45 CFR Parts 160 & 164 (CFR Annual Edition) eral Govern- ment. (2) Federal financial assistance the Department provides or otherwise makes available includes Federal fi- nancial assistance that the Depart- ment plays a role in providing or ad- ministering, including advance pay- ments of the premium tax credit and cost-sharing reduction payments under title I of the ACA, as well as payments, subsidies, or other funds extended by the Department to any entity pro- viding health insurance coverage for payment to or on behalf of a person ob- taining health insurance coverage from that entity or extended by the Depart- ment directly to such person for pay- ment to any entity providing health in- surance coverage. Federally-facilitated Exchange means the same as ‘‘Federally-facilitated Ex- change’’ defined in 45 CFR 155.20. Health program or activity means: (1) Any project, enterprise, venture, or undertaking to: (i) Provide or administer health-re- lated services, health insurance cov- erage, or other health-related coverage; (ii) Provide assistance to persons in obtaining services, health-related health insurance coverage, or other health-related coverage; (iii) Provide clinical, pharmaceutical, or medical care; (iv) Engage in h ovide assistance to persons in obtaining services, health-related health insurance coverage, or other health-related coverage; (iii) Provide clinical, pharmaceutical, or medical care; (iv) Engage in health or clinical re- search; or (v) Provide health education for health care professionals or others. (2) All of the operations of any entity principally engaged in the provision or administration of any health projects, enterprises, ventures, or undertakings described in paragraph (1) of this defi- nition, including, but not limited to, a State or local health agency, hospital, health clinic, health insurance issuer, physician’s practice, pharmacy, com- munity-based health care provider, nursing facility, residential or commu- nity-based treatment facility, or other similar entity or combination thereof. A health program or activity also in- cludes all of the operations of a State Medicaid program, Children’s Health Insurance Program, and Basic Health Program. Individual with limited English pro- ficiency means an individual whose pri- mary language for communication is not English and who has a limited abil- ity to read, write, speak, or understand English. An individual with limite lish pro- ficiency means an individual whose pri- mary language for communication is not English and who has a limited abil- ity to read, write, speak, or understand English. An individual with limited English proficiency may be competent in English for certain types of commu- nication (e.g., speaking or under- standing), but still be limited English proficient for other purposes (e.g., read- ing or writing). Information and communication tech- nology (ICT) means information tech- nology and other equipment, systems, technologies, or processes, for which the principal function is the creation, manipulation, storage, display, receipt, or transmission of electronic data and information, as well as any associated content. Examples of ICT include, but are not limited to: computers and pe- ripheral equipment; information ki- osks and transaction machines; tele- communications equipment; telehealth interfaces or applications; customer premises equipment; multifunction of- fice machines; software; mobile appli- cations; websites; videos; and elec- tronic documents. Language assistance services may in- clude, but are not limited to: (1) Oral language assistance, includ- ing interpretation ware; mobile appli- cations; websites; videos; and elec- tronic documents. Language assistance services may in- clude, but are not limited to: (1) Oral language assistance, includ- ing interpretation in non-English lan- guages provided in-person or remotely by a qualified interpreter for an indi- vidual with limited English pro- ficiency, and the use of qualified bilin- gual or multilingual staff to commu- nicate directly with individuals with limited English proficiency; (2) Written translation, performed by a qualified translator, of written con- tent in paper or electronic form into or from languages other than English; and (3) Written notice of availability of language assistance services. Machine translation means automated translation, without the assistance of or review by a qualified human trans- lator, that is text-based and provides instant translations between various languages, sometimes with an option for audio input or output. National origin includes, but is not limited to, a person’s, or their ances- tors’, place of origin (such as country or world region) or a person’s mani- festation of the physical, cultural, or 582 Dept. of Health and Human Services § 92.4 lingu to, a person’s, or their ances- tors’, place of origin (such as country or world region) or a person’s mani- festation of the physical, cultural, or 582 Dept. of Health and Human Services § 92.4 linguistic characteristics of a national origin group. sentiment, and emotional level of the original statement; and OCR means the Office for Civil Rights of the Department. Patient care decision support tool means any automated or non-auto- mated tool, mechanism, method, tech- nology, or combination thereof used by a covered entity to support clinical de- cision-making in its health programs or activities. Qualified bilingual/multilingual staff means a member of a covered entity’s workforce who is designated by the covered entity to provide in-language oral language assistance as part of the person’s current, assigned job respon- sibilities and who has demonstrated to the covered entity that they are: (1) Proficient in speaking and under- standing both spoken English and at least one other spoken language, in- cluding any necessary specialized vo- cabulary, terminology and phrase- ology; and (2) Able to effectively, accurately, and impartially communicate directly with individuals with lim ken language, in- cluding any necessary specialized vo- cabulary, terminology and phrase- ology; and (2) Able to effectively, accurately, and impartially communicate directly with individuals with limited English proficiency in their primary languages. Qualified individual with a disability means an individual with a disability who, with or without reasonable modi- fications to rules, policies, or prac- tices, the removal of architectural, communication, or transportation bar- riers, or the provision of auxiliary aids and services, meets the essential eligi- bility requirements for the receipt of services or the participation in pro- grams or activities provided by the covered entity. Qualified interpreter for an individual with a disability means an interpreter who, via a video remote interpreting service (VRI) or an on-site appearance: (1) Has demonstrated proficiency in communicating in, and understanding: (i) Both English and a non-English language (including American Sign Language, other sign languages); or (such (ii) Another communication modal- ity cued-language as transliterators or oral transliteration); (2) Is able to interpret effectively, ac- curately, and impartially, , other sign languages); or (such (ii) Another communication modal- ity cued-language as transliterators or oral transliteration); (2) Is able to interpret effectively, ac- curately, and impartially, both recep- tively and expressively, using any nec- essary specialized vocabulary or terms without changes, omissions, or addi- tions and while preserving the tone, (3) Adheres to generally accepted in- terpreter ethics principles including client confidentiality. (4) Qualified interpreters include, for example, sign language interpreters, oral transliterators, and cued-language transliterators. Qualified interpreter for an individual with limited English proficiency means an interpreter who via a remote inter- preting service or an on-site appear- ance: (1) Has demonstrated proficiency in speaking and understanding both spo- ken English and at least one other spo- ken language (qualified interpreters for relay interpretation must demonstrate proficiency in two non-English spoken languages); (2) Is able to interpret effectively, ac- curately, and impartially to and from such language(s) and English (or be- tween two non-English languages for relay interpretation), using any nec- essary ); (2) Is able to interpret effectively, ac- curately, and impartially to and from such language(s) and English (or be- tween two non-English languages for relay interpretation), using any nec- essary specialized vocabulary or terms without changes, omissions, or addi- tions and while preserving the tone, sentiment, and emotional level of the original oral statement; and (3) Adheres to generally accepted in- terpreter ethics principles, including client confidentiality. Qualified reader means a person who is able to read effectively, accurately, and impartially using any necessary specialized vocabulary. Qualified translator means a trans- lator who: (1) Has demonstrated proficiency in writing and understanding both writ- ten English and at least one other writ- ten non-English language; (2) Is able to translate effectively, ac- curately, and impartially to and from such language(s) and English, using any necessary specialized vocabulary or terms without changes, omissions, or additions and while preserving the tone, sentiment, and emotional level of the original written statement; and (3) Adheres to generally accepted translator ethics principles, including client confidentiality. s and while preserving the tone, sentiment, and emotional level of the original written statement; and (3) Adheres to generally accepted translator ethics principles, including client confidentiality. Recipient means any State or its po- litical subdivision thereof; or any in- strumentality of a State or political 583 § 92.5 45 CFR Subtitle A (10–1–24 Edition) subdivision thereof; any public or pri- vate agency, institution, or organiza- tion; other entity; or any person, to whom Federal financial assistance is extended directly or indirectly, includ- ing any subunit, successor, assignee, or transferee of a recipient. Such term does not include any ultimate bene- ficiary. Relay inter- interpretation means preting from one language to another language. through an This mode of interpretation is often used for monolingual speakers of lan- guages of limited diffusion, including select indigenous languages. In relay interpreting, the first interpreter lis- tens to the speaker and renders the message into the intermediate lan- guage. The second interpreter receives the message in the intermediate lan- guage and interprets it into a third language for the speaker who speaks neither the fi e message into the intermediate lan- guage. The second interpreter receives the message in the intermediate lan- guage and interprets it into a third language for the speaker who speaks neither the first nor the second lan- guage. intermediate Section 504 means section 504 of the Rehabilitation Act of 1973 (Pub. L. 93– 112; 29 U.S.C. 794), as amended. Section 1557 means section 1557 of the ACA (42 U.S.C. 18116). State includes each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the United States Virgin Islands, and the Commonwealth of the Northern Mariana Islands. State Exchange means an Exchange established by a State and approved by the Department pursuant to 45 CFR part 155, subpart B. Telehealth means the use of elec- tronic information and telecommuni- cations technologies to support long- distance clinical health care, patient and professional health-related edu- cation, public health, and health ad- ministration. Technologies include videoconferencing, the internet, store- and-forward imaging, streaming media, and terrestrial and wireless commu- nications. Title I entity means any entity estab- lished under title I of ies include videoconferencing, the internet, store- and-forward imaging, streaming media, and terrestrial and wireless commu- nications. Title I entity means any entity estab- lished under title I of the ACA, as amended, including State Exchanges and Federally-facilitated Exchanges. Title VI means title VI of the Civil Rights Act of 1964 (Pub. L. 88–352; 42 U.S.C. 2000d et seq.), as amended. Title VII means title VII of the Civil Rights Act of 1964 (Pub. L. 88–352; 42 U.S.C. 2000e et seq.), as amended. Title IX means title IX of the Edu- cation Amendments of 1972 (Pub. L. 92– 318; 20 U.S.C. 1681 et seq.), as amended. UFAS means the Uniform Federal Ac- cessibility Standards (Pub. L. 90–480; 42 U.S.C. 4151 et seq.), as amended. § 92.5 Assurances required. (a) Assurances. An entity applying for Federal financial assistance to which this part applies must, as a condition of any application for Federal financial assistance, submit an assurance, on a form specified by the Director, that the entity’s health programs and activities will be operated in compliance with section 1557 and this part. A health in- surance issuer seeking certification to participate in an Exchange or a State seeki entity’s health programs and activities will be operated in compliance with section 1557 and this part. A health in- surance issuer seeking certification to participate in an Exchange or a State seeking approval to operate a State Ex- change to which section 1557 or this part applies must, as a condition of certification or approval, submit an as- surance, on a form specified by the Di- insurance rector, that the health issuer’s or State’s health program or activity will be operated in compliance with section 1557 and this part. An ap- plicant or entity may incorporate this assurance by reference in subsequent applications to the Department for Federal financial assistance or re- quests for certification to participate in an Exchange or approval to operate a State Exchange. (b) Duration of obligation. The dura- tion of the assurances required by this section is the same as the duration of the assurances required in the Depart- ment’s regulations implementing sec- tion 504, 45 CFR 84.5(b). (c) Covenants. When Federal financial assistance is provided in the form of real property or interest, the same con- ditions apply as those contained in the imple- Department’s menting section 504 b). (c) Covenants. When Federal financial assistance is provided in the form of real property or interest, the same con- ditions apply as those contained in the imple- Department’s menting section 504, at 45 CFR 84.5(c), except that the nondiscrimination obli- gation applies to discrimination on all bases covered under section 1557 and this part. regulations 584 Dept. of Health and Human Services § 92.8 § 92.6 Remedial action and voluntary action. (a) Remedial action. (1) If the Director finds that a recipient or State Ex- change has discriminated against an individual on the basis of race, color, national origin, sex, age, or disability, in violation of section 1557 or this part, such recipient or State Exchange must take such remedial action as the Direc- tor may require to overcome the ef- fects of the discrimination. (2) Where a recipient is found to have discriminated against an individual on the basis of race, color, national origin, sex, age, or disability, in violation of section 1557 or this part, and where an- other recipient exercises control over the recipient that has discriminated, the Director, where appropriate, may require either or both entities to take remedial a on 1557 or this part, and where an- other recipient exercises control over the recipient that has discriminated, the Director, where appropriate, may require either or both entities to take remedial action. (3) The Director may, where nec- essary to overcome the effects of dis- crimination in violation of section 1557 or this part, require a recipient, in its health programs and activities, or State Exchange to take remedial ac- tion with respect to: (i) Persons who are no longer partici- pants in the recipient’s or State Ex- change’s health program or activity but who were participants in the health program or activity when such discrimination occurred; or (ii) Persons who would have been par- ticipants in the health program or ac- tivity had the discrimination not oc- curred. (b) Voluntary action. A covered entity may take nondiscriminatory steps, in addition to any action that is required by section 1557 or this part, to over- come the effects of conditions that re- sult or resulted in limited participa- tion in the covered entity’s health pro- grams or activities by persons on the basis of race, color, national origin, sex, age, or disability. § 92.7 Designation and responsibil in limited participa- tion in the covered entity’s health pro- grams or activities by persons on the basis of race, color, national origin, sex, age, or disability. § 92.7 Designation and responsibilities of a Section 1557 Coordinator. (a) Section 1557 Coordinator and des- ignees. A covered entity that employs fifteen or more persons must designate and authorize at least one employee, a ‘‘Section 1557 Coordinator,’’ to coordi- nate the covered entity’s compliance with its responsibilities under section 1557 and this part in its health pro- grams and activities, including the in- vestigation of any grievance commu- nicated to it alleging noncompliance with section 1557 or this part or alleg- ing any action that would be prohib- ited by section 1557 or this part. As ap- propriate, a covered entity may assign one or more designees to carry out some of these responsibilities, but the Section 1557 Coordinator must retain ultimate oversight for ensuring coordi- nation with the covered entity’s com- pliance with this part. (b) Responsibilities of a Section 1557 Co- ordinator. A covered entity must ensure that, at minimum, the Section 1557 Co- ordinator: (1) Receives, reviews, and process y’s com- pliance with this part. (b) Responsibilities of a Section 1557 Co- ordinator. A covered entity must ensure that, at minimum, the Section 1557 Co- ordinator: (1) Receives, reviews, and processes grievances, filed under the grievance procedure as set forth in § 92.8(c); (2) Coordinates the covered entity’s recordkeeping requirements as set forth in § 92.8(c); (3) Coordinates effective implementa- tion of the covered entity’s language access procedures as set forth in § 92.8(d); (4) Coordinates effective implementa- tion of the covered entity’s effective communication procedures as set forth in § 92.8(e); (5) Coordinates effective implementa- tion of the covered entity’s reasonable modification procedures as set forth in § 92.8(f); and (6) Coordinates training of relevant employees as set forth in § 92.9, includ- ing maintaining documentation re- quired by such section. § 92.8 Policies and procedures. (a) General requirement. A covered en- tity must implement written policies and procedures in its health programs and activities that are designed to comply with the requirements of this part. The policies and procedures must include an effective date and be reason- ably designe procedures in its health programs and activities that are designed to comply with the requirements of this part. The policies and procedures must include an effective date and be reason- ably designed, taking into account the size, complexity, and the type of health programs or activities undertaken by a covered entity, to ensure compliance with this part. (b) Nondiscrimination policy. (1) A cov- ered entity must implement a written policy in its health programs and ac- tivities that, at minimum, states the covered entity does not discriminate 585 § 92.8 45 CFR Subtitle A (10–1–24 Edition) on the basis of race, color, national ori- gin (including limited English pro- ficiency and primary language), sex (consistent with the scope of sex dis- crimination described at § 92.101(a)(2)), age, or disability; that the covered en- tity provides language assistance serv- ices and appropriate auxiliary aids and services free of charge, when necessary for compliance with section 1557 or this part; that the covered entity will pro- vide reasonable modifications for indi- viduals with disabilities; and that pro- vides the current contact information for the Section 1557 Coordinator re- quired b ; that the covered entity will pro- vide reasonable modifications for indi- viduals with disabilities; and that pro- vides the current contact information for the Section 1557 Coordinator re- quired by § 92.7 (if applicable). (2) OCR considers it a best practice toward achieving compliance for a cov- ered entity to provide information that it has been granted a temporary ex- emption or granted an assurance of ex- emption under § 92.302(b) in the non- discrimination policy required by para- graph (b)(1) of this section. (c) Grievance procedures. (1) A covered entity that employs fifteen or more persons must implement written griev- ance procedures in its health programs and activities that provide for the prompt and equitable resolution of grievances alleging any action that would be prohibited by section 1557 or this part. (2) A covered entity to which this paragraph applies must retain records related to grievances filed pursuant to the covered entity’s grievance proce- dures required under paragraph (c)(1) of this section that allege discrimination on the basis of race, color, national ori- gin, sex, age, or disability for no less than three (3) calendar years from the date the c under paragraph (c)(1) of this section that allege discrimination on the basis of race, color, national ori- gin, sex, age, or disability for no less than three (3) calendar years from the date the covered entity resolves the grievance. The records must include the grievance; the name and contact information of the complainant (if pro- vided by complainant); the alleged dis- criminatory action and alleged basis (or bases) of discrimination; the date the grievance was filed; the date the grievance was resolved; grievance reso- lution; and any other pertinent infor- mation. (3) A covered entity to which this paragraph (c) applies must keep con- fidential the identity of an individual who has filed a grievance under this part except as required by law or to the extent necessary to carry out the pur- poses of this part, including the con- duct of any investigation. in (d) Language access procedures. A cov- ered entity must implement written language access procedures its health programs and activities describ- ing the covered entity’s process for providing language assistance services to individuals with limited English proficiency when required under § 92.201. At a minimum, the langu nd activities describ- ing the covered entity’s process for providing language assistance services to individuals with limited English proficiency when required under § 92.201. At a minimum, the language access procedures must include current contact information for the section 1557 Coordinator (if applicable); how an employee identifies whether an indi- vidual has limited English proficiency; how an employee obtains the services of qualified interpreters and trans- lators the covered entity uses to com- municate with an individual with lim- ited English proficiency; the names of any qualified bilingual staff members; and a list of any electronic and written translated materials the covered entity has, the languages they are translated into, date of issuance, and how to ac- cess electronic translations. (e) Effective communication procedures. A covered entity must implement writ- ten effective communication proce- dures in its health programs and ac- tivities describing the covered entity’s process for ensuring effective commu- nication for individuals with disabil- ities when required under § 92.202. At a minimum, a covered entity’s effective communication procedures must in- clud ity’s process for ensuring effective commu- nication for individuals with disabil- ities when required under § 92.202. At a minimum, a covered entity’s effective communication procedures must in- clude current contact information for the Section 1557 Coordinator (if appli- cable); how an employee obtains the services of qualified interpreters the covered entity uses to communicate with individuals with disabilities, in- cluding the names of any qualified in- terpreter staff members; and how to ac- cess appropriate auxiliary aids and services. (f) Reasonable modification procedures. A covered entity must implement writ- ten procedures in its health programs and activities describing the covered entity’s process for making reasonable modifications to its policies, practices, or procedures when necessary to avoid discrimination on the basis of dis- ability as required under § 92.205. At a minimum, the reasonable modification 586 Dept. of Health and Human Services § 92.10 procedures must include current con- tact information for the covered enti- ty’s Section 1557 Coordinator (if appli- cable); a description of the covered en- tity’s process for responding to re- quests from individual nclude current con- tact information for the covered enti- ty’s Section 1557 Coordinator (if appli- cable); a description of the covered en- tity’s process for responding to re- quests from individuals with disabil- ities for changes, exceptions, or adjust- ments to a rule, policy, practice, or service of the covered entity; and a process for determining whether mak- ing the modification would fundamen- tally alter the nature of the health pro- gram or activity, including identifying an alternative modification that does not result in a fundamental alteration to ensure the individual with a dis- ability receives the benefits or services in question. (g) Combined policies and procedures. A covered entity may combine the con- tent of the policies and procedures re- quired by paragraphs (b) through (f) of this section with any policies and pro- cedures pursuant to title VI, section 504, title IX, and the Age Act if section 1557 and the provisions in this part are clearly addressed therein. (h) Changes to policies and procedures. (1) Covered entities must review and revise the policies and procedures re- quired by paragraphs (b) through (g) of this section, as necessary, to ensure they . (h) Changes to policies and procedures. (1) Covered entities must review and revise the policies and procedures re- quired by paragraphs (b) through (g) of this section, as necessary, to ensure they are current and in compliance with section 1557 and this part; and (2) A covered entity may change a policy or procedure required by para- graphs (b) through (g) of this section at any time, provided that such changes comply with section 1557 and this part. § 92.9 Training. (a) A covered entity must train rel- evant employees of its health programs and activities on the civil rights poli- cies and procedures required by § 92.8, as necessary and appropriate for the employees to carry out their functions within the covered entity consistent with the requirements of this part. (b) A covered entity must provide training that meets the requirements of paragraph (a) of this section, as fol- lows: (1) To each relevant employee of the health program or activity as soon as possible, but no later than 30 days fol- lowing a covered entity’s implementa- tion of the policies and procedures re- quired by § 92.8, and no later than 300 days following July 5, 2024; (2) Thereafter, to each new relevant han 30 days fol- lowing a covered entity’s implementa- tion of the policies and procedures re- quired by § 92.8, and no later than 300 days following July 5, 2024; (2) Thereafter, to each new relevant employee of the health program or ac- tivity within a reasonable period of time after the employee joins the cov- ered entity’s workforce; and (3) To each relevant employee of the health program or activity whose func- tions are affected by a material change in the policies or procedures required by § 92.8 and any other civil rights poli- cies or procedures the covered entity has implemented within a reasonable period of time after the material change has been made. (4) For purposes of this section, ‘‘rel- evant employees’’ includes permanent and temporary employees whose roles and responsibilities entail interacting with patients and members of the pub- lic; making decisions that directly or indirectly affect patients’ health care, including the covered entity’s execu- tive leadership team and legal counsel; and performing tasks and making deci- sions that directly or indirectly affect patients’ financial obligations, includ- ing billing and collections. (c) A covered entity must con am and legal counsel; and performing tasks and making deci- sions that directly or indirectly affect patients’ financial obligations, includ- ing billing and collections. (c) A covered entity must contem- poraneously document its employees’ completion of the training required by paragraphs (a) and (b) of this section in written or electronic form and retain said documentation for no less than three (3) calendar years. § 92.10 Notice of nondiscrimination. (a) A covered entity must provide a notice of nondiscrimination to partici- pants, beneficiaries, enrollees, and ap- plicants of its health programs and ac- tivities, and members of the public. (1) The notice required under this paragraph (a) must include the fol- lowing information relating to the cov- ered entity’s health programs and ac- tivities: (i) The covered entity does not dis- criminate on the basis of race, color, limited national origin English proficiency and primary lan- guage), sex (consistent with the scope of sex discrimination described at § 92.101(a)(2)), age, or disability; (including (ii) The covered entity provides rea- sonable modifications for individuals with disabilities, and appropriate aux- iliary aids a imination described at § 92.101(a)(2)), age, or disability; (including (ii) The covered entity provides rea- sonable modifications for individuals with disabilities, and appropriate aux- iliary aids and services, including 587 § 92.11 45 CFR Subtitle A (10–1–24 Edition) qualified interpreters for individuals with disabilities and information in al- ternate formats, such as braille or large print, free of charge and in a timely manner, when such modifica- tions, aids, and services are necessary to ensure accessibility and an equal op- portunity to participate to individuals with disabilities; (iii) The covered entity provides lan- guage assistance services, including electronic and written translated docu- ments and oral interpretation, free of charge and in a timely manner, when such services are a reasonable step to provide meaningful access to an indi- vidual with limited English pro- ficiency; (iv) How to obtain from the covered entity the reasonable modifications, appropriate auxiliary aids and services, and language assistance services in paragraphs (a)(1)(ii) and (iii) of this section; (v) The contact information for the covered entity’s Section 1557 Coordi- nator designated iary aids and services, and language assistance services in paragraphs (a)(1)(ii) and (iii) of this section; (v) The contact information for the covered entity’s Section 1557 Coordi- nator designated pursuant to § 92.7 (if applicable); (vi) The availability of the covered entity’s grievance procedure pursuant to § 92.8(c) and how to file a grievance (if applicable); (vii) Details on how to file a discrimi- nation complaint with OCR in the De- partment; and (viii) How to access the covered enti- ty’s website, if it has one, that provides the information required under this paragraph (a)(1). (2) The notice required under this paragraph (a) must be provided in a covered entity’s health program or ac- tivity, as follows: (i) On an annual basis to partici- pants, beneficiaries, enrollees (includ- ing late and special enrollees), and ap- plicants of its health program or activ- ity; (ii) Upon request; (iii) At a conspicuous location on the covered entity’s health program or ac- tivity website, if it has one; and (iv) In clear and prominent physical locations, in no smaller than 20-point sans serif font, where it is reasonable to expect individuals seeking service from the health program e, if it has one; and (iv) In clear and prominent physical locations, in no smaller than 20-point sans serif font, where it is reasonable to expect individuals seeking service from the health program or activity to be able to read or hear the notice. (b) A covered entity may combine the content of the notice required by para- graph (a) of this section with the no- tices required by 45 CFR 80.6(d), 84.8, 86.9, and 91.32 if the combined notice clearly informs individuals of their civil rights under section 1557 and this part, so long as it includes each of the elements required by paragraph (a)(1) of this section. § 92.11 Notice of availability of lan- guage assistance services and auxil- iary aids and services. (a) A covered entity must provide a notice of availability of language as- sistance services and auxiliary aids and services that, at minimum, states that the covered entity, in its health pro- grams or activities, provides language assistance services and appropriate auxiliary aids and services free of charge, when necessary for compliance with section 1557 or this part, to par- ticipants, beneficiaries, enrollees, and applicants of its health program or ac- tivities, and me ids and services free of charge, when necessary for compliance with section 1557 or this part, to par- ticipants, beneficiaries, enrollees, and applicants of its health program or ac- tivities, and members of the public. (b) The notice required under para- graph (a) of this section must be pro- vided in English and at least the 15 lan- guages most commonly spoken by indi- viduals with limited English pro- ficiency of the relevant State or States in which a covered entity operates and must be provided in alternate formats for individuals with disabilities who re- quire auxiliary aids and services to en- sure effective communication. (c) The notice required under para- graph (a) of this section must be pro- vided in a covered entity’s health pro- gram or activity, as follows: (1) On an annual basis to partici- pants, beneficiaries, enrollees (includ- ing late and special enrollees), and ap- plicants of its health program or activ- ity; (2) Upon request; (3) At a conspicuous location on the covered entity’s health program or ac- tivity website, if it has one; (4) In clear and prominent physical locations, in no smaller than 20-point sans serif font, where it is reasonable to expect in he covered entity’s health program or ac- tivity website, if it has one; (4) In clear and prominent physical locations, in no smaller than 20-point sans serif font, where it is reasonable to expect individuals seeking service from the health program or activity to be able to read or hear the notice; and 588 Dept. of Health and Human Services § 92.101 (5) In the following electronic and written communications when these forms are provided by a covered entity: (i) Notice of nondiscrimination re- quired by § 92.10; (ii) Notice of privacy practices re- quired by 45 CFR 164.520; (iii) Application and intake forms; (iv) Notices of denial or termination of eligibility, benefits or services, in- cluding Explanations of Benefits, and notices of appeal and grievance rights; (v) Communications related to an in- dividual’s rights, eligibility, benefits, or services that require or request a re- sponse from a participant, beneficiary, enrollee, or applicant; (vi) Communications related to a public health emergency; (vii) Consent forms and instructions related to medical procedures or oper- ations, medical power of attorney, or living will (with an option of providing only one notice for all doc health emergency; (vii) Consent forms and instructions related to medical procedures or oper- ations, medical power of attorney, or living will (with an option of providing only one notice for all documents bun- dled together); (viii) Discharge papers; (ix) Communications related to the cost and payment of care with respect to an individual, including medical billing and collections materials, and good faith estimates required by sec- tion 2799B–6 of the Public Health Serv- ice Act; (x) Complaint forms; and (xi) Patient and member handbooks. (d) A covered entity shall be deemed in compliance with this section with respect to an individual if it exercises the option to: (1) On an annual basis, provide the individual with the option to opt out of receipt of the notice required by this section in their primary language and through any appropriate auxiliary aids and services, and: (i) Does not condition the receipt of any aid or benefit on the individual’s decision to opt out; (ii) Informs the individual that they have a right to receive the notice upon request in their primary language and through the appropriate auxiliary aids and services; (iii) Informs the individual that opt- ing the individual that they have a right to receive the notice upon request in their primary language and through the appropriate auxiliary aids and services; (iii) Informs the individual that opt- ing out of receiving the notice is not a waiver of their right to receive lan- guage assistance services and any ap- propriate auxiliary aids and services as required by this part; (iv) Documents, on an annual basis, that the individual has opted out of re- ceiving the notice required by this sec- tion for that year; and (v) Does not treat a non-response from an individual as a decision to opt out; or (2) Document the individual’s pri- mary language and any appropriate auxiliary aids and services and: (i) Provides all materials and com- munications in that individual’s pri- mary language and through any appro- priate auxiliary aids and services; or (ii) Provides the notice required by paragraph (a) of this section in that in- dividual’s and through any appropriate auxiliary aids and services in all communications that are identified in paragraph (c)(5) of this section. language primary Subpart B—Nondiscrimination Provisions § 92.101 Discrimination prohibited. (a) General. (1) Except as pro n all communications that are identified in paragraph (c)(5) of this section. language primary Subpart B—Nondiscrimination Provisions § 92.101 Discrimination prohibited. (a) General. (1) Except as provided in title I of the ACA, an individual must not, on the basis of race, color, na- tional origin, sex, age, disability, or any combination thereof, be excluded from participation in, be denied the benefits of, or otherwise be subjected to discrimination under any health program or activity operated by a cov- ered entity. (2) Discrimination on the basis of sex includes, but is not limited to, dis- crimination on the basis of: (i) Sex characteristics, including intersex traits; (ii) Pregnancy or related conditions; (iii) Sexual orientation; (iv) Gender identity; and (v) Sex stereotypes. (b) Specific prohibitions on discrimina- tion. (1) In any health program or ac- tivity to which this part applies: (i) A recipient and State Exchange must comply with the specific prohibi- tions on discrimination in the Depart- ment’s implementing regulations for title VI, section 504, title IX, and the Age Act, found at 45 CFR parts 80, 84, 86 (subparts C and D), and 91 (subpart B), respectively. Wher ination in the Depart- ment’s implementing regulations for title VI, section 504, title IX, and the Age Act, found at 45 CFR parts 80, 84, 86 (subparts C and D), and 91 (subpart B), respectively. Where this paragraph (b) cross-references regulatory provi- sions that use the term ‘‘recipient,’’ 589 § 92.201 45 CFR Subtitle A (10–1–24 Edition) ‘‘recipient or State Ex- the term change’’ shall apply in its place. Where this paragraph (b) cross-references reg- ulatory provisions that use the term ‘‘student,’’ cant,’’ these terms shall be replaced with ‘‘individual.’’ ‘‘employee,’’ or ‘‘appli- (ii) The Department, including Fed- erally-facilitated Exchanges, must comply with specific prohibitions on discrimination in the Department’s im- plementing regulations for title VI, section 504, title IX, and the Age Act, found at 45 CFR parts 80, 85, 86 (sub- parts C and D), and 91 (subpart B), re- spectively. Where this paragraph (b) cross-references regulatory provisions that use the term ‘‘a recipient,’’ the term ‘‘the Department or a Federally- facilitated Exchange’’ shall apply in its place. Where this paragraph (b) cross- references regulatory provisions that use the term ‘‘student,’’ ‘‘em pient,’’ the term ‘‘the Department or a Federally- facilitated Exchange’’ shall apply in its place. Where this paragraph (b) cross- references regulatory provisions that use the term ‘‘student,’’ ‘‘employee,’’ or ‘‘applicant,’’ these terms shall be re- placed with ‘‘individual.’’ (2) The enumeration of specific prohi- bitions on discrimination in paragraph (b)(1) of this section does not limit the general applicability of the prohibition in paragraph (a) of this section. Subpart C—Specific Applications to Health Programs and Activities § 92.201 Meaningful access for individ- limited English pro- uals with ficiency. (a) General requirement. A covered en- tity must take reasonable steps to pro- vide meaningful access to each indi- vidual with limited English proficiency (including companions with limited English proficiency) eligible to be served or likely to be directly affected by its health programs and activities. (b) Language assistance services re- quirements. Language assistance serv- ices required under paragraph (a) of this section must be provided free of charge, be accurate and timely, and protect the privacy and the inde- pendent decision-making ability of the individual erv- ices required under paragraph (a) of this section must be provided free of charge, be accurate and timely, and protect the privacy and the inde- pendent decision-making ability of the individual with limited English pro- ficiency. (c) Specific requirements for interpreter and translation services. (1) When inter- pretation services are required under this part, a covered entity must offer a qualified interpreter in its health pro- grams and activities. (2) When translation services are re- quired under this part, a covered entity must utilize the services of a qualified translator in its health programs and activities. (3) If a covered entity uses machine translation when the underlying text is critical to the rights, benefits, or meaningful access of an individual with limited English proficiency, when accuracy is essential, or when the source documents or materials contain complex, non-literal or technical lan- guage, the translation must be re- viewed by a qualified human trans- lator. (d) Evaluation of compliance. In evalu- ating whether a covered entity has met its obligation under paragraph (a) of this section, the Director shall: (1) Evaluate, and give substantial weigh - lator. (d) Evaluation of compliance. In evalu- ating whether a covered entity has met its obligation under paragraph (a) of this section, the Director shall: (1) Evaluate, and give substantial weight to, the nature and importance of the health program or activity and the particular communication at issue, to the individual with limited English proficiency; and (2) Take into account other relevant factors, including the effectiveness of the covered entity’s written language access procedures for its health pro- grams and activities, that the covered entity has implemented pursuant to § 92.8(d). (e) Restricted use of certain persons to interpret or facilitate communication. A covered entity must not, in its health programs and activities: (1) Require an individual with lim- ited English proficiency to provide their own interpreter, or to pay the cost of their own interpreter; (2) Rely on an adult, not qualified as an interpreter, to interpret or facili- tate communication, except: (i) As a temporary measure, while finding a qualified interpreter in an imminent involving an emergency threat to the safety or welfare of an in- dividual or the public where there is no qualified interpr As a temporary measure, while finding a qualified interpreter in an imminent involving an emergency threat to the safety or welfare of an in- dividual or the public where there is no qualified interpreter for the individual with limited English proficiency imme- diately available and the qualified in- terpreter that arrives confirms or sup- plements the initial communications with an initial adult interpreter; or 590 Dept. of Health and Human Services § 92.202 (ii) Where the individual with limited English proficiency specifically re- quests, in private with a qualified in- terpreter present and without an ac- companying adult present, that the ac- companying adult interpret or facili- accom- tate panying adult agrees to provide such assistance, the request and agreement by the accompanying adult is docu- mented, and reliance on that adult for such assistance is appropriate under the circumstances; communication, the (3) Rely on a minor child to interpret or facilitate communication, except as a temporary measure while finding a qualified interpreter in an emergency involving an imminent threat to the safety or welfare of an individual or the public where there is no qualified inte xcept as a temporary measure while finding a qualified interpreter in an emergency involving an imminent threat to the safety or welfare of an individual or the public where there is no qualified interpreter for the individual with lim- ited English proficiency immediately available and the qualified interpreter that arrives confirms or supplements the initial communications with the minor child; or (4) Rely on staff other than qualified interpreters, qualified translators, or qualified bilingual/multilingual staff to communicate with individuals with limited English proficiency. (f) Video remote interpreting services. A covered entity that provides a qualified interpreter for an individual with lim- ited English proficiency through video remote interpreting services in the covered entity’s health programs and activities must ensure the modality al- lows for meaningful access and must provide: (1) Real-time, full-motion video and audio over a dedicated high-speed, wide-bandwidth video connection or wireless connection that delivers high quality video images that do not produce lags, choppy, blurry, or grainy images, or irregular pauses in commu- nication; (2) A sharply delineated i connection or wireless connection that delivers high quality video images that do not produce lags, choppy, blurry, or grainy images, or irregular pauses in commu- nication; (2) A sharply delineated image that is large enough to display the inter- preter’s face and the participating per- son’s face regardless of the person’s body position; (3) A clear, audible transmission of voices; and (4) Adequate training to users of the technology and other involved persons so that they may quickly and effi- ciently set up and operate the video re- mote interpreting. (g) Audio remote interpreting services. A covered entity that provides a quali- fied interpreter for an individual with limited English proficiency through audio remote interpreting services in the covered entity’s health programs and activities must ensure the modal- ity allows for meaningful access and must provide: (1) Real-time audio over a dedicated high-speed, wide-bandwidth connection or wireless connection that delivers high-quality audio without lags or ir- regular pauses in communication; (2) A clear, audible transmission of voices; and (3) Adequate training to users of the technology and other involved persons so that t uality audio without lags or ir- regular pauses in communication; (2) A clear, audible transmission of voices; and (3) Adequate training to users of the technology and other involved persons so that they may quickly and effi- ciently set up and operate the remote interpreting services. (h) Acceptance of language assistance services is not required. Nothing in this section shall be construed to require an individual with limited English pro- ficiency to accept language assistance services. § 92.202 Effective communication for individuals with disabilities. (a) A covered entity must take appro- priate steps to ensure that communica- tions with individuals with disabilities (including companions with disabil- ities), are as effective as communica- tions with non-disabled individuals in its health programs and activities, in accordance with the standards found at 28 CFR 35.130 and 35.160 through 35.164. Where the regulatory provisions ref- erenced in this section use the term ‘‘public entity,’’ the term ‘‘covered en- tity’’ shall apply in its place. (b) A covered entity must provide ap- propriate auxiliary aids and services where necessary to afford individuals with disabilities an equ ty,’’ the term ‘‘covered en- tity’’ shall apply in its place. (b) A covered entity must provide ap- propriate auxiliary aids and services where necessary to afford individuals with disabilities an equal opportunity to participate in, and enjoy the bene- fits of, the health program or activity in question. Such auxiliary aids and services must be provided free of charge, in accessible formats, in a timely manner, and in such a way to protect the privacy and the independ- ence of the individual with a disability. 591 § 92.203 45 CFR Subtitle A (10–1–24 Edition) § 92.203 Accessibility for buildings and facilities. (a) No qualified individual with a dis- ability shall, because a covered entity’s facilities are inaccessible to or unus- able by individuals with disabilities, be denied the benefits of, be excluded from participation in, or otherwise be sub- jected to discrimination under any health program or activity to which this part applies. (b) Each facility or part of a facility in which health programs or activities are conducted that is constructed or al- tered by or on behalf of, or for the use of, a recipient or State Exchange must comply with the 2010 Standards if the construct h health programs or activities are conducted that is constructed or al- tered by or on behalf of, or for the use of, a recipient or State Exchange must comply with the 2010 Standards if the construction or alteration was com- menced on or after July 18, 2016, except that if a facility or part of a facility in which health programs or activities are conducted that is constructed or al- tered by or on behalf of, or for the use of, a recipient or State Exchange, was not covered by the 2010 Standards prior to July 18, 2016, such facility or part of a facility must comply with the 2010 Standards if the construction or alter- ation was commenced after January 18, 2018. If construction or alteration was begun on or after July 18, 2016, and on or before January 18, 2018, in conform- ance with UFAS, and the facility or part of the facility was not covered by the 2010 Standards prior to July 18, 2016, then it shall be deemed to comply with the requirements of this section and with 45 CFR 84.23(a) and (b). Depar- tures from particular technical and scoping requirements by the use of other methods are permitted where substantially equivalent or greater ac- cess to and usability of the facilit a) and (b). Depar- tures from particular technical and scoping requirements by the use of other methods are permitted where substantially equivalent or greater ac- cess to and usability of the facility is provided. All newly constructed or al- tered buildings or facilities subject to this section must comply with the re- quirements for a ‘‘public building or fa- cility’’ as defined in section 106.5 of the 2010 Standards. (c) Each facility or part of a facility in which health programs or activities under this part are conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or State Exchange in conformance with the 1991 Standards at appendix D to 28 CFR part 36 or the 2010 Standards shall be deemed to comply with the require- ments of this section and with 45 CFR 84.23(a) and (b) with respect to those fa- cilities, if the construction or alter- ation was commenced before July 18, 2016. Each facility or part of a facility in which health programs or activities are conducted that is constructed or al- tered by or on behalf of, or for the use of, a recipient or State Exchange in conformance with UFAS shall be deemed to comply with the require- ments tivities are conducted that is constructed or al- tered by or on behalf of, or for the use of, a recipient or State Exchange in conformance with UFAS shall be deemed to comply with the require- ments of this section and with 45 CFR 84.23(a) and (b), if the construction or alteration was commenced before July 18, 2016, and such facility would not have been required to conform with a different accessibility standard under 28 CFR 35.151. § 92.204 Accessibility of information and communication technology for individuals with disabilities. (a) A covered entity must ensure that its health programs and activities pro- vided through information and commu- nication technology are accessible to individuals with disabilities, unless doing so would result in undue finan- cial and administrative burdens or a fundamental alteration in the nature of the health programs or activities. If an action required to comply with this section would result in such an alter- ation or such burdens, a covered entity shall take any other action that would not result in such an alteration or such burdens but would nevertheless ensure that, to the maximum extent possible, individuals with disabilities receive the ty shall take any other action that would not result in such an alteration or such burdens but would nevertheless ensure that, to the maximum extent possible, individuals with disabilities receive the benefits or services of the health pro- gram or activity provided by the cov- ered entity. activities (b) A recipient or State Exchange shall ensure that its health programs and through websites and mobile applications com- ply with the requirements of section 504 of the Rehabilitation Act, as inter- preted consistent with title II of the ADA (42 U.S.C. 12131 through 12165). provided § 92.205 Requirement to make reason- able modifications. A covered entity must make reason- able modifications to policies, prac- tices, or procedures in its health pro- grams and activities when such modi- fications are necessary to avoid dis- crimination on the basis of disability, 592 Dept. of Health and Human Services § 92.207 unless the covered entity can dem- onstrate that making the modifica- tions would fundamentally alter the nature of the health program or activ- ity. For the purposes of this section, the term ‘‘reasonable modifications’’ shall be interpreted in a manner con- sistent with the te ld fundamentally alter the nature of the health program or activ- ity. For the purposes of this section, the term ‘‘reasonable modifications’’ shall be interpreted in a manner con- sistent with the term as set forth in the ADA title II regulation at 28 CFR 35.130(b)(7). § 92.206 Equal program access on the basis of sex. (a) A covered entity must provide in- dividuals equal access to its health pro- grams and activities without discrimi- nating on the basis of sex. (b) In providing access to health pro- grams and activities, a covered entity must not: (1) Deny or limit health services, in- cluding those that have been typically or exclusively provided to, or associ- ated with, individuals of one sex, to an individual based upon the individual’s sex assigned at birth, gender identity, or gender otherwise recorded; (2) Deny or limit, on the basis of an individual’s sex assigned at birth, gen- der identity, or gender otherwise re- corded, a health care professional’s ability to provide health services if such denial or limitation has the effect of excluding individuals from partici- pation in, denying them the benefits of, or otherwise subjecting them to dis- crimination on the basis o lth services if such denial or limitation has the effect of excluding individuals from partici- pation in, denying them the benefits of, or otherwise subjecting them to dis- crimination on the basis of sex under a covered health program or activity; (3) Adopt or apply any policy or prac- tice of treating individuals differently or separating them on the basis of sex in a manner that subjects any indi- vidual to more than de minimis harm, including by adopting a policy or en- gaging in a practice that prevents an individual from participating in a health program or activity consistent with the individual’s gender identity; or (4) Deny or limit health services sought for purpose of gender transition or other gender-affirming care that the covered entity would provide to an in- dividual for other purposes if the denial or limitation is based on an individ- ual’s sex assigned at birth, gender iden- tity, or gender otherwise recorded. (c) Nothing in this section requires the provision of any health service where the covered entity has a legiti- mate, nondiscriminatory reason for de- nying or limiting that service, includ- ing where the covered entity typically declines to provide the he y health service where the covered entity has a legiti- mate, nondiscriminatory reason for de- nying or limiting that service, includ- ing where the covered entity typically declines to provide the health service to any individual or where the covered entity reasonably determines that such health service is not clinically appro- priate for a particular individual. A covered entity’s determination must not be based on unlawful animus or bias, or constitute a pretext for dis- crimination. Nothing in this section is intended to preclude a covered entity from availing itself of protections de- scribed in §§ 92.3 and 92.302. (d) The enumeration of specific forms of discrimination in paragraph (b) of this section does not limit the general applicability of the prohibition in para- graph (a) of this section. § 92.207 Nondiscrimination in health coverage and other insurance health-related coverage. (a) A covered entity must not, in pro- viding or administering health insur- ance coverage or other health-related coverage, discriminate on the basis of race, color, national origin, sex, age, disability, or any combination thereof. (b) A covered entity must not, in pro- viding or administering her health-related coverage, discriminate on the basis of race, color, national origin, sex, age, disability, or any combination thereof. (b) A covered entity must not, in pro- viding or administering health insur- ance coverage or other health-related coverage: (1) Deny, cancel, limit, or refuse to issue or renew health insurance cov- erage or other health-related coverage, or deny or limit coverage of a claim, or impose additional cost sharing or other limitations or restrictions on coverage, on the basis of race, color, national ori- gin, sex, age, disability, or any com- bination thereof; (2) Have or implement marketing practices or benefit designs that dis- criminate on the basis of race, color, national origin, sex, age, disability, or any combination thereof, in health in- surance coverage or other health-re- lated coverage; (3) Deny or limit coverage, deny or limit coverage of a claim, or impose additional cost sharing or other limita- tions or restrictions on coverage, to an individual based upon the individual’s sex assigned at birth, gender identity, or gender otherwise recorded; 593 § 92.208 45 CFR Subtitle A (10–1–24 Edition) (4) Have or implement a categorical coverag ndividual based upon the individual’s sex assigned at birth, gender identity, or gender otherwise recorded; 593 § 92.208 45 CFR Subtitle A (10–1–24 Edition) (4) Have or implement a categorical coverage exclusion or limitation for all health services related to gender tran- sition or other gender-affirming care; (5) Otherwise deny or limit coverage, deny or limit coverage of a claim, or impose additional cost sharing or other limitations or restrictions on coverage, for specific health services related to gender transition or other gender-af- firming care if such denial, limitation, or restriction results in discrimination on the basis of sex; or (6) Have or implement benefit designs that do not provide or administer health insurance coverage or other health-related coverage in the most in- tegrated setting appropriate to the needs of qualified individuals with dis- abilities, including practices that re- sult in the serious risk of institutional- ization or segregation. (c) Nothing in this section requires coverage of any health service where the covered entity has a legitimate, nondiscriminatory reason for denying or limiting coverage of the health serv- ice or determining that su this section requires coverage of any health service where the covered entity has a legitimate, nondiscriminatory reason for denying or limiting coverage of the health serv- ice or determining that such health service fails to meet applicable cov- erage requirements, including reason- able medical management techniques such as medical necessity require- ments. Such coverage denial or limita- tion must not be based on unlawful animus or bias, or constitute a pretext for discrimination. Nothing in this sec- tion is intended to preclude a covered entity from availing itself of protec- tions described in §§ 92.3 and 92.302. (d) The enumeration of specific forms of discrimination in paragraph (b) of this section does not limit the general applicability of the prohibition in para- graph (a) of this section. § 92.208 Prohibition on sex discrimina- tion related to marital, parental, or family status. In determining whether an individual satisfies any policy or criterion regard- ing access to its health programs or ac- tivities, a covered entity must not take an individual’s sex, as defined in § 92.101(a)(2), into account in applying any rule concerning an individual’s current, perceived, p ts health programs or ac- tivities, a covered entity must not take an individual’s sex, as defined in § 92.101(a)(2), into account in applying any rule concerning an individual’s current, perceived, potential, or past marital, parental, or family status. § 92.209 Nondiscrimination basis of association. on the A covered entity must not exclude from participation in, deny the benefits of, or otherwise discriminate against an individual or entity in its health programs and activities on the basis of the respective race, color, national ori- gin, sex, age, or disability of the indi- vidual and another person with whom the individual or entity has a relation- ship or association. § 92.210 Nondiscrimination in the use of patient care decision support tools. (a) General prohibition. A covered en- tity must not discriminate on the basis of race, color, national origin, sex, age, or disability in its health programs or activities through the use of patient care decision support tools. (b) Identification of risk. A covered en- tity has an ongoing duty to make rea- sonable efforts to identify uses of pa- tient care decision support tools in its health programs or activities that em- ploy inpu ification of risk. A covered en- tity has an ongoing duty to make rea- sonable efforts to identify uses of pa- tient care decision support tools in its health programs or activities that em- ploy input variables or factors that measure race, color, national origin, sex, age, or disability. (c) Mitigation of risk. For each patient care decision support tool identified in paragraph (b) of this section, a covered entity must make reasonable efforts to mitigate the risk of discrimination re- sulting from the tool’s use in its health programs or activities. § 92.211 Nondiscrimination in the de- livery of health programs and ac- tivities through telehealth services. A covered entity must not, in deliv- ery of its health programs and activi- ties through telehealth services, dis- criminate on the basis of race, color, national origin, sex, age, or disability. Subpart D—Procedures § 92.301 Enforcement mechanisms. The enforcement mechanisms avail- able for and provided under title VI of the Civil Rights Act of 1964, title IX of the Education Amendments of 1972, section 504 of the Rehabilitation Act of 1973, and the Age Discrimination Act of 1975 shall apply for purposes of section 1557 as i il Rights Act of 1964, title IX of the Education Amendments of 1972, section 504 of the Rehabilitation Act of 1973, and the Age Discrimination Act of 1975 shall apply for purposes of section 1557 as implemented by this part. 594 Dept. of Health and Human Services § 92.302 § 92.302 Notification of views regard- ing application of Federal religious freedom and conscience laws. (a) General application. A recipient may rely on applicable Federal protec- tions for religious freedom and con- science, and consistent with § 92.3(c), application of a particular provision(s) of this part to specific contexts, proce- dures, or health care services shall not be required where such protections apply. (b) Assurance of religious freedom and conscience exemption. A recipient that seeks assurance consistent with para- graph (a) of this section regarding the application of particular provision(s) of this part to specific contexts, proce- dures, or health care services may do so by submitting a notification in writ- ing to the Director of OCR. Notifica- tion may be provided by the recipient at any time, including before an inves- tigation is initiated or during the pend- ency of an investigation. The ion in writ- ing to the Director of OCR. Notifica- tion may be provided by the recipient at any time, including before an inves- tigation is initiated or during the pend- ency of an investigation. The notifica- tion must include: (1) The particular provision(s) of this part from which the recipient asserts they are exempt under Federal reli- gious freedom or conscience protec- tions; (2) The legal basis supporting the re- cipient’s exemption should include the standards governing the applicable Federal religious freedom and con- science protections, such as the provi- sions in the ACA itself; the Church, Coats-Snowe, and Weldon Amend- ments; the generally applicable re- quirements of the Religious Freedom Restoration Act (RFRA); or any other applicable Federal laws; and (3) The factual basis supporting the recipient’s exemption, including identi- fication of the conflict between the re- cipient’s religious or conscience beliefs and the requirements of this part, which may include the specific con- texts, procedures, or health care serv- ices that the recipient asserts will vio- late their religious or conscience be- liefs overall or based on an individual patient matter. (c) Tempor pecific con- texts, procedures, or health care serv- ices that the recipient asserts will vio- late their religious or conscience be- liefs overall or based on an individual patient matter. (c) Temporary exemption. A temporary exemption from administrative inves- tigation and enforcement will take ef- fect upon the recipient’s submission of the notification—regardless of whether the assurance is sought before or dur- ing an investigation. The temporary exemption is limited to the application of the particular provision(s) in this part as applied to the specific contexts, procedures, or health care services identified in the notification to OCR. (1) If the notification is received be- fore an investigation is initiated, with- in 30 days of receiving the notification, OCR must provide the recipient with email confirmation acknowledging re- ceipt of the notification. OCR will then work expeditiously to reach a deter- mination of recipient’s notification re- quest. (2) If the notification is received dur- ing the pendency of an investigation, the temporary exemption will exempt conduct as applied to the specific con- texts, procedures, or health care serv- ices identified in the notifi is received dur- ing the pendency of an investigation, the temporary exemption will exempt conduct as applied to the specific con- texts, procedures, or health care serv- ices identified in the notification dur- ing the pendency of OCR’s review and determination regarding the notifica- tion request. The notification shall fur- ther serve as a defense to the relevant investigation or enforcement activity regarding the recipient until the final determination of recipient’s exemption assurance request or the conclusion of the investigation. (d) Effect of determination. If OCR makes a determination to provide as- surance of the recipient’s exemption from the application of certain provi- sion(s) of this part or that modified ap- plication of certain provision(s) is re- quired, OCR will provide the recipient its determination in writing, and if granted, the recipient will be consid- ered exempt from OCR’s administra- tive investigation and enforcement with regard to the application of that provision(s) as applied to the specific contexts, procedures, or health care services provided. The determination does not otherwise limit the applica- tion of any other provision of this part to the provision(s) as applied to the specific contexts, procedures, or health care services provided. The determination does not otherwise limit the applica- tion of any other provision of this part to the recipient or to other contexts, procedures, or health care services. (e) Appeal. A recipient subject to an adverse determination of its request for an exemption assurance may appeal OCR’s determination under the admin- istrative procedures set forth at 45 CFR part 81. The temporary exemption pro- vided for in paragraph (c) of this sec- tion will expire upon a final decision under 45 CFR part 81. 595 § 92.303 45 CFR Subtitle A (10–1–24 Edition) (f) Final agency action. A determina- tion under this section is not final for purposes of judicial review until after a final decision under 45 CFR part 81. § 92.303 Procedures for health pro- grams and activities conducted by recipients and State Exchanges. (a) The procedural provisions appli- cable to title VI apply with respect to administrative enforcement actions against health programs and activities of recipients and State Exchanges con- cerning discrimination on the basis of race, color, national origin, sex, age, disability, or any comb enforcement actions against health programs and activities of recipients and State Exchanges con- cerning discrimination on the basis of race, color, national origin, sex, age, disability, or any combination thereof, under section 1557 or this part. These procedures are found at 45 CFR 80.6 through 80.11 and 45 CFR part 81. (b) If OCR receives a complaint over which it does not have jurisdiction, it shall promptly notify the complainant and shall make reasonable efforts to refer the complaint to the appropriate Federal Government entity. (c) When a recipient or State Ex- change fails to provide OCR with re- quested information in a timely, com- plete, and accurate manner, OCR may, after attempting to reach voluntary resolution, find noncompliance with section 1557 or this part and initiate appropriate enforcement procedures, found at 45 CFR 80.8, including begin- ning the process for fund suspension or termination and taking other action authorized by law. § 92.304 Procedures for health pro- grams and activities administered by the Department. Federally-facilitated (a) The procedural provisions appli- cable to section 504 shall apply with re- spect to administrative enforcement act h pro- grams and activities administered by the Department. Federally-facilitated (a) The procedural provisions appli- cable to section 504 shall apply with re- spect to administrative enforcement actions against the Department, in- Ex- cluding changes, concerning discrimination on the basis of race, color, national origin, sex, age, disability, or any combination thereof, under section 1557 or this part. These procedures are found at 45 CFR 85.61 and 85.62. Where this section cross-references regulatory provisions that use the term ‘‘handicap,’’ the term ‘‘race, color, national origin, sex, age, or disability, or any combination thereof,’’ shall apply in its place. (b) The Department must permit ac- cess by OCR to its books, records, ac- counts, other sources of information, and facilities as may be pertinent to ascertain compliance with section 1557 or this part. Where any information re- quired of the Department is in the ex- clusive possession of any other agency, institution or person, and the other agency, institution or person fails or refuses to furnish this information, the Department shall so certify and shall set forth what efforts it has made to obtain the information. rson, and the other agency, institution or person fails or refuses to furnish this information, the Department shall so certify and shall set forth what efforts it has made to obtain the information. Asserted con- siderations of privacy or confiden- tiality may not operate to bar OCR from evaluating or seeking to enforce compliance with section 1557 or this part. Information of a confidential na- ture obtained in connection with com- pliance evaluation or enforcement shall not be disclosed except where necessary under the law. (c) The Department must not intimi- date, threaten, coerce, retaliate, or otherwise discriminate against any in- dividual or entity for the purpose of interfering with any right or privilege secured by section 1557 or this part, or because such individual or entity has made a complaint, testified, assisted, or participated in any manner in an in- vestigation, proceeding or hearing under section 1557 or this part. The identity of complainants must be kept confidential by OCR in accordance with applicable Federal law. PART 93—NEW RESTRICTIONS ON LOBBYING Subpart A—General Sec. 93.100 Conditions on use of funds. 93.105 Definitions. 93.110 Certification and discl tial by OCR in accordance with applicable Federal law. PART 93—NEW RESTRICTIONS ON LOBBYING Subpart A—General Sec. 93.100 Conditions on use of funds. 93.105 Definitions. 93.110 Certification and disclosure. Subpart B—Activities by Own Employees 93.200 Agency and legislative liaison. 93.205 Professional and technical services. 93.210 Reporting. Subpart C—Activities by Other than Own Employees 93.300 Professional and technical services. Subpart D—Penalties and Enforcement 93.400 Penalties. 93.405 Penalty procedures. 93.410 Enforcement. 596 Dept. of Health and Human Services § 93.105 Subpart E—Exemptions 93.500 Secretary of Defense. Subpart F—Agency Reports 93.600 Semi-annual compilation. Inspector General report. 93.605 APPENDIX A TO PART 93—CERTIFICATION RE- GARDING LOBBYING APPENDIX B TO PART 93—DISCLOSURE FORM TO REPORT LOBBYING AUTHORITY: Section 319, Public Law 101–121 (31 U.S.C. 1352); (5 U.S.C. 301). SOURCE: 55 FR 6754, Feb. 26, 1990, unless otherwise noted. CROSS REFERENCE: See also Office of Man- agement and Budget notice published at 54 FR 52306, December 20, 1989. Subpart A—General § 93.100 Conditions on use of funds. (a) No appropriated funds may be ex- pended by the reci lso Office of Man- agement and Budget notice published at 54 FR 52306, December 20, 1989. Subpart A—General § 93.100 Conditions on use of funds. (a) No appropriated funds may be ex- pended by the recipient of a Federal contract, grant, loan, or cooperative ageement to pay any person for influ- encing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or em- ployee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions: the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continu- ation, renewal, amendment, or modi- fication of any Federal contract, grant, loan, or cooperative agreement. (b) Each person who requests or re- ceives from an agency a Federal con- tract, grant, loan, or cooperative agreement shall file with that agency a certification, set forth in appendix A to this part, that the person has not made, and will not make, any payment prohibited by paragraph (a) of this sec- tion. (c) Each person who requests or re- ceives from an agency a Federal con- dix A to this part, that the person has not made, and will not make, any payment prohibited by paragraph (a) of this sec- tion. (c) Each person who requests or re- ceives from an agency a Federal con- tract, grant, loan, or a cooperative agreement shall file with that agency a disclosure form, set forth in appendix B to this part, if such person has made or has agreed to make any payment using nonappropriated funds (to include prof- its from any covered Federal action), which would be prohibited under para- graph (a) of this section if paid for with appropriated funds. (d) Each person who requests or re- ceives from an agency a commitment providing for the United States to in- sure or guarantee a loan shall file with that agency a statement, set forth in appendix A to this part, whether that person has made or has agreed to make any payment to influence or attempt to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with that loan insurance or guarantee. (e) Each person who requests or re- ceives from an agency a commitment providing for the United States to in- sure or guar of a Member of Congress in connection with that loan insurance or guarantee. (e) Each person who requests or re- ceives from an agency a commitment providing for the United States to in- sure or guarantee a loan shall file with that agency a disclosure form, set forth in appendix B to this part, if that per- son has made or has agreed to make any payment to influence or attempt to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with that loan insurance or guarantee. § 93.105 Definitions. For purposes of this part: (a) Agency, as defined in 5 U.S.C. 552(f), includes Federal executive de- partments and agencies as well as inde- pendent regulatory commissions and Government corporations, as defined in 31 U.S.C. 9101(1). (b) Covered Federal action means any of the following Federal actions: (1) The awarding of any Federal con- tract; (2) The making of any Federal grant; (3) The making of any Federal loan; (4) The entering into of any coopera- tive agreement; and, (5) The extension, continuation, re- newal, amendment, or modification of any Federal contract, grant, loan, or co aking of any Federal loan; (4) The entering into of any coopera- tive agreement; and, (5) The extension, continuation, re- newal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement. Covered Federal action does not in- clude receiving from an agency a com- mitment providing for the United States to insure or guarantee a loan. Loan guarantees and loan insurance are addressed independently within this part. 597 § 93.105 45 CFR Subtitle A (10–1–24 Edition) (c) Federal contract means an acquisi- tion contract awarded by an agency, including those subject to the Federal Acquisition Regulation (FAR), and any other acquisition contract for real or personal property or services not sub- ject to the FAR. (d) Federal cooperative agreement means a cooperative agreement en- tered into by an agency. (e) Federal grant means an award of financial assistance in the form of money, or property in lieu of money, by the Federal Government or a direct appropriation made by law to any per- son. The term does not include tech- nical assistance which provides serv- ices instead of money, or other assist- ance in the form of revenue sharing, loans, loan guarantees, loa e by law to any per- son. The term does not include tech- nical assistance which provides serv- ices instead of money, or other assist- ance in the form of revenue sharing, loans, loan guarantees, loan insurance, interest subsidies, insurance, or direct United States cash assistance to an in- dividual. (f) Federal loan means a loan made by an agency. The term does not include loan guarantee or loan insurance. (g) Indian tribe and tribal organization have the meaning provided in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450B). Alaskan Natives are included under the definitions of Indian tribes in that Act. (h) Influencing or attempting to influ- ence means making, with the intent to influence, any communication to or ap- pearance before an officer or employee or any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any covered Federal action. (i) Loan guarantee and loan insurance means an agency’s guarantee or insur- ance of a loan made by a person. (j) Local government means a unit of government in a State and, if char- tered, established, or otherwise recog- nized by urance means an agency’s guarantee or insur- ance of a loan made by a person. (j) Local government means a unit of government in a State and, if char- tered, established, or otherwise recog- nized by a State for the performance of a governmental duty, including a local public authority, a special district, an intrastate district, a council of govern- ments, a sponsor group representative organization, and any other instrumen- tality of a local government. (k) Officer or employee of an agency in- cludes the following individuals who are employed by an agency: (1) An individual who is appointed to a position in the Government under title 5, U.S. Code, including a position under a temporary appointment; (2) A member of the uniformed serv- ices as defined in section 101(3), title 37, U.S. Code; (3) A special Government employee as defined in section 202, title 18, U.S. Code; and, (4) An individual who is a member of a Federal advisory committee, as de- fined by the Federal Advisory Com- mittee Act, title 5, U.S. Code appendix 2. (l) Person means an individual, cor- poration, company, association, au- firm, partnership, society, thority, State, and local government, regard- less of whet ttee Act, title 5, U.S. Code appendix 2. (l) Person means an individual, cor- poration, company, association, au- firm, partnership, society, thority, State, and local government, regard- less of whether such entity is operated for profit or not for profit. This term excludes an Indian tribe, tribal organi- zation, or any other Indian organiza- tion with respect to expenditures spe- cifically permitted by other Federal law. (m) Reasonable compensation means, with respect to a regularly employed officer or employee of any person, com- pensation that is consistent with the normal compensation for such officer or employee for work that is not fur- nished to, not funded by, or not fur- nished in cooperation with the Federal Government. (n) Reasonable payment means, with respect to professional and other tech- nical services, a payment in an amount that is consistent with the amount nor- mally paid for such services in the pri- vate sector. (o) Recipient includes all contractors, subcontractors at any tier, and sub- grantees at any tier of the recipient of funds received in connection with a Federal contract, grant, loan, or coop- erative agreement. The term excludes an Indian tribe, tr tors at any tier, and sub- grantees at any tier of the recipient of funds received in connection with a Federal contract, grant, loan, or coop- erative agreement. The term excludes an Indian tribe, tribal organization, or any other Indian organization with re- spect to expenditures specifically per- mitted by other Federal law. (p) Regularly employed means, with respect to an officer or employee of a person requesting or receiving a Fed- eral contract, grant, loan, or coopera- tive agreement or a commitment pro- viding for the United States to insure or guarantee a loan, an officer or em- ployee who is employed by such person 598 Dept. of Health and Human Services § 93.110 for at least 130 working days within one year immediately preceding the date of the submission that initiates agency consideration of such person for receipt of such contract, grant, loan, cooperative agreement, loan insurance commitment, or loan guarantee com- mitment. An officer or employee who is employed by such person for less than 130 working days within one year im- mediately preceding the date of the submission that initiates agency con- sideration of such person shall be con- sidered to be regularly empl person for less than 130 working days within one year im- mediately preceding the date of the submission that initiates agency con- sideration of such person shall be con- sidered to be regularly employed as soon as he or she is employed by such person for 130 working days. (q) State means a State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, a terri- tory or possession of the United States, an agency or instrumentality of a State, and a multi-State, regional, or interstate entity having governmental duties and powers. § 93.110 Certification and disclosure. (a) Each person shall file a certifi- cation, and a disclosure form, if re- quired, with each submission that ini- tiates agency consideration of such person for: (1) Award of a Federal contract, grant, or cooperative agreement ex- ceeding $100,000; or (2) An award of a Federal loan or a commitment providing for the United States to insure or guarantee a loan exceeding $150,000. (b) Each person shall file a certifi- cation, and a disclosure form, if re- quired, upon receipt by such person of: (1) A Federal contract, grant, or co- operative agreement exceeding $100,000; or (2) A Federal loan or ll file a certifi- cation, and a disclosure form, if re- quired, upon receipt by such person of: (1) A Federal contract, grant, or co- operative agreement exceeding $100,000; or (2) A Federal loan or a commitment providing for the United States to in- sure or guarantee a loan exceeding $150,000, unless such person previously filed a certification, and a disclosure form, if required, under paragraph (a) of this section. (c) Each person shall file a disclosure form at the end of each calendar quar- ter in which there occurs any event that requires disclosure or that materi- ally affects the accuracy of the infor- mation contained in any disclosure form previously filed by such person under paragraphs (a) or (b) of this sec- tion. An event that materially affects the accuracy of the information re- ported includes: (1) A cumulative increase of $25,000 or more in the amount paid or expected to be paid for influencing or attempting to influence a covered Federal action; or (2) A change in the person(s) or indi- vidual(s) influencing or attempting to influence a covered Federal action; or, (3) A change in the officer(s), em- ployee(s), or Member(s) contacted to influence or attempt to in he person(s) or indi- vidual(s) influencing or attempting to influence a covered Federal action; or, (3) A change in the officer(s), em- ployee(s), or Member(s) contacted to influence or attempt to influence a covered Federal action. (d) Any person who requests or re- ceives from a person referred to in paragraphs (a) or (b) of this section: (1) A subcontract exceeding $100,000 at any tier under a Federal contract; (2) A subgrant, contract, or sub- contract exceeding $100,000 at any tier under a Federal grant; (3) A contract or subcontract exceed- ing $100,000 at any tier under a Federal loan exceeding $150,000; or, (4) A contract or subcontract exceed- ing $100,000 at any tier under a Federal cooperative agreement, shall file a certification, and a disclo- sure form, if required, to the next tier above. (e) All disclosure forms, but not cer- tifications, shall be forwarded from tier to tier until received by the person referred to in paragraphs (a) or (b) of this section. That person shall forward all disclosure forms to the agency. (f) Any certification or disclosure form filed under paragraph (e) of this section shall be treated as a material representation of fact upon which al shall forward all disclosure forms to the agency. (f) Any certification or disclosure form filed under paragraph (e) of this section shall be treated as a material representation of fact upon which all receiving tiers shall rely. All liability arising from an erroneous representa- tion shall be borne solely by the tier filing that representation and shall not be shared by any tier to which the er- roneous representation is forwarded. Submitting an erroneous certification or disclosure constitutes a failure to file the required certification or disclo- sure, respectively. If a person fails to file a required certification or disclo- sure, the United States may pursue all available remedies, including those au- thorized by section 1352, title 31, U.S. Code. 599 § 93.200 45 CFR Subtitle A (10–1–24 Edition) (g) For awards and commitments in process prior to December 23, 1989, but not made before that date, certifi- cations shall be required at award or commitment, covering activities oc- curring between December 23, 1989, and the date of award or commitment. However, for awards and commitments in process prior to the December 23, 1989 effective date of these provisions, but not made be urring between December 23, 1989, and the date of award or commitment. However, for awards and commitments in process prior to the December 23, 1989 effective date of these provisions, but not made before December 23, 1989, disclosure forms shall not be required at time of award or commitment but shall be filed within 30 days. (h) No reporting is required for an ac- tivity paid for with appropriated funds if that activity is allowable under ei- ther subpart B or C. Subpart B—Activities by Own Employees § 93.200 Agency and legislative liaison. (a) The prohibition on the use of ap- propriated funds, in § 93.100 (a), does not apply in the case of a payment of reasonable compensation made to an officer or employee of a person request- ing or receiving a Federal contract, grant, loan, or cooperative agreement if the payment is for agency and legis- lative liaison activities not directly re- lated to a covered Federal action. (b) For purposes of paragraph (a) of this section, providing any information specifically requested by an agency or Congress is allowable at any time. (c) For purposes of paragraph (a) of this section, the following agency and legislative liaison activities are allo nformation specifically requested by an agency or Congress is allowable at any time. (c) For purposes of paragraph (a) of this section, the following agency and legislative liaison activities are allow- able at any time only where they are not related to a specific solicitation for any covered Federal action: (1) Discussing with an agency (in- cluding individual demonstrations) the qualities and characteristics of the per- son’s products or services, conditions or terms of sale, and service capabili- ties; and, (2) Technical discussions and other activities regarding the application or adaptation of the person’s products or services for an agency’s use. (d) For purposes of paragraph (a) of this section, the following agencies and legislative liaison activities are allow- able only where they are prior to for- mal solicitation of any covered Federal action: (1) Providing any information not specifically requested but necessary for an agency to make an informed deci- sion about initiation of a covered Fed- eral action; (2) Technical discussions regarding the preparation of an unsolicited pro- posal prior to its official submission; and, (3) Capability presentations by per- sons seeki n of a covered Fed- eral action; (2) Technical discussions regarding the preparation of an unsolicited pro- posal prior to its official submission; and, (3) Capability presentations by per- sons seeking awards from an agency pursuant to the provisions of the Small Business Act, as amended by Public Law 95–507 and other subsequent amendments. (e) Only those activities expressly au- thorized by this section are allowable under this section. § 93.205 Professional and services. technical (a) The prohibition on the use of ap- propriated funds, in § 93.100 (a), does not apply in the case of a payment of reasonable compensation made to an officer or employee of a person request- ing or receiving a Federal contract, grant, loan, or cooperative agreement or an extension, continuation, renewal, amendment, or modification of a Fed- eral contract, grant, loan, or coopera- tive agreement if payment is for pro- fessional or technical services rendered directly in the preparation, submis- sion, or negotiation of any bid, pro- posal, or application for that Federal contract, grant, loan, or cooperative agreement or for meeting requirements imposed by or pursuant to law as a condition for receiving gotiation of any bid, pro- posal, or application for that Federal contract, grant, loan, or cooperative agreement or for meeting requirements imposed by or pursuant to law as a condition for receiving that Federal contract, grant, loan, or cooperative agreement. (b) For purposes of paragraph (a) of this section, professional and technical services shall be limited to advice and analysis directly applying any profes- sional or technical discipline. For ex- ample, drafting of a legal document ac- companying a bid or proposal by a law- yer is allowable. Similarly, technical advice provided by an engineer on the performance or operational capability of a piece of equipment rendered di- rectly in the negotiation of a contract is allowable. However, communications with the intent to influence made by a professional (such as a licensed lawyer) or a technical person (such as a li- censed accountant) are not allowable 600 Dept. of Health and Human Services § 93.300 under this section unless they provide advice and analysis directly applying their professional or technical exper- tise and unless the advice or analysis is rendered directly and solely in the preparation, submission or negotiat y provide advice and analysis directly applying their professional or technical exper- tise and unless the advice or analysis is rendered directly and solely in the preparation, submission or negotiation of a covered Federal action. Thus, for example, communications with the in- tent to influence made by a lawyer that do not provide legal advice or analysis directly and solely related to the legal aspects of his or her client’s proposal, but generally advocate one proposal over another are not allow- able under this section because the lawyer is not providing professional legal services. Similarly, communica- tions with the intent to influence made by an engineer providing an engineer- ing analysis prior to the preparation or submission of a bid or proposal are not allowable under this section since the engineer is providing technical services but not directly in the preparation, submission or negotiation of a covered Federal action. (c) Requirements imposed by or pur- suant to law as a condition for receiv- ing a covered Federal award include those required by law or regulation, or reasonably expected to be required by law or regulation, and any other re- quirements in the actual a condition for receiv- ing a covered Federal award include those required by law or regulation, or reasonably expected to be required by law or regulation, and any other re- quirements in the actual award docu- ments. (d) Only those services expressly au- thorized by this section are allowable under this section. § 93.210 Reporting. No reporting is required with respect to payments of reasonable compensa- tion made to regularly employed offi- cers or employees of a person. Subpart C—Activities by Other than Own Employees § 93.300 Professional and technical services. (a) The prohibition on the use of ap- propriated funds, in § 93.100 (a), does not apply in the case of any reasonable payment to a person, other than an of- ficer or employee of a person request- ing or receiving a covered Federal ac- tion, if the payment is for professional or technical services rendered directly in the preparation, submission, or ne- gotiation of any bid, proposal, or appli- cation for that Federal contract, grant, loan, or cooperative agreement or for meeting requirements imposed by or pursuant to law as a condition for re- ceiving that Federal contract, grant, loan, or cooperative agreement. (b) Th act, grant, loan, or cooperative agreement or for meeting requirements imposed by or pursuant to law as a condition for re- ceiving that Federal contract, grant, loan, or cooperative agreement. (b) The reporting requirements in § 93.110 (a) and (b) regarding filing a dis- closure form by each person, if re- quired, shall not apply with respect to professional or technical services ren- dered directly in the preparation, sub- mission, or negotiation of any commit- ment providing for the United States to insure or guarantee a loan. (c) For purposes of paragraph (a) of this section, professional and technical services shall be limited to advice and analysis directly applying any profes- sional or technical discipline. For ex- ample, drafting or a legal document ac- companying a bid or proposal by a law- yer is allowable. Similarly, technical advice provided by an engineer on the performance or operational capability of a piece of equipment rendered di- rectly in the negotiation of a contract is allowable. However, communications with the intent to influence made by a professional (such as a licensed lawyer) or a technical person (such as a li- censed accountant) are not allowable unde act is allowable. However, communications with the intent to influence made by a professional (such as a licensed lawyer) or a technical person (such as a li- censed accountant) are not allowable under this section unless they provide advice and analysis directly applying their professional or technical exper- tise and unless the advice or analysis is rendered directly and solely in the preparation, submission or negotiation of a covered Federal action. Thus, for example, communications with the in- tent to influence made by a lawyer that do not provide legal advice or analysis directly and solely related to the legal aspects of his or her client’s proposal, but generally advocate one proposal over another are not allow- able under this section because the lawyer is not providing professional legal services. Similarly, communica- tions with the intent to influence made by an engineer providing an engineer- ing analysis prior to the preparation or submission of a bid or proposal are not allowable under this section since the engineer is providing technical services but not directly in the preparation, submission or negotiation of a covered Federal action. 601 § 93.400 45 CFR Subtitl allowable under this section since the engineer is providing technical services but not directly in the preparation, submission or negotiation of a covered Federal action. 601 § 93.400 45 CFR Subtitle A (10–1–24 Edition) (d) Requirements imposed by or pur- suant to law as a condition for receiv- ing a covered Federal award include those required by law or regulation, or reasonably expected to be required by law or regulation, and any other re- quirements in the actual award docu- ments. (e) Persons other than officers or em- ployees of a person requesting or re- ceiving a covered Federal action in- clude consultants and trade associa- tions. (f) Only those services expressly au- thorized by this section are allowable under this section. Subpart D—Penalties and Enforcement § 93.400 Penalties. (a) Any person who makes an expend- iture prohibited herein shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 1 for each such expenditure. (b) Any person who fails to file or amend the disclosure form (see appen- dix B to this part) to be filed or amend- ed if required herein, shall be subject to a civil penalty of not less than $10,000 and not more than $ fails to file or amend the disclosure form (see appen- dix B to this part) to be filed or amend- ed if required herein, shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. (c) A filing or amended filing on or after the date on which an administra- tive action for the imposition of a civil penalty is commenced does not prevent the imposition of such civil penalty for a failure occurring before that date. An administrative action is commenced with respect to a failure when an inves- tigating official determines in writing to commence an investigation of an al- legation of such failure. (d) In determining whether to impose a civil penalty, and the amount of any such penalty, by reason of a violation by any person, the agency shall con- sider the nature, circumstances, ex- tent, and gravity of the violation, the 1 The amounts specified in this section are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty In- flation Adjustment Act of 1990 (Pub. L. 101– 140), as amended by the Federal Civil Pen- alties Inflation Adjustment Act Improve- ments Act of 2015 (section 701 of Pub. L. 114– 74). Annually enalty In- flation Adjustment Act of 1990 (Pub. L. 101– 140), as amended by the Federal Civil Pen- alties Inflation Adjustment Act Improve- ments Act of 2015 (section 701 of Pub. L. 114– 74). Annually adjusted amounts are pub- lished at 45 CFR part 102. effect on the ability of such person to continue in business, any prior viola- tions by such person, the degree of cul- pability of such person, the ability of the person to pay the penalty, and such other matters as may be appropriate. (e) First offenders under paragraphs (a) or (b) of this section shall be subject to a civil penalty of $10,000, absent ag- gravating circumstances. Second and subsequent offenses by persons shall be subject to an appropriate civil penalty between $10,000 and $100,000, as deter- mined by the agency head or his or her designee. (f) An imposition of a civil penalty under this section does not prevent the United States from seeking any other remedy that may apply to the same conduct that is the basis for the impo- sition of such civil penalty. [55 FR 6754, Feb. 26, 1990, as amended at 81 FR 61565, Sept. 6, 2016] § 93.405 Penalty procedures. Agencies shall impose and collect civil penalties pursuant to th impo- sition of such civil penalty. [55 FR 6754, Feb. 26, 1990, as amended at 81 FR 61565, Sept. 6, 2016] § 93.405 Penalty procedures. Agencies shall impose and collect civil penalties pursuant to the provi- sions of the Program Fraud and Civil Remedies Act, 31 U.S.C. sections 3803 (except subsection (c)), 3804, 3805, 3806, 3807, 3808, and 3812, insofar as these pro- visions are not inconsistent with the requirements herein. § 93.410 Enforcement. The head of each agency shall take such actions as are necessary to ensure that the provisions herein are vigor- ously implemented and enforced in that agency. Subpart E—Exemptions § 93.500 Secretary of Defense. (a) The Secretary of Defense may ex- empt, on a case-by-case basis, a cov- ered Federal action from the prohibi- tion whenever the Secretary deter- mines, in writing, that such an exemp- tion is in the national interest. The Secretary shall transmit a copy of each such written exemption to Congress immediately after making such a de- termination. (b) The Department of Defense may issue supplemental regulations to im- plement paragraph (a) of this section. 602 Dept. of Health and Human Services Pt. 93, App. A Subpart F—Agency Repor termination. (b) The Department of Defense may issue supplemental regulations to im- plement paragraph (a) of this section. 602 Dept. of Health and Human Services Pt. 93, App. A Subpart F—Agency Reports § 93.600 Semi-annual compilation. (a) The head of each agency shall col- lect and compile the disclosure reports (see appendix B to this part) and, on May 31 and November 30 of each year, submit to the Secretary of the Senate and the Clerk of the House of Rep- resentatives a report containing a com- pilation of the information contained in the disclosure reports received dur- ing the six-month period ending on March 31 or September 30, respectively, of that year. (b) The report, including the com- pilation, shall be available for public inspection 30 days after receipt of the report by the Secretary and the Clerk. (c) Information that involves intel- ligence matters shall be reported only to the Select Committee on Intel- ligence of the Senate, the Permanent Select Committee on Intelligence of the House of Representatives, and the Committees on Appropriations of the Senate and the House of Representa- tives in accordance with procedures agreed to by such committees. Such in- formati ence of the House of Representatives, and the Committees on Appropriations of the Senate and the House of Representa- tives in accordance with procedures agreed to by such committees. Such in- formation shall not be available for public inspection. (d) Information that is classified under Executive Order 12356 or any suc- cessor order shall be reported only to the Committee on Foreign Relations of the Senate and the Committee on For- eign Affairs of the House of Represent- atives or the Committees on Armed Services of the Senate and the House of Representatives (whichever such com- mittees have jurisdiction of matters involving such information) and to the Committees on Appropriations of the Senate and the House of Representa- tives in accordance with procedures agreed to by such committees. Such in- formation shall not be available for public inspection. (e) The first semi-annual compilation shall be submitted on May 31, 1990, and shall contain a compilation of the dis- closure reports received from Decem- ber 23, 1989 to March 31, 1990. (f) Major agencies, designated by the Office of Management and Budget (OMB), are required to provide ma- chine-readable compilations to the Secre s received from Decem- ber 23, 1989 to March 31, 1990. (f) Major agencies, designated by the Office of Management and Budget (OMB), are required to provide ma- chine-readable compilations to the Secretary of the Senate and the Clerk of the House of Representatives no later than with the compilations due on May 31, 1991. OMB shall provide de- tailed specifications in a memorandum to these agencies. (g) Non-major agencies are requested to provide machine-readable compila- tions to the Secretary of the Senate and the Clerk of the House of Rep- resentatives. (h) Agencies shall keep the originals of all disclosure reports in the official files of the agency. § 93.605 Inspector General report. (a) The Inspector General, or other official as specified in paragraph (b) of this section, of each agency shall pre- pare and submit to Congress each year, commencing with submission of the President’s Budget in 1991, an evalua- tion of the compliance of that agency with, and the effectiveness of, the re- quirements herein. The evaluation may include any recommended changes that may be necessary to strengthen or im- prove the requirements. (b) In the case of an agency that does not have an Inspect re- quirements herein. The evaluation may include any recommended changes that may be necessary to strengthen or im- prove the requirements. (b) In the case of an agency that does not have an Inspector General, the agency official comparable to an In- spector General shall prepare and sub- mit the annual report, or, if there is no such comparable official, the head of the agency shall prepare and submit the annual report. (c) The annual report shall be sub- mitted at the same time the agency submits its annual budget justifica- tions to Congress. (d) The annual report shall include the following: All alleged violations re- lating to the agency’s covered Federal actions during the year covered by the report, the actions taken by the head of the agency in the year covered by the report with respect to those alleged violations and alleged violations in previous years, and the amounts of civil penalties imposed by the agency in the year covered by the report. APPENDIX A TO PART 93—CERTIFICATION REGARDING LOBBYING Certification for Contracts, Grants, Loans, and Cooperative Agreements The undersigned certifies, to the best of his or her knowledge and belief, that: 603 Pt. 93, App. A 45 CATION REGARDING LOBBYING Certification for Contracts, Grants, Loans, and Cooperative Agreements The undersigned certifies, to the best of his or her knowledge and belief, that: 603 Pt. 93, App. A 45 CFR Subtitle A (10–1–24 Edition) (1) No Federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influ- encing or attempting to influence an officer or employee of an agency, a Member of Con- gress, an officer or employee of Congress, or an employee of a Member of Congress in con- nection with the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amend- ment, or modification of any Federal con- tract, grant, loan, or cooperative agreement. (2) If any funds other than Federal appro- priated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal contract, grant, loan, or cooperative agreement, ployee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard Form-LLL, ‘‘Disclosure Form to Report Lobbying,’’ in accordance with its instructions. (3) The undersigned shall require that the language of this certification be included in the award documents for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans, and coopera- tive agreements) and that all subrecipients shall certify and disclose accordingly. This certification is a material representa- tion of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 1 for each such failure. Statement for Loan Guarantees and Loan Insurance The undersigned states, to the best of his or her knowled a civil penalty of not less than $10,000 and not more than $100,000 1 for each such failure. Statement for Loan Guarantees and Loan Insurance The undersigned states, to the best of his or her knowledge and belief, that: If any funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this commitment providing for the United States to insure or guarantee a loan, the under- signed shall complete and submit Standard Form-LLL, ‘‘Disclosure Form to Report Lob- bying,’’ in accordance with its instructions. Submission of this statement is a pre- requisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required statement shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. [55 FR 6754, Feb. 26, 1990, as amended at 81 FR 61565, Sept. 6, 2016] 1 The amounts specified in Appendix A to Part 93 are updated annually, as adjusted in accordance with the Federal Civil Monetary P [55 FR 6754, Feb. 26, 1990, as amended at 81 FR 61565, Sept. 6, 2016] 1 The amounts specified in Appendix A to Part 93 are updated annually, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101–140), as amended by the Federal Civil Penalties Inflation Adjustment Act Im- provements Act of 2015 (section 701 of Pub. L. 114–74). Annually adjusted amounts are pub- lished at 45 CFR part 102. 604 Dept. of Health and Human Services Pt. 93, App. B APPENDIX B TO PART 93—DISCLOSURE FORM TO REPORT LOBBYING 605 Pt. 93, App. B 45 CFR Subtitle A (10–1–24 Edition) 606 Dept. of Health and Human Services Pt. 94 PART 94—RESPONSIBLE PROSPECTIVE CONTRACTORS Sec. 94.1 Purpose. 94.2 Applicability. 94.3 Definitions. 94.4 Responsibilities of Institutions regard- ing Investigator financial conflicts of in- terest. 607 § 94.1 45 CFR Subtitle A (10–1–24 Edition) 94.5 Management and reporting of financial conflicts of interest. 94.6 Remedies. AUTHORITY: 42 U.S.C. 216, 289b–1, 299c–4. SOURCE: 76 FR 53288, Aug. 25, 2011, unless otherwise noted. § 94.1 Purpose. This part promotes objectivity in re- search by establishing standards that provide a reasonabl U.S.C. 216, 289b–1, 299c–4. SOURCE: 76 FR 53288, Aug. 25, 2011, unless otherwise noted. § 94.1 Purpose. This part promotes objectivity in re- search by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under PHS con- tracts will be free from bias resulting from Investigator financial conflicts of interest. § 94.2 Applicability. This part is applicable to each Insti- tution that submits a proposal, or that receives, Public Health Service (PHS) research funding by means of a con- tract and, through the implementation of this part by the Institution, to each Investigator who is planning to partici- pate in, or is participating in such re- search; provided, however, that this part does not apply to SBIR Program Phase I applications. § 94.3 Definitions. As used in this part: Contractor means an entity that pro- vides property or services under con- tract for the direct benefit or use of the Federal Government. Disclosure of significant financial inter- ests means an Investigator’s disclosure of significant financial interests to an Institution. Financial conflict of interest (FCOI) means a significant financial in ure of significant financial inter- ests means an Investigator’s disclosure of significant financial interests to an Institution. Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. FCOI report means an Institution’s report of a financial conflict of interest to a PHS Awarding Component. Financial interest means anything of monetary value, whether or not the value is readily ascertainable. HHS means the United States De- partment of Health and Human Serv- ices, and any components of the De- partment to which the authority in- volved may be delegated. Institution means any domestic or foreign, public or private, entity or or- ganization (excluding a Federal agen- cy) that submits a proposal, or that re- ceives, PHS research funding. Institutional responsibilities means an Investigator’s professional responsibil- ities on behalf of the Institution, and as defined by the Institution in its pol- icy on financial conflicts of interest, which may include for example: activi- ties such as research, research con- sultation, teaching, professional prac- tice, insti d by the Institution in its pol- icy on financial conflicts of interest, which may include for example: activi- ties such as research, research con- sultation, teaching, professional prac- tice, institutional committee member- ships, and service on panels such as In- stitutional Review Boards or Data and Safety Monitoring Boards. Investigator means the project direc- tor or principal Investigator and any other person, regardless of title or posi- tion, who is responsible for the design, conduct, or reporting of research fund- ed by the PHS, or proposed for such funding, which may include, for exam- ple, collaborators or consultants. Key personnel includes the PD/PI and any other personnel considered to be essential to work performance in ac- cordance with HHSAR subpart 352.242– 70 and identified as key personnel in the contract proposal and contract. Manage means taking action to ad- dress a financial conflict of interest, which can include reducing or elimi- nating the financial conflict of inter- est, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias. PD/PI means a project director or principal Investigator of a PHS-fund ict of inter- est, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias. PD/PI means a project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of key personnel and Investigator under this part. PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority in- volved may be delegated, including the National Institutes of Health (NIH). PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this part. Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq. Research means a systematic inves- tigation, study or experiment designed to develop or contribute to generaliz- able knowledge relating broadly to public health, including behavioral and 608 Dept. of Health and Human Services § 94.3 social-sciences research. The term en- compasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this part, the term includes . The term en- compasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this part, the term includes any such activity for which research funding is available from a PHS Awarding Com- ponent through a contract, whether au- thorized under the PHS Act or other statutory authority. Significant financial interest means: (1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the In- vestigator’s spouse and dependent chil- dren) that reasonably appears to be re- lated to the Investigator’s institu- tional responsibilities: (i) With regard to any publicly traded entity, a significant financial interest ex- ists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remunera- tion includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest in- cludes any s of this definition, remunera- tion includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest in- cludes any stock, stock option, or other ownership interest, as deter- mined through reference to public prices or other reasonable measures of fair market value; (ii) With regard to any non-publicly traded entity, a significant financial in- terest exists if the value of any remu- neration received from the entity in the twelve months preceding the dis- closure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other own- ership interest); or (iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. (2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional responsibilities; provided, is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional responsibilities; provided, however, that this disclosure require- ment does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as de- fined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher edu- cation. The Institution’s FCOI policy will specify the details of this disclo- sure, which will include, at a min- imum, the purpose of the trip, the iden- tity of the sponsor/organizer, the des- tination, and the duration. In accord- ance with the Institution’s FCOI pol- icy, the Institutional official(s) will de- termine if further information is need- ed, including a determination or disclo- sure of monetary value, in order to de- termine whether the travel constitutes an FCOI with the PHS-funded research. (3) The term significant financial inter- est does not include the following types of financial interests: salary, royalties, or other re r the travel constitutes an FCOI with the PHS-funded research. (3) The term significant financial inter- est does not include the following types of financial interests: salary, royalties, or other remuneration paid by the In- stitution to the Investigator if the In- vestigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agree- ments to share in royalties related to such rights; any ownership interest in the Institution held by the Investi- gator, if the Institution is a commer- cial or for-profit organization; income from investment vehicles, such as mu- tual funds and retirement accounts, as long as the Investigator does not di- rectly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engage- ments sponsored by a Federal, state, or local government agency, an Institu- tion of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a re- search institute that is affiliated with an Institution of higher education; or income from service on advisory com- mittees or review panels for a Federal, sta ng hospital, a medical center, or a re- search institute that is affiliated with an Institution of higher education; or income from service on advisory com- mittees or review panels for a Federal, state, or local government agency, an Institution of higher education as de- fined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher edu- cation. 609 § 94.4 45 CFR Subtitle A (10–1–24 Edition) Small Business Innovation Research (SBIR) Program means the extramural research program for small businesses that is established by the Awarding Components of the Public Health Serv- ice and certain other Federal agencies under Public Law 97–219, the Small Business Innovation Development Act, as amended. For purposes of this part, the term SBIR Program also includes the Small Business Technology Trans- fer (STTR) Program, which was estab- lished by Public Law 102–564. § 94.4 Responsibilities of Institutions financial Investigator regarding conflicts of interest. Each Institution shall: (a) Maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with this part, and m ancial Investigator regarding conflicts of interest. Each Institution shall: (a) Maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with this part, and make such policy available via a publicly accessible Web site. If the In- stitution does not have any current presence on a publicly accessible Web site (and only in those cases), the Insti- tution shall make its written policy available to any requestor within five business days of a request. If, however, the Institution acquires a presence on a publicly accessible Web site during the time of the PHS award, the re- quirement to post the information on that Web site will apply within 30 cal- endar days. If an Institution maintains a policy on financial conflicts of inter- est that includes standards that are more stringent than this part (e.g., that require a more extensive disclo- sure of financial interests), the Institu- tion shall adhere to its policy and shall provide FCOI reports regarding identi- fied financial conflicts of interest to the PHS Awarding Component in ac- cordance with the Institution’s own standards and within the timeframe prescribed by this part. (b) Inform each rding identi- fied financial conflicts of interest to the PHS Awarding Component in ac- cordance with the Institution’s own standards and within the timeframe prescribed by this part. (b) Inform each Investigator of the Institution’s policy on financial con- flicts of interest, the Investigator’s re- sponsibilities regarding disclosure of significant financial interests, and of these regulations, and require each In- vestigator to complete training regard- ing the same prior to engaging in re- search related to any PHS-funded con- tract and at least every four years, and immediately when any of the following circumstances apply: (1) The Institution revises its finan- cial conflict of interest policies or pro- cedures in any manner that affects the requirements of Investigators; (2) An Investigator is new to an Insti- tution; or (3) An Institution finds that an Inves- tigator is not in compliance with the Institution’s financial conflict of inter- est policy or management plan. (c) If the Institution carries out the PHS-funded research through a sub- recipient (e.g., subcontractors, or con- sortium members), the Institution (awardee Institution) must take rea- sonable steps to ensur he Institution carries out the PHS-funded research through a sub- recipient (e.g., subcontractors, or con- sortium members), the Institution (awardee Institution) must take rea- sonable steps to ensure that any sub- recipient Investigator complies with this part by (1) Incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the sub- recipient will apply to the subrecipi- ent’s Investigators. (i) If the subrecipient’s Investigators must comply with the subrecipient’s fi- nancial conflicts of interest policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with this part. If the subrecipient cannot provide such cer- tification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of in- terest policy of the awardee Institution for disclosing significant financial in- terests that are directly related to the subrecipient’s work for the awardee In- stitution; (ii) Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of in- hat are directly related to the subrecipient’s work for the awardee In- stitution; (ii) Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of in- terest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the awardee Institution. Such time pe- riod(s) shall be sufficient to enable the awardee Institution to provide timely FCOI reports, as necessary, to the PHS as required by this part; (iii) Alternatively, if the subrecipi- ent’s Investigators must comply with the awardee Institution’s financial con- flicts of interest policy, the agreement referenced above shall specify time pe- riod(s) for the subrecipient to submit 610 Dept. of Health and Human Services § 94.4 all Investigator disclosures of signifi- cant financial interests to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee In- stitution to comply timely with its re- view, management, and reporting obli- gations under this part. (2) Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all sub ply timely with its re- view, management, and reporting obli- gations under this part. (2) Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with this part, i.e., prior to the expend- iture of funds and within 60 days of any subsequently identified FCOI. (d) Designate an institutional offi- cial(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the PHS-funded research. (e)(1) Require that each Investigator who is planning to participate in the PHS-funded research disclose to the In- stitution’s designated official(s) the In- vestigator’s significant financial inter- ests (and those of the Investigator’s spouse and dependent children) no later than date of submission of the Institu- tion’s proposal for PHS-funded re- search. (2) Require each Investigator who is participating in the PHS-funded re- search to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution, during the period of the aw re- search to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution, during the period of the award. Such disclosure shall include any information that was not disclosed initially to the Institution pursuant to paragraph (e)(1) of this section, or in a subsequent disclosure of significant fi- nancial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was trans- ferred from another Institution), and shall include updated information re- garding any previously disclosed sig- nificant financial interest (e.g., the up- dated value of a previously disclosed equity interest). (3) Require each Investigator who is participating in the PHS-funded re- search to submit an updated disclosure of significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest. financial significant (f) Provide guidelines consistent with this part for the designated institu- tional official(s) to determine whether an Investigator’s significant financial interest is rela est. financial significant (f) Provide guidelines consistent with this part for the designated institu- tional official(s) to determine whether an Investigator’s significant financial interest is related to PHS-funded re- search and, if so related, whether the significant financial interest is a finan- cial conflict of interest. An Investiga- tor’s significant financial interest is related to PHS-funded research when the Institution, through its designated official(s), reasonably determines that the interest: Could be affected by the PHS-funded research; or is in an entity whose fi- nancial interest could be affected by the research. The Institution may in- volve the Investigator in the des- ignated official(s)’s determination of whether a significant financial interest is related to the PHS-funded research. A financial conflict of interest exists when the Institution, through its des- ignated official(s), reasonably deter- mines that the significant financial in- terest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. (g) Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts and significantly affect the design, conduct, or reporting of the PHS-funded research. (g) Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subrecipient Investigator pursuant to paragraph (c) of this section. Manage- ment of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective re- view and mitigation report pursuant to § 94.5(a). (h) Provide initial and ongoing FCOI reports to the PHS as required pursu- ant to § 94.5(b). (i) Maintain records relating to all Investigator disclosures of financial in- terests and the Institution’s review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution’s determination of a fi- nancial conflict of interest), and all ac- tions under the Institution’s policy or retrospective review, if applicable, for at least three years from the date of final payment or, where applicable, for the time periods specified in 48 CFR part 4, subpart 4.7. (j) Establish adequate enforcement mechanisms and provide for employee 611 § 94.5 45 CFR Subtitle A (10–1–24 Edition) sanction applicable, for the time periods specified in 48 CFR part 4, subpart 4.7. (j) Establish adequate enforcement mechanisms and provide for employee 611 § 94.5 45 CFR Subtitle A (10–1–24 Edition) sanctions or other administrative ac- tions to ensure Investigator compli- ance as appropriate. (k) Certify, in each contract proposal to which this part applies, that the In- stitution: (1) Has in effect at that Institution an up-to-date, written, and enforced administrative process to identify and manage financial conflicts of interest with respect to all research projects for which funding is sought or received from the PHS; (2) Shall promote and enforce Inves- tigator compliance with this part’s re- quirements including those pertaining to disclosure of significant financial in- terests; (3) Shall manage financial conflicts of interest and provide initial and on- going FCOI reports to the PHS Award- ing Component consistent with this part; (4) Agrees to make information avail- able, promptly upon request, to the HHS relating to any Investigator dis- closure of financial interests and the Institution’s review of, and response to, such disclosure, whether or not the disclosure resulted in th pon request, to the HHS relating to any Investigator dis- closure of financial interests and the Institution’s review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution’s determination of a financial conflict of interest; and (5) Shall fully comply with the re- quirements of this part. § 94.5 Management and reporting of fi- nancial conflicts of interest. (a) Management of financial conflicts of interest. (1) Prior to the Institution’s expendi- ture of any funds under a PHS-funded research project, the designated offi- cial(s) of an Institution shall, con- sistent with § 94.4(f): review all Investi- gator disclosures of significant finan- cial interests; determine whether any significant financial interests relate to PHS-funded determine research; whether a financial conflict of interest exists; and, if so, develop and imple- ment a management plan that shall specify the actions that have been, and shall be, taken to manage such finan- cial conflict of interest. Examples of conditions or restrictions that might be imposed to manage a financial con- flict of interest include, but are not limited to: (i) Public disclosure of financial con- onflict of interest. Examples of conditions or restrictions that might be imposed to manage a financial con- flict of interest include, but are not limited to: (i) Public disclosure of financial con- flicts of interest (e.g., when presenting or publishing the research); (ii) For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants; (iii) Appointment of an independent monitor capable of taking measures to protect the design, conduct, and re- porting of the research against bias, re- sulting from the financial conflict of interest; (iv) Modification of the research plan; (v) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; (vi) Reduction or elimination of the financial interest (e.g., sale of an eq- uity interest); or (vii) Severance of relationships that create financial conflicts. (2) Whenever, in the course of an on- going PHS-funded research project, an Investigator who is new to partici- pating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant fina S-funded research project, an Investigator who is new to partici- pating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest to the In- stitution, the designated official(s) of the Institution shall, within sixty days: review the disclosure of the sig- nificant financial interest; determine whether it is related to PHS-funded re- search; determine whether a financial conflict of interest exists; and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest. Depending on the nature of the significant financial in- terest, an Institution may determine that additional interim measures are necessary with regard to the Investiga- tor’s participation in the PHS-funded research project between the date of disclosure and the completion of the Institution’s review. (3) Whenever an Institution identifies a significant financial interest that was not disclosed timely by an Investi- gator or, for whatever reason, was not previously reviewed by the Institution during an ongoing PHS-funde ution identifies a significant financial interest that was not disclosed timely by an Investi- gator or, for whatever reason, was not previously reviewed by the Institution during an ongoing PHS-funded research project (e.g., was not timely reviewed 612 Dept. of Health and Human Services § 94.5 or reported by a subrecipient), the des- ignated official(s) shall, within sixty days: review the significant financial interest; determine whether it is re- lated to PHS-funded research; deter- mine whether a financial conflict of in- terest exists; and, if so: (i) Implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward; (ii) (A) In addition, whenever a finan- cial conflict of interest is not identi- fied or managed in a timely manner in- cluding failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a financial conflict of in- terest; failure by the Institution to re- view or manage such a financial con- flict of interest; or failure by the Inves- tigator to comply with a financial con- flict o e a financial conflict of in- terest; failure by the Institution to re- view or manage such a financial con- flict of interest; or failure by the Inves- tigator to comply with a financial con- flict of interest management plan, the Institution shall, within 120 days of the Institution’s determination of non- compliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any PHS-funded re- search, or portion thereof, conducted during the time period of the non- compliance, was biased in the design, conduct, or reporting of such research. (B) The Institution is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements: (1) Project number; (2) Project title; (3) PD/PI or contact PD/PI if a mul- tiple PD/PI model is used; (4) Name of the Investigator with the FCOI; (5) Name of the entity with which the Investigator has a financial conflict of interest; (6) Reason(s) for the retrospective re- view; (7) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review pan l conflict of interest; (6) Reason(s) for the retrospective re- view; (7) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); (8) Findings of the review; and (9) Conclusions of the review. (iii) Based on the results of the retro- spective review, if appropriate, the In- stitution shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, the Institu- tion is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a de- scription of the impact of the bias on the research project and the Institu- tion’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Insti arch project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually, as specified elsewhere in this part. Depending on the nature of the fi- nancial conflict of interest, an Institu- tion may determine that additional in- terim measures are necessary with re- gard to the Investigator’s participation in the PHS-funded research project be- tween the date that the financial con- flict of interest or the Investigator’s noncompliance is determined and the completion of the Institution’s retro- spective review. (4) Whenever an Institution imple- ments a management plan pursuant to this part, the Institution shall monitor Investigator compliance with the man- agement plan on an ongoing basis until the completion of the PHS-funded re- search project. (5)(i) Prior to the Institution’s ex- penditure of any funds under a PHS- funded research project, the Institution shall ensure public accessibility, via a publicly accessible Web site or written response to any requestor within five business days of a request, of informa- funded research project, the Institution shall ensure public accessibility, via a publicly accessible Web site or written response to any requestor within five business days of a request, of informa- tion concerning any significant finan- cial interest disclosed to the Institu- tion that meets the following three cri- teria: (A) The significant financial interest was disclosed and is still held by key personnel as defined in this part; (B) The Institution determines that the significant financial interest is re- lated to the PHS-funded research; and 613 § 94.5 45 CFR Subtitle A (10–1–24 Edition) (C) The Institution determines that the significant financial interest is a financial conflict of interest. (ii) The information that the Institu- tion makes available via a publicly ac- cessible Web site or written response to any requestor within five business days of a request, shall include, at a min- imum, the following: The Investiga- tor’s name; the Investigator’s title and role with respect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant fi- nancial interest; and the approximate dollar value of the si pect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant fi- nancial interest; and the approximate dollar value of the significant financial interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$100,000 by in- crements of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily deter- mined through reference to public prices or other reasonable measures of fair market value. (iii) If the Institution uses a publicly accessible Web site for the purposes of this subsection, the information that the Institution posts shall be updated at least annually. In addition, the In- stitution shall update the Web site within sixty days of the Institution’s receipt or identification of information concerning any additional significant financial interest of the senior/key per- sonnel for the PHS-funded research project that was not previously dis- closed, or upon the disclosure of a sig- nificant financial interest of senior/key personnel new to the PHS-funded re- search project, if the Institut ded research project that was not previously dis- closed, or upon the disclosure of a sig- nificant financial interest of senior/key personnel new to the PHS-funded re- search project, if the Institution deter- mines that the significant financial in- terest is related to the PHS-funded re- search and is a financial conflict of in- terest. The Web site shall note that the information provided is current as of the date listed and is subject to up- dates, on at least an annual basis and within 60 days of the Institution’s iden- tification of a new financial conflict of interest. If the Institution responds to written requests for the purposes of this subsection, the Institution will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an an- nual basis and within 60 days of the In- stitution’s identification of a new fi- nancial conflict of interest, which should be requested subsequently by the requestor. (iv) Information concerning the sig- nificant financial interests of an indi- vidual subject to paragraph (a)(5) of this section shall remain available, for responses to written requests or requestor. (iv) Information concerning the sig- nificant financial interests of an indi- vidual subject to paragraph (a)(5) of this section shall remain available, for responses to written requests or for posting via the Institution’s publicly accessible Web site for at least three years from the date that the informa- tion was most recently updated. (6) In addition to the types of finan- cial conflicts of interest as defined in this part that must be managed pursu- ant to this section, an Institution may require the management of other finan- cial conflicts of interest in its policy on financial conflicts of interest, as the Institution deems appropriate. (b) Reporting of financial conflicts of interest. (1) Prior to the Institution’s expendi- ture of any funds under a PHS-funded research project, the Institution shall provide to the PHS Awarding Compo- nent an FCOI report regarding any In- vestigator’s significant financial inter- est found by the Institution to be con- flicting and ensure that the Institution has implemented a management plan in accordance with this part. In cases in which the Institution identifies a fi- nancial conflict of interest and elimi- nates it prior to ensure that the Institution has implemented a management plan in accordance with this part. In cases in which the Institution identifies a fi- nancial conflict of interest and elimi- nates it prior to the expenditure of PHS-awarded funds, the Institution shall not submit an FCOI report to the PHS Awarding Component. (2) For any significant financial in- terest that the Institution identifies as conflicting subsequent to the Institu- tion’s initial FCOI report during an on- going PHS-funded research project (e.g., upon the participation of an In- vestigator who is new to the research project), the Institution shall provide to the PHS Awarding Component, within sixty days, an FCOI report re- garding the financial conflict of inter- est and ensure that the Institution has implemented a management plan in ac- cordance with this part. Pursuant to paragraph (a)(3)(ii) of this section, where such FCOI report involves a sig- nificant financial interest that was not disclosed timely by an Investigator or, 614 Dept. of Health and Human Services § 94.6 for whatever reason, was not pre- viously reviewed or managed by the In- stitution (e.g., was not timely reviewed or reported by a subrecipien tigator or, 614 Dept. of Health and Human Services § 94.6 for whatever reason, was not pre- viously reviewed or managed by the In- stitution (e.g., was not timely reviewed or reported by a subrecipient), the In- stitution also is required to complete a retrospective to determine review whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research. Additionally, pursuant to paragraph (a)(3)(iii) of this section, if bias is found, the Institution is re- quired to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. (3) Any FCOI report required under paragraphs (b)(1) or (b)(2) of this sec- tion shall include sufficient informa- tion to enable the PHS Awarding Com- ponent to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Insti- tution’s management plan. Elements of the FCOI report shall include, but are not necessarily limited to the fol- lowing: (i) Project/Contract number; (ii) PD/PI or Contact PD/PI if a mul- tiple PD/PI model is use agement plan. Elements of the FCOI report shall include, but are not necessarily limited to the fol- lowing: (i) Project/Contract number; (ii) PD/PI or Contact PD/PI if a mul- tiple PD/PI model is used; (iii) Name of the Investigator with the financial conflict of interest; (iv) Name of the entity with which the Investigator has a financial con- flict of interest; (v) Nature of the financial interest (e.g., equity, consulting fee, travel re- imbursement, honorarium); $5,000–$9,999; (vi) Value of the financial interest (dollar ranges are permissible: $0– $4,999; $10,000–$19,999; amounts between $20,000–$100,000 by in- crements of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily deter- mined through reference to public prices or other reasonable measures of fair market value; (vii) A description of how the finan- cial interest relates to the PHS-funded research and the basis for the Institu- tion’s determination that the financial interest conflicts with such research; and (viii) A description of the key ele- ments of the Institution’s management plan, including: (A) Role and principal duties of the confl ion that the financial interest conflicts with such research; and (viii) A description of the key ele- ments of the Institution’s management plan, including: (A) Role and principal duties of the conflicted Investigator in the research project; (B) Conditions of the management plan; (C) How the management plan is de- signed to safeguard objectivity in the research project; (D) Confirmation of the Investiga- tor’s agreement to the management plan; (E) How the management plan will be monitored to ensure Investigator com- pliance; and (F) Other information as needed. (4) For any financial conflict of inter- est previously reported by the Institu- tion with regard to an ongoing PHS- funded research project, the Institution shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the fi- nancial conflict of interest no longer exists. The Institution shall provide annual FCOI reports to the PHS Awarding Component for the d inancial conflict is still being managed or explain why the fi- nancial conflict of interest no longer exists. The Institution shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including exten- sions with or without funds) in the time and manner specified by the PHS Awarding Component. (5) In addition to the types of finan- cial conflicts of interest as defined in this part that must be reported pursu- ant to this section, an Institution may require the reporting of other financial conflicts of interest in its policy on fi- nancial conflicts of interest, as the In- stitution deems appropriate. § 94.6 Remedies. (a) If the failure of an Investigator to comply with an Institution’s financial conflicts of interest policy or a finan- cial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-fund- ed research, the Institution shall promptly notify the PHS Awarding Component of the corrective action 615 Pt. 95 45 CFR Subtitle A (10–1–24 Edition) taken or to be taken. The PHS Award- ing Component will consider the situa- tion and, as necessary, take appro- priate action, or refer the m tive action 615 Pt. 95 45 CFR Subtitle A (10–1–24 Edition) taken or to be taken. The PHS Award- ing Component will consider the situa- tion and, as necessary, take appro- priate action, or refer the matter to the Institution for further action, which may include directions to the In- stitution on how to maintain appro- priate objectivity in the PHS-funded research project. (b) The PHS Awarding Component and/or HHS may inquire at any time (before, during, or after award) into any Investigator disclosure of financial interests and the Institution’s review of, and response to, such disclosure, re- gardless of whether or not the disclo- sure resulted in the Institution’s deter- mination of a financial conflict of in- terest. An Institution is required to submit, or permit on site review of, all records pertinent to compliance with this part. To the extent permitted by law, HHS will maintain the confiden- tiality of all records of financial inter- ests. On the basis of its review of records or other information that may be available, the PHS Awarding Com- ponent may decide that a particular fi- nancial conflict of interest will bias the objectivity of the PHS-funded re- search to such a or other information that may be available, the PHS Awarding Com- ponent may decide that a particular fi- nancial conflict of interest will bias the objectivity of the PHS-funded re- search to such an extent that further corrective action is needed or that the Institution has not managed the finan- cial conflict of interest in accordance with this part. The PHS Awarding Component may that issuance of a Stop Work Order by the Contracting Officer or other enforce- ment action is necessary until the mat- ter is resolved. determine (c) In any case in which the HHS de- termines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or re- ported by an Investigator with a finan- cial conflict of interest that was not managed or reported by the Institution as required by this part, the Institu- tion shall require the Investigator in- volved to disclose the financial conflict of interest in each public presentation of the results of the research and to re- quest an addendum to previously pub- lished presentations. PART 95—GENERAL ADMINISTRA- TION—GRANT PROGRAMS (PUB- LIC of interest in each public presentation of the results of the research and to re- quest an addendum to previously pub- lished presentations. PART 95—GENERAL ADMINISTRA- TION—GRANT PROGRAMS (PUB- LIC ASSISTANCE, MEDICAL AS- SISTANCE AND STATE CHIL- DREN’S HEALTH INSURANCE PRO- GRAMS) Subpart A—Time Limits for States To File Claims Sec. 95.1 Scope. 95.4 Definitions. 95.7 Time limit for claiming payment for expenditures made after September 30, 1979. 95.10 Time limit for claiming payment for expenditures made before October 1, 1979. 95.11 Payment of claims subject to appro- priations restrictions. 95.13 In which quarter we consider an ex- penditure made. 95.19 Exceptions to time limits. 95.22 Meaning of good cause. 95.25 When to request a waiver for good cause. 95.28 What a waiver request for good cause must include. 95.31 Where to send a waiver request for good cause. 95.34 The decision to waive the time limit for good cause. Subparts B–D [Reserved] Subpart E—Cost Allocation Plans 95.501 Purpose. 95.503 Scope. 95.505 Definitions. 95.507 Plan requirements. 95.509 Cost allocation plan amendments and certifications. 95.511 Approval of the cost allocation plan or plan amendment. 95.515 1 Purpose. 95.503 Scope. 95.505 Definitions. 95.507 Plan requirements. 95.509 Cost allocation plan amendments and certifications. 95.511 Approval of the cost allocation plan or plan amendment. 95.515 Effective date of a cost allocation plan or plan amendment. 95.517 Claims for Federal financial partici- pation. 95.519 Cost disallowance. Subpart F—Automatic Data Processing Equipment and Services—Conditions for Federal Financial Participation (FFP) GENERAL 95.601 Scope and applicability. 95.605 Definitions. SPECIFIC CONDITIONS FOR FFP 95.610 Submission of advance planning docu- ments. 95.611 Prior approval conditions. 95.612 Disallowance of Federal Financial Participation (FFP). 616 Dept. of Health and Human Services § 95.4 95.613 Procurement standards. 95.615 Access to systems and records. 95.617 Software and ownership rights. 95.619 Use of ADP systems. 95.621 ADP reviews. 95.623 Reconsideration of denied FFP for failure to obtain prior approval. 95.624 Consideration for FFP in emergency situations. 95.625 Increased FFP for certain ADP sys- tems. 95.626 Independent Verification and Valida- tion. 95.627 Waivers. FEDERAL FINANCIAL PARTICIPATION IN COSTS OF ADP ACQUISITIONS 95.631 Cost y situations. 95.625 Increased FFP for certain ADP sys- tems. 95.626 Independent Verification and Valida- tion. 95.627 Waivers. FEDERAL FINANCIAL PARTICIPATION IN COSTS OF ADP ACQUISITIONS 95.631 Cost identification for purpose of FFP claims. 95.633 Nondiscrimination requirements. 95.635 Disallowance of Federal financial participation for automated systems that fail to comply substantially with re- quirements. EXEMPTIONS 95.641 Applicability of rules for charging equipment in subpart G of this part. Subpart G—Equipment Acquired Under Public Assistance Programs 95.701 Purpose and scope of subpart. 95.703 Definitions. 95.705 Equipment costs—Federal financial participation. 95.707 Equipment management and disposi- tion. AUTHORITY: 5 U.S.C. 301, 42 U.S.C. 622(b), 629b(a), 652(a), 652(d), 654A, 671(a), 1302, and 1396a(a). Subpart A—Time Limits for States To File Claims SOURCE: 46 FR 3529, Jan. 15, 1981, unless otherwise noted. § 95.1 Scope. (a) This subpart establishes a two year time limit (15 months in some cases) for a State to claim Federal fi- nancial participation in expenditures under State plans approved under the following titles of the Social Security Act: Title I—Grants to St (15 months in some cases) for a State to claim Federal fi- nancial participation in expenditures under State plans approved under the following titles of the Social Security Act: Title I—Grants to States for Old-Age As- sistance and Medical Assistance for the Aged. Title IV-A—Grants to States for Aid and Services to Needy Families with Depend- ent Section Children 402(a)(19)(G) of the Act). (except for Title IV-B—Child Welfare Services. Title IV-D—Child Support and Establish- ment of Paternity. Title IV-E—Foster Care and Adoption Assist- ance. Title X—Grants to States for Aid to the Blind. Title XIV—Grants to States for Aid to the Permanently and Totally Disabled. Title XVI—Grants to States for Aid to the Aged, Blind, or Disabled (AABD), or for Such Aid and Medical Assistance for the Aged. Title XIX—Grants to States for Medical As- sistance Programs. Title XX—Grants to States for Services. Title XXI—Grants to States for State Chil- dren’s Health Insurance Programs. (b) This subpart also applies to claims for Federal financial participa- tion by any State which are based on any provision of the Act that is en- acted after issuance of these regula- tions and that provides, on an ent so applies to claims for Federal financial participa- tion by any State which are based on any provision of the Act that is en- acted after issuance of these regula- tions and that provides, on an entitle- ment basis, for Federal financial par- ticipation in expenditures made under State plans or programs. (c) This subpart explains under what conditions the Secretary may decide to extend the time limit for filing claims when a State believes it has good cause for not meeting the time limit. [46 FR 3529, Jan. 15, 1981, as amended at 65 FR 33632, May 24, 2000] § 95.4 Definitions. In this subpart— Adjustment to prior year costs means an adjustment in the amount of a par- ticular cost item that was previously claimed under an interim rate concept and for which it is later determined that the cost is greater or less than that originally claimed. Audit exception means a proposed ad- justment by the responsible Federal agency to any expenditure claimed by a State by virtue of an audit. Claim means a request for Federal fi- nancial participation in the manner and format required by our program regulations, and instructions or direc- tives issued thereunder. retroactive Court-ordered paymen means a request for Federal fi- nancial participation in the manner and format required by our program regulations, and instructions or direc- tives issued thereunder. retroactive Court-ordered payment means either a retroactive payment the State makes to an assistance re- cipient or an individual, under a Fed- eral or State court order or a retro- active payment we make to a State under a Federal court order. Although 617 § 95.7 45 CFR Subtitle A (10–1–24 Edition) we may accept these claims as timely, this provision does not mean that we necessarily agree to be bound by a State or Federal decision when we were not a party to the action. Federal financial participation means the Federal government’s share of an expenditure made by a State agency under any of the programs listed in § 95.1. State means the 50 States, the Dis- trict of Columbia, Guam, Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa and the Trust Terri- tories of the Pacific. for State agency for the purposes of ex- penditures financial assistance under title IV-A and for support en- forcement services under title IV-D means any agency or organization of the State or lo c. for State agency for the purposes of ex- penditures financial assistance under title IV-A and for support en- forcement services under title IV-D means any agency or organization of the State or local government which is authorized to incur matchable ex- penses; for purposes of expenditures under titles XIX and XXI, means any agency of the State, including the State Medicaid agency or State Child Health Agency, its fiscal agents, a State health agency, or any other State or local organization which in- curs matchable expenses; for purposes of expenditures under all other titles, see the definitions in the appropriate program’s regulations. The Act means the Social Security Act, as amended. We, our, and us refer to the HHS Cen- ters for Medicare & Medicaid Services (CMS), and Administration for Chil- dren and Families (ACF), depending on the program involved. [46 FR 3529, Jan. 15, 1981, as amended at 65 FR 33632, May 24, 2000; 75 FR 66336, Oct. 28, 2010] § 95.7 Time limit for claiming payment for expenditures made after Sep- tember 30, 1979. Under the programs listed in § 95.1, we will pay a State for a State agency expenditure made after September 30, 1979, only if the State fil g payment for expenditures made after Sep- tember 30, 1979. Under the programs listed in § 95.1, we will pay a State for a State agency expenditure made after September 30, 1979, only if the State files a claim with us for that expenditure within 2 years after the calendar quarter in which the State agency made the expenditure. Section 95.19 lists the exceptions to this rule. § 95.10 Time limit for claiming pay- ment for expenditures made before October 1, 1979. Under the programs listed in § 95.1, we will pay a State for a State agency expenditure made before October 1, 1979, only if the State filed or files a claim with us for that expenditure be- fore January 1, 1981. Section 95.19 lists the exceptions to this rule. § 95.11 Payment of claims subject to appropriations restrictions. Notwithstanding any other provision of this Subpart, we will pay States’ otherwise allowable claims for Federal financial participation under the pro- grams covered by this subpart, subject to the availability of funds (as provided in Acts appropriating funds to the De- partment in effect at the time in which such claims are being considered for payment), and subject to conditions or restrictions appli lity of funds (as provided in Acts appropriating funds to the De- partment in effect at the time in which such claims are being considered for payment), and subject to conditions or restrictions applicable to payments out of such funds, including provisions of the first and second continuing resolu- tions for FY 1981 (Pub. L. 96–369 and Pub. L. 96–536) and the Supplemental Appropriations and Rescission Act, 1981 (Pub. L. 97–12) that make funds under those Acts available to pay for a State agency expenditure made before Sep- tember 30, 1978, only if the State had filed a claim for that expenditure with us within one year of the expenditure. (Pub. L. 96–369, 94 Stat. 1351; Pub. L. 96–536, 94 Stat. 3166; and Pub. L. 97–12, 95 Stat. 14) [46 FR 46136, Sept. 17, 1981] § 95.13 In which quarter we consider an expenditure made. In this subpart— (a) We consider a State agency’s ex- penditure for assistance payments under title I, IV-A, IV-E, X, XIV, or XVI (AABD) to have been made in the quarter in which a payment was made to the assistance recipient, his or her protective payee, or a vendor payee, even if the payment was for a month in a previous quarter. (b) We consider a State agency’s ex in which a payment was made to the assistance recipient, his or her protective payee, or a vendor payee, even if the payment was for a month in a previous quarter. (b) We consider a State agency’s ex- penditure for services under title I, IV- A, IV-B, IV-D, IV-E, X, XIV, XVI (AABD) , XIX, or XXI to have been made in the quarter in which any State agency made a payment to the service provider. 618 Dept. of Health and Human Services § 95.501 (c) For purposes of title XX, the date of expenditure is governed by 45 CFR 1396.52(d). (d) We consider a State agency’s ex- penditure for administration or train- ing under titles I, IV-A, IV-B, IV-D, IV- E, X, XIV, XVI (AABD), XIX, or XXI to have been made in the quarter pay- ment was made by a State agency to a private agency or individual; or in the quarter to which the costs were allo- cated in accordance with the regula- tions for each program. We consider a State agency’s expenditure under these titles for non-cash expenditures such as depreciation to have been made in the quarter the expenditure was recorded in the accounting records of any State agency in accordance with generally accepted accounting principles. [46 FR 3529, Jan. 15, 19 iation to have been made in the quarter the expenditure was recorded in the accounting records of any State agency in accordance with generally accepted accounting principles. [46 FR 3529, Jan. 15, 1981, as amended at 65 FR 33632, May 24, 2000] § 95.19 Exceptions to time limits. The time limits in §§ 95.7 and 95.10 do not apply to any of the following— (a) Any claim for an adjustment to prior year costs. (b) Any claim resulting from an audit exception. (c) Any claim resulting from a court- ordered retroactive payment. (d) Any claim for which the Sec- retary decides there was good cause for the State’s not filing it within the time limit. § 95.22 Meaning of good cause. (a) Good cause for the late filing of a claim is lateness due to circumstances beyond the State’s control. (b) Examples of circumstances be- yond the State’s control include: (1) Acts of God; (2) Documented action or inaction of the Federal government. (c) Circumstances beyond the State’s control do not include neglect or ad- ministrative inadequacy on the part of the State, State agencies, the State legislature or any of their offices, offi- cers, or employees. § 95.28 What a waiver request for good cause must includ ad- ministrative inadequacy on the part of the State, State agencies, the State legislature or any of their offices, offi- cers, or employees. § 95.28 What a waiver request for good cause must include. The State’s request for waiver must include a specific explanation, jus- tification or documentation of why the claim is or will be late. This request must establish that the lateness in fil- ing the claim is for good cause as de- fined in § 95.22 and not due to neglect or administrative the claim has not been filed, the State must also tell us when the claim will be filed. inadequacy. If § 95.31 Where to send a waiver request for good cause. (a) A request which affects the pro- gram(s) of only one HHS agency, CMS or ACF and does not affect the pro- grams of any other agency or Federal Department should be sent to the ap- propriate HHS agency. (b) A request which affects programs of more than one HHS agency or Fed- eral Department should be sent to the Director, Division of Cost Allocation in the appropriate HHS Regional Office. [46 FR 3529, Jan. 15, 1981, as amended at 75 FR 66336, Oct. 28, 2010] § 95.34 The decision to waive the time limit for good cause. The Secretary will make a ion in the appropriate HHS Regional Office. [46 FR 3529, Jan. 15, 1981, as amended at 75 FR 66336, Oct. 28, 2010] § 95.34 The decision to waive the time limit for good cause. The Secretary will make a decision after reviewing the State’s request for waiver. If the Secretary decides that good cause exists, the State will be no- tified of the extended due date. If the Secretary decides that good cause does not exist or that the request for waiver does not provide enough information to make a decision, the State will be so advised. Subparts B–D [Reserved] Subpart E—Cost Allocation Plans SOURCE: 47 FR 17509, Apr. 23, 1982, unless otherwise noted. § 95.501 Purpose. § 95.25 When to request a waiver for good cause. This subpart establishes require- ments for: The State should request a waiver in writing as soon as the State recognizes that it will be unable to submit a claim within the appropriate time limit. (a) Preparation, submission, and ap- proval of State agency cost allocation plans for public assistance programs; and 619 § 95.503 45 CFR Subtitle A (10–1–24 Edition) (b) Adherence to approved cost allo- cation plans in computing claims for Federal financial participation. § 95.503 S r public assistance programs; and 619 § 95.503 45 CFR Subtitle A (10–1–24 Edition) (b) Adherence to approved cost allo- cation plans in computing claims for Federal financial participation. § 95.503 Scope. This subpart applies to all State agency costs applicable to awards made under titles I, IV-A, IV-B, IV-C, IV-D, IV-E, X, XIV, XVI (AABD), XIX, and XXI, of the Social Security Act, and under the Refugee Act of 1980, title IV, Chapter 2 of the Immigration and Na- tionality Act (8 U.S.C. 1521 et seq.), and under title V of Pub. L. 96–422, the Ref- ugee Education Assistance Act of 1980. [65 FR 33633, May 24, 2000] § 95.505 Definitions. As used in this subpart: State agency costs include all costs in- curred by or allocable to the State agency except expenditures for finan- cial assistance, medical vendor pay- ments, and payments for services and goods provided directly to program re- cipients such as day care services, fam- ily planning services or household items as provided for under the ap- proved State program plan. Cost allocation plan means a narrative description of the procedures that the State agency will use in identifying, measuring, and allocating all State agency costs the ap- proved State program plan. Cost allocation plan means a narrative description of the procedures that the State agency will use in identifying, measuring, and allocating all State agency costs incurred in support of all programs administered or supervised by the State agency. FFP or Federal financial participation means the Federal Government’s share of expenditures made by a State agen- cy under any of the programs cited in § 95.503. Operating Divisions means the Depart- ment of Health and Human Services (HHS) organizational components re- sponsible for administering public as- sistance programs. These components are the Administration for Children and Families (ACF) and the Centers for Medicare & Medicaid Services (CMS). Public assistance programs means the programs cited in § 95.503. State means the 50 States, the Dis- trict of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Northern Mariana Islands, and Guam. State agency means the State agency administering or supervising the ad- ministration of the State plan for any program cited in § 95.503. A State agen- cy may be an organizational part of a larger State department that also con- tains other compo ng or supervising the ad- ministration of the State plan for any program cited in § 95.503. A State agen- cy may be an organizational part of a larger State department that also con- tains other components and agencies. Where that occurs, the expression State agency refers to the specific component or agency within the State department that is directly responsible for the ad- ministration of, or supervising the ad- ministration of, one or more programs identified in § 95.503. State Plan means a comprehensive written commitment by the State agency to administer or supervise the administration of any of the public as- sistance programs cited in § 95.503 in accordance with all Federal require- ments. [47 FR 17509, Apr. 23, 1982, as amended at 75 FR 66336, Oct. 28, 2010] § 95.507 Plan requirements. (a) The State shall submit a cost al- location plan for the State agency as required below to the Director, Divi- sion of Cost Allocation (DCA), in the approporiate HHS Regional Office. The plan shall: (1) Describe the procedures used to identify, measure, and allocate all costs to each of the programs operated by the State agency; (2) Conform to the accounting prin- ciples and standards pre shall: (1) Describe the procedures used to identify, measure, and allocate all costs to each of the programs operated by the State agency; (2) Conform to the accounting prin- ciples and standards prescribed in Of- fice of Management and Budget Cir- cular A–87, and other pertinent Depart- ment regulations and instructions; (3) Be compatible with the State plan for public assistance programs de- scribed in 45 CFR Chapter II, III and XIII, and 42 CFR Chapter IV Sub- chapters C and D; and (4) Contain sufficient information in such detail to permit the Director, Di- vision of Cost Allocation, after con- sulting with the Operating Divisions, to make an informed judgment on the correctness and fairness of the State’s procedures for identifying, measuring, and allocating all costs to each of the programs operated by the State agen- cy. (b) The cost allocation plan shall contain the following information: (1) An organizational chart showing the placement of each unit whose costs are charged to the programs operated by the State agency. 620 Dept. of Health and Human Services § 95.509 (2) A listing of all Federal and all non-Federal programs performed, ad- ministered, or serviced by these or the programs operated by the State agency. 620 Dept. of Health and Human Services § 95.509 (2) A listing of all Federal and all non-Federal programs performed, ad- ministered, or serviced by these organi- zational units. (3) A description of the activities per- formed by each organizational unit and, where not self-explanatory an ex- planation of the benefits provided to Federal programs. (4) The procedures used to identify, measure, and allocate all costs to each benefiting program and activity (in- cluding activities subject to different rates of FFP). (5) The estimated cost impact result- ing from the proposed changes to a pre- viously approved plan. These estimated costs are required solely to permit an evaluation of the procedures used for identifying, measuring, and allocating costs. Therefore, approval of the cost allocation plan shall not constitute ap- proval of these estimated costs for use in calculating claims for FFP. Where it is impractical to obtain this data, an alternative approach should then be negotiated with the Director, DCA, prior to submission of the cost alloca- tion plan. (6) A statement stipulating that wherever costs are claimed for services provided by ative approach should then be negotiated with the Director, DCA, prior to submission of the cost alloca- tion plan. (6) A statement stipulating that wherever costs are claimed for services provided by a governmental agency outside the State agency, that they will be supported by a written agree- ment that includes, at a minimum (i) the specific service(s) being purchased, (ii) the basis upon which the billing will be made by the provider agency (e.g. time reports, number of homes in- spected, etc.) and (iii) a stipulation that the billing will be based on the ac- tual cost incurred. This statement would not be required if the costs in- volved are specifically addressed in a State-wide cost allocation plan, local- wide cost allocation plan, or an um- brella/department cost allocation plan. (7) If the public assistance programs are administered by local government agencies under a State supervised sys- tem, the overall State agency cost al- location plan shall also include a cost allocation plan for the local agencies. It shall be developed in accordance with the requirements set forth above. More than one local agency plan shall be submitted if the accounting systems or other condit ion plan for the local agencies. It shall be developed in accordance with the requirements set forth above. More than one local agency plan shall be submitted if the accounting systems or other conditions at the local agen- cies preclude an equitable allocation of costs by the submission of a single plan for all local agencies. Prior to submit- ting multiple plans for local agencies, the State should consult with the Di- rector, DCA. Where more than one local agency plan is submitted, the State shall identify the specific local agencies covered by each plan. (8) A certification by a duly author- ized official of the State stating: (i) That the information contained in the proposed cost allocation plan was prepared in conformance with Office of Management and Budget Circular A–87. (ii) That the costs are accorded con- sistent treatment through the applica- tion of generally accepted accounting principles appropriate to the cir- cumstances. (iii) That an adequate accounting and statistical system exists to support claims that will be made under the cost allocation plan; and (iv) That the information provided in support of the proposed cost allocation plan is accurate. (9) Other infor al system exists to support claims that will be made under the cost allocation plan; and (iv) That the information provided in support of the proposed cost allocation plan is accurate. (9) Other information as is necessary to establish the validity of the proce- dures used to identify, measure, and al- locate costs to all programs being oper- ated by the State agency. [47 FR 17509, Apr. 23, 1982, as amended at 65 FR 33633, May 24, 2000] § 95.509 Cost allocation plan amend- ments and certifications. (a) The State shall promptly amend the cost allocation plan and submit the amended plan to the Director, DCA if any of the following events occur: because (1) The procedures shown in the ex- isting cost allocation plan become out- dated organizational changes, changes in Federal law or reg- ulations, or significant changes in pro- gram levels, affecting the validity of the approved cost allocation proce- dures. of (2) A material defect is discovered in the cost allocation plan by the Direc- tor, DCA or the State. (3) The State plan for public assist- ance programs is amended so as to af- fect the allocation of costs. (4) Other changes occur which make the allocation basis or procedures i tor, DCA or the State. (3) The State plan for public assist- ance programs is amended so as to af- fect the allocation of costs. (4) Other changes occur which make the allocation basis or procedures in the approval cost allocation plan in- valid. 621 § 95.511 45 CFR Subtitle A (10–1–24 Edition) (b) If a State has not submitted a plan or plan amendment during a given State fiscal year, an annual statement shall be submitted to the Director, DCA certifying that its approved cost allocation plan is not outdated. This statement shall be submitted within 60 days after the end of that fiscal year. § 95.511 Approval of the cost allocation plan or plan amendment. (a) The Director, DCA, after con- sulting with the affected Operating Di- visions, shall notify the State in writ- ing of his/her findings. This notifica- tion will be made within 60 days after receipt of the proposed plan or amend- ment and shall either: (1) Advise the State that the plan or plan amendment is approved or disapproved, (2) advise the State of the changes required to make the plan or amendment accept- able, or (3) request the State to provide additional to evaluate the proposed plan or amend- ment. If the DCA cannot (2) advise the State of the changes required to make the plan or amendment accept- able, or (3) request the State to provide additional to evaluate the proposed plan or amend- ment. If the DCA cannot make a deter- mination within the 60-day period, it shall so advise the State. information needed (b) For purpose of this subpart, State agency cost allocation plans which have been approved by an authorized official of the Department of HHS prior to the effective date of this regulation are considered approved until such time as a new plan or plan amendment is required by § 95.509(a). § 95.515 Effective date of a cost alloca- tion plan amendment. As a general rule, the effective date of a cost allocation plan amendment shall be the first day of the calendar quarter following the date of the event that required the amendment (See § 95.509). However, the effective date of the amendment may be earlier or later under the following conditions: (a) An earlier date is needed to avoid a significant inequity to either the State or the Federal Government. (b) The information provided by the State which was used to approve a pre- vious plan or plan amendment is later found to be materially inco ant inequity to either the State or the Federal Government. (b) The information provided by the State which was used to approve a pre- vious plan or plan amendment is later found to be materially incomplete or inaccurate, or the previously approved plan is later found to violate a Federal statute or regulation. In either situa- tion, the effective date of any required modification to the plan will be the same as the effective date of the plan or plan amendment that contained the defect. (c) It is impractical for the State to implement the amendment on the first day of the next calendar quarter. In these instances, a later date may be es- tablished by agreement between the State and the DCA. § 95.517 Claims for Federal financial participation. (a) A State must claim FFP for costs associated with a program only in ac- cordance with its approved cost alloca- tion plan. However, if a State has sub- mitted a plan or plan amendment for a State agency, it may, at its option claim FFP based on the proposed plan or plan amendment, unless otherwise advised by the DCA. However, where a State has claimed costs based on a pro- posed plan or plan amendment the State, if necessary, shall retroact the proposed plan or plan amendment, unless otherwise advised by the DCA. However, where a State has claimed costs based on a pro- posed plan or plan amendment the State, if necessary, shall retroactively adjust its claims in accordance with the plan or amendment as subse- quently approved by the Director, DCA. The State may also continue to claim FFP under its existing approved cost allocation plan for all costs not af- fected by the proposed amendment. § 95.519 Cost disallowance. If costs under a Public Assistance program are not claimed in accordance with the approved cost allocation plan (except as otherwise provided in § 95.517), or if the State failed to submit an amended cost allocation plan as re- quired by § 95.509, the costs improperly claimed will be disallowed. (a)(1) If the issue affects the pro- gram(s) of only one Operating Division and does not affect the programs of other Operating Divisions or Federal departments, that Operating Division will determine the amount of the dis- allowance and will also inform the State of its opportunity for reconsider- ation of the determination in accord- ance with the Operating Division’s pro- cedures. Prior to issuing the notific the dis- allowance and will also inform the State of its opportunity for reconsider- ation of the determination in accord- ance with the Operating Division’s pro- cedures. Prior to issuing the notifica- tion, however, the Operating Division shall consult with the DCA to ensure that the issue does not affect the pro- grams of other Operating Divisions or Federal departments. 622 Dept. of Health and Human Services § 95.605 (2) If the State wishes to request a re- consideration of the Operating Divi- sion’s determination, it must submit the request in accordance with the Op- erating Division’s procedures. (b) If the issue affects the programs of more than one Operating Division, or Federal department or the State, the Director, DCA, after consulting with the Operating Divisions, shall de- termine the amount inappropriately claimed under each program. The Di- rector, DCA will notify the State of this determination, of the dollar affect of the determination on the claims made under each program, and will in- form the State of its opportunity for appeal of the determination under 45 CFR part 16. The State will subse- quently be notified by the appropriate Operating Division as to the dis gram, and will in- form the State of its opportunity for appeal of the determination under 45 CFR part 16. The State will subse- quently be notified by the appropriate Operating Division as to the disposi- tion of the funds in question. [47 FR 17509, Apr. 23, 1982, as amended at 62 FR 38218, July 17, 1997] Subpart F—Automatic Data Proc- essing Equipment and Serv- for Federal ices—Conditions Financial Participation (FFP) SOURCE: 51 FR 45326, Dec. 18, 1986, unless otherwise noted. GENERAL § 95.601 Scope and applicability. This subpart prescribes part of the conditions under which the Depart- ment of Health and Human Services will approve the Federal Financial Par- ticipation (FFP) at the applicable rates for the costs of automated data proc- essing incurred under an approved State plan for titles IV–B, IV–D, IV–E, XIX or XXI of the Social Security Act. The conditions of approval of this sub- part add to the statutory and regu- latory requirements for acquisition of Automated Data Processing (ADP) equipment and services under the spec- ified titles of the Social Security Act. [75 FR 66336, Oct. 28, 2010] § 95.605 Definitions. As used in this part, the term: Acceptance documents means ing (ADP) equipment and services under the spec- ified titles of the Social Security Act. [75 FR 66336, Oct. 28, 2010] § 95.605 Definitions. As used in this part, the term: Acceptance documents means a record of satisfactory completion of an ap- proved phase of work or contract, and acceptance thereof by the State agen- cy. Acquisition means acquiring ADP equipment or services from commercial sources or from State or local govern- ment resources. Acquisition Checklist means the stand- ard Department checklist that States can submit to meet prior written ap- proval requirements instead of submit- ting the actual Request for Proposal (RFP), contracts or contract amend- ments. The Acquisition Checklist al- lows States to self-certify that their acquisition documents, which include RFPs, contracts, contract amendments or similar documents, meet State and requirements, Federal procurement contain appropriate language about software ownership and licensing rights in compliance with § 95.617, and provide access to documentation in compliance with § 95.615. Advance Planning Document (APD), Initial advance automated data proc- essing planning or Initial APD means a recorded plan of action t and provide access to documentation in compliance with § 95.615. Advance Planning Document (APD), Initial advance automated data proc- essing planning or Initial APD means a recorded plan of action to request fund- ing approval for a project which will require the use of ADP service or equipment. The term APD refers to a Planning APD, or to a planning and/or development and implementation ac- tion document, i.e., Implementation APD, or to an Advance Planning Docu- ment Update. Requirements are de- tailed in § 95.610, paragraphs (a), (b), and (c). Advance Planning Document Update (APDU) is a document or record sub- mitted annually (Annual APDU) to re- port project status and/or post imple- mentation cost-savings, or, on an as- needed (As-Needed APDU) basis, to re- quest funding approval for project con- tinuation when significant project changes are anticipated; for incre- mental funding authority and project continuation when approval is being granted by phase; or to provide de- tailed information on project and/or budget activities as in § 95.610(c). specified Alternative approach to APD require- ments means that the State has devel- oped an APD that does not meet all conditions d information on project and/or budget activities as in § 95.610(c). specified Alternative approach to APD require- ments means that the State has devel- oped an APD that does not meet all conditions for APD approval in § 95.610, resulting in the need for a waiver under § 95.627(a). 623 § 95.605 45 CFR Subtitle A (10–1–24 Edition) Automated data processing or ADP means data processing performed by a system of electronic or electrical ma- chines so interconnected and inter- acting as to minimize the need for human assistance or intervention. Automated data processing equipment or ADP equipment or Hardware means automatic equipment that accepts and stores data, performs calculations and other processing steps, and produces information. This includes: (a) Electronic digital computers; (b) Peripheral or auxiliary equipment used in support of electronic com- puters; (c) Data transmission or communica- tions equipment, and (d) Data input equipment. Automatic Data Processing Services or ADP Services means: (a) Services to operate ADP equip- ment, either by agency, or by State or local organizations other than the State agency; and/or (b) Services provided by private sources or by employee ervices means: (a) Services to operate ADP equip- ment, either by agency, or by State or local organizations other than the State agency; and/or (b) Services provided by private sources or by employees of the State agency or by State and local organiza- tions other than the State agency to perform such tasks as feasibility stud- ies, system studies, system design ef- forts, development of system specifica- tions, system analysis, programming, system conversion and system imple- mentation and include, for example, the following: (1) Systems Training, (2) Systems Development, (3) Site Preparation, (4) Data Entry, and (5) Personal services related to auto- mated systems development and oper- ations that are specifically identified as part of a Planning ADP or Implemen- tation ADP. As an example, a personal service would be the service of an ex- pert individual to provide advice on the use of ADP software or hardware in de- veloping a State automated manage- ment information system. Base contract means the initial con- tractual activity, including all option years, allowed during a defined unit of time, for example, 2 years. The base contract includes option years but does not include ontract means the initial con- tractual activity, including all option years, allowed during a defined unit of time, for example, 2 years. The base contract includes option years but does not include amendments. Commercial-off-the-shelf (COTS) soft- ware means proprietary software prod- ucts that are ready-made and available for sale to the general public at estab- lished catalog or market prices. Data processing means the prepara- tion of source media containing data or basic elements of information and the use of such source media according to precise rules or procedures to accom- plish such operations as classifying, sorting, calculating, summarizing, re- cording and transmitting. Department means the Department of Health and Human Service. Design or system design means a com- bination of narrative and diagrams de- scribing the structure of a new or more efficient automatic data processing system. This includes the use of hard- ware to the extent necessary for the design phase. Development means the definition of system requirements, detailing of sys- tem and program specifications, pro- gramming and testing. This includes the use of hardware to the extent nec- essary for the de lopment means the definition of system requirements, detailing of sys- tem and program specifications, pro- gramming and testing. This includes the use of hardware to the extent nec- essary for the development phase. Emergency situation is defined as a sit- uation where: (a) A State can demonstrate to the Department an immediate need to ac- quire ADP equipment or services in order to continue the operation of one or more of the Social Security Act pro- grams covered by Subpart F, and (b) The State can clearly document that the need could not have been an- ticipated or planned for and the State was prevented from following the prior approval requirements of § 95.611. Enhanced matching rate means the higher than regular rate of FFP au- thorized by Title IV-D, IV-E, and XIX of the Social Security Act for acquisi- tion of services and equipment that conform to specific requirements de- signed to improve administration of the Child Support Enforcement, Foster Care and Adoption Assistance, and Medicaid programs. Enhancement means modifications which change the functions of software and hardware beyond their original purposes, not just to correct errors or deficiencies which may have been nd Medicaid programs. Enhancement means modifications which change the functions of software and hardware beyond their original purposes, not just to correct errors or deficiencies which may have been present in the software or hardware, or to improve the operational perform- ance of the software or hardware. 624 Dept. of Health and Human Services § 95.605 Feasibility study means a preliminary study to determine whether it is suffi- ciently probable that effective and effi- cient use of ADP equipment or systems can be made to warrant a substantial investment of staff, time, and money being requested and whether the plan is capable of being accomplished suc- cessfully. Federal program office means the Fed- eral program office within the Depart- ment that is authorized to approve re- quests for the acquisition of ADP equipment or ADP services. The Fed- eral program offices within the Admin- istration for Children and Families (ACF) are the Children’s Bureau for ti- tles IV–B (child welfare services) and IV–E (foster care and adoption assist- ance), the Office of Child Support En- forcement for title IV–D (child support enforcement), and the Centers for Medicare & Medicaid Services (C re services) and IV–E (foster care and adoption assist- ance), the Office of Child Support En- forcement for title IV–D (child support enforcement), and the Centers for Medicare & Medicaid Services (CMS) for titles XIX (Medicaid) and XXI (the Children’s Health Insurance Program) of the Social Security Act. FFP means Federal financial partici- pation. Functional Requirements Specification is defined as an initial definition of the proposed system, which documents the goals, objectives, user or programmatic requirements, management require- ments, the operating environment, and the proposed design methodology, e.g., centralized or distributed. This docu- ment details what the new system and or hardware should do, not how it is to do it. The Specifications document shall be based upon a clear and accu- rate description of the functional re- quirements for the project, and shall not, in competitive procurements, lead to requirements which unduly restrict competition. The Specification docu- ment is the user’s definition of the re- quirements the system must meet. General Systems Design means a com- bination of narrative and graphic de- scription of the generic architecture of a system