Department of Health and Human Services 

OFFICE OF

INSPECTOR GENERAL

 

 

CONFLICT-OF-INTEREST 

WAIVERS GRANTED TO HHS 

EMPLOYEES IN 2009 

Daniel R. Levinson 

Inspector General 

August 2011 

OEI-04-10-00010 
 

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 EXECUTIVE SUMMARY

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 employee’s 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 Government’s

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 SGE’s 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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EXECUTIVE SUMMARY

According to Governmentwide Federal ethics regulations and the 

Secretary’s 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, 

OGC’s 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 Secretary’s 

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 

Secretary’s 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 Secretary’s 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 
 

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EXECUTIVE SUMMARY

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 sample—82 percent—did 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 Secretary’s 

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 

HHS’s 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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EXECUTIVE SUMMARY

Require OPDIVs and STAFFDIVs to document conflict-of-interest 

waivers as recommended in Governmentwide Federal ethics 

regulations and the Secretary’s 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 Secretary’s 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 Secretary’s 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 OGC’s and OGE’s 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 Secretary’s instructions, and we updated 

our findings accordingly.

We made other technical and clarifying changes to the report based on 

OGC’s and OGE’s comments. For the full text of OGC’s and OGE’s 

comments, see Appendix H. Because OGC included OGE’s comments as 

an attachment to its comments, we do not provide OGE’s comments 

separately. 

 
 TABLE OF CONTENTS

EXECUTIVE SUMMARY ................................ ..... i

INTRODUCTION ............................................ 1 

FINDINGS ................................................. 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 

Secretary’s instructions ................................ . 19

Although not required, 18 percent of the 50 HHS 

conflict-of-interest waivers in our review included employees’ 

signatures and dates .................................... 23

RECOMMENDATIONS ..................................... 25

APPENDIXES ............................................. 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 C—Individual 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

ACKNOWLEDGMENTS ..................................... 81
 

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 INTRODUCTION

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 employee’s 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 Government’s

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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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

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.

 

Hereinafter, we will refer to HHS regular Government employees, SGEs 

not serving on committees, and political appointees as “all other HHS 

employees.” 

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 employee’s 

conflict of interest, ethics officials should first consider whether recusal would resolve the 

conflict if an “employee’s 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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INTRODUCTION

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 employee’s 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 Government’s operations and programs. 

Both the individual employee’s 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 

employer’s 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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INTRODUCTION

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 SGE’s 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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INTRODUCTION

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 CDC’s 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

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 

HHS’s programs. Further, if waivers are not documented so that the 

public understands employees’ specific conflicts of interest and their 

 

Among other things, CDC’s lack of oversight included failure to obtain 

SGEs’ signatures on some 2007 waivers, in violation of CDC policy. 

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, CDC’s 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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INTRODUCTION

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 Secretary’s 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

22 5 CFR § 2638, OGE and Executive Agency Ethics Program Responsibilities. 

 In addition, OPDIVs and STAFFDIVs may collect 

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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INTRODUCTION

other documents, such as employees’ curricula vitae or résumés, 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 

employee’s financial disclosure file, which includes financial disclosure 

forms and other documents (e.g., the employee’s 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

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 SGE’s committee) to determine whether waivers may be needed and 

for assistance documenting them.

 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. 

27 In accordance with the Secretary’s 

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 SGE’s 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

Federal Ethics Requirements and Recommendations for HHS 

Conflict-of-Interest Waivers

 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. 

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 SGE’s financial disclosures, 

the appropriate granting official certifies that the need for the 

employee’s 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 employee’s 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 employee’s 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 employee’s 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 

employee’s 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 individual’s 

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 employee’s 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 employee’s financial 

interest that poses the conflict, the matters to which the waiver applies, 

and the employee’s 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 Secretary’s 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 

[employee’s] circumstances.”

 

48 Appendix C contains the Secretary’s 

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

46 Ibid. 

 Furthermore, the 

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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Secretary’s 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 employee’s responsibility, the 

waiver should contain a reasonably detailed description of these 

responsibilities.55 The Secretary’s 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 employee’s participation in 

his or her official duties.57

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 

 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. 

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 CDC’s 

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 Secretary’s 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 HHS’s 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, CDC’s 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 Secretary’s 

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 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. 

 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). 

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 

OPDIV/STAFFDIV Waivers granted 

in 2009 

Waivers in 

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 HHS’s waivers were for SGEs on 

committees at NIH in 24 of NIH’s 27 Institutes and Centers.67

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.

 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. 

Data Collection 

We reviewed selected regulatory provisions and the Secretary’s 

instructions regarding HHS’s 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 committees—the 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 résumés).

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 Secretary’s 

instructions and whether they included employees’ signatures and 

dates. 

Selected regulatory provisions and the Secretary’s 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 

employee’s 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 employee’s 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 committee’s 

duties (for SGEs’ waivers) or the employee’s official duties (for 

all other HHS employees’ waivers). 

• the waiver contained contradictory information regarding the 

employee’s 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 employee’s 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 Secretary’s 

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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 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 Secretary’s instructions 

Fifty-six percent (28 of 50) of the 

waivers from 2009 in our review 

were not documented as 

recommended in at least 1 of 3 

selected regulatory provisions and 

the Secretary’s instructions.70

Fourteen percent (7 of 50) of the waivers did not describe employees’ 

specific interests that posed conflicts.

 

These 28 waivers were granted to employees at 5 of the 9 OPDIVs or 

STAFFDIVs in our review. 

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 Secretary’s 

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 Secretary’s 

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 Secretary’s 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 Secretary’s 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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FINDINGS

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 Secretary’s 

instructions. Appendix F also provides this information for limited 

waivers (for which all three selected regulatory provisions and the 

Secretary’s instructions apply) and nonlimited waivers (for which only 

two selected regulatory provisions and the Secretary’s 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

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: 

 

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 

HHS’s programs.

[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 

employee’s 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 employee’s financial disclosure file. To be conservative, we counted this 

waiver as being documented as recommended in the selected regulatory provision of 

describing the employee’s specific conflict of interest. 
 

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FINDINGS

The remaining waiver described a specific interest, but the description 

contradicted information in the SGE’s financial disclosure file. 

Specifically, the waiver indicated that the spouse’s employment posed a 

conflict with the SGE’s official duties. However, the financial disclosure 

file indicated that the SGE’s 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 employee’s 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 employee’s specific interests, among 

other broad categories of interests, but the waiver did not describe the 

employee’s committee or the employee’s 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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FINDINGS

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 employee’s supervisor, the Designated 

Federal Official assigned to the SGE’s 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 employee’s] financial interests, but not uniquely affecting the 

employee’s financial interest.” 

In contrast, 55 percent (17 of 31) of limited waivers clearly described 

the prohibitions on the employee’s 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 
 

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FINDINGS

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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FINDINGS

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 

employee’s signature, as included in the OGC sample waivers. In 

contrast, all 12 of the signed waivers had a line for the employee’s 

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 Secretary’s 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 Secretary’s 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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 RECOMMENDATIONS

HHS employees, including SGEs serving as subject-matter experts on 

committees, play an influential role in the Federal Government’s public 

health policies. With the HHS OGC Ethics Division’s 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 

Secretary’s 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 

HHS’s 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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RECOMMENDATIONS

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 Secretary’s 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 

Secretary’s instructions

OGC should work with the Office of the Secretary to reaffirm the 

Secretary’s January 2009 instructions and/or issue a new HHS policy 

requiring that all waivers be clearly documented to describe:

• the employee’s 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 Secretary’s instructions, other 

documents could be attached to or associated with the waivers to 

assist employees and other stakeholders in understanding them. 
 

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RECOMMENDATIONS

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 Secretary’s 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 Secretary’s 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 employee’s specific interest and the potential for conflict. The waiver’s 

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 employee’s official duties.

• The particular matters in which the employee is permitted to participate. The 

waiver’s description should contain sufficient detail for the employee 

and the public to understand the scope of the employee’s 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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RECOMMENDATIONS

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 Secretary’s 

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 Secretary’s 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 Secretary’s 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 Secretary’s 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 Secretary’s 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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RECOMMENDATIONS

Therefore, when OGC receives copies of HHS waivers that were granted 

by OPDIVs and STAFFDIVs, it should thoroughly check a sample—if 

not all—of 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 

Secretary’s instructions. As part of this review, OGC should obtain the 

employee’s financial disclosure file from the OPDIV or STAFFDIV to 

fully understand the nature of the employee’s 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 employee’s 

signature and date so that it is clear that the document must be signed 

and dated, as demonstrated in the OGC Ethics Division’s 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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RECOMMENDATIONS

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 OGC’s and OGE’s 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 Secretary’s 

instructions, and we updated our findings accordingly.

Comments from the HHS Office of the General Counsel

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 report’s interpretation of waiver documentation 

recommendations in Federal ethics regulations, but OGC stated that 

guidance and training based on the correct interpretation will benefit 

. 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 

Secretary’s instructions.
 

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RECOM MENDATIONS

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-ofinterest 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 OGC’s statements that our report contains 

fundamental errors and that we ignored the wide latitude in OGE’s 

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 Secretary’s instructions. 

We believe that documenting waivers in a manner that reflects OGE’s 

recommendations and the Secretary’s instructions is important to 

preserve the integrity of HHS’s 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. OGC’s 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 Secretary’s 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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RECOMMENDATIONS

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 report’s 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 employee’s 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 OGE’s 

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 

Secretary’s 2009 instructions provide additional clarity regarding the 

contents of HHS’s waivers, including limited waivers, and we have 

revised the report accordingly. We maintain that—regardless of the 

language used in HHS waivers prior to January 2009—for waivers to be 

documented consistently with the Secretary’s 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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RECOMMENDATIONS

We made other technical and clarifying changes to the report based on

OGC’s and OGE’s comments. For example, we clarified that (1) we did 

not determine the legal sufficiency of the waivers, (2) we used the 

Secretary’s 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 OGC’s and OGE’s comments, see 

Appendix H. Because OGC included OGE’s comments as an attachment 

to its comments, we do not provide OGE’s comments separately. 

 
 

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 APPENDIX ~ 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

President’s 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 - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 35

 APPENDIX ~ B

5 CFR Pt. 2640 – Interpretation, Exemptions, and Waiver Guidance 

Concerning 18 U.S.C. 208 (Acts Affecting a Personal Financial Interest)

Subpart C—Individual Waivers

(NOTE: Provisions relevant to the analysis in this report are shown in 

bold.)

5 CFR § 2640.301 – Waivers issued pursuant to 18 U.S.C. 208(b)(1) 

(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 employee’s services to 

the Government. Upon making that determination, the agency may 

then waive the employee’s 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 employee’s 

role in the matter or matters, and any limitations on the employee’s 

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 employee’s services to the 

Government. Statements concerning the employee’s 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 - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 36

APPENDIX~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 

employee’s 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 employee’s role in such matters. 

(NOTE: Provisions relevant to the analysis in this report are shown in 

bold.)

5 CFR § 2640.302 – Waivers issued pursuant to 18 U.S.C. 208(b)(3) 

(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 agency’s determination must be based 

on a certification that the need for the employee’s 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 individual’s 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 - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 37

APPENDIX~B

(3) The waiver must include a certification that the need for the 

individual’s 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 individual’s 

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.

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 § 2640.303 – Consultation and notification regarding waivers

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 - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 38

APPENDIX~B

the Ethics in Government Act of 1978, as amended, or which is 

otherwise subject to a prohibition on public disclosure under law.
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 39

 APPENDIX ~ C
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 40

APPENDIX~C
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 41

APPENDIX~C
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 42

APPENDIX~ C
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 43

 APPENDIX ~ 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

National Institutes of Health Institute or Center Waivers 

Granted in 2009 

Waivers in 

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 - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 44

 APPENDIX ~ 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 

Provisions and 

Instructions Not 

Documented in 

Waiver 

Special Government 

Employees on Committees 

(n=42)*

All Other Department of 

Health and Human 

Services Employees (n=8)*

All Employees 

(n=50)*

Number Percentage** Number Percentage** Number Percentage**

Description of 

employees’ specific 

conflicts of interest

7 17% 0 0% 7 14%

Description of 

particular matters in 

which employees were 

permitted to participate

22 52% 1 13% 23 46%

Description of 

particular matters in 

which employees were 

prohibited from 

participating

14 33% 0 0% 14 28%

 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 - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 45

 APPENDIX ~ 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 

Provisions and 

Instructions Not 

Documented in 

Waiver 

Limited Waivers Nonlimited Waivers All Waivers

Number Percentage Number Percentage Number Percentage

One 7 14% 9 18% 16 32%

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 - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 46

 APPENDIX~G APPENDIX ~ 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

Information Not 

Documented in Waiver

Special Government 

Employees on 

Committees (n=42)

All Other Department of 

Health and Human 

Services Employees (n=8)

All Employees 

(n=50) 

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. 
A P PEN D x 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 
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 48

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 49

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 50

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 51

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 52

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 53

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 54

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 55

APPENDIX~H
A P PEN D x H 

00$Response to: "010 Draft Report: Corif/IC!-oj.lnteretJt 

WQ/vers Granted to HHS EmploysfIII in '2009, OEI·04-10-000JO" 

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." DO·07·oo6, 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 202-482·9292. 


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). ' 

OEI·04-10·00010 CONFLICT·OF·INTEREST WAIVERS GRANTED TO HHS EMPLOYEES IN 2009 56 
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 57

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 58

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 59

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 60

APPENDIX~H
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 ethicsrelated 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 
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 62

APPENDI X~H
 

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APPENDIX~H
 

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APPENDIX~H
 

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APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 66

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 67

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 68

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 69

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 70

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 71

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 72

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 73

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 74

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 75

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 76

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 77

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 78

APPENDIX~H
 

OEI - 0 4 - 1 0 - 00010 C ONFLICT - O F - I NTEREST WAIVERS GRANTED TO HHS E MPLOYEE S IN 2009 79

APPENDIX~H
 

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APPENDIX~H
 

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APPENDIX~G ACKNOWLEDGMENTS

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. 
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 OIG’s 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.