[Federal Register Volume 62, Number 68 (Wednesday, April 9, 1997)]
[Notices]
[Pages 17195-17197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9053]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions, and Delegations of
Authority
Part D, Chapter DB (Office of Operations) 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 60 FR 56605, November 9, 1995, and in pertinent part at 56 FR
50126, October 3, 1991) is amended to reflect the reorganization of the
Center for Veterinary Medicine (CVM), Office of Operations, in the Food
and Drug Administration (FDA).
The Center for Veterinary Medicine will continue to develop and
recommend the veterinary medical policy of the Agency with respect to
the safety and effectiveness of animal drugs, feeds, feed additives,
veterinary medical devices (medical devices for animal use), and other
veterinary medical products. The restructuring of the Center is
proposed to strengthen the delivery of services to our constituents and
customer groups by streamlining the organization through delayering
lines of authority and responsibility, and improving channels of
communications at all levels within the Center.
1. Delete Office of the Center Director (HFV1), Center for
Veterinary Medicine (HFV), in its entirety and replace with the
following:
Office of the Center Director (DBVA). Directs overall Center
activities and coordinates and establishes Center policy in the areas
of research, management, scientific evaluation, compliance and
surveillance.
Approves new animal drug applications and issues notices of
withdrawal of new animal drug approvals when the opportunity for a
hearing has been waived.
Authorizes for use as edible products animals treated with
investigational drugs and terminates exemptions for investigational
trials. In conjunction with appropriate agency officials in the foods
area, provides FDA policy development and direction on environmental
impact matters.
Serves as focal point for operational review and compliance
activity policy and legislative matters; serves as focal point for
international harmonization and trade issues related to animal drugs
and feeds; leads and provides oversight of research animal issues for
FDA.
Plans, develops and implements the Center's Equal Employment
Opportunity and Affirmative Action Program.
Develops, reviews, and coordinates all Federal Register
publications pertaining to Center functions and coordinates requests
and activities pertaining to the Regulatory Flexibility Act, Executive
Orders on Regulations, Paperwork Reduction Act, and regulations
planning and implementation.
2. Delete the Office of Management (HFV1A), Center for Veterinary
Medicine (HFV), in its entirety and replace with the following:
Office of Management and Communications (DBVB). Provides guidance
and leadership in the analysis, planning, coordination and evaluation
of administrative management activities including: personnel; employee
orientation and development; procurement; travel; facilities; property;
security; records management; performance management; awards; budget
formulation and execution; information resources management; program
analysis; and management analysis. Provides administrative assistance
and support to the Veterinary Medicine Advisory Committee (VMAC)
Executive Secretary.
Plans, develops, and implements Center management policies.
Provides leadership and direction for the management and administrative
interface with the Agency, the Department and other Federal agencies.
Serves as Center interface with the Agency and Department on budget
issue resolutions.
Performs analysis, program assessments, or special studies of key
issues relative to policy review and oversight. Directs a variety of
short-range and long-range special projects or assignments of
substantial significant to the Center.
Implements Internal Control Reviews in accordance with the Office
of Management and Budget, Department and Agency guidelines. Provides
direction in the preparation of responses to the Office of Inspector
General and the General Accounting Office regarding audits and
investigation.
Directs the Center's outreach efforts to consumers, professionals
and the industry in communicating the program goals and priorities of
the Center. Maintains the CVM Home Page on the World Wide Web. Provides
automated scientific literature searches and retrieval support.
Supports public and consumer affairs, including freedom of information.
Directs the Center's Strategic Plan and the efforts of Strategic
Implementation Groups (SIG) to effectively accomplish Center goals and
objectives. Facilitates implementation of SIG recommendations.
3. Insert Administrative Staff (DBVB-1), under the Office of
Management and Communications (DBVB), reading as follows:
Administrative Staff (DBVB-1). Serves as the focal point in the
Center for administrative management activities. Coordinates the
administrative management activities in the Offices with designated
Administrative Officers, i.e., personnel management, property
acquisition and surplus, inventory, procurement, travel services,
security procedures, records management, performance management,
conflict of interest, special government employees, and
telecommunications. Safeguards the administrative management services
against waste, fraud and abuse.
Manages the Center's award systems through the Strategic Plan
Awards Committee and the CVM Incentive Awards Committee. Manages CVM's
participation in the Agency's Honor Award process, including the first
and second tier ceremonies.
Provides budget execution and fiscal accounting services for the
Center. Monitors and provides officials with continual awareness of
obligated commitments and status of funds.
Directs, develops and implements the Center's overall professional,
scientific, technical, clerical, and management training programs;
formal career development programs and New Employee Orientation
Program. Coordinates all Special training programs from the Agency and
Department.
4. Insert Communications Staff (DBVB-2), under the Office of
Management and Communications (DBVB), reading as follows:
Communications Staff (DBVB-2). Plans, produces, and publishes a
bimonthly subscription newsletter entitled the FDA VETERINARIAN and
other publications such as CVM UPDATES and consumer fliers.
Supports FDA public affairs/consumer affairs initiatives, including
[[Page 17196]]
supporting the efforts of CVM's Press Officer and FDA Public Affairs
Specialists in headquarters and the field.
Develops, prepares, and coordinates the Center's responses to
requests for information through the Freedom of Information Act (FOIA).
Provides automated, scientific literature search capabilities and
retrieval support to CVM. Keeps the Center current on improvements to
these systems.
Delivers the Center's message to our customers, both inside and
outside government, through the most effective and up-to-date medial
technologies available, including the World Wide Web, the Internet,
etc.
Establishes and coordinates industry/producer group outreach
initiatives.
Responds to inquiries to the Center, including letters and
telephone inquiries from consumers, industry representatives,
government officials, health professionals and academics.
5. Insert Program Planning and Evaluation Staff (DBVB-3), under the
Office of Management and Communications (DBVB), reading as follows:
Program Planning and Evaluation Staff (DBVB-3). Prepares the Agency
annual budget estimates. This includes all phases of budget analysis
and formulation and presentation. Assists staff in justifying budgets
for anticipated needs.
Conducts management and program analysis studies and participates
in the program planning process to identify operational goals and
evaluation methods. Designs and recommends systems and procedures and
develops policy recommendations to implement study conclusions.
Provides management and consulting services, including policy
development and analysis of proposed policy changes. Assists Center
managers in assessing management problems and designs and recommends
systems and procedures; develops and recommends policy to implement
study conclusions.
Conducts Internal Control Reviews in accordance with instructions
and guidelines provided by Agency and OMB. Conducts analysis and
presents summary of findings to management officials. Assists in the
coordination and preparation of responses to the Office of the
Inspector General and the General Accounting Office regarding audits
and investigations.
6. Insert Information Resources Management Staff (DBVB-4), under
the Office of Management and Communications (DBVB), reading as follows:
Information Resources Management Staff (DBVB-4). Implements
information resources management functions for the Center including
systems development, systems management, telecommunications plan and
ADP security.
Provides systems analysis and programming support for the Center.
Directs the utilization of the Center's central computer system and the
internal network of personal computers and video display terminals.
Provides user support for all functions involving the CVM local
area network and wide area network.
Provides support and training on ADP security including
implementation of the FDA and DHHS security requirements.
7. Delete Office of New Animal Drug Evaluation (HFVT), Center for
Veterinary Medicine (HFV), in its entirety and replace with the
following:
Office of New Animal Drug Evaluation (DBVC). Evaluates for animal
safety and effectiveness new animal drugs in pharmaceutical dosage
forms or for use in animal feed, and the safety aspects of drug and
food additive residues remaining in food produced for human consumption
from animals, intentionally or otherwise, administered drugs or food
additives.
Reviews and determines the adequacy of information submitted in
support of proposed use of investigational new animal drugs, and
recommends to the Center Director appropriate action on new animal drug
applications and acts on investigational new animal drug (INAD) notices
of exemption and authorization requests.
Evaluates manufacturing methods and procedures for new animal drug
products.
Coordinates the development and implementation of regulations and
policies pertaining to new drugs intended for animal use.
Evaluates office activities to ensure compliance with the National
Environmental Policy Act (NEPA).
Provides technical support and expert testimony in legal
proceedings relative to the approval of new animal drugs.
Participates in international activities designed to harmonize the
drug approval process.
8. Delete the Office of Surveillance and Compliance (HFVU), Center
for Veterinary Medicine (HFV), in its entirety and replace with the
following:
Office of Surveillance and Compliance (DBVD). Advises the Center
Director on surveillance and compliance policy concerning FDA
regulatory responsibility with respect to animal drugs, feeds, feed
additives, veterinary medical devices, and other veterinary medical
products.
Develops and evaluates surveillance and monitoring programs to
ensure the safety and effectiveness of animal drugs and to detect
emerging resistance to antimicrobials among zoonotic enteric pathogens.
Plans, develops, monitors, and evaluates Center surveillance and
compliance programs and coordinates their field implementation to
ensure the safety and effectiveness of marketed animal drugs, feeds,
feed additives, veterinary medical devices, and other veterinary
medical products.
Directs and coordinates the development of scientific evidence
supporting Formal Evidentiary Hearings requested by the Center.
Recommends to the Center Director the amendment or withdrawal of
approved new animal drugs applications.
Develops, coordinates, and directs the Center's Bioresearch
Monitoring Program to ensure reliability of information on which to
base new animal drug and food additive approvals.
Provides epidemiology expertise to the Center as needed.
9. Delete the Office of Science (HFVV1), Center for Veterinary
Medicine (HFV), in its entirety and replace with the following:
Office of Research (DBVE). Advises and assists the Center Director
and other officials on research matters which affect Center policy
direction and long-range goals.
Provides focal point for all research activities in the Center,
serves as the liaison for intramural and extramural research.
Provides scientific review, guidance, and support for research
activities (extramural research, training, and fellowship activities);
serves as the Center focal point for pre-award coordination.
Evaluates and reviews the adequacy of research resources; appraises
the technical aspects and contributions of Center science programs.
Initiates, manages, and reviews Center contracts, grants,
cooperative agreements, and interagency agreements with regard to
enhancing the Center research and science program activities.
Evaluates and interprets results of scientific research; initiates
and recommends action as appropriate to implement policy changes.
10. Delete Administrative Staff (HFVV2), under the Office of
Science (HFVV1), in its entirety and replace with the following:
[[Page 17197]]
Administrative Staff (DBVE-1). Manages budget, property, space, and
acquisition of equipment and services for intramural research programs.
Responsible for the maintenance, repair, and construction of
grounds, buildings, and equipment, as applicable, in support of
intramural research programs.
Develops and manages health, safety, and chemical disposal required
for intramural research programs.
Produces, reviews, and tracks correspondence, reports, and
manuscripts for the intramural research program.
11. 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 23, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-9053 Filed 4-8-97; 8:45 am]
BILLING CODE 4160-01-F
