[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