2001 CFR Title 21, Volume 1

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 20--PUBLIC INFORMATION
	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.
	20.40	Filing a request for records.
	20.41	Time limitations.
	20.42	Fees to be charged.
	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 requests.
	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.
	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.
	20.80	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.