Department of Health and Human Services 
OFFICE OF 
   
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
C - -I
ONFLICT OF NTEREST 
 
 
W G HHS
AIVERS  RANTED TO   
 
E MPLOYEES IN 2009 
 
 
 
 
 
 
Daniel R. Levinson  
Inspector General 
 
August 2011 
OEI-04-10-00010         
   
 E X E C U T I V E   S U M M A R Y  
OBJECTIVES
 
1.   To assess the extent to which conflict-of-interest waivers granted to       
Department of Health and Human Services (HHS) employees were 
documented as recommended in provisions of selected 
Governmentwide Federal ethics regulations and the instructions of 
the Secretary of Health and Human Services (Secretary) to describe:   
 the employees specific financial interest that poses the conflict of 
interest; 
 the particular matter(s) in which the employee is permitted to 
participate; and 
 the particular matter(s), if any, in which the employee is 
prohibited from participating. 
2.   To determine whether HHS employees signed and dated their 
conflict-of-interest waivers.    
BACKGROUND 
HHS employees, including special Government employees (SGE) 
serving as subject-matter experts on Federal advisory committees 
(committees), play an influential role in the Federal Governments 
public health policies.  HHS employees may have conflicts of interest 
that prohibit them from participating in certain official Government 
matters affecting their personal financial interests.  These interests 
may include outside employment, grants, and stock ownership.   
The Office of Government Ethics (OGE) promulgates Governmentwide 
Federal ethics regulations for all Executive Branch employees and 
oversees all Federal agencies ethics programs.  With oversight and 
guidance from the HHS Office of the General Counsel (OGC), an HHS 
Operating Division (OPDIV) or Staff Division (STAFFDIV) may grant 
conflict-of-interest waivers to its employees if the OPDIV or STAFFDIV 
determines that the conflict is not likely to affect the integrity of the 
employees services to the Government.  For SGEs on committees, in 
particular, an OPDIV or STAFFDIV may grant a waiver if the need for 
an SGEs services outweighs the potential for a conflict of interest.  
Waivers permit employees who have conflicts of interest to act in an 
official Government capacity on matters in which they would otherwise 
be prohibited from participating.  In 2009, HHS granted 342 waivers;  
334 waivers were granted to SGEs on committees. 
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E X E C U T I V E   S U M M A R Y  
According to Governmentwide Federal ethics regulations and the 
Secretarys instructions, all waivers should describe, among other 
things, employees specific conflicts of interest and the particular 
matters in which employees are permitted to participate.  Further, if 
the OPDIV or STAFFDIV determines that employees are not permitted 
to fully participate in particular matters related to their conflicts of 
interest, the employees waivers are considered limited.  Limited 
waivers should describe the particular matters related to the conflicts of 
interest in which the employees are prohibited from participating, 
regardless of the other matters being waived.  In addition, although it is 
not a Federal requirement for employees to sign and date their waivers, 
OGCs sample waivers have a signature line.  HHS OPDIVs and 
STAFFDIVs can document when employees receive and acknowledge 
waivers by having employees sign and date them.  Signatures and dates 
show that employees received and acknowledged their waivers and may 
be held accountable for complying with them. 
We reviewed a stratified, random sample of 50 conflict-of-interest 
waivers granted to HHS employees in 2009, including 42 waivers for 
SGEs on committees.  We determined whether the waivers in our 
sample were documented as recommended in three provisions of 
selected Governmentwide Federal ethics regulations and the Secretarys 
instructions.  We also determined whether employees signed and dated 
the waivers in our sample.  We do not generalize our findings to all 
HHS waivers granted in 2009.   
FINDINGS 
Fifty-six percent of the 50 HHS conflict-of-interest waivers in our 
review were not documented as recommended in provisions of 
selected Governmentwide Federal ethics regulations and the 
Secretarys instructions.  Fourteen percent of the sampled waivers did 
not describe employees specific interests that posed conflicts.   
Forty-six percent did not describe the particular matters in which 
employees were permitted to participate.  Twenty-eight percent were 
limited waivers that did not describe the particular matters in which 
the employees were prohibited from participating.  Twenty-four percent 
were not documented as recommended in at least two of the three 
selected provisions and the Secretarys instructions, and 8 percent were 
not documented as recommended in any of these provisions or 
instructions.  The waivers that were not documented as recommended 
were granted to employees at five of the nine OPDIVs and STAFFDIVs 
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  ii         
   
EE XX EE CC UU TT II VV EE    SS UU MM MM AA RR YY   
in our review.  All but one of these waivers were granted to SGEs on 
committees. 
Although not required, 18 percent of the 50 HHS conflict-of-interest 
waivers in our review included employees signatures and dates.  
While it is not a Federal requirement for waivers to be signed and 
dated, 18 percent of the 50 waivers in our sample included employees 
signatures and dates.  These signed and dated waivers had been 
granted to employees in six of the nine OPDIVs and STAFFDIVs in our 
review.  Most of the waivers in our sample82 percentdid not include 
employees signatures and/or dates.  All but two of the waivers that 
were not signed and/or dated were for SGEs on committees.   
Twenty-four of the waivers that were not signed and/or dated were also 
not documented as recommended in at least 1 of the 3 provisions of 
selected Governmentwide Federal ethics regulations and the Secretarys 
instructions, and 14 of these 24 were limited waivers.  These 14 limited 
waivers represent the greatest vulnerability.  The employees receiving 
them may not know they have waivers or understand the limitations 
imposed on their participation in official duties.  If these employees are 
not aware of their waivers or do not clearly understand them, they may 
violate the criminal conflict-of-interest statute by participating in 
prohibited matters. 
RECOMMENDATIONS 
According to OGE, evaluating whether to grant a waiver is one of the 
more significant duties that agency ethics officials perform.  If  
conflict-of-interest waivers are not clearly documented to show that 
employees understand their conflicts of interest and the matters, if any, 
in which they are prohibited from participating, employees may 
inadvertently violate the criminal conflict-of-interest statute.  In 
addition, if waivers do not clearly describe the particular matters in 
which employees are permitted to participate, employees may 
incorrectly refrain from providing their expertise when it would benefit 
HHSs programs.  Further, if waivers are not documented so that the 
public understands the employees conflicts of interest and their effect 
on the employees official Government duties, the public may question 
the integrity of the employees services to the Government.   
Therefore, we recommend that the HHS OGC:  
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E X E C U T I V E   S U M M A R Y  
Require OPDIVs and STAFFDIVs to document conflict-of-interest 
waivers as recommended in Governmentwide Federal ethics 
regulations and the Secretarys instructions. 
Develop additional guidance and training to assist OPDIVs and 
STAFFDIVs in documenting conflict-of-interest waivers as 
recommended in Governmentwide Federal ethics regulations and 
the Secretarys instructions.      
Take action to revise the conflict-of-interest waivers in our review 
that were not documented as recommended in Governmentwide 
Federal ethics regulations and the Secretarys instructions, if the 
waivers are still in effect.   
Expand the review of conflict-of-interest waivers for SGEs on 
committees. 
Require all employees to sign and date their conflict-of-interest 
waivers or otherwise document that they received and 
acknowledged them. 
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
OGC and OGE provided written comments on a draft of this report.  In 
response to OGCs and OGEs comments, we conducted a second review 
of many of the waivers in our sample.  We continued to find that many 
waivers were not documented as recommended in the selected 
regulatory provisions and the Secretarys instructions, and we updated 
our findings accordingly. 
We made other technical and clarifying changes to the report based on 
OGCs and OGEs comments.  For the full text of OGCs and OGEs 
comments, see Appendix H.  Because OGC included OGEs comments as 
an attachment to its comments, we do not provide OGEs comments 
separately. 
   
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 T A B L E   O F   C O N T E N T S  
EX ECUT I VE  SUM M ARY  .....................................i 
 
I NT RO DU CT I O N  ............................................ 1 
 
F I NDI NG S  .................................................  19 
  Fifty-six percent of the 50 HHS conflict-of-interest waivers in our 
review were not documented as recommended in provisions of  
selected Governmentwide Federal ethics regulations and the         
Secretarys instructions  .................................  19 
  Although not required, 18 percent of the 50 HHS  
conflict-of-interest waivers in our review included employees                
signatures and dates ....................................  23 
 
RECO M M END AT I O N S  .....................................  25 
 
APP EN DI X ES  .............................................  34 
  A:  Number of Waivers by Department of Health and Human 
Services Operating Division or Staff Division and Type of  
Employee, From 2007 to 2009 .............................  34  
  B:  5 CFR Pt. 2640, Subpart CIndividual Waivers ...........  35 
  C:  The Secretary of Health and Human Services January 2009 
Instructions ...........................................  39   
  D:  Number of Waivers Granted by the Department of Health 
and Human Services in 2009 to Special Government Employees  
on Federal Advisory Committees at the National Institutes of  
Health, by Institute or Center .............................  43 
  E:  Number and Percentage of Waivers From 2009 in Our  
Review Not Documented as Recommended in Provisions of  
Selected Governmentwide Federal Ethics Regulations and the  
Instructions of the Secretary of Health and Human Services, for 
Special Government Employees and All Other HHS Employees . 44 
  F:  Number and Percentage of Waivers From 2009 in Our  
Review Not Documented as Recommended in One, Two, or Three 
Provisions of Selected Governmentwide Federal Ethics  
Regulations and the Instructions of the Secretary of Health and  
Human Services,  for Limited and Nonlimited Waivers ........  45 
  G:  Number and Percentage of Waivers From 2009 in Our 
Review That Did Not Include Employees Signatures and/or Dates,  
for Special Government Employees and All Other Department of    
Health and Human Services Employees  ....................  46 
  H:  Agency Comments  ...................................  47 
 
ACKNO WL E DG M E N T S .....................................  81         
   
 I N T R O D U C T I O N  
OBJECTIVES 
1.   To assess the extent to which conflict-of-interest waivers granted to       
Department of Health and Human Services (HHS) employees were 
documented as recommended in provisions of selected 
Governmentwide Federal ethics regulations and the instructions of 
the HHS Secretary (Secretary) to describe:   
 the employees specific financial interest that poses the conflict of 
interest; 
 the particular matter(s) in which the employee is permitted to 
participate; and 
 the particular matter(s), if any, in which the employee is 
prohibited from participating. 
2.   To determine whether HHS employees signed and dated their 
conflict-of-interest waivers.    
BACKGROUND 
Federal employees play an influential role in the Federal Governments 
public health policies.  Federal agencies must ensure that their 
employees conflicts of interest do not compromise the integrity and 
credibility of Federal programs.1  The Office of Government Ethics 
(OGE) promulgates Governmentwide Federal ethics regulations for all 
Executive Branch employees and oversees all Federal agencies ethics 
programs.2  Further, in January 2009, the Secretary issued additional 
instructions on granting waivers and the contents of waivers.3  The 
HHS Designated Agency Ethics Official and other staff in the HHS 
Office of the General Counsel (OGC) Ethics Division provide guidance 
and oversight of ethics programs in HHS Operating Divisions (OPDIVs) 
and Staff Divisions (STAFFDIVs).4   
 
1 We use the term conflict of interest to refer to financial interests covered by the criminal 
conflict-of-interest statute (18 U.S.C.  208).  This includes both actual and potential 
financial conflicts of interest.   
2 Ethics in Government Act, 5 U.S.C. app. IV  401 and 402, 5 CFR pt. 2600.  
3 Secretary, Memorandum to Deputy Secretary and Chiefs of Staff, Heads of Operating and 
Staff Divisions, Delegation of Authority to Grant Conflict of Interest Waivers Under  
18 U.S.C.  203(d), 205(e), and 208(b).  January 16, 2009. 
4 OGC Ethics Division, Deputy Ethics Counselor HHS Ethics Program Statement of 
Functions, Responsibilities, and Authority, revised August 15, 2007. 
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I N T R O D U C T I O N  
HHS employees include special Government employees (SGEs) serving 
on Federal advisory committees (committees), regular Government 
employees, SGEs not serving on committees, and political appointees.5, 6  
Hereinafter, we will refer to HHS regular Government employees, SGEs 
not serving on committees, and political appointees as all other HHS 
employees.     
SGEs serving on committees are subject-matter experts who provide 
expert advice, ideas, and diverse opinions to the Federal Government.  
SGEs are typically actively involved in work outside the Government in 
the same areas as their official Government work.7  The category of all 
other HHS employees includes agency heads and program directors 
who typically work on broad policy matters related to their agencies or 
programs.8   
Executive Branch employees, including HHS employees, must not 
participate personally and substantially in an official capacity in any 
particular matters that would have a direct and predictable effect on  
 
5 Federal Advisory Committee Act, 5 U.S.C. app. II  2(a) and 3(2)(c).  OGE Memorandum 
to Designated Agency Ethics Officials, Federal Advisory Committee Appointments.  
DO-05-012, August 18, 2005.  Accessed at 
http://www.usoge.gov/ethics_guidance/daeograms/dgr_files/2005/do05012.pdf on July 10, 
2009.  
6 HHS employees are appointed in the civil service, act in an official capacity, or are 
supervised by a Federal official.  The President, the Secretary, and other HHS officials may 
appoint HHS employees to their positions. 
7 OGE, Conflict of Interest and the Special Government Employee:  A Summary of Ethical 
Requirements Applicable to SGEs.  Attachment to the OGE Memorandum to Designated 
Agency Ethics Officials, DO-00-003, February 15, 2000.  Accessed at 
http://www.usoge.gov/laws_regs/other_ethics_guidance/othr_gdnc/og_sge_coi_00.pdf on 
July 10, 2008.   
8 Although there are many other types of Federal employees, their official duties are usually 
narrower in scope than those of agency heads or program directors.  Therefore, other 
employees would not likely receive a waiver for their conflicts of interest and would, 
instead, be required to withdraw (i.e., recuse themselves) from the matter(s) related to their 
conflicts.  The official duties of agency heads and program directors are usually broader in 
scope, making recusal more difficult.  When determining how to resolve an employees 
conflict of interest, ethics officials should first consider whether recusal would resolve the 
conflict if an employees duties can easily be adjusted to avoid a waiver.  OGE 
Memorandum to Designated Agency Ethics Officials, Waivers Under 18 U.S.C.  208.  
DO-07-006, February 23, 2007, p. 4.  Accessed at 
http://www.usoge.gov/ethics_guidance/daeograms/dgr_files/2007/do07006.pdf on 
September 20, 2010.   
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I N T R O D U C T I O N  
their financial interests.9, 10  These interests may include outside 
employment, grants, assets, board membership, or ownership of publicly 
traded stock in excess of minimal values.11, 12   The employee must 
withdraw (i.e., recuse himself or herself) from matters relating to the 
interest, unless he or she receives a conflict-of-interest waiver.13, 14   
An appropriate OPDIV or STAFFDIV official (i.e., the granting official) 
responsible for an HHS employees appointment may grant a waiver to 
permit the employee to act in an official Government capacity in 
particular matters in which he or she would otherwise be prohibited 
from participating.  According to OGE, evaluating whether to grant a 
waiver is: 
one of the more significant duties that [OPDIV or 
STAFFDIV] ethics officials perform to ensure public 
confidence in the Governments operations and programs.  
Both the individual employees interests and those of the  
 
9 18 U.S.C.  208; 5 CFR  2635.402.  Executive Branch employees interests refer to both 
the employees own interests and those attributed to them on behalf of another person or 
entity (e.g., spouse, minor child, employer).  5 CFR 2635.402(b)(2).      
10 We use the term particular matters to refer to official duties that involve the interests 
of a specific entity (e.g., a company) or a class of entities (e.g., a sector of similar companies).  
5 CFR  2640.103(a)(1). 
11 SGEs on committees have a regulatory exemption (i.e., do not need a waiver) to 
participate in committee work regarding particular matters of general applicability that 
would affect their employer to the same extent as similarly situated entities (e.g., the 
employers competitors).  However, SGEs on committees must not participate in committee 
work that would have a special or distinct effect on the financial interests of their 
employers.  5 CFR  2640.203(g).   
12 5 CFR  2640.202(a) and (c) provide de minimis exemptions for values of publicly traded 
stock owned by employees who participate in particular matters involving specific parties 
and particular matters of general applicability, respectively.  Specifically, an employee who 
holds publicly traded stock in excess of $15,000 in companies affected by a specific party 
matter is prohibited from officially participating in that matter.  Further, if an employee 
holds stock exceeding $25,000 in a company or an aggregate of stock exceeding $50,000 in a 
sector (i.e., a group of companies in a related industry), the employee is prohibited from 
participating in official duties that could affect all companies within that sector.  
13 Secretary, Memorandum to Deputy Secretary and Chiefs of Staff, Heads of Operating 
and Staff Divisions, Delegation of Authority to Grant Conflict of Interest Waivers Under  
18 U.S.C.  203(d), 205(e), and 208(b).  January 16, 2009.      
14 18 U.S.C.  208.  The term waiver refers to waivers issued under 18 U.S.C.  208(b)(1) 
or (b)(3).  Waivers issued under 208 (b)(1) may be granted to any Federal employee of the 
Executive Branch.  5 CFR  2640.301.  Waivers issued under 208(b)(3) may be granted only 
to SGEs on committees.  5 CFR  2640.302.   
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I N T R O D U C T I O N  
Government are best served when this process is carried 
out in a careful and consistent manner.15   
OPDIVs and STAFFDIVs should document waivers in a manner that 
allows all interested parties (e.g., the HHS employees receiving the 
waivers, their supervisors, the Designated Federal Official assigned to 
the SGEs committee, the general public) to understand the specific 
conflicts of interest and their effect on employees official Government 
duties.16, 17  In addition, while it is not a Federal requirement that 
waivers be signed and dated by employees, waivers can be documented 
with the employees signatures and dates to indicate when the 
employees received and acknowledged the waivers.  If employees do not 
comply with their waivers, they may be in violation of the criminal 
conflict-of-interest statute and can be prosecuted by the Federal 
Government.  In HHS, alleged violations of criminal  
conflict-of-interest statutes must be reported to the Office of Inspector 
General (OIG).18 
If employees do not sign and date their waivers, the Government may 
not be able to hold them accountable for complying with their  
 
15 OGE Memorandum to Designated Agency Ethics Officials, Guidance on Waivers Under 
18 U.S.C.  208(b), Authorizations Under 5 C.F.R.  2635.502(d), and Waivers of 
Requirements Under Agency Supplemental Regulations.  DO-10-005, April 22, 2010, p. 5.  
Accessed at http://www.usoge.gov/ethics_guidance/daeograms/dgr_files/2010/do10005.pdf on 
September 23, 2010. 
16 Waivers are publicly available upon request.  5 CFR  2640.304(a).  Further, the White 
House has urged Federal agencies to make all waivers granted to scientific committee 
members publicly available.  Office of Science and Technology Policy Memorandum for the 
Heads of Executive Departments and Agencies, Scientific Integrity.  December 17, 2010,  
p. 3.  HHS may withhold certain information (e.g., exact number and value of stock, 
company name) before making a waiver available to the public.  18 U.S.C.  208(d); 5 CFR  
 2640.304(b). 
17 The Designated Federal Official is assigned to each committee to call, attend, and 
adjourn committee meetings; ensure efficient operations; and maintain publicly available 
committee records; among other responsibilities.  Federal Advisory Committee Act, 5 U.S.C. 
app. II  10(e).  General Services Administration, The Federal Advisory Committee Act 
(FACA) Brochure.  Accessed at http://www.gsa.gov/portal/content/101010 on November 18, 
2010. 
18 HHS, General Administration Manual, ch. 5-10, Responsibility and Procedures for 
Reporting Misconduct and Criminal Offenses, December 26, 2006.   
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I N T R O D U C T I O N  
waivers.19  For example, as described in a previous report, OIG found 
that in 2007, seven SGEs on committees at the Centers for Disease 
Control and Prevention (CDC) participated in particular matters when 
their waivers prohibited such participation.20  OIG reviewed 
information regarding these seven SGEs and determined that, largely 
as a result of CDCs systemic lack of oversight of the ethics program for 
SGEs identified in the OIG report, the actions of the seven SGEs did not 
rise to the level of criminal violations of the conflict-of-interest statute.21  
Among other things, CDCs lack of oversight included failure to obtain 
SGEs signatures on some 2007 waivers, in violation of CDC policy.     
If OPDIVs and STAFFDIVs do not clearly document waivers to show 
that employees understand their conflicts of interest and the matters, if 
any, in which they are prohibited from participating, employees may 
inadvertently violate the criminal conflict-of-interest statute.  In 
addition, if waivers do not clearly describe the particular matters in 
which employees are permitted to participate, employees may 
incorrectly refrain from providing their expertise when it could benefit 
HHSs programs.  Further, if waivers are not documented so that the 
public understands employees specific conflicts of interest and their 
 
19 Some waivers (i.e., limited waivers) contain recusal obligations requiring employees to 
withdraw from matters related to their conflicts.  Although OPDIVs or STAFFDIVs grant 
waivers to employees, the ultimate responsibility for abiding by the recusal obligations in 
the waivers rests with the employees.  OGE Memorandum to Designated Agency Ethics 
Officials, Effective Screening Arrangements for Recusal Obligations.  DO-04-012,           
June 1, 2004.  Accessed at 
http://www.usoge.gov/ethics_guidance/daeograms/dgr_files/2004/do04012.html on 
September 28, 2010.  In cases in which a waiver with a recusal obligation is granted but the 
employee never signs the waiver, and the employee violates the criminal conflict-of-interest 
statute by participating in matters requiring recusal, it may be difficult to prove that the 
employee ever saw the waiver or knew that the waiver contained the recusal obligation.  
The employee could argue that he or she thought a waiver had been granted but was 
unaware of the recusal required by the waiver.  In such cases, it may be difficult, if not 
impossible, to hold the employee accountable for the ethics violation.    
20 OIG, CDCs Ethics Program for Special Government Employees on Federal Advisory 
Committees, OEI-04-07-00260, December 2009.  Accessed at 
http://oig.hhs.gov/oei/reports/oei-04-07-00260.pdf on July 13, 2010.  
21 After reviewing the matters surrounding these seven SGEs, the OGC Ethics Division, in 
consultation with OGE, determined that CDC issued the waivers based on an incorrect 
analysis of 18 U.S.C.  208.  That is, OGC and OGE determined that the conflicts of interest 
addressed by the waivers were not conflicts under 18 U.S.C.  208.  According to OGC, while 
the SGEs may have violated the terms of their waivers, they did not violate 18 U.S.C.  208 
because they did not participate in particular matters related to a conflict of interest 
covered by 18 U.S.C.  208.  
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I N T R O D U C T I O N  
effect on the employees official Government duties, the public may 
question the integrity of the employees services to the Government.  
Additionally, waivers that do not contain employees signatures and 
dates may raise questions about whether the HHS OPDIVs or 
STAFFDIVs actually presented the waivers to the employees and 
whether the employees had a chance to review and understand them.   
Thus, if waivers are not clearly documented and/or there is no evidence 
that employees received and acknowledged their waivers (e.g., via 
signatures and dates on waivers or other documentation), OIG has 
difficulty investigating reports of alleged violations and holding 
employees accountable for complying with the criminal  
conflict-of-interest statute.  
HHS Ethics Programs 
With oversight and guidance from the HHS OGC Ethics Division, each 
HHS OPDIV and STAFFDIV administers an ethics program for its 
employees.  When administering these programs, OPDIV and 
STAFFDIV ethics officials must take into account the requirements 
placed on HHS employees pursuant to the criminal conflict-of-interest 
statute, 18 U.S.C.  208.22  In addition, ethics programs should be 
administered in accordance with Governmentwide Federal ethics 
regulations and the Secretarys January 2009 instructions.23   
HHS OPDIV and STAFFDIV ethics programs rely on HHS employees 
disclosing their personal financial interests.  HHS employees who serve 
in certain positions must file financial disclosure reports either publicly 
or confidentially.24  In addition, OPDIVs and STAFFDIVs may collect 
 
22 5 CFR  2638, OGE and Executive Agency Ethics Program Responsibilities.      
23 Ibid.  5 CFR  2640.301 and 302.  HHS Secretary, Memorandum to Deputy Secretary 
and Chiefs of Staff, Heads of Operating and Staff Divisions, Delegation of Authority to 
Grant Conflict of Interest Waivers Under 18 U.S.C.  203(d), 205(e), and 208(b).   
January 16, 2009.     
24 Financial disclosure filing requirements are set forth in 5 CFR  2634 Subpart B (for 
public filers) and 5 CFR  2634 Subpart I (for confidential filers).  Public filers disclose 
financial interests on Standard Form 278; confidential filers disclose financial interests on 
OGE Form 450.  Ethics in Government Act, 5 U.S.C. app.  101 and 107.  Alternate 
procedures for filing financial disclosures are allowed under 5 CFR  2634.905.  According to 
OGC, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) 
use alternate filing procedures for SGEs.  Most committees at FDA use another form 
instead of OGE Form 450.  In addition, SGEs at NIH annually file updates to their OGE 
Form 450 rather than filing a complete OGE Form 450 each year.   
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I N T R O D U C T I O N  
other documents, such as employees curricula vitae or resumes, to 
supplement information in the financial disclosure reports.   
Once employees disclose their interests, ethics officials can assist them 
in avoiding conflicts between their official Government duties and their 
personal financial interests.  To do this, ethics officials review an 
employees financial disclosure file, which includes financial disclosure 
forms and other documents (e.g., the employees curriculum vitae), to 
determine whether the employee has any conflicts of interest.25  The 
granting official in the OPDIV or STAFFDIV then determines case by 
case whether to grant a waiver.26  Unless an employee who has a 
conflict of interest receives a waiver, he or she is prohibited from 
participating in certain official matters affecting the interest.   
HHS OPDIV and STAFFDIV ethics officials may consult with the HHS 
OGC Ethics Division and other appropriate parties (e.g., employees, 
employees supervisors, and the Designated Federal Official assigned to 
the SGEs committee) to determine whether waivers may be needed and 
for assistance documenting them.27  In accordance with the Secretarys 
instructions, the OGC Ethics Division is required to review SGEs 
waivers where practicable prior to an OPDIV or STAFFDIV granting 
the waivers.28  Once an SGEs waiver has been finalized, a copy must be 
provided to the OGC Ethics Division.29  The OGC Ethics Division is also 
required to review all waivers for all other HHS employees.30  
Periodically, the OGC Ethics Division conducts program reviews, 
including reviews of waivers, to ensure that selected HHS OPDIVs and 
STAFFDIVs ethics programs are complying with Federal ethics 
requirements.31   
 
25 We use the term ethics officials to refer to HHS staff, including the Deputy Ethics 
Counselor, the Ethics Coordinator, and other staff who provide ethics guidance and support.   
26 5 CFR  2640.302(a) and 2640.301(a). 
27 OGC Ethics Division, Deputy Ethics Counselor HHS Ethics Program Statement of 
Functions, Responsibilities, and Authority, revised August 15, 2007. 
28 The HHS Designated Agency Ethics Official (or another appropriate ethics official) must 
review 208(b)(3) waivers where practicable.  Secretary, Memorandum to Deputy Secretary 
and Chiefs of Staff, Heads of Operating and Staff Divisions, Delegation of Authority to 
Grant Conflict of Interest Waivers Under 18 U.S.C.  203(d), 205(e), and 208(b).   
January 16, 2009, p. 2.      
29 Ibid. 
30 Specifically, the Designated Agency Ethics Official within the Ethics Division must 
review all waivers for all other HHS employees. 
31 OGC Ethics Division, Program Review Section, Guidelines for Conducting Ethics 
Program Reviews at the Department of Health and Human Services.  February 2010.   
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HHS ethics officials are also required to consult with OGE when 
practicable prior to granting a waiver.32  An April 2010 OGE 
memorandum notes that where practicable is a high standard 
requiring agencies to consult [with OGE] in all but the most exigent 
circumstances.  Waiving a criminal conflict of interest statute is not to 
be taken lightly.33   
In 2009, OPDIVs and STAFFDIVs granted 342 waivers to HHS 
employees, representing a decrease of 24 percent since 2007.        
Ninety-eight percent (334 of 342) of the waivers HHS granted in 2009 
were to SGEs on committees.34  Appendix A provides the number of 
waivers by OPDIV or STAFFDIV and type of employee (i.e., SGE or 
other Federal employee) from 2007 to 2009.  
Federal Ethics Requirements and Recommendations for HHS  
Conflict-of-Interest Waivers 
There are many Federal ethics regulations that pertain to  
conflict-of-interest waivers.35  For example, for a waiver to be legally 
effective, it must be in writing, signed and dated by the appropriate 
granting official, and granted under the appropriate statutory 
authority.36  That is, an OPDIV or STAFFDIV may grant a waiver to an 
SGE on a committee if, after reviewing the SGEs financial disclosures, 
the appropriate granting official certifies that the need for the 
employees services outweighs the potential for a conflict of interest 
created by the financial interest involved, as required by statute and 
regulation.37  Similarly, an OPDIV or STAFFDIV may grant a waiver 
that allows a Federal employee (other than an SGE on a committee) to 
work on a particular matter if the granting official determines that the 
financial interest is not so substantial as to be deemed likely to affect 
the integrity of the employees services to the Government.38  
 
32 5 CFR 2640.303.   
33 OGE Memorandum to Designated Agency Ethics Officials, Guidance on Waivers Under 
18 U.S.C.  208(b), Authorizations Under 5 C.F.R.  2635.502(d), and Waivers of 
Requirements Under Agency Supplemental Regulations.  DO-10-005, April 22, 2010, p. 5.  
Accessed at http://www.usoge.gov/ethics_guidance/daeograms/dgr_files/2010/do10005.pdf on 
September 23, 2010. 
34 OIG review of data provided by OGC, 2010.  
35 5 CFR pt. 2640.   
36 Ibid.  
37 18 U.S.C.  208(b)(3); 5 CFR  2640.302(a)(3). 
38 18 U.S.C.  208(b)(1); 5 CFR  2640.301(a)(4).  
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Further, waivers both for SGEs on committees and all other HHS 
employees should describe: 
1.  the employees specific financial interest that poses the conflict of 
interest;39, 40  
2.  the particular matter(s) in which the employee is permitted to 
participate;41, 42 and  
3.  the particular matter(s), if any, in which the employee is 
prohibited from participating.43, 44 
Appendix B contains the provisions of Governmentwide Federal ethics 
regulations regarding the issuance of individual waivers for SGEs on 
committees and all other HHS employees.  Hereinafter we will refer to 
the provisions of selected Governmentwide Federal ethics regulations 
included in our review as selected regulatory provisions.  
The OGE-promulgated regulations state that the disqualifying financial 
interest, the particular matter or matters to which the waiver applies, 
and the employees role in such matters do not need to be described with 
any particular degree of specificity to be legally sufficient.45  As such, 
the regulations allow agency flexibility to respond to a wide variety of 
 
39 For SGEs, [w]aivers issued pursuant to 18 U.S.C. 208(b)(3) should comply with the 
following requirements . . . [t]he facts upon which the certification is based should be fully 
described in the waiver, including the nature of the financial interest. . .  5 CFR  
 2640.302(a)(4).   
40 For all other HHS employees, waivers issued pursuant to 18 U.S.C. 208(b)(1) should 
comply with the following requirements . . . [t]he waiver should describe the disqualifying 
financial interest . . .  5 CFR  2640.301(a)(3).  Further, the information contained in the 
waiver . . . should provide a clear understanding of the nature and identity of the 
disqualifying financial interest, the matters to which the waiver will apply, and the 
employees role in such matters.  5 CFR  2640.301(a), Note to paragraph (a).   
41 For SGEs, [w]aivers issued pursuant to 18 U.S.C. 208(b)(3) should comply with the 
following requirements . . . [t]he facts upon which the certification is based should be fully 
described in the waiver, including . . . the particular matter or matters to which the waiver 
applies. . .  5 CFR  2640.302(a)(4). 
42 For all other HHS employees, [w]aivers issued pursuant to 18 U.S.C. 208(b)(1) should 
comply with the following requirements . . . [t]he waiver should describe. . .the particular 
matter or matters to which it applies.  5 CFR  2640.301(a)(3).   
43 For SGEs, [w]aivers issued pursuant to 18 U.S.C. 208(b)(3) should comply with the 
following requirements . . . [t]he waiver should describe any limitations on the individuals 
ability to act in the matter or matters.  5 CFR  2640.302(a)(5). 
44 For all other HHS employees, [w]aivers issued pursuant to 18 U.S.C. 208(b)(1) should 
comply with the following requirements . . . [t]he waiver should describe. . .any limitations 
on the employees ability to act in such matters.  5 CFR 2640.301(a)(3).   
45 5 CFR  2640.301, Note to paragraph (a). 
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situations.  These situations may include cases in which agencies and 
employees have more or less information available to them concerning 
the particular matters in which employees might participate, employees 
roles in such matters, and the financial impact of such matters.  The 
regulations also state, however, that a waiver should provide a clear 
understanding of the nature and identity of the employees financial 
interest that poses the conflict, the matters to which the waiver applies, 
and the employees role in such matters.46  Further, in proposing these 
regulations in 1995, OGE stated that agencies should endeavor to 
formulate waivers with enough specificity that a member of the public 
would have a clear understanding of the circumstances to which the 
waiver applies.47   
The Secretarys January 2009 instructions state that, among other 
things, waivers must fully describe the potential conflict [and] 
document the basis for the waiver.  These instructions also state that 
waivers must . . . reflect an individualized assessment of the 
[employees] circumstances.48  Appendix C contains the Secretarys 
January 2009 instructions.   
Description of the specific financial interest that poses the conflict of 
interest.  Waivers may apply to present and future interests (e.g., future 
receipt of grant funds or appointment as a board member), provided the 
interests are described with sufficient specificity.49  For SGEs waivers, 
the regulations promulgated by OGE state that the facts upon which 
the [waiver] is based should be fully described in the waiver, including 
the nature of the financial interest.50  For all other HHS employees 
waivers, the regulations state that the waiver should describe the 
disqualifying financial interest and that the information contained in 
the waiver . . . should provide a clear understanding of the nature and 
identity of the disqualifying financial interest.51  Furthermore, the 
 
46 Ibid.  
47 OGE.  Interpretation, Exemptions and Waiver Guidance Concerning 18 U.S.C. 208 (Acts 
Affecting a Personal Financial Interest) (proposed rule), 60 Fed. Reg. 47222 (Sept. 11, 1995).   
48 Secretary, Memorandum to Deputy Secretary and Chiefs of Staff, Heads of Operating 
and Staff Divisions, Delegation of Authority to Grant Conflict of Interest Waivers Under  
18 U.S.C.  203(d), 205(e), and 208(b).  January 16, 2009, p. 2.      
49 5 CFR  2640.302(a)(7) and 2640.301(a)(6).  
50 5 CFR  2640.302(a)(4). 
51 5 CFR  2640.301(a), Note to paragraph (a). 
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II NN TT RR OO DD UU CC TT II OO NN   
Secretarys instructions state that the waiver must fully describe the 
potential conflict . . . .52    
Description of the particular matter(s) in which the employee is permitted to 
participate.  A waiver should describe the particular matter(s) to which it 
applies.53  That is, the waiver should describe the particular matter(s) 
related to the conflict(s) of interest that the employee is permitted to 
undertake as part of his or her official duties.  Employees must not 
participate in the matter(s) until the waiver is granted.54  If a waiver 
applies to all particular matters under an employees responsibility, the 
waiver should contain a reasonably detailed description of these 
responsibilities.55  The Secretarys instructions state that [c]ategories 
of official actions to which a waiver applies must be narrowly drawn to 
ensure that permission for the employee to act in an otherwise 
conflicting situation is appropriately limited.56  Thus, the waiver 
should specify the particular matter(s) in which the employee is 
permitted to participate. 
Description of the particular matter(s), if any, in which the employee is 
prohibited from participating.  In cases in which the granting official does 
not permit the employee to fully participate in matters related to the 
conflict of interest, the official must grant a limited waiver.  Limited 
waivers should describe limitations on the employees participation in 
his or her official duties.57  For example, a limited waiver may permit 
the employee to participate in official matters related to an existing 
contract but prohibit the employee from participating in matters related 
to any future contract negotiations.  
In HHS, the Secretary has emphasized the importance of any 
limitations described in waivers by pointing out:  Vigilant internal 
agency practice must provide for effective screening and monitoring 
 
52 Secretary, Memorandum to Deputy Secretary and Chiefs of Staff, Heads of Operating 
and Staff Divisions, Delegation of Authority to Grant Conflict of Interest Waivers Under  
18 U.S.C.  203(d), 205(e), and 208(b).  January 16, 2009, p. 2. 
53 5 CFR  2640.302(a)(4) and 2640.301(a)(3).  
54 5 CFR  2640.301(a)(5) and 2640.302(a)(6).   
55 OGE Guidance 07 x 4.  Memorandum dated February 23, 2007, from Robert I. Cusick, 
Director, to Designated Agency Ethics Officials Regarding Waivers Under 18 U.S.C. 208 .   
56 Secretary, Memorandum to Deputy Secretary and Chiefs of Staff, Heads of Operating 
and Staff Divisions, Delegation of Authority to Grant Conflict of Interest Waivers Under  
18 U.S.C.  203(d), 205(e), and 208(b).  January 16, 2009, p. 2.      
57 5 CFR  2640.301(a)(3) and 2640.302(a)(5).  
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mechanisms when an employee has received a limited waiver from the 
conflict of interest statutory requirements.58   
Employee Signature and Date on HHS Conflict-of-Interest Waivers   
OPDIVs or STAFFDIVs must grant waivers prior to employees taking 
any action in matters for which they have conflicts.59  While it is not a 
Federal ethics requirement for them to do so, HHS OPDIVs and 
STAFFDIVs can document when employees receive and acknowledge 
their waivers by having employees sign and date them.60  Employees 
signatures and dates also document that they are accountable for 
complying with the waivers.  The OGC Ethics Division makes sample 
waivers for SGEs and all other HHS employees available to OPDIVS 
and STAFFDIVs on its Intranet site.61  The sample waiver for SGEs has 
a signature line for the SGE and an acknowledgment statement.62  The 
sample waivers for all other HHS employees have signature lines for 
the employee or the Deputy Ethics Counselor indicating that the 
 
58 Secretary, Memorandum to Deputy Secretary and Chiefs of Staff, Heads of Operating 
and Staff Divisions, Delegation of Authority to Grant Conflict of Interest Waivers Under  
18 U.S.C.  203(d), 205(e), and 208(b).  January 16, 2009, p. 3. 
59 5 CFR  2640.301(a)(5) and 2640.302(a)(6).   
60 At least one OPDIV or STAFFDIV has a policy that requires employees to sign waivers.  
For example, see CDC Policy CDC-GA-2001-05 (formerly CDC-94), Financial Disclosure for 
Federal Advisory Committee Members Appointed as Special Government Employees, 
July 5, 2001.  Accessed at http://www.cdc.gov/maso/facm/pdfs/policy294.pdf on July 13, 
2010. 
61 OGC, Sample Waiver of Conflict of Interest for Special Government Employees (SGEs) 
on Federal Advisory Committees [18 U.S.C. 208(b)(3)], Sample Waiver of Actual Conflict 
for Officers or Directors [18 U.S.C. 208(b)(1)], and Sample Waiver of Actual Conflict of 
Interest for Regular Employees [18 U.S.C. 208(b)(1)].  
62 The acknowledgment states that [t]he undersigned confirms, acknowledges, and agrees 
to the terms of the waiver and will recuse from official participation in any particular 
matters involving specific parties that arise before the {Advisory Committee name} that will 
have a direct and predictable effect on his/her own or imputed financial interests.  OGC, 
Sample Waiver of Conflict of Interest for Special Government Employees (SGEs) on 
Federal Advisory Committees [18 U.S.C. 208(b)(3)].   
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individual signing the waiver has confirmed and acknowledged the 
waiver.63   
As an alternative to obtaining employees signatures and dates, OPDIVs 
and STAFFDIVs can document other actions to ensure that employees 
understand their conflicts of interest and any limitations on their 
participation in official duties.  Such other actions could include 
emailing employees to notify them about their waivers, receiving emails 
from employees to confirm that they understand their waivers, and/or 
documenting that the employees received oral counseling about their 
waivers. 
However, regardless of when the employee signs the waiver, it is not 
considered effective until the OPDIV or STAFFDIV granting official 
signs and dates it.64 
Related Office of Inspector General Work 
In a 2009 report, OIG cited vulnerabilities in waivers for SGEs on 
committees at CDC in 2007.  Eight percent (18 of 212) of SGEs on CDCs 
17 committees had approved waivers on file in 2007.  OIG found that 
none of these 18 waivers was adequately documented.65  
METHODOLOGY 
Scope  
We reviewed a stratified, random sample of 50 conflict-of-interest 
waivers that OPDIVs and STAFFDIVs granted in 2009 to determine 
whether they were documented as recommended in 3 selected 
regulatory provisions and the Secretarys instructions.  We also 
determined whether HHS employees signed and dated their waivers.    
Our review did not include a complete determination of whether the 
waivers in our sample were legally sufficient or valid, and we do not 
 
63 The sample waiver for officers or directors has a signature line for the employee; the 
sample waiver for regular employees has a signature line for the employee or the Deputy 
Ethics Counselor.  The HHS Designated Agency Ethics Official has delegated daily 
responsibility for administering HHSs ethics programs to Deputy Ethics Counselors in each 
OPDIV or STAFFDIV.  April 7, 2011.  Accessed at 
http://www.hhs.gov/ogc/contact/contacts.html on May 2, 2011.     
64 5 CFR 2640.301(a).   
65 OIG, CDCs Ethics Program for Special Government Employees on Federal Advisory 
Committees, OEI-04-07-00260, December 2009, p. 20.  Accessed at 
http://oig.hhs.gov/oei/reports/oei-04-07-00260.pdf on July 13, 2010.  
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intend to cast doubt on the legality of any of the waivers we reviewed.  
Additionally, we did not review whether the waivers in our sample met 
all Federal ethics requirements or recommendations beyond the three 
selected regulatory provisions in our review and the Secretarys 
instructions.  For example, we did not assess whether HHS employees 
who received waivers in 2009 should have been granted the waivers.  
We also did not assess whether employees had conflicts of interest that 
were not addressed by their waivers.  Further, we did not determine 
whether the OPDIV or STAFFDIV ethics official who signed each 
waiver was the appropriate granting official.  We also did not determine 
whether each waiver was granted under the appropriate statutory 
authority.   
Finally, we did not determine whether HHS employees complied with 
their waivers after the OPDIVs or STAFFDIVs granted them.  
Sample Selection 
Three hundred forty-two conflict-of-interest waivers were granted to 
HHS employees at nine OPDIVs and STAFFDIVs in 2009.66  We 
selected a stratified, random sample of waivers from each of these 
OPDIVs and STAFFDIVs.  To select this sample, we initially grouped 
the waivers into 11 strata (see Table 1).   
We developed one stratum for each of the five OPDIVs and STAFFDIVs 
that granted waivers to SGEs on committees in 2009.  From each of 
these strata, we selected a simple random sample of waivers (ranging 
from 2 to 30), in general proportion to the number of waivers in the 
stratum.  For example, we selected the most waivers in our sample from 
the NIH stratum because it granted the largest number of HHS waivers 
in 2009.  We selected the next-highest number of waivers from the Food 
and Drug Administration stratum because it granted the second-largest 
number of HHS waivers in 2009.  We selected the fewest waivers from 
the Agency for Healthcare Research and Quality and the Health 
Resources and Services Administration strata because they granted the 
fewest HHS waivers in 2009.   
 
 
 
66 One OPDIV uses the word addendum to describe a conflict-of-interest waiver that is an 
update to a previous waiver.  Because the OPDIV indicated that these addenda are 
separate and distinct from the waivers they amend, we treated them as waivers and 
included them in the total count of waivers in our analysis. 
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Table 1:  Number of HHS Conflict-of-Interest Waivers Granted in 2009 and Number 
in the Sample, by OPDIV/STAFFDIV and Type of Employee  
Waivers granted  Waivers in 
OPDIV/STAFFDIV 
in 2009   sample 
Waivers for SGEs on Federal advisory committees   334  42 
   National Institutes of Health  287  30 
   Food and Drug Administration  23  5 
   Centers for Disease Control and Prevention  12  3 
   Agency for Healthcare Research and Quality  6  2 
   Health Resources and Services Administration  6  2 
Waivers for all other HHS employees       8    8 
   National Institutes of Health  3  3 
   Assistant Secretary for Planning and Evaluation  1  1 
   Centers for Medicare & Medicaid Services  1  1 
   Food and Drug Administration  1  1 
   Indian Health Service  1  1 
   Office of the General Counsel  1  1 
      Total   342  50 
Source:  OIG analysis of OGC data, 2009. 
 
In 2009, 84 percent (287 of 342) of HHSs waivers were for SGEs on 
committees at NIH in 24 of NIHs 27 Institutes and Centers.67  From 
each of the 24 Institutes and Centers, we selected a simple random 
sample of waivers (ranging from 1 to 3) in general proportion to the 
number of waivers granted to SGEs on committees at each of these      
24 Institutes and Centers.  Appendix D provides the number of HHS 
waivers granted in 2009 to SGEs on committees at NIH, by Institute    
or Center.  
We also developed one stratum for each of the six OPDIVs and 
STAFFDIVs that granted waivers to all other HHS employees in 2009.  
We included all eight of these waivers in our review. 
Data Collection  
We reviewed selected regulatory provisions and the Secretarys 
instructions regarding HHSs conflict-of-interest waivers in 2009.   
We obtained HHS OGC data pertaining to the 342 conflict-of-interest 
waivers that HHS OPDIVs and STAFFDIVs granted in 2009.  We then 
 
67 NIH maintains over 150 chartered committeesthe largest number of committees in any 
Executive Branch agency.  NIH, Office of Federal Advisory Committee Policy, About Us.  
Accessed at http://ofacp.od.nih.gov/about/overview.html on July 20, 2010.  Therefore, NIH 
has more SGEs on committees than any other HHS OPDIV or STAFFDIV.   
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obtained from OGC copies of the 50 waivers in our sample.  We also 
contacted OPDIVs and STAFFDIVs directly to request the waivers and 
any associated documentation.68  That is, in addition to the waivers, we 
reviewed any documentation associated with the employees interests 
referenced in the waivers, as well as any other documentation that the 
OPDIV or STAFFDIV provided.  In addition to the waivers, we 
requested copies of:  
1.  employees financial disclosure forms (i.e., OGE Form 450 or 
Standard Form 278) that correspond to waivers in our sample; and  
2.  other documents pertaining to the interests reflected in each waiver 
in our sample (e.g., emails or correspondence, employees curricula 
vitae or resumes). 
  Data Analysis 
We reviewed the 50 waivers in our sample and associated 
documentation to determine whether the waivers were documented as 
recommended in 3 selected regulatory provisions and the Secretarys 
instructions and whether they included employees signatures and 
dates.    
Selected regulatory provisions and the Secretarys instructions.  We 
determined whether the waivers contained an individualized 
assessment of the employees circumstances and provided a clear 
understanding of the circumstances to which the waivers applied.  We 
reviewed waivers to determine:  
1.  Whether each described employees specific financial interests that 
posed the conflict.  We classified a description as specific if it 
provided a clear understanding of the nature and identity of the 
employees financial interest that posed the conflict.  We classified a 
description as not specific if it contained broad categories of types of 
interests.  Further, if SGEs waivers identified specific interests, we 
determined whether the interests were also reflected in SGEs 
financial disclosure files to indicate whether granting officials based 
the waivers on their reviews of the files.   
 
68 To confirm that the supporting documentation we received from OPDIVs and 
STAFFDIVs corresponded to the waivers in our sample, we compared copies of waivers 
obtained from OGC to those from the OPDIVs and STAFFDIVs and ensured that the 
waivers were the same.   
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2.  Whether each described the particular matters in which employees 
were permitted to participate (i.e., those matters to which the 
waiver applied).  We classified a waiver as containing this 
description if it set forth the employees official duties and the 
matters being waived.  We classified a waiver as not containing this 
description if: 
  the waiver contained only a broad statement that the employee 
may participate in general matters related to the conflict of 
interest and (1) did not state what the conflict was by name 
somewhere in the waiver and (2) did not state the committees 
duties (for SGEs waivers) or the employees official duties (for 
all other HHS employees waivers).   
  the waiver contained contradictory information regarding the 
employees official duties and/or the matters being waived, either 
within the waiver or with other documents we received from the 
OPDIV or STAFFDIV.   
  the granting official did not document in the waiver the decision 
to grant or deny the waiver.69 
3.  Whether each was designated as a limited waiver and described the 
particular matters in which an employee was prohibited from 
participating.  First, we designated a waiver as limited if it was 
documented as limited (i.e., it contained language such as, This is a 
limited waiver ...) and/or contained any reference to matters in 
which the employee must not participate.  Then, we classified a 
waiver as describing the limitations on the employees participation 
if it provided any explanation of the types of matters on which the 
employee must not participate.  We classified a waiver as not 
containing this description if: 
  it contained only a broad statement that the employee must not 
participate in particular matters related to the conflict of 
interest and did not provide any detail about the matters in 
which the employee must not participate.     
  it contained contradictory information regarding the particular 
matters in which the employee was prohibited from 
 
69 HHS waivers contain checkboxes and signature lines for the granting officials to 
document decisions to grant or deny waivers.  
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participating, either within the waiver or with other documents 
we received from the OPDIV or STAFFDIV. 
Employee signature and date.  We reviewed the waivers to determine 
whether they contained employees signatures and dates.  For both 
signed and unsigned waivers, we also determined whether they had a 
line for the employees signatures.  If waivers were not signed, we 
determined whether there was any documentation to demonstrate that 
the employees received and acknowledged their waivers.  That is, we 
reviewed emails to determine whether the employees had received the 
final versions of their waivers or had acknowledged that they 
understood the contents of their waivers.  We also reviewed 
documentation to determine whether OPDIVs or STAFFDIVs had orally 
counseled the employees about their waivers.     
Finally, for waivers that were not signed and/or dated, we determined 
how many of them were not documented as recommended in at least one 
of the three selected regulatory provisions and the Secretarys 
instructions.  Employees receiving these waivers may not know they 
have a waiver or understand the effect on their participation in official 
duties.  Of these waivers, we also determined how many were limited 
waivers.   
Limitations 
We reviewed a stratified, random sample of 50 waivers granted in 2009. 
We do not generalize our findings to all HHS waivers granted in 2009 
because of the small sample size in each stratum.   
Standards  
This study was conducted in accordance with the Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors 
General on Integrity and Efficiency.
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 F I N D I N G S  
 
Fifty-six percent of the 50 HHS  Fifty-six percent (28 of 50) of the 
conflict-of-interest waivers in our review were  waivers from 2009 in our review 
not documented as recommended in provisions  were not documented as 
recommended in at least 1 of 3 
of selected Governmentwide Federal ethics 
selected regulatory provisions and 
regulations and the Secretarys instructions 
the Secretarys instructions.70  
   
These 28 waivers were granted to employees at 5 of the 9 OPDIVs or 
  STAFFDIVs in our review.   
Fourteen percent (7 of 50) of the waivers did not describe employees 
specific interests that posed conflicts.71  In addition, 46 percent (23 of 
50) of the waivers did not describe the particular matters in which 
employees were permitted to participate.72  Finally, 28 percent (14 of 
50) were limited waivers that did not describe the particular matters in 
which the employees were prohibited from participating.73  Twenty-four 
percent (12 of 50) of the waivers were not documented as recommended 
in at least 2 of the 3 selected regulatory provisions and the Secretarys 
instructions, and 8 percent (4 of 50) were not documented as 
recommended in any of these provisions or instructions.74   
Of the 28 waivers that were not documented as recommended in at least 
1 of the 3 selected regulatory provisions and the Secretarys 
instructions, all but 1 were granted to SGEs on committees.  Appendix 
E provides the number and percentage of waivers from 2009 in our 
review that were not documented as recommended in each of the three 
selected regulatory provisions and the Secretarys instructions for SGEs 
and all other HHS employees.   
 
70 Ten of these twenty-eight waivers were addenda to waivers.  These addenda are separate 
and distinct from the waivers they amend.   
71 One of the seven waivers that did not describe employees specific interests was an 
addendum. 
72 Ten of the twenty-two waivers that did not describe the particular matters in which 
employees were permitted to participate were addenda. 
73 None of the fourteen limited waivers that did not describe prohibitions on employees 
participation were addenda. 
74 One of the eight waivers that were not documented as recommended in at least two of the 
three selected regulatory provisions and the Secretarys instructions was an addendum.  
None of the four waivers that were not documented as recommended in any of these 
provisions or instructions were addenda.   
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F I N D I N G S  
Appendix F provides the number and percentage of the waivers from 
2009 in our review that were not documented as recommended in one, 
two, or three of the selected regulatory provisions and the Secretarys 
instructions.  Appendix F also provides this information for limited 
waivers (for which all three selected regulatory provisions and the 
Secretarys instructions apply) and nonlimited waivers (for which only 
two selected regulatory provisions and the Secretarys instructions 
apply). 
Fourteen percent of the 50 waivers in our review did not describe 
employees specific financial interests that posed conflicts 
Fourteen percent (7 of 50) of the waivers from 2009 we reviewed did not 
describe employees specific interests that posed conflicts, and/or the 
interests were not reflected in the employees financial disclosure files.75  
If waivers do not clearly specify the financial interests being waived, the 
employees receiving the waivers (and/or other interested parties) may 
have difficulty understanding which interests are waived and which are 
not.  Thus, the employees may inadvertently participate in matters in 
which they are prohibited from participating and/or may inadvertently 
not participate on matters in which their expertise may be valuable to 
HHSs programs. 
All seven of the waivers that did not describe employees specific 
interests were for SGEs on committees, and almost all (six of seven) 
failed to describe a specific interest that posed a conflict.  Instead, these 
waivers contained general language covering broad categories of 
interests.  For example:   
[e]mployment with honoraria or other compensation from 
the health care industry, research institutions, state and 
local government, health care product manufacturers, 
insurance companies, hospitals, medical management 
delivery organizations, or other organizations ...; and [...] 
[e]xpert witness, litigation, or advocacy services . . . . 
 
75 The Centers for Medicare & Medicaid Services (CMS) did not provide documentation 
pertaining to one employee who was granted a waiver in 2009 because CMS had lost this 
employees financial disclosure file.  We obtained the waiver from OGC and determined that 
it described a specific interest.  We could not determine whether the interest was also 
reflected in the employees financial disclosure file.  To be conservative, we counted this 
waiver as being documented as recommended in the selected regulatory provision of 
describing the employees specific conflict of interest.     
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F I N D I N G S  
The remaining waiver described a specific interest, but the description 
contradicted information in the SGEs financial disclosure file.  
Specifically, the waiver indicated that the spouses employment posed a 
conflict with the SGEs official duties.  However, the financial disclosure 
file indicated that the SGEs spouse was unemployed.  Because this was 
a limited waiver, this discrepancy may have prevented the SGE from 
participating in official duties prohibited by the waiver when, in fact, 
the interest may not have been held by or attributed to the SGE.   
In contrast, most waivers clearly described the employees specific 
interests that posed conflicts.  For example:     
Dr. [A] ... holds stock in [Pharmaceutical Company B].  
[Pharmaceutical Company B] is the parent company of 
[Company C].  [Company C] is a competing firm.  
[Company C] markets dermal fillers for facial wrinkles.  
Dr. [A] owns X,XXX shares of [Pharmaceutical Company 
B] valued at $XX,XXX.  This amount exceeds the 
exemption of $15,000 for stock holdings laid out in the 
regulations issued by the Office of Government Ethics  
(5 CFR 2640.202(a)).  (The meeting is determined to be a 
particular matter involving specific parties.)  
Forty-six percent of the 50 waivers in our review did not describe the 
particular matters in which employees were permitted to participate 
For example, one waiver allows the employee to participate in matters 
of general applicability affecting [his] current financial interests and 
any future interests of the types described above.  The financial 
interests described above in the waiver contained general language 
and covered broad categories of interests.    
Another waiver mentioned the employees specific interests, among 
other broad categories of interests, but the waiver did not describe the 
employees committee or the employees official duties.  Regarding the 
particular matters on which the employee was permitted to participate, 
the waiver stated that the employee is granted a waiver for general 
matters only and did not refer to the specific or broad interests 
contained in the waiver.   
Of the 22 waivers that did not describe the particular matters in which 
employees were permitted to participate, all but 1 were for SGEs on 
committees. 
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F I N D I N G S  
In contrast, 54 percent (27 of 50) of the waivers from 2009 we 
reviewed clearly described the matters in which employees were 
permitted to participate.  For example, one employee was permitted 
to participate in [d]iscussion and recommendations on the safety and 
efficacy of [X] THERAPY, sponsored by [Y] Technologies, Inc. 
(formerly [Z] Technologies, Inc.) for moderate to severe nasolabial fold 
wrinkles.  This is determined to be a particular matter involving 
specific parties.  
Twenty-eight percent of the 50 waivers in our review were limited waivers 
that did not describe the particular matters in which employees were 
prohibited from participating 
However, only 31 of the 50 waivers in our sample were limited waivers 
that should have contained this description; the remaining 19 permitted 
employees to fully participate in official duties with no limitations.  
Thus, 45 percent (14 of 31) of the limited waivers in our review did not 
describe the particular matters in which HHS prohibited employees 
from participating.  All 14 of these waivers were for SGEs on 
committees.   
All of the limited waivers in our review contained broad statements that 
the employees must not participate in specific matters related to their 
conflicts of interest.  However, 14 limited waivers did not provide any 
detail about these matters for the employee receiving the waiver or 
other stakeholders (e.g., the employees supervisor, the Designated 
Federal Official assigned to the SGEs committee, the public, OIG).  
Thus, these waivers did not have enough specificity to provide a clear 
understanding of the circumstances to which the waiver applied. 
For example, one employee was granted a waiver that would allow this 
individual to participate in general matters that may directly affect [the 
HHS employees] financial interests, but not uniquely affecting the 
employees financial interest.   
In contrast, 55 percent (17 of 31) of limited waivers clearly described 
the prohibitions on the employees participation.  For example:  
[T]his waiver is intended to be limited in scope in that it 
does not apply to certain actions.  You must have no 
involvement in any HHS grants, contracts, or other official 
actions that generate financial support to the [X], such as 
the procurement of [X] publications or approving 
expenditures for [X]-sponsored training for [HHS] staff.  
Likewise, you will have no involvement in HHS decisions 
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  22         
   
F I N D I N G S  
to provide speakers or other support to [X] events.  You 
also will recuse yourself from all charitable solicitation 
activities by [X] ...   
 
While it is not a Federal 
Although not required, 18 percent of the 50 HHS 
requirement for them to do so, HHS 
conflict-of-interest waivers in our review 
OPDIVs and STAFFDIVs can 
included employees signatures and dates  
document when employees receive 
and acknowledge their waivers by having employees sign and date 
them.  Employees signatures and dates also document that they may be 
held accountable for complying with the terms of their waivers.76  On its 
Intranet site, the OGC Ethics Division makes sample waivers available 
to OPDIVs and STAFFDIVs.  These samples have a signature line for 
employees to confirm and acknowledge their waivers.   
Eighteen percent (9 of 50) of the waivers from 2009 we reviewed 
included HHS employees signatures and dates.  These waivers were 
granted to employees in six of the nine OPDIVs and STAFFDIVs in our 
review. 
In contrast, 82 percent (41 of 50) of the waivers we reviewed did not 
include HHS employees signatures and/or dates.  Seventy-six percent 
(38 of 50) of the waivers had been neither signed nor dated by the HHS 
employees receiving them.  Thus, these 38 waivers are not documented 
to indicate that the employees received them or were aware that the 
waivers existed.  Three waivers were signed but were not dated by the 
HHS employees receiving them.  The 41 waivers that were not signed 
and/or dated were granted to employees at 5 of the 9 OPDIVs and 
STAFFDIVs in our review. 
For the 38 waivers that were not signed or dated, no other 
documentation was submitted by the OPDIV or STAFFDIV to document 
that these employees received and/or acknowledged their waivers.  For 
example, there were no documented emails to the 38 employees 
notifying them that they had waivers, sending them the final versions of 
their waivers, or asking them to confirm that they understood their 
waivers.77  There was also no documentation that the OPDIV or 
 
76 Waivers are not considered to be in effect, however, until they are signed and dated by 
the OPDIV or STAFFDIV granting official. 
77 One email documented that an employee received a draft version of the waiver.   
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F I N D I N G S  
STAFFDIV orally counseled the 38 employees to ensure that they 
understood their conflicts of interest or the limitations on their 
participation in official duties, as described in their waivers.   
Of the unsigned waivers, most (36 of 38) did not have a line for the 
employees signature, as included in the OGC sample waivers.  In 
contrast, all 12 of the signed waivers had a line for the employees 
signature.  These 12 waivers were granted to employees at 8 of the  
9 OPDIVs or STAFFDIVs in our review. 
Of the 41 waivers that were not signed and/or dated, all but 2 were for 
SGEs on committees.  Appendix G provides the number and percentage 
of waivers from 2009 in our review that did not include the employees 
signatures and/or dates, for SGEs and all other HHS employees.  
Twenty-four of the forty-one waivers that were not signed and/or dated 
were not documented as recommended in at least one of the three 
selected regulatory provisions and the Secretarys instructions.  Thus, 
the employees receiving these 24 waivers may not be aware of them.  
Even if they are aware the waivers exist, the employees may not 
understand their contents or their effect on the employees official 
duties. 
Twenty-four of the waivers that were not signed and/or dated were 
limited waivers.  These waivers were not documented to indicate that 
the employees knew of the waivers or the limitations that the waivers 
imposed on their official duties.  Of these 24 unsigned limited waivers, 
14 were not documented as recommended in at least 1 of the 3 selected 
regulatory provisions and the Secretarys instructions.  These 
14 waivers represent the greatest vulnerability.  The employees 
receiving these waivers may not be aware of them.  If they are aware of 
the waivers, the employees may not understand the limitations imposed 
on their participation in official duties.  If these employees are not 
aware of their limited waivers or do not clearly understand them, the 
employees may violate the criminal conflict-of-interest statute by 
participating in prohibited matters.   
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 R E C O M M E N D A T I O N S  
 
HHS employees, including SGEs serving as subject-matter experts on 
committees, play an influential role in the Federal Governments public 
health policies.  With the HHS OGC Ethics Divisions oversight and 
guidance, an HHS OPDIV and STAFFDIV may grant  
conflict-of-interest waivers to its employees.  These waivers permit the 
employees to act in an official Government capacity in which they would 
otherwise be prohibited.  OPDIVs and STAFFDIVs should document 
waivers as recommended in selected regulatory provisions and the 
Secretarys instructions.  In addition, HHS OPDIVs and STAFFDIVs 
can document when employees receive and acknowledge the waivers by 
having employees sign and date them or by otherwise documenting (e.g., 
via emails, documentation of oral counseling) that the employees 
received and acknowledged their waivers.  Employees signatures and 
dates (or other documentation) also document that they are accountable 
for complying with their waivers.   
According to OGE, evaluating whether to grant a waiver is one of the 
more significant duties that ethics officials perform.78  If  
conflict-of-interest waivers are not clearly documented to show that 
employees understand their conflicts of interest and the matters, if any, 
in which they are prohibited from participating, employees may 
inadvertently violate the criminal conflict-of-interest statute.  In 
addition, if waivers do not clearly describe the particular matters in 
which employees are permitted to participate, employees may 
incorrectly refrain from providing their expertise when it would benefit 
HHSs programs.  Further, if waivers are not documented so that the 
public understands the employees conflicts of interest and their effect 
on the employees official Government duties, the public may question 
the integrity of the employees services to the Government.  
Additionally, waivers that do not contain employees signatures and 
dates may raise questions about whether the HHS OPDIVs or 
STAFFDIVs presented the waivers to the employees and whether the 
employees had an opportunity to review and understand them.   
 
78 OGE Memorandum to Designated Agency Ethics Officials, Guidance on Waivers Under 
18 U.S.C.  208(b), Authorizations Under 5 C.F.R.  2635.502(d), and Waivers of 
Requirements Under Agency Supplemental Regulations.  DO-10-005, April 22, 2010, p. 5.  
Accessed at http://www.usoge.gov/ethics_guidance/daeograms/dgr_files/2010/do10005.pdf on 
September 23, 2010. 
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R E C O M M E N D A T I O N S  
In HHS, reports of alleged violations of the criminal conflict-of-interest 
statute must be reported to OIG.  However, if waivers are not clearly 
documented and there is no evidence that employees received and 
acknowledged their waivers (e.g., via signatures and dates on waivers or 
other documentation), OIG has difficulty investigating, and the Federal 
Government would have difficulty holding employees accountable for 
complying with the criminal conflict-of-interest statute when alleged 
violations occur.  
We found that 56 percent of HHS employee conflict-of-interest waivers 
in our review were not documented as recommended in at least one of 
three selected regulatory provisions and the Secretarys instructions, 
and 8 percent were not documented with any of these provisions or 
instructions.  In addition, although not required, 18 percent of waivers 
we reviewed were signed and dated by HHS employees.  
Therefore, we recommend that HHS OGC:  
Require OPDIVs and STAFFDIVs to document conflict-of-interest waivers as 
recommended in Governmentwide Federal ethics regulations and the 
Secretarys instructions 
OGC should work with the Office of the Secretary to reaffirm the 
Secretarys January 2009 instructions and/or issue a new HHS policy 
requiring that all waivers be clearly documented to describe: 
  the employees specific financial interest that poses the conflict of 
interest; 
  the particular matter(s) in which the employee is permitted to 
participate; and 
  the particular matter(s), if any, in which the employee is prohibited 
from participating. 
As an alternative to documenting the waivers as recommended in the 
selected regulatory provisions and the Secretarys instructions, other 
documents could be attached to or associated with the waivers to 
assist employees and other stakeholders in understanding them.   
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  26         
   
R E C O M M E N D A T I O N S  
Develop additional guidance and training to assist OPDIVs and STAFFDIVs 
in documenting conflict-of-interest waivers as recommended in 
Governmentwide Federal ethics regulations and the Secretarys instructions 
OGC should revise existing or create new guidance and training for 
OPDIV and STAFFDIV ethics officials to ensure that waivers meet the 
requirements and recommendations set forth in the criminal  
conflict-of-interest statute, Governmentwide Federal ethics regulations, 
and the Secretarys instructions.  This guidance and training should 
educate ethics officials on how to draft waivers that are individualized 
for each employee.  In addition to including the required legal language, 
some section of waivers should contain clear, plain (i.e., nonlegal) 
language that employees and other stakeholders, including employees 
supervisors, can easily understand and apply to the employees work 
circumstances.  Each waiver should also include an individualized 
interpretation of how it applies to the employees unique work 
circumstances and should provide a clear understanding of the 
circumstances to which the waiver applies or does not apply.  Providing 
clear and understandable guidance would also serve to prevent 
inadvertent violations of the criminal conflict-of-interest statute.  
Guidance should also include a detailed description of the applicable 
Federal ethics regulations and should provide examples and sample 
language to illustrate how waivers should be documented.  For example, 
the guidance could explain in more detail that a waiver should clearly 
describe the following: 
  The employees specific interest and the potential for conflict.  The waivers 
description should contain sufficient detail for the employee and the 
public to understand the nature and identity of the specific interest 
and how the interest may conflict with the employees official duties. 
  The particular matters in which the employee is permitted to participate.  The 
waivers description should contain sufficient detail for the employee 
and the public to understand the scope of the employees permission to 
act in official duties related to the specified interest and the particular 
matters to which the waiver applies.    
  The particular matters in which the employee is prohibited from participating.  
When a limited waiver is required, its description should contain 
sufficient detail for the employee and the public to understand the 
particular matters that are not being waived and in which the 
employee is prohibited from participating.  Further, the waiver should 
instruct the employee what to do if a matter related to the interest 
arises and the employee is unsure whether he or she can participate.     
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R E C O M M E N D A T I O N S  
OGC should also revise existing training or provide additional training to 
ethics officials in OPDIVs and STAFFDIVs.  The training should include 
an overview of the process for developing and granting waivers to comply 
with Governmentwide Federal ethics regulations and the Secretarys 
instructions.  The training should also provide hypothetical examples of 
HHS employees who have conflicts of interest and should educate ethics 
officials on whether a waiver should be granted and, if so, how to clearly 
document it.   
Take action to revise the conflict-of-interest waivers in our review that were 
not documented as recommended in Governmentwide Federal ethics 
regulations and the Secretarys instructions, if the waivers are still in effect 
OGC should work with OPDIVs and STAFFDIVs to determine if any 
waivers in our review are still in effect (i.e., if the employee is still 
working for HHS, if the employee still has the same conflict of interest 
and is working on the same official duties).  If any of the waivers are 
still in effect, OGC should assist OPDIVs and STAFFDIVs in their 
revision of these waivers to document them according to the three 
selected regulatory provisions and the Secretarys instructions.  OGC 
should ensure that the OPDIVs and STAFFDIVs clarify waiver terms to 
help employees understand and comply with the waivers.   
OGC should focus first on the 14 limited waivers that were not 
documented as recommended in at least 1 of the 3 selected regulatory 
provisions and the Secretarys instructions and were also not signed 
and/or dated by the employee receiving the waiver.  These limited 
waivers represent the greatest vulnerability.  If these employees are not 
aware of their limited waivers or do not understand them, and if the 
waivers are still in effect, the employees may inadvertently violate the 
criminal conflict-of-interest statute by taking part in matters in which 
they are prohibited from participating. 
Expand the review of conflict-of-interest waivers for SGEs on committees 
Consistent with the Secretarys January 2009 memorandum, the OGC 
Ethics Division must review waivers for SGEs on committees where 
practicable.79  Most HHS waivers granted in 2009 were for SGEs on 
committees, and these SGEs waivers constitute most of the problems 
we found.   
 
79 Secretary, Memorandum to Deputy Secretary and Chiefs of Staff, Heads of Operating 
and Staff Divisions, Delegation of Authority to Grant Conflict of Interest Waivers Under  
18 U.S.C.  203(d), 205(e), and 208(b).  January 16, 2009, p. 2.      
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R E C O M M E N D A T I O N S  
Therefore, when OGC receives copies of HHS waivers that were granted 
by OPDIVs and STAFFDIVs, it should thoroughly check a sampleif 
not allof the waivers from each OPDIV or STAFFDIV, particularly 
focusing on waivers for SGEs, to ensure that the waivers are 
documented as recommended in Federal ethics regulations and the 
Secretarys instructions.  As part of this review, OGC should obtain the 
employees financial disclosure file from the OPDIV or STAFFDIV to 
fully understand the nature of the employees conflicts of interest.  If 
OGC identifies problems with waivers within an OPDIV or STAFFDIV, 
it should ensure that the OPDIV or STAFFDIV clarifies with the 
employees the matters in which they are permitted to participate and 
any matters in which they are prohibited from taking part.  OGC should 
also work with OPDIV or STAFFDIV ethics officials to revise these 
waivers and require that the ethics officials work more closely with 
OGC before granting future waivers.   
Require all employees to sign and date their conflict-of-interest waivers or 
otherwise document that they received and acknowledged them 
OGC should work with the Office of the Secretary to issue official HHS 
policy that requires all employees to sign and date their waivers.  OGC 
should also require that waivers have a line for the employees 
signature and date so that it is clear that the document must be signed 
and dated, as demonstrated in the OGC Ethics Divisions sample 
waivers.80   
As an alternative to signing and dating waivers, the policy could permit 
other methods for documenting that employees received and 
acknowledged their waivers, such as by retaining emails from 
employees confirming that they understand their waivers and/or 
documenting oral counseling provided to employees about their waivers.  
While waivers are considered legally in effect once they are signed and 
dated by the appropriate granting official, employees should sign and 
date their waivers to (1) acknowledge the waivers, (2) document when 
they understood any limitations on their participation in official 
Government duties, and (3) confirm that the waivers accurately describe 
their specific circumstances and conflicts of interest.  Employees 
 
80 OGC, Sample Waiver of Conflict of Interest for Special Government Employees (SGEs) 
on Federal Advisory Committees [18 U.S.C. 208(b)(3)], Sample Waiver of Actual Conflict 
for Officers or Directors [18 U.S.C. 208(b)(1)], and Sample Waiver of Actual Conflict of 
Interest for Regular Employees [18 U.S.C. 208(b)(1)].   
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R E C O M M E N D A T I O N S  
signatures and dates on waivers also demonstrate that OPDIVs or 
STAFFDIVs presented the waivers to the employees and that the 
employees had a chance to review and understand them.  Requiring 
employees to sign and date their waivers, or otherwise documenting 
that they received and understood the waivers, may also assist in 
ensuring that they are held accountable for complying with the waivers.   
Waivers are not considered to be in effect until OPDIV or STAFFDIV 
granting officials sign and date them.  Therefore, employees signatures 
and dates should be obtained on waivers as soon as possible after the 
granting official signs and dates them.       
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
OGC and OGE provided written comments on a draft of this report.  We 
provide, below, a summary of these comments and our responses to 
each.  In addition, in response to OGCs and OGEs comments, we 
conducted a second review of many of the waivers in our sample.  OIG 
continued to find that many waivers were not documented as 
recommended in the selected regulatory provisions and the Secretarys 
instructions, and we updated our findings accordingly. 
Comments from the HHS Office of the General Counsel.  OGC stated that 
the OIG report is incorrect and ignores the wide latitude that OGE 
contemplated when making recommendations for waiver content.  OGC 
also disagreed with the finding that the waivers in our sample were not 
documented as recommended in OGE regulations and stated that our 
contrary conclusion was based on several fundamental errors.  Further, 
OGC stated that it reviewed each of the 50 waivers in our sample and 
determined that none of the waivers failed to meet legal requirements 
and that the waivers contained descriptions satisfying the OGE 
recommendations and were consistent with the conditions stated in the 
Secretarys instructions. 
OGC concurred with two of the five recommendations in the draft 
report.  Specifically, OGC concurred with the recommendation that it 
should develop additional guidance and training to assist OPDIVs and 
STAFFDIVs in documenting waivers as recommended in 
Governmentwide Federal ethics regulations.  OGC reiterated that it 
disagreed with the draft reports interpretation of waiver documentation 
recommendations in Federal ethics regulations, but OGC stated that 
guidance and training based on the correct interpretation will benefit 
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R E C O M M E N D A T I O N S  
the HHS waiver process.  OGC also concurred that it should expand the 
review of waivers for SGEs on committees, while noting that it has 
already revised its review and oversight process for waivers in a manner 
that is more expansive than the actions we recommend. 
OGC did not concur with three recommendations:  that it require 
OPDIVs and STAFFDIVs to document waivers as recommended in 
Governmentwide regulations; that it take action to revise the conflict-of-
interest waivers in our review that were not documented as 
recommended in these regulations; and that it require all employees to 
sign and date, or similarly document, their waivers.  However, OGC 
acknowledged that additional detail may be helpful for some of the 
waivers in our sample and stated that it has been working with one of 
the OPDIVs to revise the model waivers that it provides to ethics 
officials within the OPDIV.  
OIG disagrees with OGCs statements that our report contains 
fundamental errors and that we ignored the wide latitude in OGEs 
recommendations for waiver content.  OGE affords agencies wide 
latitude to craft waivers that are both legally sufficient and meet 
agencies policy objectives, such as the Secretarys instructions.      
We believe that documenting waivers in a manner that reflects OGEs 
recommendations and the Secretarys instructions is important to 
preserve the integrity of HHSs programs and policies by ensuring that 
employees and other stakeholders are aware of employees conflicts of 
interest and act accordingly when those interests arise in the course of 
the employees official Government duties.     
Given the importance of accountability, OIG continues to emphasize its 
recommendation that OGC require employees to sign and date, or 
similarly document, their waivers.  OGCs concern about a one size fits 
all approach is accommodated by our recognition that this can be 
accomplished by other means (i.e., similarly documenting waivers) to 
ensure employee accountability.  Further, OIG maintains that unsigned 
limited waivers that are not documented as recommended in the 
selected regulatory provisions and the Secretarys instructions represent 
the greatest vulnerability.  The employees receiving these waivers may 
not be aware of them or the limitations on the employees participation.  
If these employees are not aware of their limited waivers or do not 
clearly understand them, the employees may violate the criminal  
conflict-of-interest statute by participating in prohibited matters. 
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R E C O M M E N D A T I O N S  
Comments from the Office of Government Ethics.  OGE also provided 
comments on a draft of this report but was not asked to indicate 
whether it concurred with the reports recommendations.  However, 
OGE did state that, as a general matter, the recommendations in the 
report support good documentation practices that it strongly 
recommends.  OGE also expressed concern that the draft report did not 
adequately recognize that, by regulation and policy, OGE has afforded 
agencies certain latitude to create waivers that are both legally 
sufficient and meet agencies policy objectives.  OGE emphasized that 
waivers do not need to be described with any particular degree of 
specificity to be legally sufficient and that the agency issuing the waiver 
can describe the employees duties in a general way or describe a class 
of matters.  Further, OGE indicated that the draft report did not 
account for the location or availability of information in places other 
than the actual waiver. 
OGE also expressed concern regarding our finding of insufficient detail 
in limited waivers and indicated that similar language describing 
limitations has been used in waivers for decades, including in OGEs 
own waivers.  OGE expressed concern that our report casts doubt on the 
clarity and enforceability of similar limiting language that has long 
been used in the Executive Branch.   
Finally, OGE acknowledged that neither OGE regulations nor guidance 
require employees to sign and acknowledge their waivers.  OGE 
indicated that agencies have various means, apart from the actual 
waiver, to apprise employees of the scope of their permitted duties and 
any recusal obligations. 
We made revisions to the report to clearly underscore that neither OGE 
regulations nor OGE guidance provides a clear definition of the degree 
of specificity required in waivers and that waivers may be legally 
sufficient without this information.  However, we note that the 
Secretarys 2009 instructions provide additional clarity regarding the 
contents of HHSs waivers, including limited waivers, and we have 
revised the report accordingly.  We maintain thatregardless of the 
language used in HHS waivers prior to January 2009for waivers to be 
documented consistently with the Secretarys January 2009 
instructions, some section of the waivers should contain clear language 
so that employees and other stakeholders (e.g., employees supervisors, 
the public, OIG) can understand the waivers and so that employees may 
be held accountable for complying with them.   
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R E C O M M E N D A T I O N S  
We made other technical and clarifying changes to the report based on 
OGCs and OGEs comments.  For example, we clarified that (1) we did 
not determine the legal sufficiency of the waivers, (2) we used the 
Secretarys instructions when reviewing the waivers, and (3) we 
considered other documents provided by OPDIVs and STAFFDIVs when 
determining whether employees received and acknowledged their 
waivers.  For the full text of OGCs and OGEs comments, see  
Appendix H.  Because OGC included OGEs comments as an attachment 
to its comments, we do not provide OGEs comments separately.   
 
  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  33         
   
 A P P E N D I X ~ A  
 
 
Table A-1:  Number of Waivers by Department of Health and Human Services 
Operating Division or Staff Division and Type of Employee, From 2007 to 2009  
 
Operating Division or Staff Division  2007  2008  2009 
 
Agency for Healthcare Research and Quality   8  6  6 
Waivers for special Government employees (SGEs) 
 
on Federal advisory committees (committees)    8  6  6 
Waivers for all other Department of Health and 
 
Human Services (HHS) employees   0  0  0 
Assistant Secretary for Preparedness and Response  3  3  0 
 
    Waivers for SGEs on committees  3  3  0 
    Waivers for all other HHS employees  0  0  0 
 
Assistant Secretary for Planning and Evaluation  0  0  1 
    Waivers for SGEs on committees  0  0  0 
 
    Waivers for all other HHS employees  0  0  1 
Centers for Disease Control and Prevention   15  29  12 
 
    Waivers for SGEs on committees  13  28  12 
      Waivers for all other HHS employees  2  1  0 
  Centers for Medicare & Medicaid Services   1  4  1 
    Waivers for SGEs on committees  1  4  0 
 
    Waivers for all other HHS employees  0  0  1 
  Food and Drug Administration   95  37  24 
      Waivers for SGEs on committees  89  33  23 
    Waivers for all other HHS employees  6  4  1 
 
Health Resources and Services Administration   10  47  6 
 
    Waivers for SGEs on committees  10  47  6 
      Waivers for all other HHS employees  0  0  0 
  Indian Health Service   0  0  1 
    Waivers for SGEs on committees  0  0  0 
 
    Waivers for all other HHS employees  0  0  1 
 
National Institutes of Health   301  255  290 
      Waivers for SGEs on committees  287  237  287 
      Waivers for all other HHS employees  14  18  3 
Office of the General Counsel   0  0  1 
 
    Waivers for SGEs on committees  0  0  0 
 
    Waivers for all other HHS employees  0  0  1 
  Office of Public Health Services  13  3  0 
      Waivers for SGEs on committees  13  3  0 
    Waivers for all other HHS employees  0  0  0 
 
Presidents Council on Bioethics  4  3  0 
      Waivers for SGEs on committees  4  0  0 
      Waivers for all other HHS employees  0  3  0 
       Total  450  387  342 
 
              Waivers for SGEs on Committees   428  361  334 
 
              Waivers for All Other HHS Employees  22  26  8 
 
Source:  Office of Inspector General analysis of Office of the General Counsel data, 2009. 
 
   
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  34         
   
 A P P E N D I X ~ B  
5 CFR Pt. 2640  Interpretation, Exemptions, and Waiver Guidance 
Concerning 18 U.S.C. 208 (Acts Affecting a Personal Financial Interest) 
Subpart CIndividual Waivers 
5 CFR  2640.301  Waivers issued pursuant to 18 U.S.C. 208(b)(1)  
(NOTE:  Provisions relevant to the analysis in this report are shown in 
bold.) 
(a) Requirements for issuing an individual waiver under 18 U.S.C. 
208(b)(1).  Pursuant to 18 U.S.C. 208(b)(1), an agency may 
determine in an individual case that a disqualifying financial 
interest in a particular matter or matters is not so substantial as to 
be deemed likely to affect the integrity of the employees services to 
the Government.  Upon making that determination, the agency may 
then waive the employees disqualification notwithstanding the 
financial interest, and permit the employee to participate in the 
particular matter.  Waivers issued pursuant to section 208(b)(1) 
should comply with the following requirements: 
(1) The disqualifying financial interest, and the nature and 
circumstances of the particular matter or matters, must be fully 
disclosed to the Government official responsible for appointing the 
employee to his position (or other Government official to whom 
authority to issue such a waiver for the employee has been 
delegated);   
(2) The waiver must be issued in writing by the Government official 
responsible for appointing the employee to his position (or other 
Government official to whom the authority to issue such a waiver for 
the employee has been delegated); 
(3) The waiver should describe the disqualifying financial interest, 
the particular matter or matters to which it applies, the employees 
role in the matter or matters, and any limitations on the employees 
ability to act in such matters;  
(4) The waiver shall be based on a determination that the 
disqualifying financial interest is not so substantial as to be deemed 
likely to affect the integrity of the employees services to the 
Government.  Statements concerning the employees good character 
are not material to, nor the basis for making, such decision; 
(5) The waiver must be issued prior to the employee taking any 
action in the matter or matters; and 
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  35         
   
A P P E N D I X ~ B  
(6) The waiver must apply to both present and future financial 
interests, provided the interests are described with sufficient 
specificity. 
Note to paragraph (a):  The disqualifying financial interest, the 
particular matter or matters to which the waiver applies, and the 
employees role in such matters do not need to be described with any 
particular degree of specificity.  For example, if a waiver were to 
apply to all matters which an employee would undertake as part of 
his official duties, the waiver document would not have to 
enumerate those duties.  The information contained in the waiver, 
however, should provide a clear understanding of the nature and 
identity of the disqualifying financial interest, the matters to which 
the waiver will apply, and the employees role in such matters.   
5 CFR  2640.302  Waivers issued pursuant to 18 U.S.C. 208(b)(3)  
(NOTE:  Provisions relevant to the analysis in this report are shown in 
bold.) 
(a) Requirements for issuing an individual waiver under 18 U.S.C. 
208(b)(3).  Pursuant to 18 U.S.C. 208(b)(3), an agency may 
determine in an individual case that the prohibition of 18 U.S.C. 
208(a) should not apply to a special Government employee serving 
on, or an individual being considered for, appointment to an 
advisory committee established under the Federal Advisory 
Committee Act, notwithstanding the fact that the individual has one 
or more financial interests that would be affected by the activities of 
the advisory committee.  The agencys determination must be based 
on a certification that the need for the employees services outweighs 
the potential for a conflict of interest created by the financial 
interest involved.  Waivers issued pursuant to 18 U.S.C. 208(b)(3) 
should comply with the following requirements: 
(1) The advisory committee upon which the individual is serving, or 
will serve, is an advisory committee within the meaning of the 
Federal Advisory Committee Act, 5 U.S.C. app.; 
(2) The waiver must be issued in writing by the Government official 
responsible for the individuals appointment (or the Government 
official to which authority to issue such waivers has been delegated) 
after the official reviews the financial disclosure report filed by the 
individual pursuant to the Ethics in Government Act in 1978; 
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  36         
   
A P P E N D I X ~ B  
(3) The waiver must include a certification that the need for the 
individuals services on the advisory committee outweighs the 
potential for a conflict of interest; 
(4) The facts upon which the certification is based should be fully 
described in the waiver, including the nature of the financial 
interest, and the particular matter or matters to which the waiver 
applies; 
(5) The waiver should describe any limitations on the individuals 
ability to act in the matter or matters; 
(6) The waiver must be issued prior to the individual taking any 
action in the matter or matters; and 
(7) The waiver may apply to both present and future financial 
interests of the individual, provided the interests are described with 
sufficient specificity. 
5 CFR  2640.303  Consultation and notification regarding waivers 
When practicable, an official is required to consult formally or 
informally with the Office of Government Ethics prior to granting a 
waiver referred to in  2640.301 and 2640.302.  A copy of each such 
waiver is to be forwarded to the Director of the Office of Government 
Ethics. 
5 CFR  2640.304  Public availability of agency waivers 
(a) Availability.  A copy of an agency waiver issued pursuant to  
18 U.S.C. 208 (b)(1) or (b)(3) shall be made available upon request to 
the public by the issuing agency.  Public release of waivers shall be 
in accordance with the procedures set forth in section 105 of the 
Ethics in Government Act of 1978, as amended.  Those procedures 
are described in 5 CFR 2634.603. 
(b) Limitations on availability.  In making a waiver issued pursuant to 
18 U.S.C. 208 (b)(1) or (b)(3) publicly available, an agency: 
(1) May withhold from public disclosure any information contained 
in the waiver that would be exempt from disclosure pursuant to  
5 U.S.C. 552; and 
(2) Shall withhold from public disclosure information in a waiver 
issued pursuant to 18 U.S.C. 208(b)(3) concerning an individual's 
financial interest which is more extensive than that required to be 
disclosed by the individual in his financial disclosure report under 
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  37         
   
A P P E N D I X ~ B  
the Ethics in Government Act of 1978, as amended, or which is 
otherwise subject to a prohibition on public disclosure under law. 
 
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  38         
   
 A P P E N D I X ~   C    
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  39         
   
A P P E N D I X ~ C  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  40         
   
A P P E N D I X ~ C  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  41         
   
A  P P E N D I X ~ C  
 
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  42         
   
 A P P E N D I X ~ D  
 
 
Table D-1:  Number of Waivers Granted by the Department of Health and Human Services in 2009 
to Special Government Employees on Federal Advisory Committees at the National Institutes of 
Health, by Institute or Center 
Waivers  Waivers in 
National Institutes of Health Institute or Center 
Granted in 2009   Sample 
Office of the Director   56  3 
National Cancer Institute   42  2 
National Heart, Lung, and Blood Institute   21  2 
National Institute of Environmental Health Sciences   19  2 
National Institute of Child Health and Human Development   16  1 
National Institute of Allergy and Infectious Diseases   15  2 
National Institute of Mental Health   14  1 
National Center for Research Resources  11  1 
National Human Genome Research Institute   10  1 
National Institute of Arthritis and Musculoskeletal and Skin Diseases   10  1 
Clinical Center  9  1 
National Institute on Drug Abuse   9  1 
National Library of Medicine   9  1 
National Institute of General Medical Sciences   7  1 
National Institute of Neurological Disorders and Stroke   7  1 
National Institute of Deafness and Other Communication Disorders   6  1 
National Institute of Diabetes and Digestive and Kidney Diseases   6  1 
National Institute on Aging   5  1 
National Center for Complementary and Alternative Medicine   5  1 
National Center on Minority Health & Health Disparities   3  1 
National Institute of Nursing Research   3  1 
Center for Scientific Review   2  1 
Fogarty International Center   1  1 
National Eye Institute   1  1 
National Institute on Alcohol Abuse and Alcoholism   0   0 
National Institute of Biomedical Imaging and Bioengineering  0  0 
National Institute of Dental and Craniofacial Research   0  0 
   Total   287  30 
Source:  Office of Inspector General review of Department of Health and Human Services data, 2010. 
 
 
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  43         
   
 A P P E N D I X ~ E  
 
Table E-1:  Number and Percentage of Waivers From 2009 in Our Review Not Documented as 
Recommended in Provisions of  Selected Governmentwide Federal Ethics Regulations and the Instructions 
of the Secretary of Health and Human Services, for Special Government Employees and All Other 
Department of Health and Human Services Employees 
Recommended  Special Government  All Other Department of 
All Employees       
Provisions and  Employees on Committees  Health and Human 
(n=50)* 
Instructions Not  (n=42)*  Services Employees (n=8)* 
Documented in 
Number  Percentage**  Number  Percentage**  Number  Percentage** 
Waiver  
 
Description of 
employees specific  7  17%  0  0%  7  14% 
conflicts of interest 
 
Description of 
particular matters in 
which employees were  22  52%  1  13%  23  46% 
permitted to participate 
 
Description of 
particular matters in 
which employees were 
14  33%  0  0%  14  28% 
prohibited from 
participating 
 
   Total   27  64%  1  13%  28  56% 
* Column sums exceed totals because some waivers were not documented as recommended in more than one selected regulatory provision 
and the instructions of the Secretary of Health and Human Services.   
** Percentages are calculated using the total number of waivers for each type of employee.  However, only limited waivers must describe 
particular matters in which employees were prohibited from participating.  There were 31 limited waivers in our sample:  26 limited waivers for 
special Government employees and 5 limited waivers for all other HHS employees. 
 
Source:  Office of Inspector General review of Department of Health and Human Services data, 2010. 
 
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  44   
   
 A P P E N D I X ~ F  
 
 
Table F-1:  Number and Percentage of Waivers From 2009 in Our Review Not Documented as 
Recommended in One, Two, or Three Provisions of Selected Governmentwide Federal Ethics 
Regulations and the Instructions of the Secretary of Health and Human Services, for Limited and 
Nonlimited Waivers 
Number of 
Recommended  Limited Waivers  Nonlimited Waivers   All Waivers 
Provisions and 
Instructions Not 
Documented in  Number  Percentage  Number  Percentage  Number  Percentage 
Waiver  
 
7  14%  9  18%  16  32% 
One  
Two   7  14%  1  2%  8  16% 
Three   4  8%  N/A*  N/A*  4  8% 
None   13  26%  9  18%  22  44% 
   Total   31  62%  19  38%  50  100% 
* Nonlimited waivers do not describe the particular matters in which employees are prohibited from participating.   
 
Source:  Office of Inspector General review of Department of Health and Human Services data, 2010. 
 
 
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  45   
   
 AA PP PPEENND DI IX X~ ~G G   
 
 
Table G-1:  Number and Percentage of Waivers From 2009 in Our Review That Did Not Include 
Employees Signature and/or Date, for Special Government Employees and All Other Department of 
Health and Human Services Employees 
Special Government  All Other Department of 
All Employees       
Employees on  Health and Human 
Information Not  (n=50)  
Committees (n=42)  Services Employees (n=8) 
Documented in Waiver 
Number  Percentage  Number  Percentage*  Number  Percentage 
Signature and date  37  88%  1  13%  38  76% 
Date only  2  5%  1  13%  3  6% 
   Total   39  93%  2  25%  41  82% 
* Column sum exceeds total because of rounding.   
 
Source:  Office of Inspector General review of Department of Health and Human Services data, 2010.  
 
 
 
 
 
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  46  x 
A  P  PEN  D  H 
AGENCY COMMENTS 
DEPARTMENT OF HEALTH & HUMAN SERVICES  Office of the Secretary 
Office of the General Counsel 
Washington, D.C. 20201 
MAY  1 0 2011 
MEMORANDUM 
TO;  Stuart Wright 
Deputy Inspector General for Evaluation ~nd ~ections 
FROM:  David S. Cade 
Deputy General C4~. 
SUBJECT:  OIG Draft Report: Conflict-a/-Interest Waivers Granted to HHS 
Employees in 2009, OEI-04-10-00010 (March 2011) 
The Office of the General Counsel (OGC) appreciates the opportunity to review and comment 
on the Office ofthe Inspector General (OIG) draft report prepared by the Office of Evaluation 
and Inspections (OEI): Canflict-o/-Interest Waivers Granted to HHS Employees in 2009, 
OEI-04-J 0-00010 (March 2011) (Draft Report).  Evaluating possible waivers under the conflict 
ofillterest statute, 18 U.S.C.  208, is one of the more significant duties that ethics officials 
perform to ensure public confidence in the Government's programs and operations. Both the 
individual employee's interests and those ofthe Government are best served when this process is 
carried out in a careful and consistent manner. OGC shares OEI's goal of ensuring that conflict 
of interest waivers issued by Departmental components are both legally effective and 
appropriately documented in order to support the mission ofthe Department ofRealth and 
Ruman Services (RRS). 
OEI review of administrative processes often provides useful insights and recommendations. 
OEI, in this instance, has undertaken to evaluate legal instruments to ascertain whether the 
documents contain descriptive elements which OEI characterizes as "recommended in provisions 
of selected Governmentwide Federal ethics regulations." Draft Report at 1.  As OEI crosses into 
an area ofOGC's particular expertise, we do find its legal evaluation wanting. Although we 
appreciate the time and effort that went into preparing the Draft Report and acknowledge the 
corrections OEI has already made in response to our informal comments, the report continues to 
be incorrect. 
The Draft Report claims that all conflict ofinterest waivers should contain very detailed 
descriptions of: (1) the employee's specific financial interest; (2) the particular matter(s) in which 
the employee is permittcd to participate; and (3) any li.mitations regarding the particular matter(s) 
in which the employee remains prohibited from panicipating. Id.  The Draft Report then rejects, 
as insufficient documentation, textual references to broad categories ofinterests, generalized 
descriptions of an employee's duties that may affect those interests, and utilization oflegal terms 
of att that delineate classes of matters to which the waiver would apply.  Draft Report at 16-19. 
OEI-04-1 0-0001 0  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  47   
   
A P P E N D I X ~ H  
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A P P E N D I X ~ H  
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A P P E N D I X ~ H  
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A P P E N D I X ~ H  
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A P P E N D I X ~ H  
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A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  53   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  54   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  55  x 
A  P  PEN  D  H 
00$Response to: "010 Draft Report: Corif/IC!-oj.lnteretJt 
WQ/vers Granted to HHS EmploysfIII in '2009, OEI04-10-000JO" 
Pag,e 14 
where a conflicting entity is a party" but may work on broader polley matters affecting the entity 

as part ofa class or group." DO07oo6, sec. IV.l. Moreover, where a waiwris so limited, it is 

natural to expect less specific detail, In some cases anyway,'than if the agency were permitting 

the employee actually to participate in particular matters involving specifiC parties that might 

pose a more acute conflict of interest) it bas long been understood that the desirability for 

specificity can vary depending on the magnitJIde and seriousness ofthe conflict? 

In conclusion., it is critical to distinguish the legal requirements for a waiver under 18 
U.S.C, 208 from practices that may be desirable because thl<Y enhance clarity and transparenoy 
but which do not impact the,legal Bufficiency of the underlying waiver. Great care and precision 
must be taken to not confuse the two beoause to dO so could create the erroneous impression that 
agency and individual employee actions have violated the law. 
rfOGE may be offurther assistance in this matter, or Ifyou have any questions. please 

contact me at 202-4829292. 

SJl;lemly, 
'DonW.Fox 
General Counsel and 
Principal Deputy Director 
7 rn faoI, the Office ofLegal Counse~ Department Q! Justice, speoifi\llllly advised a CIIJlljlOIlent ofHHS to this effi:ct 
CClncemJng certain advI$QI}' committee memllOl'8; over 30 yean OSQ:  "Although by its literal terms 208(b)(1) 
would appear to Tequlre tho IIPPolntlng offiolal to Issue a sepaxato exemption for eaoh partiC1.llat matter 11'1 which a 
given f\nancllllinterost may arise, we have CII)lSlstwltly takon tho position that a blanket exemptlon CIIvcrlnga Biven 
f\nancia,llntwes~ may be issued in appropriate cltcumstanoe/l If the appointing Qmeial CIInelu&s that the finanolal 
in1ere8t Will not bR, i!l'! suljatantliIJlIS!2 !Iff!!;t11 i_db! ~the!l)llI1loyee's serylcealb whiteyAI' COJ1!roIt it !Irises." 2 
Op. 0.1;.0. lSI, 156 n.S (1978)(omphasls added). Noto tbat this advice was renilered explicitly conceming HIlS 
advisory committee members participating In partieular matters Qf general applicability wiIb mpect which tho 
members render "'advice Qf a general naturo from which 1IQ preference QT ac:lvantap Qvet otheJS ml!\ht be gained by 
, any partloulaqleJSon or organization,'" Jd at 156 (quoting fomIer Federal Pct8fltmel Manual).  ' 
OEI04-1000010  CONFLICTOFINTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  56   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  57   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  58   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  59   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  60  A  P  PEN  D  x  H 
The Honorable Daniel Levinson 
Page 4 
for oversight and implementing regulations in this area, has detenrtined is either legalJy required 
or a best practice.  OGE's regUlations or policy guidance do not require employees to sign and 
acknowledge their waivers and do not suggest that this practice would add value to the process. 
As described above, ag(rllcies have various means, apart from the actual waiver certification, to 
apprise employees of the scope of their permitted duties and any continuing reeusal obligations. 
In some cases, for instance, OGE could envision that a pro fonna acknowledgment signature 
might have less value than oral counseling, particularly where the employee has questions or 
doubts about the contents and meaning ofthe waiver. 
OGE has long provided expert advice to inspectors general in a wide variety of ethics
related matters.  If you have any questions about waivers under 18 U.S.C.  208 or how to 
interpret the applicable regulations or policy in this area, please contact me or my General 
Counsel, Don Fox, at 202-482-9292. 
SincBfely, 
Robert I. Cusick 
Director 
Enclosure: (Letter from Don W. Fox, General Counsel, OGE, 
to Edgar M. Swindell, DAEO, HHS, March 9,2011) 
cc: EdgarM. Swindell, Designated Agency Ethics Official 
OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  61   
   
A P P E N D I X ~ H  
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A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  63   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  64   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  65   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  66   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  67   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  68   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  69   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  70   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  71   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  72   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  73   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  74   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  75   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  76   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  77   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  78   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  79   
   
A P P E N D I X ~ H  
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  80   
   
A PA PC EK NNDOI WX ~L GE  D G M E N T S  
 
This report was prepared under the direction of Dwayne Grant, 
Regional Inspector General for Evaluation and Inspections in the 
Atlanta regional office, and Jaime Durley, Deputy Regional Inspector 
General.   
Principal Office of Evaluation and Inspections staff from the Atlanta 
regional office who contributed to the report include Starr Daniell and 
Michelle Verges.  Central office staff who contributed include Kevin 
Farber, Melinda Golub, Pamela Langer, and Talisha Searcy.   
  OEI-04-10-00010  CONFLICT-OF-INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009  81   
Office of Inspector General 
http://oig.hhs.gov 
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 
amended, is to protect the integrity of the Department of Health and Human Services 
(HHS) programs, as well as the health and welfare of beneficiaries served by those 
programs.  This statutory mission is carried out through a nationwide network of audits, 
investigations, and inspections conducted by the following operating components: 
Office of Audit Services 
The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 
audits with its own audit resources or by overseeing audit work done by others.  Audits 
examine the performance of HHS programs and/or its grantees and contractors in carrying 
out their respective responsibilities and are intended to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and 
mismanagement and promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud, waste, or abuse and promoting 
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 
of fraud and misconduct related to HHS programs, operations, and beneficiaries.  With  
investigators working in all 50 States and the District of Columbia, OI utilizes its resources 
by actively coordinating with the Department of Justice and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to criminal 
convictions, administrative sanctions, and/or civil monetary penalties. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to 
OIG, rendering advice and opinions on HHS programs and operations and providing all 
legal support for OIGs internal operations.  OCIG represents OIG in all civil and 
administrative fraud and abuse cases involving HHS programs, including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program guidance, publishes fraud alerts, and provides other 
guidance to the health care industry concerning the anti-kickback statute and other OIG 
enforcement authorities.