[Federal Register Volume 78, Number 235 (Friday, December 6, 2013)]
[Notices]
[Pages 73523-73524]
[FR Doc No: 2013-29132]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0310; FRL-9903-74-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for Sewage Sludge Treatment Plants
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NSPS for Sewage Sludge
Treatment Plants (40 CFR Part 60, Subpart O) (Renewal)'' (EPA ICR No.
1063.12, OMB Control No. 2060-0035), to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (44 U.S.C. 3501 et seq). This is a proposed extension of
the ICR, which is currently approved through March 31, 2014. Public
comments were previously requested, via the Federal Register (78 FR
33409) on June 4, 2013, during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An Agency may not conduct or sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before January 6,
2014

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2013-0310, to: (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460: and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS at 40 CFR part 60, subpart A and any changes, or
additions to the Provisions specified at 40 CFR part 60, subpart O.
Owners or operators of the affected facilities must make an initial
notification report, performance tests, periodic reports, and maintain
records of the occurrence and duration of any startup, shutdown, or
malfunction in the operation of an affected facility, or any period
during which the monitoring system is inoperative. Reports are required
semiannually at a minimum.
    Form Numbers: None.
    Respondents/affected entities: Sewage sludge treatment plant
incinerators.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart O).
    Estimated number of respondents: 112 (total).
    Frequency of response: Initially and semiannually.
    Total estimated burden: 12,464 hours (per year). ``Burden'' is
defined at 5 CFR 1320.3(b).
    Total estimated cost: $5,179,185 (per year), includes $3,960,000
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is no change in labor hours in this
ICR compared to the most recently approved ICR. This is due to two
considerations:

(1) The regulations have not changed over the past three years, and are
not anticipated to change over the next three years; and (2) the growth
rate for the industry is very low, so there is no significant change in
the overall burden. However, there is a slight increase in the
respondent labor costs due to the use of updated labor rates.

Richard T. Westlund,
Acting Director, Collection Strategies Division.
[FR Doc. 2013-29132 Filed 12-5-13; 8:45 am]
BILLING CODE 6560-50-P


Record for the Final Metal Product and Machinery Rule VARIABLE DESCRIPTIONS FOR SMALL_ FINAL. XLS VARIABLE DESCRIPTION WORKSHEET COLUMN CBI FORMULA Site ID Survey ID Phase1 A N Primary Sector Primary sector abbreviation Phase1 B Y Rev_ Src 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 Phase1 C N Firm Employment Firm employment, 1989 Phase1 D Y Site Employment Site employment, 1989 Phase1 E Y Firm Revenue Firm Revenue, 1996$ Phase1 F Y Manufacturing Threshold ( Employment) Small business threshold for manufacturing SIC codes, employment Phase1 G Y = VLOOKUP($ B5,' Sector Thresh'!$ C$ 6:$ F$ 25,2,0)

Rebuilding / Maintenance Threshold ( Dollars) Small business threshold for non manufacturing SIC codes, dollars Phase1 H Y = VLOOKUP($ B5,' Sector Thresh'!$ C$ 6:$ F$ 25,3,0)

Secondary Rebuilding / Maintenance Threshold ( Employees) Secondary small business threshold for nonmanufacturing SIC codes, employment Phase1 I Y = VLOOKUP($ B5,' Sector Thresh'!$ C$ 6:$ F$ 25,4,0)

Entity Size Entity Size: Large entity; Small entity; Maybe large entity ( exceeds one threshold but not the other); Unknown entity size Phase1 J Y = IF( P5= 1," Small", IF( Q5= 1," Maybe", IF( R5= 1," Large"," Unknown")))

Man Thresh ( Emp) Small business threshold for manufacturing SIC codes, employment Phase1 L Y Rbldg Thresh ( Rev) Small business threshold for manufacturing SIC codes, dollars Phase1 M Y = IF( D5> G5,1,0)

Rbldg Thresh ( Emp) Small business threshold for non manufacturing SIC codes, employment Phase1 N Y = IF( H5= 0," n/ a", IF( F5> H5,1,0))

Rbldg Thresh ( both) Small business threshold for non manufacturing SIC codes, dollars Phase1 O Y = IF( I5= 0," n/ a", IF( D5> I5,1,0))

small Is this site owned by a small entity? 0= no; 1= yes Phase1 P Y = IF( M5=" n/ a", N5, IF( N5=" n/ a", M5, IF( AND( M5= 0, N5= 0), 0, IF( AND( M5= 1, N5= 1), 1, IF( AND( M5= 0, N 5= 1), 2, IF( AND( N5= 0, M5= 1), 2,3)))))) maybe Is this site maybe owned by a small entity? 0= no; 1= yes Phase1 Q Y = IF( AND( C5=" M", L5= 0), 1, IF( AND( C5=" R", O5= 0), 1, IF( AND( OR( C5=" B", C5=" U"), L5= 0, O5= 0), 1, I F( AND( OR( C5=" B", C5=" U"), L5= 0, O5=" n/ a"), 1, IF( AND( C5=" R", O5=" n/ a", L5= 0), 1, IF( AND( C5=" M ", L5=" n/ a", O5= 0), 1,0)))))) large Is this site owned by a large entity? 0= no; 1= yes Phase1 R Y = IF( O5= 2,1, IF( AND( OR( C5=" B", C5=" U"), L5= 1, O5= 0), 1, IF( AND( OR( C5=" B", C5=" U"), L5= 0, O5= 1 ), 1,0))) Site ID Survey ID Phase2 A N 0 Primary Sector Primary sector code Phase2 B Y Rev_ Src 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 Phase2 C N Multi Site Is the site owned by a multi site firm? 1= no; 2= yes Phase2 D N Firm Employment Firm employment Phase2 E Y Site Employment Site employment Phase2 F Y Firm Revenue Firm revenue Phase2 G Y Site Revenue Site revenue Phase2 H Y Manufacturing Threshold ( Employees) Small business threshold for manufacturing SIC codes Phase2 I Y = VLOOKUP($ B5,' Sector Thresh'!$ C$ 6:$ F$ 25,2,0)

Rebuilding / Maintenance Threshold ( Dollars) Small business threshold for non manufacturing SIC codes Phase2 J Y = VLOOKUP($ B5,' Sector Thresh'!$ C$ 6:$ F$ 25,3,0)

Secondary Rebuilding / Maintenance Threshold ( Employees) Phase2 K Y = VLOOKUP($ B5,' Sector Thresh'!$ C$ 6:$ F$ 25,4,0)

February 14, 2003 1 of 24 small_ final. xls  Var Desc Record for the Final Metal Product and Machinery Rule VARIABLE DESCRIPTION WORKSHEET COLUMN CBI FORMULA Small Entity Size: Large entity; Small entity; Maybe large entity ( exceeds one threshold but not the other); Unknown entity size Phase2 L Y = IF( W5= 1," Small", IF( X5= 1," Maybe", IF( Y5= 1," Large"," Unknown")))

no emp Check for no employment Phase2 N Y = IF( AND( ISBLANK( E5), ISBLANK( F5)), 1,0) use site emp Use site employment because firm is n/ a Phase2 O Y = IF( AND( ISBLANK( E5), D5= 1), 1,0) use site rev Use site revenue because firm is n/ a Phase2 P Y = IF( AND( ISBLANK( G5), D5= 1), 1,0) no thresh No small business threshold because sector is unknown Phase2 Q Y = IF( P5= 1, H5, IF( D5= 1, G5, H5))

Revenue Revenue used to compare to threshold Phase2 R Y = IF( N5= 1," no emp", IF( O5= 1, F5, IF( D5= 1, E5, F5))) Employment Employment used to compare to threshold Phase2 S Y = IF( R5=" no emp"," n/ a", IF( R5> I5,1,0)) Man Thresh Manufacturing threshold used Phase2 T Y = IF( J5= 0," n/ a", IF( Q5> J5,1,0)) Rbldg Thresh Non manufacturing threshold used Phase2 U Y = IF( K5= 0," n/ a", IF( R5> K5,1,0)) small Is this site owned by a small entity? 0= no; 1= yes Phase2 V Y = IF( T5=" n/ a", U5, IF( U5=" n/ a", T5, IF( AND( T5= 0, U5= 0), 0, IF( AND( T5= 1, U5= 1), 1, IF( AND( T5= 0, U5 = 1), 2, IF( AND( U5= 0, T5= 1), 2,3)))))) maybe Is this site maybe owned by a small entity? 0= no; 1= yes Phase2 W Y = IF( AND( C5=" M", S5= 0), 1, IF( AND( C5=" R", V5= 0), 1, IF( AND( OR( C5=" B", C5=" U"), S5= 0, V5= 0), 1, I F( AND( OR( C5=" B", C5=" U"), S5= 0, V5=" n/ a"), 1, IF( AND( C5=" R", V5=" n/ a", S5= 0), 1, IF( AND( C5=" M ", S5=" n/ a", V5= 0), 1,0)))))) large Is this site owned by a large entity? 0= no; 1= yes Phase2 X Y = IF( V5= 2,1, IF( AND( OR( C5=" B", C5=" U"), S5= 1, V5= 0), 1, IF( AND( OR( C5=" B", C5=" U"), S5= 0, V5= 1 ), 1,0))) Entity Size Entity Size: Large entity; Small entity; Maybe large entity ( exceeds one threshold but not the other); Unknown entity size Phase2 Y Y = IF( AND( C5=" M", S5= 1), 1, IF( AND( C5=" R", V5= 1), 1, IF( AND( OR( C5=" B", C5=" U"), S5= 1, V5= 1), 1, I F( AND( OR( C5=" B", C5=" U"), S5= 1, V5=" n/ a"), 1, IF( AND( C5=" R", V5=" n/ a", S5= 1), 1, IF( AND( C5=" M ", S5=" n/ a", V5= 1), 1,0)))))) Site ID Survey ID I& S A N Primary Sector Primary sector code I& S B Y Site Employment Site employment I& S C Y Firm Employment Firm employment I& S D Y Manufacturing Threshold ( Employment) Small business threshold for manufacturing SIC codes I& S E Y = VLOOKUP( B16,' Sector Thresh'!$ C$ 6:$ F$ 25,2,0)

Small Is the site owned by a small entity? I& S F Y = IF( D16> E16," Large", IF( OR( ISBLANK( D16), D16= 0)," Unknown"," Small")) Sector Sector code Sector Thresh A N Name Sector name Sector Thresh B N Sect Abbr Sector abbreviation Sector Thresh C N Manufacturing Threshold ( Employees) Small business threshold for manufacturing SIC codes Sector Thresh D N Rebuilding / Maintenance Threshold ( Dollars) Small business threshold for non manufacturing SIC codes Sector Thresh E N Secondary Rebuilding / Maintenance Threshold ( Employees) Secondary small business threshold for nonmanufacturing SIC codes Sector Thresh F N February 14, 2003 2 of 24 small_ final. xls  Var Desc Record for the Final Metal Product and Machinery Rule 1 2 3 4 5 6 7 8 9 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 A B C D E F G H I J K L M N O P Q R Small Business Analysis for MP& M Phase I Surveys Simple Mode Thresholds Site ID Primary Sector Rev_ Src 1989 Firm Employment 1989 Site Employment 1996 Firm Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Entity Size Notes Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 3 M 7 M 10 R 12 M 13 M 14 M 15 M 16 M 20 M 24 U 25 B 28 M 31 U 32 M 35 M 38 M 42 M 43 M 46 M 48 M 52 M 55 B 57 M 58 M 59 R 60 U 68 M 69 M 70 M 72 M 73 M 76 M 78 B 83 M 84 M 85 B 86 M 88 U 94 M 96 M 100 M 102 B 105 M 109 U 112 M 114 M 115 M 118 U 119 M 120 M 125 B 129 M February 14, 2003 3 of 24 small_ final. xls  Phase1 Record for the Final Metal Product and Machinery Rule 1 2 3 4 A B C D E F G H I J K L M N O P Q R Small Business Analysis for MP& M Phase I Surveys Simple Mode Thresholds Site ID Primary Sector Rev_ Src 1989 Firm Employment 1989 Site Employment 1996 Firm Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Entity Size Notes Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 56 57 58 59 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 99 100 101 102 103 104 105 106 107 130 M 132 M 135 M 136 M 138 M 141 B 142 M 143 M 147 M 148 M 149 M 154 M 155 M 159 U 162 M 163 M 164 M 165 M 166 M 170 M 172 M 174 M 177 M 178 M 179 M 181 M 183 M 184 M 185 M 187 M 188 M 190 M 191 M 193 M 197 U 199 M 200 M 202 M 208 M 209 M 210 B 212 M 214 M 216 M 219 M 221 M 223 M 226 M 227 M 229 M 230 M 232 M February 14, 2003 4 of 24 small_ final. xls  Phase1 Record for the Final Metal Product and Machinery Rule 1 2 3 4 A B C D E F G H I J K L M N O P Q R Small Business Analysis for MP& M Phase I Surveys Simple Mode Thresholds Site ID Primary Sector Rev_ Src 1989 Firm Employment 1989 Site Employment 1996 Firm Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Entity Size Notes Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 233 U 235 B 239 M 245 M 247 B 248 B 249 B 252 M 254 M 261 M 262 B 264 M 265 M 266 M 267 M 268 U 273 M 274 B 276 M 279 M 280 U 281 B 282 M 283 U 284 B 285 M 288 M 289 M 293 M 296 M 301 M 302 M 303 M 304 U 305 M 306 U 309 M 313 M 314 B 315 M 319 M 322 M 323 M 325 M 326 M 331 M 333 B 335 M 336 M 338 M 340 M 345 M February 14, 2003 5 of 24 small_ final. xls  Phase1 Record for the Final Metal Product and Machinery Rule 1 2 3 4 A B C D E F G H I J K L M N O P Q R Small Business Analysis for MP& M Phase I Surveys Simple Mode Thresholds Site ID Primary Sector Rev_ Src 1989 Firm Employment 1989 Site Employment 1996 Firm Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Entity Size Notes Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 351 M 358 M 359 U 361 M 363 B 364 M 365 M 369 U 370 M 376 M 377 M 378 M 380 M 381 M 384 M 386 M 387 B 388 M 390 M 395 M 396 M 398 B 399 M 403 M 404 U 408 M 409 M 410 M 413 U 414 M 416 M 418 M 422 M 424 M 428 M 429 M 440 M 441 B 442 M 446 M 447 M 451 B 452 M 456 M 457 B 458 M 459 M 461 M 462 M 464 M 466 M 468 B February 14, 2003 6 of 24 small_ final. xls  Phase1 Record for the Final Metal Product and Machinery Rule 1 2 3 4 A B C D E F G H I J K L M N O P Q R Small Business Analysis for MP& M Phase I Surveys Simple Mode Thresholds Site ID Primary Sector Rev_ Src 1989 Firm Employment 1989 Site Employment 1996 Firm Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Entity Size Notes Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 470 M 472 U 473 M 475 M 479 R 480 M 481 M 484 M 486 M 488 M 489 M 490 M 492 B 493 M 496 M 502 M 504 M 509 M 510 M 511 M 514 M 515 M 518 M 520 M 522 B 523 M 524 M 526 M 530 M 531 M 532 B 534 M 536 U 537 M 538 B 539 B 540 U 542 M 545 M 548 M 555 M 561 M 566 M 567 M 570 M 574 M 578 M 579 M 583 M 586 M 590 M 595 B February 14, 2003 7 of 24 small_ final. xls  Phase1 Record for the Final Metal Product and Machinery Rule 1 2 3 4 A B C D E F G H I J K L M N O P Q R Small Business Analysis for MP& M Phase I Surveys Simple Mode Thresholds Site ID Primary Sector Rev_ Src 1989 Firm Employment 1989 Site Employment 1996 Firm Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Entity Size Notes Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 603 M 605 M 608 M 609 M 611 M 612 M 613 M 614 M 615 M 616 B 617 M 621 M 622 M 623 M 624 M 627 M 629 M 630 B 631 M 632 M 633 M 634 M 635 M 648 M 653 M 655 M 656 B 661 M 662 U 663 M 664 B 665 M 669 M 673 M 675 U 679 U 681 M 683 M 684 M 687 M 688 M 690 M 693 M 695 B 696 M 700 M 704 B 705 M 706 U 707 M 708 M 710 M February 14, 2003 8 of 24 small_ final. xls  Phase1 Record for the Final Metal Product and Machinery Rule 1 2 3 4 A B C D E F G H I J K L M N O P Q R Small Business Analysis for MP& M Phase I Surveys Simple Mode Thresholds Site ID Primary Sector Rev_ Src 1989 Firm Employment 1989 Site Employment 1996 Firm Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Entity Size Notes Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 711 M 714 M 717 M 718 M 720 M 726 M 730 M 732 M 740 M 741 M 746 M 747 M 749 M 751 B 752 U 753 U 756 M 758 M 760 M 763 U 764 M 767 M 771 M 774 M 775 M 777 M 780 U 785 M 787 M 789 M 790 M 796 U 797 M 799 M 800 M 807 M 808 M 809 M 813 M 814 M 815 M 816 M 821 M 823 M 824 M 829 M 831 M 836 M 837 M 850 M 851 M 853 B February 14, 2003 9 of 24 small_ final. xls  Phase1 Record for the Final Metal Product and Machinery Rule 1 2 3 4 A B C D E F G H I J K L M N O P Q R Small Business Analysis for MP& M Phase I Surveys Simple Mode Thresholds Site ID Primary Sector Rev_ Src 1989 Firm Employment 1989 Site Employment 1996 Firm Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Entity Size Notes Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 854 M 855 M 856 M 857 M 858 B 859 M 860 B 861 U 864 M 867 B 870 M 871 M 873 M 874 B 875 B 880 U 885 M 886 M February 14, 2003 10 of 24 small_ final. xls  Phase1 Record for the Final Metal Product and Machinery Rule 1 2 3 456789 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 A B C D E F G H I J K L M N O P Q Small Business Analysis for MP& M Phase II Surveys Simple Mode Thresholds Site ID Primary Sector Rev_ Src Multi Site 1996 Firm Employment 1996 Site Employment Firm Revenue Site Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Small Notes no emp use site emp use site rev Revenue 1 M 1 2 M 1 5 U 1 6 M 1 8 M 1 9 M 1 21 M 0 22 M 1 26 M 0 27 M 0 29 M 0 33 M 0 36 M 0 37 M 0 41 M 1 44 M 1 45 M 0 47 M 1 49 M 0 50 M 1 51 M 1 53 M 0 61 B 0 62 M 1 64 M 0 65 U 0 67 B 0 71 M 1 74 R 0 75 M 1 79 M 0 81 M 1 87 M 1 89 R 0 90 M 1 91 M 1 92 R 1 95 M 0 97 M 1 99 M 0 101 M 0 103 M 0 106 M 0 108 R 0 110 B 1 111 M 0 113 M 0 116 M 1 121 U 1 122 M 1 126 M 0 127 R 1 February 14, 2003 11 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 1 2 3 456789 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 R S T U V W X Y Employment Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large February 14, 2003 12 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 3 4 A B C D E F G H I J K L M N O P Q Site ID Primary Sector Rev_ Src Multi Site 1996 Firm Employment 1996 Site Employment Firm Revenue Site Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Small Notes no emp use site emp use site rev Revenue 56 57 58 59 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 99 100 101 102 103 104 105 106 107 108 109 110 128 M 1 131 M 0 137 M 0 140 M 0 146 M 1 150 M 0 151 M 1 153 R 0 156 M 1 157 M 0 161 M 0 173 M 0 176 M 1 182 M 0 186 U 1 189 M 1 192 M 1 195 M 1 196 M 0 201 M 1 203 M 1 204 M 1 207 M 0 211 M 0 215 M 1 222 M 0 224 M 0 225 M 0 228 M 0 231 B 1 234 M 1 237 M 0 240 M 1 241 M 0 242 M 0 243 M 1 246 M 0 250 M 0 253 R 1 255 M 0 257 R 0 259 M 0 263 B 1 269 M 0 270 M 1 271 M 0 286 M 1 290 M 1 291 R 0 295 M 0 298 R 1 299 M 0 300 M 1 307 M 0 308 M 0 February 14, 2003 13 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 3 4 R S T U V W X Y Employment Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 56 57 58 59 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 February 14, 2003 14 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 3 4 A B C D E F G H I J K L M N O P Q Site ID Primary Sector Rev_ Src Multi Site 1996 Firm Employment 1996 Site Employment Firm Revenue Site Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Small Notes no emp use site emp use site rev Revenue 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 310 M 0 312 M 0 316 M 1 324 B 1 327 M 0 328 M 0 329 B 0 330 M 1 332 U 0 334 M 1 337 U 0 342 M 0 349 M 0 350 M 1 355 M 1 357 M 1 371 R 0 372 M 0 374 M 1 383 M 0 392 M 1 393 M 1 400 M 1 401 M 1 402 M 1 406 M 0 407 M 1 411 M 0 412 M 0 417 R 0 419 M 1 420 M 1 421 M 0 423 M 1 425 M 0 430 M 0 433 M 1 434 U 1 435 M 1 438 R 0 439 M 1 443 M 1 445 B 1 448 M 0 449 M 1 450 M 0 453 M 1 455 M 1 460 R 0 463 M 0 471 M 1 476 M 1 477 M 0 482 M 0 487 M 1 February 14, 2003 15 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 3 4 R S T U V W X Y Employment Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 February 14, 2003 16 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 3 4 A B C D E F G H I J K L M N O P Q Site ID Primary Sector Rev_ Src Multi Site 1996 Firm Employment 1996 Site Employment Firm Revenue Site Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Small Notes no emp use site emp use site rev Revenue 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 494 M 0 495 M 0 497 M 0 498 M 1 501 R 0 503 M 1 505 R 0 506 M 0 507 M 1 513 M 0 516 M 1 517 M 0 519 M 0 525 M 1 527 M 1 528 M 1 533 M 1 543 M 1 547 M 1 549 M 1 550 M 0 552 M 0 556 R 0 560 U 1 563 M 0 564 M 1 575 M 1 577 M 1 580 M 1 584 M 1 587 M 1 591 M 0 594 M 1 598 M 0 599 M 1 600 M 0 606 M 0 607 M 1 610 M 0 619 M 1 625 M 1 626 M 1 628 M 1 636 M 0 637 U 1 639 M 1 640 U 0 641 M 0 643 M 0 645 M 1 649 M 0 650 M 1 651 M 0 658 B 0 660 U 1 February 14, 2003 17 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 3 4 R S T U V W X Y Employment Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 February 14, 2003 18 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 3 4 A B C D E F G H I J K L M N O P Q Site ID Primary Sector Rev_ Src Multi Site 1996 Firm Employment 1996 Site Employment Firm Revenue Site Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Small Notes no emp use site emp use site rev Revenue 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 666 M 0 667 M 0 668 M 1 670 M 0 671 M 1 674 M 1 678 B 1 680 M 0 682 M 0 685 M 0 694 M 1 699 M 0 701 M 0 702 M 0 703 B 0 709 B 0 712 M 1 713 M 1 715 M 1 716 M 0 719 M 0 721 M 0 722 M 0 723 M 1 724 M 0 725 M 1 727 R 0 728 M 1 729 M 0 733 B 1 734 M 0 735 M 0 737 M 1 738 M 1 745 M 1 748 M 1 755 R 0 757 M 0 759 M 0 762 R 0 765 M 1 766 M 0 768 M 1 772 M 0 773 R 0 778 M 0 779 M 1 781 M 0 782 M 0 784 M 0 786 M 1 788 M 0 791 U 0 792 M 1 793 M 1 February 14, 2003 19 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 3 4 R S T U V W X Y Employment Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 February 14, 2003 20 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 3 4 A B C D E F G H I J K L M N O P Q Site ID Primary Sector Rev_ Src Multi Site 1996 Firm Employment 1996 Site Employment Firm Revenue Site Revenue Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees) Small Notes no emp use site emp use site rev Revenue 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 795 M 1 802 M 1 804 R 0 805 M 0 806 M 1 811 M 1 817 B 1 818 M 0 819 M 0 820 M 1 822 M 0 825 M 1 830 M 0 834 M 0 839 M 1 841 B 0 842 M 0 843 R 0 844 R 0 846 M 0 848 M 0 849 M 0 862 M 0 863 B 1 866 M 0 869 U 0 879 B 1 884 M 1 887 B 1 888 R 0 891 B 1 894 M 0 905 U 0 918 R 0 921 R 0 922 M 0 926 R 1 927 M 0 929 U 0 930 M 0 934 M 0 948 U 0 February 14, 2003 21 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 3 4 R S T U V W X Y Employment Man Thresh ( Emp) Rbldg Thresh ( Rev) Rbldg Thresh ( Emp) Rbldg Thresh ( both) small maybe large 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 February 14, 2003 22 of 24 small_ final. xls  Phase2 Record for the Final Metal Product and Machinery Rule 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 A B C D E F Small Business Analysis for MP& M Iron and Steel Surveys Simple Mode Thresholds Site ID Primary Sector Site Employment Firm Employment Manufacturing Threshold ( Employment) Small 940 IS 941 IS 943 IS 944 IS 945 IS 946 IS 947 IS 949 IS 950 IS 951 IS 953 IS 954 IS 955 IS 956 IS 957 IS 958 IS 959 IS 960 IS 961 IS 962 IS 963 IS 964 IS 965 IS 966 IS February 14, 2003 23 of 24 small_ final. xls  I& S Record for the Final Metal Product and Machinery Rule 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A B C D E F SOURCE: SBA_ MPM. XLS SBA Small Business Mode Thresholds for MP& M Sectors Sector Name Sect Abbr Manufacturing Threshold ( Employees) Rebuilding / Maintenance Threshold ( Dollars) Secondary Rebuilding / Maintenance Threshold ( Employees)

1 Hardware HW 500 2 Aircraft AI 1,000 5,000,000 3 Electronic Equipment EE 750 4 Stationary Industrial Equipment SI 500 5,000,000 5 Ordnance OR 1,000 6 Aerospace AS 1,000 7 Mobile Industrial Equipment MI 500 8 Instrument IN 500 5,000,000 9 Precious and Non Precious Metals PM 500 5,000,000 10 Ship and Boat SB 1,000 5,000,000 500 11 Household Equipment HE 500 5,000,000 12 Railroad RR 1,000 1,500 13 Motor Vehicle MV 500 5,000,000 100 14 Bus and Truck BT 500 5,000,000 15 Office Machine OF 1,000 5,000,000 16 Printed Circuit Board PC 500 17 Job Shop JS 500 18 Other Metal Products OM 500 5,000,000 19 Iron and Steel IS 1,000 Unknown UNK 500 February 14, 2003 24 of 24 small_ final. xls  Sector Thresh


[Federal Register Volume 79, Number 203 (Tuesday, October 21, 2014)]
[Rules and Regulations]
[Pages 62827-62829]
[FR Doc No: 2014-25003]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2013-0293]
RIN 1625-AA11

Regulated Navigation Area; Slip 4 Early Action Area Superfund
Site, Lower Duwamish Waterway, Seattle, WA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is establishing a regulated navigation area
(RNA) on a portion of the Lower Duwamish Waterway in Seattle,
Washington. The RNA will protect the riverbed in the U.S. Environmental
Protection Agency's (EPA) Slip 4 Early Action Area (EAA). This RNA
would prohibit activities that could disrupt the integrity of the
engineered sediment and slope caps that have been placed within the
Slip 4 EAA. These activities include vessel grounding, anchoring,
dragging, trawling, spudding or other such activities that would
disturb the riverbed. It will not affect transit or navigation of this
area.

DATES: This rule is effective November 20, 2014.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0293]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LTJG Johnny Zeng, Coast Guard Sector Puget Sound,
Waterways Management Division, U.S. Coast Guard; telephone (206) 217-
6175, email<EMAIL_ADDRESS>If you have questions on
viewing or submitting material to the docket, call Barbara Hairston,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard received notice from the U.S. EPA on February 28,
2013, requesting the establishment of a RNA for Slip 4 EAA located in
the Lower Duwamish Waterway Superfund Site, Seattle, Washington. This
request was received as a result of the need to protect the riverbed in
the Lower Duwamish Waterway (LDW) from activities that could disrupt
the integrity of the engineered sediment and slope caps that have been
placed within the Slip 4 EAA to isolate underlying contaminated
sediments.
    The LDW was added to the U.S. EPA's National Priorities List
(Superfund) in September 2001 because of hazardous substance
contamination in sediments. Slip 4 was subsequently identified by the
EPA and the Washington Department of Ecology as EAA within the LDW,
based primarily on elevated concentrations of polychlorinated biphenyls
(PCBs). Slip 4 EAA cleanup activities were conducted pursuant to the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA), under U.S. EPA's non-time-critical removal action (NTCRA)
authority. In May 2006, U.S. EPA issued an Action Memorandum containing
its removal action decision for the Slip 4 EAA. The Slip 4 EAA removal
action was conducted by the City of Seattle (City) under an
administrative settlement agreement and order on consent (ASAOC),
CERCLA Docket No. 10-2006-0364.
    The selected removal action required dredging, excavation, and
offsite disposal of 17,202 tons of contaminated sediment, shoreline,
soil, and creosote-treated timber piles and other debris, and placement
of engineered sediment and slope caps throughout the EAA (approximately
3.43 acres) to isolate residual sediment contamination within the EAA.
In addition, the removal action included demolition and removal/
recycling of a portion of an aging concrete pier and supporting piling
on the northwest bank of the slip, and creation of two intertidal beach
areas and other shallow-water areas to improve habitat conditions in
the slip. Construction activities were initiated in October 2011 and
completed in February 2012. A Removal Action Completion Report
documenting the cleanup activities was completed and approved by the
U.S. EPA in July 2012.
    On April 22, 2014, an NPRM, Navigation Areas: Slip 4 EAA Superfund
Site, Seattle, WA, was published. The Coast Guard received no comments
on the NPRM and no requests for public meeting. No changes were made to
the rule published in the NPRM.

B. Basis and Purpose

    Coast Guard District Commanders are granted authority under 33 CFR
165.11 to regulate vessel traffic in areas with hazardous conditions.
This rule is necessary to prevent disturbance of the Slip 4 EAA
sediment and slope caps. Disruption of the caps may result in a
hazardous condition and harm to the marine environment. As such, this
RNA is necessary to protect the caps and will do so by prohibiting
maritime activities that could disturb or damage them. This RNA is
similar to RNAs which protect other caps in the area. Enforcement of
this RNA will be managed by Coast Guard Sector Puget Sound assets
including Vessel Traffic Service Puget Sound through radar and closed
circuit television sensors.

C. Discussion of Comments, Changes and the Final Rule

    The Coast Guard is establishing a permanent RNA in the LDW to
protect the sediment and slope caps in the Slip 4 EAA, Superfund Site
(EPA ID No. WA0002329803). It will do so by restricting anchoring,
dragging, trawling, spudding or other activities that could disrupt the
integrity of the caps and the underlying contaminated sediments located
in the RNA. No comments were received by the Coast Guard on this rule.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. This expectation is
based on the fact that the RNA established by the rule would encompass
a small area that should not impact commercial or recreational traffic,
and the prohibited

activities are not routine for the designated areas.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a significant economic impact on a
substantial number of small entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to anchor,
drag, dredge, trawl, spud, or disturb the riverbed in any fashion when
this rule is in effect. The RNA will not have a significant economic
impact on small entities due to its minimal restrictive area and the
opportunity for a waiver to be granted for any legitimate use of the
riverbed.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule affects your small
business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule would not result
in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This rule would not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and will not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This rule was determined to have potential tribal implications
under Executive Order 13175, Consultation and Coordination with Indian
Tribal Governments, because it regulates navigation on waters subject
to treaty fishing rights held by Indian Tribal Governments. The Coast
Guard and EPA consulted with the Muckleshoot and Suquamish Tribes. To
accommodate treaty fishing activity in usual and accustomed places,
which fall within the area covered by the sediment cap, the Coast Guard
included an exception for treaty fishing activity by Indian Tribes
holding such fishing rights.

12. Energy Effects

    This rule is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a
preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This rule involves a regulated
navigation area which prevents activities which would disturb the
riverbed within the areas outlined in this regulation. This rule is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. A preliminary environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine Safety, Navigation (water), Reporting and
recordkeeping

requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.1338 to read as follows:

Sec.  165.1338  Regulated Navigation Area; Slip 4 Early Action Area
Superfund Site, Lower Duwamish Waterway, Seattle, WA.

    (a) Regulated Areas. The following areas are regulated navigation
areas: All waters within the northern portion of Slip 4 bounded by the
shoreline and the southern boundary of the Early Action Area defined as
the line beginning at a point on the shore at 47[deg]32'08.47'' N,
122[deg]19'12.00'' W; thence southeast to a point on the shoreline at
47[deg]32'07.02'' N, 122[deg]19'09.23'' W (Datum: NAD 1983/91).
    (b) Regulations. (1) All vessels and persons are prohibited from
grounding, anchoring, dragging, trawling, spudding, or otherwise
contacting the riverbed within the designated regulated navigation
area. Vessels may otherwise transit or navigate within this area in
accordance with the Navigation Rules.
    (2) The prohibition described in paragraph (b)(1) of this section
does not apply to vessels or persons engaged in activities associated
with remediation efforts in the superfund sites, provided that the
Captain of the Port, Puget Sound (COTP), is given advance notice of
those activities by the Environmental Protection Agency.
    (3) The prohibition described in paragraph (b)(1) of this section
does not apply to vessels or person engaged in fishing activities
pursuant to fishing rights held by treaty with the United States.
    (c) Waivers. Upon written request stating the need and proposed
conditions of the waiver, and any proposed precautionary measures, the
COTP may authorize a waiver from this section if the COTP determines
that the activity for which the waiver is sought can take place without
undue risk to the remediation efforts described in paragraph (b)(1) of
this section. The COTP will consult with EPA in making this
determination when necessary and practicable.

    Dated: October 2, 2014.
R.T. Gromlich,
Rear Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard
District.
[FR Doc. 2014-25003 Filed 10-20-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 203 (Monday, October 21, 2019)]
[Proposed Rules]
[Pages 56152-56154]
[FR Doc No: 2019-22815]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 84, No. 203 / Monday, October 21, 2019 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0994; Product Identifier 2017-SW-002-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2017-14-05 for Airbus Helicopters Model SA330J helicopters. AD 2017-14-
05 requires replacing certain right-hand (RH) hydraulic pumps and is
prompted by reports of broken screws that attach the cover of the
hydraulic pump. This proposed AD would continue to require the same
actions as AD 2017-14-05 but would also require replacing the left-hand
(LH) hydraulic pump. The actions of this proposed AD are intended to
address an unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by December
20, 2019.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0994; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the European Aviation Safety Agency (EASA) AD, the
economic evaluation, any comments received and other information. The
street address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.helicopters.airbus.com/website/en/ref/Technical-Support_73.html. You may review this referenced service information at
the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, Senior Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views. The FAA also invites comments
relating to the economic, environmental, energy, or federalism impacts
that might result from adopting the proposals in this document. The
most helpful comments reference a specific portion of the proposal,
explain the reason for any recommended change, and include supporting
data. To ensure the docket does not contain duplicate comments,
commenters should send only one copy of written comments, or if
comments are filed electronically, commenters should submit only one
time.
    The FAA will file in the docket all comments received, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal,
the FAA will consider all comments received on or before the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or delay. The FAA may change this proposal in light of the
comments received.

Discussion

    The FAA issued a final rule; request for comment to AD 2017-14-05,
Amendment 39-18949 (82 FR 31899, July 11, 2017) (``AD 2017-14-05'') for
Airbus Helicopters Model SA330J helicopters with a LH and RH hydraulic
pump part number (P/N) FR65WEO2005-175A with a serial number 4108,
4141, 4177, 4227, 4241, 4284, 4377, 4422, 4570, 4573, 4574, 4641, 4649,
4668, 4766, 4802, 4821, 4831, 4837, 4888, 4896, 4946, 4985, 5023, 5071,
5304, 5366, 5376, 5409, 5442, 5486, 5599, 5630, 94075/01, or 94048/01
installed. AD 2017-14-05 requires replacing the RH hydraulic pump
within 15 hours time-in-service.
    AD 2017-14-05 was prompted by EASA Emergency AD No. 2016-264-E,
dated December 22, 2016 (EASA AD 2016-264-E), issued by EASA, to
correct an unsafe condition for Airbus Helicopters Model SA330J
helicopters. EASA advises of reports of broken screws that attach the
cover of the hydraulic pump. A subsequent investigation revealed that
hydrogen was introduced into a batch of screws delivered between July
1, 2015, and November 1, 2016, causing the screws to become brittle and
lack sufficient strength. These screws were installed in a batch of
hydraulic pumps, P/N FR65WEO2005-175A, identified by certain serial
numbers, EASA advises. As a result, the EASA AD requires replacing the
hydraulic pumps.
    The actions of AD 2017-14-05 were intended to prevent failure of a
cover bolt and loss of fluid from the hydraulic pump, resulting in loss
of the hydraulic system and subsequent loss of helicopter control.
    This NPRM would retain the requirements of AD 2017-14-05 but would
also require replacing the LH hydraulic pump within 110 hours TIS.
Because this proposed action would have a longer compliance time, the
FAA is providing the public an opportunity to comment.

Comments

    After AD 2017-14-05 was published, the FAA received two comments
from Airbus Helicopters.
    Airbus Helicopters requested that the FAA clarify the requirement
in AD 2017-14-05 to only replace the RH hydraulic pump, when EASA AD
2016-0264-E requires replacing both the RH and LH hydraulic pumps.
    The FAA agrees that the LH hydraulic pump also needs to be
replaced. AD 2017-14-05 was issued as a final rule; request for
comments and was effective in less than 30 days because it required
replacing the RH hydraulic pump within a short time period. When the
FAA issued AD 2017-14-05, the FAA explained that the compliance time
for replacing the LH hydraulic pump allowed enough time to provide
notice and opportunity for prior public comment. This proposed AD would
require replacing both the RH and LH hydraulic pumps.
    Airbus Helicopters also requested that the FAA clarify whether the
pumps listed in the Applicability of AD 2017-14-05 by P/N and serial
number are serviceable because EASA AD 2016-264-E allows those pumps to
be installed if repaired in accordance with Mechanics Alert Service
Bulletin No. NM/INGE/16-140, Revision 0, dated December 22, 2016
(Nexter ASB).
    Airbus Helicopters is correct that the pumps listed by P/N and
serial number in the Applicability section of AD 2017-14-05 are not
serviceable. Paragraph (e)(2) of AD 2017-14-05 prohibits installing
those pumps on any helicopter. One of the instructions in the Nexter
ASB is to re-identify the pump by adding a ``V'' after the serial
number. If a pump has been repaired in accordance with the Nexter ASB,
this AD will not apply because the pump will have a serial number that
is not listed in the Applicability section of this AD.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA of the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determined that an
unsafe condition is likely to exist or develop on other products of the
same type design.

Related Service Information

    The FAA reviewed Airbus Helicopters Emergency Alert Service
Bulletin No. SA330-29.12, Revision 0, dated December 22, 2016 (Airbus
EASB), for Model SA330J helicopters and military model SA330L, SA330Jm,
SA330S1, and SA330Sm helicopters. The Airbus EASB specifies removing
Nexter Mechanics hydraulic pumps P/N FR65WEO2005-175A with certain
serial numbers. If both the RH and LH hydraulic pumps have an affected
P/N and serial number, the Airbus EASB specifies replacing the RH
hydraulic pump before further flight and the LH hydraulic pump within
110 flying hours or 6 months. If only one hydraulic pump has an
affected P/N and serial number, the Airbus EASB specifies replacing it
within 110 flying hours or 6 months. The Airbus EASB also specifies
that, for 6 months after receipt of the Airbus EASB, before installing
an affected hydraulic pump it must be ``returned to conformity'' by
complying with Nexter ASB. After 6 months or 110 flying hours,
whichever occurs first, the Airbus ASB states the affected hydraulic
pumps are unfit for flight.

Proposed AD Requirements

    This proposed AD would require replacing the RH hydraulic pump
within 15 hours TIS and replacing the LH hydraulic pump within 110
hours TIS. This proposed AD would also prohibit installation of an
affected hydraulic pump on any helicopter.

Costs of Compliance

    The FAA estimates that this AD would affect 24 helicopters and that
labor costs average $85 per work-hour. Based on these estimates, the
FAA expects that replacing two hydraulic pumps would require 4 work-
hours and parts cost $5,000 for a total cost of $5,340 per helicopter
and $128,160 for the U.S. fleet.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    The FAA prepared an economic evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2017-14-05, Amendment 39-18949 (82 FR 31899, July 11, 2017), and adding
the following new AD:

Airbus Helicopters: Docket No. FAA-2018-0994; Product Identifier
2017-SW-002-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model SA330J helicopters,
certificated in any category, with a left-hand (LH) and a right-hand
(RH) hydraulic pump part number FR65WEO2005-175A with a serial
number 4108, 4141, 4177, 4227, 4241, 4284, 4377, 4422, 4570, 4573,
4574, 4641, 4649, 4668, 4766, 4802, 4821, 4831, 4837, 4888, 4896,
4946, 4985, 5023, 5071, 5304, 5366, 5376,

5409, 5442, 5486, 5599, 5630, 94075/01, or 94048/01 installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as failure of a screw
attaching the hydraulic pump cover. This condition could result in
failure of a cover bolt and loss of fluid from the hydraulic pump,
resulting in loss of the hydraulic system and subsequent loss of
helicopter control.

(c) Affected ADs

    This AD replaces AD 2017-14-05, Amendment 39-18949 (82 FR 31899,
July 11, 2017) (AD 2017-14-05).

(d) Comments Due Date

    The FAA must receive comments by December 20, 2019.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(f) Required Actions

    (1) Within 15 hours time-in-service (TIS) from July 26, 2017
(the effective date of AD 2017-14-05), replace the RH hydraulic pump
with an airworthy hydraulic pump that is not listed in paragraph (a)
of this AD.
    (2) Within 110 hours TIS from the effective date of this AD,
replace the LH hydraulic pump with an airworthy hydraulic pump that
is not listed in paragraph (a) of this AD.
    (3) After the effective date of this AD, do not install on any
helicopter a hydraulic pump that is listed in paragraph (a) of this
AD.

(g) Special Flight Permits

    Special flight permits are prohibited.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
Matt Fuller, Senior Aviation Safety Engineer, Safety Management
Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy.,
Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(i) Additional Information

    (1) Airbus Helicopters Emergency Alert Service Bulletin No.
SA330-29.12, Revision 0, dated December 22, 2016, and Nexter
Mechanics Alert Service Bulletin No. NM/INGE/16-140, Revision 0,
dated December 22, 2016, which are not incorporated by reference,
contain additional information about the subject of this AD. For
service information identified in this AD, contact Airbus
Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052; telephone
(972) 641-0000 or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at http://www.helicopters.airbus.com/website/en/ref/Technical-Support_73.html.
You may review a copy of the service information at the FAA, Office
of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) No. 2016-0264-E, dated December 22, 2016. You
may view the EASA AD on the internet at http://www.regulations.gov
in the AD Docket.

(j) Subject

    Joint Aircraft Service Component (JASC) Code: 2913, Hydraulic
Pump (Electric/Engine) Main.

    Issued in Fort Worth, Texas, on September 10, 2019.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2019-22815 Filed 10-18-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Pages 38996-38998]
[FR Doc No: 2019-16935]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3018]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Healthcare Provider Perception of Boxed Warning
Information Survey

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on Healthcare Provider Perception of Boxed Warning
Information Survey.

DATES: Submit either electronic or written comments on the collection
of information by October 7, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 7, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-3018 for ``Healthcare Provider Perception of Boxed Warning
Information Survey.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Healthcare Provider Perception of Boxed Warning Information Survey

OMB Control Number 0910--NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The proposed collection of information will investigate healthcare
providers' (HCPs') awareness, perceptions and beliefs about the
benefits and risks of an FDA-approved product that carries a boxed
warning. The prescribing information for an FDA-approved drug or
biologic (sometimes referred to as the ``PI'', ``package insert'', or
``prescription drug labeling'') provides a summary of the essential
information needed for the safe and effective use of that medication,
described in FDA guidance entitled ``Warnings and Precautions,
Contraindications, and Boxed Warning Sections of Labeling for Human
Prescription Drug and Biologic Products--Content and Format,''
published in October 2011 (https://www.fda.gov/media/71866/download).
In certain situations, a drug's prescribing information may include a
boxed warning in addition to other sections of the labeling to
highlight important safety information about specific serious risks of
that drug. Boxed warning information may be included as part of
prescribing information at the time of FDA approval. Boxed warning
information may also be added or modified to the prescribing
information of drugs already on the market on the basis of new safety
information.
    Boxed warnings are an important and frequently used communication
tool. A review of literature has suggested that the addition or
modification of boxed warning information in the postmarket setting
(after a drug has been approved) has had varying effects on HCPs'
practices regarding prescribing, dosing, and patient monitoring (Ref.
1). However, this review and others have identified several gaps in the
existing literature, including the limited number of drugs or drug
classes studied (Ref. 2). Further, little research has focused under
understanding how HCPs receive, process, and use boxed warning
information to support their treatment decisions and patient
counseling.
    To address this research gap, we propose conducting a web-based
survey of HCPs. The proposed collection of information will strengthen
FDA's understanding of how HCPs may receive, process, and use boxed
warning and other safety labeling information. This survey will be
conducted as part of a mixed methods research approach to explore HCPs'
beliefs (or ``mental models'') about the benefits and risks of a drug
that carries a boxed warning and how the drug's boxed warning
information may influence their communication with patients, their
treatment decisions and related decisions such as prescreening for risk
factors or monitoring for adverse events (Ref. 3). This survey research
will build upon preliminary qualitative research FDA has conducted,
under OMB control number 0910-0695, with HCPs in this target
population, through indepth individual interviews.
    The general research questions in this data collection are as
follows:
    1. What awareness, knowledge, and beliefs do HCPs have regarding
boxed warning information for a prescription drug or class of drugs?
    2. When making prescribing decisions, how do HCPs consider boxed
warning information about a potential treatment? How does boxed warning
information factor into their assessments of a drug's potential
benefits and risks to their patients?
    3. How do HCPs communicate with their patients about boxed warning
information?
    4. What factors (e.g., experience treating a condition) are
associated with HCPs' awareness, knowledge, and beliefs about boxed
warning information?
    In order to explore a range of potential perceptions and uses of
boxed warning information that may exist under different contexts, this
survey research will evaluate two medical product scenarios involving
an FDA-approved medication or class of medications that include boxed
warning information. The scenarios will include pertinent prescribing
information from the FDA-approved labeling for these medications. We
plan to conduct one pretest survey with 25 voluntary participants and
one main survey with 1,156 voluntary participants. The survey will be
conducted online. Survey response is estimated to take no longer than
20 minutes.
    Participants in the pretest survey and main survey will be
recruited online through a web-based HCP survey research panel.
Participants will be HCPs with prescribing authority who prescribe
medications to treat one of medical conditions in the medical product
scenarios. Participants will include primary care providers (including
internal medicine, family medicine, and general medicine, as well as
nurse practitioners, and physician assistants) and relevant medical
specialists. Participants will be screened for their current amount of
time spent in direct patient care, prescribing volume, and experience
treating the relevant medical condition. Demographic soft quotas will
be used to help ensure that the survey population is generally
reflective of the demographic composition of physicians in the United
States, according to the American Medical Association.
    The pretest and main studies will have the same design and will
follow the same procedure. In advance of the pretest survey, we will
conduct cognitive testing of the survey questionnaire to refine the
survey instruments. The main survey will be refined as necessary
following the pretest survey.

    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
                 Activity                      Number of    responses  per   Total annual           Average  burden per  response           Total hours
                                              respondents      respondent      responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest Screener..........................              42               1              42  0.05 (3 minutes)............................               2
Pretest Informed Consent..................              25               1              25  0.05 (3 minutes)............................               1
Pretest Survey Completes..................              25               1              25  0.28 (17 minutes)...........................               7
Main Survey Screener......................           1,927               1           1,927  0.05 (3 minutes)............................              96
Main Survey Informed Consent..............           1,156               1           1,156  0.05 (3 minutes)............................              58
Main Survey Completes.....................           1,156               1           1,156  0.28 (17 minutes)...........................             324
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............           4,331  ............................................             488
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

References

    The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are not
available electronically at https://www.regulations.gov as these
references are copyright protected. FDA has verified the website
addresses, as of the date this document publishes in the Federal
Register, but websites are subject to change over time.

1. Dusetzina, S.B., et al., ``Impact of FDA Drug Risk Communications
on Health Care Utilization and Health Behaviors: A Systematic
Review.'' Medical Care, 50(6):466-478, 2012.
2. Briesacher, B.A., et al., ``A Critical Review of Methods to
Evaluate the Impact of FDA Regulatory Actions.''
Pharmacoepidemiology Drug and Safety. 22(9):986-994, 2013.
3. Morgan, M.G. et al., Risk Communication: A Mental Models
Approach. Cambridge University Press, 2002.

    Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16935 Filed 8-7-19; 8:45 am]
 BILLING CODE 4164-01-P