[Federal Register Volume 60, Number 147 (Tuesday, August 1, 1995)]
[Notices]
[Pages 39181-39182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18754]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 at 58 FR 14214, March 16, 1993) is amended to reflect the 
following reorganization in the Food and Drug Administration (FDA).
    The Office of the Center Director (OCD), Center for Drug Evaluation 
and Research (CDER) is being reorganized to enhance CDER's 
responsiveness to its internal and external customers. The Executive 
Operations Staff is being established to combine project management, 
executive secretariat, and program management functions. The functions 
and staff of the Division of Regulatory Affairs are being transferred 
from the Office of Compliance to OCD as the Regulatory Affairs Staff.
    Under section HF-B, Organization:
    1. Delete the subparagraph Office of the Center Director (HFN1) 
under the Center for Drug Evaluation and Research (HFN), in its 
entirety and insert a new subparagraph reading as follows:
    Office of the Center Director (HFN1). Promulgates, plans, 
administers, coordinates, and evaluates overall Center scientific, 
management, and regulatory programs, plans, and policies.
    Provides leadership and direction for all Center activities.
    Coordinates and directs the Center management, planning, and 
evaluation systems to assure optimum utilization of Center manpower, 
financial resources, and facilities.
    Directs Center operations for equal employment activities.
    2. Insert a new subparagraph Executive Operations Staff (HFN11) 
under the Office of the Center Director (HFN1) reading as follows:
    Executive Operations Staff (HFN11). Provides executive secretariat 
support to the Immediate Office of the Center Director, including 
coordinating executive and legislative correspondence and activities; 
managing the preparation and coordination of meetings; and preparing 
background material, graphics, and other information for meetings, 
speeches, and presentations.
    Provides project management support for Centerwide and Agencywide 
initiatives to improve the quality and timeliness of regulatory reviews 
and improve team-based management practices.
    Provides management support and advice to senior Center management 
concerning Center programs, including Center extramural contracts and 
grants activities.
    3. Insert a new subparagraph, Regulatory Affairs Staff (HFN13), 
under the Office of the Center Director (HFN1) reading as follows:
    Regulatory Affairs Staff (HFN13). Initiates, develops, and reviews 
regulations, policies, procedures, and guidelines that affect the drug 
approval process.
    Serves as the Center's focal point on regulatory issues providing 
advice and assistance on such matters as scope, applicability, and 
intents of the Food, Drug, and Cosmetic Act and other laws, 
regulations, and policies.
    4. Delete the subparagraph, Office of Compliance (HFND), under the 
Center for Drug Evaluation and Research (HFN) and insert a new 
subparagraph reading as follows:
    Office of Compliance (HFND). Monitors the quality of marketed drugs 
through product testing, surveillance, and compliance programs.
    Advises the Center Director and other Agency officials on FDA's 
regulatory responsibilities for drugs.
    Develops standards for drug industry practices, including Current 
Good Manufacturing Practice (CGMP) regulations, and ensures their 
uniform interpretation.
    Directs the Center's bioresearch monitoring program for drug 
products.

[[Page 39182]]

    Identifies problems in drug regulation, manufacturing, and quality 
assurance and conducts voluntary compliance programs and studies.
    Develops drug quality assurance and surveillance programs; 
coordinates and directs their field implementation; and advises other 
Center components on these programs.
    Coordinates Center-field relations; provides support and guidance 
to the field on legal actions, case development, and contested cases; 
and reviews and decides disposition of field submissions involving 
deviations from standards.
    Initiates Center-field surveillance assignments to monitor pivotal 
research data submitted as part of premarketing applications.
    Recommends approval, denial of approval, or revocation of approval 
of activities that use methadone and other drugs for which treatment 
standards have been promulgated, taking any appropriate compliance 
action.
    Evaluates, in coordination with appropriate Agency Regulatory 
affairs officials, a firms' conformance with CGMP in producing drugs 
for procurement by Federal and State agencies.
    Evaluates, classifies, and recommends drug recalls and provides 
Center coordination with field recall activities.
    Develops and implements policies and procedures in support of 
Center compendial operations and directs the Compendial Monographs 
Development and Evaluation Program.
    5. 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: July 19, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-18754 Filed 7-31-95; 8:45 am]
BILLING CODE 4160-01-M