Project RAPID represents one step in the development of a larger, more complex agency wide data handling requirement involving the sharing of scientific information not only within FDA but with the entire scientific community. The basic objectives of Project RAPID are:

(a) To establish a basic system for storing and disseminating information concerning investigational and new drugs, their chemical structure, their manufacturers, their generic and trade names, their pharmacology, and their methods of use.

(b) To establish a system which will permit this information to be interrelated and distributed quickly to FDA medical officers and scientists assigned the job of reviewing and evaluating investigational drugs and new drugs.

(c) To relieve professional personnel of routine searching tasks and leave them free to do higher level work.

The system is described in the following pages. Live demonstrations of Project RAPID can be arranged by contacting: The Division of Management Systems, Office of the Assistant Commissioner for Administration, Food and Drug Administration.

PROJECT RAPID

Enactment of the Kefauver-Harris drug amendments and the new regulations requiring review by FDA of drugs under investigation have added to the volume of information coming to FDA, making the task of interrelating pertinent drug information more difficult.

The problem was studied and it was decided that a basic system for storing selected information about drugs on punchcards would be feasible and could be installed quickly--in time to meet the initial workload of reviewing proposals for investigational drugs.

What information is to be stored in the punchcards?

At present, five classes of basic information are recorded into punchcards. These include information about:

1. Chemical structure and formulation.

2. Drug manufacturer (who, where, etc.).
3. Drug names (both trade and generic).

4. Pharmacology of drugs.

5. Route of administration and dosage.

Additional information will be included in the future.

What is the source of the information to be stored?

Presently, the new system stores selected information taken from new drug applications (NDA's), proposals for investigational drugs (IND's), and reports concerning the use of investigational drugs. Eventually, it is planned to include information from other sources such as journals, periodicals, reports received from other agencies, etc.

How does the information get from the source document to punchcards?

Selected information is abstracted from NDA's and IND's and coded for punching. Because the process requires coding of chemical and other technical data, professional personnel skilled in chemical indexing are required for this work.

HOW THE SYSTEM WORKS, STEP-BY-STEP

New drug application (NDA) or investigational new drug (IND) data are received from the manufacturer in triplicate. Sequence numbers are assigned and material jacketed for uniformity.

Acknowledgment letters are prepared to be sent to the manufacturers. Master index cards are prepared, containing abstracted data.

Following preparation of the master index cards, code sheets are prepared. In many cases, a newly received IND or NDA will relate to a previously processed NDA or IND. The system is designed so that the "master index card" and code sheet for the newly received case will include information cross-referenced from the previously processed case.

Using code sheets, punched cards are created and machine verified for accuracy.

Newly created IND and NDA cards are stored for mechanized retrieval.

HOW INFORMATION IN THE SYSTEM IS RETRIEVED AND DISSEMINATED

Information is distributed:

1. Through routine reports.

2. In response to special inquiries.

1. Routine reporting

By using a combination of mechanical sorting, collating, and tabulating equipment, periodic reports are being prepared in printed form from the cards and distributed to personnel engaged in the review and evaluation of IND's and NDA's. These reports summarize, by category, all information received and recorded during specific periods.

2. Special inquiries

Telephone and written inquiries for information stored in the system are generated by the scientific and administrative staffs of the Food and Drug Administration.

Telephone and written requests are recorded onto a special form to facilitate machine search.

Control panels (tailored to individual requests) are wired in preparation for search. This operation is performed in minutes.

A mechanical search of the punched card files is performed.

Cards matching the criterion of the search are selected automatically. The content of the selected cards is printed.

Printing of the desired information is varied and custom designed to meet the specific requirements of the requester.

The printed response is delivered to the inquirer.

Mr. LARRICK. Other measures, such as the mechanization of antibiotic certification procedures and the establishment of a modern indexing technique for identifying chemical compounds through their infrared spectra are all making important contributions to FDA's increasing ability to protect consumers.

However, the most important recent step taken to prepare FDA to meet more adequately its responsibilities was the reorganization of the agency. This was the result of studies that have been made of the Food and Drug Administration by outside groups, such as the Second Citizens Advisory Committee, and by ourselves.

It is without doubt the most far-reaching reorganization that FDA has ever experienced in its over half century of existence. Chart 9 with the background material gives details about it.

Among other things, the reorganization does the following:

1. Upgrades FDA's scientific activities in a variety of ways. It provides for an Associate Commissioner responsible for the overall direction of FDA's medical and scientific activities and for representing the scientist at the highest level in important decisions and policies, and an Assistant Commissioner for Science Resources who serves as staff adviser for science communications, professional development, and extramural research.

2. Establishes three scientific bureaus. The Bureau of Medicine, relatively unchanged by the reorganization, will continue to provide expert medical evaluation to all FDA programs. We are fortunate to have Dr. Joseph F. Sadusk, Jr., reporting for duty on April 1, 1964, as our Medical Director. I submit for the record Dr. Sadusk's curriculum vitae.

Mr. FOUNTAIN. Without objection, that will become a part of the record.

(The press release announcing Dr. Sadusk's appointment and his curriculum vita follow:)

[For immediate release Feb. 25, 1964]

U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
OFFICE OF THE SECRETARY,

Washington, D.C.

Dr. Joseph F. Sadusk, Jr., has today been appointed Director of the Bureau of Medicine of the Food and Drug Administration, Commissioner George P. Larrick announced. His appointment will be effective April 1, 1964.

Dr. Sadusk will be on indefinite leave of absence from his present position with the George Washington University as chairman of the department of preventive medicine and community health, and director of the university clinics. He will continue his affiliation with the university's medical school as a professor and will teach on a limited basis.

A native of Baltimore and a graduate of Johns Hopkins University, Dr. Sadusk has also served on the faculties of the Yale University Medical School, the New York College of Medicine, and the Stanford Medical School.

Secretary of Health, Education, and Welfare Anthony J. Celebrezze said Dr. Sadusk's appointment was a "second major step" to strengthen medicine and science in the Food and Drug Administration.

"The Department has actively supported the FDA in its program to expand and improve its scientific functions," Secretary Celebrezze said. "The reorganization of FDA announced last November and now virtually completed was a first major step in this program.

"The appointment of Dr. Sadusk to be director of the Bureau of Medicine is a second major step. Dr. Sadusk will provide scientific and medical leadership of a high order at a crucial point of responsibility in FDA. His appointment not only will facilitate the consolidation of recent gains in FDA's operations but will enable FDA to strengthen still further its consumer protection activities."

Dr. Sadusk has served on the staff of New Haven Hospital, Connecticut; Bellevue Hospital, New York; and George Washington and Gallinger Hospitals, Washington, D.C. In California he was associate visiting physician at Stanford University Hospital and Presbyterian Medical Center in San Francisco, and staff physician at Peralta, Providence, and Merritt Hospitals in Oakland.

He has a long background in clinical investigations in tropical medicine and infectious diseases and, in these fields, has been consultant to the Department of Defense and the Veterans' Administration over a period of 20 years. He has contributed scores of articles to a number of medical journals and to medical textbooks in such fields as biochemistry, infectious and viral diseases, and medicolegal problems.

BIOGRAPHICAL DATA: JOSEPH FRANCIS SADUSK, JR., A.B., M.D.

1927-29: Loyola College (Baltimore).

1929-31: A.B., Johns Hopkins University.

1931-35: M.D., Johns Hopkins University School of Medicine.

1933-35: Henry Strong Denison Fellow in Physiological Chemistry.

HOUSE OFFICERSHIP TRAINING

1935-36: Resident house officer in medicine, Johns Hopkins Hospital.
1938-37: Resident house officer in obstetrics, Johns Hopkins Hospital.
1937-38: Assistant resident in medicine, New Haven Hospital.
1938-39: Assistant resident in obstetrics, Johns Hopkins Hospital.
1939-40: Resident in medicine, New Haven Hospital.

FACULTY POSITIONS

1937-38: Assistant in medicine, Yale University Medical School. 1938-39: Instructor in medicine, Yale University Medical School. 1939-42: Instructor in medicine, Yale University Medical School.

1946-47: Assistant professor of medicine, Yale University Medical School. 1947-48: Clinical instructor in medicine, New York University College of Medicine.

1948-49: Adjunct clinical professor of medicine, George Washington School of Medicine.

1949-58: Assistant clinical professor of medicine, Stanford Medical School. 1958-62: Associate clinical professor of medicine, Stanford Medical School. 1962-present: Professor and chairman, Department of Preventive Medicine and Community Health, George Washington University.

1962-present: Director of University Clinics, George Washington University Hospital.

HOSPITAL APPOINTMENTS

1940-42 and 1946-47: Associate visiting physican, New Haven Hospital. 1947-48: Assistant visiting physician, Bellevue Hospital (New York). 1948-49: Associate visiting physician, George Washington University and Gallinger Hospitals (Washington, D.C.).

1949-62: Visiting physician, Stanford-Lane Hospital and Stanford University Hospital (San Francisco-Palo Alto).

1959-62: Staff physician, Presbyterian Medical Center (San Francisco). 1949-62: Staff physician, Peralta, Providence, and Merritt Hospitals (Oakland). President, Peralta Hospital medical staff, 1958-59.

Member, board of trustees, Peralta Hospital, 1957-62.

Member, medical advisory board, Peralta Hospital, 1957-62.

1962-present: Staff physician, George Washington University Hospital. 1963-present: Consultant in infectious diseases, District of Columbia Children's Hospital.

1963-present: Consulting staff, Washington Hospital Center.

CONSULTANT POSITIONS

Consultant to Secretary of War, 1941-42.

Member, Commission on Pneumonia, Army Epidemiological Board, 1941-42. Consultant to Secretary of War, 1946-47.

Member, Commission on Viral and Rickettsial Diseases, Army Epidemiological Board, 1946-47.

Consultant in tropical medicine to Army Research and Post Graduate School, 1946-48.

Consultant in internal medicine, Laurel Heights Sanitarium, Shelton, Conn., 1946-47.

Consultant to Secretary of Defense, 1949-52.

Area consultant to Veterans' Administration in tropical medicine, 1955–61. Consultant in infectious diseases, Oakland VA hospital, 1949–62.

Consultant in tropical medicine, San Francisco VA hospital, 1955-61.

Chairman, Medical Advisory Committee, Oakland VA hospital.

Member, Civilian Health and Medical Advisory Council (Assistant Secretary of Defense for Manpower), 1961.

Executive Reserve (Secretary of Defense), U.S. Government, 1962-present.

GOVERNMENT POSITIONS AND AWARDS

U.S. Army, 1942-46, captain to colonel, Medical Corps.

1. Faculty, Army Medical School (Department of Bacteriology and School of Tropical Medicine), 1942.

2. Staff, Hawaiian Department (special assignment by Secretary of War), 1942-43.

3. United States of America Typhus Commission, executive officer, 1943-46. 4. Legion of Merit with Oak Leaf Cluster, 1943 and 1945.

5. United States of America Typhus Commission Medal, 1944.

Executive Director, Committee on Medical Sciences, Research, and Development Board, Secretary of Defense, 1945-59.

OTHER ADMINISTRATIVE

Associate medical director, Prudential Insurance Co. (organize employees health service), 1947-48.

PUBLICATIONS

Approximately 75 publications in medical journals and contributor to medical text books in the fields of biochemistry, infectious diseases, antisyphilitic therapy, viral and rickettsial diseases, and medicolegal problems.

MEDICAL SOCIETIES

Chairman, Committee on Medical Practice, Alameda-Contra Costa County Medical Association, 1950-55.

Chairman, Medical Review and Advisory Board, California Medical Association, 1954-58.

Member and chairman (1962), Committee on Medicolegal Problems, American Medical Association, 1956 to present.

Chairman, American Medical Association-American Hospital Association Committee on Medicolegal Education, 1957-59, member 1959 to present.

Member, American Medical Association Liaison Committee with American Bar Association, 1960 to present.

Member, Committee on Insurance, American College of Physicians, 1958 to present.

Member, board of trustees, American College of Physicians group life insurance plan, 1960 to present.

Various other committees of Alameda-Contra Costa Medical Association 1950-62. Chairman, Committee on Medicolegal Education, Medical Society of the District of Columbia, 1963 to present.

MEDICAL SOCIETY MEMBERSHIPS

Fellow of American College of Physicians.
American Society for Clinical Investigation.
American Federation for Clinical Research.
American Society of Tropical Medicine.

American Public Health Association.

American Medical Association and other State and county medical societies (Connecticut, New Jersey, California, and District of Columbia).

American Society of Internal Medicine.

Association of American Medical Colleges.

California Society of Internal Medicine (president 1961-62); honorary life member 1962 to present.

District of Columbia Society of Internal Medicine.

Tropical Medicine Association of Washington, D.C.

Academy of Medicine of Washington, D.C.

American Thoracic Society.

INTERNAL MEDICINE

1944: Certified by American Board of Internal Medicine. 1949-62: Practice of internal medicine, Oakland, Calif.

STATES LICENSED TO PRACTICE

California, Connecticut, District of Columbia, Maryland, New Jersey, New York..

CLUBS

The 100 Club (Oakland), 1953 to present (president 1960–61).
Cosmos Club (Washington, D.C.), 1962 to present.

Mr. LARRICK. A Bureau of Scientific Research is responsible for broad and long-range research and for the development of expertise in a number of scientific disciplines necessary for the support of FDA's various activities. A Bureau of Scientific Standards and Evaluation is responsible for pharmacological review and evaluation of industry proposals related to drugs, for pharmacological and chemical review with regard to pesticides, food additives, et cetera, and for the certification of antibiotics, insulin, and colors.

3. Facilitates coordination and leadership by the Office of the Commissioner by removing from this Office and reassigning elsewhere programs and operational workloads.

4. Improves long range and policy planning.

5. Places us in a better position to help industry meet the requirements of the law voluntarily.