[Federal Register Volume 62, Number 12 (Friday, January 17, 1997)]
[Notices]
[Pages 2674-2675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 60 FR 53379, October 13, 1995) is amended to reflect an 
organizational change in the Office of Testing and Research and the 
Office of Pharmaceutical Science, Center for Drug Evaluation and 
Research (CDER), in the Food and Drug Administration (FDA).
    CDER believes this organizational change will improve operations 
management and strengthen the existing research and testing structure 
to more effectively accomplish the Center's mission.
    Under section HF-B, Organization:
    1. Delete the subparagraphs under the Chemistry Policy Staff 
(HFNS1), Office of Pharmaceutical Science and insert the following new 
subparagraphs under Product Quality Support Staff (HFNS1), reading as 
follows:
    Product Quality Support Staff (HFNS1). Manages and facilitates the 
development, review, coordination, dissemination, organization, and 
implementation of new chemistry manufacturing policies, procedures, and 
guidelines related to chemistry and microbiology reviews of new and 
generic drug applications.
    Performs assessments of environmental impact of actions within the 
drug approval system which may significantly affect the quality of the 
human environment.
    Performs quality assurance and quality control functions for 
chemistry reviews of both new and generic drug applications.
    Provides support for the operations of quality expert working 
groups or committees focused on the chemistry manufacturing control 
technical aspects of the drug review process.
    Provides necessary training for chemists, as appropriate.
    Develops and implements policies and procedures in support of 
compendial operations and directs appropriate programs related to 
compendial initiatives.
    2. Delete the subparagraphs under the Formulation Research Staff 
(HFNS2), Office of Pharmaceutical Science (HFNS) in its entirety.
    3. Delete the subparagraphs under the Office Testing and Research 
(HFNSD) in its entirety and insert new subparagraphs reading as 
follows:
    Office of Testing and Research (HFNSD). Conducts research and 
develops scientific standards on the composition, quality, safety, and 
effectiveness of human drug products.
    Directs the FDA insulin certification program.
    Directs large scale drug quality surveillance activities for the 
Center as required by regulations.
    Conducts and coordinates basic and applied research.
    Provides scientific training for new employees through the 
development and coordination of Staff College programs.
    Sponsors cooperative university-based and industry-linked education 
programs for postdoctoral traineeships and sabbatical programs. 
Initiates and coordinates the holding of scientific workshops.
    In coordination with the Office of the Commissioner, educates the 
public on Center and Agency policy and activities.
    4. Insert the following new subparagraphs under the Regulatory 
Research and Analysis Staff (HFNSD-1), Office of Testing and Research 
(HFNSD) reading as follows:
    Regulatory Research and Analysis Staff (HFNSD-1). Serves as the 
scientific and regulatory liaison to the FDA National Center for 
Toxicological Research, the National Institute of Environmental Health 
Sciences National Toxicology Program and other Federal agencies. 
Coordinates Center-sponsored and Center-related research and 
communicates scientific information to the Office of Review Management, 
the Pharmacology/Toxicology Coordinating Committee and the Center's 
review divisions.
    Establishes and maintains a computerized toxicology knowledge 
database using data derived from Center files in areas such as 
carcinogenicity, reproductive toxicity, developmental toxicity and 
genotoxicity. Application of this resource includes regulatory review 
support, international harmonization,

[[Page 2675]]

and the development of Center regulatory policy and guidance.
    Evaluates the potential application of computer-based toxicology 
predictive modeling systems for pharmaceuticals. Utilizes toxicology 
information in Center databases to enhance the predictive power of 
modeling systems for pharmaceuticals.
    5. Insert the following new subparagraphs under the Laboratory of 
Clinical Pharmacology (HFNSD-2), Office of Testing and Research (HFNSD) 
reading as follows:
    Laboratory of Clinical Pharmacology (HFNSD-2). Serves as the 
Center's principal resource for laboratory research which is related to 
the discipline of clinical pharmacology.
    Develops preclinical model systems which assist in expediting the 
initiation of early clinical trials.
    Collaborates with the Office of Clinical Pharmacology and 
Biopharmaceutics and other Center components on appropriate research.
    Collaborates in joint projects with other Government agencies.
    6. 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: December 27, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-1201 Filed 1-16-97; 8:45 am]
BILLING CODE 4160-01-F