ML19364A078: Difference between revisions

From kanterella
Jump to navigation Jump to search
VisualWikitext
Created page by program invented by StriderTol
 
StriderTol Bot change
 
Line 17: Line 17:


=Text=
=Text=
{{#Wiki_filter:From:                           Gleaves, Billy Sent:                           Monday, December 30, 2019 10:33 AM To:                             Roberts, Kelli Anne; Yeates, Brad L.
{{#Wiki_filter:From:
Cc:                             Vogtle PEmails; Patel, Chandu; Santos, Cayetano; Hall, Victor; Butler, Rhonda; Beardsley, Jim; Brown, Michael; Lawson-Jenkins, Kim
Gleaves, Billy Sent:
Monday, December 30, 2019 10:33 AM To:
Roberts, Kelli Anne; Yeates, Brad L.
Cc:
Vogtle PEmails; Patel, Chandu; Santos, Cayetano; Hall, Victor; Butler, Rhonda; Beardsley, Jim; Brown, Michael; Lawson-Jenkins, Kim  


==Subject:==
==Subject:==
Vogtle 3&4 LAR-19-020 "Cyber Security Plan Changes" Acceptance Letter Attachments:                   Vogtle LAR-19-020 Cyber Security Plan Change ACCEPTANCE LETTER.pdf Kelli and Brad, The NRC has accepted for review your LAR 19-020, Cyber Security Plan Changes, dated December 20, 2019. By this email, the staff is issuing the associated acceptance letter into the public record. The enclosed acceptance letter accepts your proposed schedule for completion of this action by September 30, 2020 (NEIMA date), however, the staff will endeavor to expedite the review with the goal to complete and issue by May 1, 2020 and will inform you if our resource estimate changes or if our goal date changes.
Vogtle 3&4 LAR-19-020 "Cyber Security Plan Changes" Acceptance Letter Attachments:
Vogtle LAR-19-020 Cyber Security Plan Change ACCEPTANCE LETTER.pdf Kelli and Brad, The NRC has accepted for review your LAR 19-020, Cyber Security Plan Changes, dated December 20, 2019. By this email, the staff is issuing the associated acceptance letter into the public record. The enclosed acceptance letter accepts your proposed schedule for completion of this action by September 30, 2020 (NEIMA date), however, the staff will endeavor to expedite the review with the goal to complete and issue by May 1, 2020 and will inform you if our resource estimate changes or if our goal date changes.
This email with attached acceptance letter is being submitted to public ADAMS capture with this email. An accession number will be assigned by ADAMS.
This email with attached acceptance letter is being submitted to public ADAMS capture with this email. An accession number will be assigned by ADAMS.
Respectfully, Billy William (Billy) Gleaves Senior Project Manager NRO/DLSE/Licensing Branch 2 (was Licensing Branch 4)
Respectfully, Billy William (Billy) Gleaves Senior Project Manager NRO/DLSE/Licensing Branch 2 (was Licensing Branch 4)
US Nuclear Regulatory Commission The contents of this message may be sensitive. If this message has been received in error, please delete it without reading it. Your receipt of this message is not intended to waive any applicable privilege. Do not disseminate this message without the permission of the author. Communications by this author do not represent NRC policy and are not binding on the Commission.
US Nuclear Regulatory Commission The contents of this message may be sensitive. If this message has been received in error, please delete it without reading it. Your receipt of this message is not intended to waive any applicable privilege. Do not disseminate this message without the permission of the author. Communications by this author do not represent NRC policy and are not binding on the Commission.  


Hearing Identifier:       Vogtle_COL_Docs_Public Email Number:             513 Mail Envelope Properties       (BL0PR0901MB4387F3B404BDA78266F4AA109F270)
Hearing Identifier:
Vogtle_COL_Docs_Public Email Number:
513 Mail Envelope Properties (BL0PR0901MB4387F3B404BDA78266F4AA109F270)  


==Subject:==
==Subject:==
Vogtle 3&4 LAR-19-020 "Cyber Security Plan Changes" Acceptance Letter Sent Date:               12/30/2019 10:32:53 AM Received Date:           12/30/2019 10:32:56 AM From:                     Gleaves, Billy Created By:               Bill.Gleaves@nrc.gov Recipients:
Vogtle 3&4 LAR-19-020 "Cyber Security Plan Changes" Acceptance Letter Sent Date:
12/30/2019 10:32:53 AM Received Date:
12/30/2019 10:32:56 AM From:
Gleaves, Billy Created By:
Bill.Gleaves@nrc.gov Recipients:  
"Vogtle PEmails" <Vogtle.PEmails@nrc.gov>
"Vogtle PEmails" <Vogtle.PEmails@nrc.gov>
Tracking Status: None "Patel, Chandu" <Chandu.Patel@nrc.gov>
Tracking Status: None "Patel, Chandu" <Chandu.Patel@nrc.gov>
Line 40: Line 51:
Tracking Status: None "Roberts, Kelli Anne" <KROBERTS@southernco.com>
Tracking Status: None "Roberts, Kelli Anne" <KROBERTS@southernco.com>
Tracking Status: None "Yeates, Brad L." <blyeates@southernco.com>
Tracking Status: None "Yeates, Brad L." <blyeates@southernco.com>
Tracking Status: None Post Office:             BL0PR0901MB4387.namprd09.prod.outlook.com Files                             Size                 Date & Time MESSAGE                           1289                 12/30/2019 10:32:56 AM Vogtle LAR-19-020 Cyber Security Plan Change ACCEPTANCE LETTER.pdf                           260991 Options Priority:                         Normal Return Notification:               No Reply Requested:                   No Sensitivity:                       Normal Expiration Date:
Tracking Status: None Post Office:
BL0PR0901MB4387.namprd09.prod.outlook.com Files Size Date & Time MESSAGE 1289 12/30/2019 10:32:56 AM Vogtle LAR-19-020 Cyber Security Plan Change ACCEPTANCE LETTER.pdf 260991 Options Priority:
Normal Return Notification:
No Reply Requested:
No Sensitivity:
Normal Expiration Date:  


                                                    
                                                    
                                                    
                                                    
                                                    
                                        'HFHPEHU




0U%ULDQ+:KLWOH\'LUHFWRU

5HJXODWRU\$IIDLUV

6RXWKHUQ1XFOHDU2SHUDWLQJ&RPSDQ\,QF

&RORQQDGH3DUNZD\%LQ1(&
'HFHPEHU


0U%ULDQ+:KLWOH\\'LUHFWRU
5HJXODWRU\\$IIDLUV
6RXWKHUQ1XFOHDU2SHUDWLQJ&RPSDQ\\,QF
&RORQQDGH3DUNZD\\%LQ1(&
%LUPLQJKDP$/
%LUPLQJKDP$/




68%-(&7 $&&(37$1&(5(9,(:2)6287+(5118&/($523(5$7,1*&203$1<&#xb6;6
68%-(&7
$&&(37$1&(5(9,(:2)6287+(5118&/($523(5$7,1*&203$1<&#xb6;6
5(48(67)25/,&(16($0(1'0(17)257+(92*7/((/(&75,&
5(48(67)25/,&(16($0(1'0(17)257+(92*7/((/(&75,&
              *(1(5$7,1*3/$1781,76 &<%(56(&85,7<3/$1&+$1*(6
*(1(5$7,1*3/$1781,76 &<%(56(&85,7<3/$1&+$1*(6
                /$5  (3,'12///$ 
/$5  (3,'12///$ 


'HDU0U:KLWOH\
'HDU0U:KLWOH\\


%\OHWWHUGDWHG'HFHPEHU $JHQF\ZLGH'RFXPHQWV$FFHVVDQG0DQDJHPHQW6\VWHP
%\\OHWWHUGDWHG'HFHPEHU $JHQF\\ZLGH'RFXPHQWV$FFHVVDQG0DQDJHPHQW6\\VWHP
  $'$06 $FFHVVLRQ1R0/% WKH6RXWKHUQ1XFOHDU2SHUDWLQJ&RPSDQ\ 61& 
$'$06 $FFHVVLRQ1R0/% WKH6RXWKHUQ1XFOHDU2SHUDWLQJ&RPSDQ\\ 61& 
VXEPLWWHGDOLFHQVHDPHQGPHQWUHTXHVW /$5 IRUWKH9RJWOH(OHFWULF*HQHUDWLQJ3ODQW 9(*3 
VXEPLWWHGDOLFHQVHDPHQGPHQWUHTXHVW /$5 IRUWKH9RJWOH(OHFWULF*HQHUDWLQJ3ODQW 9(*3 
&RPELQHG/LFHQVH &2/ 1XPEHUV13)DQ13)UHIHUUHGWRDV8QLWVDQG7KH
&RPELQHG/LFHQVH &2/ 1XPEHUV13)DQ13)UHIHUUHGWRDV8QLWVDQG7KH
UHTXHVWHGDPHQGPHQWSURSRVHVFKDQJHVWRWKH9(*38QLWVDQG&\EHU6HFXULW\3ODQ
UHTXHVWHGDPHQGPHQWSURSRVHVFKDQJHVWRWKH9(*38QLWVDQG&\\EHU6HFXULW\\3ODQ


7KHSXUSRVHRIWKLVOHWWHULVWRSURYLGHWKHUHVXOWVRIWKH861XFOHDU5HJXODWRU\&RPPLVVLRQ
7KHSXUSRVHRIWKLVOHWWHULVWRSURYLGHWKHUHVXOWVRIWKH861XFOHDU5HJXODWRU\\&RPPLVVLRQ
15& VWDII&#xb6;VDFFHSWDQFHUHYLHZRIWKH/$57KHDFFHSWDQFHUHYLHZLVDVWDIISURFHVVWR
15& VWDII&#xb6;VDFFHSWDQFHUHYLHZRIWKH/$57KHDFFHSWDQFHUHYLHZLVDVWDIISURFHVVWR
GHWHUPLQHLIWKHUHLVVXIILFLHQWWHFKQLFDOLQIRUPDWLRQLQVFRSHDQGGHSWKWRDOORZWKH15&VWDIIWR
GHWHUPLQHLIWKHUHLVVXIILFLHQWWHFKQLFDOLQIRUPDWLRQLQVFRSHDQGGHSWKWRDOORZWKH15&VWDIIWR
FRPSOHWHLWVGHWDLOHGWHFKQLFDOUHYLHZ7KHDFFHSWDQFHUHYLHZLVDOVRLQWHQGHGWRLGHQWLI\
FRPSOHWHLWVGHWDLOHGWHFKQLFDOUHYLHZ7KHDFFHSWDQFHUHYLHZLVDOVRLQWHQGHGWRLGHQWLI\\
ZKHWKHUWKHDSSOLFDWLRQKDVDQ\UHDGLO\DSSDUHQWLQIRUPDWLRQLQVXIILFLHQFLHVLQLWV
ZKHWKHUWKHDSSOLFDWLRQKDVDQ\\UHDGLO\\DSSDUHQWLQIRUPDWLRQLQVXIILFLHQFLHVLQLWV
FKDUDFWHUL]DWLRQRIWKHUHJXODWRU\UHTXLUHPHQWVRUWKHOLFHQVLQJEDVLVRIWKHSODQW
FKDUDFWHUL]DWLRQRIWKHUHJXODWRU\\UHTXLUHPHQWVRUWKHOLFHQVLQJEDVLVRIWKHSODQW


&RQVLVWHQWZLWK7LWOHRIWKHCode of Federal Regulations &)5 6HFWLRQDQ
&RQVLVWHQWZLWK7LWOHRIWKHCode of Federal Regulations &)5 6HFWLRQDQ
DPHQGPHQWWRWKHOLFHQVHPXVWIXOO\GHVFULEHWKHFKDQJHVUHTXHVWHGDQGIROORZDVFORVHO\DV
DPHQGPHQWWRWKHOLFHQVHPXVWIXOO\\GHVFULEHWKHFKDQJHVUHTXHVWHGDQGIROORZDVFORVHO\\DV
DSSOLFDEOHWKHIRUPSUHVFULEHGIRURULJLQDODSSOLFDWLRQV6HFWLRQRIWKH&)5DGGUHVVHV
DSSOLFDEOHWKHIRUPSUHVFULEHGIRURULJLQDODSSOLFDWLRQV6HFWLRQRIWKH&)5DGGUHVVHV
WKHFRQWHQWRIWHFKQLFDOLQIRUPDWLRQUHTXLUHG7KLVVHFWLRQVWLSXODWHVWKDWWKHVXEPLWWDODGGUHVV
WKHFRQWHQWRIWHFKQLFDOLQIRUPDWLRQUHTXLUHG7KLVVHFWLRQVWLSXODWHVWKDWWKHVXEPLWWDODGGUHVV
WKHGHVLJQDQGRSHUDWLQJFKDUDFWHULVWLFVXQXVXDORUQRYHOGHVLJQIHDWXUHVDQGSULQFLSDOVDIHW\
WKHGHVLJQDQGRSHUDWLQJFKDUDFWHULVWLFVXQXVXDORUQRYHOGHVLJQIHDWXUHVDQGSULQFLSDOVDIHW\\
FRQVLGHUDWLRQV
FRQVLGHUDWLRQV




%:KLWOH\                                     
%:KLWOH\\





7KH15&VWDIIKDVUHYLHZHG\RXUDSSOLFDWLRQDJDLQVWWKHUHJXODWRU\UHTXLUHPHQWVDQGKDV
7KH15&VWDIIKDVUHYLHZHG\\RXUDSSOLFDWLRQDJDLQVWWKHUHJXODWRU\\UHTXLUHPHQWVDQGKDV
FRQFOXGHGWKDWLWSURYLGHVVXIILFLHQWWHFKQLFDOGHWDLOWRHQDEOHWKH15&VWDIIWREHJLQLWVGHWDLOHG
FRQFOXGHGWKDWLWSURYLGHVVXIILFLHQWWHFKQLFDOGHWDLOWRHQDEOHWKH15&VWDIIWREHJLQLWVGHWDLOHG
UHYLHZDQGPDNHDQLQGHSHQGHQWDVVHVVPHQWUHJDUGLQJWKHDFFHSWDELOLW\RIWKHSURSRVHG
UHYLHZDQGPDNHDQLQGHSHQGHQWDVVHVVPHQWUHJDUGLQJWKHDFFHSWDELOLW\\RIWKHSURSRVHG
FKDQJHVLQWHUPVRIUHJXODWRU\UHTXLUHPHQWVDQGWKHSURWHFWLRQRISXEOLFKHDOWKDQGVDIHW\DQG
FKDQJHVLQWHUPVRIUHJXODWRU\\UHTXLUHPHQWVDQGWKHSURWHFWLRQRISXEOLFKHDOWKDQGVDIHW\\DQG
WKHHQYLURQPHQW
WKHHQYLURQPHQW


*LYHQWKHOHVVHUVFRSHDQGGHSWKRIWKHDFFHSWDQFHUHYLHZDVFRPSDUHGWRWKHGHWDLOHG
*LYHQWKHOHVVHUVFRSHDQGGHSWKRIWKHDFFHSWDQFHUHYLHZDVFRPSDUHGWRWKHGHWDLOHG
WHFKQLFDOUHYLHZWKHUHPD\EHLQVWDQFHVLQZKLFKLVVXHVWKDWLPSDFWWKH15&VWDII&#xb6;VDELOLW\WR
WHFKQLFDOUHYLHZWKHUHPD\\EHLQVWDQFHVLQZKLFKLVVXHVWKDWLPSDFWWKH15&VWDII&#xb6;VDELOLW\\WR
FRPSOHWHWKHGHWDLOHGWHFKQLFDOUHYLHZDUHLGHQWLILHGGHVSLWHFRPSOHWLRQRIDQDGHTXDWH
FRPSOHWHWKHGHWDLOHGWHFKQLFDOUHYLHZDUHLGHQWLILHGGHVSLWHFRPSOHWLRQRIDQDGHTXDWH
DFFHSWDQFHUHYLHZ<RXZLOOEHDGYLVHGRIDQ\IXUWKHULQIRUPDWLRQQHHGHGWRVXSSRUWWKH15&
DFFHSWDQFHUHYLHZ<RXZLOOEHDGYLVHGRIDQ\\IXUWKHULQIRUPDWLRQQHHGHGWRVXSSRUWWKH15&
VWDII&#xb6;VGHWDLOHGWHFKQLFDOUHYLHZE\VHSDUDWHFRUUHVSRQGHQFH
VWDII&#xb6;VGHWDLOHGWHFKQLFDOUHYLHZE\\VHSDUDWHFRUUHVSRQGHQFH


61&KDVUHTXHVWHGVWDIIDSSURYDORIWKLV/$5E\0D\7KHVWDIILQWHQGVWRFRPSOHWH
61&KDVUHTXHVWHGVWDIIDSSURYDORIWKLV/$5E\\0D\\7KHVWDIILQWHQGVWRFRPSOHWH
WKLVDFWLRQE\6HSWHPEHU+RZHYHUWKHVWDIIZLOOWU\WRH[SHGLWHLWVUHYLHZWRKDYHLW
WKLVDFWLRQE\\6HSWHPEHU+RZHYHUWKHVWDIIZLOOWU\\WRH[SHGLWHLWVUHYLHZWRKDYHLW
FRPSOHWHGE\0D\XQOHVVZHDJUHHWRDGLIIHUHQWGDWHDWDODWHUWLPHGXHWR
FRPSOHWHGE\\0D\\XQOHVVZHDJUHHWRDGLIIHUHQWGDWHDWDODWHUWLPHGXHWR
FLUFXPVWDQFHVEH\RQGRXUFRQWURO7KHVWDIIHVWLPDWHWRVXSSRUWWKLVUHYLHZEDVHGRQWKLV
FLUFXPVWDQFHVEH\\RQGRXUFRQWURO7KHVWDIIHVWLPDWHWRVXSSRUWWKLVUHYLHZEDVHGRQWKLV
OLPLWHGDFFHSWDQFHUHYLHZLVDSSUR[LPDWHO\KRXUVZKLFKPD\FKDQJHDVWKHUHYLHZ
OLPLWHGDFFHSWDQFHUHYLHZLVDSSUR[LPDWHO\\KRXUVZKLFKPD\\FKDQJHDVWKHUHYLHZ
SURFHHGV
SURFHHGV


,I\RXKDYHDQ\TXHVWLRQVSOHDVHFRQWDFWPHDW  RUELOOJOHDYHV#QUFJRY
,I\\RXKDYHDQ\\TXHVWLRQVSOHDVHFRQWDFWPHDW  RUELOOJOHDYHV#QUFJRY


6LQFHUHO\
6LQFHUHO\\


                                                    /RA/
/RA/  


:LOOLDP %LOO\ *OHDYHV6HQLRU3URMHFW0DQDJHU
:LOOLDP %LOO\\ *OHDYHV6HQLRU3URMHFW0DQDJHU
9RJWOH3URMHFW2IILFH
9RJWOH3URMHFW2IILFH
2IILFHRI1XFOHDU5HDFWRU5HJXODWLRQ
2IILFHRI1XFOHDU5HDFWRU5HJXODWLRQ




'RFNHW1R 
'RFNHW1R
    

   









FF&KDQGX3DWHO
FF&KDQGX3DWHO
 &D\HWDQR6DQWRV

 9LF+DOO
&D\\HWDQR6DQWRV
 .HOOL5REHUWV61&}}

9LF+DOO

.HOOL5REHUWV61&}}

Latest revision as of 16:11, 23 December 2024

COL Docs - Vogtle 3&4 LAR-19-020 Cyber Security Plan Changes Acceptance Letter
ML19364A078
Person / Time
Site: Vogtle  
Issue date: 12/30/2019
From:
NRC
To:
NRC/NRR/DNRL
References
Download: ML19364A078 (4)
v • d • e


Text

From:

Gleaves, Billy Sent:

Monday, December 30, 2019 10:33 AM To:

Roberts, Kelli Anne; Yeates, Brad L.

Cc:

Vogtle PEmails; Patel, Chandu; Santos, Cayetano; Hall, Victor; Butler, Rhonda; Beardsley, Jim; Brown, Michael; Lawson-Jenkins, Kim

Subject:

Vogtle 3&4 LAR-19-020 "Cyber Security Plan Changes" Acceptance Letter Attachments:

Vogtle LAR-19-020 Cyber Security Plan Change ACCEPTANCE LETTER.pdf Kelli and Brad, The NRC has accepted for review your LAR 19-020, Cyber Security Plan Changes, dated December 20, 2019. By this email, the staff is issuing the associated acceptance letter into the public record. The enclosed acceptance letter accepts your proposed schedule for completion of this action by September 30, 2020 (NEIMA date), however, the staff will endeavor to expedite the review with the goal to complete and issue by May 1, 2020 and will inform you if our resource estimate changes or if our goal date changes.

This email with attached acceptance letter is being submitted to public ADAMS capture with this email. An accession number will be assigned by ADAMS.

Respectfully, Billy William (Billy) Gleaves Senior Project Manager NRO/DLSE/Licensing Branch 2 (was Licensing Branch 4)

US Nuclear Regulatory Commission The contents of this message may be sensitive. If this message has been received in error, please delete it without reading it. Your receipt of this message is not intended to waive any applicable privilege. Do not disseminate this message without the permission of the author. Communications by this author do not represent NRC policy and are not binding on the Commission.

Hearing Identifier:

Vogtle_COL_Docs_Public Email Number:

513 Mail Envelope Properties (BL0PR0901MB4387F3B404BDA78266F4AA109F270)

Subject:

Vogtle 3&4 LAR-19-020 "Cyber Security Plan Changes" Acceptance Letter Sent Date:

12/30/2019 10:32:53 AM Received Date:

12/30/2019 10:32:56 AM From:

Gleaves, Billy Created By:

Bill.Gleaves@nrc.gov Recipients:

"Vogtle PEmails" <Vogtle.PEmails@nrc.gov>

Tracking Status: None "Patel, Chandu" <Chandu.Patel@nrc.gov>

Tracking Status: None "Santos, Cayetano" <Cayetano.Santos@nrc.gov>

Tracking Status: None "Hall, Victor" <Victor.Hall@nrc.gov>

Tracking Status: None "Butler, Rhonda" <Rhonda.Butler@nrc.gov>

Tracking Status: None "Beardsley, Jim" <James.Beardsley@nrc.gov>

Tracking Status: None "Brown, Michael" <Michael.Brown@nrc.gov>

Tracking Status: None "Lawson-Jenkins, Kim" <Kim.Lawson-Jenkins@nrc.gov>

Tracking Status: None "Roberts, Kelli Anne" <KROBERTS@southernco.com>

Tracking Status: None "Yeates, Brad L." <blyeates@southernco.com>

Tracking Status: None Post Office:

BL0PR0901MB4387.namprd09.prod.outlook.com Files Size Date & Time MESSAGE 1289 12/30/2019 10:32:56 AM Vogtle LAR-19-020 Cyber Security Plan Change ACCEPTANCE LETTER.pdf 260991 Options Priority:

Normal Return Notification:

No Reply Requested:

No Sensitivity:

Normal Expiration Date:











'HFHPEHU





0U%ULDQ+:KLWOH\\'LUHFWRU

5HJXODWRU\\$IIDLUV

6RXWKHUQ1XFOHDU2SHUDWLQJ&RPSDQ\\,QF

&RORQQDGH3DUNZD\\%LQ1(&

%LUPLQJKDP$/





68%-(&7

$&&(37$1&(5(9,(:2)6287+(5118&/($523(5$7,1*&203$1<¶6

5(48(67)25/,&(16($0(1'0(17)257+(92*7/((/(&75,&

  • (1(5$7,1*3/$1781,76 &<%(56(&85,7<3/$1&+$1*(6

/$5  (3,'12///$ 



'HDU0U:KLWOH\\



%\\OHWWHUGDWHG'HFHPEHU $JHQF\\ZLGH'RFXPHQWV$FFHVVDQG0DQDJHPHQW6\\VWHP

$'$06 $FFHVVLRQ1R0/% WKH6RXWKHUQ1XFOHDU2SHUDWLQJ&RPSDQ\\ 61& 

VXEPLWWHGDOLFHQVHDPHQGPHQWUHTXHVW /$5 IRUWKH9RJWOH(OHFWULF*HQHUDWLQJ3ODQW 9(*3 

&RPELQHG/LFHQVH &2/ 1XPEHUV13)DQ13)UHIHUUHGWRDV8QLWVDQG7KH

UHTXHVWHGDPHQGPHQWSURSRVHVFKDQJHVWRWKH9(*38QLWVDQG&\\EHU6HFXULW\\3ODQ



7KHSXUSRVHRIWKLVOHWWHULVWRSURYLGHWKHUHVXOWVRIWKH861XFOHDU5HJXODWRU\\&RPPLVVLRQ

15& VWDII¶VDFFHSWDQFHUHYLHZRIWKH/$57KHDFFHSWDQFHUHYLHZLVDVWDIISURFHVVWR

GHWHUPLQHLIWKHUHLVVXIILFLHQWWHFKQLFDOLQIRUPDWLRQLQVFRSHDQGGHSWKWRDOORZWKH15&VWDIIWR

FRPSOHWHLWVGHWDLOHGWHFKQLFDOUHYLHZ7KHDFFHSWDQFHUHYLHZLVDOVRLQWHQGHGWRLGHQWLI\\

ZKHWKHUWKHDSSOLFDWLRQKDVDQ\\UHDGLO\\DSSDUHQWLQIRUPDWLRQLQVXIILFLHQFLHVLQLWV

FKDUDFWHUL]DWLRQRIWKHUHJXODWRU\\UHTXLUHPHQWVRUWKHOLFHQVLQJEDVLVRIWKHSODQW



&RQVLVWHQWZLWK7LWOHRIWKHCode of Federal Regulations &)5 6HFWLRQDQ

DPHQGPHQWWRWKHOLFHQVHPXVWIXOO\\GHVFULEHWKHFKDQJHVUHTXHVWHGDQGIROORZDVFORVHO\\DV

DSSOLFDEOHWKHIRUPSUHVFULEHGIRURULJLQDODSSOLFDWLRQV6HFWLRQRIWKH&)5DGGUHVVHV

WKHFRQWHQWRIWHFKQLFDOLQIRUPDWLRQUHTXLUHG7KLVVHFWLRQVWLSXODWHVWKDWWKHVXEPLWWDODGGUHVV

WKHGHVLJQDQGRSHUDWLQJFKDUDFWHULVWLFVXQXVXDORUQRYHOGHVLJQIHDWXUHVDQGSULQFLSDOVDIHW\\

FRQVLGHUDWLRQV



%:KLWOH\\







7KH15&VWDIIKDVUHYLHZHG\\RXUDSSOLFDWLRQDJDLQVWWKHUHJXODWRU\\UHTXLUHPHQWVDQGKDV

FRQFOXGHGWKDWLWSURYLGHVVXIILFLHQWWHFKQLFDOGHWDLOWRHQDEOHWKH15&VWDIIWREHJLQLWVGHWDLOHG

UHYLHZDQGPDNHDQLQGHSHQGHQWDVVHVVPHQWUHJDUGLQJWKHDFFHSWDELOLW\\RIWKHSURSRVHG

FKDQJHVLQWHUPVRIUHJXODWRU\\UHTXLUHPHQWVDQGWKHSURWHFWLRQRISXEOLFKHDOWKDQGVDIHW\\DQG

WKHHQYLURQPHQW



  • LYHQWKHOHVVHUVFRSHDQGGHSWKRIWKHDFFHSWDQFHUHYLHZDVFRPSDUHGWRWKHGHWDLOHG

WHFKQLFDOUHYLHZWKHUHPD\\EHLQVWDQFHVLQZKLFKLVVXHVWKDWLPSDFWWKH15&VWDII¶VDELOLW\\WR

FRPSOHWHWKHGHWDLOHGWHFKQLFDOUHYLHZDUHLGHQWLILHGGHVSLWHFRPSOHWLRQRIDQDGHTXDWH

DFFHSWDQFHUHYLHZ<RXZLOOEHDGYLVHGRIDQ\\IXUWKHULQIRUPDWLRQQHHGHGWRVXSSRUWWKH15&

VWDII¶VGHWDLOHGWHFKQLFDOUHYLHZE\\VHSDUDWHFRUUHVSRQGHQFH



61&KDVUHTXHVWHGVWDIIDSSURYDORIWKLV/$5E\\0D\\7KHVWDIILQWHQGVWRFRPSOHWH

WKLVDFWLRQE\\6HSWHPEHU+RZHYHUWKHVWDIIZLOOWU\\WRH[SHGLWHLWVUHYLHZWRKDYHLW

FRPSOHWHGE\\0D\\XQOHVVZHDJUHHWRDGLIIHUHQWGDWHDWDODWHUWLPHGXHWR

FLUFXPVWDQFHVEH\\RQGRXUFRQWURO7KHVWDIIHVWLPDWHWRVXSSRUWWKLVUHYLHZEDVHGRQWKLV

OLPLWHGDFFHSWDQFHUHYLHZLVDSSUR[LPDWHO\\KRXUVZKLFKPD\\FKDQJHDVWKHUHYLHZ

SURFHHGV



,I\\RXKDYHDQ\\TXHVWLRQVSOHDVHFRQWDFWPHDW  RUELOOJOHDYHV#QUFJRY



6LQFHUHO\\



/RA/



LOOLDP %LOO\\ *OHDYHV6HQLRU3URMHFW0DQDJHU

9RJWOH3URMHFW2IILFH

2IILFHRI1XFOHDU5HDFWRU5HJXODWLRQ





'RFNHW1R





















FF&KDQGX3DWHO



&D\\HWDQR6DQWRV



9LF+DOO



.HOOL5REHUWV61&

Retrieved from "https://kanterella.com/w/index.php?title=ML19364A078&oldid=4686562"