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SMG 2121.1

FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

EXTERNAL RELATIONS

LIABILITY RELEASE AGREEMENT:

USE OF FDA RESEARCH FACILITIES BY NON-GOVERNMENT USERS

Transmittal Number 84-38 -- Date: 05/04/84

[PDF Version]

 1. Purpose
 2. References
 3. Sample Agreement Format
 4. Distribution of Agreement
 5. Legal Advice and Assistance

1. PURPOSE 

This Guide illustrates a sample release agreement to be used for absolving FDA of liability in case of personal injury, death, and failure or damage to the non-Government user's experiments or equipment.

2. REFERENCES 

a. Part 9, Title 45, Code of Federal Regulations (45 CFR 9; Chapter 13-10 HEW General Administration Manual) Use of HEW Research Facilities by Academic Scientists, Engineers and Students."

b. Guide FDA 1445.6 General Administrative. Delegation of Authority, "Authority to Authorize Use of FDA Scientific Research and Study Facilities."

3. SAMPLE AGREEMENT FORMAT 

This agreement shall be completed and approved prior to the use of FDA facilities by non-Government users:

Liability Release Agreement

I, (name)______________________________________, of (address)_____________________________________________________________, in consideration of the use of the Food and Drug Administration laboratory facilities located in (building)______________________________,(room) _____________________________________, (division)_________________________________________, for the period of ______________________ to ________________________________, for the purpose of ___________________________________________________________________________________, hereby agree as follows:

1. I absolve the FDA of all liability which may result from my personal injury and/or death:

2. I absolve the FDA of all liability which may result from damage to my equipment or failure of my experiments;

3. I will conduct myself and my experiments with care and comply with all safety regulations and procedures while using facilities of the FDA; and

4. I will report all accidents regardless of how minor and regardless of whether or not it involves injury to my person, my property or the property of the FDA.

I have read this form carefully and fully and understand its terms.

/s/___________________________________________________
Date___________________________________
(Non-Government User)

/s/___________________________________________________
Date___________________________________
FDA (Co-worker of Non-Government User)

/s/ Approved___________________________________________________
Date___________________________________

 

4. DISTRIBUTION OF AGREEMENT 

a. Facility Director forwards original and two copies to Approving Official,

b. Approving Official returns two signed copies to Facility Director, and

c. Non-Government user is provided a copy of approved agreement.

5. LEGAL ADVICE AND ASSISTANCE 

In unusual situations where the standard type agreement is not suitable, another agreement may be executed provided the Office of the General Counsel, OS, concurs as to the legality of its special provisions.