[Federal Register Volume 59, Number 34 (Friday, February 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3780]


[[Page Unknown]]

[Federal Register: February 18, 1994]


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DEPARTMENT OF ENERGY
 

Availability of Modular Cooperative Research and Development 
Agreement (CRADA)

AGENCY: Office of Technology Utilization, Office of Laboratory 
Management, Department of Energy.

ACTION: Notice of availability and opportunity for public comment.

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SUMMARY: This notice announces the availability of the Department of 
Energy Modular Cooperative Research and Development Agreement (CRADA). 
The Modular CRADA is a compendium of provisions which will be used for 
preparing CRADAs between Department of Energy laboratories and non-
Federal Participants. The modular CRADA reflects input from 
headquarters, Operations Office and Laboratory elements. It also 
reflects extensive formal and informal technology transfer partner 
feedback as well as the Department's experience of over 600 CRADAs. It 
contains the basis and rationale for the language used, as well as pre-
approved options and guidance for use of the language. The modular 
CRADA includes several other important features distinguishing it from 
previous Department of Energy model CRADAs: (1) It does not require as 
much oversight by Departmental headquarters, does not have as much 
required language; (2) it provides more options in certain areas, such 
as product liability; and (3) it more fully communicates the 
Department's rationale for its CRADA language. The modular CRADA is 
expected to be periodically reviewed and revised as part of the 
Department of Energy's continuous improvement process. Comments from 
the public are encouraged.

ADDRESSES: A copy of the modular CRADA is available for inspection and 
reproduction at the public reading room of the U.S. Department of 
Energy, Forrestal Building, 1000 Independence Avenue, SW, Washington, 
DC. The public reading room is open from 10 a.m. to 4 p.m.; you may 
contact reading room staff at (202) 586-6020. If you want a copy of the 
modular CRADA mailed to you directly, please contact the U.S. 
Department of Energy at the address below. Comments on the modular 
CRADA are welcome and may be sent to the address below.

FOR FURTHER INFORMATION OR TO COMMENT CONTACT: U.S. Department of 
Energy, PA-5, 1000 Independence Avenue, SW., Washington, DC 20585, 
Phone: 202-586-5575, Fax: 202-586-7303.

SUPPLEMENTARY INFORMATION: An overview and the table of contents of the 
modular CRADA are attached.

    Issued at Washington, DC, on February 4, 1994.
Antionette Grayson Joseph,
Acting Director, Office of Laboratory Management.

The Modular CRADA

Introduction

    This document, to be referred to as the Department of Energy (DOE) 
Modular Cooperative Research and Development Agreement (CRADA), is a 
compendium of provisions which may be drawn upon for crafting CRADAs. 
It has been developed to be responsive to the needs of different CRADA 
Participants while protecting the interests of the Government and the 
U.S. taxpayers and is a tool for DOE and its Government-Owned 
Contractor-Operated (GOCO) laboratories, hereafter referred to as 
laboratories, to facilitate the negotiation, development and timely 
approval of CRADAs.
    This Modular CRADA incorporates three types of provisions:
    (1) Those few that are required by statute or policy, [set off by 
double underscore] are strongly recommended for timely approval, and 
can only be changed with DOE Headquarters approval. Changing double 
underscored language or examples may delay the process. Double 
underscored language can be eliminated where it doesn't apply, such as, 
for example the deletion of the definition of ``Subject Invention'' 
where it is not anticipated that there will be any subject inventions 
under the CRADA.
    (2) Those that sound judgment suggests have a valid basis for being 
included in the terms and conditions of the CRADA, consistent with the 
guidelines incorporated herein. These can be modified in one of three 
ways:

--By using the pre-approved options provided in the guidance;
--By modifying the language without changing its substantive meaning; 
and
--By negotiating the language that changes its substantive meaning, or 
even deleting the language with appropriate justification; in each of 
these two instances, operations office approval is required.

    (3) Those that are left solely to the negotiations between the 
laboratory and the Participants. [Shown in brackets.]
    Through a spirit of teamwork and a policy of ``no surprises,'' this 
document should enable DOE and its laboratories to be responsive to a 
broad range of Participant needs. This approach is intended to convey 
the maximum flexibility in CRADA development, and in speed of 
negotiations and approval, while fostering consistency across DOE and 
its laboratories.
    In drafting a CRADA from the options provided in the Modular CRADA, 
the laboratory should be careful not to create internal conflicts 
within the agreement. The draft CRADA should still follow the form 
(i.e., order of provisions) of the DOE Modular CRADA in order to 
facilitate operations office review and approval.
    In this document, the format for presenting the various provisions 
of the CRADA will consist of:

--A statement of the article, with language required by statute or 
policy double underscored;
--A rationale for the article; and
--Pre-approved optional provisions for the article (set off inside a 
box).

    Example: Article 1 (Title)

--Required provisions (if any)
--Rationale or basis for requirement
--Pre-approved optional provisions (if any)
--Rationale/appropriate circumstances
--Pre-approved optional provisions #2
--Rationale/appropriate circumstances
--Bracketed provisions
--Rationale/explanation
--General Guidance

The Sample CRADA

    A sample DOE CRADA, which is attached, incorporates the double 
underscore provisions and some of the more common optional provisions 
provided in the Modular CRADA. It is a tool for communicating DOE's 
general requirements and expectations to potential Participants in a 
clear and consistent manner. The sample DOE CRADA should be provided to 
potential Participants as the first hand-out in all instances, such as 
at conferences and trade shows and DOE sponsored events. When the 
sample DOE CRADA is used for these purposes, it may be modified only to 
the extent that the laboratory name is inserted.

Negotiating and Approving CRADAs

    By law and through prime contract provisions, the laboratories have 
been delegated the authority and responsibility for negotiating the 
CRADA, including a Statement of Work. In exercising that authority, 
laboratories need to strike a balance between consistency and 
flexibility.
    To the extent the negotiated CRADA uses language that does not 
deviate from the double underlined provisions and uses the pre-approved 
optional provisions, the Operations Office review and approval of the 
CRADA will be faster.
    The Operations Offices are the approval authority for Joint Work 
Statements (JWSs) and CRADAs. To facilitate Operations Office review, 
laboratories should identify all deviations from the double underlined 
provisions or pre-approved optional provisions at the time the CRADA is 
submitted for approval. It is recommended that two proposed CRADA 
versions be submitted by the laboratories to the Operations Offices--
one which highlights all deviations from the Modular CRADA provisions 
using ``redline'' and ``strikeout'' features and one which is a 
``clean'' version. All deviations which are considered by the 
laboratories to be substantive should be supported by appropriate 
justification. Any deviation from the double underlined provisions 
requires approval of DOE Headquarters. After receiving any proposed 
deviations to double underscored language from a laboratory, the 
Operations Office will transmit the language and reasons for the 
requested deviation to the Director of the Office of Technology 
Utilization (LM-20) in Headquarters, who will confer with the 
appropriate elements in Headquarters in determining if the requested 
deviation is acceptable and inform the Operations Office of the 
Headquarters' determination. Any deviations from the pre-approved 
optional provisions, except for deviations to double underscored 
language which must be approved by Headquarters, requires review and 
approval by the Operations Office. In the case of changes from the pre-
approved optional provisions which the Operations Office agrees are 
non-substantive, such approval may be reflected merely by approval of 
the CRADA. In the case of substantive changes, specific approval in the 
form of a notation on the ``redline'' version, or other supporting 
documents, will suffice. Any requests for modification of the CRADA by 
the Operations Office to the laboratory must comply with the 
requirements of 15 U.S.C. 3710a(c)(5)(C).
    While available for consultation to both the laboratory and the 
prospective Participant, the Operations Office should refrain from 
becoming a third party to the negotiations. Each Operations Office is 
encouraged to designate a single point of contact to facilitate the 
CRADA review and approval process at the Operations Office. Like the 
Operations Offices, Program offices and others should refrain from 
becoming a third party to the negotiations between the laboratory and 
the prospective Participant.

The Importance of Teamwork and Communication

    In order to use this document effectively, close cooperation and 
communication between the laboratory and DOE is essential. Issues that 
can be foreseen as key issues, especially critical departures from pre-
approved language, should be discussed as early as possible. There 
should be a minimum of surprises in the process. At the same time, the 
laboratory and DOE should be open to proposed changes from Participants 
where the changes help the process of negotiation but do not infringe 
upon the Government's rights. When alternative language is clearly 
called for, such alternative language should be used. One of the 
objectives of this document is to provide pre-approved alternative 
language for different situations, as well as guidance and rationale 
for using that alternative language.
    The DOE Modular CRADA will be updated on a routine basis to 
incorporate new language and alternatives, based on input from the 
Participants, laboratories, Operations Offices, and DOE programs. 
Laboratory staff with proposed updates should contact their Operations 
Office, and Operations Office staff with proposed updates should 
contact the DOE Office of Technology Utilization.
    The following points should be addressed in a CRADA as minimum 
guidance for an effective CRADA. The attached DOE Sample CRADA is the 
basic set of CRADA provisions; other clauses are provided in the 
Guidance to accommodate different arrangements between Contractors and 
Participants. Many of the specific articles and clauses are negotiable 
between the Parties.

Table of Contents

    Introduction to the DOE Modular CRADA, The DOE Sample CRADA, 
Negotiating and Approving CRADAs, The Importance of Teamwork and 
Communications.

DOE-Approved CRADA Language and Guidance

Title of CRADA
Article I: Definitions
Article II: Statement of Work
Article III: Funding and Costs
Article IV: Personal Property
Article V: Disclaimer
Article VI: Product Liability
Article VII: Obligations as to Proprietary Information
Article VIII: Obligations as to Protected CRADA Information
Article IX: Rights in Generated Information
Article X: Export Control
Article XI: Reports and Abstracts
Article XII: Pre-Publication Review
Article XIII: Copyrights
Article XIV: Reporting Inventions
Article XV: Title to Inventions
Article XVI: Filing Patent Applications
Article XVII: Trademarks
Article XVIII: Mask Works
Article XIX: Cost of Intellectual Property Protection
Article XX: Reports of Invention Use
Article XXI: DOE March-in Rights
Article XXII: U.S. Competitiveness
Article XXIII: Assignment of Personnel
Article XXIV: Force Majeure
Article XXV: Administration of the CRADA
Article XXVI: Records and Accounting for Government Property
Article XXVII: Notices
Article XXVIII: Disputes
Article XXIX: Entire CRADA and Modifications
Article XXX: Termination
Article ____: Project Management
Article ____: Order of Precedence
Article ____: Waiver

Documents Section:

Document A: Procedure for Foreign Ownership, Control and Influence 
review
Document B: U.S. Competitiveness Work Sheet
Document C: Format for Expanded Software Abstract
Document D: The DOE Sample CRADA

[FR Doc. 94-3780 Filed 2-17-94; 8:45 am]
BILLING CODE 6450-01-P