Attachment B - Sample Task Order SOW.docx

Food and Drug Administration

On-site Record Information Management

Sample Task Order Statement of Work Records Management Staff Document Control Center and Records Management Services

Attachment B Solicitation No. 75F40120R00004 On-Site Record Information Management (RIM)

Table of Contents

Attachment B Solicitation No. 75F40120R00004 On-Site Record Information Management (RIM)

1. INTRODUCTION

The Mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance the public health through the regulation of biological and related products. This includes blood, vaccines, and cellular and gene therapy products, human and cell tissues for implantation or transplantation, and medical devices involved in the collection and processing of blood and blood components; and advanced therapies per statutory authorities. The regulation of these products is founded on science, law and data standardization to ensure purity, potency, safety, efficacy and availability. The vision of CBER is that it advances the public health and merits the public trust through innovative regulation to ensure that safe and effective products reach the public as rapidly as possible. CBER demonstrates international leadership in science-based regulation through a managed regulatory process, coordinated research, and the use of partnerships. Included in CBER goals is a managed and integrated regulatory process, from discovery of a product to post-marketing, and participation in interactive information systems.

The Records Management Staff (RMS) supports CBER in its public health mission by providing life cycle records management. The RMS focuses on critical program areas related to records management, scientific support, bioinformatics, regulatory data quality and process, document management functions and business operations support for the CBER community in their efforts to ensure the purity, potency, safety and efficacy of biologics.

2. BACKGROUND

2.1 SERVICE LOCATIONS

The Contractor shall perform the tasks outlined in the Task Order (TO) at the following CBER locations. Locations in the metropolitan Maryland area may be added and deleted, as needed. Service locations include:

White Oak campus, 10903 New Hampshire Ave, Silver Spring, MD 20993

2.1 QUALITY CONTROL

The Contractor shall establish and maintain a complete Quality Control Plan to ensure the requirements of the Task Order are provided as specified. A draft plan must be submitted as part of the Contractor's work plan. A final copy must be provided to the Task Order Contracting Officer’s Representative (Task Order COR) one (1) month from the Task Order start date and as changes occur. The plan shall include:

· An inspection system covering all the TO services;

· Methods for identifying and addressing defects in the quality of service before the level of performance becomes unacceptable.

All documentation related to inspections conducted by the Contractor shall be made available to the Government at the request of the Task Order COR.

2.2 QUALITY ASSURANCE

The Government will evaluate the Contractor's performance under this Task Order. The Government will record all surveillance observations. When an observation indicates unsatisfactory performance, the Government will request the Contractor's representative to initial the observation.

Performance Evaluation Meetings - The Task Order project manager may be required to meet at least weekly with the Task Order COR during the first month of the Task Order. Meetings will be as often as necessary thereafter, as determined by the Task Order COR.

2.3 PHYSICAL/PERSONNEL SECURITY

All positions under this Task Order must meet and receive Tier 4 Security Public Trust Position clearance (Sensitive High Risk), as outlined in the IDIQ contract.

Physical security requirements are included in the standard clauses of the IDIQ contract.

The Contractor shall be responsible for safeguarding all Government property provided for use under this Task Order. At the close of each work period, Government facilities, equipment and material shall be secured.

Badging - All Contractor staff are required to wear government issued badges (PIV card) while in FDA facilities. Badges will be issued by the FDA badging office. Lost, stolen, mutilated or destroyed badges will be reported to the Task Order COR immediately. Badges for terminated employees must be surrendered to the Task Order COR on the employee’s last work day. If an employee is being terminated for cause the project manager must inform the Task Order COR one business day in advance, this will allow time to suspend network account, card reader and building access.

Controlled Entry - Entrance into all locations of the Document Control Center (DCC) are to be controlled through a single-entry point. FDA visitors are required to sign in and out at the entrance and state the purpose of their visit. A log shall be kept of all such visits. Non-FDA persons are not allowed access to these areas. Permanent Contractor workforce personnel and authorized CBER employees (as determined by the Task Order COR) are not required to sign in or out. The Contractor shall provide the Task Order COR a roster of Contractor personnel that are employed for this Task Order and shall update as necessary.

Key, Lock and Code Control - The Contractor shall establish and implement a procedure for ensuring that all keys, lock combinations and access codes issued to Contractor personnel by the Government are not lost, misplaced and not used by unauthorized persons. The Government will furnish all keys, combinations and access codes required for satisfactory accomplishment of tasks described in this Task Order.

Keys issued to the Contractor shall not be duplicated. Combinations and access codes shall not be disseminated beyond a "need to know" basis.

The Contractor shall report loss of a key or compromise of a combination or access code immediately to the Task Order COR or RMS chief. The Government will replace all keys lost by the Contractor or, at the Government’s discretion, existing locks will be replaced; the direct cost of which will be charged to the Contractor. Cost of replacing combination locks resulting from Contractor caused compromise of combination will also be assessed to the Contractor. Combinations to locks may also be changed at the discretion of the Government.

2.4 HOURS OF OPERATION

Normal Hours - The Contractor shall maintain continuous service in the Document Control Center during the following hours:

Monday – Friday - 8:00 a.m. - 4:30 p.m., Eastern Time (ET)

Recognized Federal Holidays - The Contractor is not required to provide service on Federal holidays outlined in the IDIQ contract. The Contractor shall follow the inclement weather statement outlined in the IDIQ contract.

In the case of a Continuity of Operations Plan (COOP) event, the Contractor may be directed by the Task Order COR to initiate actions that restore operability of the DCC and perform other tasks that the RMS deems essential.

The ability to “maintain document availability for critical review” has been identified as an “essential function” in CBER’s COOP Plan. Responsibility for this activity rests with the Task Order COR, the RMS chief and the Contractor’s Task Order Project Manager. One or more of these positions may be considered part of the CBER COOP Emergency Relocation Group (CERG).

Early closing of the DCC will be at the discretion of the Task Order COR or the RMS chief, and will follow the policies of CBER’s Immediate Office of Director (IOD).

2.5 PROPERTY, EQUIPMENT AND SUPPLIES

The Government will provide, without cost to the Contractor, the facilities, equipment and materials needed for this Task Order. See standard clauses in the IDIQ contract for property inventory and maintenance.

2.6 OTHER DIRECT COSTS AND TRAVEL

CBER anticipates that there will be no Other Direct Costs (ODC) or Contractor charged travel costs for this Task Order.

All standard definitions are outlined in the IDIQ contract.

2.7.2 TECHNICAL DEFINITIONS PARTICULAR TO THIS STATEMENT OF WORK

Biologic License Application File – Contains information about the manufacturing procedures, clinical studies and testing methods of biologic products as well as information about manufacturing locations. This information is submitted as part of a Biologics License Application (BLA) for all products. It is updated in the form of a Biologic License Supplement (BLS). Supplements may be brief or very extensive depending on the product, manufacturing, testing requirements and purpose of the supplement. Amendments are submitted during the review as a response to a CBER communication or to supply additional information. See 21 CFR Part 600.

Investigational Related Applications (IRA) – This term refers to application for drugs or biologics for investigational clinical use. It includes the following primary submission types:

Investigational New Drug (IND) and Investigational Device Exemption (IDE) -Contains information about the manufacture of and clinical trials of investigational new drugs and devices. The Application and any amendments submitted to CBER are forwarded to the appropriate reviewing division or office. After review, two copies of all submissions and amendments are maintained. A third copy is circulated for review and then destroyed when no longer needed.

Emergency Use Authorization (EUA) – This term refers to a portion of Section 564 of the Food, Drug and Cosmetic Act. This section allows the agency to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared national emergency.

For this declaration to take place, an applicant must submit a request and associated documents to the agency for review and processing. CBER uses the term EUA to describe the submission itself and its related processing.

Master File (MF) - A Master File is a submission of information by an applicant who intends it to be incorporated by reference when an IRA or Marketing application is submitted, or to permit others to reference the document without the information being disclosed to a third party. It may contain information about facilities and operating procedures or drug substance or components used to manufacture a product or packaging material and components used in production. These files are referenced by the manufacturer in an IRA or Marketing application or supplement and then are reviewed by the scientific staff as they review the applications.

New Drug Application File (NDA) - These files are for drugs, which are regulated by CBER but are not considered biologics. These filings after receipt reviewed are tracked like license applications. They are filed and maintained after review and approval.

Product Protocol Release File - Contains forms showing the results of the manufacturer's processing and testing of individual lots of a product which are subject to lot by lot release, a summary sheet showing testing and review by CBER laboratories. A copy of the release document sent to the manufacturer authorizing distribution of the product in interstate commerce is also attached.

Protocols are received by and processed in the Division of Manufacturing and Product Control (DMPQ) and reviewed for accuracy, completeness and correctness of results and then sent to the individual laboratories for further review and any required testing. When the lot is recommended for release, DMPQ prepares the release form, notifies the manufacturer of the status and the protocol and forms are then sent to DCC for filing.

Device Pre-Market Application (PMA) and Premarket Notification (510k) - These files are submissions for a Premarket Application (PMA) for a new device or application (510(k)) for medical devices judged to be substantially equivalent to a device which is already on the market. They are received and forwarded to appropriate scientific reviewing staff and then filed after review and approval.

Humanitarian Device Exemption (HDE) – A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations.

513G Submissions - A request for information respecting the class in which a device has been classified or the requirements applicable to a device.

Product Development Protocol (PDP) -- The PDP is essentially a contract that describes the agreed upon details of design and development activities, the outputs of these activities, and acceptance criteria for these outputs. The clinical evaluation of a device and the development of necessary information for marketing approval are merged into one regulatory mechanism. Ideal candidates for the PDP process are those devices in which the technology is well established in industry.

Direct DeNovo - Mechanism for classifying new devices for which there is no predicate device. Intended for lower risk devices.

Blood and Tissue Registration Files – These files contain copies of Blood Establishment Registration Form FDA 2830 and Tissue Establishment Registration Form FDA 3356 received yearly from all registered blood and tissue banks and may contain copies of inspection reports or correspondence associated with the location.

Unlicensed Establishment Files -- These files contain establishment information, variance requests, donor re-entry information for unlicensed or unregistered blood banking facilities. Submissions are typically classified as Unlicensed Establishment Submission (UES).

Computer Databases, Systems and Repositories- Currently several Oracle databases and other systems are used by RMS. Some information in databases may be used to locate submissions and fill requests. They include, but are not limited to:

· Document Accountability and Tracking System (DATS): This is the RMS primary database capturing a variety of information related to CBER submissions.

· Electronic Document Room (EDR) is the repository for all CBER electronic submissions.

· SharePoint Sites are used to store and make accessible records management related information and guidance useful for internal and external CBER staff.

· Regulatory Management System – Biologics License Application (RMS-BLA) used to track and report on BLAs using assigned Submission Tracking Numbers (STN).

· Biologics Investigational and Related Applications Management System (BIRAMS) is used for tracking and reporting on IND, IDE, EUA and MF.

· Blood Logging and Tracking System (BLT) and Device Tracking System (DST) are used to maintain information related to the status and review progress of submissions for the approval of devices and products related to blood handling. DST will replace the BLT system over the next two (2) years.

· Biologics Information Tracking System (BITS) focuses on providing small application modules to allow for the processing of regulatory material that is not handled by the other CBER business systems. The modules share a common user interface, Oracle Apex, and database schema.

· Unlicensed Variance and Re-entry (BITS-URVR) used to track variance requests and donor re-entry requests for unlicensed blood establishments.

Additional databases may be used and described in this document or may be developed subsequently.

Submission Formats and Standards

· Electronic Common Technical Document (eCTD) -- The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

· eSubmitter -- The FDA's eSubmitter software is part of an electronic submissions process that is available for voluntary use by sponsors, manufacturers, and importers to create a variety of submission types within the drug, blood, device, radiological health, tobacco, animal drug and animal food regulated industries.

· eCopy -- An electronic copy (eCopy) is an electronic version of a medical device submission stored on a compact disc (CD), digital video disc (DVD), flash drive or other accepted electronic media. Since January 1, 2013, the eCopy is required for all CBER medical device submission.

The Records Management Staff (RMS) provides life-cycle records/information management support to CBER. Over the last twenty (20) years, CBER has developed a unique program that marries mandated Federal record keeping requirements with its public health mission.

Recent changes in the organizational structure of CBER, along with the continued efficiencies of electronic applications and digital imaging, have streamlined submission processing. These efficiencies have eliminated the need for the routine routing, delivery and return of all paper application submissions. The Center’s priority is to leverage these efficiencies, reshape the DCC’s priorities and streamline operations to a more agile model. This operational agility will allow for a more flexible staffing model. The RMS also has a mandate to provide records information management support for all CBER records regardless of business use or media type.

3.2 SCOPE

The scope of this Task Order is to provide submission processing services, collection maintenance and records management services to the Center for Biologics Evaluation and Research.

3.3 OBJECTIVE

The objectives of this Task Order are to:

· Execute the daily operation of the CBER Document Control Center;

· Support the CBER Records Management Staff and its program responsibilities to the Center, Agency and the Department;

· Support the CBER shift to fully electronic records environment;

· Safeguard the CBER’s physical and digital records.

3.4 TASK 1: Record Information Management Support (IDIQ 1.14) The RMS Records Information Management Support function moves CBER to a more knowledge-based information governance environment. This environment will integrate Generally Accepted Recordkeeping Principles, NARA’s M-12-18 guidance and information governance with standing business processes, while taking advantage of cutting-edge technology.

3.4.1 Records Inventory (IDIQ 1.14)

At the direction of the Task Order COR, the Contractor shall conduct baseline and follow-on records inventories. The inventories may deal with any or all records found in the Center. Records will be of various media types on a variety of storage platforms. The Contractor shall develop, with Task Order COR approval and RMS subject matter expert support (RMS/SME), an approach and methodologies for conducting inventories.

3.4.2 File Plan Development (IDIQ 1.14.1)

As part of the Center-wide records management program, CBER has developed a comprehensive file plan (CFP). The CFP accommodates all records series identified during the baseline records inventory. The CFP maps to existing records schedules -- CBER, FDA, Department of Health and Human Services (HHS) and National Archives and Records Administration-General Records Schedules (NARA-GRS). The CFP is based on Designing and Implementing Recordkeeping Systems (DIRKS) methodology and uses a Commercial Off the Shelf (COTS) taxonomy tool (Synercon’s a.k.a.).

At the direction of the Task Order COR and with RMS/SME support, the Contractor shall continue development, implementation and management of the CFP. The CFP shall include, but is not limited to, researching additional methodology strategies, drafting new records series and updating the taxonomy tool. The CFP shall continue to be media neutral and shall account for various storage platforms found in the Center. At the direction of the Task Order COR, the CFP shall be expanded to include record series from other FDA Centers/Offices.

3.4.3 Records Control Schedule Development (IDIQ 1.14.2)

The RMS is responsible for the development of CBER specific Records Control Schedules (RCS) and coordinating the approval process. This includes conducting gap analysis of existing RCS, researching predicate schedules, drafting RCS language, meeting with RCS stakeholders and evaluating/updating existing schedules.

At the direction of the Task Order COR and with RMS/SME support, the Contractor shall research, analyze, develop, draft or update CBER’s RCS. The Contractor shall develop a detailed approach for RCS gap analysis and RCS production considering FDA, HHS and NARA requirements. Since RCS development is closely tied to the CFP, the Contractor shall utilize RCS features in the a.k.a. taxonomy tool.

3.4.4 Records Management Training and Outreach (IDIQ 1.14.5, 1.14.7) The RMS provides records and document management training to a range of CBER staff, both Full Time Employee (FTE) and non-FTE, at all levels of the organization. This includes briefings for CBER senior management on records management issues that affect the Center’s mission.

At the Task Order COR’s direction, the Contractor shall develop training protocols for records users and records custodians. This shall include a variety of training options from simple records center user orientation to more advanced records custodian training. The Contractor may be required to develop information for senior level briefings. At the direction of the Task Order COR, the Contractor shall develop presentations, slides and handouts for formal and informal training sessions.

The Contractor, at the direction of the Task Order COR, shall support the process by arranging meetings, creating handouts, taking meeting minutes and providing records management expertise, as needed. The Contractor, at the direction of the Task Order, shall prepare additional outreach and records management communications plans for the RMS.

3.4.5 Electronic and New Media Records Management (IDIQ 1.15.4) Electronic records management is a constantly changing topic in Federal recordkeeping. Government-wide issues such as e-mail management, web records and databases are being managed to varying degrees. New Media e-records issues such as cloud storage, Wiki’s, Blogs (traditional and microblogs) and Social Networks are fast becoming common in the Federal environment. Much like other agencies, CBER is moving toward these technologies.

As part of the redesign of the CBER Electronic Document Room (EDR), the Center has been strengthening its electronic records management processes. The EDR includes a Records Management Application (RMA) to manage all electronic records series found in CBER.

The Contractor, at the direction of the Task Order COR, shall audit and quality check programmatic and office administration records added to the CBER EDR. The quality check shall focus on the document descriptions entered by the user and the CFP categories assigned. The quality check process shall require expertise in document level indexing, creation of indexing guidelines and quality control plans.

The Contractor, at the direction of the Task Order COR, shall develop a process to handle New Media e-records throughout their life-cycle. The Contractor shall consult with RMS on new electronic records management issues and related industry solutions.

The Contractor, at the direction of the Task Order COR, shall provide implementation support and management of COTS RMA tool. RMA support shall be mainly limited to the records manager roles, but may be expanded. RMA support shall coordinate seamlessly with the CBER CFP.

3.4.7 Office Level Records Management Support and Program Consultation (IDIQ 1.14.5) The RMS is responsible for integrating a life-cycle records management program into CBER’s business processes. An important part of the program will be providing direct records management support to CBER offices for a variety of Federal records. This will include the development and implementation of media neutral records policies.

At the direction of the Task Order COR, the Contractor shall develop records management initiatives that will provide direct support to CBER offices. This shall include supporting the RMS/SME in directly advising and consulting with CBER offices on records storage, maintenance and disposition issues. The Contractor shall plan, implement and provide staff consultation services, as directed by the Task Order COR. This may include planning and attending steering committees and working groups that address records management issues.

The CBER DCC receives and processes regulatory records in various stages of Investigational or Marketing review. The submissions are related to biologic products (see 21 CFR 312, 21 CFR 314, 21 CFR 600 and 21 CFR 800). For business processing purposes, the submissions are grouped as Investigational Related Applications (IND, IDE, EUA, and Master File) and Marketing (BLA, BLS, PMA, 510(k), NDA, ANDA, URE, HDE, 513G).

Changes to federal regulations and record-keeping requirements have resulted in CBER’s transition from paper-based submissions processing to predominantly electronic document management services. Such services include, but are not limited to, the implementation of processes associated with document imaging, quality control, validation of key data, and collaboration with subject matter experts and technical staff.

The Contractor shall perform document preparation imaging and quality control of all incoming paper submissions received in the DCC processing. The Task Order COR will notify the Contractor of file types exempted from this requirement.

The Contractor shall report technical issues, including, but not limited to, accessibility, reliability, functionality and other technical issues that may affect the ability of the Contractor to perform tasks.

The Contractor shall assist with performing User Acceptance Testing and documenting the results to support the development, modification and enhancement of CBER information systems and repositories used by the RMS.

The Contractor shall develop or update internal document management related procedures and guidance.

The Contractor shall keep abreast of current document management tools, practices and trends to support the improvement and efficacies of CBER processes and procedures.

For purposes of clarification for this Task Order, the terms “Jacket” and “Folder” may be used interchangeably.

While CBER has moved to an electronic submission and review environment, it is possible that the occasional hardcopy of a new submission will need to be routed to a review office. Requests for routing (documents for review), circulation (folders for reference) or specific requested DCC actions from CBER staff are received by email or the DCC Action Notice process. The outputs for these requests shall be generated at least two (2) times each working day by the Contractor, no later than 10:30AM and 2:00 PM ET, for action, as described in the following appropriate sections.

The Contractor shall perform the following duties related to the processing of incoming submissions. Incomplete or questionable submissions shall not be date stamped for processing until after being positively identified by the Task Order COR or designated CBER staff.

3.5.5 Shipments (IDIQ 1.3.2, 1.13.3)

Shipments are delivered to the CBER DCC by commercial carriers (UPS, FedEx, DHL, etc), private couriers, the FDA mail system and via inter-center transfer. Incoming shipment with tracking numbers, air-bill numbers or Certified Mail numbers shall be entered in the DATS shipment screen prior to opening and identification for processing. Shipment information shall be entered throughout the day as to expedite submission processing in the timeframes listed below.

The Contractor shall escort couriers from the FDA loading dock (Building 52) to the DCC delivery entrance. Couriers delivering to the FDA campus shall be responsible for moving the shipments from the loading dock to the DCC. Only at the direction of the Task Order COR or designee, shall the Contractor take possession of a shipment at the loading dock and bring it to the DCC.

3.5.6 Digital Imaging of Regulatory Submissions and Applications (Task 1.13.6) CBER’s digital imaging (scanning) program is focused on all incoming paper submissions. The Contractor shall scan paper regulatory submissions and load them to the CBER EDR. This includes all paper IRA and Marketable submissions that are not required to meet the FDA electronic submission mandate. The Contractor shall follow all relevant FDA standards (listed below) for digital imaging, including work flow process, quality control, image quality, equipment calibration, document certification and required indexing.

Imaging parameters outlined in the FDA standards shall be modified via technical direction from the Task Order COR or designee as the imaging program evolves. Application types, document types, number of pages, page size and color content shall all be added. The following imaging parameters shall be followed.

· Scanned images must be readable and as true a representation of the hardcopy source document as possible;

· Text pages shall be scanned at 300dpi;

· Color graphics and photographs shall be scanned at 600dpi;

· Scanned images shall be rendered to the PDF format before loading to the EDR;

· Scanned images must have Optical Character Recognition (OCR);

· Large paper submissions between 100 – 150 pages shall be logically broken out into batches and scanned;

· At the direction of the Task Order COR, the Contractor shall Hyperlink index selected large submissions or selected documents.

At the direction of the Task Order COR, the Contractor shall scan existing collections of records to facilitate storage/use requirements by the RMS or the Center.

3.5.7 Rejection of paper and non-standard eSubmissions (IDIQ 1.13.2) FDA requires that certain applications be submitted in the eCTD format via the FDA Gateway. Providing Regulatory Submissions in Electronic Format --Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. Guidance for Industry was published in April 2017 (updated January 2019) and outlines FDA’s requirements for submitting electronically. In May 2017, the RMS began rejecting paper and hard-media Marketing applications that required an eCTD Gateway submission. Since May 2018, commercial Investigational New Drug Applications and Master Files (excluding Type 3) are required to submit eCTD through the FDA Gateway. The Contractor, at the direction of the Task Order COR, shall reject applications that fail to meet the eSubmission requirements.

Paper and Media Submissions: Paper IRA and Marketing submissions that must be submitted per the eSubmission guidance shall be rejected. This includes commercial IND submissions, Master Files submissions (excluding Type 3), New Drug Applications, Abbreviated New Drug Applications and PDUFA Biologic License Applications and supplements.

IRA Rejections: At the time of submission triage, the Contractor shall use the FDA-1571 and/or the Biologics Investigational Related Application Management system (BIRAMS) to determine eSubmission compliance. Submissions not required to meet the eSubmission guidance (research IND or Type 3 Master Files) shall be processed as outlined below. Applications that require electronic submission shall be captured in DATS using the non-application type REJ. Once confirmed and quality control checked in DATS by the Task Order COR or designated RMS employee, the Contractor shall prepare the Rejection Notice and send it to the applicant. An electronic copy of the rejection shall be stored on the DCC share drive (I: drive).

Marketing Submissions: At the time of submission triage, the Contractor shall use the Regulatory Management System – Biologics License Application (RMS-BLA) to check the PDUFA status to determine eSubmission compliance. Applications not required to meet the eSubmission guidance (non-PDUFA BLAs) shall be processed as outlined below. Submissions that require electronic submission shall be captured in DATS using the non- application type REJ. Once confirmed and quality control checked in DATS by the Task Order COR or designated RMS employee, the Contractor shall prepare the Rejection Notice and send it to the applicant. An electronic copy of the rejection shall be stored on the DCC share drive (I: drive).

Failed Gateway eCTD Submissions: Electronic eCTD submissions that contain certain High errors shall be rejected. At the direction of the Task Order COR, the Contractor shall reject certain High error eCTD submissions. The rejections shall be captured in the DATS database using the non-application type REJ. The Task Order COR or designated RMS person will QC the rejection in DATS. The Contractor shall prepare the Rejection Notice and send it to the applicant. An electronic copy of the rejection shall be stored as directed by the Task Order COR.

3.5.8 Processing Original Investigational Related Applications (IND, IDE, EUA and MF) (IDIQ 1.13.3) IRA submissions that are required to be submitted electronically (eCTD via GIA) shall not be processed. See rejection process above. IDE submission must follow the joint CDRH/CBER eCopy Guidance, which is separate from the eSubmission requirement.

For New Investigational Related Applications (IRA) that are not required to be submitted eCTD through the FDA Gateway critical data elements shall be entered in the DATS database ,including the title, date received, sponsor information and number of volumes and copies. An IRA number shall be generated. The CBER received date shall be stamped on the cover letter and Form FDA-1571. Document barcodes shall be affixed in sequential order to the first page of each copy and volume of the IRA. A coversheet shall be generated from the appropriate tracking database.

The Contractor shall perform document preparation for imaging and scan submission in accordance with CBER’s requirements, as outlined in Section 2.2. The Contractor shall: prepare the scanned image for loading into the official repository by assigning a file name in accordance with current CBER DCC naming convention, and save it to the appropriate folder and location in accordance with current procedures. The contractor shall implement quality control procedures, to include, but not limited to, a page by page comparison or random sampling with the paper source document. The Contractor shall provide certification that the scanned copy is a true representation of the source document.

If not already received in binders, one (1) copy of the IRA (designated Archival) shall be placed in the appropriate binders. These binders shall be given folder barcode sequence numbers. Using the DATS database, all documents placed in a folder shall be associated with the folder barcode sequence number. Since all FDA generated IRA correspondence are managed electronically in the EDR, no physical correspondence volume should be made.

Submissions containing electronic media (CD, DVD, etc.) that conforms with electronic submission binding guidance or is submitted via the FDA Electronic Submissions Gateway shall be loaded into the EDR. The EDR load process includes entering the submission information into the DATS database and copying the e-submission into the EDR. The EDR will link the e-submission to the tracking database metadata. Quality control checks to determine complete and accurate loading of the submission shall be carried out.

IDE submission must include one (1) electronic copy as outlined in the joint CDRH/CBER eCopy Guidance. IDE submissions without an eCopy shall be processed and the product office (OBRR or OTAT) shall be notified that no eCopy was received.

The Contractor shall complete a quality check of all database entries, binding and labeling to ensure accuracy. The Contractor shall complete a quality check of all EDR load processes.

Receipt, database entry, binding and labeling shall be completed within one (1) working day after submission receipt. EDR loading, including scanned images, shall be completed within twelve (12) working hours of submission receipt.

3.5.9 Processing IRA Amendments (IDIQ 1.13.3)

IRA submissions that are required to be submitted electronically (eCTD via GIA) shall not be processed. See rejection process above. IDE submission must follow the joint CDRH/CBER eCopy Guidance, which is separate from the eSubmission requirement.

Amendments to an IRA that are not subject to rejection shall be entered in the DATS database capturing critical data elements, including IRA number, serial number, date received and number of volumes/copies. The tracking database will generate the amendment number.

The CBER received date shall be stamped on the cover letter and Form FDA-1571. Document barcodes shall be affixed in sequential order to the first page of each copy and volume of the application. The Contractor shall perform document preparation for imaging and scan submission in accordance with CBER’s requirements, as outlined in Section 2.2. The Contractor shall prepare the scanned image for loading into the official repository by assigning a file name in accordance with current CBER DCC naming convention, and then save it to the appropriate folder and location in accordance with current procedures. The Contractor shall implement quality control procedures, to include, but not limited to, a page by page comparison or random sampling with paper source document. The Contractor shall provide certification that the scanned copy is a true representation of the source document.

Submissions containing electronic media (CD, DVD, etc.) that conform with the electronic submission binding guidance or is submitted via the FDA Electronic Submissions Gateway and by email shall be loaded into the EDR. The EDR load process includes entering the submission information into the DATS database and copying the e-submission into the EDR. The EDR will link the e-submission to the tracking database metadata. Quality control checks to determine complete and accurate loading of the submission shall be carried out.

IDE amendments that do not include an eCopy shall be processed. The RPM assigned shall be notified via email that no eCopy was received.

The Contractor shall complete a quality check on all database entries and labeling to ensure accuracy. The Contractor shall complete a quality check of all EDR load processes.

Receipt, database entry and labeling shall be completed within one (1) working day after submission receipt. EDR loading shall be completed within twelve (12) working hours after submission receipt.

3.5.10 Processing Marketing Application (BLA, BLS, PMA, 510(k), HDE, NDA, ANDA, UES, 513G) (IDIQ 1.13.3) Marketing submissions that are required to be submitted electronically (eCTD via GIA) shall not be processed. See rejection process in above. Device submissions [PMA, 510(K), Qsub, etc.] must follow the joint CDRH/CBER eCopy Guidance, which is separate from the eSubmission requirement.

Marketing submissions, not required to be submitted electronically (new applications, supplements, amendments, and post-market submissions), shall be entered in the DATS database capturing critical data elements, including sender information, submission date, received date, responsible CBER office, mail-code, and related STN. A submission log number will be generated and physically captured with the CBER received date stamp on the cover letter and Form FDA-356h. Copies shall be designated Archival, Duplicate and sequential numbers. Document barcodes shall be affixed in sequential order to the first page of each copy and volume of the application. Document barcodes shall be captured in DATS and associated with the submission log number.

Submissions containing electronic media (CD, DVD, etc.) or received via the FDA Electronic Submissions Gateway and email shall be loaded into the EDR. The EDR load process includes entering the submission information into the DATS database and copying the e-submission into the EDR. The EDR will link the e-submission to the tracking database metadata. Quality control checks to determine complete and accurate loading of the submission shall be carried out.

The Contractor shall complete a quality check on all database entries and labeling to ensure accuracy. The Contractor shall complete a quality check of all EDR load processes.

Receipt, database entry and labeling shall be completed within one (1) working day after submission receipt. EDR loading shall be completed within twelve (12) working hours after submission receipt.

Paper submissions (excluding BLA/NDA submissions that fall under the electronic submission rule and Devices) with no corresponding electronic media shall be imaged and loaded into the CBER EDR. The Contractor shall perform document preparation for imaging and scan submission in accordance with CBER’s requirements. The Contractor shall prepare the scanned image for loading into the official repository by assigning a file name in accordance with current CBER DCC naming convention and save it to the appropriate folder and location in accordance with current procedures. The Contractor shall implement quality control procedures, to include, but not limited to, a page by page comparison or random sampling with paper source document. The Contractor shall provide certification that the scanned copy is a true representation of the source document.

3.5.13 Routing of Submissions (IRA, Marketable and Pre-Application) (IDIQ 1.13.3) Due to the mandatory electronic submission requirement, eCopy guidance and the digital imaging of remaining paper application the routine routing of materials for review shall not occur. There may be some instances where paper for media submission received on an external hard-drive cannot be scanned and/or loaded in the CBER EDR. In those instances, the paper copy or external hard-drive shall be routed. In the case of Original IRA or an Original Marketable submission, the Task Order COR or designee will be notified prior to routing.

All routings listed below, except eCopy Device routings, shall be done only upon request from the Regulatory Project Manager, or appropriate product/review office official.

IRA Original Submission: Following submission processing, one (1) copy of a paper Original IRA shall be routed to the responsible office’s representative. The routing shall be captured in DATS utilizing the folder sequence barcode number(s). To confirm delivery, the folder sequence barcode(s) shall be entered in the Point-to-Point (P2P) tracking system and a P2P coversheet shall be generated. All folders shall be bundled or packed to ensure accurate, safe and accountable delivery.

Initial routing of an Original IRA shall be completed within one (1) working day of submission receipt.

The responsible office’s representative may request routings of the additional copies using the DCCIND email account or the Electronic Original Submission (e-OS) form. The Contractor shall generate the Routing Report from the DATS database. The Contractor shall then route the additional copies to identified CBER personnel following the general process listed above.

Routing requests via e-OS or DCCIND shall be completed within one (1) working day after the request is generated from the Routing Report.

The Contractor shall complete a quality check of all database entries and routing coversheets to ensure accuracy.

IRA Amendments: IDE amendments (eCopy). IDE amendments that follow the eCopy process shall have the duplicate copy routed to the RPM, CSO or G-Reviewer, as appropriate. The routing shall be captured in the DATS database utilizing the document barcode number(s). To confirm delivery, the document barcode(s) shall be entered into the P2P module and a coversheet shall be generated. All amendments shall be bundled or packed to ensure accurate, safe and accountable delivery. Initial routing of the paper copy of an IDE amendment shall be completed within one and a quarter (1) working day of submission receipt.

CBER review teams that require the routing of an IRA amendment will send an email to the DCCIND account requesting a paper routing.

The paper routing process shall include the following. The routing shall be captured in the DATS database utilizing the document barcode number(s). To confirm delivery, the document barcode(s) shall be entered into the P2P module and a coversheet shall be generated. All amendments shall be bundled or packed to ensure accurate, safe and accountable delivery.

Emailed routing requests of an IRA amendment shall be completed within one (1) working day of request receipt.

Routing requests via e-PIAS for IDE submissions or for IRA submissions, as directed by the Task Order COR, shall be completed within one (1) working day after the request is generated from the Routing Report or within one (1) working day of the email. In the case where more routings are requested than the DCC has copies, the requests shall be entered in the DATS Pending Routing queue. Once a copy becomes available, it shall be routed within one (1) working day of the return.

The Contractor shall complete a quality check of all database entries and routing coversheets to ensure accuracy.

Routing of Marketing Applications: Following submission processing, one (1) paper copy of a Marketing submission shall be routed to the responsible office’s representative. The routing shall be captured in DATS utilizing the document barcode number(s). In order to confirm delivery, the document barcode(s) shall be entered into the P2P module and a coversheet shall be generated. All Marketing submissions shall be bundled or packed to ensure accurate, safe and accountable delivery.

Initial routing of a Marketing submission shall be completed within two (2) working days of submission receipt.

The responsible office’s representative will request routings for BLA related submissions using the Marketing Application Request System (MARS) function in RMS-BLA. The Contractor shall run the Routing Report from the DATS database. The Contractor shall then route the additional copies to identified CBER personnel following the general process listed above.

The responsible office’s representative will request routing for applications not tracked in RMS- BLA using the DCCMarketable email account. Upon checking this account, the Contractor shall route the additional copies to identified CBER personnel following the general process listed above.