[Federal Register: November 2, 2010 (Volume 75, Number 211)]
[Notices]
[Page 67358-67360]
[DOCID:fr02no10-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-1-000]

Pine Prairie Energy Center, LLC; Notice of Intent to Prepare an
Environmental Assessment for the Proposed Phase III Expansion Project
and Request for Comments on Environmental Issues

October 26, 2010.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Phase III Expansion Project
(Project), involving construction and operation of facilities by Pine
Prairie Energy Center, LLC (Pine Prairie) in Evangeline Parish,
Louisiana. This EA will be used by the Commission in its decision-
making process to determine whether the project is in the public
convenience and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the project. Your input will help the Commission staff
determine what issues need to be evaluated in the EA. Please note that
the scoping period will close on November 27, 2010.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives are asked to notify their constituents of this planned
project and encourage them to comment on their areas of concern.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility On My Land? What Do I Need To Know?'' was attached to the
project notice Pine Prairie provided to landowners. This fact sheet
addresses a

number of typically-asked questions, including the use of eminent
domain and how to participate in the Commission's proceedings. It is
also available for viewing on the FERC Web site (http://www.ferc.gov).

Summary of the Proposed Project

    The Phase III Expansion Project consists of:
     Construction of two new natural gas storage caverns (i.e.,
Cavern Nos. 6 and 7) with individual total working gas capacity of 12
billion cubic feet (Bcf) and total storage capacities (working gas plus
base gas) of 15.4 Bcf;
     Construction of approximately 2 miles of 24-inch diameter
brine disposal pipeline;
     Constructing approximately 0.10 mile of 16-inch diameter
low pressure raw water pipeline and 0.40 mile of 20-inch diameter brine
return pipeline;
     Converting approximately 2.20 miles of existing 16-inch
diameter brine disposal pipeline into raw water pipeline;
     Installation of two 5,750 horsepower electric motor drive
compression units in an expansion of the electric compressor building;
and
     Installation of one filter separator and one meter tube to
the existing Texas Gas Transmission interconnect.
    The Phase III Expansion Project would expand Pine Prairie's
currently certificated working gas capacity from 48 to 80 Bcf. The
general location of the project facilities is shown in Appendix 1.\1\
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    \1\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies of appendices were sent to
all those receiving this notice in the mail and are available at
http://www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street, NE,
Washington, DC 20426, or call<PHONE_NUMBER>. For instructions on
connecting to eLibrary, refer to the last page of this notice.
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Land Requirements for Construction

    Construction of the planned facilities would disturb about 23.9
acres of land for the aboveground facilities and the pipeline.
Following construction, about 12.3 acres would be maintained for
permanent operation of the project's facilities; the remaining acreage
would be restored and allowed to revert to former uses.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\2\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping''. The main goal of
the scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. All comments
received will be considered during the preparation of the EA.
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    \2\ ``We'', ``us'', and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
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    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed project under these
general headings:
     Geology and soils;
     Land use;
     Water resources, fisheries, and wetlands;
     Cultural resources;
     Vegetation and wildlife;
     Endangered and threatened species;
     Air quality and noise; and
     Public safety.
    We will also evaluate reasonable alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    Our independent analysis of the issues will be presented in the EA.
The EA will be placed in the public record and, depending on the
comments received during the scoping process, may be published and
distributed to the public. A comment period will be allotted if the EA
is published for review. We will consider all comments on the EA before
we make our recommendations to the Commission. To ensure your comments
are considered, please carefully follow the instructions in the Public
Participation section below.
    With this notice, we are asking agencies with jurisdiction and/or
special expertise with respect to environmental issues to formally
cooperate with us in the preparation of the EA. These agencies may
choose to participate once they have evaluated the proposal relative to
their responsibilities. Agencies that would like to request cooperating
agency status should follow the instructions for filing comments
provided under the Public Participation section of this notice.

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with applicable State Historic Preservation Office (SHPO), and to
solicit their views and those of other government agencies, interested
Indian tribes, and the public on the project's potential effects on
historic properties.\3\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPO(s) as the project
is further developed. On natural gas facility projects, the APE at a
minimum encompasses all areas subject to ground disturbance (examples
include construction right-of-way, contractor/pipe storage yards,
compressor stations, and access roads). Our EA for this project will
document our findings on the impacts on historic properties and
summarize the status of consultations under section 106.
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    \3\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Historic
properties are defined in those regulations as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register for Historic
Places.
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Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. The more specific
your comments, the more useful they will be. To ensure that your
comments are timely and properly recorded, please send your comments so
that they will be received in Washington, DC on or before November 27,
2010.
    For your convenience, there are three methods which you can use to
submit your comments to the Commission. In all instances please
reference the project docket number (CP11-1-000) with your submission.
The Commission encourages electronic filing of comments and has expert
eFiling staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's Web site at http://
www.ferc.gov under the link to Documents and Filings. An eComment is an
easy method for interested persons to submit brief, text-only comments
on a project;
    (2) You may file your comments electronically by using the eFiling
feature, which is located on the Commission's Web site at http://
www.ferc.gov under the link to Documents and Filings. With eFiling you
can provide comments in a variety of formats by attaching them as a
file with your submission. New eFiling

users must first create an account by clicking on ``eRegister.'' You
will be asked to select the type of filing you are making. A comment on
a particular project is considered a ``Comment on a Filing''; or
    (3) You may file a paper copy of your comments at the following
address:

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Room 1A, Washington, DC 20426.

Environmental Mailing List

    The environmental mailing list includes Federal, State, and local
parish government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own land within
certain distances of aboveground facilities, and anyone who submits
comments on the project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed project.
    If the EA is published for distribution, copies will be sent to the
environmental mailing list for public review and comment. If you would
prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (Appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are
included in the User's Guide under the ``e-filing'' link on the
Commission's Web site.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site at http://www.ferc.gov using the ``eLibrary'' link. Click
on the eLibrary link, click on ``General Search'' and enter the docket
number, excluding the last three digits in the Docket Number field
(i.e., CP11-1). Be sure you have selected an appropriate date range.
For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at http://www.ferc.gov/EventCalendar/
EventsList.aspx along with other related information.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-27561 Filed 11-1-10; 8:45 am]
BILLING CODE 6717-01-P


Record for the Final Metal Product and Machinery Rule 12345 6 789 10 11 12 13 14 15 16 A B C D E F VARIABLE DESCRIPTIONS FOR FACDATA_ FINAL. XLS VARIABLE DESCRIPTION WORKSHEET COLUMN CBI FORMULA SID$ Survey ID FacData A N Survey Survey ID FacData B N Sector Sector Abbreviation FacData C Y Emp Size Entity Size: Large business= 0; Small business= 1; Maybe Large ( exceeds one threshold but not the other)= 2; Unknown= 3 FacData D Y The Phase 1, Phase 2, and Iron & Steel data come from Small_ Final. xls. The muni data comes from MuniMPCT_ Final. xls. The rail data comes from RailMPCT_ Final. xls. Flow Cat Flow Range: 0: <= 1 million gallons per year; 1: 1 2 mgy; 2: 2 3 mgy; 3: 3 4 mgy; 4: 4 5 mgy; 5: 5 6.25 mgy; 6: over 6.25 mgy FacData E Y = VLOOKUP( A6, Flow, 3,0)

Weight Sample weight FacData F Y Survey Type Survey Type ( e. g., long, municipality) FacData G N Subcat Subcategory FacData H Y Flow Baseline Annual Flow FacData I Y = VLOOKUP( A6, Flow, 2,0) Revenue Source Revenue Source: M= Revenues come from manufacturing only; R= Revenues come from rebuilding and maintenance only; B= Revenues come from both manufacturing and rebuilding and maintenance; U= Unknown; MU= Municipality FacData J N = VLOOKUP( A6,[ RevbySct_ Final. xls] Summary!$ A$ 3:$ BV$ 1000,64,0)

Discharge Discharge type: D= Direct; I= Indirect FacData K N SID$ Survey ID Flow A N Flow Baseline site annual flow Flow B Y Cat Flow Range: 0: <= 1 million gallons per year; 1: 1 2 mgy; 2: 2 3 mgy; 3: 3 4 mgy; 4: 4 5 mgy; 5: 5 6.25 mgy; 6: over 6.25 mgy Flow C Y = IF( B7<= 1000000,0, IF( B7<= 2000000,1, IF( B7<= 3000000,2, IF( B7<= 4000000,3, IF( B7<= 5000000,4, IF( B7<= 6250000,5,6))))))

February 14, 2003 Page 1 of 18 facdata_ Final. xls  Var Desc Record for the Final Metal Product and Machinery Rule 12 345 6789 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 A B C D E F G H I J K 1 2 3 4 5 6 7 8 9 10 11 Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 1 1 Long M I 2 2 Long M I 3 3 Phase 1 M I 4 4 Municipality MU I 5 5 Long U I 6 6 Long M I 7 7 Phase 1 M I 8 8 Long M D 9 9 Long M I 10 10 Phase 1 R I 12 12 Phase 1 M I 13 13 Phase 1 M I 14 14 Phase 1 M I 15 15 Phase 1 M I 16 16 Phase 1 M I 17 17 Municipality MU I 18 18 Municipality MU D 20 20 Phase 1 M I 21 21 Long M I 22 22 Long M I 23 23 Municipality MU I 24 24 Phase 1 U I 25 25 Phase 1 B I 26 26 Long M I 27 27 Long M I 28 28 Phase 1 M I 29 29 Long M I 30 30 Municipality MU I 31 31 Phase 1 U I 32 32 Phase 1 M I 33 33 Long M I 35 35 Phase 1 M I 36 36 Long M I 37 37 Short M I 38 38 Phase 1 M I 39 39 Municipality MU D 40 40 Municipality MU I 41 41 Long M I 42 42 Phase 1 M I 43 43 Phase 1 M I 44 44 Long M I 45 45 Long M I 46 46 Phase 1 M I 47 47 Long M I 48 48 Phase 1 M I 50 50 Long M I 51 51 Long M I 52 52 Phase 1 M I 53 53 Long M I 55 55 Phase 1 B I 57 57 Phase 1 M I 58 58 Phase 1 M I 59 59 Phase 1 R I 60 60 Phase 1 U I February 14, 2003 Page 2 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 61 61 Long B I 62 62 Long M I 62 62 Long M D 64 64 Long M I 65 65 Long U I 65 65 Long U D 67 67 Long B I 68 68 Phase 1 M I 69 69 Phase 1 M I 70 70 Phase 1 M I 71 71 Short M I 72 72 Phase 1 M I 73 73 Phase 1 M I 74 74 Long R I 75 75 Long M I 76 76 Phase 1 M I 78 78 Phase 1 B I 79 79 Long M I 80 80 Rail R I 81 81 Long M I 83 83 Phase 1 M I 84 84 Phase 1 M I 85 85 Phase 1 B I 86 86 Phase 1 M I 87 87 Long M I 88 88 Phase 1 U I 89 89 Short R I 90 90 Long M I 91 91 Long M I 92 92 Long R I 93 93 Municipality MU I 94 94 Phase 1 M I 95 95 Short M I 96 96 Phase 1 M I 97 97 Long M I 98 98 Municipality MU I 99 99 Long M I 100 100 Phase 1 M D 101 101 Long M I 102 102 Phase 1 B I 103 103 Long M I 104 104 Municipality MU I 105 105 Phase 1 M I 106 106 Short M I 108 108 Long R I 109 109 Phase 1 U I 110 110 Long B I 111 111 Long M I 112 112 Phase 1 M I 113 113 Long M I 114 114 Phase 1 M I 115 115 Phase 1 M I 116 116 Long M I 117 117 Municipality MU I 118 118 Phase 1 U D 119 119 Phase 1 M I February 14, 2003 Page 3 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 120 120 Phase 1 M I 121 121 Long U I 122 122 Long M I 123 123 Municipality MU I 124 124 Rail R D 125 125 Phase 1 B I 126 126 Long M I 127 127 Long R I 128 128 Long M D 129 129 Phase 1 M I 130 130 Phase 1 M I 131 131 Long M I 132 132 Phase 1 M I 134 134 Municipality MU I 135 135 Phase 1 M I 136 136 Phase 1 M I 137 137 Long M I 138 138 Phase 1 M I 139 139 Municipality MU I 140 140 Long M I 141 141 Phase 1 B I 142 142 Phase 1 M D 143 143 Phase 1 M D 145 145 Rail R I 146 146 Long M I 147 147 Phase 1 M I 148 148 Phase 1 M I 149 149 Phase 1 M I 150 150 Long M I 151 151 Long M I 152 152 Municipality MU I 153 153 Long R I 154 154 Phase 1 M I 155 155 Phase 1 M I 156 156 Long M I 157 157 Long M I 158 158 Rail R I 159 159 Phase 1 U I 161 161 Short M I 162 162 Phase 1 M I 163 163 Phase 1 M I 164 164 Phase 1 M I 165 165 Phase 1 M I 166 166 Phase 1 M I 167 167 Municipality MU I 170 170 Phase 1 M I 171 171 Municipality MU I 172 172 Phase 1 M D 173 173 Long M I 174 174 Phase 1 M I 176 176 Long M I 177 177 Phase 1 M D 178 178 Phase 1 M I 179 179 Phase 1 M I 181 181 Phase 1 M I 182 182 Long M I February 14, 2003 Page 4 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 183 183 Phase 1 M I 184 184 Phase 1 M I 185 185 Phase 1 M I 186 186 Long U I 187 187 Phase 1 M D 188 188 Phase 1 M I 189 189 Long M I 190 190 Phase 1 M I 191 191 Phase 1 M I 192 192 Long M I 193 193 Phase 1 M I 194 194 Rail R I 195 195 Long M I 196 196 Long M I 197 197 Phase 1 U I 199 199 Phase 1 M I 200 200 Phase 1 M I 201 201 Long M I 202 202 Phase 1 M I 203 203 Long M I 204 204 Long M I 205 205 Municipality MU I 207 207 Long M I 208 208 Phase 1 M I 209 209 Phase 1 M I 210 210 Phase 1 B D 211 211 Long M I 212 212 Phase 1 M I 213 213 Municipality MU D 214 214 Phase 1 M D 215 215 Long M I 216 216 Phase 1 M I 218 218 Municipality MU I 219 219 Phase 1 M I 221 221 Phase 1 M I 222 222 Long M I 223 223 Phase 1 M I 224 224 Short M I 225 225 Long M I 226 226 Phase 1 M I 227 227 Phase 1 M I 228 228 Long M I 229 229 Phase 1 M I 230 230 Phase 1 M I 231 231 Long B I 232 232 Phase 1 M I 233 233 Phase 1 U I 235 235 Phase 1 B I 236 236 Rail R I 237 237 Long M I 238 238 Rail R I 239 239 Phase 1 M I 240 240 Long M I 241 241 Long M I 242 242 Long M I 243 243 Long M I February 14, 2003 Page 5 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 245 245 Phase 1 M I 246 246 Long M I 247 247 Phase 1 B I 248 248 Phase 1 B I 249 249 Phase 1 B I 250 250 Long M I 252 252 Phase 1 M I 253 253 Long R I 254 254 Phase 1 M I 255 255 Long M I 257 257 Long R I 258 258 Municipality MU I 259 259 Long M I 261 261 Phase 1 M I 262 262 Phase 1 B I 263 263 Long B I 264 264 Phase 1 M I 265 265 Phase 1 M D 266 266 Phase 1 M D 267 267 Phase 1 M I 268 268 Phase 1 U I 269 269 Long M I 270 270 Long M I 271 271 Long M I 272 272 Municipality MU I 273 273 Phase 1 M I 274 274 Phase 1 B D 276 276 Phase 1 M I 277 277 Municipality MU I 278 278 Municipality MU D 279 279 Phase 1 M I 280 280 Phase 1 U I 281 281 Phase 1 B D 282 282 Phase 1 M I 283 283 Phase 1 U D 284 284 Phase 1 B I 285 285 Phase 1 M I 286 286 Short M I 288 288 Phase 1 M I 289 289 Phase 1 M I 290 290 Long M I 291 291 Short R I 292 292 Municipality MU I 293 293 Phase 1 M I 295 295 Long M I 296 296 Phase 1 M I 298 298 Long R I 299 299 Long M I 300 300 Long M I 301 301 Phase 1 M I 302 302 Phase 1 M I 303 303 Phase 1 M I 304 304 Phase 1 U D 305 305 Phase 1 M I 306 306 Phase 1 U I 307 307 Short M I February 14, 2003 Page 6 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 308 308 Long M I 309 309 Phase 1 M I 310 310 Long M I 311 311 Municipality MU I 312 312 Long M I 313 313 Phase 1 M I 314 314 Phase 1 B I 315 315 Phase 1 M I 316 316 Long M I 318 318 Municipality MU I 319 319 Phase 1 M I 322 322 Phase 1 M I 323 323 Phase 1 M I 324 324 Long B I 325 325 Phase 1 M I 326 326 Phase 1 M I 327 327 Long M I 328 328 Long M I 329 329 Long B I 330 330 Long M I 331 331 Phase 1 M I 332 332 Long U I 333 333 Phase 1 B I 334 334 Long M D 335 335 Phase 1 M I 336 336 Phase 1 M I 337 337 Long U I 338 338 Phase 1 M I 340 340 Phase 1 M I 341 341 Municipality MU I 342 342 Long M I 345 345 Phase 1 M I 346 346 Municipality MU I 347 347 Municipality MU I 348 348 Municipality MU I 349 349 Long M I 350 350 Long M I 351 351 Phase 1 M I 352 352 Rail R I 355 355 Long M I 357 357 Long M I 358 358 Phase 1 M I 358 358 Phase 1 M D 359 359 Phase 1 U I 360 360 Municipality MU D 361 361 Phase 1 M I 362 362 Municipality MU I 363 363 Phase 1 B I 364 364 Phase 1 M I 365 365 Phase 1 M I 368 368 Municipality MU I 369 369 Phase 1 U I 370 370 Phase 1 M I 372 372 Long M I 373 373 Rail R I 374 374 Long M I February 14, 2003 Page 7 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 376 376 Phase 1 M I 377 377 Phase 1 M I 378 378 Phase 1 M I 379 379 Municipality MU I 380 380 Phase 1 M I 381 381 Phase 1 M I 382 382 Rail R I 383 383 Long M I 384 384 Phase 1 M I 385 385 Municipality MU I 386 386 Phase 1 M I 387 387 Phase 1 B I 388 388 Phase 1 M I 390 390 Phase 1 M I 391 391 Municipality MU I 392 392 Long M I 393 393 Long M I 394 394 Municipality MU I 395 395 Phase 1 M I 396 396 Phase 1 M I 397 397 Municipality MU I 398 398 Phase 1 B I 399 399 Phase 1 M I 400 400 Long M I 401 401 Long M I 402 402 Long M I 403 403 Phase 1 M D 404 404 Phase 1 U I 405 405 Municipality MU I 406 406 Long M I 407 407 Long M I 408 408 Phase 1 M I 409 409 Phase 1 M I 410 410 Phase 1 M I 411 411 Long M I 412 412 Long M D 413 413 Phase 1 U I 414 414 Phase 1 M I 416 416 Phase 1 M I 417 417 Long R I 418 418 Phase 1 M I 419 419 Long M I 420 420 Long M I 421 421 Long M I 422 422 Phase 1 M I 423 423 Short M I 424 424 Phase 1 M I 425 425 Long M I 427 427 Municipality MU I 428 428 Phase 1 M I 429 429 Phase 1 M I 430 430 Long M I 433 433 Long M I 434 434 Short U I 435 435 Long M I 436 436 Rail R I February 14, 2003 Page 8 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 437 437 Municipality MU I 439 439 Long M I 440 440 Phase 1 M I 441 441 Phase 1 B I 442 442 Phase 1 M I 443 443 Long M I 445 445 Long B I 446 446 Phase 1 M I 447 447 Phase 1 M I 448 448 Short M I 449 449 Long M I 450 450 Long M I 451 451 Phase 1 B I 452 452 Phase 1 M I 453 453 Long M I 455 455 Long M I 456 456 Phase 1 M I 457 457 Phase 1 B I 458 458 Phase 1 M I 459 459 Phase 1 M I 460 460 Long R I 461 461 Phase 1 M I 462 462 Phase 1 M I 463 463 Long M I 464 464 Phase 1 M I 465 465 Municipality MU I 466 466 Phase 1 M I 467 467 Municipality MU I 468 468 Phase 1 B D 470 470 Phase 1 M I 471 471 Short M I 472 472 Phase 1 U I 473 473 Phase 1 M D 475 475 Phase 1 M I 476 476 Short M I 477 477 Long M I 478 478 Municipality MU I 479 479 Phase 1 R I 480 480 Phase 1 M I 481 481 Phase 1 M I 482 482 Short M I 483 483 Municipality MU I 484 484 Phase 1 M I 485 485 Municipality MU D 486 486 Phase 1 M I 487 487 Long M I 488 488 Phase 1 M I 489 489 Phase 1 M I 490 490 Phase 1 M I 491 491 Municipality MU I 492 492 Phase 1 B I 493 493 Phase 1 M I 494 494 Long M I 495 495 Long M I 496 496 Phase 1 M I 497 497 Long M I February 14, 2003 Page 9 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 498 498 Long M I 498 498 Long M D 499 499 Municipality MU I 500 500 Rail R I 501 501 Long R I 502 502 Phase 1 M I 503 503 Long M I 504 504 Phase 1 M I 505 505 Short R I 506 506 Long M I 507 507 Long M I 508 508 Municipality MU I 509 509 Phase 1 M I 510 510 Phase 1 M I 511 511 Phase 1 M I 513 513 Long M I 514 514 Phase 1 M I 515 515 Phase 1 M I 516 516 Long M I 517 517 Long M I 518 518 Phase 1 M I 519 519 Long M I 520 520 Phase 1 M I 521 521 Municipality MU I 522 522 Phase 1 B I 523 523 Phase 1 M I 524 524 Phase 1 M I 525 525 Long M I 526 526 Phase 1 M I 527 527 Short M I 528 528 Long M I 530 530 Phase 1 M I 531 531 Phase 1 M I 532 532 Phase 1 B I 533 533 Long M I 534 534 Phase 1 M I 535 535 Municipality MU I 536 536 Phase 1 U I 537 537 Phase 1 M I 538 538 Phase 1 B I 539 539 Phase 1 B I 540 540 Phase 1 U I 541 541 Municipality MU I 542 542 Phase 1 M I 543 543 Long M I 545 545 Phase 1 M I 547 547 Long M I 548 548 Phase 1 M I 549 549 Long M I 550 550 Long M I 552 552 Long M I 553 553 Municipality MU I 554 554 Municipality MU I 555 555 Phase 1 M I 556 556 Short R I 557 557 Municipality MU I February 14, 2003 Page 10 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558 559 560 561 562 563 558 558 Municipality MU D 560 560 Long U I 561 561 Phase 1 M I 562 562 Rail R I 563 563 Long M I 564 564 Long M I 565 565 Municipality MU I 566 566 Phase 1 M I 567 567 Phase 1 M I 569 569 Municipality MU I 570 570 Phase 1 M D 571 571 Municipality MU I 572 572 Rail R I 573 573 Municipality MU I 574 574 Phase 1 M D 575 575 Long M I 577 577 Long M I 578 578 Phase 1 M I 579 579 Phase 1 M I 580 580 Long M I 581 581 Municipality MU I 582 582 Municipality MU I 583 583 Phase 1 M D 584 584 Long M I 586 586 Phase 1 M I 587 587 Long M I 588 588 Municipality MU D 590 590 Phase 1 M I 591 591 Long M I 594 594 Long M I 595 595 Phase 1 B I 596 596 Rail R I 597 597 Long M I 598 598 Long M I 599 599 Long M D 600 600 Long M I 602 602 Municipality MU I 603 603 Phase 1 M I 605 605 Phase 1 M I 606 606 Long M I 607 607 Short M I 608 608 Phase 1 M I 609 609 Phase 1 M I 610 610 Long M I 611 611 Phase 1 M I 612 612 Phase 1 M I 613 613 Phase 1 M I 614 614 Phase 1 M I 615 615 Phase 1 M I 616 616 Phase 1 B D 617 617 Phase 1 M I 619 619 Long M I 620 620 Rail R I 621 621 Phase 1 M I 622 622 Phase 1 M D 623 623 Phase 1 M I February 14, 2003 Page 11 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 564 565 566 567 568 569 570 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586 587 588 589 590 591 592 593 594 595 596 597 598 599 600 601 602 603 604 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 624 624 Phase 1 M I 625 625 Long M I 626 626 Long M I 627 627 Phase 1 M I 628 628 Long M I 629 629 Phase 1 M D 630 630 Phase 1 B I 631 631 Phase 1 M I 632 632 Phase 1 M I 633 633 Phase 1 M I 634 634 Phase 1 M I 635 635 Phase 1 M I 636 636 Long M I 637 637 Long U I 638 638 Rail R I 639 639 Long M I 640 640 Long U I 641 641 Long M I 643 643 Long M I 645 645 Long M I 646 646 Municipality MU I 647 647 Municipality MU I 648 648 Phase 1 M I 649 649 Long M I 650 650 Long M D 651 651 Long M I 653 653 Phase 1 M I 655 655 Phase 1 M I 656 656 Phase 1 B I 657 657 Municipality MU I 658 658 Long B I 659 659 Rail R I 660 660 Long U I 661 661 Phase 1 M I 662 662 Phase 1 U I 663 663 Phase 1 M I 664 664 Phase 1 B I 665 665 Phase 1 M I 666 666 Short M I 667 667 Long M I 668 668 Long M D 669 669 Phase 1 M I 670 670 Long M I 671 671 Short M I 672 672 Municipality MU I 673 673 Phase 1 M I 674 674 Long M I 675 675 Phase 1 U I 679 679 Phase 1 U I 680 680 Short M I 681 681 Phase 1 M I 682 682 Long M I 683 683 Phase 1 M I 684 684 Phase 1 M I 685 685 Long M I 686 686 Municipality MU I February 14, 2003 Page 12 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 642 643 644 645 646 647 648 649 650 651 652 653 654 655 656 657 658 659 660 661 662 663 664 665 666 667 668 669 670 671 672 673 674 675 687 687 Phase 1 M I 688 688 Phase 1 M I 689 689 Municipality MU I 690 690 Phase 1 M I 691 691 Municipality MU I 692 692 Municipality MU I 693 693 Phase 1 M I 694 694 Long M I 695 695 Phase 1 B I 696 696 Phase 1 M I 698 698 Short R I 699 699 Short M I 700 700 Phase 1 M I 701 701 Long M D 702 702 Long M I 703 703 Short B I 704 704 Phase 1 B I 705 705 Phase 1 M I 706 706 Phase 1 U I 707 707 Phase 1 M I 708 708 Phase 1 M I 709 709 Long B I 710 710 Phase 1 M I 711 711 Phase 1 M I 712 712 Long M I 713 713 Long M I 714 714 Phase 1 M I 715 715 Long M I 716 716 Long M I 717 717 Phase 1 M I 718 718 Phase 1 M I 719 719 Long M I 720 720 Phase 1 M I 721 721 Long M I 722 722 Short M I 723 723 Long M I 724 724 Long M I 725 725 Long M I 726 726 Phase 1 M D 727 727 Long R I 728 728 Long M I 729 729 Long M I 730 730 Phase 1 M I 732 732 Phase 1 M I 733 733 Long B I 734 734 Long M I 735 735 Short M I 736 736 Municipality MU I 737 737 Long M I 738 738 Long M I 740 740 Phase 1 M I 741 741 Phase 1 M I 743 743 Municipality MU D 744 744 Municipality MU I 745 745 Long M I 746 746 Phase 1 M I February 14, 2003 Page 13 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 676 677 678 679 680 681 682 683 684 685 686 687 688 689 690 691 692 693 694 695 696 697 698 699 700 701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 716 717 718 719 720 721 722 723 724 725 726 727 728 729 730 731 747 747 Phase 1 M I 748 748 Long M I 748 748 Long M D 749 749 Phase 1 M I 751 751 Phase 1 B I 752 752 Phase 1 U I 753 753 Phase 1 U I 755 755 Long R I 756 756 Phase 1 M I 757 757 Long M I 758 758 Phase 1 M I 759 759 Long M I 760 760 Phase 1 M I 761 761 Rail R I 762 762 Long R I 763 763 Phase 1 U D 764 764 Phase 1 M I 765 765 Long M I 766 766 Long M I 767 767 Phase 1 M I 768 768 Long M I 770 770 Municipality MU D 771 771 Phase 1 M I 772 772 Short M I 773 773 Long R I 774 774 Phase 1 M I 775 775 Phase 1 M I 777 777 Phase 1 M I 778 778 Long M I 779 779 Long M I 780 780 Phase 1 U I 781 781 Long M I 782 782 Long M I 783 783 Municipality MU D 784 784 Long M I 785 785 Phase 1 M I 786 786 Long M I 787 787 Phase 1 M I 788 788 Long M I 789 789 Phase 1 M I 790 790 Phase 1 M I 791 791 Long U I 792 792 Long M I 793 793 Long M I 794 794 Municipality MU I 795 795 Long M I 796 796 Phase 1 U D 797 797 Phase 1 M I 798 798 Rail R I 799 799 Phase 1 M I 800 800 Phase 1 M I 801 801 Municipality MU I 802 802 Long M I 803 803 Municipality MU I 804 804 Short R I 805 805 Long M I February 14, 2003 Page 14 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 732 733 734 735 736 737 738 739 740 741 742 743 744 745 746 747 748 749 750 751 752 753 754 755 756 757 758 759 760 761 762 763 764 765 766 767 768 769 770 771 772 773 774 775 776 777 778 779 780 781 782 783 784 785 786 787 806 806 Long M I 807 807 Phase 1 M I 808 808 Phase 1 M I 809 809 Phase 1 M I 810 810 Municipality MU I 811 811 Long M I 813 813 Phase 1 M I 814 814 Phase 1 M I 815 815 Phase 1 M I 816 816 Phase 1 M I 817 817 Long B I 818 818 Short M I 819 819 Long M I 820 820 Long M I 821 821 Phase 1 M I 822 822 Long M I 823 823 Phase 1 M I 824 824 Phase 1 M I 825 825 Short M I 826 826 Municipality MU I 827 827 Municipality MU I 828 828 Municipality MU D 829 829 Phase 1 M I 830 830 Long M I 830 830 Long M D 831 831 Phase 1 M I 833 833 Municipality MU I 834 834 Long M I 835 835 Rail R I 836 836 Phase 1 M I 837 837 Phase 1 M I 839 839 Long M I 841 841 Short B I 842 842 Short M I 843 843 Short R I 844 844 Short R D 845 845 Municipality MU I 846 846 Long M I 848 848 Long M I 849 849 Long M I 850 850 Phase 1 M I 851 851 Phase 1 M I 852 852 Rail R D 853 853 Phase 1 B I 854 854 Phase 1 M I 855 855 Phase 1 M I 856 856 Phase 1 M I 857 857 Phase 1 M I 858 858 Phase 1 B I 859 859 Phase 1 M I 860 860 Phase 1 B I 861 861 Phase 1 U I 862 862 Long M I 863 863 Short B I 864 864 Phase 1 M I 866 866 Long M I February 14, 2003 Page 15 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 788 789 790 791 792 793 794 795 796 797 798 799 800 801 802 803 804 805 806 807 808 809 810 811 812 813 814 815 816 817 818 819 820 821 822 823 824 825 826 827 828 829 830 831 832 833 834 835 836 837 838 839 840 841 842 843 867 867 Phase 1 B I 868 868 Municipality MU D 869 869 Long U I 870 870 Phase 1 M I 871 871 Phase 1 M I 873 873 Phase 1 M I 874 874 Phase 1 B I 875 875 Phase 1 B I 877 877 Municipality MU I 878 878 Municipality MU D 879 879 Long B I 880 880 Phase 1 U I 881 881 Rail R I 882 882 Municipality MU I 884 884 Long M I 885 885 Phase 1 M I 886 886 Phase 1 M I 887 887 Short B I 888 888 Short R I 890 890 Municipality MU I 891 891 Short B I 892 892 Municipality MU I 893 893 Municipality MU I 894 894 Short M I 895 895 Municipality MU D 896 896 Municipality MU I 898 898 Municipality MU I 900 900 Municipality MU I 902 902 Municipality MU I 904 904 Municipality MU I 905 905 Short R I 906 906 Municipality MU D 907 907 Municipality MU I 908 908 Municipality MU I 910 910 Municipality MU I 913 913 Municipality MU I 915 915 Municipality MU I 916 916 Municipality MU I 917 917 Municipality MU I 919 919 Municipality MU I 920 920 Municipality MU I 921 921 Short R I 922 922 Short M I 923 923 Municipality MU I 924 924 Municipality MU I 925 925 Municipality MU I 926 926 Short R I 927 927 Short M I 928 928 Municipality MU I 930 930 Short M I 933 933 Municipality MU I 934 934 Short M I 936 936 Municipality MU I 937 937 Municipality MU I 939 939 Municipality MU I 940 940 Iron & Steel M I February 14, 2003 Page 16 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 345 6 A B C D E F G H I J K Facility Data SID$ Survey ID Sector Emp Size Flow Cat Weight Survey Type Subcat Flow Revenue Source Discharge 844 845 846 847 848 849 850 851 852 853 854 855 856 857 858 859 860 861 862 863 864 865 866 867 868 869 941 941 Iron & Steel M D 942 942 Municipality MU I 943 943 Iron & Steel M D 944 944 Iron & Steel M I 945 945 Iron & Steel M I 946 946 Iron & Steel M D 947 947 Iron & Steel M D 948 948 Short U I 949 949 Iron & Steel M D 950 950 Iron & Steel M I 951 951 Iron & Steel M D 952 952 Municipality MU I 953 953 Iron & Steel M D 954 954 Iron & Steel M D 955 955 Iron & Steel M I 956 956 Iron & Steel M I 957 957 Iron & Steel M D 958 958 Iron & Steel M D 959 959 Iron & Steel M I 960 960 Iron & Steel M D 961 961 Iron & Steel M D 962 962 Iron & Steel M I 963 963 Iron & Steel M D 964 964 Iron & Steel M D 965 965 Iron & Steel M I 966 966 Iron & Steel M I February 14, 2003 Page 17 of 18 facdata_ Final. xls  FacData Record for the Final Metal Product and Machinery Rule 1 23456789 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 A B C 1 2 3 Flow Category Baseline SID$ Flow Flow Category 1 2 3 4 5 6 7 8 9 10 12 13 14 15 16 17 18 20 21 22 23 24 25 26 27 28 29 30 31 32 33 35 36 37 38 39 40 41 42 43 44 45 46 47 48 50 51 52 53 55 57 58 59 Note: All data except site identification not shown to protect confidential business information. Sample page provided to show structure of worksheet. February 14, 2003 Page 18 of 18 facdata_ Final. xls  Flow


[Federal Register Volume 79, Number 18 (Tuesday, January 28, 2014)]
[Notices]
[Page 4526]
[FR Doc No: 2014-01546]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending December 21, 2013

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et seq.). The due date for Answers,
Conforming Applications, or Motions to Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2006-24190.
    Date Filed: December 20, 2013.
    Due Date for Answers, Conforming Applications, or Motion to Modify
Scope: January 10, 2014.
    Description: Application of ACM AIR CHARTER Luftfahrtgesellschaft
mbH (``AMC'') requesting issuance of an exemption and an amended
foreign air carrier permit authorizing AMC to engage in the following,
without limitation as to the size of aircraft that may be used: (i)
Foreign charter air transportation of persons, property and mail from
any point or points behind any Member State of the European Union, via
any point or points in any EU Member State and via intermediate points,
to any point or points in the United States and beyond; (ii) foreign
charter air transportation of persons, property and mail between any
point or points in the United States and any point or points in any
member of the European Common Aviation Area; (iii) foreign charter air
transportation of cargo between any point or points in the United
States and any other point or points; (iv) other charters pursuant to
the prior approval requirements; and (v) charter transportation
authorized by any additional route rights made available to European
Union carriers in the future, to the extent permitted by ACM'S homeland
license on file with the Department.

Barbara J. Hairston,
Supervisory Dockets Officer, Docket Operations, Federal Register
Liaison.
[FR Doc. 2014-01546 Filed 1-27-14; 8:45 am]
BILLING CODE 4910-9X-P


information requested, or does not attend the scheduled conference, the
Associate Administrator may dismiss the request for administrative
review.
    (2) Decision on administrative review. The Associate Administrator
will complete the administrative review and notify the person in
writing of the decision. The decision constitutes final Agency action.
If the Associate Administrator decides the removal was not valid, FMCSA
will reinstate the person and reissue a certification credential to
expire on the expiration date of the certificate that was invalidated
under paragraph (g) of this section. The reinstated certified VA
medical examiner must:
    (i) Continue to meet the requirements of Sec. Sec.  390.123 through
390.135 and the applicable requirements of part 391 of this chapter.
    (ii) Report to FMCSA any changes in the registration information
submitted under Sec.  390.123(a)(3) within 30 days of the
reinstatement.
    (iii) Be licensed, certified, or registered in accordance with
applicable State laws and regulations to perform physical examinations.
    (iv) Maintain documentation of licensure, registration, or
certification in a State to perform physical examinations and maintain
documentation of and completion of all training required by Sec. Sec.
390.125 and 390.131 of this part. The certified VA medical examiner
must make this documentation available to an authorized representative
of FMCSA or an authorized representative of Federal, State, or local
government. The certified VA medical examiner must provide this
documentation within 48 hours of the request for investigations and
within 10 days of the request for regular audits of eligibility.
    (v) Complete periodic training as required by the Director, Office
of Carrier, Driver and Vehicle Safety Standards.
    (e) Emergency removal. In cases of either willfulness or in which
public health, interest, or safety requires, the provisions of
paragraph (b) of this section are not applicable and the Director,
Office of Carrier, Driver and Vehicle Safety Standards may immediately
remove a certified VA medical examiner from the National Registry of
Certified Medical Examiners and invalidate the certification credential
issued under Sec.  390.129. A person who has been removed under the
provisions of this paragraph may request an administrative review of
that decision as described under paragraph (d) of this section.
    (f) Reinstatement on the National Registry of Certified Medical
Examiners. No sooner than 30 days after the date of removal from the
National Registry of Certified Medical Examiners, a person who has been
voluntarily or involuntarily removed may apply to the Director, Office
of Carrier, Driver and Vehicle Safety Standards to be reinstated. The
person must:
    (1) Continue to meet the requirements of Sec. Sec.  390.123 through
390.135 and the applicable requirements of part 391 of this chapter.
    (2) Report to FMCSA any changes in the registration information
submitted under Sec.  390.123(a)(3).
    (3) Be licensed, certified, or registered in accordance with
applicable State laws and regulations to perform physical examinations.
    (4) Maintain documentation of licensure, registration, or
certification in a State to perform physical examinations and maintain
documentation of and completion of all training required by Sec. Sec.
390.125 and 390.131. The certified VA medical examiner must make this
documentation available to an authorized representative of FMCSA or an
authorized representative of Federal, State, or local government. The
certified VA medical examiner must provide this documentation within 48
hours of the request for investigations and within 10 days of the
request for regular audits of eligibility.
    (5) Complete training and testing as required by the Director,
Office of Carrier, Driver and Vehicle Safety Standards.
    (6) In the case of a person who has been involuntarily removed,
provide documentation showing completion of any corrective actions
required in the notice of proposed removal.
    (g) Effect of final decision by FMCSA. If a person is removed from
the National Registry of Certified Medical Examiners under paragraph
(c) or (e) of this section, the certification credential issued under
Sec.  390.129 is no longer valid. However, the removed person's
information remains publicly available for 3 years, with an indication
that the person is no longer listed on the National Registry of
Certified Medical Examiners as of the date of removal.

PART 391--QUALIFICATIONS OF DRIVERS AND LONGER COMBINATION VEHICLES
(LCV) DRIVER INSTRUCTORS

0
12. The authority citation for part 391 is revised to read as follows:

    Authority:  49 U.S.C. 504, 508, 31133, 31136, 31149, 31502; sec.
4007(b), Pub. L. 102-240, 105 Stat. 1914, 2152; sec. 114, Pub. L.
103-311, 108 Stat. 1673, 1677; sec. 215, Pub. L. 106-159, 113 Stat.
1748, 1767; sec. 32934, Pub. L. 112-141, 126 Stat. 405, 830; secs.
5403 and 5524, Pub. L. 114-94, 129 Stat. 1312, 1548, 1560; sec. 2,
Pub. L. 115-105, 131 Stat. 2263; and 49 CFR 1.87.

0
13. Amend Sec.  391.43 by revising paragraph (b) to read as follows:

Sec.  391.43  Medical examination; certificate of physical examination.

* * * * *
    (b) Exceptions:

    (1) A licensed optometrist may perform so much of the medical
examination as pertains to visual acuity, field of vision, and the
ability to recognize colors as specified in paragraph (10) of Sec.
391.41(b).
    (2) A certified VA medical examiner must only perform medical
examinations of veteran operators.
* * * * *

    Issued under authority delegated in 49 CFR 1.87 on: June 5,
2018.
Raymond P. Martinez,
Administrator.
[FR Doc. 2018-12474 Filed 6-8-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Rules and Regulations]
[Pages 52195-52197]
[FR Doc No: 2014-20882]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. FDA-2014-N-1176]

Medical Devices; Hematology and Pathology Devices; Classification
of Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test
System for Specimen Characterization

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying early
growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH)
test system for specimen characterization into class II (special
controls). The special controls that will apply to this device are
identified in this order and will be part of the codified language for
the early growth response 1 (EGR1) gene fluorescence in-site
hybridization (FISH) test system for specimen characterization
classification. The Agency is classifying the device into class II
(special controls) in order to provide a reasonable assurance of safety
and effectiveness of the device.

DATES: This order is effective October 3, 2014. The classification was
applicable July 29, 2013.

FOR FURTHER INFORMATION CONTACT: Shyam Kalavar, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5568, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Public Law 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on March 20, 2013, classifying the Vysis EGR1 FISH Probe Kit--SC
into class III, because it was not substantially equivalent to a device
that was introduced or delivered for introduction into interstate
commerce for commercial distribution before May 28, 1976, or a device
that was subsequently reclassified into class I or class II. On April
9, 2013, Abbott Molecular, Inc., submitted a request for classification
of Vysis EGR1 FISH Probe Kit--SC under section 513(f)(2) of the FD&C
Act. The manufacturer recommended that the device be classified into
class II.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the de novo request, FDA determined that the
device can be classified into class II with the establishment of
special controls. FDA believes these special controls, in addition to
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on July 29, 2013, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding Sec.  864.1870.
    Following the effective date of this final classification
administrative order, any firm submitting a premarket notification
(510(k)) for an early growth response 1 (EGR1) gene fluorescence in-
situ hybridization (FISH) test system for specimen characterization
will need to comply with the special controls named in the final
administrative order.
    The device is assigned the generic name early growth response 1
(EGR1) gene fluorescence in-situ hybridization (FISH) test system for
specimen characterization, and it is identified as a device intended to
detect the EGR1 probe target on chromosome 5q in bone marrow specimens
from patients with acute myeloid leukemia (AML) or myelodysplastic
syndrome (MDS). The assay results are intended to be interpreted only
by a qualified pathologist or cytogeneticist. These devices do not
include automated systems that directly report results without review
and interpretation by a qualified pathologist or cytogeneticist. These
devices also do not include any device intended for use to select
patient therapy, predict patient response to therapy, or to screen for
disease as well as any device with a claim for a particular diagnosis,
prognosis, monitoring, or risk assessment.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks
in table 1:

           Table 1--Identified Risks and Required Mitigations
------------------------------------------------------------------------
             Identified risks                   Required mitigations
------------------------------------------------------------------------
False negative result.....................  Special controls (1), (2),
                                             and (3).
False positive result.....................  Special controls (1), (2),
                                             and (3).
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to
the general controls, address these risks to health and provide
reasonable assurance of safety and effectiveness:
    1. Premarket notification submissions must also include the
following information:
    a. A detailed description of all probes included in the kit;
    b. Purpose of each probe;
    c. Probe molecular specificity;
    d. Probe specificity;
    e. Probe limits;
    f. Probe sensitivity;
    g. Specification of required ancillary reagents, instrumentation,
and equipment;
    h. Specification of the specimen collection, processing, storage,
and slide preparation methods;
    i. Specification of the assay procedure;
    j. Specification of control elements that are incorporated into the
recommended testing procedures;
    k. Specification of risk mitigation elements: Description of all
additional procedures, methods, and practices incorporated into the
directions for use that mitigate risks associated with testing;
    l. Specification of the criteria for test result interpretation and
reporting;
    m. Device analytical sensitivity data;
    n. Device analytical specificity data;
    o. Device reference limit data;
    p. Device precision/reproducibility data;
    q. Device stability data to include:
    i. Real-time stability;
    ii. Freeze-thaw stability;
    iii. Transport and temperature stability;
    iv. Post-hybridization signal stability;
    v. Photostability of probe; and
    r. Documentation that demonstrates the clinical validity of the
device. The documentation must include data from clinical studies, a
minimum of two peer-reviewed published literature references using the
specific device seeking marketing clearance, or both. Documentation for
the clinical studies and peer-reviewed published literature references
cited must include the following elements:
    i. Documentation that the sponsor's probe was used in the
literature reference,
    ii. Number and type of specimens,
    iii. Target population studied,
    iv. Upper reference limit, and
    v. Range of positive probe results.
    2. Your Sec.  809.10(b)(12) (21 CFR 809.10(b)(12)) compliant
labeling must include a statement summarizing the data identified in
Sec.  864.1870(b)(1)(xiii) through (b)(1)(xviii) and a description of
the studies supporting the information, including the pre-specified
acceptance criteria for these performance studies, justification for
the pre-specified acceptance criteria, and whether the pre-specified
acceptance criteria were met.
    3. Your Sec.  809.10 compliant labeling must include:
    a. A warning that reads ``The assay results are intended to be
interpreted only by a qualified pathologist or cytogeneticist.''
    b. A warning that reads ``This device is not for high-risk uses
such as selecting therapy, predicting therapeutic response or disease
screening.''
    c. A warning that reads ``The use of this device for diagnosis,
monitoring or risk assessment has not been established.''
    Early growth response 1 (EGR1) gene fluorescence in-situ
hybridization (FISH) test system for specimen characterization are
prescription devices restricted to patient use only upon the
authorization of a practitioner licensed by law to administer or use
the device. (See section 520(e) of the FD&C Act (21 U.S.C. 360j(e)) and
21 CFR 801.109 (Prescription devices).). Prescription-use restrictions
are a type of general control as defined in section 513(a)(1)(A)(i) of
the FD&C Act.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the early growth response 1 (EGR1)
gene fluorescence in-situ hybridization (FISH) test system for specimen
characterization they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120 and
the collections of information in 21 CFR parts 801 and 809 regarding
labeling have been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 864

    Blood, Medical devices, Packaging and containers.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
864 is amended as follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

0
1. The authority citation for 21 CFR part 864 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  864.1870 to subpart B to read as follows:

Sec.  864.1870  Early growth response 1 (EGR1) gene fluorescence in-
situ hybridization (FISH) test system for specimen characterization.

    (a) Identification. An early growth response 1 (EGR1) gene
fluorescence in-situ hybridization (FISH) test system for specimen
characterization is a device intended to detect the EGR1 probe target
on chromosome 5q in bone marrow specimens from patients with acute
myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The assay
results are intended to be interpreted only by a qualified pathologist
or cytogeneticist. These devices do not include automated systems that
directly report results without review and interpretation by a
qualified pathologist or cytogeneticist.

These devices also do not include any device intended for use to select
patient therapy, predict patient response to therapy, or to screen for
disease as well as any device with a claim for a particular diagnosis,
prognosis, monitoring, or risk assessment.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must also include the
following information:
    (i) A detailed description of all probes included in the kit;
    (ii) Purpose of each probe;
    (iii) Probe molecular specificity;
    (iv) Probe specificity;
    (v) Probe limits;
    (vi) Probe sensitivity;
    (vii) Specification of required ancillary reagents,
instrumentation, and equipment;
    (viii) Specification of the specimen collection, processing,
storage and slide preparation methods;
    (ix) Specification of the assay procedure;
    (x) Specification of control elements that are incorporated into
the recommended testing procedures;
    (xi) Specification of risk mitigation elements: Description of all
additional procedures, methods, and practices incorporated into the
directions for use that mitigate risks associated with testing;
    (xii) Specification of the criteria for test result interpretation
and reporting;
    (xiii) Device analytical sensitivity data;
    (xiv) Device analytical specificity data;
    (xv) Device reference limit data;
    (xvi) Device precision/reproducibility data;
    (xvii) Device stability data to include:
    (A) Real-time stability,
    (B) Freeze-thaw stability,
    (C) Transport and temperature stability,
    (D) Post-hybridization signal stability,
    (E) Photostability of probe, and
    (xviii) Documentation that demonstrates the clinical validity of
the device. The documentation must include data from clinical studies,
a minimum of two peer-reviewed published literature references using
the specific device seeking marketing clearance, or both. Documentation
for the clinical studies and peer-reviewed published literature
references cited must include the following elements:
    (A) Documentation that the sponsor's probe was used in the
literature reference,
    (B) Number and type of specimens,
    (C) Target population studied,
    (D) Upper reference limit, and
    (E) Range of positive probe results.
    (2) Your Sec.  809.10(b)(12) of this chapter compliant labeling
must include a statement summarizing the data identified in paragraphs
(b)(1)(xiii) through (xviii) of this section and a description of the
studies supporting the information, including the pre-specified
acceptance criteria for these performance studies, justification for
the pre-specified acceptance criteria, and whether the pre-specified
acceptance criteria were met.
    (3) Your Sec.  809.10 of this chapter compliant labeling must
include:
    (i) A warning that reads ``The assay results are intended to be
interpreted only by a qualified pathologist or cytogeneticist.''
    (ii) A warning that reads ``This device is not for high-risk uses
such as selecting therapy, predicting therapeutic response or disease
screening.''
    (iii) A warning that reads ``The use of this device for diagnosis,
monitoring or risk assessment has not been established.''

    Dated: August 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-20882 Filed 9-2-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Notices]
[Pages 22553-22554]
[FR Doc No: 2013-08806]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0391]

Generic Drug Facilities, Sites, and Organizations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
generic drug facility self-identification reporting period for fiscal
year (FY) 2014 will begin on May 1, 2013, and close on June 1, 2013.
Generic drug facilities, certain sites, and organizations identified in
a generic drug submission are required by the Generic Drug User Fee
Amendments of 2012 (GDUFA) to submit, update, or reconfirm
identification information to FDA annually.

DATES: For FY 2014, identification information must be submitted,
updated, or reconfirmed between May 1, 2013, and June 1, 2013.

ADDRESSES: Electronic tools for submitting the required information may
be found on FDA's Web site at the following addresses:
     eSubmitter tool: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm108165.htm.
     Structured Product Labeling (SPL) Xforms: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm.

Other applications are available commercially.

FOR FURTHER INFORMATION CONTACT: Jaewon Hong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 4145, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: GDUFA (Pub. L. 112-144, Title III) was
signed into law by the President on July 9, 2012, as part of the Food
and Drug Administration Safety and Innovation Act. GDUFA is designed to
speed the delivery of safe and effective generic drugs to the public
and reduce costs to industry. GDUFA enables FDA to assess user fees to
fund critical and measurable enhancements to FDA's generic drugs
program. GDUFA will also significantly

improve global supply chain transparency by requiring owners of
facilities producing generic drug products and active pharmaceutical
ingredients and certain other sites and organizations that support the
manufacture or approval of these products to electronically self-
identify with FDA and update that information annually.
    Annual self-identification is required for two purposes. First, it
is necessary to determine the universe of facilities required to pay
user fees. Second, self-identification is a central component of an
effort to promote global supply chain transparency. The information
provided through self-identification enables quick, accurate, and
reliable surveillance of generic drugs and facilitates inspections and
compliance.
    Persons who self-identified for FY 2013 must self-identify again
for FY 2014 between May 1, 2013, and June 1, 2013. Additional
information including who is required to self-identify, how the
information is submitted to FDA, the penalty for failure to self-
identify, and the technical specifications are available on http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm.
    Please note that registration and listing under section 510 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is a different
process than self-identification under GDUFA. Many persons will thus be
required to submit information separately to the respective systems.
Each system populates its own database to meet unique requirements and
deadlines. Both, however, are built on the same platform and based on
the same technical standards.

    Dated: April 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08806 Filed 4-15-13; 8:45 am]
BILLING CODE 4160-01-P