45 CFR Parts 160 & 164 (CFR Annual Edition) reliance on fully licensed physicians, and on physician assist- ants, nurse practitioners and other non-physician personnel in an ex- panded role in the delivery of health care, such as admission patient his- tories, making patient rounds, record- ing patient progress notes, doing the initial and follow-up evaluation of pa- tients, performing routine laboratory and related studies, or (2) Utilization of the team approach to health care delivery (individuals functioning as an integral part of an interprofessional team of health per- sonnel organized under the leadership of a physician working toward more ef- ficient and/or more effective delivery of health services). (c) The extent to which changes (in- cluding improvement of educational and medical services) have been consid- ered and which have been or will be ap- plied to make the program more at- tractive to graduates of medical schools who are citizens of the United States, as demonstrated, for example, by: (1) Adding additional services to the existing programs to provide a broader educational experience for residents, (2) Expanding affiliations with other residency programs to offer a broader experience for residents, (3) Exp rvices to the existing programs to provide a broader educational experience for residents, (2) Expanding affiliations with other residency programs to offer a broader experience for residents, (3) Expanding undergraduate clerk- ships to provide a broader educational experience. (4) Creating or modifying administra- tive units which will provide broader clinical experiences, or (5) Initiating research projects. (d) The adequacy of the recruitment efforts which have been and will be un- dertaken to attract graduates of med- ical schools who are citizens of the United States, as demonstrated, for ex- ample, by: (1) Broad-based advertisement of the program and of the institution through notices in journals, contacts with med- ical schools, etc. (2) Forming committees for the pur- pose of recruiting U.S. citizens. (3) Working with national organiza- tions which are involved with medical students and U.S. graduate medical trainees, e.g., the American Medical Student Association and the Physician National House Staff Association, to attract U.S. citizens. (e) The extent to which the program on a year-by-year basis has phased down its dependence upon aliens who are graduates of foreign med cian National House Staff Association, to attract U.S. citizens. (e) The extent to which the program on a year-by-year basis has phased down its dependence upon aliens who are graduates of foreign medical schools so that the program will not be dependent upon the admission to the program of any additional such aliens after December 31, 1983. 164 Dept. of Health and Human Services Pt. 60 PART 57—VOLUNTEER SERVICES Sec. 57.1 Applicability. 57.2 Definitions. 57.3 Volunteer service programs. 57.4 Acceptance and use of volunteer serv- ices. 57.5 Services and benefits available to vol- unteers. AUTHORITY: Sec. 223, 58 Stat. 683, as amend- ed by 81 Stat. 539: 42 U.S.C. 217b. SOURCE: 34 FR 13868, Aug. 29, 1969, unless otherwise noted. § 57.1 Applicability. The regulations in this part apply to the acceptance of volunteer and un- compensated services for use in the op- eration of any health care facility of the Department or in the provision of health care. § 57.2 Definitions. As used in the regulations in this part: Secretary means the Secretary of Health and Human Services. Department means the Department of Health and Human Services. Volunteer services are services per- formed by individ gulations in this part: Secretary means the Secretary of Health and Human Services. Department means the Department of Health and Human Services. Volunteer services are services per- formed by individuals (hereafter called volunteers) whose services have been offered to the Government and accept- ed under a formal agreement on a with- out compensation basis for use in the operation of a health care facility or in the provision of health care. Health care means services to pa- tients in Department facilities, bene- ficiaries of the Federal Government, or individuals or groups for whom health services are authorized under the pro- grams of the Department. Health care facility means a hospital, clinic, health center, or other facility established for the purpose of providing health care. used to supplement, but not to take the place of, personnel whose services are obtained through the usual employ- ment procedures. § 57.4 Acceptance and use of volunteer services. The Secretary, or his designee, shall establish requirements for: Accepting volunteer services from individuals or groups of individuals, using volunteer services, giving appropriate recogni- tion to volunteers, and maintain signee, shall establish requirements for: Accepting volunteer services from individuals or groups of individuals, using volunteer services, giving appropriate recogni- tion to volunteers, and maintaining records of volunteer services. § 57.5 Services and benefits available to volunteers. (a) The following provisions of law may be applicable to volunteers whose services are offered and accepted under the regulations in this part: (1) Subchapter I of Chapter 81 of Title 5 of the United States Code relating to medical services for work related inju- ries; (2) Title 28 of the United States Code relating to tort claims; (3) Section 7903 of Title 5 of the United States Code relating to protec- tive clothing and equipment; and (4) Section 5703 of Title 5 of the United States Code relating to travel and transportation expenses. (b) Volunteers may also be provided such other benefits as are authorized by law or by administrative action of the Secretary or his designee. PART 60—NATIONAL PRACTITIONER DATA BANK Subpart A—General Provisions Sec. 60.1 The National Practitioner Data Bank. 60.2 Applicability. 60.3 Definitions. Subpart B—Reporting of Information § 57.3 Volunteer service programs. P ONER DATA BANK Subpart A—General Provisions Sec. 60.1 The National Practitioner Data Bank. 60.2 Applicability. 60.3 Definitions. Subpart B—Reporting of Information § 57.3 Volunteer service programs. Programs for the use of volunteer services may be established by the Sec- retary, or his designee, to broaden and strengthen the delivery of health serv- ices, contribute to the comfort and well being of patients in Department hospitals or clinics, or expand the serv- ices required in the operation of a health care facility. Volunteers may be 60.4 How information must be reported. 60.5 When information must be reported. 60.6 Reporting errors, omissions, revisions, or whether an action is on appeal. 60.7 Reporting medical malpractice pay- ments. 60.8 Reporting licensure actions taken by Boards of Medical Examiners. 60.9 Reporting licensure and certification actions taken by states. 60.10 Reporting Federal licensure and cer- tification actions. 165 § 60.1 45 CFR Subtitle A (10–1–24 Edition) 60.11 Reporting negative actions or findings taken by peer review organizations or private accreditation entities. 60.12 Reporting adverse actions taken against clinical privileges. 60.13 Reporting Fed 0.11 Reporting negative actions or findings taken by peer review organizations or private accreditation entities. 60.12 Reporting adverse actions taken against clinical privileges. 60.13 Reporting Federal or state criminal convictions related to the delivery of a health care item or service. 60.14 Reporting civil judgments related to the delivery of a health care item or service. 60.15 Reporting exclusions from participa- tion in Federal or state health care pro- grams. 60.16 Reporting other adjudicated actions or decisions. Subpart C—Disclosure of Information by the National Practitioner Data Bank 60.17 Information which hospitals must re- quest from the National Practitioner Data Bank. 60.18 Requesting information from the Na- tional Practitioner Data Bank. 60.19 Fees applicable to requests for infor- mation. 60.20 Confidentiality of National Practi- tioner Data Bank information. 60.21 How to dispute the accuracy of Na- tional Practitioner Data Bank informa- tion. 60.22 Immunity. AUTHORITY: 42 U.S.C. 11101–11152; 42 U.S.C. 1396r–2; 42 U.S.C. 1320a–7e SOURCE: 78 FR 20484, Apr. 5, 2013, unless otherwise noted. Subpart A—General Provisions § 60.1 The National Practitioner Data Bank. HORITY: 42 U.S.C. 11101–11152; 42 U.S.C. 1396r–2; 42 U.S.C. 1320a–7e SOURCE: 78 FR 20484, Apr. 5, 2013, unless otherwise noted. Subpart A—General Provisions § 60.1 The National Practitioner Data Bank. The Health Care Quality Improve- ment Act of 1986 (HCQIA), as amended, title IV of Public Law 99–660 (42 U.S.C. 11101 et seq.) (hereinafter referred to as ‘‘title IV’’), authorizes the Secretary to establish (either directly or by con- tract) a National Practitioner Data Bank (NPDB) to collect and release certain information relating to the professional competence and conduct of physicians, dentists, and other health care practitioners. Section 1921 of the Social Security Act (hereinafter referred to as ‘‘section 1921’’), as amended, (42 U.S.C. 1396r–2) expanded the requirements under the NPDB and requires each state to adopt a system of reporting to the Secretary adverse licensure or certification actions taken against health care practitioners, to health care entities, providers, and suppliers, as well as certain final ad- verse actions taken by state law and fraud enforcement agencies against health care practitioners, providers, and suppliers. Section 1128E of the So- cial Securit ppliers, as well as certain final ad- verse actions taken by state law and fraud enforcement agencies against health care practitioners, providers, and suppliers. Section 1128E of the So- cial Security Act (hereinafter referred to as ‘‘section 1128E’’), as amended, (42 U.S.C. 1320a–7e) authorizes the Sec- retary implement a national healthcare fraud and abuse data collec- tion program for the reporting and dis- closing of certain final adverse actions taken by Federal Government agencies and health plans against health care practitioners, providers, and suppliers. Information from section 1921 and sec- tion 1128E is to be reported and distrib- uted through the NPDB. The regula- tions in this part set forth the report- ing and disclosure requirements for the NPDB, as well as procedures to dispute the accuracy of information contained in the NPDB. [78 FR 20484, Apr. 5, 2013, 78 FR 25860, May 6, 2013] § 60.2 Applicability. The regulations in this part establish reporting requirements applicable to hospitals, health care entities, Boards of Medical Examiners, and professional societies of health care practitioners which take adverse licensure or profes- sional review actions; state lic icable to hospitals, health care entities, Boards of Medical Examiners, and professional societies of health care practitioners which take adverse licensure or profes- sional review actions; state licensing or certification authorities, peer re- view organizations, and private accred- itation entities that take licensure or certification actions or negative ac- tions or findings against health care practitioners, health care entities, pro- viders, or suppliers; entities (including insurance companies) making pay- ments as a result of medical mal- practice actions or claims; and Federal government agencies, state law and fraud enforcement agencies and health plans that take final adverse actions against health care practitioners, pro- viders, and suppliers. They also estab- lish procedures to enable individuals or entities to obtain information from the NPDB or to dispute the accuracy of NPDB information. [78 FR 20484, Apr. 5, 2013, 78 FR 25860, May 6, 2013] 166 Dept. of Health and Human Services § 60.3 § 60.3 Definitions. Adversely affecting means reducing, restricting, suspending, revoking, or denying clinical privileges or member- ship in a health care entity. relationship. This n Services § 60.3 § 60.3 Definitions. Adversely affecting means reducing, restricting, suspending, revoking, or denying clinical privileges or member- ship in a health care entity. relationship. This Affiliated or associated refers to health care entities with which a subject of a final adverse action has a business or professional in- cludes, but is not limited to, organiza- tions, associations, corporations, or partnerships. This also includes a pro- fessional corporation or other business entity composed of a single individual. Board of Medical Examiners, or Board, means a body or subdivision of such body which is designated by a state for the purpose of licensing, monitoring, and disciplining physicians or dentists. This term includes a Board of Osteo- pathic Examiners or its subdivision, a Board of Dentistry or its subdivision, or an equivalent body as determined by the state. Where the Secretary, pursu- ant to section 423(c)(2) of the HCQIA (42 U.S.C. 11112(c)), has designated an al- ternate entity to carry out the report- ing activities of § 60.12 of this part due to a Board’s failure to comply with § 60.8 of this part, the term Board of Medical Examiners or Board refers to al- ternate entity to carry out the report- ing activities of § 60.12 of this part due to a Board’s failure to comply with § 60.8 of this part, the term Board of Medical Examiners or Board refers to this alternate entity. Civil judgment means a court-ordered action rendered in a Federal or state court proceeding, other than a criminal proceeding. This reporting requirement does not include Consent Judgments that have been agreed upon and en- tered to provide security for civil set- tlements in which there was no finding or admission of liability. Clinical privileges means the author- ization by a health care entity to a health care practitioner for the provi- sion of health care services, including privileges and membership on the med- ical staff. Criminal conviction means a convic- tion as described in section 1128(i) of the Social Security Act. Dentist means a doctor of dental sur- gery, doctor of dental medicine, or the equivalent who is legally authorized to practice dentistry by a state (or who, without authority, holds himself or herself out to be so authorized). Exclusion means a temporary or per- manent debarment of an individual or entity from participation in any Fed- er a state (or who, without authority, holds himself or herself out to be so authorized). Exclusion means a temporary or per- manent debarment of an individual or entity from participation in any Fed- eral or state health-related program, in accordance with which items or serv- ices furnished by such person or entity will not be reimbursed under any Fed- eral or state health-related program. Federal Government agency includes, but is not limited to: (1) The U.S. Department of Justice; (2) The U.S. Department of Health and Human Services; (3) Federal law enforcement agencies, including law enforcement investiga- tors; (4) Any other Federal agency that ei- ther administers or provides payment for the delivery of health care services, including, but not limited to the U.S. Department of Defense and the U.S. Department of Veterans Affairs; and (5) Federal agencies responsible for the licensing and certification of health care practitioners, providers, and suppliers. Formal peer review process means the conduct of professional review activi- ties through formally adopted written procedures which provide for adequate notice and an opportunity for a hear- ing. Formal proceeding means a proce means the conduct of professional review activi- ties through formally adopted written procedures which provide for adequate notice and an opportunity for a hear- ing. Formal proceeding means a proceeding held before a state licensing or certifi- cation authority, peer review organiza- tion, or private accreditation entity that maintains defined rules, policies, or procedures for such a proceeding. Health care entity means, for purposes of this part: (1) A hospital; (2) An entity that provides health care services, and engages in profes- sional review activity through a formal peer review process for the purpose of furthering quality health care, or a committee of that entity; or (3) A professional society or a com- mittee or agent thereof, including those at the national, state, or local level, of health care practitioners that engages in professional review activity through a formal peer review process, for the purpose of furthering quality health care. (4) For purposes of paragraph (2) of this definition, an entity includes: a health maintenance organization which is licensed by a state or deter- mined to be qualified as such by the Department of Health and Human Services; and (2) of this definition, an entity includes: a health maintenance organization which is licensed by a state or deter- mined to be qualified as such by the Department of Health and Human Services; and any group or prepaid 167 § 60.3 45 CFR Subtitle A (10–1–24 Edition) medical or dental practice which meets the criteria of paragraph (2). Health care practitioner, licensed health care practitioner, licensed practitioner, or practitioner means an individual who is licensed or otherwise authorized by a state to provide health care services (or any individual who, without au- thority, holds himself or herself out to be so licensed or authorized). Health care provider means, for pur- poses of this part, a provider of services as defined in section 1861(u) of the So- cial Security Act; any organization (in- cluding a health maintenance organi- zation, preferred provider organization or group medical practice) that pro- vides health care services and follows a formal peer review process for the pur- pose of furthering quality health care, and any other organization that, di- rectly or through contracts, provides health care services. Health care supplier means, for pur- poses of this part, pur- pose of furthering quality health care, and any other organization that, di- rectly or through contracts, provides health care services. Health care supplier means, for pur- poses of this part, a provider of medical and other health care services as de- scribed in section 1861(s) of the Social Security Act; or any individual or enti- ty, other than a provider, who fur- nishes, whether directly or indirectly, or provides access to, health care serv- ices, supplies, items, or ancillary serv- ices (including, but not limited to, du- rable medical equipment suppliers, manufacturers of health care items, pharmaceutical suppliers and manufac- turers, health record services [such as medical, dental, and patient records], health data suppliers, and billing and transportation service suppliers). The term also includes any individual or entity under contract to provide such supplies, items, or ancillary services; health plans as defined in this section (including employers that are self-in- sured); and health insurance producers (including but not limited to agents, brokers, solicitors, consultants, and re- insurance intermediaries). Health plan means, for purposes of this part, a plan - sured); and health insurance producers (including but not limited to agents, brokers, solicitors, consultants, and re- insurance intermediaries). Health plan means, for purposes of this part, a plan, program or organiza- tion that provides health benefits, whether directly, through insurance, reimbursement or otherwise, and in- cludes but is not limited to: (1) A policy of health insurance; (2) A contract of a service benefit or- ganization; (3) A membership agreement with a health maintenance organization or other prepaid health plan; (4) A plan, program, agreement, or other mechanism established, main- tained, or made available by a self-in- sured employer or group of self-insured employers, a health care practitioner, provider, or supplier group, third-party administrator, integrated health care delivery system, employee welfare as- sociation, public service group or orga- nization or professional association; (5) An insurance company, insurance service, or insurance organization that is licensed to engage in the business of selling health care insurance in a state and which is subject to state law which regulates health insurance; and (6) An organization that provides benefit that is licensed to engage in the business of selling health care insurance in a state and which is subject to state law which regulates health insurance; and (6) An organization that provides benefit plans whose coverage is limited to outpatient prescription drugs. Hospital means, for purposes of this part, an entity described in paragraphs (1) and (7) of section 1861(e) of the So- cial Security Act. Medical malpractice action or claim means a written complaint or claim de- manding payment based on a health care practitioner’s provision of or fail- ure to provide health care services, and includes the filing of a cause of action based on the law of tort, brought in any state or Federal court or other ad- judicative body. Negative action or finding by a Federal or State licensing or certification au- thority, peer review organization, or private accreditation entity means: (1) A final determination of denial or termination of an accreditation status from a private accreditation entity that indicates a risk to the safety of a patient(s) or quality of health care services; (2) Any recommendation by a peer re- view organization to sanction a health care practitioner; or (3) Any negati that indicates a risk to the safety of a patient(s) or quality of health care services; (2) Any recommendation by a peer re- view organization to sanction a health care practitioner; or (3) Any negative action or finding that, under the state’s law, is publicly available information and is rendered by a licensing or certification author- ity, including but not limited to, limi- tations on the scope of practice, liq- uidations, injunctions, and forfeitures. This definition also includes final ad- verse actions rendered by a Federal or state licensing or certification author- ity, such as exclusions, revocations, or 168 Dept. of Health and Human Services § 60.3 suspension of license or certification, that occur in conjunction with settle- ments in which no finding of liability has been made (although such a settle- ment itself is not reportable under the statute). This definition excludes ad- ministrative fines or citations and cor- rective action plans and other per- sonnel actions, unless they are: (i) Connected to the delivery of health care services; or (ii) Taken in conjunction with other adverse licensure or certification ac- tions such as revocation, suspension, censure, repri ess they are: (i) Connected to the delivery of health care services; or (ii) Taken in conjunction with other adverse licensure or certification ac- tions such as revocation, suspension, censure, reprimand, probation, or sur- render. Organization name means the sub- ject’s business or employer at the time the underlying acts occurred. If more than one business or employer is appli- cable, the one most closely related to the underlying acts should be reported as the ‘‘organization name,’’ with the others being reported as ‘‘affiliated or associated health care entities.’’ Organization type means a description of the nature of that business or em- ployer. Other adjudicated actions or decisions means formal or official final actions taken against a health care practi- tioner, provider, or supplier by a Fed- eral governmental agency, a state law or fraud enforcement agency, or a health plan, which include the avail- ability of a due process mechanism, and are based on acts or omissions that affect or could affect the payment, pro- vision, or delivery of a health care item or service. For example, a formal or of- ficial final action taken by a Federal governmental agency, a state law or affect or could affect the payment, pro- vision, or delivery of a health care item or service. For example, a formal or of- ficial final action taken by a Federal governmental agency, a state law or fraud enforcement agency, or a health plan may include, but is not limited to, a personnel-related action such as sus- pensions without pay, reductions in pay, reductions in grade for cause, ter- minations, or other comparable ac- tions. A hallmark of any valid adju- dicated action or decision is the avail- ability of a due process mechanism. The fact that the subject elects not to use the due process mechanism pro- vided by the authority bringing the ac- tion is immaterial, as long as such a process is available to the subject be- fore the adjudicated action or decision is made final. In general, if an ‘‘adju- dicated action or decision’’ follows an agency’s established administrative procedures (which ensure that due process is available to the subject of the final adverse action), it would qual- ify as a reportable action under this definition. This definition specifically excludes clinical privileging actions taken by Federal Government agencies or state law and fraud enforcement a uld qual- ify as a reportable action under this definition. This definition specifically excludes clinical privileging actions taken by Federal Government agencies or state law and fraud enforcement agencies and similar paneling decisions made by health plans. This definition does not include overpayment deter- minations made by Federal or state government programs, their contrac- tors or health plans, and it does not in- clude denial of claims determinations made by Federal Government agencies, state law or fraud enforcement agen- cies, or health plans. This definition also does not include business or ad- ministrative decisions taken by health plans that result in contract termi- nations unrelated to health care fraud or abuse or quality of care (e.g., when a practitioner’s contract is terminated because the practitioner no longer practices at a facility in the health plan’s network, or a health plan termi- nates all provider contracts in a cer- tain geographic area because it ceases business operations in that area). For health plans that are not government entities, an action taken following ade- quate notice and the opportunity for a hearing that meets the standards of due pro business operations in that area). For health plans that are not government entities, an action taken following ade- quate notice and the opportunity for a hearing that meets the standards of due process set out in section 412(b) of the HCQIA (42 U.S.C. 11112(b)) also would qualify as a reportable action under this definition. Peer review organization means, for purposes of this part, an organization with the primary purpose of evaluating the quality of patient care practices or services ordered or performed by health care practitioners measured against objective criteria which define accept- able and adequate practice through an evaluation by a sufficient number of health care practitioners in such an area to ensure adequate peer review. The organization has due process mechanisms available to health care practitioners. This definition excludes utilization and quality control peer re- view organizations described in Part B of Title XI of the Social Security Act 169 § 60.3 45 CFR Subtitle A (10–1–24 Edition) (referred to as QIOs) and other organi- zations funded by the Centers for Medi- care & Medicaid Services (CMS) to sup- port the QIO program. Physician means, for purposes of t itle A (10–1–24 Edition) (referred to as QIOs) and other organi- zations funded by the Centers for Medi- care & Medicaid Services (CMS) to sup- port the QIO program. Physician means, for purposes of this part, a doctor of medicine or osteop- athy legally authorized to practice medicine or surgery by a state (or who, without authority, holds himself or herself out to be so authorized). Private accreditation entity means an entity or organization that: (1) Evaluates and seeks to improve the quality of health care provided by a health care entity, provider, or sup- plier; (2) Measures a health care entity’s, provider’s, or supplier’s performance based on a set of standards and assigns a level of accreditation; (3) Conducts ongoing assessments and periodic reviews of the quality of health care provided by a health care entity, provider, or supplier; and (4) Has due process mechanisms available to health care entities, pro- viders, or suppliers. Professional review action means an action or recommendation of a health care entity: (1) Taken in the course of profes- sional review activity; (2) Based on the professional com- petence or professional conduct of an individual health care prac recommendation of a health care entity: (1) Taken in the course of profes- sional review activity; (2) Based on the professional com- petence or professional conduct of an individual health care practitioner which affects or could affect adversely the health or welfare of a patient or pa- tients; and (3) Which adversely affects or may adversely affect the clinical privileges or membership in a professional soci- ety of the health care practitioner. (4) This term excludes actions which are primarily based on: (i) The health care practitioner’s as- sociation, or lack of association, with a professional society or association; (ii) The health care practitioner’s fees or the health care practitioner’s advertising or engaging in other com- petitive acts intended to solicit or re- tain business; (iii) The health care practitioner’s participation in prepaid group health plans, salaried employment, or any other manner of delivering health serv- ices whether on a fee-for-service or other basis; (iv) A health care practitioner’s asso- ciation with, supervision of, delegation of authority to, support for, training of, or participation in a private group practice with, a member or members of ; (iv) A health care practitioner’s asso- ciation with, supervision of, delegation of authority to, support for, training of, or participation in a private group practice with, a member or members of a particular class of health care practi- tioner or professional; or (v) Any other matter that does not relate to the competence or profes- sional conduct of a health care practi- tioner. Professional review activity means an activity of a health care entity with re- spect to an individual health care prac- titioner: (1) To determine whether the health care practitioner may have clinical privileges with respect to, or member- ship in, the entity; (2) To determine the scope or condi- tions of such privileges or membership; or (3) To change or modify such privi- leges or membership. Quality Improvement Organization means a utilization and quality control peer review organization (as defined in part B of title XI of the Social Security Act) that: (1)(i) Is composed of a substantial number of the licensed doctors of medi- cine and osteopathy engaged in the practice of medicine or surgery in the area and who are representative of the practicing physicians in the area, des- ignated by the Se the licensed doctors of medi- cine and osteopathy engaged in the practice of medicine or surgery in the area and who are representative of the practicing physicians in the area, des- ignated by the Secretary under section 1153, with respect to which the entity shall perform services under this part, or (ii) Has available to it, by arrange- ment or otherwise, the services of a sufficient number of licensed doctors of medicine or osteopathy engaged in the practice of medicine or surgery in such area to assure that adequate peer re- view of the services provided by the various medical specialties and sub- specialties can be assured; (2) Is able, in the judgment of the Secretary, to perform review functions required under section 1154 in a manner consistent with the efficient and effec- tive administration of this part and to perform reviews of the pattern of qual- ity of care in an area of medical prac- tice where actual performance is meas- ured against objective criteria which define acceptable and adequate prac- tice; and 170 Dept. of Health and Human Services § 60.5 (3) Has at least one individual who is a representative of consumers on its governing body. Secretary means the Secr ceptable and adequate prac- tice; and 170 Dept. of Health and Human Services § 60.5 (3) Has at least one individual who is a representative of consumers on its governing body. Secretary means the Secretary of Health and Human Services and any other officer or employee of the De- partment of Health and Human Serv- ices to whom the authority involved has been delegated. State means the fifty states, the Dis- trict of Columbia, Puerto Rico, the Islands, Guam, American Virgin Samoa, and the Northern Mariana Is- lands. State law or fraud enforcement agency includes, but is not limited to: (1) A state law enforcement agency; (2) A state Medicaid fraud control unit (as defined in section 1903(q) of the Social Security Act); and (3) A state agency administering (in- cluding those providing payment for services) or supervising the administra- tion of a state health care program (as defined in section 1128(h) of the Social Security Act). State licensing or certification agency includes, but is not limited to, any au- thority of a state (or of a political sub- division thereof) responsible for the li- censing or certification of health care practitioners (or any peer review orga- nization or ot limited to, any au- thority of a state (or of a political sub- division thereof) responsible for the li- censing or certification of health care practitioners (or any peer review orga- nization or private accreditation entity reviewing the services provided by health care practitioners), health care entities, providers, or suppliers. Exam- ples of such state agencies include De- partments of Professional Regulation, Health, Social Services (including State Survey and Certification and Medicaid Single State agencies), Com- merce, and Insurance. Voluntary surrender of license or cer- tification means a surrender made after a notification of investigation or a for- mal official request by a Federal or state licensing or certification author- ity for a health care practitioner, health care entity, provider, or sup- plier to surrender the license or certifi- cation (including certification agree- ments or contracts for participation in Federal or state health care programs). The definition also includes those in- stances where a health care practi- tioner, health care entity, provider, or supplier voluntarily surrenders a li- cense or certification (including pro- gram participation on also includes those in- stances where a health care practi- tioner, health care entity, provider, or supplier voluntarily surrenders a li- cense or certification (including pro- gram participation agreements or con- tracts) in exchange for a decision by the licensing or certification authority to cease an investigation or similar proceeding, or in return for not con- ducting an investigation or proceeding, or in lieu of a disciplinary action. [78 FR 20484, Apr. 5, 2013, 78 FR 25860, May 6, 2013] Subpart B—Reporting of Information § 60.4 How information must be re- ported. Information must be reported to the NPDB as required under §§ 60.7, 60.8, 60.9, 60.10, 60.11, 60.12, 60.13, 60.14, 60.15 and 60.16 in such form and manner as the Secretary may prescribe. § 60.5 When information must be re- ported. Information required under §§ 60.7, 60.8, and 60.12 must be submitted to the NPDB within 30 days following the ac- tion to be reported, beginning with ac- tions occurring on or after September 1, 1990; information required under § 60.11 must be submitted to the NPDB within 30 days following the action to be reported, beginning with actions oc- curring on or after January 1, 1992; and ember 1, 1990; information required under § 60.11 must be submitted to the NPDB within 30 days following the action to be reported, beginning with actions oc- curring on or after January 1, 1992; and information required under §§ 60.9, 60.10, 60.13, 60.14, 60.15, and 60.16 must be submitted to the NPDB within 30 days following the action to be re- ported, beginning with actions occur- ring on or after August 21, 1996. Per- sons or entities responsible for submit- ting reports of malpractice payments (§ 60.7), negative actions or findings (§ 60.11), or adverse actions (§ 60.12) must additionally provide to their re- spective state authorities a copy of the report they submit to the NPDB. Fol- lowing is the list of reportable actions: (a) Malpractice payments (§ 60.7); (b) Licensure and certification ac- tions (§§ 60.8, 60.9, and 60.10); (c) Negative actions or findings (§ 60.11); (d) Adverse actions (§ 60.12); (e) Health Care-related Criminal Con- victions (§ 60.13); (f) Health Care-related Civil Judg- ments (§ 60.14); (g) Exclusions from Federal or state health care programs (§ 60.15); and 171 § 60.6 45 CFR Subtitle A (10–1–24 Edition) (h) Other adjudicated actions of deci- sions ( ated Civil Judg- ments (§ 60.14); (g) Exclusions from Federal or state health care programs (§ 60.15); and 171 § 60.6 45 CFR Subtitle A (10–1–24 Edition) (h) Other adjudicated actions of deci- sions (§ 60.16). [78 FR 20484, Apr. 5, 2013, 78 FR 25860, May 6, 2013] § 60.6 Reporting errors, omissions, re- visions or whether an action is on appeal. (a) Persons and entities are respon- sible for the accuracy of information which they report to the NPDB. If er- rors or omissions are found after infor- mation has been reported, the person or entity which reported it must send an addition or correction to the NPDB and, in the case of reports made under § 60.12 of this part, also to the Board of Medical Examiners, as soon as possible. The NPDB will not accept requests for readjudication of the case by the NPDB, and will not examine the under- lying merits of a reportable action. (b) An individual or entity which re- ports information on licensure or cer- tification, negative actions or findings, clinical privileges, criminal convic- tions, civil or administrative judg- ments, exclusions, or adjudicated ac- tions or decisions under § 60.8, § 60.9, § 60.10, § 60.11, § 60.12, § 60.13, § 60.14, , clinical privileges, criminal convic- tions, civil or administrative judg- ments, exclusions, or adjudicated ac- tions or decisions under § 60.8, § 60.9, § 60.10, § 60.11, § 60.12, § 60.13, § 60.14, § 60.15, or § 60.16 must also report any revision of the action originally re- ported. Revisions include, but are not limited to, reversal of a professional review action or reinstatement of a li- cense. In the case of actions reported under § 60.9, § 60.10, § 60.13, § 60.14, § 60.15 or § 60.16, revisions also include wheth- er an action is on appeal. Revisions are subject to the same time constraints and procedures of § 60.5, § 60.8, § 60.9, § 60.10, § 60.11, § 60.12, § 60.13, § 60.14, § 60.15, or § 60.16 as applicable to the original action which was reported. (c) The subject will be sent a copy of all reports, including revisions and cor- rections to the report. (d) Upon receipt of a report, the sub- ject: (1) Can accept the report as written; (2) May provide a statement to the NPDB that will be permanently ap- pended to the report, either directly or through a designated representative; (The NPDB will distribute the state- ment to queriers, where identifiable, and to the reporting at will be permanently ap- pended to the report, either directly or through a designated representative; (The NPDB will distribute the state- ment to queriers, where identifiable, and to the reporting entity and the subject of the report. Only the subject can, upon request, make changes to the statement. The NPDB will not edit the statement; however the NPDB reserves the right to redact personal identifying and offensive language that does not change the factual nature of the state- ment.); or (3) May follow the dispute process in accordance with § 60.21. [78 FR 20484, Apr. 5, 2013, 78 FR 25860, May 6, 2013] § 60.7 Reporting medical malpractice payments. (a) Who must report. Each entity, in- cluding an insurance company, which makes a payment under an insurance policy, self-insurance, or otherwise, for the benefit of a health care practi- tioner in settlement of or in satisfac- tion in whole or in part of a claim or a judgment against such health care practitioner for medical malpractice, must report information as set forth in paragraph (b) of this section to the NPDB and to the appropriate state li- censing board(s) in the state in which the act or omission upon which the medical ce, must report information as set forth in paragraph (b) of this section to the NPDB and to the appropriate state li- censing board(s) in the state in which the act or omission upon which the medical malpractice claim was based. For purposes of this section, the waiver of an outstanding debt is not construed as a ‘‘payment’’ and is not required to be reported. (b) What information must be reported. Entities described in paragraph (a) of this section must report the following information: (1) With respect to the health care practitioner for whose benefit the pay- ment is made: (i) Name, (ii) Work address, (iii) Home address, if known, (iv) Social Security Number, if known, and if obtained in accordance with section 7 of the Privacy Act of 1974 (5 U.S.C. 552a note), (v) Date of birth, (vi) Name of each professional school attended and year of graduation, (vii) For each professional license: the license number, the field of licen- sure, and the name of the state or ter- ritory in which the license is held, (viii) Drug Enforcement Administra- tion registration number, if known, and (ix) Name of each hospital with which he or she is affiliated, if known; 172 Dept. of Health and Human S he license is held, (viii) Drug Enforcement Administra- tion registration number, if known, and (ix) Name of each hospital with which he or she is affiliated, if known; 172 Dept. of Health and Human Services § 60.8 (2) With respect to the reporting enti- ty: (i) Name and address of the entity making the payment, (ii) Name, title, and telephone num- ber of the responsible official submit- ting the report on behalf of the entity, and (iii) Relationship of the reporting en- tity to the health care practitioner for whose benefit the payment is made; (3) With respect to the judgment or settlement resulting in the payment: (i) Where an action or claim has been filed with an adjudicative body, identi- fication of the adjudicative body and the case number, (ii) Date or dates on which the act(s) or omission(s) which gave rise to the action or claim occurred, (iii) Date of judgment or settlement, (iv) Amount paid, date of payment, and whether payment is for a judgment or a settlement, (v) Description and amount of judg- ment or settlement and any conditions attached thereto, including terms of payment, (vi) A description of the acts or omis- sions and injuries or illnesses upon which the act ption and amount of judg- ment or settlement and any conditions attached thereto, including terms of payment, (vi) A description of the acts or omis- sions and injuries or illnesses upon which the action or claim was based, (vii) Classification of the acts or omissions in accordance with a report- ing code adopted by the Secretary, and (viii) Other information as required by the Secretary from time to time after publication in the FEDERAL REG- ISTER and after an opportunity for pub- lic comment. (c) Sanctions. Any entity that fails to report information on a payment re- quired to be reported under this section is subject to a civil money penalty not to exceed the amount specified at 42 CFR 1003.103(c). (d) Interpretation of information. A payment in settlement of a medical malpractice action or claim shall not be construed as creating a presumption that medical malpractice has occurred. [78 FR 20484, Apr. 5, 2013, 78 FR 25860, May 6, 2013] § 60.8 Reporting actions taken by Boards of Medical Exam- iners. licensure (a) What actions must be reported. Each Board of Medical Examiners must report to the NPDB any action based on reasons relating to a physician’s or dentist’s professional dical Exam- iners. licensure (a) What actions must be reported. Each Board of Medical Examiners must report to the NPDB any action based on reasons relating to a physician’s or dentist’s professional competence or professional conduct: (1) Which revokes or suspends (or otherwise restricts) a physician’s or dentist’s license, (2) Which censures, reprimands, or places on probation a physician or den- tist, or (3) Under which a physician’s or den- tist’s license is surrendered. (b) Information that must be reported. The Board must report the following information for each action: (1) The physician’s or dentist’s name, (2) The physician’s or dentist’s work address, (3) The physician’s or dentist’s home address, if known, (4) The physician’s or dentist’s Social Security number or Individual Tax Identification Number if known, and if obtained in accordance with section 7 of the Privacy Act of 1974 (5 U.S.C. 552a note), (ITIN), (5) National Provider Identifier (NPI), (6) The physician’s or dentist’s date of birth, (7) Name of each professional school attended by the physician or dentist and year of graduation, (8) For each professional license, the physician’s or dentist’s license number, ntist’s date of birth, (7) Name of each professional school attended by the physician or dentist and year of graduation, (8) For each professional license, the physician’s or dentist’s license number, the field of licensure and the name of the state or territory in which the li- cense is held, (9) The physician’s or dentist’s Drug Enforcement Administration registra- tion number, if known, (10) A description of the acts or omis- sions or other reasons for the action taken, (11) A description of the Board ac- tion, the date the action was taken, its effective date and duration, (12) Classification of the action in ac- cordance with a reporting code adopted by the Secretary, and (13) Other information as required by the Secretary from time to time after publication in the FEDERAL REGISTER and after an opportunity for public comment. (c) Sanctions. If, after notice of non- compliance and providing opportunity to correct noncompliance, the Sec- retary determines that a Board has failed to submit a report as required by 173 § 60.9 45 CFR Subtitle A (10–1–24 Edition) this section, the Secretary will des- ignate another qualified entity for the reporting of information under § 60.12 of th submit a report as required by 173 § 60.9 45 CFR Subtitle A (10–1–24 Edition) this section, the Secretary will des- ignate another qualified entity for the reporting of information under § 60.12 of this part. § 60.9 Reporting licensure and certifi- cation actions taken by states. (a) What actions must be reported. Each state is required to adopt a sys- tem of reporting to the NPDB actions, as listed below, which are taken against a health care practitioner, health care entity, provider, or sup- plier (all as defined in § 60.3 of this part). The actions taken must be as a result of formal proceedings (as defined in § 60.3). The actions which must be re- ported are: (1) Any adverse action taken by the licensing or certification authority of the state as a result of a formal pro- ceeding, including revocation or sus- pension of a license, or certification agreement or contract for participa- tion in a government health care pro- gram (and the length of any such sus- pension), reprimand, censure, or proba- tion; (2) Any dismissal or closure of the formal proceeding by reason of the health care practitioner, health care entity, provider, or supplier surren- dering the license or certifi ensure, or proba- tion; (2) Any dismissal or closure of the formal proceeding by reason of the health care practitioner, health care entity, provider, or supplier surren- dering the license or certification agreement or contract for participa- tion in a government health care pro- gram, or leaving the state or jurisdic- tion; (3) Any other loss of license or loss of the certification agreement or contract in a government for participation health care program, or the right to apply for, or renew, a license or certifi- cation agreement or contract of the health care practitioner, health care entity, provider or supplier, whether by operation of law, voluntary surrender, nonrenewal (excluding non-renewals due to nonpayment of fees, retirement, or change to inactive status), or other- wise; (4) Any negative action or finding by such authority, organization, or entity regarding the health care practitioner, health care entity, provider, or sup- plier. (b) What information must be reported. Each state must report the following information (not otherwise reported under § 60.8 of this part): (1) If the subject is an individual, per- sonal identifiers, including: (i) Name, (ii) Social Secur Each state must report the following information (not otherwise reported under § 60.8 of this part): (1) If the subject is an individual, per- sonal identifiers, including: (i) Name, (ii) Social Security Number or ITIN, if known, and if obtained in accordance with section 7 of the Privacy Act of 1974 (5 U.S.C. 552a note), (iii) Home address or address of record, (iv) Sex, and (v) Date of birth. (2) If the subject is an individual, em- ployment or professional identifiers, including: (i) Organization name and type, (ii) Occupation and specialty, if ap- plicable, (iii) National Provider Identifier (NPI), (iv) Name of each professional school attended and year of graduation, and (v) With respect to the professional license (including professional certifi- cation and registration) on which the reported action was taken, the license number, the field of licensure, and the name of the state or territory in which the license is held. (3) If the subject is an organization, identifiers, including: (i) Name, (ii) Business address, (iii) Federal Employer Identification Number (FEIN), or Social Security Number when used by the subject as a Taxpayer Identification Number (TIN), (iv) The NPI, (v ng: (i) Name, (ii) Business address, (iii) Federal Employer Identification Number (FEIN), or Social Security Number when used by the subject as a Taxpayer Identification Number (TIN), (iv) The NPI, (v) Type of organization, and (vi) With respect to the license (in- cluding certification and registration) on which the reported action was taken, the license and the name of the state or territory in which the license is held. (4) For all subjects: (i) A narrative description of the acts or omissions and injuries upon which the reported action was based, (ii) Classification of the acts or omis- sions in accordance with a reporting code adopted by the Secretary, (iii) Classification of the action taken in accordance with a reporting code adopted by the Secretary, and the amount of any monetary penalty re- sulting from the reported action, (iv) The date the action was taken, its effective date and duration, 174 Dept. of Health and Human Services § 60.10 (v) Name of the agency taking the ac- tion, (vi) Name and address of the report- ing entity, and (vii) The name, title and telephone number of the responsible official sub- mitting the report on behalf of the re- porting entity. (c) What tion, (vi) Name and address of the report- ing entity, and (vii) The name, title and telephone number of the responsible official sub- mitting the report on behalf of the re- porting entity. (c) What information may be reported, if known. Reporting entities described in paragraph (a) of this section may voluntarily report, if known, the fol- lowing information: (1) If the subject is an individual, per- sonal identifiers, including: (i) Other name(s) used, (ii) Other address, (iii) FEIN, when used by the indi- vidual as a TIN, and (iv) If deceased, date of death. (2) If the subject is an individual, em- ployment or professional identifiers, including: (i) Other state professional license number(s), field(s) of licensure, and the name(s) of the state or territory in which the license is held, (ii) Other numbers assigned by Fed- eral or state agencies, including, but not limited to DEA registration num- ber(s), Unique Physician Identification Number(s) (UPIN), and Medicaid and Medicare provider number(s), (iii) Name(s) and address(es) of any health care entity with which the sub- ject is affiliated or associated, and (iv) Nature of the subject’s relation- ship to each associated or af ovider number(s), (iii) Name(s) and address(es) of any health care entity with which the sub- ject is affiliated or associated, and (iv) Nature of the subject’s relation- ship to each associated or affiliated health care entity. (3) If the subject is an organization, identifiers, including: (i) Other name(s) used, (ii) Other address(es) used, (iii) Other FEIN(s) or Social Security Number(s) used, (iv) Other NPI(s) used, (v) Other state license number(s) and the name(s) of the state or territory in which the license is held, (vi) Other numbers assigned by Fed- eral or state agencies, including, but not limited to DEA registration num- ber(s), Clinical Laboratory Improve- ment Act (CLIA) number(s), Food and Drug Administration (FDA) number(s), and Medicaid and Medicare provider number(s), (vii) Names and titles of principal of- ficers and owners, (viii) Name(s) and address(es) of any health care entity with which the sub- ject is affiliated or associated, and (ix) Nature of the subject’s relation- ship to each associated or affiliated health care entity. (4) For all subjects: (i) Whether the subject will be auto- matically reinstated. (ii) The date of appeal, if any. (d) Access to do relation- ship to each associated or affiliated health care entity. (4) For all subjects: (i) Whether the subject will be auto- matically reinstated. (ii) The date of appeal, if any. (d) Access to documents. Each state must provide the Secretary (or an enti- ty designated by the Secretary) with access to the documents underlying the actions described in paragraphs (a)(1) through (4) of this section, as may be necessary for the Secretary to deter- mine the facts and circumstances con- cerning the actions and determinations for the purpose of carrying out section 1921. (e) Sanctions for failure to report. The Secretary will provide for a publi- cation of a public report that identifies failures to report information on ad- verse actions as required to be reported under this section. § 60.10 Reporting Federal and certification actions. licensure (a) What actions must be reported. Fed- eral licensing and certification agen- cies must report to the NPDB the fol- lowing final adverse actions that are taken against a health care practi- tioner, physician, dentist, provider, or supplier (regardless of whether the final adverse action is the subject of a pending appeal): (1) Formal or offi s that are taken against a health care practi- tioner, physician, dentist, provider, or supplier (regardless of whether the final adverse action is the subject of a pending appeal): (1) Formal or official actions, such as revocation or suspension of a license or certification agreement or contract for participation in government health care programs (and the length of any such suspension), reprimand, censure or probation, (2) Any dismissal or closure of the proceedings by reason of the health care practitioner, provider, or supplier surrendering their license or certifi- cation agreement or contract for par- ticipation in government health care programs, or leaving the state or juris- diction, (3) Any other loss of the license or loss of the certification agreement or contract for participation in govern- ment health care programs, or the right to apply for, or renew, a license 175 § 60.10 45 CFR Subtitle A (10–1–24 Edition) or certification agreement or contract of the health care practitioner, pro- vider, or supplier, whether by oper- ation of law, voluntary surrender, non- renewal (excluding non-renewals due to nonpayment of fees, retirement, or change to inactive status), or ot ctitioner, pro- vider, or supplier, whether by oper- ation of law, voluntary surrender, non- renewal (excluding non-renewals due to nonpayment of fees, retirement, or change to inactive status), or other- wise, and (4) Any other negative action or find- ing by such Federal agency that is pub- licly available information. (b) What information must be reported. Each Federal agency described in para- graph (a) of this section must report the following information: (1) If the subject is an individual, per- sonal identifiers, including: (i) Name, (ii) Social Security Number or ITIN, (iii) Home address or address of record, (iv) Sex, and (v) Date of birth. (2) If the subject is an individual, em- ployment or professional identifiers, including: (i) Organization name and type, (ii) Occupation and specialty, if ap- plicable, (iii) National Provider Identifier (NPI), (iv) Name of each professional school attended and year of graduation, and (v) With respect to the state profes- sional license (including professional certification and registration) on which the reported action was taken, the license number, the field of licen- sure, and the name of the state or ter- ritory in which the licen including professional certification and registration) on which the reported action was taken, the license number, the field of licen- sure, and the name of the state or ter- ritory in which the license is held. (3) If the subject is an organization, identifiers, including: (i) Name, (ii) Business address, (iii) Federal Employer Identification Number (FEIN), or Social Security Number (or ITIN) when used by the subject as a Taxpayer Identification Number (TIN), (iv) The NPI, (v) Type of organization, and (vi) With respect to the state license (including certification and registra- tion) on which the reported action was taken, the license and the name of the state or territory in which the license is held. (4) For all subjects: (i) A narrative description of the acts or omissions and injuries upon which the reported action was based, (ii) Classification of the acts or omis- sions in accordance with a reporting code adopted by the Secretary, (iii) Classification of the action taken in accordance with a reporting code adopted by the Secretary, and the amount of any monetary penalty re- sulting from the reported action, (iv) The date the action was taken, its effective date and duration ordance with a reporting code adopted by the Secretary, and the amount of any monetary penalty re- sulting from the reported action, (iv) The date the action was taken, its effective date and duration, (v) Name of the agency taking the ac- tion, (vi) Name and address of the report- ing entity, and (vii) The name, title, and telephone number of the responsible official sub- mitting the report on behalf of the re- porting entity. (c) What information may be reported, if known. Reporting entities described in paragraph (a) of this section may voluntarily report, if known, the fol- lowing information: (1) If the subject is an individual, per- sonal identifiers, including: (i) Other name(s) used, (ii) Other address, (iii) FEIN, when used by the indi- vidual as a TIN, and (iv) If deceased, date of death. (2) If the subject is an individual, em- ployment or professional identifiers, including: (i) Other state professional license number(s), field(s) of licensure, and the name(s) of the state or territory in which the license is held, (ii) Other numbers assigned by Fed- eral or state agencies, including, but not limited to DEA registration num- ber(s), Unique Physician Identification Numbe or territory in which the license is held, (ii) Other numbers assigned by Fed- eral or state agencies, including, but not limited to DEA registration num- ber(s), Unique Physician Identification Number(s) (UPIN), and Medicaid and Medicare provider number(s), (iii) Name(s) and address(es) of any health care entity with which the sub- ject is affiliated or associated, and (iv) Nature of the subject’s relation- ship to each associated or affiliated health care entity. (3) If the subject is an organization, identifiers, including: (i) Other name(s) used, (ii) Other address(es) used, (iii) Other FEIN(s) or Social Security Number(s) used, (iv) Other NPI(s) used, 176 Dept. of Health and Human Services § 60.12 (v) Other state license number(s) and the name(s) of the state or territory in which the license is held, (vi) Other numbers assigned by Fed- eral or state agencies, including, but not limited to DEA registration num- ber(s), Clinical Laboratory Improve- ment Act (CLIA) number(s), Food and Drug Administration (FDA) number(s), and Medicaid and Medicare provider number(s), (vii) Names and titles of principal of- ficers and owners, (viii) Name(s) and address(es) of any health care entit nd Drug Administration (FDA) number(s), and Medicaid and Medicare provider number(s), (vii) Names and titles of principal of- ficers and owners, (viii) Name(s) and address(es) of any health care entity with which the sub- ject is affiliated or associated, and (ix) Nature of the subject’s relation- ship to each associated or affiliated health care entity. (4) For all subjects: (i) Whether the subject will be auto- matically reinstated. (ii) The date of appeal, if any. (d) Sanctions for failure to report. The Secretary will provide for a publi- cation of a public report that identifies those agencies that have failed to re- port information on adverse actions as required to be reported under this sec- tion. § 60.11 Reporting negative actions or findings taken by peer review orga- nizations or private accreditation entities. (a) What actions must be reported. Peer review organizations and private ac- creditation entities are required to re- port any negative actions or findings (as defined in § 60.3 of this part) which are taken against a health care practi- tioner, health care entity, provider, or supplier to the NPDB and provide a copy to the appropriate state licensing or certifica d in § 60.3 of this part) which are taken against a health care practi- tioner, health care entity, provider, or supplier to the NPDB and provide a copy to the appropriate state licensing or certification agency. The health care practitioner, health care entity, provider, or supplier must be licensed or otherwise authorized by the state to provide health care services. The ac- tions taken must be as a result of for- mal proceedings (as defined in § 60.3). (b) What information must be reported. Each peer review organization and pri- vate accreditation entity must report the information as required in § 60.9(b) of this part. (c) What information may be reported, if known. Each peer review organiza- tion and private accreditation entity should report, if known, the informa- tion as described in § 60.9(c). (d) Access to documents. Each peer re- view organization and private accredi- tation entity must provide the Sec- retary (or an entity designated by the Secretary) with access to the docu- ments underlying the actions described in this section as may be necessary for the Secretary to determine the facts and circumstances concerning the ac- tions and determinations for the pur- pose o u- ments underlying the actions described in this section as may be necessary for the Secretary to determine the facts and circumstances concerning the ac- tions and determinations for the pur- pose of carrying out section 1921. § 60.12 Reporting adverse actions taken against clinical privileges. (a) Reporting by health care entities to the NPDB—(1) Actions that must be re- ported and to whom the report must be made. Each health care entity must re- port to the NPDB and provide a copy of the report to the Board of Medical Ex- aminers in the state in which the health care entity is located the fol- lowing actions: (i) Any professional review action that adversely affects the clinical privileges of a physician or dentist for a period longer than 30 days, (ii) Acceptance of the surrender of clinical privileges or any restriction of such privileges by a physician or den- tist: (A) While the physician or dentist is under investigation by the health care entity relating to possible incom- petence or improper professional con- duct, or (B) In return for not conducting such an investigation or proceeding, or (iii) In the case of a health care enti- ty which is a professional society, when tence or improper professional con- duct, or (B) In return for not conducting such an investigation or proceeding, or (iii) In the case of a health care enti- ty which is a professional society, when it takes a professional review ac- tion concerning a physician or dentist. (2) Voluntary reporting on other health care practitioners. A health care entity may report to the NPDB information as described in paragraph (a)(3) of this section concerning actions described in paragraph (a)(1) in this section with re- spect to other health care practi- tioners. (3) What information must be reported. The health care entity must report the following information concerning ac- tions described in paragraph (a)(1) of this section with respect to a physician or dentist: (i) Name, 177 § 60.13 45 CFR Subtitle A (10–1–24 Edition) (ii) Work address, (iii) Home address, if known, (iv) Social Security Number, if known, and if obtained in accordance with section 7 of the Privacy Act of 1974, (v) Date of birth, (vi) Name of each professional school attended and year of graduation, (vii) For each professional license: the license number, the field of licen- sure, and the name of the state or ter- ritory in h, (vi) Name of each professional school attended and year of graduation, (vii) For each professional license: the license number, the field of licen- sure, and the name of the state or ter- ritory in which the license is held, (viii) DEA registration number, if known, (ix) A description of the acts or omis- sions or other reasons for privilege loss, or, if known, for surrender, (x) Action taken, date the action was taken, and effective date of the action, and (xi) Other information as required by the Secretary from time to time after publication in the FEDERAL REGISTER and after an opportunity for public comment. (b) Reporting by the Board of Medical Examiners to the NPDB. Each Board must report any known instances of a health care entity’s failure to report information as required under para- graph (a)(1) of this section. In addition, each Board of Medical Examiners must simultaneously report this information licensing to the appropriate state board in the state in which the health care entity is located, if the Board of Medical Examiners is not such licens- ing board. (c) Sanctions—(1) Health care entities. If the Secretary has reason to believe that a health care entity has sub are entity is located, if the Board of Medical Examiners is not such licens- ing board. (c) Sanctions—(1) Health care entities. If the Secretary has reason to believe that a health care entity has substan- tially failed to report information in accordance with this section, the Sec- retary will conduct an investigation. If the investigation shows that the health care entity has not complied with this section, the Secretary will provide the entity with a written notice describing the noncompliance, giving the health care entity an opportunity to correct the noncompliance, and stating that the entity may request, within 30 days after receipt of such notice, a hearing with respect to the noncompliance. The request for a hearing must contain a statement of the material factual issues in dispute to demonstrate that there is cause for a hearing. These issues must be both substantive and relevant. The hearing will be held in the Washington, DC, metropolitan area. The Secretary will deny a hearing if: (i) The request for a hearing is un- timely, (ii) The health care entity does not provide a statement of material factual issues in dispute, or (iii) The statement of factual issues in disput ring if: (i) The request for a hearing is un- timely, (ii) The health care entity does not provide a statement of material factual issues in dispute, or (iii) The statement of factual issues in dispute is frivolous or inconsequen- tial. In the event that the Secretary de- nies a hearing, the Secretary will send a written denial to the health care en- tity setting forth the reasons for de- nial. If a hearing is denied, or, if as a result of the hearing the entity is found to be in noncompliance, the Sec- retary will publish the name of the health care entity in the FEDERAL REG- ISTER. In such case, the immunity pro- tections provided under section 411(a) of HCQIA will not apply to the health care entity for professional review ac- tivities that occur during the 3-year period beginning 30 days after the date of publication of the entity’s name in the FEDERAL REGISTER. (2) Board of Medical Examiners. If, after notice of noncompliance and pro- viding opportunity to correct non- compliance, the Secretary determines that a Board of Medical Examiners has failed to report information in accord- ance with paragraph (b) of this section, the Secretary will designate another qualified entity f the Secretary determines that a Board of Medical Examiners has failed to report information in accord- ance with paragraph (b) of this section, the Secretary will designate another qualified entity for the reporting of this information. § 60.13 Reporting Federal or state criminal convictions related to the delivery of a health care item or service. (a) Who must report. Federal and state prosecutors must report criminal con- victions against health care practi- tioners, providers, and suppliers re- lated to the delivery of a health care item or service (regardless of whether the conviction is the subject of a pend- ing appeal). (b) What information must be reported. Entities described in paragraph (a) of this section must report the following information: (1) If the subject is an individual, per- sonal identifiers, including: 178 Dept. of Health and Human Services § 60.13 (i) Name, (ii) Social Security Number (or ITIN) (states must report this information, if known, and if obtained in accordance with section 7 of the Privacy Act of 1974), (iii) Home address or address of record, (iv) Sex, and (v) Date of birth. (2) If the subject is an individual, that individual’s employment or pr accordance with section 7 of the Privacy Act of 1974), (iii) Home address or address of record, (iv) Sex, and (v) Date of birth. (2) If the subject is an individual, that individual’s employment or pro- fessional identifiers, including: (i) Organization name and type, (ii) Occupation and specialty, if ap- plicable, and (iii) National Provider Identifier (NPI). (3) If the subject is an organization, identifiers, including: (i) Name, (ii) Business address, (iii) Federal Employer Number (FEIN), or Social Security Number (or ITIN) when used by the subject as a Taxpayer Identification Number (TIN), (iv) The NPI, and (v) Type of organization. (4) For all subjects: (i) A narrative description of the acts or omissions and injuries upon which the reported action was based, (ii) Classification of the acts or omis- sions in accordance with a reporting code adopted by the Secretary, (iii) Name and location of court or ju- dicial venue in which the action was taken, (iv) Docket or court file number, (v) Type of action taken, (vi) Statutory offense(s) and count(s), (vii) Name of primary prosecuting agency (or the plaintiff in civil ac- tions), (viii) Date of sentence or judgment, (ix) Length of , (v) Type of action taken, (vi) Statutory offense(s) and count(s), (vii) Name of primary prosecuting agency (or the plaintiff in civil ac- tions), (viii) Date of sentence or judgment, (ix) Length of incarceration, deten- tion, probation, community service, or suspended sentence, (x) Amounts of any monetary judg- ment, penalty, fine, assessment, or res- titution, (xi) Other sentence, judgment, or or- ders, (xii) If the action is on appeal, (xiii) Name and address of the report- ing entity, and (xiv) The name, title, and telephone number of the responsible official sub- mitting the report on behalf of the re- porting entity. (c) What information may be reported, if known. Entities described in para- graph (a) of this section and each state should report, if known, the following information: (1) If the subject is an individual, per- sonal identifiers, including: (i) Other name(s) used, (ii) Other address(es), and (iii) FEIN, when used by the indi- vidual as a TIN. (2) If the subject is an individual, that individual’s employment or pro- fessional identifiers, including: (i) State professional license (includ- ing professional certification and reg- istration) number(s), field(s) of l n individual, that individual’s employment or pro- fessional identifiers, including: (i) State professional license (includ- ing professional certification and reg- istration) number(s), field(s) of licen- sure, and the name(s) of the state or territory in which the license is held, (ii) Other numbers assigned by Fed- eral or state agencies, including, but not limited to DEA registration num- ber(s), Unique Physician Identification Number(s) (UPIN), and Medicaid and Medicare provider number(s); (iii) Name(s) and address(es) of any health care entity with which the sub- ject is affiliated or associated, and (iv) Nature of the subject’s relation- ship to each associated or affiliated health care entity. (3) If the subject is an organization, identifiers, including: (i) Other name(s) used, (ii) Other address(es) used, (iii) Other FEIN(s) or Social Security Numbers(s) (or ITINs) used, (iv) Other NPI(s) used, (v) State license (including certifi- cation and registration) number(s) and the name(s) of the state or territory in which the license is held, (vi) Other numbers assigned by Fed- eral or state agencies, including, but not limited to DEA registration num- ber(s), Clinical Laborato ame(s) of the state or territory in which the license is held, (vi) Other numbers assigned by Fed- eral or state agencies, including, but not limited to DEA registration num- ber(s), Clinical Laboratory Improve- ment Act (CLIA) number(s), Food and Drug Administration (FDA) number(s), and Medicaid and Medicare provider number(s), (vii) Names and titles of principal of- ficers and owners, (viii) Name(s) and address(es) of any health care entity with which the sub- ject is affiliated or associated, and 179 § 60.14 45 CFR Subtitle A (10–1–24 Edition) (ix) Nature of the subject’s relation- ship to each associated or affiliated health care entity. (4) For all subjects: (i) Prosecuting agency’s case number, (ii) Investigative agencies involved, (iii) Investigative agencies case or file number(s), and (iv) The date of appeal, if any. (d) Access to documents. Each state must provide the Secretary (or an enti- ty designated by the Secretary) with access to the documents underlying the actions described in paragraphs (a)(1) through (4) of this section, as may be necessary for the Secretary to deter- mine the facts and circumstances con- cerning the actions and determinations for the purpose o scribed in paragraphs (a)(1) through (4) of this section, as may be necessary for the Secretary to deter- mine the facts and circumstances con- cerning the actions and determinations for the purpose of carrying out section 1921. (e) Sanctions for failure to report. The Secretary will provide for publication of a public report that identifies those agencies that have failed to report in- formation on criminal convictions as required to be reported under this sec- tion. [78 FR 20484, Apr. 5, 2013, 78 FR 25860, May 6, 2013] § 60.14 Reporting civil judgments re- lated to the delivery of a health care item or service. (a) Who must report. Federal and state attorneys and health plans must report civil judgments against health care practitioners, providers, or suppliers related to the delivery of a health care item or service (regardless of whether the civil judgment is the subject of a pending appeal). If a government agen- cy is party to a multi-claimant civil judgment, it must assume the responsi- bility for reporting the entire action, including all amounts awarded to all the claimants, both public and private. If there is no government agency as a party, but there are multiple health esponsi- bility for reporting the entire action, including all amounts awarded to all the claimants, both public and private. If there is no government agency as a party, but there are multiple health plans as claimants, the health plan which receives the largest award must be responsible for reporting the total action for all parties. (b) What information must be reported. Entities described in paragraph (a) of this section must report the informa- tion as required in § 60.13(b) of this part. (c) What information may be reported, if known. Entities described in para- graph (a) of this section should report, if known the information as described in § 60.13(c) of this part. (d) Access to documents. Each state must provide the Secretary (or an enti- ty designated by the Secretary) with access to the documents underlying the actions described in paragraphs (a)(1) through (4) of this section, as may be necessary for the Secretary to deter- mine the facts and circumstances con- cerning the actions and determinations for the purpose of carrying out section 1921. (e) Sanctions for failure to report. Any health plan that fails to report infor- mation on a civil judgment required to be repo actions and determinations for the purpose of carrying out section 1921. (e) Sanctions for failure to report. Any health plan that fails to report infor- mation on a civil judgment required to be reported under this section will be subject to a civil money penalty (CMP) of not more than $25,000 for each such adverse action not reported. Such pen- alty will be imposed and collected in the same manner as CMPs under sub- section (a) of section 1128A of the So- cial Security Act. The Secretary will provide for publication of a public re- port that identifies those government agencies that have failed to report in- formation on civil judgments as re- quired to be reported under this sec- tion. § 60.15 Reporting exclusions from par- ticipation in Federal or state health care programs. (a) Who must report. Federal Govern- ment agencies and state law and fraud enforcement agencies must report health care practitioners, providers, or suppliers excluded from participating in Federal or state health care pro- grams, including exclusions that were made in a matter in which there was also a settlement that is not reported because no findings or admissions of li- ability have been made (regardle lth care pro- grams, including exclusions that were made in a matter in which there was also a settlement that is not reported because no findings or admissions of li- ability have been made (regardless of whether the exclusion is the subject of a pending appeal). (b) What information must be reported. Entities described in paragraph (a) of this section must report the following information: (1) If the subject is an individual, per- sonal identifiers, including: (i) Name, (ii) Social Security Number (or ITIN) (state law and fraud enforcement agen- cies must report this information if known, and if obtained in accordance 180 Dept. of Health and Human Services § 60.15 with section 7 of the Privacy Act of 1974), (iii) Home address or address of record, (iv) Sex, and (v) Date of birth. (2) If the subject is an individual, that individual’s employment or pro- fessional identifiers, including: (i) Organization name and type, (ii) Occupation and specialty, if ap- plicable, and (iii) National Provider Identifier (NPI). (3) If the subject is an organization, identifiers, including: (i) Name, (ii) Business address, (iii) Federal Employer Identification Number (FEIN) or Social Security Number Provider Identifier (NPI). (3) If the subject is an organization, identifiers, including: (i) Name, (ii) Business address, (iii) Federal Employer Identification Number (FEIN) or Social Security Number (or ITIN) when used by the subject as a Taxpayer Identification Number (TIN), (iv) The NPI, and (v) Type of organization. (4) For all subjects: (i) A narrative description of the acts or omissions and injuries upon which the reported action was based, (ii) Classification of the acts or omis- sions in accordance with a reporting code adopted by the Secretary, (iii) Classification of the action taken in accordance with a reporting code adopted by the Secretary, and the amount of any monetary penalty re- sulting from the reported action, (iv) The date the action was taken, its effective date and duration, (v) If the action is on appeal, (vi) Name of the agency taking the action, (vii) Name and address of the report- ing entity, and (viii) The name, title, and telephone number of the responsible official sub- mitting the report on behalf of the re- porting entity. (c) What information may be reported, if known. Entities described in para- graph (a) of this section should report, if known, ble official sub- mitting the report on behalf of the re- porting entity. (c) What information may be reported, if known. Entities described in para- graph (a) of this section should report, if known, the following information: (1) If the subject is an individual, per- sonal identifiers, including: (i) Other name(s) used, (ii) Other address(es), (iii) FEIN, when used by the indi- vidual as a TIN, (iv) Name of each professional school attended and year of graduation, and (v) If deceased, date of death. (2) If the subject is an individual, that individual’s employment or pro- fessional identifiers, including: (i) State professional license (includ- ing professional registration and cer- tification) number(s), field(s) of licen- sure, and the name(s) of the state or territory in which the license is held, (ii) Other numbers assigned by Fed- eral or state agencies, including, but not limited to DEA registration num- ber(s), Unique Physician Identification Number(s) (UPIN), and Medicaid and Medicare provider number(s), (iii) Name(s) and address(es) of any health care entity with which the sub- ject is affiliated or associated, and (iv) Nature of the subject’s relation- ship to each asso Medicare provider number(s), (iii) Name(s) and address(es) of any health care entity with which the sub- ject is affiliated or associated, and (iv) Nature of the subject’s relation- ship to each associated or affiliated health care entity. (3) If the subject is an organization, identifiers, including: (i) Other name(s) used, (ii) Other address(es) used, (iii) Other FEIN(s) or Social Security Numbers(s) (or ITINs) used, (iv) Other NPI(s) used, (v) State license (including registra- tion and certification) number(s) and the name(s) of the state or territory in which the license is held, (vi) Other numbers assigned by Fed- eral or state agencies, including, but not limited to DEA registration num- ber(s), Clinical Laboratory Improve- ment Act (CLIA) number(s), Food and Drug Administration (FDA) number(s), and Medicaid and Medicare provider number(s), (vii) Names and titles of principal of- ficers and owners, (viii) Name(s) and address(es) of any health care entity with which the sub- ject is affiliated or associated, and (ix) Nature of the subject’s relation- ship to each associated or affiliated health care entity. (4) For all subjects: (i) If the subject will be automati- cally rei t is affiliated or associated, and (ix) Nature of the subject’s relation- ship to each associated or affiliated health care entity. (4) For all subjects: (i) If the subject will be automati- cally reinstated, and (ii) The date of appeal, if any. (d) Access to documents. Each state must provide the Secretary (or an enti- ty designated by the Secretary) with access to the documents underlying the actions described in paragraphs (a)(1) 181 § 60.16 45 CFR Subtitle A (10–1–24 Edition) through (4) of this section, as may be necessary for the Secretary to deter- mine the facts and circumstances con- cerning the actions and determinations for the purpose of carrying out section 1921. (e) Sanctions for failure to report. The Secretary will provide for publication of a public report that identifies those government agencies that have failed to report information on exclusions or debarments as required to be reported under this section. [78 FR 20484, Apr. 5, 2013, 78 FR 25860, May 6, 2013] § 60.16 Reporting other adjudicated actions or decisions. (a) Who must report. Federal Govern- ment agencies, state law or fraud en- forcement agencies, and health plans must report other adjudicated action 6 Reporting other adjudicated actions or decisions. (a) Who must report. Federal Govern- ment agencies, state law or fraud en- forcement agencies, and health plans must report other adjudicated actions or decisions as defined in § 60.3 of this part related to the delivery, payment or provision of a health care item or service against health care practi- tioners, providers, and suppliers (re- gardless of whether the other adju- dicated action or decision is subject to a pending appeal). (b) What information must be reported. Entities described in paragraph (a) of this section must report the informa- tion as required in § 60.15(b) of this part. (c) What information may be reported, if known. Entities described in para- graph (a) of this section should report, if known, the information as described in § 60.15(c) of this part. (d) Access to documents. Each state must provide the Secretary (or an enti- ty designated by the Secretary) with access to the documents underlying the actions described in paragraphs (a)(1) through (4) of this section, as may be necessary for the Secretary to deter- mine the facts and circumstances con- cerning the actions and determinations for the purpose of ribed in paragraphs (a)(1) through (4) of this section, as may be necessary for the Secretary to deter- mine the facts and circumstances con- cerning the actions and determinations for the purpose of carrying out section 1921. (e) Sanctions for failure to report. Any health plan that fails to report infor- mation on another adjudicated action or decision required to be reported under this section will be subject to a civil money penalty (CMP) of not more than $25,000 for each such action not re- ported. Such penalty will be imposed and collected in the same manner as CMPs under subsection (a) of section 1128A of the Social Security Act. The Secretary will provide for publication of a public report that identifies those government agencies that have failed to report information on other adju- dicated actions as required to be re- ported under this section. Subpart C—Disclosure of Informa- tion by the National Practi- tioner Data Bank § 60.17 Information which hospitals must request from the National Practitioner Data Bank. (a) When information must be re- quested. Each hospital, either directly or through an authorized agent, must request information from the NPDB concerning a healt the National Practitioner Data Bank. (a) When information must be re- quested. Each hospital, either directly or through an authorized agent, must request information from the NPDB concerning a health care practitioner, as follows: (1) At the time a health care practi- tioner applies for a position on its med- ical staff (courtesy or otherwise) or for clinical privileges at the hospital; and (2) Every 2 years for any health care practitioner who is on its medical staff (courtesy or otherwise) or has clinical privileges at the hospital. (b) Failure to request information. Any hospital which does not request the in- formation as required in paragraph (a) of this section is presumed to have knowledge of any information reported to the NPDB concerning this health care practitioner. (c) Reliance on the obtained informa- tion. Each hospital may rely upon the information provided by the NPDB to the hospital. A hospital shall not be held liable for this reliance unless the hospital has knowledge that the infor- mation provided was false. [78 FR 20484, Apr. 5, 2013, 78 FR 25860, May 6, 2013] § 60.18 Requesting from the National Practitioner Data Bank. information (a) Who may request inform dge that the infor- mation provided was false. [78 FR 20484, Apr. 5, 2013, 78 FR 25860, May 6, 2013] § 60.18 Requesting from the National Practitioner Data Bank. information (a) Who may request information and what information may be available. Infor- mation in the NPDB will be available, upon request, to the persons or enti- ties, or their authorized agents, as de- scribed below: 182 Dept. of Health and Human Services § 60.18 (1) Information reported under §§ 60.7, 60.8, and 60.12 of this part is available to: (i) A hospital that requests informa- tion concerning a health care practi- tioner who is on its medical staff (cour- tesy or otherwise) or has clinical privi- leges at the hospital, (ii) A health care practitioner who requests information concerning him- self or herself, (iii) A State Medical Board of Exam- iners or other state authority that li- censes health care practitioners, (iv) A health care entity which has entered or may be entering into an em- ployment or affiliation relationship with a health care practitioner, or to which the health care practitioner has applied for clinical privileges or ap- pointment to the medical staff, (v) An attorney, or individual rep- re relationship with a health care practitioner, or to which the health care practitioner has applied for clinical privileges or ap- pointment to the medical staff, (v) An attorney, or individual rep- resenting himself or herself, who has filed a medical malpractice action or claim in a state or Federal court or other adjudicative body against a hos- pital, and who requests information re- garding a specific health care practi- tioner who is also named in the action or claim. This information will be dis- closed only upon the submission of evi- dence that the hospital failed to re- quest information from the NPDB, as required by § 60.17(a) of this part, and may be used solely with respect to liti- gation resulting from the action or claim against the hospital, (vi) A health care entity with respect to professional review activity, and (vii) A person or entity requesting statistical form information, which does not permit the identifica- tion of any individual or entity. in a (2) Information reported under §§ 60.9, 60.10, 60.11, 60.13, 60.14, 60.15, and 60.16 of this part is available to the agencies, authorities, and officials listed below that request information on licensure or cert on reported under §§ 60.9, 60.10, 60.11, 60.13, 60.14, 60.15, and 60.16 of this part is available to the agencies, authorities, and officials listed below that request information on licensure or certification actions, any other neg- ative actions or findings, or final ad- verse actions concerning an individual practitioner, health care entity, pro- vider, or supplier. These agencies, au- thorities, and officials may obtain data for the purposes of determining the fit- ness of individuals to provide health care services, protecting the health and safety of individuals receiving health care through programs administered by the requesting agency, and protecting the fiscal integrity of these programs. (i) Agencies administering (including those providing payment for services) Federal health care programs, includ- ing private entities administering such programs under contract, (ii) State licensing or certification agencies and Federal agencies respon- sible for the licensing and certification of health care practitioners, providers, or suppliers, (iii) State agencies administering or supervising the administration of state health care programs (as defined in 42 U.S.C. 1128(h)), (iv) S tion of health care practitioners, providers, or suppliers, (iii) State agencies administering or supervising the administration of state health care programs (as defined in 42 U.S.C. 1128(h)), (iv) State law or fraud enforcement agencies, (v) Law enforcement officials and agencies such as: (A) United States Attorney General, (B) United States Chief Postal In- spector, (C) United States Inspectors General; (D) United States Attorneys, (E) United States Comptroller Gen- eral, (F) United States Drug Enforcement Administration, (G) United States Nuclear Regu- latory Commission, or (H) Federal Bureau of Investigation, (vi) Utilization and quality control peer review organizations described in part B of title XI and to appropriate entities with contracts under section 1154(a)(4)(C) of the Social Security Act with respect to eligible organizations reviewed under the contracts, but only with respect to information provided pursuant to §§ 60.9, 60.10, and 60.11 of this part, as well as information pro- vided pursuant to §§ 60.13, 60.14, 60.15, and 60.16 of this part by Federal agen- cies and health plans, (vii) Hospitals and other health care entities (as defined in section 431 of the Heal tion pro- vided pursuant to §§ 60.13, 60.14, 60.15, and 60.16 of this part by Federal agen- cies and health plans, (vii) Hospitals and other health care entities (as defined in section 431 of the Health Care Quality Improvement Act of 1986), with respect to health care practitioners who have entered (or may be entering) into employment or affili- ation relationships with, or have ap- plied for clinical privileges or appoint- ments to the medical staff of such hos- pitals or other health care entities, but only with respect to information pro- vided pursuant to §§ 60.9, 60.10, and 60.11, as well as information provided pursuant to §§ 60.13, 60.14, 60.15, and 183 § 60.19 45 CFR Subtitle A (10–1–24 Edition) 60.16 by Federal agencies and health plans, ance, travel, and rent and depreciation on land, buildings, and equipment), (viii) Health plans, (ix) A health care practitioner, health care entity, provider, or sup- plier who requests information con- cerning himself, herself, or itself, and (x) A person or entity requesting sta- tistical information, in a form which does not permit the identification of any individual or entity. (For example, researchers may use statistical infor- mat nd (x) A person or entity requesting sta- tistical information, in a form which does not permit the identification of any individual or entity. (For example, researchers may use statistical infor- mation to identify the total number of nurses with adverse licensure actions in a specific state. Similarly, research- ers may use statistical information to identify the total number of health care entities denied accreditation.) (b) Procedures for obtaining NPDB in- formation. Persons and entities may ob- tain information from the NPDB by submitting a request in such form and manner as the Secretary may pre- scribe. These requests are subject to fees as described in § 60.19 of this part. [78 FR 20484, Apr. 5, 2013, 78 FR 25860, May 6, 2013] § 60.19 Fees applicable to requests for information. (a) Policy on fees. The fees described in this section apply to all requests for information from the NPDB. The amount of such fees will be sufficient to recover the full costs of operating the NPDB. The actual fees will be an- nounced by the Secretary in periodic notices in the FEDERAL REGISTER. How- ever, for purposes of verification and dispute resolution at the time the re- port is accepted, th he actual fees will be an- nounced by the Secretary in periodic notices in the FEDERAL REGISTER. How- ever, for purposes of verification and dispute resolution at the time the re- port is accepted, the NPDB will provide a copy—at the time a report has been submitted, automatically, without a request and free of charge, of the record to the health care practitioner, entity, provider, or supplier who is the subject of the report and to the re- porter. (b) Criteria for determining the fee. The amount of each fee will be determined based on the following criteria: (1) Direct and indirect personnel costs, including salaries and fringe ben- efits such as medical insurance and re- tirement, (2) Physical overhead, consulting, and other indirect costs (including ma- terials and supplies, utilities, insur- (3) Agency management and super- visory costs, (4) Costs of enforcement, research, and establishment of regulations and guidance, (5) Use of electronic data processing equipment to collect and maintain in- formation—the actual cost of the serv- ice, including computer search time, runs and printouts, and (6) Any other direct or indirect costs related to the provision of services. (c) Asses maintain in- formation—the actual cost of the serv- ice, including computer search time, runs and printouts, and (6) Any other direct or indirect costs related to the provision of services. (c) Assessing and collecting fees. The Secretary will announce through no- tice in the FEDERAL REGISTER from time to time the methods of payment of NPDB fees. In determining these methods, the Secretary will consider efficiency, effectiveness, and conven- ience for the NPDB users and the De- partment. Methods may include: credit card, electronic fund transfer, and other methods of electronic payment. § 60.20 Confidentiality of National Practitioner Data Bank informa- tion. (a) Limitations on disclosure. Informa- tion reported to the NPDB is consid- ered confidential and shall not be dis- closed outside the Department of Health and Human Services, except as specified in §§ 60.17, 60.18, and 60.21 of this part. Persons and entities receiv- ing information from the NPDB, either directly or from another party, must use it solely with respect to the pur- pose for which it was provided. The Data Bank report may not be disclosed, but nothing in this section will prevent the disclosure of information b r party, must use it solely with respect to the pur- pose for which it was provided. The Data Bank report may not be disclosed, but nothing in this section will prevent the disclosure of information by a party from its own files used to create such reports where disclosure is other- wise authorized under applicable state or Federal law. (b) Penalty for violations. Any person who violates paragraph (a) of this sec- tion shall be subject to a civil money penalty of up to $11,000 for each viola- tion. This penalty will be imposed pur- suant to procedures at 42 CFR part 1003. 184 Dept. of Health and Human Services § 60.22 § 60.21 How to dispute the accuracy of National Practitioner Data Bank in- formation. (a) Who may dispute the NPDB infor- mation. The NPDB will routinely mail or transmit electronically to the sub- ject a copy of the report filed in the NPDB. In addition, as indicated in § 60.18, the subject may also request a copy of such report. The subject of the report or a designated representative may dispute the accuracy of a report concerning himself, herself, or itself as set forth in paragraph (b) of this sec- tion. (b) Procedures for disputing a report with the reporting en representative may dispute the accuracy of a report concerning himself, herself, or itself as set forth in paragraph (b) of this sec- tion. (b) Procedures for disputing a report with the reporting entity. (1) If the sub- ject disagrees with the reported infor- mation, the subject must request in the format as determined by the Sec- retary that the NPDB enter the report into ‘‘disputed status.’’ (2) The NPDB will send the report, with a notation that the report has been placed in ‘‘disputed status,’’ to queriers (where identifiable), the re- porting entity and the subject of the report. (3) The subject must attempt to enter into discussion with the reporting enti- ty to resolve the dispute. If the report- ing entity revises the information originally submitted to the NPDB, the NPDB will notify the subject and all entities to whom reports have been sent that the original information has been revised. If the reporting entity does not revise the reported informa- tion, or does not respond to the subject within 60 days, the subject may request that the Secretary review the report for accuracy. The Secretary will decide whether to correct the report within 30 days of the request. This t to the subject within 60 days, the subject may request that the Secretary review the report for accuracy. The Secretary will decide whether to correct the report within 30 days of the request. This time frame may be extended for good cause. The subject also may provide a statement to the NPDB, either directly or through a designated representative that will permanently append the re- port. (c) Procedures for requesting a review of a disputed report. (1) The subject must request, in the format as determined by the Secretary, that the Secretary review the report for accuracy. The subject must return this request to the NPDB along with appropriate mate- rials that support the subject’s posi- tion. The Secretary will only review the accuracy of the reported informa- tion, and will not consider the merits or appropriateness of the action or the due process that the subject received. (2) After the review, if the Secretary: (i) Concludes that the information is accurate and reportable to the NPDB, the Secretary will inform the subject and the NPDB of the determination. The Secretary will include a brief statement (Secretarial Statement) in the report that describes the basis for the deci NPDB, the Secretary will inform the subject and the NPDB of the determination. The Secretary will include a brief statement (Secretarial Statement) in the report that describes the basis for the decision. The report will be re- moved from ‘‘disputed status.’’ The NPDB will distribute the corrected re- port and statement(s) to previous queriers (where identifiable), the re- porting entity and the subject of the report. (ii) Concludes that the information contained in the report is inaccurate, the Secretary will inform the subject of the determination and direct the NPDB or the reporting entity to revise the report. The Secretary will include a brief statement (Secretarial State- ment) in the report describing the find- ings. The NPDB will distribute the cor- rected report and statement(s) to pre- vious queriers (where identifiable), the reporting entity and the subject of the report. (iii) Determines that the disputed issues are outside the scope of the De- partment’s review, the Secretary will inform the subject and the NPDB of the determination. The Secretary will include a brief statement (Secretarial Statement) in the report describing the findings. The report will be removed f tary will inform the subject and the NPDB of the determination. The Secretary will include a brief statement (Secretarial Statement) in the report describing the findings. The report will be removed from ‘‘disputed status.’’ The NPDB will distribute the report and the state- ment(s) to previous queriers (where identifiable), the reporting entity and the subject of the report. (iv) Determines that the adverse ac- tion was not reportable and therefore should be removed from the NPDB, the Secretary will inform the subject and direct the NPDB to void the report. The NPDB will distribute a notice to previous queriers (where identifiable), the reporting entity and the subject of the report that the report has been voided. § 60.22 Immunity. Individuals, entities or their author- ized agents, and the NPDB shall not be 185 Pt. 63 45 CFR Subtitle A (10–1–24 Edition) held liable in any civil action filed by the subject of a report unless the indi- vidual, entity, or authorized agent sub- mitting the report has actual knowl- edge of the falsity of the information contained in the report. PART 63—GRANT PROGRAMS AD- MINISTERED BY THE OFFICE OF THE ASSISTANT SECRETARY FOR PLANNING AND EVALUATION the report has actual knowl- edge of the falsity of the information contained in the report. PART 63—GRANT PROGRAMS AD- MINISTERED BY THE OFFICE OF THE ASSISTANT SECRETARY FOR PLANNING AND EVALUATION Subpart A—General Sec. 63.1 Purpose and scope. 63.2 Eligibility for award. 63.3 Program announcements and solicita- tions. 63.4 Cooperative arrangements. 63.5 Effective date of approved grant. 63.6 Evaluation of applications. 63.7 Disposition of applications. 63.8 Supplemental regulations and grant conditions. Subpart B—Financial Provisions 63.16 Scope of subpart. 63.17 Amount of award. 63.18 Limitations on costs. 63.19 Budget revisions and minor devi- ations. 63.20 Period during which grant funds may be obligated. 63.21 Obligation and liquidation by grantee. 63.22 Cost sharing. 63.23 Telecommunications Demonstration Grants. Subpart C—Special Provisions 63.30 Scope of subpart. 63.31 Protection of human subjects. 63.32 Data collection instruments. 63.33 Treatment of animals. 63.34 Principal investigators. 63.35 Dual compensation. 63.36 Fees to Federal employees. 63.37 Leasing facilities. 63.38 Publications. 63.39 Religious worship or instruction. AUTHORITY: Sec. 602, Community Services investigators. 63.35 Dual compensation. 63.36 Fees to Federal employees. 63.37 Leasing facilities. 63.38 Publications. 63.39 Religious worship or instruction. AUTHORITY: Sec. 602, Community Services Act (42 U.S.C. 2942); sec. 1110, Social Security Act (42 U.S.C. 1310). SOURCE: 40 FR 23295, May 29, 1975, unless otherwise noted. Subpart A—General § 63.1 Purpose and scope. (a) Applicability. Except to the extent inconsistent with an applicable Federal statute the regulations in this part apply to all grant awards of Federal as- sistance made by the Assistant Sec- retary for Planning and Evaluation or his designee, hereinafter referred to in this part as the Assistant Secretary. Such grants include those under sec- tion 232 of the Community Services Act (42 U.S.C. 2835), section 1110 of the So- cial Security Act (42 U.S.C. 1310), sec- tion 392A of the Communications Act of 1934, and such other authority as may be delegated to the Assistant Sec- retary for policy research activities. (b) Exceptions to applicability. The award and administration of contracts and cooperative agreements by the As- sistant Secretary shall not be covered by this subchapter. Contracts entered into by the Ass xceptions to applicability. The award and administration of contracts and cooperative agreements by the As- sistant Secretary shall not be covered by this subchapter. Contracts entered into by the Assistant Secretary shall be subject to the regulations in CFR Title 48, Chapter 3. Generally, the As- sistant Secretary will select between grant and contract procedures and in- struments, both with regard to the so- licitation process and with respect to unsolicited proposals, on the basis of criteria set forth in the proposed revi- sion of 45 CFR 75.201(a) published at 39 FR 27469 at any subsequent revision thereof. (c) Objectives—(1) Policy research. The overall objective of policy research ac- tivities is to obtain information, as it relates to the mission of the Depart- ment of Health and Human Services, about the basic causes of and methods for preventing and eliminating poverty and dependency and about improved methods for delivering human re- sources services. Such information is obtained through the conduct of basic and applied research, statistical anal- yses, and demonstrations and evalua- tions which have demonstrated a high probability of impacting on the formu- lation or mo ained through the conduct of basic and applied research, statistical anal- yses, and demonstrations and evalua- tions which have demonstrated a high probability of impacting on the formu- lation or modification of major Depart- mental policies and programs. (2) Telecommunications demonstrations. The overall objective of the Tele- communications Demonstration Pro- gram is to promote the development of nonbroadcast telecommunications fa- cilities and services for the trans- mission, distribution, and delivery of 186 Dept. of Health and Human Services § 63.4 health, education, and social service information. [40 FR 23295, May 29, 1975, as amended at 42 FR 36149, July 13, 1977; 85 FR 72911, Nov. 16, 2020] § 63.2 Eligibility for award. (a) Groups and organizations eligible. Except where otherwise prohibited by law, any public or nonprofit private agency, institution, or organization which is found by the Assistant Sec- retary to be authorized and qualified by educational, scientific, or other rel- evant competence to carry out a pro- posed project in accordance with the regulations of this subchapter shall be eligible to receive a grant under this part. (b) Project eligible—(1) Policy r er rel- evant competence to carry out a pro- posed project in accordance with the regulations of this subchapter shall be eligible to receive a grant under this part. (b) Project eligible—(1) Policy research. Any project found by the Assistant Secretary to be a research, pilot, eval- uation, or demonstration project with- in the meaning of this section and § 63.1 shall be eligible for an award. Eligible projects may include planning, policy modeling or research utilization stud- ies; experiments; demonstrations; field investigations; statistical data collec- tions or analyses; or other types of in- vestigation or studies, or combinations thereof, and may either be limited to one aspect of a problem or subject, or may consist of two or more related problems or subjects for concurrent or consecutive investigation and may in- volve multiple disciplines, facilities, and resources. (2) Telecommunications demonstrations. Any projects which meet the special criteria in § 63.6(c) shall be eligible for a telecommunications demonstration grant. [40 FR 23295, May 29, 1975, as amended at 42 FR 36149, July 13, 1977] § 63.3 Program announcements and so- licitations. (a) In each fiscal year the A ible for a telecommunications demonstration grant. [40 FR 23295, May 29, 1975, as amended at 42 FR 36149, July 13, 1977] § 63.3 Program announcements and so- licitations. (a) In each fiscal year the Assistant Secretary may from time to time so- licit applications through one or more general or specialized program an- nouncements. Such announcements will be published in the FEDERAL REG- ISTER as notices and will include: (1) A clear statement of the type(s) of applications requested; (2) A specified plan, time(s) of appli- cation, and criteria for reviewing and approving applications; (3) Any grant terms or conditions of general applicability (other than those set forth in this part) which are nec- essary (i) to meet the statutory re- quirements of applicable legislation, (ii) to assure or protect the advance- ment of the project, or (iii) to conserve grant funds. (b) Applications for grants: Any ap- plicant eligible for grant assistance may submit on or before such cutoff date or dates as the Assistant Sec- retary may announce in program so- licitations, an application containing such pertinent information and in ac- cordance with the forms and instruc- tions as prescribed herein a as the Assistant Sec- retary may announce in program so- licitations, an application containing such pertinent information and in ac- cordance with the forms and instruc- tions as prescribed herein and addi- tional forms and instructions as may be specified by the Assistant Secretary. Such application shall be executed by the applicant or an official or rep- resentative of the applicant duly au- thorized to make such application. The Assistant Secretary may require any party eligible for assistance under this subchapter to submit a preliminary proposal for review and approval prior to the acceptance of an application submitted under these provisions. (c) All applications and preliminary proposals should be addressed to: Grants Officer, Office of the Assistant Sec- retary for Planning and Evaluation, De- partment of Health and Human Services, 330 Independence Avenue, SW, Room 5027, Washington, DC 20201. § 63.4 Cooperative arrangements. (a) Eligible parties may enter into cooperative arrangements with other eligible parties, including those in an- other State, to apply for assistance. (b) A joint application made by two or more applicants for assistance under this subchapter may hav rangements with other eligible parties, including those in an- other State, to apply for assistance. (b) A joint application made by two or more applicants for assistance under this subchapter may have separate budgets corresponding to the programs, services and activities performed by each of the joint applicants or may have a combined budget. If joint appli- cations present separate budgets, the Assistant Secretary may make sepa- rate awards, or may award a single grant authorizing separate amounts for each of the joint applicants. (c) In the case of each cooperative ar- rangement authorized under paragraph 187 § 63.5 45 CFR Subtitle A (10–1–24 Edition) (a) of this section and receiving assist- ance, except where the Assistant Sec- retary makes separate awards under paragraph (b) of this section all such applicants (1) shall be deemed to be joint legal recipients of the grant award and (2) shall be jointly and sev- erally responsible for administering the project assisted under such grant. § 63.5 Effective date of approved grant. Federal financial participation is normally available only with respect to obligations incurred subsequent to the effective date of an approved project. grant. § 63.5 Effective date of approved grant. Federal financial participation is normally available only with respect to obligations incurred subsequent to the effective date of an approved project. The effective date of the project will be set forth in the notification of grant award. Grantees may be reimbursed for costs resulting from obligations in- curred before the effective date of the grant award if such costs are author- ized by the Assistant Secretary in the notification of grant award or subse- quently in writing, and otherwise would be allowable as costs of the grant under the applicable regulations and grant terms and conditions. § 63.6 Evaluation of applications. (a) Review procedures. All applications filed in accordance with § 63.3 shall be evaluated by the Assistant Secretary through officers, employees, and such experts or consultants engaged for this purpose as he/she determines are spe- cially qualified in the areas of research pursued by this office. The evaluation criteria below will be supplemented each fiscal year by a program an- nouncement outlining priorities and objectives for policy research, and by other general or specialized solicita- tions. Such su n criteria below will be supplemented each fiscal year by a program an- nouncement outlining priorities and objectives for policy research, and by other general or specialized solicita- tions. Such supplements may modify the criteria in paragraphs (b) and (c) of this section to provide greater speci- ficity or otherwise improve their appli- cability to a given announcement or solicitation. (b) Criteria for evaluation of Policy Re- search Projects. Review of applications under paragraph (a) of this section will take into account such factors as: (1) Scientific merit and the signifi- cance of the project in relation to pol- icy objectives; (2) Feasibility of the project; (3) Soundness of research design, sta- tistical technique, and procedures and methodology; (4) Theoretical and technical sound- ness of the proposed plan of operation including consideration of the extent to which: (i) The objectives of the proposed project are sharply defined, clearly stated, and capable of being attained by the proposed procedures; (ii) The objectives of the proposed project show evidence of contributing to the achievement of policy objec- tives; (iii) Provisions are made for adequate evaluation of ed by the proposed procedures; (ii) The objectives of the proposed project show evidence of contributing to the achievement of policy objec- tives; (iii) Provisions are made for adequate evaluation of the effectiveness of the project and for determining the extent to which the objectives are accom- plished; and (iv) Appropriate provisions are made for satisfactory inservice training con- nected with project services. (5) Expected potential for utilizing the results of the proposed project in other projects or programs for similar purposes; (6) Sufficiency of size, scope, and du- ration of the project so as to secure productive results; (7) Adequacy of qualifications and ex- perience, including managerial, of per- sonnel; (8) Adequacy of facilities and other resources; and (9) Reasonableness of estimated cost in relation to anticipated results. (c) Criteria for evaluation of Tele- communications Demonstrations Projects. for Tele- Review of applications communications Demonstrations grants will take into account such fac- tors as are listed in paragraphs (c) (1) through (10) of this section. Each appli- cant must include in the application, prior to final evaluation by the Assist- an ts will take into account such fac- tors as are listed in paragraphs (c) (1) through (10) of this section. Each appli- cant must include in the application, prior to final evaluation by the Assist- ant Secretary, documentation indi- cating specifically and separately how and to what extent each of these cri- teria have been or will be met: (1) That the project for which appli- cation is made demonstrates innova- tive methods or techniques of utilizing nonbroadcast telecommunications equipment or facilities to satisfy the purpose of this authority; (2) That the project will have original research value which will demonstrate to other potential users that such methods or techniques are feasible and cost-effective; 188 Dept. of Health and Human Services § 63.8 (3) That the services to be provided are responsive to local needs as identi- fied and assessed by the applicant; (4) That the applicant has assessed existing telecommunications facilities (if any) in the proposed service area and explored their use of interconnec- tion in conjunction with the project; (5) That there is significant local commitment (e.g., evidence of support, participation, and contribution by local institutions xplored their use of interconnec- tion in conjunction with the project; (5) That there is significant local commitment (e.g., evidence of support, participation, and contribution by local institutions and agencies) to the proposed project, indicating that it ful- fills local needs, and gives some prom- ise that operational systems will result from successful demonstrations and will be supported by service recipients or providers; (6) That demonstrations and related activities assisted under this section will remain under the administration and control of the applicant; (7) That the applicant has the mana- gerial and technical capability to carry out the project for which the applica- tion is made; (8) That the facilities and equipment acquired or developed pursuant to the applications will be used substantially for the transmission, distribution, and delivery of health, education, or social service information, and that use of such facilities and equipment may be shared among these and additional public or other services; (9) That the provision has been made to submit a summary and factual eval- uation of the results of the demonstra- tion at least annually for each year in which f additional public or other services; (9) That the provision has been made to submit a summary and factual eval- uation of the results of the demonstra- tion at least annually for each year in which funds are received, in the form of a report suitable for dissemination to groups representative of national health, education, and social service telecommunications interests; and, (10) That the project has potential for stimulating cooperation and sharing among institutions and agencies, both within and across disciplines. (d) Applicant’s performance on prior award. Where the applicant has pre- viously received an award from the De- partment of Health and Human Serv- ices, the applicant’s compliance or noncompliance with requirements ap- plicable to such prior award as re- flected in past written evaluation re- ports, memoranda on performance, and completeness of required submissions: Provided, That in any case where the Assistant Secretary proposes to deny assistance based upon the applicant’s noncompliance with requirements ap- plicable to a prior award, he shall do so only after affording the applicant rea- sonable notice and an opportunity to rebut the proposed basis for denial of ant’s noncompliance with requirements ap- plicable to a prior award, he shall do so only after affording the applicant rea- sonable notice and an opportunity to rebut the proposed basis for denial of assistance. [40 FR 23295, May 29, 1975, as amended at 42 FR 36149, July 13, 1977] § 63.7 Disposition of applications. (a) Approval, disapproval, or deferral. On the basis of the review of an appli- cation pursuant to § 63.6 the Assistant Secretary will either (1) approve the application in whole or in part, for such amount of funds and subject to such conditions as he/she deems nec- essary or desirable for the completion of the approved project, (2) disapprove the application, or (3) defer action on the application for such reasons as lack of funds or a need for further review. (b) Notification of disposition. The As- sistant Secretary will notify the appli- cant in writing of the disposition of its application. A signed notification of grant award will be issued to notify the applicant of an approved project appli- cation. § 63.8 Supplemental regulations and grant conditions. (a) Grants under section 232 of the Com- munity Services Act. (1) Any grants awarded with funds appropriated u an approved project appli- cation. § 63.8 Supplemental regulations and grant conditions. (a) Grants under section 232 of the Com- munity Services Act. (1) Any grants awarded with funds appropriated under section 232 of the Community Services Act shall be subject to the following regulations issued by the Director of the Community Services Administra- tion (formerly the Office of Economic Opportunity): 45 CFR 1060.2 ......... 45 CFR 1060.3 ......... (Income Poverty Guidelines.) (Limitation on Benefits to Those Vol- untarily Poor.) 45 CFR 1067.1 ......... (Suspension and Termination of As- 45 CFR 1068.6 ......... 45 CFR 1069.1 ......... 45 CFR 1069.2 ......... sistance.) (Grantee Compliance with IRS Re- quirements for Withheld Federal In- come and Social Security Taxes.) (Employee Participation in Direct Ac- tion.) (Limitations with Respect to Unlawful Demonstrations, Rioting, and Civil Disturbances.) 45 CFR 1070.1 ......... (Public Access to Grantee Informa- tion.) No other portions of Chapter X of this title are applicable to such grants. 189 § 63.16 45 CFR Subtitle A (10–1–24 Edition) (2) Grants awarded with funds appro- priated under section 232 of the Com- munity Services Act s Chapter X of this title are applicable to such grants. 189 § 63.16 45 CFR Subtitle A (10–1–24 Edition) (2) Grants awarded with funds appro- priated under section 232 of the Com- munity Services Act shall also be sub- ject to the applicable statutory re- quirements in sections 242, 243, and 244, and title VI of the Community Services Act. The Assistant Secretary will ad- vise grantees of the nature of these re- quirements at or prior to the time of award. (3) In the event that any provision of this part is inconsistent with a provi- sion of law or a regulation referenced in paragraphs (a)(1) and (2) of this sec- tion with respect to any grant funded under section 232 of the Community Services Act, the provision of this part shall, to the extent of any such incon- sistency, not be effective. (b) Grants under other statutory au- thority. Grants awarded by the Assist- ant Secretary may be subject to regu- lations, other than those set forth in this part, which have been issued under the authority of statutes authorizing particular awards. In such a case, that fact will be set forth in the program announcement soliciting applications for such grants published in the FED- ERAL REGISTER uthority of statutes authorizing particular awards. In such a case, that fact will be set forth in the program announcement soliciting applications for such grants published in the FED- ERAL REGISTER pursuant to § 63.3. (c) Other regulations applicable to grants under this part. Federal financial assistance provided under this part shall be subject to the following addi- tional regulations except as otherwise provided in this part: (1) Part 75 of this title, establishing uniform administrative requirements, cost principles and audit requirements for grants by the Department of Health and Human Services. (2) Part 80 of this title, effectuating the provisions of title VI of the Civil Rights Act of 1964; and (3) Part 16 of this title, establishing a Departmental Grant Appeals Board for the resolution of specified post-award grant disputes. [40 FR 23295, May 29, 1975, as amended at 81 FR 3012, Jan. 20, 2016] Subpart B—Financial Provisions § 63.16 Scope of subpart. This subpart sets forth supplemental financial provisions which apply to all grants awarded by the Assistant Sec- retary, except as specified in § 63.23 of this subpart. [40 FR 23295, May 29, 1975, as amended at 42 FR 36149, upplemental financial provisions which apply to all grants awarded by the Assistant Sec- retary, except as specified in § 63.23 of this subpart. [40 FR 23295, May 29, 1975, as amended at 42 FR 36149, July 13, 1977] § 63.17 Amount of award. Federal assistance shall be provided only to meet allowable costs incurred by the award recipient in carrying out an approved project in accordance with the authorizing legislation and the reg- ulations of this part. § 63.18 Limitations on costs. The amount of the award shall be set forth in the grant award document. The total cost to the Government will not exceed the amount set forth in the grant award document or any modifica- tion thereof approved by the Assistant Secretary which meets the require- ments of applicable statutes and regu- lations. The Government shall not be obligated to reimburse the grantee for costs incurred in excess of such amount unless and until the Assistant Sec- retary has notified the grantee in writ- ing that such amount has been in- creased and has specified such in- creased amount in a revised grant award document. Such revised amount shall thereupon constitute the max- imum cost to the Government for the performan has been in- creased and has specified such in- creased amount in a revised grant award document. Such revised amount shall thereupon constitute the max- imum cost to the Government for the performance of the grant. § 63.19 Budget revisions and minor de- viations. Pursuant to § 74.102(d) of this title, paragraphs (b)(3) and (b)(4) of that sec- tion are waived. § 63.20 Period during which grant funds may be obligated. (a) The amount of the grant award shall remain available for obligation by the grantee during the period speci- fied in the grant award or until other- wise terminated. Such period may be extended by revision of the grant with or without additional funds pursuant to paragraph (b) of this section where otherwise permitted by law. (b) When it is determined that special or unusual circumstances will delay the completion of the project beyond the period for obligation, the grantee must in writing request the Assistant Secretary to extend such period and must indicate the reasons therefor. 190 Dept. of Health and Human Services § 63.23 § 63.21 Obligation and liquidation by grantee. Obligations will be considered to have been incurred by a grantee on the basis of documentar ons therefor. 190 Dept. of Health and Human Services § 63.23 § 63.21 Obligation and liquidation by grantee. Obligations will be considered to have been incurred by a grantee on the basis of documentary evidence of bind- ing commitments for the acquisition of goods or property or for the perform- ance of work, except that funds for per- sonal services, for services performed by public utilities, for travel, and for the rental of facilities, shall be consid- ered to have been obligated as of the time such services were rendered, such travel was performed, and such rented facilities were used, respectively. § 63.22 Cost sharing. Policy Research funds shall not be used to pay any recipient of a grant for the conduct of a research project an amount equal to as much as the entire cost of the project. § 63.23 Telecommunications onstration Grants. Dem- The provisions of this section apply only to grants awarded under authority of 392A of the Communications Act of 1934. (a) Funds provided under the Tele- communications Demonstrations Pro- gram shall be available to support the planning, development, and acquisition or leasing of facilities and equipment necessary to the demonstration. How- the Tele- communications Demonstrations Pro- gram shall be available to support the planning, development, and acquisition or leasing of facilities and equipment necessary to the demonstration. How- ever, funds shall not be available for the construction, remodeling, or repair of structures to house facilities or equipment acquired or developed with such funds, except that such funds may be used for minor remodeling which is necessary for and incident to the in- stallation of such facilities or equip- ment. (b) Funds shall not be available for the development of programming ma- terials or content. (c) The funding of any demonstration under this authority shall continue for not more than three years from the date of the original grant or contract. (1) Applications for assistance under the Act may project goals and activi- ties over a period of up to three years. Approval of a multi-year project is in- tended to offer the project a reasonable degree of stability over time and to facilitiate additional long range plan- ning. (2) Applications proposing a multi- year project must be accompanied by an explanation of the need for multi- year support, an overview of the objec- tives and a iate additional long range plan- ning. (2) Applications proposing a multi- year project must be accompanied by an explanation of the need for multi- year support, an overview of the objec- tives and activities proposed, and budg- et estimates to attain these objectives in any proposed subsequent year. (3) Subject to the availability of funds, an application for assistance to continue a project during the project period will be reviewed on a non-com- petitive basis to determine— (i) If the award recipient has com- plied with the award terms and condi- tions, the Act, and applicable regula- tions; (ii) The effectiveness of the project to date in terms of progress toward its goals, or the constructive changes pro- posed as a result of the ongoing evalua- tion of the project; and, (iii) If continuation of the project would be in the best interests of the Government. (d) The use of equipment in dem- onstration projects shall be subject to the rules and regulations of the Fed- eral Communications Commission (FCC), and grant funds may not be ex- pended or obligated for purchase, lease, or use of such equipment prior to ap- propriate and necessary coordination by the grantee with the Commi tions Commission (FCC), and grant funds may not be ex- pended or obligated for purchase, lease, or use of such equipment prior to ap- propriate and necessary coordination by the grantee with the Commission. In particular: (1) For any project requiring a new or modification of an existing authoriza- tion(s) from the FCC, application(s) to the FCC for such authorization(s) must have been tendered for filing prior to the closing date established by any so- licitation for grant applications offered under the Telecommunications Dem- onstration Program. (2) If the project is to be associated with an existing telecommunications activity requiring an FCC authoriza- tion, such operating authority for that activity must be current and valid. (3) For any project requiring a new or modification of an existing authoriza- tion(s) from the FCC, the applicant must file with the Secretary of Health and Human Services a copy of each FCC application and any amendments thereto. (4) For any project requiring a new or modification of an existing authoriza- tion(s) from the FCC, the applicant must tender for filing with the FCC a 191 § 63.30 45 CFR Subtitle A (10–1–24 Edition) copy of the application to ng a new or modification of an existing authoriza- tion(s) from the FCC, the applicant must tender for filing with the FCC a 191 § 63.30 45 CFR Subtitle A (10–1–24 Edition) copy of the application to the Sec- retary for a telecommunications dem- onstration grant. (5) If the applicant fails to file re- quired applications by the closing date established by the solicitation for grant applications, or if the FCC re- turns as substantially incomplete or deficient, dismisses, or denies an appli- cation required for the project, or any part thereof, or for the operation of any facility with which the project is associated, the Secretary may return the application for Federal assistance. (e) For the purposes of this program, the term ‘‘non-broadcast telecommuni- cations facilities’’ includes but is not limited to, cable television systems, communications satellite systems and related terminal equipment, and other methods of transmitting, emitting, or receiving images and sounds or intel- ligence by means of wire, radio, opti- cal, electromagnetic, and other means (including non-broadcast utilization of telecommunications equipment nor- mally associated with broadcasting use). (f) Each app nce by means of wire, radio, opti- cal, electromagnetic, and other means (including non-broadcast utilization of telecommunications equipment nor- mally associated with broadcasting use). (f) Each applicant shall provide such information as the Assistant Secretary deems necessary to make a Federal as- sessment of the impact of the project on the quality of the human environ- ment in accordance with section 102(2)(C) of the National Environmental Policy Act of 1969 (including the Na- tional Historical Preservation Act and other environmental acts). (42 U.S.C. 4332(2)(C)). [42 FR 36149, July 13, 1977] Subpart C—Special Provisions § 63.30 Scope of subpart. This subpart sets forth supplemental special provisions which apply to all grants awarded by the Assistant Sec- retary. § 63.31 Protection of human subjects. All grants made pursuant to this part are subject to the specific provisions of part 46 of this subtitle relating to the protection of human subjects. § 63.32 Data collection instruments. (a) Definitions. For the purposes of this section ‘‘Child’’ means an indi- vidual who has not attained the legal age of consent to participate in re- search as determined under the appli- cabl uments. (a) Definitions. For the purposes of this section ‘‘Child’’ means an indi- vidual who has not attained the legal age of consent to participate in re- search as determined under the appli- cable law of the jurisdiction in which such research is to be conducted. ‘‘Data-collection instruments’’ means tests, questionnaires, inven- tories, interview schedules or guides, rating scales, and survey plans or any other forms which are used to collect information on substantially identical items from 10 or more respondents. ‘‘Respondents’’ means individuals or organizations from whom information is collected. (b) Applicability. This section does not apply to instruments which deal solely with (1) functions of technical pro- ficiency, such as scholastic aptitude or school achievement, or (2) routine de- mographic information. (c) Protection of privacy. (1) No project supported under this part may involve the use of data collection instruments which constitute invasion of personal privacy through inquiries regarding such matters as religion, sex, race, or politics. (2) A grantee which proposes to use a data collection instrument shall set forth in the grant application an expla- nation hrough inquiries regarding such matters as religion, sex, race, or politics. (2) A grantee which proposes to use a data collection instrument shall set forth in the grant application an expla- nation of the safeguards which will be used to restrict the use and disclosure of information so obtained to purposes directly connected with the project, in- cluding provisions for the destruction of such instruments where no longer needed for the purposes of the project. (d) Clearance of instruments. (1) Grant- ees will not be required to submit data- collection instruments to the Assistant Secretary or obtain the Assistant Sec- retary’s approval for the use of these instruments, except where the notifica- tion of grant award specifically so pro- vides. (2) If a grantee is required under paragraph (d)(1) of this section to sub- mit data-collection instruments for the approval of the Assistant Secretary or if a grantee wishes the Assistant Sec- retary to review a data-collection in- strument, the grantee shall submit seven copies of the document to the As- sistant Secretary along with seven cop- ies of the Office of Management and Budget’s standard form No. 83 and seven copies of the Support e grantee shall submit seven copies of the document to the As- sistant Secretary along with seven cop- ies of the Office of Management and Budget’s standard form No. 83 and seven copies of the Supporting State- ment as required in the ‘‘Instructions 192 Dept. of Health and Human Services § 63.39 for Requesting OMB Approval under the Federal Reports Act’’ (Standard form No. 83A). (e) Responsibility for collection of infor- mation. A grantee shall not in any way represent or imply (either in a letter of transmittal, in the data-gathering in- struments themselves, or in any other manner) that the information is being collected by or for the Federal Govern- ment or any department, agency or in- strumentality thereof. Basic responsi- bility for the study and the data-gath- ering instruments rests with the grant- ee. (f) Parental consent. In the case of any survey using data-collection instru- ments in which children are involved as respondents, the grantee, in addition to observing the other requirements contained in this section, and in part 46 of this subtitle as appropriate, shall provide assurances satisfactory to the Assistant Secretary that informed con- sent will be obtained from r requirements contained in this section, and in part 46 of this subtitle as appropriate, shall provide assurances satisfactory to the Assistant Secretary that informed con- sent will be obtained from the parents of each such respondent prior to the use of such instruments, except that a waiver from the requirements of this paragraph for specific data-collection activities may be granted upon the written request by the grantee and a determination by the Assistant Sec- retary that a waiver is necessary in order to fully carry out the purposes of the grant. this subtitle or such other regulations as may be indicated in the grant terms and conditions. [40 FR 23295, May 29, 1975, as amended at 81 FR 3012, Jan. 20, 2016] § 63.35 Dual compensation. If a project staff member or consult- ant of one grantee is involved simulta- neously in two or more projects sup- ported by any funds either under this part or otherwise, he/she may not be compensated for more than 100 percent of his/her time from any funds during any part of the period of dual involve- ment. § 63.36 Fees to Federal employees. The grantee shall not use funds from any sources to pay a fee to, or travel expenses of, employees o m any funds during any part of the period of dual involve- ment. § 63.36 Fees to Federal employees. The grantee shall not use funds from any sources to pay a fee to, or travel expenses of, employees of the Federal Government for lectures, attending program functions, or any other activi- ties in connection with the grant. § 63.37 Leasing facilities. In the case of a project involving the leasing of a facility, the grantee shall demonstrate that it will have the right to occupy, to operate, and, if nec- essary, to maintain and improve the leased facility during the proposed pe- riod of the project. § 63.33 Treatment of animals. § 63.38 Publications. If animals are utilized in any project receiving assistance, the applicant for such assistance shall provide assur- ances satisfactory to the Assistant Secretary that such animals will be provided with proper care and humane treatment; in accordance with the Ani- mal Welfare Act (7 U.S.C. 2131 et seq.) and regulations set forth in (9 CFR parts 1, 2, 3, 4). § 63.34 Principal investigators. The principal investigator(s) des- ignated in successful grant applica- tions as responsible for the conduct of the approved project, shall not be re- ts 1, 2, 3, 4). § 63.34 Principal investigators. The principal investigator(s) des- ignated in successful grant applica- tions as responsible for the conduct of the approved project, shall not be re- placed without the prior approval of the Assistant Secretary or his des- ignee. Failure to seek and acquire such approval may result in the grant award being terminated in accordance with the procedures set forth in § 75.372 of Any publication or presentation re- sulting from or primarily related to Federal financial assistance under this part shall contain an acknowledgement essentially as follows: The activity which is the subject of this re- port was supported in whole or part by a grant from the Office of the Assistant Sec- retary for Planning and Evaluation, Depart- ment of Health and Human Services. How- ever, the opinions expressed herein do not necessarily reflect the position or policy of that Office and no official endorsement by that Office should be inferred. § 63.39 Religious worship or instruc- tion. Federal funds shall not be used for the making of any payment for reli- gious worship or instruction, or for the construction, operation, or mainte- nance of so much of any f worship or instruc- tion. Federal funds shall not be used for the making of any payment for reli- gious worship or instruction, or for the construction, operation, or mainte- nance of so much of any facility as is 193 Pt. 73 45 CFR Subtitle A (10–1–24 Edition) used or to be used for sectarian in- struction or as a place for religious in- struction. PART 73—STANDARDS OF CONDUCT Subpart A—General Provisions Sec. 73.735–101 Purpose. 73.735–102 Definitions. 73.735–103 Applicability. Subpart B—Responsibilities 73.735–201 Employees and supervisors. 73.735–202 Management officials. Subpart C—Conduct on the Job 73.735–706 Teaching, lecturing, and speech- making. 73.735–707 Holding office in professional so- cieties. 73.735–708 Administrative approval of cer- tain outside activities. 73.735–709 Annual reporting of outside ac- tivities. 73.735–710 Maintenance of records. Subpart H—Financial Interest 73.735–801 Participation in matters affecting a personal financial interest. 73.735–802 Executive order prohibitions. 73.735–803 Prohibition against involvement in financial transactions based on infor- mation obtained through Federal em- ployment. 73.735–804 Waiver of the prohibitions in this su order prohibitions. 73.735–803 Prohibition against involvement in financial transactions based on infor- mation obtained through Federal em- ployment. 73.735–804 Waiver of the prohibitions in this subpart. 73.735–805 Advice and guidance on conflicts 73.735–301 Courtesy and consideration for matters. others. 73.735–302 Support of department programs. 73.735–303 Use of government funds. 73.735–304 Use of government property. 73.735–305 Conduct in Federal buildings. 73.735–306 Sexual harassment. 73.735–307 Use of official information. Subpart D—Financial Obligations 73.735–401 General provisions. 73.735–806 Documentation and publication of opinions. Subpart I—Reporting Financial Interests 73.735–901 Reporting requirement of the Ethics in Government Act of 1978. 73.735–902 Reporting requirements for cer- tain employees not covered by the Ethics in Government Act of 1978. 73.735–903 Action if conflicts of interest or possible conflicts are noted. Subpart E—Gifts, Entertainment, and Favors 73.735–904 Resolution of apparent or actual 73.735–501 Prohibited acceptance of gifts, en- tertainment, and favors. 73.735–502 Permissible acceptance of gifts, entertainment, and favors. 73.735–503 Cr 73.735–904 Resolution of apparent or actual 73.735–501 Prohibited acceptance of gifts, en- tertainment, and favors. 73.735–502 Permissible acceptance of gifts, entertainment, and favors. 73.735–503 Criminal provisions relating to gifts, entertainment, and favors. 73.735–504 Gifts to official superiors. 73.735–505 Acceptance of awards and prizes. 73.735–506 Gifts and decorations from for- eign governments. 73.735–507 Acceptance of travel and subsist- ence. 73.735–508 Other prohibitions. conflicts of interest. Subpart J—Provisions Relating to Experts, Consultants and Advisory Committee Members 73.735–1001 Coverage. 73.735–1002 Ethical standards of conduct. 73.735–1003 Conflicts of interest statutes. 73.735–1004 Requesting waivers or exemp- tions. 73.735–1005 Salary from two sources. 73.735–1006 Reporting financial interests. 73.735–1007 Political activity. Subpart F—Political Activity 73.735–601 Applicability. 73.735–602 Permissible activities. 73.735–603 Prohibited activities. Subpart G—Outside Activities 73.735–701 General provisions. 73.735–702 Criminal prohibitions on outside activities. Subpart K—Special Government Employees Other Than Consultants 73.735–1101 General provision. —Outside Activities 73.735–701 General provisions. 73.735–702 Criminal prohibitions on outside activities. Subpart K—Special Government Employees Other Than Consultants 73.735–1101 General provision. Subpart L—Disciplinary Action 73.735–1201 General provisions. Subpart M—Reporting Violations 73.735–703 Statutory prohibitions related to employment by a foreign government. 73.735–1301 Responsibility for reporting pos- sible criminal violations. 73.735–704 Professional and consultative 73.735–1302 Responsibility for reporting alle- services. gations of misconduct. 73.735–705 Writing and editing. 73.735–1303 Prohibition of reprisals. 194 Dept. of Health and Human Services § 73.735–201 73.735–1304 Referral of matters arising under the standards of this part. Subpart N—Conduct and Responsibilities of Former Employees 73.735–1401 Prohibitions against post-em- ployment conflicts of interest. APPENDIX A TO PART 73—LIST OF SOME OF- FENSES FOR WHICH DISCIPLINARY ACTION MAY BE TAKEN APPENDIX B TO PART 73—CODE OF ETHICS FOR GOVERNMENT SERVICE AUTHORITY: 5 U.S.C. 7301, 42 U.S.C. 216; E.O. 11222, 30 FR 6469; 5 CFR 735.101 et seq. SOURCE: 46 FR 7369, Jan. 23, 1981, unless otherwise noted. Subpart PART 73—CODE OF ETHICS FOR GOVERNMENT SERVICE AUTHORITY: 5 U.S.C. 7301, 42 U.S.C. 216; E.O. 11222, 30 FR 6469; 5 CFR 735.101 et seq. SOURCE: 46 FR 7369, Jan. 23, 1981, unless otherwise noted. Subpart A—General Provisions § 73.735–101 Purpose. To assure that the business of the De- partment of Health and Human Serv- ices (HHS) is conducted effectively, ob- jectively, and without improper influ- ence or the appearance of improper in- fluence, employees and special Govern- ment employees must be persons of in- tegrity and must observe high stand- ards of honesty, impartiality, and be- havior. They must not engage in any conduct prejudicial to the Government and must avoid conflicts of private in- terests with public duties and respon- sibilities. In accord with these prin- ciples, the regulations in this part are issued to inform HHS employees and special Government employees what standards of conduct are expected of them in performing their duties and what activities are permitted or pro- hibited both while they are employed and after their employment with the Department is ended. § 73.735–102 Definitions. In this part: (a) Employee means an officer or em- ployee of HHS other than a - hibited both while they are employed and after their employment with the Department is ended. § 73.735–102 Definitions. In this part: (a) Employee means an officer or em- ployee of HHS other than a special Government employee and includes Commissioned Officers of the Public Health Service who are on active duty, and individuals on assignment or detail to HHS pursuant to the Intergovern- mental Personnel Act (5 U.S.C. 3371– 3376). The term also includes HHS em- ployees who are detailed to non-Fed- eral or other Federal organizations. At times the term ‘‘regular employee’’ is used in place of ‘‘employee’’ to make a clear distinction between special Gov- ernment employees and others em- ployed by the Federal government. (b) Special Government employee means an individual who is retained, des- ignated, appointed, or employed to per- form temporary duties either on a full- time or intermittent basis, with or without compensation, for not to ex- ceed 130 days during any period of 365 consecutive days. (c) Person means an individual, a cor- poration, a company, an association, a firm, a partnership or any other orga- nization. (d) Former employee means a former employee of HHS or former cutive days. (c) Person means an individual, a cor- poration, a company, an association, a firm, a partnership or any other orga- nization. (d) Former employee means a former employee of HHS or former special Government employee as defined in paragraph (b) of this section. (e) Principal Operating Component has the meaning given to that term in the Department’s General Administration Manual. In addition, when used in these regulations, it includes the Office of the Secretary. (f) Department means the Department of Health and Human Services. § 73.735–103 Applicability. (a) The regulations in this part apply to all employees of the Department and to special Government employees to the extent indicated in Subparts J and K. They apply whether an employee is on leave, including leave without pay, or on duty. (b) These regulations may be supple- mented by regulations governing prin- cipal operating components, or sub- units of principal operating compo- nents, provided the clearance and pub- lication requirements for standards of conduct regulations are met and ap- proval is obtained from the Depart- ment Ethics Counselor and the Assist- ant Secretary for Personnel Adminis- tration. Subpa lication requirements for standards of conduct regulations are met and ap- proval is obtained from the Depart- ment Ethics Counselor and the Assist- ant Secretary for Personnel Adminis- tration. Subpart B—Responsibilities § 73.735–201 Employees and super- visors. (a) Employees and special Govern- ment employees shall be responsible for observing all generally accepted rules of conduct and the specific provi- sions of law and the regulations of this part that apply to them. They are re- quired to become familiar with these 195 § 73.735–202 45 CFR Subtitle A (10–1–24 Edition) regulations and to exercise informed judgments to avoid misconduct or con- flicts of interest. They shall secure ap- provals when required and file finan- cial disclosure reports or statements in accordance with the provisions of this part. Failure to observe any of these regulations may be cause for discipli- nary action. Some of the provisions are required by law and carry criminal penalties which are in addition to any disciplinary action which could be taken. When employees have doubts about any provision, they should con- sult their supervisor, personnel office, or the Department Ethics Counselor or a deput to any disciplinary action which could be taken. When employees have doubts about any provision, they should con- sult their supervisor, personnel office, or the Department Ethics Counselor or a deputy counselor. (b) Supervisors, because of their day- to-day relationships with employees, are responsible to a large degree for making sure high standards of conduct are maintained. They must become fa- miliar with the Department’s stand- ards of conduct regulations and apply the standards to the work they do and supervise. Supervisors shall take suit- able action, including disciplinary ac- tion in accordance with subpart L of these regulations, when violations occur. § 73.735–202 Management officials. (a) The Department has an obligation to enforce the requirements of this part in all respects and to help employ- ees, special Government employees, and supervisors carry out their respon- sibilities to maintain high standards of ethical conduct. This includes an obli- gation for managers to provide infor- mation and training concerning the HHS conduct regulations, to provide advice and guidance with respect to them, and to review for possible con- flicts of interest certain outside acti provide infor- mation and training concerning the HHS conduct regulations, to provide advice and guidance with respect to them, and to review for possible con- flicts of interest certain outside activi- ties and financial interests of employ- ees. The officials responsible for dis- charging the Department’s obligations in this regard are identified in para- graphs (b) through (f) of this section. (b) Department Ethics Counselor. The Assistant General Counsel, Busi- ness and Administrative Law Division, shall be the Department Ethics Coun- selor and shall serve as the Designated Agency Official for matters arising under the Ethics in Government Act of 1978, (Pub. L. 95–521). The responsibil- ities of the Department Ethics Coun- selor shall include: (1) Rendering authoritative advice and guidance on matters of general ap- plicability under the standards of this part and all other laws and regulations governing employee conduct, with par- ticular reference to conflicts of inter- est matters. (2) Coordinating the Department’s counselling and training services re- garding conflicts of interest and assur- ing that employees of the Department are kept informed of developments in conflict ers. (2) Coordinating the Department’s counselling and training services re- garding conflicts of interest and assur- ing that employees of the Department are kept informed of developments in conflict of interest laws and other re- lated matters of ethics. (3) Receiving information on con- flicts of interest and appearances of conflicts of interest involving employ- ees of the Department and forwarding this information to the appropriate management official, or the Inspector General, as necessary, with his or her legal evaluation of the matters ad- dressed. (4) Reviewing the financial disclosure reports, requests for approval of out- side activities, and similar reports filed by Executive level officers, non-career executives, deputy ethics counselors, and Schedule C employees in the Office of the Secretary for the purpose of identifying and resolving possible and actual conflicts of interest. (5) Maintaining liaison with the Of- fice of Government Ethics. (6) Advising management officials on the resolution of conflicts of interest by any of the remedies set forth in § 73.735–904 of this part. (7) Maintaining accurate and com- plete documentation of all formal guid- ance and advice ials on the resolution of conflicts of interest by any of the remedies set forth in § 73.735–904 of this part. (7) Maintaining accurate and com- plete documentation of all formal guid- ance and advice regarding conflict of interest matters subject to the provi- sions of this part, except for routine or repetitious cases where the guidance given is not precedential. (8) Maintaining and publishing from time to time a list of those cir- cumstances or situations which have resulted or may result in noncompli- ance with conflict of interest laws or regulations. [Section 206(b)(7), Pub. L. 95–521]. (9) Designating and training an ap- propriate number of reviewing officials to assist him or her in carrying out the duties of the Designated Agency Offical under the Ethics in Government Act. 196 Dept. of Health and Human Services § 73.735–302 (10) Maintaining effective lines of communication with deputy ethics counselors on all matters regarding employee conduct and ethics. (c) Deputy Ethics Counselors. Assist- ant General Counsels and Regional At- torneys are designated deputy ethics counselors to assist the Department’s Counselor in carrying out his or her re- sponsibilities, particularly nselors. Assist- ant General Counsels and Regional At- torneys are designated deputy ethics counselors to assist the Department’s Counselor in carrying out his or her re- sponsibilities, particularly with re- spect to employees in the organization in which the deputy counselor serves. Regional Attorneys shall provide such assistance for all employees of the De- partment in organizations for which the Principal Regional Official pro- vides personnel services. (d) The Assistant Secretary for Per- sonnel Administration shall be respon- sible for developing and issuing proce- dures and requirements for the imple- mentation of these regulations and for monitoring the application of such pro- cedures and requirements throughout the Department. (e) Heads of Principal Operating Components and the Assistant Sec- retary for Management and Budget for the Office of the Secretary shall be ul- timately responsible for assuring that persons who work for their respective organizations comply with the stand- ards of this part. Their responsibilities shall include: (1) Designating officials to review and approve outside activity requests in accordance with § 73.735–708 of this part or statements of stand- ards of this part. Their responsibilities shall include: (1) Designating officials to review and approve outside activity requests in accordance with § 73.735–708 of this part or statements of employment or financial interests under § 73.735–902. A list of the officials designated for these purposes shall be provided to the De- partment Ethics Counselor and to the Assistant Secretary for Personnel Ad- ministration and shall be updated in January and July of each year. (2) Designating for the components of his or her organization, other than those for which a principal regional of- ficial provides personnel services, one or more individuals to oversee and co- ordinate the administrative aspects of these regulations. Responsibilities of such a person include making sure each employee or special government em- ployee is provided a copy of these regu- lations, or an appropriate summary thereof; ensuring that training in the requirements of the regulations is pro- vided to supervisors and to new em- ployees; providing for the distribution, receipt, review and retention of finan- cial interest reports and statements as directed by the Department Ethics Counselor and the Assistant s and to new em- ployees; providing for the distribution, receipt, review and retention of finan- cial interest reports and statements as directed by the Department Ethics Counselor and the Assistant Secretary for Personnel Administration; sending annual reminders as required; pro- viding for a file of outside work re- quests; giving information and assist- ance to employees on a day-to-day basis; and making available to employ- ees the names and addresses of the De- partment’s Ethics Counselor and dep- uty ethics counselors. (f) Principal Regional Officials (PROs) shall designate one or more re- gional employees to perform, for com- ponents for which personnel services are provided by the PROs, the respon- sibilities in paragraph (e)(2) of this sec- tion. Subpart C—Conduct on the Job § 73.735–301 Courtesy and consider- ation for others. (a) An employee’s conduct on the job is, in all respects, of concern to the Federal government. Courtesy, consid- eration, and promptness in dealing with the public must be shown in car- rying out official responsibilities, and actions which deny the dignity of indi- viduals or conduct which is disrespect- ful to others must be avoided. Employ- ees ith the public must be shown in car- rying out official responsibilities, and actions which deny the dignity of indi- viduals or conduct which is disrespect- ful to others must be avoided. Employ- ees must recognize that inattention to matters of common courtesy can ad- versely affect the quality of service the Department is responsible for pro- viding. Where appropriate, courtesy to the public should be included in the standards for employee performance. (b) Of equal importance is the re- quirement that courtesy be shown in day-by-day interaction with co-work- ers. Employees shall be polite to and considerate of other employees, and shall respect their needs and concerns in the work environment. § 73.735–302 Support of department programs. (a) When a Department program is based on law, Executive Order or regu- lation, every employee has a positive obligation to make it function as effi- ciently and economically as possible and to support it as long as it is a part 197 § 73.735–303 45 CFR Subtitle A (10–1–24 Edition) of recognized public policy. An em- ployee may, therefore, properly make an address explaining and interpreting such a program, citing its achieve- ments, defending it CFR Subtitle A (10–1–24 Edition) of recognized public policy. An em- ployee may, therefore, properly make an address explaining and interpreting such a program, citing its achieve- ments, defending it against uninformed or unjust criticism, or soliciting views for improving it. (b) An employee shall not, either di- rectly or indirectly, use appropriated funds to influence, or attempt to influ- ence, a Member of Congress to favor or oppose legislation. However, when au- thorized by his or her supervisor, an employee is not prohibited from: (1) Testifying, on request, as a rep- resentative of the Department on pend- ing legislation or proposals before Con- gressional Committees; or (2) Assisting Congressional Commit- tees in drafting bills or reports on re- quest, when it is clear that the em- ployee is serving solely as a technical expert under the direction of com- mittee leadership. (c) All employees shall be familiar with regulations and published instruc- tions that relate to their official duties and responsibilities and shall comply with those directives. This includes carrying out proper orders from offi- cials authorized to give them. (d) Employees are required to assist the official duties and responsibilities and shall comply with those directives. This includes carrying out proper orders from offi- cials authorized to give them. (d) Employees are required to assist the Inspector General and other inves- tigative officials in the performance of their duties or functions. This require- ment includes the giving of statements or evidence to investigators of the In- spector General’s office or other HHS investigators authorized to conduct in- vestigations into potential violations. § 73.735–303 Use of government funds. (a) An employee shall not: (1) Improperly use official travel; (2) Improperly use payroll and other vouchers and documents on which Gov- ernment payments are based; (3) Take or fail to account for funds with which the employee is entrusted in his or her official position; or (4) Take other Government funds for personal use. Violation of these prohi- bitions carry criminal penalties. (b) In addition, employees shall avoid wasteful actions or behavior in the per- formance of their assigned duties. § 73.735–304 Use of government prop- erty. (a) An employee shall not directly or indirectly use, or allow the use of, Gov- ernment property of any havior in the per- formance of their assigned duties. § 73.735–304 Use of government prop- erty. (a) An employee shall not directly or indirectly use, or allow the use of, Gov- ernment property of any kind, includ- ing property leased to the Government, for other than officially approved ac- tivities. An Employee has a positive duty to protect and conserve Govern- ment property, including equipment, supplies, and other property entrusted or issued to him or her. For example: (1) Only official documents and mate- rials may be processed on Government reproduction facilities. Both super- visors and employees must assure that this rule is strictly followed. (Excep- tion for employee welfare and recre- ation associations is stated in Chapter 25–10, General Administration Manual. Exception for labor organizations is stated in Personnel Instruction 711–1.) (2) Employees may drive or use Gov- ernment automobiles or aircraft only on official business. Use of a Govern- ment owned, leased, or rented vehicle or aircraft for non-official purposes may result in suspension for at least 30 days or removal from the Federal serv- ice. 31 U.S.C. 638a. Example: Normally, use of a Government automobile ted vehicle or aircraft for non-official purposes may result in suspension for at least 30 days or removal from the Federal serv- ice. 31 U.S.C. 638a. Example: Normally, use of a Government automobile by travel between home and place of duty would not be considered official business and could not be authorized. An ex- ception to this rule might be appropriate in a situation where an employee is required to leave early in the morning to attend a meet- ing in a distant city, or to return late in the day from such a meeting. Allowing the em- ployee to drive a government car to his or her home the night before in order to leave from home, or to return to his or her home in the evening upon completion of the trip is permissible, provided the employee does not use the car for any personal reason. § 73.735–305 Conduct in Federal build- ings. (a) An employee shall not participate while on Government-owned or leased property or while on duty for the Gov- ernment, in any gambling activity in- cluding the operation of a gambling de- vice, in conducting a lottery or pool, in a game for money or property, or in selling or purchasing a numbers slip or ticket. 198 Dept. of Health and Human Servic uding the operation of a gambling de- vice, in conducting a lottery or pool, in a game for money or property, or in selling or purchasing a numbers slip or ticket. 198 Dept. of Health and Human Services § 73.735–307 (b) An employee shall not while in or on Government-owned or leased prop- erty or while on duty for the Govern- ment solicit alms and contributions, engage in commercial soliciting and vending, display or distribute commer- cial advertisements, or collect private debts. (c) The prohibitions in paragraphs (a) and (b) of this section do not preclude: (1) Activities necessitated by an em- ployee’s law enforcement duties; (2) Participation in Federally spon- sored fund-raising activities conducted pursuant to Executive Order 10927, or similar HHS-approved activities; or (3) Buying a lottery ticket at an au- thorized State lottery outlet for a lot- tery authorized by State law and con- ducted by an agency of a State within that State. (d) General Services Administration regulations on ‘‘Conduct on Federal Property’’ apply to all property under the control of the General Services Ad- ministration, and they are also appli- cable to all buildings and space under the control of ons on ‘‘Conduct on Federal Property’’ apply to all property under the control of the General Services Ad- ministration, and they are also appli- cable to all buildings and space under the control of this Department. These regulations prohibit, among other things, gambling, being intoxicated, and possession, distribution, or use of narcotic or dangerous drugs on the premises. The GSA regulations are found in Subpart 101–20.3 of the GSA Regulations, 41 CFR 101–20.3. § 73.735–306 Sexual harassment. Sexual harassment is deliberate un- solicited verbal comments, gestures, or physical contact of a sexual nature which are unwelcome. Sexual harass- ment is unacceptable conduct and is expressly prohibited. In addition, su- pervisors and managers are prohibited from taking or promising personnel ac- tions in exchange for sexual favors, or failing to take an action because an employee or applicant for employment, refuses to engage in sexual conduct. This same prohibition applies to rela- tionships between Department per- sonnel who take or recommend action on a grant or contract and the grantee or contractor. Those employees who wish to file a complaint of sexual har- assment should contact ps between Department per- sonnel who take or recommend action on a grant or contract and the grantee or contractor. Those employees who wish to file a complaint of sexual har- assment should contact the Office of Equal Employment Opportunity (EEO) within their respective agencies for guidance. (Time frames for pursuing a charge alleging sexual harassment are the same as for any other complaint based on allegations of sex discrimina- tion.) § 73.735–307 Use of official informa- tion. (a) The public interest requires that certain information in the possession of the Government be kept confiden- tial, and released only with general or specific authority under Department or operating component regulations. Such information may involve the national security or be private, personal, or business information which has been furnished to the Government in con- fidence. In addition, information in the possession of the Government and not generally available may not be used for private gain. The following paragraphs set forth the rules to be followed by Department employees in handling in- formation in official files or docu- ments: (1) Classified information. Employees who have access to inf following paragraphs set forth the rules to be followed by Department employees in handling in- formation in official files or docu- ments: (1) Classified information. Employees who have access to information which is classified for security reasons in ac- cordance with Executive Order 12065 are responsible for its custody and safe- keeping, and for assuring that it is not disclosed to unauthorized persons. See the Department’s Security Manual, Part 3 for details. (2) Security and investigative informa- tion. Security and investigative data received from Government agencies or other sources for official use only with- in the Department or developed under a pledge of confidence is not to be di- vulged to unauthorized persons or agencies. (3) Information obtained in confidence. Certain Department units (e.g., Food and Drug Administration, and the So- cial Security Administration) obtain in the course of their program activities certain information from businesses or individuals which they are forbidden by law from disclosing. These statutory prohibitions are found in 21 U.S.C. 331j, and 18 U.S.C. 1905. Each employee is re- sponsible for observing these laws. (4) Use of information fo y are forbidden by law from disclosing. These statutory prohibitions are found in 21 U.S.C. 331j, and 18 U.S.C. 1905. Each employee is re- sponsible for observing these laws. (4) Use of information for private gain. Government employees are sometimes able to obtain information about some action the Government is about to take or some other matter which is not generally known. Information of this 199 § 73.735–401 45 CFR Subtitle A (10–1–24 Edition) kind shall not be used by the employee to further his or her or someone else’s private financial or other interests. Such a use of official information is clearly a violation of a public trust. Employees shall not, directly or indi- rectly, make use of, or permit others to make use of, for the purpose of fur- thering any private interest, official information not made available to the general public. (b) The Privacy Act provides crimi- nal penalties for an employee who will- fully discloses individually identifiable information from records, disclosure of which is prohibited by that Act. 5 U.S.C. 552a(i). Subpart D—Financial Obligations § 73.735–401 General provisions. (a) The Department considers the in- debtedness of its employees to be disclosure of which is prohibited by that Act. 5 U.S.C. 552a(i). Subpart D—Financial Obligations § 73.735–401 General provisions. (a) The Department considers the in- debtedness of its employees to be a matter of their own concern. However, employees shall not by failure to meet their just financial obligations reflect adversely on the Government as their employer. Employees are expected to pay each just financial obligation in a proper and timely manner. A ‘‘just fi- nancial obligation’’ is one acknowl- edged by the employee or reduced to judgment by a court, or one imposed by law such as Federal, State, or local taxes. ‘‘In a proper and timely man- ner’’ is a manner which the Depart- ment determines does not, under the circumstances, reflect adversely on the part of an employee in meeting his or her financial obligations, particularly those that relate to support of the em- ployee’s family, to payment of Federal, State, or local taxes, or to payments to tax-supported institutions such as a city or State hospital, or educational institution. If for some reason an em- ployee is unable to pay these obliga- tions promptly, he or she is expected to make satisfactory arrangements for p h as a city or State hospital, or educational institution. If for some reason an em- ployee is unable to pay these obliga- tions promptly, he or she is expected to make satisfactory arrangements for payment and abide by these arrange- ments. (b) Disciplinary action may be con- sidered when an employee has handled his or her financial affairs in such a way that: (1) Action on complaints received from creditors requires the use of a considerable amount of official time, or (2) It appears that financial difficul- ties are impairing the employee’s effi- ciency on the job, or (3) Because of the employee’s finan- cial irresponsibility, the attitude of the general public toward the Department may be adversely affected; and the em- ployee after counseling does not make arrangements to meet his or her finan- cial obligations. Subpart E—Gifts, Entertainment, and Favors § 73.735–501 Prohibited acceptance of gifts, entertainment, and favors. (a) Except as provided in §§ 73.735–502 and 73.735–506, an employee shall not directly or indirectly solicit or accept anything of monetary value, including gifts, gratuities, favors, entertainment or loans from a person who the em- ployee knows, or should an employee shall not directly or indirectly solicit or accept anything of monetary value, including gifts, gratuities, favors, entertainment or loans from a person who the em- ployee knows, or should know because of the nature of the employee’s work: (1) Has, or is seeking to obtain, con- tractual or other business or financial relations with the employee’s principal sub-unit operating component, or thereof; or with a component of the De- partment with respect to which the employee has official duties; (2) Conducts operations or activities that are regulated by the employee’s principal operating component, or sub- unit thereof or by a component of the Department with respect to which the employee has official duties; or (3) Has interests that may be sub- stantially affected by the performance or non-performance of the employee’s official duties. (b) Employees may not designate a person or an organization, including charitable or non-profit organizations, to accept any gift which an employee is prohibited from accepting directly. § 73.735–502 Permissible acceptance of gifts, entertainment, and favors. (a) An employee may accept a gift, gratuity, favor, entertainment, loan or simila ployee is prohibited from accepting directly. § 73.735–502 Permissible acceptance of gifts, entertainment, and favors. (a) An employee may accept a gift, gratuity, favor, entertainment, loan or similar favor of monetary value which stems from a family relationship such as that between the employee and his or her parents, spouse or children, if it is clear that the relationship is the mo- tivating factor. 200 Dept. of Health and Human Services § 73.735–504 (b) Loans from banks or other finan- cial institutions may be accepted on customary terms. (c) Unsolicited advertising or pro- motional material such as pens, note pads, calendars and similar items of nominal intrinsic value may be accept- ed. (d) An employee may accept food or refreshment of nominal value on infre- quent occasions in the ordinary course of a luncheon or dinner meeting or on an inspection tour only if the employee is properly in attendance and there is not a reasonable opportunity to pay. Example 1: Employee is on the premises of Company participating in a meeting at a normal mealtime. A representative of Com- pany provides a meal for all meeting partici- pants from a Company facility and there is no established m premises of Company participating in a meeting at a normal mealtime. A representative of Com- pany provides a meal for all meeting partici- pants from a Company facility and there is no established method for payment. Em- ployee may accept. Example 2: Employee is on the premises of Company and he or she goes outside for lunch with a representative of the Company. The representative offers to pay the bill. Since it is practical for the employee to pay for his or her own meal, the employee may not accept. (e) An employee may also accept food or refreshment of nominal value on in- frequent occasions if the food and/or re- freshment is offered to all participants or attendees of a meeting or conven- tion. Example 1: During the course of a conven- tion of a professional organization a lunch- eon open to all attendees is sponsored by a corporation which conducts business with the Department and the employee has offi- cial dealings with representatives of the cor- poration. The employee may attend the luncheon. § 73.735–503 Criminal provisions relat- ing to gifts, entertainment, and fa- vors. (a) The law provides criminal pen- alties for whoever, directly or indi- rectly: (1) Receives or attend the luncheon. § 73.735–503 Criminal provisions relat- ing to gifts, entertainment, and fa- vors. (a) The law provides criminal pen- alties for whoever, directly or indi- rectly: (1) Receives or accepts anything of value for or because of any official act the employee has performed or will perform; or (2) Gives, offers or promises anything of value for the performance of an offi- cial act or to influence the perform- ance of an official act. 18 USC 201. (b) The law prohibits an employee from receiving any salary or any con- tribution to, or supplementation of, his or her salary as compensation for serv- ices as an officer or employee of the Government from any source other than the United States or any State, county or municipality. This law does not prohibit an employee from con- tinuing to participate in a bona fide pension, retirement, group life, health or accident insurance, profit-sharing, stock bonus or other employee welfare or benefit plan maintained by a former employer. 18 U.S.C. 209. Example 1: A corporate executive is asked to accept a position in the Department. The corporation offers to continue to pay the ex- ecutive the difference between his or her sal- ary . 18 U.S.C. 209. Example 1: A corporate executive is asked to accept a position in the Department. The corporation offers to continue to pay the ex- ecutive the difference between his or her sal- ary as a Government employee and that re- ceived by an employee of the corporation. Such payment would be considered to be ‘‘compensation for’’ the employee’s Govern- ment service and is prohibited. Example 2: A corporate executive is asked to accept a position in the Department. The corporation proposes to pay him or her a spe- cial severance payment in anticipation of this or her serving in the Government. This proposal would be prohibited because there is no distinction between the proposed lump- sum payment and the prohibited continu- ation of salary payments described in the ex- ample above. Example 3: A corporate executive is asked to accept a position in the Department. The corporation has an established policy which provides for an amount of severance pay to be paid any departing executive and proposes to make payment based on that policy when the executive leaves. The executive may ac- cept these cir- cumstances it is clear that the severance pay is in payment for past services no tive and proposes to make payment based on that policy when the executive leaves. The executive may ac- cept these cir- cumstances it is clear that the severance pay is in payment for past services not in antici- pation of the future services for the Govern- ment. the payment. Under § 73.735–504 Gifts to official superiors. An employee shall not solicit a con- tribution from another employee for a gift to an official superior, make a do- nation as a gift to an official superior, or accept a gift from an employee re- ceiving less pay than himself or her- self. 5 U.S.C. 7351. This section does not prohibit a voluntary gift of nominal value or donation in nominal amount made on a special occasion such as marriage, illness or retirement. 201 § 73.735–505 45 CFR Subtitle A (10–1–24 Edition) § 73.735–505 Acceptance of awards and prizes. (a) Employees may accept awards, in- cluding cash awards, given in recogni- tion of a meritorious public contribu- tion or achievement. However, if there is any indication that the award may improperly influence the employee in the performance of his or her offical duties, advice about the acceptance of it should be sought from a deputy eth- ics counselor any indication that the award may improperly influence the employee in the performance of his or her offical duties, advice about the acceptance of it should be sought from a deputy eth- ics counselor. Also, an employee may not accept an award from an organiza- tion which the employee knows, or should know, has a contractual or other business arrangement with, or is regulated by, the principal operating component, or a sub-unit, in which he or she is employed or with respect to which the employee has official duties, unless acceptance is approved by the head of the employee’s principal oper- ating component. The head of the com- ponent may not approve acceptance unless he or she is satisfied that no ac- tual conflict of interest would result. (b) Employees may generally accept trophies, entertainment, rewards, and prizes given to competitors in contests or events which are open to the public. (c) Employees may not accept gifts, awards, decorations or other things of value from a foreign government ex- cept as provided in § 73.735–506. § 73.735–506 Gifts and decorations from foreign governments. (a) An employee may not request or otherwise encourage the tender of a gift or decoratio n government ex- cept as provided in § 73.735–506. § 73.735–506 Gifts and decorations from foreign governments. (a) An employee may not request or otherwise encourage the tender of a gift or decorations from a foreign gov- ernment or official thereof. (b) An employee may accept from a foreign government: (1) A gift which is in the nature of medical treatment or an educational scholarship; (2) A tangible gift of minimal value tendered or received as a mark of cour- tesy; (‘‘Minimal value’’ means a retail value in the United States at the time of acceptance of not more than one hundred dollars, unless the Adminis- trator of the General Services Adminis- tration adjusts the value by regula- tion.) or (3) A tangible gift of more than mini- mal value when it appears that to refuse the gift would be likely to cause offense or embarrassment or otherwise adversely affect the foreign relations of the United States. However, the ac- ceptance of such a gift would be on be- half of the United States and the gift would become the property of the United States. See the Department’s General Administration Manual, Chap- ter 20–25 for information regarding the disposition of a gift accepted under t es and the gift would become the property of the United States. See the Department’s General Administration Manual, Chap- ter 20–25 for information regarding the disposition of a gift accepted under these circumstances. (c) An employee may also accept from a foreign government gifts of travel or expenses for travel (such as transportation, food and lodging) that take place entirely outside the United States and are of more than minimal value, if such acceptance is consistent with the interests of the United States and is approved by the travel approving authority in accordance with the De- partment’s Travel Manual. See General Administration Manual, Chapter 20–25 for a requirement to report such travel. (d) An employee may accept, retain, and wear a decoration tendered in rec- ognition of active field service in time of combat operations or awarded for other outstanding or unusually meri- torious performance, subject to the ap- proval of the Secretary or his or her designee. (e) Members of an employee’s family and household are also subject to the regulations in this section. A member of an employee’s family and household is a relative by blood, marriage or adoption who is a reside s of an employee’s family and household are also subject to the regulations in this section. A member of an employee’s family and household is a relative by blood, marriage or adoption who is a resident of the household. However, if a member of an employee’s family and household is employed by another agency of the Government, the offer or acceptance of a gift shall be treated under the regula- tions of that agency. (f) For purposes of this section ‘‘for- eign government’’ means: (1) Any unit of foreign government authority including any foreign na- tional, state, local and municipal gov- ernment; (2) Any international or multi- national organization whose member- ship is composed of any unit of foreign government described in paragraph (f)(1) of this section; or (3) Any agent or representative of any such unit or organization when acting as such agent or representative. (5 U.S.C. 7342) 202 Dept. of Health and Human Services § 73.735–601 § 73.735–507 Acceptance of travel and subsistence. (a) Except as provided in paragraph (b) of this section, employees may ac- cept accommodations, subsistence, and travel in cash or in kind in connection with official travel for attendance at meeti e. (a) Except as provided in paragraph (b) of this section, employees may ac- cept accommodations, subsistence, and travel in cash or in kind in connection with official travel for attendance at meetings, conferences, training in non- Governmental facilities or for per- forming advisory services, if approved in accordance with the provisions of the HHS Travel Manual. (5 U.S.C. 4111; 42 U.S.C. 3506) (b) Employees may not accept ac- commodations, subsistence, or travel in cash or in kind in connection with official travel from a non-Govern- mental source with which they have of- ficial dealings unless Government or commercial travel and/or accommoda- tions are not available. If travel and/or subsistence is accepted for official travel under these circumstances, such acceptance and the basis for it must be reported in writing to the Head of the Principal Operating Component or As- sistant Secretary for Management and Budget for the Office of the Secretary. § 73.735–508 Other prohibitions. Employees shall avoid any action whether or not specifically prohibited by this part, which might result in or create the appearance of: (a) Using public office for private gain; (b) Giving preferent Employees shall avoid any action whether or not specifically prohibited by this part, which might result in or create the appearance of: (a) Using public office for private gain; (b) Giving preferential treatment to any person; (c) Impeding Government efficiency or economy; (d) Losing complete independence or impartiality in the performance of their Government duties; (e) Making a Government decision outside official channels; or (f) Affecting adversely the confidence of the public in the integrity of the Government. Subpart F—Political Activity § 73.735–601 Applicability. (a) All employees in the Executive Branch of the Federal Government, in- cluding non-career employees, are sub- ject to basic political activity restric- tions in subchapter III of chapter 73 of title 5, United States Code (the former Hatch Act) and Civil Service Rule IV. Employees are individually responsible for refraining from prohibited political activity. Ignorance of a prohibition does not excuse a violation. This sub- part summarizes provisions of law and regulation concerning political activ- ity of employees. The Federal Per- sonnel Manual and other publications of the Office of Personnel Management con This sub- part summarizes provisions of law and regulation concerning political activ- ity of employees. The Federal Per- sonnel Manual and other publications of the Office of Personnel Management contain more detailed information on this subject. These may be reviewed in Department personnel offices, or will be made available by the Ethics Coun- selor, or the deputy counselor for the employee’s organizational component. (b) The Secretary and Under Sec- retary are exempt from the prohibi- tions concerning active participation in political management and political campaigns. Also exempt are other offi- cials of the Department, except the In- spector General and Deputy Inspector General, who are appointed by the President by and with the advice and consent of the Senate, and who deter- mine policies to be pursued by the United States in the nationwide admin- istration of Federal laws. (c) Intermittent employees are sub- ject to the restrictions when in active duty status only and for the entire 24 hours of any day of actual employ- ment. (d) Employees on leave, on leave without pay, or on furlough even though an employee’s resignation has been accepted, are subject to the re- stricti entire 24 hours of any day of actual employ- ment. (d) Employees on leave, on leave without pay, or on furlough even though an employee’s resignation has been accepted, are subject to the re- strictions. Separated employees who have received a lump-sum payment for annual leave are not subject to the re- striction during the period covered by the lump-sum payment or thereafter, provided they do not return to Federal employment during that period. Em- ployees are not permitted to take a leave of absence to work with a polit- ical candidate, committee, or organiza- tion or to become a candidate for office with the understanding that they will resign their position if nominated or elected. (e) Employees are accountable for po- litical activity by another person act- ing as their agent or under the employ- ee’s direction or control, if they are thus accomplishing indirectly what they may not lawfully do directly and openly. 203 § 73.735–602 45 CFR Subtitle A (10–1–24 Edition) (f) Though officers in the Public Health Service Commissioned Corps are not subject to the restrictions in Subchapter III of Chapter 73 of Title 5, United States Code, the provisions of this subpart apply to them. ficers in the Public Health Service Commissioned Corps are not subject to the restrictions in Subchapter III of Chapter 73 of Title 5, United States Code, the provisions of this subpart apply to them. § 73.735–602 Permissible activities. (a) Section 7324 of Title 5, United States Code, provides that employees have the right to vote as they please and to express their opinions on polit- ical subjects and candidates. Generally, however, employees are prohibited from taking an active part in political management or political campaigns or using official authority or influence to interfere with an election or affect its results. There are some exemptions from the restrictions of the statute: (1) Employees may engage in polit- ical activity in connection with any identified question not specifically with a national or State political party. They also may engage in polit- ical activity in connection with an election, if none of the candidates rep- resents a party any of whose can- didates for presidential elector re- ceived votes at the last preceding elec- tion at which presidential electors were selected. (2) An exception relates to political campaigns within, or in communities adjacent presidential elector re- ceived votes at the last preceding elec- tion at which presidential electors were selected. (2) An exception relates to political campaigns within, or in communities adjacent to, the District of Columbia, or in communities the majority of whose voters are employees of the Fed- eral government. Communities to which the exception applies are specifi- cally designated by the Office of Per- sonnel Management. Information re- garding the localities and the condi- tions under which the exceptions are granted may be obtained from per- sonnel offices or the Department Coun- selor or deputy counselors. (b) A covered employee is permitted to: (1) Register and vote in any election; (2) Express his or her opinion as an individual citizen privately and pub- licly on political subjects and can- didates; (3) Display a political picture, stick- er, badge or button; (4) Participate in the nonpartisan ac- tivities of a civic, community, social, labor, or professional organization, or of a similar organization; (5) Be a member of a political party or other political organization and par- ticipate in its activities to the extent consistent with law; (6) Attend a political con on, or of a similar organization; (5) Be a member of a political party or other political organization and par- ticipate in its activities to the extent consistent with law; (6) Attend a political convention, rally, fund raising function; or other political gathering; (7) Sign a political petition as an in- dividual citizen; (8) Make a financial contribution to a political party organization; (9) Take an active part, as an inde- pendent candidate, or support of an independent candidate, in a partisan election in localities identified as per- missible for such activities by the Of- fice of Personnel Management; (10) Take an active part, as a can- didate or in support of a candidate, in a nonpartisan election; (11) Be politically active in connec- tion with a question which is not spe- cifically identified with a political party, such as a constitutional amend- ment, referendum, approval of a mu- nicipal ordinance or any other question or issue of a similar character; (12) Serve as an election judge or clerk, or in a similar position to per- form nonpartisan duties as prescribed by State or local law; and (13) Otherwise participate fully in public affairs, except as prohibited by law ection judge or clerk, or in a similar position to per- form nonpartisan duties as prescribed by State or local law; and (13) Otherwise participate fully in public affairs, except as prohibited by law, in a manner which does not mate- rially compromise his or her efficiency or integrity as an employee or the neu- trality, efficiency, or integrity of his or her agency. (c) The head of a principal operating component may prohibit or limit the participation of an employee or class of employees of his or her component in an activity permitted by paragraph (b) of this section, if participation in the activity would interfere with the effi- cient performance of official duties, or create a conflict or apparent conflict of interest. § 73.735–603 Prohibited activities. (a) The following are prohibited ac- tivities: (1) Serving as an officer of a political party, a member of a national, State or local committee of a political party, an officer or member of a committee of a partisan political club, or being a can- didate for any of these positions; 204 Dept. of Health and Human Services § 73.735–603 (2) Organizing or reorganizing a polit- ical party organization or political club; (3) Direct ub, or being a can- didate for any of these positions; 204 Dept. of Health and Human Services § 73.735–603 (2) Organizing or reorganizing a polit- ical party organization or political club; (3) Directly or indirectly soliciting, receiving, collecting, handling, dis- bursing, or accounting for assessments, contributions, or other funds for a par- tisan political purpose or in connection with a partisan election; (4) Organizing, selling tickets to, seeking support for, or actively partici- pating in a fund-raising activity of, a political party or political club; (5) Taking an active part in man- aging the political party campaign of a candidate for public office or political office; (6) Being a candidate for, or cam- paigning for, an elective public office, except as permitted in § 73.735–602(b)(9); (7) Taking an active part in an orga- nized solicitation of votes in support of or in opposition to a candidate for pub- lic office or political party office; (8) Acting as recorder, watcher, chal- lenger, or similar officer at the polls on behalf of a political party or candidate in a partisan election; (9) Driving voters to the polls on be- half of a political paty or a candidate in a , chal- lenger, or similar officer at the polls on behalf of a political party or candidate in a partisan election; (9) Driving voters to the polls on be- half of a political paty or a candidate in a partisan election; (10) Endorsing or opposing a can- didate in a partisan election in a polit- ical advertisement, a broadcast, cam- paign literature, or similar material; (11) Serving as a delegate, alternate, or proxy to a political party conven- tion; (12) Addressing a State or national convention or caucus, or a rally or similar gathering of a political party, in support of or in opposition to a can- didate for public or political party of- fice, or on a partisan political question; and (13) Initiating or circulating a nomi- nating petition for a candidate in a partisan election. (b) In addition, certain political ac- tivities are prohibited by Federal criminal law: (1) Officers and employees may not directly or indirectly solicit or receive, or be in any way involved in soliciting or receiving, any assessment, subscrip- tion or contribution for any political purpose whatever from another officer or employee. This prohibition extends to one who acts as a mere agent or messenger for