Source: http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&r=PART&n=21y1.0.1.1.16
Timestamp: 2014-11-26 21:30:30
Document Index: 175365264

Matched Legal Cases: ['§20', '§20', '§20', '§20', '§20', '§21', 'art 21', '§21', '§20', '§20', '§20']

§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 Division of Freedom of Information at the address located on the agency's web site at http://www.fda.gov.
§20.26 Indexes of certain records.(a) Indexes shall be maintained, and revised at least quarterly, for the following Food and Drug Administration records:(1) Final orders published in the FEDERAL REGISTER with respect to every denial or withdrawal of approval of a new drug application or a new animal drug application for which a public hearing has been requested.(2) Statements of policy and interpretation adopted by the agency and still in force and not published in the Federal Register.(3) Administrative staff manuals and instructions to staff that affect a member of the public.(4) Records that have been released to any person in response to a Freedom of Information request and that the agency has determined have become, or are likely to become, the subject of subsequent requests for substantially the same records.(b) Each such index will be made available by accessing the agency's web site at http://www.fda.gov. A printed copy of each index is available by writing or visiting the Freedom of Information Staff's address on the agency's web site at http://www.fda.gov.
§20.30 Food and Drug Administration Division of Freedom of Information.(a) The office responsible for Agency compliance with the Freedom of Information Act and this part is the Division of Freedom of Informationat the address located on the agency's web site at http://www.fda.gov.(b) All requests for Agency records shall be sent in writing to this office.
§20.40 Filing a request for records.(a) All requests for Food and Drug Administration records shall be made in writing by mailing or delivering the request to the Freedom of Information Staff at the address on the agency's web site at http://www.fda.gov or by faxing it to the fax number listed on the agency's web site at http://www.fda.gov. All requests must contain the postal address and telephone number of the requester and the name of the person responsible for payment of any fees that may be charged.(b) A request for Food and Drug Administration records shall reasonably describe the records being sought, in a way that they can be identified and located. A request should include all pertinent details that will help identify the records sought.(1) If the description is insufficient to locate the records requested, the Food and Drug Administration will so notify the person making the request and indicate the additional information needed to identify the records requested.(2) Every reasonable effort shall be made by the Food and Drug Administration to assist in the identification and location of the records sought.(c) Upon receipt of a request for records, the Division of Freedom of Information shall enter it in a public log. The log shall state the date received, the name of the person making the request, the nature of the record requested, the action taken on the request, the date of determination letter sent pursuant to §20.41(b), and the date(s) any records are subsequently furnished.(d) A request by an individual, as defined in §21.3(a) of this chapter, for a record about himself shall be subject to:(1) The special requirements of part 21 of this chapter (the privacy regulations), and not to the provisions of this subpart, if the record requested is retrieved by the individual's name or other personal identifier and is contained in a Privacy Act Record System, as defined in §21.3(c) of this chapter.(2) The provisions of this subpart if the record requested is not retrieved by the individual's name or other personal identifier, whether or not the record is contained in a Privacy Act Record System.
§20.107 Food and Drug Administration manuals.(a) Food and Drug Administration administrative staff manuals and instructions that affect a member of the public are available for public disclosure. An index of all such manuals is available by writing to the Division of Freedom of Informationat the address located on the agency's web site at http://www.fda.gov.; or by visiting the Division of Freedom of Information Public Reading Room, located in rm. 1050, at the same address. The index and all manuals created by the agency on or after November 1, 1996, will be made available through the Internet at http://www.fda.gov.(b) Manuals relating solely to internal personnel rules and practices are not available for public disclosure except to the extent that the Commissioner determines that they should be disclosed pursuant to §20.82.(c) All Food and Drug Administration action levels which are used to determine when the agency will take regulatory action against a violative product, limits of sensitivity and variability of analytical methods which are used in determining whether a product violates the law, and direct reference levels above which Food and Drug Administration field offices may request legal action directly to the office of the General Counsel, are available for public disclosure.
§20.120 Records available in Food and Drug Administration Public Reading Rooms.(a) The Freedom of Information Staff and the Division of Dockets Management Public Reading Room are located at the same address. Both are located in rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. The telephone number for the Division of Docket Management is 301-827-6860; the telephone number for the Freedom of Information Staff's Public Reading Room is located at the address on the agency's web site at http://www.fda.gov. Both public reading rooms are open from 9 a.m. to 4 p.m., Monday through Friday, excluding legal public holidays.(b) The following records are available at the Division of Freedom of Information Public Reading Room:(1) A guide for making requests for records or information from the Food and Drug Administration;(2) Administrative staff manuals and instructions to staff that affect a member of the public;(3) Food and Drug Administration records which have been released to any person in response to a Freedom of Information request and which the agency has determined have become or are likely to become the subject of subsequent requests for substantially the same records;(4) Indexes of records maintained in the Division of Freedom of Information Public Reading Room; and(5) Such other records and information as the agency determines are appropriate for inclusion in the public reading room.(c) The following records are available in the Division of Dockets Management's Public Reading Room:(1) Final opinions, including concurring and dissenting opinions, as well as orders, made in the adjudication of cases;(2) Statements of policy and interpretation adopted by the agency that are still in force and not published in the Federal Register;(3) Indexes of records maintained in the Division of Dockets Management's Public Reading Room; and(4) Such other records and information as the agency determines are appropriate for inclusion in the public reading room.(d) The agency will make reading room records created by the Food and Drug Administration on or after November 1, 1996, available electronically through the Internet at the agency's World Wide Web site which can be found at http://www.fda.gov. At the agency's discretion, the Food and Drug Administration may also make available through the Internet such additional records and information it believes will be useful to the public.