Statement of Organization, Functions, and Delegations of Authority, 16372-16375 [2020-06046]
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person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved FDA collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collection of information for ‘‘Current
Good Manufacturing Practices for
Finished Pharmaceuticals and Medical
Gases’’ has been approved under OMB
control number 0910–0139. The
collection of information for
‘‘Postmarketing Adverse Drug
Experience Reporting’’ has been
approved under OMB control number
0910–0230. The collection of
information for ‘‘MedWatch: Adverse
Event and Product Experience Reporting
System (Paper-Based)’’ has been
approved under OMB control number
0910–0291. The collection of
information for ‘‘Format and Content
Requirements for Over-the-Counter Drug
Product Labeling’’ has been approved
under OMB control number 0910–0340.
The collection of information for ‘‘FDA
Adverse Event and Products Experience
Reports; Electronic Submissions’’ has
been approved under OMB control
number 0910–0645. The collection of
information for ‘‘Adverse Event
Reporting for Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act’’ has been
approved under OMB control number
0910–0800.
IV. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: March 17, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05959 Filed 3–20–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation for Public Comments on
Section 209 of the Pandemic and AllHazards Preparedness and Advancing
Innovation Act
Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
AGENCY:
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Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Request for public comment.
The Office of the Assistant
Secretary for Health in the Department
of Health and Human Services seeks
public comment regarding Section 209
of the Pandemic and All-Hazards
Preparedness and Advancing Innovation
Act.
Congress passed the Pandemic and
All-Hazards Preparedness and
Advancing Innovation Act (PAHPAIA)
in June 2019. Section 209 of this
legislation states that the Secretary of
Health and Human Services shall
submit to Congress a report containing
recommendations related to maintaining
an adequate national blood supply. The
legislation poses four specific questions
regarding the adequacy of the national
blood supply. HHS welcomes any
public feedback related to how these
questions should be addressed and/or
potential solutions. The set of questions
is available in the SUPPLEMENTARY
INFORMATION section below.
DATES: To be assured consideration,
electronic or written/paper comments
must be submitted no later than
midnight Eastern Standard Time (EST)
on April 22, 2020.
ADDRESSES: Individuals are encouraged
to submit responses electronically to
ACBTSA@hhs.gov. Please indicate ‘‘RFI
RESPONSE’’ in the subject line of your
email. Written responses should be
addressed to: U.S. Department of Health
and Human Services, Mary E. Switzer
Building, 330 C Street SW, Room L600,
Washington, DC 20024 Attn: ACBTSA–
PAHPAIA Sec. 209. Mailed paper
submissions and electronic submissions
received after the deadline will not be
reviewed. Responses to this notice are
not offers and cannot be accepted by the
federal government to form a binding
contract or issue a grant.
FOR FURTHER INFORMATION CONTACT: Mr.
James Berger, Designated Federal
Officer, Office of Infectious Disease and
HIV/AIDS Policy, (202) 795–7608.
SUPPLEMENTARY INFORMATION:
(1) Challenges associated with the
continuous recruitment of blood donors
(including those newly eligible to
donate);
(2) Ensuring the adequacy of the
blood supply in the case of public
health emergencies;
(3) Implementation of the transfusion
transmission monitoring system; and
(4) Other measures to promote safety
and innovation, such as the
development, use, or implementation of
new technologies, processes, and
SUMMARY:
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procedures to improve the safety and
reliability of the blood supply.
Dated: March 11, 2020.
James J. Berger,
Senior Advisor for Blood and Tissue Policy,
Office of Infectious Disease and HIV/AIDS
Policy.
[FR Doc. 2020–06047 Filed 3–20–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
[OIG–1810–N]
Statement of Organization, Functions,
and Delegations of Authority
Office of Inspector General
(OIG), HHS.
ACTION: Notice.
AGENCY:
This notice replaces all
language in Part Q (Office of the
Secretary) of the Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services (HHS or the Department),
Office of Inspector General (OIG),
(published March 15, 2016).
SUPPLEMENTARY INFORMATION: The
Statement of Organization, Functions,
and Delegations of Authority conforms
to and carries out the statutory
requirements for operating OIG. The
organizational changes reflected in this
notice are primarily to realign the
functions within OIG to better reflect
the current work environment and
priorities and to more clearly delineate
responsibilities for the various activities
within OIG’s offices.
OIG was established by law as an
independent and objective oversight
unit of the Department to carry out the
mission of preventing fraud and abuse
and promoting economy, efficiency, and
effectiveness of HHS programs and
operations. In furtherance of this
mission, the organization:
• Conducts and supervises audits,
investigations, evaluations, and
inspections relating to HHS programs
and operations;
• identifies systemic weaknesses
giving rise to opportunities for fraud
and abuse in HHS programs and
operations and makes recommendations
to prevent their recurrence;
• leads and coordinates activities to
prevent and detect fraud and abuse in
HHS programs and operations;
• detects wrongdoers and abusers of
HHS programs and beneficiaries so
appropriate remedies may be brought to
SUMMARY:
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bear, including imposing administrative
sanctions against providers of health
care under Medicare and Medicaid who
commit certain prohibited acts; and
• keeps the Secretary of Health and
Human Services and Congress fully and
currently informed about problems and
deficiencies in the administration of
HHS programs and operations and about
the need for and progress of corrective
action.
In addition, OIG works with the
Department of Justice (DOJ), on behalf of
the Secretary, to operate the Health Care
Fraud and Abuse Control Program. In
accordance with authority enacted in its
annual appropriations, OIG also
provides protection services to the
Secretary and conducts criminal
investigations of violations of Federal
child support provisions.
In support of its mission, OIG carries
out and maintains an internal quality
assurance system and a peer-review
system with other Offices of Inspector
General, including periodic quality
assessment studies and quality control
reviews, to provide reasonable
assurance that applicable laws,
regulations, policies, procedures,
standards, and other requirements are
followed, are effective, and are
functioning as intended in OIG
operations.
Section Q, Office of Inspector General—
Organization
There is at the head of OIG a statutory
Inspector General, appointed by the
President and confirmed by the Senate.
OIG consists of six organizational units:
1. Immediate Office of the Inspector
General (QA)
2. Office of Management and Policy
(QC)
3. Office of Evaluation and Inspections
(QE)
4. Office of Counsel to the Inspector
General (QG)
5. Office of Audit Services (QH)
6. Office of Investigations (QJ)
Section Q, Office of Inspector General—
Functions
The component sections that follow
describe the specific functions of the
organization.
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Section QA.00, Immediate Office of the
Inspector General—Mission
The Immediate Office of the Inspector
General is directly responsible for
meeting the statutory mission of OIG as
a whole and for promoting effective OIG
internal quality assurance systems,
including quality assessment studies
and quality control reviews of OIG
processes and products.
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Section QA.10, Immediate Office of the
Inspector General—Organization
Section QC.00, Office of Management
and Policy—Mission
The Immediate Office comprises the
Inspector General, Principal Deputy
Inspector General, Chief of Staff, several
technical advisors, including the Chief
Medical Officer, and staff.
The Office of Management and Policy
(OMP) provides management, guidance,
and resources in support of OIG.
Section QA.20, Immediate Office of the
Inspector General—Functions
The Inspector General is appointed by
the President, with the advice and
consent of the Senate, and reports to
and is under the general supervision of
the Secretary or, to the extent such
authority is delegated, the Deputy
Secretary. The Inspector General does
not report to and is not subject to
supervision by any other officer in the
Department. In keeping with the
independence conferred by the
Inspector General Act, the Inspector
General assumes and exercises, through
line management, all functional
authorities related to the administration
and management of OIG and all
mission-related authorities stated or
implied in the law or delegated directly
from the Secretary. The Inspector
General provides executive leadership
to the organization and exercises general
supervision over the personnel and
functions of its major components. The
Inspector General determines the budget
needs of OIG, sets OIG policies and
priorities, oversees OIG operations, and
provides reports to the Secretary and
Congress. By statute, the Inspector
General exercises general personnel
authority, e.g., selection, promotion, and
assignment of employees, including
members of the Senior Executive
Service. The Inspector General delegates
related authorities as appropriate. The
Principal Deputy Inspector General
assists the Inspector General in the
management of OIG, and during the
absence of the Inspector General, acts as
the Inspector General. The Principal
Deputy Inspector General supervises the
Chief Counsel to the Inspector General,
the Deputy Inspectors General, who
head the major OIG components, as well
as the Chief of Staff.
The Immediate Office interacts with
the Department, Congress, and the
public and leads OIG’s congressional,
media, and public affairs functions. The
office also plans, conducts, and
participates in a variety of interagency
cooperative projects and undertakings
relating to fraud and abuse with the
DOJ, the Centers for Medicare &
Medicaid Services (CMS), and other
governmental agencies, and is
responsible for the reporting and
legislative functions required by the
Inspector General Act.
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Section QC.10, Office of Management
and Policy—Organization
OMP is directed by the Deputy
Inspector General for Management and
Policy, who, aided by Assistant
Inspectors General, assures that OIG has
the financial and administrative
resources necessary to fulfill its mission.
This office carries out its
responsibilities through headquarters
functions.
Section QC.20, Office of Management
and Policy—Functions
The staffs within OMP are responsible
for formulating and executing OIG’s
budget, developing policy, and
managing information technology,
human resources, executive resources,
procurement activities, and physical
space. OMP also executes and maintains
an internal quality assurance system,
which includes quality control reviews
of its processes and products to ensure
that OIG policies and procedures are
followed and function as intended.
OMP provides centralized services and
management to deliver to OIG data,
tools, skills, and support to use data and
data analytics. Finally, OMP coordinates
organizational performance
management activities.
Section QE.00, Office of Evaluation and
Inspections—Mission
The Office of Evaluation and
Inspections (OEI) is responsible for
conducting indepth evaluations of HHS
programs, operations, and processes to
identify vulnerabilities and recommend
corrective action; to prevent and detect
fraud and abuse; and to promote
efficiency and effectiveness in HHS
programs and operations. OEI conducts
its work in accordance with the Quality
Standards for Inspection and Evaluation
issued by the Council of the Inspectors
General on Integrity and Efficiency.
Section QE.10, Office of Evaluation and
Inspections—Organization
OEI is directed by the Deputy
Inspector General for the Office of
Evaluation and Inspections, who, aided
by Assistant Inspectors General, is
responsible for carrying out OIG’s
responsibilities to evaluate the
effectiveness and efficiency of HHS
programs and operations. The office is
comprised of headquarters and regional
functions.
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Section QE.20, Office of Evaluation and
Inspections—Functions
OEI is responsible for conducting
evaluations of HHS programs;
conducting data and trend analysis; and
recommending changes in programs,
procedures, policies, regulations, and
legislation. OEI develops evaluation
policies, procedures, techniques, and
guidelines to be followed by all OEI staff
in conducting evaluations. The office
maintains an internal quality assurance
program. OEI also oversees the activities
of State Medicaid Fraud Control Units
(MFCUs) to ensure the MFCUs’
compliance with Federal grant
regulations, administrative rules, and
performance standards for the purpose
of certifying or recertifying the MFCUs
annually. The office also maintains
automated data and management
information systems used by all OEI
employees, a quality assurance/peerreview program, and policy and
procedure manuals.
Section QG.00, Office of Counsel to the
Inspector General—Mission
In accordance with section 3(g) of the
Inspector General Act (5 U.S.C. App.
§ 3(g)), the Office of Counsel to the
Inspector General (OCIG) provides all
legal advice to OIG and represents OIG
in administrative litigation. OCIG
proposes and litigates civil money
penalty (CMP) and program exclusion
cases within the jurisdiction of OIG. It
coordinates False Claims Act matters
involving HHS programs and resolves
voluntary disclosure cases. OCIG
develops guidance to assist providers in
establishing compliance programs;
monitors ongoing compliance of
providers subject to integrity
agreements; and promotes industry
awareness through advisory opinions,
fraud alerts, and special advisory
bulletins.
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Section QG.10, Office of Counsel to the
Inspector General—Organization
OCIG is directed by the Chief Counsel
to the Inspector General, who also
serves as OIG’s Deputy Ethics Counselor
and is aided by Assistant Inspectors
General. The office carries out its
responsibilities through headquarters
functions.
Section QG.20, Office of Counsel to the
Inspector General—Functions
OCIG provides legal advice to OIG on
issues that arise in the exercise of OIG’s
responsibilities under the Inspector
General Act of 1978, as amended. Such
issues include the scope and exercise of
the Inspector General’s authorities and
responsibilities; investigative
techniques and procedures (including
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criminal procedure); the sufficiency and
impact of legislative proposals affecting
OIG and HHS; and the conduct and
resolution of investigations, audits, and
inspections. The office evaluates the
legal sufficiency of OIG findings and
recommendations and develops formal
legal opinions to support these findings
and recommendations. The office also
provides legal advice on OIG internal
administration and operations,
including appropriations, procurement,
delegations of authority, OIG
regulations, personnel matters,
disclosure of information under the
Freedom of Information Act (FOIA), and
safeguarding information under the
Privacy Act. Additionally, OCIG
coordinates OIG’s regulatory review
functions required by the Inspector
General Act and responses to all
requests made under FOIA. The office is
responsible for the clearance and
enforcement of OIG subpoenas.
The office represents OIG in
administrative litigation and related
appeals. This includes representing OIG
in personnel and Equal Employment
Opportunity matters; coordinating OIG’s
representation in Federal tort actions
involving OIG employees; and
representing OIG in bid protests before
the Government Accountability Office
and the U.S. Court of Federal Claims.
OCIG also determines whether to
propose or implement administrative
sanctions, including CMPs and
assessments within OIG’s jurisdiction.
The office effectuates mandatory and
permissive exclusions from
participation in Federal health care
programs under the Social Security Act;
decides on all requests for reinstatement
from, or waiver of, exclusions; and
participates in developing standards
governing the imposition of these
exclusion authorities. The office also
oversees OIG’s suspension and
debarment referral program. The office
litigates and resolves all appealed or
contested exclusions from participation
in Federal health care programs under
the Social Security Act. In conjunction
with DOJ, the office represents HHS in
all False Claims Act cases, including qui
tam cases, and is responsible for final
approval of civil False Claims Act
settlements for the Department,
including the resolution of the program
exclusion authorities that have been
delegated to OIG.
In conjunction with the Office of
Investigations, OCIG coordinates
resolution of all voluntary and
mandatory disclosure under OIG’s
Provider Self-Disclosure Protocol, the
contractor self-disclosure requirement
and otherwise. OCIG develops and
monitors corporate and individual
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integrity agreements adopted in
connection with settlement agreements,
conducts onsite reviews, and develops
audit and investigative review standards
for monitoring such integrity
agreements in conjunction with other
OIG components. The office also
resolves breaches of integrity
agreements through the development of
corrective action plans and the
imposition of sanctions.
OCIG, through the Whistleblower
Protection Coordinator, provides
education to agency employees about
prohibitions against whistleblower
retaliation, and the rights and remedies
available for such matters.
Finally, OCIG issues advisory
opinions to the health care industry and
members of the public on whether a
current or proposed activity would
constitute grounds for the imposition of
a sanction under the anti-kickback
statute, the CMP law, or the program
exclusion authorities. The office
develops procedures for submitting and
processing requests for advisory
opinions and for determining the fees
that will be imposed. It solicits and
responds to proposals for new
regulatory safe harbors to the antikickback statute, modifications to
existing safe harbors, and new fraud
alerts. OCIG consults with DOJ on
proposed advisory opinions and safe
harbors before issuance or publication.
The office provides legal advice to the
components of OIG, other HHS offices,
and DOJ concerning matters involving
the interpretation of the anti-kickback
statute and other legal authorities, and
assists those components or offices in
analyzing the applicability of the antikickback statute to particular practices
or activities under review.
Section QH.00, Office of Audit
Services—Mission
The Office of Audit Services (OAS) is
responsible for protecting the integrity
of HHS operations and programs by
conducting audits that identify and
report ways to improve the economy,
efficiency, and effectiveness of
operations and services to beneficiaries
of HHS programs and to help reduce
fraud, waste, abuse, and
mismanagement. OAS conducts audits
and oversees audit work performed by
others. It conducts its work in
accordance with Government Auditing
Standards and follows applicable legal,
regulatory, and administrative
requirements.
Section QH.10, Office of Audit
Services—Organization
OAS is directed by the Deputy
Inspector General for Audit Services,
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who, aided by Assistant Inspectors
General, performs the functions
designated in section 3(d)(1)(A) of the
Inspector General Act for the position of
Assistant Inspector General for
Auditing. The office comprises
headquarters and regional functions and
includes a designated Whistleblower
Protection Ombudsman, and the
functions thereof, as required by law
(section 3(d)(1)(C) of the Inspector
General Act).
Section QH.20, Office of Audit
Services—Functions
OAS establishes audit priorities;
performs audits; oversees the progress of
audits; coordinates with stakeholders on
bodies of work; recommends changes in
program policies, regulations, and
legislation to prevent fraud, waste, and
abuse and improve programs and
operations; and reports on the impact of
audit work. The office develops audit
policies, procedures, techniques, and
guidelines to be followed by all OAS
staff in conducting audits. OAS
maintains an internal quality assurance
program, conducts peer reviews of other
OIGs, and maintains automated data
and management information systems
used by all OAS employees. The office
also provides oversight for audits of
State and local governments,
universities, and nonprofit
organizations conducted by non-Federal
auditors.
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Section QJ.00, Office of Investigations—
Mission
The Office of Investigations (OI) is
granted full statutory law enforcement
authority under the Homeland Security
Act of 2003 (Pub. L. 107–296). OI is
responsible for protecting the integrity
of the programs administered and/or
funded by HHS by conducting criminal,
civil, and administrative investigations
of fraud and misconduct related to HHS
programs, operations, and employees.
The office serves as OIG’s liaison to DOJ
on all matters relating to investigations
of HHS programs and personnel and
reports to the Attorney General when
there are reasonable grounds to believe
Federal criminal law has been violated.
OI serves as a liaison to CMS, State
licensing boards, and other outside
organizations and entities with regard to
exclusion, compliance, and enforcement
activities.
Section QJ.10, Office of Investigations—
Organization
OI is directed by the Deputy Inspector
General for Investigations, aided by
Assistant Inspectors General, and
performs the functions designated in the
law (section 3(d)(1)(B) of the Inspector
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General Act) for the position of
Assistant Inspector General for
Investigations. The office is comprised
of headquarters and regional functions.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Section QJ.20, Office of Investigations—
Functions
Center for Scientific Review; Amended
Notice of Meeting
OI conducts criminal, civil, and
administrative investigations of
allegations of fraud, waste, abuse,
mismanagement, and violations of
standards of conduct within the
jurisdiction of OIG. OI establishes
investigative priorities, evaluates the
progress of investigations, and reports
findings to the Inspector General. The
office develops and implements
investigative techniques, programs,
guidelines, and policies; manages OI’s
quality assurance/peer-review program,
and conducts peer reviews of other
OIGs. OI also carries out and maintains
an internal quality assurance system.
The system includes quality assessment
studies and quality control reviews of
OI processes and products to ensure that
policies and procedures are followed
effectively and are functioning as
intended. OI implements policies and
procedures and plans, develops,
implements, and evaluates all levels of
training for OI employees. The staff
provides for the personal protection of
the Secretary and other Department
officials, as needed, and all emergency
operations preparedness and response.
OI coordinates the adoption of advanced
digital forensic acquisition and
examination and information security
technologies to assist in the
investigation, prevention, and detection
of fraud and abuse; maintains an
automated data and management
information system used by all OI
employees; provides technical expertise
on computer applications for
investigations; and coordinates and
approves investigative computer
matches with other agencies. In
addition, the office operates a toll-free
hotline to permit individuals to report
suspected fraud, waste, and abuse
within HHS programs.
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel, March
24, 2020, 10:00 a.m. to March 24, 2020,
01:00 p.m., National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 which was
published in the Federal Register on
February 25, 2020, 85 FR 10708.
The format of the Special Emphasis
Panel; Member Conflicts: Sensory
Processes and Pain has been changed to
a Virtual Meeting. The meeting date,
time and location remain the same. The
meeting is closed to the public.
Dated: March 17, 2020.
Christi A. Grimm,
Principal Deputy Inspector General.
[FR Doc. 2020–06046 Filed 3–20–20; 8:45 am]
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National Institutes of Health
Dated: March 17, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–05968 Filed 3–20–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel, March
27, 2020, 01:00 p.m. to March 27, 2020,
05:00 p.m., National Institutes of Health,
Rockledge II, 6701 Rockledge Dr.,
Bethesda, MD 20892 which was
published in the Federal Register on
March 04, 2020, 85 FR 12799.
The format of the Special Emphasis
Panel; Member Conflict: Sleep, Stress,
Motion, and Taste has been changed to
a Telephone Assisted Meeting. The
meeting date, time and location remain
the same. The meeting is closed to the
public.
Dated: March 17, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–05967 Filed 3–20–20; 8:45 am]
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Agencies
[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Notices]
[Pages 16372-16375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06046]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
[OIG-1810-N]
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: Office of Inspector General (OIG), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice replaces all language in Part Q (Office of the
Secretary) of the Statement of Organization, Functions, and Delegations
of Authority for the Department of Health and Human Services (HHS or
the Department), Office of Inspector General (OIG), (published March
15, 2016).
SUPPLEMENTARY INFORMATION: The Statement of Organization, Functions,
and Delegations of Authority conforms to and carries out the statutory
requirements for operating OIG. The organizational changes reflected in
this notice are primarily to realign the functions within OIG to better
reflect the current work environment and priorities and to more clearly
delineate responsibilities for the various activities within OIG's
offices.
OIG was established by law as an independent and objective
oversight unit of the Department to carry out the mission of preventing
fraud and abuse and promoting economy, efficiency, and effectiveness of
HHS programs and operations. In furtherance of this mission, the
organization:
Conducts and supervises audits, investigations,
evaluations, and inspections relating to HHS programs and operations;
identifies systemic weaknesses giving rise to
opportunities for fraud and abuse in HHS programs and operations and
makes recommendations to prevent their recurrence;
leads and coordinates activities to prevent and detect
fraud and abuse in HHS programs and operations;
detects wrongdoers and abusers of HHS programs and
beneficiaries so appropriate remedies may be brought to
[[Page 16373]]
bear, including imposing administrative sanctions against providers of
health care under Medicare and Medicaid who commit certain prohibited
acts; and
keeps the Secretary of Health and Human Services and
Congress fully and currently informed about problems and deficiencies
in the administration of HHS programs and operations and about the need
for and progress of corrective action.
In addition, OIG works with the Department of Justice (DOJ), on
behalf of the Secretary, to operate the Health Care Fraud and Abuse
Control Program. In accordance with authority enacted in its annual
appropriations, OIG also provides protection services to the Secretary
and conducts criminal investigations of violations of Federal child
support provisions.
In support of its mission, OIG carries out and maintains an
internal quality assurance system and a peer-review system with other
Offices of Inspector General, including periodic quality assessment
studies and quality control reviews, to provide reasonable assurance
that applicable laws, regulations, policies, procedures, standards, and
other requirements are followed, are effective, and are functioning as
intended in OIG operations.
Section Q, Office of Inspector General--Organization
There is at the head of OIG a statutory Inspector General,
appointed by the President and confirmed by the Senate. OIG consists of
six organizational units:
1. Immediate Office of the Inspector General (QA)
2. Office of Management and Policy (QC)
3. Office of Evaluation and Inspections (QE)
4. Office of Counsel to the Inspector General (QG)
5. Office of Audit Services (QH)
6. Office of Investigations (QJ)
Section Q, Office of Inspector General--Functions
The component sections that follow describe the specific functions
of the organization.
Section QA.00, Immediate Office of the Inspector General--Mission
The Immediate Office of the Inspector General is directly
responsible for meeting the statutory mission of OIG as a whole and for
promoting effective OIG internal quality assurance systems, including
quality assessment studies and quality control reviews of OIG processes
and products.
Section QA.10, Immediate Office of the Inspector General--Organization
The Immediate Office comprises the Inspector General, Principal
Deputy Inspector General, Chief of Staff, several technical advisors,
including the Chief Medical Officer, and staff.
Section QA.20, Immediate Office of the Inspector General--Functions
The Inspector General is appointed by the President, with the
advice and consent of the Senate, and reports to and is under the
general supervision of the Secretary or, to the extent such authority
is delegated, the Deputy Secretary. The Inspector General does not
report to and is not subject to supervision by any other officer in the
Department. In keeping with the independence conferred by the Inspector
General Act, the Inspector General assumes and exercises, through line
management, all functional authorities related to the administration
and management of OIG and all mission-related authorities stated or
implied in the law or delegated directly from the Secretary. The
Inspector General provides executive leadership to the organization and
exercises general supervision over the personnel and functions of its
major components. The Inspector General determines the budget needs of
OIG, sets OIG policies and priorities, oversees OIG operations, and
provides reports to the Secretary and Congress. By statute, the
Inspector General exercises general personnel authority, e.g.,
selection, promotion, and assignment of employees, including members of
the Senior Executive Service. The Inspector General delegates related
authorities as appropriate. The Principal Deputy Inspector General
assists the Inspector General in the management of OIG, and during the
absence of the Inspector General, acts as the Inspector General. The
Principal Deputy Inspector General supervises the Chief Counsel to the
Inspector General, the Deputy Inspectors General, who head the major
OIG components, as well as the Chief of Staff.
The Immediate Office interacts with the Department, Congress, and
the public and leads OIG's congressional, media, and public affairs
functions. The office also plans, conducts, and participates in a
variety of interagency cooperative projects and undertakings relating
to fraud and abuse with the DOJ, the Centers for Medicare & Medicaid
Services (CMS), and other governmental agencies, and is responsible for
the reporting and legislative functions required by the Inspector
General Act.
Section QC.00, Office of Management and Policy--Mission
The Office of Management and Policy (OMP) provides management,
guidance, and resources in support of OIG.
Section QC.10, Office of Management and Policy--Organization
OMP is directed by the Deputy Inspector General for Management and
Policy, who, aided by Assistant Inspectors General, assures that OIG
has the financial and administrative resources necessary to fulfill its
mission. This office carries out its responsibilities through
headquarters functions.
Section QC.20, Office of Management and Policy--Functions
The staffs within OMP are responsible for formulating and executing
OIG's budget, developing policy, and managing information technology,
human resources, executive resources, procurement activities, and
physical space. OMP also executes and maintains an internal quality
assurance system, which includes quality control reviews of its
processes and products to ensure that OIG policies and procedures are
followed and function as intended. OMP provides centralized services
and management to deliver to OIG data, tools, skills, and support to
use data and data analytics. Finally, OMP coordinates organizational
performance management activities.
Section QE.00, Office of Evaluation and Inspections--Mission
The Office of Evaluation and Inspections (OEI) is responsible for
conducting indepth evaluations of HHS programs, operations, and
processes to identify vulnerabilities and recommend corrective action;
to prevent and detect fraud and abuse; and to promote efficiency and
effectiveness in HHS programs and operations. OEI conducts its work in
accordance with the Quality Standards for Inspection and Evaluation
issued by the Council of the Inspectors General on Integrity and
Efficiency.
Section QE.10, Office of Evaluation and Inspections--Organization
OEI is directed by the Deputy Inspector General for the Office of
Evaluation and Inspections, who, aided by Assistant Inspectors General,
is responsible for carrying out OIG's responsibilities to evaluate the
effectiveness and efficiency of HHS programs and operations. The office
is comprised of headquarters and regional functions.
[[Page 16374]]
Section QE.20, Office of Evaluation and Inspections--Functions
OEI is responsible for conducting evaluations of HHS programs;
conducting data and trend analysis; and recommending changes in
programs, procedures, policies, regulations, and legislation. OEI
develops evaluation policies, procedures, techniques, and guidelines to
be followed by all OEI staff in conducting evaluations. The office
maintains an internal quality assurance program. OEI also oversees the
activities of State Medicaid Fraud Control Units (MFCUs) to ensure the
MFCUs' compliance with Federal grant regulations, administrative rules,
and performance standards for the purpose of certifying or recertifying
the MFCUs annually. The office also maintains automated data and
management information systems used by all OEI employees, a quality
assurance/peer-review program, and policy and procedure manuals.
Section QG.00, Office of Counsel to the Inspector General--Mission
In accordance with section 3(g) of the Inspector General Act (5
U.S.C. App. Sec. 3(g)), the Office of Counsel to the Inspector General
(OCIG) provides all legal advice to OIG and represents OIG in
administrative litigation. OCIG proposes and litigates civil money
penalty (CMP) and program exclusion cases within the jurisdiction of
OIG. It coordinates False Claims Act matters involving HHS programs and
resolves voluntary disclosure cases. OCIG develops guidance to assist
providers in establishing compliance programs; monitors ongoing
compliance of providers subject to integrity agreements; and promotes
industry awareness through advisory opinions, fraud alerts, and special
advisory bulletins.
Section QG.10, Office of Counsel to the Inspector General--Organization
OCIG is directed by the Chief Counsel to the Inspector General, who
also serves as OIG's Deputy Ethics Counselor and is aided by Assistant
Inspectors General. The office carries out its responsibilities through
headquarters functions.
Section QG.20, Office of Counsel to the Inspector General--Functions
OCIG provides legal advice to OIG on issues that arise in the
exercise of OIG's responsibilities under the Inspector General Act of
1978, as amended. Such issues include the scope and exercise of the
Inspector General's authorities and responsibilities; investigative
techniques and procedures (including criminal procedure); the
sufficiency and impact of legislative proposals affecting OIG and HHS;
and the conduct and resolution of investigations, audits, and
inspections. The office evaluates the legal sufficiency of OIG findings
and recommendations and develops formal legal opinions to support these
findings and recommendations. The office also provides legal advice on
OIG internal administration and operations, including appropriations,
procurement, delegations of authority, OIG regulations, personnel
matters, disclosure of information under the Freedom of Information Act
(FOIA), and safeguarding information under the Privacy Act.
Additionally, OCIG coordinates OIG's regulatory review functions
required by the Inspector General Act and responses to all requests
made under FOIA. The office is responsible for the clearance and
enforcement of OIG subpoenas.
The office represents OIG in administrative litigation and related
appeals. This includes representing OIG in personnel and Equal
Employment Opportunity matters; coordinating OIG's representation in
Federal tort actions involving OIG employees; and representing OIG in
bid protests before the Government Accountability Office and the U.S.
Court of Federal Claims.
OCIG also determines whether to propose or implement administrative
sanctions, including CMPs and assessments within OIG's jurisdiction.
The office effectuates mandatory and permissive exclusions from
participation in Federal health care programs under the Social Security
Act; decides on all requests for reinstatement from, or waiver of,
exclusions; and participates in developing standards governing the
imposition of these exclusion authorities. The office also oversees
OIG's suspension and debarment referral program. The office litigates
and resolves all appealed or contested exclusions from participation in
Federal health care programs under the Social Security Act. In
conjunction with DOJ, the office represents HHS in all False Claims Act
cases, including qui tam cases, and is responsible for final approval
of civil False Claims Act settlements for the Department, including the
resolution of the program exclusion authorities that have been
delegated to OIG.
In conjunction with the Office of Investigations, OCIG coordinates
resolution of all voluntary and mandatory disclosure under OIG's
Provider Self-Disclosure Protocol, the contractor self-disclosure
requirement and otherwise. OCIG develops and monitors corporate and
individual integrity agreements adopted in connection with settlement
agreements, conducts onsite reviews, and develops audit and
investigative review standards for monitoring such integrity agreements
in conjunction with other OIG components. The office also resolves
breaches of integrity agreements through the development of corrective
action plans and the imposition of sanctions.
OCIG, through the Whistleblower Protection Coordinator, provides
education to agency employees about prohibitions against whistleblower
retaliation, and the rights and remedies available for such matters.
Finally, OCIG issues advisory opinions to the health care industry
and members of the public on whether a current or proposed activity
would constitute grounds for the imposition of a sanction under the
anti-kickback statute, the CMP law, or the program exclusion
authorities. The office develops procedures for submitting and
processing requests for advisory opinions and for determining the fees
that will be imposed. It solicits and responds to proposals for new
regulatory safe harbors to the anti-kickback statute, modifications to
existing safe harbors, and new fraud alerts. OCIG consults with DOJ on
proposed advisory opinions and safe harbors before issuance or
publication. The office provides legal advice to the components of OIG,
other HHS offices, and DOJ concerning matters involving the
interpretation of the anti-kickback statute and other legal
authorities, and assists those components or offices in analyzing the
applicability of the anti-kickback statute to particular practices or
activities under review.
Section QH.00, Office of Audit Services--Mission
The Office of Audit Services (OAS) is responsible for protecting
the integrity of HHS operations and programs by conducting audits that
identify and report ways to improve the economy, efficiency, and
effectiveness of operations and services to beneficiaries of HHS
programs and to help reduce fraud, waste, abuse, and mismanagement. OAS
conducts audits and oversees audit work performed by others. It
conducts its work in accordance with Government Auditing Standards and
follows applicable legal, regulatory, and administrative requirements.
Section QH.10, Office of Audit Services--Organization
OAS is directed by the Deputy Inspector General for Audit Services,
[[Page 16375]]
who, aided by Assistant Inspectors General, performs the functions
designated in section 3(d)(1)(A) of the Inspector General Act for the
position of Assistant Inspector General for Auditing. The office
comprises headquarters and regional functions and includes a designated
Whistleblower Protection Ombudsman, and the functions thereof, as
required by law (section 3(d)(1)(C) of the Inspector General Act).
Section QH.20, Office of Audit Services--Functions
OAS establishes audit priorities; performs audits; oversees the
progress of audits; coordinates with stakeholders on bodies of work;
recommends changes in program policies, regulations, and legislation to
prevent fraud, waste, and abuse and improve programs and operations;
and reports on the impact of audit work. The office develops audit
policies, procedures, techniques, and guidelines to be followed by all
OAS staff in conducting audits. OAS maintains an internal quality
assurance program, conducts peer reviews of other OIGs, and maintains
automated data and management information systems used by all OAS
employees. The office also provides oversight for audits of State and
local governments, universities, and nonprofit organizations conducted
by non-Federal auditors.
Section QJ.00, Office of Investigations--Mission
The Office of Investigations (OI) is granted full statutory law
enforcement authority under the Homeland Security Act of 2003 (Pub. L.
107-296). OI is responsible for protecting the integrity of the
programs administered and/or funded by HHS by conducting criminal,
civil, and administrative investigations of fraud and misconduct
related to HHS programs, operations, and employees. The office serves
as OIG's liaison to DOJ on all matters relating to investigations of
HHS programs and personnel and reports to the Attorney General when
there are reasonable grounds to believe Federal criminal law has been
violated. OI serves as a liaison to CMS, State licensing boards, and
other outside organizations and entities with regard to exclusion,
compliance, and enforcement activities.
Section QJ.10, Office of Investigations--Organization
OI is directed by the Deputy Inspector General for Investigations,
aided by Assistant Inspectors General, and performs the functions
designated in the law (section 3(d)(1)(B) of the Inspector General Act)
for the position of Assistant Inspector General for Investigations. The
office is comprised of headquarters and regional functions.
Section QJ.20, Office of Investigations--Functions
OI conducts criminal, civil, and administrative investigations of
allegations of fraud, waste, abuse, mismanagement, and violations of
standards of conduct within the jurisdiction of OIG. OI establishes
investigative priorities, evaluates the progress of investigations, and
reports findings to the Inspector General. The office develops and
implements investigative techniques, programs, guidelines, and
policies; manages OI's quality assurance/peer-review program, and
conducts peer reviews of other OIGs. OI also carries out and maintains
an internal quality assurance system. The system includes quality
assessment studies and quality control reviews of OI processes and
products to ensure that policies and procedures are followed
effectively and are functioning as intended. OI implements policies and
procedures and plans, develops, implements, and evaluates all levels of
training for OI employees. The staff provides for the personal
protection of the Secretary and other Department officials, as needed,
and all emergency operations preparedness and response. OI coordinates
the adoption of advanced digital forensic acquisition and examination
and information security technologies to assist in the investigation,
prevention, and detection of fraud and abuse; maintains an automated
data and management information system used by all OI employees;
provides technical expertise on computer applications for
investigations; and coordinates and approves investigative computer
matches with other agencies. In addition, the office operates a toll-
free hotline to permit individuals to report suspected fraud, waste,
and abuse within HHS programs.
Dated: March 17, 2020.
Christi A. Grimm,
Principal Deputy Inspector General.
[FR Doc. 2020-06046 Filed 3-20-20; 8:45 am]
BILLING CODE 4152-01-P