[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Proposed Rules]
[Pages 41016-41022]
[FR Doc No: 2013-16428]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 541

[Docket No. NHTSA-2013-0073]

Preliminary Theft Data; Motor Vehicle Theft Prevention Standard

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

ACTION: Publication of preliminary theft data; request for comments.

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SUMMARY: This document requests comments on data about passenger motor
vehicle thefts that occurred in calendar year (CY) 2011, including
theft rates for existing passenger motor vehicle lines manufactured in
model year (MY) 2011. The preliminary theft data indicate that the
vehicle theft rate for CY/MY 2011 vehicles (0.10 thefts per thousand
vehicles) significantly decreased by 91.45 percent from the theft rate
for CY/MY 2010 vehicles (1.17 thefts per thousand vehicles).
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.

DATES: Comments must be submitted on or before September 9, 2013.

ADDRESSES: You may submit comments identified by Docket No. NHTSA-2012-
0073 by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the Public
Participation heading of the Supplementary Information section of this
document. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketsInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets.

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 (202)

366-4139. 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 or 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 the section
33104(b)(4) mandate, this document reports the preliminary theft data
for CY 2010 the most recent calendar year for which data are available.
    In calculating the 2011 theft rates, NHTSA followed the same
procedures it has used since publication of the 1983/1984 theft rate
data (50 FR 46669, November 12, 1985). The 2011 theft rate for each
vehicle line was calculated by dividing the number of reported thefts
of MY 2011 vehicles of that line stolen during calendar year 2011 by
the total number of vehicles in that line manufactured for MY 2011, as
reported to the Environmental Protection Agency (EPA). 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 approximately 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 preliminary 2011 theft data show a significant decrease in the
vehicle theft rate when compared to the theft rate experienced in CY/MY
2010 (For 2010 theft data, see 77 FR 58500, September 21, 2012). The
preliminary theft rate for MY 2011 passenger vehicles stolen in
calendar year 2011 decreased to 0.10 thefts per thousand vehicles
produced, a decrease of 91.45 percent from the rate of 1.17 thefts per
thousand vehicles experienced by MY vehicles in CY 2010. For MY 2011
vehicles, out of a total of 226 vehicle lines, four 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
four vehicle lines with a theft rate higher than 3.5826, four are
passenger car lines, none are multipurpose passenger vehicle lines, and
none are light-duty truck lines.
    The agency believes that the theft rate reduction is a result of
several factors, including vehicle parts marking; the increased use of
standard antitheft devices and other advances in electronic technology
(i.e., immobilizers) and theft prevention methods; increased and
improved prosecution efforts by law enforcement organizations; and,
increased public awareness which may have contributed to the overall
reduction in vehicle thefts. The preliminary MY 2011 theft rate
reduction is consistent with the general decreasing trend of theft
rates over the past 19 years as indicated by Figure 1.

[GRAPHIC] [TIFF OMITTED] TP09JY13.014

    In Table I, NHTSA has tentatively ranked each of the MY 2011
vehicle lines in descending order of theft rate. Public comment is
sought on the accuracy of the data, including the data for the
production volumes of individual vehicle lines.
    Comments must not exceed 15 pages in length (49 CFR 553.21).
Attachments may be appended to these submissions without regard to the
15 page limit. This limitation is intended to encourage commenters to
detail their primary arguments in a concise fashion.
    If a commenter wishes to submit certain information under a claim
of confidentiality, three copies of the complete submission, including
purportedly confidential business information, should be submitted to
the Chief Counsel, NHTSA, at the street address given in the FOR
FURTHER INFORMATION CONTACT section, and two copies from which the
purportedly confidential information has been deleted should be
submitted to the docket. A request for confidentiality should be
accompanied by a cover letter setting forth the information specified
in the agency's confidential business information regulation. 49 CFR
part 512.
    All comments received before the close of business on the comment
closing date indicated above for this document will be considered, and
will be available for examination in the docket at the above address
both before and after that date. To the extent possible, comments filed
after the closing date will also be considered. Comments on this
document will be available for inspection in the docket. NHTSA will
continue to file relevant information as it becomes available for
inspection in the docket after the closing date, and it is recommended
that interested persons continue to examine the docket for new
material.
    Those persons desiring to be notified upon receipt of their
comments in the rules docket should enclose a self-addressed, stamped
postcard in the envelope with their comments. Upon receiving the
comments, the docket supervisor will return the postcard by mail.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://DocketsInfo.dot.gov.

    Authority:  49 U.S.C. 33101, 33102 and 33104; delegation of
authority at 49 CFR 1.50.

   Preliminary Report of Theft Rates for Model Year 2011 Passenger Motor Vehicles Stolen in Calendar Year 2011
----------------------------------------------------------------------------------------------------------------
                                                                                2011  Theft
                                                                                Production   rate  (per
                                      Manufacturer      Make/model (line)     Thefts      (mfr's)       1,000
                                                                               2011         2011       vehicles
                                                                                produced)
----------------------------------------------------------------------------------------------------------------
 1..............................  CHRYSLER...........  DODGE CHARGER.....          216       44,849       4.8162
 2..............................  MITSUBISHI.........  GALANT............           71       16,728       4.2444
 3..............................  GENERAL MOTORS.....  CADILLAC STS......           18        4,637       3.8818
 4..............................  LAMBORGHINI........  GALLARDO..........            1          259       3.8610
 5..............................  HYUNDAI............  ACCENT............          106       30,231       3.5063
 6..............................  GENERAL MOTORS.....  CHEVROLET IMPALA..          591      172,098       3.4341
 7..............................  GENERAL MOTORS.....  CHEVROLET HHR.....          230       68,454       3.3599
 8..............................  GENERAL MOTORS.....  CHEVROLET AVEO....          142       42,367       3.3517
 9..............................  NISSAN.............  INFINITI FX35.....           21        6,711       3.1292
 10.............................  NISSAN.............  GT-R..............            1          326       3.0675
 11.............................  KIA................  RIO...............           51       18,803       2.7123
 12.............................  PORSCHE............  PANAMERA..........           22        8,144       2.7014
 13.............................  CHRYSLER...........  DODGE CHALLENGER..           60       24,237       2.4756
 14.............................  NISSAN.............  VERSA.............          229       97,410       2.3509
 15.............................  FORD MOTOR CO......  MERCURY GRAND                23       10,050       2.2886
                                                        MARQUIS.
 16.............................  NISSAN.............  SENTRA............          213       95,341       2.2341
 17.............................  NISSAN.............  ALTIMA............          387      179,269       2.1588
 18.............................  AUDI...............  AUDI A8...........           10        4,751       2.1048
 19.............................  MAZDA..............  6.................           52       25,456       2.0427
 20.............................  GENERAL MOTORS.....  CHEVROLET CAMARO..          196       97,518       2.0099
 21.............................  MERCEDES-BENZ......  S-CLASS...........           19        9,652       1.9685
 22.............................  TOYOTA.............  MATRIX............            9        4,588       1.9616
 23.............................  GENERAL MOTORS.....  CHEVROLET MALIBU..          400      211,025       1.8955
 24.............................  MITSUBISHI.........  ENDEAVOR..........           22       12,018       1.8306
 25.............................  CHRYSLER...........  DODGE AVENGER.....           73       41,013       1.7799
 26.............................  CHRYSLER...........  DODGE CALIBER.....           65       37,104       1.7518
 27.............................  KIA................  FORTE.............           91       52,119       1.7460
 28.............................  FORD MOTOR CO......  MUSTANG...........          107       61,620       1.7365
 29.............................  SAAB...............  9-3...............            3        1,750       1.7143
 30.............................  GENERAL MOTORS.....  CADILLAC DTS......           28       17,146       1.6330
 31.............................  NISSAN.............  MAXIMA............          101       62,836       1.6074
 32.............................  TOYOTA.............  CAMRY/SOLARA......          781      486,288       1.6060
 33.............................  FORD MOTOR CO......  TAURUS............          118       76,821       1.5360
 34.............................  TOYOTA.............  YARIS.............           38       24,850       1.5292
 35.............................  AUDI...............  AUDI A3...........           10        6,734       1.4850
 36.............................  CHRYSLER...........  300...............           42       28,373       1.4803
 37.............................  FORD MOTOR CO......  CROWN VICTORIA....           27       19,244       1.4030
 38.............................  JAGUAR LAND ROVER..  XJ................            4        2,852       1.4025
 39.............................  FORD MOTOR CO......  MERCURY MARINER...           12        8,656       1.3863
 40.............................  FORD MOTOR CO......  FOCUS.............          127       91,762       1.3840
 41.............................  MERCEDES-BENZ......  CLS-CLASS.........            2        1,472       1.3587
 42.............................  HONDA..............  ACURA ZDX.........            1          737       1.3569
 43.............................  NISSAN.............  INFINITI G25/G37..           72       53,917       1.3354
 44.............................  MAZDA..............  RX-8..............            1          768       1.3021
 45.............................  MASERATI...........  GRANTURISMO.......            2        1,545       1.2945
 46.............................  MAZDA..............  3.................          123       97,252       1.2648
 47.............................  BENTLEY MOTORS.....  CONTINENTAL.......            1          809       1.2361
 48.............................  MERCEDES-BENZ......  C-CLASS...........           74       60,373       1.2257
 49.............................  SUZUKI.............  SX4...............           16       13,280       1.2048
 50.............................  KIA................  SEDONA VAN........           20       16,717       1.1964
 51.............................  HYUNDAI............  ELANTRA...........          119       99,916       1.1910
 52.............................  NISSAN.............  CUBE..............           17       14,294       1.1893
 53.............................  HYUNDAI............  SONATA............          350      301,276       1.1617
 54.............................  HONDA..............  CIVIC.............          158      136,721       1.1556
 55.............................  TOYOTA.............  SCION XB..........           23       19,909       1.1553
 56.............................  VOLVO..............  S40...............            5        4,352       1.1489
 57.............................  SUZUKI.............  KIZASHI...........            7        6,110       1.1457
 58.............................  CHRYSLER...........  JEEP LIBERTY......           65       57,104       1.1383
 59.............................  FORD MOTOR CO......  FUSION............          239      211,964       1.1276
 60.............................  AUDI...............  AUDI A6...........            8        7,108       1.1255
 61.............................  CHRYSLER...........  200...............           72       64,140       1.1225
 62.............................  CHRYSLER...........  DODGE NITRO.......           40       35,638       1.1224
 63.............................  KIA................  SPORTAGE..........           50       45,604       1.0964
 64.............................  NISSAN.............  INFINITI M37/M56..           16       14,818       1.0798
 65.............................  BMW................  7.................           13       12,087       1.0755
 66.............................  TOYOTA.............  SCION TC..........           20       18,637       1.0731
 67.............................  KIA................  OPTIMA............           69       64,320       1.0728

 68.............................  FORD MOTOR CO......  LINCOLN TOWN CAR..           15       14,209       1.0557
 69.............................  HONDA..............  CR-Z..............           17       16,421       1.0353
 70.............................  MERCEDES-BENZ......  GLK-CLASS.........           21       21,303       0.9858
 71.............................  TOYOTA.............  COROLLA...........          215      223,032       0.9640
 72.............................  FORD MOTOR CO......  LINCOLN MKT.......            4        4,274       0.9359
 73.............................  VOLVO..............  S80...............            4        4,281       0.9344
 74.............................  BMW................  M3................            7        7,575       0.9241
 75.............................  GENERAL MOTORS.....  GMC CANYON PICKUP.            6        6,510       0.9217
 76.............................  TOYOTA.............  LEXUS GS..........            5        5,485       0.9116
 77.............................  FORD MOTOR CO......  LINCOLN MKS.......           12       13,171       0.9111
 78.............................  VOLVO..............  C30...............            5        5,530       0.9042
 79.............................  JAGUAR LAND ROVER..  LAND ROVER LR2....            3        3,333       0.9001
 80.............................  MITSUBISHI.........  ECLIPSE...........            5        5,610       0.8913
 81.............................  GENERAL MOTORS.....  CHEVROLET CORVETTE           11       12,353       0.8905
 82.............................  HYUNDAI............  SANTA FE..........           62       69,685       0.8897
 83.............................  HYUNDAI............  GENERAL MOTORSSIS.           26       29,398       0.8844
 84.............................  GENERAL MOTORS.....  BUICK LUCERNE.....           28       31,887       0.8781
 85.............................  SUZUKI.............  VITARA/GRAND                  5        5,704       0.8766
                                                        VITARA.
 86.............................  VOLKSWAGEN.........  JETTA/GLI.........          128      148,313       0.8630
 87.............................  PORSCHE............  CAYMAN............            1        1,199       0.8340
 88.............................  KIA................  SOUL..............           80       96,970       0.8250
 89.............................  JAGUAR LAND ROVER..  XK/XKR............            3        3,662       0.8192
 90.............................  MERCEDES-BENZ......  E-CLASS...........           61       74,557       0.8182
 91.............................  BMW................  B7................           10       12,493       0.8005
 92.............................  GENERAL MOTORS.....  BUICK LACROSSE/              49       62,533       0.7836
                                                        ALLURE.
 93.............................  FORD MOTOR CO......  EDGE..............          105      134,206       0.7824
 94.............................  HONDA..............  ACURA TL..........           10       12,807       0.7808
 95.............................  HONDA..............  ACCORD............          173      221,250       0.7819
 96.............................  CHRYSLER...........  JEEP PATRIOT......           41       53,153       0.7714
 97.............................  GENERAL MOTORS.....  CADILLAC CTS......           43       57,930       0.7423
 98.............................  VOLVO..............  C70...............            5        6,867       0.7281
 99.............................  HONDA..............  ACCORD CROSSTOUR..            9       12,388       0.7265
101.............................  KIA................  SORENTO...........          121      168,443       0.7183
102.............................  TOYOTA.............  LEXUS IS..........           22       30,811       0.7140
103.............................  FORD MOTOR CO......  FIESTA............           55       77,183       0.7126
104.............................  AUDI...............  AUDI R8...........            1        1,416       0.7062
105.............................  HONDA..............  ACURA MDX.........           36       51,201       0.7031
106.............................  NISSAN.............  PATHFINDER........           22       31,439       0.6998
107.............................  GENERAL MOTORS.....  BUICK REGAL.......           35       50,439       0.6939
108.............................  BMW................  1.................            9       13,131       0.6854
109.............................  AUDI...............  AUDI A4/A5........           29       42,875       0.6764
110.............................  NISSAN.............  370Z..............            4        6,218       0.6433
111.............................  FORD MOTOR CO......  ESCAPE............          133      207,528       0.6409
112.............................  CHRYSLER...........  JEEP WRANGLER.....           66      103,837       0.6356
113.............................  GENERAL MOTORS.....  CHEVROLET COLORADO           16       25,283       0.6328
                                                        PICKUP.
114.............................  BMW................  5.................           42       66,525       0.6313
115.............................  MERCEDES-BENZ......  SL-CLASS..........            2        3,188       0.6274
116.............................  HONDA..............  INSIGHT...........            8       12,924        0.619
117.............................  HONDA..............  ELEMENT...........            7       11,460       0.6108
118.............................  BMW................  3.................          100      164,060       0.6095
119.............................  MAZDA..............  2.................           11       18,108       0.6075
120.............................  TOYOTA.............  SCION XD..........            4        6,609       0.6052
121.............................  JAGUAR LAND ROVER..  XF................            7       11,734       0.5966
122.............................  AUDI...............  AUDI Q5...........           14       23,731       0.5900
123.............................  CHRYSLER...........  JEEP COMPASS......           25       42,921       0.5825
124.............................  MAZDA..............  CX-9..............           17       29,203       0.5821
125.............................  VOLKSWAGEN.........  TIGUAN............           15       25,785       0.5817
126.............................  TOYOTA.............  TACOMA PICKUP.....           71      122,520       0.5795
127.............................  HONDA..............  ACURA RDX.........            9       15,590       0.5773
128.............................  GENERAL MOTORS.....  CHEVROLET CRUZE...          100      177,381       0.5638
129.............................  MAZDA..............  CX-7..............           21       37,655       0.5577
130.............................  BMW................  Z4/M..............            3        5,450       0.5505
131.............................  TOYOTA.............  RAV4..............          100      181,785       0.5501
132.............................  GENERAL MOTORS.....  CADILLAC SRX......           32       59,077       0.5417
133.............................  VOLKSWAGEN.........  CC................            7       13,003       0.5383
134.............................  CHRYSLER...........  DODGE JOURNEY.....           17       32,094       0.5297
135.............................  VOLKSWAGEN.........  EOS...............            1        1,908       0.5241

136.............................  NISSAN.............  ROGUE.............           72      138,221       0.5209
137.............................  FORD MOTOR CO......  FLEX..............           17       32,847       0.5176
138.............................  AUDI...............  AUDI S4/S5........            4        7,820       0.5115
139.............................  PORSCHE............  911...............            3        5,892       0.5092
140.............................  NISSAN.............  FRONTIER PICKUP...           23       47,081       0.4885
141.............................  SUBARU.............  IMPREZA...........           24       49,315       0.4867
142.............................  VOLVO..............  XC90..............            5       10,641       0.4699
143.............................  TOYOTA.............  SIENNA VAN........           87      187,467       0.4641
144.............................  TOYOTA.............  4RUNNER...........           26       56,942       0.4566
145.............................  TOYOTA.............  HIGHLANDER........           38       87,503       0.4343
146.............................  TOYOTA.............  VENZA.............           18       42,351       0.4250
147.............................  SUBARU.............  LEGACY............           21       50,878       0.4128
148.............................  HYUNDAI............  TUCSON............           32       78,643       0.4069
149.............................  FORD MOTOR CO......  LINCOLN MKX.......           11       27,119       0.4056
150.............................  MITSUBISHI.........  LANCER............           11       28,316       0.3885
151.............................  HONDA..............  PILOT.............           63      163,910       0.3844
152.............................  NISSAN.............  JUKE..............           16       42,380       0.3775
153.............................  NISSAN.............  MURANO............           21       56,539       0.3714
154.............................  HYUNDAI............  AZERA.............            1        2,699       0.3705
155.............................  FORD MOTOR CO......  LINCOLN MKZ.......            9       24,752       0.3636
156.............................  TOYOTA.............  FJ CRUISER........            4       11,018       0.3630
157.............................  HONDA..............  ACURA TSX.........            8       22,189       0.3605
158.............................  GENERAL MOTORS.....  CHEVROLET EQUINOX.           67      188,476       0.3555
159.............................  BMW................  MINI COOPER.......           17       48,663       0.3493
160.............................  FORD MOTOR CO......  RANGER PICKUP.....           34       99,043       0.3433
161.............................  MITSUBISHI.........  OUTLANDER.........           12       35,054       0.3423
162.............................  VOLVO..............  S60...............            1        2,951       0.3389
163.............................  FORD MOTOR CO......  MERCURY MILAN.....            2        6,291       0.3179
164.............................  VOLKSWAGEN.........  GOLF/RABBIT/GTI...           10       31,726       0.3152
165.............................  NISSAN.............  QUEST VAN.........            5       16,012       0.3123
166.............................  MAZDA..............  TRIBUTE...........            1        3,206       0.3119
167.............................  HONDA..............  FIT...............           13       41,694       0.3118
168.............................  HYUNDAI............  EQUUS.............            1        3,305       0.3026
169.............................  TOYOTA.............  AVALON............           17       56,692       0.2999
170.............................  SUBARU.............  OUTBACK...........           37      129,071       0.2867
171.............................  MERCEDES-BENZ......  SMART FORTWO......            1        3,542       0.2823
172.............................  HONDA..............  CR-V..............           70      255,339       0.2742
173.............................  NISSAN.............  XTERRA............            6       21,983       0.2729
174.............................  GENERAL MOTORS.....  GMC TERRAIN.......           22       83,531       0.2634
175.............................  BMW................  X3................            6       23,188       0.2588
176.............................  HONDA..............  ODYSSEY VAN.......           25      103,550       0.2414
177.............................  TOYOTA.............  LEXUS RX..........           18       76,526       0.2352
178.............................  TOYOTA.............  LEXUS ES..........           10       44,249       0.2260
179.............................  FORD MOTOR CO......  TRANSIT CONNECT               6       28,091       0.2136
                                                        VAN.
180.............................  TOYOTA.............  LEXUS LS..........            2        9,861       0.2028
181.............................  TOYOTA.............  LEXUS CT..........            2       10,216       0.1958
182.............................  MAZDA..............  MX-5 MIATA........            1        5,464       0.1830
183.............................  TOYOTA.............  PRIUS.............           22      133,660       0.1646
184.............................  NISSAN.............  INFINITI EX35.....            1        6,118       0.1635
185.............................  SUBARU.............  FORESTER..........           11       74,829       0.1470
186.............................  VOLVO..............  XC60..............            4       36,854       0.1085
187.............................  HYUNDAI............  VERACRUZ..........            1       10,861       0.0921
188.............................  LOTUS..............  EVORA.............            0          347       0.0000
189.............................  ASTON MARTIN.......  DB9...............            0           86       0.0000
190.............................  ASTON MARTIN.......  V8 VANTAGE........            0          259       0.0000
191.............................  ASTON MARTIN.......  DBS...............            0          104       0.0000
192.............................  ASTON MARTIN.......  RAPIDE............            0          317       0.0000
193.............................  AUDI...............  AUDI TT...........            0        1,434       0.0000
194.............................  AUDI...............  AUDI S6...........            0          159       0.0000
195.............................  BENTLEY MOTORS.....  MULSANNE..........            0          235       0.0000
196.............................  BMW................  X5................            0       37,865       0.0000
197.............................  BMW................  X6................            0        4,430       0.0000
198.............................  BMW................  ACTIVE HYBRID 7L..            0          584       0.0000
199.............................  ROLLS ROYCE........  DROPHEAD COUPE                0           82       0.0000
                                                        CONVERTIBLE.
200.............................  FERRARI............  458...............            0          662       0.0000
201.............................  FERRARI............  599...............            0          247       0.0000
202.............................  FERRARI............  612 SCAGLIETTI....            0            1       0.0000

203.............................  FERRARI............  CALIFORNIA........            0          518       0.0000
204.............................  GENERAL MOTORS.....  CADILLAC FUNERAL              0          752       0.0000
                                                        COACH/HEARSE.
205.............................  GENERAL MOTORS.....  CADILLAC LIMOUSINE            0          488       0.0000
206.............................  GENERAL MOTORS.....  PONTIAC G3........            0          243       0.0000
207.............................  GENERAL MOTORS.....  CHEVROLET VOLT....            0        4,370       0.0000
208.............................  HONDA..............  ACURA RL..........            0        1,012       0.0000
209.............................  KIA................  RONDO.............            0          109       0.0000
210.............................  KIA................  BORREGO...........            0           14       0.0000
211.............................  LOTUS..............  ELISE.............            0          232       0.0000
212.............................  MASERATI...........  QUATTROPORTE......            0          635       0.0000
213.............................  MERCEDES-BENZ......  SLK-CLASS.........            0        1,288       0.0000
214.............................  MERCEDES-BENZ......  CL-CLASS..........            0          723       0.0000
215.............................  MERCEDES-BENZ......  F-CELL............            0           44       0.0000
216.............................  MERCEDES-BENZ......  SLS-CLASS.........            0          863       0.0000
217.............................  PORSCHE............  BOXSTER...........            0        1,967       0.0000
218.............................  ROLLS ROYCE........  PHANTOM...........            0           67       0.0000
219.............................  ROLLS ROYCE........  GHOST.............            0          854       0.0000
220.............................  SAAB...............  9-5...............            0        2,034       0.0000
221.............................  SUBARU.............  B9 TRIBECA........            0        2,780       0.0000
222.............................  SUZUKI.............  EQUATOR...........            0        2,160       0.0000
223.............................  TOYOTA.............  LEXUS SC..........            0       45,155       0.0000
224.............................  TOYOTA.............  LEXUS HS..........            0        2,356       0.0000
225.............................  VOLVO..............  V50...............            0          865       0.0000
226.............................  VOLVO..............  XC70..............            0        5,069       0.0000
----------------------------------------------------------------------------------------------------------------

    Issued on: June 25, 2013.
Christopher J. Bonanti,
Associate Administrator for Rulemaking.
[FR Doc. 2013-16428 Filed 7-8-13; 8:45 am]
BILLING CODE 4910-59-P


--------------------------------------------------------------------------------
Initial Review Checklist for ICR Desk Officers  -  ICR Renewal Packages
INSTRUCTIONS: Complete Initial Review Checklist within 2 business days of receiving the ICR renewal package. Provide checklist to Team Lead when complete.

ICR Information
ICR Title
Environmental Impact Assessment of Nongovernmental Activities in Antarctica (Renewal)
EPA ICR Number
1808.10
OMB Control Number
2020-0007
ICR Desk Officer
Aaron Jackson

Step 1: Review ICR Package for Completeness
Note: If the answer to any of the questions in this section is NO, the ICR renewal package is NOT complete and needs to be returned to the ICR Owner.  Via email, indicate to the ICR Owner what is missing and that it needs to be included in order for the ICR package to be marked as "received."  Include the ICR Team Lead on this email.  If the answers to ALL of these questions are YES, proceed to Step 2 in the checklist.

                            Comments for Team Lead

Does the ICR package contain all of the required files - Supporting Statement, Draft Federal Register Notice and ICR Submission Worksheet?

Has the comment period for the 1[st] Federal Register Notice closed?
8/30/2022
                                       x
Does the Supporting Statement contain all major sections listed in template?
Template does not match section 6 of the template. Tables were not used to calculate burden. It is all written

Has the ICR Owner completed consultations as part of this ICR renewal cycle?
HINT: Section 3c of the supporting statement should address the consultations conducted for this renewal.
Ron Naveen and Denise Landau responded to EPA's consultation request
Step 2: Update ICR Tracker Information

                            Comments for Team Lead
                                      ☐
Enter the received date in the ICR Tracker in the "Submitted to OMS" column.

Check to see if the EPA ICR Number in the ICR materials provided by the POC match EPA ICR Number listed in the ICR Tracker.

The ICR Number in the 1[st] FRN, 1808.09, is incorrect as well. I corrected the ICR Number on the SS, Worksheet, and 2[nd] FRN.
Step 3: Update ICRAS Information

                            Comments for Team Lead

Create a new ICR package in ICRAS if one does not already exist.

Check if there any other pending packages in ICRAS (whether pending at EPA or OMB).

                             If so, list packages.

Check to see if the EPA ICR Number in the ICR materials provided by the POC match EPA ICR Number listed in ICRAS.

                         If not, describe difference.
Step 4: Content Review

                            Comments for Team Lead

Determine if the total annual hours/costs are changing by more than 25%.
HINT: Look at the Bottom Line Burden section of the Supporting Statement and compare those amounts to the current amounts listed in ICRAS. If the difference between those numbers is larger than the existing burden hours/costs divided by 4, the change exceeds 25%.
There is a 94% increase of 1,444 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase is the result of an anticipated increase in the number of respondent universe, the result of the inclusion of more complex information regarding safety and environmental issues, more diverse tourist activities and outcomes from current Antarctic Treaty Consultative meetings, and the accounting of a potential PERM, CEE and Emergency Report submitted by any of the 29 anticipated operators (every three years).
                                      ☐
Check if there are Part 2 tabs in the ICR Submission Worksheet for all existing Part 2 ICs in ICRAS.
                           If not, list missing ICs.
Step 5: Request FRL Number

                            Comments for Team Lead
                                       x
Submit request to create a new FRL # and prepare the Typesetting Request.
NOTE: For OCSPP ICRs, check the FR Notice first to see if there is already an FRL Number.  If there is an FRL Number, provide this to Bill so he can add it to the Typesetting Request.
N/A
--------------------------------------------------------------------------------
ICR Supporting Statement Outline  -  Part A

 1. Identification of the Information Collection
 	1(a) Title of the Information Collection
 	1(b) Short Characterization/Abstract
 2. Need for and use of the Collection
 	2(a) Need/Authority for the Collection
 	2(b) Practical Utility/Users of the Data
 3. Non-duplication, Consultations, and Other Collection Criteria
 	3(a) Non-duplication
 	3(b) Public Notice Required Prior to ICR submission to OMB
 	3(c) Consultations
 	3(d) Effects of Less Frequent Collection
 	3(e) General Guidelines
 	3(f) Confidentiality
 	3(g) Sensitive Questions
 4. The Respondents and the Information Requested
 	4(a) Respondents/SIC Codes
 	4(b) Information Requested
 		(i) Data items, including record keeping requirements
 		(ii) Respondent Activities
 5. The Information Collected - Agency Activities, Collection Methodology, and Information Management
 	5(a) Agency Activities
 	5(b) Collection Methodology and Management
 	5(c) Small Entity Flexibility
 	5(d) Collection Schedule
 6. Estimating the Burden and Cost of the Collection
 	6(a) Estimating Respondent Burden
 	6(b) Estimating Respondent Costs
 		(i) Estimating Labor Costs
 		(ii) Estimating Capital and Operations and Maintenance Costs
 		(iii) Capital/Start-up Operating and Maintenance (O&M) Costs
 		(iv) Annualizing Capital Costs
 	6(c) Estimating Agency Burden and Cost
 	6(d) Estimating the Respondent Universe and Total Burden and Costs
 	6(e) Bottom Line Burden Hours and Cost Tables
 		(i) Respondent Tally
 		(ii) The Agency Tally
 		(iii) Variations in the Annual Bottom Line
 	6(f) Reasons for Change in Burden
 	6(g) Burden Statement


[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11276-11278]
[FR Doc No: 2018-05165]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82848; File No. SR-MRX-2018-08]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing
of Proposed Rule Change To Introduce the ATR Protection for Orders That
Are Routed to Away Markets

March 9, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 23, 2018, Nasdaq MRX, LLC (``MRX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II, below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to introduce its Acceptable Trade Range
protection for orders that are routed to away markets pursuant to the
Options Order Protection and Locked/Crossed Markets Plan.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqmrx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange offers an Acceptable Trade Range (``ATR'') protection
that prevents the execution of quotes and orders on the regular order
book outside of set thresholds. The purpose of the proposed rule change
is to enhance this ATR protection for orders that are routed to away
markets pursuant to the Options Order Protection and Locked/Crossed
Markets Plan (``Linkage Plan'') instead of being executed immediately
on the Exchange or resting on the regular order book.
    As codified in Rule 714(b)(1), the Exchange's trading system
calculates an Acceptable Trade Range to limit the range of prices at
which an order or quote will be allowed to execute.\3\ The Acceptable
Trade Range is calculated by taking the reference price, plus or minus
a value to be determined by the Exchange (i.e., the reference price-(x)
for sell orders/quotes and the reference price + (x) for buy orders or
quotes).\4\ Upon receipt of a new order or quote, the reference price
is the national best bid (``NBB'') for sell orders/quotes and the
national best offer (``NBO'') for buy orders/quotes. If an order or
quote reaches the outer limit of the Acceptable Trade Range without
being fully executed then any unexecuted balance will be cancelled.
---------------------------------------------------------------------------

    \3\ The ATR protection is not available for All-or-None orders.
    \4\ There are three categories of options for ATR: (1) Penny
Pilot Options trading in one cent increments for options trading at
less than $3.00 and increments of five cents for options trading at
$3.00 or more, (2) Penny Pilot Options trading in one-cent
increments for all prices, and (3) Non-Penny Pilot Options.
---------------------------------------------------------------------------

    Currently, the trading system calculates an appropriate reference
price for an incoming order or quote when that order or quote rests or
trades on the regular order book but not when orders are routed to an
away market pursuant to the Linkage Plan without first trading on the
Exchange. The Exchange now proposes to enhance its ATR protection by
applying it to orders that are routed to away markets without first
trading on the Exchange. As proposed, Rule 714(a)(1) will continue to
provide that the reference price for the ATR protection is the NBB for
sell orders/quotes and the NBO for buy orders/quotes. For clarity,
however, the Exchange proposes to move this language to a separate
bullet under proposed Rule 714(a)(1)(ii). In addition, proposed Rule
714(a)(1)(ii) will indicate that the reference price is calculated upon
receipt of a new order or quote, provided that if the applicable NBB or
NBO price is improved at the time an order is routed to an away market,
a new reference price is calculated based on the NBB or NBO at that
time.
    Although the Exchange will continue to use the NBB or NBO as the
reference price for the ATR protection, the Exchange believes that it
is appropriate to update the reference price if the applicable NBB or
NBO price is improved at the time an order is routed to an away market.
Orders that are routed to away markets are eligible for the ``Flash''
auction process described in Supplementary Material .02 to Rule 1901.
When a Flash auction is initiated, members are given an opportunity to
enter responses to trade with the order for a time period established
by the Exchange not to exceed one (1) second.\5\ Because the applicable
NBB or NBO price may change during the Flash auction, the Exchange
believes that it is appropriate to consider the updated NBB or NBO
price at the time the order is actually routed to an away market, if
doing so would provide additional protection to the order--i.e., if the
NBB or NBO price used as the reference price is improved at that time.
If the NBB or NBO price is not improved, the ATR protection will
continue to use the NBB or NBO price on entry as the reference price,
thereby providing the maximum protection to the order. The following
examples illustrate how the ATR protection will be applied to orders
routed to away markets:
---------------------------------------------------------------------------

    \5\ Currently, the exposure period for the Flash auction is set
to 150 milliseconds.
---------------------------------------------------------------------------

    Example 1
1. ATR threshold set to $0.15 for non-penny symbols
2. NBBO is $0.90 (35) x $1.00 (25):
    a. BATS: $0.90 (10) x $1.00 (25)
    b. CBOE: $0.90 (25) x $1.05 (25)
    c. MIAX: $0.85 (25) x $1.15 (25)
    d. MRX: $0.85 (50) x $1.20 (50)
3. Member enters a Limit Order to buy 200 contracts at $1.20
4. Flash auction initiated at a price of $1.00
5. CBOE quote improved establishing a new NBBO of $0.90 (35) x $0.95
(25):
    a. BATS: $0.90 (10) x $1.00 (25)
    b. CBOE: $0.90 (25) x $0.95 (25)
    c. MIAX: $0.85 (25) x $1.15 (25)
    d. MRX: $0.85 (50) x $1.20 (50)
6. No responses entered and Flash auction terminates and routes:
    a. 25 contracts to buy to CBOE at $0.95
    b. 25 contracts to buy to BATS at $1.00
7. Because the NBO is improved at time of routing, the reference
price is set to the improved NBO price of $0.95, establishing an
Acceptable Trade Range of $1.10
8. The remaining balance of 150 contracts that cannot be executed
within the

Acceptable Trade Range is cancelled
    Example 2
1. ATR threshold set to $0.15 for non-penny symbols
2. NBBO is $0.90 (35) x $1.00 (25):
    a. BATS: $0.90 (10) x $1.00 (25)
    b. CBOE: $0.90 (25) x $1.05 (25)
    c. MIAX: $0.85 (25) x $1.15 (25)
    d. MRX: $0.85 (50) x $1.20 (50)
3. Member enters a Limit Order to buy 200 contracts at $1.20
4. Flash auction initiated at a price of $1.00
5. BATS quote worsened establishing a new NBBO of $0.90 (35) x $1.05
(50):
    a. BATS: $0.90 (10) x $1.05 (25)
    b. CBOE: $0.90 (25) x $1.05 (25)
    c. MIAX: $0.85 (25) x $1.15 (25)
    d. MRX: $0.85 (50) x $1.20 (50)
6. No responses entered and Flash auction terminates and routes:
    a. 25 contracts to buy to BATS at $1.05
    b. 25 contracts to buy to CBOE at $1.05
    c. 25 contracts to buy to MIAX at $1.15
7. Because the NBO is worsened at time of routing, the reference
price is set to the initial NBO price of $1.00, establishing an
Acceptable Trade Range of $1.15
8. The remaining balance of 125 contracts that cannot be executed
within the Acceptable Trade Range is cancelled
Implementation
    The Exchange proposes to launch the ATR functionality described in
this proposed rule change no later than October 31, 2018. The Exchange
will announce the implementation date of this functionality in an
Options Trader Alert issued to members prior to the launch date.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\6\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Specifically, the Exchange believes that the proposed rule change
would remove impediments to and perfect the mechanism of a free and
open market by enhancing the Exchange's ATR protection. The ATR
functionality is designed to ensure that orders and quotes entered on
the Exchange are executed at reasonable prices based on the applicable
NBBO price on receipt. Currently, the Exchange's ATR protection
calculates a reference price at the time an order or quote rests or
trades locally but not when an order is routed to an away market
pursuant to the Linkage Plan without first trading on the Exchange. To
further protect orders that are subject to routing that have not traded
on the Exchange, the Exchange is proposing to implement the ATR
protection for those orders. The Exchange will continue to use the NBBO
as the reference price for the ATR protection but now that the Exchange
is protecting orders that are routed away pursuant to the Linkage Plan
without trading on the Exchange, the Exchange proposes to use the NBBO
price on routing instead of the NBBO on receipt only in those
circumstances where the NBBO is improved at the time of routing. As
described earlier in this proposed rule change, the Exchange operates a
Flash auction that provides an opportunity for Members to match or
improve the NBBO price prior to routing eligible orders to away
markets. Since the NBBO price may change during the Flash auction's
exposure period, the Exchange believes that the ATR protection should
take improved NBBO prices into account when determining whether a
particular price is a reasonable execution price. The Exchange
believes, however, that a worsened NBBO price should not be considered
as this would decrease rather than increase the protection provided to
such an order. In sum, the proposed changes to the ATR protection will
protect investors and the public interest by providing additional
protections designed to ensure that quotes and orders entered on the
Exchange are executed at reasonable prices, and thereby perfect the
mechanism of a free and open market and a national market system.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
designed to enhance the Exchange's ATR protection by extending that
protection to orders that are routed to away markets that did not first
trade on the Exchange. The proposed protection will apply equally to
all orders that are routed to away markets pursuant to the Linkage
Plan. The Exchange believes that this change is the result of a
competitive market where exchanges must continually improve the
functionality offered to market participants in order to remain
competitive.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-MRX-2018-08 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-MRX-2018-08. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be

available for website viewing and printing in the Commission's Public
Reference Room, 100 F Street NE, Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-MRX-
2018-08 and should be submitted on or before April 4, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-05165 Filed 3-13-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 72 (Friday, April 16, 2021)]
[Notices]
[Page 20184]
[FR Doc No: 2021-07777]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4487-DR; Docket ID FEMA-2021-0001]

North Carolina; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Carolina (FEMA-4487-DR), dated March 25, 2020,
and related determinations.

DATES: This amendment was issued February 2, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, pursuant to the
President's Memorandum to Extend Federal Support to Governors' Use of
the National Guard to Respond to COVID-19 and to Increase Reimbursement
and Other Assistance Provided to States, dated January 21, 2021 and the
President's Memorandum on Maximizing Assistance from the Federal
Emergency Management Agency, dated February 2, 2021 FEMA is amending
the cost-sharing arrangements regarding Federal funds provided under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the ``Stafford Act'') for all of
the COVID-19 emergency and major disaster declarations. FEMA is
amending this declaration as follows:

    Federal funds for emergency protective measures (Category B),
including direct Federal assistance, under the Public Assistance
program (Section 403) are authorized at 100 percent of total
eligible costs for work performed from January 20, 2020 through
September 30, 2021.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-07777 Filed 4-15-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22049-22050]
[FR Doc No: 2018-10002]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR18-42-000.
    Applicants: Columbia Gas of Ohio, Inc.
    Description: Tariff filing per 284.123(b),(e)/: COH Rates effective
4-2-2018.
    Filed Date: 4/24/18.
    Accession Number:<PHONE_NUMBER>78.
    Comments/Protests Due: 5 p.m. ET 5/15/18.

    Docket Number: PR18-44-000.
    Applicants: Louisville Gas and Electric Company.
    Description: Tariff filing per 284.123(b),(e)/: Revised Statement
of Operating Conditions TCJA Surcredit to be effective 4/1/2018.
    Filed Date: 5/1/18.
    Accession Number:<PHONE_NUMBER>81.
    Comments/Protests Due: 5 p.m. ET 5/22/18.

    Docket Number: PR18-45-000.
    Applicants: UGI Utilities, Inc.
    Description: Tariff filing per 284.123(b),(e)+(g): Application for
Authorization for Limited Jurisdiction Transportation Service to be
effective 10/1/2018.
    Filed Date: 5/2/18.
    Accession Number:<PHONE_NUMBER>55.
    Comments Due: 5 p.m. ET 5/23/18.
    284.123(g) Protests Due: 5 p.m. ET 7/2/18.

    Docket Number: PR18-46-000.
    Applicants: UGI Central Penn Gas, Inc.
    Description: Tariff filing per 284.123(b),(e)/: Application to
Abandon Limited Jurisdiction Certificate to be effective 10/1/2018.
    Filed Date: 5/2/18.
    Accession Number:<PHONE_NUMBER>56.
    Comments/Protests Due: 5 p.m. ET 5/23/18.

    Docket Number: PR18-47-000.
    Applicants: UGI Penn Natural Gas, Inc.
    Description: Tariff filing per 284.123(e)/.224: Cancellation of SOC
and Certificate to be effective 10/1/2018.
    Filed Date: 5/3/18.
    Accession Number:<PHONE_NUMBER>00.
    Comments/Protests Due: 5 p.m. ET 5/24/18.

    Docket Number: PR17-57-003.
    Applicants: Houston Pipe Line Company LP.
    Description: Tariff filing per 284.123(b),(e)+(g): 3rd Amended Rate
Election of Houston Pipe Line Company LP Effective 11/01/2017.
    Filed Date: 5/3/18.
    Accession Number:<PHONE_NUMBER>41.
    Comments Due: 5 p.m. ET 5/24/18.
    284.123(g) Protests Due: 5 p.m. ET 7/2/18.

    Docket Numbers: RP18-771-000.
    Applicants: Chandeleur Pipe Line, LLC.
    Description: Imbalance Annual True-Up Filing Waiver Request of
Chandeleur Pipe Line, LLC.
    Filed Date: 4/30/18.
    Accession Number: 20180430-5455.
    Comments Due: 5 p.m. ET 5/14/18.

    Docket Numbers: RP18-702-001.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Tariff Amendment: Amendment to RP18-702 to be
effective 6/1/2018.
    Filed Date: 5/2/18.
    Accession Number: 20180502-5178.
    Comments Due: 5 p.m. ET 5/14/18.

    Docket Numbers: RP18-276-001.
    Applicants: Southern Star Central Gas Pipeline, Inc.
    Description: Compliance filing Gas Quality Resolution to be
effective 4/26/2018.

    Filed Date: 5/3/18.
    Accession Number: 20180503-5036.
    Comments Due: 5 p.m. ET 5/15/18.

    Docket Numbers: RP18-794-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmt
(Newfield 18 to Sequent 1982) to be effective 5/3/2018.
    Filed Date: 5/3/18.
    Accession Number: 20180503-5003.
    Comments Due: 5 p.m. ET 5/15/18.

    Docket Numbers: RP18-795-000.
    Applicants: Arlington Storage Company, LLC.
    Description: Compliance filing Compliance Filing to Implement Firm
Wheeling Service to be effective 6/4/2018.
    Filed Date: 5/3/18.
    Accession Number: 20180503-5040.
    Comments Due: 5 p.m. ET 5/15/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 4, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-10002 Filed 5-10-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Proposed Rules]
[Pages 35669-35672]
[FR Doc No: 2011-14768]

Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 /
Proposed Rules

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 352

[Docket No. FDA-1978-N-0018; formerly Docket No. 1978N-0038]
RIN 0910-ZA40

Sunscreen Drug Products for Over-the-Counter Human Use; Request
for Data and Information Regarding Dosage Forms

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; request for data and
information.

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

SUMMARY: We (Food and Drug Administration or FDA) are asking sunscreen
manufacturers and other interested parties to submit data on over-the-
counter (OTC) sunscreen drug products marketed without approved
applications that are formulated in certain dosage forms. These data
are necessary to address questions about these dosage forms. For spray
dosage forms, we are requesting data to resolve specific questions
about both effectiveness and safety. We are also inviting comment on
possible labeling and testing requirements for spray dosage forms. This
information will be used in establishing monograph conditions,
including dosage forms, for sunscreens that are generally recognized as
safe and effective (GRASE) and not misbranded.

DATES: Submit data and information either electronically or in writing
by September 15, 2011.

ADDRESSES: You may submit comments, identified by docket number FDA-
1978-N-0018 (formerly Docket No. 1978N-0038) and/or RIN number 0910-
ZA40, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name
and docket number FDA-1978-N-0018 and RIN 0910-ZA40 for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information provided
if not marked as confidential.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, insert the docket
numbers, found in brackets in the heading of this document, into the
``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Reynold Tan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Mail Stop 5411, Silver Spring, MD 20993, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Purpose of This Document

    FDA is requesting additional data necessary to establish monograph
conditions for sunscreens, including specification of certain dosage
forms. In this document, we discuss those dosage forms that we consider
currently to be part of the OTC Drug Review, and thus eligible for
potential inclusion in a sunscreen monograph, and those dosage forms
that we do not consider eligible. For the dosage forms that are
eligible, we seek to ensure that the record is complete, so as to
support a future monograph identifying conditions, including dosage
forms and appropriate testing and labeling, for sunscreens to be GRASE
and not misbranded. Finally, as explained below, sunscreens in certain
dosage forms such as wipes, towelettes, powders, body washes, and
shampoos are not currently considered eligible for inclusion in the
sunscreen monograph, and even if their eligibility were established,
they lack a sufficient record to support inclusion in the sunscreen
monograph.
    Although spray dosage forms are among those dosage forms we
consider potentially eligible for inclusion in the final sunscreen
monograph, they currently lack a record comparable to other dosage
forms that could be included in the sunscreen monograph. Considering
the greatly increasing number of sunscreen products formulated as
sprays, it is critical that the safety and effectiveness of this dosage
form be adequately supported. From their existing marketing of spray
sunscreens, manufacturers may have the necessary data, but to date
these data have not been submitted to FDA. To further encourage
submission of data and allow us to move to a proposed rule as quickly
as possible, we have developed possible labeling and testing specific
to sprays, for which we solicit comment.
    Although at this time we expect to receive the necessary data, if
we do not obtain sufficient data to support monograph conditions for
sunscreen products formulated in certain dosage forms, these products
may not be included in the future OTC sunscreen monograph. Any
sunscreen product not included in a future final monograph could obtain
approval to market by submitting new drug applications (NDAs) under
section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
These products might in the future be able to submit NDA deviations in
accordance with 21 CFR 330.11, limiting the scope of review necessary
to obtain approval. It should be noted that, where a final monograph
exists, the content of an NDA that deviates only in limited respects
from the monograph may omit all information except that pertinent to
the deviation.

II. Enforcement Policy

    In the absence of an effective final monograph for OTC sunscreen
products, questions may arise regarding FDA's enforcement policy for
OTC sunscreen products in various dosage forms that are marketed
without approved applications. For clarification, we are issuing a
draft guidance document that explains the Agency's intended enforcement
policy on the various dosage forms for OTC sunscreen products that are
marketed during the absence of an effective sunscreen final monograph.
This draft guidance document is being published elsewhere in this issue
of the Federal Register. We are also publishing elsewhere in this issue
of the Federal Register a final rule for OTC sunscreen products
containing certain ingredients and marketed without approved
applications that specifies labeling and testing requirements, without
regard to dosage form.

III. Dosage Forms Currently Eligible for Inclusion in a Sunscreen
Monograph

    We have not explicitly stated in previous rulemakings which dosage
forms of OTC sunscreen drug products we would consider to be GRASE and
not misbranded. However, in 21 CFR 352.52(d), we identified several
dosage forms, including sprays, for the purposes of labeling: ``(e.g.,
cream, gel,

lotion, oil, spray, etc.).'' In 21 CFR 352.72(e), we further identified
oils, lotions, creams, gels, butters, and pastes and ointments for the
purposes of testing. We also identified sticks in the August 25,1978,
advanced notice of proposed rulemaking (ANPR) (43 FR 38206 at 38207,
38223, 38224, 38229, and 38239) as lip protectants, which are allowed
to contain sunscreen active ingredients and are formulated as sticks
(existing 21 CFR 352.60).
    For a drug product to be eligible for review, the drug product must
either be a product that can be substantiated to have been marketed OTC
before the OTC Drug Review began in 1972, or it must be determined to
be eligible through submission of a time and extent application (21 CFR
330.14). With respect to OTC sunscreen drug products, the following
dosage forms are eligible for review and potential inclusion in the
monograph:
     Oils
     Lotions
     Creams
     Gels
     Butters
     Pastes
     Ointments
     Sticks
     Sprays
    On the existing record, we anticipate that all of these listed
dosage forms, except sprays, would be included in the future OTC
sunscreen monograph as GRASE and not misbranded under the labeling and
testing established in new 21 CFR 201.327. However, the record does not
yet contain comparable safety and effectiveness data and information
for spray dosage forms.
    Although we have information about how sunscreens in eligible
dosage forms other than sprays are applied, including data on the
amounts of oils, creams, and lotions consumers typically apply (Refs. 1
and 2), spray dosage forms are sufficiently different from other
eligible dosage forms identified during the course of development of
the sunscreen monograph that the data and information for these dosage
forms are not directly applicable. The nature of other eligible dosage
forms identified during the course of development of the sunscreen
monograph (oils, creams, lotions, gels, butters, pastes, ointments,
sticks) requires that consumers dispense the product into their hand or
directly onto their skin and rub these products into the skin to some
extent, with most of the amount dispensed applied. Sprays, however, in
particular aerosolized sprays, are dispensed in a more diffuse manner
even when applied directly to the body. Due to the different modes of
dispensing and application between sprays and the other dosage forms,
we do not know if consumers obtain the same protection with sprays as
these other dosage forms. With sprays, we also do not know how much of
the typical dispensed amount is effectively transferred to the skin.
Adequate, uniform coverage of sprays may also be difficult to assess,
because some sprays are applied in a thin, clear layer which is more
difficult to visualize than other dosage forms. Some spray products are
similarly meant to be rubbed into the skin, but we do not know if
consumers typically rub these spray products into the skin. Thus, upon
review of the record, we have determined that additional data or
information (as outlined below) are necessary, and must be sufficient
to support appropriate monograph conditions (e.g., testing and labeling
specific to sprays) to be included in the future final monograph. Thus,
we are soliciting data to address the following questions to build a
record comparable to other dosage forms such as lotions:
     What amounts of sunscreen spray do consumers typically
dispense and what amounts are effectively transferred to the skin?)
     How uniform is the sunscreen application across the sun-
exposed area of skin?
     How frequently do consumers reapply the product?
     If a product is labeled with a direction to rub it into
the skin, do consumers typically follow this direction?
     How does rubbing the product into the skin change the
effectiveness?
     How do the protection levels (SPF values) when typical
amounts are applied compare with those under laboratory conditions?
     Should the SPF and broad spectrum tests be modified to
address sprays? If so, how?
    In addition to answering these questions for spray dosage forms, it
would be useful if studies also directly compared spray dosage forms to
the other eligible dosage forms previously identified during the course
of development of the sunscreen monograph. We are interested in whether
use of sunscreen sprays differs enough from use of other eligible
sunscreen dosage forms that the SPF values on sunscreen sprays are not
comparable to those on other sunscreens. We are also interested in
whether use differs among sunscreen spray products. Some sunscreen
sprays are dispensed by pumps rather than as aerosolized sprays. Other
sprays may turn into a foam upon contact with the skin. We would be
interested in data and information that helps us assess how our
concerns about sunscreen sprays in general apply to different types of
sunscreen sprays. (See section V. ``Submission of Data and
Information'' for information on submitting these data.)
    As we have done previously for other spray OTC products, we are
also requesting data to understand the possibility and consequences of
unintentional inhalation of spray sunscreens, an issue not presented by
the other eligible dosage forms because they are applied directly to
the skin:
     What are the risks associated with inhalation of sunscreen
active ingredients and propellants?
     What are typical particle size distributions for sunscreen
spray products?
     Are animal toxicity studies necessary for determining the
potential for toxicity resulting from inhalation?
     Is the labeling discussed in this document adequate to
prevent unintentional inhalation? If not, please provide alternative
labeling.
    In responding to the first question, (What are the risks associated
with inhalation of sunscreen active ingredients and propellants?), we
request submission of any reports of adverse events associated with
unintentional inhalations of currently marketed sunscreen spray
products.
    To encourage submission and in anticipation of receiving this
necessary data/information, we have used the available data and
information on sprays to develop possible labeling and testing for
comment. To address the possibility that inhalation of aerosolized
particulates could cause adverse health effects, we are considering
proposing a warning for sunscreen spray products that reads:
     ``When using this product keep away from face to avoid
breathing it.''
    We are also considering specific directions for sunscreen spray
products that read:
     ``hold container 4 to 6 inches from the skin to apply''
     ``do not spray directly into face. Spray on hands then
apply to face.''
     ``do not apply in windy conditions''
     ``use in a well-ventilated area''
    Sunscreen spray products would be required to be labeled with these
warnings and directions in addition to the other warnings and
directions required for all sunscreen products.
    We are also considering a proposal to modify a directions statement
to ensure that sunscreen products in spray dosage forms are applied
comparably to sunscreen products in other dosage forms. The sun
protection factor (SPF)

and broad spectrum test procedures in the 2011 final rule (published
elsewhere in this issue of the Federal Register) require that test
products be applied in an amount of 2 milligrams per square centimeter
(mg/cm\2\) and 0.75 mg/cm\2\, respectively, and then spread evenly by
hand (21 CFR 201.327(i)(4)(iii) and (j)(2)). Comparable product
application during testing, as required by these standard testing
conditions, is necessary to ensure consistent and comparable test
values between sunscreen products. However, valid comparison of SPF
test values and broad spectrum test results between products further
requires comparable product application during actual use. Therefore,
we are considering proposing directions for the application of sprays
to more closely follow the way they are applied in SPF and broad
spectrum testing. The modified directions statement would read:
     ``spray [select one of the following: `liberally' or
`generously'] and spread evenly by hand 15 minutes before sun
exposure.''
    We invite comment on all of the labeling statements we are
considering. If there are other labeling statements that should be
considered, in order for us to propose them for inclusion in a final
monograph, we will need adequate data supporting the alternative
labeling, just as we are requesting data to support the labeling we
have already developed for consideration. In developing any alternative
labeling for consideration, we advise submitters that the directions
for application should reflect how the SPF and broad spectrum test
procedures are performed.
    We are considering adding the following sentence to the SPF and
broad spectrum test procedures (21 CFR 201.327(i) and (j),
respectively) to require the following regarding application of test
material: ``For spray formulations, dispense the product into a
weighing vessel and then apply the appropriate weight of liquid.'' This
revision is based upon the one public test modification for a sunscreen
spray product that we are aware of (Ref. 3). However, the information
regarding the test method did not contain validation of the test as it
relates to sprays. To support proposing this modification as a
monograph condition, we need data to validate the modified test method;
we also remain open to any other testing alternative that is supported
by sufficient data to demonstrate that it would be an appropriate
monograph condition for sprays. To support a testing alternative, data
would need to show that testing a spray product according to the
alternative test produces SPF and broad spectrum test results that can
be validly compared to SPF and broad spectrum test results for other
dosage forms. We solicit comment on whether this test modification
would be appropriate for all spray dosage forms and whether
modifications are needed to address differences in dispensing and
application between spray dosage forms. For example, some current spray
labels direct the user to spray directly onto skin and some also direct
the user to rub in. As noted, we are soliciting comment on directions
calling for spray products to be spread by hand, as is done under the
current test method. If spray manufacturers instead seek labeling
indicating that spray application is alone sufficient (e.g., ``no-rub''
labeling), we seek validated testing to support this labeling. We
invite manufacturers to discuss possible methods and validations with
us.
    The foregoing discussion concentrates on specific dosage forms that
we have concluded are eligible for potential inclusion in the sunscreen
monograph. Although we particularly solicit specific data regarding
sprays, we welcome the submission of any additional information
relevant to the safety and effectiveness of other eligible dosage
forms. We also invite submitters to identify any additional dosage
forms that may be eligible for inclusion in the OTC monograph based on
marketing prior to the outset of the OTC drug review in 1972, and to
provide information to support their eligibility. If eligible, any
additional dosage forms will also require a sufficient record to
support finding them to be generally recognized as safe and effective
if they are to be proposed for inclusion in the OTC sunscreen
monograph. See 21 CFR 330.10 for information regarding the types of
information to be submitted to support eligibility and inclusion in an
OTC drug monograph.

IV. Dosage Forms Not Eligible for Inclusion in a Sunscreen Monograph

    In response to the August 27, 2007, proposed rule for OTC sunscreen
products (72 FR 49070), several submissions recommended that we include
the following dosage forms in the final sunscreen monograph (Ref. 4):
     Wipes
     Towelettes
     Powders
     Body washes
     Shampoos
    We currently do not consider these dosage forms eligible for review
under the OTC monograph process. We were unable to identify any
sunscreen products in wipe, towelette, powder, body wash, or shampoo
dosage forms that were marketed OTC before the OTC Drug Review began.
To determine eligibility for the OTC Drug Review, we must have actual
product labeling or a facsimile of labeling that documents the
conditions of marketing of the product prior to May 1972 (21 CFR
330.10(a)(2)). Conditions include active ingredient, dosage form,
dosage strength, route of administration, and specific OTC use of the
product (21 CFR 330.14(a)). These are the same criteria used to
establish that OTC drugs initially marketed in the United States after
the OTC Drug Review began or without U.S. marketing experience meet the
``material extent'' or ``material time'' provisions of the FD&C Act's
``new drug'' definition (21 U.S.C. part 201, section 201(p)(2)) and are
eligible for the OTC Drug Review (21 CFR 330.14(c)(3)). We also have
not received any time and extent applications for OTC sunscreen
products formulated as wipes, towelettes, powders, body washes or
shampoos. Therefore, sunscreens formulated as wipes, towelettes,
powders, body washes, or shampoos are not currently eligible for review
under the OTC sunscreen monograph. If their eligibility is to be
established, the required information must be submitted in the form of
a time and extent application (21 CFR 330.14). Determination of
eligibility would not itself be sufficient for inclusion in the OTC
sunscreen monograph. As discussed in 21 CFR 330.14(e), we would publish
a notice of eligibility if the dosage form was found eligible and then
we would request data to demonstrate the safety and effectiveness of
the dosage form for its intended OTC use (21 CFR 330.14(f)).

V. Submission of Data and Information

    Interested persons may submit data and information as described
under the ADDRESSES heading at the beginning of this document. Submit a
single copy of electronic submissions or two paper copies of any mailed
submissions, except that individuals may submit one paper copy.
Submissions are to be identified with the docket number found in
brackets in the heading of this document. Received submissions may be
viewed electronically at http://www.regulations.gov or by visiting the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

VI. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES), under docket number FDA-1978-N-0018

(formerly Docket No. 1978N-0038) unless otherwise noted, and may be
seen by interested persons between 9 a.m. and 4 p.m., Monday through
Friday.
    1. Neale et al., Archives of Dermatology, 138:1319-25, 2002.
    2. Autier et al., British Journal of Dermatology, 144:288-91, 2001.
    3. Docket No. FDA-1978-N-0018 (formerly Docket No. 1978N-0038):
C712, Schering Plough.
    4. Docket No. FDA-1978-N-0018 (formerly Docket No. 1978N-0038): FDA
List of Docket Submissions Regarding Dosage Forms Issues: C683, C712,
C716, EC2720.
    This ANPR is issued under 21 U.S.C. 321, 331, 351, 352, 353, 355,
358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262,
264 and under the authority of the Commissioner of Food and Drugs.

    Dated: June 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14768 Filed 6-14-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: December 8, 2008 (Volume 73, Number 236)]
[Notices]
[Page 74505-74506]
[DOCID:fr08de08-59]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Risk Communication Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Risk Communication Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 26, 2009, from
8 a.m. to 5 p.m. and February 27, 2009, from 8 a.m. to 2 p.m.
    Addresses: Submit electronic comments and information to http://
www.regulations.gov. Comments are to be identified with the docket
number found in brackets in the heading of this document. Written
comments should be submitted to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, by close of business on March 31, 2009. All
comments received will be posted without change, including any personal
information provided. Comments received on or before February 12, 2009,
will be provided to the committee before or at the meeting; comments
received after that time will still be considered by FDA.
    Location: National Transportation Safety Board (NTSB) Conference
Center, 429 L'Enfant Plaza SW., Washington, DC 20594 (at Metro's
L'Enfant Plaza station; parking is limited and public transportation is
recommended.)
    Contact Person: Lee L. Zwanziger, Office of the Commissioner,
Office of Policy, Planning and Preparedness, Office of Planning (HFP-
60), Food and Drug Administration, 5600 Fishers Lane (for express
delivery: rm. 15-22), Rockville, MD, 20857,<PHONE_NUMBER>, FAX: 301-827-
3285, Food and Drug Administration, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area), code<PHONE_NUMBER>. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications

that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On February 26 and 27, 2009, there will be a discussion of
different types of prescription drug information currently available to
patients in the form of Medication Guides, Patient Package Inserts
(PPIs), and Consumer Medication Information (CMI).
    CMI is information developed by the private sector and distributed
with each prescription at the pharmacy, as provided by law. On August
6, 1996, Public Law 104-180 was enacted and adopted the following goals
with regard to CMI: 75 percent of people receiving new prescriptions
would receive ``useful'' written patient information with their
prescriptions by 2000, and 95 percent of people receiving new
prescriptions would receive ``useful'' written patient information with
their prescriptions by 2006. The committee will review and discuss a
recently completed survey designed to assess whether the year 2006 goal
was achieved (for results, see committee background, to be posted as
described in this document). The committee will also discuss possible
next steps for assuring that consumers receive useful written
information with their prescriptions.
    The survey is a followup to the year 2001 evaluation of the quality
of consumer medication information dispensed in community pharmacies
(http://www.fda.gov/cder/reports/prescriptionInfo/default.htm). To
assist the private sector in meeting the year 2006 goal, FDA published
a guidance on producing ``Useful Written Consumer Medication
Information (CMI)'' (http://www.fda.gov/cder/guidance/7139fnl.htm).
    In 1998, FDA published a final rule that required the development
of a Medication Guide for a small number of drugs that the agency
considered posed a serious and significant health concern (63 FR 66378,
December 1, 1998). A Medication Guide is produced by the drug sponsor,
reviewed and approved by FDA and is a component of the approved
professional product labeling. An FDA public meeting was held in June
2007 to obtain feedback on the development, distribution,
comprehensibility and accessibility of Medication Guides. At that
meeting, stakeholders voiced a concern that for prescription drugs with
both a Medication Guide and CMI, patients would be getting
unnecessarily duplicative information (meeting summary: http://
www.fda.gov/cder/meeting/SummaryPublicHearingMedicationGuides.htm).
    Finally, PPIs are also required for some drugs and are considered
part of the approved product labeling, for example, for estrogens and
oral contraceptives.
    FDA will seek the advice of the advisory committee, and commentary
from stakeholders and from the public, for consideration as it
considers appropriate next steps to improve the communication of
information about prescription drugs to patients.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is or
will be available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm,
click on the year 2009 and scroll down to the appropriate advisory
committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 19, 2009. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 3 p.m. on February 26 and between
approximately 10:30 a.m. and 11:30 a.m. on February 27. Those desiring
to make formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before February 19, 2009. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by February 20, 2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Lee L. Zwanziger at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 26, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-28887 Filed 12-5-08; 8:45 am]

BILLING CODE 4160-01-S