The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been made. The tables include legacy projects (those submitted prior to enactment of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and Cosmetic Act (FD&C Act), which was created by Section 3011 of the 21st Century Cures Act). These tables only include documents from requestors that were received after the passage of the 21st Century Cures Act. The tables are updated on a biannual basis and provide information on the COA qualification project, including FDA’s decision to accept or not accept the submission, and FDA’s recommendations on further COA development.

FDA’s posting of information submitted to the Agency by outside parties requesting qualification of a drug development tool is not an endorsement or recommendation by FDA of the tool’s use. Information about submissions is made publicly available in accordance with section 507 of the FD&C Act. The FDA makes no representations, guarantees, or warranties as to the accuracy, completeness, currency, or suitability of the information in submissions. See the FDA decision letter corresponding to each submission for FDA considerations and recommendations related to each request for qualification.

The COA Qualification Submissions tables were last updated to include submissions received through December 31, 2019. To view qualified COAs, please visit: Qualified Clinical Outcome Assessments (COAs).

Office of Drug Evaluation (ODE) I:
Division of Cardiovascular and Renal Products (DCaRP)

*Under review prior to the passage of the 21st Century Cures Act

Division of Neurology Products (DNP)

Division of Psychiatry Products (DPP)

Office of Drug Evaluation (ODE) II:
Division of Anesthesia, Analgesia, and Addiction Products (DAAAP)

Division of Metabolism and Endocrinology Products (DMEP)

Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
AsthmaDDT COA #000099: Child Asthma Diary (CAD)Symptom severityChildren (4-11 years) with a clinical diagnosis of mild to severe persistent asthma requiring a daily long-term control medicationPRO/ObsROLetter of Intent- Accepted
Chronic Fatigue Syndrome (CFS)
Myalgic Encephalomyelitis (ME)
Systemic Exertion Intolerance Disease (SEID)
DDT COA #000080: PROMIS® Fatigue for ME/CFS/SEIDFatiguePatients with CFS, ME, or SEIDPROLetter of Intent- Accepted
Chronic Obstructive Pulmonary Disease (COPD)DDT COA #000072: Constant Work Rate ExerciseExercise enduranceCOPD patients with moderate to very severe lung function impairment:

  • Patients diagnosed with COPD
  • Post-bronchodilator FEV1/FVC <70%
  • Post-bronchodilator FEV1 <80% predicted normal
  • Male or female patients, at least 40 years of age

Current or ex-smokers with a smoking history of more than 10 pack-years.

PerfOLetter of Intent- Accepted
Idiopathic pulmonary fibrosis (IPF)DDT COA #000027: A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF)Symptom experience, daily functioning and other health-related quality of life impactsAdult patients (>18 years) with IPFPROLetter of Intent- Accepted
Rheumatoid Arthritis (RA)DDT COA #000015: PROMIS® Short Form Fatigue 10a in Rheumatoid ArthritisFatigueAdult patients (>18 years) with a definite diagnosis of RA based on a score of ≥ 6 on the American College of Rheumatology/European League Against Rheumatism 2010 Rheumatoid Arthritis Classification CriteriaPROIn transition to 507 process 

Office of Drug Evaluation (ODE) III:
Division of Gastroenterology and Inborn Error Products (DGIEP)

Division of Dermatology and Dental Products (DDDP)

Office of Antimicrobial Products (OAP):
Division of Anti-Infective Products (DAIP)

*Under review prior to the passage of the 21st Century Cures Act

Office of Hematology and Oncology Products (OHOP) 

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
CancerDDT COA #000079: PROMIS® Physical Function in Oncology Physical functioningAdult patients (> 18 years) with solid tumors or hematologic malignancies with a performance status range 0-3 and receiving active anti-cancer therapyPROLetter of Intent- Accepted

Division of Hematology Products (DHP)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Sickle Cell Disease (SCD)DDT COA #000057: Sickle Cell Pain Diary Pain intensity and pain interferencePediatric patients with SCDPROLetter of Intent- Accepted

Division of Oncology Products 1 (DOP1)

Division of Oncology Products 2 (DOP 2)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Plexiform neurofibroma (PN)DDT COA #000061: Plexiform Neurofibroma Impact in Children & AdultsTumor-related pain intensity, pain interference, and physical functioningChildren(>5 years) and adults with neurofibromatosis type 1 (NF1) and PNPROLetter of Intent- Accepted

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