[Federal Register Volume 60, Number 166 (Monday, August 28, 1995)]
[Notices]
[Page 44503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21263]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Organization, Functions, and Delegations of 
Authority

    Part H, Chapter HF (Food and Drug Administration) of the Statement 
of Organization, Functions, and Delegations of Authority for the 
Department of Health and Human Services (35 FR 3685, February 25, 1970, 
and 56 FR 29484, June 27, 1991, as amended most recently in pertinent 
part at 53 FR 8978, March 18, 1988) is amended to reflect the following 
reorganization in the Food and Drug Administration (FDA).
    The functional statements for the Office of Compliance, Center for 
Drug Evaluation and Research (CDER), are being revised and updated to 
more accurately reflect the activities carried out by this Office.
    Under section HF-B, Organization:
    1. Delete the subparagraph, Office of Compliance (HFND), under the 
Center for Drug Evaluation and Research (HFN) and insert a new 
subparagraph reading as follows:
    Office of Compliance (HFND). Monitors the quality of marketed 
drugs, including nontraditional drugs, through product testing, 
surveillance, and compliance programs.
    Develops policy and standards for labeling, current good 
manufacturing practice issues, clinical and good laboratory practice 
investigations, postmarketing surveillance, and drug industry practices 
to demonstrate the safety and effectiveness of human drug products and 
ensures the uniform interpretation of such standards.
    Develops and directs drug product quality enforcement programs; 
postmarketing drug quality surveillance programs; and compliance 
programs for over-the-counter (OTC), nontraditional, and other drug 
monographs. Directs the Center's bioresearch monitoring program for 
human drug products.
    Advises the Center Director and other Agency officials on FDA's 
regulatory and enforcement responsibilities for human drugs.
    Initiates Center-field surveillance assignments to monitor pivotal 
research data submitted as part of premarketing applications. 
Coordinates preapproval inspections and results as part of the final 
product approval process.
    Coordinates Center-field relations; provides support and guidance 
to the field on legal actions, case development, and contested cases; 
and reviews and decides disposition of field submissions involving 
deviations from standards.
    Evaluates, classifies, and recommends human drug recalls and 
provides Center coordination with field recall activities. Monitors the 
resolution of all drug shortage situations involving compliance issues.
    Coordinates international inspections, results, and communications 
with inspectorates of other nations. Participates in international 
standards-setting activities.
    5. Prior Delegations of Authority. Pending further delegations, 
directives, or orders by the Commissioner of Food and Drugs, all 
delegations of authority to positions of the affected organizations in 
effect prior to this date shall continue in effect in them or their 
successors.

    Dated: August 14, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-21263 Filed 8-25-95; 8:45 am]
BILLING CODE 4160-01-M