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Title 21 - Food and Drugs
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 20 - PUBLIC INFORMATION
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| 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. | ||
| 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 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. | ||
| 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. | ||
| 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. | ||
| 20-65 | National defense and foreign policy. | ||
| 20-66 | Internal personnel rules and practices. | ||
| 20-67 | Records exempted by other statutes. | ||
| 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. | ||
| 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 Food and Drug Administration Public Reading Rooms. | ||