Section_3-_CDER_Appendices.pdf

Appendix J.1: Monthly Report

Monthly Project Status Report, December 2012

Revised 10/7/2013

On-Site Records Information Management (RIM) RFP

SECTION 3: CDER REFERENCE DOCUMENTS (APPENDICES) FDA-14-223-SOL-00005

dcolbert Typewritten Text

PART J: APPENDICES

Monthly Project Status Report

December 2012

Project Name: Base Contract, Document Control Rooms

Department: FDA, CDER

Focus Area: Monthly activities, project status

Prepared By:

Document Owner(s) Project/Organization Role

Project Status Report Version Control

Version Date Author Change Description

TABLE OF CONTENTS

1 PROJECT STATUS REPORT PURPOSE

2 PROJECT STATUS REPORT

2.1 Project Status Report Details

2.1.1 Significant Activities

2.1.2 Problems Encountered During the Previous Months and Remedies

2.1.3 Open Discussion Items

2.1.4 Kudos and Complaints

3 PROJECT STATUS REPORT APPROVALS

4 APPENDICES

4.1 CDER Document Rooms Overview Trends

4.2 New Drug Application (NDA) Statistics, CY 2012

4.3 Investigational New Drug (IND) Application Statistics, CY 2012

4.4 Abbreviated New Drug Application (ANDA) Statistics, CY 2012

4.5 Biologic License Application (BLA) Statistics, CY 2012

4.6 Drug Master File (DMF) Application Statistics, CY 2012

4.7 OPDP Submissions Statistics, CY 2012

4.8 Electronic Submissions, All Submission Types, CY 2012

4.9 Various CDR Statistics

4.10 BMIS Submissions Processed, CY 2012

4.11 Outgoing Letters and Faxes

4.12 Method of Delivery, All Applications

4.13 Volume Counts, IND, NDA, ANDA, MF Applications

1 PROJECT STATUS REPORT PURPOSE

This report provides the following details:

• Significant activities

• General activities

• Staffing issues

• Problems encountered during the previous month and Remedies

• Potential problems

• Project statistics

• Quality control checks

The report also include notes and items discussed in bi-weekly Project Status meetings and, Document Room Standards (DRS) meetings, and other meetings in which document room staff and management participate.

The reporting period is from the first day of the month through the last day. The report is submitted on the fifth working day of the following month.

2 PROJECT STATUS REPORT

2.1 Project Status Report Details

2.1.1 Significant Activities

Contractor shall provide narrative

Operations

Meetings Contractor shall provide narrative

Training and Quality Assurance Contract shall provide narrative

Deliverables

Contractor shall provide a list of monthly deliverables.

2.1.2 Problems Encountered During the Previous Months and Remedies

Contractor shall provide narrative.

2.1.3 Open Discussion Items

2.1.4 Kudos and Complaints

Date Type From Description Quote Resolution or Analysis

3 PROJECT STATUS REPORT APPROVALS

Prepared by _________________________________ Program Manager

4 APPENDICES

The gathered metrics and statistics are based on the consolidated work performed at White Oak, CDR, and OGD document rooms. The IND, NDA, MF, and ANDA data are captured from DARRTS reports. Others are calculated using other means, including the Automated Production Logs (APL) system, EDR Quality Control Agent (QCA), and other logs and spreadsheets.

4.1 CDER Document Rooms Overview Trends

4.2 New Drug Application (NDA) Statistics, CY 2012

New Drug Applications (NDA) - Incoming Submissions, CY 2012 High Priority Standard Priority New NDAs Re -

Submissions Meeting Requests and Packages

Proprietary Name

Fast Track

Supplements Annual Reports With PMR/

PMC

Status

Without

PMR/ PMC

Status

Annual Report Amendments

January 4 25 30 19 0 198 51 157 0

February 8 22 33 19 0 214 88 186 0

March 11 40 38 18 0 247 42 159 0

April 5 19 32 31 0 213 55 155 0

May 11 34 39 24 1 202 67 164 0

June 11 34 35 28 0 235 66 142 0

July 7 28 27 25 1 206 84 136 0

August 10 29 31 28 0 236 97 148 0

September 14 26 28 15 0 188 58 120 0

October 9 28 37 26 0 211 75 131 0

November 6 17 32 19 0 217 87 136 0

December 17 30 31 26 1 220 85 144 0

Cumulative 113 332 393 278 3 2,587 855 1,778 0

New Drug Applications: continued

New Drug Applications (NDA) - Incoming Submissions, CY 2012

Standard Priority Total Incoming Submissions (Cat/SubCat)

Total Incoming Submissions

(SD)

Pre - Assigned

Pre - Submissions

PEPFAR

P- Reports

Change of Name/ Address

Change of Applicant

Patent Information

All Other

Count % of Total

275 57 37 32 1,137 2,022 1,871 0 0 0 0.00%

337 71 18 54 1,189 2,239 2,070 0 0 0 0.00%

280 111 11 54 1,182 2,193 2,032 0 0 0 0.00%

251 59 13 29 1,152 2,014 1,846 0 0 0 0.00%

348 97 23 36 1,115 2,161 1,983 0 0 1 0.05%

308 116 8 29 1,154 2,166 1,945 0 1 0 0.00%

284 74 17 36 ,968 1,893 1,774 0 1 0 0.00%

301 51 115 47 1,246 2,339 2,175 0 4 1 0.00%

232 70 15 54 1,174 1,994 1,818 0 0 0 0.00%

256 33 27 30 1,214 2,077 1,886 0 0 0 0.00%

278 75 21 55 1,082 2,025 1,854 0 1 0 0.00%

292 49 41 62 1,271 2,269 2,001 0 0 2 0.10%

3,442 863 346 518 13,884 25,392 2,3255 0 7 4 0.00%

4.3 Investigational New Drug (IND) Application Statistics, CY 2012

Investigational New Drug Applications (IND) - Incoming Submissions

HIGH PRIORITY STANDARD PRIORITY

New

INDs Re- Activation / Re- Instatement

Meeting Requests and Packages

Proprietary Name

Fast Track

SPAs Annual Reports

Change of Name/ Address

Change of Applicant

All Other

January 195 1 228 21 2 0 596 134 0 7,025 February 206 4 291 16 3 0 689 163 0 7,682 March 252 0 293 34 8 0 754 211 0 8,433 April 202 5 288 24 7 0 552 113 0 7,635 May 206 1 300 17 10 0 650 209 0 8,047 June 204 4 272 14 9 0 675 166 0 7,722 July 172 4 283 17 6 0 678 170 0 7,745 August 210 4 315 12 8 0 720 176 0 8,571 September 205 6 281 13 8 0 588 116 0 7,402 October 230 2 292 10 16 0 658 114 0 8,226 November 202 0 249 8 8 0 589 102 0 8,098 December 221 2 294 17 15 0 623 103 0 7,479 Cumulative 2,505 33 3,386 203 100 0 7,772 1,777 0 94,065

Investigational New Drug Applications (IND) - Incoming Submissions Total

Incoming Submissions (Cat/SubCat)

Total Incoming Submissions

(SD)

Pre - Submissions

Pre - Assigned

Commercial Research Unknown PEPFAR PEPFAR % of

Total

January 8,202 6,836 39 0 53 142 0 0 0.0% February 9,054 7,557 68 0 46 160 0 0 0.0% March 9,985 8,346 100 0 61 191 0 0 0.0% April 8,826 7,419 101 0 49 153 0 0 0.0% May 9,440 7,995 140 0 68 137 1 0 0.0% June 9,066 7,615 105 0 67 136 1 0 0.0% July 9,075 7,525 162 0 45 125 2 0 0.0% August 10,016 8,423 127 0 66 144 0 0 0.0% September 8,619 7,220 67 0 48 156 1 0 0.0% October 9,548 7,956 73 0 62 168 0 0 0.0% November 9,256 7,715 50 0 56 145 1 0 0.0% December 8,754 7,376 69 0 64 157 0 0 0.0% Cumulative 109,841 91,983 1,101 0 685 1,814 6 0 0.0%

2,000

4,000

6,000

8,000

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12,000

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2008 2009 2010 2011 2012

IND Incoming Submissions - Trend

Paper and Electronic

Trend

SOW

avg./month

Actual avg./month

1,000

2,000

3,000

4,000

5,000

6,000

7,000

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2008 2009 2010 2011 2012

IND Incoming Submissions - Paper vs. Electronic

Paper

Electronic

SOW

avg./month

Actual avg./month

4.4 Abbreviated New Drug Application (ANDA) Statistics, CY 2012

New Abbreviated Drug Applications (ANDA) - Incoming Submissions High Priority Standard Priority New

ANDAs Re- Submissions

Meeting Requests and Packages

Proprietary Name

Supplements Annual Reports With

PMR/

PMC

Status

Without

PMR/ PMC

Status

Annual Report Amendments

January 62 55 1 7 329 0 579 0

February 72 65 5 12 318 0 637 0

March 91 57 2 5 584 1 587 0

April 87 57 6 6 443 0 589 0

May 59 48 10 8 436 0 662 0

June 114 43 3 11 419 0 696 0

July 68 67 0 4 360 0 725 0

August 53 63 1 8 671 0 761 0

September 164 41 2 13 453 0 551 0

October 75 44 5 20 329 0 754 0

November 56 58 2 8 342 0 571 0

December 162 80 0 5 574 1 608 0

Cumulative 1,063 678 37 107 5,258 2 7,720 0

Abbreviated New Drug Applications: continued

New Abbreviated Drug Applications (ANDA) - Incoming Submissions Standard Priority Total

Incoming Submissions (Cat/SubCat)

Total Incoming Submissions

(SD)

Pre - Assigned

Pre- Submissions

PEPFAR

P- Reports

Change of Name/ Address

Change of Applicant

Patent Information

All Other

Count % of Total

874 27 26 182 1,687 3,829 3,200 62 0 1 0.00%

959 22 56 183 1,724 4,053 3,503 74 0 0 0.00%

927 32 20 284 2,098 4,688 3,915 46 9 0 0.00%

1,069 22 11 244 2,104 4,638 3,863 46 38 1 0.00%

968 56 38 246 2,064 4,595 3,845 55 62 2 0.00%

861 71 31 157 2,340 4,746 3,903 51 1 1 0.00%

1,098 31 22 231 1,879 4,485 3,759 46 1 0 0.00%

977 49 46 281 2,010 4,920 4,138 8 0 1 0.02%

972 265 28 182 1,987 4,658 3,876 21 21 2 0.04%

915 21 30 164 1,404 3,761 3,224 19 64 0 0.00%

1,048 130 62 149 2,728 5,154 4,504 39 41 0 0.00%

1,101 14 20 229 1,763 4,557 3,729 49 40 1 0.02%

11,769 740 390 2,532 23,788 54,084 45,459 516 277 9 0.00%

2,000

3,000

4,000

5,000

6,000

7,000

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2008 2009 2010 2011 2012

ANDA Incoming Submissions - Trend

Paper and Electronic

Trend

SOW

avg./month

Actual avg./month

2,000

3,000

4,000

5,000

6,000

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2008 2009 2010 2011 2012

ANDA Incoming Submissions - Paper vs. Electronic

Paper

Electronic

SOW

avg./month

Actual avg./month

4.5 Biologic License Application (BLA) Statistics, CY 2012

Month Incoming BLA Submissions, CY 2012

Electronic Paper Total Gateway Physical January 184 2 7 193

February 223 6 15 244

March 247 3 16 266

April 222 4 12 238

May 251 4 10 265

June 211 3 8 222

July 222 7 19 248

August 231 4 21 256

September 200 1 11 212

October 227 2 20 249

November 194 4 16 214

December 234 5 15 254

Cumulative 2,646 45 170 2,861

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2008 2009 2010 2011 2012

BLA Incoming Submissions - Trend

Paper and Electronic Trend

SOW

avg./month Actual avg./month

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2008 2009 2010 2011 2012

BLA Incoming Submissions - Paper vs. Electronic

Paper

Electronic

SOW

avg./month Actual avg./month

4.6 Drug Master File (DMF) Application Statistics, CY 2012

Please Note: There was an unresolved discrepancy in the DMF data therefore the metrics has been removed from the tables below.

The total DMF volume of submissions for CY’12 cited in the Task Order is 24,970.

Incoming Drug Master File

Mon soth Original Subsequent Supporting Document

Original Plus Sub-Total

Amendment Authorization Annual Sub-Total

January

February

March

April

May

June

July

August

September

October

November

December

Cumulative 24,970

2%

98%

Master Files - Original vs. Subsequent, CY 2012

Original

Subsequent

2,000

3,000

4,000

5,000

6,000 Ja nu ar y

Fe br ua ry

M ar ch

Ap ri l

M ay

Ju ne Ju ly

Au gu st

Se pt em be r

O ct ob er

N ov em be r

D ec em be r

Co un t

Master Files, CY 2012

Subsequent Supporting Document Annual

Subsequent Supporting Document Authorization

Subsequent Supporting Document Amendment

Original

2,000

3,000

4,000

5,000

6,000

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2008 2009 2010 2011 2012

MF Incoming Submissions - Trend

Paper and Electronic

Trend

2,000

3,000

4,000

5,000

6,000

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2008 2009 2010 2011 2012

MF Incoming Submissions - Paper vs. Electronic

Paper

Electronic

4.7 OPDP Submissions Statistics, CY 2012

Incoming OPDP Submissions (Marketing Material) Incoming Total

Incoming Outgoing Reviewer

Reassignment New

Jackets Created

ADMIS

(Form 2253) MACMIS MAGTR Letters /

DFS

January 3,014 187 5 3,206 N/A 32 186 February* 3,716 176 4 3,892 N/A 21 176 March 3,726 162 0 3,888 N/A 15 162 April 3,507 176 0 3,683 N/A 0 176 May 4,027 241 0 4,268 N/A 0 241 June 3,957 124 1 4,082 N/A 2 124 July 3,251 177 4 3,432 N/A 10 181 August 3,799 136 0 3,935 N/A 5 136 September 3,317 162 4 3,483 N/A 10 166 October 3,969 164 2 4,135 N/A 12 166 November 3,156 139 0 3,485 N/A 5 139 December 3,488 185 1 3,674 N/A 4 186 Cumulative 42,917 2,028 19 45,147 N/A 116 2,039

1,000

1,500

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2008 2009 2010 2011 2012

OPDP Incoming Submissions - Trend

Paper and Electronic

Trend

-500

1,000

1,500

2,000

2,500

3,000

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2008 2009 2010 2011 2012

OPDP Incoming Submissions - Paper vs. Electronic

Paper

Electronic

4.8 Electronic Submissions, All Submission Types, CY 2012

Electronic

Paper Only Grand Total (Electronic Total + Paper Only) Gateway

(without media) Electronic

(with Media) Other (Mixed) Electronic Total

January 4,847 168 206 5,221 5,319 10,540

February 5,541 217 210 5,968 5,917 11,885

March 6,277 177 188 6,642 6,107 12,749

April 5,594 174 209 5,977 5,711 11,688

May 6,283 171 184 6,638 5,827 12,465

June 6,029 185 171 6,385 5,410 11,795

July 5,854 180 185 6,219 5,796 12,015

August 6,893 159 188 7,240 5,809 13,049

September 5,787 134 168 6,089 5,520 11,609

October 6,406 220 218 6,844 5,729 12,573

November 6,482 120 166 6,768 5,441 12,209

December 6,133 205 188 6,526 5,971 12,497

Cumulative 72,126 2,110 2,281 76,517 68,557 145,074

2,000

3,000

4,000

5,000

6,000

7,000

8,000

Co un t

Electronic Submissions Processed, by Source, CY

Other (Mixed)

Electronic (with Media)

Gateway (without Media)

50%

1%2%

47%

All Submission Processed, by Method of Delivery, CY 2012

Gateway (without Media)

Electronic (with Media)

Other (Mixed)

Paper Only

4.9 Various CDR Statistics

CDR Requests

NDA IND DMF FRC EDR1 OGD Total January 73 43 0 112 0 0 228

February 52 129 0 195 0 0 376

March 61 122 0 485 0 0 668

April 72 14 0 295 0 0 381

May 77 60 0 329 0 0 466

June 163 45 0 545 0 0 753

July 142 164 0 154 1 0 461

August 259 255 0 298 1 0 813

September 148 253 0 271 3 0 675

October 139 119 0 810 0 0 1,068

November 384 117 0 442 10 0 953

December 110 44 0 268 4 0 426

Cumulative 1,680 1,365 0 4,204 19 0 7,268

1 Backup tapes and folders

Electronic Submissions (Not Processed2), by Type Month eCTD Samples AERS 15-Day Reports January 2 121 3,127

February 7 77 2,856

March 1 91 3,261

April 7 71 2,823

May 3 74 3,403

June 5 86 3,087

July 3 62 3,021

August 8 59 3,088

September 4 44 2,735

October 9 62 2,662

November 4 58 2,572

December 3 73 3,046

Cumulative 56 878 35,681

2 These electronic submissions are received at the CDR, date-stamped, logged, and processed for mail receipt. They are then forwarded to the appropriate third-party FDA contractor for further processing.

Retirement to FRC

No. of Accessions No. of Applications No. of Volumes No. of Boxes

January 10 3,037 13,392 500

February 9 1,464 6,022 450

March 6 1,297 4,199 300

April 72 14 569 295

May 11 3,090 7,603 550

June 6 656 3,410 300

July 6 490 2,661 300

August 4 306 4,609 200

September 1 42 465 50

October 0 0 0 0

November 0 0 0 0

December 0 0 0 0

Cumulative 67 13,732 52,109 3,350

Miscellaneous

Genomics Form 3542 January 0 6

February 0 4

March 0 8

April 0 3

May 0 4

June 0 4

July 0 10

August 0 5

September 0 8

October 0 3

November 0 7

December 0 4

Cumulative 0 66

4.10 BMIS Submissions Processed, CY 2012

BMIS

Submissions Entries January 459 4,868

February 450 4,399

March 594 5,545

April 315 3,088

May 436 3,960

June 461 5,154

July 321 5,402

August 533 8,964

September 493 11,870

October 564 4,410

November 718 5,924

December 844 9,069

Cumulative 6,188 72,653

4.11 Outgoing Letters and Faxes

Action Packages Outgoing Letters and Faxes NDA and IND ANDA

Letters Faxes Letters Faxes Count Volumes Total Count Certified DSI (as % of total) Count Pages Total Count Certified Count Pages

January 15 26 1,571 21 33 83 -- 523 -- 351 --

February 19 30 1,486 70 32 60 -- 562 -- 408 --

March 11 20 1,553 80 32 63 -- 531 -- 357 --

April 10 19 1,472 88 55 80 -- 661 -- 345 --

May 16 20 1,510 9 33 60 -- 625 -- 345 --

June 18 12 1,513 35 56 57 -- 501 -- 366 --

July 14 27 1,535 11 70 64 -- 482 -- 352 --

August 14 22 1,535 8 35 80 -- 1,282 -- 421 --

September 9 14 1,329 48 59 53 -- 707 -- 309 --

October 19 22 1,490 43 41 55 -- 587 -- 28 --

November 11 17 1,406 32 52 47 -- 651 -- 93 --

December 14 35 1,383 1 46 72 -- 489 -- 98 --

Cumulative 168 264 17,783 516 577 774 -- 7,601 -- 3,473 --

Outgoing Letters and Faxes

MF OPDP

Letters Faxes Letters Faxes Total Count Certified Count Pages Total

Count Certified Count Pages

January 179 -- 94 -- 52 -- -- --

February 134 -- 120 -- 28 -- -- --

March 132 -- 90 -- 35 -- -- --

April 181 -- 105 -- 48 -- -- --

May 123 -- 98 -- 44 -- -- --

June 120 -- 103 -- 39 -- -- --

July 167 -- 124 -- 49 -- -- --

August 174 -- 98 -- 41 -- -- --

September 163 -- 83 -- 43 -- -- --

October 267 -- 56 -- 32 -- -- --

November 188 -- 55 -- 42 -- -- --

December 127 -- 93 -- 53 -- -- --

Cumulative 1,955 0 1,119 0 506 -- -- --

4.12 Method of Delivery, All Applications

Method of Delivery, by Application Type – Monthly Application Type

Gateway Physical Documents Unknown Total Electronic Mixed (Paper and

Electronic) Paper

Unique Count

% of total Gateway receipts

Count % of total Electronic receipts

Unique Count

% of total Mixed receipts

Unique Count

% of total Paper receipts

Unique Count

% of total Unknown receipts

Unique Count

(SD)

% of Total incoming submissions

IND 4,839 53 105 5 144 26 2,286 30 1 33 7,375 38

NDA 1,542 17 64 3 63 11 331 4 0 0 2,000 10

ANDA 2,411 26 99 5 144 26 1,072 14 1 33 3,727 19

MF 331 4 62 3 4 1 2,510 33 1 33 2,908 15

OPDP 0 0 1,744 84 195 35 1,297 17 0 0 3,236 17

Total 9,123 100 2,074 100 550 100 7,496 100 3 100 19,246 100

% of Method of Delivery

47% 11% 3% 39% 0% 100%

Method of Delivery, Cumulative YTD Statistics, by Application Type, by Month

IND NDA

Paper Physical

Gateway Mixed Unknown Total # of

Documents Paper Physical

Electronic Gateway Mixed Unknown Total # of

Documents

January 2,649 75 3,947 143 1 6,815 346 49 1,405 61 0 1,861

February 2,817 116 4,443 153 2 7,531 414 43 1,513 81 0 2,051

March 3,009 90 5,089 138 2 8,328 360 48 1,541 69 0 2,018

April 2,622 84 4,555 137 1 7,399 279 60 1,449 50 0 1,838

May 2,664 81 5,083 127 0 7,955 357 34 1,519 59 0 1,969

June 2,529 80 4,851 129 0 7,589 373 39 1,451 65 0 1,928

July 2,628 98 4,638 125 2 7,491 329 45 1,319 56 0 1,749

August 2,699 78 5,525 130 4 8,436 368 51 1,705 52 0 2,176

September 2,311 68 4,715 124 0 7,218 295 41 1,440 42 0 1,818

October 2,514 89 5,205 141 3 7,952 319 55 1,459 52 0 1,885

November 2,360 51 5,188 113 1 7,713 301 40 1,460 53 0 1,854

December 2,286 105 4,839 144 1 7,375 331 64 1,542 64 0 2,001

Total: 31,088 1,015 58,078 1,604 17 91,802 4,072 569 17,803 704 0 23,148 % of Incoming Submissions

34% 1% 63% 2% 0% 100% 18% 2% 77% 3% 0% 100%

ANDA MF

Gateway Mixed Unknown Total # of

Documents Paper Physical

Electronic Gateway Mixed Unknown Total # of

Documents

January 873 91 1,864 234 0 3,062 1,804 59 118 9 1 1,991

February 1,047 160 1,850 237 0 3,294 2,244 70 152 4 0 2,470

March 922 82 2,492 228 0 3,724 2,193 47 186 4 0 2,430

April 1,025 81 2,352 221 0 3,679 2,061 48 168 15 0 2,292

May 952 94 2,376 198 0 3,620 2,163 54 247 9 0 2,473

June 910 105 2,236 238 0 3,489 1,927 58 202 3 0 2,190

July 1,156 134 2,048 189 0 3,527 2,127 53 224 4 0 2,408

August 936 136 2,810 248 0 4,130 2,076 39 273 2 0 2,390

September 1,026 70 2,472 254 0 3,822 2,104 38 161 8 0 2,311

October 892 67 2,105 161 0 3,225 2,114 71 201 1 0 2,387

November 961 137 3,134 270 0 4,502 2,025 38 252 1 0 2,316

December 1,070 99 2,411 144 1 3,725 2,510 62 330 4 1 2,907

Total: 11,770 1,256 28,150 2,622 1 43,799 25,348 637 2,514 64 2 28,565 % of Incoming

27% 3% 64% 6% 0% 100% 89% 2% 9% 0% 0% 100%

OPDP Total

Gateway Mixed Unknown Total # of

Documents Paper Physical

Electronic Gateway Mixed Unknown Total # of

Documents

January 1,543 971 0 116 0 2,630 5,672 274 7,334 447 2 13,729

February 1,707 1,238 0 262 0 3,207 6,522 389 7,958 475 2 15,346

March 1,764 1,460 0 197 1 3,422 6,484 267 9,308 439 2 16,500

April 1,490 1,364 0 182 0 3,036 5,987 273 8,524 423 1 15,208

May 1,805 1,659 0 165 0 3,629 6,136 263 9,225 393 0 16,017

June 1,613 1,792 0 173 0 3,578 5,739 282 8,740 435 0 15,196

July 1,473 1,300 0 134 0 2,907 6,240 330 8,229 374 2 15,175

August 1,449 1,670 0 226 0 3,345 7,528 1,974 10,313 658 4 20,477

September 1,334 1,516 0 140 0 2,990 7,070 1,733 8,788 568 0 18,159

October 1,642 1,621 0 197 1 3,461 7,481 1,903 8,970 552 4 18,910

November 1,290 1,522 0 137 0 2,949 6,937 1,788 10,034 574 1 19,334

December 1,298 1,744 0 195 0 3,237 7,495 2,074 9,122 551 3 19,245

Total: 18,408 17,857 0 2,124 2 38,391 79,291 11,550 106,545 5,889 21 233,675 % of Incoming

64% 63% 0% 7% 0% 100% 39% 6% 52% 3% 0% 100%

4.13 Volume Counts, IND, NDA, ANDA, MF Applications

NDA IND

Volumes Created Volumes

Shredded Total

NDA

Volumes Created

Volumes Created Volumes Shredded

Total

IND

Volumes Created Archival X

Volumes All Other

Archival X Volumes

All Other

January 492 113 148 753 753 3,114 215 1,787 5,116 5,116

February 573 123 210 906 906 3,465 263 1,900 5,628 5,628

March 539 115 291 945 945 3,487 225 2,001 5,713 5,713

April 415 109 122 646 646 3,243 219 1,909 5,371 5,371

May 523 102 124 749 749 3,357 207 2,034 5,598 5,598

June 515 106 150 772 771 3,026 206 1,720 4,952 4,952

July 449 102 143 694 694 3,192 217 1,895 5,304 5,304

August 491 103 143 13 737 3,287 206 2,211 411 5,704

September 440 85 123 5 648 2,707 192 1,595 363 4,494

October 455 110 132 15 697 3,262 235 2,193 500 5,690

November 429 94 162 16 685 2,740 169 1,692 362 4,601

December 584 122 169 12 875 2,915 250 1,977 307 5,142

Cumulative 5,905 1,284 1,917 5,526 9,106 37,795 2,604 22,914 39,625 63,313

ANDA MF

Volumes Created Volumes

Shredded Total

ANDA

Volumes Created

Volumes Created Volumes Shredded

Total MF Volumes Created

Archival X Volumes

All Other

Archival (A and B)

X Volumes

All Other

January 1,263 414 124 1,801 1,801 3,591 0 0 3,591 3,591

February 1,411 439 47 1,897 1,897 4,055 0 0 4,055 4,055

March 1,224 366 39 1,629 1,629 3,923 0 0 3,923 3,923

April 1,284 362 38 1,684 1,684 3,570 0 0 3,570 3,570

May 1,209 347 29 1,585 1,585 3,916 0 0 3,916 3,916

June 1,342 429 179 1,950 1,950 3,449 0 0 3,449 3,449

July 1,355 386 52 1,793 1,793 3,811 0 0 3,811 3,811

August 1,347 445 61 0 1,853 3,798 0 0 1 3,798

September 1,286 408 175 0 1,869 3,865 0 0 0 3,865

October 1,161 292 41 0 1,494 3,843 0 0 0 3,843

November 1,332 401 33 0 1,766 3,495 0 0 5 3,495

December 1,333 284 19 0 1,636 4,583 0 0 1 4,583

Cumulative 15,547 4,573 837 12,339 20,957 45,899 0 0 26,322 45,899

Appendix J.2: Commitment Letter

Company Logo (If applicable)

Name of Company Point of Contact Street Address City / State / Zip Code

RFP Number and Description

I, (name of employee), provide my commitment to support (name of company), on CDER’s Records Management Support Task Order, for the duration of the project, and give my permission to be included on the project as “Key Personnel.” I look forward to working on this important project for the FDA.

Sincerely, (employee signature)

(Print employee’s name)

Appendix J.3: Draft Transition Calendar

Draft Transition Schedule

January 2014 Week Monday Tuesday Wednesday Thursday Friday

10:00 1 2 Overview Training (1) 9:30 3 Status Meeting

12:00 11:00

1:30 New Year's Day Overview Training (2) 1:30 Ammendale Walkthrough

3:30 Daily Standup 3:30

4:00 4:00

10:00 6 CDR Training 7 CDR: Courier Services 8 CDR: Processing New NDAs 9

CDR: Document Request Fulfillment and Fileback

9:30 10 Status Meeting

12:00 11:00 Transition Status

1:30 CDR: Mail Receipt, Triage and Distribution

CDR: Processing New INDs

CDR: Jacketing/Support Services

Barcode Training 12:00

3:30 Daily Standup Daily Standup Daily Standup Daily Standup 1:30 Lessons Learned

4:00 2:30

10:00 13 Barcode: Document Room Inventory & 14 Barcode: Retirement 15 DMF Training 16 DMF: DMF Processing (2) 9:30 17 Status Meeting

12:00 11:00 Transition Status

1:30 Barcode: Office to Office Inventory

Barcode: FRC Requests DMF: DMF Processing (1) DMF: DMF Processing (3) 12:00

3:30 Daily Standup Daily Standup Daily Standup Daily Standup 1:30 Management Review

4:00 2:30

10:00 20 21 DMF: Request Fulfillment and Fileback 22 BMIS: Paper 23 White Oak Walkthrough 9:30 24 Status Meeting

12:00 11:00 Transition Status

1:30 Martin Luther King, Jr. BMIS Training BMIS: Electronic DR1 Training 12:00

3:30 Birthday Daily Standup Daily Standup Daily Standup 1:30 Management Review

4:00 2:30

10:00 27 DR 1: IND Processing (1) 28 DR 1: NDA Processing (1) 29 DR 1: BLA Processing (1) 30 DR 1: Outbound Communications

9:30 31 Status Meeting

12:00 11:00 Transition Status

1:30 DR 1: IND Processing (2) DR 1: NDA Processing (2) DR 1: BLA Processing (2) DR 1: Request Fulfillment 12:00

3:30 Daily Standup Daily Standup Daily Standup Daily Standup 1:30 Management Review

4:00 2:30

February 2014 Week Monday Tuesday Wednesday Thursday Friday

10:00 3 EDR Training 4 EDR: Processing Gateway Submissions 5

EDR: General Support Activities 6

EDR: Analysis and Reporting

9:30 7 Status Meeting

12:00 11:00 Transition Status

1:30 EDR: Processing Physical Media

EDR: BLA

Communications

EDR: PMR/PMC OPDP Training 12:00

3:30 Daily Standup Daily Standup Daily Standup Daily Standup 1:30 Lessons Learned

4:00 2:30

10:00 10 OPDP: Mail Receipt and Triage 11 OPDP: 2253 (2) 12 OPDP: Non-2253(2) 13 OGD Walkthrough 9:30 14 Status Meeting

12:00 11:00 Transition Status

1:30 OPDP: 2253 (1) OPDP: Non-2253 (1) OPDP: Scanning, Requests/Oversized

OGD Training 12:00

3:30 Daily Standup Daily Standup Daily Standup Daily Standup 1:30 Management Review

4:00 2:30

10:00 17 18 OGD: Mail Receipt, Triage and Distribution 19

OGD: ANDA Processing

(2) 20 OGD: Scanning Support 9:30 21 Status Meeting

12:00 11:00 Transition Status

1:30 Washington's OGD: ANDA Processing (1)

OGD: Outbound Communications

OGD: Request Fulfillment 12:00

3:30 Birthday Daily Standup Daily Standup Daily Standup 1:30 Management Review

4:00 2:30

10:00 24 OC Training 25 OC: OSI 26 Refresher Training 27 Refreasher Training 9:30 28 Status Meeting

12:00 11:00 Transition Status

1:30 OC: OCDR

SSPCC & Refresher Training

Refresher Training Refreasher Training 12:00

3:30 Daily Standup Daily Standup Daily Standup Daily Standup 1:30 Transition Complete

4:00 OGD GFE Walkthrough CDR GFE Walkthrough WO GFE Walkthrough 2:30

Legend

Walkthrough

Training

Observation

FDA Status Meeting

Holiday

Appendix J.4: Monthly Report

Center for Drug Evaluation and Research Electronic Document Room (EDR)

Monthly Project Status

Report – September 2013

Project Monthly Status Report

Project Name: Electronic Document Room (EDR)

Department: FDA, CDER

Focus Area: Monthly Activities, Project Status

Prepared By

Document Owner(s) Project/Organization Role

Project Status Report Version Control

Version Date Author Change Description

Additions and Deletions (effective April 2010)

Date Section Author Description

TABLE OF CONTENTS

1 EDR PROJECT STATUS REPORT DETAILS

1.1 Significant Activities

1.2 Planned Activities

1.3 Staffing Issues

1.4 Problems Encountered During the Month

1.5 Potential Problems

2 TASK ORDER 5 – ELECTRONIC SUBMISSION (ESUB) VALIDATIONERROR! BOOKMARK NOT DEFINED.

2.1 Purpose ........................................................................ Error! Bookmark not defined.

2.2 Scope & Deliverables ................................................... Error! Bookmark not defined.

2.3 Tracking & Reporting

2.3.1 Cumulative Failed Submission Category Distribution

2.3.2 ASR Failed by Sponsor Distribution – Top 10 Sponsors

2.3.3 ASR Failed eCTD Submissions

2.3.4 ASR Failed Non-eCTD Submissions

2.4 Total Rejected Submissions

2.4.1 Rejected OPDP (DDMAC) Submissions

2.4.2 Rejected ASR eCTD Submissions

2.4.3 Rejected – ASR Non-eCTD Submissions

2.4.4 Rejected – Physical eCTD Submissions Rejected

2.4.5 Rejected – Physical Non-eCTD Submissions

2.5 Findings & Recommendations

2.6 Reviewer Requests

2.7 ASR Clean-Up Requests

EDR PROJECT STATUS REPORT APPROVALS

3 APPENDICES

3.1 Appendix A – Total Electronic Submissions

3.2 Appendix B – Submissions Manually Processed by EDR, This Month

3.3 Appendix C – Gateway Submissions Processed by EDR, Year to Date

3.4 Appendix D – Gateway Utilization (per ESG gateway)

3.5 Appendix E – Top 10 Sponsor Failed Category Counts & Percentages

3.6 Appendix F – Cumulative Electronic Submissions, YTD

3.7 Appendix G – Submission Format by Delivery Method by Application Type, YTD

1 EDR Project Status Report Details

1.1 Significant Activities

The EDR’s focus during the month included:

1. Processing incoming material, both physical media and Gateway submissions

2. Restoring data per the Project Officer’s instructions

3. Restoring data per IT Call Center tickets; those provided by the Project Officer and

OIT

4. Performing quality audits, accountability audits, and ensuring that all submissions received were processed in a timely manner

5. Responding to FDA reviewers’ problems and requests

6. Correcting broken links and updating EDR files that were lost or had become corrupt

7. Review procedures and update business processed to increase efficiency

Core Id Processing from ESG

April May June July* Aug Sept Dup Seq Rec'd 59 74 53 137 83 80 Total Failed 307 259 216 321 320 259 Percentage 19% 29% 25% 43% 26% 31%

* In July the ESG gateway was upgraded

New M1 module – ASR Processing and Email design (Example of significant activity)

Contractor shall provide narrative of each significant activity

IP Waiver Requests – Access for Gateway Processing (Example of significant activity)

PMR/PMC Coordinator – Ongoing Support (Example of significant activity)

Below is a summary of the quantity of communications received by month by communication type:

PMR/PMC Communications Communication ID Description Jan Feb Mar Apr May Jun Jul Aug Sep Avg COR-NDAACTION-03 Approval 11 8 10 8 8 4 7 7 2 7.2 COR-NDAACTION-04 Accelerated Approval 0 1 0 0 0 0 0 0 0 0.1 COR-NDAACTION-05 Animal Efficacy Approval 0 0 0 0 0 0 0 0 0 0.0

COR-sNDAACTION-05 Approval 44 70 85 87 61 68 47 74 63 66.6 COR-sNDAACTION-07 Accelerated Approval 1 0 0 0 0 0 0 0 0 0.1 COR-sNDAACTION-08 Animal Efficacy Approval 0 0 0 0 0 0 0 0 0 0.0 COR-sNDAACTION-06 Approval CMC 91 92 94 95 81 97 94 98 84 91.8

COR-NDAPMC-01 Acknowledgement New PMR/PMC 0 0 1 3 1 2 2 1 0 1.1 COR-sNDAPMC-06 Acknowledgement New PMR/PMC (S) 0 0 0 1 0 0 0 0 0 0.1

COR-NDAPMC-03 Fulfilled 5 8 6 8 9 6 9 10 2 7.0 COR-sNDAPMC-02 Fulfilled (S) 2 5 5 1 3 2 2 3 1 2.7

COR-NDAPMC-05 Release 0 2 3 5 2 2 4 2 3 2.6 COR-sNDAPMC-04 Release (S) 0 0 1 3 2 0 0 0 0 0.7

COR-NDAPMC-08 Revised Milestones 0 2 1 2 2 2 3 1 3 1.8

FRM-ADMIN-18 ASR Review 18 41 16 40 31 7 34 21 25 25.9

COR-PEDRREA-08 Pediatric- Deferral Extension Granted 0 0 7 11 11 12 19 3 3 7.3 COR-PEDRREA-04 Pediatric- Deferral Extension Extended 0 0 1 1 0 0 0 0 0 0.2

Totals 172 229 230 265 211 202 221 220 194.4

2013 Monthly Totals

BLA Communications – Training

Contractor shall provide narrative if applicable

BLA Communications - Issues

BLA Communications – Business Object Report Defects

BLA Communications - Workload

Communication by Type

Apr May June July Aug Sep Rolling 6 Mos

Consult Review 18 20 15 15 28 26 122

Form 137 190 148 143 137 180 935 Letter 196 194 190 188 199 219 1186 Review 183 140 136 144 153 178 934 Total 534 544 489 490 517 603 3177 Expected 400 400 400 400 400 400 2400 Variance 134 144 89 90 117 203 777 Percentage +/- 25% 26% 18% 18% 23% 34% 24%

Year to Date (2012) Breakdown of Submission format by Application Type

There is a drastic difference in eCTD vs NON-eCTD format depending upon Delivery Method.

IND submissions received via the Gateway are 99.9% eCTD.

IND submissions received on CD are 31% eCTD.

NDA submissions received via the Gateway are 97% eCTD.

NDA submissions received on CD are 14% eCTD.

ANDA submissions received via the Gateway are 78% eCTD.

ANDA submissions received on CD are 31% eCTD.

Tables have been added as Appendix 3.7 showing Physical Electronic and Gateway for 2012 and 2013 by all Application Types.

Consolidated Rejection Report – Monthly/Weekly Rejection Report

The contractor shall provide the FDA Contracting Officer Representative a report on a weekly basis.

High Errors and Urgent ASR submission notification Below is an overview of the HIGH and URGENT error messages we received this month:

Error Number Error Description Count Status

Failed due to High errors from GSValidate 3 Rejected

URGENT: GSVALIDATE_CRITICAL_CHKSVC 1 Rejected

EDR Productivity Reports

See the Appendices for statistics on EDR productivity and incoming Gateway submissions.

Equipment, Maintenance & Support

Contractor shall provide a narrative

Replacement of CDSEDR4 Staging Server

This server has been turned off and needs to be disposed of.

Replacement of CDSEDR2 Staging Server

This server has been turned off and needs to be disposed of.

Disposal of the old UPS systems

There are two old UPS systems that need to be disconnect from a hardwired 50 amp circuit and the equipment needs to be disposed of.

General Training

The contractor shall provide a narrative

Meetings

Quality Control Checks

1.2 Planned Activities

Provide on-going support for the operation of the EDR and any project assistance we are asked to provide.

Training

Meetings

Deliverables

Contractor shall identify planned deliverables.

1.3 Staffing Issues

Contractor shall provide a narrative

Base Contract Contractor shall provide a narrative eSub Validation and Reporting

<REMAINDER OF PAGE INTENTIONALLY BLANK TO ACCOMMODATE FOLLOWING CHART>

Below is the organizational chart for the EDR.

The contractor shall provide an organizational chart for the EDR

1.4 Problems Encountered During the Month

Contractor shall provide a narrative.

1.5 Potential Problems

Rejections – Contractor shall provide a narrative regarding rejections

Rejection Processing (Gateway & Physical Electronic)

Contractor shall provide a narrative regarding rejections

Outstanding Issues List

Current Outstanding list will be provided post award. The current list has 5 high priority items, 2 medium priority, and 1 low priority item (total = 8). Contractor is expected to maintain an outstanding list in the Monthly Report.

<REMAINDER OF PAGE INTENTIONALLY BLANK TO ACCOMMODATE FOLLOWING CHARTS>

1.6 Tracking & Reporting

ASR Failed Submission Reporting

The contractor shall provide a narrative describing potential causes for ASR Failed

1.6.1 Cumulative Failed Submission Category Distribution

The following data displays the ASR cumulative failed submissions by category distribution for the month of September. A total of 259 failed submission notices were received and manually processed or rejected.

Category # of Failed

Submissions Duplicate/Incorrect sequence 80 More than one form in a submission 39 Incorrect gateway submission type identified 30 Unable to extract information from PDF form 21 Incorrect, missing or incomplete us-regional.xml 14 ASR Unable to Process 12 Mismatched application number in the us-regional.xml 11 Submitted to the wrong gateway Center 10 Missing form 356h, 1571, or 2252 9 Not in standard eCTD format and structure 9 No data received 7 GS Validate high errors 4 Mismatched Application Type 4 Others 9 Total 259

31%

15% 12%

8%

5% 5%4%

3%

2% 1%

ASR Cumulative Failed Submission Category Duplicate/Incorrect sequence

More than one form in a submission

Incorrect gateway submission type identified

Unable to extract information from PDF form

Incorrect, missing or incomplete us-regional.xml

ASR Unable to Process

Mismatched application number in the us-regional.xml

Submitted to the wrong gateway Center

Missing form 356h, 1571, or 2252

Not in standard eCTD format and structure

No data received

GS Validate high errors

Mismatched Application Type

Invalid file type received

Mismatch application type/number between cover letter and fillable form Duplicate/incorrect content

More than one sequence/Core Id/submission received

1.6.2 ASR Failed by Sponsor Distribution – Top 10 Sponsors

The chart below identifies the top ten sponsors with failed submissions. For a breakdown of failed sponsor submissions by category, see Sections 5.4 Appendix D – Top 10 Sponsor Category Counts & Percentages.

Detailed metrics intentionally deleted – Contractor shall provide metrics

Sponsor Top # of Failed

Total 168

ASR Failed by Sponsor Distribution - Top 10 Sponsors

1.6.3 ASR Failed eCTD Submissions

Of the ASR eCTD failed submissions, 18% were processed.

eCTD

Submissions Duplicate/Incorrect sequence 80 Incorrect gateway submission type identified 30 Incorrect, missing or incomplete us-regional.xml 14 Mismatched application number in the us-regional.xml 11 ASR Unable to Process 10 Not in standard eCTD format and structure 9 GS Validate high errors 4 Mismatched Application Type 4 Submitted to the wrong gateway Center 3 Mismatch application number between cover letter and fillable form 1 More than one sequence/Core Id/submission received 1 Total 167

48%

18%

8%6%

5%

2%

1%

ASR Cumulative Failed eCtd Submissons Duplicate/Incorrect sequence

Incorrect gateway submission type identified Incorrect, missing or incomplete us-regional.xml Mismatched application number in the us-regional.xml ASR Unable to Process

Not in standard eCTD format and structure GS Validate high errors

Mismatched Application Type

Submitted to the wrong gateway Center

Mismatch application type/number between cover letter and fillable form More than one sequence/Core Id/submission received

1.6.4 ASR Failed Non-eCTD Submissions

Of the ASR Non-eCTD failed submissions, 83% were processed.

Non-eCTD

Submissions More than one form in a submission 39 Unable to extract information from PDF form 21 Missing form 356h, 1571, or 2252 9 No data received 7 Submitted to the wrong gateway Center 7 Invalid file type received 3 ASR Unable to Process 2 Duplicate/incorrect content 2 Mismatch application number between cover letter and fillable form 2 Total 92

1.7 Total Rejected Submissions

For the month of September, the EDR had 166 rejected submissions,

• 154 Gateways and 12 Physical.

• 142 eCTD and 24 Non-eCTD.

Rejection Category Number Rejected

Duplicate sequence received 85 Mismatched application/sequence/type 22 Not in standard eCTD format 13 Invalid file type received 5 GS Validate high error 4 Sent to wrong center 4 Per Sponsor/CSO Request 3 Multiple/application/sequence/Us-regional.xml received 1 No data received 1 Total 166

1.7.1 Rejected OPDP (DDMAC) Submissions

For the month, the EDR had 4 Rejected OPDP (DDMAC) submissions, # of Rejected

DDMAC

Submissions Invalid file type received 2 No data received 2 Total 4

Rejected OPDP (DDMAC) Submissions

Invalid file type received

No data received

1.7.2 Rejected ASR eCTD Submissions

Of the ASR eCTD failed submissions, 82% were rejected and are shown below.

ASR eCTD

Submissions Duplicate sequence received 85 Mismatched application/sequence/type 22 Not in standard eCTD format 13 Invalid file type received 5 GS Validate high error 4 Sent to wrong center 4 Per Sponsor/CSO Request 3 Multiple/application/sequence/Us-regional.xml received 1 No data received 1 Total 138

61%

16% 9%

4%

3%

2%

1%

Rejected ASR Failed eCTD Submissions Duplicate sequence received

Mismatched application/sequence/type Not in standard eCTD format

Invalid file type received

GS Validate high error

Sent to wrong center

Per Sponsor/CSO Request

Multiple/application/sequence/Us-regional.xml received

1.7.3 Rejected – ASR Non-eCTD Submissions

Of the ASR Non-eCTD failed submissions, 17% were rejected and are shown below.

ASR Non-eCTD Submissions

Sent to wrong center 6 No data received 5 Invalid file type received 3 Duplicate content received 1 Mismatched application/sequence/type 1 Total 16

1.7.4 Rejected – Physical eCTD Submissions Rejected

# of Rejected Physical eCTD Submissions

Duplicate sequence received 2 Not in standard eCTD format 2 Total 4

Rejected Physical eCTD Submissions

Duplicate sequence received

Not in standard eCTD format

1.7.5 Rejected – Physical Non-eCTD Submissions

Physical

Non-eCTD Submissions

Invalid file type received 5 No data received 3 Total 8

62%

38%

Rejected Physical Non-eCTD Submissions

Invalid file type received

1.8 Findings & Recommendations

1.9 Reviewer Requests

During the month, the EDR responded to 30 Reviewer Requests. Of those:

Type of Request Number of Requests

Research 20 Expedite 4 Modification 3 Assignment 2 EDR Access 1

1.10 ASR Clean-Up Requests

The majority of “Clean-Up Requests” are due to gateway submissions that were successfully processed by ASR and an E record created in DARRTS.

If the replacement record is an N (new) or WD (withdraw) record, the Document Room does not have the rights to create these record types. A new record request is sent to DQMT, a new record is created in DARRTS, and then an email is forwarded to EDR to move the contents of the E record to the new record. EDR then forwards a message back to DQMT and OIT to remove the E record from DARRTS and EDR. This is entirely a manual email driven process.

Another type of “Clean-Up Request” occurs when submissions are rejected.

• 12 Clean-up requests were processed

EDR PROJECT STATUS REPORT APPROVALS

Prepared by

EDR Project Manager

Approved by

Program Manager

2 APPENDICES

2.1 Appendix A – Total Electronic Submissions

Total Electronic Submissions Received (July): 12,121

Method Jan-09 FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Physical 2,040 1,952 2,567 2,269 1,944 1939 1,854 1,780 1,578 1,653 1,569 1,548

Gateway 2,268 2,998 3,235 3,208 3493 3692 3,824 4,075 4,182 4,758 4,552 4,953

Total 4,308 4,950 5,802 5,477 5,437 5,631 5,678 5,855 5,760 6,411 6,121 6,501

Delivery Method Jan-10 FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Physical 1,270 1,239 1,661 1,507 1,236 1,292 1,247 1,213 1,172 1,074 1,034 1,110

Gateway 4,171 4,660 5,798 5,351 5,639 6,136 5,696 5,899 5,980 6,279 6,485 7,119

Total 5,441 5,899 7,459 6,858 6,875 7,428 6,943 7,112 7,152 7,353 7,519 8,229

Delivery Method Jan-11 FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Physical 938 1,067 1,080 942 767 1,041 777 1,800 2,051 1,978 2,100 2,161

Gateway 6,350 7,248 8,213 7,649 8,008 8,251 7,686 8,364 7,999 7,858 7,902 8,005

Total 7,288 8,315 9,293 8,591 8,775 9,292 8,463 10,164 10,050 9,836 10,002 10,166

Delivery Method Jan-12 FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Physical 1,605 2,059 2,098 1,930 2,237 2,142 1,915 2,207 2,005 2,146 2,185 2,032

Gateway 7,455 8,054 9,465 8,588 9,250 8,815 8,324 10,366 9,079 8,971 10,244 9,069

Total 9,060 10,113 11,563 10,518 11,487 10,957 10,239 12,573 11,084 11,117 12,429 11,101

Method Jan-13 FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Physical 2,048 2,055 2,278 2,526 2,594 2,286 2,295 2,331 2,318

Gateway 9,095 9,657 10,724 10,915 11,210 10,322 10,635 9,079 9,803

Total 11,143 11,712 13,002 13,441 13,804 12,608 12,930 11,410 12,121

Began processing DDMAC Physical Electronic submissions in Aug 2011.

2.2 Appendix B – Submissions Manually Processed by EDR, This Month

Sep-13 Application Type Source Format NDA ANDA IND BLA DMF DDMAC Total

Gateway - Failed.

Manually Processed eCTD 29 67 69 258 321 0 744

Non-eCTD 12 84 8 0 0 0 104

Physical Electronic Media eCTD 9 37 31 3 21 0 101

Non-eCTD 39 170 158 0 2 1,848 2,217

Total All 89 358 266 261 344 1,848 3,166

Physical Applications Processed

NDA ANDA IND BLA DMF DDMAC Total January 93 219 166 1 40 1,529 2,048 February 101 214 195 2 34 1,509 2,055 March 95 180 256 3 37 1,707 2,278 April 106 210 250 4 24 1,932 2,526 May 86 240 224 4 26 2,014 2,594 June 68 191 191 2 42 1,792 2,286 July 93 149 238 3 44 1,768 2,295 August 91 189 261 3 30 1,757 2,331 September 48 207 189 3 23 1,848 2,318 October 0 November 0 December 0 Year to Date 781 1,799 1,970 25 300 15,856 20,731 Monthly Avg 87 200 219 3 33 1762 2303 Daily Avg 4 9 10 0 2 80 105

2.3 Appendix C – Gateway Submissions Processed by EDR, Year to Date

Gateway Applications Processed

NDA ANDA IND BLA MF DDMAC Total January 1,463 2,297 4,639 191 214 0 8,804 February 1,488 2,104 5,508 217 228 0 9,545 March 1,537 2,439 6,068 226 309 0 10,579 April 1,680 2,805 6,206 242 294 0 11,227 May 1,688 2,512 6,505 241 305 0 11,251 June 1,498 2,154 6,190 247 264 0 10,353 July 1,496 2,178 6,489 253 319 0 10,735 August 1,443 2,431 5,913 267 242 0 10,296 September 1,405 2,291 5,384 258 324 0 9,662 October 0 November 0 December 0 Year to Date 13,698 21,211 52,902 2,142 2,499 0 92,452 Monthly Avg 1,522 2,357 5,878 238 278 0 10,272 Daily Avg 69 107 267 11 13 0 467

2.4 Appendix D – Gateway Utilization (per ESG gateway)

Submissions Received at the Gateway, 2006 – 2013.

YTD 2006 - Monthly Average = 205 YTD 2010 - Monthly Average = 5,768 YTD 2007 - Monthly Average = 931 YTD 2011 - Monthly Average = 7,794 YTD 2008 - Monthly Average = 2,066 YTD 2012 - Monthly Average = 8,965 YTD 2009 - Monthly Average = 3,770 YTD 2013 - Monthly Average =10,160

The charts below represent the utilization of the gateway by Industry as found on the ESG statistics website. The values reflect all submissions to the gateway regardless of successful, failure or rejected outcome.

Gateway submissions received for the month of September is: 9,803

Increase in Submissions from September 2012 to September2013: 8%

Annual Monthly Average Increase, 13%

2.5 Appendix E – Top 10 Sponsor Failed Category Counts & Percentages

Sponsor Category Description

# of Sponsor Submissions per Category

Total # of Sponsor

Submissions % of Sponsor Submissions

More than one form in a submission 30 42 71.43%

Duplicate/Incorrect sequence 6 42 14.29% ASR Unable to Process 2 42 4.76% Incorrect, missing or incomplete us-regional.xml 2 42 4.76% Not in standard eCTD format and structure 1 42 2.38% Unable to extract information from PDF form 1 42 2.38%

Submitted to the wrong gateway Center 8 20 40.00% No data received 7 20 35.00% Invalid file type received 3 20 15.00% Duplicate/Incorrect sequence 2 20 10.00%

Duplicate/Incorrect sequence 7 15 83.33% Mismatched Application Type 2 15 5.56% Incorrect gateway submission type identified 2 15 5.56% Not in standard eCTD format and structure 2 15 5.56%

Mismatched application number in the US- Regional.xml 1 15 6.67%

Submitted to the wrong gateway Center 1 15 6.67%

Duplicate/Incorrect sequence 13 13 100.00%

Missing form 356h, 1571, or 2252 7 13 53.85% Unable to extract information from PDF form 2 13 15.38% Duplicate/Incorrect sequence 1 13 7.69%

Regional.xml 1 13 7.69%

More than one form in a submission 1 13 7.69% ASR Unable to Process 1 13 7.69%

Incorrect, missing or incomplete us-regional.xml 5 12 41.67% Incorrect gateway submission type identified 4 12 33.33% More than one form in a submission 3 12 25.00%

More than one form in a submission 6 11 54.55% Unable to extract information from PDF form 4 11 36.36%

Incorrect gateway submission type identified 1 11 9.09%

Regional.xml 6 10 60.00%

Duplicate/Incorrect sequence 1 10 10.00% ASR Unable to Process 1 10 10.00% Submitted to the wrong gateway Center 1 10 10.00% Incorrect gateway submission type identified 1 10 10.00%

Duplicate/Incorrect sequence 4 9 44.44% Incorrect, missing or incomplete us-regional.xml 3 9 33.33% ASR Unable to Process 1 9 11.11% More than one sequence included in submission 1 9 11.11%

Duplicate/Incorrect sequence 7 9 77.78% Mismatched Application Type 1 9 11.11% Submitted to the wrong gateway Center 1 9 11.11%

Incorrect gateway submission type identified 8 8 100.00%

Unable to extract information from PDF form 6 6 100.00%

2.6 Appendix F – Cumulative Electronic Submissions, YTD

2013 Received

YTD

Processed YTD by ASR Manually

Physical Media

OND 14,057 14,057

OGD 1,799 1,799

Other

Gateway All 92,452 87,578 4,874

Sub Total 87,578 20,730

Grand Total 108,308 108,308

• 87,578 gateway submissions successfully (partially) processed by ASR.

• 4,874 gateway submissions failed ASR and were processed manually.

• 166 total submissions were rejected this month.

• 2,043 total submissions were rejected year to date.

2.7 Appendix G – Submission Format by Delivery Method by Application Type, YTD

2013-Physical Type FORMAT

Year to

Date % of Total NDA eCTD 148 19% Non-eCTD 633 81% ANDA eCTD 354 20% Non-eCTD 1445 80% IND eCTD 326 17% Non-eCTD 1644 83% BLA eCTD 19 76% Non-eCTD 6 24% MF eCTD 264 88% Non-eCTD 36 12% DDMAC eCTD 0 0% Non-eCTD 15856 100%

Total eCTD 1111 5% Non-eCTD 19620 95%

20,731

2012 – Physical Type FORMAT

Year to

Date % of Total NDA eCTD 253 20% Non-eCTD 1,039 80% ANDA eCTD 1,346 36% Non-eCTD 2,378 64% IND eCTD 409 18% Non-eCTD 1,918 82% BLA eCTD 28 62% Non-eCTD 17 38% MF eCTD 536 100% Non-eCTD 1 0% DDMAC eCTD 2 0% Non-eCTD 16,634 100% Total eCTD 2,574 11% Non-eCTD 20,233 89%

Grand Total 22,807

2013- Gateway Type FORMAT

Year to Date % of Total

NDA eCTD 13285 97% Non-eCTD 413 3% ANDA eCTD 17281 81% Non-eCTD 3930 19% IND eCTD 52805 100% Non-eCTD 97 0% BLA eCTD 2142 100% Non-eCTD 2 0% MF eCTD 2495 100% Non-eCTD 4 0% Total eCTD 88008 95% Non-eCTD 4446 5%

Total 92,454

2012- Gateway Type FORMAT

Year to Date

% of Total

NDA eCTD 16,745 97% Non-eCTD 594 3% ANDA eCTD 22,314 78% Non-eCTD 6234 22% IND eCTD 56,694 100% Non-eCTD 66 0% BLA eCTD 2,643 100% Non-eCTD 3 0% MF eCTD 2,039 100% Non-eCTD 0 0% Total eCTD 100,435 94% Non-eCTD 6,339 6%

Total 106,774

Regulatory Information Specialist

(EDR)

Industry & Reviewer Community

Division of Data Managements Services & Solutions (DDMSS) eData Management Solutions Team

Contracting Officer’s Representative (COR)

Data Management Services Team (DMST)

OPDP Document Room Liaison

OGD Document Room Liaison

OND Document Room Liaison

DMF Steering Committee

Document Room Contract Staff

DMST

Cross Functional DARRTS Forums

Cross Functional OIM Forums (ASR, GS

Validate, eCTD etc.)

DDMSS Communication Flowchart

On-Site Records Information Management (RIM) RFP

SECTION 3: CDER REFERENCE DOCUMENTS (APPENDICES) FDA-14-223-SOL-00005

dcolbert Typewritten Text dcolbert Typewritten Text dcolbert Typewritten Text dcolbert Typewritten Text dcolbert Typewritten Text dcolbert Typewritten Text dcolbert Typewritten Text dcolbert Typewritten Text dcolbert Typewritten Text dcolbert Typewritten Text dcolbert Typewritten Text Appendix J.5: DDMSS Communication Flowchart dcolbert Typewritten Text

Appendix J.6 DRAFT QUALITY ASSURANCE, ACCEPTABLE QUALITY LEVELS, AND SLAs FOR CDER DCC OPERATIONS

AND SUPPORT

DEFINITIONS:

1. Same business day or next scheduled delivery means that most submissions will be delivered by 7 PM that same business day or by 9AM the next morning for submissions that came in later in the day.

2. The term 1 business day is that the submission will be delivered within 1 business day from the time the submission was received (e.g., if the submission came in Tuesday at 11AM, the reviewer will have access to the submission before 11AM on Wednesday)

3. The term “Business Day” coincides with DCC operation hours. Please note most DCCs are open 11 to 12 hours a day. See hours of operation in the

CDER DCC SOW.

Supplemental Terms and Conditions

1. CDER reserves the right to:

a. Obtain metrics data from sources not identified for monitoring contractor performance.

b. Conduct random sampling to obtain metrics statistics.

2. If a submission contains one or more submission types the contractor may add the acceptable threshold to their processing time for each additional supporting document:

a. For example, a new paper IND is received (less than 5 volumes) with a Title VIII form as supporting documentation, the contractor would have

• 40 minutes to process the new paper application and 8 minutes to process the Title VIII form = 48 minutes

Box No.