[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
