Frances Oldham Kelsey Papers [Finding Aid]. Library of Congress

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Frances Oldham Kelsey Papers

A Finding Aid to the Collection in the Library of Congress

Manuscript Division, Library of Congress Washington, D.C. 2016

Contact information: http://hdl.loc.gov/loc.mss/mss.contact

Additional search options available at: http://hdl.loc.gov/loc.mss/eadmss.ms009300

LC Online Catalog record: http://lccn.loc.gov/mm97084006

Prepared by T. Michael Womack with the assistance of Sherralyn McCoy Revised and expanded by Melinda K. Friend with the assistance of Sherralyn McCoy Collection Summary Title: Frances Oldham Kelsey Papers Span Dates: 1890-2016 Bulk Dates: (bulk 1950-2000) ID No.: MSS84006 Creator: Kelsey, Frances Oldham, 1914-2015 Extent: 78,000 items; 253 containers plus 4 oversize; 101.4 linear feet; 103 digital files (3.7MB) Language: Collection material in English Location: Manuscript Division, Library of Congress, Washington, D.C. Summary: Pharmacologist and government official. Correspondence, memoranda, research files, subject file, biographical material, laboratory notebooks and notes, reports and studies, academic material, press releases and clippings, speeches, statements, testimonies, articles and other writings, memorabilia, printed matter, financial records, family and estate papers, reminiscences, card indexes, patient files and records, photographs, microfiche, digital files, and other papers chronicling Kelsey's career as a pharmacologist and instructor at the University of Chicago in Illinois and the University of South Dakota in Vermillion, and as a regulator investigating new drugs at the United States Food and Drug Administration.

Selected Search Terms The following terms have been used to index the description of this collection in the Library's online catalog. They are grouped by name of person or organization, by subject or location, and by occupation and listed alphabetically therein. People Geiling, E. M. K. (Eugene Maximilian Karl), 1891- Essentials of pharmacology. 1947. Kelsey, F. E. (Fremont Ellis). Essentials of pharmacology. 1947. Kelsey, F. E. (Fremont Ellis). F.E. Kelsey files. 1939-1968. Kelsey, Frances Oldham, 1914-2015. Kelsey, Frances Oldham, 1914-2015. Essentials of pharmacology. 1947. Swann, John Patrick, 1956- Organizations American Medical Association. National Institutes of Health (U.S.) United States. Food and Drug Administration. United States. Food and Drug Administration. Bioresearch Monitoring Program. United States. Food and Drug Administration. Division of Scientific Investigations. United States. Surgeon-General's Office. University of Chicago--Faculty. University of South Dakota--Faculty. Subjects Civil service--Awards--United States. Drugs--Law and legislation--United States. Drugs--Testing--United States. Fraud in science. Laboratories--Quality control. Medicine--Research. Pharmaceutical policy--United States. Pharmacology. Quacks and quackery. Teratology. Thalidomide. Occupations Pharmacologists.

Frances Oldham Kelsey Papers 2 Public officials.

Administrative Information Provenance The papers of Frances Oldham Kelsey, pharmacologist and government official, were transferred to the Library of Congress in 1997 by the United States Food and Drug Administration under the instructions of Kelsey. Two later editions were transferred from the United States Food and Drug Administration by John Patrick Swann in 2003. Additions from Kelsey's daughters, Susan Duffield and Christine Kelsey, were received in 2012 and 2016. Processing History The papers of Frances Oldham Kelsey were arranged and described in 1998. The finding aid was revised in 2009. Additional material received between 2003 and 2016 was processed as Part II in 2016. Transfers Items have been transferred from the Manuscript Division to other custodial divisions of the Library. Sound recordings and a DVD have been transferred to the Motion Picture, Broadcasting, and Recorded Sound Division. Some photographs have been transferred to the Prints and Photographs Division. All transfers are identified in these divisions as part of the Frances Oldham Kelsey Papers. Copyright Status Copyright in the unpublished writings of Frances Oldham Kelsey in these papers and in other collections of papers in the custody of the Library of Congress has been dedicated to the public. Access and Restrictions Restrictions apply governing the use, photoduplication, or publication of items in this collection. Consult reference staff in the Manuscript Division for information concerning these restrictions. In addition, many collections are stored off-site and advance notice is needed to retrieve these items for research use. Digital Format Digital files were received as part of the papers of Frances Oldham Kelsey. Reference copies were created from the original digital media. Advanced notice is required for access to digital content; consult reference staff in the Manuscript Division for more information. Preferred Citation Researchers wishing to cite this collection should include the following information: Container number or digital ID number, Frances Oldham Kelsey Papers, Manuscript Division, Library of Congress, Washington, D.C.

Biographical Note Date Event 1914, July 24 Born, Cobble Hill, Vancouver Island, British Columbia, Canada

1934 B.Sc., McGill University, Montreal, Quebec, Canada

1935 M.Sc., McGill University, Montreal, Quebec, Canada

1938 Ph.D., Pharmacology, University of Chicago, Chicago, Ill.

Frances Oldham Kelsey Papers 3 1938-1950 Instructor, University of Chicago, Chicago, Ill., conducting advanced research in pharmacology; assistant professor, 1946-1950

circa 1941-circa 1946 Civilian, Office of Scientific Research and Development, Malaria Research Program, conducting studies related to the chemotherapy of malaria

1943 Married Fremont Ellis Kelsey (died 1966)

1947 Published with F. E. Kelsey and E. M. K. Geiling Essentials of Pharmacology. Philadelphia: Lippincott; 2nd edition, 1951; 3rd edition, 1955; 4th edition, 1960

1950 M.D., University of Chicago, Chicago, Ill.

1950-1952 Editorial associate, Journal of the American Medical Association, American Medical Association, Chicago, Ill.

1953-1954 Intern, Sacred Heart Hospital, Yankton, S. Dak.

1954-1957 Associate professor of pharmacology, University of South Dakota, Vermillion, S. Dak. Recipient, Lederle Medical Faculty Award

1956 Became a United States citizen

1957-1960 Private medical practice, Vermillion, S. Dak.

1960-1963 Medical officer, Bureau of Medicine, United States Food and Drug Administration

1962 Recipient, President's Award for Distinguished Federal Civilian Service for refusal to approve commercial distribution of thalidomide in the United States

1963-1966 Medical officer, Investigational Drug Branch, Division of New Drugs, Bureau of Medicine, United States Food and Drug Administration

1965 Inducted into National Women's Hall of Fame, New York World's Fair, New York, N.Y.

1966-1967 Director, Division of Oncology and Radiopharmaceutical Drug Products, Office of New Drugs, Bureau of Medicine, United States Food and Drug Administration

1967-1968 Assistant to the director for Scientific Investigations, Bureau of Medicine, United States Food and Drug Administration

1968-1971 Director, Division of Scientific Investigations, Office of Medical Support, Bureau of Medicine, United States Food and Drug Administration

1971-1977 Director, Scientific Investigations Staff, Office of Scientific Evaluation, Bureau of Drugs, United States Food and Drug Administration

1977-1982 Director, Division of Scientific Investigations, Office of Scientific Evaluation, Bureau of Drugs, United States Food and Drug Administration

Frances Oldham Kelsey Papers 4 1982-1987 Director, Division of Scientific Investigations, Office of Compliance, Center for Drugs and Biologics, United States Food and Drug Administration

1987-1995 Director, Division of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration

1995-200? Deputy for Scientific and Medical Affairs, United States Food and Drug Administration

2000 Inducted into National Women's Hall of Fame, Seneca Falls, N.Y.

2005 Retired from United States Food and Drug Administration

2010 Recipient, first Drug Safety Excellence Award, United States Food and Drug Administration; award renamed The Dr. Frances O. Kelsey Drug Safety Excellence Award

2014 Moved to London, Ontario, Canada

2015 Named to the Order of Canada

2015, Aug. 7 Died, London, Ontario, Canada

Scope and Content Note Introduction The papers of Frances Oldham Kelsey (1914-2015) span the years 1890-2016, with the bulk of the items concentrated between 1950 and 2000. The collection consists of two parts. Part I covers Kelsey's career as a pharmacologist and government official at the United States Food and Drug Administration (FDA), primarily from 1960 to 1990. Part II comprises the bulk of the collection and documents Kelsey career in pharmacolgy before and during her years at the FDA. Further descriptions of each part follow. Excisions of information from some of the documents in the collection were carried out by the FDA. Part I Part I of the papers spans the years 1913-1998, with the bulk of the items concentrated in the period between 1960 and 1990. Part I includes Kelsey's files created during her work as a pharmacologist and government official at the FDA and consists of three series: Office File , Speeches and Writings File , and Research File . Included in the papers are biographical material, correspondence, memoranda, speeches, editorials, background information and chapter drafts for a book, reports and statements, studies, press releases, newspaper and magazine clippings, reprints of articles, proceedings of hearings, research files, and other material pertaining to Kelsey's career as a researcher and regulator of investigational new drugs at the FDA. The Office File consists of general correspondence and other material of an administrative nature documenting Kelsey's activities at the FDA primarily during the 1960s. The file of biographical material in particular contains information regarding Kelsey's receipt of the President's Award for Distinguished Federal Civilian Service in 1962 for her refusal to approve the commercial distribution of thalidomide in the United States. Following the thalidomide controversy, Kelsey was much sought after as a public speaker. Correspondence regarding invitations to speak documents her numerous engagements. Kelsey's work as an investigator is reflected by her office memoranda and by memoranda for the record which summarize her participation in conferences, interviews, telephone conversations, and other interactions. Detailed trip reports chronicle her participation in national and international conferences on pharmacology and related fields. The historical file in the series consists of photocopies of memoranda written between 1994 and 1997 by Kelsey during the process of transferring her files to John Patrick Swann, historian at the FDA, where the collection was originally housed. Scattered throughout the papers attached to the respective item or items described, the original memoranda range in length

Frances Oldham Kelsey Papers 5 from a sentence to three pages and describe single items as well as whole batches of material. By bringing the photocopies of the memoranda together into one location, the historical file constitutes a collection of Kelsey's reflections on her long career at the FDA. It provides valuable information on current scientific research and development, the discovery of new drugs and therapies and their effects, prominent individuals in the field, controversies within the pharmaceutical industry as well as the FDA, and day-to-day issues encountered at the workplace. The Speeches and Writings File consists primarily of interviews, speeches, background information and chapter drafts for a book, editorials, and articles by others. Kelsey's activity as a public speaker over a thirty-year period is chronicled in the speeches file. During the early 1960s, she frequently spoke on the drug thalidomide. Other topics include promising new cures for diseases, quack remedies, and the tension between the desire of pharmaceutical companies to release new drugs on the market as quickly as possible and the regulatory mechanism of the FDA in demanding stringent drug testing. Essentials of Pharmacology, coauthored with E. M. K. Geiling and F. E. Kelsey, her husband, is represented by numerous folders of background information and drafts of chapters eight and nine. The editorials file consists primarily of brief scientific articles written by Kelsey while an editorial associate with the American Medical Association in Chicago during the early 1950s. The Research File constitutes the largest section of material in the collection. Many of the files reflect Kelsey's research on various new drugs undergoing the regulatory process for FDA approval, such as Avazyme, Bamfolin, Daroil, Fluorouracil, Librium, Parotin, Ritalin, Triparanol, and Vesprin. Kelsey's participation on numerous committees is also documented. The computerization of scientific information during the early 1960s is reflected in the files on the National Library of Medicine and Arthur D. Little, Inc., regarding its proposal to establish an integrated agency-wide scientific information system. The material on DES (diethylstilbestrol), DMSO (dimethyl sulfoxide), and thalidomide is quite extensive and reflects the considerable attention given these controversial drugs by Kelsey. The subject of quackery appears throughout the Research File. Controversies in the field of new drug research are reflected in the files on Emanuel Revici concerning selenium diethyl dithiocarbonate (SDD) as a treatment for cancer, on William K. Summers's promotion of tetrahydroaminoacridine (THA) (Tacrine) as a treatment for Alzheimer's disease, and on Henry Turkel's request for approval of "U" series drugs as a treatment for cancer. Folders under the heading investigational new drugs (INDs) relate to congressional legislation primarily resulting from Senator Estes Kefauver's investigations in the early 1960s. Files on congressional hearings feature the involvement of various congressional committees in reviewing and overseeing the FDA in its capacity as guarantor of the purity and efficacy of the nation's drugs. These files reflect the growing change in public attitude regarding the ethics of drug testing on selected sections of the population who often had little or no control over their involvement in new drug trials which could frequently prove life-threatening. Subject studies in vulnerable populations constitute a large section of material in the series. The testee categories include fetuses, infants, children, geriatrics, prisoners, and women of childbearing potential. The Kelsey Papers also contain numerous reports documenting studies and research which had significant effects upon the drug regulatory process in the United States during the second half of the twentieth century. Part II Part II of the papers spans the years 1890-2016, with the bulk of the items concentrated in the period from 1950 to 2000. Part II includes Kelsey's files covering her career in pharmacology before and during her years at the FDA. The papers are organized into the following series: Correspondence , Personal File , Office File , Speeches and Writings File , Subject File , F. E. Kelsey Files , Oversize , and Digital Files The Correspondence contains mostly incoming letters to Kelsey from friends, colleagues, organizations, and the public. Letters sent by friends, who address Kelsey as "Frankie" and her husband as "Ellis," often discuss everyday life, current events, and persons known to both. The largest amount of correspondence relates to thalidomide, with the bulk received in 1962, as the public and others thanked Kelsey for her refusal to approve the commercial distribution of thalidomide in the United States. She continued to receive such letters for the remainder of her career. Further correspondence from friends and colleagues is located in the Personal File . The Personal File includes biographical material, family and estate papers, and files kept by Kelsey while at the University of Chicago in Illinois and in South Dakota at the University of South Dakota in Vermillion, the Yankton State Hospital in Yankton, and her private medical practice. The biographical material includes awards and certificates, biographical sketches, curricula vitae, a large file of clippings either about or mentioning Kelsey, and material from her school days in Canada. The family and estate papers include correspondence and other material related to the death of her husband, F. E.

Frances Oldham Kelsey Papers 6 Kelsey, and her administration of the estate of her mentor and friend E. M. K. Geiling. Under the tutelage of Geiling at the University of Chicago, Kelsey conducted advanced research in pharmacology, the posterior pituitary, and also worked on a synthetic cure for malaria. The research file, comprised mostly of article reprints involving research on pituitary and thyroid glands, seems to have been kept jointly by Geiling and Kelsey. At the University of South Dakota medical school, Kelsey carried out research involving thyroid disease, radioisotopes, and the relation of thyroid disorders to mental illness. The Office File consists of a chronological file and other material of an administrative nature documenting Kelsey's activities at the FDA primarily from 1967 to 2000. The chronological file probably served as a central file and contains copies of outgoing correspondence and memoranda. Unfiled correspondence and memoranda that may have been intended for the chronological file are located in the Subject File of Part II under miscellany. The historical file created in the Part I: Office File series was discontinued in Part II with the memoranda kept in place throughout the collection. However, Kelsey's chronological file of some of these memoranda is contained under the heading of John Patrick Swann. The Speeches and Writings File consists of interviews, speeches, speaking engagements, background information for a book, articles, editorials, and book reviews. Interviews are interspersed throughout the speaking engagements with the two conducted by the FDA at the beginning of the series. Kelsey's speeches cover many of the same topics found in Part I, but also treat drug laws and legislation, FDA policies and regulations, drug testing on humans, clinical investigators and investigations, good clinical practices, good laboratory practices, and teratogenic drugs and substances that can disturb embryonic or fetal development leading to birth defects or pregnancy termination. Not every folder in the speaking engagements contains a speech. Her articles, some coauthored with F. E. Kelsey, reflect her involvement with research and pharmacology throughout her career. The book reviews, editorials, and the Queries and Minor Notes/Questions and Answers section pertain to Kelsey's years as an editorial associate for the Journal of the American Medical Association in Chicago during the 1950s. Files relating to Essentials of Pharmacology also appear in Part II with the arrangement of the background information still correlating to different chapters in the book. While again covering chapters 1 through 20, the files do not contain material for chapters 3, 4, 13, and 14. Additional files, however, include material for chapters 21 through 34. The appearance of later material in the background information indicates that Kelsey continued interfiling into it past the final publication of the book in 1960. It should be noted that many of the chapter topics also appear as topics in the Subject File . The Subject File constitutes the largest amount of material in the papers and covers many of the same topics, persons, and organizations found in Part I: Research File and other series. Kelsey's files as director of the Division of Scientific Investigations at the FDA include the Bioresearch Monitoring Program, clinical evaluations, clinical investigations and investigators, drug laws and legislation, drug testing, FDA policies and regulations, fraud in science, good clinical practices, good laboratory practices, institutional review boards, investigational new drugs, methadone monitoring, new drug applications, radioactive drug research, teratology, and thalidomide. The historical material is comprised of files marked by Kelsey as "mostly historical," but also includes drug legislation, federal regulations, reminiscences about and articles by FDA personnel, clippings, and other material chronicling the history of the FDA. Under the heading of miscellany, the chronological material consists of unfiled correspondence and memoranda that may have been intended for the chronological file in the Office File . Clippings are comprised of unfiled articles probably intended for various topics located in the Subject File and in the Speeches and Writings File under Essentials of Pharmacology. The extensive files on thalidomide contain material dating from the 1960s to the 2000s and include correspondence, studies, articles, clippings, early press coverage of Kelsey, reports, inspections, exhibits, and legal case material including Kelsey's testimony and memorandum. The F. E. Kelsey Files were compiled by Kelsey's husband while he worked at the National Institutes of Health in Washington, D.C., and as assistant to the surgeon general. Material under the heading of miscellany is comprised of unfiled items arranged chronologically. Some correspondence, writings, and other material related to F. E. Kelsey is located in the Personal File under the headings of South Dakota and University of Chicago. Part II is rounded out by an Oversize series consisting of awards, certificates, citations, diplomas, card indexes, a menu, a map, memoranda, and a broadside. The Digital Files contain mostly Kelsey's memoranda to John Patrick Swann, drafts of her performance plans, and the 1995 annual report of the Office of Compliance. There is also a smattering of lists, speeches, notes, forms, article abstracts, correspondence, and writings by Aya Collins.

Frances Oldham Kelsey Papers 7 Arrangement of the Papers This collection is arranged in two parts and eleven series: • Part I: Office File, 1960-1997 • Part I: Speeches and Writings File, 1913-1993 • Part I: Research File, 1917-1998 • Part II: Correspondence, 1932-2015 • Part II: Personal File, 1890-2016 • Part II: Office File, 1959-2003 • Part II: Speeches and Writings File, 1929-2010 • Part II: Subject File, 1902-2012 • Part II: F. E. Kelsey Files, 1939-1968 • Part II: Oversize, 1934-2012 • Part II: Digital Files, 1991-1997

Frances Oldham Kelsey Papers 8 Description of Series

Container Series BOX I:1-I:4 Part I: Office File, 1960-1997 Biographical material, correspondence, memoranda, a file of memoranda for the record describing portions of the collection, and trip reports. Arranged alphabetically by type of material and thereunder chronologically.

BOX I:4-I:10 Part I: Speeches and Writings File, 1913-1993 Interviews, speeches, background information, drafts of a book, editorials, and miscellaneous writings by Kelsey and others. Organized according to authorship by Kelsey or others and thereunder by type of material or file.

BOX I:11-I:35 Part I: Research File, 1917-1998 Correspondence, memoranda, reports, statements, studies, proposals, reviews, guidelines, reprints of articles, newspaper and magazine clippings, press releases, testimonies, minutes, and printed matter. Arranged alphabetically by subject, name of person or organization, or type of material and thereunder chronologically.

BOX II:1-II:13 Part II: Correspondence, 1932-2015 Mostly incoming correspondence, including attachments, from friends, colleagues, organizations, and the public relating to personal and professional activities. Arranged chronologically by date.

BOX II:13-II:41 Part II: Personal File, 1890-2016 Correspondence, biographical information, clippings, awards and diplomas, academic material, memorabilia, patient files and records, laboratory notebooks, estate papers, financial records, research file, printed matter, subject files, card indexes, reminiscences, photographs, and a drawing book and sketches. Arranged alphabetically by name of person or organization, topic, location, or type of material and thereunder alphabetically or chronologically.

BOX II:41-II:57 Part II: Office File, 1959-2003 Correspondence, memoranda, chronological file, financial disclosures, performance plans and appraisals, trip reports, address file, personnel folder, staff lists, and notes. Arranged alphabetically by name of person, type of material, or topic and thereunder alphabetically or chronologically.

BOX II:57-II:95 Part II: Speeches and Writings File, 1929-2010 Correspondence, interviews, speeches, articles, backgound information for a book, dissertation, editorials, book reviews, illustrations, drafts, page proofs, printed matter, photographs, and miscellaneous writings by Kelsey and others. Organized according to authorship by Kelsey or others and thereunder by type of material or file.

Frances Oldham Kelsey Papers 9 Arranged alphabetically by subject, name of person or organization, or type of material and thereunder chronologically.

BOX II:210-II:218 Part II: F. E. Kelsey Files, 1939-1968 Correspondence, memoranda, subject file, testimony, personal file, writings, reports, grants, surveys, and printed matter. Arranged alphabetically by type of material or topic and thereunder alphabetically or chronologically.

II:OV 1-II:OV 4 Part II: Oversize, 1934-2012 Awards, certificates, citations, diplomas, card indexes, a menu, a map, memoranda, and a broadside. Arranged and described according to the series, containers, and folders from which the items were removed.

DF 1 Part II: Digital Files, 1991-1997 Text files consisting of memoranda, performance plans, lists of meetings and speeches, speeches, an annual report, notes, forms, article abstracts, correspondence, and writings by Aya Collins. The material is in WordPerfect document files with one Microsoft Word file. The series comprises 103 files and 3.7 MB of data. Preserved as received and no arrangement or reorganization of the files occurred.

Frances Oldham Kelsey Papers 10 Container List

Container Contents

BOX I:1-I:4 Part I: Office File, 1960-1997 Biographical material, correspondence, memoranda, a file of memoranda for the record describing portions of the collection, and trip reports. Arranged alphabetically by type of material and thereunder chronologically.

BOX I:1 Biographical material, 1960-1967, 1973, 1995 BOX I:1 General correspondence BOX I:1 1962-1968 (8 folders) BOX I:2 1971-1996 (6 folders) BOX I:2 Historical file, 1994-1997, undated (2 folders) BOX I:2 Invitations to speak BOX I:2 Accepted BOX I:2 1962 BOX I:2 1963 BOX I:2 Jan.-June BOX I:3 Aug.-Dec. BOX I:3 1964-1967 (5 folders) BOX I:3 Declined BOX I:3 1962-1963 BOX I:4 1964-1967 (2 folders) BOX I:4 Memoranda BOX I:4 Conferences, 1966-1967 BOX I:4 Interviews, 1966-1967 BOX I:4 Miscellaneous, 1962-1966 BOX I:4 Office, 1965-1967, 1973-1974 BOX I:4 Telephone conversations, 1965-1967 BOX I:4 Trip reports, 1963-1994

BOX I:4 By Kelsey BOX I:4 Interviews, 1962-1963 BOX I:4 Speeches BOX I:4 List

Frances Oldham Kelsey Papers 11 Part I: Speeches and Writings File, 1913-1993 Container Contents

BOX I:4 Nos. 1-35, 1963-1967 (5 folders) BOX I:5 Nos. 36-91, 1967-1982 (13 folders) BOX I:6 Nos. 92-132, 1982-1993 (9 folders) BOX I:6 Miscellaneous, 1960-1968, 1985 BOX I:6 Writings BOX I:6 Book, Essentials of Pharmacology BOX I:6 Outline, undated BOX I:6 Background information BOX I:6 Chapter 1, 1913-1990, undated (2 folders) BOX I:7 Chapters 2-6, 1930-1992, undated (7 folders) BOX I:8 Chapters 7-10, 1945-1993, undated (7 folders) BOX I:9 Chapters 11-19b, 1945-1992, undated (11 folders) BOX I:10 Chapter 20, 1950-1992, undated (2 folders) BOX I:10 Draft, chapters 8-9, undated (2 folders) BOX I:10 Editorials, 1950-1962, undated (3 folders) BOX I:10 Miscellany, 1962-1968, undated BOX I:10 By others, articles, 1945, 1957-1991, undated (3 folders)

BOX I:11 714X (Drug), United States v. Pixley, 1996 BOX I:11 Abel, John Jacob, biographical material, 1917-1968, undated BOX I:11 Actinomycin C, 1963 BOX I:11 Adrenocorticoids, undated BOX I:11 Adverse Drug Effects Advisory Panel, 1975-1976, undated BOX I:11 Adverse reaction reporting, 1955-1961, 1986-1988, undated BOX I:11 Aldactone, 1975-1979 BOX I:11 Aldomet, 1961, undated BOX I:11 Ambodryl hydrochloride compound, 1961, undated BOX I:11 American Arbitration Association, proposal for ethical review of investigational new drug studies, 1973-1974 BOX I:11 American College of Neuropsychopharmacology, 1977

Frances Oldham Kelsey Papers 12 Part I: Research File, 1917-1998 Container Contents

BOX I:11 Arnold, John D., ethical problems of human experimentation in clinical drug trials, 1975-1988 BOX I:11 Arthur D. Little, Inc., establishment of an integrated agency-wide scientific information system at the U.S. Food and Drug Administration, 1962-1965, undated (2 folders) BOX I:11 Avazyme, 1960-1962, undated BOX I:11 Bamfolin, 1964 BOX I:12 Bendectin, 1979-1981, 1998, undated (3 folders) BOX I:12 Benoxaprofen, 1984 BOX I:12 Billings, John Shaw, National Library of Medicine centennial, 1965 BOX I:12 Bismuth sodium triglycollamate (Bistrimate), 1960-1966, undated BOX I:12 Bureau of Drugs, U.S. Food and Drug Administration, 1971-1973, undated BOX I:12 Chelation therapy, 1973-1985, undated BOX I:12 Chloramphenicol, 1961-1968, undated BOX I:12 Chlordiazepoxide hydrochloride, 1962, undated BOX I:12 Committees BOX I:12 Advisory Committee on Investigational Drugs BOX I:12 1962-1964 BOX I:13 1964-1966, undated (2 folders) BOX I:13 Advisory Committee on Protocols for Safety Evaluations, 1966-1967, undated BOX I:13 Advisory Committee on Psychotomimetic Drugs, 1960-1968, undated BOX I:13 Citizens Committee, 1960-1962, undated BOX I:13 Research Involving Human Subjects Committee, 1970-1990 BOX I:13 Congressional hearings BOX I:13 House of Representatives BOX I:13 Dingell, John D., investigation into acceptance of subsidized accommodations and related items by U.S. Food and Drug Administration officials, 1989 BOX I:13 Fountain, L. H. (Lawrence), U.S. Food and Drug Administration's oversight of investigational new drugs BOX I:13 1963-1966 (2 folders) BOX I:14 1966-1969, undated BOX I:14 Gore, Albert (1948- ), ethics in biomedical research, 1981 (3 folders) BOX I:14 Kastenmeier, Robert W., subject studies in vulnerable populations--prisoners, 1973-1975, 1981 (2 folders) BOX I:14 Senate BOX I:14 Kefauver, Estes, investigation of drug industry, 1917, 1960-1962, undated BOX I:15 Kennedy, Edward M., subject studies in vulnerable populations--prisoners, 1962-1978, undated (4 folders) BOX I:15 Kennedy, Robert F., LSD (Drug), 1966-1969 BOX I:15 Cumid, 1962, undated BOX I:15 Cyclert, 1961-1962, undated BOX I:15 Daroil, 1964-1966

Frances Oldham Kelsey Papers 13 Part I: Research File, 1917-1998 Container Contents

BOX I:15 De Haen, Paul, reports on new pharmaceutical products, 1963-1971 (2 folders) BOX I:15 Decadron, 1961-1962, undated BOX I:15 Defoliants and herbicides, 1969-1971, 1996, undated BOX I:16 DES (Drug) BOX I:16 Correspondence, 1950-1978 BOX I:16 Memoranda, 1970-1978 BOX I:16 Miscellany, 1950-1978, undated BOX I:16 Press releases, 1972 BOX I:16 Printed matter, 1948-1985, undated (2 folders) BOX I:16 Reports and statements, 1972-1979, undated BOX I:16 Task force, 1978 BOX I:16 Diapulse device, 1967, 1995 BOX I:16 Dihydrostreptomycin (DHSM), 1953, 1962, undated BOX I:16 Division of Biologics Standards, U.S. Food and Drug Administration, 1972-1976 BOX I:16 Division of Scientific Investigations, U.S. Food and Drug Administration, 1964, 1985-1987, undated BOX I:16 DMSO (Drug) BOX I:16 Bibliography, 1964 BOX I:16 Correspondence, 1965-1967, 1980-1981 (2 folders) BOX I:17 Leake, Chauncey Depew, consulting editor, Biological Actions of Dimethyl Sulfoxide, 1967 BOX I:17 McGrady, Pat, The Persecuted Drug: The Story of DMSO, 1980 BOX I:17 Memoranda BOX I:17 Conferences, 1965, 1980-1981 BOX I:17 Miscellaneous, 1965-1966, 1980-1981 BOX I:17 Office, 1964-1988 (2 folders) BOX I:17 Telephone conversations, 1965-1980 BOX I:17 Miscellany, 1965, undated BOX I:17 Press releases, 1964-1981 BOX I:18 Printed matter, 1965-1982, undated (2 folders) BOX I:18 Reports and statements, 1965-1966, undated BOX I:18 Subcommittee on Health and Scientific Research, Senate Committee on Labor and Human Resources, hearing and exhibits, 1980, undated BOX I:18 Dornwal, 1961-1964, undated BOX I:18 Drug efficacy study, National Academy of Sciences-National Research Council, 1969, undated BOX I:18 Drug Research Board, National Academy of Sciences-National Research Council, 1965 BOX I:18 Dyes, 1936, 1960-1989, undated BOX I:18 Elavil, 1961-1963, undated BOX I:18 Equal rights for women in the federal government, 1962-1972 BOX I:18 Estrogenic substances in plants, 1959, undated BOX I:19 Fluoridation, 1960-1979, 1990, undated (4 folders) BOX I:19 Fluorouracil, 1961-1962, undated

Frances Oldham Kelsey Papers 14 Part I: Research File, 1917-1998 Container Contents

BOX I:19 Furaltadone (Altafur), 1961 BOX I:19 Galega, 1965-1967 BOX I:19 Gestest, 1961, undated BOX I:19 Hi and Dry (cream deodorant), 1961, undated BOX I:19 Hypertension, 1961-1962, undated BOX I:19 International Clearinghouse for Birth Defects Monitoring Systems, 1972-1978, undated BOX I:19 Investigational Drug Branch, U.S. Food and Drug Administration, 1966 BOX I:19 Investigational new drugs (INDs) BOX I:19 Adverse comments, Division of Toxicological Evaluation, 1966 BOX I:19 Comments on regulatory procedures, 1961-1975, undated (2 folders) BOX I:20 Division of Oncology and Radiopharmaceutical Drug Products, U.S. Food and Drug Administration, 1966-1967 BOX I:20 Inventory of early INDs, 1963 BOX I:20 Proposed regulations and revisions, 1938, 1962-1975, undated BOX I:20 Regulatory language, series form paragraphs, undated BOX I:20 Treatment, 1981-1990 (2 folders) BOX I:20 Kevadon See Container I:33 , Kevadon literature BOX I:20 Krebiozen, 1959-1982, undated BOX I:20 Lactostat and climacterin, 1961-1962, undated BOX I:21 Laetrile, 1967-1983, undated (5 folders) BOX I:21 Lavema, 1961, undated BOX I:21 Leake, Chauncey Depew BOX I:21 Obituary, 1978 BOX I:21 "Preserving Our Science Archives," Science, 1960 BOX I:21 Lentran, 1961-1962, undated BOX I:21 Ley, Herbert L., testimony regarding drug testing problems and the role of the U.S. Food and Drug Administration, 1969 BOX I:21 Librium, 1961-1962, undated BOX I:21 Lin, Chíao-chih, and other Chinese physicians on tour in the United States, 1945, 1972 BOX I:21 Listica, 1960-1962, undated BOX I:21 Lithium, 1966 BOX I:21 LSD (Drug), 1994 BOX I:21 Medical Fluid 360, 1966 BOX I:21 Megazyme, 1962, undated BOX I:22 Mental Health Law Project (phenothiazines in institutions), 1964-1974 BOX I:22 Meprobamate, 1958-1966 BOX I:22 Merital, 1986-1990 (2 folders) BOX I:22 Methotrexate, 1961 BOX I:22 Miscellany, 1963-1996, undated BOX I:22 MK 665 (Drug), 1966 BOX I:22 Monase, 1960-1963, undated BOX I:22 Myosed, 1961-1962, undated

Frances Oldham Kelsey Papers 15 Part I: Research File, 1917-1998 Container Contents

BOX I:22 National Center for Drugs and Biologics, U.S. Food and Drug Administration, 1972, 1983-1984 BOX I:22 National Library of Medicine, Bethesda, Md., computerization of scientific information, 1961-1964 BOX I:22 New drug applications (NDAs), U.S. Food and Drug Administration BOX I:22 Logs, 1957-1961 (2 folders) BOX I:23 Reviews, 1963 BOX I:23 New Drug Branch, U.S. Food and Drug Administration, 1960 BOX I:23 Nicotinamide adenine dinucleotide (NAD), 1966-1968, 1989 BOX I:23 Nitrogen mustards, undated BOX I:23 Nobrium, 1956-1962, undated BOX I:23 Norlutin, 1961, undated BOX I:23 Ocular Drug Toxicities Symposium, Bethesda, Md., 1966-1971 BOX I:23 Orphan drugs, 1977-1992 BOX I:23 Parotin, 1963 BOX I:23 Patient package inserts, 1969-1990, undated (2 folders) BOX I:23 Potassium thiazide, 1964-1965, undated BOX I:23 Practolol, 1980 BOX I:23 Preludin, 1957-1962, undated BOX I:23 Prescribing authority for pharmacists, 1983 BOX I:23 Prescription drug labeling, 1969-1990, undated BOX I:23 Procaine with polyvinylpyrrolidone (PVP) BOX I:23 1964-1980 BOX I:24 1983-1986, undated (2 folders) BOX I:24 Prodilidine, 1961-1962, undated BOX I:24 Progonasyl, 1971-1973 BOX I:24 Propoquin, 1962, undated BOX I:24 Quackery BOX I:24 1954-1988 (4 folders) BOX I:25 1989-1992, undated (2 folders) BOX I:25 Radiochromate injection, 1961, undated BOX I:25 Radio-rose bengal, 1961-1962, undated BOX I:25 Ramps (Campanula rapunculus), 1969-1977 BOX I:25 Rand cancer vaccine, 1966-1967 BOX I:25 Rectalad, undated BOX I:25 Reports BOX I:25 Annual reports, Center for the Study of Drug Development, 1985-1987 BOX I:25 Checks and balances in the practice of medicine and pharmacy: issues in prescribing and dispensing drugs, Medicine In the Public Interest, 1988 BOX I:26 Commissioner's report of investigation of charges, joint hearings, Subcommittee on Health, Labor and Public Welfare Committee; Subcommittee on Administrative Practice and Procedure, Judiciary Committee, U.S. Senate (15-16 August 1974), 1975

Frances Oldham Kelsey Papers 16 Part I: Research File, 1917-1998 Container Contents

BOX I:26 Drug efficacy study, National Academy of Sciences, 1969 BOX I:26 Drug information for the biomedical community: a report of a preliminary study of the needs for a national drug information clearinghouse, Institute for Advancement of Medical Communication, 1963 BOX I:26 An experiment in early post-marketing surveillance of drugs, IMS America, 1978 BOX I:26 Final report of the Tuskegee syphilis study ad hoc advisory panel, Department of Health, Education, and Welfare, 1973 BOX I:26 Findings and recommendations of the review panel on new drug regulation, Commissioner of Food and Drugs, 1978 BOX I:27 Maximizing the benefits of antibiotics, Medicine In the Public Interest, 1986 BOX I:27 Medical dark ages circa 1984 or cancer alternative therapies' cure rates, Ralph R. Hovnanian, 1984 BOX I:27 Miscellany, 1959-1964 BOX I:27 Post-approval pharmaceutical research and development, Medicine In the Public Interest, 1988 BOX I:27 Prescription drug information for patients and direct-to-consumer advertising, Medicine In the Public Interest, 1984 BOX I:27 Report on the conference on clinical pharmacology, National Academy of Sciences, 1971 BOX I:27 Review of studies of the effect induced in animals and man by the administration of the nonnutritive sweetening agent saccharin, Bureau of Science-Bureau of Medicine, 1970 BOX I:27 Therapeutic substitution symposium, Medicine In the Public Interest, 1986 BOX I:27 Revici, Emanuel, controversy regarding clinical investigation of selenium diethyl dithiocarbonate (SDD) as a treatment for cancer, 1989-1996, undated BOX I:27 Ritalin, 1958-1961, undated BOX I:27 Rutherford v. United States, deposition of Kelsey regarding cancer treatment, 1977 BOX I:27 Secozole, 1962 BOX I:27 Shoe-fitting fluoroscopes, 1949-1969, undated BOX I:27 Silicone injection, 1966-1975 BOX I:27 Somnafac, 1961-1963, undated BOX I:27 Strilexate, 1961-1962, undated BOX I:28 Subacute myelo-optico-neuropathy (SMON), 1978-1984 (2 folders) BOX I:28 Subject studies in vulnerable populations BOX I:28 Fetuses, infants, and children, 1961-1991, undated (3 folders) BOX I:28 Geriatrics BOX I:28 1959-1980 BOX I:29 1981-1993, undated (4 folders) BOX I:29 Prisoners BOX I:29 1963-1973 (3 folders) BOX I:30 1974-1980 (8 folders) BOX I:30 Undated (1 folder) BOX I:31 (1 folder) BOX I:31 Women of childbearing potential, 1972-1993

Frances Oldham Kelsey Papers 17 Part I: Research File, 1917-1998 Container Contents

BOX I:31 Summers, William K., controversy regarding clinical investigation of tetrahydroaminoacridine (THA) (Tacrine), as a treatment for Alzheimer's disease BOX I:31 Alzheimer's disease, 1978-1994, undated (2 folders) BOX I:31 Clinical investigation, 1985-1989 (2 folders) BOX I:31 Correspondence regarding Summers, 1987-1992, undated BOX I:31 Correspondence with Summers BOX I:31 1986-1987 BOX I:32 1988-1992, undated (2 folders) BOX I:32 Suprofen, 1986-1989 (2 folders) BOX I:32 Teratology studies guidelines, 1982 BOX I:32 Thalidomide BOX I:32 Animal studies, 1962-1984, undated (2 folders) BOX I:32 Bibliography, 1961-1973, undated BOX I:33 Foreign government reports, 1961-1976, undated BOX I:33 Investigations by Bureau of Field Administration, 1962-1969, 1994 BOX I:33 Kevadon literature, 1960-1966, 1986-1987, undated (2 folders) BOX I:33 Kühne's theory on leprosy (Paul Kühne), 1964-1994, undated BOX I:33 London Times, article of 27 June 1976, 1962-1976, undated BOX I:33 Lutwak-Mann on effects in males (Cecilia Lutwak-Mann), 1960-1964, 1994, undated BOX I:33 Medical Tribune, 1962-1964, undated BOX I:34 Miscellany, 1960-1994, undated (6 folders) BOX I:34 Pharmaceutical industry reports, 1961-1963, undated BOX I:34 Pharmaceutical industry's opposition to "Drug Industry Act of 1962," 1962 BOX I:34 Subcommittee on Administrative Practice and Procedure, Senate Judiciary Committee, 1962-1965 BOX I:35 Sievers, G., "Clinical, Statistical Studies on Teratologic Problems of Current Interest," 1964 BOX I:35 Various therapeutic uses, 1963-1989, undated BOX I:35 Triamcinolone diacetate (Aristocorte Forte and Aristocorte Parenteral), 1961-1962, undated BOX I:35 Triparanol (MER-29), 1961-1962, 1980 BOX I:35 Trisoralen, 1960-1962, undated BOX I:35 Turkel, Henry, controversy regarding U.S. Food and Drug Administration's refusal to approve new drug application for "U" series drugs, 1968-1969 BOX I:35 University Group Diabetes Program, 1972-1978, undated BOX I:35 Vesprin, 1961-1962, undated BOX I:35 Voices 12/60, educational audiocassette on teratogenicity of drugs, American Society of Hospital Pharmacists, with Kelsey et al. speaking, 1976-1977

Frances Oldham Kelsey Papers 18 Part II: Correspondence, 1932-2015 Container Contents

BOX II:1 Notes identifying some correspondents, undated BOX II:1 1932-1961 (5 folders) BOX II:1 1962 BOX II:1 Jan.-June BOX II:1 July BOX II:1 1-16 (4 folders) BOX II:2 17-26 (8 folders) BOX II:3 27-31 (3 folders) BOX II:3 Aug. BOX II:3 1-4 (4 folders) BOX II:4 5-16 (10 folders) BOX II:5 17-31 (3 folders) BOX II:5 circa Aug. BOX II:5 Sept.-Dec. (5 folders) BOX II:6 No month BOX II:6 1963-1964 (6 folders) BOX II:7 1965-1969 (5 folders) BOX II:7 circa 1960s BOX II:7 1970-1973 (3 folders) BOX II:8 1974-1984 (11 folders) BOX II:9 1985-1992 (8 folders) BOX II:10 1993-1996 (7 folders) BOX II:11 1997-2002 (9 folders) BOX II:12 2003-2015 (11 folders) BOX II:12 Undated (2 folders) BOX II:13 (1 folder)

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records, research file, printed matter, subject files, card indexes, reminiscences, photographs, and a drawing book and sketches. Arranged alphabetically by name of person or organization, topic, location, or type of material and thereunder alphabetically or chronologically.

BOX II:13 Academic report cards and achievements, 1927-1939, 1950, undated BOX II:13 American Medical Association BOX II:13 General, 1954-1955, undated BOX II:13 Journal of the American Medical Association BOX II:13 Correspondence, 1953-1960, undated BOX II:13 Logbook, 1950-1952 BOX II:13 American Newspaper Women’s Club, 1963, 1980, 2000, undated BOX II:13 Appointments, U.S. Food and Drug Administration, 1960, 1995 BOX II:13 Asteroid 6260 named after Kelsey, 1995-1997, undated BOX II:13 Awards, certificates, citations, and diplomas BOX II:13 Lists, 1964-2016 BOX II:13 Documents See also Oversize BOX II:13 1934-1978 (4 folders) BOX II:14 1980-2014, undated (4 folders) BOX II:14 Biographical sketches BOX II:14 General sketches and U.S. Food and Drug Administration biographical forms, 1963-1966, 1976, 1993-1998, undated BOX II:14 Who’s Who, circa 1955, 1997-2000, undated BOX II:14 Birth certificate, 1914, 1979 BOX II:14 Birthdays BOX II:14 Eightieth, 1994 BOX II:14 Ninety-ninth, 2013 BOX II:14 Ninety-ninth or one-hundreth, circa 2013-circa 2014 BOX II:14 One-hundreth, 2014 (2 folders) BOX II:15 Book inscriptions, photocopies, 1951, 1962, 1968-1980 BOX II:15 Brynner, Rock, regarding interview with Kelsey for his book Dark Remedy, 2000-2001 BOX II:15 Canada Heirloom Series, 1997-1998, undated BOX II:15 Christmas card lists, 1986-1991 BOX II:15 Civil Service Commission and Health, Education and Welfare Department, 1957-1960, undated BOX II:15 Clippings BOX II:15 About Kelsey and mentions BOX II:15 1938, 1954-1962 (7 folders) BOX II:15 circa 1962 BOX II:16 1963-1999 (8 folders) BOX II:17 2000-2014, undated (3 folders) BOX II:17 Fragments

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BOX II:17 Armadillos, 1974, undated BOX II:17 British royal family, 1936-1937, 1959, undated BOX II:17 Canada and Vancouver Island, circa 1963-1980, 1997, undated BOX II:17 Cartoons, circa 1960-circa 2002 BOX II:17 Cats, circa 1971-circa 2002 BOX II:17 Sinclair, Upton, 1962-1966, 1985 BOX II:17 Corporate income, 1965-1986 BOX II:17 Craigdarroch Castle Historical Museum Society, Victoria, British Columbia, Canada, 1992-1999 BOX II:17 Curricula vitae, circa 1995-circa 1999, undated BOX II:18 Death of F. E. Kelsey BOX II:18 Condolence letters, 1966-1967 (6 folders) BOX II:19 (6 folders) BOX II:20 (2 folders) BOX II:20 Funeral and memorials, 1966-1967, undated BOX II:20 Obituaries, 1966-1967 BOX II:20 Drawing book, 1927 BOX II:20 Family and genealogical information, 1938, 1958-1965, 1989-2000, undated BOX II:20 Frances Kelsey Secondary School, Mill Bay, Vancouver Island, British Columbia, Canada, 1980, 1987-2003, undated (3 folders) BOX II:20 Fried, Stephen, regarding interview with Kelsey for his book Bitter Pills, 1996-1998 BOX II:20 Geiling, E. M. K. BOX II:20 Allied Van Lines, 1958 BOX II:20 Biographical sketches, undated BOX II:21 Correspondence, 1937-1969, undated (3 folders) BOX II:21 Estate papers BOX II:21 Correspondence BOX II:21 Attorneys, 1967-1971, undated (6 folders) BOX II:22 Kelsey, Frances Oldham, 1966-1980, 1988 (2 folders) BOX II:22 Inventories, 1967 BOX II:22 Miscellany, 1967 BOX II:22 Power of attorney, 1962 BOX II:22 Farewell and birthday party, 1961 BOX II:22 Hilltop Farmer’s Cooperative Agreement, 1944 BOX II:22 John Jacob Abel material, 1890, 1924-1939, 1945, 1955-1957, 1963, undated (4 folders) BOX II:22 Licenses, 1929, 1949, 1960-1966 BOX II:22 Miscellany, 1936, 1948, 1961-1962, undated BOX II:22 New York state taxes/Ellison & Ellison, 1964-1965 BOX II:22 Obituaries, 1971-1972 BOX II:23 Personnel folder, 1959-1965 BOX II:23 Photographs and negatives, undated

Frances Oldham Kelsey Papers 21 Part II: Personal File, 1890-2016 Container Contents

BOX II:23 Reminiscences by Kelsey, 1996-2001, undated BOX II:23 Writings BOX II:23 List, 1917-1937 BOX II:23 Articles, 1925-1959, 1965 (3 folders) BOX II:23 Yearbook, 1912 BOX II:23 Get well cards, 1978 (2 folders) BOX II:24 (6 folders) BOX II:24 Golf charts, 1980, undated BOX II:24 Household expense ledgers, 1944-1948 BOX II:24 Immigration and Naturalization Service, 1937-1938, 1955 BOX II:24 J. B. Lippincott Co., 1947-1960 BOX II:25 Lederle Medical Faculty Awards, 1962-1968, 1999 BOX II:25 McGill University, Montreal, Quebec, Canada BOX II:25 Laboratory notes, 1933-1935 BOX II:25 Memorabilia, circa 1933-circa 1935, 1971, 1981, 1994-2000, undated (3 folders) BOX II:25 Tests, 1933-1935 BOX II:25 Medical licenses, 1960-1983 BOX II:25 Memorabilia and miscellany, 1960-1961, 1967-1969, 1977-1983, 1990-1996, undated (2 folders) BOX II:25 National and state boards of medical examiners, correspondence and tests, 1950-1955, undated BOX II:26 Obituaries of others, 1964-2001 (2 folders) BOX II:26 Passport and immunization record, 1969, 1976-1979, 1992 BOX II:26 Photographs and negatives, miscellaneous, 1999, undated BOX II:26 Queen Margaret’s School, Duncan, British Columbia, Canada, 1962-1963, 1977 BOX II:26 Research file BOX II:26 Card index, undated See Oversize BOX II:27 Amphibians, 1932-1945, 1959 BOX II:27 Bats, 1936 BOX II:27 Bears, 1947 BOX II:27 Birds, 1914, 1934-1942, 1951 (3 folders) BOX II:27 Bovines, 1930, 1941-1944 BOX II:27 Cats, 1929-1940, undated BOX II:27 Cetaceans, 1929, 1935-1946, undated BOX II:28 Dogs, 1934-1939, 1955 BOX II:28 Edentates and elephants, 1938-1946 BOX II:28 Fish, 1932-1944 (2 folders) BOX II:28 Hamsters, 1944 BOX II:28 Horses, 1940-1942 BOX II:28 Humans, 1926-1927, 1933-1948 (2 folders) BOX II:28 Mice, 1943-1955

Frances Oldham Kelsey Papers 22 Part II: Personal File, 1890-2016 Container Contents

BOX II:28 Miscellany BOX II:28 1912-1915 BOX II:29 1921-1942 (7 folders) BOX II:30 1943-1958, undated (4 folders) BOX II:30 Opossums, 1938 BOX II:30 Pigs, 1921-1922, 1928, 1944 BOX II:30 Rabbits, 1933-1943, 1953 BOX II:30 Rats, 1932-1944, 1956 (2 folders) BOX II:31 Reptiles, 1936-1944 BOX II:31 Sheep, 1937 BOX II:31 Staining techniques, 1933-1938 BOX II:31 Thyroid and iodine BOX II:31 1940-1956 (7 folders) BOX II:32 1957-1959, undated (2 folders) BOX II:32 St. Margaret’s School, Victoria, British Columbia, Canada, 1931-1932, 1943-1944, 1970, 1981-2000 (3 folders) BOX II:32 Shawnigan Lake School, Shawnigan, British Columbia, Canada, 1976, 1996-1997, undated BOX II:32 Sigma Delta Epsilon-Graduate Women in Science, 1986 BOX II:32 Sketches of sea life by Kelsey, 1933 BOX II:32 Society of Women Geographers, 1957, 1975-2001, undated (3 folders) BOX II:33 Soroptimists, 1928, 1962, 1981-1985, 1990-2001, undated BOX II:33 South Dakota BOX II:33 Estate of Donald H. and Bonita Iline Slaughter, house, 1952 BOX II:33 Initiation into Ashrama Temple No. 97, Daughters of the Nile, 1957-1960 BOX II:33 Memorabilia, 1953-1960, 1975 BOX II:33 Miscellany, 1954-1955, 1967-1968, 1982-1983, 1990, 1998-2000, undated BOX II:33 Private medical practice BOX II:34 Patient accounts ledger, 1958 BOX II:33 Receipts and reimbursements BOX II:33 Burke State Bank, Burke, S. Dak., 1958, 1967 BOX II:33 General, 1958-1960 BOX II:33 State v. Ruffing, order for Kelsey to appear, 1958 BOX II:33 University of South Dakota, Vermillion, S. Dak. BOX II:33 Abbott Laboratories, Chicago, Ill., 1956-1958 BOX II:33 Appointment of Kelsey as associate professor of medicine, 1955 BOX II:33 Atomic Energy Commission, 1954-1961, undated BOX II:33 Authorities to operate, 1959, undated BOX II:33 Bond, Norman, treatment with Phosphorus-32, 1957-1960 BOX II:33 Clinical radioisotopes training courses, 1955-1958 BOX II:33 Cobalt experiments, 1955-1956, undated

Frances Oldham Kelsey Papers 23 Part II: Personal File, 1890-2016 Container Contents

BOX II:34 Faculty publications, 1954-1960 BOX II:34 Frances O. and F. Ellis Kelsey Endowed Award, 1988-2014, undated (2 folders) BOX II:34 General correspondence, 1952-1960 BOX II:34 Grade book for physiology and pharmacology classes, 1956-1960 BOX II:34 Hard, Walter L., 1955-1960, undated BOX II:34 Laboratory notebooks BOX II:34 Animal data, 1954, Nov. 8-1955, Mar. 31 BOX II:34 Animal experiments, 1957, Jan. 23-Nov. 17 BOX II:35 Clinical radioisotope laboratory, 1954, June 11-1955, May 13 BOX II:35 Clinical radioisotope studies #2, 1955, May 19-1957, Nov. 13 BOX II:35 Lederle Medical Faculty Award, won by Kelsey, 1954-1960 BOX II:35 Pharmacology 301, 1955 BOX II:35 Physicians’ Professional Liability Insurance, 1954-1960 BOX II:35 Protein-bound iodine BOX II:35 Chemical methods, 1954-1959 BOX II:35 Laboratory notebooks BOX II:35 Gullock, A. H., 1955, May-1957, Dec. BOX II:35 Kelsey, Frances Oldham BOX II:35 1954, Dec. 22-1957, Sept. 16 (2 folders) BOX II:36 1957, Aug. 14-1958, July 21 BOX II:36 Patient card file, circa 1955-circa 1960 See Oversize BOX II:37 Patient cards, miscellaneous, 1958-1960 BOX II:37 Patient evaluations, 1955-1960, undated BOX II:37 Yankton State Hospital, Yankton, S. Dak. BOX II:37 Charts, tables, and other data, circa 1955-circa 1960 BOX II:37 Code book, undated BOX II:37 Yohe, Charles D., 1955-1957 BOX II:37 Seed, Lincoln, 1953-1956 BOX II:37 Theses of students, 1953-1960 (2 folders) BOX II:37 Steinberg, Gerald, 1964-1965 BOX II:37 University of Chicago, Chicago, Ill. BOX II:37 Class notes BOX II:37 Anthropology 211, circa 1936 BOX II:37 Autonomic nervous system, undated BOX II:37 Clinic appointment cards for Kelsey and family, 1941-1949 BOX II:38 Department of Pharmacology BOX II:38 Advanced degrees granted by, 1938-1959 BOX II:38 Publications by department members BOX II:38 Index, circa 1949 BOX II:38 No. 1-No. 143, 1936-1949 (3 folders) BOX II:39 General correspondence, 1936-1953, 1962 BOX II:39 International House, 1936, 1999 BOX II:39 Laboratory notebook

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BOX II:39 Loose items, circa 1937-circa 1941 BOX II:39 Volume, 1937-1941 BOX II:39 Logbook of readings, 1942-1944 BOX II:39 Memorabilia BOX II:39 Class reunion, 1995 BOX II:40 General, 1935-1948, 1954-1956, circa 1962, 1970, 1979, 1987-1989, undated (2 folders) BOX II:40 Graduation, 1938, 1950 (2 folders) BOX II:40 Negatives of slides from collection kept by E. M. K. Geiling, undated (2 folders) BOX II:40 Reminiscences by Kelsey, 1997-1999, undated BOX II:40 Stenn, Harriett, thesis, undated BOX II:40 Toxicological analysis, 1950 BOX II:40 Whale/cetacean research BOX II:40 Illustrations for publications, undated (1 folder) BOX II:41 (1 folder) BOX II:41 Unpublished paper, circa 1936 BOX II:41 University of New Brunswick, Fredericton, New Brunswick, Canada, 1976, 1998 BOX II:41 Vancouver Island University, Nanaimo, British Columbia, Canada, 2012 BOX II:41 Victoria College/University of Victoria/University of British Columbia, Victoria, British Columbia, Canada, 1930-circa 1934, 1966, 1977-1995, 2004, undated BOX II:41 War ration books, circa 1942-circa 1945 BOX II:41 Washington Forum, 1966-1988 BOX II:41 Whales/cetaceans BOX II:41 Donation of film Whaling for Science, and reminiscences by Kelsey, 1983-1995, undated BOX II:41 General, 1959-1961, 1970-2000, undated BOX II:41 Women’s Medical College of Pennsylvania, Philadelphia, Pa., 1967-1968 BOX II:41 Writing scientific papers, printed matter, 1934, 1951-1958, undated

BOX II:41 Chronological file BOX II:41 1966 BOX II:41 1967 BOX II:41 Jan.-Feb. (2 folders) BOX II:42 Mar.-Dec. (5 folders) BOX II:42 1968-1969 (14 folders) BOX II:43 1970-1972 (17 folders)

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BOX II:44 1973-1974 (8 folders) BOX II:44 1975 BOX II:44 Jan.-June (5 folders) BOX II:45 July-Dec. (6 folders) BOX II:45 1976-1977 (8 folders) BOX II:45 1978 BOX II:45 Feb.-May (2 folders) BOX II:46 June-Dec. (4 folders) BOX II:46 1979 (7 folders) BOX II:46 1980 BOX II:46 Jan.-Oct. (7 folders) BOX II:47 Nov.-Dec. BOX II:47 1981 (9 folders) BOX II:47 1982 BOX II:47 Mar. (1 folder) BOX II:48 (1 folder) BOX II:48 Apr.-Aug. BOX II:48 1983-1991, undated BOX II:48 Collective bargaining agreement, 1999 BOX II:48 General administration, 1972-1979, 1999, undated BOX II:48 General Counsel’s Office, 1981-1983 BOX II:48 Kelsey, Frances Oldham BOX II:48 Address file and business cards, undated BOX II:48 Calendar fragments, 1997-2001 BOX II:49 Correspondence BOX II:49 From John Patrick Swann, 1990-2002, undated BOX II:49 General, 1992-1995 BOX II:49 Daily log (partial), 1979-1984 BOX II:49 Equal Employment Opportunity Commission complaints BOX II:49 Butler v. Young, 1981-1985, undated BOX II:49 General, 1981 BOX II:49 Financial disclosures BOX II:49 General, 1985-1988, 1999-2000, undated BOX II:49 Reports, 1982-2000 (3 folders) BOX II:49 Foreign countries visited, 1934, 1963-1986 BOX II:50 Memoranda

Frances Oldham Kelsey Papers 26 Part II: Office File, 1959-2003 Container Contents

BOX II:50 General, 1961-1999 (7 folders) BOX II:51 Swann, John Patrick BOX II:51 Chronological file, 1994-1999, undated (2 folders) BOX II:51 Miscellaneous, 1991-2001, undated BOX II:51 Memoranda book pages, 1969-1987 (3 folders) BOX II:51 Note cards, 1990, undated BOX II:51 Notebooks, undated BOX II:52 Notes BOX II:52 Miscellaneous, 1979-1985, 1995-2003, undated (3 folders) BOX II:52 Typed, 1993-1995 BOX II:52 Performance plans and appraisals BOX II:52 Early, 1967, 1978 BOX II:52 Senior Executive Service, fiscal years BOX II:52 1980-1988 BOX II:53 1989-2001, undated (4 folders) BOX II:53 Personnel folder BOX II:53 1960-1979 (2 folders) BOX II:54 1981-2003, undated (2 folders) BOX II:54 Security investigative data, 1967, 1976-1986, undated BOX II:54 Time and attendance sheets, 2000-2002 BOX II:54 Trip reports, 1963-1992 (3 folders) BOX II:54 Laderman, Ross S. BOX II:54 Correspondence, 1993 BOX II:54 Memoranda, 1993 BOX II:54 Notes, 1993 BOX II:55 Miscellany BOX II:55 Early memoranda, 1959-1972 (2 folders) BOX II:55 Staff lists, 1979, 1993-1998, undated BOX II:55 Trip reports of others, 1983-1994 BOX II:55 Organization and reorganization BOX II:55 Bureau of Drugs and Division of Scientific Investigations, 1972-1978, 1999, undated BOX II:55 Center for Drug Evaluation and Research, 1988-1997, undated BOX II:55 Center for Drugs and Biologics, 1981-1984, 1999 BOX II:55 Office of Compliance, Fiscal Year 1995 BOX II:55 U.S. Food and Drug Administration BOX II:55 Consolidation, 1992 BOX II:55 General, 1963-circa 1971, 1997 BOX II:55 Richardson, Mary L.

Frances Oldham Kelsey Papers 27 Part II: Office File, 1959-2003 Container Contents

BOX II:55 Correspondence, 1995 BOX II:56 Memoranda, 1995 BOX II:56 Notes, 1995 BOX II:56 Senior Executive Service BOX II:56 “1982 Survey of SES Members in HHS: Chart Book,” 1982 BOX II:56 General, 1978-1998, undated (3 folders) BOX II:56 Sexual harassment procedures, 1979-1992, undated BOX II:57 Standards of conduct, 1975-1981 BOX II:57 Wilms, Heinz G. BOX II:57 General, 1980-1985, 1999 (3 folders) BOX II:57 National Clearing House on Licensure, Enforcement and Regulation, 1983 (2 folders)

BOX II:57 By Kelsey BOX II:57 Interviews for the U. S. Food and Drug Administration BOX II:57 1974 BOX II:58 1991 (2 folders) BOX II:58 Speech and engagement file BOX II:58 Log of conferences attended, 1961-1995 BOX II:58 Chronological file BOX II:58 1960-1962 (28 folders) BOX II:59 1963 BOX II:59 Jan.-July (30 folders) BOX II:60 Aug.-Dec. (11 folders) BOX II:60 1964 BOX II:60 Feb.-Mar. (4 folders) BOX II:60 May (3 folders) BOX II:61 (2 folders) BOX II:61 June-Dec. (8 folders) BOX II:61 1965 (12 folders)

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BOX II:62 1966 (10 folders) BOX II:62 1967 BOX II:62 Jan.-Apr. (7 folders) BOX II:63 May-Nov. (9 folders) BOX II:63 1968 (9 folders) BOX II:63 1969 BOX II:63 Feb.-July (6 folders) BOX II:64 Sept.-Dec. (2 folders) BOX II:64 1970-1972 (14 folders) BOX II:64 1973 BOX II:64 June (1 folder) BOX II:65 (2 folders) BOX II:65 Aug.-Nov. (5 folders) BOX II:65 1974 (8 folders) BOX II:66 1975-1977 (14 folders) BOX II:66 1978 BOX II:66 Feb.-June (2 folders) BOX II:67 Sept.-Nov. (4 folders) BOX II:67 1979-1980 (8 folders) BOX II:68 1981-1982 See also Oversize (13 folders) BOX II:69 1983 (9 folders) BOX II:69 1984 BOX II:69 Jan.-June (8 folders) BOX II:70 Sept.-Nov. (5 folders) BOX II:70 1985 BOX II:70 Jan.-July (4 folders) BOX II:71 Aug.-Nov. (9 folders) BOX II:71 1986

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BOX II:71 Feb.-June (5 folders) BOX II:72 July-Sept. (2 folders) BOX II:72 1987 (5 folders) BOX II:72 1988 BOX II:72 Feb.-June (6 folders) BOX II:73 July-Oct. (6 folders) BOX II:73 1989 BOX II:73 Mar.-Sept. (7 folders) BOX II:74 Nov. BOX II:74 1990 BOX II:74 Mar.-June (8 folders) BOX II:74 July (1 folder) BOX II:75 (1 folder) BOX II:75 Sept.-Dec. (4 folders) BOX II:75 1991 BOX II:75 Jan.-June (6 folders) BOX II:75 Sept. (1 folder) BOX II:76 (1 folder) BOX II:76 Nov.-Dec. (4 folders) BOX II:76 1992 BOX II:76 Jan.-May (7 folders) BOX II:77 June-Oct. (5 folders) BOX II:77 1993 (4 folders) BOX II:77 1994 BOX II:77 Apr. BOX II:77 Nov. (1 folder) BOX II:78 (1 folder) BOX II:78 1995 (3 folders) BOX II:78 1996 BOX II:78 Mar.-May (3 folders)

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BOX II:78 June (1 folder) BOX II:79 (1 folder) BOX II:79 Sept. BOX II:79 1997-1998 (5 folders) BOX II:79 1999 BOX II:79 Mar. BOX II:80 June-Dec. (3 folders) BOX II:80 2000-2002, 2010 (7 folders) BOX II:81 Miscellany BOX II:81 1962-1997 (6 folders) BOX II:82 1998-2003 (2 folders) BOX II:82 Speeches BOX II:82 Lists, 1988, Oct. 1-1996, Mar. 22 BOX II:82 Charts and illustrations, undated BOX II:82 Chronological file BOX II:82 1962-1966 (8 folders) BOX II:82 1967 (1 folder) BOX II:83 (1 folder) BOX II:83 1968-1978 (12 folders) BOX II:83 1979 (1 folder) BOX II:84 (1 folder) BOX II:84 1980-1986, undated (8 folders) BOX II:84 Miscellaneous, 1962, 1973, 1997, undated BOX II:84 Numbered BOX II:84 Index BOX II:84 Nos. 1-21A, 1963-1964 (2 folders) BOX II:85 Nos. 22-69, 1965-1978 (7 folders) BOX II:86 Nos. 70-112, 1979-1990 (6 folders) BOX II:87 Nos. 113-120, 1991-1993 BOX II:87 Writings BOX II:87 Lists of publications BOX II:87 Articles BOX II:87 1936-1963 (6 folders)

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BOX II:88 1964-circa 1992 (7 folders) BOX II:88 Book, Essentials of Pharmacology BOX II:88 Outline, undated BOX II:88 Chapters, background information BOX II:88 No. 1, 1954-1961 BOX II:89 Nos. 2-19, 1932-1937, 1950-1961, undated (14 folders) BOX II:90 Nos. 20-22, 1929, 1937, 1953-1992, undated (8 folders) BOX II:91 Nos. 23-28, 1936-1991, undated (6 folders) BOX II:91 No. 29, 1946-1971, 1984-2002, undated (3 folders) BOX II:92 (1 folder) BOX II:92 Nos. 30-34, 1945, 1951-2001, undated (7 folders) BOX II:92 Miscellany, 1948, 1954 BOX II:93 Book reviews, 1950-1959, undated BOX II:93 Dissertation, 1938 BOX II:93 Editorials, 1951-1959, undated (3 folders) BOX II:93 Fragments, undated BOX II:93 Miscellaneous BOX II:93 1960-1997 (2 folders) BOX II:93 Undated (1 folder) BOX II:94 (1 folder) BOX II:94 Queries and Minor Notes/Questions and Answers sections, 1952-1961, undated BOX II:94 Requests for reprints, 1940-1971, 1981-1992 (4 folders) BOX II:94 Submission on thalidomide written for the Lyndon Baines Johnson Presidential Library, Austin, Tex., 1968 BOX II:94 By others, articles BOX II:94 1950-1955 BOX II:95 1960-2000, undated (6 folders)

BOX II:95-II:210 Part II: Subject File, 1902-2012 Correspondence, memoranda, reports, statements, studies, proposals, reviews, guidelines, reprints of articles, clippings, press releases, testimonies, minutes, printed matter, and microfiche. Arranged alphabetically by subject, name of person or organization, or type of material and thereunder chronologically.

BOX II:95 Accutane See Containers II:208-II:209, Vitamin D and Vitamin A BOX II:95 Adverse drug reaction reports, 1963-1966

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BOX II:95 Adverse drug reactions, 1972, 1989, 1995-1998 BOX II:96 Advisory Committee on Fertility and Maternal Health Drugs, transcript, 1981 BOX II:96 Advisory Committee on the Teratogenic Effect of Certain Drugs, 1966 BOX II:96 AIDS (Disease), 1981-2000 BOX II:96 Alcohol, fetal alcohol syndrome, and Antabuse (disulfiram), 1932, 1969-1988, 1994-2000, undated (2 folders) BOX II:96 Amantadine, 1975 BOX II:96 American Arbitration Association, proposal for ethical review of investigational new drug studies, 1962-1974, 1996, undated BOX II:96 American Medical Association, 1962-1963, undated BOX II:97 American Medical Women’s Association, 1967-1972, 1979-1987 BOX II:97 American Medical Writers’ Association, circa 1960-1984, 1990-1999, undated (3 folders) BOX II:97 American Revolution Bicentennial Commission, Department of Health, Education and Welfare Committee, 1970-1971 BOX II:97 American Society for Pharmacological and Experimental Therapeutics/Western Pharmacological Society, 1961, 1966-1973, 1979-1980, 1998-1999 BOX II:97 Amino acids for treatment of inborn errors of metabolism, 1970-1972, 1984, undated BOX II:97 Amniocentesis (intrauterine diagnosis), 1970-1978, 1989-1991, undated BOX II:97 Amphetamines, 1962-1978, 1986-1991 BOX II:97 Anesthetic agents, 1970-1977, undated BOX II:97 Animal screening procedures See Containers II:194-II:195, Teratology, screening procedures BOX II:98 Antihistamines, 1949-1989, 1998-2001, undated (7 folders) BOX II:98 Antihypertensives, 1969-1972, 1978-1986, undated BOX II:98 Antimalarial Program and antimalarial drugs See Containers II:91-II:92, Essentials of Pharmacology, Chapter 29 BOX II:98 Antimetabolites/anticancer, 1954-1985, 1991, undated See also Container II:173, Methotrexate BOX II:98 Apgar, Virginia, 1960, 1968, 1984-1985, 2000, undated BOX II:98 Aprindine See Container II:139, Eli Lilly and Co. Task Group BOX II:98 Archer, John D. See Container II:196, same heading BOX II:98 Aronow, Wilbert S., investigation BOX II:98 1979-1982 BOX II:99 1983-1984, 1996-1997 (2 folders) BOX II:99 Artificial sweeteners BOX II:99 Aspartame/NutraSweet See Container II:145, same heading BOX II:99 Cyclamates, 1965-1971, undated BOX II:99 Saccharin, 1977 BOX II:99 Aspirin See Container II:191, Salicylates BOX II:99 Asteroids, 1972-1985, 1994-1998 BOX II:99 Ayerst Laboratories, New York, N.Y. See Container II:187, Practolol BOX II:99 Barbituates, 1972, 1980-1982 BOX II:99 Baycol, 2001 BOX II:99 Behavioral teratology, 1938, 1961-1986, 1992, undated (4 folders)

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BOX II:100 Bendectin, 1962-1999, undated See also Containers II:170-II:171, Maternal-Child Problems Task Force (5 folders) BOX II:100 Benoxaprofen (Oraflex), 1983-1988 See also Container II:139, Eli Lilly and Co. Task Group BOX II:100 Beta-blockers See Container II:98, Antihypertensives BOX II:100 Bioavailability, 1971, 1984-1991 BOX II:100 Biopharmaceutics, 1981, 1989 BOX II:100 Bioresearch Monitoring Program (BIMO), U.S. Food and Drug Administration BOX II:100 Automatic Data Processing budget, 1983-1985 BOX II:100 Clinical Investigations Data File System, 1969, 1979-198-1983, 1999, undated (3 folders) BOX II:101 Clinical investigators form and clinical facilities file system, 1969-1975, 1999, undated BOX II:101 General BOX II:101 1971-1979 (7 folders) BOX II:101 1980 (1 folder) BOX II:102 (1 folder) BOX II:102 1981-1982 (5 folders) BOX II:102 1983 (1 folder) BOX II:103 (1 folder) BOX II:103 1984-1999, undated (4 folders) BOX II:103 Information Systems User Committee/BIMO Systems Task Group BOX II:103 Chronology, 1979-1980 BOX II:103 General BOX II:103 1977-1978 (2 folders) BOX II:103 1979 (1 folder) BOX II:104 (1 folder) BOX II:104 1980-1982 (6 folders) BOX II:105 1983, 1999 (4 folders) BOX II:105 Presentation to BIMO Steering Committee, 1978, 1999 BOX II:105 Key events in National Center for Drugs and Biologics, circa 1981 BOX II:105 Meetings BOX II:105 BIMO program managers BOX II:105 1996 (5 folders) BOX II:106 1997 (10 folders) BOX II:106 Compliance Coordinating Committee, 1996 BOX II:106 Project Management Systems, implementation sessions

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BOX II:106 1975-1980 (3 folders) BOX II:107 1981-1983 (2 folders) BOX II:107 Reports BOX II:107 Annual, Fiscal Year 1980-Fiscal Year 1984 (5 folders) BOX II:107 Monthly BOX II:107 1984 BOX II:108 1985-1988 (6 folders) BOX II:108 1989 BOX II:108 Jan.-Mar. (2 folders) BOX II:109 Apr.-Nov. (6 folders) BOX II:110 Dec. BOX II:110 1990 (4 folders) BOX II:110 1991 BOX II:110 Jan.-July (2 folders) BOX II:111 Aug.-Dec. (2 folders) BOX II:111 1992 (5 folders) BOX II:112 1993 (4 folders) BOX II:112 1994 BOX II:112 Jan.-Apr. (2 folders) BOX II:113 May-Dec. (3 folders) BOX II:113 1995 BOX II:113 Jan.-Aug. (3 folders) BOX II:114 Sept.-Dec. BOX II:114 1996 (5 folders) BOX II:114 Transfer of classification No Action Indicated for BIMO inspection reports to field offices, 1979 BOX II:114 Work plans, 1987-1990 BOX II:115 Birth defects/reviews, 1976, 1986-1990 BOX II:115 Birth surveys, 1963-1999, undated (4 folders) BOX II:115 Breast milk, drugs in, 1947-1993, 2001, undated (2 folders) BOX II:116 Bromocryptine, 1977-1985

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BOX II:116 Bureau of Drugs, U.S. Food and Drug Administration BOX II:116 Clinical Investigator Stratified Surveillance Strategy, 1976-1980, undated BOX II:116 Deputy director, 1979-1982 (2 folders) BOX II:116 Caffeine, 1966, 1978-1982, undated BOX II:116 Carcinogenesis/teratology, 1963-1983, undated BOX II:116 Carrisyn/Carrington Laboratories, Dallas, Tex., 1986-1996 (2 folders) BOX II:116 Celebrex/Vioxx, 1999-2002 BOX II:117 Center for Drug Evaluation and Research, U.S. Food and Drug Administration BOX II:117 General, 1997-2000, undated BOX II:117 Reports, 1992-1995 (3 folders) BOX II:117 Research Steering Committee BOX II:117 1987-1988 (3 folders) BOX II:118 1990-1991 BOX II:118 Time reporting system, 1997-1999 BOX II:118 Chelation therapy, 2001 BOX II:118 Chick embryo studies, 1962-1972 BOX II:118 Chloramphenicol (Chloromycetin), 1962-1967, 1996-1997 BOX II:118 Chymopapain (Discase), 1973-1976, 1984, 1997-2000 BOX II:118 Chymotrypsin See Container II:140, Enzymes BOX II:118 Clinical Investigator Conflict of Interest Task Force, U.S. Food and Drug Administration BOX II:118 1987-1991 (3 folders) BOX II:118 1992 (1 folder) BOX II:119 (1 folder) BOX II:119 1993-2000, undated BOX II:119 Clinical trials, 1981, 1990, 1999, undated BOX II:119 Clomiphene (Clomid), 1961-1989, undated BOX II:119 Close, John H., 1977-1978, 1999 BOX II:119 Cobalt summary, Ray D. Uphoff and Albert L. Maduska, 1966, undated BOX II:119 Cocaine, 1986-1997, undated BOX II:119 Colestipol, 1971-1974 BOX II:119 Complementary and alternative medicine, 1996-2001, undated BOX II:119 Compliance Policy Guides Manual (partial), microfiche, 1985 Microfiche shelf no. 22,656 BOX II:119 Compliance Program, evaluations reports, 1975-1977 BOX II:119 Computer-Assisted New Drug Applications BOX II:119 General, 1980, 1988-1990, undated BOX II:119 Guidance manual, 1992 BOX II:119 Confidentiality statute See Containers II:188-II:189, Privacy Act/Confidentiality statute BOX II:120 Conflict of interest regulations, 1976-1978, circa 1993 BOX II:120 Congenital malformations review papers, 1957-1985, undated (5 folders)

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BOX II:120 Congressional BOX II:120 Hearings BOX II:120 House of Representatives BOX II:120 Commission on the Federal Drug Approval Process (McMahon Commission) BOX II:120 1981-1988 (4 folders) BOX II:121 1996-1999, undated (2 folders) BOX II:121 Drug Safety, 1964 (2 folders) BOX II:121 Fraud in biomedical research, 1981 BOX II:121 National Ambient Air Quality Standards, 1984 BOX II:121 Use of Advisory Committees by the U.S. Food and Drug Administration (Fountain Committee), 1982, 1997-1999 BOX II:121 Senate BOX II:121 Interagency Coordination in Drug Research Regulation BOX II:121 1961 See Oversize BOX II:121 1962 BOX II:121 Mar.-May BOX II:121 Aug. (1 folder) BOX II:122 (4 folders) BOX II:122 1963 BOX II:122 Investigation of drug industry (Estes Kefauver), 1960-1964, 1997 BOX II:122 United States Government and the future of international medical research, 1961 BOX II:123 Miscellany BOX II:123 Questions, undated BOX II:123 Testimony, 1960-1961, 1970, 2000 (4 folders) BOX II:123 Reports BOX II:123 House of Representatives, circa 1963-1966 (2 folders) BOX II:123 Office of Technology Assessment, 1974-1976 BOX II:124 Senate, 1960-1966 (2 folders) BOX II:124 Consumer information publications by U.S. Food and Drug Administration, 1956-1988, undated (4 folders) BOX II:124 Contracts and Grants Review Committee, 1988-1989 (2 folders) BOX II:124 Contracts for studies BOX II:124 Auerbach Associates, FDA 72-63, 1972 BOX II:125 Center for Disease Control, possible contract, 1973 BOX II:125 Children’s Hospital Research Foundation, Cincinnati, Ohio BOX II:125 FDA 68-44, FDA 70-7, FDA 71-11 BOX II:125 1967-1970 (7 folders)

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BOX II:126 1971-1976 (5 folders) BOX II:126 FDA 641-8-131, 1968 BOX II:126 Mayo Foundation, Rochester, Minn., FDA 72-339, FDA 7837-73(B) BOX II:126 1971-1973 (2 folders) BOX II:127 1974-1976 BOX II:127 National Academy of Sciences-National Research Council, FDA 70-22, FDA 71-52, FDA 72-1, 1970-1974, 1999 (2 folders) BOX II:127 University of Miami, Miami, Fla. BOX II:127 FDA 66-210, 1967-1968 BOX II:127 FDA 67-54, FDA 68-47, FDA 69-34 BOX II:127 1967-1970 (4 folders) BOX II:128 1971-1975, 1999 BOX II:128 FDA 641-8-157, 1968-1973 BOX II:128 Control and dispensing of drugs, 1960-1963, 1996, undated BOX II:128 Coulston Foundation, Alamogordo, N. Mex./Frederick Coulston, 1966, 1992, 1998-2000 BOX II:128 Daroil, 1964-1965 BOX II:128 Darvon, 1979-1980 See also Container II:139, Eli Lilly and Co. Task Group BOX II:128 Data handling of scientific information, 1959-1964, 1995-1999, undated BOX II:128 Day, J. Edward, 1965, 1996, undated BOX II:128 Day, Paul L., 1961, 1999, undated BOX II:128 Definition of terms “drug” and “new drug,” undated BOX II:128 Defoliants and herbicides See Container II:186, Pesticides and environmental hazards BOX II:128 DeMarco, Peter See Container II:189, Procaine with polyvinylpyrrolidone (PVP) BOX II:128 Depo-Provera, 1966, 1975-1984, undated BOX II:128 DES (Drug), 1953, 1972-2000, undated BOX II:128 DFMO (Drug), 2000-2001 BOX II:128 DHSM (Drug) See same container, Dihydrostreptomycin BOX II:128 Dicumarol and related anticoagulants, 1970-1986, 1996-1997 BOX II:128 “Diet” pills, 1985, 1997-2001, undated BOX II:128 Dietary supplements, 1982, 1998-2001, undated BOX II:128 Diethyl glycol See Container II:139, Elixir sulfanilamide BOX II:128 Diethylstilbestrol See same container, DES (Drug) BOX II:128 Difluoromethyl-ornithine See same container, DFMO (Drug) BOX II:128 Dihydrostreptomycin (DHSM), 1959, undated BOX II:128 Dimethyl sulfoxide See Containers II:135-II:136, DMSO (Drug) BOX II:128 Diphenylhydantoin BOX II:128 1963-1969 BOX II:129 1970-1998, undated (3 folders) BOX II:129 Dithiocarb, 1963-1966, 1996, undated BOX II:129 Diuretics, 1962-1966, 1972-1978, 1994, undated BOX II:129 Division of Scientific Investigations, U.S. Food and Drug Administration

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BOX II:129 Awards, division members, 1972-1983, undated (3 folders) BOX II:129 Central file, 1989-1990, 1997, undated (1 folder) BOX II:130 (1 folder) BOX II:130 Clinical Investigations Branch BOX II:130 Debarment of investigators, circa 1996 BOX II:130 Disqualified/restricted/assurance lists, 1970, 1980-1982, 1990-2000 (3 folders) BOX II:130 General BOX II:130 1963-1981 (3 folders) BOX II:131 1982-1997, undated (5 folders) BOX II:131 Warning letters to investigators, circa 1993-1998 BOX II:131 Institutional Review Branch BOX II:131 1972-1979 BOX II:131 1980 (1 folder) BOX II:132 (2 folders) BOX II:132 1981 (3 folders) BOX II:132 1982 (1 folder) BOX II:133 (3 folders) BOX II:133 1983-1984, 1991, 1999, undated (3 folders) BOX II:133 Nonclinical Laboratory Studies Branch BOX II:133 Good laboratory practices See Containers II:147-II:148, same heading BOX II:133 Significant investigations prior to June 20, 1979 (Government Accounting Office request), 1987 BOX II:133 Methadone Monitoring Branch See Container II:172, Methadone monitoring BOX II:133 Paperwork systems and procedures, 1976-1978, 1999 BOX II:134 Policies and procedures, 1973-1990, undated (2 folders) BOX II:134 Radioactive Drug Research Committees, 1974-1984, 1992, 1999, undated (2 folders) BOX II:134 Regulatory Management Branch, 1977-1991, 1999, undated (3 folders) BOX II:134 Speeches by division members BOX II:134 1967, 1971-1972 BOX II:135 1980-1992, undated (5 folders) BOX II:135 DMSO (Drug) BOX II:135 1963-1966 (2 folders) BOX II:136 1980-1983, 1994-1999, undated (3 folders)

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BOX II:136 Doriden, 1962-1972, 1995, undated BOX II:136 Dornwal, 1964, 1997, undated BOX II:136 Drobuline, 1982-1983, 1997 See also Container II:139, Eli Lilly and Co. Task Group BOX II:136 Drug controls, foreign BOX II:136 1958-1987 (5 folders) BOX II:137 1988-1993, undated (8 folders) BOX II:138 Drug equivalency, 1966-1971, 1982-1990, undated BOX II:138 Drug Research Board, National Academy of Sciences, 1965-1973, 1996 (2 folders) BOX II:138 Drugs and deformities BOX II:138 1960-1987 (4 folders) BOX II:139 1990-2000, undated BOX II:139 Dusheiko, Geoffrey M., 1994-1996 BOX II:139 Edgewood Arsenal, Edgewood, Md., site visit, 1965, 1972-1975, 1997 BOX II:139 Efficacy guidelines See Container II:148, Guidance for Industry: Providing Adequate Clinical Evidence of Effectiveness , draft BOX II:139 Eflornithine See Container II:128, DFMO (Drug) BOX II:139 Eli Lilly and Co. Task Group See also Container II:100, Benoxaprofen ; Container II:128, Darvon ; Container II:136, Drobuline BOX II:139 General, 1980-1981 BOX II:139 Report, 1983 (2 folders) BOX II:139 Elixir sulfanilamide, 1967, 1983, circa 1993, 2002 BOX II:139 Ellenhorn, Matthew J., 1963, circa 1966, 1996-1999 BOX II:140 Enzymes, 1960-1962, 1996 BOX II:140 Epidemiology, 1962-1988, undated (3 folders) BOX II:140 Establishment Evaluation System BOX II:140 Division of Scientific Investigations, flow charts and milestones, circa 1995-circa 1996 BOX II:140 General, 1995-1996 BOX II:140 Ethical consideration BOX II:140 1965-1979 (2 folders) BOX II:141 1980-1999, undated BOX II:141 Ethical criteria, 1960-2001, undated (5 folders) BOX II:141 European Teratology Society, 1971-1977, 1994-2000 (2 folders) BOX II:142 Executive Women in Government, 1994-1996 BOX II:142 Exempt drugs, 1979 BOX II:142 FDA Distinguished Alumni/Professor Emeritus Policy Task Force, 1998 BOX II:142 Federal Executive Professional Association, 1979-1986, 1998 BOX II:142 Feldene (piroxicam), 1983-1986

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BOX II:142 Fetus and newborn, miscellaneous, 1961-1979, 1985-1986, undated (2 folders) BOX II:142 Fialuridine (FIAU), 1993-1994, 2001 BOX II:142 Flunixin, 1976-1977 BOX II:142 Folic acid, memorandum to John Patrick Swann with attachments, 1951-1952, 1963, 1995, undated BOX II:143 Foreign clinical studies, U.S. Food and Drug Administration policy, 1973-1992, undated (3 folders) BOX II:143 Foreign travel requests, 1978-1982 BOX II:143 Foreign visitors, 1963-1968, 1979-1986, 1994-1997 BOX II:143 Fraud in science, cases and publicity BOX II:143 circa 1961-1987 (4 folders) BOX II:144 1988-1999, undated (5 folders) BOX II:144 Freedom of Information Act, correspondence and requests BOX II:144 1977-1980 BOX II:145 1981-1987 BOX II:145 G. D. Searle & Co. BOX II:145 Aldactone, 1975 BOX II:145 Aspartame/NutraSweet, 1983-1996, undated BOX II:145 Copper-7, 1988, 1997 BOX II:145 Enovid/Ovulen, 1962, 1979 BOX II:145 Searle Investigation Task Force, 1975-1976, 1982-1985 (2 folders) BOX II:145 Gene therapy, death in, 1980-1981, 1999-2000 BOX II:145 General Accounting Office BOX II:145 Anticancer drugs, 1983 BOX II:145 General BOX II:145 1973-1976 BOX II:146 1986-1990 BOX II:146 Generic drugs, 1987-1989 BOX II:146 Genetic factors, 1956-1990, undated (6 folders) BOX II:146 Gerovital, 1976-1980, 1999 BOX II:146 Gibson, William C., 1957-1963, 1996-2001 BOX II:146 “Ginger jake” affair, 1991-1994 BOX II:147 Good laboratory practices BOX II:147 1964-1981 (9 folders) BOX II:148 1982-1992, 1999, undated (5 folders) BOX II:148 Grecu, Eugen O., informal conference at U.S. Food and Drug Administration, transcript and exhibits, 1992 BOX II:148 Griseofulvin, 1963-1974, 1982-1988, undated BOX II:148 Guidance for Industry: Providing Adequate Clinical Evidence of Effectiveness, draft, 1997

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BOX II:149 Guidelines for clinical evaluations, printed matter, 1977-1980, 1987 (2 folders) BOX II:149 Gulf War/Desert Storm, consent waivers and syndrome, 1992-2000 BOX II:149 Hayes, Arthur Hull, 1979-1983 (2 folders) BOX II:149 Hayflick, Leonard, 1978-1982 BOX II:149 Heart tonic, 1965, 1997 BOX II:149 Hensley, Michael J., 1977-1981, 1999-2000 BOX II:149 Herbal remedies BOX II:149 1992-1999 BOX II:150 2000-2002, undated BOX II:150 Heroin and morphine, prenatal exposure and addiction, 1958-1990, 1999-2000, undated (2 folders) BOX II:150 Hexachloophene, 1972, 1978 BOX II:150 Hexobendine, 1973 BOX II:150 Historical material BOX II:150 CDC capsules, press coverage, 1962 BOX II:150 Drug legislation, press coverage, 1962 BOX II:150 Federal regulations BOX II:150 1960-1961 BOX II:150 1962 (1 folder) BOX II:151 (1 folder) BOX II:151 1963-1979 (6 folders) BOX II:152 1980-1999, undated (5 folders) BOX II:152 General BOX II:152 1902, 1918, 1928, 1934-1939, 1951-1961 (2 folders) BOX II:153 1962-1964 (7 folders) BOX II:154 1965-1974 (7 folders) BOX II:155 1975-2005, undated (7 folders) BOX II:155 Micro-Dynameters and other topics, press coverage, 1962 BOX II:156 “News Items,” 1962 (2 folders) BOX II:156 History competitions, requests for information and interviews, 1971, 1989-1999, undated (2 folders) BOX II:156 Homeopathy, 1962-1963, 1989-1997 BOX II:156 Hydrazine sulfate, 1976-1980, 1995-2000 BOX II:156 Hyperthermia and birth defects, 1966, 1973, 1980-1983, undated BOX II:156 Hypoglycemic oral agents, 1963-1971, 1976-1984, 1998-2000 BOX II:157 Imipramine, 1963, 1969-1976, 1986 BOX II:157 Indocin, 1966, 2000

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BOX II:157 Industrial Bio-Test Laboratories, Northbrook, Ill., 1977-1983, 2000-2001 BOX II:157 Influenza epidemic of 1918, 1982, 1997-2001 BOX II:157 Informed consent and patient consent See Containers II:157-II:164, Institutional review boards and consent BOX II:157 Insecticides See Container II:186, Pesticides and environmental hazards BOX II:157 Institutional review boards and consent BOX II:157 Articles and clippings BOX II:157 1961-1993 (5 folders) BOX II:158 1996-2000, undated (3 folders) BOX II:158 Deferred consent, 1990-1993, undated (2 folders) BOX II:158 General BOX II:158 1962-1973 (5 folders) BOX II:159 1974-1983 (8 folders) BOX II:160 1984-1996 (10 folders) BOX II:161 1997-2000, undated (6 folders) BOX II:161 Guidance for IRBs and Clinical Investigators, 1998 BOX II:161 IRB Re-Engineering Task Force and subcommittees, U.S. Food and Drug Administration BOX II:161 1998 (2 folders) BOX II:162 (5 folders) BOX II:162 2000 BOX II:162 Mariposa Foundation, 1988-1990, undated BOX II:162 Memoranda with National Institutes of Health, 1973-1974, 2000, undated BOX II:163 Miscellaneous workshops, 2001, undated BOX II:163 Notes, 1999 BOX II:163 Patient follow-up, 1973-1974, 1982-1983 BOX II:163 Patient interviews and records, 1979-1981, 2000, undated BOX II:163 Reports BOX II:163 Advisory Committee on Human Radiation Experiments, circa 1995 BOX II:163 General, 1976-1983, 1994-1996 (3 folders) BOX II:164 Research Involving Human Subjects Committee, 1983, 1989, 1999-2000, undated BOX II:164 Seeding trials, 1987-1988 BOX II:164 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) BOX II:164 1987-1990 (5 folders) BOX II:164 1991 (2 folders) BOX II:165 (1 folder)

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BOX II:165 1992 (4 folders) BOX II:165 1993 BOX II:165 Jan. BOX II:165 Feb. (2 folders) BOX II:166 (2 folders) BOX II:166 Mar.-Sept. (6 folders) BOX II:167 Oct.-Nov. (3 folders) BOX II:167 1994-1997, 2000-2001, undated (3 folders) BOX II:167 International Research and Development Corp., 1978, 1986-1991, 1996-1999 (1 folder) BOX II:168 (1 folder) BOX II:168 Investigational Drug Branch, U.S. Food and Drug Administration, 1960-1967, undated BOX II:168 Investigational new drugs (INDs) BOX II:168 Charges for, 1982-1987, 1995 BOX II:168 Differences in opinion during IND/New Drug Application processes, 1979 BOX II:168 IND cover sheet and BIMO data collection sheet, 1974-1979 (2 folders) BOX II:168 Miscellany, 1964-1965, 1996-1997 BOX II:168 Outline submitted to Goddard, 1967 BOX II:168 Revision of IND and NDA regulations, 1974 BOX II:168 Rewrite, 1984 BOX II:168 Isoniazid, 1960-1974, undated BOX II:168 Jolly, Eugene Richard, 1958, 1975-1976, 1982-1986, 1998-1999, undated BOX II:168 Kerlan, Irvin, 1958-1961, 1966, 1997, undated BOX II:168 Krebiozen, 1953, 1962-1966, 1984, 1999 BOX II:169 Laetrile BOX II:169 General, 1977-1982, 1997-2000 BOX II:169 Testimony of Kelsey, 1979 BOX II:169 Ley, Herbert L., questions for interview, 1967-circa 1968, 1998 BOX II:169 Librium and valium, 1960-1990, undated (2 folders) BOX II:169 Lithium, 1966-1972, 1975-1986, undated BOX II:169 Livingston lysate, 1969 BOX II:169 Lotronex (Alosetron), 2000-2002 BOX II:169 LSD (Drug), 1963, 1969-1971, 1977, 1996-1999 BOX II:169 Male role in fertility and birth defects, 1952, 1962-1972, 1978-1981, 1987-1989, 1998, undated BOX II:169 Marine pharmacology, 1969-1991, 1998-2001, undated BOX II:169 Marrazzi, Amedeo S., 1975-1976, 1999, undated BOX II:170 Maternal-Child Problems Task Force See also Container II:100, Bendectin BOX II:170 1979-1981 (6 folders)

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BOX II:170 1982 (1 folder) BOX II:171 (2 folders) BOX II:171 1983, 1996, undated (3 folders) BOX II:171 Memoranda of understanding BOX II:171 Defense Department, investigational new drugs, 1969, 1974-1981, 1986-1987, 1997-1998 (2 folders) BOX II:171 General, 1971-1975, 1982-1988, 1998, undated BOX II:171 National Institutes of Health, 1975-1981 BOX II:172 New York Department of Health, 1978-1979 BOX II:172 Veteran’s Administration, 1977-1984 BOX II:172 Mercury, 1968-1987, 1996, undated BOX II:172 Methadone monitoring, 1971-1990, 1999, undated (5 folders) BOX II:173 Methotrexate, 1948-1972, 1978, undated See also Container II:98, Antimetabolites/anticancer (3 folders) BOX II:173 Methyl CCNU (Drug) See Containers II:180-II:182, National Cancer Institute BOX II:173 Mifeprex (mifepristone), 2000 BOX II:173 Mintz, Morton, 1966, 1996 BOX II:173 Miscellany BOX II:173 Chronological BOX II:173 1961-1973 (6 folders) BOX II:174 1974-1979 (8 folders) BOX II:174 1980 (1 folder) BOX II:175 (1 folder) BOX II:175 1981-1983 (6 folders) BOX II:176 1984-1994 (11 folders) BOX II:177 1995-2001 (8 folders) BOX II:178 2002, undated (2 folders) BOX II:178 Fragments, undated BOX II:178 Clippings BOX II:178 1951-1999 (6 folders) BOX II:179 2000-2002, undated (4 folders) BOX II:179 Fragments, 1955, 1966-1974, 1983-1986, 1997-2001 BOX II:179 Misconduct in science BOX II:179 Public Health Service initiatives and procedures, 1983-1988 BOX II:179 Reports to the Office of Management and Systems, 1982-1983, 1997-1999 (1 folder)

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BOX II:180 (1 folder) BOX II:180 Modell, Walter, 1959, 1967-1971, undated BOX II:180 Monensin See Container II:139, Eli Lilly and Co. Task Group BOX II:180 Monosodium glutamate (MSG), 1967-1973, 1996, undated BOX II:180 Moulton, Barbara, 1963-1965, 1980, 1996-2000, undated BOX II:180 Multivitamins, circa 1951, 1962-1963. 1972, 1980-2001 BOX II:180 National Cancer Institute BOX II:180 1964-1980 (3 folders) BOX II:181 1981 (6 folders) BOX II:181 1982 (1 folder) BOX II:182 (1 folder) BOX II:182 1983-1985, 1992-1997, undated (2 folders) BOX II:182 National Center for Toxicological Research Protocol Task Force, 1966-1972, 2000 BOX II:182 National Institutes of Health BOX II:182 National Institute of Mental Health BOX II:182 Death of subject, 1980-1981, 1997-1999 BOX II:182 Principal Investigators of Early Clinical Drug Evaluation Units, meeting minutes, 1961-1962 BOX II:182 Perinatal study See Container II:196, Foundation for Medical Research Perinatal Study BOX II:182 Representatives of the U.S. Food and Drug Administration on study sections, 1963-1965, undated BOX II:182 Neonatal pharmacology, 1960-1982, undated (2 folders) BOX II:182 Nester, John O., circa 1992-2000 BOX II:183 New Drug Application (NDA) Preservation Committee BOX II:183 General, 1962-1964, 1982, 1992-2001, undated BOX II:183 Lists of NDAs reviewed by Kelsey, undated BOX II:183 Lists of NDAs (1938-1948) to be transferred to National Archives, Washington, D.C., 1995-1996 BOX II:183 Printout of NDAs approved from 1949, Jan. 1 to 1956, Dec. 31, 1995 BOX II:183 New Drug Evaluation Office, U.S. Food and Drug Administration BOX II:183 Associate director, 1977-1982, 2001 (2 folders) BOX II:184 Committee to Update the Management Information System, 1982-1983 BOX II:184 Deputy associate director, 1980-1982 BOX II:184 General, 1976-1983 BOX II:184 Minutes of division director meetings, 1980-1984 (2 folders) BOX II:184 Project Management Systems, implementation session, 1980 BOX II:184 New uses for approved drugs See Container II:208, “Use of Drugs for Unapproved Indications: Your Legal Responsibility” BOX II:184 Nishimura, Hideo BOX II:184 General, 1966-1969, 1976, 1996-2000 BOX II:184 Writings, 1968-1975, 1983

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BOX II:184 Nurses’ responsibilities in clinical investigations, undated BOX II:184 Nutritional aspects, 1968-1974, 1981, undated BOX II:185 Office of Planning Evaluation, studies, 1978-1981, 1993 (4 folders) BOX II:185 Omeprazole, 1989-1990, undated BOX II:185 Organizational Effectiveness Project, 1970, 1981-1982, undated (2 folders) BOX II:185 Orphan drugs, 1973, 1982-1983, 1992, 1998, undated BOX II:186 Oxsoralen (methoxsalen), 1992-1993 BOX II:186 Pediatric labeling rule, draft, 1997 BOX II:186 PEG-Superoxide Dimutase (PEG-SOD), 1993 BOX II:186 Penicillamine, 1969-1971, 1983-1984, undated BOX II:186 Pentamidine, 1982-1987, 1996, undated BOX II:186 Pesticides and environmental hazards, 1950-1984, 1996-1998, undated (4 folders) BOX II:186 Phase I trials, 1976-1982 BOX II:186 Phenacetin, 1961-1962, 1980, 1996 BOX II:186 Phenformin, 1979-1980 BOX II:187 Placebos, 1950-2000 (2 folders) BOX II:187 Placental transmission of drugs, 1962-1973, 1979, undated BOX II:187 Podophyllin, drug deformities, 1962-1963, 1972, 1984 BOX II:187 Poisonous plants and animals, 1955, 1961-2002, undated (3 folders) BOX II:187 Poquil, 1953-1956 BOX II:187 Practolol, 1975, 1996 BOX II:187 Prednisolone, 1968, 1997 BOX II:187 Pregnancy and drug metabolism, 1965-1977, circa 1982, undated BOX II:188 Pregnancy labeling, 1966-1969, 1975-1983, 1997-2001 BOX II:188 Preludin, drug deformities, 1962, 1973 BOX II:188 Primidone See Containers II:128-II:129, Diphenylhydantoin BOX II:188 Prison studies/testing, 1968-1983, 1991, 1999-2000 (4 folders) BOX II:188 Privacy Act/Confidentiality statute BOX II:188 Bioresearch monitoring, 1974-1984 BOX II:188 Statutory protection for medical records, 1977 BOX II:189 Task Force on Health and Medical Records, 1974-1977 BOX II:189 Procaine with polyvinylpyrrolidone (PVP) BOX II:189 General, 1968-1987, 1995-2000, undated BOX II:189 Testimony of Kelsey, 1979 BOX II:189 Progestin and other sex steroids, 1942, 1950-2000, undated (4 folders) BOX II:189 Prolactin See Container II:116, Bromocryptine BOX II:189 Proprandol See Container II:98, Antihypertensives BOX II:189 Propulsid, 2000-2001 BOX II:189 Prostaglandins, 1970-1973, 1984-1985, undated BOX II:190 Pruzansky, Samuel, 1954-1960, 1967-1969

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BOX II:190 Psychotropic drugs, 1962-1984, 1993-2002, undated BOX II:190 Public Employees Roundtable, photographic slides, 1984 BOX II:190 Quaaludes, 1972-1980, 1996 BOX II:190 Quackery, 1962-1965, 1975, 1989-1999, undated BOX II:190 Quinine and quinine drugs, 1954-1956, 1964-1972, 1978-1991, 1996-1999 BOX II:190 Radiation, 1929, 1962-1999, undated (3 folders) BOX II:190 Radioactive Drug Research Committees See Container II:134, same heading BOX II:191 Ratner, Herbert, 1962, 1968, 1996-1999 BOX II:191 Regulatory Affairs Professionals Society, 1980, 1990-1997 BOX II:191 Research Testing Laboratories, Inc., Great Neck, N.Y., transcript of conference, 1993 BOX II:191 Retinoids See Containers II:208-II:209, Vitamin D and Vitamin A BOX II:191 Review Panel on New Drug Regulation, final report, 1977 BOX II:191 Reye’s syndrome See same container, Salicylates BOX II:191 Rezulin See Container II:156, Hypoglycemic oral agents BOX II:191 Rounds, 1972-1981, undated BOX II:191 Royal Society of Medicine, London, England, 1965-1969, 1989, 1996-1999 BOX II:191 Salicylates, 1959-1985, undated BOX II:191 Schering Corp. See Container II:142, Flunixin BOX II:191 Schiffirin, M. J., 1965, 1973, 1984, 1998 BOX II:191 Selenium See Container II:206, Toxicology BOX II:191 Semustine See Containers II:180-II:182, National Cancer Institute BOX II:191 Separation of functions, 1980 BOX II:191 Serc (Drug), 1968-1969, 1996, undated BOX II:191 Serotonin, 1963-1964, 1970, undated BOX II:191 Shepard, Thomas H., Compendium of Teratogens, 1971, 1996 BOX II:192 Shopsin, Baron, 1991 BOX II:192 Sigma Xi, The Scientific Research Society, U.S. Food and Drug Administration club, 1982-1987, 1996-1997, 2012 BOX II:192 Sjoerdsma, Albert, honorary banquet for, 1989 BOX II:192 Society of Nuclear Medicine, 1960-1973, 1998, undated BOX II:192 Society of Toxicology, 1964, undated BOX II:192 Special Survey: Sponsors and Investigators of Clinical Investigations, report on BOX II:192 1970-1980 (6 folders) BOX II:192 Undated (1 folder) BOX II:193 (1 folder) BOX II:193 Spermacides/trichamonacides, 1972-1986 BOX II:193 Staff College Executive Committee, 1989-1990 BOX II:193 Stem cells, 2000-2001 BOX II:193 Stolpen, Adam, “Allergic Drug Reactions: Where Does the Duty Lie?” circa 1970, 1997 BOX II:193 Straus, Marc J., 1980-1982, 1996-1997, undated (4 folders) BOX II:193 Submission management and review tracking, 1995 BOX II:193 Summers, William K., 1987-1989, 1997-1999, undated BOX II:193 Supplements, memoranda by Kelsey, 1968

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BOX II:194 Suprofen, 1987 BOX II:194 Tamoxifen, report, 1997 BOX II:194 Taussig, Helen B., 1977, 1988, 1994, 2001, undated BOX II:194 Teplick, Steven K., hearing at U.S. Food and Drug Administration, 1993-1999 BOX II:194 Teratology BOX II:194 General, 1946, 1960-1962, 1968-1997, undated (2 folders) BOX II:194 Screening procedures BOX II:194 1962-1969 (3 folders) BOX II:195 circa 1960s BOX II:195 1970-1995, undated (9 folders) BOX II:195 Teratology Society, 1961, 1974, 1984-1988, 1998, 2011, undated BOX II:196 Tetracyclines/sulfonamides, 1961-1979, undated BOX II:196 Thalidomide BOX II:196 Archer, John D., 1960-1979, 1986, 1996-1998, undated (2 folders) BOX II:196 Bell, Peter D., “The Thalidomide Case,” 1963, 1995 BOX II:196 Broadsides, “Drug Detective, Frances O. Kelsey, M.D.,” circa 1963 See also Oversize BOX II:196 Burkholz, Herbert, “Giving Thalidomide a Second Chance,” 1997 BOX II:196 Chick studies, 1962-1969 BOX II:196 CIBA Pharmaceutical Co., 1962, undated BOX II:196 Cost recovery for thalidomide for sponsor-investigator investigational new drugs, 1996, undated BOX II:196 Deformities, no evidence of, 1962-1963 BOX II:196 Drug deformities BOX II:196 Foundation for Medical Research Perinatal Study, Philadelphia, Pa., 1962-1966 BOX II:196 Northrup, Harriett E., 1962 BOX II:197 Epstein, Beryl, and Samuel Epstein, Who Says You Can’t?, 1968 BOX II:197 Exhibits, 1956-1961 BOX II:197 FDA Consumer Memo and FDA Fact Sheet, 1968, 1974 BOX II:197 FDA Dermatological and Ophthalmic Drugs Advisory Committee, 1996-1997 BOX II:197 FDA Thalidomide Working Group BOX II:197 1961, 1988-1998 (7 folders) BOX II:198 1999-2001 (4 folders) BOX II:198 Undated and fragments BOX II:198 FDA/National Institutes of Health Workshop, “Thalidomide: Potential Benefits and Risks,” 1997 (1 folder) BOX II:199 (2 folders) BOX II:199 General BOX II:199 1960-1979 (6 folders)

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BOX II:200 1980-2002, undated (7 folders) BOX II:200 Inspection report for SKG #5627, 1962 BOX II:201 Investigation of Trent Busby, 1961-1962 BOX II:201 Isomers and others, 1961-1963, 1970, 1979-1990, undated (2 folders) BOX II:201 Kevadon BOX II:201 Memoranda, 1960-1962 (3 folders) BOX II:201 Microfiche of documents from unapproved new drug applications 12611 and 12711 (thalidomide) obtained through Freedom of Information Act request of John Carey, 1978 Microfiche shelf no. 22,656 BOX II:201 Telephone calls, 1962-1963 (2 folders) BOX II:201 Legal cases BOX II:201 Diamond, Thomas David, 1962, 1969 BOX II:201 Grünenthal GmbH BOX II:201 Brochure material, William S. Merrell Co., circa 1961 BOX II:202 Correspondence BOX II:202 Distillers Co. (Biochemicals), circa 1959-1962 BOX II:202 National Drug Co., 1961-1962 (2 folders) BOX II:202 William S. Merrell Co., 1961-1962 (3 folders) BOX II:202 Kelsey memorandum, 1994 BOX II:202 Marshall, Alan David, 1962 BOX II:202 McCarrick v. Richardson-Merrell, includes testimony of Kelsey, 1971 BOX II:202 McKenna v. United States, 1995-1996 BOX II:203 Rowe, Lynette Suzanne, 2012 BOX II:203 United States v. John Doe, 1962 BOX II:203 Material received through Freedom of Information Act request of Burton L. Appleton, 1960-1961, 1995 BOX II:203 Names marketed under, undated BOX II:203 Peripheral neuritis, 1961-1973, 1984, 1993-1997 BOX II:203 Popular and semipopular articles, 1963 BOX II:203 Press coverage and Kelsey, 1962 BOX II:203 Numbered BOX II:203 Vols. 3-9 (5 folders) BOX II:204 Vols. 11-14 (3 folders) BOX II:204 Unnumbered BOX II:204 Vols. A-D (4 folders) BOX II:205 Vols. E-M (9 folders)

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BOX II:206 Smith, Kline & French Laboratories, Philadelphia, Pa., 1962, 1995 (2 folders) BOX II:206 Survey of city health workers, 1962 BOX II:206 Taussig, Helen B. See Container II:194, same heading BOX II:206 Therakos, Inc. See Container II:186, Oxsoralen BOX II:206 Third-party certification, 1994-2000 (3 folders) BOX II:206 Third-party notification, 1979-1984, undated (2 folders) BOX II:206 Thyroid: diseases, iodine, iodine 131, and thyroxine, 1960-1972, 1978-1988, 1998-2001, undated BOX II:206 Toxic shock syndrome, 1980-1984 BOX II:206 Toxicology BOX II:206 1944, 1952-1969 BOX II:207 1970, 1977-1982, 1993-1998, undated BOX II:207 Tranquilizers BOX II:207 General, 1962-1969, 1980, 1991, 1998, undated BOX II:207 Milkovitch, Lucille, 1972-1974, undated BOX II:207 Stelazine investigation, 1953-1962, undated (2 folders) BOX II:207 Triancinalone, 1962-1968 BOX II:207 Triflocin, 1975, 1996, undated BOX II:207 Triparanol (MER-29), 1962-1966, 2001 BOX II:208 Tuchmann-Duplessis, Herbert, articles, 1963-1964 BOX II:208 University Group Diabetes Program, 1976-1979, 1996-1999 BOX II:208 Urokinase, 1972-1974 BOX II:208 “Use of Drugs for Unapproved Indications: Your Legal Responsibility,” 1972, 1987 BOX II:208 Useless drugs lists, circa 1960-circa 1962 BOX II:208 Vasodilator, 1962, 1972, 1997 BOX II:208 Versed, 1989, undated BOX II:208 Vicks investigation, 1975 BOX II:208 Vidarabine, 1975-1979 BOX II:208 Viral infections including German measles, 1941, 1961-1974, 1980-1993, undated (2 folders) BOX II:208 Virazole, 1978-1988, 1996-2000, undated (4 folders) BOX II:208 Vitamin D and Vitamin A BOX II:208 1962-1969 BOX II:209 1970-2002, undated (5 folders) BOX II:209 Vitamin K, 1962-1964, 1970 BOX II:209 Women in medicine and science, 1961-1970, 1981-1985, 1996-2001, undated BOX II:209 World Health Organization BOX II:209 Draft guidelines for good clinical practices, 1991-1993 BOX II:210 General, 1979, undated BOX II:210 World Medical Association, declaration of Helsinki, Finland, 1976-1983, 1989, 1999, undated

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BOX II:210 Yunnan baiyao, undated

BOX II:210 Certificate, 1939 BOX II:210 General correspondence, 1960-1966 BOX II:210 Miscellany BOX II:210 Chronological file BOX II:210 1952-1962 (4 folders) BOX II:211 1963-1967, undated (6 folders) BOX II:211 “News Items,” 1965 BOX II:211 Personal folder, 1959-1966, undated BOX II:211 Subject file BOX II:211 Ad hoc review letters, 1960-1961, undated BOX II:211 Advisory Committee on Epidemiology and Biometry BOX II:211 General, 1961-1962, undated BOX II:212 Subcommittee on Evaluation, 1958-1962, undated (3 folders) BOX II:212 American Chemical Society, 1960-1961 BOX II:212 American Institute of Biological Sciences, 1961, undated BOX II:212 American Medical Association, 1961 BOX II:212 American Society for Pharmacology and Experimental Therapeutics, Committee on Educational Affairs, survey of graduate education in pharmacology, 1959-1962, undated (3 folders) BOX II:212 Anecdotes, 1960, undated BOX II:212 Association of American Medical Colleges, 1959-1961 BOX II:212 Budget, National Institutes of Health, 1959-1961, undated BOX II:213 Bureau of Environmental Health, 1960-1961 (2 folders) BOX II:213 California Heart Association Research Committee, 1958-1961 BOX II:213 Civil Service regulations, 1960-1961, undated BOX II:213 Congressional testimony of Kelsey, 1963 BOX II:213 Daily board, research grants, 1960-1961 (3 folders) BOX II:213 Epidemiology and biometry training grants, annual reports, 1961 BOX II:213 Federation for American Societies for Experimental Biology, 1959-1961, undated BOX II:213 Food and Drug Administration BOX II:213 General BOX II:213 1959-1961 BOX II:214 1962, undated BOX II:214 New drugs, 1960-1962 BOX II:214 Pharmacology Division, 1959-1961, undated

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BOX II:214 General Research Support Grant Program, 1961 BOX II:214 Governor’s Committee for the Handicapped, Pennsylvania, 1961-1962 BOX II:214 Graduate Medical Education Conference, University of Pennsylvania, Philadelphia, Pa., 1961 BOX II:214 Health Research Facilities Program, 1959-1960 BOX II:214 International medical research, 1958-1961 BOX II:214 Journal of Medical Education, 1961, 1966 BOX II:215 Masserman, Christine McGuire and Jules H., 1953, 1961 BOX II:215 Medical student research training, 1960-1961, undated BOX II:215 Mundt, Karl E., 1961 BOX II:215 National Academy of Sciences-National Research Council, 1961 BOX II:215 National Library of Medicine, Bethesda, Md., 1958-1965 BOX II:215 National Science Foundation, 1960-1962 BOX II:215 Neurological diseases and blindness, undated BOX II:215 New medical schools, 1956-1961, undated (2 folders) BOX II:215 New programs, 1958-1961, undated (2 folders) BOX II:216 Newsletter items, 1959-1961, undated BOX II:216 Pediatric pharmacology, 1960, undated BOX II:216 Pesticides, 1960 BOX II:216 Postage stamps, 1960-1961, undated BOX II:216 Primate centers, 1961 BOX II:216 Program planning, 1960-1961, undated BOX II:216 Research Grants Branch, minutes, 1960-1961 BOX II:216 Research Training Branch, staff, 1960-1961, undated BOX II:216 Resources analysis, 1961 BOX II:216 Society for General Systems Research BOX II:216 1957-1958 (2 folders) BOX II:217 1959 BOX II:217 Special research resources, 1961, undated BOX II:217 Stanford University, Stanford, Calif., 1962 BOX II:217 Surgeon General’s Conference on Health Communications, Warrenton, Va., 1962 BOX II:217 Testing, 1960-1961 BOX II:217 Training Branch, 1961 BOX II:217 Training grants and fellowships, 1960-1961, undated BOX II:217 Training survey of scientific areas, 1961, undated BOX II:217 Travel for staff, 1959-1961 BOX II:217 Writings BOX II:217 Lists, 1935-1965 BOX II:217 1939-1949

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BOX II:218 1950-1968 (3 folders)

BOX II:OV 1 Personal File BOX II:OV 1 Awards, certificates, citations, and diplomas BOX II:OV 1 Documents, 1934-1935, 1952, 1962-1971, 1984, 2001, 2012, undated (Containers II:13- II:14) BOX II:OV 2 Research file BOX II:OV 2 Card index, undated (Container II:26) BOX II:OV 3 University of South Dakota, Vermillion, S. Dak. BOX II:OV 3 Protein-bound iodine BOX II:OV 3 Patient card file, circa 1955-circa 1960 (Container II:36) BOX II:OV 4 Speeches and Writings File BOX II:OV 4 By Kelsey BOX II:OV 4 Speech and engagement file BOX II:OV 4 1982, Aug. 31-Sept. 3 BOX II:OV 4 Menu, 1982, Sept. 2 (Container II:68) BOX II:OV 4 Writings BOX II:OV 4 Book, Essentials of Pharmacology, BOX II:OV 4 Chapters, background information BOX II:OV 4 No. 29 BOX II:OV 4 Map showing world distribution of malaria vectors, 1951 (Container II:91) BOX II:OV 4 Subject file BOX II:OV 4 Congressional BOX II:OV 4 Hearings BOX II:OV 4 Senate BOX II:OV 4 Interagency Coordination in Drug Research Regulation BOX II:OV 4 Memoranda from Senator Hubert H. Humphrey, 1961 (Container II:121) BOX II:OV 4 Thalidomide BOX II:OV 4 Broadside, "Drug Detective, Frances O. Kelsey, M.D." circa 1963 (Container II:196)

DF 1 Digital files, 1991-1997 Digital ID: mss84006_125_001 Digital ID: mss84006_125_002 Digital ID: mss84006_125_003

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Digital ID: mss84006_125_004 Digital ID: mss84006_125_005 Digital ID: mss84006_125_006 Digital ID: mss84006_125_007 Digital ID: mss84006_125_008 Digital ID: mss84006_125_009

Frances Oldham Kelsey Papers 55