[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR74.36]



[Page 226-227]

 

                        TITLE 45--PUBLIC WELFARE

 

           SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

    PART 74_UNIFORM ADMINISTRATIVE REQUIREMENTS FOR AWARDS AND SUBAWARDS TO INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, OTHER NONPROFIT ORGANIZATIONS, AND 

COMMERCIAL ORGANIZATIONS--Table of Contents

 

                    Subpart C_Post-Award Requirements

 

Sec. 74.36  Intangible property.



    (a) The recipient may copyright any work that is subject to 

copyright and was developed, or for which ownership was purchased, under 

an award. The HHS awarding agency reserves a royalty-free, nonexclusive 

and irrevocable right to reproduce, publish, or otherwise use the work 

for Federal purposes, and to authorize others to do so.

    (b) Recipients are subject to applicable regulations governing 

patents and inventions, including government-wide regulations issued by 

the Department of Commerce at 37 CFR part 401, ``Rights to Inventions 

Made by Nonprofit Organizations and Small Business Firms Under 

Government Grants, Contracts and Cooperative Agreements.''

    (c) The Federal Government has the right to:

    (1) Obtain, reproduce, publish or otherwise use the data first 

produced under an award; and

    (2) Authorize others to receive, reproduce, publish, or otherwise 

use such data for Federal purposes.

    (d)(1) In addition, in response to a Freedom of Information Act 

(FOIA) request for research data relating to published research findings 

produced under an award that were used by the Federal Government in 

developing an agency action that has the force and effect of law, the 

HHS Awarding Agency shall request, and the recipient shall provide, 

within a reasonable time, the research data so that they can be made 

available to the public through the procedures established under the 

FOIA. If the HHS Awarding Agency obtains the research data solely in 

response to a FOIA request, the agency may charge the requester a 

reasonable fee equaling the full incremental cost of obtaining the 

research data. This fee should reflect costs incurred by the agency, the 

recipient, and applicable subrecipients. This fee is in addition to any 

fees the agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A)).

    (2) The following definitions apply for purposes of this paragraph 

(d):

    (i) Research data is defined as the recorded factual material 

commonly accepted in the scientific community as necessary to validate 

research findings, but not any of the following: preliminary analyses, 

drafts of scientific papers, plans for future research, peer reviews, or 

communications with colleagues. This ``recorded'' material excludes 

physical objects (e.g., laboratory samples). Research data also do not 

include:

    (A) Trade secrets, commercial information, materials necessary to be 

held confidential by a researcher until they are published, or similar 

information which is protected under law; and

    (B) Personnel and medical information and similar information the 

disclosure of which would constitute a clearly unwarranted invasion of 

personal privacy, such as information that could be used to identify a 

particular person in a research study.



[[Page 227]]



    (ii) Published is defined as either when:

    (A) Research findings are published in a peer-reviewed scientific or 

technical journal; or

    (B) A Federal agency publicly and officially cites the research 

findings in support of an agency action that has the force and effect of 

law.

    (iii) Used by the Federal Government in developing an agency action 

that has the force and effect of law is defined as when an agency 

publicly and officially cites the research findings in support of an 

agency action that has the force and effect of law.

    (3) The requirements set forth in paragraph (d)(1) of this section 

do not apply to commercial organizations.

    (e) Title to intangible property and debt instruments purchased or 

otherwise acquired under an award or subaward vests upon acquisition in 

the recipient. The recipient shall use that property for the 

originally--authorized purpose, and the recipient shall not encumber the 

property without approval of the HHS awarding agency. When no longer 

needed for the originally authorized purpose, disposition of the 

intangible property shall occur in accordance with the provisions of 

Sec. 74.34 (g) and (h).



[59 FR 43760, Aug. 25, 1994, as amended at 65 FR 14407, 14418, Mar. 16, 

2000]