Standards of conduct and conflicts of interest (21 CFR 19.1-19.55)

248 21 CFR Ch. I (4–1–16 Edition) § 17.54 § 17.54 Deposit in the Treasury of the United States. All amounts assessed pursuant to this part shall be delivered to the Di rector, Division of Financial Manage ment (HFA–100), Food and Drug Ad ministration, rm. 11–61, 5600 Fishers Lane, Rockville, MD 20857, and shall be deposited as miscellaneous receipts in the Treasury of the United States. PART 19—STANDARDS OF CON DUCT AND CONFLICTS OF INTER EST Subpart A—General Provisions Sec. 19.1 Scope. 19.5 Reference to Department regulations. 19.6 Code of ethics for government service. 19.10 Food and Drug Administration Con flict of Interest Review Board. Subpart B—Reporting of Violations 19.21 Duty to report violations. Subpart C—Disqualification Conditions 19.45 Temporary disqualification of former employees. 19.55 Permanent disqualification of former employees. AUTHORITY: 21 U.S.C. 371. SOURCE: 42 FR 15615, Mar. 22, 1977, unless otherwise noted. Subpart A—General Provisions § 19.1 Scope. This part governs the standards of conduct for, and establishes regula tions to prevent conflicts of interest by, all Food and Drug Administration employees. § 19.5 Reference to Department regula tions. (a) The provisions of 45 CFR part 73, establishing standards of conduct for all Department employees, are fully applicable to all Food and Drug Admin istration employees, except that such regulations shall be applicable to spe cial government employees, i.e., con sultants to the Food and Drug Admin istration, only to the extent stated in subpart L of 45 CFR part 73. (b) The provisions of 45 CFR part 73a supplement the Department standards of conduct and apply only to Food and Drug Administration employees except special government employees. § 19.6 Code of ethics for government service. The following code of ethics, adopted by Congress on July 11, 1958, shall apply to all Food and Drug Administra tion employees: CODE OF ETHICS FOR GOVERNMENT SERVICE Any person in Government service should: 1. Put loyalty to the highest moral prin ciples and to country above loyalty to per sons, party, or Government department. 2. Uphold the Constitution, laws, and legal regulations of the United States and of all governments therein and never be a party to their evasion. 3. Give a full day’s labor for a full day’s pay; giving to the performance of his duties his earnest effort and best thought. 4. Seek to find and employ more efficient and economical ways of getting tasks accom plished. 5. Never discriminate unfairly by the dis pensing of special favors or privileges to any one, whether for remuneration or not; and never accept, for himself or his family, fa vors or benefits under circumstances which might be construed by reasonable persons as influencing the performance of his govern mental duties. 6. Make no private promises of any kind binding upon the duties of office, since a Government employee has no private word which can be binding on public duty. 7. Engage in no business with the Govern ment, either directly or indirectly, which is inconsistent with the conscientious perform ance of his governmental duties. 8. Never use any information coming to him confidentially in the performance of governmental duties as a means for making private profit. 9. Expose corruption wherever discovered. 10. Uphold these principles, ever conscious that public office is a public trust. § 19.10 Food and Drug Administration Conflict of Interest Review Board. (a) The Commissioner shall establish a permanent five-member Conflict of Interest Review Board, which shall re view and make recommendations to the Commissioner on all specific or policy matters relating to conflicts of interest arising within the Food and VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00258 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 249 Food and Drug Administration, HHS § 19.45 Drug Administration that are for warded to it by: (1) The Associate Com missioner for Management and Oper ations or (2) anyone who is the subject of an adverse determination by the As sociate Commissioner for Management and Operations on any matter arising under the conflict of interest laws, ex cept a determination of an apparent violation of law. The Director, Division of Ethics and Program Integrity, Office of Management and Operations, shall serve as executive secretary of the Re view Board. (b) It shall be the responsibility of every Food and Drug Administration employee with whom any specific or policy issue relating to conflicts of in terest is raised, or who otherwise wish es to have any such matter resolved, to forward the matter to the Associate Commissioner for Management and Op erations for resolution, except that re porting of apparent violations of law are governed by § 19.21. (c) All general policy relating to con flicts of interest shall be established in guidance documents pursuant to the provisions of § 10.90(b) of this chapter and whenever feasible shall be incor porated in regulations in this subpart. (d) All decisions relating to specific individuals shall be placed in a public file established for this purpose by the Division of Freedom of Information, e.g., a determination that a consultant may serve on an advisory committee with specific limitations or with public disclosure of stock holdings, except that such determination shall be writ ten in a way that does not identify the individual in the following situations: (1) A determination that an employee must dispose of prohibited financial in terests or refrain from incompatible outside activities in accordance with established Department or agency reg ulations. (2) A determination that a proposed consultant is not eligible for employ ment by the agency. (3) A determination that public dis closure of any information would con stitute an unwarranted invasion of per sonal privacy in violation of § 20.63 of this chapter. [42 FR 15615, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 50 FR 52278, Dec. 23, 1985; 55 FR 1404, Jan. 16, 1990; 65 FR 56479, Sept. 19, 2000; 76 FR 31469, June 1, 2011] Subpart B—Reporting of Violations § 19.21 Duty to report violations. (a) The Office of Internal Affairs, Of fice of the Commissioner, is responsible for obtaining factual information for the Food and Drug Administration on any matter relating to allegations of misconduct, impropriety, conflict of interest, or other violations of Federal statutes by agency personnel. (b) Any Food and Drug Administra tion employee who has factual infor mation showing or who otherwise be lieves that any present or former Food and Drug Administration employee has violated or is violating any provision of this subpart or of 45 CFR parts 73 or 73a or of any statute listed in appendix A to 45 CFR part 73 should report such in formation directly to the Office of In ternal Affairs. Any such reports shall be in writing or shall with the assist ance of the Office of Internal Affairs, be reduced to writing, and shall be promptly investigated. (c) Any report pursuant to paragraph (b) of this section and any records re lating to an investigation of such re ports shall be maintained in strict con fidence in the files of the Office of In ternal Affairs, shall be exempt from public disclosure, and may be reviewed only by authorized Food and Drug Ad ministration employees who are re quired to do so in the performance of their duties. [42 FR 15615, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 50 FR 52278, Dec. 23, 1985; 60 FR 47478, Sept. 13, 1995] Subpart C—Disqualification Conditions § 19.45 Temporary disqualification of former employees. Within 1 year after termination of employment with the Food and Drug Administration, no former Food and Drug Administration employee, includ ing a special government employee, VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00259 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 250 21 CFR Ch. I (4–1–16 Edition) § 19.55 shall appear personally before the Food and Drug Administration or other fed eral agency or court as agent or attor ney for any person other than the United States in connection with any proceeding or matter in which the United States is a party or has a direct and substantial interest and which was under his official responsibility at any time within one year preceding termi nation of such responsibility. The term official responsibility means the direct administrative or operating authority, whether intermediate or final, and ei ther exercisable alone or with others, and either personally or through subor dinates, to approve, disapprove, or oth erwise direct government action. § 19.55 Permanent disqualification of former employees. No former Food and Drug Adminis tration employee, including a special government employee, shall knowingly act as agent or attorney for anyone other than United States in connection with any judicial or other proceeding, application, request for a ruling or other determination, contract, claim, controversy, charge, accusation, or other particular matter involving a specific party or parties in which the United States is a party or has a direct and substantial interest and in which he participated personally and substan tially through decision, approval, dis approval, recommendation, rendering of advice, investigation, or otherwise as a Food and Drug Administration employee. PART 20—PUBLIC INFORMATION Subpart A—Official Testimony and Information Sec. 20.1 Testimony by Food and Drug Adminis tration employees. 20.2 Production of records by Food and Drug Administration employees. 20.3 Certification and authentication of Food and Drug Administration records. Subpart B—General Policy 20.20 Policy on disclosure of Food and Drug Administration records. 20.21 Uniform access to records. 20.22 Partial disclosure of records. 20.23 Request for existing records. 20.24 Preparation of new records. 20.25 Retroactive application of regulations. 20.26 Indexes of certain records. 20.27 Submission of records marked as con fidential. 20.28 Food and Drug Administration deter minations of confidentiality. 20.29 Prohibition on withdrawal of records from Food and Drug Administration files. 20.30 Food and Drug Administration Free dom of Information Staff. 20.31 Retention schedule of requests for Food and Drug Administration records. 20.32 Disclosure of Food and Drug Adminis tration employee names. 20.33 Form or format of response. 20.34 Search for records. Subpart C—Procedures and Fees 20.40 Filing a request for records. 20.41 Time limitations. 20.42 Aggregation of certain requests. 20.43 Multitrack processing. 20.44 Expedited processing. 20.45 Fees to be charged. 20.46 Waiver or reduction of fees. 20.47 Situations in which confidentiality is uncertain. 20.48 Judicial review of proposed disclosure. 20.49 Denial of a request for records. 20.50 Nonspecific and overly burdensome re quests. 20.51 Referral to primary source of records. 20.52 Availability of records at National Technical Information Service. 20.53 Use of private contractor for copying. 20.54 Request for review without copying. 20.55 Indexing trade secrets and confidential commercial or financial information. Subpart D—Exemptions 20.60 Applicability of exemptions. 20.61 Trade secrets and commercial or fi nancial information which is privileged or confidential. 20.62 Inter- or intra-agency memoranda or letters. 20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal pri vacy. 20.64 Records or information compiled for law enforcement purposes. 20.65 National defense and foreign policy. 20.66 Internal personnel rules and practices. 20.67 Records exempted by other statutes. Subpart E—Limitations on Exemptions 20.80 Applicability of limitations on exemp tions. 20.81 Data and information previously dis closed to the public. 20.82 Discretionary disclosure by the Com missioner. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00260 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B