[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
