[Federal Register Volume 60, Number 69 (Tuesday, April 11, 1995)]
[Notices]
[Pages 18416-18417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8853]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Public Health Service; Statement of Organization, Functions, and
Delegations of Authority
Part H, Chapter HE (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 52552, October 18, 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
the continued execution of existing responsibilities. The Commissioner
of Food and Drugs has determined that this integration and coordination
can best be accomplished by establishing a Strategic Systems Staff, an
Administrative Systems Automation Staff, and a Division of Plans,
Methods, and Resources within the Office of Information Resources
Management (OIRM). In addition, the Division of Information Management,
and the Parklawn Computer Center will be transferred from the Office of
Management to OIRM under the Office of Management and Systems.
Under Chapter HF, Section HF-B, Organization
1. Under the Office of Management and Systems (HFA7), Office of
Information Resources Management (HFA8), insert the following new
subparagraphs, Strategic Systems Staff (HFA8A), Administrative Systems
Automation Staff (HFA8B), Division of Plans, Methods, and Resources
(HFA8C), Division of Information Management (HFA8D), and Parklawn
Computer Center (HFA8E) reading as follows:
Strategic Systems Staff (HFA8A). Provides overall coordination of
strategic systems initiatives to ensure that Agency strategic goals and
priorities are met while being responsive to users. Coordinates
strategic systems project development, prioritization, and funding
estimates and provides oversight accountability to assure sound project
management practices for strategic systems initiatives. Represents
Agency in discussions with PHS, HHS other governmental components, and
external groups regarding strategic systems initiatives.
Coordinates the development of tactical implementation plans for
strategic systems initiatives, including objectives, deliverables,
funding, and timeframes. Monitors performance related to project plans
and surfaces critical issues needing to be addressed.
Provides expert technical guidance to senior Agency officials on
strategic systems development to improve operating efficiencies and
capabilities.
Provides Agency leadership in the development and implementation of
an overall information systems architecture, including technical
information standards.
Provides technical oversight for major contracts which support the
planning for, development of, and implementation of strategic systems
initiatives (which provide support for, or are critical to, multiple
Agency components). Evaluates and documents contractor performance,
including costs, technical specifications, and schedules.
Administrative Systems Automation Staff (HFA8B). Develops strategic
goals and objectives for the automation of FDA administrative processes
in conjunction with overall Agency strategic plans and represents the
Agency in discussions with PHS, HHS, other governmental components, and
external groups regarding administrative management systems automation
initiatives.
Manages the design, development, implementation, and operation of
the Agency's automated administrative management system, including the
modification of business practices to maximize the efficiency and
effectiveness of administrative processes.
Coordinates administrative systems automation initiatives to ensure
that Agency management goals and priorities are consistent with
statutory and regulatory requirements, Federal and HHS standards and
policies, and internal operating needs.
Monitors performance related to project plans, contractor
deliverables, and process improvements associated with automation of
administrative management operations.
Provides support to FDA's administrative organizations for the
enhancement modification, and maintenance of FDA's Integrated
Administrative Management Systems.
Division of Plans, Methods, and Resources (HFA8C). Coordinates the
development and integration of IRM planning processes. This includes
development of the FDA Information Systems Strategic Plan in
conjunction with the overall Agency Strategic Plan and the FDA 5-year
Long Range IRM Strategic Plan developed to meet OMB requirements.
Represents the Agency in discussions with PHS, HHS, other governmental
components, and external groups regarding IRM planning issues. Provides
support to other OIRM components in the development of tactical ADP
plans. Serves as a central point for coordinating, consolidating, and
developing IRM policy.
Develops and directs Agency management programs relating to
reports, directives, correspondence, records, and forms. Conducts
records and paperwork management studies for the Agency on either a
periodic, self-initiated basis, or in response to requests for
assistance.
Consolidates annual resource requests for all OIRM components,
prepares annual budget requests, and administers OIRM's approved
budgets from different funding sources. Provides administrative support
services required by all OIRM components.
Serves as a focal point for certain Agencywide IRM activities such
as support of FDA's IRM Council, coordination of FDA responses to IRM
audit activities, and other external IRM initiatives. Carries out high-
priority IRM projects and monitors major IRM projects managed by other
FDA elements.
Division of Information Management (HFA8D). Supervises specific
information resources management functions, including ADP security and
the telecommunications program for FDA. Represents FDA on all Federal
IRM issues (FIRMR) with HHS and other governmental and external
organizations.
Provides FDA telecommunications services and initiates or reviews
all [[Page 18417]] requisitions involving telecommunications.
Manages and monitors FDA's ADP Procurement Requests, contract
proposals, and interagency agreements to assure that FIRMR requirements
are adhered to.
Provides operational support to the Office of the Commissioner and
Deputy Commissioners by providing consultation, technical advice,
programming, systems analysis and assistance in the selection and use
of equipment and services to process information
Dorects the FDA ADP Security Program.
Parklawn Computer Center (HFA8E). Operates and manages the central
computer facility in the Parklawn complex performing fee-for-service
ADP functions for FDA and other PHS/HHS components.
Develops operational policy and procedures and provides technical
support for scientific and administrative information systems operated
within PCC.
Participates in the development of short-and long-range computer
center plans to make the best possible use of resources and to consider
new ADP systems methodologies.
Reviews and makes recommendations on hardware, software, and
service procurements when requested by serviced agencies to assure
compatibility with PCC equipment and conformance with established PCC
policies and procedures.
Designs, develops, and operates the Departmental Information
Management Exchange System (DIMES), the Departmental nationwide data
communications network.
Develops and operates a Center Performance Management Program to
evaluate hardware utilization and to measure workload processed to
assure optimum operation.
2. Delete subparagraphs (h-5) Parklawn Computer Center (HFA79) and
(h-8) Division of Information Management (HFA73), in their entirety.
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: March 23, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-8853 Filed 4-10-95; 8:45 am]
BILLING CODE 4160-1-M
