From:
"Ulatowski, Rhiannon"<EMAIL_ADDRESS>Sent:
Mon, 13 Feb 2023 09:57:01
To:
"Jones; DonnaLee"<EMAIL_ADDRESS>Coke ICR2<EMAIL_ADDRESS>"Beranek; Rob"<EMAIL_ADDRESS>"Maicher; Thomas W."<EMAIL_ADDRESS>"Kurdila; Julianne"<EMAIL_ADDRESS>"Kistler; Katie E"<EMAIL_ADDRESS>"Zavoda; Rich"<EMAIL_ADDRESS>Subject:
RE: Cleveland-Cliffs Steel  -  Burns Harbor, IN - Coke CAA Section 114 - Fenceline monitoring

Good morning, Dr. Jones,

Our contractor, CleanAir Engineering, has contacted the lab to confirm timeline for receiving results and we expect Burn Harbor will be able to submit the first 3-month set of results to EPA during the week of Feb 27.

Please let me know if you have any questions,

Rhiannon ulatowski
Environmental Engineer-Air
p<PHONE_NUMBER>   m<PHONE_NUMBER>
<EMAIL_ADDRESS><EMAIL_ADDRESS>CLEVELAND-CLIFFS INC.

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Thursday, February 9, 2023 10:42 AM
To: Ulatowski, Rhiannon<EMAIL_ADDRESS>Coke ICR2<EMAIL_ADDRESS>Beranek, Rob<EMAIL_ADDRESS>Maicher, Thomas W<EMAIL_ADDRESS>Kurdila, Julianne<EMAIL_ADDRESS>Kistler, Katie E<EMAIL_ADDRESS>Zavoda, Rich<EMAIL_ADDRESS>Cc: Raymond, Gabrielle<EMAIL_ADDRESS>McGinn, Kevin (he/him/his<EMAIL_ADDRESS>Shappley, Ned<EMAIL_ADDRESS>French, Chuck<EMAIL_ADDRESS>--------------------------------------------------------------------------------
Subject: [EXTERNAL] RE: Cleveland-Cliffs Steel  -  Burns Harbor, IN - Coke CAA Section 114 - Fenceline monitoring Importance: High

Thank you for the response. We are missing some dates in order to do the revised QAPP deadline calculation, so when will you be submitting your results?

Regards,
--------------------------------------------------------------------------------
Donna Lee Jones, Ph.D.
--------------------------------------------------------------------------------
Senior Technical Advisor, Metals Sector
--------------------------------------------------------------------------------
U. S. Environmental Protection Agency
--------------------------------------------------------------------------------
Office of Air Quality Planning and Standards
--------------------------------------------------------------------------------
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
--------------------------------------------------------------------------------
Research Triangle Park, NC  27711
--------------------------------------------------------------------------------
Tele:<PHONE_NUMBER>
--------------------------------------------------------------------------------
Fax:<PHONE_NUMBER>
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: Ulatowski, Rhiannon<EMAIL_ADDRESS>Sent: Wednesday, February 8, 2023 5:25 PM
To: Coke ICR2<EMAIL_ADDRESS>Jones, DonnaLee<EMAIL_ADDRESS>Beranek, Rob<EMAIL_ADDRESS>Maicher, Thomas W<EMAIL_ADDRESS>Kurdila, Julianne<EMAIL_ADDRESS>Kistler, Katie E<EMAIL_ADDRESS>Zavoda, Rich<EMAIL_ADDRESS>Cc: Raymond, Gabrielle<EMAIL_ADDRESS>Subject: RE: Cleveland-Cliffs Steel  -  Burns Harbor, IN - Coke CAA Section 114 - Fenceline monitoring

Good afternoon,

Burns Harbor timely initiated the fugitive monitoring after EPA approved the Quality Assurance Project Plan (QAPP) on 9/12/22.  We have not yet received the first 3 months of fugitive monitoring data from our monitoring contractor CleanAir Engineering.  Dependent upon timely receiving the analytical results from the contract laboratory, we plan to submit the first 3 months of monitoring data in accordance with Section A.9.9 of the EPA approved QAPP which included "Reports will be submitted to the EPA one (1) month after retrieval of the last set of samples collected during the first and second three (3) month sampling period, respectively.  The reporting timeline is based on the time required to ship the samples to the laboratory for analysis, receive the laboratory results, and prepare the report for submittal to the EPA."  Please let me know if you have any questions.

Please let me know if you have any questions,

Rhiannon ulatowski
Environmental Engineer-Air
p<PHONE_NUMBER>   m<PHONE_NUMBER>
<EMAIL_ADDRESS>CLEVELAND-CLIFFS INC.

From: Coke ICR2<EMAIL_ADDRESS>Sent: Tuesday, February 7, 2023 2:39 PM
To: Ulatowski, Rhiannon<EMAIL_ADDRESS>Jones, DonnaLee<EMAIL_ADDRESS>Beranek, Rob<EMAIL_ADDRESS>Maicher, Thomas W<EMAIL_ADDRESS>Kurdila, Julianne<EMAIL_ADDRESS>Kistler, Katie E<EMAIL_ADDRESS>Zavoda, Rich<EMAIL_ADDRESS>Cc: Raymond, Gabrielle<EMAIL_ADDRESS>Coke ICR2<EMAIL_ADDRESS>Subject: [EXTERNAL] Cleveland-Cliffs Steel  -  Burns Harbor, IN - Coke CAA Section 114 - Fenceline monitoring

Hello,

We noticed that you have not submitted your first 3 months of fugitive monitoring results yet, based on the due date of 1/30/2023 (within 140 days of the date EPA approves the monitoring plan; EPA approved monitoring plan 9/12/2022).

Please provide an update on when you will be submitting your data.

Thank you


[Federal Register: May 12, 2009 (Volume 74, Number 90)]
[Notices]
[Page 22203]
[DOCID:fr12my09-80]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Hoosier Valley Railroad Museum, Inc.

[Waiver Petition Docket Number FRA-2009-0023]

    The Hoosier Valley Railroad Museum, Inc. (HVRM) seeks a waiver of
compliance from 49 CFR 240.201(d) which states, ``After December 31,
1991, no railroad shall permit or require any person to operate a
locomotive in any class of locomotive or train service unless that
person has been certified as a qualified locomotive engineer and issued
a certificate that complies with Sec.  240.223.'' HVRM desires to
conduct an ``engineer-for-an-hour'' charter, which would allow ``non-
certified'' individuals to operate a locomotive.
    HVRM currently operates on track owned by the town of North Judson,
Indiana, which is controlled and operated by the Chesapeake and Indiana
Railroad (CKIN). HVRM currently operates between milepost (MP) 212.5
and MP 223.0 on CKIN. The Museum Depot is located at approximately MP
213.4. HVRM proposes to conduct the engineer-for-an-hour operations
between MP 213.5 and MP 216.
    HVRM will verify that each participant is in possession of a valid
state issued motor vehicle license, evaluate each participant visually
for fitness to operate the locomotive with respect to obvious signs of
alcohol and/or drug use, and will have a certified locomotive engineer
in the cab at all times. The operations will be conducted under
Absolute Block Authority (a section of track that can only be occupied
by one train at a time) on a designated portion of track only during
daylight hours. An HVRM qualified locomotive engineer will conduct a
job briefing with each participant to ensure all parties know and
understand the movement to be made and know and understand individual
responsibilities in the proposed movements. HVRM would limit engineer-
for-an-hour train size to one (1) locomotive and not more than three
(3) cars with no revenue passengers or members of the public on board
during operations. Any accident or incident that occurs during an
engineer-for-an-hour movement will be immediately reported to the
Federal Railroad Administration.
    HVRM believes that granting this waiver will enable it to generate
funds to support its goal of acquiring and refurbishing railroad
antiquities so that they may be enjoyed by future generations. HVRM
also believes these operations will not pose any safety concerns to the
public at large.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2009-0023) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78).

    Issued in Washington, DC, on May 6, 2009.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
 [FR Doc. E9-11020 Filed 5-11-09; 8:45 am]

BILLING CODE 4910-06-P


160...........................................................           147,853,117.00                 2,059.84
161...........................................................           113,883,427.93                 1,586.59
162...........................................................
163...........................................................           116,699,318.87                 1,625.82
164...........................................................           129,812,902.58                 1,808.51
165...........................................................           106,768,335.00                 1,487.46
166...........................................................           140,139,530.00                 1,952.38
167...........................................................            82,905,120.00                 1,155.01
168...........................................................            99,813,775.33                 1,390.57
169...........................................................            61,257,698.00                   853.42
170...........................................................           265,568,648.00                 3,699.81

171...........................................................            98,014,634.68                 1,365.51
172...........................................................            95,296,632.53                 1,327.64
173...........................................................            52,272,295.77                   728.24
174...........................................................            38,307,460.47                   533.69
175...........................................................            84,787,219.45                 1,181.23
176...........................................................            79,498,966.79                 1,107.55
177...........................................................            55,374,006.21                   771.45
178...........................................................           156,404,961.23                 2,178.98
179...........................................................            60,642,356.86                   844.85
180...........................................................           118,133,629.00                 1,645.80
181...........................................................            76,062,700.00                 1,059.68
182...........................................................           248,176,128.68                 3,457.51
183...........................................................            79,008,100.00                 1,100.71
184...........................................................            85,278,937.00                 1,188.08
185...........................................................            70,228,707.00                   978.40
186...........................................................            62,833,390.18                   875.37
187...........................................................            41,480,726.45                   577.90
188...........................................................           176,929,414.00                 2,464.92
189...........................................................            29,253,925.81                   407.56
190...........................................................           105,263,657.06                 1,466.50
191...........................................................            77,787,800.00                 1,083.71
192...........................................................            68,984,712.00                   961.07
193...........................................................            61,335,825.68                   854.51
194...........................................................            67,297,274.77                   937.56
195...........................................................            51,129,783.08                   712.32
196...........................................................
197...........................................................            68,089,568.19                   948.60
198...........................................................            40,730,576.79                   567.44
199...........................................................            39,525,291.39                   550.65
200...........................................................            91,093,000.00                 1,269.08
201...........................................................            57,676,030.00                   803.52
202...........................................................             6,831,789.24                    95.18
203...........................................................           316,923,604.92                 4,415.27
204...........................................................            56,604,000.00                   788.59
205...........................................................            33,836,692.76                   471.40
206...........................................................             3,686,360.00                    51.36
207...........................................................            87,223,619.59                 1,215.17
208...........................................................            22,659,425.86                   315.68
209...........................................................            36,155,445.78                   503.71
210...........................................................            27,633,449.00                   384.98
211...........................................................             3,789,049.10                    52.79
212...........................................................
213...........................................................
214...........................................................            11,802,608.52                   164.43
215...........................................................            39,707,587.00                   553.19
216...........................................................            69,601,570.00                   969.67
217...........................................................            26,765,942.82                   372.89
218...........................................................            32,246,115.00                   449.24
219...........................................................             5,604,885.00                    78.09
220...........................................................            15,282,378.75                   212.91
221...........................................................            21,777,071.28                   303.39
222...........................................................            19,782,551.00                   275.60
223...........................................................            25,665,436.26                   357.56
224...........................................................            24,403,825.19                   339.99
225...........................................................            69,596,229.05                   969.59
226...........................................................            15,677,771.93                   218.42
227...........................................................            25,267,934.00                   352.02
228...........................................................            22,258,692.00                   310.10
229...........................................................            10,262,505.79                   142.97
230...........................................................
231...........................................................            18,989,070.64                   264.55
232...........................................................            14,408,226.00                   200.73
233...........................................................            18,945,600.00                   263.94
234...........................................................            13,376,162.82                   186.35
235...........................................................            20,807,919.37                   289.89
236...........................................................            17,593,056.07                   245.10
237...........................................................            15,126,721.74                   210.74
238...........................................................            13,674,994.00                   190.52

239...........................................................             6,144,297.00                    85.60
240...........................................................            14,525,850.31                   202.37
241...........................................................            38,208,766.82                   532.31
242...........................................................            14,895,098.80                   207.51
243...........................................................            11,078,635.00                   154.34
244...........................................................            10,226,692.01                   142.47
245...........................................................            11,521,371.11                   160.51
246...........................................................            11,162,808.43                   155.52
247...........................................................            18,083,706.64                   251.94
248...........................................................            15,739,833.71                   219.28
249...........................................................             9,587,210.86                   133.57
250...........................................................            18,980,980.00                   264.44
251...........................................................             5,974,342.18                    83.23
252...........................................................            18,009,063.00                   250.90
253...........................................................            12,371,171.00                   172.35
254...........................................................            16,961,858.62                   236.31
255...........................................................            12,751,377.12                   177.65
256...........................................................             7,665,867.62                   106.80
257...........................................................            14,798,978.38                   206.17
258...........................................................            11,422,776.00                   159.14
259...........................................................             9,486,103.23                   132.16
260...........................................................            18,142,315.00                   252.75
261...........................................................            13,643,800.00                   190.08
262...........................................................
263...........................................................            21,333,324.60                   297.21
264...........................................................            14,024,523.06                   195.38
265...........................................................             9,609,378.96                   133.87
266...........................................................             3,764,664.51                    52.45
267...........................................................             9,263,917.20                   129.06
268...........................................................            13,514,542.97                   188.28
269...........................................................             7,063,688.49                    98.41
270...........................................................             9,204,383.57                   128.23
271...........................................................
272...........................................................             4,165,675.24                    58.03
273...........................................................             8,795,482.50                   122.54
274...........................................................
275...........................................................             7,151,874.00                    99.64
276...........................................................             2,656,709.93                    37.01
277...........................................................
278...........................................................            11,041,371.25                   153.82
279...........................................................             9,618,241.51                   134.00
280...........................................................            10,409,870.33                   145.03
281...........................................................             2,381,247.97                    33.17
282...........................................................            79,562,536.00                 1,108.44
283...........................................................             5,028,862.00                    70.06
284...........................................................             3,583,471.00                    49.92
285...........................................................             6,047,686.70                    84.25
286...........................................................            10,121,031.10                   141.00
287...........................................................
288...........................................................             4,562,944.01                    63.57
289...........................................................             1,995,032.12                    27.79
290...........................................................             3,603,016.17                    50.20
291...........................................................            49,058,772.00                   683.47
292...........................................................             5,326,788.04                    74.21
293...........................................................             5,199,894.30                    72.44
294...........................................................
295...........................................................             7,396,224.93                   103.04
296...........................................................             8,377,144.03                   116.71
297...........................................................            10,426,990.00                   145.27
298...........................................................             4,328,332.63                    60.30
299...........................................................
300...........................................................            22,059,594.00                   307.33
301...........................................................             2,719,871.36                    37.89
302...........................................................
303...........................................................             9,336,370.70                   130.07
304...........................................................             8,250,582.32                   114.94
305...........................................................            11,309,704.54                   157.56
306...........................................................             2,825,954.04                    39.37

307...........................................................             3,015,453.22                    42.01
308...........................................................             2,985,881.79                    41.60
309...........................................................             3,550,440.79                    49.46
310...........................................................             3,796,542.00                    52.89
311...........................................................               681,600.00                     9.50
312...........................................................             6,701,908.00                    93.37
313...........................................................             7,515,141.47                   104.70
314...........................................................             1,813,867.00                    25.27
315...........................................................            25,693,200.00                   357.95
316...........................................................             8,571,418.81                   119.41
317...........................................................             4,618,323.00                    64.34
318...........................................................             2,871,231.32                    40.00
319...........................................................             1,312,921.00                    18.29
320...........................................................             3,167,425.85                    44.13
321...........................................................               101,019.48                     1.41
322...........................................................             3,859,688.00                    53.77
323...........................................................             4,632,446.85                    64.54
324...........................................................
325...........................................................             2,755,282.00                    38.39
326...........................................................             3,449,977.69                    48.06
327...........................................................             2,682,536.34                    37.37
328...........................................................             6,303,034.00                    87.81
329...........................................................             1,464,170.44                    20.40
330...........................................................             2,405,671.00                    33.51
331...........................................................             3,837,456.05                    53.46
332...........................................................             2,098,139.00                    29.23
333...........................................................               927,380.00                    12.92
334...........................................................
335...........................................................               453,254.09                     6.31
336...........................................................             8,591,832.75                   119.70
337...........................................................             3,385,354.11                    47.16
338...........................................................
339...........................................................             1,634,758.00                    22.77
340...........................................................               935,226.00                    13.03
341...........................................................               823,172.38                    11.47
342...........................................................             7,230,086.55                   100.73
343...........................................................             2,994,432.00                    41.72
344...........................................................             5,133,362.77                    71.52
345...........................................................
346...........................................................             1,744,000.00                    24.30
347...........................................................
348...........................................................             5,993,119.17                    83.49
349...........................................................
350...........................................................               652,857.00                     9.10
351...........................................................               424,927.00                     5.92
352...........................................................               953,388.28                    13.28
353...........................................................
354...........................................................             2,291,065.00                    31.92
355...........................................................             3,155,865.00                    43.97
356...........................................................               374,015.00                     5.21
357...........................................................             1,665,732.44                    23.21
358...........................................................               128,500.00                     1.79
359...........................................................               401,400.00                     5.59
360...........................................................               830,021.00                    11.56
361...........................................................               910,747.00                    12.69
362...........................................................             1,232,435.70                    17.17
363...........................................................            14,888,100.00                   207.42
364...........................................................             1,702,250.00                    23.72
365...........................................................             3,676,612.12                    51.22
366...........................................................               919,741.00                    12.81
367...........................................................             3,712,051.51                    51.72
368...........................................................               635,368.00                     8.85
369...........................................................               447,894.00                     6.24
370...........................................................             2,272,345.00                    31.66
371...........................................................             1,374,837.10                    19.15
372...........................................................             1,552,729.36                    21.63
373...........................................................             2,180,116.97                    30.37
374...........................................................

375...........................................................               798,527.92                    11.12
376...........................................................
377...........................................................             1,399,199.54                    19.49
378...........................................................             4,536,762.00                    63.20
379...........................................................             1,061,788.00                    14.79
380...........................................................             2,827,862.97                    39.40
381...........................................................             1,053,097.00                    14.67
382...........................................................               939,300.00                    13.09
383...........................................................                   254.00                     0.00
384...........................................................             1,088,114.00                    15.16
385...........................................................               773,060.00                    10.77
386...........................................................               387,116.56                     5.39
387...........................................................               873,812.55                    12.17
388...........................................................               665,749.00                     9.27
389...........................................................               795,558.50                    11.08
390...........................................................             2,597,253.00                    36.18
391...........................................................               948,046.00                    13.21
392...........................................................             1,107,547.00                    15.43
393...........................................................             3,654,035.00                    50.91
394...........................................................               521,279.00                     7.26
395...........................................................               410,769.00                     5.72
396...........................................................             2,622,813.00                    36.54
397...........................................................               554,541.44                     7.73
398...........................................................               179,200.00                     2.50
399...........................................................               841,840.24                    11.73
400...........................................................               523,709.00                     7.30
401...........................................................
402...........................................................
403...........................................................               462,520.50                     6.44
404...........................................................               379,314.02                     5.28
405...........................................................               217,857.00                     3.04
406...........................................................               513,184.27                     7.15
407...........................................................               130,200.00                     1.81
408...........................................................               480,937.70                     6.70
409...........................................................               658,680.86                     9.18
410...........................................................             1,230,112.99                    17.14
411...........................................................             5,625,111.00                    78.37
412...........................................................               620,200.00                     8.64
413...........................................................             3,879,491.00                    54.05
414...........................................................               852,915.67                    11.88
415...........................................................               468,524.00                     6.53
416...........................................................               338,139.73                     4.71
417...........................................................                86,853.84                     1.21
418...........................................................               382,210.00                     5.32
419...........................................................
420...........................................................               183,173.25                     2.55
421...........................................................               655,954.75                     9.14
422...........................................................               165,639.00                     2.31
423...........................................................
424...........................................................                84,016.00                     1.17
425...........................................................
426...........................................................               220,899.00                     3.08
427...........................................................
428...........................................................
429...........................................................                38,100.00                     0.53
430...........................................................                78,640.00                     1.10
431...........................................................               212,985.00                     2.97
432...........................................................                79,334.00                     1.11
433...........................................................
434...........................................................                22,991.02                     0.32
435...........................................................                 8,120.00                     0.11
436...........................................................                44,988.45                     0.63
437...........................................................                81,718.00                     1.14
438...........................................................                91,513.00                     1.27
439...........................................................               234,239.00                     3.26
440...........................................................               509,039.50                     7.09
441...........................................................
442...........................................................                28,633.00                     0.40

443...........................................................
444...........................................................                 7,497.00                     0.10
445...........................................................                69,548.86                     0.97
446...........................................................             1,243,936.05                    17.33
447...........................................................               111,283.00                     1.55
448...........................................................
449...........................................................               435,740.00                     6.07
450...........................................................
451...........................................................             1,907,630.00                    26.58
452...........................................................
453...........................................................                94,505.19                     1.32
454...........................................................               500,187.00                     6.97
455...........................................................               189,004.00                     2.63
456...........................................................
457...........................................................                 5,154.00                     0.07
458...........................................................
459...........................................................
460...........................................................
461...........................................................                   426.90                     0.01
462...........................................................                 1,065.00                     0.01
463...........................................................               150,058.61                     2.09
464...........................................................               282,990.00                     3.94
465...........................................................                16,625.00                     0.23
466...........................................................
467...........................................................
468...........................................................               139,267.00                     1.94
469...........................................................                49,367.91                     0.69
470...........................................................               330,964.00                     4.61
471...........................................................                 6,532.00                     0.09
472...........................................................
473...........................................................
474...........................................................                     9.00                     0.00
475...........................................................                34,000.00                     0.47
476...........................................................                15,708.00                     0.22
477...........................................................                14,355.00                     0.20
478...........................................................               151,323.00                     2.11
479...........................................................                 6,090.28                     0.08
480...........................................................                67,340.20                     0.94
481...........................................................                16,356.00                     0.23
482...........................................................                    37.00                     0.00
483...........................................................                94,762.08                     1.32
484...........................................................                16,191.00                     0.23
485...........................................................                30,000.00                     0.42
486...........................................................                17,679.82                     0.25
487...........................................................                 3,762.52                     0.05
488...........................................................
489...........................................................               111,812.00                     1.56
490...........................................................
491...........................................................                30,513.00                     0.43
492...........................................................                86,676.00                     1.21
493...........................................................
494...........................................................                   500.00                     0.01
495...........................................................                98,319.74                     1.37
496...........................................................                36,465.84                     0.51
497...........................................................                20,653.01                     0.29
498...........................................................                29,603.84                     0.41
499...........................................................
500...........................................................                 4,165.29                     0.06
501...........................................................                 7,100.00                     0.10
502...........................................................
503...........................................................
504...........................................................                 5,582.00                     0.08
505...........................................................
506...........................................................                38,770.00                     0.54
507...........................................................                18,855.43                     0.26
508...........................................................
509...........................................................                 9,817.02                     0.14
510...........................................................                   900.00                     0.01

511...........................................................                 4,472.75                     0.06
512...........................................................                   266.00                     0.00
513...........................................................                 5,298.16                     0.07
514...........................................................
515...........................................................                   169.00                     0.00
516...........................................................
517...........................................................                 4,646.78                     0.06
518...........................................................                 4,646.78                     0.06
519...........................................................                 6,417.00                     0.09
520...........................................................                   257.00                     0.00
521...........................................................                13,387.78                     0.19
522...........................................................                 1,313.00                     0.02
523...........................................................
524...........................................................                23,714.00                     0.33
525...........................................................                 4,488.00                     0.06
526...........................................................                 2,787.00                     0.04
527...........................................................                 1,200.00                     0.02
528...........................................................
529...........................................................                 1,947.72                     0.03
530...........................................................                 2,360.20                     0.03
531...........................................................                   200.00                     0.00
532...........................................................                15,261.00                     0.21
533...........................................................                   267.00                     0.00
534...........................................................
535...........................................................                     2.00                     0.00
536...........................................................
537...........................................................                 1,895.46                     0.03
538...........................................................                 1,369.04                     0.02
539...........................................................                 1,047.00                     0.01
540...........................................................                 1,507.00                     0.02
541...........................................................
542...........................................................                 2,183.01                     0.03
543...........................................................                   973.00                     0.01
544...........................................................
545...........................................................                   760.01                     0.01
546...........................................................                 2,774.00                     0.04
547...........................................................                    45.00                     0.00
548...........................................................                   747.00                     0.01
549...........................................................
550...........................................................                   799.00                     0.01
551...........................................................                   257.00                     0.00
552...........................................................                   207.00                     0.00
553...........................................................
554...........................................................                     6.00                     0.00
555...........................................................
556...........................................................                   402.00                     0.01
557...........................................................
558...........................................................
559...........................................................                   164.00                     0.00
560...........................................................
561...........................................................
562...........................................................
563...........................................................
564...........................................................
565...........................................................                   118.00                     0.00
566...........................................................                     5.00                     0.00
567...........................................................
568...........................................................                    68.00                     0.00
569...........................................................                    75.00                     0.00
570...........................................................                    15.00                     0.00
571...........................................................                    34.00                     0.00
572...........................................................
573...........................................................                     9.00                     0.00
574...........................................................
575...........................................................                    85.00                     0.00
576...........................................................                    75.00                     0.00
577...........................................................
578...........................................................

579...........................................................                    54.00                     0.00
580...........................................................                    26.00                     0.00
581...........................................................                    34.00                     0.00
582...........................................................                   423.55                     0.01
583...........................................................                     6.00                     0.00
584...........................................................
585...........................................................                    91.00                     0.00
586...........................................................                    43.00                     0.00
587...........................................................
588...........................................................                    25.00                     0.00
589...........................................................
590...........................................................                    16.00                     0.00
591...........................................................                    20.00                     0.00
592...........................................................                    31.00                     0.00
593...........................................................
594...........................................................                    25.00                     0.00
595...........................................................
596...........................................................                    29.00                     0.00
597...........................................................                    22.00                     0.00
598...........................................................
599...........................................................
600...........................................................                     3.00                     0.00
601...........................................................                    26.00                     0.00
602...........................................................
603...........................................................
604...........................................................                    55.02                     0.00
605...........................................................                    20.00                     0.00
606...........................................................
607...........................................................                    18.00                     0.00
608...........................................................
609...........................................................
610...........................................................                    18.00                     0.00
611...........................................................
612...........................................................                    27.00                     0.00
613...........................................................
614...........................................................
615...........................................................                    14.00                     0.00
616...........................................................                     8.00                     0.00
617...........................................................                    18.00                     0.00
618...........................................................
619...........................................................
620...........................................................
621...........................................................
622...........................................................                    16.00                     0.00
623...........................................................                     3.00                     0.00
624...........................................................                     1.00                     0.00
625...........................................................                     7.00                     0.00
626...........................................................
627...........................................................                     6.00                     0.00
628...........................................................
629...........................................................                     8.00                     0.00
630...........................................................                    11.00                     0.00
631...........................................................                     9.00                     0.00
632...........................................................
633...........................................................                     2.26                     0.00
634...........................................................                    10.00                     0.00
635...........................................................
636...........................................................                     8.00                     0.00
637...........................................................                     2.00                     0.00
638...........................................................
639...........................................................                     4.00                     0.00
640...........................................................                    15.00                     0.00
641...........................................................
642...........................................................
643...........................................................                     6.00                     0.00
644...........................................................                     1.00                     0.00
645...........................................................
646...........................................................                     2.00                     0.00

647...........................................................                     1.00                     0.00
648...........................................................                     2.00                     0.00
649...........................................................                     3.00                     0.00
650...........................................................
651...........................................................
652...........................................................
653...........................................................
654...........................................................
655...........................................................                     4.00                     0.00
656...........................................................                     5.00                     0.00
657...........................................................
658...........................................................
659...........................................................                     1.00                     0.00
660...........................................................
661...........................................................                     3.00                     0.00
662...........................................................                     8.00                     0.00
663...........................................................
664...........................................................
665...........................................................
666...........................................................
667...........................................................
668...........................................................
669...........................................................
670...........................................................
671...........................................................
672...........................................................                     1.00                     0.00
673...........................................................
674...........................................................
675...........................................................
676...........................................................
677...........................................................
678...........................................................
679...........................................................                     1.00                     0.00
680...........................................................
681...........................................................
682...........................................................
683...........................................................
----------------------------------------------------------------------------------------------------------------

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

    \161\ CAT LLC recognizes that an Industry Member's knowledge of
its own fees in the illustrative example would be helpful in
analyzing the Funding Proposal. Accordingly, if a CAT Executing
Broker is interested in learning which anonymized CAT Executing
Broker in the illustrative example represents its volume and fees,
the CAT Executing Broker may contact the FINRA CAT Helpdesk by email
at [email protected]. Accordingly, subject to verification of the
identity of the requesting party as an authorized representative of
the relevant Industry Member, the Helpdesk will provide the
authorized representative of the CAT Executing Broker with the
number of the applicable anonymized CAT Executing Broker in Exhibit
C. In addition, upon request, the Helpdesk also will provide the CAT
Executing Broker with a breakdown of its executed equivalent share
volume and corresponding fee by (1) Listed Options, NMS Stocks and
OTC Equity Securities, (2) by transactions executed on each exchange
and transactions executed otherwise than on an exchange, and (3) by
buy-side transactions and sell-side transactions. CAT LLC notes that
the calculations provided in the table may reflect minor variations
due to rounding.
---------------------------------------------------------------------------

[FR Doc. 2023-05690 Filed 3-20-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Notices]
[Pages 1476-1477]
[FR Doc No: 2022-00345]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2011-0009]

Petition for Extension of Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on November 7 and 8, 2021, the
Nevada Northern Railway Museum (NNR) petitioned the Federal Railroad
Administration (FRA) for an extension of a waiver of compliance from
certain

provisions of the Federal railroad safety regulations contained at 49
CFR parts 215 (Railroad Freight Car Safety Standards) and 224
(Reflectorization of Rail Freight Rolling Stock). The relevant FRA
Docket Number is FRA-2011-0009.
    Specifically, NNR requested to extend its special approval pursuant
to 49 CFR 215.203, Restricted cars, for a total of 13 cars, including 2
cabooses (NN 22 and NN 3), 2 flat cars (NN 23 and NN 100), 5 hopper
cars (WSOR 102, WSOR 128, WSOR 134, WSOR 158, and WSOR 159), and 4
boxcars (NN 1021, NN 1023, NN 1024, and NN1025) that are more than 50
years from the date of original construction.\1\ NNR also requests to
extend its existing relief from 49 CFR 215.303, Stenciling of
restricted cars, and 224.101, General requirements. NNR seeks to
continue use of the cars in mobile storage, occasional tourist
photographic events, and tourist excursion operations. In support of
its request, NNR states that the relief would enable the cars to
maintain historic integrity and that the cars would remain on NNR's
track, not connected to the general railroad system.
---------------------------------------------------------------------------

    \1\ Along with its request to renew the relief in this docket,
NNR submitted a request to extend the relief in Docket Number FRA-
2016-0110 and combine that relief into the FRA-2011-0009 docket.
---------------------------------------------------------------------------

    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by February 25, 2022 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable. Anyone can search the electronic
form of any written communications and comments received into any of
our dockets by the name of the individual submitting the comment (or
signing the document, if submitted on behalf of an association,
business, labor union, etc.). Under 5 U.S.C. 553(c), the U.S.
Department of Transportation (DOT) solicits comments from the public to
better inform its processes. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2022-00345 Filed 1-10-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 78, Number 130 (Monday, July 8, 2013)]
[Notices]
[Pages 40815-40816]
[FR Doc No: 2013-16225]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69898; File No. SR-NASDAQ-2013-093]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify the Fees Under the QMM Pricing Incentive Program Under Rules
7014 and 7015

July 1, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 \2\ thereunder, notice is hereby given
that on June 26, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II and III, below, which Items have been prepared by NASDAQ.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    NASDAQ is proposing changes to fees under its Qualified Market
Maker (``QMM'') pricing incentive program under Rules 7014 and 7015.
NASDAQ proposes to implement the proposed rule change on July 1, 2013.
The text of the proposed rule change is available on the Exchange's Web
site at http://nasdaq.cchwallstreet.com/, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    Under NASDAQ's QMM Program, a member may be designated as a QMM
with respect to one or more of its market participant identifiers
(``MPIDs'') if:
     the member is not assessed any ``Excess Order Fee'' under
Rule 7018 during the month; \3\ and
---------------------------------------------------------------------------

    \3\ Rule 7018(m). Last year, NASDAQ introduced an Excess Order
Fee, aimed at reducing inefficient order entry practices of certain
market participants that place excessive burdens on the systems of
NASDAQ and its members and that may negatively impact the usefulness
and life cycle cost of market data. In general, the determination of
whether to impose the fee on a particular MPID is made by
calculating the ratio between (i) entered orders, weighted by the
distance of the order from the NBBO, and (ii) orders that execute in
whole or in part. The fee is imposed on MPIDs that have an ``Order
Entry Ratio'' of more than 100.
---------------------------------------------------------------------------

     through such MPID the member quotes at the national best
bid or best offer (``NBBO'') at least 25% of the time during regular
market hours \4\ in an average of at least 1,000 securities during the
month.\5\
---------------------------------------------------------------------------

    \4\ Defined as 9:30 a.m. through 4:00 p.m., or such shorter
period as may be designated by NASDAQ on a day when the securities
markets close early (such as the day after Thanksgiving).
    \5\ A member MPID is considered to be quoting at the NBBO if it
has a displayed order at either the national best bid or the
national best offer or both the national best bid and offer. On a
daily basis, NASDAQ will determine the number of securities in which
the member satisfied the 25% NBBO requirement. To qualify for QMM
designation, the MPID must meet the requirement for an average of
1,000 securities per day over the course of the month. Thus, if a
member MPID satisfied the 25% NBBO requirement in 900 securities for
half the days in the month, and satisfied the requirement for 1,100
securities for the other days in the month, it would meet the
requirement for an average of 1,000 securities.
---------------------------------------------------------------------------

    A member that is a QMM with respect to a particular MPID (a ``QMM
MPID'') is eligible to receive certain discounts and credits. NASDAQ is
now proposing to eliminate one of these discounts. At present, a QMM
receives a discount on fees for ports used for entering orders for a
QMM MPID, up to a total discount equal to the lesser of the QMM's total
fees for such ports or $5,000.\6\ As provided in Rule 7015, the
specific fees subject to this discount are: (i) All ports using the
NASDAQ Information Exchange (``QIX'') protocol,\7\ (ii) Financial
Information Exchange (``FIX'') trading ports,\8\ and (iii) ports using
other trading telecommunications protocols.\9\ Beginning July 1, 2013,
the port discount will be eliminated. All other discounts and credits
associated with the QMM program will remain in effect.
---------------------------------------------------------------------------

    \6\ The ports subject to the discount are not used for receipt
of market data.
    \7\ The applicable undiscounted fees are $1,200 per month for a
port pair or ECN direct connection port pair, and $1,000 per month
for an unsolicited message port. See Rule 7015(a).
    \8\ The applicable undiscounted fee is $500 per port per month.
See Rule 7015(b).
    \9\ The applicable undiscounted fee is $500 per port pair per
month. See Rule 7015(g).
---------------------------------------------------------------------------

2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\10\ in general, and with
Sections 6(b)(4), 6(b)(5), and 6(b)(8) of the Act,\11\ in particular,
in that it provides for the equitable allocation of reasonable dues,
fees and other charges among members and issuers and other persons
using any facility or system which NASDAQ operates or controls, is not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers, and does not impose any burden on competition not
necessary or

appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f.
    \11\ 15 U.S.C. 78f(b)(4), (5) and (8).
---------------------------------------------------------------------------

    The proposed change with respect to the QMM Program is reasonable
because even with the change, QMMs will still continue to receive
meaningful financial incentives consistent with the commitment to
enhancing market quality that is reflected in their achievement of the
program's quoting requirements. The proposed change is consistent with
an equitable allocation of fees and is not unfairly discriminatory
because it will cause the fees paid by QMMs with respect to order entry
ports to be equivalent to the fees paid by other market participants
for comparable access. Finally, the change does not impose any burden
on competition that is not necessary or appropriate because although it
will result in a fee increase for QMMs currently qualifying for the
discount, it will also serve to return the applicable fees to the level
in place before the introduction of the QMM program and make them
equivalent to fees paid by other market participants for comparable
access.

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. NASDAQ notes that
it operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, NASDAQ must
continually adjust its fees to remain competitive with other exchanges
and with alternative trading systems that have been exempted from
compliance with the statutory standards applicable to exchanges.
Because competitors are free to modify their own fees in response, and
because market participants may readily adjust their order routing
practices, NASDAQ believes that the degree to which fee changes in this
market may impose any burden on competition is extremely limited. In
this instance, although the proposed change eliminates one of the
discounts provided through a previously introduced pricing incentive
program, the incentive program in question remain in place and is
itself reflective of the need for exchanges to offer significant
financial incentives to attract order flow in a highly competitive
environment. Moreover, if the changes are unattractive to market
participants, it is likely that NASDAQ will lose market share as a
result. Accordingly, NASDAQ does not believe that the proposed changes
will impair the ability of members or competing order execution venues
to maintain their competitive standing in the financial markets.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \12\ and paragraph (f) of Rule 19b-4
thereunder.\13\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please
include File Number SR-NASDAQ-2013-093 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2013-093. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2013-093 and should
be submitted on or before July 29, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-16225 Filed 7-5-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Notices]
[Page 51027]
[FR Doc No: 2020-18139]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Number: PR20-55-003.
    Applicants: The East Ohio Gas Company.
    Description: Tariff filing per 284.123(b),(e)/: Amend Operating
Statement of The East Ohio Gas Company 4-30-2020 to be effective 4/1/
2020.
    Filed Date: 8/13/2020.
    Accession Number:<PHONE_NUMBER>24.
    Comments/Protests Due: 5 p.m. ET 8/25/2020.

    Docket Numbers: RP20-1093-000.
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Spire Negotiated Rate to be
effective 10/1/2020.
    Filed Date: 8/13/20.
    Accession Number: 20200813-5017.
    Comments Due: 5 p.m. ET 8/25/20.

    Docket Numbers: RP20-1094-000.
    Applicants: Trunkline Gas Company, LLC.
    Description: Sec.  4(d) Rate Filing: Reservation Charge Crediting
Clarification to be effective 9/13/2020.
    Filed Date: 8/13/20.
    Accession Number: 20200813-5031.
    Comments Due: 5 p.m. ET 8/25/20.

    Docket Numbers: RP20-1095-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20200813 Carlton Flow
Obligation to be effective 11/1/2020.
    Filed Date: 8/13/20.
    Accession Number: 20200813-5036.
    Comments Due: 5 p.m. ET 8/25/20.

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

    Dated: August 13, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-18139 Filed 8-18-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)]
[Proposed Rules]
[Pages 3449-3450]
[FR Doc No: 2018-01299]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2016-D-2343]

Hazard Analysis and Risk-Based Preventive Controls for Human
Food; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of another draft chapter of a multichapter
guidance for industry entitled ``Hazard Analysis and Risk-Based
Preventive Controls for Human Food: Draft Guidance for Industry.'' This
multichapter draft guidance is intended to explain our current thinking
on how to comply with the requirements for hazard analysis and risk-
based preventive controls under our rule entitled ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food.'' The newly available draft chapter is
entitled ``Chapter 15--Supply-Chain Program for Human Food Products.''

DATES: Submit either electronic or written comments by May 25, 2018 to
ensure that the Agency considers your comment on this draft guidance
before it begins work on the final version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive
Controls for Human Food: Draft Guidance for Industry.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
Office of Food Safety, Center for Food Safety and Applied Nutrition,
Food and Drug Administration (HFS-300), 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. It enables FDA to focus more on
preventing food safety problems rather than relying primarily on
reacting to problems after they occur. FSMA recognizes the important
role industry plays in ensuring the safety of the food supply,
including the adoption of modern systems of preventive controls in food
production.
    Section 103 of FSMA amended section 418 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 350g) by adding requirements for
hazard analysis and risk-based preventive controls for establishments
that are required to register as food facilities under our regulations,
in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C
Act (21 U.S.C. 350d). We have established regulations to implement
these requirements within part 117 (21 CFR part 117).

    In the Federal Register of August 24, 2016 (81 FR 57816), we
announced the availability of several chapters (Chapters 1-5) of a
multichapter draft guidance for industry entitled ``Hazard Analysis and
Risk-Based Preventive Controls for Human Food.'' In the Federal
Register of August 31, 2017 (82 FR 41364), we announced the
availability of an additional chapter (Chapter 6). We now are
announcing the availability of an additional draft chapter of this
multichapter guidance for industry.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on ``Hazard
Analysis and Risk-Based Preventive Controls for Human Food''. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
    The multichapter draft guidance for industry is intended to explain
our current thinking on how to comply with the requirements for hazard
analysis and risk-based preventive controls under part 117, principally
in subparts C and G. The chapter that we are announcing in this
document is entitled ``Chapter 15--Supply-Chain Program for Human Food
Products.''
    We intend to announce the availability for public comment of
additional chapters of the draft guidance as we complete them.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in 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 117 have been approved under OMB
control number 0910-0751.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: January 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01299 Filed 1-24-18; 8:45 am]
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[Federal Register: August 11, 2008 (Volume 73, Number 155)]
[Notices]
[Page 46624-46625]
[DOCID:fr11au08-64]

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ENVIRONMENTAL PROTECTION AGENCY

[OW-FRL-8702-6]

Methodology for Deriving Ambient Water Quality Criteria for the
Protection of Human Health; Draft Technical Support Document, Volume 3:
Development of Site-Specific Bioaccumulation Factors

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Time Extension for Acceptance of Scientific Views on
draft document.

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

SUMMARY: On June 30, 2008, EPA published a Federal Register notice that
solicited scientific views on the Draft Technical Support Document,
Volume 3: Development of Site-Specific Bioaccumulation Factors
(hereafter ``Draft Site-Specific BAF TSD'') that accompanies the
Methodology and the National BAF TSD. See 73 FR 36866. Today, in
response to stakeholder requests, EPA is notifying the public that we
will extend the time period to submit scientific views on this document
for 45 days, until September 29, 2008.

DATES: Scientific views must be received on or before September 29,
2008. Scientific views postmarked after this date may not receive the
same consideration.

ADDRESSES: Submit your scientific views, identified by Docket ID No.
EPA-HQ-OW-2008-0494, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting scientific views.
     Email<EMAIL_ADDRESS>     Mail: U.S. Environmental Protection Agency; EPA Docket
Center (EPA/DC) Water Docket, MC 2822T; 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460.
     Hand Delivery: EPA Docket Center, 1301 Constitution Ave,
NW., EPA West, Room 3334, Washington DC. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your scientific views to Docket ID No. EPA-HQ-
OW-2008-0494. EPA's policy is that all scientific views received will
be included in the public docket without change and may be made
available online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov website
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Office of Water
Docket/ EPA/DC, 1301 Constitution Ave, NW., EPA West,

Room 3334, Washington DC. This Docket Facility is open from 8:30 a.m.
until 4:30 p.m., EST, Monday through Friday, excluding legal holidays.
The telephone number for the Public Reading Room is<PHONE_NUMBER>, and
the telephone number for the Office of Water is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Heidi L. Bethel, Health and Ecological
Criteria Division (4304T), U.S. EPA, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460;<PHONE_NUMBER><EMAIL_ADDRESS>
    Dated: August 1, 2008.
Suzanne M. Rudzinski,
Acting Office Director, Office of Science and Technology.
[FR Doc. E8-18483 Filed 8-8-08; 8:45 am]

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