic regimen and who may be at higher risk of poor response or adverse events.
Does the FOA encourage multidisciplinary research teams?
Yes. Because the goals span clinical outcomes, molecular mechanisms, and advanced genetics, the program strongly encourages multidisciplinary teams that include both clinical researchers and basic scientists.
What is the intended long-term impact of the funded research?
The FOA emphasizes long-term value in being able to categorize patients into meaningful response groups so providers can select safer and more effective analgesic strategies for each individual, reducing reliance on trial-and-error prescribing.
What grant mechanism is used?
This opportunity used the NIH R01 research project grant mechanism.
How much funding was expected to be available?
The estimated total funding level stated in the announcement was $2,000,000.
Is cost sharing or matching required?
No. The opportunity did not require cost sharing or matching.
What is the CFDA number associated with this opportunity?
The opportunity fell under CFDA 93.121, "Oral Diseases and Disorders Research."
When was the opportunity posted and when were applications due?
The opportunity was posted on January 8, 2015, and the application due date was June 24, 2015.
Is this funding opportunity still open?
No. The opportunity was later archived on July 25, 2015.
Who was eligible to apply?
Eligibility was broad and included many organization types, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit entities (including small businesses), state and local governments, tribal governments and tribal organizations, U.S. territories, and certain foreign organizations, along with various designated serving institutions and community-based or faith-based organizations as described in the eligibility text.
Are foreign organizations eligible?
Yes. The eligibility information included certain foreign organizations.
What agency issued this announcement?
The funding opportunity was issued by the National Institutes of Health (NIH).
Does the FOA specify the types of drugs being studied?
The FOA references analgesics commonly used in dental or orofacial pain management and emphasizes studying how genetic differences influence response, side effects, and treatment outcomes for these medications.
What kinds of outcomes does the FOA want studies to address?
The FOA centers on outcomes tied to analgesic treatment, including pain relief, side effects and adverse events, toxicity-related harms, and overall treatment success, as explained through genetic and molecular mechanisms.
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