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MOU 225-74-1010

Memorandum of Understanding

Between
The Animal and Plant Health Inspection Service
United States Department of Agriculture 

and

The National Institues of Health
United States Department of Health and Human Services

and

The Food and Drug Administration
United States Department of Health and Human Services

 

MEMORANDUM OF UNDERSTANDING AND AGREEMENT

Regarding Importation of Biological Specimens
Under the US--USSR Scientific Exchange Agreement

 

A. Background:

In accordance with the bicountry agreement for US – USSR collaborative research in viral oncology, there are occasions for importation by National Institutes of Health (NIH) into the U.S.A. of biological specimens from the collaborating laboratories of the USSR. It is in the good interests of the United States and the terms of the intercountry agreement that, to the extent possible, these specimens be received by NIH and submitted by the National Cancer Institute (NCI) and others to appropriate research studies.

It is the recognized responsibility of individuals concerned with the above program, and of the proper authorities of the U.S. Department of Agriculture (USDA), to take whatever steps necessary to prevent the imported biological specimens from becoming the source of exotic diseases in the livestock populations of the United States. It is also recognized that the USDA has regulatory authority to refuse permission or to approve the importation of potentially hazardous biological specimens and to prescribe the terms and conditions for the handling of imported specimens.

 

B. Agreed Procedure:

This section outlines in general the procedures and testing methods agreed upon at the NIH-USDA meeting held 9 July 1973 and in subsequent discussions. Changes in details, within these accepted procedures, can be effected through the liaison officers for this agreement listed below; significant changes in the procedures and testing methods can be effected only through a document bearing the signatures of the signatories to this Memorandum of Understanding and Agreement.

 

USDA Liaison Office- Dr. K.R. Hook Animal and Plant Inspection Service
U.S. Department of Agriculture
Federal Center Building
Hyattsville, Maryland 20782
(301) 436-8017

 

NIH Liaison Office - Dr. E.C. Chamberlayne
NIH Quarantine Permit Service Office
Building 31, Room 7A50
National Institutes of Health
Bethesda, Maryland 20014
(301) 496-2516

 

1. To the extent possible, NIH will apply for a USDA import permit prior to each importation of pertinent biological specimens involved in the NCI viral oncology studies.

 

2. Specimens, for which an import permit has been issued by the USDA, shall go directly to the "NIH Quarantine Site" (i.e., Suite 100, Bldg. 41, NIH). While processing to maintain viability of the specimens may take place within the "Site," no specimens, deemed to be of a potential livestock disease hazard, shall be removed from the "Site" except as specifically approved by USDA.

 

3. All specimens with a potential livestock disease hazard will be submitted to the following testing.

 

a) For exotic mycoplasmas by:

Dr. Michael F. Barile
Division of Bacterial Products, BB/FDA
Bldg. 29, Rm. 424, NIH

 

b) For tentative evidence, and to the extent listed below, of certain animal disease viruses by:

NCI Staff Scientists
Bldg. 41, Suite 100, NIH

-or when approved by USDA by NCI contractor:

Laboratory of Dr. S. A. Mayyasi
Pfizer, Inc.
Maywood, New Jersey 07607

as follows:

 

(1) Release of potential virus from cells by a variety of methods (freeze-thawing, denaturing, enzyme destruction, etc.); following which the released material should be concentrated and inoculated for determination of CPE into:

(i) The following primary cultures:

Bovine embryonic kidney
Bovine thyroid

(ii) At least two of the following cell cultures:

PK15, MDBK, Vero

(iii) Material should be inoculated into embryonated chicken eggs, and intracerabrally into mice.

 

(2) Materials giving suspicious test results are to be tested against specific neutralizing antisera, supplied gratis by PIADL/USDA

 

(3) In the absence of positive or suspicious results in the tests listed under (1) above, the cell cultures should be examined, by NCI, by electron microscopy (EM) for the presence of microbial agent particles. When such particles are detected by EM further testing of the specimens will be decided by the proper authorities related to this agreement.

 

(4) Specimens for which positive results occur in testing indicated above in 3. a) or b) (1) and (2) will be released to a USDA courier for transport to PIADL for further testing, providing:

(a) NCI retains a prerogative to choose as an alternate action, for each set of specimens found positive in testing in 3. a) or b) (1) and (2), destruction at the "Site" of the set of specimens, or

(b) NCI/NIH transmit to ARS/USDA, on Standard Form 1080, $6,000.00 for testing at PIADL each set of specimens.

 

(5) Specimens for which negative results occur in testing indicated above in 3. a) and b) will be released for in vitro research studies in laboratories as specifically approved by USDA.

 

(6) None of the specimens described in 2. above shall be submitted to in vivo studies, or release to the U.S. scientific community, until aliquots of the candidate specimens have been tested by PIADL and/or as specifically released by USDA.

 

C. Understanding:

Test results will be discussed by those involved in this procedure prior to decisions and actions regarding imported specimens.

Except as indicated herein, or to the extent other arrangements are made, funding of the testing outlined above will be provided by the agency or the staff members, or contractors, conducting the tests.

 

This Memorandum of Understanding and Agreement may be cancelled or modified through notification or negotiation conveyed or conducted via the USDA and NIH Liaison Offices listed in section B above.

Approved and Accepted
for the United States Deparment of Agriculture

Signed by: Dr. Frank J. Mulhern
Administrator, Animal and Plant Health Inspection Service, USDA

Date: July 5, 1974

Approved and Accepted
for the United States Deparment of Agriculture

Signed by: Mr. T.W. Edminster
Associate Director, Agriculture Research Service, USDA

Date: July 15, 1974

Approved and Accepted
for the National Institutes of Health

Signed by: Dr. John B. Moloney
Associate Director, Viral Oncology, DCCP, NCI, NIH

Date: April 30, 1974

Approved and Accepted
for the Food and Drug Administration

Signed by: Sam D. Fine
Associate Commissioner for Compliance (HFC-1)

Date: April 11, 1974