PART 5501—SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES Authority: 5 U.S.C. 301, 7301, 7353; 5 U.S.C. App. (Ethics in Government Act of 1978); 25 U.S.C. 450i(f); 42 U.S.C. 216; E.O. 12674, 54 FR 15159, 3 CFR, 1989 Comp., p. 215, as modified by E.O. 12731, 55 FR 42547, 3 CFR, 1990 Comp., p. 306; 5 CFR 2635.105, 2635.203, 2635.403, 2635.802, 2635.803. Source: 61 FR 39763, July 30, 1996, unless otherwise noted. § 5501.101 General. (a) Purpose. (b) Applicability. (c) Definitions. (1) Federally recognized Indian tribe or Alaska Native village or regional or village corporation et seq., (2) Significantly regulated organization [61 FR 39763, July 30, 1996, as amended at 70 FR 5558, Feb. 3, 2005; 70 FR 51568, Aug. 31, 2005] § 5501.102 Designation of HHS components as separate agencies. (a) Separate agency components of HHS. (1) Administration on Aging; (2) Administration for Children and Families: (3) Agency for Healthcare Research and Quality; (4) Agency for Toxic Substances and Disease Registry; (5) Centers for Disease Control and Prevention; (6) Centers for Medicare and Medicaid Services; (7) Food and Drug Administration; (8) Health Resources and Services Administration; (9) Indian Health Service; (10) National Institutes of Health; (11) Program Support Center; and (12) Substance Abuse and Mental Health Services Administration. (b) Definitions Employee of a component (2) Remainder of HHS (c) Applicability of separate agency designations. (1) Determining when a person is a prohibited source within the meaning of 5 CFR 2635.203(d) for purposes of applying: (i) The regulations at subpart B of 5 CFR part 2635 governing gifts from outside sources; and (ii) The regulations at § 5501.106 requiring prior approval of outside employment and other outside activities; and (iii) The regulations at § 5501.111 governing the receipt of awards by employees of the National Institutes of Health; and (2) Determining whether teaching, speaking or writing relates to the employee's official duties within the meaning of 5 CFR 2635.807(a)(2)(i). [61 FR 39763, July 30, 1996, as amended at 70 FR 5558, Feb. 3, 2005; 70 FR 51568, Aug. 31, 2005] § 5501.103 Gifts from federally recognized Indian tribes or Alaska Native villages or regional or village corporations. (a) Tribal or Alaska Native gifts. (b) Limitations on use of exception. [61 FR 39763, July 30, 1996, as amended at 70 FR 5558, Feb. 3, 2005] § 5501.104 Prohibited financial interests applicable to employees of the Food and Drug Administration. (a) General prohibition. (b) Exceptions. (1) An employee or spouse or minor child of an employee may have a financial interest, such as a pension or other employee benefit, arising from employment with a significantly regulated organization. Note to paragraph ( b FDA employees who file public or confidential financial disclosure reports pursuant to 5 CFR part 2634, as opposed to spouses and minor children of such employees, are generally prohibited under § 5501.106(c)(3) from engaging in current employment with a significantly regulated organization. (2) An employee who is not required to file a public or confidential financial disclosure report pursuant to 5 CFR part 2634, or the spouse or minor child of such employee, may hold a financial interest in a significantly regulated organization if: (i) The total cost or value, measured at the time of acquisition, of the combined interests of the employee and the employee's spouse and minor children in the regulated organization is equal to or less than the de minimis (ii) The holding, if it represents an equity interest, constitutes less than 1 percent of the total outstanding equity of the organization; and (iii) The total holdings in significantly regulated organizations account for less than 50 percent of the total value of the combined investment portfolios of the employee and the employee's spouse and minor children. (3) An employee or spouse or minor child of an employee may have an interest in a significantly regulated organization that constitutes any interest in a publicly traded or publicly available investment fund (e.g., a mutual fund), or a widely held pension or similar fund, which, in the literature it distributes to prospective and current investors or participants, does not indicate the objective or practice of concentrating its investments in significantly regulated organizations, if the employee neither exercises control nor has the ability to exercise control over the financial interests held in the fund. (4) In cases involving exceptional circumstances, the Commissioner or the Commissioner's designee may grant a written exception to permit an employee, or the spouse or minor child of an employee, to hold a financial interest in a significantly regulated organization based upon a determination that the application of the prohibition in paragraph (a) of this section is not necessary to ensure public confidence in the impartiality or objectivity with which HHS programs are administered or to avoid a violation of part 2635 of this title. Note to paragraph ( b With respect to any excepted financial interest, employees are reminded of their obligations under 5 CFR part 2635, and specifically their obligation under subpart D of part 5501 to disqualify themselves from participating in any particular matter in which they, their spouses or minor children have a financial interest arising from publicly traded securities that exceeds the de minimis (c) Reporting and divestiture. [61 FR 39763, July 30, 1996, as amended at 70 FR 5558, Feb. 3, 2005] § 5501.105 Exemption for otherwise disqualifying financial interests derived from Indian or Alaska Native birthrights. (a) Under 18 U.S.C. 208(b)(4), an employee who otherwise would be disqualified may participate in a particular matter where the otherwise disqualifying financial interest that would be affected results solely from the interest of the employee, or the employee's spouse or minor child, in birthrights: (1) In an Indian tribe, band, nation, or other organized group or community, including any Alaska Native village corporation as defined in or established pursuant to the Alaska Native Claims Settlement Act, which is recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians; (2) In an Indian allotment the title to which is held in trust by the United States or which is inalienable by the allottee without the consent of the United States; or (3) In an Indian claims fund held in trust or administered by the United States. (b) The exemption described in paragraph (a) of this section applies only if the particular matter does not involve the Indian allotment or claims fund or the Indian tribe, band, nation, organized group or community, or Alaska Native village corporation as a specific party or parties. § 5501.106 Outside employment and other outside activities. (a) Applicability. (b) Definitions. (1) Compensation (2) Consultative services (3) Professional services (c) Prohibited outside employment and activities Prohibited assistance in the preparation of grant applications or contract proposals. (2) Prohibited employment in HHS-funded activities. (3) Prohibited outside activities applicable to employees of the Food and Drug Administration. (i) Engage in any self-employed business activity for which the sale or promotion of FDA-regulated products is expected to constitute ten percent or more of annual gross sales or revenues; or (ii) Engage in employment, as defined in 5 CFR 2635.603(a), whether or not for compensation, with a significantly regulated organization, as defined in § 5501.101(c)(2), unless the employment meets either of the following exceptions: (A) The employment consists of the practice of medicine, dentistry, veterinary medicine, pharmacy, nursing, or similar practices, provided that the employment does not involve substantial unrelated non-professional duties, such as personnel management, contracting and purchasing responsibilities (other than normal “out-of-stock” requisitioning), and does not involve employment by a medical product manufacturer in the conduct of biomedical research; or (B) The employment primarily involves manual or unskilled labor or utilizes talents, skills, or interests in areas unrelated to the substantive programmatic activities of the FDA, such as clerical work, retail sales, service industry jobs, building trades, maintenance, or similar services. (4) Prohibited outside practice of law applicable to attorneys in the Office of the General Counsel. (A) Assert a legal position that is or appears to be in conflict with the interests of the Department of Health and Human Services, the client to which the attorney owes a professional responsibility; or (B) Interpret any statute, regulation or rule administered or issued by the Department. (ii) Exceptions. (A) Acting, with or without compensation, as an agent or attorney for, or otherwise representing, the employee's parents, spouse, child, or any person for whom, or for any estate for which, the employee is serving as guardian, executor, administrator, trustee, or other personal fiduciary to the extent permitted by 18 U.S.C. 203 and 205, or from providing advice or counsel to such persons or estate; or (B) Acting, without compensation, as an agent or attorney for, or otherwise representing, any person who is the subject of disciplinary, loyalty, or other personnel administration proceedings in connection with those proceedings to the extent permitted by 18 U.S.C. 205, or from providing uncompensated advice or counsel to such person; or (C) Giving testimony under oath or from making statements required to be made under penalty for perjury or contempt. (iii) Specific approval procedures. (B) The exception to 18 U.S.C. 205 described in paragraph (c)(4)(ii)(B) of this section does not apply unless the employee has obtained the approval of a supervisory official who has authority to determine whether the employee's proposed representation of another person in a personnel administration matter is consistent with the faithful performance of the employee's duties. (d) Prior approval for outside employment and other outside activities General approval requirement. (i) Provide consultative or professional services, including service as an expert witness; (ii) Engage in teaching, speaking, writing, or editing that: (A) Relates to the employee's official duties within the meaning of 5 CFR 2635.807(a)(2)(i)(B) through (E); or (B) Would be undertaken as a result of an invitation to engage in the activity that was extended to the employee by a person or organization that is a prohibited source within the meaning of 5 CFR 2635.203(d), as modified by the separate HHS component agency designations in § 5501.102; or (iii) Provide services to a non-Federal entity as an officer, director, or board member, or as a member of a group, such as a planning commission, advisory council, editorial board, or scientific or technical advisory board or panel, which requires the provision of advice, counsel, or consultation. (2) Additional approval requirement for employees of the Food and Drug Administration and the National Institutes of Health. (3) Exceptions to prior approval requirements. (A) The activity or the position held in the organization requires the provision of professional services within the meaning of paragraph (b)(3) of this section; or (B) The activity is performed for compensation other than the reimbursement of expenses. (ii) Notwithstanding the requirements of paragraphs (d)(1) and (d)(2) of this section, prior approval is not required for participation in an employment or other outside activity that has been exempted under paragraph (d)(7) of this section. (4) Submission of requests for approval. (ii) All requests for prior approval shall include the following information: (A) The employee's name, contact information, organizational location, occupational title, grade, step, salary, appointment type, and financial disclosure filing status; (B) The nature of the proposed outside employment or other outside activity, including a full description of the specific duties or services to be performed; (C) A description of the employee's official duties that relate to the proposed activity; (D) A description of how the employee's official duties will affect the interests of the person for whom or organization with which the proposed activity will be performed; (E) The name and address of the person for whom or organization with which the work or activity will be done, including the location where the services will be performed; (F) A statement as to whether travel is involved and, if so, whether the transportation, lodging, meals, or per diem will be at the employee's expense or provided by the person for whom or organization with which the work or activity will be done, and a description of the arrangements and an estimate of the costs of items to be furnished or reimbursed by the outside entity; (G) The estimated total time that will be devoted to the activity. If the proposed outside activity is to be performed on a continuing basis, a statement of the estimated number of hours per year; for other employment, a statement of the anticipated beginning and ending date; (H) A statement as to whether the work can be performed entirely outside of the employee's regular duty hours and, if not, the estimated number of hours and type of leave that will be required; (I) The method or basis of any compensation to be received (e.g., fee, honorarium, retainer, salary, advance, royalty, stock, stock options, non-travel related expenses, or other form of remuneration tendered in cash or in-kind in connection with the proposed activity) from the person for whom or organization with which the work or activity will be done; (J) The amount of any compensation to be received from the person for whom or organization with which the work or activity will be done; (K) The amount and date of any compensation received, or due for services performed, within the current and previous six calendar years immediately preceding the submission of the request for approval from the person for whom or organization with which the work or activity will be done (including any amount received or due from an agent, affiliate, parent, subsidiary, or predecessor of the proposed payor); (L) A statement as to whether the compensation is derived from an HHS grant, contract, cooperative agreement, or other source of HHS funding or attributed to services related to an activity funded by HHS, regardless of the specific source of the compensation; (M) For activities involving the provision of consultative or professional services, a statement indicating whether the client, employer, or other person on whose behalf the services are performed is receiving, or intends to seek, an HHS grant, contract, cooperative agreement, or other funding relationship; (N) For activities involving teaching, speaking, or writing, a syllabus, outline, summary, synopsis, draft or similar description of the content and subject matter involved in the course, speech, or written product (including, if available, a copy of the text of any speech) and the proposed text of any disclaimer required by 5 CFR 2635.807(b)(2) or by the instructions or manual issuances authorized under paragraph (d)(6) of this section; and (O) Such other relevant information that the designated agency ethics official or, with the concurrence of the designated agency ethics official, each of the separate agency components of HHS listed in § 5501.102(a) determines is necessary or appropriate in order to evaluate whether a proposed activity is likely to involve conduct prohibited by statute or Federal regulations, including 5 CFR part 2635 and this part. (5) Standard for approval. Note: The granting of approval for an outside activity does not relieve the employee of the obligation to abide by all applicable laws governing employee conduct nor does approval constitute a sanction of any violation. Approval involves an assessment that the general activity as described on the submission does not appear likely to violate any criminal statutes or other ethics rules. Employees are reminded that during the course of an otherwise approvable activity, situations may arise, or actions may be contemplated, that, nevertheless, pose ethical concerns. Example 1: A clerical employee with a degree in library science volunteers to work on the acquisitions committee at a local public library. Serving on a panel that renders advice to a non-Federal entity is subject to prior approval. Because recommending books for the library collection normally would not pose a conflict with the typing duties assigned the employee, the request would be approved. Example 2: While serving on the library acquisitions committee, the clerical employee in the preceding example is asked to help the library business office locate a missing book order. Shipment of the order is delayed because the publisher has declared bankruptcy and its assets, including inventory in the warehouse, have been frozen to satisfy the claims of the Internal Revenue Service and other creditors. The employee may not contact the Federal bankruptcy trustee to seek, on behalf of the public library, the release of the books. Even though the employee's service on the acquisitions committee had been approved, a criminal statute, 18 U.S.C. 205, would preclude any representation by a Federal employee of an outside entity before a Federal court or agency with respect to a matter in which the United States is a party or has a direct and substantial interest. (6) Duration of approval. (7) Responsibilities of the designated agency ethics official and component agencies. (ii) HHS components may specify internal procedures governing the submission of prior approval requests and designate appropriate officials to act on such requests. The instructions or manual issuances may include examples of outside employment and other outside activities that are permissible or impermissible consistent with 5 CFR part 2635 and this part. With respect to teaching, speaking, writing, or editing activities, the instructions or manual issuances may specify preclearance procedures and/or require disclaimers indicating that the views expressed do not necessarily represent the views of the agency or the United States. (iii) The officials within the respective HHS components who are responsible for the administrative aspects of these regulations and the maintenance of records shall make provisions for the filing and retention of requests for approval of outside employment and other outside activities and copies of the notification of approval or disapproval. (e) Waivers. [61 FR 39763, July 30, 1996, as amended at 70 FR 5558, Feb. 3, 2005; 70 FR 51568, Aug. 31, 2005] § 5501.107 Teaching, speaking and writing by special Government employees in the Public Health Service. (a) Applicability. (b) Permissible compensation. § 5501.108 Exception to the prohibition against assisting in the prosecution of claims against, or acting as an agent or attorney before, the Government, applicable only to employees assigned to federally recognized Indian tribes or Alaska Native villages or regional or village corporations pursuant to the Intergovernmental Personnel Act. (a) 18 U.S.C. 205. (b) Exception applicable only to employees assigned to federally recognized Indian tribes or Alaska Native villages or regional or village corporations pursuant to the Intergovernmental Personnel Act. § 5501.109 Prohibited outside activities applicable to employees of the National Institutes of Health. (a) Applicability. (b) Definitions. (1) Compensation (2) Continuing professional education (3) Data and safety monitoring board (4) Educational activity provider (5) Employment (6) Grand rounds (7) Grant or scientific review committee (8) Health care provider or insurer (9) Scientific peer review (10) Substantially affected organization (i) A biotechnology or pharmaceutical company; a medical device manufacturer; or a corporation, partnership, or other enterprise or entity significantly involved, directly or through subsidiaries, in the research, development, or manufacture of biotechnological, biostatistical, pharmaceutical, or medical devices, equipment, preparations, treatments, or products; (ii) Any organization a majority of whose members are described in paragraph (b)(10)(i) of this section; and (iii) Any other organization determined by the designated agency ethics official or, in consultation with the designated agency ethics official, by the NIH Director or the NIH Director's designee that is substantially affected by the programs, policies, or operations of the NIH. (11) Supported research institution (i) Is, or within the last year has been, an applicant for or recipient of an NIH grant, cooperative agreement, or research and development contract; (ii) Is, or within the last year has been, a proposer of or party to a cooperative research and development agreement (CRADA) with the NIH; or (iii) Any organization a majority of whose members are described in paragraphs (b)(11)(i) or (ii) of this section. (12) Unrestricted educational grant (i) Selects or recommends the moderators, speakers, or presenters at the sponsored event; (ii) Independently provides additional funding to the moderators, speakers, or presenters in connection with the educational activity; (iii) Determines or recommends the audience composition; (iv) Specifies or recommends the topics to be addressed, or (v) Controls or recommends the planning, content, or implementation of the program in a manner inconsistent with guidelines established by a relevant professional association or accrediting organization that are designed to ensure that such activities are accurate, balanced, educational, free from commercial bias, nonpromotional, and independent of the influence of the funding source. (13) Unrestricted financial contribution (i) Selects or recommends the author, reviewer, referee, or editor; (ii) Independently provides additional funding to the author, reviewer, referee, or editor in connection with the writing or editing activity; (iii) Determines or recommends the targeted audience of the writing or editing activity; (iv) Specifies or recommends the topics to be addressed, or (v) Controls or recommends the planning, content, or distribution of the written or edited product in a manner inconsistent with ethical guidelines commonly accepted within the relevant research community for disseminating scientific information which are designed to ensure that such writing or editing is accurate, unbiased, nonpromotional, transparent with respect to disclosure of potential conflicts, and independent of the influence of the funding source. (c) Prohibitions Prohibited outside activities with substantially affected organizations, supported research institutions, and health care providers or insurers. (i) Engage in employment with a substantially affected organization, a supported research institution, or a health care provider or insurer; (ii) Teach, speak, write, or edit for compensation for any substantially affected organization, supported research institution, or health care provider or insurer; or (iii) Engage in any employment or self-employed business activity that involves the sale or promotion of products or services of a substantially affected organization or a health care provider or insurer, except for the purpose of commercializing invention rights obtained by the employee pursuant to Executive Order 10096, 15 U.S.C. 3710d, or implementing regulations. (2) General exception. (3) Specific exceptions. (i) Teaching. (A) Teaching a course requiring multiple presentations as permitted under 5 CFR 2635.807(a)(3); or (B) Delivering a class lecture that is unrelated to the employee's official duties within the meaning of 5 CFR 2635.807 if the activity is performed as part of a regularly scheduled course offered under the established curriculum of an institution of higher education as defined at 20 U.S.C. 1001. (ii) Clinical, medical, or health-related professional practice. (A) The provision of health-related professional services to such individuals is not part of any ongoing research project conducted or funded by the NIH; (B) The employee does not establish a private practice relationship with a current or recently discharged NIH patient or subject of an NIH-conducted or NIH-funded clinical trial or protocol; (C) The employee does not personally refer private practice patients to the NIH; and (D) The professional practice does not involve substantial unrelated non-professional duties, such as personnel management, contracting and purchasing responsibilities (other than “out-of-stock” requisitioning), and does not involve employment by a medical product manufacturer in the conduct of biomedical research. (iii) Clerical, retail, service industry, building trades, maintenance, or similar services. (iv) Continuing professional education. (v) Authorship of writings subjected to scientific peer review or a substantially equivalent editorial review process. (vi) Data and safety monitoring boards. (A) The members of the DSMB are not selected or paid for their service by a substantially affected organization; (B) The clinical study is not funded under a grant, cooperative agreement, or research and development contract from, or conducted pursuant to a cooperative research and development agreement (CRADA) with, or aided under another funding mechanism by, the NIH; and (C) If the service is performed for compensation, the service does not entail prohibited assistance in the preparation of documents intended for submission to HHS within the meaning of § 5501.106(c)(1), and the clinical study is not an HHS-funded activity described in § 5501.106(c)(2). (vii) Grand rounds. (A) The employee's presentation includes an interactive component, such as visiting patients or discussing individual clinical cases, or interacting for educational purposes with undergraduates, graduates, or post-graduate students and fellows, in addition to any lecture; (B) The audience is composed primarily of faculty and students or trainees registered in a biomedical or health-related program of studies; and (C) A substantially affected organization or a speakers' bureau affiliated with a substantially affected organization does not sponsor or underwrite the costs of the Grand Rounds program or the employee's presentation, except pursuant to an unrestricted educational grant. (viii) Grant or scientific review committee. (A) The members of the grant or scientific review committee are not selected or paid for their service by a substantially affected organization; (B) The grant award or program in relation to which the recommendation of the grant or scientific review committee is sought is not funded under a grant, cooperative agreement, or research and development contract from, conducted pursuant to a cooperative research and development agreement (CRADA) with, or aided under another funding mechanism by, the NIH; and (C) If the service is performed for compensation, the service does not entail prohibited assistance in the preparation of documents intended for submission to HHS within the meaning of § 5501.106(c)(1), and the grant award or program in relation to which the recommendation of the grant or scientific review committee is sought is not an HHS-funded activity described in § 5501.106(c)(2). [70 FR 5560, Feb. 3, 2005, as amended at 70 FR 51569, Aug. 31, 2005] § 5501.110 Prohibited financial interests applicable to senior employees of the National Institutes of Health. (a) Applicability. (b) Definitions. (1) Senior employee (2) Substantially affected organization (c) Prohibition applicable to senior employees. (d) Exceptions for certain financial interests. (1) Pension or other employee benefit. Note to paragraph ( d NIH employees, as opposed to spouses and minor children of employees, are generally prohibited under § 5501.109 from engaging in current employment with a substantially affected organization. (2) De minimis holdings. (i) The aggregate market value of the combined interests of the senior employee and the senior employee's spouse and minor children in any one substantially affected organization is equal to or less than the de minimis (ii) The holding, if it represents an equity interest, constitutes less than 1 percent of the total outstanding equity of the organization; and (iii) The total holdings in substantially affected organizations and sector mutual funds that, in the literature they distribute to prospective and current investors or participants, state the objective or practice of concentrating their investments in the securities of substantially affected organizations account for less than 50 percent of the total value of the combined investment portfolios of the senior employee and the senior employee's spouse and minor children. (3) Diversified mutual funds. (4) Exceptional circumstances. (5) Technology transfer. (6) Sector mutual funds. (ii) A senior employee or spouse or minor child of a senior employee may have an interest in a substantially affected organization that constitutes any interest in a sector mutual fund that, in the literature it distributes to prospective and current investors or participants, states the objective or practice of concentrating its investments in the securities of substantially affected organizations provided that: (A) The aggregate market value of the combined ownership interests of the senior employee and the senior employee's spouse and minor children in such sector funds is equal to or less than the de minimis (B) The total holdings in substantially affected organizations and in sector mutual funds that, in the literature they distribute to prospective and current investors or participants, state the objective or practice of concentrating their investments in the securities of substantially affected organizations account for less than 50 percent of the total value of the combined investment portfolios of the senior employee and the senior employee's spouse and minor children. Note to paragraph ( d With respect to any excepted financial interest, employees are reminded of their obligations under 5 CFR part 2635, and specifically their obligation under subpart D to disqualify themselves from participating in any particular matter in which they, their spouses or minor children have a financial interest arising from publicly traded securities that exceeds the de minimis (e) Reporting and divestiture. [70 FR 5562, Feb. 3, 2005, as amended at 70 FR 51571, Aug. 31, 2005] § 5501.111 Awards tendered to employees of the National Institutes of Health. (a) Applicability. (b) Definitions. (c) Additional limitations on awards to employees of the National Institutes of Health. (1) Limitations applicable to employees with official responsibility for matters affecting an award donor. (i) Is seeking official action from the employee, any subordinate of the employee, or any agency component or subcomponent under the employee's official responsibility; (ii) Does business or seeks to do business with any agency component or subcomponent under the employee's official responsibility; (iii) Conducts activities substantially affected by the programs, policies, or operations of any agency component or subcomponent under the employee's official responsibility; or (iv) Is an organization a majority of whose members are described in paragraphs (c)(1)(i) through (iii) of this section. (2) Prior approval of awards (ii) Approval shall be granted only upon a determination that acceptance of the award is not prohibited by statute or Federal regulation, including 5 CFR part 2635 and this part. Note to paragraph ( c In some circumstances cash and other things of value provided in connection with the provision of personal services, including speaking or writing, may be compensation, not a gift. Other ethics rules governing outside activities may restrict receipt of such compensation. See, for example, 5 CFR 2635.807. (d) Exception. (1) There is a determination by the NIH Director (or the Secretary, with respect to awards tendered to the NIH Director) that acceptance of the gift will further an agency interest because it confers an exceptionally high honor in the fields of medicine or scientific research. The following criteria will be considered in making such a determination: (i) The identity of the awarding organization; (ii) The longevity of the awards program; (iii) The source of award funds; (iv) The size of the monetary component of the award recognition; (v) The identity and credentials of past award recipients; (vi) The degree of publicity attendant to receipt of the award; and (vii) The impact of the substantive contribution being recognized; (2) Absent the prohibition in paragraph (c)(1) of this section, the gift would be permitted under part 2635 of this title; and (3) The designated agency ethics official shall have determined that the application of the prohibition in paragraph (c)(1) of this section is not necessary to ensure public confidence in the impartiality or objectivity with which NIH programs are administered or to avoid a violation of part 2635 of this title. (e) Disposition of improperly accepted awards Failure to obtain prior approval. (2) Receipt of prohibited award. (i) Reject the award and instruct the donor to strike the honoree's name from any list of award recipients; (ii) Remove the recognition from the employee's résumé or curriculum vitae; (iii) Return any tangible indicia of the recognition to the donor; and (iv) Forfeit the award by returning it to the donor. [70 FR 5563, Feb. 3, 2005, as amended at 70 FR 51572, Aug. 31, 2005] § 5501.112 One-year disqualification of employees of the National Institutes of Health from certain matters involving an award donor. An employee, other than a special Government employee, of the National Institutes of Health who has, within the last year, accepted an award permitted under 5 CFR 2635.204(d) or § 5501.111 shall not participate in any particular matter involving specific parties in which the donor is or represents a party unless authorized to do so under 5 CFR 2635.502(d). [70 FR 5564, Feb. 3, 2005]