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Federal Rogislar / Vol. 53, No. 140 / Thursday, July 21. 19UU / Notices 
laboratories and auditing tho data from 
the studies conducted in the UK. 
B. National Inspection Programs 
The participating parties assess 
compliance of a laboratory wtth the 
standards of good laboratory practice by 
having a trained government inspector 
conduct a laboratory inspection 
approximately once every two years. 
The inspection programs permit 
assessment of current laboratory 
operations as well as the audit of data 
from completed studies. Laboratories 
are generally pro-notified and 
inspectional procedures are mutually 
consistent among the parties. A report of 
the results of the inspection is prepared 
that describes laboratory operations and 
addressas conformity with good 
laboratory practice standards and when 
appropriate, verification of adheronce to 
study plans and data validation. 
C. Compliance 
Each of the parties has established 
satisfactory procedures to secure the 
compliance of laboratories with tho 
standards of good laboratory practice. 
These procedures Include, for example, 
notifying a laboratory of deficiencies 
observed and the Issuance of corrective 
and/or warning notices, or the removal 
of a laboratory from national GLP 
compliance programs. Those and other 
actions may lead regulatory authorities 
to invalidate specific studies or to 
cancel or refuse registration of specific 
chemicals. In some cases, depending 
upon the gravity and extent of the 
violation, more severe penalties may be 
applied. 
III. Substance of the Agreement 
A. The parties agree that: 1. 
Adherence to adequate standards of 
good laboratory practice Is essential to 
the conduct of high quality safety 
testing; 
2. A national program of periodic 
Inspections conducted by a trained 
inspectorate is required to monitor 
adherence to the standards of good 
laboratory practical 
3. Appropriate compliance procedures 
are necessary to assure adherence to the 
standards of good laboratory practice: 
4. Studies conducted in accordance 
with the respective standards of good 
laboratory practice promulgated by 
either country are to be acceptable to 
the parties for evaluation of safety. 
B, Each party will: 1. Inform the other 
parties of changes in their respective . 
good laboratory practice standards and 
thoir respective inspection program?;.- 
2. Provide tho othor parties quarterly, 
with the names and addresses of health 
and environmental testing laboratories 
operating within their national 
boundaries, the dates inspected, and the 
compliance. designation of tho 
laboratories which are inspected under 
the good laboratory- practice program: 
3. Provide upon request of one of tho 
other parties, further information 
regarding whether or not a specific 
laboratory or study is in compliance 
with the good laboratory practice 
Standards; 
4. Agree to a request by the other 
party to conduct a good laboratory 
practice inspection or data audit at a 
specified health or environmental 
laboratory whenever (a) there is serious 
concern about the quality and integrity 
of the data submitted to either country, 
(b) an Inspection has nol been 
performed within the last 2 years, or (c) 
an approval of an application for 
research and/or marketing parmit is 
pending based upon tests performed in a 
specified testing facility whith are 
important to granting the approval. In 
exceptional situations in which tho 
requesting party can Justify a special 
concern, the requesting party may 
designate one or more of its scientists to 
participate In the audit of a study; 
5. Conduct a joint Inspection of a 
laboratory each year in order to 
maintain a continuing understanding of 
each party’s inspection techniques. 
These joint inspections are to alternate 
each year in the United States and the 
United Kingdom; 
6. Recognize the need to protect from 
public disclosure data and information 
that are exchanged between the parties 
' d that fall within the definition of a 
de secret, or confidential commercial 
financial Information. 
IV. Participating Parties 
A. Food and Drug Administration, 5600 
Fishers Lane. Rockville, Maryland 
20857 
B. Environmental Protection Agency, 401 
M Street. SW., Washington. DC 20460 
C. Department of Health and Social 
Security, Hannibal House, Elephant 
and Castle, London SEl 6TE England 
V. Liaison Officers 
The parties respectively appoint the 
following officials to serve as liaison 
officars for all communications 
regarding matters relative to the 
memorandum, 
A. For the Food. and Drug 
Administration: Director, Division of 
Compliance Policy, Office of Regulatory 
Affairs, (Currently: Mr. Ernest L, 
Brisson), 5600 Fishers Lane, Rockvillu, 
Maryland 20587. 
B. For the Environmental Protgection 
Agency: Director, Laboratory Data 
Integrity Program, Office of Compliance 
Monitoring, (Currently: Dr. Dexter 
Goldman), 401 M Street, SW., 
Washington, DC 20460. 
C. For tho Department of Health and 
Social Security: Chief, Good Laboratory 
Practice Monitoring Unit, Medical 
Division of Toxicology and 
Environmental Protection, (Currently: 
Mr. M. J. Van den Heuvet), Hannibal 
House, Elephant and Castle, London, 
SEl OTE England. 
VI, Duration of Agreement 
This agreement shall became effective 
upon the date of the last signature and 
shall remain in effect for a period of five 
(5) years. It may be extended or 
amendod by mutual written consent or 
terminated by any party upon written 
notice to the other parties. 
Approved and accepted for the food 
and Drug Administration. 
Frank E. Young, 
Commissioner of Food and Drugs. 
Date; Murch 28, 1089. 
Approved and accepted for the. 
Environmental Protection Agency. 
John A Moore, 
Assistant Administrator, OPTS. 
Date: Fobruary 3. 1888. 
Approved and accepted for the 
Department of Health and Social 
Security. 
Dr. B.H. MacClbbon, 
Head, Medical Division of Toxicology and 
Environmental Protection. 
Date: December 31, 1087. 
(PR Doc. 88-18379 Fllod 7-20-38: 8:45am) 
DlUINQ CODE 4MO-01-M 
National Institutes of Health 
Recombinant DNA Advisory 
Committee Ad Hoc Subcommittee on 
International Projects; Meeting 
Pursuant lo Pub. L. 82-463, notice is 
hereby given of a meeting of the 
Recombinant DNA Advisory Committee 
Ad Hoc Subcommittee on International 
Projects at the National Institutes of 
Health, Building 31C, Conference Room 
7. 8000 Rockville Pike, Bethesda. 
Maryland 20892, on August 15, 1988, 
from approximately 9:00 a.m. to 
adjournment al approximately 5:00 p.m. 
to discuss applicability of NIH 
Guidelines to projects carried out 
abroad. This meeting will be open to the 
public. Attendance by the public will be 
limited to space available. , , 
Further information may bo obtained 
from Dr, William J. Gartland, Executive 
Secretary. Recombinant DNA Advisory 
Committee Ad.Hoc Subcommittee on 
International Projects. Office of 
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Recombinant DNA Research, Volume 13 
