[Federal Register: March 10, 2010 (Volume 75, Number 46)]
[Rules and Regulations]
[Page 11005-11010]
[DOCID:fr10mr10-6]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 541

[Docket No. NHTSA-2009-0085]

Final Theft Data; Motor Vehicle Theft Prevention Standard

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Publication of final theft data.

-----------------------------------------------------------------------

SUMMARY: This document publishes the final data on thefts of model year
(MY) 2007 passenger motor vehicles that occurred in calendar year (CY)
2007. The final 2007 theft data indicated a decrease in the vehicle
theft rate experienced in CY/MY 2007. The final theft rate for MY 2007
passenger vehicles stolen in calendar year 2007 is 1.86 thefts per
thousand vehicles, a decrease of ten percent from the rate of 2.08
thefts per thousand in 2006. Publication of these data fulfills NHTSA's
statutory obligation to periodically obtain accurate and timely theft
data and publish the information for review and comment.

FOR FURTHER INFORMATION CONTACT: Ms. Deborah Mazyck, Office of
International Policy, Fuel Economy and Consumer Programs, NHTSA, 1200
New Jersey Avenue, SE., Washington, DC 20590. Ms. Mazyck's telephone
number is<PHONE_NUMBER>. Her fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: NHTSA administers a program for reducing
motor vehicle theft. The central feature of this program is the Federal
Motor Vehicle Theft Prevention Standard, 49 CFR part 541. The standard
specifies performance requirements for inscribing and affixing vehicle
identification numbers (VINs) onto certain major original equipment and
replacement parts of high-theft lines of passenger motor vehicles.
    The agency is required by 49 U.S.C. 33104(b)(4) to periodically
obtain, from the most reliable source, accurate and

timely theft data and publish the data for review and comment. To
fulfill this statutory mandate, NHTSA has published theft data annually
beginning with MYs 1983/84. Continuing to fulfill the Sec.  33104(b)(4)
mandate, this document reports the final theft data for CY 2007, the
most recent calendar year for which data are available.
    In calculating the 2007 theft rates, NHTSA followed the same
procedures it used in calculating the MY 2006 theft rates. (For 2006
theft data calculations, see 73 FR 60633, October 14, 2008). As in all
previous reports, NHTSA's data were based on information provided to
NHTSA by the National Crime Information Center (NCIC) of the Federal
Bureau of Investigation. The NCIC is a government system that receives
vehicle theft information from nearly 23,000 criminal justice agencies
and other law enforcement authorities throughout the United States. The
NCIC data also include reported thefts of self-insured and uninsured
vehicles, not all of which are reported to other data sources.
    The 2007 theft rate for each vehicle line was calculated by
dividing the number of reported thefts of MY 2007 vehicles of that line
stolen during calendar year 2007 by the total number of vehicles in
that line manufactured for MY 2007, as reported to the Environmental
Protection Agency (EPA).
    The final 2007 theft data show a decrease in the vehicle theft rate
when compared to the theft rate experienced in CY/MY 2006. The final
theft rate for MY 2007 passenger vehicles stolen in calendar year 2007
decreased to 1.86 thefts per thousand vehicles produced, a decrease of
10.6 percent from the rate of 2.08 thefts per thousand vehicles
experienced by MY 2006 vehicles in CY 2006. The data has shown an
overall decreasing trend in theft rates since CY 1993, with periods of
increase from one year to the next.
    For MY 2007 vehicles, out of a total of 206 vehicle lines, 16 lines
had a theft rate higher than 3.5826 per thousand vehicles, the
established median theft rate for MYs 1990/1991. (See 59 FR 12400,
March 16, 1994). Of the 16 vehicle lines with a theft rate higher than
3.5826, 14 are passenger car lines, two are a multipurpose passenger
vehicle lines, and none are light-duty truck lines.
    The MY 2007 theft rate reduction is consistent with the general
decreasing trend of theft rates over the past 15 years as indicated by
Figure 1. We note, however, that the theft rate from 2003 to 2007 is
virtually unchanged (1.84 to 1.86). This suggests that the progress
made since 1992 may have reached the limits of current approaches to
reducing vehicle thefts, and that some new approaches should be added.
[GRAPHIC] [TIFF OMITTED] TR10MR10.026

    The agency believes that the theft rate reduction could be the
result of several factors including the increased use of standard
antitheft devices (i.e., immobilizers), vehicle parts marking,
increased and improved prosecution efforts by law enforcement
organizations and increased public awareness measures.
    On Wednesday, June 10, 2009, NHTSA published the preliminary theft
rates for CY 2007 passenger motor vehicles in the Federal Register (74
FR 27493). The agency tentatively ranked each of the MY 2007 vehicle
lines in descending order of theft rate. The public was requested to
comment on the accuracy of the data and to provide final production
figures for individual vehicle lines. The agency used written comments
to make the necessary adjustments to its data. As a result of the
adjustments, some of the final theft rates and rankings of vehicle
lines changed from those published in the June 2009 notice. The agency
received written comments from Volkswagen Group of America, Inc. (VW)
and Nissan North America, Inc. (Nissan).
    In its comments, VW informed the agency that the entries for the
Audi RS4, Audi A8, Audi A4/A4 Quattro/S4/S4 Avant and Audi RS4 were
listed with incorrect manufacturer designations. The final theft data
has been revised to reflect that Audi is the manufacturer for

the Audi RS4, Audi A8, Audi A4/A4 Quattro/S4/S4 Avant and Audi RS4
vehicles.
    Additionally, Nissan informed the agency that its Nissan Xterra and
Versa vehicle lines were not listed in the agency's June 2009
publication of preliminary data. Upon review, the agency found that the
Xterra vehicle line has a gross vehicle weight rating (GVWR) over 6,000
pounds. Therefore, because the scope of the Federal Motor Vehicle Theft
Prevention Standard applies to only vehicles with a GVWR of 6,000
pounds or less, the Nissan Xterra was not included on the agency's
publication. The agency also notes that the Nissan Versa was
erroneously omitted from the publication of preliminary theft data and
therefore, has corrected the final theft data to reflect the theft rate
information for the Nissan Versa. As a result of this correction, the
Nissan Versa is ranked No. 95 with a theft rate of 1.3216.
    Further reanalysis of the theft rate data also revealed that the
production volume listed for the Pontiac G5 was incorrect. The
production volume for the Pontiac G5 has been corrected and the final
theft list has been revised accordingly. As a result of the correction,
the Pontiac G5 previously ranked No. 94 with a theft rate of 1.3216 is
now ranked No. 2 with a theft rate of 11.2523.
    Review of the theft rate data also revealed that the Chrysler
Crossfire was not included on the publication of preliminary theft
data. NHTSA has corrected the final theft data to include the Chrysler
Crossfire. As a result of this correction, the final theft list has
been revised accordingly. The Chrysler Crossfire, previously omitted,
is now ranked No. 193 with a theft rate of 0.0000.
    The following list represents NHTSA's final calculation of theft
rates for all 2007 passenger motor vehicle lines. This list is intended
to inform the public of calendar year 2007 motor vehicle thefts of
model year 2007 vehicles and does not have any effect on the
obligations of regulated parties under 49 U.S.C. Chapter 331, Theft
Prevention.

      Final Report of Theft Rates For Model Year 2007 Passenger Motor Vehicles Stolen in Calendar Year 2007
----------------------------------------------------------------------------------------------------------------
                                                                                2007 theft
                                                                                rate (per
                                Manufacturer     Make/model (line)   Thefts 2007    Production         1,000
                                                                                (Mfr's) 2007      vehicles
                                                                                produced)
----------------------------------------------------------------------------------------------------------------
1...........................  CHRYSLER.......  DODGE MAGNUM........          344           28059         12.2599
2...........................  GENERAL MOTORS.  PONTIAC G5..........           54            4799         11.2523
3...........................  CHRYSLER.......  DODGE CHARGER.......         1148          120636          9.5162
4...........................  GENERAL MOTORS.  CHEVROLET MONTE               174           21689          8.0225
                                                CARLO.
5...........................  GENERAL MOTORS.  PONTIAC GRAND PRIX..          534           77689          6.8736
6...........................  CHRYSLER.......  300.................          715          121529          5.8834
7...........................  MITSUBISHI.....  LANCER..............           12            2355          5.0955
8...........................  ROLLS ROYCE....  PHANTOM.............            2             398          5.0251
9...........................  MERCEDES-BENZ..  215 (CL-CLASS)......           43            9296          4.6256
10..........................  FORD MOTOR CO..  TAURUS..............          510          114616          4.4496
11..........................  CHRYSLER.......  SEBRING.............          338           78059          4.3301
12..........................  CHRYSLER.......  PT CRUISER..........          443          104546          4.2374
13..........................  SUZUKI.........  FORENZA.............          133           34236          3.8848
14..........................  GENERAL MOTORS.  PONTIAC G6..........          629          164306          3.8282
15..........................  GENERAL MOTORS.  CHEVROLET MALIBU....          487          127718          3.8131
16..........................  MITSUBISHI.....  GALANT..............          103           27141          3.7950
17..........................  MAZDA..........  6...................          201           56178          3.5779
18..........................  AUDI...........  AUDI RS4............            5            1475          3.3898
19..........................  CHRYSLER.......  PACIFICA............          197           60392          3.2620
20..........................  GENERAL MOTORS.  CHEVROLET COBALT....          703          215663          3.2597
21..........................  FORD MOTOR CO..  MUSTANG.............          518          159345          3.2508
22..........................  FORD MOTOR CO..  LINCOLN TOWN CAR....          114           35281          3.2312
23..........................  CHRYSLER.......  DODGE CALIBER.......          560          175537          3.1902
24..........................  KIA............  OPTIMA..............          127           40914          3.1041
25..........................  NISSAN.........  350Z................           49           15831          3.0952
26..........................  NISSAN.........  INFINITI FX35.......           40           13346          2.9972
27..........................  GENERAL MOTORS.  CADILLAC DTS........          140           47396          2.9538
28..........................  GENERAL MOTORS.  CHEVROLET IMPALA....          769          267375          2.8761
29..........................  KIA............  SPECTRA.............          171           64591          2.6474
30..........................  KIA............  RIO.................           83           31947          2.5981
31..........................  MITSUBISHI.....  ECLIPSE.............          107           42300          2.5296
32..........................  FORD MOTOR CO..  FOCUS...............          576          229738          2.5072
33..........................  GENERAL MOTORS.  CHEVROLET AVEO......          166           67104          2.4738
34..........................  HYUNDAI........  SONATA..............          302          123439          2.4466
35..........................  VOLVO..........  S40.................           53           21905          2.4195
36..........................  HYUNDAI........  ELANTRA.............          192           80133          2.3960
37..........................  NISSAN.........  MAXIMA..............          152           63601          2.3899
38..........................  BMW............  M6..................            8            3400          2.3529
39..........................  MITSUBISHI.....  ENDEAVOR............           30           12805          2.3428
40..........................  NISSAN.........  SENTRA..............          225           96584          2.3296
41..........................  FORD MOTOR CO..  CROWN VICTORIA......           17            7424          2.2899
42..........................  CHRYSLER.......  JEEP LIBERTY........          209           91466          2.2850
43..........................  GENERAL MOTORS.  CHEVROLET HHR.......          223           99681          2.2371
44..........................  MERCEDES-BENZ..  220 (S-CLASS).......           91           41867          2.1735
45..........................  TOYOTA.........  COROLLA.............          740          351414          2.1058
46..........................  NISSAN.........  INFINITI FX45.......            1             475          2.1053

47..........................  GENERAL MOTORS.  CHEVROLET                     257          122918          2.0908
                                                TRAILBLAZER.
48..........................  GENERAL MOTORS.  BUICK LACROSSE/               113           54938          2.0569
                                                ALLURE.
49..........................  HUMMER.........  H3..................           95           46341          2.0500
50..........................  NISSAN.........  ALTIMA..............          413          202162          2.0429
51..........................  SUZUKI.........  RENO................           62           30424          2.0379
52..........................  FORD MOTOR CO..  MERCURY GRAND                  81           39757          2.0374
                                                MARQUIS.
53..........................  JAGUAR.........  XK8.................            6            2965          2.0236
54..........................  KIA............  SORENTO.............           64           31798          2.0127
55..........................  MAZDA..........  5...................           33           16424          2.0093
56..........................  GENERAL MOTORS.  SATURN ION..........          185           94117          1.9656
57..........................  AUDI...........  AUDI A8.............           10            5106          1.9585
58..........................  HYUNDAI........  ACCENT..............           86           44314          1.9407
59..........................  GENERAL MOTORS.  CADILLAC CTS........           97           53360          1.8178
60..........................  FORD MOTOR CO..  FUSION..............          266          146464          1.8161
61..........................  NISSAN.........  PATHFINDER..........           76           42137          1.8036
62..........................  HYUNDAI........  AZERA...............           40           22218          1.8003
63..........................  CHRYSLER.......  DODGE CARAVAN/GRAND           284          164003          1.7317
                                                CARAVAN.
64..........................  GENERAL MOTORS.  CHEVROLET CORVETTE..           65           37744          1.7221
65..........................  BMW............  M5..................            2            1163          1.7197
66..........................  VOLKSWAGEN.....  JETTA...............          146           84922          1.7192
67..........................  GENERAL MOTORS.  PONTIAC G6..........           54           32894          1.6416
68..........................  BMW............  6...................           11            6779          1.6227
69..........................  FORD MOTOR CO..  FREESTAR VAN........           30           18579          1.6147
70..........................  NISSAN.........  INFINITI M35/M45....           48           30144          1.5924
71..........................  TOYOTA.........  YARIS...............          252          159292          1.5820
72..........................  HONDA..........  ACCORD..............          664          421206          1.5764
73..........................  CHRYSLER.......  DODGE NITRO.........          133           84441          1.5751
74..........................  MAZDA..........  RX-8................            9            5728          1.5712
75..........................  FORD MOTOR CO..  MERCURY MILAN.......           55           35375          1.5548
76..........................  AUDI...........  AUDI A6/A6 QUATTRO/            18           11660          1.5437
                                                S6/S6 AVANT.
77..........................  FORD MOTOR CO..  FIVE HUNDRED........           94           61270          1.5342
78..........................  TOYOTA.........  AVALON..............          121           79137          1.5290
79..........................  NISSAN.........  MURANO..............          137           92516          1.4808
80..........................  TOYOTA.........  HIGHLANDER..........          148          100956          1.4660
81..........................  TOYOTA.........  CAMRY/SOLARA........         1003          685729          1.4627
82..........................  NISSAN.........  INFINITI G35........           83           57041          1.4551
83..........................  GENERAL MOTORS.  CHEVROLET UPLANDER             87           60061          1.4485
                                                VAN.
84..........................  GENERAL MOTORS.  CADILLAC STS........           24           16746          1.4332
85..........................  GENERAL MOTORS.  CADILLAC XLR........            2            1400          1.4286
86..........................  HONDA..........  S2000...............            7            4907          1.4265
87..........................  KIA............  AMANTI..............            6            4343          1.3815
88..........................  MERCEDES-BENZ..  208 (CLK-CLASS).....           19           13825          1.3743
89..........................  NISSAN.........  FRONTIER PICKUP.....           87           64010          1.3592
90..........................  GENERAL MOTORS.  CHEVROLET COLORADO             95           70012          1.3569
                                                PICKUP.
91..........................  GENERAL MOTORS.  GMC CANYON PICKUP...           25           18483          1.3526
92..........................  BMW............  7...................           22           16421          1.3397
93..........................  TOYOTA.........  FJ CRUISER..........          112           83830          1.3360
94..........................  MAZDA..........  3...................          153          114723          1.3336
95..........................  NISSAN.........  VERSA...............          107           80962          1.3216
96..........................  SUBARU.........  IMPREZA.............           51           39198          1.3011
97..........................  AUDI...........  AUDI A4/A4 QUATTRO/            64           49645          1.2892
                                                S4/S4 AVANT.
98..........................  NISSAN.........  QUEST VAN...........           47           36661          1.2820
99..........................  HONDA..........  ACURA TSX...........           29           22669          1.2793
100.........................  KIA............  SPORTAGE............           58           45512          1.2744
101.........................  TOYOTA.........  TACOMA PICKUP.......          206          165714          1.2431
102.........................  FORD MOTOR CO..  RANGER PICKUP.......           94           77539          1.2123
103.........................  TOYOTA.........  4RUNNER.............          132          109124          1.2096
104.........................  MERCEDES-BENZ..  170 (SLK-CLASS).....            9            7459          1.2066
105.........................  GENERAL MOTORS.  SATURN AURA.........           77           64851          1.1873
106.........................  GENERAL MOTORS.  PONTIAC TORRENT.....           35           29918          1.1699
107.........................  HONDA..........  HONDA CIVIC.........          389          332639          1.1694
108.........................  GENERAL MOTORS.  CADILLAC FUNERAL                1             857          1.1669
                                                COACH/HEARSE.
109.........................  MITSUBISHI.....  OUTLANDER...........           37           31873          1.1609
110.........................  AUDI...........  AUDI A3/A3 QUATTRO..            8            6992          1.1442
111.........................  VOLKSWAGEN.....  GOLF/RABBIT/GTI.....           46           41314          1.1134
112.........................  GENERAL MOTORS.  CHEVROLET EQUINOX...           94           87031          1.0801
113.........................  HYUNDAI........  TIBURON.............           15           13951          1.0752
114.........................  VOLKSWAGEN.....  PASSAT..............           42           39867          1.0535

115.........................  MERCEDES-BENZ..  129 (SL-CLASS)......            8            7648          1.0460
116.........................  FORD MOTOR CO..  MERCURY MONTEGO.....           16           15439          1.0363
117.........................  GENERAL MOTORS.  GMC ENVOY...........           38           36989          1.0273
118.........................  HYUNDAI........  TUCSON..............           45           44033          1.0220
119.........................  HONDA..........  ACURA 3.2 TL........            5            4905          1.0194
120.........................  GENERAL MOTORS.  BUICK TERRAZA VAN...            8            7865          1.0172
121.........................  FORD MOTOR CO..  ESCAPE..............          110          108788          1.0111
122.........................  JAGUAR.........  X-TYPE..............            3            3018          0.9940
123.........................  HONDA..........  ACURA 3.5 RL........           49           49471          0.9905
124.........................  JAGUAR.........  VANDEN PLAS/SUPER V8            1            1010          0.9901
125.........................  SUZUKI.........  SX4.................           15           15421          0.9727
126.........................  VOLVO..........  S80.................           10           10805          0.9255
127.........................  GENERAL MOTORS.  PONTIAC VIBE........           30           32499          0.9231
128.........................  HONDA..........  ELEMENT.............           31           33688          0.9202
129.........................  MAZDA..........  B SERIES PICKUP.....            3            3285          0.9132
130.........................  BMW............  5...................           47           51970          0.9044
131.........................  GENERAL MOTORS.  SATURN SKY..........           14           15546          0.9006
132.........................  GENERAL MOTORS.  BUICK LUCERNE.......           76           85922          0.8845
133.........................  TOYOTA.........  LEXUS LS............           31           35167          0.8815
134.........................  HONDA..........  ACURA RDX...........           22           25159          0.8744
135.........................  CHRYSLER.......  JEEP WRANGLER.......           88          100955          0.8717
136.........................  FORD MOTOR CO..  EDGE................          105          121525          0.8640
137.........................  KIA............  RONDO...............           22           25524          0.8619
138.........................  TOYOTA.........  LEXUS RX............           82           98473          0.8327
139.........................  VOLKSWAGEN.....  EOS.................           11           13406          0.8205
140.........................  TOYOTA.........  RAV4................          145          181051          0.8009
141.........................  FORD MOTOR CO..  FREESTYLE...........           30           38047          0.7885
142.........................  HYUNDAI........  SANTA FE............           89          113815          0.7820
143.........................  BMW............  Z4/M................            8           10568          0.7570
144.........................  GENERAL MOTORS.  PONTIAC SOLSTICE....           16           21310          0.7508
145.........................  SUZUKI.........  AERIO...............            4            5544          0.7215
146.........................  PORSCHE........  CAYMAN..............            4            5552          0.7205
147.........................  PORSCHE........  911.................            9           12521          0.7188
148.........................  TOYOTA.........  LEXUS IS............           41           57055          0.7186
149.........................  MERCEDES-BENZ..  203 (C-CLASS).......           83          116282          0.7138
150.........................  BENTLEY MOTORS.  CONTINENTAL.........            3            4265          0.7034
151.........................  BMW............  X3..................           22           31365          0.7014
152.........................  SUBARU.........  B9 TRIBECA..........            8           11538          0.6934
153.........................  BMW............  3...................           97          139966          0.6930
154.........................  MAZDA..........  MAZDA CX-7..........           52           75137          0.6921
155.........................  VOLVO..........  S60.................           14           20268          0.6907
156.........................  CHRYSLER.......  JEEP PATRIOT........           20           29421          0.6798
157.........................  ASTON MARTIN...  VANTAGE.............            1            1474          0.6784
158.........................  KIA............  SEDONA VAN..........           41           60873          0.6735
159.........................  HONDA..........  FIT.................           46           68642          0.6701
160.........................  SUBARU.........  LEGACY/OUTBACK......           10           14963          0.6683
161.........................  TOYOTA.........  SIENNA VAN..........           63           96072          0.6558
162.........................  HONDA..........  ACURA MDX...........           35           53550          0.6536
163.........................  FORD MOTOR CO..  MERCURY MONTEREY VAN            1            1553          0.6439
164.........................  FORD MOTOR CO..  LINCOLN MKX.........           22           34571          0.6364
165.........................  GENERAL MOTORS.  BUICK RAINIER.......            3            4723          0.6352
166.........................  SUBARU.........  OUTBACK.............           27           42747          0.6316
167.........................  HONDA..........  PILOT...............           77          122033          0.6310
168.........................  FORD MOTOR CO..  LINCOLN ZEPHYR......           20           32952          0.6069
169.........................  JAGUAR.........  XKR.................            3            5030          0.5964
170.........................  TOYOTA.........  LEXUS GS............           17           28638          0.5936
171.........................  VOLVO..........  V50.................            2            3373          0.5929
172.........................  MERCEDES-BENZ..  210 (E-CLASS).......           31           52557          0.5898
173.........................  MAZDA..........  MX-5 MIATA..........            7           13353          0.5242
174.........................  VOLVO..........  XC90................           15           30762          0.4876
175.........................  GENERAL MOTORS.  BUICK RENDEZVOUS....           14           29187          0.4797
176.........................  VOLKSWAGEN.....  NEW BEETLE..........           13           27249          0.4771
177.........................  HYUNDAI........  VERACRUZ............            6           12726          0.4715
178.........................  VOLVO..........  XC70................            6           13197          0.4546
179.........................  HONDA..........  CR-V................          104          229378          0.4534
180.........................  PORSCHE........  BOXSTER.............            2            4427          0.4518
181.........................  TOYOTA.........  LEXUS ES............           54          121577          0.4442
182.........................  SUBARU.........  FORESTER............           19           43985          0.4320

183.........................  BMW............  MINI COOPER.........           15           38511          0.3895
184.........................  JAGUAR.........  S-TYPE..............            1            2582          0.3873
185.........................  TOYOTA.........  PRIUS...............           53          158715          0.3339
186.........................  SAAB...........  9-3.................            7           22401          0.3125
187.........................  HONDA..........  ODYSSEY VAN.........           64          208166          0.3074
188.........................  FORD MOTOR CO..  MERCURY MARINER.....            6           20842          0.2879
189.........................  VOLVO..........  C70.................            1            5612          0.1782
190.........................  TOYOTA.........  LEXUS SC............            8           80617          0.0992
191.........................  ASTON MARTIN...  DB9.................            0             688          0.0000
192.........................  BENTLEY MOTORS.  ARNAGE..............            0             140          0.0000
193.........................  BENTLEY MOTORS.  AZURE...............            0             184          0.0000
194.........................  CHRYSLER.......  CROSSFIRE...........            0            3412          0.0000
195.........................  FERRARI........  141.................            0             364          0.0000
196.........................  FERRARI........  612 SCAGLIETTI......            0              66          0.0000
197.........................  FERRARI........  430.................            0            1382          0.0000
198.........................  GENERAL MOTORS.  CADILLAC LIMOUSINE..            0             648          0.0000
199.........................  JAGUAR.........  XJ8/XJ8L............            0            1645          0.0000
200.........................  JAGUAR.........  XJR.................            0             221          0.0000
201.........................  LAMBORGHINI....  MURCIELAGO..........            0             164          0.0000
202.........................  LAMBORGHINI....  GALLARDO............            0             558          0.0000
203.........................  MASERATI.......  QUATTROPORTE........            0            2176          0.0000
204.........................  SAAB...........  9-5.................            0            4084          0.0000
205.........................  SPYKER.........  C8..................            0               7          0.0000
206.........................  VOLVO..........  V70.................            0            3899          0.0000
----------------------------------------------------------------------------------------------------------------

    Issued on: March 4, 2010.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
[FR Doc. 2010-5080 Filed 3-9-10; 8:45 am]
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[Federal Register Volume 87, Number 211 (Wednesday, November 2, 2022)]
[Notices]
[Pages 66191-66192]
[FR Doc No: 2022-23785]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0446]

Expanded Access to Investigational Drugs for Treatment Use:
Questions and Answers; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Expanded Access to Investigational Drugs for Treatment Use: Questions
and Answers.'' Since 2017, FDA has received many questions concerning
implementation of the regulatory requirements of the expanded access
program. In addition, FDA developed recommendations for fulfilling the
new requirements for expanded access submissions promulgated in the
21st Century Cures Act (Cures Act) (2016) and the FDA Reauthorization
Act of 2017 (FDARA). FDA is providing this guidance in a question-and-
answer format, addressing the most recent frequently asked questions
and sharing recommendations to fulfill the new statutory requirements.
This guidance revises the guidance of the same title issued in June
2016 and updated in October 2017.

DATES: Submit either electronic or written comments on the draft
guidance by January 3, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-D-0446 for ``Expanded Access to Investigational Drugs for
Treatment Use: Questions and Answers.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Expanded Access to Investigational Drugs for
Treatment Use: Questions and Answers.'' Under the expanded access
regulation provided in 21 CFR part 312, subpart I, FDA allows

use of investigational drugs for treatment of patients with serious or
immediately life-threatening diseases or conditions who lack
therapeutic alternatives. FDA issued a guidance in 2016 (updated in
2017) in a question-and-answer format to respond to the most frequently
asked questions on various provisions of the regulation regarding
expanded access.
    The Cures Act added section 561A to the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-0) to include new
requirements regarding expanded access. Under section 561A of the FD&C
Act, a manufacturer or distributor of one or more investigational drugs
for the diagnosis, monitoring, or treatment of one or more serious
diseases or conditions is required to make its policy for evaluating
and responding to expanded access requests (expanded access policy)
readily available to the public, such as by posting the policy on a
publicly available website. In addition, FDARA (Pub. L. 115-52) amended
the FD&C Act to require that the expanded access policy for an
investigational drug be posted by the earlier of (1) the first
initiation of a phase 2 or phase 3 study with respect to such
investigational drug or (2) within 15 days after the drug receives a
fast track, breakthrough, or regenerative advanced therapy designation.
    This revised draft guidance includes responses to stakeholder
questions received since publication of the updated final guidance in
2017 and includes the Agency's recommendations related to new
requirements of the Cures Act and FDARA that are related to expanded
access. This guidance revises the guidance for industry of the same
title issued in June 2016 and updated in October 2017. Significant
changes to the 2017 version of the guidance include additional
recommendations related to institutional review board review, informed
consent, and new requirements established by the Cures Act and FDARA.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
``Expanded Access to Investigational Drugs for Treatment Use: Questions
and Answers.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR parts 50 and
56 have been approved under OMB control number 0910-0130; the
collections of information under the Expanded Access regulations (21
CFR 312.300 through 312.320) have been approved under OMB control
number 0910-0814; and the collections of information in 42 CFR part 11
have been approved under OMB control number 0925-0586.

III. Electronic Access

    Persons with access to the internet may obtain the revised draft
guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23785 Filed 11-1-22; 8:45 am]
BILLING CODE 4164-01-P