if practicable, of the due date for submission of the appellee's brief. In the decision, the entity deciding the appeal may decline to review the case, affirm the initial decision or decision granting summary decision (with or without an opinion), or reverse the initial decision or decision granting summary decision, or increase, reduce, reverse, or remand any civil money penalty determined by the presiding officer in the initial decision. If the entity deciding the appeal declines to review the case, the initial decision or the decision granting summary decision shall constitute the final decision of FDA and shall be final and binding on the parties 30 days after the declination by the entity deciding the appeal.

(k) The standard of review on a disputed issue of fact is whether the initial decision is supported by substantial evidence on the whole record. The standard of review on a disputed issue of law is whether the initial decision is erroneous.

$17.48 Harmless error.

No error in either the admission or the exclusion of evidence, and no error or defect in any ruling or order or in any act done or omitted by the presiding officer or by any of the parties is grounds for vacating, modifying, or otherwise disturbing an otherwise appropriate ruling or order or act, unless refusal to take such action appears to the presiding officer or the Commissioner of Food and Drugs or other entity deciding the appeal (currently the DAB) to be inconsistent with substantial justice. The presiding officer and the entity deciding the appeal at every stage of the proceeding will disregard any error or defect in the proceeding that does not affect the substantial rights of the parties.

a petition for stay of such decision under §10.35 of this chapter.

(b) The Chief Counsel of FDA has been designated by the Secretary of Health and Human Services as the officer on whom copies of petitions for judicial review are to be served. This officer is responsible for filing the record on which the final decision is based. The record of the proceeding is certified by the entity deciding the appeal (currently the DAB).

(c) Exhaustion of an appeal to the entity deciding the appeal (currently the DAB) is a jurisdictional prerequisite to judicial review.

by, all Food and Drug Administration employees.

§ 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 Ethics and Program Integrity, 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 guidance documents 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; 55 FR 1404, Jan. 16, 1990; 65 FR 56479, Sept. 19, 2000]

Subpart B-Reporting of Violations

§ 19.21 Duty to report violations.

(a) The Office of Internal Affairs, Office 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 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 Office of Internal Affairs. Any such reports shall be in writing or shall with the assistance 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 relating to an investigation of such reports shall be maintained in strict confidence in the files of the Office of Internal Affairs, 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.

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, 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.

§ 19.55 Permanent disqualification of former employees.

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

[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]

Sec.

20.1

Testimony by Food and Drug Administration employees.

20.43 Waiver or reduction of fees. 20.44 Presubmission review of request for confidentiality of voluntarily submitted data or information.

20.45 Situations in which confidentiality is uncertain.

20.46 Judicial review of proposed disclosure. 20.47 Denial of a request for records. 20.48 Nonspecific and overly burdensome re

quests.

20.49 Referral to primary source of records. 20.50 Availability of records at National Technical Information Service. 20.51 Use of private contractor for copying. 20.52 Request for review without copying. 20.53 Indexing trade secrets and confidential commercial or financial information.

Subpart D-Exemptions

20.60 Applicability of exemptions. 20.61

Trade secrets and commercial or financial 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.

Administrative enforcement records.

20.102 Court enforcement records.

20.103 20.104

Correspondence.

Summaries of oral discussions. 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration.

20.106 Studies and reports prepared by or with funds provided by the Food and Drug Administration.

20.107 Food and Drug Administration manuals.

20.108 Agreements between the Food and Drug Administration and other departments, agencies, and organizations. 20.109 Data and information obtained by contract.

20.110 Data and information about Food and Drug Administration employees. 20.111 Data and information submitted voluntarily to the Food and Drug Administration.

20.112 Voluntary drug experience reports submitted by physicians and hospitals. 20.113 Voluntary product defect reports. 20.114 Data and information submitted pursuant to cooperative quality assurance agreements.

20.115 Product codes for manufacturing or sales dates.

20.116 Drug and device listing information. 20.117 New drug information. 20.118 Advisory committee records. 20.119 Lists of names and addresses.

AUTHORITY: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 2421, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.

SOURCE: 42 FR 15616, Mar. 22, 1977, unless otherwise noted.

Subpart A-Official Testimony and Information

§ 20.1 Testimony by Food and Drug Administration employees.

(a) No officer or employee of the Food and Drug Administration or of any other office or establishment in the Department of Health and Human Services, except as authorized by the Commissioner of Food and Drugs pursuant to this section or in the discharge of his official duties under the laws administered by the Food and Drug Administration, shall give any testimony before any tribunal pertaining to any function of the Food and Drug Administration or with respect to any information acquired in the discharge of his official duties.

(b) Whenever a subpoena, in appropriate form, has been lawfully served upon an officer or employee of the Food and Drug Administration commanding the giving of any testimony, such officer or employee shall, unless otherwise authorized by the Commissioner, appear in response thereto and respectfully decline to testify on the grounds that it is prohibited by this section.

(c) A person who desires testimony from any employee may make written request therefor, verified by oath, directed to the Commissioner setting forth his interest in the matter sought to be disclosed and designating the use to which such testimony will be put in the event of compliance with such request: Provided, That a written request therefor made by a health, food, or drug officer, prosecuting attorney, or member of the judiciary of any State, Territory, or political subdivision thereof, acting in his official capacity, need not be verified by oath. If it is determined by the Commissioner, or any other officer or employee of the Food and Drug Administration whom he may designate to act on his behalf for

the purpose, that such testimony will be in the public interest and will promote the objectives of the act and the agency, the request may be granted. Where a request for testimony is granted, one or more employees of the Food and Drug Administration may be designated to appear, in response to a subpoena, and testify with respect thereto.

§ 20.2 Production of records by Food and Drug Administration employ

ees.

(a) Any request for records of the Food and Drug Administration, whether it be by letter or by a subpena duces tecum or by any other writing, shall be handled pursuant to the procedures established in subpart B of this part, and shall comply with the rules governing public disclosure established in subparts C, D, E, and F of this part and in other regulations cross-referenced in § 20.100(c).

(b) Whenever a subpoena duces tecum, in appropriate form, has been lawfully served upon an officer or employee of the Food and Drug Administration commanding the production of any record, such officer or employee shall appear in response thereto, respectfully decline to produce the record on the ground that it is prohibited by this section, and state that the production of the record(s) involved will be handled by the procedures established in this part.

§ 20.3 Certification and authentication of Food and Drug Administration records.

(a) Upon request, the Food and Drug Administration will certify the authenticity of copies of records that are requested to be disclosed pursuant to this part or will authenticate copies of records previously disclosed.

(b) A request for certified copies of records or for authentication of records shall be sent in writing to the Freedom of Information Staff (HFI-35), Food and Drug Administration, Room 12A-16, 5600 Fishers Lane, Rockville, MD 20857.

[42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981]