[Federal Register Volume 60, Number 198 (Friday, October 13, 1995)]
[Notices]
[Pages 53379-53382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25326]



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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 56 FR 58250, on November 18, 1991) is amended to reflect an 
organizational change in the Center for Drug Evaluation and Research 
(CDER) in the Food and Drug Administration (FDA).
    The Food and Drug Administration plans to realign its major human 
drug program functions into two primary lead areas: drug review 
management and pharmaceutical science. The Office of Review Management 
(ORM) and the Office of Pharmaceutical Science (OPS), each to be headed 
by a Deputy Center Director, will report directly to the Director of 
CDER. FDA believes this 

[[Page 53380]]
reorganization will rebuild and strengthen the existing structure of 
the new drug review process to more effectively accomplish CDER's 
mission. The new ORM structure will align the drug review components 
into smaller, more cohesive offices to allow a more efficient review 
process and facilitate communication both up and down organizational 
lines.
    The chemistry review function will be separated into an Office of 
New Drug Chemistry within OPS. In addition, OPS will also oversee the 
pharmacological, biopharmaceutical, and generic drug review functions. 
CDER believes the consolidation of these functions will contribute to 
the quality of chemistry reviews by improving basic management and 
oversight of the chemistry program. The realignment will also 
facilitate the development and dissemination of consistent and uniform 
policies through a single source.
    CDER's new organizational structure will streamline its operations 
while continuing to meet its statutory mandates, the goals agreed to 
under the Prescription Drug User Fee Act, and the requirements of the 
National Performance Review.
     Under Chapter HF, Section HF-B, Organization:
     1. Delete the following subparagraphs under the Center for Drug 
Evaluation and Research (HFN1) in their entirety Office of Drug 
Standards (HFNE), Office of Drug Evaluation I (HFNG), Office of Drug 
Evaluation II (HFNK), Office of Epidemiology and Biostatistics (HFNJ), 
Office of Research Resources (HFNL), Office of Generic Drugs (HFNM), 
and Office Over-the-Counter Drug Products (HFNN).
     2. Insert the following new subparagraphs under the Center for 
Drug Evaluation and Research (HFN1) reading as follows:
    Office of Review Management (HFNR). Develops and implements the 
Center's review management and scientific policies, including user fee 
policies, pertaining to the drug review process.
     Reviews investigational new drug applications (INDs) for all 
classes of drug products for human use with the exception of generic 
drug applications, and recommends appropriate action with respect to 
safety and effectiveness of clinical trials.
     Evaluates for safety and effectiveness and approves new drug 
applications (NDAs for drug products for human use.
     Coordinates and/or reviews and decides on the appropriate action, 
including approval or disapproval, of all applications for over-the-
counter (OTC) drug products, OTC drug monographs, prescription drug 
switches to OTC drug status, and other OTC-related drug products, with 
the exception of generic drug applications.
     Develops and implements standards for the safety and effectiveness 
of prescription drug products for human use and (OTC) drugs.
    Oversees surveillance programs conducted to collect and evaluate 
the effects and use trends of marketed drug products.
     Provides direction and policy formulation for pharmacology/
toxicology-related issues for the Center.
     In carrying out these functions, cooperates with other FDA 
components, other PHS organizations, governmental and international 
agencies, volunteer health organizations, universities, individual 
scientists, nongovernmental laboratories, and manufacturers of drug 
products.
     Advisors and Consultants Staff (HFN1-1). Directs and manages 
Center programs involving the use of scientific advisors, consultants, 
and committees.
     Provides direction for Center scientific liaison with medical and 
scientific communities, industry, and the private sector.
     Counsels and coordinates with Center managers on the use of 
scientific experts and resources.
     Develops Center policy and guidelines related to the appointment 
and utilization of scientific advisors and consultants.
    Office of Drug Evaluation I (HFNRA). Reviews notices of claimed 
investigational exemptions for new drugs (INDs) within classes of drugs 
regulated by this Office and recommends appropriate action with respect 
to safety and effectiveness of clinical trials.
     Evaluates for safety and effectiveness and approves new drug 
applications (NDAs) for products regulated by this Office, and 
evaluates supplements that propose changes in the conditions upon which 
NDA approvals are based.
     Develops policy and procedures governing the review and evaluation 
of drug investigations and NDAs.
     Evaluates and takes appropriate action on recommendations 
concerning withdrawal of approval of NDAs for products regulated by 
this Office.
     Performs consulting medical and scientific evaluations of 
submissions on generic drugs, drugs under monograph, and over-the-
counter drug products regulated by other offices in the Center.
     Conducts, in coordination with other Agency components, continuing 
surveillance and medical evaluation of labeling, clinical experience, 
and reports submitted by holders of NDAs for products regulated by this 
Office.
     Oversees the development and implementation of standards for the 
safety and effectiveness of drug advertising and labeling.
     Monitors, evaluates, and develops policy for prescription drug 
promotion and labeling.
     Initiates necessary actions to maintain industry compliance with 
prescription drug advertising and labeling regulations.
     Participates in Agency sponsored consumer and professional 
educational programs on drug standards.
     Office of Drug Evaluation II (HFNRB). Reviews notices of claimed 
investigational exemptions for new drugs (INDs) within classes of drugs 
regulated by this Office and recommends appropriate action with respect 
to safety and effectiveness of clinical trials.
    Evaluates for safety and effectiveness and approves new drug 
applications (NDAs) for products regulated by this Office, and 
evaluates supplements that propose changes in the conditions upon which 
NDA approvals are based.
     Develops policy and procedures governing the review and evaluation 
of drug investigations and NDAs.
     Evaluates and takes appropriate action on recommendations 
concerning withdrawal of approval for NDAs for products regulated by 
this Office.
    Performs consulting medical and scientific evaluations of 
submission on generic drugs, drugs under monograph, and over-the-
counter drug products regulated by other offices in the Center.
    Conducts, in coordination with other Agency components, continuing 
surveillance and medical evaluation of labeling, clinical experience, 
and reports submitted by holders of NDAs for products regulated by this 
Office.
    Office of Drug Evaluation III (HNNRC). Reviews notices of claimed 
investigational exemptions for new drugs (INDs) within classes of drugs 
regulated by this Office and recommends appropriate action with respect 
to safety and effectiveness of clinical trials.
    Evaluates for safety and effectiveness and approves new drug 
applications (NDAs) for products regulated by this Office, and 
evaluates supplements that propose changes in the conditions upon which 
NDA approvals are based.
    -Develops policy and procedures governing the review and evaluation 
of drug investigations and NDAs.
    Evaluates and takes appropriate action on recommendations 
concerning withdrawal of approval of NDAs for products regulated by 
this Office.

[[Page 53381]]

    Performs consulting medical and scientific evaluations of 
submissions on generic drugs, drugs under monograph, and over-the-
counter drug products regulated by other offices in the Center.
    Conducts, in coordination with other Agency components, continuing 
surveillance and medical evaluation of labeling, clinical experience, 
and reports submitted by holders of NDAs for products regulated by this 
Office.
    Office of Drug Evaluation IV (HFNRD). Reviews notices of claimed 
investigational exemptions for new drugs (INDs) within classes of drugs 
regulated by this Office and recommends appropriate action with respect 
to safety and effectiveness of clinical trials.
     Evaluates for safety and effectiveness and approves new drug 
applications (NDAs) for products regulated by this Office, and 
evaluates supplements that propose changes in the conditions upon which 
NDA approvals are based.
     Develops policy and procedures governing the review and evaluation 
of drug investigations and NDAs.
     Evaluates and takes appropriate action on recommendations 
concerning withdrawal of approval for NDAs for products regulated by 
this Office.
     Performs consulting medical and scientific evaluations of 
submission on generic drugs, drugs under monograph, and over-the-
counter drug products regulated by other offices in the Center.
     Conducts, in coordination with other Agency components, continuing 
surveillance and medical evaluation of labeling, clinical experience, 
and reports submitted by holders of NDAs for products regulated by this 
Office.
    Office of Drug Evaluation V (HFNRE). Reviews notices of claimed 
investigational exemptions for new drugs (INDs) within classes of drugs 
regulated by this Office and recommends appropriate action with respect 
to safety and effectiveness of clinical trials.
     Evaluates the safety and effectiveness and approves new drug 
applications (NDAs) for products regulated by this Office, and 
evaluates supplements that propose changes in the conditions upon which 
NDA approvals are based.
     Evaluates for safety and effectiveness and approves applications 
for over-the-counter (OTC) drug products.
     Oversees the development of policy and procedures governing the 
review and evaluation of drug investigations, NDAs, and OTCs.
     Evaluates and takes appropriate action on recommendations 
concerning withdrawal of approval for NDAs for products regulated by 
this Office.
     Performs consulting medical and scientific evaluations of 
submission on generic drugs, drugs under monograph, and over-the-
counter drug products regulated by other offices in the Center.
     Conducts, in coordination with other Agency components, continuing 
surveillance and medical evaluation of labeling, clinical experience, 
and reports submitted by holders of NDAs for products regulated by this 
Office.
    Office of Epidemiology and Biostatistics (HFNRG). On behalf of both 
CDER and CBER, conducts programs to collect and evaluate 
epidemiological and nonepidemiological information on drug and 
biological product usage, adverse reactions, poisonings, safety, 
quality, and effectiveness.
     Disseminates drug and biological product information to other 
components of the Center and the Agency.
     Collaborates with users of drug and biological product information 
to insure that information collected and evaluated is sufficient, 
relevant, and useful.
    Provides statistical services to Center scientific and regulatory 
programs.
    Conducts research on, develops, and evaluates statistical 
methodologies.
    Conducts research and develops information using epidemiological 
and other strategies to determine the best way to communicate drug and 
biological product usage information to health professionals and 
consumers.
    Develops liaison with sources of medical and scientific information 
related to drugs and biological products.
    Office of Pharmaceutical Science (HFNS). Provides advice and 
information to other components of the Center and the Agency on 
pharmaceutical programs and issues.
     Oversees research and development of scientific standards on the 
composition, quality, safety, and effectiveness of human drug products 
and provides expert advice based on that research in support of the 
drug review regulatory process.
    Oversees the development of standards for the safety and 
effectiveness of generic drugs.
    Oversees the review and evaluation of Abbreviated New Drug 
Applications (ANDAs), Abbreviated Antibiotic Drug Applications (AADAs), 
and their amendments or supplements and determines approvability.
    Oversees the science issues of chemistry, manufacturing, and 
control reviews; ensures consistency of new drug chemistry reviews; and 
manages the overall coordination of IND and NDA chemistry reviews.
    Oversees the review and evaluation of pharmacokinetic, 
pharmacodynamic, drug metabolism, bioavailability, and bioequivalence 
protocols and data in INDs, NDAs, antibiotic applications and their 
supplements and amendments.
    Oversees the FDA's insulin certification program.
    Oversees the testing of drug samples obtained for compliance 
programs, evaluation of methods in new drug applications, approval in 
the abbreviated new drug application process, and special 
investigations or testing for other scientific and regulatory 
components of the Agency.
    Chemistry Policy 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.
    Advises and assists Center management on program and policy issues 
concerning compendial operations.
    Formulations Research Staff (HFNS2). Oversees scientific activities 
which form the basis for regulatory approval of drug substances and 
products within CDER.
    -Facilitates scientific investigations which result in the 
development of tests and specifications to assure the performance of 
drug products.
    -Manages and oversees extramural research contracts which provide 
data in support of regulatory standards, policies, and decisions.
    Operations Staff (HFNS3). Advises the Deputy Director for 
Pharmaceutical Science on all administrative management matters 
relating to the day-to-day activities of the Office of Pharmaceutical 
Science.
    -Provides direct administrative support to the Office in the areas 
of financial and personnel management 

[[Page 53382]]
and management consulting and office services.
    Plans and develops management policies and programs which support 
operations of all Office components.
    Develops and conducts evaluation studies to determine the 
effectiveness of Center and Office programs, policies, and priorities 
and to forecast workloads to determine resource allocations and select 
alternative operating plans. Proposes improvements in program 
effectiveness and efficiency.
    Monitors workflow to determine that program goals and objectives 
are met.
    Office of Clinical Pharmacology and Biopharmaceutics (HFNSA). 
Evaluates pharmacokinetic, pharmacodynamic, bioavailability, 
bioequivalence, and drug metabolism protocols and data in notices of 
claimed investigational exemption for new drugs (INDs), new drug 
applications (NDAs), antibiotic applications (Form 5), and their 
supplements and amendments.
    Approves, disapproves, or recommends new bioavailability, 
bioequivalence, pharmacokinetic, pharmacodynamic, and drug metabolism 
studies and/or protocols.
    Identifies potential clinical pharmacology and biopharmaceuitcal 
problems and prepares protocols and guidelines for conducting relevant 
studies.
    Reviews and evaluates drug disposition data, dosing regimen, and 
specialized drug delivery systems to assure drug bioavailability.
    Initiates, monitors, and conducts biopharmaceutical research.
    Office of Generic Drugs (HFNSB). Oversees the development and 
implementation of standards for the safety and effectiveness of generic 
drugs.
    Reviews and evaluates Abbreviated New Drug Applications (ANDAs), 
Abbreviated Antibiotic Drug Applications (AADAs), and their amendments 
or supplements and determines approvability.-
    Establishes bioequivalency specifications for drug products and 
develops guidelines for bioequivalency reviews, industry protocols, and 
studies.
    Oversees all aspects of labeling submissions for ANDAs and AADAs.
    Office of New Drug Chemistry (HFNSC). Manages the science issues of 
chemistry, microbiology, manufacturing, and control reviews and ensures 
consistency in new drug chemistry reviews.
    Manages the overall coordination for IND and NDA chemistry and 
microbiology review processes within the Office.
    Reviews and evaluates the chemistry and microbiology portion of 
INDs, NDAs, amendments, and supplements for drugs regulated by this 
Office and recommends appropriate action with respect to safety.
    Evaluates manufacturing methods, controls, and facilities of 
manufacturers of drugs submitted for approval in NDAs for drugs 
regulated by the Office.
    Develops policy and procedures governing the chemistry and 
microbiology review and evaluation of INDs and NDAs.
    Provides advice and information to other components of the Center 
and the Agency on chemistry, manufacturing, and control issues as they 
relate to human drugs regulated by the Center.
    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.
    Coordinates Centerwide research activities in biomathematical/
statistical, pharmaco-epidemiological, econometric, and regulatory 
process or administration-oriented subject areas.
    Coordinates basic and applied pharmaceutical research including in 
vitro physiochemical or analytical biochemistry studies and in vivo 
rodent, nonhuman primate, and human clinical research.
    Develops and coordinates Center extramural research policy and 
monitors research projects.
    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 other Agency components, educates the public 
on Center and Agency policy and activities.
    3. 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 data shall continue in effect in them or their 
successors.

    Dated: September 1, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-25326 Filed 10-12-95; 8:45 am]
BILLING CODE 4160-01-F