09-25-0210 SYSTEMS LISTING
Shipment Records of Drugs of Abuse to Authorized Researchers, HHS/NIH/NIDA.
Chemistry and Physiological Systems Research Branch (CPSRB), Division of Neuroscience and Behavioral Research, National Institute on Drug Abuse (NIDA), Neuroscience Center, Room 4282, 6001 Executive Boulevard, Bethesda, MD 20892-9555.
Research Triangle Institute, Research Triangle Park, NC 27709.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
IIndividual researchers and organizations who are registered with the Drug Enforcement Administration (DEA), Department of Justice (DOJ), some since 1966, and who have voluntarily submitted documentation to the National Institute on Drug Abuse (NIDA) in order to obtain, through the NIDA Drug Supply Program (DSP), drugs of abuse for use in a research project.
CATEGORIES OF RECORDS IN THE SYSTEM:
While the records in this system are research project-related, they support the eligibility of individual researchers to receive drugs of abuse. Types of information contained in the records are: researcher's name, curricula vitae, research protocol, DEA and (if applicable) Nuclear Regulatory Commission registration numbers (when a radio labeled compound is requested and shipped), business address (location of research project) and telephone number, summary of research project(s), requests for substance(s), name and amount of each compound requested and shipped, dates material is shipped and received, shipment numbers, and order form numbers.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
PPublic Health Service Act, sections 301, and 405 (42 U.S.C. 241 and 284); Controlled Substances Act of 1970 (21 U.S.C. 801 et seq.); Atomic Energy Act of 1954, as amended, section 81 (42 U.S.C 2111); and Energy Reorganization Act of 1974, section 201 (42 U.S.C. 5841).
To facilitate operation of DSP which is a centralized research support service through which the United States Government supplies to the national and international scientific community for research purposes, most Schedule I and many Schedule II-V controlled and noncontrolled substances as specified in the Controlled Substances Act (CSA) of 1970 (21 U.S.C. 801 et seq.). Controlled substances are chemicals and other substances, and their immediate precursors, that the Attorney General has determined to have such potential for abuse as to warrant regulation under the CSA. Some of these substances are radio labeled materials. Radio labeled materials are substances to which a small amount of radioactivity is added for use in various studies, such as drug metabolism and mechanisms of drug actions.
This system of records was established to facilitate DSP by enabling NIDA:
To verify that requests for drugs of abuse, some of which are radio labeled, are from authorized individuals/organizations for use in a research project;
To verify that the amounts of the materials requested by researchers for animal, in vivo, and in vitro research are justified and available;
To supply controlled substances in amounts approved by the Food and Drug Administration (FDA) to researchers conducting research with human subjects;
To ship these materials securely in accordance with CSA and the Atomic Energy Act; and
To maintain records of these transactions.
FDA also may use the records in routine inspections in accordance with FDA's responsibilities to develop standards on the composition, safety, and efficacy of drugs administered to humans, and to monitor experimental usage of drugs.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM:
NIDA maintains "hard copy" records in file folders and automated records on computer disk.
Authorized NIDA and contractor personnel index and retrieve the computerized records by a researcher code number assigned by a computer program at the time a new record is established. Authorized NIDA personnel index and retrieve "hard copy" records by researcher's name. NIDA maintains a computerized, alphabetical cross-reference list that matches names and numbers.
RETENTION AND DISPOSAL:
NIDA maintains an individual's record for five years after the researcher's last request for, or shipment of, a drug of abuse. We consider the record inactive after that, and erase it from the computer disk by a delete routine. The delete routine automatically deletes the computerized cross-reference as well. We destroy the "hard copy" record by shredding. The system is checked once a year for inactive records.
SYSTEM MANAGER(S) AND ADDRESS(ES):
Program Director, Drug Supply Program, Chemistry and Physiological Systems Research Branch, Division of Neuroscience and Behavioral Research, National Institute on Drug Abuse (NIDA), Neuroscience Center, Room 4282, 6001 Executive Boulevard, Bethesda, MD 20892-9555.
To determine if a record exists, write to the System Manager at the address above. An individual may learn if a record exists about himself or herself upon written request. The request should include the researcher's name and business address at the time of last shipment. The request must be signed in ink by the individual researcher. Verifiable proof of identity is required.
RECORD ACCESS PROCEDURE:
Same as Notification Procedures. Requesters should also reasonably specify the record contents being sought. An individual may also request an accounting of disclosures of his/her record, if any.
CONTESTING RECORD PROCEDURE:
Contact the official at the address specified under Notification Procedures above and reasonably identify the record, specify the information being contested, the corrective action sought, with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant.
RECORD SOURCE CATEGORIES:
Initial source is the individual researcher. Some of the DEA registration information provided by a researcher is verified through a DEA computer check. FDA provides information concerning type and amount of controlled substance(s) to be shipped to an individual researcher for research projects involving human subjects.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: