[Federal Register Volume 60, Number 83 (Monday, May 1, 1995)]
[Notices]
[Pages 21214-21215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10644]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[FDA-225-94-3000]


Memorandum of Understanding Between the Food and Drug 
Administration and the National Institutes of Health

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between FDA and the National 
Institutes of Health (NIH). The purpose of this MOU is to establish a 
relationship between the Center for Drug Evaluation and Research, FDA, 
and the Epilepsy Branch, National Institute of Neurological Diseases 
and Stroke, NIH, so that joint experiments can be conducted relating to 
drug metabolism and drug-drug interactions.

DATES: The agreement became effective December 13, 1993.

FOR FURTHER INFORMATION CONTACT: Jerry M. Collins, Center for Drug 
Evaluation and Research (HFD-400), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-4750.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and memoranda of understanding 
between FDA and others shall be published in the Federal Register, the 
agency is publishing notice of this memorandum of understanding.

    Dated: April 25, 1995.
William B. Schultz,
Deputy Commissioner for Policy.

Memorandum of Understanding Between the U.S. Department of Health and 
Human Services, National Institutes of Health, National Institute of 
Neurological Diseases and Stroke, Epilepsy Branch and the U.S. 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research

I. Purpose

    The purpose of the proposed Memorandum of Understanding (MOU) is 
to establish a relationship between the Center for Drug Evaluation 
and Research (CDER), Food and Drug Administration, and the Epilepsy 
Branch, National Institute of Neurological Diseases and Stroke, so 
that joint experiments can be conducted relating to drug metabolism 
and drug-drug interactions.

II. Background

    Drug metabolism and drug-drug interactions represent significant 
issues for the FDA's mission to ensure safe and effective drugs with 
adequate instructions for use. For both metabolism and interactions, 
studies in vitro can provide substantial information needed for drug 
development and regulation. Review and laboratory scientists in CDER 
have become increasingly involved in the development of the 
technology for testing in vitro, and its application to modern drug 
development and regulation.
    The Antiepileptic Drug Development (ADD) Program of the National 
Institute of Neurological Disorders and Stroke (NINDS) was 
established to collaborate with the private sector and academia 
effective and safe drugs for the treatment of seizures in epileptic 
patients. The ADD Program includes preclinical pharmacodynamic and 
pharmacokinetic as well as clinical investigations. The Preclinical 
Pharmacology Section of the Epilepsy Branch is responsible for 
identifying potential compounds through a multistage screening 
program. At present, drug-drug interactions are found by chance, as 
new therapeutic agents proceed through the developmental process and 
enter clinical trials with comedicated epileptic patients. A 
critical need exists to establish possible drug-drug interactions 
prior to the initiation of clinical trials.

III. Substance of Agreement

    Staff of both the FDA's Division of Clinical Pharmacology and 
the Preclinical Pharmacology Section, Epilepsy Branch, NINDS will 
collaborate in determining metabolic pathways and potential drug-
drug interactions of ADD Program compounds. The basic technology for 
evaluating drug-drug interactions exists in the FDA's laboratory 
through the use of human liver slices and subcellular fractions. The 
division of labor for these studies are based on the expertise and 
equipment found in each laboratory. Analytical methods for the 
identification and quantification of metabolites of the experimental 
compounds and clinically effective antiepileptic drugs will be 
developed in both laboratories under a mutual agreement based on 
available resources. The compounds will be supplied by the Epilepsy 
Branch following an agreement with the pharmaceutical sponsor. All 
data from these studies will remain confidential as stipulated under 
the present NINDS ADD Program preclinical confidentiality agreement. 
Any information obtained or generated under this Memorandum of 
Understanding will not be disclosed by FDA staff to anyone outside 
FDA or NINDS without permission from NINDS or the pharmaceutical 
sponsor. [[Page 21215]] 

IV. Participating Parties

Epilepsy Branch, National Institute of Neurological Disorders and 
Stroke, National Institutes of Health, Federal Bldg, Rm. 118, 
Bethesda, MD 20892
Division of Clinical Pharmacology, Office of Research Resources, 
Center for Drug Evaluation and Research, Food and Drug 
Administration, 4 Research Ct., Rm. 314, Rockville, MD 20850

V. Liaison Officers

For the Epilepsy Branch: Harvey Kupferberg, Ph.D., Epilepsy Branch, 
NINDS, NIH, Federal Bldg, Rm. 118, (301) 496-1846 [phone], (301) 
496-9916 [fax]
For the Division of Clinical Pharmacology: John M. Strong, Ph.D., 
Food and Drug Administration, 4 Research Ct., Rm. 314, Rockville, MD 
20850, (301) 427-1065 [phone], (301) 427-1026 [fax]

VI. Period of Agreement

    This agreement becomes effective upon acceptance by both parties 
and will continue in effect indefinitely. It may be modified by 
mutual written consent or terminated by either party upon a 60-day 
advance written notice to the other party.
    Approved and Accepted for the Epilepsy Branch, NINDS
By: Harvey J. Kupferberg
Title: Chief, PPS, EB, DCDND, NINDS, NIH
Date: December 13, 1993
    Approved and Accepted for the Food and Drug Administration
By: Jerry M. Collins
Title: Director, Office of Research Resources, CDER/FDA
Date: December 1, 1993
[FR Doc. 95-10644 Filed 4-28-95; 8:45 am]
BILLING CODE 4160-01-F