Title 21

SECTION 20.120

20.120 Records available in Food and Drug Administration Public Reading Rooms.

§ 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.

(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.

[68 FR 25287, May 12, 2003; 68 FR 65392, Nov. 20, 2003, as amended at 76 FR 31470, June 1, 2011; 79 FR 68115, Nov. 14, 2014]