[Federal Register Volume 59, Number 200 (Tuesday, October 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25720]


[[Page Unknown]]

[Federal Register: October 18, 1994]


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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 59 FR 9487, February 28, 1994) is amended to reflect an 
organizational change in the Food and Drug Administration (FDA).
    FDA has increasing demands for integration and coordination among 
Agency information systems both in pursuit of new initiatives and in 
improved efficiencies in the continued execution of existing 
responsibilities. The Commissioner or Food and Drugs has determined 
that this integration and coordination can best be accomplished by 
moving the paperwork and records management activities into the Office 
of Information Resources Management (OIRM) and moving OIRM out of the 
Office of Management. OIRM will be combined with the strategic systems 
planning activities in the Office of Management and Systems (OMS). OIRM 
will be elevated to report directly to the Deputy Commissioner for 
Management and Systems. The functions of OIRM will be expanded 
specifically to include strategic systems activities.
    Under Chapter HF, Section HF-B, Organization:
    1. Delete subparagraph Office of Management (HFA7) in its entirety 
and insert a new subparagraph under the Office Management and Systems 
(HFA6), reading as follows:
    Office of Management (HFA7). Advises and assists the Commissioner 
and other key officials on all phases of management inherent in the 
operations of FDA.
    Directs the effective utilization of all management resources and 
the implementation of operating programs by coordinating the funding, 
manpower, facilities, and non-ADP equipment resources of the Agency.
    Assures that the conduct of Agency administrative and financial 
management activities, including budget, finance, personnel, 
organization, methods, grants and contracts, procurement and property, 
and similar support activities, effectively supports program 
operations.
    Develops policy and procedures necessary to maintain the integrity 
of trade secrets and other privileged information submitted by industry 
to FDA; formulates Agencywide non-ADP security policy and investigates 
and recommends action concerning security problems.
    Coordinates Agency response to external audits, including 
negotiation of difference, preparation of official Agency responses to 
audit findings, implementation of accepted recommendations, and 
preparation of progress reports for the HHS Inspector General and the 
Secretary.
    Provides a focal point for committee management activities within 
FDA.
    Processes the public response to proposed FDA rulemaking and formal 
adjudications.
    Coordinates the preparation of internal travel plans, including the 
Annual International Travel Plan for the Commissioner's approval.
    2. Insert a new subparagraph Office of Information Resources 
Management (HFA8) under the Office of Management and Systems (HFA6) 
reading as follows:
    Serves as the focal point for the Agencywide strategic information 
resources management program.
    Advises the Commissioner and other key officials on information 
resources management and strategic systems issues.
    Coordinates information resources management and telecommunications 
strategic planning.
    Participates and facilitates decisionmaking on information 
priorities and resource allocations.
    Identifies and coordinates the development of Agency systems 
initiatives and project management of automated administrative 
programs.
    Directs the Agency's centralized ADP user support.
    Develops and provides ADP contractual oversight of automated 
programs.
    Houses the Parklawn Computer Center.
    Provides leadership and guidance to Headquarters staff offices and 
operating activities and field activities for management programs 
relating to reports, directives, correspondence, records, forms, and 
microforms.
    Under Chapter HF, Section HF-D, 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: October 7, 1994.
Donna E. Shalala,
Secretary.
[FR Doc. 94-25720 Filed 10-17-94; 8:45 am]
BILLING CODE 4160-01-M