Department of Health and Human Services


OFFICE OF 

INSPECTOR GENERAL 

OUTSIDE ACTIVITIES


OF FDA EMPLOYEES


Daniel R. Levinson


Inspector General 


February 2006


OEI-01-04-00400

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 all 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 in order to reduce waste, abuse, and 

mismanagement and to promote economy and efficiency throughout HHS. 

Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) conducts management and program 

evaluations (called inspections) that focus on issues of concern to HHS, Congress, and 

the public. The findings and recommendations contained in the inspections generate 

rapid, accurate, and up-to-date information on the efficiency, vulnerability, and 

effectiveness of departmental programs. OEI also oversees State Medicaid Fraud 

Control units which investigate and prosecute fraud and patient abuse in the Medicaid 

program. 

Office of Investigations 

The Office of Investigations (OI) conducts criminal, civil, and administrative 

investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries 

and of unjust enrichment by providers. The investigative efforts of OI lead to criminal 

convictions, administrative sanctions, 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 in OIG's internal operations. OCIG imposes program exclusions and civil 

monetary penalties on health care providers and litigates those actions within HHS. 

OCIG also represents OIG in the global settlement of cases arising under the Civil False 

Claims Act, develops and monitors corporate integrity agreements, develops compliance 

program guidances, renders advisory opinions on OIG sanctions to the health care 

community, and issues fraud alerts and other industry guidance. 
Δ EXECUTIVE SUMMAR Y 

OBJECTIVES 

1. To describe the nature of outside activities for which Food and Drug 

Administration (FDA) employees received approval between 

2000 and 2003. 

2. To determine the extent to which FDA senior-level employees 

provided required information on their outside activity request 

forms and financial disclosure statements between 2000 and 2003. 

3. To assess FDA’s process for reviewing outside activity requests 

between 2000 and 2003. 

BACKGROUND 

In general, employees of the Department of Health and Human Services 

(HHS) are allowed to work privately with non-Federal entities on their 

personal time through outside activities, which in some cases require 

prior approval. Examples of outside activities include consulting, 

teaching, speaking, and writing related to official duties. These 

activities must not conflict with employees’ official duties. Employees 

may be financially compensated for these activities. Outside activities 

must be approved in accordance with regulations issued by the Office of 

Government Ethics and supplemental rules issued by HHS. 

The media and Congress have recently paid increased attention to the 

oversight of outside activities within HHS. A December 2003 

investigative report in The Los Angeles Times raised concerns regarding 

the ethics program at the National Institutes of Health (NIH). In a 

hearing conducted by the U.S. House of Representatives Committee on 

Energy and Commerce that focused on the NIH, an FDA employee was 

called to testify regarding his approved participation in an outside 

activity with a significantly regulated organization. Certain FDA 

employees are prohibited from working with significantly regulated 

organizations, which are entities whose products are regulated by FDA. 

In June 2004, FDA completed an internal review of all ongoing outside 

activities to determine whether they complied with applicable laws and 

regulations. To further ensure the integrity of the FDA review process 

for outside activities, the Committee on Energy and Commerce 

requested that the Office of Inspector General conduct an independent 

review of FDA’s oversight of outside activities. 

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The Ethics and Integrity Staff within FDA’s Office of the Commissioner, 

Office of Management, implements and oversees the ethics program at 

FDA, which includes providing oversight of outside activities and the 

filing of financial disclosure statements that collect details on 

employees’ assets, income, liabilities, and outside activities. FDA, 

through the Ethics and Integrity Staff, takes a decentralized approach 

to the review and approval of outside activities, delegating the review 

and approval authority to the eight offices and centers within FDA, 

hereafter referred to as centers. 

When an employee seeks to participate in an outside activity, he or she 

submits an outside activity request (the HHS-520 form) to his or her 

supervisor. The supervisor makes a recommendation regarding 

whether the activity should be approved and then forwards the form to 

staff reviewers who provide additional review before forwarding it to the 

final approving official, who determines whether the activity will be 

approved. 

We reviewed FDA’s database of all outside activity requests employees 

submitted between 2000 and 2003. We also conducted a retrospective 

review of all outside activity requests and supporting documentation 

that senior-level employees submitted to FDA between January 1, 2000, 

and December 31, 2003. We defined senior-level employees to be those 

who, as of January 2004, were required to file Standard Form 278 

public disclosure financial forms. We only reviewed requests that were 

received by FDA; we did not assess whether employees conducted any 

additional outside activities that were not reported in requests to FDA. 

We also interviewed the staff in each center identified by FDA as the 

most knowledgeable about the outside activity review process between 

2000 and 2003. Finally, we reviewed written procedures related to 

outside activities from the eight centers. 

NATURE OF OUTSIDE ACTIVITIES 

Eleven percent of all FDA employees received approval for a total of 

2,592 outside activities between calendar years 2000 and 2003. Of 

the 13,973 employees at FDA as of the end of fiscal year 2003, 

1,571 employees received approval to participate in outside activities 

between 2000 and 2003. Most employees participated in only one 

activity. Eighty percent of the activities were conducted by employees 

who file confidential financial disclosure forms. The most common types 

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of outside activities involved teaching, lecturing, speechwriting, and 

presenting. 

Twenty-six percent of FDA senior-level employees received approval 

for a total of 55 outside activities between calendar years 2000 and 

2003. Of the 90 senior-level employees at FDA as of January 2004, 

23 received approval to participate in outside activities between 2000 

and 2003. Most senior-level employees participated in one or two 

outside activities, and most of the activities were not compensated. 

The most common types of outside activities for senior-level employees 

involved serving on boards or writing and editing. Forty percent of 

senior-level employees’ approved activities were performed during time 

off from work. 

VULNERABILITIES 

Limited information inhibits FDA’s ability to effectively review 

outside activity requests. 

o Complete information allows FDA reviewers to effectively assess 

the appropriateness of proposed outside activities and to identify 

potential conflicts of interest. Of the 55 approved outside 

activities for senior-level employees, all but 3 were missing at 

least 1 piece of information required on the HHS-520 form. 

o Although nearly all of the forms had deficiencies, most of these 

omissions, considered independently, appeared to be minor. 

However, the extent and frequency of these deficiencies in the 

forms we reviewed raise systemic concerns about how FDA 

collects and reviews information regarding employees’ outside 

activities. 

o Even when required information was provided, it was often 

limited. The information contained in the senior-level employees’ 

outside activity requests reviewed often contained vague or 

minimal information, or lacked position descriptions or 

documentation regarding the details of the outside activities. 

o Outside activities of senior-level employees were not disclosed as 

required on annual financial disclosure forms 46 percent of the 

time. 

o Limited information made it difficult for our reviewers to identify 

potential conflicts of interest and to determine the 

appropriateness of several activities of senior-level employees. 

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Inadequacies in the review process limit FDA’s ability to effectively 

review outside activity requests. 

o FDA policies and procedures do not fully address many key 

aspects of the process. 

o Twenty-three of the fifty-five outside activity requests we 

reviewed for senior-level employees were approved after the start 

date. Seven activities were approved for longer than the 5-year 

maximum period allowed at the time of our review. In three 

instances, forms with multiple activities were approved. 

o We did not find written recusals for any of the senior-level 

employees’ outside activities. However, we were not able to 

determine whether written recusals were required. No center 

routinely notified supervisors of approved outside activity 

requests. 

o Staff in the eight centers do not receive specialized training 

regarding the review of outside activity requests. At five of the 

eight centers, the function of review of outside activities was a 

collateral duty for staff responsible for determining the 

completeness of information on the request forms. 

RECOMMENDATIONS 

We identified numerous problems regarding inadequate documentation 

and insufficient processes and procedures that may hinder the ability of 

reviewers to assess the appropriateness of the outside activities. 

Considered together, these vulnerabilities indicate the importance of 

continued vigilance to ensure the integrity of the review process. We 

recognize that both HHS and FDA have several initiatives planned or 

underway. The effectiveness of FDA’s new system for reviewing outside 

activities will continue to be dependent on the quality of information 

submitted and the adequacy of the review process. We make the 

following recommendations to FDA on ways to improve and ensure the 

integrity of its review process for outside activities: 

Improve the quality and extent of information for outside activities. 

o Require all employees to submit additional details on the nature 

of their proposed outside activities and their current official 

duties. 

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o Ensure that all employees fill out their outside activity requests 

completely. 

o Cross-check financial disclosure forms with those employees’ 

outside activities for the previous year. 

Address the inadequacies in the review process for outside 

activities. 

o Develop complete policies and procedures on outside activities for 

all centers and employees. 

o Ensure that outside activity requests are approved before their 

scheduled start dates. 

o Ensure that activities are approved for periods not exceeding the 

maximum amount of time allowed by HHS or FDA. 

o Ensure that each outside activity receives its own separate 

review. 

o Require recusals, if needed, to be made in writing and 

disseminated to immediate supervisors and other key personnel 

for all outside activities that are related to employees’ official 

duties. 

o Ensure that supervisors are notified of all approvals and 

disapprovals. 

o Enhance training related to outside activities. 

o Consider centralizing some or all aspects of the review process for 

outside activities. 

SUMMARY OF AGENCY COMMENTS 

In its comments, FDA notes a variety of HHS and agency initiatives 

that address the recommendations we made, including the revised 

HHS-520 and new written policies and procedures. 

One area with which FDA clearly takes issue is our discussion of 

recusals. FDA points out that the HHS-520 form itself provides 

information on recusal obligations to employees, and that by 

recommending approval of an outside activity, a supervisor 

acknowledges that an employee will recuse himself or herself 

whenever appropriate. FDA also suggests that our recommendation 

regarding recusals implies that when a written recusal is made, an 

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activity that otherwise would not be approved because of a conflict of 

interest becomes approvable. 

OFFICE OF INSPECTOR GENERAL RESPONSE 

While this review was underway, both HHS and FDA announced or 

implemented initiatives aimed at strengthening the review process for 

outside activities. We recognize that the revised supplemental 

regulations and FDA’s forthcoming policies and procedures address 

some of the recommendations we make in this report. We encourage 

HHS and FDA to continue their efforts to improve the outside activities 

review process. 

In response to FDA’s concerns about recusals, we reiterate that written 

recusals, when necessary, are protective of employees who are 

participating in outside activities. The process of an employee writing a 

separate recusal statement and the supervisor reviewing that statement 

provides an opportunity for important, deliberate discussion and 

planning that may not arise in the absence of a written statement. 

Under no circumstances should FDA approve outside activities that 

pose conflicts of interest, and in fact, we found no evidence that it has. 

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Δ T ABLE OF CONTENTS 

EXECUTI VE SUMMARY ........................................ i

INTRODUCTI ON ................................................ 1 

NATURE OF OUTS IDE ACTI V ITIES .......................... 9 

VULNERABILITIES ............................................ 12 

Limited information on outside activities ................... 12

Inadequacies in the review process ........................ 16

RECOM M E NDATI O NS ......................................... 20 

SUMMARY OF AGENCY COMMENTS ........................ 26 

OFFICE OF I N SPECTOR GENERAL RESPONS E ........... 26 

ENDNOTE S ..................................................... 28 

APPENDI XES .................................................. 32 

A: Methodology........................................ 32

B: Nature of Outside Activities ........................... 38

C: Errors Found on Outside Activity Requests. .............. 50

D: HHS and FDA Initiatives. ............................ 52

E: Agency Comments ................................... 54

ACKN O W LEDGMENTS ......................................... 60
Δ INTRODU C TION 

OBJECTIVES 

1. To describe the nature of outside activities for which Food and Drug 

Administration (FDA) employees received approval between 

2000 and 2003. 

2. To determine the extent to which FDA senior-level employees 

provided required information on their outside activity request 

forms and financial disclosure statements between 2000 and 2003. 

3. To assess FDA’s process for reviewing outside activity requests 

between 2000 and 2003. 

BACKGROUND 

Federal employees hold positions of public trust and are accountable for 

the responsible use of public funds. As such, the public expects Federal 

employees’ actions and decisions to demonstrate integrity and 

objectivity. Therefore, pursuant to congressional mandate, the Office of 

Government Ethics (OGE) has put into place an ethics program that 

addresses a broad array of topics, including employees’ outside 

activities. Each department in the executive branch is responsible for 

implementing its ethics program. 

In general, employees of the Department of Health and Human Services 

(HHS) are allowed to work and interact privately with non-Federal 

entities on their personal time through outside activities, which in some 

cases require prior approval. Examples of outside activities include 

consulting, teaching, speaking, and writing related to employees’ official 

duties. These activities must not conflict with employees’ official duties, 

and may or may not involve financial compensation. 

Outside activities are not necessarily related to employees’ professions, 

but some outside activities provide employees of FDA with opportunities 

to work with industry, academia, hospitals, and nonprofit organizations 

to help enhance knowledge and foster scientific discoveries. Some 

outside activities can allow FDA employees to build and maintain their 

professional expertise. Outside activities can also provide opportunities 

for FDA employees to maintain licensures or certifications. 

Certain outside activities may create actual or apparent conflicts of 

interest for employees. Pursuant to 18 U.S.C. § 208(a), an actual 

conflict of interest arises when an employee personally and 

substantially participates, in an official capacity, in a particular matter 

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in which he or she has a personal or imputed financial interest, if the 

matter will have a “direct and predictable effect” on that interest. 

Additionally, pursuant to 5 CFR § 2635.502, the appearance of a loss of 

impartiality arises when an employee participates, in an official 

capacity, in a matter in which he has certain defined associations or 

interests that would “cause a reasonable person . . . to question his 

impartiality in the matter.” 

Recent Concerns Regarding Outside Activities Within HHS 

The media and Congress have recently paid increased attention to the 

oversight of outside activities within HHS. A December 2003 

investigative report in The Los Angeles Times raised concerns regarding 

the ethics program at the National Institutes of Health (NIH).1 The Los 

Angeles Times article alleged that the approval of consulting 

arrangements for several senior-level scientists at NIH had created 

serious conflicts of interest that may have biased agency decisions. 

These allegations resulted in a number of internal and external 

inquiries, including several congressional hearings, into potential 

conflicts of interest arising from outside activities at NIH. 

In a hearing conducted by the U.S. House of Representatives Committee 

on Energy and Commerce that focused on NIH, an FDA employee was 

called to testify regarding his approved participation in an outside 

activity with a significantly regulated organization. Certain FDA 

employees are prohibited from working with significantly regulated 

organizations, which are organizations whose products are regulated by 

FDA (see pages 4–5 for more information). FDA indicated, in a 

prepared statement submitted to the committee, that at the time of 

approval the organization was not significantly regulated, but that the 

organization’s status had changed during the course of the activity. 

After learning of this case, FDA conducted an internal review of all 

ongoing outside activities to determine whether they complied with 

applicable laws and regulations. To further ensure the integrity of the 

FDA review process for outside activities, the Committee on Energy and 

Commerce requested that the Office of Inspector General (OIG) conduct 

an independent review of FDA’s oversight of outside activities. 

Requirements for Outside Activities at FDA 

Office of Government Ethics. OGE was established by the Ethics in 

Government Act of 1978, 5 U.S.C. App. OGE oversees ethics programs 

at all executive branch agencies. In October 1992, OGE promulgated 

Governmentwide Standards of Ethical Conduct for Employees of the 

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Executive Branch, which became effective on February 3, 1993, and 

include Subpart H on outside activities.2 OGE regulations require 

employees to comply with 18 U.S.C. § 209, which bars employees from 

accepting outside compensation for work conducted in an official 

capacity.3 OGE regulations also prohibit employees from engaging in 

outside activities, both compensated and uncompensated, that would 

conflict with those employees’ official duties to such a degree that they 

would have to be disqualified from performing essential parts of their 

jobs.4 Further, employees are required to endeavor to avoid actions that 

would create any appearance of violating the standards of ethical 

conduct.5 

Although OGE promulgates the rules that provide a general framework 

for ethical conduct, it delegates to individual departments the authority 

to permit particular kinds of outside activities and/or to require prior 

approval for outside activities. However, OGE does conduct routine 

audits of agencies’ ethics programs to ensure compliance with applicable 

regulations. OGE conducted such a review of FDA’s ethics program in 

2004. 

OGE also oversees Government financial disclosure requirements. 

Certain executive branch employees, including some FDA employees, 

must disclose their compensated outside activities on annual financial 

disclosure forms. Financial disclosure may be public or confidential, 

depending on an employee’s pay schedule and grade. 

Employees for whom the minimum base pay in their pay band is equal 

to or greater than 120 percent of the minimum rate of base pay for the 

GS-15, and certain other designated officials such as Presidential 

appointees and members of the uniformed services above a certain pay 

grade, must annually file the public financial disclosure form, the 

Standard Form (SF)-278.6 An agency may also propose that OGE 

require filing of the SF-278 for additional positions, through a process 

known as equal classification. An agency would propose equal 

classification if it could demonstrate that the responsibilities and 

influence of certain positions were equivalent to those of employees in 

other agencies or components who, by virtue of their salary structures, 

were required to file the SF-278. When equal classification is granted, 

employees in those positions must file the SF-278. 

The SF-278 form captures all outside sources of assets worth at least 

$1,000, as well as outside income and liabilities, along with the financial 

value for each item. Also, the SF-278 captures all compensated outside 

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activities for which the income is greater than $200 and certain 

compensated and uncompensated positions. 

Other employees who do not file the SF-278 but who hold positions of 

significant decisionmaking authority, as determined by FDA, are 

required to annually file the confidential financial disclosure form, the 

OGE-450. Recently, FDA expanded the number of employees who are 

required to annually file the OGE-450.7 This form captures certain 

assets worth at least $1,000; income, liabilities, and outside activities 

for which compensation exceeds $200; and certain compensated and 

uncompensated positions. However, the OGE-450 form does not require 

employees to disclose the precise financial values of these items. 

In fiscal year 2003, 54 percent of FDA employees were required to file 

one of these financial disclosure forms. Employees who do not meet the 

criteria for either the SF-278 or the OGE-450 do not file any annual 

financial disclosure forms. 

Department of Health and Human Services. Agencies may impose, with 

OGE concurrence, additional limitations on outside activities. In 1996, 

HHS promulgated the HHS Supplemental Standards of Ethical Conduct 

for employees.8 The HHS supplemental regulations prohibit HHS 

employees from engaging in any compensated employment related to 

HHS-funded activities; they also prohibit employees from providing 

consultative or professional services for compensation in preparing 

grant applications, contract proposals, and certain other documents for 

submission to HHS. In addition, the regulations require employees to 

request and receive written approval for certain outside activities prior 

to engaging in those outside activities. The types of activities that 

trigger the prior approval requirement include, but are not limited to: 

(1) providing consultative or professional services; (2) teaching, 

speaking, writing, or editing that relates to official duties or results 

from contact with certain prohibited sources; and (3) serving on certain 

boards or advisory bodies.9 

The HHS supplemental regulations provide additional restrictions on 

relationships between FDA employees and significantly regulated 

organizations.10 The regulations define significantly regulated 

organizations as “organization[s] for which the sales of products 

regulated by the Food and Drug Administration (FDA) constitute ten 

percent or more of annual gross sales in the organization’s previous 

fiscal year; where an organization does not have a record of sales of 

FDA-regulated products, it will be deemed to be significantly regulated 

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if its operations are solely in fields regulated by FDA.”11 With limited 

exceptions, FDA employees and their spouses and children are 

prohibited from having financial interests in significantly regulated 

organizations. In addition, FDA employees who are required to file 

annual financial disclosure forms are also generally prohibited from 

participating in outside activities with significantly regulated 

organizations. Finally, all FDA employees are required to obtain prior 

approval before engaging in any outside employment or self-employed 

business activity.12 

In February 2005, HHS issued, with OGE concurrence, an interim final 

rule that revised portions of the HHS supplemental regulations.13 

Previously, the HHS supplemental regulations stipulated that outside 

activities shall be approved unless they violated a statutory or 

regulatory requirement. Under the interim final rule, however, the 

standard for approval is higher. Previously, the regulations stated that, 

“Approval shall be granted unless it is determined that the outside 

employment or other outside activity is expected to involve conduct 

prohibited by statute or Federal regulation . . . .”14 However, the 

interim final rule established a higher standard for approval: “Approval 

shall be granted only upon a determination that the outside 

employment or other outside activity is not expected to involve conduct 

prohibited by statute or Federal regulation . . . .”15 Our review was 

conducted prior to the interim final rule; therefore, our findings are 

based on the previous version of the supplemental regulations. 

Outside Activity Approval Process at FDA 

The Ethics and Integrity Staff within FDA’s Office of the Commissioner, 

Office of Management, implements and oversees the ethics program at 

FDA, which includes providing oversight of outside activities and the 

filing of financial disclosure statements. During the period of our 

review, FDA’s Deputy Ethics Counselor delegated the authority to 

approve outside activity request forms to the Ethics and Integrity Staff. 

The Ethics and Integrity Staff took a decentralized approach to the 

review of outside activities, delegating the review authority to the eight 

offices and centers within FDA, hereafter referred to as centers.16 

Outside activity requests. Generally, the review process for outside 

activity requests begins when an employee completes and submits a 

Request for Approval of Outside Activity form, the HHS-520. All fulltime and part-time HHS employees who wish to engage in certain 

outside activities must complete this document. The HHS-520 collects 

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information on an employee’s position, the nature of the proposed 

outside activity, the period of time over which the outside activity will 

be performed, and the method of compensation; it thereby helps 

reviewers determine whether a proposed outside activity may pose a 

real or apparent conflict of interest. As of January 2004, the amount of 

compensation must also be provided, pursuant to a HHS-wide directive 

from the Designated Agency Ethics Official.17 This official has authority 

delegated from the Secretary of HHS to oversee the HHS ethics 

program. Further, in April 2005, HHS released a new version of the 

HHS-520, which requires employees to provide additional information 

regarding their requests for outside activities. Our review covered 

requests submitted prior to these changes. 

The review process for outside activities has also changed since the 

period of our review, calendar years (CY) 2000 through 2003. In this 

report, we capture the review process that was in place during the 

period of our review. Although this process varied across the eight 

centers, generally an employee submitted the HHS-520 form to his or 

her supervisor, who performed an initial review and recommended 

whether the request should be approved. Staff reviewers in the centers, 

typically program or management analysts, then saw and reviewed the 

request before forwarding it to the final approving official, who made 

the final determination regarding approval.18 The final approving 

official was typically the center director but, during the period of our 

review, final approving officials often delegated the final approving 

authority to members of their staffs, often the staff reviewers in the 

centers. However, as of June 2004, FDA required center directors to 

provide the final review of all requests, and no longer permitted them to 

delegate this authority.19 Throughout this report, we use the general 

term reviewers to refer to all of the individuals who have roles in the 

outside activity review process, which includes supervisors, staff 

reviewers, and final approving officials. 

As stated previously, regulations generally prevent FDA employees who 

are required to file annual financial disclosure reports from engaging in 

outside activities that involve significantly regulated organizations. 

The list of these organizations, referred to as the yellow book, is updated 

annually by the Ethics and Integrity Staff. 

After requests have been approved or disapproved, centers forward 

HHS-520 forms to FDA’s Ethics and Integrity Staff, who maintain a 

database of all outside activity requests. 

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METHODOLOGY 

Our review is based on four data sources: (1) FDA’s database of outside 

activities, (2) a file review of outside activity requests and related 

documentation, (3) interviews, and (4) a procedure review. (For a 

complete description of our methodology, see Appendix A.) 

We analyzed FDA’s database of all outside activity requests submitted 

between CYs 2000 and 2003 to make summary statements about the 

number and nature of outside activities at FDA as a whole. 

We chose the timeframe between CYs 2000 and 2003 because it allowed 

us to examine trends by year. We did not include CY 2004 because 

complete data were not available and some outside activities policies 

and procedures changed during CY 2004. 

For our file review, we conducted a retrospective review of all outside 

activity requests that senior-level employees submitted for approval 

between CYs 2000 and 2003. We defined senior-level employees to be 

those who were required to file SF-278 public disclosure forms as of 

January 2004. FDA provided us with a list of 90 employees who met 

that criterion. This group of senior-level employees included, but was 

not limited to, center and office directors and deputy directors. 

Our file review included three methodologies: (1) a descriptive review, 

(2) a completeness review, and (3) a compliance review. For the 

descriptive review, we tallied the number and nature of the outside 

activity requests overall and conducted trend analyses of the approved 

activities. One limitation of this review is that it may have been subject 

to underreporting, as we did not assess whether employees conducted 

any additional outside activities between CYs 2000 and 2003 that were 

not reported to FDA in outside activity requests. For the completeness 

review, we calculated the extent to which the required documentation 

was filled out completely and correctly. 

For the compliance review, two OIG analysts, and when necessary a 

third, independently assessed each approved outside activity using a set 

protocol and documented whether the activity appeared to be allowable 

under existing requirements. A limitation of this review is that we 

made our assessments based solely on the documentation provided by 

FDA and did not follow up with employees or reviewers for further 

details on the outside activities. 

We also interviewed the employees in each center who were identified 

by FDA as being those most knowledgeable about the review process in 

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the centers between CYs 2000 and 2003. These employees are typically 

program and management analysts in the centers (we refer to them 

throughout this report as staff reviewers). We used a structured 

questionnaire to conduct the interviews. Questions addressed topics 

such as centers’ procedures for reviewing outside activity requests and 

challenges staff reviewers face in reviewing outside activity requests. 

Finally, we requested operating procedures related to outside activities 

from all centers. We assessed and compared these documents. 

We conducted this inspection in accordance with the “Quality Standards 

for Inspections” issued by the President’s Council on Integrity and 

Efficiency and the Executive Council on Integrity and Efficiency. 

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Δ N A TURE OF OUTSIDE ACTIVITIES

In this section we provide a summary of the number and types of 

outside activities in which FDA employees participated between 

CYs 2000 and 2003. We start with a summary of all employees, then 

address senior-level employees. For more information on the nature of 

FDA employees’ outside activities, see Appendix B. 

Eleven percent of all FDA employees received 

approval for a total of 2,592 outside activities 

between CYs 2000 and 2003 

FDA approved all but 14 outside activity requests 

o Of the 13,973 employees at FDA as of the end of fiscal year 2003, 

1,576 employees requested approval for 2,606 outside activities 

between CYs 2000 and 2003. FDA approved 2,592 outside activity 

requests for 1,571 employees. It is not surprising that most 

activities were approved; departmental supplemental regulations 

at the time the requests were submitted stipulated that outside 

activity requests are to be approved unless they violated statute 

or regulation.20 

Most employees received approval for one outside activity, but a few 

received approval for more than five 

o Of the 1,571 employees who received approval for outside 

activities between CYs 2000 and 2003, 68 percent received 

approval for just 1 activity, and another 20 percent received 

approval for 2 activities. 

o Three percent of employees participated in more than five 

activities between CYs 2000 and 2003. The maximum was 

38 approved outside activities for 1 employee. 

Employees who filed the confidential financial disclosure statement 

accounted for 80 percent of the approved outside activities 

o Employees who did not file financial disclosure statements 

accounted for 18 percent of the approved outside activities, and 

employees who filed public financial disclosure statements 

accounted for the remaining 2 percent. 

Employees at the two largest centers accounted for 60 percent of the 

approved outside activities 

o Employees at the Center for Drug Evaluation and Research 

received approval for 812 outside activities, and employees at the 

OE I-01-04-00 400 OU T S I D E AC T I V I T I E S O F FDA E M P L O YEES 9 
N A TURE OF OUTSI D E ACTIV ITIE S 

Office of Regulatory Affairs received approval for 750 approved 

outside activities, between CYs 2000 and 2003. 

The most common types of approved outside activities involved teaching, 

lecturing, speechwriting, and presenting 

o FDA characterized 19 percent of approved outside activities as 

involving teaching, lecturing, speechwriting, and presenting. 

Seventeen percent involved activities characterized by FDA as 

“miscellaneous” activities, including self-employment. Fourteen 

percent involved providing consultative or professional services.21 

Twenty-six percent of FDA senior-level 

employees received approval for a total of 

55 outside activities between CYs 2000 and 2003 

FDA approved all 55 outside activity requests made by senior-level 

employees 

o Of the 90 senior-level employees at FDA as of January 2004, 

23 submitted 55 outside activity requests. FDA approved all of 

them. 

Most of the 23 senior-level employees with approved outside activities 

received approval for 1 or 2 outside activities 

o Of the 23 senior-level employees who received approval for outside 

activities, 14 received approval for only 1 or 2 outside activities 

between CYs 2000 and 2003. The maximum was five approved 

outside activities for one employee. 

Senior-level employees at three centers accounted for 64 percent of the 

approved outside activities for senior-level employees 

o Senior-level employees at the Center for Food Safety and Applied 

Nutrition received approval for 15 outside activities; senior-level 

employees at the Center for Drug Evaluation and Research and 

the Center for Veterinary Medicine each received approval for 

10 outside activities. 

The most common types of approved outside activities for senior-level 

employees involved serving on a board or writing and editing 

o Thirty-six percent of the approved outside activities for seniorlevel employees involved serving on a board. Another 20 percent 

involved writing and editing. 

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N A TURE OF OUTSI D E ACTIV ITIE S 

The most common venues for senior-level employees’ outside activities 

were journals and other publications, professional societies, and 

universities 

o Journals and other publications, professional societies, and 

universities each accounted for 20 percent of the approved outside 

activities for senior-level employees. 

o None of the activities involved the biotechnology or 

pharmaceutical industries or any significantly regulated 

organizations. 

Fifty-eight percent of approved outside activities for senior-level employees 

involved no compensation 

o For the 20 activities that did involve compensation, the most 

common form was reimbursement for travel and expenses. 

Forty percent of approved outside activities for senior-level employees 

involved time off, and 29 percent of these activities involved a week or more 

of time off 

o Senior-level employees indicated that they would take time off to 

perform 22 outside activities. For those 22 activities, employees 

indicated that they would take between 1 and 36 business days 

off. The median amount of time off was 7 business days per 

activity. 

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ΔVULNE R ABI L ITIE S 

 VULNERABILITIE S 

Limited information inhibits FDA’s ability to 

effectively review outside activity requests 

Of the 55 approved outside activities for senior-level employees, all but 

3 were missing at least 1 piece of information required on the HHS-520 form 

Although nearly all of the forms had deficiencies, most of these 

omissions, considered independently, appeared to be minor. However, 

the extent and frequency of these deficiencies raise systemic concerns 

about how FDA collects and reviews information regarding employee 

outside activities. The areas highlighted in this section represent some 

of the more serious omissions or errors. Appendix C contains a complete 

listing of deficiencies on the outside activity requests. 

When the information provided on outside activity request forms is 

incomplete, it becomes more difficult for supervisors, staff reviewers, 

and final approving officials to identify and address potential concerns. 

The information contained on the HHS-520 is, at FDA, the only 

information that employees are required to provide when they request 

approval for outside activities. Complete information allows FDA 

reviewers to consider potential conflicts of interest and make informed 

recommendations with regard to approval. 

Several items on the HHS-520 solicit information that is used to provide 

assurance that potential conflicts of interest, prohibited by regulations, 

are not present in proposed activities. Forms were often missing 

responses to these items. Seven requests were missing statements 

about whether compensation would be derived from HHS grants or 

contracts. Five requests were missing statements about whether wouldbe associates would be seeking grants from Federal agencies. One 

request was missing a statement that the outside activity did not 

conflict with official duties. 

Though all centers use the same HHS-520 form, internal processing 

policies and procedures vary from center to center. Three of eight 

centers explicitly state in their procedures that forms submitted for 

approval should always be complete, and as we have noted, complete 

information is crucial for making informed decisions on outside activity 

requests. FDA staff reviewers at six of eight centers described forms 

not being filled out completely or adequately as a moderate or minor 

challenge.22 

We also found a number of examples of supervisors failing to provide 

required information on the forms. Four requests were missing the 

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VULNE R ABI L ITIE S 

supervisors’ signatures. Seven requests were missing supervisors’ 

recommendations regarding approval. The supervisor is responsible for 

verifying that proposed outside activities do not overlap with employees’ 

official duties. The result of this substantive review is a 

recommendation to the final approving official on whether requests 

should be approved. 

Nine requests were missing the signature of the final approving official, 

and 14 were missing the final approving official’s decision regarding 

approval. All five centers that have written procedures on outside 

activities detail the appropriate signature and approval processes for 

outside activity requests in those procedures. 

Nine requests were missing the second page of the HHS-520. This page 

contains space for reviewers to comment on the requests. This page also 

generally contains a signed statement that the employee received the 

“Notice to Applicants for Prior Approval of Outside Activities” and the 

“Excerpts from the Standards of Ethical Conduct for Employees of the 

Executive Branch and the Department of Health and Human Services 

Supplemental Agency Ethics Regulations,” which summarize the 

responsibilities of employees who are engaged in outside activities. 

When request forms are incomplete, the staff reviewers must follow up 

to obtain complete information on proposed outside activities. At two of 

the eight centers, the FDA staff reviewers we interviewed indicated that 

they always or often follow up with employees for additional 

information during the review process; staff reviewers at another two 

centers indicated that they sometimes follow up with employees for 

more information. 

Even when required information was provided, it was often limited 

In our review of senior-level employees’ outside activity requests, we 

often encountered information that was vague or otherwise limited. 

Based on the limited nature of information provided on the HHS-520 

forms, it was often not possible for our reviewers to determine what 

tasks were involved in the proposed outside activities or how those tasks 

related to employees’ official duties; therefore, it was difficult to 

determine whether the activities were appropriately approved for these 

senior-level employees. At least 1 of our reviewers needed more 

information on employees’ job duties for 53 of the cases reviewed, and at 

least 1 reviewer needed more information on the nature of employees’ 

proposed outside activities for 50 of the cases reviewed. For all 

requests, at least one reviewer needed more information on the 

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VULNE R ABI L ITIE S 

difference between employees’ official duties and the proposed outside 

activities. For 49 of the cases reviewed, at least 1 reviewer wanted 

additional information on the outside organizations with which the 

employees would be working. 

Beyond the HHS-520 form, FDA does not require additional 

documentation that could be useful for the supervisors, staff reviewers, 

and final approving officials. Only eight of the senior-level employees’ 

requests had additional information attached. Of these eight, four 

requests included letters of invitation, three included correspondence 

related to the outside engagements, and one included additional 

information on the outside organization. No position descriptions or job 

billets were attached to any requests. Information contained in these 

types of attached documents can provide important context to FDA 

reviewers. 

To address concerns about inadequately detailed requests, the HHS 

Designated Agency Ethics Official recently reminded officials 

throughout HHS of the importance of performing due diligence when 

reviewing ethics forms. In a memo, this official stated that: 

“Performing ‘due diligence’ that is appropriate to the circumstances 

should be a standard operating procedure. Conduct internet searches, 

make phone calls to the entities involved, talk to the employees, elicit 

responses from them . . . .”23 

Outside activities of senior-level employees were not disclosed as required 

on annual financial disclosure forms 46 percent of the time 

Regulations require employees who file annual financial disclosure 

reports to disclose any outside activities in each year they are engaged 

in the outside activities.24 

However, supervisors, staff reviewers, and final approving officials in 

the centers do not oversee the employees’ annual financial disclosure 

statements and therefore cannot reconcile outside activity requests with 

financial disclosure forms. Recently, FDA announced that it will be 

reconciling employees’ outside activity requests and financial disclosure 

statements annually.25 

Limited information made it difficult for our reviewers to determine the 

appropriateness of several activities of senior-level employees 

Determining whether an outside activity comported with pertinent 

ethics regulations required a judgment based on limited information. 

To increase the consistency of this judgment, two OIG reviewers 

independently reviewed each outside activity request to assess its 

OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 14 
VULNE R ABI L ITIE S 

appropriateness. A third and final reviewer resolved cases in which the 

two initial reviewers disagreed. 

Our review included all available documentation associated with these 

activities for senior-level employees, as provided by FDA. However, it is 

important to point out that these documents do not necessarily include 

all facts known to or considered by the FDA reviewers at the time of 

their reviews. FDA staff reviewers indicated that they sometimes 

conduct additional research to get information about proposed activities. 

Reviewers may also have additional information and knowledge 

regarding particular center employees’ official duties. 

In no instance was the documentation we reviewed adequate for us to 

make a definitive determination regarding whether an activity was 

appropriate. As demonstrated in this section, the information contained 

in the documentation for outside activity requests was often minimal, 

which made it difficult to determine whether activities were 

appropriate. Therefore, based upon the information contained on the 

forms alone, we could not state with certainty that any activity was or 

was not allowable. Instead, we made one of three determinations for 

each activity: (1) appears to be allowable, (2) appears not to be 

allowable, or (3) cannot determine. 

For cases in which the documentation did not suggest any violation of 

the regulations, our reviewers identified activities as “appears to be 

allowable,” even if more information would be necessary to definitively 

determine that they were in fact allowable. Our reviewers would only 

have identified activities as “appears not to be allowable” if the 

documentation suggested any violations of the regulations. Finally, our 

reviewers identified activities as “cannot be determined” when the 

information available was so incomplete that they were unable to make 

a determination, or when the information available raised concerns that 

the activity may have violated the regulations. 

None of the outside activity requests we reviewed involved significantly 

regulated organizations. Ultimately, our reviewers determined that 

44 activities appeared to be allowable and none appeared not to be 

allowable; however, our reviewers could not determine the 

appropriateness of the remaining 11 activities because the information 

provided was so incomplete or the forms were filled out incorrectly. 

Inadequate documentation for outside activities can, intentionally or 

unintentionally, obscure potential violations. If reviewers conduct 

additional research on requests, they may uncover and resolve those 

OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 15 
VULNE R ABI L ITIE S 

potential problems before violations occur, but this may not happen in 

every case. We forwarded the 11 activities for which we could not make 

determinations on appropriateness to FDA for further review. FDA 

determined through additional review that all of these 11 activities 

were allowable. 

In this section, we describe several 

inadequacies in the review process 

Inadequacies in the review process limit FDA’s ability 

to effectively review outside activity requests 

for outside activities. In many 

cases, neither FDA policies nor center procedures address these issues. 

Approvals after the start date 

FDA approved 23 of the 55 outside activity requests we reviewed for 

senior-level employees after the start dates listed on those requests. 

HHS regulations mandate that outside activities must be approved in 

advance.26 

In our review, many approvals after the start dates were due to late 

submissions. For 12 of the 23 late approvals, employees submitted the 

outside activity requests after the activities had already begun. Late 

requests were filed anywhere between 4 and 279 calendar days after 

those activities were supposed to begin, with a median of 65 calendar 

days after the start dates provided on the HHS-520 forms. Additionally, 

late approvals may occur if any of the reviewers need to follow up with 

employees for additional information on their requests.27 

Between 2000 and 2003, none of the eight centers provided deadlines for 

the submission of outside activity requests in their written procedures. 

However, one center recently changed its procedures to specify that 

requests should be submitted at least 3 weeks in advance of the start 

dates to allow sufficient time for review. 

Approvals exceeding the maximum time period allowed by FDA 

Between CYs 2000 and 2003, FDA allowed employees to request 

approval for activities for periods up to 5 years.28 We found seven 

instances of activities of senior-level employees being approved for 

periods exceeding 5 years. Not only does this violate FDA policy, but it 

also makes it difficult to ensure that activities continue to be 

appropriate as employees may change official job duties over time. 

Recently, both HHS and FDA have limited the timeframe for approvals 

of outside activities to 1-year periods.29 

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VULNE R ABI L ITIE S 

Approvals of multiple activities on one request form 

In three instances, outside activity requests of senior-level employees 

were approved despite the fact that multiple outside entities were listed 

on the forms. In one case, an employee requested permission to review 

articles for multiple publications. In another case, an employee 

requested permission to work with multiple clinical and research 

centers. In a third case, an employee requested permission to work with 

five separate organizations, including a foreign government entity. 

Neither FDA policies nor center procedures address the issue of 

multiple activities on a single request. It is important that a unique 

HHS-520 form be submitted for each distinct outside activity, because 

this form is designed to provide details on only one particular activity. 

Activities with different entities may pose different types of concerns, 

and so requests to engage in separate outside activities should be 

submitted and reviewed independently. 

Inadequate use of written recusals 

We did not find written recusals present for any of the senior-level 

employees’ outside activities that we reviewed. However, we were not 

able to determine whether written recusals were required. Staff 

reviewers we interviewed indicated that they had limited experience 

with recusals, and it is uncertain to what extent recusals are addressed 

at the time activities are approved. Also, FDA’s expectations with 

regard to written recusals are unclear; neither FDA policies nor center 

procedures mention the use of written or unwritten recusals. 

Pursuant to the prohibition in the Federal conflict of interest statute, 

18 U.S.C. 208, and OGE regulations, all employees who participate in 

outside activities are obligated either to recuse themselves—in other 

words disqualify themselves—from any official duty matters that may 

create an actual conflict of interest or an appearance of loss of 

impartiality in the performance of official duties, or to request a waiver 

or authorization.30 To make employees aware of this obligation, all 

employees participating in outside activities are supposed to receive two 

forms, the “Notice to Applicants for Prior Approval of Outside Activities” 

and “Excerpts from the Standards of Ethical Conduct,” which mention 

the requirement that employees recuse themselves, but do not include 

further details. OGE guidance suggests that written recusals can help 

to prevent conflicts of interest from arising.31 

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VULNE R ABI L ITIE S 

Inadequate notification of supervisors 

Staff reviewers at none of the eight centers reported that they routinely 

notify employees’ supervisors of final decisions on outside activity 

requests, although staff reviewers at some centers did indicate that 

employees’ administrative staffs may be notified of final decisions. 

Therefore, even though supervisors review and sign off on outside 

activity requests before sending them for final approval, they are 

frequently not made aware of final decisions. When supervisors are 

unaware of ongoing outside activities, they may not be able to monitor 

employees’ assignments to avoid conflicts of interest. Neither FDA 

policies nor center procedures address notification of supervisors. 

Inadequate followup on ongoing outside activities 

Staff reviewers at only two centers reported that they follow up on 

ongoing outside activities, and they reported that they only follow up to 

determine whether activities are continuing or whether they will be 

renewed at the end of their approval periods. Staff reviewers at none of 

the centers reported that they follow up to determine whether the 

nature or time commitment of approved activities are in line with the 

specifications of the requests, whether employees’ official job duties 

have changed, or whether ethics rules are being observed. 

Neither FDA policies nor center procedures address the frequency or 

amount of followup for ongoing outside activities; however, in 2004, 

FDA announced that it will only approve activities for 1-year periods.32 

In addition, the interim final rule limits approvals to 1-year periods, 

and further calls for employees who participate in outside activities to 

submit reports on their outside activities annually.33 This shortened 

period of approval will result in followup for all outside activities at 

least once per year. 

Inadequate training 

Staff reviewers at only one of the eight centers reported providing 

training on outside activities to its employees during the past several 

years. There is currently no requirement for annual ethics training for 

all employees at FDA, although new FDA employees receive ethics 

training, and annual ethics training is required for employees who file 

financial disclosure reports.34 Still, staff reviewers at only one center 

identified inadequate training of employees as a moderate challenge, 

staff reviewers at four centers identified it as a minor challenge, and 

staff reviewers at the remaining three centers indicated that it was not 

a challenge. 

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VULNE R ABI L ITIE S 

Neither FDA nor any of the centers have provided training specifically 

geared toward supervisors, and none of the staff reviewers we 

interviewed indicated that this posed a major or moderate challenge, 

although staff reviewers at four centers identified inadequate 

supervisor training as a minor challenge. Yet, it is crucial to have welltrained supervisors who understand their roles in the outside activity 

review process and vet outside activity requests adequately. 

Finally, neither FDA nor any of the centers have provided training 

specifically geared toward reviewers. It is important that these 

reviewers are trained to effectively review outside activity requests. 

FDA staff reviewers we spoke with at one center indicated that 

insufficient training of reviewers posed a moderate challenge, and staff 

reviewers at two other centers indicated that this was a minor 

challenge. It is crucial that reviewers are trained regarding how to 

properly screen requests for potential conflicts of interest. 

Varying levels of staffing 

At five of the eight centers, the review of outside activities was a 

collateral duty for staff reviewers. This includes the two centers with 

the most outside activity requests between CYs 2000 and 2003. The 

other centers had at least one full-time person dedicated to outside 

activities and, in some cases, other ethics matters. In centers where 

outside activity review is a collateral duty, it may be difficult for staff 

reviewers to develop expertise in the review of requests. Perhaps this is 

one reason that staff reviewers did not recognize as challenges many of 

the inadequacies we have identified. Staff reviewers at one center 

identified inadequate staffing as a moderate challenge, and staff 

reviewers at three centers indicated that it was a minor challenge. 

Staff reviewers at the remaining four centers indicated that inadequate 

staffing was not a challenge. 

OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 19 
Δ RECOMME NDA TIONS 

Although we did not identify any outside activities that appeared to 

violate applicable statutes or regulations, we did identify numerous 

problems regarding inadequate documentation and insufficient 

processes and procedures that may hinder the ability of reviewers to 

assess the appropriateness of the outside activities. Considered 

together, these vulnerabilities indicate the importance of continued 

vigilance in ensuring the integrity of FDA’s review process and in 

preventing employees from participating in inappropriate outside 

activities in the future. 

We recognize that both HHS and FDA have several initiatives planned 

or underway that aim to improve the review process for outside 

activities. (See Appendix D for a list of these initiatives.) Most notably, 

in February 2005, HHS issued an interim final rule to revise the 

supplemental regulations; this interim final rule addresses some of the 

vulnerabilities identified in this report. Over the past year, FDA also 

issued to employees new guidance documents on outside activities 

processes. We encourage HHS and FDA to continue their efforts to 

improve the outside activities review process. 

The effectiveness of FDA’s new system for reviewing outside activities 

will continue to depend on the quality of information submitted and the 

adequacy of the review process. Below, we make recommendations to 

FDA on ways to improve information and ensure the integrity of its 

review process for outside activities. 

Improve the Quality and Extent of Information for Outside Activities 

Require all employees to submit additional details on the nature of their 

proposed outside activities and their current official duties. Having sufficient 

information on the nature of an activity is crucial to determining 

whether the activity should be approved. Equally important is having 

sufficient information on the nature of an employee’s current job duties. 

Together, this information allows reviewers to identify any overlap 

between a proposed outside activity and an employee’s official duties. 

HHS has revised the HHS-520 form to capture additional information 

on outside activities. However, FDA must ensure that employees 

provide adequate, substantive information. 

We recommend that FDA require employees to submit the following 

with all outside activity requests: 

o Statements, written by employees, that describe precisely and 

accurately in substantive ways the work that will be performed 

for outside entities. 

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R E C O MMENDA T I O N S 

o Detailed descriptions of employees’ current job-related activities, 

in addition to copies of their position descriptions. The interim 

final rule requires employees to submit additional information 

about their official duties and any relationships between their 

official duties and their outside activities.35 

o Written letters of invitation and agendas, whenever they are 

available. These items can provide important information on 

what is involved in proposed outside activities. 

o All consulting contracts and other agreements, whenever they are 

available. These agreements can provide important information 

on the nature of proposed activities. 

Ensure that all employees fill out their outside activity requests completely. 

We found that not only were required forms incomplete, but also that 

answers were sometimes too vague to be meaningful. It is important 

for reviewers to have complete information because it allows them to 

consider potential conflicts of interest and make informed 

recommendations as to whether requests should be approved. To 

assist employees in filling out these forms properly, FDA could 

develop standardized checklists that would provide employees with 

guidance to ensure that all proper documentation is submitted and 

complete. In no instance should FDA approve an outside activity 

when documentation is incomplete. 

Cross-check financial disclosure forms with employees’ outside activities for 

the previous year. We found that outside activities were not always 

properly disclosed on the applicable financial statements as required 

by OGE regulations.36 Ensuring disclosure on these forms promotes 

transparency in employees’ outside affiliations and earnings. It also 

serves as another check on whether employees are free of conflicts of 

interest. FDA has already indicated that it will begin performing this 

annual cross-check; we encourage FDA to develop a policy that 

explicitly requires this annual review, which will help ensure that 

employees are accurately reporting required information. 

Address the Inadequacies in the Review Process for Outside Activities 

Develop complete policies and procedures on outside activities for all centers 

and employees. The FDA Ethics and Integrity Staff maintains a Web 

site with information on outside activities, including the supplemental 

regulations, recent advisories, and directions for completing the HHS520 form. However, these policies and procedures do not address many 

key aspects of the process that we found to be problematic. Despite the 

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R E C O MMENDA T I O N S 

problems we found, staff reviewers at only one of eight centers indicated 

that a lack of clear policies posed a major challenge. 

Although FDA provides some guidance for outside activities on its ethics 

Web site, it lacks agency-wide policies and procedures. Furthermore, 

not all centers maintain their own written procedures. To ensure that 

employees are aware of the ethics rules for outside activities and to 

ensure consistency, it is important that FDA develop standard agencywide policies and procedures that address how to submit requests, as 

well as how to review requests. These policies and procedures should 

encompass the recommendations we offer in this report. FDA is 

currently developing policies and procedures for reviewing outside 

activities and intends to distribute them to staff upon completion. 

Ensure that outside activity requests are approved before their scheduled start 

dates. HHS regulations require that all approvals occur prior to start 

dates.37 However, we found that many outside activity requests are still 

being approved after the start date. FDA should reemphasize the 

expectation that centers comply with these regulations and should 

ensure that centers are in compliance. 

Further, it is important for centers to collect information when 

employees come forward after the fact to disclose activities, as this 

provides a record of employees’ noncompliance and the nature of the 

activities conducted. However, this does not mean that activities should 

be approved when they are disclosed after the start date. In fact, if 

centers discover that ongoing or completed outside activities are not 

allowable, appropriate disciplinary action should be taken 

(e.g., counseling, written or oral reprimands, requiring the employee to 

return any compensation, prohibiting participation in future outside 

activities, and, in the most extreme circumstances, removing the 

employee). Even for cases in which outside activities are allowable, 

FDA should consider taking appropriate disciplinary action, especially if 

employees demonstrate patterns of submitting late requests. 

To help ensure that there is adequate time for a careful, thorough 

review of each request, FDA should establish an appropriate timeframe 

for employees to submit their requests. This should allow time for 

reviewers to conduct their reviews and follow up with the employees, if 

necessary, for clarification. We recognize that such a deadline may not 

always be feasible, but we encourage FDA to use the deadline whenever 

possible. 

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R E C O MMENDA T I O N S 

Ensure that activities are approved for periods not exceeding the maximum 

amount of time allowed by HHS or FDA. We found seven activities that 

FDA approved for more than 5 years, in violation of its policy at the 

time of approving outside activities for a maximum of 5 years. Recently, 

FDA changed its policy so that outside activities can only be approved 

for 1-year periods.38 FDA must ensure that its employees and reviewers 

comply with this policy. 

Ensure that each outside activity receives it own separate review. We found 

three instances in which employees requested approval for multiple 

outside activities on the same forms, and one additional instance in 

which an employee said only that he would review articles for journals, 

but did not provide the names of the journals or publishers. FDA must 

ensure that each outside activity request receives its own complete and 

independent review. Each request should be submitted individually, 

with its own supporting documentation. This will help ensure that 

reviewers are able to thoroughly review each individual proposed 

activity for potential conflicts of interest. 

Require recusals, if needed, to be made in writing and disseminated to 

immediate supervisors and other key personnel for all outside activities that are 

related to employees’ official duties. Pursuant to the prohibition of 

18 U.S.C. § 208 and OGE regulations, all employees who participate in 

outside activities are obligated to recuse themselves—in other words 

disqualify themselves—from any official duty matters that may create 

actual or apparent conflicts of interest unless they request and receive a 

waiver or authorization.39 OGE guidance suggests that written recusals 

can help to prevent conflicts of interest from arising.40 

All employees participating in outside activities are supposed to receive 

two forms, the “Notice to Applicants for Prior Approval of Outside 

Activities” and “Excerpts from the Standards of Ethical Conduct,” which 

mention the requirement that employees recuse themselves, but do not 

include further details. These materials are included in the revised 

HHS-520 form. Recusals protect employees who are participating in 

outside activities by allowing for the establishment of screening and 

gatekeeping practices that help to ensure that employees do not 

encounter conflicts between their official duties and outside activities.41 

Having a recusal in writing is important because it provides a way to 

inform supervisors and subordinates of a disqualification and its scope. 

It also serves as a point of accountability. Supervisors and other key 

personnel who are informed of recusals can serve as important checks 

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R E C O MMENDA T I O N S 

on employees to ensure that they are meeting their recusal obligations. 

We recognize that simply by recommending approval of an outside 

activity a supervisor is acknowledging that an employee is obligated to 

recuse himself or herself whenever necessary. However, the process of 

an employee writing a separate recusal statement and the supervisor 

reviewing that statement provides an opportunity for important, 

deliberate discussion and planning that may not arise in the absence of 

a written statement. 

Further, we recognize that if recusals are very widely disseminated, 

there are implications for employee privacy. However, at the very least, 

an employee’s immediate supervisors should be aware of any recusal. 

Supervisors serve as gatekeepers who can ensure that information 

implicated in employees’ recusals does not reach those employees. 

Ensure that supervisors are notified of all approvals and disapprovals. We 

found that supervisors were not systematically notified of final decisions 

on outside activity requests. In addition to being aware of any recusals, 

it is important for the integrity of the process that all relevant parties 

are informed of final decisions regardless of outcome. Supervisors can 

play an important role in ensuring that their employees’ work remains 

free of conflicts even after activities are approved as job duties and 

assignments change over time. 

Enhance training related to outside activities. Existing OGE regulations 

require annual ethics training for only those employees who file 

financial disclosure forms.42 The regulations do not require annual 

ethics training for all employees. We recommend that FDA require all 

employees, regardless of whether they file financial disclosure forms, to 

participate in annual ethics training that addresses outside activities. 

The fact that so many of the HHS-520 forms we reviewed contained 

deficiencies signaled to us that employees may need additional training 

on how to adequately complete these forms. 

In addition to training all employees, FDA should also require all 

supervisors to receive regular training on how to review requests for 

outside activities. Supervisors play a critical role in the review process, 

and therefore they should know how to conduct these reviews 

effectively. Further, all staff reviewers and final approving officials 

should receive training on how to review requests. 

Consider centralizing some or all aspects of the review process for outside 

activities. FDA already has a centralized ethics office, the Ethics and 

Integrity Staff, that reviews all financial disclosure forms. This office 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 24 
R E C O MMENDA T I O N S 

currently maintains copies of all outside activity requests. Further, it 

has begun to perform an additional check of outside activity requests 

submitted by FDA employees after final determinations have been made 

within requesting employees’ respective centers. Staff reviewers 

indicated that they frequently contact the Ethics and Integrity Staff 

with questions on proposed outside activities. 

FDA may have much to gain in terms of consistency and complete 

documentation by centralizing all or some facets of the outside activities 

review process, including: 

o Centralized training for all employees, supervisors, staff 

reviewers, and final approving officials; 

o Centralized routine internal audits of the outside activity review 

process conducted by the centers; and 

o Centralized decisionmaking regarding outside activity requests. 

We recognize that centers vary in size and mission and that taking 

steps toward centralization may be challenging. Further, the presence 

of reviewers in the centers may serve as a reminder of the important 

role of ethics in the day-to-day business of FDA. Entirely removing the 

current role of reviewers from the centers may have the effect of losing 

specialized knowledge regarding (1) the activities common to individual 

centers, and (2) the evolving duties and activities of center employees 

who are engaged in outside activities. 

Yet, consolidating the oversight of these functions into one area with 

full-time experts may have significant benefits. First and foremost, it 

would allow FDA to further develop the knowledge and experience of its 

cadre of full-time ethics officials, whose expertise in the review of 

outside activities would continue to evolve. Currently, the review of 

outside activities is a collateral duty for some staff. 

Centralization could help ensure the independence of the 

decisionmaking process, since the Ethics and Integrity Staff is more 

removed than current reviewers from the employees in the centers. 

Reviewers would not be making decisions regarding their immediate 

colleagues. Further, a central ethics staff would be in a better position 

than individual center staff to ensure that financial disclosure forms 

and outside activity requests correspond, as the review of financial 

forms is already a centralized duty of the Ethics and Integrity Staff. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 25 
R E C O MMENDA T I O N S 

Finally, centralization would provide FDA with the ability to conduct 

analysis to identify potentially problematic trends within and across 

centers over time. 

SUMMARY OF AGENCY COMMENTS 

In its comments, FDA notes a variety of HHS and agency initiatives 

that address the recommendations we made. For example, FDA 

describes how the recently revised HHS-520 form will capture 

additional information on all proposed outside activities. Further, 

FDA is creating written policies and procedures regarding outside 

activities and has enhanced aspects of its outside activities training. 

FDA also identifies some of the potential benefits of outside activities. 

One area with which FDA takes issue is our discussion of recusals. 

FDA points out that the HHS-520 form itself provides information on 

recusal obligations to employees, and that by recommending approval 

of an outside activity, a supervisor acknowledges that an employee 

will recuse himself or herself whenever appropriate. FDA also 

suggests that our recommendation regarding recusals implies that 

when a written recusal is made, an activity that otherwise would not 

be approved because of a conflict of interest becomes approvable. 

For FDA’s complete comments, see Agency Comments, page 54. 

OFFICE OF INSPECTOR GENERAL RESPONSE 

While this review was underway, both HHS and FDA announced or 

implemented initiatives aimed at strengthening the review process for 

outside activities. We recognize that the revised supplemental 

regulations and FDA’s forthcoming policies and procedures address 

some of the recommendations we make in this report. We encourage 

HHS and FDA to continue their efforts to improve the outside activities 

review process. 

In response to FDA’s comments about recusals, we reiterate that 

written recusals, when necessary, are protective of employees who 

participate in outside activities. As OGE has observed, 

“Documentation, whether or not required, provides greater protection 

both for the individual employee and the agency with regard to the 

scope and terms of the commitment to recuse.”43 The process of an 

employee writing a recusal statement and the supervisor reviewing that 

statement provides an opportunity for important, deliberate discussion 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 26 
R E C O MMENDA T I O N S 

and planning that may not arise in the absence of a written statement. 

That written recusal statement may be made somewhere on the HHS520 form itself, or in a separate e-mail or memorandum. 

Further, we reiterate that written recusals allow for the establishment 

of screening and gatekeeping practices that help to ensure that 

employees do not encounter conflicts between their official duties and 

outside activities. As OGE has stated, “. . . a screening arrangement 

creates a viable process for preventing covered matters from coming 

before an employee. This, in turn, could prevent a violation of an 

employee’s recusal obligations.”44 We do not mean to imply that 

otherwise-problematic activities are approvable where recusals are 

present; rather, recusals inform supervisors and coworkers of potential 

conflicts that could arise during the course of an outside activity. Under 

no circumstances should FDA approve outside activities that pose 

conflicts of interest, and in fact, we found no evidence that it has. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 27 
Δ ENDNOTE S 

1 Wilman, D. December 7, 2003. Stealth Merger: Drug Companies and 

Government Medical Research. The Los Angeles Times: A1, A32-33. 

2 5 CFR Part 2635. 

3 5 CFR § 2635.801(d)(5). 

4 5 CFR § 2635.802(b). 

5 5 CFR § 2635.801(c). 

6 5 CFR § 2634.202. 

7 Food and Drug Administration memorandum to all FDA employees, 

June 4, 2004. 

8 5 CFR § 5501. 

9 5 CFR § 5501.106(d). 

10 5 CFR § 5501.106(c)(3). This section of the supplemental regulations 

remained essentially unchanged under the interim final rule. 

70 Fed. Reg. 5543, 5559 (Feb. 3, 2005). 

11 5 CFR § 5501.101. 

12 5 CFR § 5501.106(d)(2). 

13 70 Fed. Reg. 5543 (Feb. 3, 2005). The final rule was issued in 

70 Fed. Reg 51559 (Aug. 31, 2005). 

14 5 CFR § 5501.106(d)(4). 

15 70 Fed. Reg. 5543,5559 (Feb. 3, 2005). 

16 The FDA Deputy Ethics Counselor is now the final approving official 

for all outside activity requests. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 28 
17 Department of Health and Human Services memorandum to Deputy 

Ethics Counselors and Ethics Contacts, January 27, 2004. 

18 Further, staff reviewers indicated that additional individuals may 

review requests or comment before the final decision is made. 

19 Food and Drug Administration memorandum to all FDA employees, 

June 4, 2004. 

20 5 CFR § 5501.106(d)(4). At the time this review was conducted, the 

regulation stipulated that “Approval shall be granted unless it is 

determined that the outside employment or other outside activity is 

expected to involve conduct prohibited by statute or Federal 

regulation . . . .” In the interim final rule of February 2005, the standard of 

approval is higher: “Approval shall be granted only upon a determination 

that the outside employment or other outside activity is not expected to 

involve conduct prohibited by statute or Federal regulation . . . .” 

[emphasis added]. 

21 We aggregated two of FDA’s classifications of outside activities: 

Professional and Consultative Services (295), and Consulting (65). 

22 Staff reviewers at two centers described it as not being a challenge at 

all. 

23 Department of Health and Human Services memorandum to Deputy 

Ethics Counselors and Ethics Contacts, August 13, 2004, p. 1. 

24 5 CFR § 2634.307 for public filers; 5 CFR § 2634.907(a)(6) for 

confidential filers. 

25 Food and Drug Administration memorandum to all FDA employees, 

June 4, 2004. 

26 5 CFR § 5501.106(d)(1). This expectation remains the same in the 

February 2005 interim final rule. 70 Fed. Reg. 5543, 5559 (Feb. 3, 2005). 

27 For initial outside activity requests that were submitted prior to the 

start dates listed on those requests, the median amount of time between 

employees’ signatures and final approving officials’ signatures was 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 29 
12.5 calendar days. Of the 16 initial outside activity requests for which we 

could perform this calculation, 8 were submitted less than 12.5 calendar 

days in advance. 

28 Food and Drug Administration memorandum to all FDA employees, 

October 4, 2004. 

29 Food and Drug Administration memorandum to all FDA employees, 

October 4, 2004. Also, the February 2005 interim final rule calls for 

approvals not to exceed 1 year. 

30 5 CFR § 2635, Subpart D (for conflicting financial interests) and 

5 CFR § 2635, Subpart E (for appearance of loss of impartiality). 

31 U.S. Office of Government Ethics memorandum to Designated Agency 

Ethics Officials (“Recusal Obligation and Screening Arrangements”), 

April 26, 1999. OGE referenced and elaborated on this 1999 memorandum 

in a subsequent memorandum to Designated Agency Ethics Officials, 

General Counsels, and Inspectors General (“Effective Screening 

Arrangements for Recusal Obligations”), June 1, 2004. 

32 Food and Drug Administration memorandum to all FDA employees, 

October 28, 2004. 

33 70 Fed. Reg. 5543, 5559 (Feb. 3, 2005). 

34 5 CFR § 2638.704(a) for public filers; 5 CFR § 2638.705(a)(3) for 

confidential filers. 

35 Additionally, the interim final rule calls for supervisors to prepare 

statements “. . . addressing the extent to which the employee’s duties are 

related to the proposed outside activity . . . .” 70 Fed. Reg. 5543, 5559 

(Feb. 3, 2005). 

36 5 CFR § 2634.307 for public reports; 5 CFR § 2634.907(a)(6) for 

confidential reports. 

37 5 CFR § 5501.106(d)(1). The requirement for prior approval remains 

the same in the February 2005 interim final rule. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 30 
38 Food and Drug Administration memorandum to all FDA employees, 

October 4, 2004. Also, the February 2005 interim final rule calls for 

approvals not to exceed 1 year. 

39 5 CFR § 2635, Subpart D (for conflicting financial interests) and 

5 CFR § 2635, Subpart E (for appearance of loss of impartiality). 

40 U.S. Office of Government Ethics memorandum to Designated Agency 

Ethics Officials (“Recusal Obligation and Screening Arrangements”), 

April 26, 1999. OGE referenced and elaborated on this 1999 memorandum 

in a subsequent memorandum to Designated Agency Ethics Officials, 

General Counsels, and Inspectors General (“Effective Screening 

Arrangements for Recusal Obligations”), June 1, 2004. 

41 Ibid. 

42 5 CFR § 2638.704(a) for public filers; 5 CFR § 2638.705(a)(3) for 

confidential filers. 

43 U.S. Office of Government Ethics memorandum to Designated Agency 

Ethics Officials, April 26, 1999, p. 2. 

44 U.S. Office of Government Ethics memorandum to Designated Agency 

Ethics Officials, General Counsels, and Inspectors General, June 1, 2004, 

p. 2. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 31 
Δ APPENDIX ~ A 

METHODOLOGY 

FDA Database 

FDA provided us with a copy of a database maintained by the Ethics 

and Integrity Staff that contained information on all outside activity 

requests submitted by all FDA employees between CYs 2000 and 2003. 

We used this database to make summary statements about the number 

and nature of outside activities at FDA as a whole. 

Throughout this report, we analyze data from the timeframe between 

CYs 2000 and 2003. We chose this period because it allowed us to 

examine trends by year. Further, complete data for CY 2004 were not 

available, and some outside activities policies and procedures changed 

during CY 2004. 

File Reviews 

We conducted a retrospective review of all outside activity requests that 

senior-level employees submitted to FDA between CYs 2000 and 2003. 

We defined senior-level employees to be those who were required to file 

SF-278 public disclosure forms as of January 1, 2004. FDA provided us 

with a list of 90 employees who met that criterion. This group included, 

but was not limited to, center and office directors and deputy directors. 

We focused our review on senior-level employees because these 

employees may be most likely to engage in outside activities that 

involve substantial influence and compensation, and therefore may be 

most likely to pose the greatest risk for FDA in terms of potential 

conflicts of interest. However, restricting our review to employees in 

this group presents some limitations. For example, it may be the case 

that employees who do not hold senior-level positions are more likely to 

engage in high-risk, high-compensation outside activities. 

We requested outside activity request forms (HHS-520 forms) and 

supporting documentation for all outside activities requested by these 

senior-level employees within the timeframe of our review. Supporting 

documentation that we received included, as appropriate: 

o Public Financial Disclosure (SF-278) Reports, 

o Confidential Financial Disclosure (OGE-450) Reports, 

o Correspondence, 

o Reviewer notes, and 

o Letters of invitation. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 32 
APP E N D I X ~ A 

We considered a request to be within the timeframe of our review if the 

date the employee signed the request fell between January 1, 2000, and 

December 31, 2003. We received 55 outside activity requests from FDA 

that met this criterion. We did not assess whether employees conducted 

any additional outside activities between 2000 and 2003 that were not 

reported in outside activity requests, which represents a potential 

limitation of our review. However, the responsibility for submitting 

request forms rests with employees. 

Our review included initial requests, revised requests, and renewal 

requests. An initial request is made when an employee submits an 

HHS-520 for the first time for a particular activity. A revised request 

would be submitted if an employee had to change information provided 

on an initial request. A renewed request is submitted if an activity 

continues beyond the end date originally stated in the initial request. 

Our population of approved outside activities included initial requests, 

renewals, revised requests, and outside activity requests that did not 

specify the request type. Because we intended to analyze all outside 

activity requests submitted in the timeframe of our study, we included 

all types of requests regardless of whether the supervisor or final 

approving official provided complete information. 

Our file review included three methodologies: (1) a descriptive review, 

(2) a completeness review, and (3) a compliance review. 

Descriptive review. For each outside activity request in our timeframe, 

we extracted the details of the outside activity from the HHS-520 and 

supporting documents into a Microsoft Access® database. If the amount 

of compensation for the activity was listed on the HHS-520, the 

applicable financial disclosure form, or any other documentation in the 

file, we recorded that. Finally, we noted any additional documentation 

that the employee submitted as part of the outside activity request. We 

tallied the number and nature of outside activities overall, as well as by 

year, activity type, compensation type, institute, employee type, and 

time commitment. When an employee provided an estimated range for 

the time commitment, we used the midpoint in our analysis. 

Completeness review. We calculated the extent to which forms were 

filled out completely and correctly. For each outside activity request in 

our timeframe, we documented in our database the dates on which the 

employee, the supervisor, and the final approving official signed off on 

the outside activity request. We also recorded, whenever applicable, 

whether or not the employee had listed the outside activity on his or her 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 33 
APP E N D I X ~ A 

financial disclosure form (SF-278 or OGE-450) for that year.1 We 

documented the number of missing signatures, and also noted other 

missing items of information on the HHS-520 form. 

Compliance review. We reviewed all approved outside activity requests 

that senior-level employees submitted between January 1, 2000, and 

December 31, 2003, to determine whether the activities complied with 

the pertinent requirements for avoiding conflicts of interest. 

We used the following statutes, regulations, and policies as our criteria: 

o Federal ethics laws regarding conflict of interest 

(18 U.S.C. § 205, 18 U.S.C. § 208, and 18 U.S.C. § 209); 

o Governmentwide Standards of Ethical Conduct for Employees of 

the Executive Branch (codified in 5 CFR § 2635); 

o HHS Supplemental Standards of Ethical Conduct 

(codified in 5 CFR § 5501); and 

o FDA policy. 

We compared the organizations listed on outside activity request forms 

to the FDA yellow book listings of significantly regulated organizations 

for each year in the period of our review to determine whether proposed 

activities involved organizations listed as significantly regulated at the 

time the requests were made. (An exception to the prohibition on 

outside activities with significantly regulated organizations applies 

where “the employment is limited to clerical or similar services (such as 

cashier or janitorial services) in retail stores, such as supermarkets, 

drug stores, or department stores.”)2 

Aside from employment with significantly regulated entities, it is 

important to note that the criteria used for our compliance review do not 

explicitly prohibit certain types of outside activities (e.g., consulting 

arrangements). Therefore, determining whether an outside activity 

1 We used this information to calculate the frequency with which outside activity requests 

were recorded as required by regulation. For each year between CYs 2000 and 2003, we 

determined whether an activity was ongoing by checking the start and end dates 

provided on the HHS-520 form. If an activity was ongoing during a particular year, we 

cross-checked the employee’s appropriate financial disclosure (if available) to determine 

whether that activity was listed anywhere on the form. We then divided the number of 

times that activities were disclosed in the years during which they were ongoing 

(56 times) by the number of times activities should have been disclosed (104 times). 

Overall, activities were only disclosed as required 54 percent of the time. 

2 5 CFR § 5501.106. 

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APP E N D I X ~ A 

adhered to the regulations necessarily involved a judgment call on our 

part. To increase consistency, two OIG reviewers used a standardized 

protocol to independently review each outside activity request and any 

available supporting documentation. A final OIG reviewer was 

consulted to resolve cases in which the two initial reviewers disagreed. 

For the cases in which the two initial reviewers agreed, no third 

reviewer was used. 

Our review included all available FDA documentation regarding these 

activities. However, it is important to point out that these documents 

do not necessarily include all facts known to or considered by FDA 

reviewers at the time of their reviews. The staff reviewers we 

interviewed indicated to us that they often do additional research to get 

information about proposed activities. 

In no instance was the documentation we reviewed adequate for our 

reviewers to make a definitive determination regarding whether an 

activity was appropriate. As demonstrated in the “Vulnerabilities” 

section of this report, the information contained in the documentation 

for outside activity requests was often inadequate; inadequate 

information limits reviewers’ ability to make decisions on 

appropriateness. Therefore, we cannot state with absolute certainty 

that any activity was or was not allowable. Instead, we made one of 

three determinations for each activity: (1) appears to be allowable, 

(2) appears not to be allowable, and (3) cannot determine. 

For the cases in which the documentation contained enough information 

and did not appear to violate any regulations, our reviewers identified 

the activity as “appears to be allowable,” even if more information would 

be necessary to definitively determine that the activity was in fact 

allowable. Our reviewers would only have identified an activity as 

“appears not to be allowable” if the documentation indicated a violation 

of the regulations. Finally, our reviewers identified activities as “cannot 

be determined” when the information available was so incomplete that 

they were unable to make a determination, or when the information 

raised concerns that the activity may have violated the regulations. 

Ultimately, our reviewers could not determine the appropriateness of 

11 activities, but did determine that none of the activities violated 

statute or regulations. However, it is quite possible that we have 

underestimated the number of activities that should not have been 

approved. Inadequate documentation for outside activities can, 

intentionally or unintentionally, hide potential violations. If reviewers 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 35 
APP E N D I X ~ A 

conduct additional research on requests, they may uncover and resolve 

those potential problems before they become violations, but this may not 

happen in every case. 

In general, we did not seek additional information beyond what was 

provided in the files. For example, we did not speak with any employees 

or reviewers at FDA or research outside organizations with which 

employees requested permission to work. As a result, an important 

limitation of this methodology is that we cannot comment on whether 

FDA reviewers considered additional facts during their reviews of these 

outside activity requests. 

We recorded, as part of our assessment, whether specific pieces of 

additional information would have been helpful in making 

determinations. This information included greater detail on the 

following items: the nature of the outside activity, the nature of the 

employee’s job duties, the difference between the outside activity and 

the employee’s job duties, and the outside organization. 

Interviews With FDA Staff Reviewers 

We interviewed the employees in each of the eight centers whom FDA 

designated as responsible for and/or most knowledgeable about the 

review process for outside activities between CYs 2000 and 2003. We 

refer to these employees as staff reviewers. We used a structured 

questionnaire to conduct these interviews. The questionnaire addressed 

centers’ procedures for reviewing outside activity requests; the training 

that centers provide to employees, supervisors, staff reviewers, and final 

approving officials on outside activities; staff reviewers’ approaches to 

identifying ethics violations regarding outside activities; challenges staff 

reviewers face in the outside activities review process; and staff 

reviewers’ recommendations for improving processes for outside 

activities. We conducted all interviews by telephone. We also spoke 

with FDA Ethics and Integrity Staff to learn of initiatives FDA has 

planned or underway to improve its system for addressing outside 

activities. FDA Ethics and Integrity Staff served as a resource for 

clarifying our questions on FDA ethics policy throughout our review. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 36 
APP E N D I X ~ A 

Procedure Review 

We requested operating procedures related to outside activities from all 

eight centers. FDA allows, but does not require, its centers to develop 

written operating procedures for implementing FDA policies on outside 

activities. Staff reviewers at five centers indicated that their centers 

have written procedures and provided those procedures to us. These 

included standard operating procedures, Web site printouts, and 

memoranda. We counted the number of centers that maintained these 

documents and compared the documents to one another. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 37 
Δ APPENDIX ~ B 

NATURE OF OUTSIDE ACTIVITIES 

Eleven percent of all FDA employees received approval to 

participate in a total of 2,592 outside activities between 

CYs 2000 and 2003. 

FDA approved all but 14 outside activity requests. Of the 13,973 employees 

at FDA, 1,576 employees submitted 2,606 outside activity requests 

between CYs 2000 and 2003. FDA approved 2,592 requests for 

1,571 employees and disapproved 14 requests. (See Table 1 below.) It is 

not surprising that the overwhelming majority of requests were 

approved. For the period covered by this review, HHS supplemental 

regulations called for outside activity requests to be approved unless 

they clearly violated statute.3 The interim final rule calls for a higher 

standard of approval: activities are only to be approved “upon a 

determination that [activities are not] expected to involve conduct 

prohibited by statute or Federal regulation . . . .” Further, FDA 

employees may confer with supervisors, staff reviewers, or Ethics and 

Integrity Staff before formally submitting requests to ensure that their 

proposals are approvable. 

The number of requests for outside activities increased between 

CYs 2001 and 2002. One possible explanation for this increase may be 

the overall growth of the FDA workforce between CYs 2001 and 2002. 

 Table 1. Number of FDA Employees and

 Outside Activity Requests by Year, CY 2000–2003

Calendar Year Number 

of Employees * 

Number of 

Outside Activity 

Requests 

Number of 

Approved Outside 

Activity Requests 

2000 

2001 

2002 

2003 

13,047

13,104

14,038

13,973

 515

 515

 784

 792

 515 

512 

779 

786 

Totals - 2,606 2,592

 * Reported as the number of employees at the end of the fiscal year.

 Source: Office of Inspector General analysis of FDA data, 2005. 

3 5 CFR § 5501.106. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 38 
APP E N D I X ~ B 

Most employees received approval for one outside activity, but a few received 

approval for more than five. Of the 1,571 employees who received approval 

to participate in outside activities between CYs 2000 and 2003, 

68 percent received approval for only 1 activity, and another 20 percent 

received approval for 2 outside activities. Three percent of employees 

received approval for more than 5 activities over the 4-year period. The 

maximum was 38 approved outside activities for 1 employee between 

CYs 2000 and 2003. (See Table 2 below.) 

 Table 2. Number of Approved Outside Activities

 for FDA Employees, CY 2000–2003

Number of 

Approved Activities 

Number of 

Employees Participating 

Percent of 

Employees Participating 

1

2

3

4

5

6

7 or more

 1,066

 311

 92

 49

 16

 17

 20

 68 

20 

6 

3 

1 

1 

1 

Totals 1,571 100

 Source: Office of Inspector General analysis of FDA data, 2005. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 39 
APP E N D I X ~ B 

Employees who file the confidential financial disclosure form accounted for 80 

percent of the approved outside activities. Employees who are required to 

annually file the confidential financial disclosure form (OGE-450) 

accounted for 80 percent of approved outside activities between 

CYs 2000 and 2003. Employees who do not file any financial disclosure 

accounted for 18 percent of approved outside activities, and employees 

who file the public financial disclosure form accounted for only 2 percent 

of approved outside activities, between CYs 2000 and 2003. 

(See Table 3 below.) 

 Table 3. Number of Approved Outside Activities

 for FDA Employees by Filer Status, CY 2000–2003

Filer Status 

Number of 

Approved 

Outside 

Activities 

Percent of 

Approved 

Outside 

Activities 

Number of 

Employees * 

Percent of 

Employees

 Confidential Filer 

 Nonfiler

 Public Filer

2,084

 457

 51

 80

 18

 2

 7,374

 6,463

 136

 53

 46

 1

 Totals 2,592 100 13,973 100

 * Reported as the number of employees at the end of fiscal year 2003.

 Source: Office of Inspector General analysis of FDA data, 2005.

Certain FDA employees must disclose their compensated outside 

activities on an annual financial disclosure form, which may be public or 

confidential, depending on an employee’s pay. By statute, some 

employees who meet income or appointment requirements must file the 

public financial disclosure form, the SF-278. FDA requires additional 

employees in positions of significant decisionmaking authority to 

annually file the confidential financial disclosure form, the OGE-450. 

This form requires employees to list certain compensated and 

uncompensated positions. Most employees, however, are not required to 

file any sort of financial disclosure. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 40 
APP E N D I X ~ B 

Employees at the two largest centers accounted for 60 percent of the approved 

outside activities. Employees at the Center for Drug Evaluation and 

Research received approval for 812 outside activities, and employees at 

the Office of Regulatory Affairs received approval for 750 approved 

outside activities, between CYs 2000 and 2003. The percentage of 

employees participating in outside activities, by center, ranged from 

7 percent at the Office of the Commissioner to 14 percent at the Center 

for Veterinary Medicine. (See Table 4 below.) 

 Table 4. Approved Outside Activities for FDA Employees,

 by Center, CY 2000–2003

Center 

Number of 

Approved 

Outside 

Activity 

Requests 

Percent of 

Approved 

Outside 

Activity 

Requests 

Number of 

Participating 

Center 

Employees 

Percent of 

Participating 

Center 

Employees **

 Center for Drug Evaluation and Research

 Office of Regulatory Affairs

 Center for Food Safety and Applied Nutrition

 Center for Biologics Evaluation and Research

 Center for Devices and Radiological Health

 Office of the Commissioner

 Center for Veterinary Medicine

 National Center for Toxicological Research

 812 

750 

259 

244

 205

 142

 130

 50

31

29

10

 9

 8

 5

 5

 2

 423 

536 

131 

116 

142

 113

 78 

32

13

13

10

10

 9

 7

14

 9

 Totals 2,592 * 1,571 -

 * Column does not sum to 100 due to rounding.

 ** Reported as the number of employees at the end of fiscal year 2003.

 Source: Office of Inspector General analysis of FDA data, 2005.

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 41 
APP E N D I X ~ B 

. 

The most common types of approved outside activities involved teaching, 

lecturing, speechwriting, and presenting. Nineteen percent of the approved 

outside activities involved teaching, lecturing, speechwriting, and 

presenting. Seventeen percent involved what FDA designated as 

“miscellaneous” activities, and another 14 percent involved consulting 

or providing professional or consultative services. (See Table 5 below.) 

 Table 5. Nature of Approved Outside Activities

 for FDA Employees, CY 2000–2003

Type of Outside Activity 

1 

Number of 

Approved 

Outside 

Activities 

Percent of 

Approved 

Outside 

Activities

 Teaching, Lecturing, Speechwriting, and Presenting

 Miscellaneous

 Consulting, Professional, and Consultative Services

 Trade, Industrial, and Service Occupations

 Writing, Editing, and Serving on Editorial Boards

 Clinical Professional Practice

 Holding Office in a Professional Organization or Society

 Sales and Clerical Positions

 Serving on a Board or Committee

 Private Professional Practice and Other Professional Activities

 Self-Employed Positions

2 

3 

4 

5 

490

 436

 360

 294

 227

 221

 218

 189

 65

 55

 37

 19

 17

 14

 11

 9

 9

 8

 7

 3

 2

 1

 Totals 2,592 100

1 We report the types of activities by the classifications FDA made in its database of outside

 activities.

2 This category included, for example, a variety of self-employed positions that were categorized

 as miscellaneous before FDA created a separate self-employed activity category in the database. 3 We aggregated two of FDA's classifications of outside activities: Professional and Consultative

 Services (295) and Consulting (65). 4 We aggregated two of FDA's classifications of outside activities: Writing and Editing (162) and

 Writing/Editing/Member of Editorial Board (65). 5 We aggregated two of FDA's classifications of outside activities: Other Professional Activity with

 Remuneration (35) and Private Professional Practice (20).

 Source: Office of Inspector General analysis of FDA data, 2005.

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 42 
-

APP E N D I X ~ B 

Twenty-six percent of FDA senior-level employees received 

approval to participate in a total of 55 outside activities 

between CYs 2000 and 2003. 

We defined senior-level employees as those who were required to file the 

SF-278 public financial disclosure form as of January 2004. This group 

includes, for example, center directors and deputy directors. 

FDA approved all 55 outside activity requests made by senior-level employees. 

Of the 90 senior-level employees at FDA as of January 2004, 

23 submitted 55 outside activity requests. FDA approved all of these 

requests. (See Table 6 below.) As described earlier in this Appendix, 

there are several possible explanations for a high approval rate. 

The number of senior-level employees requesting approval, and the 

number of approvals, remained relatively constant from CYs 2000 to 

2003. 

 Table 6. Number of FDA Senior Level Employees and

 Approved Outside Activity Requests by Year, CY 2000–2003

Calendar Year Number of Employees 

Requesting Approval 

Number of Approved 

Outside Activity Requests 

2000

2001

2002 

2003 

9 

9 

12 

11 

13 

11 

15 

16 

Totals - 55

 Source: Office of Inspector General analysis of FDA data, 2005. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 43 
-

APP E N D I X ~ B 

Most senior-level employees received approval for one or two outside activities. 

Over half of the senior-level employees at FDA received approval for 

only one or two outside activities between CYs 2000 and 2003. The 

median number of outside activities approved per employee was two. 

The maximum was five approved outside activities for one employee 

between CYs 2000 and 2003. (See Table 7 below.) 

 Table 7. Number of Approved Outside Activities

 for FDA Senior Level Employees, CY 2000–2003

Number 

of Activities 

Number of 

Participating Employees 

Percent of 

Participating Employees 

1 

2 

3 

4 

5 

6 

8 

4 

4 

1

26 

35 

17 

17 

4 

Totals 23 *

 * Column does not sum to 100 due to rounding.

 Source: Office of Inspector General analysis of FDA data, 2005.

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 44 
-

APP E N D I X ~ B 

Senior-level employees at three centers accounted for 64 percent of the 

approved outside activities. Senior-level employees at the Center for Food 

Safety and Applied Nutrition received approval for 15 outside activities 

between CYs 2000 and 2003. At both the Center for Drug Evaluation 

and Research and the Center for Veterinary Medicine, senior-level 

employees received approval for 10 outside activities between CYs 2000 

and 2003. (See Table 8 below.) 

 Table 8. Approved Outside Activities for FDA Senior Level Employees,

 by Center, CY 2000–2003

Center 

Number of 

Approved 

Outside 

Activity 

Requests for 

Senior-Level 

Employees 

Percent of 

All Approved 

Outside 

Activity 

Requests for 

Senior-Level 

Employees 

Number of 

Senior-Level 

Employees 

at Center 

Participating 

Number of 

Senior-Level 

Employees 

at Center **

 Center for Food Safety and Applied Nutrition 

 Center for Drug Evaluation and Research 

 Center for Veterinary Medicine 

 Office of the Commissioner

 Center for Biologics Evaluation and Research

 Office of Regulatory Affairs

 National Center for Toxicological Research

 Center for Devices and Radiological Health 

15 

10 

10 

9 

6 

4

 1

-

27 

18 

18 

16 

11 

7 

2 

-

7 

6 

3

3 

2

1

1

0

18

13

 7

25

 9

 9

 1

 8

 Totals 55 ** 23 90

 * Column does not sum to 100 due to rounding.

 ** Reported as the number of senior-level employees as of January 1, 2004.

 Source: Office of Inspector General analysis of FDA data, 2005.

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 45 
-

APP E N D I X ~ B 

The most common types of approved outside activities of senior-level 

employees involved serving on a board or writing and editing. 

Thirty-six percent of the approved outside activities for senior-level 

employees involved serving on boards. Another 20 percent of approved 

outside activities for senior-level employees involved writing and 

editing. (See Table 9 below.) 

 Table 9. Nature of Approved Outside Activities

 for FDA Senior Level Employees, CY 2000–2003

Type of Outside Activity * Number of Approved 

Outside Activities 

Percent of Approved 

Outside Activities

 Serving on a Board 

 Writing and Editing 

 Clinical Professional Practice

 Serving on a Committee

 Lecturing

 Serving as a Professor

 Legal Consulting

 Other

 Performing Research

 Consulting

20 

11 

4

 4

 4

 4

 3

 2

 2

 1

36

20

 7

 7

 7

 7

 5

 4

 4

 2

 Totals 55 **

 * We report the types of activities by the classifications our reviewers made.

 ** Column does not sum to 100 due to rounding.

 Source: Office of Inspector General analysis of FDA data, 2005.

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 46 
APP E N D I X ~ B 

The most common venues for senior-level employees’ outside activities were 

journals and other publications, professional societies, and universities. 

Journals and other publications, professional societies, and universities 

each accounted for 20 percent of the approved outside activities for 

senior-level employees. None of the activities involved the 

biotechnology or pharmaceutical industries or any other significantly 

regulated organizations. (See Table 10 below.) 

 Table 10. Types of Organizations With Which FDA Senior-Level

 Employees Received Approval for Outside Activities, CY 2000–2003

Type of Outside Organization * Number of Approved 

Outside Activities 

Percent of Approved 

Outside Activities

 Professional Societies 

 Journals and Publishers 

 Universities 

 Hospitals and Clinics

 Personal and Social Organizations

 Financial Institutions

 Law Firms

 Cannot Determine

 Charities

 Museums

11

11

11

 6

 5

 3

 3

 2

 2

 1

 20

 20

 20

 11

 9

 5

 5

 4

 4

 2

 Totals 55 100

 * We report the types of organizations by the classifications our reviewers made.

 Source: Office of Inspector General analysis of FDA data, 2005. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 47 
-

APP E N D I X ~ B 

Fifty-eight percent of approved outside activities for senior-level employees 

involved no compensation. Employees must report on their HHS-520s the 

type(s) of compensation they are to receive for performing outside 

activities. An outside activity may involve more than one type of 

compensation; employees may also perform outside activities without 

compensation. There are no limits on the types or amounts of 

compensation that employees may receive for outside activities. 

Of the 20 activities for which employees reported that they would 

receive compensation, the most common form was reimbursement for 

travel and expenses. Of these 20 activities, we were able to obtain the 

actual amount of compensation for only 5. Four of these five activities 

involved reimbursement for travel and expenses ranging from $1,800 to 

almost $32,000 per activity. The other activity involved an honorarium 

valued between $1,000 and $15,000.4 (See Table 11 below.) 

 Table 11. Types of Compensation That FDA Senior Level

 Employees Received for Approved Outside Activities, CY 2000–2003

Type of Compensation * 

Number of Approved 

Activities Involving 

This Type 

Percent of Approved 

Activities Involving 

This Type **

 None 

 Expense and Travel Reimbursement 

Fees

 Royalties

 Honoraria

 Salaries

 Per Diem Payments

32 

12 

5

 2

 1

 1

 1

58

22

 9

 4

 2

 2

 2

 * Three outside activity requests did not indicate whether or what types of compensation would be

 received.

 ** Column sums to more than 100 percent because some outside activities involved more than

 one type of compensation.

 Source: Office of Inspector General analysis of FDA data, 2005.

4 Prior to January 2004, employees were not required to report the amount of 

compensation to be received for outside activities on the HHS-520 forms. Therefore, 

when possible, we obtained this information from annual financial disclosure forms and 

from employees who voluntarily disclosed the amount of compensation on their HHS-520 

forms. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 48 
APP E N D I X ~ B 

This portion of our analysis regarding compensation is limited by the 

fact that compensation amounts were self-reported by the employees. 

We did not independently verify the types or amounts of compensation 

that employees actually received. 

Forty percent of approved outside activities for senior-level employees involved 

time off, and 29 percent of these activities involved a week or more of time off. 

To participate in outside activities, employees often have to take time 

off from work. For the 22 outside activities for which senior-level 

employees indicated that time off would be required, these employees 

reported that they would take off between 1 and 36 business days from 

work. The median amount of time employees anticipated taking off to 

perform outside activities was 7 business days per activity. 

As noted earlier in this report, 13 senior-level employees received 

approval for multiple outside activities between CYs 2000 and 2003. To 

do so, three of these senior-level employees reported taking more than a 

month off from work over this 4-year period. Further, one senior-level 

employee reported taking more than 7 months off from work to perform 

outside activities between 2000 and 2003. 

Employees may also use personal time, or hours outside of the normal 

workday, to engage in outside activities. For 46 of the 55 senior-level 

outside activity requests we reviewed, employees documented the 

amount of time that would be spent on the activities. Total time spent 

on activities, including both time off and time outside of the workday, 

ranged from 1 to 143 calendar days per activity. The median amount of 

time spent on outside activities, per activity, was 12.5 calendar days. 

There are no explicit limits on the amount of time that employees may 

use to perform outside activities. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 49 
-

Δ APPENDIX ~ C 

ERRORS FOUND ON OUTSIDE ACTIVITY REQUESTS FOR 

FDA SENIOR-LEVEL EMPLOYEES 

The following tables illustrate: (1) the frequency of errors on FDA 

senior-level employees’ outside activity request forms, and (2) the 

problems we uncovered in our review of FDA senior-level employees’ 

outside activity request forms. 

 Number of Errors Found on Approved Outside Activity Requests

 of FDA Senior Level Employees, CY 2000–2003

Number of 

Errors 

Number of Request Forms 

With Errors 

Percent of Request Forms 

With Errors 

0 

1 

2 

3 

4 

5 

6 

7 

3

0

14

12

12

8

4

2

 5 

0 

 25 

 22 

 22 

 15 

7 

4 

Totals 55 100

 Source: Office of Inspector General analysis of FDA data, 2005. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 50 
-

APP E N D I X ~ C 

 Errors Found on Approved Outside Activity Requests

 of FDA Senior Level Employees, CY 2000–2003

Missing Item on the HHS-520 Number of 

Requests 

Percent of 

Requests

 Missing at least one of the following items 52 95

 HHS-520, Item 4: Grade and salary (one or both missing) 

 HHS-520, Item 18: Action taken (any part of Item 18) 

 Item 18a: Final action 

 Item 18b: Final approving official signature 

 Item 18c: Final approving official title 

 Item 18d: Signature date 

 HHS-520, Item 16: Additional information attached? 

 HHS-520: Request type 

 HHS-520, Item 17: Action recommended by reviewing

 official (any part of Item 17)

 Item 17a: Recommended action

 Item 17b: Reviewing official signature

 Item 17c: Reviewing official title

 Item 17d: Signature date

 Second page of the HHS-520

 HHS-520, Item 12: Will compensation be derived from an

 HHS grant or contract?

 HHS-520, Item 8: Estimated time involved

 HHS-520, Item 10: If providing consultative or professional

 services, are your would-be associates receiving or will they

 seek, a grant or contract from a federal agency?

 HHS-520, Item 11: Method of basis of compensation 

 HHS-520, Item 5: Name, address and business of person

 or organization for whom outside services will be performed

 HHS-520, Item 6: Location where services will be performed

 HHS-520, Item 3: Title of position

 HHS-520, Item 9: Do your official duties relate in any way

 to the proposed activity?

 HHS-520, Item 1: Name 

 HHS-520, Item 2: Organizational location 

 HHS-520, Item 7: Nature of activity 

 HHS-520, Item 13: Statement that form contains true,

 complete, and correct information 

 HHS-520, Item 14: Signature of employee 

 HHS-520, Item 15: Signature date 

40 

22 

14 

9 

14 

12 

16 

15 

9 

7 

4

 7 

5

 9 

7 

6 

5

 3

 2

 2

 1

 1

-

-

-

-

-

-

73

40

25

16

25

22

29

27

16

13

 7

13

 9

16

13

11

 9

 5

 4

 4

 2

 2

-

-

-

-

-

-

 Source: Office of Inspector General analysis of FDA data, 2005. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 51 
ΔAPP E N D I X ~ C 

 APPENDIX ~ D 

HHS AND FDA INITIATIVES 

To strengthen the process for reviewing outside activity requests, HHS 

and FDA have the following initiatives recently completed, planned, or 

underway. 

HHS Interim Final Rule 

HHS issued an interim final rule in February 2005 that imposes new 

responsibilities on FDA and other HHS employees who engage in 

outside activities.5 The following are some of the provisions of the 

interim final rule that relate to outside activities: 

o Employees must provide additional detailed information in their 

outside activities requests. The revised HHS-520 form, released 

in April 2005, captures significantly more information than the 

previous version. 

o Employees must file annual reports on their outside activities. 

o Outside activities may only be approved for 1-year periods. 

Other HHS Initiatives 

o As of January 2004, HHS employees who request approval for 

outside activities must list the amount of compensation to be 

received on their request forms. 

o In August 2004, the HHS Designate Agency Ethics Official sent a 

memorandum to officials throughout HHS to remind them of the 

importance of performing due diligence when reviewing ethics 

forms. 

o In April 2005, HHS released a revised version of the HHS-520 

form that captures more information than the previous version. 

FDA Internal Review 

o In June 2004, the Acting FDA Commissioner ordered a review of 

approximately 1,800 outside activities to assess compliance with 

relevant ethics rules. This review found no outside activities that 

raised concerns, except for one problematic activity of which FDA 

was already aware. 

5 70 Fed. Reg. 5,543, Feb. 3, 2005. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 52 
APP E N D I X ~ D 

FDA Enhanced Oversight 

In light of the June 2004 internal review of outside activities, the 

Acting FDA Commissioner announced several new requirements for 

outside activities, including the following: 

o Prior to the interim final rule, FDA limited approvals for outside 

activities to 1-year periods. 

o FDA first required center directors to be the final approving 

officials for all outside activity requests, and later required the 

FDA Deputy Ethics Counselor to be the final approving authority 

for all outside activity requests. This duty cannot be delegated, as 

it often was in the past. 

o FDA has expanded the number of employees who are required to 

annually file the confidential financial disclosure form, the 

OGE-450. 

o FDA will begin conducting annual reviews of outside activities in 

which they will cross-check financial disclosure forms to 

determine compliance with filing regulations. 

o FDA is working on a comprehensive Agency-Wide Staff Manual 

Guide on Outside Activities, which will be released to all 

employees upon completion. 

FDA Enhanced Information Management 

o Prior to the release of the revised HHS-520 form in April 2005, 

FDA employees were required to use the HHS-520-1 outside 

activities request form, which was unique to FDA and, in part, 

completed electronically. 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 53 
Δ APPENDIX ~ E 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 54 
APP E N D I X ~ E 

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APP E N D I X ~ E 

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APP E N D I X ~ E 

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APP E N D I X ~ E 

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APP E N D I X ~ E 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 59 
Δ ACKNOWLEDGMENTS 

This report was prepared under the direction of Joyce M. Greenleaf, 

Regional Inspector General for Evaluation and Inspections in the 

Boston regional office. Other principal Office of Evaluation and 

Inspections staff who contributed include: 

Aimée Golbitz, Team Leader 

Steven Keenan, Project Leader 

Michael Flood, Program Analyst 

Ayana Everett, Program Specialist 

Elise Stein, Director, Public Health and Human Services 

Technical Assistance 

Barbara Tedesco, Mathematical Statistician 

Kevin Farber, Mathematical Statistician 

Office of Counsel to the Inspector General 

Melinda Golub, Senior Counsel 

 OE I-01-04-00 400 OU T S I DE AC T I V I T I E S O F FDA E M P L O YEES 60