{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where part_number = 99 sorted by section_id", "rows": [["14:14:2.0.1.3.16.1.9.1", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "A", "Subpart A\u2014General", "", "\u00a7 99.1 Applicability.", "FAA", "", "", "[Docket 25113, 53 FR 18217, May 20, 1988, as amended by Amdt. 99-14, 53 FR 44182, Nov. 2, 1988; 66 FR 49822, Sept. 28, 2001; 69 FR 16755, Mar. 30, 2004]", "(a) This subpart prescribes rules for operating all aircraft (except for Department of Defense and law enforcement aircraft) in a defense area, or into, within, or out of the United States through an Air Defense Identification Zone (ADIZ) designated in subpart B.\n\n(b) Except for \u00a7\u00a7 99.7, 99.13, and 99.15 this subpart does not apply to the operation of any aircraft-\n\n(1) Within the 48 contiguous States and the District of Columbia, or within the State of Alaska, on a flight which remains within 10 nautical miles of the point of departure;\n\n(2) Operating at true airspeed of less than 180 knots in the Hawaii ADIZ or over any island, or within 12 nautical miles of the coastline of any island, in the Hawaii ADIZ;\n\n(3) Operating at true airspeed of less than 180 knots in the Alaska ADIZ while the pilot maintains a continuous listening watch on the appropriate frequency; or\n\n(4) Operating at true airspeed of less than 180 knots in the Guam ADIZ.\n\n(c) An FAA ATC center may exempt the following operations from this subpart (except \u00a7 99.7) on a local basis only, with the concurrence of the U.S. military commanders concerned, or pursuant to an agreement with a U.S. Federal security or intelligence agency:\n\n(1) Aircraft operations that are conducted wholly within the boundaries of an ADIZ and are not currently significant to the air defense system.\n\n(2) Aircraft operations conducted in accordance with special procedures prescribed by a U.S. military authority, or a U.S. Federal security or intelligence agency concerned."], ["14:14:2.0.1.3.16.1.9.10", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "A", "Subpart A\u2014General", "", "\u00a7 99.17 Deviation from flight plans and ATC clearances and instructions.", "FAA", "", "", "[69 FR 16756, Mar. 30, 2004]", "(a) No pilot may deviate from the provisions of an ATC clearance or ATC instruction except in accordance with \u00a7 91.123 of this chapter.\n\n(b) No pilot may deviate from the filed IFR flight plan when operating an aircraft in uncontrolled airspace unless that pilot notifies an appropriate aeronautical facility before deviating.\n\n(c) No pilot may deviate from the filed DVFR flight plan unless that pilot notifies an appropriate aeronautical facility before deviating."], ["14:14:2.0.1.3.16.1.9.11", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "A", "Subpart A\u2014General", "", "\u00a7\u00a7 99.19-99.31 [Reserved]", "FAA", "", "", "", ""], ["14:14:2.0.1.3.16.1.9.2", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "A", "Subpart A\u2014General", "", "\u00a7 99.3 Definitions.", "FAA", "", "", "[Docket FAA-2001-10693, 66 FR 49822, Sept. 28, 2001, as amended at 69 FR 16755, Mar. 30, 2004]", "Aeronautical facility  means, for the purposes of this subpart, a communications facility where flight plans or position reports are normally filed during flight operations.\n\nAir defense identification zone  (ADIZ) means an area of airspace over land or water in which the ready identification, location, and control of all aircraft (except for Department of Defense and law enforcement aircraft) is required in the interest of national security.\n\nDefense area  means any airspace of the contiguous United States that is not an ADIZ in which the control of aircraft is required for reasons of national security.\n\nDefense visual flight rules  (DVFR) means, for the purposes of this subpart, a flight within an ADIZ conducted by any aircraft (except for Department of Defense and law enforcement aircraft) in accordance with visual flight rules in part 91 of this title."], ["14:14:2.0.1.3.16.1.9.3", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "A", "Subpart A\u2014General", "", "\u00a7 99.5 Emergency situations.", "FAA", "", "", "", "In an emergency that requires immediate decision and action for the safety of the flight, the pilot in command of an aircraft may deviate from the rules in this part to the extent required by that emergency. He shall report the reasons for the deviation to the communications facility where flight plans or position reports are normally filed (referred to in this part as \u201can appropriate aeronautical facility\u201d) as soon as possible."], ["14:14:2.0.1.3.16.1.9.4", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "A", "Subpart A\u2014General", "", "\u00a7 99.7 Special security instructions.", "FAA", "", "", "[69 FR 16756, Mar. 30, 2004]", "Each person operating an aircraft in an ADIZ or Defense Area must, in addition to the applicable rules of this part, comply with special security instructions issued by the Administrator in the interest of national security, pursuant to agreement between the FAA and the Department of Defense, or between the FAA and a U.S. Federal security or intelligence agency."], ["14:14:2.0.1.3.16.1.9.5", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "A", "Subpart A\u2014General", "", "\u00a7 99.9 Radio requirements.", "FAA", "", "", "[Docket FAA-2001-10693, 66 FR 49822, Sept. 28, 2001, as amended at 69 FR 16756, Mar. 30, 2004]", "(a) A person who operates a civil aircraft into an ADIZ must have a functioning two-way radio, and the pilot must maintain a continuous listening watch on the appropriate aeronautical facility's frequency.\n\n(b) No person may operate an aircraft into, within, or whose departure point is within an ADIZ unless\u2014\n\n(1) The person files a DVFR flight plan containing the time and point of ADIZ penetration, and\n\n(2) The aircraft departs within five minutes of the estimated departure time contained in the flight plan.\n\n(c) If the pilot operating an aircraft under DVFR in an ADIZ cannot maintain two-way radio communications, the pilot may proceed, in accordance with original DVFR flight plan, or land as soon as practicable. The pilot must report the radio failure to an appropriate aeronautical facility as soon as possible.\n\n(d) If a pilot operating an aircraft under IFR in an ADIZ cannot maintain two-way radio communications, the pilot must proceed in accordance with \u00a7 91.185 of this chapter."], ["14:14:2.0.1.3.16.1.9.6", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "A", "Subpart A\u2014General", "", "\u00a7 99.11 ADIZ flight plan requirements.", "FAA", "", "", "[Docket 25113, 53 FR 18217, May 20, 1988; 53 FR 44182, Nov. 2, 1988, as amended by Amdt. 99-15, 54 FR 34331, Aug. 18, 1989; 66 FR 49822, Sept. 28, 2001; 69 FR 16756, Mar. 30, 2004]", "(a) No person may operate an aircraft into, within, or from a departure point within an ADIZ, unless the person files, activates, and closes a flight plan with the appropriate aeronautical facility, or is otherwise authorized by air traffic control.\n\n(b) Unless ATC authorizes an abbreviated flight plan\u2014\n\n(1) A flight plan for IFR flight must contain the information specified in \u00a7 91.169; and\n\n(2) A flight plan for VFR flight must contain the information specified in \u00a7 91.153(a) (1) through (6).\n\n(3) If airport of departure is within the Alaskan ADIZ and there is no facility for filing a flight plan then:\n\n(i) Immediately after takeoff or when within range of an appropriate aeronautical facility, comply with provisions of paragraph (b)(1) or (b)(2) as appropriate.\n\n(ii) Proceed according to the instructions issued by the appropriate aeronautical facility.\n\n(c) The pilot shall designate a flight plan for VFR flight as a DVFR flight plan.\n\n(d) The pilot in command of an aircraft for which a flight plan has been filed must file an arrival or completion notice with an appropriate aeronautical facility."], ["14:14:2.0.1.3.16.1.9.7", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "A", "Subpart A\u2014General", "", "\u00a7 99.12 [Reserved]", "FAA", "", "", "", ""], ["14:14:2.0.1.3.16.1.9.8", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "A", "Subpart A\u2014General", "", "\u00a7 99.13 Transponder-on requirements.", "FAA", "", "", "[Docket 24903, 55 FR 8395, Mar. 7, 1990. Redesignated at 69 FR 16756, Mar. 30, 2004]", "(a)  Aircraft transponder-on operation.  Each person operating an aircraft into or out of the United States into, within, or across an ADIZ designated in subpart B of this part, if that aircraft is equipped with an operable radar beacon transponder, shall operate the transponder, including altitude encoding equipment if installed, and shall reply on the appropriate code or as assigned by ATC.\n\n(b)  ATC transponder equipment and use.  Effective September 7, 1990, unless otherwise authorized by ATC, no person may operate a civil aircraft into or out of the United States into, within, or across the contiguous U.S. ADIZ designated in subpart B of this part unless that aircraft is equipped with a coded radar beacon transponder.\n\n(c)  ATC transponder and altitude reporting equipment and use.  Effective December 30, 1990, unless otherwise authorized by ATC, no person may operate a civil aircraft into or out of the United States into, within, or across the contiguous U.S. ADIZ unless that aircraft is equipped with a coded radar beacon transponder and automatic pressure altitude reporting equipment having altitude reporting capability that automatically replies to interrogations by transmitting pressure altitude information in 100-foot increments.\n\n(d) Paragraphs (b) and (c) of this section do not apply to the operation of an aircraft which was not originally certificated with an engine-driven electrical system and which has not subsequently been certified with such a system installed, a balloon, or a glider."], ["14:14:2.0.1.3.16.1.9.9", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "A", "Subpart A\u2014General", "", "\u00a7 99.15 Position reports.", "FAA", "", "", "[69 FR 16756, Mar. 30, 2004]", "(a) The pilot of an aircraft operating in or penetrating an ADIZ under IFR\u2014\n\n(1) In controlled airspace, must make the position reports required in \u00a7 91.183; and\n\n(2) In uncontrolled airspace, must make the position reports required in this section.\n\n(b) No pilot may operate an aircraft penetrating an ADIZ under DVFR unless\u2014\n\n(1) The pilot reports to an appropriate aeronautical facility before penetration: the time, position, and altitude at which the aircraft passed the last reporting point before penetration and the estimated time of arrival over the next appropriate reporting point along the flight route;\n\n(2) If there is no appropriate reporting point along the flight route, the pilot reports at least 15 minutes before penetration: The estimated time, position, and altitude at which the pilot will penetrate; or\n\n(3) If the departure airport is within an ADIZ or so close to the ADIZ boundary that it prevents the pilot from complying with paragraphs (b)(1) or (2) of this section, the pilot must report immediately after departure: the time of departure, the altitude, and the estimated time of arrival over the first reporting point along the flight route.\n\n(c) In addition to any other reports as ATC may require, no pilot in command of a foreign civil aircraft may enter the United States through an ADIZ unless that pilot makes the reports required in this section or reports the position of the aircraft when it is not less that one hour and not more that 2 hours average direct cruising distance from the United States."], ["14:14:2.0.1.3.16.2.9.1", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "B", "Subpart B\u2014Designated Air Defense Identification Zones", "", "\u00a7 99.41 General.", "FAA", "", "", "[69 FR 16756, Mar. 30, 2004]", "The airspace above the areas described in this subpart is established as an ADIZ. The lines between points described in this subpart are great circles except that the lines joining adjacent points on the same parallel of latitude are rhumb lines."], ["14:14:2.0.1.3.16.2.9.2", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "B", "Subpart B\u2014Designated Air Defense Identification Zones", "", "\u00a7 99.43 Contiguous U.S. ADIZ.", "FAA", "", "", "[Docket FAA-2001-10693, 66 FR 49822, Sept. 28, 2001. Redesignated at 69 FR 16756, Mar. 30, 2004]", "The area bounded by a line from 43\u00b015\u2032 N, 65\u00b055\u2032W; 44\u00b021\u2032 N; 67\u00b016\u2032W; 43\u00b010\u2032 N; 69\u00b040\u2032W; 41\u00b005\u2032 N; 69\u00b040\u2032W; 40\u00b032\u2032 N; 72\u00b015\u2032W; 39\u00b055\u2032 N; 73\u00b000\u2032W; 39\u00b038\u2032 N; 73\u00b000\u2032W; 39\u00b036\u2032 N; 73\u00b040\u2032W; 37\u00b000\u2032 N; 75\u00b030\u2032W; 36\u00b010\u2032 N; 75\u00b010\u2032W; 35\u00b010\u2032 N; 75\u00b010\u2032W; 32\u00b000\u2032 N; 80\u00b030\u2032W; 30\u00b030\u2032 N; 81\u00b000\u2032W; 26\u00b040\u2032 N; 79\u00b040\u2032W; 25\u00b000\u2032 N; 80\u00b005\u2032W; 24\u00b025\u2032 N; 81\u00b015\u2032W; 24\u00b020\u2032 N; 81\u00b045\u2032W; 24\u00b030\u2032 N; 82\u00b006\u2032W; 24\u00b041\u2032 N; 82\u00b006\u2032W; 24\u00b043\u2032 N; 82\u00b000\u2032W; 25\u00b000\u2032 N; 81\u00b030\u2032W; 25\u00b010\u2032 N; 81\u00b023\u2032W; 25\u00b035\u2032 N; 81\u00b030\u2032W; 26\u00b015\u2032 N 82\u00b020\u2032W; 27\u00b050\u2032 N; 83\u00b005\u2032W; 28\u00b055\u2032 N; 83\u00b030\u2032W; 29\u00b042\u2032 N; 84\u00b000\u2032W; 29\u00b020\u2032 N; 85\u00b000\u2032W; 30\u00b000\u2032 N; 87\u00b010\u2032W; 30\u00b000\u2032 N; 88\u00b030\u2032W; 28\u00b045\u2032 N; 88\u00b055\u2032W; 28\u00b045\u2032 N; 90\u00b000\u2032W; 29\u00b025\u2032 N; 94\u00b000\u2032W; 28\u00b020\u2032 N; 96\u00b000\u2032W; 27\u00b030\u2032 N; 97\u00b000\u2032W; 26\u00b000\u2032 N; 97\u00b000\u2032W; 25\u00b058\u2032 N; 97\u00b007\u2032W; westward along the U.S./Mexico border to 32\u00b032\u203203\u2033 N, 117\u00b007\u203225\u2033 W; 32\u00b030\u2032 N; 117\u00b025\u2032W; 32\u00b035\u2032 N; 118\u00b030\u2032W; 33\u00b005\u2032 N; 119\u00b045\u2032W; 33\u00b055\u2032 N; 120\u00b040\u2032W; 34\u00b050\u2032 N; 121\u00b010\u2032W; 38\u00b050\u2032 N; 124\u00b000\u2032W; 40\u00b000\u2032 N; 124\u00b035\u2032W; 40\u00b025\u2032 N; 124\u00b040\u2032W; 42\u00b050\u2032 N; 124\u00b050\u2032W; 46\u00b015\u2032 N; 124\u00b030\u2032W; 48\u00b030\u2032 N; 125\u00b000\u2032W; 48\u00b020\u2032 N; 128\u00b000\u2032W; 48\u00b020\u2032 N; 132\u00b000\u2032W; 37\u00b042\u2032 N; 130\u00b040\u2032W; 29\u00b000\u2032 N; 124\u00b000\u2032W; 30\u00b045\u2032 N; 120\u00b050\u2032W; 32\u00b000\u2032 N; 118\u00b024\u2032W; 32\u00b030\u2032 N; 117\u00b020\u2032W; 32\u00b032\u203203\u2033 N; 117\u00b007\u203225\u2033 W; eastward along the U.S./Mexico border to 25\u00b058\u2032 N, 97\u00b007\u2032W; 26\u00b000\u2032 N; 97\u00b000\u2032W; 26\u00b000\u2032 N; 95\u00b000\u2032W; 26\u00b030\u2032 N; 95\u00b000\u2032W; then via 26\u00b030\u2032 N; parallel to 26\u00b030\u2032 N; 84\u00b000\u2032W; 24\u00b000\u2032 N; 83\u00b000\u2032W; then Via 24\u00b000\u2032 N; parallel to 24\u00b000\u2032 N; 79\u00b025\u2032W; 25\u00b040\u2032 N; 79\u00b025\u2032W; 27\u00b030\u2032 N; 78\u00b050\u2032W; 30\u00b045\u2032 N; 74\u00b000\u2032W; 39\u00b030\u2032 N; 63\u00b045\u2032W; 43\u00b000\u2032 N; 65\u00b048\u2032W; to point of beginning."], ["14:14:2.0.1.3.16.2.9.3", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "B", "Subpart B\u2014Designated Air Defense Identification Zones", "", "\u00a7 99.45 Alaska ADIZ.", "FAA", "", "", "[Docket FAA-2001-10693, 66 FR 49822, Sept. 28, 2001. Redesignated at 69 FR 16756, Mar. 30, 2004]", "The area is bounded by a line from 54\u00b000\u2032 N; 136\u00b000\u2032W; 56\u00b057\u2032 N; 144\u00b000\u2032W; 57\u00b000\u2032 N; 145\u00b000\u2032W; 53\u00b000\u2032 N; 158\u00b000\u2032W; 50\u00b000\u2032 N; 169\u00b000\u2032W; 50\u00b000\u2032 N; 180\u00b000\u2032; 50\u00b000\u2032 N; 170\u00b000\u2032E; 53\u00b000\u2032 N; 170\u00b000\u2032E; 60\u00b000\u203200\u2033 N; 180\u00b000\u2032; 65\u00b000\u2032 N; 169\u00b000\u2032W; then along 169\u00b000\u2032W; to 75\u00b000\u2032 N; 169\u00b000\u2032W; then along the 75\u00b000\u2032 N; parallel to 75\u00b000\u2032 N, 141\u00b000\u2032W; 69\u00b050\u2032 N; 141\u00b000\u2032W 71\u00b018\u2032 N; 156\u00b044\u2032W; 68\u00b040\u2032 N; 167\u00b010\u2032W; 67\u00b000\u2032 N; 165\u00b000\u2032W; 65\u00b040\u2032 N; 168\u00b015\u2032W; 63\u00b045\u2032 N; 165\u00b030\u2032W; 61\u00b020\u2032 N; 166\u00b040\u2032W; 59\u00b000\u2032 N; 163\u00b000\u2032W; then south along 163\u00b000\u2032W to 54\u00b000\u2032 N, 163\u00b000\u2032W; 56\u00b030\u2032 N; 154\u00b000\u2032W; 59\u00b020\u2032 N; 146\u00b000\u2032W; 59\u00b030\u2032 N; 140\u00b000\u2032W; 57\u00b000\u2032 N; 136\u00b000\u2032W; 54\u00b035\u2032 N, 133\u00b000\u2032W; to point of beginning."], ["14:14:2.0.1.3.16.2.9.4", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "B", "Subpart B\u2014Designated Air Defense Identification Zones", "", "\u00a7 99.47 Guam ADIZ.", "FAA", "", "", "[Docket 25113, 53 FR 18217, May 20, 1988. Redesignated at 69 FR 16756, Mar. 30, 2004]", "(a)  Inner boundary.  From a point 13\u00b052\u203207\u2033 N, 143\u00b059\u203216\u2033 E, counterclockwise along the 50-nautical-mile radius arc of the NIMITZ VORTAC (located at 13\u00b027\u203211\u2033 N, 144\u00b043\u203251\u2033 E); to a point 13\u00b002\u203208\u2033 N, 145\u00b028\u203217\u2033 E; then to a point 14\u00b049\u203207\u2033 N, 146\u00b013\u203258\u2033 E; counterclockwise along the 35-nautical-mile radius arc of the SAIPAN NDB (located at 15\u00b006\u203246\u2033 N, 145\u00b042\u203242\u2033 E); to a point 15\u00b024\u203221\u2033 N, 145\u00b011\u203221\u2033 E; then to the point of origin.\n\n(b)  Outer boundary.  The area bounded by a circle with a radius of 250 NM centered at latitude 13\u00b032\u203241\u2033 N, longitude 144\u00b050\u203230\u2033 E."], ["14:14:2.0.1.3.16.2.9.5", 14, "Aeronautics and Space", "I", "F", "99", "PART 99\u2014SECURITY CONTROL OF AIR TRAFFIC", "B", "Subpart B\u2014Designated Air Defense Identification Zones", "", "\u00a7 99.49 Hawaii ADIZ.", "FAA", "", "", "[Docket 25113, 53 FR 18217, May 20, 1988. Redesignated at 69 FR 16756, Mar. 30, 2004]", "(a)  Outer boundary.  The area included in the irregular octagonal figure formed by a line connecting 26\u00b030\u2032 N, 156\u00b000\u2032 W; 26\u00b030\u2032 N, 161\u00b000\u2032 W; 24\u00b000\u2032 N, 164\u00b000\u2032 W; 20\u00b000\u2032 N, 164\u00b000\u2032 W; 17\u00b000\u2032 N, 160\u00b000\u2032 W; 17\u00b000\u2032 N, 156\u00b000\u2032 W; 20\u00b000\u2032 N, 153\u00b000\u2032 W; 22\u00b000\u2032 N, 153\u00b000\u2032 W; to point of beginning.\n\n(b)  Inner boundary.  The inner boundary to follow a line connecting 22\u00b030\u2032 N, 157\u00b000\u2032 W; 22\u00b030\u2032 N, 160\u00b000\u2032 W; 22\u00b000\u2032 N, 161\u00b000\u2032 W; 21\u00b000\u2032 N, 161\u00b000\u2032 W; 20\u00b000\u2032 N, 160\u00b000\u2032 W; 20\u00b000\u2032 N, 156\u00b030\u2032 W; 21\u00b000\u2032 N, 155\u00b030\u2032 W; to point of beginning."], ["21:21:1.0.1.1.33.1.98.1", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "A", "Subpart A\u2014General Information", "", "\u00a7 99.1 Scope.", "FDA", "", "", "", "(a) This part applies to the dissemination of information on human drugs, including biologics, and devices where the information to be disseminated:\n\n(1) Concerns the safety, effectiveness, or benefit of a use that is not included in the approved labeling for a drug or device approved by the Food and Drug Administration for marketing or in the statement of intended use for a device cleared by the Food and Drug Administration for marketing; and\n\n(2) Will be disseminated to a health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or Federal or State Government agency.\n\n(b) This part does not apply to a manufacturer's dissemination of information that responds to a health care practitioner's unsolicited request."], ["21:21:1.0.1.1.33.1.98.2", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "A", "Subpart A\u2014General Information", "", "\u00a7 99.3 Definitions.", "FDA", "", "", "", "(a)  Agency  or  FDA  means the Food and Drug Administration.\n\n(b) For purposes of this part, a  clinical investigation  is an investigation in humans that tests a specific clinical hypothesis.\n\n(c)  Group health plan  means an employee welfare benefit plan (as defined in section 3(1) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1002(1))) to the extent that the plan provides medical care (as defined in paragraphs (c)(1) through (c)(3) of this section and including items and services paid for as medical care) to employees or their dependents (as defined under the terms of the plan) directly or through insurance, reimbursement, or otherwise. For purposes of this part, the term  medical care  means:\n\n(1) Amounts paid for the diagnosis, cure, mitigation, treatment, or prevention of disease, or amounts paid for the purpose of affecting any structure or function of the body;\n\n(2) Amounts paid for transportation primarily for and essential to medical care referred to in paragraph (c)(1) of this section; and\n\n(3) Amounts paid for insurance covering medical care referred to in paragraphs (c)(1) and (c)(2) of this section.\n\n(d)  Health care practitioner  means a physician or other individual who is a health care provider and licensed under State law to prescribe drugs or devices.\n\n(e)  Health insurance issuer  means an insurance company, insurance service, or insurance organization (including a health maintenance organization, as defined in paragraph (e)(2) of this section) which is licensed to engage in the business of insurance in a State and which is subject to State law which regulates insurance (within the meaning of section 514(b)(2) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1144(b)(2))).\n\n(1) Such term does not include a group health plan.\n\n(2) For purposes of this part, the term  health maintenance organization  means:\n\n(i) A Federally qualified health maintenance organization (as defined in section 1301(a) of the Public Health Service Act (42 U.S.C. 300e(a)));\n\n(ii) An organization recognized under State law as a health maintenance organization; or\n\n(iii) A similar organization regulated under State law for solvency in the same manner and to the same extent as such a health maintenance organization.\n\n(f)  Manufacturer  means a person who manufactures a drug or device or who is licensed by such person to distribute or market the drug or device. For purposes of this part, the term may also include the sponsor of the approved, licensed, or cleared drug or device.\n\n(g)  New use  means a use that is not included in the approved labeling of an approved drug or device, or a use that is not included in the statement of intended use for a cleared device.\n\n(h)  Pharmacy benefit manager  means a person or entity that has, as its principal focus, the implementation of one or more device and/or prescription drug benefit programs.\n\n(i) A  reference publication  is a publication that:\n\n(1) Has not been written, edited, excerpted, or published specifically for, or at the request of, a drug or device manufacturer;\n\n(2) Has not been edited or significantly influenced by such a manufacturer;\n\n(3) Is not solely distributed through such a manufacturer, but is generally available in bookstores or other distribution channels where medical textbooks are sold;\n\n(4) Does not focus on any particular drug or device of a manufacturer that disseminates information under this part and does not have a primary focus on new uses of drugs or devices that are marketed or are under investigation by a manufacturer supporting the dissemination of information; and\n\n(5) Does not present materials that are false or misleading.\n\n(j)  Scientific or medical journal  means a scientific or medical publication:\n\n(1) That is published by an organization that has an editorial board, that uses experts who have demonstrated expertise in the subject of an article under review by the organization and who are independent of the organization, to review and objectively select, reject, or provide comments about proposed articles, and that has a publicly stated policy, to which the organization adheres, of full disclosure of any conflict of interest or biases for all authors or contributors involved with the journal or organization;\n\n(2) Whose articles are peer-reviewed and published in accordance with the regular peer-review procedures of the organization;\n\n(3) That is generally recognized to be of national scope and reputation;\n\n(4) That is indexed in the Index Medicus of the National Library of Medicine of the National Institutes of Health; and\n\n(5) That is not in the form of a special supplement that has been funded in whole or in part by one or more manufacturers.\n\n(k)  Supplemental application  means:\n\n(1) For drugs, a supplement to support a new use to an approved new drug application;\n\n(2) For biologics, a supplement to an approved license application;\n\n(3) For devices that are the subject of a cleared 510(k) submission and devices that are exempt from the 510(k) process, a new 510(k) submission to support a new use or, for devices that are the subject of an approved premarket approval application, a supplement to support a new use to an approved premarket approval application."], ["21:21:1.0.1.1.33.2.98.1", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "B", "Subpart B\u2014Information To Be Disseminated", "", "\u00a7 99.101 Information that may be disseminated.", "FDA", "", "", "", "(a) A manufacturer may disseminate written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling for an approved drug or device or in the statement of intended use for a cleared device, provided that the manufacturer complies with all other relevant requirements under this part. Such information shall:\n\n(1) Be about a drug or device that has been approved, licensed, or cleared for marketing by FDA;\n\n(2) Be in the form of:\n\n(i) An unabridged reprint or copy of an article, peer-reviewed by experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or device involved, which was published in a scientific or medical journal. In addition, the article must be about a clinical investigation with respect to the drug or device and must be considered to be scientifically sound by the experts described in this paragraph; or\n\n(ii) An unabridged reference publication that includes information about a clinical investigation with respect to the drug or device, which experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or device that is the subject of the clinical investigation would consider to be scientifically sound;\n\n(3) Not pose a significant risk to the public health;\n\n(4) Not be false or misleading. FDA may consider information disseminated under this part to be false or misleading if, among other things, the information includes only favorable publications when unfavorable publications exist or excludes articles, reference publications, or other information required under \u00a7 99.103(a)(4) or the information presents conclusions that clearly cannot be supported by the results of the study; and\n\n(5) Not be derived from clinical research conducted by another manufacturer unless the manufacturer disseminating the information has the permission of such other manufacturer to make the dissemination.\n\n(b) For purposes of this part:\n\n(1) FDA will find that all journal articles and reference publications (as those terms are defined in \u00a7 99.3) are scientifically sound except:\n\n(i) Letters to the editor;\n\n(ii) Abstracts of a publication;\n\n(iii) Those regarding Phase 1 trials in healthy people;\n\n(iv) Flagged reference publications that contain little or no substantive discussion of the relevant clinical investigation; and\n\n(v) Those regarding observations in four or fewer people that do not reflect any systematic attempt to collect data, unless the manufacturer demonstrates to FDA that such reports could help guide a physician in his/her medical practice.\n\n(2) A reprint or copy of an article or reference publication is \u201cunabridged\u201d only if it retains the same appearance, form, format, content, or configuration as the original article or publication. Such reprint, copy of an article, or reference publication shall not be disseminated with any information that is promotional in nature. A manufacturer may cite a particular discussion about a new use in a reference publication in the explanatory or other information attached to or otherwise accompanying the reference publication under \u00a7 99.103."], ["21:21:1.0.1.1.33.2.98.2", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "B", "Subpart B\u2014Information To Be Disseminated", "", "\u00a7 99.103 Mandatory statements and information.", "FDA", "", "", "", "(a) Any information disseminated under this part shall include:\n\n(1) A prominently displayed statement disclosing:\n\n(i) For a drug, \u201cThis information concerns a use that has not been approved by the Food and Drug Administration.\u201d For devices, the statement shall read, \u201cThis information concerns a use that has not been approved or cleared by the Food and Drug Administration.\u201d If the information to be disseminated includes both an approved and unapproved use or uses or a cleared and uncleared use or uses, the manufacturer shall modify the statement to identify the unapproved or uncleared new use or uses. The manufacturer shall permanently affix the statement to the front of each reprint or copy of an article from a scientific or medical journal and to the front of each reference publication disseminated under this part;\n\n(ii) If applicable, the information is being disseminated at the expense of the manufacturer;\n\n(iii) If applicable, the names of any authors of the information who were employees of, or consultants to, or received compensation from the manufacturer, or who had a significant financial interest in the manufacturer during the time that the study that is the subject of the dissemination was conducted up through 1 year after the time the article/reference publication was written and published;\n\n(iv) If applicable, a statement that there are products or treatments that have been approved or cleared for the use that is the subject of the information being disseminated; and\n\n(v) The identification of any person that has provided funding for the conduct of a study relating to the new use of a drug or device for which such information is being disseminated; and\n\n(2) The official labeling for the drug or device;\n\n(3) A bibliography of other articles (that concern reports of clinical investigations both supporting and not supporting the new use) from a scientific reference publication or scientific or medical journal that have been previously published about the new use of the drug or device covered by the information that is being disseminated, unless the disseminated information already includes such a bibliography; and\n\n(4) Any additional information required by FDA under \u00a7 99.301(a)(2). Such information shall be attached to the front of the disseminated information or, if attached to the back of the disseminated information, its presence shall be made known to the reader by a sticker or notation on the front of the disseminated information and may consist of:\n\n(i) Objective and scientifically sound information pertaining to the safety or effectiveness of the new use of the drug or device and which FDA determines is necessary to provide objectivity and balance. This may include information that the manufacturer has submitted to FDA or, where appropriate, a summary of such information and any other information that can be made publicly available; and\n\n(ii) An objective statement prepared by FDA, based on data or other scientifically sound information, bearing on the safety or effectiveness of the new use of the drug or device.\n\n(b) Except as provided in paragraphs (a)(1)(i) and (a)(4) of this section, the statements, bibliography, and other information required by this section shall be attached to such disseminated information.\n\n(c) For purposes of this section, factors to be considered in determining whether a statement is \u201cprominently displayed\u201d may include, but are not limited to, type size, font, layout, contrast, graphic design, headlines, spacing, and any other technique to achieve emphasis or notice. The required statements shall be outlined, boxed, highlighted, or otherwise graphically designed and presented in a manner that achieves emphasis or notice and is distinct from the other information being disseminated."], ["21:21:1.0.1.1.33.2.98.3", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "B", "Subpart B\u2014Information To Be Disseminated", "", "\u00a7 99.105 Recipients of information.", "FDA", "", "", "", "A manufacturer disseminating information on a new use under this part may only disseminate that information to a health care practitioner, a pharmacy benefit manager, a health insurance issuer, a group health plan, or a Federal or State Government agency."], ["21:21:1.0.1.1.33.3.98.1", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "C", "Subpart C\u2014Manufacturer's Submissions, Requests, and Applications", "", "\u00a7 99.201 Manufacturer's submission to the agency.", "FDA", "", "", "[63 FR 64581, Nov. 20, 1998, as amended at 70 FR 14980, Mar. 24, 2005; 80 FR 18090, Apr. 3, 2015]", "(a) Sixty days before disseminating any written information concerning the safety, effectiveness, or benefit of a new use for a drug or device, a manufacturer shall submit to the agency:\n\n(1) An identical copy of the information to be disseminated, including any information (e.g., the bibliography) and statements required under \u00a7 99.103;\n\n(2) Any other clinical trial information which the manufacturer has relating to the effectiveness of the new use, any other clinical trial information that the manufacturer has relating to the safety of the new use, any reports of clinical experience pertinent to the safety of the new use, and a summary of such information. For purposes of this part, clinical trial information includes, but is not limited to, published papers and abstracts, even if not intended for dissemination, and unpublished manuscripts, abstracts, and data analyses from completed or ongoing investigations. The reports of clinical experience required under this paragraph shall include case studies, retrospective reviews, epidemiological studies, adverse event reports, and any other material concerning adverse effects or risks reported for or associated with the new use. If the manufacturer has no knowledge of clinical trial information relating to the safety or effectiveness of the new use or reports of clinical experience pertaining to the safety of the new use, the manufacturer shall provide a statement to that effect;\n\n(3) An explanation of the manufacturer's method of selecting the articles for the bibliography (e.g., the databases or sources and criteria (i.e., subject headings/keywords) used to generate the bibliography and the time period covered by the bibliography); and\n\n(4) If the manufacturer has not submitted a supplemental application for the new use, one of the following:\n\n(i) If the manufacturer has completed studies needed for the submission of a supplemental application for the new use:\n\n(A) A copy of the protocol for each completed study or, if such protocol was submitted to an investigational new drug application or an investigational device exemption, the number(s) for the investigational new drug application or investigational device exemption covering the new use, the date of submission of the protocol(s), the protocol number(s), and the date of any amendments to the protocol(s); and\n\n(B) A certification stating that, \u201cOn behalf of [insert manufacturer's name], I certify that [insert manufacturer's name] has completed the studies needed for the submission of a supplemental application for [insert new use] and will submit a supplemental application for such new use to the Food and Drug Administration no later than [insert date no later than 6 months from date that dissemination of information under this part can begin]\u201d; or\n\n(ii) If the manufacturer has planned studies that will be needed for the submission of a supplemental application for the new use:\n\n(A) The proposed protocols and schedule for conducting the studies needed for the submission of a supplemental application for the new use. The protocols shall comply with all applicable requirements in parts 312 of this chapter (investigational new drug applications) and 812 of this chapter (investigational device exemptions). The schedule shall include the projected dates on which the manufacturer expects the principal study events to occur (e.g., initiation and completion of patient enrollment, completion of data collection, completion of data analysis, and submission of the supplemental application); and\n\n(B) A certification stating that, \u201cOn behalf of [insert manufacturer's name], I certify that [insert manufacturer's name] will exercise due diligence to complete the clinical studies necessary to submit a supplemental application for [insert new use] and will submit a supplemental application for such new use to the Food and Drug Administration no later than [insert date no later than 36 months from date that dissemination of information under this part can begin or no later than such time period as FDA may specify pursuant to an extension granted under \u00a7 99.303(a)];\u201d or\n\n(iii) An application for exemption from the requirement of a supplemental application; or\n\n(5) If the manufacturer has submitted a supplemental application for the new use, a cross-reference to that supplemental application.\n\n(b) The manufacturer's attorney, agent, or other authorized official shall sign the submission and certification statement or application for exemption. If the manufacturer does not have a place of business in the United States, the submission and certification statement or application for exemption shall contain the signature, name, and address of the manufacturer's attorney, agent, or other authorized official who resides or maintains a place of business in the United States.\n\n(c) The manufacturer shall send three copies of the submission and certification statement or application for exemption to FDA. The outside of the shipping container shall be marked as \u201cSubmission for the Dissemination of Information on an Unapproved/New Use.\u201d The manufacturer shall send the submission and certification statement or application for exemption to the appropriate FDA component listed in paragraphs (c)(1) through (c)(3) of this section.\n\n(1) For biological products and devices regulated by the Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002;\n\n(2) For human drug products, biological products, and devices regulated by the Center for Drug Evaluation and Research, the Division of Drug Marketing, Advertising, and Communications (HFD-42), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; or\n\n(3) For medical devices, the Promotion and Advertising Policy Staff (HFZ-302), Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850.\n\n(d) The 60-day period shall begin when FDA receives a manufacturer's submission, including, where applicable, a certification statement or an application for an exemption."], ["21:21:1.0.1.1.33.3.98.2", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "C", "Subpart C\u2014Manufacturer's Submissions, Requests, and Applications", "", "\u00a7 99.203 Request to extend the time for completing planned studies.", "FDA", "", "", "", "(a) A manufacturer may request, prior to or at the time of making a submission to FDA under \u00a7 99.201, that FDA extend the 36-month time period for completing the studies and submitting a supplemental application for the new use that is the subject of the information to be disseminated. Such request must set forth the reasons that such studies cannot be completed and submitted in a supplemental application within 36 months.\n\n(b) A manufacturer who has certified that it will complete the studies necessary to submit a supplemental application for a new use within a specified period of time from the date that dissemination of information under this part can begin under \u00a7 99.201(a)(4)(ii), but later finds that it will be unable to complete such studies and submit a supplemental application within that time period may request an extension of time from FDA. The manufacturer, in its request for extension, shall identify the product, the new use, and shall:\n\n(1) Describe the study or studies that cannot be completed on time and explain why the study or studies cannot be completed on time;\n\n(2) Describe the current status of the incomplete study or studies and summarize the work conducted, including the dates on which principal events concerning the study or studies occurred; and\n\n(3) Estimate the additional time needed to complete the studies and submit a supplemental application. The requested extension shall not exceed an additional 24 months.\n\n(c) The manufacturer shall send three copies of the request for extension to the same FDA office that received the manufacturer's initial submission and certification statement. The outside of the envelope shall be marked as \u201cRequest for Time Extension\u2014Dissemination of Information on an Unapproved Use.\u201d"], ["21:21:1.0.1.1.33.3.98.3", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "C", "Subpart C\u2014Manufacturer's Submissions, Requests, and Applications", "", "\u00a7 99.205 Application for exemption from the requirement to file a supplemental application.", "FDA", "", "", "", "(a) In certain circumstances, described in paragraph (b) of this section, a manufacturer may submit an application for an exemption from the requirement to submit a supplemental application for a new use for purposes of disseminating information on that use.\n\n(b) The manufacturer's application for an exemption shall identify the basis for the proposed exemption and shall include materials demonstrating that it would be economically prohibitive or that it would be unethical to conduct the studies necessary to submit a supplemental application for the new use.\n\n(1) If the basis for the manufacturer's application for exemption is that it would be economically prohibitive to incur the costs necessary to submit a supplemental application for a new use, the manufacturer shall, at a minimum, provide:\n\n(i) Evidence explaining why existing data characterizing the safety and effectiveness of the drug or device, including data from the study described in the information to be disseminated, are not adequate to support the submission of a supplemental application for the new use. Such evidence shall include an analysis of all data relevant to the safety and effectiveness of the use, a summary of those data, and any documentation resulting from prior discussions with the agency concerning the adequacy of the existing data; and\n\n(ii) Evidence demonstrating that the cost of the study or studies for the new use reasonably exceeds the expected revenue from the new use minus the costs of goods sold and marketing and administrative expenses attributable to the new use of the product. Such evidence shall include:\n\n(A) A description of the additional studies that the manufacturer believes are necessary to support the submission of a supplemental application for the new use, including documentation from prior discussions, if any, with the agency concerning the studies that would be needed, and an estimate of the projected costs for such studies;\n\n(B) The expected patient population for the new use;\n\n(C) The expected revenue for the new use, including an explanation of the price at which the drug or device will be sold;\n\n(D) Any exclusivity for the drug or device for the new use; and\n\n(E) Any other information that the manufacturer has showing that conducting the studies on the new use would be economically prohibitive; and\n\n(iii) An attestation by a responsible individual of the manufacturer or an individual acting on the manufacturer's behalf verifying that the estimates included with the submission are accurate and were prepared in accordance with generally accepted accounting procedures. The data underlying and supporting the estimates shall be made available to FDA upon request. Alternatively, a manufacturer may submit a report of an independent certified public accountant in accordance with the Statement of Standards for Attestation established by the American Institute of Certified Public Accountants and agreed upon procedures performed with respect to the estimates submitted under this section.\n\n(2) If the basis for the manufacturer's application for exemption is that it would be unethical to conduct the studies necessary for the supplemental application for a new use, the manufacturer shall provide evidence:\n\n(i) Explaining why existing data characterizing the safety and effectiveness of the drug or device, including data from the study described in the information to be disseminated, are not adequate to support the submission of a supplemental application for the new use. Such evidence shall include an analysis of all data relevant to the safety and effectiveness of the new use, a summary of those data, and any documentation resulting from prior discussions with the agency concerning the adequacy of the existing data; and\n\n(ii) Explaining why it would be unethical to conduct the further studies that would be necessary for the approval of the new use. Such evidence shall establish that, notwithstanding the insufficiency of available data to support the submission of a supplemental application for the new use, the data are persuasive to the extent that withholding the drug or device in a controlled study (e.g., by providing no therapy, a placebo, an alternative therapy, or an alternative dose) would pose an unreasonable risk of harm to human subjects. In assessing the appropriateness of conducting studies to support the new use, the manufacturer may provide evidence showing that the new use is broadly accepted as current standard medical treatment or therapy. The manufacturer shall also address the possibility of conducting studies in different populations or of modified design (e.g., adding the new therapy to existing treatments or using an alternative dose if monotherapy studies could not be conducted)."], ["21:21:1.0.1.1.33.4.98.1", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "D", "Subpart D\u2014FDA Action on Submissions, Requests, and Applications", "", "\u00a7 99.301 Agency action on a submission.", "FDA", "", "", "", "(a)  Submissions.  Within 60 days after receiving a submission under this part, FDA may:\n\n(1) Determine that the manufacturer does not comply with the requirements under this part and that, as a result, the manufacturer shall not disseminate any information under this part;\n\n(2) After providing the manufacturer notice and an opportunity for a meeting, determine that the information submitted regarding a new use fails to provide data, analyses, or other written matter that is objective and balanced and:\n\n(i) Require the manufacturer to disseminate additional information, including information that the manufacturer has submitted to FDA or, where appropriate, a summary of such information or any other information that can be made publicly available, which, in the agency's opinion:\n\n(A) Is objective and scientifically sound;\n\n(B) Pertains to the safety or effectiveness of the new use; and\n\n(C) Is necessary to provide objectivity and balance; and\n\n(ii) Require the manufacturer to disseminate an objective statement prepared by FDA that is based on data or other scientifically sound information available to the agency and bears on the safety or effectiveness of the drug or device for the new use; and\n\n(3) Require the manufacturer to maintain records that will identify individual recipients of the information that is to be disseminated when such individual records are warranted due to special safety considerations associated with the new use.\n\n(b)  Protocols/Studies.  Within 60 days after receiving a submission under this part, FDA shall:\n\n(1) If the manufacturer has planned studies that will be needed for the submission of a supplemental application for the new use, review the manufacturer's proposed protocols and schedule for completing such studies and determine whether the proposed protocols are adequate and whether the proposed schedule for completing the studies is reasonable. FDA shall notify the manufacturer of its determination; or\n\n(2) If the manufacturer has completed studies that the manufacturer believes would be an adequate basis for the submission of a supplemental application for the new use, conduct a review of the protocols submitted for such studies to determine whether they are adequate. FDA shall notify the manufacturer of its determination."], ["21:21:1.0.1.1.33.4.98.2", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "D", "Subpart D\u2014FDA Action on Submissions, Requests, and Applications", "", "\u00a7 99.303 Extension of time for completing planned studies.", "FDA", "", "", "", "(a) Upon review of a drug or device manufacturer's proposed protocols and schedules for conducting studies needed for the submission of a supplemental application for a new use, FDA may, with or without a request for an extension from the manufacturer, determine that such studies cannot be completed and submitted within 36 months. The agency may exercise its discretion in extending the time period for completing the studies and submitting a supplemental application. Extensions under this paragraph are not subject to any time limit, but shall be made before the manufacturer begins the studies needed for the submission of a supplemental application for the new use.\n\n(b) The manufacturer may, after beginning the studies needed for the submission of a supplemental application for a new use, request in writing that FDA extend the time period for conducting studies needed for the submission of a supplemental application for a new use and submitting a supplemental application to FDA. FDA may grant or deny the request or, after consulting the manufacturer, grant an extension different from that requested by the manufacturer. FDA may grant a manufacturer's request for an extension if FDA determines that the manufacturer has acted with due diligence to conduct the studies needed for the submission of a supplemental application for a new use and to submit such a supplemental application to FDA in a timely manner and that, despite such actions, the manufacturer needs additional time to complete the studies and submit the supplemental application. Extensions under this paragraph shall not exceed 24 months.\n\n(c) If FDA extends the time period for completing the studies and submitting a supplemental application under paragraph (a) of this section after the manufacturer has submitted a certification under \u00a7 99.201(a)(4)(ii)(B), or if FDA grants a manufacturer's request for an extension under paragraph (b) of this section, the manufacturer shall submit a new certification under \u00a7 99.201(a)(4)(ii)(B) that sets forth the timeframe within which clinical studies will be completed and a supplemental application will be submitted to FDA."], ["21:21:1.0.1.1.33.4.98.3", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "D", "Subpart D\u2014FDA Action on Submissions, Requests, and Applications", "", "\u00a7 99.305 Exemption from the requirement to file a supplemental application.", "FDA", "", "", "", "(a) Within 60 days after receipt of an application for an exemption from the requirement of a supplemental application, FDA shall approve or deny the application.\n\n(1) If FDA does not act on the application for an exemption within the 60-day period, the application for an exemption shall be deemed to be approved.\n\n(2) If an application for an exemption is deemed to be approved, FDA may, at any time, terminate such approval if it determines that the requirements for granting an exemption have not been met. FDA shall notify the manufacturer if the approval is terminated.\n\n(b) In reviewing an application for an exemption, FDA shall consider the materials submitted by the manufacturer and may consider any other appropriate information, including, but not limited to, any pending or previously approved applications for exemption submitted by the manufacturer.\n\n(c) FDA may grant an application for an exemption if FDA determines that:\n\n(1) It would be economically prohibitive for the manufacturer to incur the costs necessary to submit a supplemental application for a new use, which at a minimum requires:\n\n(i) That existing data characterizing the safety and effectiveness of the drug or device, including data from the study described in the information to be disseminated are not adequate to support the submission of a supplemental application for the new use; and\n\n(ii) That the cost of the study or studies for the new use reasonably exceeds the expected revenue from the new use minus the cost of goods sold and marketing and administrative expenses attributable to the new use of the product, and there are not less expensive ways to obtain the needed information; or\n\n(2) It would be unethical to conduct clinical studies needed to support the submission of a supplemental application for the new use because:\n\n(i) Existing data characterizing the safety and effectiveness of the drug or device, including data from the study described in the information to be disseminated are not adequate to support the submission of a supplemental application for the new use; and\n\n(ii) Although available evidence would not support the submission of a supplemental application for the new use, the data are persuasive to the extent that withholding the drug or device in a controlled study would pose an unreasonable risk of harm to human subjects and no studies in different populations or of modified design can be utilized. In determining whether it would be unethical to conduct clinical studies, the agency shall consider, in addition to the persuasiveness of available evidence of effectiveness, whether the new use of the drug or device is broadly accepted as current standard medical treatment or therapy."], ["21:21:1.0.1.1.33.5.98.1", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "E", "Subpart E\u2014Corrective Actions and Cessation of Dissemination", "", "\u00a7 99.401 Corrective actions and cessation of dissemination of information.", "FDA", "", "", "", "(a)  FDA actions based on post dissemination data.  If FDA receives data after a manufacturer has begun disseminating information on a new use and, based on that data, determines that the new use that is the subject of information disseminated under this part may not be effective or may present a significant risk to public health, FDA shall consult the manufacturer and, after such consultation, take appropriate action to protect the public health. Such action may include ordering the manufacturer to cease disseminating information on the new use and to take appropriate corrective action.\n\n(b)  FDA actions based on information disseminated by a manufacturer.  If FDA determines that a manufacturer is disseminating information that does not comply with the requirements under this part, FDA may:\n\n(1) Provide to the manufacturer an opportunity to bring itself into compliance with the requirements under this part if the manufacturer's noncompliance constitutes a minor violation of these requirements; or\n\n(2) Order the manufacturer to cease dissemination of information and to take corrective action. FDA shall issue such an order only after it has:\n\n(i) Provided notice to the manufacturer regarding FDA's intent to issue an order to cease dissemination; and\n\n(ii) Provided to the manufacturer an opportunity for a meeting. FDA need not provide an opportunity for a meeting if the manufacturer certified that it will submit a supplemental application for the new use within 6 months of the date that dissemination can begin and the noncompliance involves a failure to submit such supplemental application.\n\n(c)  FDA actions based on a manufacturer's supplemental application.  FDA may order a manufacturer to cease disseminating information under this part and to take corrective action if:\n\n(1) In the case of a manufacturer that has submitted a supplemental application for the new use, FDA determines that the supplemental application does not contain adequate information for approval of the new use;\n\n(2) In the case of a manufacturer that has certified that it will submit a supplemental application for the new use within 6 months, the manufacturer has not, within the 6-month period, submitted a supplemental application for the new use;\n\n(3) In the case of a manufacturer that has certified that it will submit a supplemental application for the new use within 36 months or within such time as FDA has determined to be appropriate under \u00a7 99.303(a) or (b), such manufacturer has not submitted the supplemental application within the certified time, or FDA, after an informal hearing, has determined that the manufacturer is not acting with due diligence to initiate or complete the studies necessary to support a supplemental application for the new use; or\n\n(4) In the case of a manufacturer that has certified that it will submit a supplemental application for the new use within 36 months or within such time as FDA has determined to be appropriate under \u00a7 99.303(a) or (b), the manufacturer has discontinued or terminated the clinical studies that would be necessary to support a supplemental application for a new use.\n\n(d)  Effective date of orders to cease dissemination.  An order to cease dissemination of information shall be effective upon date of receipt by the manufacturer, unless otherwise stated in such order.\n\n(e)  Cessation of dissemination by a noncomplying manufacturer.  A manufacturer that begins to disseminate information in compliance with this part, but subsequently fails to comply with this part, shall immediately cease disseminating information under this part. A manufacturer that discontinues, terminates, or fails to conduct with due diligence clinical studies that it certified it would complete under \u00a7 99.201(a)(4)(ii) shall be deemed not in compliance with this part. A manufacturer shall notify FDA immediately if it ceases dissemination under this paragraph."], ["21:21:1.0.1.1.33.5.98.2", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "E", "Subpart E\u2014Corrective Actions and Cessation of Dissemination", "", "\u00a7 99.403 Termination of approvals of applications for exemption.", "FDA", "", "", "", "(a) FDA may, at any time, terminate the approval of an application for an exemption from the requirement to file a supplemental application if:\n\n(1) The application for an exemption had been deemed to be approved because the agency had not acted on the application within 60 days after its receipt by FDA;\n\n(2) The manufacturer is disseminating written information on the new use; and\n\n(3) FDA determines that it would be economically and ethically possible for the manufacturer to conduct the clinical studies needed to submit a supplemental application for the new use.\n\n(b) If FDA terminates a deemed approval of an application for an exemption under paragraph (a) of this section, FDA also may:\n\n(1) Order the manufacturer to cease disseminating information; and\n\n(2) Order the manufacturer to take action to correct the information that has been disseminated if FDA determines that the new use described in the disseminated information would pose a significant risk to public health.\n\n(c) FDA shall notify the manufacturer if it terminates the deemed approval of an application for an exemption under paragraph (a) of this section. If FDA also issues an order to cease dissemination of information, the manufacturer shall comply with the order no later than 60 days after its receipt.\n\n(d) FDA may, at any time, terminate the approval of an application for an exemption from the requirement to file a supplemental application for a new use if, after consulting with the manufacturer that was granted such exemption, FDA determines that the manufacturer no longer meets the requirements for an exemption on the basis that it is economically prohibitive or unethical to conduct the studies needed to submit a supplemental application for the new use.\n\n(e) If FDA terminates an approval of an application for an exemption under paragraph (d) of this section, the manufacturer must, within 60 days of being notified by FDA that its exemption approval has been terminated, file a supplemental application for the new use that is the subject of the information being disseminated under the exemption, certify, under \u00a7 99.201(a)(4)(i) or (a)(4)(ii) that it will file a supplemental application for the new use, or cease disseminating the information on the new use. FDA may require a manufacturer that ceases dissemination of information on the new use to undertake corrective action."], ["21:21:1.0.1.1.33.5.98.3", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "E", "Subpart E\u2014Corrective Actions and Cessation of Dissemination", "", "\u00a7 99.405 Applicability of labeling, adulteration, and misbranding authority.", "FDA", "", "", "", "The dissemination of information relating to a new use for a drug or device may constitute labeling, evidence of a new intended use, adulteration, or misbranding of the drug or device if such dissemination fails to comply with section 551 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa) and the requirements of this part. A manufacturer's failure to exercise due diligence in submitting the clinical studies that are necessary for the approval of a new use that is the subject of information disseminated under this part or in beginning or completing such clinical studies shall be deemed a failure to comply with section 551 of the act and the requirements of this part."], ["21:21:1.0.1.1.33.6.98.1", 21, "Food and Drugs", "I", "A", "99", "PART 99\u2014DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES", "F", "Subpart F\u2014Recordkeeping and Reports", "", "\u00a7 99.501 Recordkeeping and reports.", "FDA", "", "", "", "(a) A manufacturer disseminating information under this part shall:\n\n(1) Maintain records sufficient to allow the manufacturer to take corrective action as required by FDA. The manufacturer shall make such records available to FDA, upon request, for inspection and copying. Such records shall either:\n\n(i) Identify, by name, those persons receiving the disseminated information; or\n\n(ii) Identify, by category, the recipients of the disseminated information, unless FDA requires the manufacturer to retain records identifying individual recipients of the disseminated information. Manufacturers whose records identify recipients by category only shall:\n\n(A) Identify subcategories of recipients where appropriate (e.g., oncologists, pediatricians, obstetricians, etc.); and\n\n(B) Ensure that any corrective action to be taken will be sufficiently conspicuous to individuals within that category of recipients;\n\n(2) Maintain an identical copy of the information disseminated under this part; and\n\n(3) Upon the submission of a supplemental application to FDA, notify the appropriate office identified in \u00a7 99.201(c) of this part.\n\n(b) A manufacturer disseminating information on a new use for a drug or device shall, on a semiannual basis, submit to the FDA office identified in \u00a7 99.201(c) of this part:\n\n(1) A list containing the titles of articles and reference publications relating to the new use of drugs or devices that the manufacturer disseminated to a health care practitioner, pharmacy benefit manager, health insurance issuer, group health plan, or Federal or State Government agency. The list shall cover articles and reference publications disseminated in the 6-month period preceding the date on which the manufacturer provides the list to FDA;\n\n(2) A list identifying the categories of health care practitioners, pharmacy benefit managers, health insurance issuers, group health plans, or Federal or State Government agencies that received the articles and reference publications in the 6-month period described in paragraph (b)(1) of this section. The list shall also identify which category of recipients received a particular article or reference publication;\n\n(3) A notice and summary of any additional clinical research or other data relating to the safety or effectiveness of the new use, and, if the manufacturer possesses such clinical research or other data, a copy of the research or data. Such other data may include, but is not limited to, new articles published in scientific or medical journals, reference publications, and summaries of adverse effects that are or may be associated with the new use;\n\n(4) If the manufacturer is conducting studies necessary for the submission of a supplemental application, the manufacturer shall submit periodic progress reports on these studies to FDA. Such reports shall describe the studies' current status (i.e., progress on patient enrollment, any significant problems that could affect the manufacturer's ability to complete the studies, and expected completion dates). If the manufacturer discontinues or terminates a study before completing it, the manufacturer shall, as part of the next periodic progress report, state the reasons for such discontinuation or termination; and\n\n(5) If the manufacturer was granted an exemption from the requirements to submit a supplemental application for the new use, any new or additional information that relates to whether the manufacturer continues to meet the requirements for such exemption. This information may include, but is not limited to, new or additional information regarding revenues from the product that is the subject of the dissemination and new or additional information regarding the persuasiveness of the data on the new use, including information regarding whether the new use is broadly accepted as current standard medical treatment or therapy.\n\n(c) A manufacturer shall maintain a copy of all information, lists, records, and reports required or disseminated under this part for 3 years after it has ceased dissemination of such information and make such documents available to FDA for inspection and copying."], ["34:34:1.1.1.1.32.1.113.1", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "A", "Subpart A\u2014General", "", "\u00a7 99.1 To which educational agencies or institutions do these regulations apply?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 61 FR 59295, Nov. 21, 1996; 65 FR 41852, July 6, 2000]", "(a) Except as otherwise noted in \u00a7 99.10, this part applies to an educational agency or institution to which funds have been made available under any program administered by the Secretary, if\u2014\n\n(1) The educational institution provides educational services or instruction, or both, to students; or\n\n(2) The educational agency is authorized to direct and control public elementary or secondary, or postsecondary educational institutions.\n\n(b) This part does not apply to an educational agency or institution solely because students attending that agency or institution receive non-monetary benefits under a program referenced in paragraph (a) of this section, if no funds under that program are made available to the agency or institution.\n\n(c) The Secretary considers funds to be made available to an educational agency or institution of funds under one or more of the programs referenced in paragraph (a) of this section\u2014\n\n(1) Are provided to the agency or institution by grant, cooperative agreement, contract, subgrant, or subcontract; or\n\n(2) Are provided to students attending the agency or institution and the funds may be paid to the agency or institution by those students for educational purposes, such as under the Pell Grant Program and the Guaranteed Student Loan Program (titles IV-A-1 and IV-B, respectively, of the Higher Education Act of 1965, as amended).\n\n(d) If an educational agency or institution receives funds under one or more of the programs covered by this section, the regulations in this part apply to the recipient as a whole, including each of its components (such as a department within a university)."], ["34:34:1.1.1.1.32.1.113.2", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "A", "Subpart A\u2014General", "", "\u00a7 99.2 What is the purpose of these regulations?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 61 FR 59295, Nov. 21, 1996; 73 FR 74851, Dec. 9, 2008]", "The purpose of this part is to set out requirements for the protection of privacy of parents and students under section 444 of the General Education Provisions Act, as amended.\n\n34 CFR 300.610 through 300.626 contain requirements regarding the confidentiality of information relating to children with disabilities who receive evaluations, services or other benefits under Part B of the Individuals with Disabilities Education Act (IDEA). 34 CFR 303.402 and 303.460 identify the confidentiality of information requirements regarding children and infants and toddlers with disabilities and their families who receive evaluations, services, or other benefits under Part C of IDEA. 34 CFR 300.610 through 300.627 contain the confidentiality of information requirements that apply to personally identifiable data, information, and records collected or maintained pursuant to Part B of the IDEA."], ["34:34:1.1.1.1.32.1.113.3", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "A", "Subpart A\u2014General", "", "\u00a7 99.3 What definitions apply to these regulations?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 60 FR 3468, Jan. 17, 1995; 61 FR 59295, Nov. 21, 1996; 65 FR 41852, July 6, 2000; 73 FR 74851, Dec. 9, 2008; 76 FR 75641, Dec. 2, 2011]", "The following definitions apply to this part:\n\nAct  means the Family Educational Rights and Privacy Act of 1974, as amended, enacted as section 444 of the General Education Provisions Act.\n\nAttendance  includes, but is not limited to\u2014\n\n(a) Attendance in person or by paper correspondence, videoconference, satellite, Internet, or other electronic information and telecommunications technologies for students who are not physically present in the classroom; and\n\n(b) The period during which a person is working under a work-study program.\n\nAuthorized representative  means any entity or individual designated by a State or local educational authority or an agency headed by an official listed in \u00a7 99.31(a)(3) to conduct\u2014with respect to Federal- or State-supported education programs\u2014any audit or evaluation, or any compliance or enforcement activity in connection with Federal legal requirements that relate to these programs.\n\nBiometric record,  as used in the definition of  personally identifiable information,  means a record of one or more measurable biological or behavioral characteristics that can be used for automated recognition of an individual. Examples include fingerprints; retina and iris patterns; voiceprints; DNA sequence; facial characteristics; and handwriting.\n\nDates of attendance.  (a) The term means the period of time during which a student attends or attended an educational agency or institution. Examples of dates of attendance include an academic year, a spring semester, or a first quarter.\n\n(b) The term does not include specific daily records of a student's attendance at an educational agency or institution.\n\nDirectory information  means information contained in an education record of a student that would not generally be considered harmful or an invasion of privacy if disclosed.\n\n(a) Directory information includes, but is not limited to, the student's name; address; telephone listing; electronic mail address; photograph; date and place of birth; major field of study; grade level; enrollment status ( e.g.,  undergraduate or graduate, full-time or part-time); dates of attendance; participation in officially recognized activities and sports; weight and height of members of athletic teams; degrees, honors, and awards received; and the most recent educational agency or institution attended.\n\n(b) Directory information does not include a student's\u2014\n\n(1) Social security number; or\n\n(2) Student identification (ID) number, except as provided in paragraph (c) of this definition.\n\n(c) In accordance with paragraphs (a) and (b) of this definition, directory information includes\u2014\n\n(1) A student ID number, user ID, or other unique personal identifier used by a student for purposes of accessing or communicating in electronic systems, but only if the identifier cannot be used to gain access to education records except when used in conjunction with one or more factors that authenticate the user's identity, such as a personal identification number (PIN), password or other factor known or possessed only by the authorized user; and\n\n(2) A student ID number or other unique personal identifier that is displayed on a student ID badge, but only if the identifier cannot be used to gain access to education records except when used in conjunction with one or more factors that authenticate the user's identity, such as a PIN, password, or other factor known or possessed only by the authorized user.\n\nDisciplinary action or proceeding  means the investigation, adjudication, or imposition of sanctions by an educational agency or institution with respect to an infraction or violation of the internal rules of conduct applicable to students of the agency or institution.\n\nDisclosure  means to permit access to or the release, transfer, or other communication of personally identifiable information contained in education records by any means, including oral, written, or electronic means, to any party except the party identified as the party that provided or created the record.\n\nEarly childhood education program  means\u2014\n\n(a) A Head Start program or an Early Head Start program carried out under the Head Start Act (42 U.S.C. 9831  et seq. ), including a migrant or seasonal Head Start program, an Indian Head Start program, or a Head Start program or an Early Head Start program that also receives State funding;\n\n(b) A State licensed or regulated child care program; or\n\n(c) A program that\u2014\n\n(1) Serves children from birth through age six that addresses the children's cognitive (including language, early literacy, and early mathematics), social, emotional, and physical development; and\n\n(2) Is\u2014\n\n(i) A State prekindergarten program;\n\n(ii) A program authorized under section 619 or part C of the Individuals with Disabilities Education Act; or\n\n(iii) A program operated by a local educational agency.\n\nEducational agency or institution  means any public or private agency or institution to which this part applies under \u00a7 99.1(a).\n\nEducation program  means any program that is principally engaged in the provision of education, including, but not limited to, early childhood education, elementary and secondary education, postsecondary education, special education, job training, career and technical education, and adult education, and any program that is administered by an educational agency or institution.\n\nEducation records.  (a) The term means those records that are:\n\n(1) Directly related to a student; and\n\n(2) Maintained by an educational agency or institution or by a party acting for the agency or institution.\n\n(b) The term does not include:\n\n(1) Records that are kept in the sole possession of the maker, are used only as a personal memory aid, and are not accessible or revealed to any other person except a temporary substitute for the maker of the record.\n\n(2) Records of the law enforcement unit of an educational agency or institution, subject to the provisions of \u00a7 99.8.\n\n(3)(i) Records relating to an individual who is employed by an educational agency or institution, that:\n\n(A) Are made and maintained in the normal course of business;\n\n(B) Relate exclusively to the individual in that individual's capacity as an employee; and\n\n(C) Are not available for use for any other purpose.\n\n(ii) Records relating to an individual in attendance at the agency or institution who is employed as a result of his or her status as a student are education records and not excepted under paragraph (b)(3)(i) of this definition.\n\n(4) Records on a student who is 18 years of age or older, or is attending an institution of postsecondary education, that are:\n\n(i) Made or maintained by a physician, psychiatrist, psychologist, or other recognized professional or paraprofessional acting in his or her professional capacity or assisting in a paraprofessional capacity;\n\n(ii) Made, maintained, or used only in connection with treatment of the student; and\n\n(iii) Disclosed only to individuals providing the treatment. For the purpose of this definition, \u201ctreatment\u201d does not include remedial educational activities or activities that are part of the program of instruction at the agency or institution; and\n\n(5) Records created or received by an educational agency or institution after an individual is no longer a student in attendance and that are not directly related to the individual's attendance as a student.\n\n(6) Grades on peer-graded papers before they are collected and recorded by a teacher.\n\nEligible student  means a student who has reached 18 years of age or is attending an institution of postsecondary education.\n\nInstitution of postsecondary education  means an institution that provides education to students beyond the secondary school level; \u201csecondary school level\u201d means the educational level (not beyond grade 12) at which secondary education is provided as determined under State law.\n\nParent  means a parent of a student and includes a natural parent, a guardian, or an individual acting as a parent in the absence of a parent or a guardian.\n\nParty  means an individual, agency, institution, or organization.\n\nThe term includes, but is not limited to\u2014\n\n(a) The student's name;\n\n(b) The name of the student's parent or other family members;\n\n(c) The address of the student or student's family;\n\n(d) A personal identifier, such as the student's social security number, student number, or biometric record;\n\n(e) Other indirect identifiers, such as the student's date of birth, place of birth, and mother's maiden name;\n\n(f) Other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty; or\n\n(g) Information requested by a person who the educational agency or institution reasonably believes knows the identity of the student to whom the education record relates.\n\nRecord  means any information recorded in any way, including, but not limited to, handwriting, print, computer media, video or audio tape, film, microfilm, and microfiche.\n\nSecretary  means the Secretary of the U.S. Department of Education or an official or employee of the Department of Education acting for the Secretary under a delegation of authority.\n\nStudent,  except as otherwise specifically provided in this part, means any individual who is or has been in attendance at an educational agency or institution and regarding whom the agency or institution maintains education records."], ["34:34:1.1.1.1.32.1.113.4", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "A", "Subpart A\u2014General", "", "\u00a7 99.4 What are the rights of parents?", "ED", "", "", "", "An educational agency or institution shall give full rights under the Act to either parent, unless the agency or institution has been provided with evidence that there is a court order, State statute, or legally binding document relating to such matters as divorce, separation, or custody that specifically revokes these rights."], ["34:34:1.1.1.1.32.1.113.5", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "A", "Subpart A\u2014General", "", "\u00a7 99.5 What are the rights of students?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 58 FR 3188, Jan. 7, 1993; 65 FR 41853, July 6, 2000; 73 FR 74852, Dec. 9, 2008]", "(a)(1) When a student becomes an eligible student, the rights accorded to, and consent required of, parents under this part transfer from the parents to the student.\n\n(2) Nothing in this section prevents an educational agency or institution from disclosing education records, or personally identifiable information from education records, to a parent without the prior written consent of an eligible student if the disclosure meets the conditions in \u00a7 99.31(a)(8), \u00a7 99.31(a)(10), \u00a7 99.31(a)(15), or any other provision in \u00a7 99.31(a).\n\n(b) The Act and this part do not prevent educational agencies or institutions from giving students rights in addition to those given to parents.\n\n(c) An individual who is or has been a student at an educational institution and who applies for admission at another component of that institution does not have rights under this part with respect to records maintained by that other component, including records maintained in connection with the student's application for admission, unless the student is accepted and attends that other component of the institution."], ["34:34:1.1.1.1.32.1.113.6", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "A", "Subpart A\u2014General", "", "\u00a7 99.6 [Reserved]", "ED", "", "", "", ""], ["34:34:1.1.1.1.32.1.113.7", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "A", "Subpart A\u2014General", "", "\u00a7 99.7 What must an educational agency or institution include in its annual notification?", "ED", "", "", "[61 FR 59295, Nov. 21, 1996]", "(a)(1) Each educational agency or institution shall annually notify parents of students currently in attendance, or eligible students currently in attendance, of their rights under the Act and this part.\n\n(2) The notice must inform parents or eligible students that they have the right to\u2014\n\n(i) Inspect and review the student's education records;\n\n(ii) Seek amendment of the student's education records that the parent or eligible student believes to be inaccurate, misleading, or otherwise in violation of the student's privacy rights;\n\n(iii) Consent to disclosures of personally identifiable information contained in the student's education records, except to the extent that the Act and \u00a7 99.31 authorize disclosure without consent; and\n\n(iv) File with the Department a complaint under \u00a7\u00a7 99.63 and 99.64 concerning alleged failures by the educational agency or institution to comply with the requirements of the Act and this part.\n\n(3) The notice must include all of the following:\n\n(i) The procedure for exercising the right to inspect and review education records.\n\n(ii) The procedure for requesting amendment of records under \u00a7 99.20.\n\n(iii) If the educational agency or institution has a policy of disclosing education records under \u00a7 99.31(a)(1), a specification of criteria for determining who constitutes a school official and what constitutes a legitimate educational interest.\n\n(b) An educational agency or institution may provide this notice by any means that are reasonably likely to inform the parents or eligible students of their rights.\n\n(1) An educational agency or institution shall effectively notify parents or eligible students who are disabled.\n\n(2) An agency or institution of elementary or secondary education shall effectively notify parents who have a primary or home language other than English."], ["34:34:1.1.1.1.32.1.113.8", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "A", "Subpart A\u2014General", "", "\u00a7 99.8 What provisions apply to records of a law enforcement unit?", "ED", "", "", "[60 FR 3469, Jan. 17, 1995]", "(a)(1)  Law enforcement unit  means any individual, office, department, division, or other component of an educational agency or institution, such as a unit of commissioned police officers or non-commissioned security guards, that is officially authorized or designated by that agency or institution to\u2014\n\n(i) Enforce any local, State, or Federal law, or refer to appropriate authorities a matter for enforcement of any local, State, or Federal law against any individual or organization other than the agency or institution itself; or\n\n(ii) Maintain the physical security and safety of the agency or institution.\n\n(2) A component of an educational agency or institution does not lose its status as a  law enforcement unit  if it also performs other, non-law enforcement functions for the agency or institution, including investigation of incidents or conduct that constitutes or leads to a disciplinary action or proceedings against the student.\n\n(b)(1) Records of a law enforcement unit means those records, files, documents, and other materials that are\u2014\n\n(i) Created by a law enforcement unit;\n\n(ii) Created for a law enforcement purpose; and\n\n(iii) Maintained by the law enforcement unit.\n\n(2) Records of a law enforcement unit does not mean\u2014\n\n(i) Records created by a law enforcement unit for a law enforcement purpose that are maintained by a component of the educational agency or institution other than the law enforcement unit; or\n\n(ii) Records created and maintained by a law enforcement unit exclusively for a non-law enforcement purpose, such as a disciplinary action or proceeding conducted by the educational agency or institution.\n\n(c)(1) Nothing in the Act prohibits an educational agency or institution from contacting its law enforcement unit, orally or in writing, for the purpose of asking that unit to investigate a possible violation of, or to enforce, any local, State, or Federal law.\n\n(2) Education records, and personally identifiable information contained in education records, do not lose their status as education records and remain subject to the Act, including the disclosure provisions of \u00a7 99.30, while in the possession of the law enforcement unit.\n\n(d) The Act neither requires nor prohibits the disclosure by an educational agency or institution of its law enforcement unit records."], ["34:34:1.1.1.1.32.2.113.1", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "B", "Subpart B\u2014What Are the Rights of Inspection and Review of Education Records?", "", "\u00a7 99.10 What rights exist for a parent or eligible student to inspect and review education records?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 61 FR 59296, Nov. 21, 1996]", "(a) Except as limited under \u00a7 99.12, a parent or eligible student must be given the opportunity to inspect and review the student's education records. This provision applies to\u2014\n\n(1) Any educational agency or institution; and\n\n(2) Any State educational agency (SEA) and its components.\n\n(i) For the purposes of subpart B of this part, an SEA and its components constitute an educational agency or institution.\n\n(ii) An SEA and its components are subject to subpart B of this part if the SEA maintains education records on students who are or have been in attendance at any school of an educational agency or institution subject to the Act and this part.\n\n(b) The educational agency or institution, or SEA or its component, shall comply with a request for access to records within a reasonable period of time, but not more than 45 days after it has received the request.\n\n(c) The educational agency or institution, or SEA or its component shall respond to reasonable requests for explanations and interpretations of the records.\n\n(d) If circumstances effectively prevent the parent or eligible student from exercising the right to inspect and review the student's education records, the educational agency or institution, or SEA or its component, shall\u2014\n\n(1) Provide the parent or eligible student with a copy of the records requested; or\n\n(2) Make other arrangements for the parent or eligible student to inspect and review the requested records.\n\n(e) The educational agency or institution, or SEA or its component shall not destroy any education records if there is an outstanding request to inspect and review the records under this section.\n\n(f) While an education agency or institution is not required to give an eligible student access to treatment records under paragraph (b)(4) of the definition of  Education records  in \u00a7 99.3, the student may have those records reviewed by a physician or other appropriate professional of the student's choice."], ["34:34:1.1.1.1.32.2.113.2", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "B", "Subpart B\u2014What Are the Rights of Inspection and Review of Education Records?", "", "\u00a7 99.11 May an educational agency or institution charge a fee for copies of education records?", "ED", "", "", "", "(a) Unless the imposition of a fee effectively prevents a parent or eligible student from exercising the right to inspect and review the student's education records, an educational agency or institution may charge a fee for a copy of an education record which is made for the parent or eligible student.\n\n(b) An educational agency or institution may not charge a fee to search for or to retrieve the education records of a student."], ["34:34:1.1.1.1.32.2.113.3", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "B", "Subpart B\u2014What Are the Rights of Inspection and Review of Education Records?", "", "\u00a7 99.12 What limitations exist on the right to inspect and review records?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 61 FR 59296, Nov. 21, 1996]", "(a) If the education records of a student contain information on more than one student, the parent or eligible student may inspect and review or be informed of only the specific information about that student.\n\n(b) A postsecondary institution does not have to permit a student to inspect and review education records that are:\n\n(1) Financial records, including any information those records contain, of his or her parents;\n\n(2) Confidential letters and confidential statements of recommendation placed in the education records of the student before January 1, 1975, as long as the statements are used only for the purposes for which they were specifically intended; and\n\n(3) Confidential letters and confidential statements of recommendation placed in the student's education records after January 1, 1975, if:\n\n(i) The student has waived his or her right to inspect and review those letters and statements; and\n\n(ii) Those letters and statements are related to the student's:\n\n(A) Admission to an educational institution;\n\n(B) Application for employment; or\n\n(C) Receipt of an honor or honorary recognition.\n\n(c)(1) A waiver under paragraph (b)(3)(i) of this section is valid only if:\n\n(i) The educational agency or institution does not require the waiver as a condition for admission to or receipt of a service or benefit from the agency or institution; and\n\n(ii) The waiver is made in writing and signed by the student, regardless of age.\n\n(2) If a student has waived his or her rights under paragraph (b)(3)(i) of this section, the educational institution shall:\n\n(i) Give the student, on request, the names of the individuals who provided the letters and statements of recommendation; and\n\n(ii) Use the letters and statements of recommendation only for the purpose for which they were intended.\n\n(3)(i) A waiver under paragraph (b)(3)(i) of this section may be revoked with respect to any actions occurring after the revocation.\n\n(ii) A revocation under paragraph (c)(3)(i) of this section must be in writing."], ["34:34:1.1.1.1.32.3.113.1", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "C", "Subpart C\u2014What Are the Procedures for Amending Education Records?", "", "\u00a7 99.20 How can a parent or eligible student request amendment of the student's education records?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988; 53 FR 19368, May 27, 1988, as amended at 61 FR 59296, Nov. 21, 1996]", "(a) If a parent or eligible student believes the education records relating to the student contain information that is inaccurate, misleading, or in violation of the student's rights of privacy, he or she may ask the educational agency or institution to amend the record.\n\n(b) The educational agency or institution shall decide whether to amend the record as requested within a reasonable time after the agency or institution receives the request.\n\n(c) If the educational agency or institution decides not to amend the record as requested, it shall inform the parent or eligible student of its decision and of his or her right to a hearing under \u00a7 99.21."], ["34:34:1.1.1.1.32.3.113.2", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "C", "Subpart C\u2014What Are the Procedures for Amending Education Records?", "", "\u00a7 99.21 Under what conditions does a parent or eligible student have the right to a hearing?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 61 FR 59296, Nov. 21, 1996]", "(a) An educational agency or institution shall give a parent or eligible student, on request, an opportunity for a hearing to challenge the content of the student's education records on the grounds that the information contained in the education records is inaccurate, misleading, or in violation of the privacy rights of the student.\n\n(b)(1) If, as a result of the hearing, the educational agency or institution decides that the information is inaccurate, misleading, or otherwise in violation of the privacy rights of the student, it shall:\n\n(i) Amend the record accordingly; and\n\n(ii) Inform the parent or eligible student of the amendment in writing.\n\n(2) If, as a result of the hearing, the educational agency or institution decides that the information in the education record is not inaccurate, misleading, or otherwise in violation of the privacy rights of the student, it shall inform the parent or eligible student of the right to place a statement in the record commenting on the contested information in the record or stating why he or she disagrees with the decision of the agency or institution, or both.\n\n(c) If an educational agency or institution places a statement in the education records of a student under paragraph (b)(2) of this section, the agency or institution shall:\n\n(1) Maintain the statement with the contested part of the record for as long as the record is maintained; and\n\n(2) Disclose the statement whenever it discloses the portion of the record to which the statement relates."], ["34:34:1.1.1.1.32.3.113.3", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "C", "Subpart C\u2014What Are the Procedures for Amending Education Records?", "", "\u00a7 99.22 What minimum requirements exist for the conduct of a hearing?", "ED", "", "", "", "The hearing required by \u00a7 99.21 must meet, at a minimum, the following requirements:\n\n(a) The educational agency or institution shall hold the hearing within a reasonable time after it has received the request for the hearing from the parent or eligible student.\n\n(b) The educational agency or institution shall give the parent or eligible student notice of the date, time, and place, reasonably in advance of the hearing.\n\n(c) The hearing may be conducted by any individual, including an official of the educational agency or institution, who does not have a direct interest in the outcome of the hearing.\n\n(d) The educational agency or institution shall give the parent or eligible student a full and fair opportunity to present evidence relevant to the issues raised under \u00a7 99.21. The parent or eligible student may, at their own expense, be assisted or represented by one or more individuals of his or her own choice, including an attorney.\n\n(e) The educational agency or institution shall make its decision in writing within a reasonable period of time after the hearing.\n\n(f) The decision must be based solely on the evidence presented at the hearing, and must include a summary of the evidence and the reasons for the decision."], ["34:34:1.1.1.1.32.4.113.1", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "D", "Subpart D\u2014May an Educational Agency or Institution Disclose Personally Identifiable Information From Education Records?", "", "\u00a7 99.30 Under what conditions is prior consent required to disclose information?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 58 FR 3189, Jan. 7, 1993; 69 FR 21671, Apr. 21, 2004]", "(a) The parent or eligible student shall provide a signed and dated written consent before an educational agency or institution discloses personally identifiable information from the student's education records, except as provided in \u00a7 99.31.\n\n(b) The written consent must:\n\n(1) Specify the records that may be disclosed;\n\n(2) State the purpose of the disclosure; and\n\n(3) Identify the party or class of parties to whom the disclosure may be made.\n\n(c) When a disclosure is made under paragraph (a) of this section:\n\n(1) If a parent or eligible student so requests, the educational agency or institution shall provide him or her with a copy of the records disclosed; and\n\n(2) If the parent of a student who is not an eligible student so requests, the agency or institution shall provide the student with a copy of the records disclosed.\n\n(d) \u201cSigned and dated written consent\u201d under this part may include a record and signature in electronic form that\u2014\n\n(1) Identifies and authenticates a particular person as the source of the electronic consent; and\n\n(2) Indicates such person's approval of the information contained in the electronic consent."], ["34:34:1.1.1.1.32.4.113.10", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "D", "Subpart D\u2014May an Educational Agency or Institution Disclose Personally Identifiable Information From Education Records?", "", "\u00a7 99.39 What definitions apply to the nonconsensual disclosure of records by postsecondary educational institutions in connection with disciplinary proceedings concerning crimes of violence or non-forcible sex offenses?", "ED", "", "", "[65 FR 41853, July 6, 2000]", "As used in this part:\n\nAlleged perpetrator of a crime of violence  is a student who is alleged to have committed acts that would, if proven, constitute any of the following offenses or attempts to commit the following offenses that are defined in appendix A to this part:\n\nArson \n \n Assault offenses \n \n Burglary \n \n Criminal homicide\u2014manslaughter by negligence \n \n Criminal homicide\u2014murder and nonnegligent manslaughter \n \n Destruction/damage/vandalism of property \n \n Kidnapping/abduction \n \n Robbery \n \n Forcible sex offenses.\n\nArson\n\nAssault offenses\n\nBurglary\n\nCriminal homicide\u2014manslaughter by negligence\n\nCriminal homicide\u2014murder and nonnegligent manslaughter\n\nDestruction/damage/vandalism of property\n\nKidnapping/abduction\n\nRobbery\n\nForcible sex offenses.\n\nAlleged perpetrator of a nonforcible sex offense  means a student who is alleged to have committed acts that, if proven, would constitute statutory rape or incest. These offenses are defined in appendix A to this part.\n\nFinal results  means a decision or determination, made by an honor court or council, committee, commission, or other entity authorized to resolve disciplinary matters within the institution. The disclosure of final results must include only the name of the student, the violation committed, and any sanction imposed by the institution against the student.\n\nSanction imposed  means a description of the disciplinary action taken by the institution, the date of its imposition, and its duration.\n\nViolation committed  means the institutional rules or code sections that were violated and any essential findings supporting the institution's conclusion that the violation was committed."], ["34:34:1.1.1.1.32.4.113.2", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "D", "Subpart D\u2014May an Educational Agency or Institution Disclose Personally Identifiable Information From Education Records?", "", "\u00a7 99.31 Under what conditions is prior consent not required to disclose information?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988; 53 FR 19368, May 27, 1988, as amended at 58 FR 3189, Jan. 7, 1993; 61 FR 59296, Nov. 21, 1996; 65 FR 41853, July 6, 2000; 73 FR 74852, Dec. 9, 2008; 74 FR 401, Jan. 6, 2009; 76 FR 75641, Dec. 2, 2011]", "(a) An educational agency or institution may disclose personally identifiable information from an education record of a student without the consent required by \u00a7 99.30 if the disclosure meets one or more of the following conditions:\n\n(1)(i)(A) The disclosure is to other school officials, including teachers, within the agency or institution whom the agency or institution has determined to have legitimate educational interests.\n\n(B) A contractor, consultant, volunteer, or other party to whom an agency or institution has outsourced institutional services or functions may be considered a school official under this paragraph provided that the outside party\u2014\n\n( 1 ) Performs an institutional service or function for which the agency or institution would otherwise use employees;\n\n( 2 ) Is under the direct control of the agency or institution with respect to the use and maintenance of education records; and\n\n( 3 ) Is subject to the requirements of \u00a7 99.33(a) governing the use and redisclosure of personally identifiable information from education records.\n\n(ii) An educational agency or institution must use reasonable methods to ensure that school officials obtain access to only those education records in which they have legitimate educational interests. An educational agency or institution that does not use physical or technological access controls must ensure that its administrative policy for controlling access to education records is effective and that it remains in compliance with the legitimate educational interest requirement in paragraph (a)(1)(i)(A) of this section.\n\n(2) The disclosure is, subject to the requirements of \u00a7 99.34, to officials of another school, school system, or institution of postsecondary education where the student seeks or intends to enroll, or where the student is already enrolled so long as the disclosure is for purposes related to the student's enrollment or transfer.\n\nSection 4155(b) of the No Child Left Behind Act of 2001, 20 U.S.C. 7165(b), requires each State to assure the Secretary of Education that it has a procedure in place to facilitate the transfer of disciplinary records with respect to a suspension or expulsion of a student by a local educational agency to any private or public elementary or secondary school in which the student is subsequently enrolled or seeks, intends, or is instructed to enroll.\n\n(3) The disclosure is, subject to the requirements of \u00a7 99.35, to authorized representatives of\u2014\n\n(i) The Comptroller General of the United States;\n\n(ii) The Attorney General of the United States;\n\n(iii) The Secretary; or\n\n(iv) State and local educational authorities.\n\n(4)(i) The disclosure is in connection with financial aid for which the student has applied or which the student has received, if the information is necessary for such purposes as to:\n\n(A) Determine eligibility for the aid;\n\n(B) Determine the amount of the aid;\n\n(C) Determine the conditions for the aid; or\n\n(D) Enforce the terms and conditions of the aid.\n\n(ii) As used in paragraph (a)(4)(i) of this section,  financial aid  means a payment of funds provided to an individual (or a payment in kind of tangible or intangible property to the individual) that is conditioned on the individual's attendance at an educational agency or institution.\n\n(5)(i) The disclosure is to State and local officials or authorities to whom this information is specifically\u2014\n\n(A) Allowed to be reported or disclosed pursuant to State statute adopted before November 19, 1974, if the allowed reporting or disclosure concerns the juvenile justice system and the system's ability to effectively serve the student whose records are released; or\n\n(B) Allowed to be reported or disclosed pursuant to State statute adopted after November 19, 1974, subject to the requirements of \u00a7 99.38.\n\n(ii) Paragraph (a)(5)(i) of this section does not prevent a State from further limiting the number or type of State or local officials to whom disclosures may be made under that paragraph.\n\n(6)(i) The disclosure is to organizations conducting studies for, or on behalf of, educational agencies or institutions to:\n\n(A) Develop, validate, or administer predictive tests;\n\n(B) Administer student aid programs; or\n\n(C) Improve instruction.\n\n(ii) Nothing in the Act or this part prevents a State or local educational authority or agency headed by an official listed in paragraph (a)(3) of this section from entering into agreements with organizations conducting studies under paragraph (a)(6)(i) of this section and redisclosing personally identifiable information from education records on behalf of educational agencies and institutions that disclosed the information to the State or local educational authority or agency headed by an official listed in paragraph (a)(3) of this section in accordance with the requirements of \u00a7 99.33(b).\n\n(iii) An educational agency or institution may disclose personally identifiable information under paragraph (a)(6)(i) of this section, and a State or local educational authority or agency headed by an official listed in paragraph (a)(3) of this section may redisclose personally identifiable information under paragraph (a)(6)(i) and (a)(6)(ii) of this section, only if\u2014\n\n(A) The study is conducted in a manner that does not permit personal identification of parents and students by individuals other than representatives of the organization that have legitimate interests in the information;\n\n(B) The information is destroyed when no longer needed for the purposes for which the study was conducted; and\n\n(C) The educational agency or institution or the State or local educational authority or agency headed by an official listed in paragraph (a)(3) of this section enters into a written agreement with the organization that\u2014\n\n( 1 ) Specifies the purpose, scope, and duration of the study or studies and the information to be disclosed;\n\n( 2 ) Requires the organization to use personally identifiable information from education records only to meet the purpose or purposes of the study as stated in the written agreement;\n\n( 3 ) Requires the organization to conduct the study in a manner that does not permit personal identification of parents and students, as defined in this part, by anyone other than representatives of the organization with legitimate interests;\n\nand\n\n( 4 ) Requires the organization to destroy all personally identifiable information when the information is no longer needed for the purposes for which the study was conducted and specifies the time period in which the information must be destroyed.\n\n(iv) An educational agency or institution or State or local educational authority or Federal agency headed by an official listed in paragraph (a)(3) of this section is not required to initiate a study or agree with or endorse the conclusions or results of the study.\n\n(v) For the purposes of paragraph (a)(6) of this section, the term  organization  includes, but is not limited to, Federal, State, and local agencies, and independent organizations.\n\n(7) The disclosure is to accrediting organizations to carry out their accrediting functions.\n\n(8) The disclosure is to parents, as defined in \u00a7 99.3, of a dependent student, as defined in section 152 of the Internal Revenue Code of 1986.\n\n(9)(i) The disclosure is to comply with a judicial order or lawfully issued subpoena.\n\n(ii) The educational agency or institution may disclose information under paragraph (a)(9)(i) of this section only if the agency or institution makes a reasonable effort to notify the parent or eligible student of the order or subpoena in advance of compliance, so that the parent or eligible student may seek protective action, unless the disclosure is in compliance with\u2014\n\n(A) A Federal grand jury subpoena and the court has ordered that the existence or the contents of the subpoena or the information furnished in response to the subpoena not be disclosed;\n\n(B) Any other subpoena issued for a law enforcement purpose and the court or other issuing agency has ordered that the existence or the contents of the subpoena or the information furnished in response to the subpoena not be disclosed; or\n\n(C) An  ex parte  court order obtained by the United States Attorney General (or designee not lower than an Assistant Attorney General) concerning investigations or prosecutions of an offense listed in 18 U.S.C. 2332b(g)(5)(B) or an act of domestic or international terrorism as defined in 18 U.S.C. 2331.\n\n(iii)(A) If an educational agency or institution initiates legal action against a parent or student, the educational agency or institution may disclose to the court, without a court order or subpoena, the education records of the student that are relevant for the educational agency or institution to proceed with the legal action as plaintiff.\n\n(B) If a parent or eligible student initiates legal action against an educational agency or institution, the educational agency or institution may disclose to the court, without a court order or subpoena, the student's education records that are relevant for the educational agency or institution to defend itself.\n\n(10) The disclosure is in connection with a health or safety emergency, under the conditions described in \u00a7 99.36.\n\n(11) The disclosure is information the educational agency or institution has designated as \u201cdirectory information\u201d, under the conditions described in \u00a7 99.37.\n\n(12) The disclosure is to the parent of a student who is not an eligible student or to the student.\n\n(13) The disclosure, subject to the requirements in \u00a7 99.39, is to a victim of an alleged perpetrator of a crime of violence or a non-forcible sex offense. The disclosure may only include the final results of the disciplinary proceeding conducted by the institution of postsecondary education with respect to that alleged crime or offense. The institution may disclose the final results of the disciplinary proceeding, regardless of whether the institution concluded a violation was committed.\n\n(14)(i) The disclosure, subject to the requirements in \u00a7 99.39, is in connection with a disciplinary proceeding at an institution of postsecondary education. The institution must not disclose the final results of the disciplinary proceeding unless it determines that\u2014\n\n(A) The student is an alleged perpetrator of a crime of violence or non-forcible sex offense; and\n\n(B) With respect to the allegation made against him or her, the student has committed a violation of the institution's rules or policies.\n\n(ii) The institution may not disclose the name of any other student, including a victim or witness, without the prior written consent of the other student.\n\n(iii) This section applies only to disciplinary proceedings in which the final results were reached on or after October 7, 1998.\n\n(15)(i) The disclosure is to a parent of a student at an institution of postsecondary education regarding the student's violation of any Federal, State, or local law, or of any rule or policy of the institution, governing the use or possession of alcohol or a controlled substance if\u2014\n\n(A) The institution determines that the student has committed a disciplinary violation with respect to that use or possession; and\n\n(B) The student is under the age of 21 at the time of the disclosure to the parent.\n\n(ii) Paragraph (a)(15) of this section does not supersede any provision of State law that prohibits an institution of postsecondary education from disclosing information.\n\n(16) The disclosure concerns sex offenders and other individuals required to register under section 170101 of the Violent Crime Control and Law Enforcement Act of 1994, 42 U.S.C. 14071, and the information was provided to the educational agency or institution under 42 U.S.C. 14071 and applicable Federal guidelines.\n\n(b)(1)  De-identified records and information.  An educational agency or institution, or a party that has received education records or information from education records under this part, may release the records or information without the consent required by \u00a7 99.30 after the removal of all personally identifiable information provided that the educational agency or institution or other party has made a reasonable determination that a student's identity is not personally identifiable, whether through single or multiple releases, and taking into account other reasonably available information.\n\n(2) An educational agency or institution, or a party that has received education records or information from education records under this part, may release de-identified student level data from education records for the purpose of education research by attaching a code to each record that may allow the recipient to match information received from the same source, provided that\u2014\n\n(i) An educational agency or institution or other party that releases de-identified data under paragraph (b)(2) of this section does not disclose any information about how it generates and assigns a record code, or that would allow a recipient to identify a student based on a record code;\n\n(ii) The record code is used for no purpose other than identifying a de-identified record for purposes of education research and cannot be used to ascertain personally identifiable information about a student; and\n\n(iii) The record code is not based on a student's social security number or other personal information.\n\n(c) An educational agency or institution must use reasonable methods to identify and authenticate the identity of parents, students, school officials, and any other parties to whom the agency or institution discloses personally identifiable information from education records.\n\n(d) Paragraphs (a) and (b) of this section do not require an educational agency or institution or any other party to disclose education records or information from education records to any party except for parties under paragraph (a)(12) of this section."], ["34:34:1.1.1.1.32.4.113.3", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "D", "Subpart D\u2014May an Educational Agency or Institution Disclose Personally Identifiable Information From Education Records?", "", "\u00a7 99.32 What recordkeeping requirements exist concerning requests and disclosures?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 61 FR 59297, Nov. 21, 1996; 73 FR 74853, Dec. 9, 2008]", "(a)(1) An educational agency or institution must maintain a record of each request for access to and each disclosure of personally identifiable information from the education records of each student, as well as the names of State and local educational authorities and Federal officials and agencies listed in \u00a7 99.31(a)(3) that may make further disclosures of personally identifiable information from the student's education records without consent under \u00a7 99.33(b).\n\n(2) The agency or institution shall maintain the record with the education records of the student as long as the records are maintained.\n\n(3) For each request or disclosure the record must include:\n\n(i) The parties who have requested or received personally identifiable information from the education records; and\n\n(ii) The legitimate interests the parties had in requesting or obtaining the information.\n\n(4) An educational agency or institution must obtain a copy of the record of further disclosures maintained under paragraph (b)(2) of this section and make it available in response to a parent's or eligible student's request to review the record required under paragraph (a)(1) of this section.\n\n(5) An educational agency or institution must record the following information when it discloses personally identifiable information from education records under the health or safety emergency exception in \u00a7 99.31(a)(10) and \u00a7 99.36:\n\n(i) The articulable and significant threat to the health or safety of a student or other individuals that formed the basis for the disclosure; and\n\n(ii) The parties to whom the agency or institution disclosed the information.\n\n(b)(1) Except as provided in paragraph (b)(2) of this section, if an educational agency or institution discloses personally identifiable information from education records with the understanding authorized under \u00a7 99.33(b), the record of the disclosure required under this section must include:\n\n(i) The names of the additional parties to which the receiving party may disclose the information on behalf of the educational agency or institution; and\n\n(ii) The legitimate interests under \u00a7 99.31 which each of the additional parties has in requesting or obtaining the information.\n\n(2)(i) A State or local educational authority or Federal official or agency listed in \u00a7 99.31(a)(3) that makes further disclosures of information from education records under \u00a7 99.33(b) must record the names of the additional parties to which it discloses information on behalf of an educational agency or institution and their legitimate interests in the information under \u00a7 99.31 if the information was received from:\n\n(A) An educational agency or institution that has not recorded the further disclosures under paragraph (b)(1) of this section; or\n\n(B) Another State or local educational authority or Federal official or agency listed in \u00a7 99.31(a)(3).\n\n(ii) A State or local educational authority or Federal official or agency that records further disclosures of information under paragraph (b)(2)(i) of this section may maintain the record by the student's class, school, district, or other appropriate grouping rather than by the name of the student.\n\n(iii) Upon request of an educational agency or institution, a State or local educational authority or Federal official or agency listed in \u00a7 99.31(a)(3) that maintains a record of further disclosures under paragraph (b)(2)(i) of this section must provide a copy of the record of further disclosures to the educational agency or institution within a reasonable period of time not to exceed 30 days.\n\n(c) The following parties may inspect the record relating to each student:\n\n(1) The parent or eligible student.\n\n(2) The school official or his or her assistants who are responsible for the custody of the records.\n\n(3) Those parties authorized in \u00a7 99.31(a) (1) and (3) for the purposes of auditing the recordkeeping procedures of the educational agency or institution.\n\n(d) Paragraph (a) of this section does not apply if the request was from, or the disclosure was to:\n\n(1) The parent or eligible student;\n\n(2) A school official under \u00a7 99.31(a)(1);\n\n(3) A party with written consent from the parent or eligible student;\n\n(4) A party seeking directory information; or\n\n(5) A party seeking or receiving records in accordance with \u00a7 99.31(a)(9)(ii)(A) through (C)."], ["34:34:1.1.1.1.32.4.113.4", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "D", "Subpart D\u2014May an Educational Agency or Institution Disclose Personally Identifiable Information From Education Records?", "", "\u00a7 99.33 What limitations apply to the redisclosure of information?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 61 FR 59297, Nov. 21, 1996; 65 FR 41853, July 6, 2000; 73 FR 74853, Dec. 9, 2008; 76 FR 75642, Dec. 2, 2011]", "(a)(1) An educational agency or institution may disclose personally identifiable information from an education record only on the condition that the party to whom the information is disclosed will not disclose the information to any other party without the prior consent of the parent or eligible student.\n\n(2) The officers, employees, and agents of a party that receives information under paragraph (a)(1) of this section may use the information, but only for the purposes for which the disclosure was made.\n\n(b)(1) Paragraph (a) of this section does not prevent an educational agency or institution from disclosing personally identifiable information with the understanding that the party receiving the information may make further disclosures of the information on behalf of the educational agency or institution if\u2014\n\n(i) The disclosures meet the requirements of \u00a7 99.31; and\n\n(ii)(A) The educational agency or institution has complied with the requirements of \u00a7 99.32(b); or\n\n(B) A State or local educational authority or Federal official or agency listed in \u00a7 99.31(a)(3) has complied with the requirements of \u00a7 99.32(b)(2).\n\n(2) A party that receives a court order or lawfully issued subpoena and rediscloses personally identifiable information from education records on behalf of an educational agency or institution in response to that order or subpoena under \u00a7 99.31(a)(9) must provide the notification required under \u00a7 99.31(a)(9)(ii).\n\n(c) Paragraph (a) of this section does not apply to disclosures under \u00a7\u00a7 99.31(a)(8), (9), (11), (12), (14), (15), and (16), and to information that postsecondary institutions are required to disclose under the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act, 20 U.S.C. 1092(f) (Clery Act), to the accuser and accused regarding the outcome of any campus disciplinary proceeding brought alleging a sexual offense.\n\n(d) An educational agency or institution must inform a party to whom disclosure is made of the requirements of paragraph (a) of this section except for disclosures made under \u00a7\u00a7 99.31(a)(8), (9), (11), (12), (14), (15), and (16), and to information that postsecondary institutions are required to disclose under the Clery Act to the accuser and accused regarding the outcome of any campus disciplinary proceeding brought alleging a sexual offense."], ["34:34:1.1.1.1.32.4.113.5", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "D", "Subpart D\u2014May an Educational Agency or Institution Disclose Personally Identifiable Information From Education Records?", "", "\u00a7 99.34 What conditions apply to disclosure of information to other educational agencies or institutions?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 61 FR 59297, Nov. 21, 1996; 73 FR 74854, Dec. 9, 2008]", "(a) An educational agency or institution that discloses an education record under \u00a7 99.31(a)(2) shall:\n\n(1) Make a reasonable attempt to notify the parent or eligible student at the last known address of the parent or eligible student, unless:\n\n(i) The disclosure is initiated by the parent or eligible student; or\n\n(ii) The annual notification of the agency or institution under \u00a7 99.7 includes a notice that the agency or institution forwards education records to other agencies or institutions that have requested the records and in which the student seeks or intends to enroll or is already enrolled so long as the disclosure is for purposes related to the student's enrollment or transfer;\n\n(2) Give the parent or eligible student, upon request, a copy of the record that was disclosed; and\n\n(3) Give the parent or eligible student, upon request, an opportunity for a hearing under subpart C.\n\n(b) An educational agency or institution may disclose an education record of a student in attendance to another educational agency or institution if:\n\n(1) The student is enrolled in or receives services from the other agency or institution; and\n\n(2) The disclosure meets the requirements of paragraph (a) of this section."], ["34:34:1.1.1.1.32.4.113.6", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "D", "Subpart D\u2014May an Educational Agency or Institution Disclose Personally Identifiable Information From Education Records?", "", "\u00a7 99.35 What conditions apply to disclosure of information for Federal or State program purposes?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 73 FR 74854, Dec. 9, 2008; 76 FR 75642, Dec. 2, 2011]", "(a)(1) Authorized representatives of the officials or agencies headed by officials listed in \u00a7 99.31(a)(3) may have access to education records in connection with an audit or evaluation of Federal or State supported education programs, or for the enforcement of or compliance with Federal legal requirements that relate to those programs.\n\n(2) The State or local educational authority or agency headed by an official listed in \u00a7 99.31(a)(3) is responsible for using reasonable methods to ensure to the greatest extent practicable that any entity or individual designated as its authorized representative\u2014\n\n(i) Uses personally identifiable information only to carry out an audit or evaluation of Federal- or State-supported education programs, or for the enforcement of or compliance with Federal legal requirements related to these programs;\n\n(ii) Protects the personally identifiable information from further disclosures or other uses, except as authorized in paragraph (b)(1) of this section; and\n\n(iii) Destroys the personally identifiable information in accordance with the requirements of paragraphs (b) and (c) of this section.\n\n(3) The State or local educational authority or agency headed by an official listed in \u00a7 99.31(a)(3) must use a written agreement to designate any authorized representative, other than an employee. The written agreement must\u2014\n\n(i) Designate the individual or entity as an authorized representative;\n\n(ii) Specify\u2014\n\n(A) The personally identifiable information from education records to be disclosed;\n\n(B) That the purpose for which the personally identifiable information from education records is disclosed to the authorized representative is to carry out an audit or evaluation of Federal- or State-supported education programs, or to enforce or to comply with Federal legal requirements that relate to those programs; and\n\n(C) A description of the activity with sufficient specificity to make clear that the work falls within the exception of \u00a7 99.31(a)(3), including a description of how the personally identifiable information from education records will be used;\n\n(iii) Require the authorized representative to destroy personally identifiable information from education records when the information is no longer needed for the purpose specified;\n\n(iv) Specify the time period in which the information must be destroyed; and\n\n(v) Establish policies and procedures, consistent with the Act and other Federal and State confidentiality and privacy provisions, to protect personally identifiable information from education records from further disclosure (except back to the disclosing entity) and unauthorized use, including limiting use of personally identifiable information from education records to only authorized representatives with legitimate interests in the audit or evaluation of a Federal- or State-supported education program or for compliance or enforcement of Federal legal requirements related to these programs.\n\n(b) Information that is collected under paragraph (a) of this section must\u2014\n\n(1) Be protected in a manner that does not permit personal identification of individuals by anyone other than the State or local educational authority or agency headed by an official listed in \u00a7 99.31(a)(3) and their authorized representatives, except that the State or local educational authority or agency headed by an official listed in \u00a7 99.31(a)(3) may make further disclosures of personally identifiable information from education records on behalf of the educational agency or institution in accordance with the requirements of \u00a7 99.33(b); and\n\n(2) Be destroyed when no longer needed for the purposes listed in paragraph (a) of this section.\n\n(c) Paragraph (b) of this section does not apply if:\n\n(1) The parent or eligible student has given written consent for the disclosure under \u00a7 99.30; or\n\n(2) The collection of personally identifiable information is specifically authorized by Federal law."], ["34:34:1.1.1.1.32.4.113.7", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "D", "Subpart D\u2014May an Educational Agency or Institution Disclose Personally Identifiable Information From Education Records?", "", "\u00a7 99.36 What conditions apply to disclosure of information in health and safety emergencies?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988; 53 FR 19368, May 27, 1988, as amended at 61 FR 59297, Nov. 21, 1996; 73 FR 74854, Dec. 9, 2008]", "(a) An educational agency or institution may disclose personally identifiable information from an education record to appropriate parties, including parents of an eligible student, in connection with an emergency if knowledge of the information is necessary to protect the health or safety of the student or other individuals.\n\n(b) Nothing in this Act or this part shall prevent an educational agency or institution from\u2014\n\n(1) Including in the education records of a student appropriate information concerning disciplinary action taken against the student for conduct that posed a significant risk to the safety or well-being of that student, other students, or other members of the school community;\n\n(2) Disclosing appropriate information maintained under paragraph (b)(1) of this section to teachers and school officials within the agency or institution who the agency or institution has determined have legitimate educational interests in the behavior of the student; or\n\n(3) Disclosing appropriate information maintained under paragraph (b)(1) of this section to teachers and school officials in other schools who have been determined to have legitimate educational interests in the behavior of the student.\n\n(c) In making a determination under paragraph (a) of this section, an educational agency or institution may take into account the totality of the circumstances pertaining to a threat to the health or safety of a student or other individuals. If the educational agency or institution determines that there is an articulable and significant threat to the health or safety of a student or other individuals, it may disclose information from education records to any person whose knowledge of the information is necessary to protect the health or safety of the student or other individuals. If, based on the information available at the time of the determination, there is a rational basis for the determination, the Department will not substitute its judgment for that of the educational agency or institution in evaluating the circumstances and making its determination."], ["34:34:1.1.1.1.32.4.113.8", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "D", "Subpart D\u2014May an Educational Agency or Institution Disclose Personally Identifiable Information From Education Records?", "", "\u00a7 99.37 What conditions apply to disclosing directory information?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 73 FR 74854, Dec. 9, 2008; 76 FR 75642, Dec. 2, 2011]", "(a) An educational agency or institution may disclose directory information if it has given public notice to parents of students in attendance and eligible students in attendance at the agency or institution of:\n\n(1) The types of personally identifiable information that the agency or institution has designated as directory information;\n\n(2) A parent's or eligible student's right to refuse to let the agency or institution designate any or all of those types of information about the student as directory information; and\n\n(3) The period of time within which a parent or eligible student has to notify the agency or institution in writing that he or she does not want any or all of those types of information about the student designated as directory information.\n\n(b) An educational agency or institution may disclose directory information about former students without complying with the notice and opt out conditions in paragraph (a) of this section. However, the agency or institution must continue to honor any valid request to opt out of the disclosure of directory information made while a student was in attendance unless the student rescinds the opt out request.\n\n(c) A parent or eligible student may not use the right under paragraph (a)(2) of this section to opt out of directory information disclosures to\u2014\n\n(1) Prevent an educational agency or institution from disclosing or requiring a student to disclose the student's name, identifier, or institutional email address in a class in which the student is enrolled; or\n\n(2) Prevent an educational agency or institution from requiring a student to wear, to display publicly, or to disclose a student ID card or badge that exhibits information that may be designated as directory information under \u00a7 99.3 and that has been properly designated by the educational agency or institution as directory information in the public notice provided under paragraph (a)(1) of this section.\n\n(d) In its public notice to parents and eligible students in attendance at the agency or institution that is described in paragraph (a) of this section, an educational agency or institution may specify that disclosure of directory information will be limited to specific parties, for specific purposes, or both. When an educational agency or institution specifies that disclosure of directory information will be limited to specific parties, for specific purposes, or both, the educational agency or institution must limit its directory information disclosures to those specified in its public notice that is described in paragraph (a) of this section.\n\n(e) An educational agency or institution may not disclose or confirm directory information without meeting the written consent requirements in \u00a7 99.30 if a student's social security number or other non-directory information is used alone or combined with other data elements to identify or help identify the student or the student's records."], ["34:34:1.1.1.1.32.4.113.9", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "D", "Subpart D\u2014May an Educational Agency or Institution Disclose Personally Identifiable Information From Education Records?", "", "\u00a7 99.38 What conditions apply to disclosure of information as permitted by State statute adopted after November 19, 1974, concerning the juvenile justice system?", "ED", "", "", "[61 FR 59297, Nov. 21, 1996]", "(a) If reporting or disclosure allowed by State statute concerns the juvenile justice system and the system's ability to effectively serve, prior to adjudication, the student whose records are released, an educational agency or institution may disclose education records under \u00a7 99.31(a)(5)(i)(B).\n\n(b) The officials and authorities to whom the records are disclosed shall certify in writing to the educational agency or institution that the information will not be disclosed to any other party, except as provided under State law, without the prior written consent of the parent of the student."], ["34:34:1.1.1.1.32.5.113.1", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "E", "Subpart E\u2014What Are the Enforcement Procedures?", "", "\u00a7 99.60 What functions has the Secretary delegated to the Office and to the Office of Administrative Law Judges?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 58 FR 3189, Jan. 7, 1993; 82 FR 6253, Jan. 19, 2017]", "(a) For the purposes of this subpart,  Office  means the Office of the Chief Privacy Officer, U.S. Department of Education.\n\n(b) The Secretary designates the Office to:\n\n(1) Investigate, process, and review complaints and violations under the Act and this part; and\n\n(2) Provide technical assistance to ensure compliance with the Act and this part.\n\n(c) The Secretary designates the Office of Administrative Law Judges to act as the Review Board required under the Act to enforce the Act with respect to all applicable programs. The term  applicable program  is defined in section 400 of the General Education Provisions Act."], ["34:34:1.1.1.1.32.5.113.2", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "E", "Subpart E\u2014What Are the Enforcement Procedures?", "", "\u00a7 99.61 What responsibility does an educational agency or institution, a recipient of Department funds, or a third party outside of an educational agency or institution have concerning conflict with State or local laws?", "ED", "", "", "[76 FR 75642, Dec. 2, 2011]", "If an educational agency or institution determines that it cannot comply with the Act or this part due to a conflict with State or local law, it must notify the Office within 45 days, giving the text and citation of the conflicting law. If another recipient of Department funds under any program administered by the Secretary or a third party to which personally identifiable information from education records has been non-consensually disclosed determines that it cannot comply with the Act or this part due to a conflict with State or local law, it also must notify the Office within 45 days, giving the text and citation of the conflicting law."], ["34:34:1.1.1.1.32.5.113.3", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "E", "Subpart E\u2014What Are the Enforcement Procedures?", "", "\u00a7 99.62 What information must an educational agency or institution or other recipient of Department funds submit to the Office?", "ED", "", "", "[76 FR 75643, Dec. 2, 2011]", "The Office may require an educational agency or institution, other recipient of Department funds under any program administered by the Secretary to which personally identifiable information from education records is non-consensually disclosed, or any third party outside of an educational agency or institution to which personally identifiable information from education records is non-consensually disclosed to submit reports, information on policies and procedures, annual notifications, training materials, or other information necessary to carry out the Office's enforcement responsibilities under the Act or this part."], ["34:34:1.1.1.1.32.5.113.4", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "E", "Subpart E\u2014What Are the Enforcement Procedures?", "", "\u00a7 99.63 Where are complaints filed?", "ED", "", "", "[65 FR 41854, July 6, 2000, as amended at 73 FR 74854, Dec. 9, 2008]", "A parent or eligible student may file a written complaint with the Office regarding an alleged violation under the Act and this part. The Office's address is: Family Policy Compliance Office, U.S. Department of Education, 400 Maryland Avenue, SW., Washington, DC 20202."], ["34:34:1.1.1.1.32.5.113.5", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "E", "Subpart E\u2014What Are the Enforcement Procedures?", "", "\u00a7 99.64 What is the investigation procedure?", "ED", "", "", "[53 FR 11943, Apr. 11, 1988, as amended at 58 FR 3189, Jan. 7, 1993; 65 FR 41854, July 6, 2000; 73 FR 74854, Dec. 9, 2008; 76 FR 75643, Dec. 2, 2011]", "(a) A complaint must contain specific allegations of fact giving reasonable cause to believe that a violation of the Act or this part has occurred. A complaint does not have to allege that a violation is based on a policy or practice of the educational agency or institution, other recipient of Department funds under any program administered by the Secretary, or any third party outside of an educational agency or institution.\n\n(b) The Office investigates a timely complaint filed by a parent or eligible student, or conducts its own investigation when no complaint has been filed or a complaint has been withdrawn, to determine whether an educational agency or institution or other recipient of Department funds under any program administered by the Secretary has failed to comply with a provision of the Act or this part. If the Office determines that an educational agency or institution or other recipient of Department funds under any program administered by the Secretary has failed to comply with a provision of the Act or this part, it may also determine whether the failure to comply is based on a policy or practice of the agency or institution or other recipient. The Office also investigates a timely complaint filed by a parent or eligible student, or conducts its own investigation when no complaint has been filed or a complaint has been withdrawn, to determine whether a third party outside of the educational agency or institution has failed to comply with the provisions of \u00a7 99.31(a)(6)(iii)(B) or has improperly redisclosed personally identifiable information from education records in violation of \u00a7 99.33.\n\n(c) A timely complaint is defined as an allegation of a violation of the Act that is submitted to the Office within 180 days of the date of the alleged violation or of the date that the complainant knew or reasonably should have known of the alleged violation.\n\n(d) The Office may extend the time limit in this section for good cause shown."], ["34:34:1.1.1.1.32.5.113.6", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "E", "Subpart E\u2014What Are the Enforcement Procedures?", "", "\u00a7 99.65 What is the content of the notice of investigation issued by the Office?", "ED", "", "", "[73 FR 74855, Dec. 9, 2008, as amended at 76 FR 75643, Dec. 2, 2011]", "(a) The Office notifies in writing the complainant, if any, and the educational agency or institution, the recipient of Department funds under any program administered by the Secretary, or the third party outside of an educational agency or institution if it initiates an investigation under \u00a7 99.64(b). The written notice\u2014\n\n(1) Includes the substance of the allegations against the educational agency or institution, other recipient, or third party; and\n\n(2) Directs the agency or institution, other recipient, or third party to submit a written response and other relevant information, as set forth in \u00a7 99.62, within a specified period of time, including information about its policies and practices regarding education records.\n\n(b) The Office notifies the complainant if it does not initiate an investigation because the complaint fails to meet the requirements of \u00a7 99.64."], ["34:34:1.1.1.1.32.5.113.7", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "E", "Subpart E\u2014What Are the Enforcement Procedures?", "", "\u00a7 99.66 What are the responsibilities of the Office in the enforcement process?", "ED", "", "", "[76 FR 75643, Dec. 2, 2011]", "(a) The Office reviews a complaint, if any, information submitted by the educational agency or institution, other recipient of Department funds under any program administered by the Secretary, or third party outside of an educational agency or institution, and any other relevant information. The Office may permit the parties to submit further written or oral arguments or information.\n\n(b) Following its investigation, the Office provides to the complainant, if any, and the educational agency or institution, other recipient, or third party a written notice of its findings and the basis for its findings.\n\n(c) If the Office finds that an educational agency or institution or other recipient has not complied with a provision of the Act or this part, it may also find that the failure to comply was based on a policy or practice of the agency or institution or other recipient. A notice of findings issued under paragraph (b) of this section to an educational agency or institution, or other recipient that has not complied with a provision of the Act or this part\u2014\n\n(1) Includes a statement of the specific steps that the agency or institution or other recipient must take to comply; and\n\n(2) Provides a reasonable period of time, given all of the circumstances of the case, during which the educational agency or institution or other recipient may comply voluntarily.\n\n(d) If the Office finds that a third party outside of an educational agency or institution has not complied with the provisions of \u00a7 99.31(a)(6)(iii)(B) or has improperly redisclosed personally identifiable information from education records in violation of \u00a7 99.33, the Office's notice of findings issued under paragraph (b) of this section\u2014\n\n(1) Includes a statement of the specific steps that the third party outside of the educational agency or institution must take to comply; and\n\n(2) Provides a reasonable period of time, given all of the circumstances of the case, during which the third party may comply voluntarily."], ["34:34:1.1.1.1.32.5.113.8", 34, "Education", "", "", "99", "PART 99\u2014FAMILY EDUCATIONAL RIGHTS AND PRIVACY", "E", "Subpart E\u2014What Are the Enforcement Procedures?", "", "\u00a7 99.67 How does the Secretary enforce decisions?", "ED", "", "", "[76 FR 75643, Dec. 2, 2011]", "(a) If an educational agency or institution or other recipient of Department funds under any program administered by the Secretary does not comply during the period of time set under \u00a7 99.66(c), the Secretary may take any legally available enforcement action in accordance with the Act, including, but not limited to, the following enforcement actions available in accordance with part D of the General Education Provisions Act\u2014\n\n(1) Withhold further payments under any applicable program;\n\n(2) Issue a complaint to compel compliance through a cease and desist order; or\n\n(3) Terminate eligibility to receive funding under any applicable program.\n\n(b) If, after an investigation under \u00a7 99.66, the Secretary finds that an educational agency or institution, other recipient, or third party has complied voluntarily with the Act or this part, the Secretary provides the complainant and the agency or institution, other recipient, or third party with written notice of the decision and the basis for the decision.\n\n(c) If the Office finds that a third party, outside the educational agency or institution, violates \u00a7 99.31(a)(6)(iii)(B), then the educational agency or institution from which the personally identifiable information originated may not allow the third party found to be responsible for the violation of \u00a7 99.31(a)(6)(iii)(B) access to personally identifiable information from education records for at least five years.\n\n(d) If the Office finds that a State or local educational authority, a Federal agency headed by an official listed in \u00a7 99.31(a)(3), or an authorized representative of a State or local educational authority or a Federal agency headed by an official listed in \u00a7 99.31(a)(3), improperly rediscloses personally identifiable information from education records, then the educational agency or institution from which the personally identifiable information originated may not allow the third party found to be responsible for the improper redisclosure access to personally identifiable information from education records for at least five years.\n\n(e) If the Office finds that a third party, outside the educational agency or institution, improperly rediscloses personally identifiable information from education records in violation of \u00a7 99.33 or fails to provide the notification required under \u00a7 99.33(b)(2), then the educational agency or institution from which the personally identifiable information originated may not allow the third party found to be responsible for the violation access to personally identifiable information from education records for at least five years."], ["49:49:1.0.1.1.41.1.43.1", 49, "Transportation", "A", "", "99", "PART 99\u2014EMPLOYEE RESPONSIBILITIES AND CONDUCT", "A", "Subpart A\u2014General", "", "\u00a7 99.735-1 Cross-reference to ethical conduct standards and financial disclosure regulations.", "DOT", "", "", "[61 FR 39904, July 31, 1996]", "Employees of the Department of Transportation are subject to the executive branch-wide Standards of Ethical Conduct at 5 CFR part 2635, the Department of Transportation regulations at 5 CFR part 6001 which supplement the executive branch-wide standards and the executive branch-wide financial disclosure regulations at 5 CFR part 2634."], ["49:49:1.0.1.1.41.3.43.1", 49, "Transportation", "A", "", "99", "PART 99\u2014EMPLOYEE RESPONSIBILITIES AND CONDUCT", "F", "Subpart F\u2014Responsibilities of the Government Employee and Special Government Employee Following Departure From Government Service", "", "\u00a7 99.735-80 Applicability.", "DOT", "", "", "[58 FR 7995, Feb. 11, 1993]", "The provisions of this subpart apply only to employees who terminated government service before January 1, 1991."], ["49:49:1.0.1.1.41.3.43.2", 49, "Transportation", "A", "", "99", "PART 99\u2014EMPLOYEE RESPONSIBILITIES AND CONDUCT", "F", "Subpart F\u2014Responsibilities of the Government Employee and Special Government Employee Following Departure From Government Service", "", "\u00a7 99.735-81 Post-employment duties and responsibilities.", "DOT", "", "", "", "The duties and obligations of a Government employee (or a special Government employee) do not end when government service terminates by retirement, resignation, or for any other reason. In fact the U.S. Code sets forth specific criminal penalties for certain activities by former Government employees. To summarize broadly, section 207 of title 18, U.S. Code, prohibits a former Government employee from acting as agent or attorney in various types of proceedings and matters on behalf of a non-Government party when the employee was involved in the subject matter while working for the Government. The duration and nature of the prohibitions depend in part on the depth of the employee's involvement in the matter while in Government service. Section 208 of the same title relates to activities performed while a Government employee that benefit an employee's prospective private employer. All Government employees and special Government employees should become familiar with the provisions of the two statutory sections cited, which have been made a part of this regulation as appendix E, so that they will be aware of the restrictions which might affect them upon their termination from the Government service."], ["9:9:1.0.1.4.40.1.74.1", 9, "Animals and Animal Products", "I", "D", "99", "PART 99\u2014RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER CERTAIN ACTS", "A", "Subpart A\u2014General", "", "\u00a7 99.1 Scope and applicability of rules of practice.", "APHIS", "", "", "[48 FR 30095, June 30, 1983. Redesignated at 52 FR 29502, Aug. 10, 1987, as amended at 68 FR 6345, Feb. 7, 2003]", "The Uniform Rules of Practice for the Department of Agriculture promulgated in subpart H of part 1, subtitle A, title 7, Code of Federal Regulations, are the Rules of Practice applicable to adjudicatory, administrative proceedings under the following statutory provisions:\n\nAct of May 29, 1884, commonly known as the Animal Industry Act, section 7, as amended (21 U.S.C. 117),\n \n Act of August 30, 1890, section 6, as amended (21 U.S.C. 104),\n \n Act of February 2, 1903, commonly known as the Cattle Contagious Diseases Act of 1903, section 3, as amended (21 U.S.C. 122),\n \n Act of July 2, 1962, section 6(a), as amended (21 U.S.C. 134e),\n \n Act of May 6, 1970, section 2, as amended (21 U.S.C. 135a).\n \n The Animal Health Protection Act, section 10414 (7 U.S.C. 8313)\n\nAct of May 29, 1884, commonly known as the Animal Industry Act, section 7, as amended (21 U.S.C. 117),\n\nAct of August 30, 1890, section 6, as amended (21 U.S.C. 104),\n\nAct of February 2, 1903, commonly known as the Cattle Contagious Diseases Act of 1903, section 3, as amended (21 U.S.C. 122),\n\nAct of July 2, 1962, section 6(a), as amended (21 U.S.C. 134e),\n\nAct of May 6, 1970, section 2, as amended (21 U.S.C. 135a).\n\nThe Animal Health Protection Act, section 10414 (7 U.S.C. 8313)\n\nIn addition, the Supplemental Rules of Practice set forth in subpart B of this part shall be applicable to such proceedings."], ["9:9:1.0.1.4.40.2.74.1", 9, "Animals and Animal Products", "I", "D", "99", "PART 99\u2014RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER CERTAIN ACTS", "B", "Subpart B\u2014Supplemental Rules of Practice", "", "\u00a7 99.10 Stipulations.", "APHIS", "", "", "[48 FR 30095, June 30, 1983. Redesignated and amended at 52 FR 29502, Aug. 10, 1987]", "(a) At any time prior to the issuance of a complaint seeking a civil penalty under any of the Acts listed in \u00a7 99.1, the Administrator, in his discretion, may enter into a stipulation with any person in which:\n\n(1) The Administrator or the Administrator's delegate gives notice of an apparent violation of the applicable Act, or the regulations issued thereunder, by such person and affords such person an opportunity for a hearing regarding the matter as provided by such Act;\n\n(2) Such person expressly waives hearing and agrees to pay a specified penalty within a designated time; and\n\n(3) The Administrator agrees to accept the penalty in settlement of the particular matter involved if the penalty is paid within the designated time.\n\n(b) If the penalty is not paid within the time designated in such a stipulation, the amount of the stipulated penalty shall not be relevant in any respect to the penalty which may be 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