[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR20.1] [Page 216-218] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 20_PUBLIC INFORMATION--Table of Contents Subpart A_Official Testimony and Information Sec. 20.1 Testimony by Food and Drug Administration employees. 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. [[Page 217]] 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 confidential. 20.28 Food and Drug Administration determinations of confidentiality. 20.29 Prohibition on withdrawal of records from Food and Drug Administration files. 20.30 Food and Drug Administration Freedom of Information Staff. 20.31 Retention schedule of requests for Food and Drug Administration records. 20.32 Disclosure of Food and Drug Administration 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 requests. 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 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 privacy. 20.64 Records or information compiled for law enforcement purposes. Subpart E_Limitations on Exemptions 20.80 Applicability of limitations on exemptions. 20.81 Data and information previously disclosed to the public. 20.82 Discretionary disclosure by the Commissioner. 20.83 Disclosure required by court order. 20.84 Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees. 20.85 Disclosure to other Federal government departments and agencies. 20.86 Disclosure in administrative or court proceedings. 20.87 Disclosure to Congress. 20.88 Communications with State and local government officials. 20.89 Communications with foreign government officials. 20.90 Disclosure to contractors. 20.91 Use of data or information for administrative or court enforcement action. Subpart F_Availability of Specific Categories of Records 20.100 Applicability; cross-reference to other regulations. 20.101 Administrative enforcement records. 20.102 Court enforcement records. 20.103 Correspondence. 20.104 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. 20.120 Records available in Feed and Drug Administration Public Reading Rooms. 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, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1. Source: 42 FR 15616, Mar. 22, 1977, unless otherwise noted. [[Page 218]] (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.