[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

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

[CITE: 45CFR94.3]



[Page 478-479]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 94_RESPONSIBLE PROSPECTIVE CONTRACTORS--Table of Contents

 

Sec.  94.3  Definitions.



    As used in this part:

    Contractor means an entity that provides property or services for 

the direct benefit or use of the Federal Government.

    HHS means the United States Department of Health and Human Services, 

and any components of the Department to which the authority involved may 

be delegated.

    Institution means any public or private entity or organization 

(excluding a Federal agency)

    (1) That submits a proposal for a research contract whether in 

response to a solicitation from the PHS or otherwise, or

    (2) That assumes the legal obligation to carry out the research 

required under the contract.

    Investigator means the principal investigator and any other person 

who is responsible for the design, conduct, or reporting of a research 

project funded by PHS, or proposed for such funding. For purposes of the 

requirements of this part relating to financial interests, 

``Investigator'' includes the Investigator's spouse and dependent 

children.

    PHS means the Public Health Service, an operating division of the 

U.S. Department of Health and Human Services, and any components of the 

PHS to which the authority involved may be delegated.

    PHS Awarding Component means an organizational unit of the PHS that 

funds research that is subject to this part.

    Public Health Service Act or PHS Act mean the statute codified at 42 

U.S.C. 201 et seq.

    Research means a systematic investigation designed to develop or 

contribute to generalizable knowledge relating broadly to public health, 

including behavioral and social-sciences research. The term encompasses 

basic and applied research and product development. As used in this 

part, the term includes any such activity for which funding is available 

from a PHS Awarding Component, whether authorized under the PHS Act or 

other statutory authority.

    Significant Financial Interest means anything of monetary value, 

including but not limited to, salary or other payments for services 

(e.g., consulting fees or honoraria); equity interests (e.g., stocks, 

stock options or other ownership interests); and intellectual property 

rights (e.g., patents copyrights and royalties from such rights). The 

term does not include:

    (1) Salary, royalties, or other remuneration from the applicant 

institution;

    (2) Any ownership interests in the institution, if the institution 

is an applicant under the SBIR program;

    (3) Income from seminars, lectures, or teaching engagements 

sponsored by public or nonprofit entities;

    (4) Income from service on advisory committees or review panels for 

public or nonprofit entities;

    (5) An equity interest that when aggregated for the Investigator and 

the Investigator's spouse and dependent children, meets both of the 

following tests: Does not exceed $10,000 in value as determined through 

reference to public prices or other reasonable measures of fair market 

value, and does not represent more than a five percent ownership 

interest in any single entity; or

    (6) Salary, royalties or other payments that when aggregated for the 

investigator and the investigator's spouse and dependent children over 

the



[[Page 479]]



next twelve months, are not reasonably expected to exceed $10,000.

    Small Business Innovation Research (SBIR) Program means the 

extramural research program for small business that is established by 

the awarding components of the Public Health Service and certain other 

Federal agencies under Public Law 97-219, the Small Business Innovation 

Development Act, as amended. For purposes of this part, the term SBIR 

Program includes the Small Business Technology Transfer (STTR) Program, 

which was established by Public Law 102-564.