The primary mission of the PHS is to improve human health
by increasing scientific knowledge related to health and disease
through the conduct and support of biomedical and behavioral research.
In pursuit of its mission, PHS supports a broad spectrum of research
approaches, ranging from basic laboratory research to clinical research.
This continuum of research activities creates a synergism essential to the
effective advancement of knowledge. The synergy that exists among these research
approaches is dependent upon the ability of PHS investigators to discuss and explore
new ideas freely and openly. Under the Federal Technology Transfer Act (FTTA) of 1986,
and Executive Order No. 12591, the PHS has been mandated to encourage and facilitate
collaboration among federal laboratories, state and local governments, universities,
and the private sector in order to assist in the transfer of federal technology to the
market place. One vehicle for this collaboration is the Cooperative Research and
Development Agreement (CRADA).
A CRADA is an agreement between one or more PHS laboratories and at least
one other party, under which the PHS laboratories provides
personnel, services, facilities, equipment, or other resources with or
without reimbursement (but not funds to non-federal parties) and the other party
provide funds, personnel, services, facilities, equipment, or other resources toward the
conduct of specified research or development efforts which are consistent with the missions
of the laboratory.
CRADAs confer intellectual property rights on PHS inventions. The PHS Model
CRADA and PHS Model Materials CRADA (M-CRADA) are standard documents developed by
PHS to facilitate the negotiation and approval process and to incorporate PHS policies
on collaborative agreements and technology transfer.
The intent of Congress in establishing CRADAs was to promote national
technological competitiveness and the rapid transfer of the fruits of innovation
to the marketplace. CRADA research and development at the PHS should be directed to
the development of biological and behavioral technology, products, and processes by
transferring relevant knowledge acquired from PHS research efforts to state
and local governments, universities, and the private sector.
Advances in biomedical and behavioral research depend on a continuum of research
efforts, from those aimed at discovering new knowledge, to those aimed at expanding
existing knowledge, to those aimed at developing new procedures and products.
There is not always a clear distinction among these research activities to allow
a concise definition of which activities are appropriate for a CRADA. All CRADAs
must be consonant with the primary biomedical research mission of the PHS and the
specific laboratory involved, ensuring that no aspect of that mission is compromised.
For example, a proposed CRADA would not be appropriate if the fundamental mission of
the PHS is compromised by creating, either explicitly or indirectly, more than minimal
constraints on research freedom and communication.
Although there is no restriction on the topic of research appropriate
for a CRADA, all CRADA research projects must be highly focussed and
delineated and each proposed CRADA must be carefully assessed for its
overall research objectives. In considering a proposed CRADA, PHS
operating components will determine if the objectives of a proposed
collaboration warrant the establishment of a CRADA or if its goals are more
appropriately met through a procurement contract, material transfer agreement, cooperative
agreement or other contractual mechanism. Also, the proposed collaborator's scientific and
business capabilities will be assessed.
Prohibition on General Funding
A CRADA is not intended to be a general funding mechanism to support directed
research in a PHS laboratory. The majority of a laboratory's resources should not
derive from CRADAs. CRADA-derived funds may not supplant appropriated funds in
supporting PHS research. They are to be used only to defray the cost of the project
specified in the CRADA.
Laboratories must be prepared to address the impact on the ongoing
research if a CRADA and related financial support is terminated unexpectedly.
The sole purpose of a CRADA cannot be to support post-doctoral fellows and/or technicians, to
obtain funds, or to purchase equipment and/or supplies. Conversely, the sole justification of
a CRADA cannot be for a PHS laboratory to conduct research or tests for the collaborator.
Ensuring Research Freedom
PHS investigators generally are free to choose the subject matter of their
research, consistent with the mission of their Institute and the research programs
of their Laboratories. No CRADA may contravene this freedom.
CRADAs that explicitly attempt to direct PHS research are not appropriate.
Additionally, in considering any proposed CRADA, attention must be given to whether directed
research implicitly will be the net effect. For example, the greater the extent to which
a laboratory's resources derive from a CRADA, the less likely it will be that the laboratory
will pursue other research opportunities outside of the CRADA; the broader the scope of a CRADA
research plan, the less able a laboratory will be to provide fair access and interact with others.
The achievement of this balance will be considered in the decision-making process. Thus, consideration
should be given to:
Scientific Communication and Dissemination of Research Results
- a. the fraction of a laboratory's appropriated resources devoted to CRADA research;
- b. the fraction of a laboratory's total resources that derive from CRADA support, and
the time and scope of work devoted to a given CRADA;
- c. the amount of time that any one investigator would give to one or more CRADAs;
- d. the number of CRADAs an investigator or Laboratory/Branch has with one company; and
- e. the number of CRADAs that any given company might have with the PHS and its
It is fundamental to the mission of PHS that research results be published and
discussed at public fora. Further, PHS scientists must operate within an atmosphere of
scientific collegiality. Reasonable confidentiality requirements and brief delays in
dissemination of research results are permitted under a CRADA, as necessary, in order
to protect proprietary materials and intellectual property rights. CRADAs which in any
way attempt to unreasonably restrict or constrain scientific interaction or the dissemination
of research information will not be approved. In considering any proposed CRADA, consideration
must be given to the possibility that the level of confidentiality associated with that CRADA
project might, on balance, inappropriately impair the degree of openness necessary to maintain
effective scientific communication and to serve the public interest.
Requirement of Intellectual Contribution by Collaborator
CRADAs are authorized only with collaborators who will make significant intellectual
contributions to the research project undertaken or will contribute essential research
materials or technical resources not otherwise reasonably available to PHS. CRADAs cannot
attempt to direct or restrict research in a PHS laboratory. Sponsored research, such as routine,
conventional testing, with no collaborative, intellectual contribution, is not appropriate for a CRADA.
Avoidance of Conflict of Interest
Pursuant to the CRADA-authorizing statute, every federal laboratory
must ensure that there are no conflicts of interest in any CRADA. Extramural
PHS staff scientists who administer grants and contracts may have an inherent
conflict of interest that would preclude their participation in CRADAs. Intramural
PHS scientists also may have conflicts of interest, in that they serve as a project
officer on a contract or have authority over funding decisions in the course of their
research. In both cases, the employee may have financial interests that would be affected
by their proposed CRADA. Therefore, any conflict of interest--actual or apparent--must be
addressed in the review and approval of CRADAs.
Fair Access to CRADA Opportunities
In compliance with the intent of the Federal Technology Transfer Act (FTTA) and the PHS Policy for Promoting
Fair Access to CRADA Opportunities, the PHS shall ensure that outside organizations
have fair access to collaborative opportunities, the licensing of federal technologies,
and PHS scientific expertise, giving special consideration to small business and preference
to those that are located in the U.S. and agree to manufacture in the U.S. products developed
under the CRADA. Fair access to CRADAs is not to be considered as synonymous with the
term "open competition," as defined for contracts and small purchases. Evidence of fair
access or discussion of unique resource requirements should be maintained as part of
the official IC CRADA file.
Companies can initiate the CRADA discussions by contacting a PHS
scientist with whom they would like to work. Participants in CRADAs
can include the individual PHS agency and one or more other parties (other agencies,
state and local governments, non-profit and not-for-profit institutions, private corporations).
A competitive process is generally not required in choosing a CRADA partner,
although it is required by PHS fair access guidelines under limited circumstances.
An agency may choose to use competition in a collaboration when interested parties
are unknown or the technology/ project is such that competition is in the public's
best interest. An announcement may be placed in the Federal Register or Commerce
Business Daily with a selection made known to the responding parties. An ad hoc
evaluation committee may be formed to review submissions, if appropriate.
A written CRADA document should be developed as soon as both participating
scientists negotiate the Research Plan (the written description of the research
and development project, including each party's contribution to the planned
research and development). Federal laboratories may contribute staff, facilities,
equipment, and supplies, but not funds. The collaborating party may contribute
funds in addition to staff, facilities, equipment, and supplies. NIH has a model
CRADA which is required and used as the basis for all negotiations with outside parties.
The model CRADA contains three appendices: a) the Research Plan, b) Financial and Staffing
Contributions of the Parties, and c) Exceptions or Modifications to this CRADA.
PHS scientists are required to fill out and attach a Conflict of Interest and Fair Access
Survey form. The purpose of this form is to assure that a PHS scientist does not have a
conflict of interest. regarding the CRADA research (such as consulting with the same company)
and that proper consideration has been given to fair access guidelines.
Each PHS agency has a Technology Development Coordinator (TDC) who facilitates the drafting of an acceptable
CRADA and related Appendices, advising the PHS scientist in the development of the
overall agreement. The CRADA and Appendices are generally negotiated by the TDC in
conjunction with the other party. The negotiated CRADA must be approved by the PHS
scientist, the Laboratory or Branch Chief, and the Scientific Director. The TDC then
forwards the agreement to the Office of Technology Transfer (OTT) and the Office of
General Counsel for review, who then forward the agreement to the CRADA Subcommittee
of the Technology Transfer Policy Board for final approval recommendation. Generally,
all CRADAs containing exclusive licensing-related clauses must be reviewed by the
agency's CRADA Review Subcommittee.
The Federal Technology Transfer Act provides for a 30-day period in
which to disapprove or modify a CRADA after its finalization. When there are no
changes required, the CRADA is signed and returned to the TDC at each PHS agency or
institute. The TDC is responsible for obtaining the proper signatures required for
execution by the company. Agreements have no mandatory term length and can be extended
by the mutual agreement of the parties if there is no substantial change in the Research
Plan. Because scientific objectives and circumstances change, it is essential to include
in a CRADA a specific time period for financial accountability and provisions for early
In order to expedite the commencement of the Research Plan, prior to final
execution of the CRADA, an interim Letter of Intent may be signed with the
company. Once an invention is made within the scope of a CRADA agreement, the
OTT will negotiate the CRADA-related license with the commercial partner.
Technology Transfer Policy Staff
6011 Executive Blvd., Suite 325
Rockville, MD 20852
Kate Sinclair-Dunn, M.A.