GAO-23-105415, CARES ACT: Structural Characteristics That Can Help Insulate HHS Agencies against Potential Political Interference

Summary

GAO-23-105415 is a Government Accountability Office report to congressional addressees dated December 15, 2022, on structural characteristics that can help insulate HHS agencies against potential political interference. It reviews CDC, FDA, NIH and ASPR against the characteristics described in the Sourcebook of United States Executive Agencies. GAO reports that all four agencies have active advisory committees and that FDA, NIH and ASPR have Senate-confirmed leaders, but that they lack many insulating features found at independent agencies such as the Federal Reserve. It states that each agency has between two and five political appointees in key positions and that appointees at CDC, FDA and ASPR increased at least twofold from 2016 through 2020. Reform ideas include converting FDA into an independent agency and making the CDC director a Senate-confirmed position.

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United States Government Accountability Office

Report to Congressional Addressees

December 2022

CARES ACT
Structural
Characteristics That
Can Help Insulate
HHS Agencies against
Potential Political
Interference

GAO-23-105415


December 2022

CARES ACT
Structural Characteristics That Can Help Insulate HHS
Agencies against Potential Political Interference
Highlights of GAO-23-105415, a report to
congressional addressees

Why GAO Did This Study

What GAO Found

HHS agencies—including CDC, FDA,
NIH, and ASPR—have been at the
forefront of the federal government’s
response to the COVID-19 pandemic
since the President declared it a
national emergency on March 13,
2020. Recent reports from GAO and
others have identified shortcomings in
this response, including allegations of
political interference.

The Sourcebook of United States Executive Agencies describes over 60
structural characteristics or features related to an agency’s organization or
design. These features can affect an agency’s degree of autonomy from political
influences and help insulate it from political interference. These characteristics
include: 10 that describe general information about an agency (e.g., whether it is
established in statute); 35 that relate to an agency’s leadership structure and
personnel (e.g., the number of political appointees serving); eight that insulate
agency policy (e.g., whether it has self-funding authority); and 11 other key
structural features of an agency (e.g., whether it has advisory committees
established).

This report examines the key
characteristics that can help insulate
agencies from political interference and
describes the structural characteristics
that the selected HHS agencies have
in place.
GAO identified characteristics of
agency insulation from political
interference by reviewing scholarly
literature, policy reviews, and other
sources, and interviewing political
science experts. GAO obtained
perspectives about scientific integrity
and political interference at the
selected agencies and ideas for
structural reforms by interviewing
former and current agency officials.
This report presents GAO’s findings on
structural characteristics at selected
HHS agencies. GAO continues to
examine selected HHS agencies’
experiences with political interference
and any steps that could be taken to
strengthen protections against such
interference.
GAO provided a draft of this report to
HHS for review. The agency provided
written and technical comments on the
draft, both of which we incorporated as
appropriate.

View GAO-23-105415. For more information,
contact Sharon M. Silas at 202-512-7114 or
SilasS@GAO.gov

Selected Department of Health and Human Services (HHS) agencies—Centers
for Disease Control and Prevention (CDC), Food and Drug Administration (FDA),
National Institutes of Health (NIH), and Administration for Strategic Preparedness
and Response (ASPR)—have several of these structural characteristics in place.
For example:
•

All four selected agencies have active advisory committees that advise
on key areas of scientific decision-making, which can help insulate them
from political interference by allowing the participation of external experts
in agency decision-making.

•

Three selected agencies—FDA, NIH, and ASPR—have leaders who are
selected by the President and confirmed by the Senate, which can help
protect against political interference. For example, it may be more
politically difficult to remove Senate-confirmed agency heads, particularly
those confirmed with bipartisan support.

However, the selected HHS agencies do not have many of the structural
characteristics that can help insulate them from political interference compared to
independent agencies, such as the Federal Reserve, because they are located in
an executive department. For example, the selected agencies have few, if any,
characteristics that can limit the President’s influence over agency leaders and
policy, such as limits on the retention of agency leaders.
In addition, all four selected HHS agencies each have between two and five
political appointees serving in key senior leadership and policy positions, which
can increase presidential control over agencies. Moreover, the number of political
appointees at CDC, FDA, and ASPR has increased at least twofold from 2016
through 2020.
Multiple senior agency officials highlighted how the government-wide
coordination required in response to an emergency like the COVID-19 pandemic
can create more opportunity for potential political interference. Experts and
former agency heads have identified structural reforms that may improve
insulation of selected HHS agencies against political interference in future public
health emergencies. These structural reform ideas include converting FDA into
an independent agency; making the CDC director a Senate-confirmed position;
and reducing the number of political appointees at the selected agencies.

United States Government Accountability Office


Contents

Letter

1
Background
Selected HHS Agencies Have Several Characteristics That Can
Help Insulate against Potential Political Interference; Structural
Reforms May Improve Insulation
Agency Comments and Our Evaluation

5
12
25

Appendix I

Objective, Scope, and Methodology

28

Appendix II

Structural Characteristics in Place at Selected Department of Health
and Human Services (HHS) Agencies

35

Appendix III

Comments from the Department of Health and Human Services

52

Appendix IV

GAO Contact and Staff Acknowledgments

55

Tables
Table 1: Categories and Examples of Structural Characteristics
from the Sourcebook of United States Executive
Agencies, 2nd Edition
Table 2: Political Appointee Positions at Selected Department of
Health and Human Services Agencies
Table 3: Structural Characteristics at Selected Department of
Health and Human Services (HHS) Agencies – General
Information
Table 4: Structural Characteristics at Selected Department of
Health and Human Services (HHS) Agencies –
Leadership Structure and Agency Head Selection and
Retention
Table 5: Structural Characteristics at Selected Department of
Health and Human Services (HHS) Agencies – Limitations
on Agency Appointments and Removals
Table 6: Structural Characteristics at Selected Department of
Health and Human Services (HHS) Agencies – Political
Appointees and Agency Personnel

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11
15
37

39
41
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Table 7: Structural Characteristics at Selected Department of
Health and Human Services (HHS) Agencies – Features
Insulating Agency Policy from the President
Table 8: Structural Characteristics at Selected Department of
Health and Human Services (HHS) Agencies – Features
Insulating Agency Policy from Congress
Table 9: Structural Characteristics at Selected Department of
Health and Human Services (HHS) Agencies –
Government-Wide Management and Transparency Laws
Table 10: Structural Characteristics at Selected Department of
Health and Human Services (HHS) Agencies – Advisory
Committees, Rulemaking, and Adjudication

46
47
49
50

Figures
Figure 1: Mission, History, and Organizational Structure of
Selected Department of Health and Human Services
(HHS) Agencies
Figure 2: Number of Political Appointees at Selected Department
of Health and Human Services Agencies, September
2008-September 2022

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GAO-23-105415 CARES Act


Abbreviations
ASPR
CDC
COVID-19
FDA
HHS
NIH
OMB

Administration for Strategic Preparedness and Response
Centers for Disease Control and Prevention
Coronavirus Disease 2019
Food and Drug Administration
Department of Health and Human Services
National Institutes of Health
Office of Management and Budget

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GAO-23-105415 CARES Act


Letter

441 G St. N.W.
Washington, DC 20548

December 15, 2022
Congressional Addressees
Department of Health and Human Services (HHS) agencies—including
the Centers for Disease Control and Prevention (CDC), the Food and
Drug Administration (FDA), the National Institutes of Health (NIH), and
the Administration for Strategic Preparedness and Response (ASPR)—
have been at the forefront of the federal government’s response to the
COVID-19 pandemic since the President declared it a national
emergency on March 13, 2020. 1 Recent reports from GAO and others
have identified shortcomings in this response, including allegations of
political interference, or political involvement that sought to undermine an
agency’s impartiality, nonpartisanship, and professional judgment. 2
In January 2022, we added HHS’s leadership and coordination of public
health emergencies, such as the COVID-19 pandemic, to our High Risk
List after our prior work identified persistent deficiencies in HHS’s

1On July 22, 2022, the Secretary of Health and Human Services removed the Office of the

Assistant Secretary for Preparedness and Response from the HHS Office of the Secretary
and created a new operating division in the department, to be known as the Administration
for Strategic Preparedness and Response (ASPR). In this report, we refer to ASPR under
the new organizational name and structure, though our review was conducted primarily
when the previous organizational structure was in place.

2For the purposes of this report, we adapted a definition of “political interference” from a

2017 report by the National Academies of Sciences, Engineering, and Medicine that
states that undue external influences are those from outside an agency that seek to
undermine its impartiality, nonpartisanship, and professional judgment. See National
Academies of Sciences, Engineering, and Medicine, Principles and Practices for a Federal
Statistical Agency: Sixth Edition. (Washington, D.C.: 2017). According to the National
Academies of Sciences, Engineering, and Medicine, its mission is to provide independent,
objective analysis and advice to the nation, including the federal government, and it
conducts other activities to solve complex problems and inform public policy decisions.
Midway through our review, in January 2022, the Scientific Integrity Fast-Track Action
Committee (interagency task force) of the National Science and Technology Council
published a report that defined “interference” to mean inappropriate, scientifically
unjustified intervention in the conduct, management, communication, or use of science.
The report further defined “political interference” to mean interference conducted by
political officials or motivated by political considerations. Scientific Integrity Fast-Track
Action Committee of the National Science and Technology Council, Protecting the
Integrity of Government Science, (January 2022). We did not use this definition for the
purposes of our review.

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GAO-23-105415 CARES Act


preparedness and response efforts. 3 Additionally, in April 2022, we
reported that agency respondents from CDC, FDA, and NIH told us that
they observed instances of potential political interference that may have
compromised the scientific integrity of certain aspects of the COVID-19
pandemic response. 4
Federal agencies have certain policies, characteristics, and design
features that can help insulate them from political interference. For
example, since 2007, Congress and multiple administrations have taken
actions to protect the integrity of federal science agencies by ensuring
that they have policies and procedures in place that protect against the
suppression or alteration of scientific findings for political purposes. 5
Additionally, agencies have features that may affect their independence
and accountability, according to various U.S. government reports and
political science literature. 6 For example, according to the Administrative
3The High Risk List is a list of federal programs and operations that are vulnerable to

fraud, waste, abuse, and mismanagement, or need transformation. See GAO, COVID-19:
Significant Improvements Are Needed for Overseeing Relief Funds and Leading
Responses to Public Health Emergencies, GAO-22-105291. (Washington, D.C.: Jan. 27,
2022).

4See GAO, Scientific Integrity: HHS Agencies Need to Develop Procedures and Train

Staff on Reporting and Addressing Political Interference, GAO-22-104613. (Washington,
D.C.: Apr. 20, 2022). For the purposes of GAO-22-104613 and this report, the term
“scientific integrity” refers to the use of scientific evidence and data to make policy
decisions that are based on established scientific methods and processes and are not
inappropriately influenced by political considerations. When appropriate, these decisions
are then shared openly with the public.

5For example, the America COMPETES Act of 2007 required the Director of the Office of

Science and Technology Policy to ensure that all civilian federal agencies that conduct
scientific research develop policies and procedures for the public release of data and
results of research conducted by their scientists. Pub. L. No. 110-69, § 1009, 121 Stat.
572, 581-82 (2007) (codified at 42 U.S.C. § 6620). Since 2009, multiple administrations
have provided executive departments and agencies with a range of guidance for ensuring
scientific integrity, such as principles for ensuring scientific integrity in agency culture,
public communications, and professional development.

6See, for example, Marshall J. Breger and Gary J. Edles, Independent Agencies in the

United States: Law, Structure, and Politics (New York: Oxford University Press, 2015);
and K. Datla and R. L. Revesz, “Deconstructing Independent Agencies (and Executive
Agencies), Cornell Law Review, vol. 98, no. 4 (2013): 769.
One expert we spoke with noted that no agency is fully insulated from political influence or
unaccountable to the political system. Instead, agency insulation from political interference
may be viewed as a continuum, depending on how much presidential or congressional
influence is present within an agency.

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Conference of the United States’ Sourcebook of United States Executive
Agencies (Sourcebook), the structural characteristics of agencies related
to their organization and design can affect the degree of agency
autonomy from political influences, including both the legitimate exercise
of the President’s and Congress’s constitutional duties and political
interference. 7 Agency features that allow for presidential and
congressional influence, such as appointments, removals, and
appropriations, can also help provide for agency accountability to elected
officials. Conversely, structural features that enhance agency autonomy
from the President and Congress may also help insulate it from potential
political interference.
You asked us to review structural protections against political interference
at selected HHS agencies. 8 In addition, the CARES Act directs us to
monitor and oversee the federal government’s efforts to prepare for,
respond to, and recover from the pandemic. 9 This report examines the
key characteristics that can help insulate agencies from political
interference and describes the structural characteristics that the selected

7J. Selin and D. Lewis, Sourcebook of United States Executive Agencies (Second Edition)

(Washington, D.C.: Administrative Conference of the United States, October 2018). See
https://www.acus.gov/research-projects/sourcebook-united-states-executive-agenciessecond-edition. Accessed December 1, 2022. The Administrative Conference of the
United States is an independent federal agency charged with convening expert
representatives from the public and private sectors to promote efficiency, participation,
and fairness in the promulgation of federal regulations and in the administration of federal
programs.

The U.S. government is comprised of three coequal branches—legislative, executive, and
judicial—that have constitutional duties to supervise and direct the operations of federal
agencies. For example, Presidents execute federal laws by directing agency activities,
and Congress oversees the execution of laws by creating and funding federal programs
and agencies. See U.S. Const. art. I, §§ 8, 9; and art. II, § 3.
8GAO has ongoing work to examine selected HHS agencies’ experiences with political

interference under our CARES Act mandate. We will report on these findings in a future
report.

9Pub. L. No. 116-136, § 19010, 134 Stat. 281, 579-81 (2020). In addition to our reports on

individual programs, we have regularly issued government-wide reports on the federal
response to the COVID-19 pandemic. For the latest report, see GAO, COVID-19: Current
and Future Federal Preparedness Requires Fixes to Improve Health Data and Address
Improper Payments, GAO-22-105397 (Washington, D.C.: Apr. 27, 2022). All of these
reports are available on GAO’s website at https://www.gao.gov/coronavirus.

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HHS agencies have in place. 10 We focused on four agencies within HHS
that have played key roles in the public health response to the COVID-19
pandemic: CDC, FDA, NIH, and ASPR.
To address this objective, we examined the Sourcebook, which provides
a comprehensive list of structural characteristics and describes how they
may affect political interference and agency responsiveness to political
officials. We determined the extent to which the characteristics identified
in the Sourcebook as helping to insulate agencies from political
interference were in place at the selected agencies. To determine which
characteristics were in place, we reviewed agency statutes and public
laws; the House Committee on Oversight and Reform, United States
Government Policy and Supporting Positions (Plum Book); the Federal
Advisory Committee Act database; other U.S. government sources; and
agency written responses. We also reviewed relevant federal guidance on
scientific integrity as well as HHS’s scientific integrity policy, and agencyspecific scientific integrity policies and procedures. 11
To obtain perspectives about scientific integrity and political interference
at the selected agencies and ideas for structural reforms, we spoke
individually with a bipartisan selection of 10 former agency heads—at
least one from each of the selected agencies. We also spoke with current
and former senior agency officials; when referring to these interviewees,
we use the term “senior agency official.” In addition, we conducted
interviews with 16 employees, including managers and non-managers,
from three of the four selected agencies—CDC, FDA, and NIH. 12 When
reporting our results, we use the term “respondent” to refer to an
employee we interviewed as part of our semi-structured interview
10In April 2022, we issued a related report on scientific integrity at FDA, CDC, NIH, and
ASPR, which examined (1) the procedures in place at the selected agencies to address
allegations of political interference in scientific decision-making and the extent to which
agencies received such allegations and (2) available training provided by the selected
agencies on scientific integrity policies and procedures, including those related to political
interference. See GAO-22-104613.
11See HHS, Policies and Principles for Assuring Scientific Integrity, (March 2012).
12ASPR was excluded from this methodology because at the time of this review, it
followed HHS’s Policies and Principles for Assuring Scientific Integrity and did not have its
own scientific integrity policy. “Managers” include senior management at the
subcomponent, typically a branch chief or director. “Non-managers” include all personnel
in a subcomponent that are directly involved in carrying out the scientific mission of the
subcomponent, including employees with supervisory experience and employees with
non-supervisory experience.

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methodology. 13 For more information on our objective, scope, and
methodology, see appendix I.
We conducted this performance audit from October 2020 to December
2022 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit to
obtain sufficient, appropriate evidence to provide a reasonable basis for
our findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our findings
and conclusions based on our audit objective.

Background

HHS and Selected
Agencies

HHS’s mission is to enhance the health and well-being of all Americans
by supporting sound, sustained advances in the sciences underlying
medicine, public health, and social services. Within HHS, the four
selected agencies have distinct missions, histories, and organizational
structures (see fig. 1).

13Our results from these interviews represent the views of those who provided information
and are not generalizable to any other employees.

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Figure 1: Mission, History, and Organizational Structure of Selected Department of Health and Human Services (HHS)
Agencies

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Notes:
a
See Pub. L. No. 102-531, § 312, 106 Stat. 3469, 3504-06. Ten HHS offices and agencies, including
ASPR, CDC, FDA, and NIH, are designated components of the U.S. Public Health Service.
b
In August 2022, CDC announced a plan to reorganize the agency’s structure to prioritize public
health needs and efforts to curb continuing outbreaks. Among others things, preliminary actions
include restructuring the agency’s communications office, creating a new executive council, and
establishing an office of intergovernmental affairs.
c

See Pub. L. No. 59-384, 34 Stat. 768.
See Health Research Extension Act of 1985, Pub. L. No. 99-158, 99 Stat. 820.

d

See Pub. L. No. 109-417, § 102, 120 Stat. 2831, 2832-34 (2006).

e

COVID-19 Pandemic
Response

HHS is the federal department responsible for leading and coordinating
the federal public health and medical response to emergencies and
disasters. 14 Throughout the COVID-19 pandemic response, HHS and its
agencies have coordinated with federal, state, local, tribal, and territorial
governments, as well as public and private partners, to: develop
diagnostic tests; collect and report COVID-19 indicator data; and support
the development, manufacturing, and distribution of vaccines and
therapeutics to prevent and treat COVID-19. Selected HHS agencies
have, in some cases, adopted certain operating postures and procedures
to respond to the COVID-19 pandemic. 15
•

CDC. CDC employs a centralized Incident Management System
within its Emergency Operations Center for the COVID-19 agencywide response to allow for the coordination of resources, information,
and experts. 16 The Incident Management System is comprised of task
force teams focused on different areas of the response, such as
epidemiology and surveillance, or data and analytics, according to
CDC officials.

•

FDA. FDA facilitates patient access to medical products—including
drugs, biologics, and medical devices—used to prevent, treat, or

14HHS is the lead agency for the public health and medical services functions of the
National Response Framework, a guide issued by the Department of Homeland Security
that dictates how the nation responds to all types of disasters and emergencies. The
Federal Emergency Management Agency leads the overall framework, thereby leading
the federal response during such emergencies and disasters.
15Certain agencies, such as ASPR, did not change their standard operating procedures as
part of their COVID-19 pandemic response.
16According to CDC, an Incident Management System is a temporary, formal organization

structure that is activated to support a response, adjusted to meet rapidly changing
demands of that response, and then disbanded at the end of the response.

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diagnose COVID-19, such as through emergency use authorizations,
in addition to the traditional approval process. 17
•

NIH. NIH supports the development of COVID-19 vaccines and
treatments by creating and distributing testing products and
supporting research, including executing and funding COVID-19related clinical trials to assess the safety and efficacy of vaccines and
therapeutics.

•

ASPR. ASPR serves as the principal advisor to the Secretary of
Health and Human Services on all matters related to the federal public
health and medical response to public health emergencies, such as
COVID-19. It also oversees the Strategic National Stockpile, which
contains medical countermeasures—including drugs, vaccines,
supplies, and other materials—to respond to a broad range of public
health emergencies.

In addition to the efforts taken by HHS and its agencies, the COVID-19
pandemic response has required support from the existing federal public
health emergency systems and structures, as well as from new entities
and processes created within the Executive Office of the President. For
example, the White House Coronavirus Task Force was established in
January 2020 to coordinate a whole-of-government approach during the
Trump administration. Since the Biden administration took office in
January 2021, the White House COVID-19 Response Team has been
responsible for coordinating across the federal government on the
COVID-19 response and for communicating to the public and other
stakeholders about these efforts. Additionally, the Office of Management
and Budget’s (OMB) Office of Information and Regulatory Affairs
developed expedited interagency review procedures for rulemaking and
guidance related to the COVID-19 pandemic to ensure a coordinated
federal response. 18

17Typically, FDA must approve, license, or clear a new product before it can be marketed
in the United States. See 21 U.S.C. § 355 (drugs); 21 U.S.C. § 360e(c) and 360(k)
(devices); and 42 U.S.C. § 262 (biologics). However, during an emergency, FDA may
temporarily allow the use of a product that has not been approved, licensed, or cleared by
issuing an emergency use authorization, provided certain statutory criteria are met. See
21 U.S.C. § 360bbb-3.
18See Office of Management and Budget, Promoting Public Trust in the Federal
Government and Effective Policy Implementation through Interagency Review and
Coordination of the American Rescue Plan Act, M-21-24, (Apr. 26, 2021).

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Scientific Integrity

In 2012, HHS issued a scientific integrity policy that describes principles
designed to ensure the integrity of scientific and scholarly activities that
the department conducts and supports, and the science it uses to inform
management and public policy decisions. 19 As of September 2022, HHS
was updating this policy in response to direction from the Executive Office
of the President. Specifically, a 2021 presidential memorandum included
requirements for heads of agencies to take certain actions to strengthen
scientific integrity, including developing and publishing procedures for
implementing the agency’s scientific integrity policy, as appropriate and
consistent with applicable law. 20 The 2021 presidential memorandum also
directed the White House’s Office of Science and Technology Policy to
convene an interagency task force to conduct a review of the
effectiveness of agency scientific integrity policies and publish a report on
its findings, which was issued by the resulting task force in January
2022. 21 At the time of our review, agency implementation of the

OMB oversees the implementation of the President’s policy, budget, management, and
regulatory objectives. Among other functions, OMB is responsible for budget development
and execution, coordination and review of all significant federal regulations from executive
agencies, and clearance and coordination of legislative and other materials, such as
agency testimony, legislative proposals, and other communications with Congress, across
executive departments and agencies.
19See HHS, Policies and Principles for Assuring Scientific Integrity (March 2012). The

policy also allows HHS agencies to develop their own complementary policies, but does
not require them to do so. CDC, FDA, and NIH developed agency-specific scientific
integrity policies, which are being updated, as of September 2022, in response to direction
from the Executive Office of the President. At the time of our review, ASPR relied on
HHS’s scientific integrity policy, though agency officials told us that it would consider
developing an agency-specific scientific integrity policy as part of its transition to an
operating division.

20The White House, Memorandum on Restoring Trust in Government Through Scientific
Integrity and Evidence-Based Policymaking (January 27, 2021).
21 Scientific Integrity Fast-Track Action Committee of the National Science and
Technology Council, Protecting the integrity of Government Science, (January 2022).

Among other things, the report identified additional scientific integrity principles, such as
considering violations of scientific integrity to be similar in importance to violations of
government ethics, with comparable consequences. The report stated that the interagency
task force will begin developing a framework to support regular assessment and iterative
improvement of agency scientific integrity policies. Heads of agencies are to ensure that
their scientific integrity policies reflect the findings of the report and the requirements
outlined in the framework. At the time of our review, officials from the Office of Science
and Technology Policy told us that the framework would be issued in fall 2022.

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approaches outlined in the January 2021 memorandum and January
2022 report were ongoing, according to agency officials.

Structural Characteristics

According to the Sourcebook, certain structural characteristics can help
insulate agencies from political interference from:
•

the President (and the administration), such as limitations on the
appointment and removal of agency leaders and number of political
appointees at an agency; and

•

Congress, such as agency authority to collect fees to finance its
programs and activities.

The Sourcebook provides a comprehensive list of over 60 structural
characteristics and describes how these characteristics may affect
agency autonomy, or lack thereof, over personnel, policy, finances, and
decision-making (see Table 1). 22

22The Sourcebook describes these structural characteristics for over 270 federal

agencies, including six components of the Executive Office of the President; 15 executive
departments and 173 bureaus within those departments; and 78 agencies outside of the
Executive Office of the President and executive departments and two bureaus within
those agencies.

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Table 1: Categories and Examples of Structural Characteristics from the Sourcebook of United States Executive Agencies,
2nd Edition
Category

Description

General Informationa

This category has 10 characteristics that describe general information about an agency. These
characteristics can affect an agency’s independence or responsiveness to the President and Congress.
Example characteristics include:
•
Agency location (executive department, etc.);
•
Date the agency was created; and
•
Whether the agency is established in statute.

Leadership Structure
and Agency Personnel

This category has 35 characteristics related to agency leaders and personnel. These characteristics can
affect a president’s ability to influence who leads and operates the agency.b
Example characteristics include:
•
Number of political appointees;
•
Limits on the appointment and removal of agency leaders; and
•
Limits on the selection and retention of agency leaders.

Features Insulating
Agency Policy

This category has eight characteristics related to agency policy-making and resources. These
characteristics can affect presidential and congressional influence over agency actions and priorities.
Example characteristics include:
•
Office of Management and Budget review of agency budget, rules, and communications with
Congress;
•
Agency self-funding authority (e.g. authority to collect fees in addition to regular appropriations); and
•
Statutory mandates for select agency reports to Congress.

Other Key Structural
Features

This category has 11 characteristics related to an agency’s administrative and decision-making
processes. These characteristics can affect an agency’s independence or responsiveness to the
President and Congress.
Example characteristics include:
•
Advisory committees;
•
Agency-wide management and transparency positions (Chief Information Officer, Inspector General,
etc.); and
•
Adjudication authority (e.g. agency can conduct or hold hearings).

Source: J. Selin and D. Lewis, Sourcebook of United States Executive Agencies (Second Edition) (Washington, D.C.: Administrative Conference of the United States, October 2018). | GAO-23-105415

Notes:
a
In the Sourcebook of United States Executive Agencies, what we are referring to as the General
Information category is called “Housekeeping Variables.”
b
For the most part, structural characteristics in this category can help insulate an agency from political
interference from the President. However, some characteristics in this category also have implications
for congressional influence because they can affect the level of congressional input into the selection
of agency leaders, such as whether an agency head is Senate-confirmed.

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Selected HHS
Agencies Have
Several
Characteristics That
Can Help Insulate
against Potential
Political Interference;
Structural Reforms
May Improve
Insulation
Selected HHS Agencies
Have Several Structural
Characteristics That Can
Help Insulate against
Potential Political
Interference

Of the structural characteristics identified in the Sourcebook as helping
insulate agencies from political interference, the selected HHS agencies
had at least one in place in each of the General Information, Leadership
Structure and Agency Personnel, and Other Key Structural Features
categories. 23 We describe below several examples of structural
characteristics that the selected agencies have or, in most cases, do not
have in place and how these characteristics can relate to political
interference. 24 We also describe other characteristics—such as agency
policies and procedures that support a culture of scientific integrity—that
senior agency officials and agency respondents we spoke with told us
can help insulate agencies from political interference. See appendix II for
the full list of structural characteristics for each agency.

General Information

Of the 10 structural characteristics in this category that describe general
information about the selected agencies, it is most noteworthy that all of
the selected agencies are located in an executive department. As a
23We group the structural characteristics into four categories identified from the
Sourcebook: (1) General Information; (2) Leadership Structure and Agency Personnel; (3)
Features Insulating Agency Policy; and (4) Other Key Structural Features.
24The total number of structural characteristics for the selected agencies is not indicative

of greater insulation from political interference. For example, in some cases, the absence
of certain characteristics or data associated with certain characteristics can help insulate
agencies from political interference, such as the number of political appointees at an
agency. In addition, some characteristics, such as the agency’s location in the federal
government, affect which other characteristics are relevant, and, as a result, no agency
can have all possible characteristics. Finally, some characteristics can help insulate
agencies from political interference from one political actor (e.g., Congress or the
President) relative to another, such as whether an agency’s leader is Senate-confirmed.

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result, the selected agencies do not have many of the characteristics that
can help insulate them from political interference from the President and
Congress compared to independent agencies, such as the Federal
Reserve. For example, the selected agencies do not have many of the
characteristics that can limit the President’s influence over agency
leaders and policy, such as limits on the removal of agency leaders.
In contrast, the Federal Reserve has several structural characteristics that
the Sourcebook identifies as increasing independence from executive
control and insulation from political interference. For example, the Federal
Reserve System is governed by a multi-member body (i.e., Board of
Governors) rather than a single agency head, and its members are
appointed to fixed, staggered terms (14 years). 25
According to the Sourcebook, agencies located in executive departments,
like HHS, generally have fewer characteristics that can help insulate them
from political interference compared to independent agencies because, in
many cases, Congress designed independent agencies to be expert and
insulated from politics. In addition, being an agency located in a larger
department, such as HHS, can also increase opportunities for political
interference because the agency may normally receive direction from the
department secretary (a political appointee) and may have to obtain
department-level approval before making certain policy changes, based
on our review of the Sourcebook, a political science article, and an
interview with a former FDA commissioner.

Leadership Structure and
Agency Personnel

Of the 35 structural characteristics in this category, NIH had three; CDC
and FDA both had two; and ASPR had one. 26 Of note, three of the four
selected agencies have a statutory mandate that the President, with the
advice and consent of the Senate, appoints the agency leader.
Specifically, FDA, NIH, and ASPR have leaders that are selected by the
President and confirmed by the Senate, whereas the CDC director does
not require Senate confirmation. 27 A former FDA commissioner told us
25See 12 U.S.C. § 242.
26We excluded 14 characteristics from our count. Specifically, we excluded eight

characteristics related multimember commissions and board of directors because they
were not applicable to the selected agencies. We also did not consider as part of our
count six other characteristics because they described the number of employees and
political appointees at the agency.

27See 21 U.S.C. § 393(d)(1) (FDA), 42 U.S.C. § 282(a) (NIH), and 42 U.S.C. § 300hh-

10(a) (ASPR). In contrast to the other three agencies, CDC and the position of CDC
director are not explicitly established in statute.

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that, in their opinion, Senate-confirmed agency heads, like the FDA
commissioner, are more protected from political interference. For
example, it may be more politically difficult to remove Senate-confirmed
agency heads, particularly those confirmed with bipartisan support.
In general, agency leadership is one area in which the selected agencies
have few, if any, structural characteristics that can help insulate them
from political interference. Specifically the selected agencies have few
characteristics that place limits on the appointment, removal, selection,
and retention of agency leaders. For example, the selected agencies do
not have statutory mandates that fix the term, or length, of the
appointment of agency leaders or require that they have specific
qualifications, such as health care or scientific expertise. According to the
Sourcebook, characteristics related to agency leadership can help
insulate agencies from presidential interference because they can affect
the degree of influence the President has over agency leaders.
Relatedly, the selected agencies each have between two and five political
appointees serving in key senior leadership and policy positions, which
can increase presidential control over agencies. 28 Specifically, political
appointees—who generally serve at the pleasure of the President—can
make and advocate for agency policy on behalf of an administration.
According to the Sourcebook, agencies with more political appointees are
more likely to be responsive to the White House and subject to partisan
politics. From 1960 to 2008, the number and percentage of political
appointees have almost doubled, driven, in part, by political actors
seeking to gain greater control over federal policy-making, according to
the Sourcebook. Of the selected agencies, ASPR has the largest number
of political appointees with five, while CDC has the least with two (see
Table 2). In addition, the numbers of political appointees increased from
2016 through 2020 at CDC, FDA, and ASPR, but has since declined at
CDC and FDA as of 2022; the number of political appointees at NIH has
varied over time (see fig. 2).

28There are four major categories of political appointees: presidential appointees with
Senate confirmation; presidential appointees; non-career employees in the Senior
Executive Service; and Schedule C employees. In 2019, GAO identified about 4,000
political appointee positions from these four major categories across the entire executive
branch as of June 30, 2016. For more information on government-wide political
appointees, see GAO, Federal Ethics Programs: Government-wide Political Appointee
Data and Some Ethics Oversight Procedures at Interior and SBA Could Be Improved,
GAO-19-249 (Washington, D.C.: Mar. 14, 2019).

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Table 2: Political Appointee Positions at Selected Department of Health and Human Services Agencies
Agency

Positions Held by Political Appointees

Total Number of
Agency Employees

Centers for Disease Control
and Prevention (CDC)

CDC Director
Senior Counselor (as of August 2022)

12,952
(as of August 2022)

Food and Drug
Administration (FDA)

Commissioner of Food and Drugs (FDA Commissioner)
Deputy Commissioner for Policy, Legislation, and International Affairs
Associate Commissioner for External Affairs (as of September 2022)

National Institutes of Health
(NIH)

NIH Director (vacant since December 2021)
National Cancer Institute Director
Senior Director (as of August 2022)

Administration for Strategic
Assistant Secretary for Preparedness and Response
Preparedness and Response Chief of Staff
(ASPR)
Chief Strategy Officer
Senior Policy Advisor for COVID Response (2 total)
(as of September 2022)

17,868
(as of September 2022)
18,927
(as of August 2022)
984
(as of September 2022)

Source: GAO analysis of data from CDC, FDA, NIH, and ASPR officials. | GAO-23-105415

Note: The political appointee positions identified for each agency include four types of appointments:
presidential appointees with Senate confirmation; presidential appointees; non-career employees in
the Senior Executive Service; and Schedule C employees. Vacant positions are included in the count.

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Figure 2: Number of Political Appointees at Selected Department of Health and Human Services Agencies, September 2008September 2022

Note: The Senate Homeland Security and Governmental Affairs Committee and the House
Committee on Oversight and Reform publish the Plum Book every 4 years. The Plum Book is

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generally published in December after the presidential election and is based on agency data reported
to the Office of Personnel Management as of the June prior to the election.
The total number of political appointees for each year is comprised of four types of appointments
identified in the Plum Book: presidential appointees with Senate confirmation; presidential
appointees; non-career employees in the Senior Executive Service; and Schedule C employees.
Vacant positions are included in the count.

A former NIH director told us that an agency’s political appointees play an
important role by serving as coordinators between the agency and the
administration, as well as the agency’s touchpoint to Congress. However,
the former director stated that the relatively small number of political
appointees at NIH helps protect the agency from political interference.
Additionally, the former director said that, over time, the executive branch
has sought to gain more control over agencies, with the exception of NIH,
through the use of political appointees. As such, the former NIH director
believed that other agencies, such as FDA and CDC, have a harder time
protecting against political interference, because they have more
positions staffed by political appointees.
In contrast, the selected agencies have other structural characteristics in
place related to agency personnel that can help insulate them from
political interference. These include fixed terms for the appointment of
agency officials other than the agency head or statutory authority to hire
for select scientific or technical positions outside federal civil service
requirements. 29 According to the Sourcebook, these characteristics can
help insulate agencies from political interference from the President
because they limit presidential influence over the removal and selection of
agency leaders, including those responsible for leading scientific work.
Additionally, differing authorities for agency personnel can make it more
difficult for the President or Congress to direct agency policy.
For example, NIH institute and center directors, such as the director of
the National Institute of Allergy and Infectious Diseases, are appointed to
5-year terms, although there are no limits on the number of
reappointments an institute and center director may serve. 30 In addition,
29There are a number of statutory authorities to expedite the hiring process for federal
employees or to achieve certain public policy goals. For example, provisions under Title
42 of the U.S. Code provide authority for HHS to hire individuals to fill mission critical
positions in science and medicine. For additional information, see GAO, Federal Hiring:
OPM Needs to Improve Management and Oversight of Hiring Authorities, GAO-16-521
(Washington, D.C.: Aug. 2, 2016).
30See 42 U.S.C. § 284(a)(2).

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the Secretary of Health and Human Services may hire “outstanding and
qualified” candidates to scientific and technical positions in FDA that
support the development, review, and regulation of medical products
without regard for certain civil service provisions. 31

Features Insulating Agency
Policy

Of the eight structural characteristics in this category, FDA had two; CDC
and NIH both had one; and ASPR had none. 32 Of note, the selected
agencies had none of the characteristics that the Sourcebook identifies as
potentially helping to insulate policy-making from political interference by
the President, such as those related to bypassing OMB review. For
example, all of the selected agencies must submit their budgets,
significant rules, and communications with Congress to HHS for
department-level review, and then to OMB for review by the
administration. 33 According to the Sourcebook, bypassing OMB review
can help insulate agencies from political interference because it limits the
President’s control over agency resources, budget execution, and policymaking.

Other Key Structural Features

Of the 11 structural characteristics in this category, FDA and NIH had
eight, CDC had seven, and ASPR had five. Of note, all the agencies had
at least one structural characteristic related to advisory committees and
rulemaking, which can help insulate them from political interference in
agency decision-making. For example, advisory committees can help
insulate agencies from political interference by allowing external actors,
such as scientific experts and researchers, to advise on agency decisionmaking, based on our review of a political science article. However, CDC
officials told us that, during an emergency response, when the need for
rapid information is heightened, quickly convening external experts
through a formal process may not be feasible.

31For example, the FDA commissioner has the authority to determine and set the pay rate
of these positions, notwithstanding any requirements related to pay rates set by the Office
of Personnel Management. See 21 U.S.C. § 379d-3a(b).
32We did not consider as part of our count two characteristics because they described the

extent of certain aspects of congressional oversight for the selected agencies. Specifically,
we excluded the number of statutorily mandated recurring agency reports to Congress
and the number of committees specified by statute as overseeing the agency.

33See Office of Management and Budget, Circular No. A-11 Preparation, Submission, and
Execution of the Budget (August 2021); Exec. Order No. 12866, Regulatory Planning and
Review, 58 Fed. Reg. 51,735 (Oct. 4, 1993); and Office of Management and Budget,
Circular No A-19 Legislative Coordination and Clearance (September 1979).

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A former NIH director told us that advisory committees help protect
against political interference, particularly with regard to controversial
research topics, because federal law helps ensure that they are
comprised of diverse members with fixed terms for their appointment. 34
These fixed terms help prevent administrations from changing the
composition of committees in their favor.
All four agencies have active advisory committees that advise on key
areas of agencies’ scientific decision-making, such as grant funding and
vaccine licensure. 35

Other Characteristics

•

NIH has the most number of active advisory committees (144), which
provide peer review of research grant applications and advise on
research programs and policy and program development for the
agency’s institutes and centers.

•

FDA has 31 advisory committees, which provide independent expert
advice on scientific, technical, and policy matters related to blood,
vaccines, and other biologics; human drugs; tobacco products; and
medical devices.

•

CDC has 20 advisory committees, which provide advice and
recommendations on a broad range of public health issues, such as
occupational and environmental health, childhood and adult
immunizations, and injury prevention and control.

•

ASPR has four advisory committees, which coordinate federal efforts
to prevent, prepare, respond, and recover from public health
emergencies or medical disasters.

Separate from structural characteristics identified in the Sourcebook,
agency policies and procedures that support a culture of scientific

34The Federal Advisory Committee Act helps assure that federal advisory committees: (1)
provide advice that is relevant, objective, and open to the public; (2) act promptly to
complete their work; and (3) comply with reasonable cost controls and record keeping
requirements. The act requires that committee memberships be “fairly balanced in terms
of the points of view represented and the functions to be performed.” See Pub. L. No. 92463, 86 Stat. 770 (1972) (codified, as amended, at 5 U.S.C. app.).
35Advisory committees at the four agencies are either established in statute or based on
agency- or department-specific general statutory authorities to create advisory
committees. For example, see 42 U.S.C. § 217a.

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integrity can also help insulate agencies from political interference. 36
According to the Scientific Integrity Fast-Track Action Committee report, a
strong organizational culture of scientific integrity is a necessary
foundation to protect agencies against inappropriate influence, including
political interference. 37 Such an organizational culture fosters open
discussion and transparent processes and promotes an awareness of,
and compliance with, scientific integrity policies by agency officials at all
levels.
Similarly, senior agency officials and agency respondents we spoke with
identified agency scientific integrity-related processes and culture as
helping insulate the selected agencies from political interference, and
described the key role that agency leaders play in protecting scientific
integrity at the selected agencies. Specifically:
•

Agency processes. Senior agency officials discussed several types
of agency scientific integrity-related processes that helped insulate
agency staff and decision-making from political interference. For
example,
•

A former FDA commissioner told us that FDA’s regulatory and
scientific processes help ensure the independence of the agency’s
career staff and help insulate the agency’s decision-making from
political pressure, particularly during emergencies, such as the
COVID-19 pandemic.

•

A former NIH director said that, in their view, of all the HHS
agencies, NIH is the most independent and protected from
political interference because of its peer-review process, which
prevents the agency’s research funding from being allocated
based on political considerations.

•

A senior CDC official told us that CDC’s clearance process for
guidance and other products helps prevent political interference

36In April 2022, we recommended that CDC, FDA, NIH, and HHS develop procedures for

reporting and addressing allegations of political interference so that employees know how
to report such allegations and the agencies have a clear, consistent process for
investigating and addressing them. See GAO-22-104613.
37Scientific Integrity Fast-Track Action Committee of the National Science and Technology

Council, Protecting the integrity of Government Science, (January 2022). The report
identified several practices that can help support scientific integrity at agencies, including:
(1) agency leadership and modeling of appropriate behaviors; (2) processes that protect
the integrity of the research process, such as peer review; (3) mechanisms for
communicating scientific information with integrity; (4) staff training on scientific integrity;
and (5) policies and procedures to safeguard against scientific integrity violations.

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and protects scientific integrity at the agency because of the large
number of people at CDC involved in the review process.

Structural Reforms May
Improve Insulation of
Selected HHS Agencies
against Potential Political
Interference in Future
Public Health
Emergencies

•

Agency culture. Current and former senior agency officials and
agency respondents with whom we spoke described how the culture
at their respective agencies helps support agency independence and
scientific integrity. For example, a former FDA commissioner told us
that the agency has a “longstanding” culture that promotes
independence, including at the senior leadership level. A respondent
from NIH said that NIH has a science-based and nonpartisan culture
at every level of the agency, including at the director level, which
helps uphold scientific integrity at the agency.

•

Agency leadership. Senior agency officials and agency respondents
told us that agency leadership also can play a key role in protecting
agencies’ scientific integrity and insulating career staff from political
interference.
•

Senior agency officials from all four agencies told us that one of
the primary responsibilities of agency heads is to ensure scientific
integrity at their agency. For example, a former CDC director said
the agency head must be the strongest advocate for practice- and
evidence-based public health policies that are supported by
science.

•

Multiple agency respondents said they believed agency leadership
shields staff from political pressure so scientists can focus on
making science-based decisions. For example, one respondent
from FDA told us scientific integrity and insulation from political
interference at FDA is contingent on having the “right” senior
leaders in place, and FDA senior leaders insulated staff from
political pressure the agency experience during the COVID-19
pandemic.

Multiple senior agency officials told us that whole-of-government
responses to public health emergencies like the COVID-19 pandemic
may create more opportunity for potential political interference. For
example, current and former senior agency officials told us that the
constantly evolving nature of the pandemic, and the critical public health
threat it posed, prompted a whole-of-government response in which
traditional agency roles and approaches to scientific decision-making
were altered. In addition, multiple senior agency officials highlighted how
the coordination and quick action required in an emergency response can
result in more political involvement in scientific decision-making than is
standard, thus creating more opportunity for political interference.

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For example, a CDC senior official stated that the unprecedented
involvement of political appointees from outside CDC in the Morbidity and
Mortality Weekly Report review process in 2020 was intended to support
a coordinated government pandemic response. 38 However, in some
cases, this involvement resulted in officials from outside of CDC
requesting that scientific findings be altered, which current and former
CDC officials felt jeopardized the publication’s scientific integrity and
public trust in its content. 39
Experts and former agency heads told us they believe certain structural
reforms may help insulate HHS agencies from political interference going
forward. Specifically, former agency heads suggested the following
structural reform ideas:
•

FDA as an independent agency. Two former FDA commissioners
told us FDA should be separated from HHS because of its regulatory
role. This echoes a proposal they developed in 2019, along with five
other former commissioners, to transform FDA into an independent
federal agency. 40 The proposal stated that greater FDA independence
could help further the agency’s ability to ensure predictable, sciencebased decision-making; promote the agency’s capacity to act swiftly in
an emergency; and enhance transparency and sustain public
confidence. However, a former FDA commissioner we spoke with said
that a potential downside to having FDA moved out of HHS would be
that it would no longer be located in the same department with other

38According to the CDC, the Morbidity and Mortality Weekly Report series is the agency’s

primary vehicle for scientific publication of timely, reliable, authoritative, accurate,
objective, and useful public health information and recommendations. Readership
predominantly consists of physicians, nurses, public health practitioners, epidemiologists
and other scientists, researchers, educators, and laboratorians.

39An October 2022 report from the Select Subcommittee on the Coronavirus Crisis found

that in 2020, senior HHS officials attempted to alter or suppress at least 19 different CDC
scientific reports, including those published in the Morbidity and Mortality Weekly Report.
See Select Subcommittee on the Coronavirus Crisis, “‘It Was Compromised’: The Trump
Administration’s Unprecedented Campaign to Control CDC and Politicize Public Health
During the Coronavirus Crisis.” (Washington, D.C.: October 2022)

40In June 2016, six former FDA commissioners publicly announced their consensus view
that FDA should be transformed into an independent federal agency. In January 2019, the
Aspen Institute published Context & Evidence: Why an Independent FDA?, a white paper
that summarized discussions with the former FDA commissioners (including a seventh,
who joined the group in 2017) on this topic. The seven FDA commissioners were: Robert
Califf, Margaret Hamburg, Andrew von Eschenbach, Mark McClellan, Jane Henney, David
A. Kessler, and Frank Young.

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public health agencies, such as NIH and CDC, with which it needs to
coordinate closely. Additionally, HHS officials told us that separating
FDA from HHS would disrupt many longstanding collaborations and
agreements that support a wide range of coordinated federal efforts,
and the department strongly disagrees with the suggestion.
•

Senate-confirmed CDC director. As of December 2022, Congress
was considering legislation that would require the CDC director be a
Senate-confirmed position. 41 CDC officials told us that the agency
does not believe this reform would be beneficial. Former CDC
directors, however, have mixed opinions about whether it would be
beneficial overall for the agency to have a Senate-confirmed
director. 42 For example, during a university-sponsored panel
discussion in April 2022, one former CDC director said that making
the position Senate-confirmed would politicize and delay the process
for selecting the CDC director. According to the former director, this
would increase the risk that individuals would be nominated to the
position for their industry or political connections rather than their
technical and public health management expertise.

•

Term appointments. A former CDC director with whom we spoke
suggested having a term appointment for the CDC director to help
insulate the position from political interference and ensure consistency
of the agency’s leadership across different administrations. A former
FDA commissioner made a similar suggestion, recommending that
the FDA commissioner be appointed to a 6-year term, so the position
is not tied to the election cycle.

•

Fewer political appointees. A former CDC director told us that, in
their view, CDC should not have any political appointees other than
the CDC director. The former director said that during the COVID-19
pandemic, political appointees at CDC undermined public trust in the
agency through their attempts to influence CDC publications. A former
FDA commissioner stated that, during their tenure at FDA, they
sought to reduce the number of political appointees by filling critical

41See PREVENT Pandemics Act, S. 3799, 117th Cong. (2022). As of December 2022,
this bill had been reported out of the Senate Committee on Health, Education, Labor and
Pensions.
42For example, see Harvard T. H. Chan School of Public Health panel discussion, “CDC at
the Crossroads,” April 5, 2022. Accessed via
https://www.hsph.harvard.edu/event/cdc-at-the-crossroads/, on April 27, 2022.

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positions, such as the agency’s general counsel, with career scientists
and practitioners. 43
In 2022, two of the selected HHS agencies began undertaking
organizational reforms to improve their response to public health
emergencies and strengthen public trust. Specifically, in July 2022, the
Secretary of Health and Human Services removed ASPR from the Office
of the Secretary and created a new operating division within HHS in an
effort to better mobilize a coordinated national response to future
disasters and emergencies. Additionally, in August 2022, the CDC
director proposed a series of organizational changes aimed at making the
agency more nimble and responsive during health emergencies, including
creating an executive council to help set agency priorities.
According to current agency officials, these reforms are designed to
improve the agencies’ response capabilities, and are not specifically
intended to address issues related to scientific integrity or strengthen
protections against political interference. However, CDC officials told us
that the implementation of some of the agency’s planned reforms, such
as moving the Office of Science, which includes the Office of Scientific
Integrity, into the Office of the Director, could strengthen the agency’s
scientific integrity efforts. At the time of this review, officials from all of the
selected HHS agencies told us that they were not considering reviewing
and implementing any additional structural reforms that could improve
agency insulation against potential political interference. According to the
officials, they feel that their agencies’ current plans, structure, and
processes are sufficient.
GAO will continue to examine selected HHS agencies’ experiences with
political interference during the COVID-19 response and any steps that
could be taken to strengthen protections against such interference under

43According to the Plum Book, agencies have some discretion as to the number of political
appointee positions they have. For example, agencies may request the Office of
Personnel Management to place a position in Schedule C. Schedule C positions
authorized by the Office of Personnel Management are automatically revoked when the
incumbent leaves the position. In addition, the proportion of non-career employees in the
Senior Executive Service varies by agency, generally up to a limit of 25 percent of the
agency’s number of Senior Executive Service positions. The Office of Personnel
Management approves each use of a non-career authority by an agency, and the authority
reverts to the Office of Personnel Management when the non-career appointee leaves the
position.

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our CARES Act mandate. We will report on these findings in a future
report.

Agency Comments
and Our Evaluation

We provided a draft of this report to HHS for comment. HHS provided
written comments on a draft of this report, which are reproduced in
appendix III, and technical comments, both of which we incorporated as
appropriate. In its response to our draft report, HHS stated that it is
actively working to implement the January 27, 2021, presidential
Memorandum on Restoring Trust in Government through Scientific
Integrity and Evidence-based Policymaking through the formation of a
working group that is updating HHS’s scientific integrity policy. HHS noted
that FDA, NIH, CDC, and ASPR are also actively engaged in updating the
relevant agency-specific policies and procedures and that it believes that
the “ongoing efforts to enhance scientific integrity will better protect
against political interference in scientific activities, and have fewer
negative unintended consequences, than several of the structural
changes suggested by GAO.” The proposed structural reforms that we
discuss in our report are not recommendations from GAO, but instead,
were suggestions from outside experts and former agency heads at FDA,
NIH, CDC, and ASPR and may warrant further consideration.
We will send copies of this report to the Secretary of Health and Human
Services and other interested parties. In addition, the report will be
available at no charge on GAO’s website at http://www.gao.gov .
If you or your staff have any questions about this report, please contact
me at (202) 512-7114 or at SilasS@gao.gov. Contact points for our Office
of Congressional Relations and Office of Public Affairs can be found on
the last page of this report. Other major contributors to this report are
listed in appendix IV.

Sharon M. Silas
Director, Health Care

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List of Addressees
The Honorable Patrick Leahy
Chairman
The Honorable Richard Shelby
Vice Chairman
Committee on Appropriations
United States Senate
The Honorable Ron Wyden
Chairman
The Honorable Mike Crapo
Ranking Member
Committee on Finance
United States Senate
The Honorable Patty Murray
Chair
The Honorable Richard Burr
Ranking Member
Committee on Health, Education, Labor, and Pensions
United States Senate
The Honorable Gary C. Peters
Chairman
The Honorable Rob Portman
Ranking Member
Committee on Homeland Security and Governmental Affairs
United States Senate
The Honorable Rosa L. DeLauro
Chair
The Honorable Kay Granger
Ranking Member
Committee on Appropriations
House of Representatives
The Honorable Frank Pallone, Jr.
Chairman
The Honorable Cathy McMorris Rodgers
Republican Leader
Committee on Energy and Commerce
House of Representatives

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The Honorable Bennie G. Thompson
Chairman
The Honorable John Katko
Ranking Member
Committee on Homeland Security
House of Representatives
The Honorable Carolyn B. Maloney
Chairwoman
The Honorable James Comer
Ranking Member
Committee on Oversight and Reform
House of Representatives
The Honorable Richard E. Neal
Chairman
The Honorable Kevin Brady
Republican Leader
Committee on Ways and Means
House of Representatives
The Honorable James E. Clyburn
Chairman
Select Subcommittee on the Coronavirus Crisis
Committee on Oversight and Reform
House of Representatives
The Honorable Elizabeth Warren
United States Senate
The Honorable Paul D. Tonko
House of Representatives

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Appendix I: Objective, Scope, and
Methodology
Appendix I: Objective, Scope, and
Methodology

This report examines the key characteristics that can help insulate
agencies from political interference and describes the structural
characteristics that the selected Department of Health and Human
Services (HHS) agencies have in place. 1 For the purposes of this report,
the term “political interference” refers to political influences that seek to
undermine impartiality, nonpartisanship, and professional judgment. We
adapted this definition from a 2017 report by the National Academies of
Sciences, Engineering, and Medicine, which states that undue external
influences are those from outside the agency that seek to undermine its
impartiality, nonpartisanship, and professional judgment. 2 Our definition of
political interference reflects that interference may also come from within
an agency.
The term “scientific integrity” refers to the use of scientific evidence and
data to make policy decisions that are based on established scientific
methods and processes and are not inappropriately influenced by political
considerations. When appropriate, these decisions are shared openly
with the public. We developed this definition based on our review of the
principles contained in the 2009 presidential memorandum on scientific

1In April 2022, we issued a related report on scientific integrity at the selected agencies,

which examines (1) the extent to which the selected agencies received allegations or
identified instances of political interference that compromised scientific decision making,
and the procedures that are in place to address allegations; and (2) the steps the selected
agencies have taken to train staff on their scientific integrity policies and procedures,
including political inference. See GAO, Scientific Integrity: HHS Agencies Need to Develop
Procedures and Train Staff on Reporting and Addressing Political Interference,
GAO-22-104613. (Washington, D.C.: Apr. 20, 2022).

2See National Academies of Sciences, Engineering, and Medicine, Principles and
Practices for a Federal Statistical Agency: Sixth Edition. (Washington, D.C.: 2017).

Midway through our review, in January 2022, the Scientific Integrity Fast-Track Action
Committee (interagency task force) of the National Science and Technology Council
published a report that defined “interference” to mean inappropriate, scientifically
unjustified intervention in the conduct, management, communication, or use of science.
The report further defined “political interference” to mean interference conducted by
political officials or motivated by political considerations. Scientific Integrity Fast-Track
Action Committee of the National Science and Technology Council, Protecting the
Integrity of Government Science, (January 2022). We did not use this definition for the
purposes of our review.

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Appendix I: Objective, Scope, and
Methodology

integrity and the 2010 Office of Science and Technology Policy
memorandum. 3
For our review, we selected four agencies within HHS that have key roles
in conducting and supporting scientific research, communicating
information to the public, and leading other aspects of the public health
response to the COVID-19 pandemic: the Centers for Disease Control
and Prevention (CDC), the Food and Drug Administration (FDA), the
National Institutes of Health (NIH), and the Administration for Strategic
Preparedness and Response (ASPR). 4 The news media reported
allegations of scientific integrity violations or political interference in
scientific decision-making related to the COVID-19 pandemic response at
all four agencies. 5
To identify the key characteristics that can insulate federal agencies from
political interference, we reviewed scholarly literature, policy reviews and
other sources, and interviewed two university-affiliated political science
experts. Through these steps, we identified the Sourcebook of United
States Executive Agencies (Sourcebook), which provides a
comprehensive list of over 60 structural characteristics that describe the

3The White House, Office of the Press Secretary, Scientific Integrity, Memorandum for the

Heads of Executive Departments and Agencies (Washington, D.C.: March 9, 2009), and
Office of Science and Technology Policy, Scientific Integrity, Memorandum for the Heads
of Executive Departments and Agencies (Dec. 17, 2010).

4 In July 2022, the Secretary of Health and Human Services removed ASPR from the HHS

Office of the Secretary and created a new operating division in the department, to be
known as the Administration for Strategic Preparedness and Response (ASPR). In this
report, we refer to ASPR under the new organizational name and structure, though our
review was conducted primarily when the previous organizational structure was in place.

5See, for example: Rich Mendez, “Trump officials bragged about pressuring CDC to alter

Covid reports, emails reveal,” CNBC, April 9, 2021; Katie Thomas and Sheri Fink, “F.D.A.
‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say,” The New York Times,
August 24, 2020; Jon Cohen and Meredith Wadman, “NIH’s axing of bat coronavirus grant
a ‘horrible precedent’ and might break rules, critics say,” Science, April 30, 2020; Nicholas
Florko, “An ousted vaccine agency director offers an explosive, direct allegation: Trump is
politicizing science,” STAT, April 22, 2020.

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Appendix I: Objective, Scope, and
Methodology

features and organization of federal agencies, including how these
characteristics relate to agency insulation from political interference. 6
To further assess the sufficiency of the Sourcebook for our review, we
conducted a search in the bibliographic database Scopus of political
science literature that, as of March 2021, cited the Sourcebook. Of the 40
articles that cited the Sourcebook, we reviewed 11 full articles for: (1)
alternative perspectives or criticism of the Sourcebook or the structural
characteristics identified in the report; (2) confirmation or supporting
information on the Sourcebook’s characteristics; and (3) additional
typologies or characteristics that may insulate agencies from political
interference. We determined that eight of the 11 articles were relevant to
assessing the sufficiency of the Sourcebook, and of those eight reviewed,
there were no articles that challenged the validity, criticized, or otherwise
disputed the Sourcebook. Based on our review of the selected literature,
we determined that the Sourcebook was sufficient for identifying
characteristics that scholars have recognized as potentially insulating
agencies from political interference.
To collect information on the structural characteristics in place at the four
agencies, we primarily reviewed the sources of information identified in
the Sourcebook. 7 Specifically, we reviewed the agencies’ establishing

6J. Selin and D. Lewis, Sourcebook of United States Executive Agencies (Second Edition)

(Washington, D.C.: Administrative Conference of the United States, October 2018). The
Sourcebook describes these structural characteristics for over 270 federal agencies,
including six components of the Executive Office of the President; 15 executive
departments and 173 bureaus within those departments; and 78 agencies outside of the
Executive Office of the President and executive departments and two bureaus within
those agencies.
The Sourcebook was originally commissioned by the Administrative Conference of the
United States in 2012. The Administrative Conference of the United States is an
independent federal agency charged with convening expert representatives from the
public and private sectors to promote efficiency, participation, and fairness in the
promulgation of federal regulations and in the administration of federal programs.

7Sourcebook researchers collected data on the structural characteristics from the
agency’s establishing statute; other public laws; Office of Management and Budget
circulars; the Senate Homeland Security and Government Affairs Committee, United
States Government Policy and Supporting Positions, 2016, (Plum Book); federal
workforce data from the Office of Personnel Management’s FedScope website; the
Federal Register; U.S. House of Representatives, Reports to be Made to Congress, H.R.
Doc. No. 117-4 (2021); and Office of Personnel Management information on federal
Administrative Law Judges.

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Methodology

statute; other public laws; Office of Management and Budget (OMB)
circulars; the House Committee on Oversight and Reform, United States
Government Policy and Supporting Positions (Plum Book); and the
Federal Register. In addition to these sources, we also reviewed other
agency statutes, agencies’ websites, the Federal Advisory Committee Act
database, and agency written responses to our requests for information
on select characteristics. Since CDC is not explicitly established in
statute, we reviewed statutes related to CDC’s operating divisions and
offices, as well as the agency’s role in combatting public health threats
and capabilities related to bioterrorism and public health emergencies.
To determine the reliability of political appointee data we obtained from
the Plum Book, we reviewed a prior GAO report that evaluated the
comprehensiveness and timeliness of several data sources that identified
political appointees serving in the executive branch, including the Plum
Book. The report found that political appointee data in the Plum Book are
comprehensive, but not timely. 8 To address limitations on the timeliness
of Plum Book data, we obtained the most current data on the number,
types, and position titles of political appointees from the selected
agencies. To determine the reliability of advisory committee data we
obtained from the Federal Advisory Committee Act, we reviewed the
websites of the selected agencies to verify the list and names of
committees collected from the Federal Advisory Committee Act database.
We found that information from the database on advisory committee
name, establishment authority, and status—specifically, whether the
committee was inactive—was complete and generally accurate. To
address limitations on the accuracy of the Federal Advisory Committee
The Sourcebook discussed several limitations in the data collection methodology. First,
the Sourcebook pulled information only from the establishing statute, and noted that it was
possible that other statutory provisions outside of the establishing statute impose
additional requirements on the agency or specify additional structural features of the
agency. Additionally, the Sourcebook noted that not all structural features are detailed in
statute. Agencies promulgate regulations to implement law and clarify areas where
statutory law is unclear. Agencies also clarify this uncertainty in regulation, practice, or
agency bylaws. Finally, in some cases, administrative common law adds content to what
is not explicitly included in statute.
8GAO, Federal Ethics Programs: Government-wide Political Appointee Data and Some

Ethics Oversight Procedures at Interior and SBA Could Be Improved, GAO-19-249
(Washington, D.C.: Mar. 14, 2019).

The Senate Homeland Security and Governmental Affairs Committee and the House
Committee on Oversight and Reform publish the Plum Book every 4 years. The Plum
Book is generally published in December after the presidential election and is based on
agency data reported to the Office of Personnel Management as of the June prior to the
election.

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Appendix I: Objective, Scope, and
Methodology

Act database information, we requested that the four agencies verify and
update the name, establishment authority, and operating status (active or
inactive) of the advisory committees we identified.
We met with former agency heads and external organizations to discuss
their perspectives on scientific integrity-related topics, including political
interference. We also asked their opinions about structural reforms
related to the agencies’ organization and design that could help to
insulate them from such interference. We selected former agency heads
from different Republican and Democratic administrations, including two
former CDC directors, three former FDA commissioners, the then-current
FDA Acting Commissioner, two former NIH directors, one former
Assistant Secretary for Preparedness and Response, and one former
director of the Biomedical Advanced Research and Development
Authority. We also met with other current senior agency officials to
discuss their general views on issues related to scientific integrity and
political interference within HHS. 9
We also reviewed HHS’s scientific integrity policy and agency-specific
policies related to scientific integrity, communications, and clearance
processes, and discussed the agency-specific policies with agency
officials, asked clarifying questions, and reviewed their written
responses. 10 Additionally, we met with representatives from the Brennan
Center for Justice and the Union of Concerned Scientists and reviewed
reports on scientific integrity that those organizations issued. 11
We also conducted semi-structured interviews with 16 employees, which
included managers and non-managers at three of the four selected
9We spoke with agency officials serving in both the Trump and Biden administrations, as

we conducted this audit from October 2020 to December 2022, across the change in
administrations. When referring to these interviewees, we use the term “senior agency
official.”

10HHS, Policies and Principles for Assuring Scientific Integrity, (March 2012). CDC, CDC
Guidance on Scientific Integrity, (April 2016). FDA, Scientific Integrity at FDA, Staff
Manual Guide 9001.1, (Feb. 2012). NIH, NIH Policies and Procedures for Promoting
Scientific Integrity, (Nov. 2012).
11The Brennan Center for Justice is a nonpartisan law and policy institute.

The Union of Concerned Scientists is a national nonprofit organization that combines
technical analysis and advocacy to create innovative, practical solutions for a healthy,
safe, and sustainable future.

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Appendix I: Objective, Scope, and
Methodology

agencies—CDC, FDA, and NIH. 12 Specifically, we collected information
on employee perspectives on their agency’s implementation of its
scientific integrity policy, their agency’s ability to protect against political
interference, and their familiarity or experience with instances of potential
political interference.
We used a nongeneralizable stratified purposeful sampling approach to
select participants. The strata or agency subcomponents were developed
by identifying three subcomponents—such as centers, institutes, or
offices—within each agency with a mission relevant to COVID-19
research and response. 13 Additionally, we selected some, but not all, of
our subcomponents on the basis that they were affected by alleged
political interference during the COVID-19 pandemic. 14
We selected two participants (one manager and one non-manager) from
each of our nine strata: (1) CDC’s National Center for Immunization and
Respiratory Diseases; (2) CDC’s Center for Surveillance, Epidemiology,
and Laboratory Services; (3) CDC’s Maritime Unit; (4) FDA’s Center for
Biologics Evaluation and Research; (5) FDA’s Center for Drug Evaluation
and Research; (6) FDA’s Center for Devices and Radiological Health; (7)
12A semi-structured interview methodology generally involves asking a similar set of
questions of multiple interviewees, which enable summaries of responses across
interviewees. ASPR was excluded from this methodology because it follows HHS’s
Policies and Principles for Assuring Scientific Integrity and does not have its own scientific
integrity policy principles and procedures like CDC, FDA, and NIH have. “Managers”
include senior management at the subcomponent, typically a branch chief or director.
“Non-managers” include all personnel in a subcomponent that are directly involved in
carrying out the scientific mission of the subcomponent, including employees with
supervisory experience and employees with non-supervisory experience.
13Participation in the semi-structured interviews was voluntary. Some employees at CDC,
FDA, and NIH declined to participate in the interviews. In such cases, we selected a new
potential participant. We intended to conduct a total of 18 interviews, however, none of the
employees we contacted from FDA’s Center for Biologics Evaluation and Research
accepted our invitation to participate in a semi-structured interview, bringing our total to 16
interviews.

When reporting our results, we use “respondent” to refer to an employee we interviewed
as part of our semi-structured interview methodology. When summarizing responses in
our reporting, we use the term “multiple” for instances where at least two respondents are
referenced in a statement.
14For the purposes of developing our strata, we determined that a subcomponent was
affected by alleged political interference if there were external reports from, among others,
media organizations, former HHS officials, or public interest organizations alleging political
interference in scientific decision-making.

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Methodology

NIH’s National Heart, Lung, and Blood Institute; (8) NIH’s National
Institute of Allergy and Infectious Diseases; and (9) NIH’s National
Institute of Biomedical Imaging and Bioengineering.
To build our sampling frame for selection of the participants, we used
publicly available lists of agency employees, which included managers
and non-managers. For one of our strata, we built our sampling frame
using a list of employees, which included managers and non-managers
provided to us by CDC officials. We then worked with each agency to
schedule semi-structured interviews with each of the 16 participants who
accepted our invitation to be interviewed. At the request of HHS, we
conducted the semi-structured interviews with an agency liaison present
unless the participant requested that the liaison not attend. 15 These
agency liaisons did not actively participate in any substantive part of the
discussions. Our results from these interviews represent the views of the
employees who participated and are not generalizable to any other
employees, even within our selected strata.
We conducted this performance audit from October 2020 to December
2022 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit to
obtain sufficient, appropriate evidence to provide a reasonable basis for
our findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our findings
and conclusions based on our audit objectives.

15An FDA official from FDA’s Office of the Chief Counsel also attended multiple FDA

interviews at the request of the interview participants. This official did not actively
participate in any substantive part of the discussions.

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Appendix II: Structural Characteristics in
Place at Selected Department of Health and
Human Services (HHS) Agencies
Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

The tables below describe the structural characteristics, or features
related to agency organization or design, in place at four HHS agencies:
Centers for Disease Control and Prevention (CDC), Food and Drug
Administration (FDA), National Institutes of Health (NIH), and
Administration for Strategic Preparedness and Response (ASPR). 1 We
identified these structural characteristics from the Sourcebook of United
States Executive Agencies (Sourcebook)—a report produced by the
Administrative Conference of the United States, an independent U.S.
government agency. 2 The Sourcebook describes the diversity of federal
agencies and their structural characteristics, including how these
characteristics can relate to political interference. 3 Structural
characteristics can help insulate agencies from political interference from
Congress, the President, or both because they affect, in part, the
influence Congress and the President have over an agency’s decisionmaking and its responsiveness to political officials and other
stakeholders, such as industry.
We grouped the structural characteristics in the tables below into four
categories identified from the Sourcebook: (1) General Information; (2)
Leadership Structure and Agency Personnel; (3) Features Insulating

1In July 2022, the Secretary of Health and Human Services elevated the Office of the
Assistant Secretary for Preparedness and Response from a staff division to a new
operating division in HHS, to be known as the Administration for Strategic Preparedness
and Response (ASPR). In this report, we refer to ASPR under the new organizational
name and structure, though our review was conducted primarily when the previous
organizational structure was in place.
2J. Selin and D. Lewis, Sourcebook of United States Executive Agencies (Second Edition)

(Washington, D.C.: Administrative Conference of the United States, October 2018). The
Sourcebook is the primary authoritative treatment of the structure and organization of the
federal government, based on our review of political science literature and interviews with
university-affiliated political science experts.
The Administrative Conference of the United States is an independent federal agency
charged with convening expert representatives from the public and private sectors to
promote efficiency, participation, and fairness in the promulgation of federal regulations
and in the administration of federal programs.

3The Sourcebook describes these structural characteristics for over 270 federal agencies,

including six components of the Executive Office of the President; 15 executive
departments and 173 bureaus within those departments; and 78 agencies outside of the
Executive Office of the President and executive departments and two bureaus within
those agencies.

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Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Agency Policy; and (4) Other Key Structural Features. 4 Specifically, we
described whether the selected agencies have the characteristic in place
(e.g., Yes, No) and provided additional information for selected
characteristics, such as relevant statutes pertaining to the characteristic,
as applicable. 5 See appendix I for more information about our scope and
methodology for this review.

General Information

This category comprises 10 characteristics that describe general
information about an agency. Characteristics in this category can affect
an agency’s independence or how responsive an agency is to the
President and Congress. Of note, all of the selected agencies are located
within an executive department and, as a result, have fewer
characteristics that can help insulate them from political interference,
particularly from the President, compared to independent agencies.

4In the Sourcebook, what we are referring to as the General Information category is called

“Housekeeping Variables.” For the most part, the names and descriptions of the
characteristics in the tables also derive from the Sourcebook. However, we adapted the
descriptions of some characteristics in the Other Key Structural Features category to
describe more specifically how these characteristics are reflected at the selected
agencies.

5We primarily reviewed the sources of information identified in the Sourcebook to collect

information on the structural characteristics at the selected agencies. Specifically, we
reviewed the agencies’ establishing statute; other public laws; Office of Management and
Budget (OMB) circulars; the House Committee on Oversight and Reform, United States
Government Policy and Supporting Positions (Plum Book); and the Federal Register. In
addition to these sources, we reviewed other agency statutes, agencies’ websites, the
Federal Advisory Committee Act database, and agency written responses to collect
information on select characteristics.
The total number of structural characteristics for the selected agencies is not indicative of
greater insulation from political interference. For example, in some cases, the absence of
certain characteristics or data associated with certain characteristics can help insulate
agencies from political interference, such as the number of political appointees at an
agency. In addition, some characteristics, such as the agency’s location in the federal
government, affect which other characteristics are relevant, and, as a result, no agency
can have all possible characteristics. Finally, some characteristics can help insulate
agencies from political interference from one political actor (e.g., Congress or the
President) relative to another, such as whether an agency’s leader is Senate-confirmed.

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Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Table 3: Structural Characteristics at Selected Department of Health and Human Services (HHS) Agencies – General
Information

Characteristic and Description

Centers for Disease
Control and
Prevention (CDC)

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic for
Preparedness and
Response (ASPR)

Name

Centers for Disease
Food and Drug
Control and Prevention Administration

National Institutes of
Health

Administration for
Strategic
Preparedness and
Response

Statute
Sections of the U.S. Code that
establish the agency

Nonea

21 U.S.C. § 393

42 U.S.C. § 281

42 U.S.C. § 300hh-10

Date of Creation

July 1, 1946b

June 30, 1906c

March 3, 1901d

December 19, 2006e

Executive Office of the
President
Agency is a component of the
Executive Office of the President

No

No

No

No

Exec. Dept.
Agency is an executive
department or a component of an
executive department

Yes

Yes

Yes

Yes

Bureau
Yes
Agency is a component of a larger
department or agency

Yes

Yes

Yes

Corporation
Agency is a wholly owned
government corporation

No

No

No

No

CodeRef
Yes
Agency is referenced anywhere in
the U.S. Code

Yes

Yes

Yes

StatMandate
Federal statute mandates the
establishment of the agency

Yesg

Yesh

Yesi

No (see above)

No (see above)

No (see above)

Nof

StatPermit
Nof
Federal statute permits, but does
not mandate, the establishment of
the agency
Source: GAO analysis of the U.S. Code and agency websites. | GAO-23-105415

Notes:
a
There are numerous references to the CDC in federal statute, but the agency is not expressly
established in law.
b
CDC traces its history to 1946, when the Malaria Control in War Areas program within the U.S.
Public Health Service transitioned into the Communicable Disease Center. The Preventive Health
Amendments of 1992 changed the agency’s name and all references in statute to the Centers for
Disease Control and Prevention. See Pub. L. No. 102-531, § 312, 106 Stat. 3469, 3504-06.

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Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

c
Although it was not known by its present name until 1930, FDA traces its modern regulatory
functions to the enactment of the Pure Food and Drugs Act of 1906, Pub. L. No. 59-384, 34 Stat. 768.
d
According to NIH, the founding legislation for the agency was a 1901 supplemental appropriations
act that provided funds for a laboratory within the Marine Hospital Service, predecessor agency to the
U.S. Public Health Service, to investigate infectious and contagious diseases and public health
matters. NIH’s establishing statute was enacted in 1985. See Health Research Extension Act of 1985,
Pub. L. No. 99-158, 99 Stat. 820.
e
Pandemic and All-Hazards Preparedness Act, Pub. L. No. 109-417, § 102, 120 Stat. 2831, 2832-34
(2006).

Unlike the other selected HHS agencies, CDC is not explicitly established in statute, although the
authority exists to do so. Many elements of CDC’s operations are established in statute, such as
CDC’s role in defending against and combatting public health threats and capabilities related to
bioterrorism and public health emergencies. See 42 U.S.C. § 247d-4. In addition, several of CDC’s
operating divisions and offices are explicitly authorized, such as the National Center for Health
Statistics. See 42 U.S.C. § 242k.

f

See 21 U.S.C. § 393.

g

See 42 U.S.C. § 281.

h

See 42 U.S.C. § 300hh-10.

i

Leadership Structure and
Agency Personnel

This category comprises 35 characteristics that relate to various aspects
of an agency’s leadership and personnel. 6 Characteristics in this category
and, in some cases, the absence or reduction of these characteristics,
such as the number of political appointees, can help insulate agencies
from political interference by the President because they can affect how
much influence the President has over who leads and operates the
agency. 7 Of the 35 characteristics in this category, NIH had three, CDC
and FDA had two, and ASPR had one. 8 Of note, the selected agencies
have almost none of the characteristics that can help insulate their
leaders from political interference by the President, such as those that
place limits on the appointment, removal, selection, and retention of
agency leaders.

6We excluded eight of the 35 characteristics in this category from the tables because the

selected agencies were not multimember commissions and did not have a board of
directors.

7For the most part, structural characteristics in this category can help insulate an agency
from political interference from the President. However, some characteristics in this
category also have implications for congressional influence because they can affect the
level of congressional input into the selection of agency leaders, such as whether an
agency head is Senate-confirmed.
8We excluded 14 characteristics from our count. Specifically, we excluded the eight

characteristics related to multimember commissions and board of directors because they
were not applicable to the selected agencies. We also did not consider as part of our
count six characteristics in Table 4 because they described the number of employees and
political appointees at the selected agencies.

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Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Table 4: Structural Characteristics at Selected Department of Health and Human Services (HHS) Agencies – Leadership
Structure and Agency Head Selection and Retention
Centers for Disease
Control and
Prevention (CDC)

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic
Preparedness and
Response (ASPR)

No

No

No

No

Acting Service Rulesa
No
Statute specifies that in the event
of absence, disability, or vacancy
at the position of agency head, the
President may designate an
individual to fill the vacancy

No

No

No

PAS Headb
Statute specifies that the
President, with advice and
consent of Senate, appoints the
agency head and the agency
head is not an official from
another agency

Noc

Yesd

Yese

Yesf

President Selects Chair
Statute specifies that the
President designates the agency
head but does not provide for
Senate advice and consent

No

No

No

No

Sec/Com Selects Head
No
For bureaus within larger
agencies, statute specifies that
the head of the larger organization
designates the agency head

No

No

No

Outside Head
Statute specifies that the head of
the agency is an official who also
serves in a position in the
administration that is outside of
the agency

No

No

No

No

Head Removal
Statute specifies that the head
may only be removed for
inefficiency, neglect of duty, or
malfeasance in office; or statute
specifies a term of office for the
head of the agency

No

No

No

No

Characteristic and Description
Multimember
Agency is a multimember
commission, has a board of
directors, or the like

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Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Characteristic and Description
ChairServe President
Statute specifies that head of
agency serves at the pleasure of
the President

Centers for Disease
Control and
Prevention (CDC)

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic
Preparedness and
Response (ASPR)

No

No

No

No

Source: GAO analysis of the U.S. code. | GAO-23-105415

Notes:
a
Or, statute designates a specific official within the agency who may perform the agency head’s
duties in case of absence, disability, or vacancy and does not allow for presidential designation.
b
PAS is a presidential appointment with Senate confirmation. See House Committee on Oversight
and Reform, United States Government Policy and Supporting Positions (Plum Book) (2020).
c
The PREVENT Pandemics Act, a bill introduced in March 2022, would require the CDC director to be
a Senate-confirmed position. S. 3799, 117th Cong. (2022). As of December 2022, this bill had been
reported out of the Senate Committee on Health, Education, Labor and Pensions.

See 21 U.S.C. § 393(d)(1).

d

See 42 U.S.C. § 282(a).

e
f

See 42 U.S.C. § 300hh-10(a).

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Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Table 5: Structural Characteristics at Selected Department of Health and Human Services (HHS) Agencies – Limitations on
Agency Appointments and Removals

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic
Preparedness and
Response (ASPR)

Citizen of US
No
Statute mandates that board
members or commissioners or the
agency head must be citizens of
the United States

No

No

No

Civilian
No
Statute mandates that board
members or commissioners or the
agency head must be civilians

No

No

No

Geographic
Statute places a geographic
limitation on the nomination or
selection of board members or
commissioners or the agency
head

No

No

No

No

Demographic
Statute places a demographic
limitation on the nomination or
selection of board members or
commissioners or the agency
head

No

No

No

No

Expertise
No
Statute places an expertise or
experience limitation on the
nomination or selection of
members or commissioners or the
agency head

No

No

No

Lower Level Expertisea
Statute places an expertise or
experience limitation on the
nomination or selection of
individuals below the level of
agency head

No

No

No

No

Conflict of Interestb
No
Agency statute places a conflict of
interest limitation on the
nomination or selection of
members

No

No

No

Characteristic and Description

Centers for Disease
Control and
Prevention (CDC)

Page 41

GAO-23-105415 CARES Act


Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Centers for Disease
Control and
Prevention (CDC)

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic
Preparedness and
Response (ASPR)

Congressional Input
Statute provides some
mechanism for congressional
input in the nomination process
aside from confirmation

No

No

No

No

Fixed Terms
Statute specifies a fixed term for
members, commissioners, or
agency heads

No

No

No

No

Lower Level Fixed Termsc
Yesd
Statute specifies a fixed term for
an employee of the agency other
than members, commissioners, or
agency heads

No

Yese

Nof

For Cause
No
Statute states that members of the
commission or board or the
agency head may only be
removed by the President for
“neglect of duty,” “malfeasance in
office,” “inefficiency,” or similar
language

No

No

No

ServePresident
Statute specifies that officials
serve at the pleasure of the
President

No

No

No

Characteristic and Description

No

Source: GAO analysis of the U.S. code and agency written responses. | GAO-23-105415

Notes:
a
In the Sourcebook, this characteristic is “LLExpertise.” Expertise requirements for members of
advisory commissions are excluded from this characteristic.
b
For the purposes of our review, we interpreted this characteristic to refer to members of a board of
directors, commissioners, or agency heads. Separate from any conflict of interest limitations that may
be mandated by agency statute, the executive branch ethics program is aimed at preventing conflicts
of interest on the part of executive branch employees, including agency heads. For example, political
appointees and high-ranking government officials are required to complete a public financial
disclosure report to help prevent and mitigate conflicts of interest. See GAO, Federal Ethics
Programs: Government-wide Political Appointee Data and Some Ethics Oversight Procedures at
Interior and SBA Could Be Improved, GAO-19-249 (Washington, D.C.: Mar. 14, 2019).
c
In the Sourcebook, this characteristic is “LL Fixed Terms.” Fixed terms for members of advisory
commissions are excluded from this characteristic.
d
For example, the director of CDC’s National Institute for Occupational Safety and Health is appointed
to a 6-year term, unless previously removed by the Secretary of Health and Human Services. See 29
U.S.C. § 671(b).
e
For example, certain directors of NIH’s institutes and centers are appointed to 5-year terms, but
there is no limit on the number of terms a director may serve. See 42 U.S.C. § 284(a)(2).

Page 42

GAO-23-105415 CARES Act


Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

The Secretary of Health and Human Services may appoint highly qualified individuals to scientific or
professional positions in ASPR’s Biomedical Advanced Research and Development Authority for up
to 6 years. See 42 U.S.C. § 247d-7e(c)(7)(A)(iii). However, this provision applies to the Biomedical
Advanced Research and Development Authority specifically and not to ASPR more broadly.

f

Table 6: Structural Characteristics at Selected Department of Health and Human Services (HHS) Agencies – Political
Appointees and Agency Personnel

Characteristic and Description

Centers for Disease
Control and
Prevention (CDC)

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic
Preparedness and
Response (ASPR)

PASa
Number of positions in agency
subject to presidential
appointment with Senate
confirmation

None

1b (as of September
2022)

1c (as of November
2022)

1d (as of September
2022)

NAe
Number of Senior Executive
Service general positions in
agency filled by noncareer
appointment

2f (as of August 2022)

2g (as of September
2022)

1h (as of November
2022)

2i (as of September
2022)

SchCj
Number of positions in agency
filled by Schedule C Excepted
Appointment

None

None

None

2k (as of September
2022)

PAl
Number of positions in agency
subject to presidential
appointment without Senate
confirmation that are not
noncareer SES positions or
Schedule C positions

None

None

1m (as of November
2022)

None

XSn
Number of policy and supporting
positions in the agency subject to
statutory excepted appointment
that are not PAS, NA, SC, or PA
positions

None

None

None

None

Agency-specific personnel
5 U.S.C. § 5012 excepts agency
employees from the definition of
“employee”; agency’s statute
permits the agency to use
employment systems particular to
that agency; or agency’s statute
allows a limited number of
employees to fall outside of civil
service provisions

Yeso

Yesp

Yesq

Nor

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GAO-23-105415 CARES Act


Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Characteristic and Description
Employees
Number of employees in the
agency

Centers for Disease
Control and
Prevention (CDC)

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic
Preparedness and
Response (ASPR)

12,952 (as of August
2022)

17,868 (as of
September 2022)

984 (as of September
2022)

18,927 (as of August
2022)

Source: GAO analysis of the U.S. code and data from agency officials. | GAO-23-105415

Notes:
a
PAS is a presidential appointment with Senate confirmation. See House Committee on Oversight
and Reform, United States Government Policy and Supporting Positions (Plum Book) (2020).

The political appointee in this category is the Commissioner of Food and Drugs (FDA commissioner).

b

The political appointee in this category is the NIH director. NIH officials told us that, as of August
2022, this position has been vacant since December 2021.
c

The political appointee in this category is the Assistant Secretary for Preparedness and Response.

d

NA is a noncareer political appointment. Noncareer appointees may be appointed to any senior
executive service general position. There is no requirement for competitive staffing for noncareer
appointees, but the agency head must certify that the appointee meets the qualifications
requirements for the position. See the 2020 Plum Book.
e

f

The political appointees in this category are: the CDC director; and Senior Counselor.

The political appointees in this category are: the Deputy Commissioner for Policy, Legislation, and
International Affairs; and Associate Commissioner for External Affairs.
g

The political appointees in this category is the Senior Director.

h

The political appointees in this category are: the Chief of Staff; and Chief Strategy Officer.

i

j
SchC is a Schedule C excepted political appointment. These positions are excepted from the
competitive service because of their confidential or policy-determining character. See the 2020 Plum
Book.
k

The political appointees in this category are Senior Policy Advisors for the COVID Response.

PA is a presidential appointment without Senate confirmation. See the 2020 Plum Book.

l

m

The political appointee in this category is the National Cancer Institute director.

XS is an appointment exempted by statute. See the 2020 Plum Book.

n

o
For example, the Secretary of Health and Human Services may appoint a limited number of “highly
qualified” individuals to scientific positions at CDC that have expertise in biosurveillance, as well as
other related scientific or technical fields, without regard to certain civil service provisions. See 42
U.S.C. § 247d-4(f).
p
For example, the Secretary of Health and Human Services may appoint “outstanding and qualified”
candidates to scientific positions in FDA that support the development, review, and regulation of
medical products, without regard to certain civil service provisions. See 21 U.S.C. § 379d-3a.
q
For example, the Secretary of Health and Human Services may appoint a limited number of technical
employees to positions in NIH to perform, administer, or support countermeasure research and
development activities, without regard to certain civil service provisions. See 42 U.S.C. § 247d6a(e)(1).
r
The Secretary of Health and Human Services may appoint a limited number of “highly qualified”
individuals to scientific positions in ASPR’s Biomedical Advanced Research and Development
Authority, without regard to certain civil service provisions. See 42 U.S.C. § 247d-7e(c)(7). However,
this provision applies to the Biomedical Advanced Research and Development Authority specifically
and not to ASPR more broadly.

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GAO-23-105415 CARES Act


Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Features Insulating
Agency Policy

This category comprises eight characteristics that relate to various
aspects of agency policy-making and resources. Characteristics in this
category can help insulate agencies from political interference by either
the President or Congress, because they can affect how much influence
and oversight the President and Congress have over agency actions and
priorities. For example, those characteristics related to bypassing OMB
review can help to insulate an agency from political interference by the
President, while characteristics related to agency funding and
congressional oversight can help to insulate an agency from political
interference by Congress. Of the eight characteristics in this category,
FDA had two, CDC and NIH had one, and ASPR had none. 9 Of note, the
selected agencies had none of the characteristics that can help insulate
their policy-making from political interference by the President.

9We did not consider as part of our count two characteristics from Table 6 because they

described the extent of certain aspects of congressional oversight for the selected
agencies; specifically the number of statutorily mandated recurring agency reports to
Congress and the number of committees specified by statute as overseeing the agency.

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GAO-23-105415 CARES Act


Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Table 7: Structural Characteristics at Selected Department of Health and Human Services (HHS) Agencies – Features
Insulating Agency Policy from the President
Centers for Disease
Control and
Prevention (CDC)

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic
Preparedness and
Response (ASPR)

Exempted OMB Budget Reviewa
The President must submit the
agency’s budget requests to
Congress without revision, with
the President’s budget proposals;
or the agency submits its budget
directly to Congress without Office
of Management and Budget
(OMB) review

No

No

Nob

No

Exempted OMB Rule Reviewc
The agency is exempted from
submitting all regulatory actions to
the administrator of OMB’s Office
of Information and Regulatory
Affairs

No

No

No

No

Exempted OMB
Communications Reviewd
The agency asserts “informal”
legislative bypass authority
without any explicit authority,
statutory or otherwise, even
though OMB Circular A-19 covers
the agency

No

No

No

No

Independent Litigating
Agency authorizing statute
includes provisions relating to
independent litigating authority

No

No

No

No

Characteristic and Description

Source: GAO analysis of the U.S. code, OMB circulars, and NIH’s website. | GAO-23-105415

Notes:
In the Sourcebook, this characteristic is “No OMB Budget Review.”

a

In addition to submitting its annual budget request as part of the President’s budget, the National
Cancer Act authorizes NIH’s National Cancer Institute to submit an annual Professional Judgment
Budget directly to the President and Congress that reflects the Institute’s research priorities and
identifies areas of potential investment in cancer research. See 42 U.S.C. § 285a-2(b)(9). Congress
may review the National Cancer Institute’s Professional Judgment Budget and the President’s budget
request to develop and pass appropriations to fund the Institute’s operations.
b

c

In the Sourcebook, this characteristic is “No OMB Rule Review.”

Or, statutory law exempts the agency from submitting its communications to OMB for coordination
and clearance prior to transmittal to Congress. In the Sourcebook, this characteristic is “No OMB
Communications Review.”
d

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GAO-23-105415 CARES Act


Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Table 8: Structural Characteristics at Selected Department of Health and Human Services (HHS) Agencies – Features
Insulating Agency Policy from Congress

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic
Preparedness and
Response (ASPR)

Independent Fundinga
Yesb
Statute authorizes the agency to:
(1) collect fees to cover a
substantial portion of the agency’s
operating expenses; (2) collect
fees for products and services; or
(3) accept and use gifts,
donations, or property. Or, statute
establishes a working capital fund
or other similar fund without fiscal
year limitation

Yesc

Yesd

No

No Approp
Statute authorizes the agency to
assess and collect fees or
charges for the purpose of
covering a substantial portion of
the cost of operating expenses
incurred by the agency

No

Yese

No

No

Reporting Requirements
Number of statutorily mandated
recurring agency reports to
Congress

16f (as of November
2022)

42g (as of October
2021)

10h (as of October
2021)

4i (as of October 2021)

4k

8l

4m

Characteristic and Description

Centers for Disease
Control and
Prevention (CDC)

Number Committees
5j
Number of committees specified
by statute as overseeing the
agency in any way, including, inter
alia, receiving reports, hearing
testimony, or exercising a
legislative veto

Source: GAO analysis of the U.S. code, public laws, HHS budget data, and agency written responses. | GAO-23-105415

Notes:
a
Or, statute authorizes the agency to participate in activities generally associated with the business of
banking. According to the Sourcebook, the most important characteristic by which Congress controls
agency actions and priorities is appropriations because an agency may only spend federal revenues
or funds if Congress has appropriated them. However, in some cases, Congress has limited its
influence over agency funding by allowing agencies more freedom to collect and spend revenues,
such as the ability to charge and spend fees for specific purposes. These agency self-funding
mechanisms are captured in this characteristic.
b
Multiple statutes authorize CDC to collect user or administrative fees for a variety of activities, such
as conducting sanitation inspections of cruise ships (42 U.S.C. § 269(a)). CDC is also authorized to
accept and use any gift, donation, or devise of real or personal property from the National Foundation
for the Centers for Disease Control and Prevention to facilitate the agency’s work. See 42 U.S.C. §
280e-11(h)(1). CDC also administers a working capital fund to improve the provision of supplies and
service. See Consolidated Appropriations Act, 2012, Pub. L. No. 112–74, div. F, title II, 125 Stat. 786,
1070 (2011).

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GAO-23-105415 CARES Act


Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

c
Multiple statutes authorize FDA to assess and collect user fees for a variety of activities, such as
those related to prescription drugs (21 U.S.C. § 379h), and tobacco products (21 U.S.C. § 387s).
User fees collected by FDA must be appropriated to the agency through the annual appropriations
process, and FDA’s major user fee programs must be reauthorized every 5 years. FDA is also
authorized to accept gifts or donations of services or property to carry out certain requirements (21
U.S.C. § 379b(c)). FDA also administers a working capital fund to provide services for agency
programs (21 U.S.C. § 399i).
d
Multiple statutes authorize NIH to collect fees for a variety of activities, such as for the library
services provided by the National Library of Medicine (42 U.S.C § 286(d)(2)). In addition, NIH’s
institute and center directors are also authorized to accept gifts for their respective activities (42
U.S.C. § 284(b)(1)(I)).
e
According to FDA officials, FDA’s operating costs for fiscal year 2021 totaled $3.01 billion, of which
$1.33 billion (or 44 percent) were covered by user fees.

CDC is statutorily required to provide 16 reports to Congress on topics such as sudden unexpected
infant/childhood death (42 U.S.C. § 300c-14).

f

g
FDA is statutorily required to provide 42 reports to Congress on topics such as drug shortages (21
U.S.C. § 356c-1(a)) and prescription drug activities (21 U.S.C. § 379h-2(a)).
h
NIH is statutorily required to provide 10 reports to Congress on topics such as on the use of breast
cancer research funds (39 U.S.C. § 414).

ASPR is statutorily required to provide four reports to Congress on topics such as the Strategic
National Stockpile (42 U.S.C. § 247d-6b(a)(2)).

i

j
These committees are: the Senate Committee on Appropriations; Senate Committee on Health,
Education, Labor and Pensions; House Committee on Appropriations; House Committee on Energy
and Commerce; and House Select Subcommittee on the Coronavirus Crisis.

These committees are: the Senate Committee on Appropriations; Senate Committee on Health,
Education, Labor and Pensions; House Committee on Appropriations; and House Committee on
Energy and Commerce.

k

These committees are: the Senate Committee on Health, Education, Labor and Pensions; Senate
Committee on Appropriations; Senate Homeland Security and Governmental Affairs; Senate Small
Business and Entrepreneurship Committee; House Committee on Energy and Commerce; House
Committee on Appropriations; House Committee on Oversight and Reform; and House Small
Business Committee.

l

m
These committees are: the Senate Committee on Appropriations; Senate Committee on Health,
Education, Labor and Pensions; House Committee on Appropriations; and House Committee on
Energy and Commerce.

Other Key Structural
Features

This category comprises 11 characteristics related to agency
administrative and decision-making processes. Characteristics in this
category can affect how responsive the agency is to the President or
Congress. Of the 11 characteristics in this category, FDA and NIH had
eight, CDC had seven, and ASPR had five. Of note, all the agencies had
at least one structural characteristic related to advisory committees and
rulemaking, which can help insulate them from political interference in
agency decision-making.

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Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Table 9: Structural Characteristics at Selected Department of Health and Human Services (HHS) Agencies – Government-Wide
Management and Transparency Laws
Centers for Disease
Control and
Prevention (CDC)

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic
Preparedness and
Response (ASPR)

CIOa
The agency is statutorily
mandated to have a Chief
Information Officer (CIO), or is a
subpart of an agency statutorily
mandated to have a Chief
Information Officer

Yesb

Yesb

Yesb

Yesb

IGc
The agency is statutorily
mandated to have an Inspector
General (IG), or is a subpart of an
agency statutorily mandated to
have an Inspector General

Yesd

Yesd

Yesd

Yesd

CFOe
The agency is statutorily
mandated to have a Chief
Financial Officer (CFO), or is a
subpart of an agency statutorily
mandated to have a Chief
Financial Officer

Yesf

Yesf

Yesf

Yesf

Sunshine
The agency is subject to the
Government in the Sunshine Act
of 1976

No

No

No

No

Characteristic and Description

Source: GAO analysis of the U.S. code and agency websites. | GAO-23-105415

Notes:
a
In the Sourcebook, the description of this characteristic is: the agency is statutorily mandated to have
a Chief Information Officer.
b
HHS’s Office of the Chief Information Officer leads the development and implementation of
enterprise information technology across the department, and certain functions and authorities have
been delegated to chief information officers at CDC, FDA, and NIH.
c
In the Sourcebook, the description of this characteristic is: the agency is an “establishment” or
“designated federal entity” as defined by the Inspector General Act of 1978 and Office of
Management and Budget’s (OMB) published list of designated federal entities, and has an Office of
Inspector General that is headed by an Inspector General who is appointed by the President with the
advice and consent of the Senate or who is appointed by the agency; or the agency is a “federal
entity” as defined by the Inspector General Act of 1978 and OMB’s published list of federal entities
and has an audit office that is required to report an annual audit and investigative activities to each
house of Congress and the Director of OMB.
d
HHS’s Office of Inspector General has broad oversight over HHS programs, including those at
ASPR, CDC, FDA, and NIH.
e
In the Sourcebook, the description of this characteristic is: the Chief Financial Officers Act mandates
that the agency have a Chief Financial Officer appointed by the President and confirmed by the

Page 49

GAO-23-105415 CARES Act


Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Senate or appointed by the head of the agency and is a career executive from either the competitive
service or the Senior Executive Service.
f
HHS’s Office of the Assistant Secretary of Financial Resources provides advice and guidance on all
aspects of HHS’s budget and financial management, and grants and acquisition management, and
directs and implements these activities across the department. In addition, certain functions and
authorities have been delegated to chief financial officers at CDC, FDA, and NIH.

Table 10: Structural Characteristics at Selected Department of Health and Human Services (HHS) Agencies – Advisory
Committees, Rulemaking, and Adjudication

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic
Preparedness and
Response (ASPR)

Advisory Committeesa
Yesb
Statute establishes an advisory
committee attached to the agency
or any of its subparts

Yesc

Yesd

Yese

Establish Advisory
Committeesa
Statute specifies that one or more
advisory committees may be
established to advise the agency,
or any of its subparts, in any way

Yesf

Yesg

Yesh

No

Outside Approval
Statute specifies that one or more
agency actions require outside
approval before being taken

Noi

No

Yesj

No

Rulemaking
Statute authorizes agency to
promulgate rules and/or
regulations

Yes

Yes

Yes

Yesk

Significant Rule
Yes
Based on the Federal Register,
agency has promulgated a rule in
the last 15 years that the Unified
Agenda of Regulatory and
Deregulatory Actions classified as
significant under Executive Order
12,866

Yes

Yes

No

Adjudication
Statute gives agency, or any
subpart of the agency, the
authority to conduct or hold
hearings or adjudication, take
testimony, receive evidence,
employ administrative law judges,
or other similar adjudicatory
functions

Yesl

No

No

Characteristic and Description

Centers for Disease
Control and
Prevention (CDC)

No

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GAO-23-105415 CARES Act


Appendix II: Structural Characteristics in Place
at Selected Department of Health and Human
Services (HHS) Agencies

Characteristic and Description
Administrative Law Judges
Agency employs administrative
law judges

Centers for Disease
Control and
Prevention (CDC)

Food and Drug
National Institutes of
Administration (FDA) Health (NIH)

Administration for
Strategic
Preparedness and
Response (ASPR)

No

Nom

No

No

Source: GAO analysis of the U.S. code, Federal Advisory Committee Act database, Federal Register, and agency websites and written responses. | GAO-23-105415

Notes:
a
The Sourcebook describes these characteristics as relating to “advisory commissions” rather than
“advisory committees.”

CDC has 10 statutorily-established advisory committees, one of which is administratively inactive.

b
c

FDA has eight active, statutorily-established advisory committees and boards.

According to NIH, the agency has 47 statutorily-established program advisory committees and
national advisory councils and boards, 11 of which are administratively inactive and one of which was
terminated as of March 2021.

d

ASPR has four active, statutorily-established advisory committees and boards.

e

CDC has 11 active advisory committees and boards established based on HHS’s general statutory
authority to create advisory councils or committees under 42 U.S.C. § 217a.

f

g
FDA has 23 active advisory committees and boards established based on the agency’s general
statutory authority to create technical and scientific review groups under 21 U.S.C. § 394.
h
NIH has 109 active program advisory committees, national advisory councils and boards, boards of
scientific counselors, integrated/initial review groups, and special emphasis panels based on NIH and
HHS’s general and NIH’s institute-specific authorities to create technical and scientific peer review
groups, scientific program advisory committees, and advisory councils or committees. See 42 U.S.C.
§§ 282(b)(16), 283k(b), 284(c)(3), 285a-2(b)(7), and 217a.

According to CDC, the authorities that have been delegated to CDC and under which the agency
operates, in general, do not expressly require approval from outside sources, though some include an
expectation to seek recommendations prior to taking action. See, e.g., 42 U.S.C. § 241(a)(3).

i

j
For example, NIH grant proposals require the approval of a technical or scientific peer board attached
to the agency before they can be funded. See 42 U.S.C. § 289a-1(a)(2).

According to ASPR, while ASPR and its Biomedical Advanced Research and Development Authority
have authority to issue rules, their statutory authorities generally do not require rulemaking.

k

FDA is authorized to hold formal and informal evidentiary hearings for certain regulatory decisions or
actions, such as to dispute FDA’s decision not to approve a new drug application (21 U.S.C. § 355(c)
and (d)) and to withdraw accelerated approval of a drug product (21 U.S.C. § 356(c)(3)). In addition,
the Federal Food, Drug and Cosmetic Act provides a list of prohibited acts that could result in certain
penalties. See 21 U.S.C. §§ 331 and 333.

l

m
According to FDA, it relies on the staff of administrative law judges in HHS’s Departmental Appeals
Board when the law requires an administrative law judge to preside over a hearing. In cases when an
administrative law judge is not required, FDA’s Office of the Commissioner will sometimes appoint a
presiding officer from within FDA to preside over a hearing, as appropriate.

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Appendix III: Comments from the
Department of Health and Human Services
Appendix III: Comments from the Department
of Health and Human Services

Page 52

GAO-23-105415 CARES Act


Appendix III: Comments from the Department
of Health and Human Services

Page 53

GAO-23-105415 CARES Act


Appendix III: Comments from the Department
of Health and Human Services

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GAO-23-105415 CARES Act


Appendix IV: GAO Contact and Staff
Acknowledgments
Appendix IV: GAO Contact and Staff
Acknowledgments

GAO contact

Sharon M. Silas at (202) 512-7114 or SilasS@gao.gov

Staff
Acknowledgments

In addition to the contact named above, Ray Sendejas (Assistant
Director), Amanda Cherrin (Analyst-in-Charge), Sam Amrhein, Anna
Beischer, Adam Brooks, Jenny Chanley, Joycelyn Cudjoe, Kaitlin
Farquharson, Sandra George, Cynthia Khan, Amelia Koby, Douglas G.
Hunker, Rob Marek, Priyanka Panjwani, Amy Pereira, Eric Peterson,
Vikki Porter, Corinne Quinones, Caylin Rathburn-Smith, Roxanna Sun,
and Candice Wright made key contributions to this report.

(105415)

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GAO-23-105415 CARES Act


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