Preproposal Slides to OAGS.ppt
PPT presentation 36 MB Posted
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- FDA DOCUMENT CONTROL ROOM
- Solicitation number
- FDA-SOL-08-00653
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Pre-proposal Slide Presentation
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| FDA DOC - repeat.doc | DOC document | |
| Transcriptfda.doc | DOC document | |
| RFP-Performance Table Rev A.pdf | ||
| Attendee List Document Control Room.doc | DOC document | |
| 000005.pdf | ||
| FDA RFP_Questions2.docx | DOCX document | |
| 000004.pdf | ||
| 000003.pdf | ||
| 000002.pdf | ||
| Amendment 000001.pdf | ||
| FDA. DC Contract.pdf | ||
| SF1449.pdf | ||
| DRAFT SOW - FDA DOCUMENT CONTROL ROOM SERVICES SOLICITATION.doc | DOC document |
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DOCUMENT CONTROL ROOM PRE-PROPOSAL CONFERENCE
June 11, 2008
This pre-proposal conference is for informational purposes only. It may answer some offerors questions, however, statements and responses to questions are not legally binding. Changes resulting from the conference are official only if issued through an amendment to the RFP. A transcript of this conference and the register of attendees will be posted to Federal Business Opportunities.
AGENDA
Opening Remarks (Paul S. Henig) General Information (Patricia Pemberton) OAGS General Contract Information (Patricia Pemberton)
FFP
Task Orders Technical & Cost Proposal OBPS Pre-proposal Conference Agenda (Paul S. Henig / Wendy Aaronson) Facilities – Locations & Operations Operational Flow Diagrams Processing Time Constraints On-site Tour (Paul S. Henig) Questions and Responses (Patricia Pemberton / Paul S. Henig / Wendy Aaronson) Previously Submitted Questions On-site Questions Closing Remarks (Patricia Pemberton / Paul S. Henig)
Facility Locations
Facility Operations
CENTRAL DOCUMENT ROOM (CDR)
| CDR interacts with: |
| FDA’s - Gaither Rd. Scanning Facility |
| White Oak Campus (Bldg. 21, 22, 51) |
| Federal Records Center (FRC) |
| Supports the following CDER Organizations: |
| All Application (IND, NDA, BLA, DMF) Review Offices except Office of Generic Drugs (OGD) |
| DDMAC |
| Office of Compliance (OC) |
| Operations Performed: |
| Mail Receipt/Scanning/Processing/Distributions |
| Data Abstraction / Entry |
| Courier Services |
| Records Management |
| Records Storage |
| Records Retirement |
| Supply Storage |
| Records Inventory Control Services |
| Special Projects Support |
| FRC Retrieval Request Services |
WHITE OAK CAMPUS
| BLDG. 21 & 22 – Supports Application (IND, NDA, BLA) Review |
| Bldg. 22 – |
| EDR & Main Document Room for INDs, NDA, and BLAs |
| CDER Reviewer Area |
| BLDG. 22 -- Operations Performed: |
| Mail Identification & Triage |
| Review Material Processing |
| Review Material Distribution to all CDER offices (Bldg. 22, 21, 51, NIH campus) |
| Support Reviewer Area |
| Electronic Media Processing |
| Records Management |
| Office-to-Office Document Inventory Services |
| Records Retrieval and File Backs |
| BLDG. 21 -- Operations Performed: |
| Distribution of Processed Review material |
| Retrieval of Review material |
| Office-to-Office Document Inventory Services |
| BLDG. 51 – Supports Office of Compliance (OC) & DDMAC |
| DDMAC Document Room |
| Compliance Document Room |
| OC Division of Scientific Investigations Document Room |
OGD
| 3 Sites |
| Metro Park North-I |
| Metro Park North-II (Main document room) |
| Wilkins Off-site Facility |
| Operations at Metro Park North-I and II |
| Mail Identification & Triage |
| Review Material Processing |
| Review Material Distribution |
| Support Reviewer Area |
| Electronic Media Processing |
| Records Management |
| Office-to-Office Document Inventory Services |
| Records Retrieval and File Backs |
| Operations at Wilkins Off-site Facility – |
| Storage and Retrieval |
| Overflow Site |
Start
Industry
Submissions - IND, NDA, BLA, MF, 15 day reports,VGDS
CDR
Open, date stamp, & log
High level sort and prioritize
Electronic submission?
Process and data entry into COMIS or DARRTS or RMS-BLA
Send to EDR
Load submission into EDR
Notify PM, reviewers
Backup and archive
End
Yes
Original NDA or IND?
Assign application number
Perform data entry
Create and label jackets; scan in INVAS
Send to DR1
Second sort and prioritize
DMF?
No
Send to DMF staff
Data abstraction and data entry into DARRTS
Jacket, label, bar code
File
DR1
Original IND or NDA?
Expedited delivery directly to CPM
Data entry updates from CPM
Distribution to reviewers
Data abstraction and data entry; notify PM if high priority submission
PM review
Data entry updates from PM
Create and label jackets; bar code and scan in INVAS
Pick up materials from reviewers
Reviewers perform review and return documents when completed
Scan in INVAS
Additional data entry, if required (e.g., closing assignments in COMIS)
File (Active Fileroom)
Store (Inactive Fileroom at CDR)
Retirement
Start
Industry
Submissions - IND, NDA, BLA, MF, 15 day reports,VGDS
CDR
Open, date stamp, & log
High level sort and prioritize
Electronic submission?
Process and data entry into COMIS or DARRTS or RMS-BLA
Send to EDR
Load submission into EDR
Notify PM, reviewers
Backup and archive
End
Original NDA or IND?
Assign application number
Perform data entry
Create and label jackets; scan in INVAS
Send to DR1
Second sort and prioritize
DMF?
Send to DMF staff
Data abstraction and data entry into DARRTS
Jacket, label, bar code
File
DR1
Original IND or NDA?
Expedited delivery directly to CPM
Data entry updates from CPM
Distribution to reviewers
Data abstraction and data entry; notify PM if high priority submission
PM review
Data entry updates from PM
Create and label jackets; bar code and scan in INVAS
Pick up materials from reviewers
Reviewers perform review and return documents when completed
Scan in INVAS
Additional data entry, if required (e.g., closing assignments in COMIS)
File (Active Fileroom)
Store (Inactive Fileroom at CDR)
Retirement
Critical Processing Time Constraints
RFP
SOW
Sect. Description Standard
| D.1 | Central Document Room | |
| D.1.7.4 | Mail Distribution, Sort, and Prioritization | 99% - accuracy for priority Documents |
| D.1.7.4.1 | New IND processing | 99% - accuracy, processed within 3-working days upon receipt by CDER |
| D.1.7.4.4 | New NDA processing | 99% - accuracy, processed within 3-working days upon receipt by CDER |
| D.1.7.4.7 | Electronic Submissions | 99% - accuracy, processed and delivered to EDR staff within 1-working days |
| D.3 | Office of New Drugs (OND) | |
| D.3.3.2 | Identification and Validation | 99% - processing accuracy Identification & Validation of Priority Documents |
| D.3.3.2.3 | OND Data Entry | 99% - processing accuracy Data Abstraction & Entry |
| D.3.3.2.4 | NDA Data Entry into COMIS & ECH | 99% - processing accuracy Data Abstraction & Entry into COMIS and ECH |
| D.3.3.2.7 | IND Data Entry into DARRTS | 99% - processing accuracy Data Abstraction & Entry into DARRTS |
| D.3.3.2.8 | BLA Data Entry into RMS-BLA | 99% - processing accuracy Data Abstraction & Entry into RMS-BLA |
| D.3.4 | Labeling and Barcoding | 99% - processing accuracy |
| D.3.10 | IND, NDA, BLA Review Material Distribution to CDER's Program Managers | 99% - processing accuracy Review Material Distribution within: 2-days for Priority Documents / 3-days for Non-Priority Documents |
| D.3.11 | Turnover Material Processing | 99% - processing accuracy |
| within 1-working day of sign-off by CDER's PM |
| D.4 | DDMAC | |
| D.4.2 | DDMAC Mail Processing | 99% - mail processing accuracy; Identify & Route "priority" mail within 1-working day / Distribute all "non-priority" within 2-working days |
| D.5 | Office of Generic Drugs (OGD) | |
| D.5.4.1.5 | Processing Electronic Data for an ANDA | 99% - processing accuracy; process Electronic media within 24-hours upon receipt |
| D.6 | Drug Master Files (DMF) | |
| D.6.11 | DMF Requests | 99% - processing accuracy; Contractor shall respond to DMF requests within 1-working day |
| D.9 | Electronic Document Room (EDR) | |
| D.9.3 | Acceptable Quality Levels (AQL) | 99% overall performance quality level |
| process electronic document within 48-hours, respond to CDER reviewer requests within 1-working day |
| D.9.4.2 | Misdirected Mail | 99% - processing accuracy; forward misdirected mail to appropriate CDER Review Div. within 1-working day |
| D.9.6.2.1 | Receipt of Gateway Submissions | 99% - processing accuracy; complete processing within 24-hours upon receipt of the e-mail notification |
| D.9.7 | EDR Tracking/Logging/Reporting | 99% - processing accuracy; operation shall take no longer than 2-working days |
| D.9.8 | Daily Workload Report | All submissions pending for more than 2-working days are listed separately with all receipt and problem information and tracked daily for progress. |
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