Statement of Organization, Functions, and Delegations of Authority, 16372-16375 [2020-06046]

Download as PDF 16372 Federal Register / Vol. 85, No. 56 / Monday, March 23, 2020 / Notices 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] BILLING CODE 4164–01–P jbell on DSKJLSW7X2PROD with NOTICES 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: VerDate Sep<11>2014 17:26 Mar 20, 2020 Jkt 250001 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: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 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] BILLING CODE 4150–28–P 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: E:\FR\FM\23MRN1.SGM 23MRN1 Federal Register / Vol. 85, No. 56 / Monday, March 23, 2020 / Notices 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. jbell on DSKJLSW7X2PROD with NOTICES 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. VerDate Sep<11>2014 17:26 Mar 20, 2020 Jkt 250001 16373 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. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 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. E:\FR\FM\23MRN1.SGM 23MRN1 16374 Federal Register / Vol. 85, No. 56 / Monday, March 23, 2020 / Notices 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. jbell on DSKJLSW7X2PROD with NOTICES 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 VerDate Sep<11>2014 17:26 Mar 20, 2020 Jkt 250001 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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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, E:\FR\FM\23MRN1.SGM 23MRN1 Federal Register / Vol. 85, No. 56 / Monday, March 23, 2020 / Notices 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. jbell on DSKJLSW7X2PROD with NOTICES 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 VerDate Sep<11>2014 17:26 Mar 20, 2020 Jkt 250001 16375 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] BILLING CODE 4152–01–P PO 00000 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] BILLING CODE 4140–01–P Frm 00063 Fmt 4703 Sfmt 9990 E:\FR\FM\23MRN1.SGM 23MRN1

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]


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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

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