[Code of Federal Regulations]
[Title 5, Volume 3]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 5CFR5502.107]

[Page 790-791]
 
                    TITLE 5--ADMINISTRATIVE PERSONNEL
 
          CHAPTER XLV--DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
PART 5502_SUPPLEMENTAL FINANCIAL DISCLOSURE REQUIREMENTS FOR EMPLOYEES OF THE 
 
Sec. 5502.107  Supplemental disclosure of financial interests in substantially 

affected organizations applicable to employees of the National Institutes of 

Health.

    (a) Applicability. This section does not apply to special Government 
employees.
    (b) Definitions. For purposes of this section:
    (1) Clinical investigator means an employee identified as a 
principal investigator, accountable investigator, lead associate 
investigator, medical advisory investigator, associate investigator, or 
other subinvestigator in an NIH clinical study involving human subjects 
under a clinical research protocol approved by an institutional review 
board.
    (2) Clinical research has the meaning set forth in 42 U.S.C. 
284d(b).
    (3) Institutional review board (IRB) means any board, committee, or 
other group formally designated by an institution to review a clinical 
research protocol and approve the initiation of biomedical research 
involving human subjects and to assess periodically the progress of the 
investigation to protect the rights and welfare of the trial 
participants.
    (4) Confidential filer means an employee who meets the criteria in 5 
CFR 2634.904 and who has not been excluded from the requirement of 
filing a confidential financial disclosure report under the procedures 
in 5 CFR 2634.905.
    (5) Public filer means an employee who meets the criteria in 5 CFR 
2634.202 and who has not been excluded from the requirement of filing a 
public financial disclosure report under the procedures in 5 CFR 
2634.203.
    (6) Remainder of HHS has the meaning set forth in Sec. 
5501.102(b)(2) of this chapter.
    (7) Separate agency component has the meaning set forth in Sec. 
5501.102(a) of this chapter.
    (8) Substantially affected organization has the meaning set forth in 
Sec. 5501.109(b)(10) of this chapter.
    (c) Report of financial interests in substantially affected 
organizations--(1) New entrant employees. A new entrant employee who is 
a public filer or a confidential filer or who is designated to

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serve as a clinical investigator shall report in writing within 30 days 
after entering on duty with the NIH any financial interest in a 
substantially affected organization and the value thereof held upon 
commencement of employment with the agency.
    (2) Reassigned employees. An employee of a separate agency 
component, other than the NIH, or of the remainder of HHS who is either 
a public filer, a confidential filer, or a clinical investigator who is 
reassigned to a position at the NIH shall report in writing within 30 
days of entering on duty with the NIH any financial interest in a 
substantially affected organization and the value thereof held on the 
effective date of the reassignment to the agency.
    (3) Incumbent employees. An incumbent employee of the NIH who is 
either a public filer, a confidential filer, or a clinical investigator 
who acquires any financial interest in a substantially affected 
organization shall report such interest and the value thereof in writing 
within 30 days after acquiring the financial interest. Any incumbent 
employee, irrespective of financial disclosure filing status, who is 
designated a clinical investigator shall report in writing within 30 
days of the approval of the clinical research protocol by the relevant 
institutional review board any financial interest in a substantially 
affected organization and the value thereof held on the date of the IRB 
approval.
    (4) Initial report by on duty employees. An employee on duty at the 
NIH on August 31, 2005, who is either a public filer, a confidential 
filer, or a clinical investigator shall report in writing on or before 
October 31, 2005, any financial interest in a substantially affected 
organization and the value thereof held on the date the report is filed.

[70 FR 51573, Aug. 31, 2005, as amended at 70 FR 61713, Oct. 26, 2005]

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