under § 16.40 be the presiding officer, notwithstanding paragraph (c)(1) of this section. If accepted, as a matter of discretion, by the Commissioner or the delegate, the request is binding upon the party making the request. (3) A different presiding officer may be substituted for the one originally designated under § 16.22 without notice to the parties. [44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989] § 16.44 Communication to presiding officer and Commissioner. (a) Regulatory hearings are not subject to the separation of functions rules in § 10.55. (b) Those persons who are directly involved in the investigation or presentation of the position of FDA or any party at a regulatory hearing that is required by the act or a regulation should avoid any off-the-record communication on the matter to the presiding officer or the Commissioner or their advisors if the communication is inconsistent with the requirement of § 16.95(b)(1) that the administrative record be the exclusive record for decision. If any communication of this type occurs, it is to be reduced to writing and made part of the record, and the other party provided an opportunity to respond. (c) A copy of any letter or memorandum of meeting between a participant in the hearing and the presiding officer or the Commissioner, e.g., a response by the presiding officer to a request for a change in the time of the hearing, is to be sent to all participants by the person writing the letter or the memorandum. Subpart D-Procedures for 8 16.60 Hearing procedure. (a) A regulatory hearing is public, except when the Commissioner determines that all or part of a hearing should be closed to prevent a clearly unwarranted invasion of personal privacy; to prevent the disclosure of a trade secret or confidential commercial or financial information that is not available for public disclosure under § 20.61; or to protect investigatory records complied for law enforcement purposes that are not available for public disclosure under § 20.64. (1) The Commissioner may determine that a regulatory hearing is closed either on the Commissioner's initiative or on a request by the party asking for a regulatory hearing, in the request for the hearing. (2) If the hearing is a private hearing, no persons other than the party requesting the hearing, counsel and witnesses, and an employee or consultant or other person subject to a commercial arrangement as defined in § 20.81(a) and FDA representatives with a direct professional interest in the subject matter of the proceeding are entitled to attend. (3) If the hearing is a public hearing, it will be announced on the public calendar described in § 10.100(a) whenever feasible, and any interested person who attends the hearing may participate to the extent of presenting relevant information. (b) A regulatory hearing will be conducted by a presiding officer. Employees of FDA will first give a full and complete statement of the action which is the subject of the hearing, together with the information and reasons supporting it, and may present any oral or written information relevant to the hearing. The party requesting the hearing may then present any oral or written information relevant to the hearing. All parties may confront and conduct reasonable cross-examination of any person (except for the presiding officer and counsel for the parties) who makes any statement on the matter at the hearing. (c) The hearing is informal in nature, and the rules of evidence do not apply. No motions or objections relating to the admissibility of information and views will be made or considered, but any other party may comment upon or rebut all such data, information, and views. (d) The presiding officer may order the hearing to be transcribed. The party requesting the hearing may have the hearing transcribed, at the party's expense, in which case a copy of the transcript is to be furnished to FDA. Any transcript of the hearing will be included with the presiding officer's report of the hearing. (e) The presiding officer shall prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. Whenever time permits, the parties to the hearing will be given the opportunity to review and comment on the presiding officer's report of the hearing. (f) The presiding officer shall include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and shall include a recommended decision, with a statement of reasons, unless the Commissioner directs otherwise. (g) The presiding officer has the power to take such actions and make such rulings as are necessary or appropriate to maintain order and to conduct a fair, expeditious, and impartial hearing, and to enforce the requirements of this part concerning the conduct of hearings. The presiding officer may direct that the hearing be conducted in any suitable manner permitted by law and these regulations. (h) The Commissioner or the presiding officer has the power under § 10.19 to suspend, modify, or waive any provision of this part. § 16.62 Right to counsel. Any party to a hearing under this part has the right at all times to be advised and accompanied by counsel. Subpart E-Administrative Record and Decision § 16.80 Administrative record of a regulatory hearing. (a) The administrative record of the regulatory hearing consists of the following: (1) The notice of opportunity for hearing and the response. (2) All written information and views submitted to the presiding officer at the hearing or after if specifically permitted by the presiding officer. (3) Any transcript of the hearing. Part 20 governs the availability for public disclosure of each document that is a part of the administrative record of a regulatory hearing. § 16.95 Administrative decision and record for decision. (a) With respect to a regulatory hearing at the Commissioner's initiative under § 16.1(a), the Commissioner shall consider the administrative record of the hearing specified in § 16.80(a) together with all other relevant information and views available to FDA in determining whether regulatory action should be taken and, if so, in what form. (b) With respect to a regulatory hearing required by the act or a regulation under § 16.1(b)— (1) The administrative record of the hearing specified in § 16.80(a) constitutes the exclusive record for decision; (2) On the basis of the administrative record of the hearing, the Commissioner shall issue a written decision stating the reasons for the Commissioner's administrative action and the basis in the record; and (3) For purposes of judicial review under § 10.45, the record of the administrative proceeding consists of the record of the hearing and the Commissioner's decision. 19.5 Reference to Department regulations. 19.6 Code of ethics for government service. 19.10 Food and Drug Administration Conflict 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: Sec. 701(a), 52 Stat. 1055 (21 U.S.C. 371(a)); 21 CFR 5.10. SOURCE: 42 FR 15615, Mar. 22, 1977, unless otherwise noted. Subpart A-General Provisions 8 19.1 Scope. This part governs the standards of conduct for, and establishes regulations to prevent conflicts of interest by, all Food and Drug Administration employees. 8 19.5 Reference to Department regulations. (a) The provisions of 45 CFR Part 73, establishing standards of conduct for all Department employees, are fully applicable to all Food and Drug Administration employees, except that such regulations shall be applicable to special government employees, i.e., consultants to the Food and Drug Administration, 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 Administration employees: CODE OF ETHICS FOR GOVERNMENT SERVICE Any person in Government service should: 1. Put loyalty to the highest moral principles and to country above loyalty to persons, 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 accomplished. 5. Never discriminate unfairly by the dispensing of special favors or privileges to anyone, whether for remuneration or not; and never accept, for himself or his family, favors or benefits under circumstances which might be construed by reasonable persons as influencing the performance of his governmental 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 Government, either directly or indirectly, which is inconsistent with the conscientious performance 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 review and make recommendations to the Commissioner on all specific or policy matters relating to conflicts of interest arising within the Food and Drug Administration that are forwarded to it by: (1) The Associate Commissioner for Management and Operations or (2) anyone who is the subject of an adverse determination by the Associate Commissioner for Management and Operations on any matter arising under the conflict of interest laws, except a determination of an apparent violation of law. The Director, Division of Human Resources Management, Office of Management and Operations, shall serve as executive secretary of the Review 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 interest is raised, or who otherwise wishes to have any such matter resolved, to forward the matter to the Associate Commissioner for Management and Operations for resolution, except that reporting of apparent violations of law are governed by § 19.21. (c) All general policy relating to conflicts of interest shall be established in guidelines pursuant to the provisions of § 10.90(b) of this chapter and whenever feasible shall be incorporated 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 Freedom of Information Staff, 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 written in a way that does not identify the individual in the following situations: (1) A determination that an employee must dispose of prohibited financial interests or refrain from incompatible outside activities in accordance with established Department or agency regulations. (2) A determination that a proposed consultant is not eligible for employment by the agency. (3) A determination that public disclosure of any information would constitute an unwarranted invasion of personal 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] Subpart B-Reporting of Violations § 19.21 Duty to report violations. (a) The Division of Ethics and Program Integrity, Office of Management and Operations, 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 Administration employee who has factual information showing or who otherwise believes 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 information directly to the Division of Ethics and Program Integrity. Any such reports shall be in writing or shall with the assistance of the Division of Ethics and Program Integrity, be reduced to writing, and shall be promptly investigated. (c) Any report pursuant to paragraph (b) of this section and any records relating to an investigation of such reports shall be maintained in strict confidence in the files of the Division of Ethics and Program Integrity, shall be exempt from public disclosure, and may be reviewed only by authorized Food and Drug Administration employees who are required 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] Subpart C-Disqualification Conditions 8 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, including a special government employee, shall appear personally before the Food and Drug Administration or other federal agency or court as agent or attorney 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 termination of such responsibility. The term "official responsibility" means the direct administrative or operating authority, whether intermediate or final, and either exercisable alone or with others, and either personally or through subordinates, to approve, disapprove, or otherwise direct government action. No former Food and Drug Administration 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 substantially through decision, approval, disapproval, 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 Administration 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. |