DRAFT SOW - FDA DOCUMENT CONTROL ROOM SERVICES SOLICITATION.doc

PART D

Attachments

Statement of Work

D.1

CENTRAL DOCUMENT ROOM

D.1.2

Introduction to the Central Document Room Facility (CDR/Ammendale)

The Central Document Room (CDR) houses multiple operations at the Ammendale facility. A variety of Drug submissions from the Drug Industry community are received and processed at CDR. Submissions processing includes Investigational New Drugs (IND), New Drug Applications (NDA), Biologics License Applications (BLA) and Drug Master Files (DMF), the IND/NDA Application Volume Accountability System (INVAS), and the Bioresearch Monitoring Information System (BMIS).

CDR also serves as the central mail receipt point for CDER regulatory submissions from various sources, and as a storage facility for physical submission media processed at Ammendale.

D.1.3

CDR Mail Processing

The Contractor shall be responsible for providing the necessary personnel with the appropriate labor skills and knowledge, along with the necessary resources, required to support the following mail processing tasks and support activities.

D.1.4

Mail Receipt

The Central Document Room receives mail from a variety of commercial mail distributors.

Mail may come in the form of small and large boxes and envelopes.

Upon receipt of the mail delivery, the CDR document room staff shall receive a log sheet from the courier listing the contents and number of pieces of mail delivered. The CDR staff shall be responsible for confirming that the log sheet is accurate and all pieces received are accounted for in accordance with the log sheet.

The Contractor shall ensure that the physical condition of the mail is acceptable and not damaged or shows signs that the material has be tampered with and resealed. Upon completion of these tasks the CDR staff is responsible for approving mail receipt.

D.1.5

USPS Mail Receipt

The Contractor shall only accept and log USPS mail.

Upon completion of this task the CDR courier delivers this mail to the Government’s Gaithersburg Scanning Facility. The CDR courier shall be responsible for picking up this mail after the security scanning task has been completed and returned to the CDR for initial mail processing.

D.1.6

Scanning Mail

The Contractor shall scan all incoming mail to ensure that the safety and integrity of each article is acceptable and in accordance to FDA’s security standards and policies.

The operation of the X-ray scanning machine shall be performed in accordance with the manufacturer’s operational instructions and standards, as defined in the manufacturer’s Operational Manual (in support for this specific X-Ray machine model). The operator must be certified to operate the X-ray scanning machine.

If a scanned article is considered to be unsafe or suspicious in nature, the scanning operator is responsible in contacting FDA’s Security office, the Project Officer, and the Contractor’s Management. The operator shall invoke assistance from FDA’s Security Office on how to proceed.

The Central Document Room facility manager shall be responsible for evacuating the facility and instructing all personnel to a safe location away from the mail receipt area.

FDA’s Security Office shall be responsible for handling and resolving unsafe situations.

D.1.7

Mail Identification and Triage

D.1.7.1

Mail Stamp and High Level Sort

The Contractor shall open and stamp the receipt date on all received mail. The mail is then sorted by submission type, including:

· Investigation New Drug (IND)

· New Drug Application (NDA)

· Biologics License Application (BLA)

· Drug Master File (DMF)

· 15-Day Reports (IND/NDA/BLA)

· Adverse Event Reporting System (AERS) Reports

· Periodic (P) Reports

· DDMAC Submissions

· Drug Registration and Listing (DRLS) Submissions

· Sample Electronic Documents

· Electronic Submissions (IND/NDA/BLA)

· Special Assessment Protocols

· Meeting/Briefing Packages

· Voluntary Genomic Data Submissions

· Desk copies

· Documents from the District Office

· Receipts of Returned Requests

The following mail items are only logged, sorted, and forwarded to the respective teams:

· Drug Registration and Listing (DRLS) Submissions

· DDMAC Submissions

· Adverse Event Reporting System (AERS) Reports

D.1.7.2

Unstamped Mail

The Contractor shall not date stamp the following material:

· Desk copies,

· documents from the District Office

· receipts of returned Reviewer requests

The Contractor shall immediately transport Desk copies to the White Oak document room (DR1) for processing and distribution to the appropriate CDER Review Division.

D.1.7.3

Misdirected Mail

The Contractor shall research and determine the correct addressee and deliver the misdirected mail article.

D.1.7.4

Mail Distribution, Sort, and Prioritization

The appropriate FDA form and cover letter usually identify the purpose of the submission. From this information, the CDR staff shall be responsible for determining the priority level at which the submission shall be processed.

All DMF material is received and processed at CDR.

A secondary sort is performed at CDR on IND, NDA and BLA material to identify new applications and high priority submissions.

Due to staging area space constraints’ at DR1, all new IND and NDA multi-volume submissions are processed at CDR. Also, all electronic submissions containing physical media are initially processed at CDR and then forwarded to the EDR Staff at DR1.

All other material that has been sorted by application type and priority is forwarded to DR1 for processing.

Priority documents have review clocks associated with them. The review clock is specified in regulation, policy, or procedures. Current priority documents are, but are not limited to, the document types below:

· New INDs

· New NDAs

· New BLAs

· New NDA and BLA supplements

· IND treatment protocols

· Voluntary Genomic Data Submissions

· Meeting requests

· Request to charge

· Request for Special Protocol Assessments

· Briefing packages

· Response to clinical hold

· Resubmissions (this includes requests to reactivate)

· Requests for Proprietary Name Review

The contractor must maintain a 99% processing accuracy standard in identifying application type and priority.

D.1.7.4.1 New Investigational New Drugs (IND) Processing

The Contractor shall perform the following processing operations and tasks in support of new IND submissions, including:

· Data abstraction and entry

· jacket Archive and copies,

· make additional copies if insufficient number of copies are submitted

· Print out barcode labels and attach to jackets

· forward to DR1

There is a maximum three-day timeframe to process all new INDs.

D.1.7.4.2 New IND Data Entry into DARRTS (Document Archiving, Reporting and Regulatory Tracking System)

The Contractor shall perform data abstraction and data entry into CDER’s DARRTS electronic tracking system for all new INDs that are received at CDR. The following data are abstracted from FDA forms, IND’s cover letter, or from the IND’s protocol:

· Application Number

· Sponsor/Applicant Name

· IND type (Commercial or Research)

· Indication

· Review Division

· Established Drug Name

· Proprietary Drug Name (if applicable)

· Therapeutic Drug Class Code

· Document Category/Subcategory

· Submit (Letter) Date

· CDER Receipt Date

· Volume Number

· Discipline Reviews as required

· Reviewer Assignment

· Application properties (e.g., emergency IND, single patient IND, exploratory, therapeutic biologic)

· Submission properties (e.g., AIDS, orphan product)

The Contractor shall perform a quality control of all data entered into DARRTS to ensure data completeness and accuracy. This quality review is required to take place within one (1) working day of the initial data entry.

Noted discrepancies found during verification or at any other time shall be resolved by the contractor or forwarded through appropriate channels for resolution within one (1) working day from detection.

A log documenting these discrepancies shall be kept by the contractor and made available weekly to the Project Officer.

D.1.7.4.3 Jacketing, Barcoding and Labeling the Jacket

Although review jackets are color-coded, industry is not required to submit their applications in specific jackets. See http://www.fda.gov/cder/ddms/binders.htm for more information. If submissions are received for processing without a jacket, a jacket shall be prepared.

The Contractor shall perform the following processing operations and tasks:

· All archival volumes must be jacketed. All material to be jacketed first needs to be hole-punched.

· Re-jacket (if applicable) the first volume only (.1 volume) for duplicate and triplicate volumes.

· All jacket volumes are bar-coded and labeled with the following information: IND number, sponsor, drug name, volume number, and volume range.

D.1.7.4.4 New Drug Application (NDA) Processing

The CDR staff shall perform the following processing operations and tasks in support of new NDA submissions, including:

· Data abstraction and entry

· jacket Archive and copies,

· make additional copies if insufficient number of copies are submitted

· Print out barcode labels and attach to jackets

· forward to DR1

There is a maximum two Business day timeframe to process all new NDAs.

D.1.7.4.4 NDA Data Abstraction and Entry into COMIS

The Contractor shall perform data abstraction and data entry into CDER’s COMIS database for new NDAs. The following data are abstracted from FDA 356h form and the cover letter:

· Application number

· NDA Type

· Applicant Name and Address

· Reviewing Division

· Submit Date

· Received Date

· Drug Name/Trade

· Drug Name/Generic

· Dosage Form

· Indication

The Contractor shall perform a quality control of all data entered into COMIS to ensure completeness and accuracy. This quality review is required to take place within one (1) working day of the initial data entry.

Noted discrepancies found during verification or at any other time shall be resolved by the contractor or forwarded through appropriate channels for resolution within one (1) working day from detection.

A log documenting these discrepancies shall be kept by the contractor and made available weekly to the Project Officer.

D.1.7.4.5 Jacketing, Barcoding, and Labeling the Jacket

CDR Contractor shall assemble and label the NDA jackets according to the discipline for each copy. There are a total of 7 different colored jackets representing a particular CDER review discipline:

· Blue – Archival Copy

· Red – Chemist’s Review Copy

· Orange – Pharmacokinetics Review Copy

· Green – Statistical Review Copy

· Tan – Clinical Review Copy

· Yellow – Pharmacology Review Copy

· White – Microbiology Review Copy

All jacket volumes are bar-coded using the INVAS barcode tracking system.

Jackets are labeled with the following information:

· Application number,

· Applicant,

· Drug name,

· Volume number,

· Volume range.

D.1.7.4.6 Electronic Submissions

Electronic submissions that consist of physical media are initially processed at CDR because of space limitations at DR1. Electronic media can be received in the following form:

· CD-ROM

· Tape

· DVD

The Contractor shall perform the following electronic submission processing operations and tasks, including:

· Create an archival jacket for the paper component

· Create a jacket for the physical media

· Perform data abstraction and data entry into the appropriate databases

· Deliver the processed submission to the EDR staff for further processing.

D.1.7.4.7 Jacketing, Barcoding, and Labeling the Jacket

The Contractor shall perform the following processing operations and tasks in support of jacketing, barcoding, and labeling electronic submissions:

· All paper archival volumes must be jacketed. Prior to jacketing, all paper material shall be hole-punched.

· The physical media is separated from the paper and placed in another jacket. This allows delivery of the archival jacket to the review division and loading the electronic submission to occur concurrently.

· All jacket volumes are bar-coded and labeled with the following information: IND number, sponsor, drug name, volume number, and volume range.

D.1.8

Other Documents Processed at CDR

D.1.8.1

Voluntary Genomic Data Submissions (VGDS)

The Voluntary Data Submission is processed as a pre-submission in DARRTS and forwarded to the IPRG for review and storage.

D.1.8.2

Patent Declaration (Form FDA 3542/3542a)

A patent declaration form (Form FDA 3542/3542a) must be submitted to FDA 30 days after an NDA or NDA supplement is approved. FDA Form 3542a is required when submitting patent information with original submissions, amendments, and supplements prior to approval.

CDR receives both FDA Form 3542 and 3542a. The form may be submitted in paper or electronically on physical media.

The Contractor shall perform the following processing operations and tasks:

· Date stamp Original and Copy

· Data entry

· Forward Original to appropriate CDER Review Division

· Forward Copy to OGD

The Contractor shall perform the following data entry operations into COMIS:

· Application Number

· Drug Name

· Organization code

· Sponsor Name

· Sponsor Letter

· Stamp dates

D.1.8.3

15-Day Reports

CDR Contractor shall receive all NDA and BLA 15-Day Report submissions. The original NDA and BLA 15-day reports are date stamped, logged and forwarded to the AERS contractor. The duplicate is shredded.

D.1.8.4

Adverse Event Reporting System Submissions (AERS)

All submissions received related to the Adverse Event Reporting System (AERS) may include compact discs, a cover letter, and/or a form FDA 356H.

The Contractor shall date stamp, verify, and copy the AERS submission. Upon completion of these activities, the entire AERS submission is forwarded to the AERS contractor for processing.

D.1.8.5

Periodic Adverse Experience Reports (P-Reports)

Periodic adverse (drug) experience reports are required for marketed products under 21 CFR 314.80, 314.98 and 600.80. Industry may request a waiver to submit the reports in the ICH format known as a Periodic Safety Update Reports (PSURs).

For paper reports, the CDR staff shall perform the following processing operations and tasks, including:

· Date stamp and log both the original and copy of the P-report

· Forward the copy to the AERS contractor for processing

· Archive the original in the NDA, ANDA, or BLA file

For electronic PSURs, the CDR staff shall data enter the PSUR report into the appropriate databases and forward the electronic media to the EDR for loading.

D.1.8.6

District Office

All District Office mail is received at the Central Document Room. Materials designated for District Offices include memos, reviews, correspondence, and other documents.

The Contractor shall bundle this mail and transport to DR1 for processing.

D.1.8.7

Responding to Requests for Pre-assigned Application Numbers

Requests for pre-assigned application numbers for INDs, NDAs, BLAs, DMFs, and ANDAs are received in an e-mail communication from sponsors, applicants, or representatives.

Both domestic and foreign companies may call to request a Pre-assigned Application number. Information from the e-mail is entered into the appropriated database to create an application number.

The contractor shall respond to the request with an email containing the pre-assigned number.

D.1.8.8

Bioresearch Monitoring Information System (BMIS)

The Bioresearch Monitoring Information System (BMIS) is a data entry system that is used to store information on investigators performing clinical trials under an IND. BMIS information is extracted from new IND applications and new investigator information. It is divided into three main series of records

· Clinical Investigator (CI) records: information on the investigator, including name, demographic data and associated INDs

· Institutional Review Board (IRB) records: information on the institution that accommodates the study, including name, demographic data, chairperson contact info, and associated INDs

· Contract Research Organization (CRO) records: contract research organization names/demographic data/associated INDs

Information for BMIS in the IND is typically documented on the FDA Form 1572, the curriculum vitae, cover letters, and listings of investigators within an IND submission.

In terms of CI and IRB records, the record data does not need to be presented explicitly in order to be included in BMIS, all relevant information is acceptable. CRO data is identified by a “yes” being checked in section 13 of form FDA 1571, and with an attached statement containing the name and address of the CRO. There is no standard format, however, for the data.

The contractor shall abstract information about clinical investigators, IRBs, and CROs. The contractor shall also abstract the protocol title and number from the Form 1572.

D.1.9

CDR Courier Services

D.1.9.1

Routing Mail to White Oak

The Contractor shall provide courier services to the following locations and/or personnel located at FDA’s White Oak Campus:

· White Oak Document Room (WO22/DR1)

· DDMAC (DR2)

· Office of Business Process Support (OBPS)

· Electronic Document Room (EDR)

· White Oak Mail Room (WO22 Mail Room)

· White Oak Document Rooms in Building 51

· Misc. locations with in the White Oak Facility, as needed.

The Contractor shall maintain a routing log for all items picked up from their respective areas in FDA’s White Oak campus. Materials shall be signed for and the time of receipt recorded on the routing log.

D.1.9.2

Other Courier Routes

Other courier stops requiring CDR courier services are listed below:

· MPN II (Rockville)

· Wilkins Ave. (Rockville)

· US Mail/Scanning Facility (Gaithersburg)

· Parklawn Building (Rockville)

· HFC-130 (Division of Field Investigations, Located at Parklawn in Rockville)

The Contractor may be called upon to provide courier services for “Special” courier runs to locations that are not normally serviced by the CDR courier. These “Special” courier runs may entail the delivery or pick-up of a critical review document needed to finalize a submission review.

An example of a Special courier run would be the pick-up of a submission that has been retired to the Federal Records Center in Laurel, Maryland. These courier runs are on an immediate need basis.

D.1.9.3

Retrieval – Completing Requests for Documents

CDR receives document requests via e-mail from CDER’s review community for submissions that may or may not be archived and stored at CDR.

D.1.9.4

OND/OGD Drug Jackets

About 70% of the requests received by CDR are for documents that are stored at the Central Document Room and the balance of 30% of requests are stored at the Federal Records Center (FRC).

Upon receipt of the reviewer’s e-mail request, a FDA form 3320 (Retired/Storage NDA/ANDA/IND/DMF Request) is filled out by the CDR staff with the following information that was provided from the reviewer’s e-mail:

· Document requested (NDA/ANDA/IND/DMF)

· Name of requestor

· Division name and mail code

· Telephone number

· Description of Documents

· Volume Numbers

· Date request received

The Contractor shall document on the FDA 3320 form that the request has been received by email from the respective reviewer.

If the documents are stored at White Oak, they are located using the “locate a volume” option in INVAS. The documents are retrieved from storage, scanned out to the reviewer, and forwarded to the reviewer via the CDR courier.

The action taken is noted on the FDA 3320 form and the Contractor signs and dates the form. The Contractor shall attach a copy of the FDA 3320 form to the document. A duplicate copy of the form is filed at CDR.

If the documents are stored at the FRC, the Contractor forwards the request to FRC. FRC personnel shall process the request and forward the records to CDR. CDR shall be responsible for receipt of this material and shall deliver material to the requesting reviewer along with a signed and dated FDA 3320 form. The Contractor shall document the action taken and a duplicate copy of the FDA 3320 form shall be filed at CDR.

In the event a document has been previously requested and forwarded on, the name, division, and date forwarded are noted on the form, and the form is forwarded to the requesting party, indicating they must contact the CSO of that division for further information.

D.1.9.5

DMF Jackets

All DMF requests are handled directly by the DMF staff. See Section VI for more specific detail on how DMF Jacket requests are processed by the DMF staff.

D.1.9.6

Active and Inactive Filing

Documents returned to CDR are checked back in using INVAS and are returned to their proper location in storage.

Files that were checked out from the FRC are transported to FRC, via the CDR courier. If the file has been retired while checked out, the file is deemed inactive and returned to FRC.

D.1.9.7

Storage

CDER archival files are stored and managed at the CDR facility. The files are managed by the use of CDER’s INVAS barcode tracking system.

The majority of regulatory documents that are received by the CDR document room staff are assigned a specific tracking barcode label. The Contractor, using the INVAS system will create the tracking barcode label and attach this barcode label to the assigned volume.

Note: The tracking barcode label shall accompany the volume throughout the review process and shall be the specific identifier of this specific application from start to finish of the review process, including retirement.

Archival files are also boxed. A barcode label is applied to the box for long-term storage.

D.1.9.7

Retirement

The Contractor shall process regulatory documents for retirement to the Federal Records Center (FRC). CDER’s DRM staff shall ensure that the CDR receives a listing of regulatory documents that are scheduled for retirement to FRC.

Upon receiving the listing of regulatory documents scheduled for retirement, the Contractor shall provide the following services:

· The boxes are removed from their appropriate locations at CDR and scanned out to the Federal Records Center (FRC).

· A Records Transmittal and Receipt form is filled out by the Contractor and sent to FRC for approval, prior to shipping the retirement records.

The Records Transmittal and Receipt form identifies the office retiring the records and the FRC center the records will be sent to (Suitland, Md. facility serves CDR).

The Contractor shall record on the form the following information:

· Accession Number,

· Volume Number,

· Agency Box Numbers,

· A series description with dates of records included on the first page,

· Disposal Authority,

· Disposal Date.

The form is several pages long, with subsequent pages identifying each series of records that is being retired by the appropriate application number and corresponding volume number, as well as the box that each volume is placed in and identified by box number.

Upon completing the Records Transmittal & Receipt form along with two copies, the Contractor shall forward these documents to the DRM’s Records Manager, for QC inspection.

Upon completion of QC inspection, the records manager submits the form to FRC for review and final approval. FRC, upon final approval, returns the approved form back to CDR notifying that the retirement shipment is ready for pick-up by FRC.

When approval is granted, the Contractor shall record the accession number and box number on each box to identify it. Each shipment contains a total of 200 boxes. Upon completion of this task, CDR notifies FRC that the shipment is ready for pick-up.

The Records transmittal and receipt form is sent with the boxes to FRC, with a copy filed at CDR. A signed copy of the form is sent to the FDA Records liaison officer, upon arrival at FRC.

C.1.10 Other CDR Miscellaneous Activities

D.1.10.1 Shredding

CDR maintains shred bins throughout the Ammendale facility. The Contractor shall shred sensitive documentation or any regulatory documentation that is not deemed archival.

The Contractor shall place all shred material in the properly marked shred bins, which are specifically located at assigned areas within the CDR facility.

The Contractor shalld perform random inspections of shred bins and trash receptacles to ensure that the proper material is being disposed of correctly. The Contractor shall have periodic training sessions to address what should be shredded and what can be disposed of by normal means.

D.1.10.2 CDR Facility Maintenance Issues

The Contractor shall report any CDR facility maintenance issues to the Project Officer. The Project Officer shall inform CDER’s Faculty Group for resolution of the facility problem.

D.1.10.3 Facility

All general facility and building issues are handled by the FDA facilities representative and the Project Officer in conjunction with the Contractor’s Program Manager.

D.1.10.4 CDR Equipment

The Contractor shall direct any issues or concerns relating to malfunctioning or non-operational CDR equipment to their immediate supervisor. The Project Officer shall forwarded these issues to CDER’s Facility Group for resolution.

D.1.10.5 Supplies

Requests for supplies and the inventory of supplies shall be the responsibility of the Contractor. Supply requests shall be submitted to the Program Office for processing.

D.2

BAR CODE TEAM

D.2.1

Barcode Team

The Contractor shall maintain an accurate tracking history of all CDER regulatory documents submitted to CDER by the Pharmaceutical community.

The Contractor shall provide the following services and operational functions:

· Provide Record Management services in support INDs, NDAs, ANDAs, and DMFs

· Ensure that all physical documentation is easily accessable to CDER personnel during normal working hours

· Conduct Document Room Inventory Inspections on a random to identify misfiled documents

· Perform “Office-to-Office” Regulatory Document Inventory Inspections on a monthly basis

· Perform Records Retirement Operations and Tasks

· Perform those Operations and Tasks required to support Special Projects

Note: CDER’s IND/NDA Volume Accountability System (INVAS) is the primary tool used to track and monitor regulatory documents throughout CDER’s Review community.

D.2.2

Barcode Team Functions and Program Operations

The Contractor shall provide the appropriate personnel and resources necessary to support the following Barcode Team functions and program operations:

· Records Management

· Inventory Control Management

· Records Retirement

· Special Projects

D.2.3

Records Management

The Contractor shall ensure that records stored in all CDER regulatory document rooms are properly filed and easily retrievable.

The Contractor shall ensure that adequate filing space is maintained for all CDER regulatory document rooms.

D.2.4

Inventory Control Management

The Contractor shall provide the appropriate personnel and resources necessary to develop, implement, and manage an Inventory Control Management system. The Inventory Control Management system shall provide the following activities and operations in support of CDER’s regulatory documentation:

· Barcode Label activities

· Inventory Inspections

· Inventory Data Entry and Upload operations

· Filing and Storage activities

· File Retrieval and File Back activities

The current Inventory Control Management system is CDER’s IND/NDA Volume Accountability System (INVAS).

D.2.4.1

Barcode Label Activities

The INVAS system relies primarily upon the use of barcode labels for identifying and locating applications.

The Contractor shall affix barcode labels on the inside jacket of each application. One label denotes the application’s Volume Number, while the second label identifies the Application Number.

During inventory inspection activities, the Contractor shall replace barcode labels if original labels are damaged or not affixed to the jackets properly.

D.2.4.2

Inventory Inspection Types

The Contractor shall provide the appropriate personnel and resources necessary to conduct the following inventory inspections:

· CDER “Office-to-Office” inventories

· CDER Document Room inventories

· Checking-In and Checking-out data in the event of a computer system outage

The Contractor shall develop and distribute an inventory inspection calendar to each CDER review division. This inventory inspection calendar shall outline the times and dates that the inventory shall be performed for that specific CDER review division.

The Contract shall be responsible for providing alternate dates and times if the initial dates and times assigned are not acceptable by the Review division schedule for that inventory time slot.

D.2.4.3

CDER “Office to Office” Inventory Inspection

The Contractor shall perform “Office-to-Office” inventories to the following CDER organizations:

· Office of New Drugs (OND) Review Divisions

· Office of Generic Drugs (OGD) Review Divisions

The “Office-to-Office” Inventory Inspections shall be performed using CDER’s INVAS tracking program with the use of portable hand-held scanners.

Prior to “Office-to-Office” inventory inspections, the Contractor shall create barcode labels that contain the reviewer’s COMIS/DARRTS assignment number code. These labels are placed on the office door jam for every CDER employee who requires inventory inspection.

This information will be associated with bar-coded documents so as to identify physical location of documents in the INVAS system.

The following bar-coded documents shall be inventoried by the Bar-code Team:

· IND Archival

· NDA Archival

· BLA Archival

· DMF Archival

· DMF Red Duplicate Jackets

· X Volumes

For “Common areas” and mail stops a barcode label containing a four digit room number shall be generated to capture any regulatory material found in the areas during the inventory inspection.

Documents located in areas not clearly identifiable with a single occupant and areas or offices used by multiple reviewers will be captured using a single location, or captured using the nearest bar-coded area or office.

Bar-coded jackets on open shelves, desk tops, mail in-box trays, or other open areas shall be inventoried. Boxes or buckets, clearly labeled and identifiable as bar-coded, jacketed regulatory submissions shall be inventoried.

The Contractor shall ensure that during “Office-to-Office” inventories that every effort is made not to disrupt the office area and that all documents remain in order.

D.2.4.4

Document Room Inventory

The Contractor shall conduct CDER Document Room inventory inspections for the following document rooms:

· Central Document Room (CDR) – located at Beltsville, Maryland

· DR1 – located on FDA White Oak Campus

· OGD’s Document Rooms – located at Metro Park North I&II, Rockville, Maryland

· Compliance Document Room – located on FDA White Oak Campus

· DDMAC Document Room – located on FDA White Oak Campus

CDER Document Room Inventory Inspections shall be performed using CDER’s INVAS tracking progam with the use of portable hand-held scanners.

The Contractor shall ensure that all scanner data captured during inventory inspections was properly transferred and uploaded into the INVAS database.

D.2.4.5

Inventories due to Computer Outages or System Problems

In the event of a computer outage or system problem the Contractor would scan documents that were checked-out or checked-in to the document room during the disruption of normal processing operations.

D.2.4.6

Inventory Data Entry and Upload operations

The Contractor shall verify that all inventory inspection information was successfully scanned to the hand-held portable scanner.

The Contractor shall perform a quality control inspection on the scanned data to ensure that the quality and accuracy of captured data on the hand-held portable scanner is acceptable.

If data is unacceptable, the Contractor shall document the data discrepancies and forward to the Contractor’s quality control inspectors for their corrective action.

D.2.4.7

Portable Scanner Data Transfer

After the Contractor has verified that the portable scanner data is accurate and acceptable, the data is uploaded to the dedicated computer using RapidGen software.

The Contractor shall perform a quality control inspection on the transferred data to ensure that the data was successfully transferred.

If the data was not successfully transferred, the Contractor shall document the data transfer discrepancies and forward to the Contractor’s quality control inspectors for their corrective action.

D.2.4.8

INVAS Data Uploads

The Contractor shall be responsible for data uploading the inventory inspection data into the INVAS database.

The Contractor shall perform a quality control inspection on the inventory inspection data to ensure that the data was successfully uploaded to the INVAS database.

If the upload was not successful, the Contractor shall document the data upload discrepancies and forward to the Contractor’s quality control inspectors for their corrective action.

D.2.5

Records Retirement The following Records Retirement processing services and support activities shall be performed by the Contractor:

· Retirement Records Storage

· Preparation of Retirement Records for transfer to FRC

· Shipping Retirement Records to FRC

D.2.5.1

Retirement Records Storage

The Contractor shall manage the storage of CDER retirement records. Retirement records are stored at CDER’s Central Document Room (CDR), prior to their transfer to FRC for final retirement.

The Contractor shall receive retirement records from following CDER document rooms:

· OND: White Oak Bldg. 22 -- DR1

· OGD: MPN-I & MPN-II, Wilkins Ave. document rooms

· DDMAC: White Oak Bldg. 51

The Contractor shall process and store these records in the CDR facility. The records shall be stored so that these records can be retrievable within 24-hours upon request.

D.2.5.2

Preparation of Retirement Records for transfer to FRC

The Contractor shall prepare all CDER retirement records slated for transfer to FRC for final archivial storage.

The Contractor shall perform the following processing operations and support tasks:

· separate the retirement records into series

Note: a series is defined as a "block of records having the same disposition authority and same disposition date."

· identify these records by the records schedule, item number, and cutoff date

· box records in accordance to FRC shipping standards

Note: a standard transfer consists of 200 applications boxed and paletted for transfer to FRC

· record all documents being transferred to FRC on the Records Transmittal and Receipt form (SF-135)

· email the completed SF-135 form to CDER’s Records Management Officer

· Create a detailed folder title list consisting of 200 applications

· email the folder title list to CDER’s Records Management Officer

Note: the folder title list may be recorded on the SF-135 form or on a separate sheet of paper and included as an attachment. The folder title list must accompany the transfer shipment to FRC.

Upon receipt of the approved SF-135 form from FRC, the Contractor shall perform the following box preparation operations:

· Record the transfer number and the box number in their designated area on each box

· Record the Session number in the upper left-hand corner for each box

· Record the box number in the upper right-hand corner sequentially for each box (example: Box 1 of 200)

· Write FDA in the middle of each box

For shipments over 20 boxes, the Contractor shall perform all the necessary processing tasks required to ensure that the boxes arrive at FRC in the correct numerical order. Box-1 must be unloaded first and must contain a copy of the approved SF-135 form.

For shipments under 20 boxes or less, the Contractor shall be responsible for sending this shipment via mail, either in a postal container or by bulk mail.

D.2.5.3

Shipping Retirement Records to FRC

The Contractor shall contact FRC to request a shipping date.

The Project Officer shall inform the Contractor with the date and time when FRC shall arrive at CDR for shipment pick up.

The Contractor shall place a completed SF-135 form and a cover letter in the first box of FRC shipment.

After FRC has received all documents and every record has been shelved, FRC will issues a location number and shall submit a signed copy of the SF-135 to the Contractor as an official record and receipt of the shipment.

The Contractor shall manage these FRC shipment receipts.

D.2.5.4

Special FRC Retrieval Requests

The Contractor shall provide those services and support activities required to retrieve requested Archival material from FRC. FRC retrieval requests are initiated by CDER’s review community via an email requesting a special pick-up from FRC.

The Contractor shall make all arrangements with FRC and provide the courier services for picking up the material requested and delivering the material to the requester.

D.2.6

Special Projects

The Contractor shall provide those services and support activities necessary to support the following Special Projects:

· Document Room Shelf Shifting

· Special Application File Retrieval Projects

D.3

OFFICE OF NEW DRUGS (OND)

D.3.1

Introduction

The OND Division Document Room (DR1) is responsible for providing all services and support activities necessary in the support of the review of Investigational Drug Applications (IND), New Drug Applications (NDA), and Biologics License Applications (BLA). The DR1 shall process multiple incoming document types as identified in the appendices (DARRTS supporting documents and COMIS document codes).

The Contractor shall be responsible for providing the necessary personnel and resources required to perform the following processing tasks and support activities:

· Mail Receipt and Processing

· OND Review Material Processing ( IND, NDA, BLA, and DMF)

· Quality Assurance & Quality Control Plans

· NDA Review Material Distribution to OND Reviewer Community

· Turnover Material Processing

· Material Distribution to OND Review Divisions

· DR1 Operational Functions and Support Activities

Incoming document types may consist of any correspondence directly related or associated to an application by referencing an IND, NDA, BLA, and/or a DMF application number. The contractor shall identify incoming original and subsequent amendments in a timely manner as defined below:

· Complete all mail activity within one (1) working day following the receipt of the IND, NDA, BLA, and/or DMF submission in the DR1.

· Complete all required processing within two (2) working days following the receipt by CDER for all new INDs, NDAs, and BLAs.

Note: total processing time is inclusive of Central Document Room (CDR) processing time.

· Complete all Treatment IND or Treatment IND Protocol processing within eight (8) hours of receipt by CDER. Note: total processing time is inclusive of Central Document Room (CDR) processing time.

· Complete all required processing with two (2) working days following the receipt by CDER for priority documents: meeting requests, special protocol assessment requests, and response to clinical hold.

· Complete all required processing within two (2) working days following the receipt by CDER for all new efficacy supplements and prior approval manufacturing supplements.

· Complete all required processing with two (2) working days of receipt by CDER for all other documents.

D.3.2

Mail Receipt and Processing

The Contractor shall develop and implement mail receipt and processing SOPs (standard-operating-procedures) necessary in supporting mail receipt and processing tasks.

DR1 processes a variety of Incoming document types. The document type defines how the contractor shall set processing priorities and workload levels, so as to comply with contractual processing timelines and standards.

Mail receipt and triage is the first step in identifying certain document types and the order of priority at which these documents shall be processed.

The contractor shall maintain a 99% processing accuracy standard.

Acceptance and approval of SOPs shall be the responsibility of the Program Office prior to implementation.

D.3.2.1

Incoming Mail Receipt

The majority of incoming mail is received at the Central Document Room (CDR) in Beltsville, MD. When mail is received, it is immediately stamped, sorted, identified, and triaged. With the exception of original INDs and NDAs, the mail that has been triaged by CDR is delivered to the DR1 document room located in White Oak staff for final mail processing.

Mail from the CDR is brought to the DR1 document room twice daily.

Note: Special deliveries may be required depending on the urgency and priority of the document. These deliveries can occur anytime within the DR1 document room’s operational hours (7:00 a.m. – 5:45 p.m.).

The balance of incoming mail emanates from internal sources such as the review divisions, inter-office mail stops, and inter-center courier deliveries. Infrequently, misrouted mail is also hand-carried and delivered to the DR1 document room by FDA personnel.

Note: Commercial courier deliveries (FedEx, UPS etc) are not accepted at the DR1 document room.

The Contractor shall develop and implement mail receipt logs that document and track mail receipt at CDR and DR1. These logs shall document at a minimum mail type, time received, volume counts, and name of document room personnel who logged mail. These logs shall be made available to the Project Officer weekly or upon request.

D.3.2.2

Mail Identification and Triage

When the CDR courier delivers the OND incoming mail, a delivery log must accompany the shipment identifying the contents of the shipment. The DR1 document room staff confirms the delivery contents against the delivery log. Regulatory mail shall be routed to the responsible area for processing.

Regulatory mail receipt questions or unresolved mail issues shall be forwarded to CDER’s Project Manager (PM) assigned to the appropriate drug review area for which the mail receipt issue is associated or falls under review. The document room staff shall request assistance and guidance from the appropriate PM in resolving mail receipt issues.

The DR1 document room staff shall research the intended recipient or processing area for any non-regulatory mail that is inadvertently received. When the intended recipient or processing area has been identified, the document room staff shall forward mail immediately.

Note: The contractor shall be responsible for documenting all irregular mail receipt cases, as described above, in a tracking log. The tracking log shall contain a description of the article of mail, who and where it was sent to and the time and date sent. The contractor shall maintain this log and shall have it made available to the Program Office upon request.

It is the responsibility of the Contractor to document any discrepancies or abnormalities associated to the shipment. The Program Office must be informed of this situation within 48 hours. The Program Office shall initiate a corrective action team to investigate and provide corrective action steps to resolve the situation.

Note: The following is important mail identification and triage information:

· For INDs and BLAs, original, duplicate, and triplicate volumes are delivered to the DR1 document room. For NDA’s, only original and duplicate volumes should be received.

· If the correct number of copies have not been supplied (3 for an IND and BLA / 2 for an NDA), and the material is less than 2” thick, the document room staff is responsible for photocopying the needed number of copies to make a complete set. If the material is more than 2” thick, the document room staff is responsible for notifying the PM to request more copies from the Drug sponsor.

· For all IND/NDA/BLA material, stamp the face sheet of the document in each archival volume with the “DR1 stamp” in addition to the application form.

· No Electronic media is processed by the DR1 document room. If Electronic media is discovered during DR1 processing, the document room shall alert the EDR Project Officer of the discovery and then immediately deliver Electronic media to the EDR for processing.

D.3.3

DR-1 Material Processing

DR-1 Material Processing involves accurate identification of the document, analyzing for completeness, data abstraction and data entry into appropriate database, jacketing, barcoding, preparing a transmittal form, and distributing to the appropriate FDA review division.

D.3.3.1

Sources of Material

DR1 receives incoming regulatory documents and FDA generated review material. Refer to Table XXX for volume of material received.

Incoming regulatory documents can be formatted entirely in paper media, electronic media, or a hybrid of paper media and electronic media and are received by OND, in three different ways:

· From the Central Document Room,

· From OND’s Review Divisions and other internal FDA organizations,

· From FDA personnel.

The majority of FDA-generated review material is received electronically. FDA-generated review material for BLAs is received in a paper format.

D.3.3.2

Identification and Validation

The Contractor shall perform the following mail receipt identification and validation tasks:

· Identify Priority documents during mail triage and immediately separate these documents from the non-priority documents for immediate processing.

Priority documents are listed below:

· New INDs

· New NDAs

· New BLAs

· New NDA and BLA supplements

· IND treatment protocols

· Meeting requests

· Request to charge

· Special protocols

· Briefing packages

· Response to clinical hold

· Bundle in batches all “priority documents” and place on the “priority documents” shelf for immediate processing.

· Validate that each initial IND submission and each subsequent submission to that document are accompanied by a SF 1571 form.

· Validate that each initial NDA submission and each subsequent submission to that document is accompanied by a SF 356h form.

· Bundle all Non-Priority documents are for processing.

· Validate that the corresponding OND Mail Processing Log is attached to each group of submissions.

· The contractor must maintain a 99% processing accuracy standard.

D.3.3.2.1 Desk Copy and Trailer Volumes

The DR1 document room staff shall be responsible for providing processing services to execute the following tasks in support of Desk Copy and Trailer Volume processing activities:

· If an extra submission is marked “Desk Copy”, the document room staff shall be responsible for logging in the desk copy and giving it to the PM. Desk copies are not bar-coded.

· When trailer volumes are received, a pink sheet is attached to the boxed volumes by the document room staff indicating the total number of boxes received.

Note: The total number of boxes includes the first volume that was taken out for processing.

All trailer volumes are kept in the mailroom staging area, separated by review division. After processing, the trailer volumes are matched back up with the first volume of the submission.

D.3.3.2.2 OND Jacket Creation

Although review jackets are color-coded, industry is not required to submit their applications in specific jackets. See http://www.fda.gov/cder/ddms/binders.htm for more information. If submissions are received for processing without a jacket, a jacket must be prepared.

The contractor is responsible for providing the appropriate personnel and resources to support the following processing tasks:

· All archival volumes must be jacketed. All material to be jacketed first needs to be hole-punched.

· Re-jacket (if applicable) the first volume only (.1 volume) for duplicate and triplicate volumes.

All jacket volumes are bar-coded and labeled with the following information: IND or NDA number, sponsor, volume number etc. for tracking purposes.

D.3.3.2.3 OND Data Entry

The Contractor shall perform the following processing tasks in support of OND data entry:

· Verify the IND, NDA, or BLA number on the submission with the Mail Receipt Log.

· Verify the application’s number from the SF-1571 form is consistent with the cover letter and the document’s content.

· Immediately inform Project Officer of any validation errors or discrepancies uncovered during verification processing.

· Document and record any validation errors or discrepancies.

· Resolve validation errors or discrepancies within 24 hours from initial discovery of error or discrepancy.

D.3.3.2.4 NDA Data Entry into COMIS and ECH:

The Contractor shall perform data abstraction and data entry of all NDA data into CDER’s COMIS and ECH electronic systems. The following data are abstracted from forms and the cover letter.

· Application Number

· Sponsor/Applicant Name

· Sponsor code

· Review Division

· Established Drug Name

· Proprietary Drug Name (if applicable)

· Therapeutic Drug Class Code

· Document Type

· Document Sequence Number

· Document Modifier

· Submit (Letter) Date

· CDER Receipt Date

· Bar Code Volume Number

· Discipline Reviews as required

· Reviewer Assignment

· Review Completion Date

· Reviewer Status

· Document Decision Type

· Decision Date

· Application Status

· Status Date

The contractor shall perform quality control of all data entry. This quality review must take place within (1) working day of the initial data entry.

Discrepancies found during verification or at any other time shall be resolved or forwarded through appropriate channels for resolution immediately (maximum of one working day).

A log documenting these discrepancies shall be kept and made available for review by the Project Officer upon request.

D.3.3.2.5 Post Data Entry -- Transmittal Form-FDA 2774A, The Contractor shall perform the following data entry services and support activities in support of Transmittal Form, FDA #2774A:

· Record the noted information into their respective fields on transmittal form – FDA #2774A, HFD, ARCHIVAL JACKET, MEDIA SUBMISSION, LETTER DATE, STAMP DATE, DR1 DATE, DOC TYPE, SEQ NUMBER, MOD, IND/NDA TYPE, TO: PROJECT MANAGER.

· The Contractor shall enter the names of any additional pool reviewers, the type of assignment, number of copies submitted and the number of volumes submitted, the data entry operator’s name and date in which the data entry task was completed.

· The Contractor shall attach the completed transmittal form to the front of the first “Archival Volume” (the .1 volume or temporary volume)

· If multiple volumes have been placed in boxes, the Contractor shall identify the archival volume by placing a (marker) signifying the location of the additional volumes.

· For non-priority documents, place the completed document in the designated area for barcoding.

· For priority documents immediately barcode.

D.3.3.2.6 INVAS – IND/NDA Volume Accountability System

INVAS is used primarily as an electronic inventory and jacket locating system.