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MOU 225-04-8000A

Memorandum of Understanding

Between
The Food and Drug Administration

and

 

The National Library of Medicine

 

I. Purpose

The purpose of this agreement is to transfer an initial lot of records and arrange the future transfer of similar records on a continual basis from the Food and Drug Administration (FDA) to the National Library of Medicine, National Institute of Health (NIH).

 

II. Background

This agreement is needed to ensure the preservation of and access to a collection of historically significant records. Judicial case files (formerly known as seizure case files) are the published and unpublished documentation of action taken by the Bureau of Chemistry (1907-1927), the Food, Drug, and Insecticide Administration (1927-1930), and the Food and Drug Administration (1930 to the present) against violations of the laws under the jurisdiction of FDA and its predecessor agencies; for the majority of actions, the laws in question are the 1906 Food and Drugs Act and the 1938 Food, Drug, and Cosmetic Act. Because of the increasing breadth of these laws, the judicial case files offer a unique insight into the span of the twentieth-century American marketplace—especially certain health related industries—and the consumer’s place therein. Also, they shed light on the relationship between government and industry, particularly in the way manufacturers provided health care and nutrition to the public. Such a view would be difficult or impossible to achieve in any other single collection of records.

 

The National Archives has classified the judicial case files as temporary records in FDA’s Records Control Schedule. Under provisions for the disposition of temporary records in 36 CFR 1228.60 and 36 CFR 1228.136, FDA has sought to identify a venue where these records can be cared for indefinitely and made available to the public. The National Library of Medicine has a well-known archive that has been used by researchers from around the world. The judicial case files fit in well with NLM’s archival documentation strategy that, among other aims, captures the development of biomedical science and health care in America. As with its many other collections of records, NLM would be able to publicize the judicial case files to a wide audience of historians and other researchers.

 

III. Substance of Agreement and Responsibilities of Each Agency

This agreement binds FDA as a donor of certain of its records, and NLM as a recipient and repository of the same records. FDA agrees not to destroy any judicial case files, and to transfer all rights, responsibilities, and ownership of said records to NLM. FDA acknowledges that the copyright of all materials contained in the collection that have been prepared by Federal officials in the performance of their official duties are in the public domain. NLM in turn agrees to apply to this collection all standard operating procedures of archival management, to utilize for this collection the same means used to publicize other collections in its archive, and to make the collection available to all interested parties under the policies in effect for administration of archival collections. NLM may transfer to another institution or dispose of any of the materials that it determines are not required by the Library. However, prior to such a transfer or disposal, NLM will notify FDA and arrange to return these materials, if so requested.

 

The transaction of records is to be initiated with a transfer, as soon as practicable, of one group of records consisting of 13 accession lots, covering the approximate period from 1907-1963. These records are identified below:

 

Records Series WNRC Accession No. Period Covered Volume
Seizure/Prosec.
boxes;
88-59B-2098 1907-1937 870 cu. ft. (1446
bx 1-1446)
Seizure Case 88-52A-89) 1938-1940 121 cu. ft. (121 boxes; bx 1-121)
Seizure Case boxes; 88-52AA-214 1940-1944 37 cu. ft. (37 bx 1-37)
Seizure Case 88-52AB-214 1940-1944 135 cu. ft. (135 boxes; bx 52-186)
E&F Case 88-52B-214 1940-1944 191 cu. ft. (191 boxes; bx 187-377)
F Seizure Case boxes; 88-52C-214 1940-1944 63 cu. ft. (81 bx 378-458)
Seizure/Prosec. 88-52D-214 1940-1944 14cu. ft. (14 boxes; bx 38-51)
Seizure Case 88-56A-278 1945-1947 208 cu. ft. (208 boxes; bx 1-208)
MFG Card Index 88-56B-278 1907-1940 16 cu. ft. (16 boxes; bx 209-224)
Seizure Case 88-59A-2703 1947-1950 189 cu. ft. (189 boxes; bx 1-189)
Seizure Case 88-60A-554 1951-1954 186 cu. ft. (186 boxes; bx 1-186
Seizure Case 88-63A-128 1954-1957 117 cu. ft. (117 boxes; bx 1-117)
Seizure Case 88-64A-314 1958-1963 100 cu. ft. (100 boxes; bx 1-100)

 

Subsequent transfers of records dated after 1963, though the volume of records in each transaction may vary, will occur at regular intervals, at times and places agreeable to both parties. However, no records less than 20 years old will be transferred. No later than 31 December 2005, all judicial case files up through 1970 will be transferred by FDA to NLM; no later than 31 December 2007, all judicial case files up through 1980 will be transferred by FDA to NLM; and no later than 31 December 2009, all judicial case files up through 1988 will be transferred by FDA to NLM. Thereafter, every five years FDA will transfer to NLM all judicial case files that are 21 years old or older.

 

IV. Name and Address of Participating Parties

 

A. Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

 

B. National Library of Medicine
National Institute of Health
8600 Rockville Pike
Bethesda, Maryland 20894

 

V. Liaison Officers

 

A. Contacts for FDA

a) Seung Ja Sinatra, FDA Records Officer, Division of Management
Systems, Office of Management Programs, Office of Managements
Systems, Office of the Commissioner, HFA-250, Room 4B-41, 5600
Fishers Lane, Rockville, Maryland 20857, 301-827-4274
(ssinatra@oc.fda.gov)

b) John P. Swann, FDA Historian, FDA History Office, Office of Resource Management, Office of Regulatory Affairs, HFC-24, Room 12-69, 5600
Fishers Lane, Rockville, Maryland 20857, 301-827-3756
(jswann@ora.fda.gov)

 

B. Contacts for NLM

a) National Institutes of Health, 8600 Rockville Pike, Bethesda, MD 20894,
301-594-0975 (paul_theerman@nlm.nih.gov)

b) John Rees, Associate Curator of Manuscripts, History of Medicine
Division, Room 1 E-21, Building 38, National Library of Medicine,
National Institutes of Health, 8600 Rockville Pike, Bethesda, MD 20894,
301-496-8953 (john_rees@nlm.nih.gov)

 

VI. Period of Agreement

The agreement becomes effective upon signature of both parties and will continue without expiration. It may be modified by mutual consent or terminated by either party upon 120 days written notice.

Approved and Accepted
for the National Library of Medicine

Signed by: Jon G. Retzlaff
Executive Officer
National Library of Medicine

Date: December 30, 2003

 

Approved and Accepted
for the Food and Drug Administration

Signed by: Jeff Weber
Associate Commissioner for Management
Office of Management
Food and Drug Administration

Date: December 23, 2003