21214 Federal Register / Vol. 60, No. 83 / Monday, May 1, 1995 / Notices

0) or ‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the INTRODUCTION may be

obtained through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: April 24, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–10591 Filed 4–28–95; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 93F–0050]

E. I. du Pont de Nemours and Co.;

Withdrawal of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to future

filing, of a food additive petition (FAP

3B4360) proposing that the food

additive regulations be amended to

provide for the safe use of

perfluoroalkylethyl acrylate copolymer,

produced by the copolymerization of

perfluoroalkylethyl acrylate, octadecyl

methacrylate, vinylidene chloride, 2-

hydroxyethyl methacrylate and

polyoxyethylene methacrylate, as an oil

and water repellant in paper and

paperboard intended for food-contact

use.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

216), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3086.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

March 12, 1993 (58 FR 13603), FDA

announced that a food additive petition

(FAP 3B4360) had been filed by E. I. Du

Pont de Nemours and Co., Du Pont

Chemicals, Jackson Laboratory,

Chamber Works, Deepwater, NJ 08023.

The petition proposed to amend the

food additive regulations in § 176.170

Components of paper and paperboard

in contact with aqueous and fatty foods

(21 CFR 176.170) to provide for the safe

use of perfluoroalkylethyl acrylate

copolymer, produced by the

copolymerization of perfluoroalkylethyl

acrylate, octadecyl methacrylate,

vinylidene chloride, 2-hydroxyethyl

methacrylate, and polyoxyethylene

methacrylate, as an oil and water

repellant in paper and paperboard

intended for food-contact use. Du Pont

has now withdrawn the petition without

prejudice to a future filing (21 CFR

171.7).

Dated: April 11, 1995.

Alan M. Rulis,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–10645 Filed 4–28–95; 8:45 am]

BILLING CODE 4160–01–F

[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.

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 drugdrug 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 drugdrug 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.