[Code of Federal Regulations]
[Title 5, Volume 3]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 5CFR5501.101]

[Page 743]
 
                    TITLE 5--ADMINISTRATIVE PERSONNEL
 
          CHAPTER XLV--DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
PART 5501--SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE 
DEPARTMENT OF HEALTH AND HUMAN SERVICES--Table of Contents
 
Sec. 5501.101  General.

    (a) Purpose. The regulations in this part apply to employees of the 
Department of Health and Human Services (HHS) and supplement the 
Standards of Ethical Conduct for Employees of the Executive Branch 
contained in 5 CFR part 2635. In addition to 5 CFR part 2635 and this 
part, employees are required to comply with implementing guidance and 
procedures issued by HHS components in accordance with 5 CFR 
2635.105(c). Employees are also subject to the executive branch-wide 
financial disclosure regulations at 5 CFR part 2634, the Employee 
Responsibilities and Conduct regulations at 5 CFR part 735, and the HHS 
regulations regarding conduct at 45 CFR part 73.
    (b) Applicability. The regulations in this part apply to individuals 
who are ``employees'' within the meaning of 5 CFR 2635.102(h). The 
regulations thus apply to special Government employees, except to the 
extent they are specifically excluded from certain provisions, and to 
uniformed service officers in the Public Health Service Commissioned 
Corps on active duty.
    (c) Definitions. Unless a term is otherwise defined in this part, 
the definitions set forth in 5 CFR part 2635 apply to terms in this 
part. In addition, for purposes of this part:
    (1) Federally recognized Indian tribe or Alaska Native village or 
regional or village corporation means any Indian tribe, band, nation, or 
other organized group or community, including any Alaska Native village 
or regional or village corporation as defined in or established pursuant 
to the Alaska Native Claims Settlement Act, 43 U.S.C. 1601 et seq., 
which is recognized as eligible for the special programs and services 
provided by the United States to Indians because of their status as 
Indians.
    (2) Significantly regulated organization means an organization for 
which the sales of products regulated by the Food and Drug 
Administration (FDA) constitute ten percent or more of annual gross 
sales in the organization's previous fiscal year; where an organization 
does not have a record of sales of FDA-regulated products, it will be 
deemed to be significantly regulated if its operations are solely in 
fields regulated by FDA.