[Federal Register Volume 60, Number 14 (Monday, January 23, 1995)]
[Notices]
[Pages 4417-4418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1551]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service


Food and Drug Administration 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 52 FR 34851, September 15, 1987) is amended to reflect an 
organizational change in the Food and Drug Administration (FDA).
    The positions assigned to perform the centralized investigative 
activities located in the Division of Ethics and Program Integrity, 
Office of Management, Office of Management and Systems, FDA, will be 
transferred to the new Office of Internal Affairs within the Office of 
the Commissioner. The functions and staff associated with the 
activities will report directly to FDA's Deputy Commissioner/Senior 
Advisor in the Immediate Office of the Commissioner. Since these 
activities could involve investigations of alleged employee misconduct 
anywhere in the Agency and because of the importance of providing the 
FDA Commissioner with an early warning of any potential misconduct, the 
Deputy Commissioner/Senior Advisor to the Commissioner is the 
appropriate person to direct these activities. Functional statements 
for the newly established Office of Internal Affairs are identified 
below.
    Under section HF-B, Organization:
    1. Insert a new paragraph (a-5), Office of Internal Affairs (HFA-G) 
under the Office of the Commissioner (HFA) reading as follows:
    Provides a centralized Agencywide investigative resource for the 
Commissioner, the Deputy Commissioners, and top Agency management.
    Provides a centralized investigative liaison between FDA and the 
Office of the Inspector General (OIG).
    Serves as an FDA investigative resource to conduct internal FDA 
investigations and to support OIG investigations. [[Page 4418]] 
    Conducts special assignments relative to the functions of this 
Office as requested.
    2. Delete subparagraph (h-7), Division of Ethics and Program 
Integrity (HFA72) in its entirety and insert a new subparagraph under 
the Office of Management and Systems (HFA6), Office of Management 
(HFA7) reading as follows:
    (h-7) Division of Ethics and Program Integrity (HFA72). Directs and 
coordinates a multidiscipline team of administrative and/or program 
specialists who conduct scheduled reviews of FDA Headquarters and field 
components to determine adherence to existing managerial policy and 
practices; assures that recommendations resulting from the review 
findings are implemented.
    Directs FDA's personnel security program and provides professional 
leadership and authoritative guidance in these areas. Formulates policy 
and procedures necessary to maintain the integrity of privileged 
information submitted by industry.
    Implements Internal Control Reviews in accordance with OMB 
guidelines.
    Directs the formulation of FDA policies and procedures concerning 
conflicts of interest and employee associations with regulated 
industries, reviews financial interests including outside activities of 
FDA employees, decides conflict of interest issues, and counsels and 
trains employees on the avoidance of conflicts of interest.
    Acts on FDA liaison with the Office of the Inspector General (OIG) 
regarding audits. Coordinates preparation of FDA responses to OIG audit 
findings, monitors implementation of FDA responses.
    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: January 5, 1995.
Donna E. Shalala,
Secretary.
[FR Doc. 95-1551 Filed 1-20-95; 8:45 am]
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