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  5. Controlled Substance Staff Functional Roles
  1. Center for Drug Evaluation and Research | CDER

Controlled Substance Staff Functional Roles

  1. Serves as the CDER, FDA, and Department of Health and Human Services (HHS) focus for all activities regarding drug scheduling, abuse, and dependence, including international drug scheduling and control. This role, a DHHS function under the Controlled Substances Act (CSA), is delegated to the FDA, and is performed by CSS within CDER.  CSS is responsible for writing the "Eight-Factor Analyses" —  scientific and medical assessments and drug scheduling recommendation to the Drug Enforcement Administration (DEA) of the Department of Justice — required of DHHS under the CSA.

     
  2. Serves as the FDA and CDER liaison with DEA,  the White House Office of National Drug Control Policy (ONDCP),  the Substance Abuse and Mental Health Services Administration (SAMHSA), and the National Institute on Drug Abuse (NIDA) regarding all matters of drug scheduling and the identification of new trends in and risks related to abuse and dependence.

     
  3. Serves as the FDA and CDER liaison with DEA in the determination of manufacturing quotas for Schedule I and II drugs and in the DEA licensure of Schedule I drug researchers.
     
  4. Provides consultation to other FDA Centers, including the Center for Biologics Evaluation and Research (CBER), the Center for Veterinary Medicine (CVM), and the Center for Food Safety and Nutrition (CFSAN) regarding abuse liability assessment and drug scheduling matters.

     
  5. Develops the U.S. position on International Scheduling issues in collaboration with the Department of State, DEA, and the National Institute on Drug Abuse (NIDA). Has the primary role under the Psychotropic Convention and a supporting role under the Single Convention on Narcotic Drugs.
     
  6. Serves as FDA's experts in the area of abuse and dependence. Consults with CDER Review Divisions and performs abuse liability reviews for Investigative New Drug Applications (INDs) and for New Drug Applications (NDAs) of Central Nervous System-active (CNS-active) drugs with known or potential risk for abuse and dependence.

     
  7. Performs protocol reviews concerning pre-clinical and clinical protocols submitted for controlled substances and potentially abused drugs.
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