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SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 1 - PART I: CDER TASK ORDER TABLE OF CONTENTS: CDER RECORDS MANAGEMENT TASK ORDER

I.1 TASK ORDER INTRODUCTION: ............................................................................................ - 3 -

I.1.1 BACKGROUND ............................................................................................................................ - 3 -

I.1.2 CDER RECORDS MANAGEMENT ENVIRONMENT ............................................................ - 3 -

1. CDER REVIEW OFFICES ................................................................................................................ - 3 -

I.1.3 OBJECTIVES .............................................................................................................................. - 13 -

I.1.4 SCOPE: ........................................................................................................................................ - 14 -

I.2 GENERAL AND SPECIFIC TASKS (FIXED PRICE) ........................................................... - 14 -

I.2.1 QUALITY CONTROL................................................................................................................ - 14 -

I.2.2 TASK ORDER MANAGEMENT ............................................................................................. - 14 -

I.2.3 TWO-MONTH TRANSITION-IN PERIOD .......................................................................... - 20 -

I.2.4 CDER RECORDS MATERIAL PROCESSING AND OPERATIONAL SUPPORT ACTIVITIES ......................................................................................................................................... - 22 -

I.2.5 RELOCATION SUPPORT (OPTIONAL LINE ITEM/ SEPARATELY PRICED) (FIXED PRICE) .................................................................................................................................................. - 33 -

I.2.6 TWO-MONTH TRANSITION-OUT (OPTIONAL LINE ITEM) (FIXED PRICE) ......... - 34 -

I.3 CONTRACT ADMINISTRATION .......................................................................................... - 36 -

I.3.1 PERIOD OF PERFORMANCE ................................................................................................ - 36 -

I.3.2 PLACE OF PERFORMANCE ................................................................................................... - 36 -

I.3.3 HOURS OF OPERATION ........................................................................................................ - 37 -

I.3.4 HOLIDAYS AND AFTER HOUR AVAILABILITY .............................................................. - 38 -

I.3.5 INVOICING ................................................................................................................................. - 38 -

I.3.6 GOVERNMENT FURNISHED EQUIPMENT (GFE) ........................................................... - 38 -

I.3.7 CONTRACT STAFF .................................................................................................................. - 39 -

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 2 - I.4 SPECIAL TERMS AND CONDITIONS .................................................................................. - 41 -

I.4.2 HHSAR AND FAR FLOW DOWN CLAUSES ....................................................................... - 41 -

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 3 - TITLE: CDER RECORDS MANAGEMENT TASK ORDER

I.1 TASK ORDER INTRODUCTION: The mission of the Center for Drug Evaluation and Research (CDER) is to promote and safeguard the health of the American public by ensuring drugs are safe, effective, and available in a timely manner. CDER performs pre-market review on new and investigational prescription drugs, biological therapeutics drugs, over the counter drugs, and generic drugs. In addition, CDER performs post market evaluation to ensure approved drugs are safe, identifies adverse events, and withdraws products from the market if necessary. The Center monitors promotional records material such as; TV, radio, and print drug ads. This Task Order supports CDER’s mission by having a contract vehicle in place to ensure CDER’s records material received in Document Control Center Facilities (DCCs) is accurately processed. CDER’s Office of Business Informatics (OBI) is charged with overseeing and supporting daily document control operations. Specifically, the Division of Data Management Services and Solutions (DDMSS) is responsible for streamlining the distribution of traditional and electronic submissions to the reviewer community, establishing standard procedures for processing records information, and preserving the integrity of the data received. To facilitate effective and reliable customer service, communication, and collaboration DDMSS has several Government liaisons that interface with CDER Records Project Managers (RPMs) and the reviewer community. DDMSS is divided into two teams. The Data Management Services Team (DMST) is responsible for managing records received in CDER DCCs and the eData Management Solutions Team (eDMST) is responsible for monitoring the quality and volume electronic submissions.

I.1.1 BACKGROUND In Calendar Year 2012 (CY’12) CDER processed a total of 233,675 paper and electronic submissions. The total volume of submissions represents Abbreviated New Drug Applications (ANDAs), Biological License Applications (BLA), Drug Master Files (DMFs), Investigational New Drug applications (IND), New Drug Applications (NDA), and Office of Prescription Drug Promotion submissions (OPDP). The volume of submissions increases on average 12% annually. For example, this would mean CDER expects to receive approximately 261,716 submissions by the end of FY’13. For more information on the volume of CDER submissions please see CDER TO Attachment No. 1 titled, CDER DCC 2012 December Monthly report. Currently CDER has approximately 3,500 FDA staff supporting the records review process.

I.1.2 CDER RECORDS MANAGEMENT ENVIRONMENT 1. CDER REVIEW OFFICES CDER’s DCC Facilities collect, process, distribute, and store paper and electronic submissions for several CDER Offices and Divisions. CDER currently has a total of 13 Offices. The DCC contractor will be responsible for providing support to all offices that have a need for records management support. Currently, the DCCs primarily support the following offices:

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 4 -

a. Office of New Drugs (OND) OND is a super office within CDER that manages and services six sub-offices and nineteen divisions. OND is responsible for ensuring safe and effective drugs are available to the American people. Types of record materials received and processed for OND are: NDAs, INDs, BLAs, User Fee Validation and Payment forms for prescription and biological drugs, annual reports, Adverse Event Reports (AERs), Post Market Requirements and Communications (PMR and PMC), correspondence, and other associated forms. Paper and Electronic records materials for OND are currently received in the following DCC Facilities: CDR, DR1, and EDR. The number of pages per submission can vary drastically but typically fall between 800 and 2400 pages with multiple volumes and boxes. Volumes are limited to a width of 2” or average of 400 pages per inch.

b. Office of Generic Drugs (OGD) OGD is a sub-office with nine divisions under the Office of Pharmaceutical Science (OPS). OGD primarily evaluates and approves ANDAs and their supplement submissions. Types of records Material received for OGD include ANDAs, Abbreviated Investigational New Drug Applications (AINDAs), supplements, amendments, correspondence, annual reports, AERs, and PMRs / PMCs. Paper and Electronic records materials for OGD are currently received in the following DCC Facilities: MPN1, MPN2, and MPN7, and EDR.

c. Office of Prescription Drug Promotion (OPDP)

OPDP is a sub-office with two divisions under the Office of Medical Policy (OMP). OPDP monitors drug advertising and promotional labeling to ensure they are not false or misleading. Types of record materials received for OPDP review are: television, radio, audio, and other promotional advertisement material. Paper and Electronic records materials for OPDP are currently received in the following DCC Facilities: DR2 and EDR. Please note it is expected OPDP will start receiving electronic submissions starting June 2014 with the release of eCTD 3.2.2 and GS Version 8. As a result, the amount of paper submissions processed annually should decrease substantially. The Contractor will be expected to accommodate to this shift.

d. Office of Compliance (OC) CDER OC is a leader in protecting consumer health by minimizing consumer exposure to unsafe, ineffective, or poor quality drugs. OC is comprised of four sub-offices and eleven divisions. Currently, the DCC contractor is responsible for receiving internal OC files already processed by OC staff and storing them at CDR, DR1, and Room 0471. EIRs are stored at CDR. The Office of Scientific Investigation (OSI) files are currently stored at DR1. Overflow files are stored in Room 0471. OC files take up a small portion of DCC space at 1,500 Linear Square footage in CDR Unit A and approximately 7,400 linear square footage between in DR1 and DR2. In support of OC, the DCC contractor also processes and validates OC’s Secure Supply Chain Pilot Program (SSCPP) form. The SSCPP is a stand-alone form that primarily comes in through the gateway. The SSCPP program is new therefore; there is no historical data on the volume of forms received. CDER anticipates receiving no more than 300 forms per year.

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 5 - 2. REGULATORY APPLICATION TYPES CDER DCCs primarily process regulatory records material that requires FDA review and approval. Regulatory material is priority and is subject to reviewer time clocks; as a result accurate and efficient processing is crucial to CDER’s mission. Types of regulatory material are:

a. Abbreviated Investigational New Drug Application (AIND)

AINDs are applications requiring bioequivalence studies be conducted using either an approved or unapproved generic version of a previously approved drug product. The filing of an AIND to conduct bioequivalence studies applies to only a limited category of products and conditions.

b. Abbreviated New Drug Application (ANDA) ANDAs are applications to market a drug product which has the same active ingredient (s), strength, and dosage form as a previously approved product (generally a full NDA). In CY’12 the document room processed 45,459 ANDA applications. The major submission requirements for this “new product” are evidence of bioequivalence with the previously approved product and full description of chemistry, manufacturing and controls, and labeling that conforms to that of the innovator’s product.

c. Biological License Application (BLA) A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical effects of the biologic product. In CY’12 the document room processed 2,861 BLA submissions. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.

d. Emergency Use Authorization (EUA) Application EUA applications allow the FDA to authorize the introduction into interstate commerce of unapproved products or unapproved uses of approved products (drugs, biologics, devices) for a potential or actual emergency.

e. Investigational New Drug (IND) Application INDs are applications filed with FDA by the sponsor who wishes to conduct clinical investigations. In CY’12 the document control room processed 91,983 IND applications. The material contained within the IND describes the investigational drug’s chemistry, manufacturing and controls data, preclinical (animal) data and any other prior clinical experience. The sponsor also provides in the IND the plan of study (including the actual proposed clinical protocols to be undertaken), the identification of the clinical investigators and their qualifications. Types of IND are as follows:

• Commercial IND A Commercial IND is an IND, Treatment IND or Emergency IND for which the applicant is a Pharmaceutical firm.

• Emergency IND

An Emergency IND is authorized by the FDA when the need for an investigational drug arises and there is insufficient time for the submission of an IND in accordance with directives. In such a

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 6 - case, the FDA may authorize the use of the drug for a specified purpose before an IND is submitted and assign an IND application number based on a request by telephone or other rapid means of communication.

• Research IND A Research IND is an IND, Treatment IND or Emergency IND for which the applicant is an individual representing himself (including college grants, etc.)

• Treatment IND or Treatment Protocol A treatment IND or protocol may be filed with the FDA during a clinical investigation of a drug for a serious or immediately life threatening disease condition which has no alternative treatment or therapy available and to facilitate the availability of the promising new drugs as early in the drug development process as possible. Although the information received is the same as IND, treatment IND is given highest priority.

f. New Drug Application (NDAs) NDAs are applications submitted to the FDA by an applicant to obtain approval to market a drug product within the United States. In CY’12 the document room processed 23,255 NDA submissions.

3. MISCELLANEOUS REPORTS, LETTERS, FILES, REQUESTS, SUBMISSIONS, AND CORRESPONDENCE

a. Adverse Drug Reaction (ADR) Report

After an ANDA and NDA has been approved by the FDA, the applicant is required to report the incidence and type of adverse reactions associated with the use of the drug in increased frequency of occurrences of ADRs in 15-Day Alert Reports. Periodic Reports of other ADRs are compiled and submitted to the FDA on a regular schedule. Form FDA 3500A is submitted with most ADR Reports.

b. Annual Report A report submitted each year within 60 days of the anniversary date of approval of the application to the FDA division responsible for reviewing the application. This report includes an FDA form 2252 and briefly summarizes the previous year for significant new information that might affect the safety, effectiveness, or labeling of the drug product. The report contains information on distribution data, labeling, chemistry, manufacturing, controls, changes, a full description of the manufacturing and controls changes not requiring a supplemental application, non-clinical laboratory studies, copies and summaries of unpublished reports, clinical data and Status reports.

c. Administrative Change Requests The FDA receives and processes change of name, address, and ownership requests by sponsors, applicants, and / holders. The document room assists in the process by properly identifying, coding, prioritizing, and distributing change requests.

d. Desk Copies

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 7 - Desk Copies are extra copies of submissions that are requested by FDA Records Project Managers and reviewers. They are labeled by the sponsor or document room staff as “desk copy”. Desk Copies are working copies only, therefore not inventoried or retained. Typically they are distributed to the user community and destroyed in accordance with Records Control Schedules (RCSs). The document control room does not maintain desk copies. Desk Copies cannot be requested for electronic submissions.

e. Drug Development Tools (DDT) Qualification Programs The Drug Development Tools (DDTs) Qualification Program was created by CDER as part of the FDA’s Critical Path Initiative (CPI) to provide a framework for development and regulatory acceptance of scientific tools for use in drug development programs. DDT qualification programs currently exist for biomarkers, clinical outcome assessments (COAs), and animal models for use under the Animal Rule. The document room is responsible for processing DDT submissions and forwarding to the reviewer community.

f. Drug Master Files (DMF) DMFs sent to the Food and Drug Administration (FDA) contains confidential information which describes in detail the manufacturing facilities, manufacturing processes, packaging processes, storage processes, and the articles used in the manufacturing of drug products. In CY’12 the document room processed 24,970 DMF submissions. A DMF is submitted solely at the discretion of the holder. Electronic DMF submissions must be in eCTD format, only 5% of all DMF submissions are electronic and the remaining is received in paper format. The number of electronic submissions received is expected to significantly increase by 2017. Paper and Electronic DMFs support both OND and OGD operations and are received and processed in the following DCCs: CDR and EDR. Types of subsequent materials received and processed with DMFs are:

• Holder Change, Change of Ownership, and Transfer of Ownership and US Agent Appointment Letters

The FDA receives and processes requests from DMF holders to the transfer ownership of DMFs. If the transferee accepts ownership they will submit a US Agent Appointment Letter.

• Letter-of-Authorization A written statement by the holder of the DMF or a designated agent or representative to permit FDA to refer to the information in a DMF on behalf of another party in support of an IND, NDA, ANDA, BLA or other DMF.

• Overdue Notice Letters The FDA sends Overdue Notice Letters to DMF holders notifying them that an annual report was not received and the files will be closed if the annual report is not received within a designated timeframe. Please see CDER TO Attachment No. 1 for more information regarding the volume of outgoing letters.

g. Dunning Letters If FDA proposes to terminate an IND, FDA will notify the sponsor in writing (Dunning Letters).

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 8 - The goal of the process is to issue the Dunning Letters to Sponsors of IND applications where there has been no recent activity. Please see CDER TO Attachment No. 1 for more information regarding the volume of outgoing letters.

h. iPledge Consent Forms and Documents The FDA reviews and authorizes physicians, pharmacies, and pharmacists that prescribe and sell pharmaceuticals with the component isotretinoine to reduce the exposure to at risk persons. Physicians, pharmacies, and pharmacists are required to register in the iPledge website and submit an iPledge consent form to the FDA. The consent form verifies prescribers and sellers will use FDA’s Risk Evaluation and Mitigation (REM) strategy to reduce exposure to at risk populations. The document room assists in this effort by properly identifying, categorizing, coding, and distributing iPledge Consent forms and associated documents.

i. Medical Gas Certificates As a result of the Food and Drug Administration Safety and Innovation Act (FDASIA), sections of the Federal Food, Drug and Cosmetic Act (FD&C Act), now includes a new approval process for certain “designated” medical gases. Until FDA certification has been obtained, anyone marketing a designated medical gas is marketing an unapproved new drug. In order to begin or continue marketing these gases requires an individual or entity to request certification from FDA for an indication or indications for that gas. To facilitate the process of requesting certifications, FDA has developed a form (Form FDA 3864) that applicants must complete when making their requests. To assist in this process the document room is responsible for identifying and appropriately coding applications received with the FDA 3864 form.

j. Meeting Requests and Associated Documents Formal meeting requests from sponsors, applicants, and / or holders to meet with FDA reviewer community. In CY’12 the document room received approximately 4,000 meeting requests for ANDAs, NDAs, and INDs. Meeting requests are Priority because reviewers have only 14 days to respond to industry.

k. OPDP Submissions • Non-2253 Submissions (Red Jacket)

These submission packages generally do not include a FDA 2253 form. The submissions generally consist of requests for advisory and related correspondence, complaints and related correspondence, enforcement and other related correspondence, and general correspondence.

• MAGTR submissions (Blue Jacket) Marketing and advertising supporting document and communication that is not associated with a regulatory application.

• High Priority and Enforcement Requested 2253 Submissions Incoming submissions of promotional materials submitted at the time of initial publication or dissemination and accompanied by a completed FDA form 2253 (21 CFR 314.81 or 601.12). 2253 submissions generally include a 2253 form, the promotional materials listed on the 2253 form, in either paper or electronic form, and the approved product labeling.


In CY’12 the document room processed 45,147 OPDP submissions.

l. Post Marketing Requirements and Commitments (PMRs / PMCs) The phrase postmarketing requirements and commitments refers to studies and clinical trials that sponsors conduct after approval to gather additional information about a product's safety, efficacy, or optimal use. The Document Room receives and distributes PMRs and PMCs to the FDA’s post marketing surveillance group. In CY’12 the DCC distributed approximately 10,400 PMR / PMCs.

m. Proprietary Name Requests The FDA receives and reviews industry requests for a trademark and / or brand name related to ANDAs, BLAs, NDA, and INDs. Proprietary name requests are submitted on FDA forms 1571 and 356h. The document room assists in this effort by properly identifying, coding, prioritizing, and distributing proprietary name requests.

n. Pre-Assignments Electronic Common Technical Document (E-CTD) format is the emerging format for electronic regulatory submissions. This format requires the submitting Applicant/Sponsor to include the application number in the submission as received. Consequently, the Applicant/Sponsor must request a number for their application prior to submission. In addition, all submissions that are delivered by the FDA Gateway require an application number. The Document Control Room processes all Pre-assign number requests.

o. Pre-Submissions Documents that are submitted for review prior to submitting the application.

p. President’s Emergency Plan for AIDs Relief (PEPFAR) The Document Control Room processes NDA, IND, and ANDA applications and supplements for HIV combination therapies that can be used in PEPFAR. PEPFAR related applications are priority documents that receive an abbreviated review process. In FY’12 only thirteen PEPFAR related applications were received and processed.

q. Special Protocol Assessment (SPAs) SPAs are requests by sponsors to reach an agreement with the FDA on the design and size of a clinical trial. The document room assists in this effort by properly identifying, prioritizing, coding, and distributing the SPAs.

r. Subsequent Submission Any submission other than the original submission. This includes amendments, supplements, forms, reports, letters, correspondence, etc.

s. Supplement Submissions Supplement Submissions are post approval changes to an original ANDA, BLA, and NDA applications. Types of major supplement submissions are efficacy; labeling; manufacturing; bioequivalence, and chemistry manufacturing and control (CMC). The applicants are responsible for indicating the supplement type on the applicable standard form. The document room assists in processing supplement submissions by properly identifying, prioritizing, categorizing, coding,

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 10 - and distributing supplement material.

t. Tier Resubmission: A Tier Resubmission is a response from the applicant to an FDA Action letter (TA or CR). It opens the Submission that was reviewed to pending status and triggers a new User Fee goal.

u. Tier Amendment:

It is an amendment to either an ANDA application or supplement in “Pending” Status. When the status is CR, the amendment review will be deferred to when a Tier Resubmission is received. If received during a “pending” cycle then the tier amendment will adjust (may extend but never shorten) the goal appropriately.

v. Title VIII (FDA Form 3674)

In order to achieve compliance with Title VIII of the Food and Drug Administration Amendment Act of 2007, the FDA is required to provide application review documentation relevant to certain clinical trials to the public via the www.Clinicaltrials.gov website managed and maintained by NIH. To assist in this process the document room is responsible for identifying and appropriately coding applications received with the FDA 3674 form.

w. Voluntary Genomic Data Submissions (VGDS) The FDA encourages voluntary submission of genomic data that is used to help the Agency gain an understanding of VGDS while not being part of the regulatory business process. VGDSs can be submitted as standalones or associated with an existing application. All VGDS submissions are submitted with a cover sheet identifying the submission as a Voluntary Genomic Data Submission. The document room assists in this effort by properly identifying, prioritizing, coding, and distributing the VGDSs to the reviewer community. 4. DOCUMENT CONTROL CENTER FACILITIES CDER receives the largest volume of regulatory submissions within the FDA. CDER currently has several DCC Facilities that processes, distributes, stores, and retires regulatory and non-regulatory records material. a. CENTRAL DOCUMENT ROOM (CDR)(Beltsville, MD) –

• CDR UNIT A CDR Unit A functions as the point of receipt for INDs, New Drug Applications (NDAs), Biologic License Applications (BLA), DMFs, OC investigational reports, and OC Establishment Inspection Reports (EIRs) and Non-EIRs. Applications are identified, sorted, and sometimes stored in Unit A.

• CDR UNIT B CDR Unit B functions as the records retention area for INDs, NDAs, BLAs, DMFs, and EIRs. Unit B is the staging area for retirement of NDAs and INDs. The Barcode team is also housed at Unit B.

• CDR UNIT H CDR Unit H is an application overflow storage area for submissions. b. WHITE OAK FACILITIES:


• Document Room One (DR1) DR1 is responsible for supporting all records management and operations in support of the Office of New Drugs (OND), Office of New Drug Quality Assessment (ONDQA), Office of Biotechnology Products (OBP), and Office of Pharmaceutical Science (OPS). This includes processing new applications, subsequent forms and letters, amendments, and correspondence for NDAs, INDs, and BLAs. The Office of Compliance (OC) Good Clinical Practice (GCP), Institutional Review Board (IRB), Good Laboratory Practice (GLP), and Bioequivalence Review (BEQ) files are also stored at DR1.

• Document Room Two (DR2)

DR2 is responsible for supporting all records management and operations in support of the Office of Prescription Drug Promotion (OPDP). DR2 includes Room 0471. This room is an extension of DR2 and supports several offices. It serves as an overflow storage area for BLAs, old NDAs, 2253s, oversized material, and OC files.

• Electronic Document Room (EDR)

The EDR provides network access and archival management of electronically submitted drug application documents. The EDR processes documents received in eCTD format through CDER’s Electronic Submissions Gateway (ESG). The EDR also processes non-eCTD submissions received on electronic media.

• The Office of Generic Drug (OGD) Satellite Office The OGD Satellite Office will be established in Bldg 71 of the White Oak Campus in spring 2014. The objective for setting up a satellite office is to provide direct support to the OGD reviewer community, such as triage, process support, and distribution. c. METRO PARK NORTH (MPN) FACILITIES:

• MPN1 MPN1 is responsible for processing all types of records materials such as, new applications, supplements, amendments, and correspondence for ANDAs associated with application number series 10-20K, 40k, 60k, 80k. MPN1 operations are expected to transition over to MPN7 in Spring 2014.

• MPN2 MPN2 is responsible for processing new ANDA applications, supplements, amendments, and correspondence for application number series 70K, 90K, and 200K. In addition MPN2 functions as an EDR and supports receipt of submissions received through ESG. MPN2 operations are expected to transition over to MPN7 in Spring 2014.

• MPN7 MPN7 is the Central Point of Entry (CPE) for ANDA application submissions. In addition, all ANDA related FDA communications, and FRC material are processed here.

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 12 - 5. MOVEMENT TOWARDS ELECTRONIC SUBMISSIONS CDER is actively involved in moving towards a 100% electronic environment therefore during the life of this task order CDER expects substantial built-in efficiencies in outgoing years. Calendar Year (CY) 2012 data reports indicate CDER received 58% of all submissions through the electronic gateway, 3% mixed, and 39% paper. Based on historical data CDER expects an increase in the volume of electronic submissions over the course the next five years. CDER paper submissions have steadily decreased by an average of 10% annually between 2009 and 2012. Legislative mandates require all New Drug Application (NDAs), Abbreviated New Drug Applications (ANDAs), and Drug Master Files (DMFs) be submitted electronically by 2017 and commercial Investigational New Drug (IND) shall be submitted electronically by 2018. With the anticipated release of Electronic Common Technical Document (eCTD) 3.2.2 and Global Submit (GS) version 8 in June 2014, the FDA will be accepting electronic promotional and advertising submissions for the Office of Prescription Drug Promotion (OPDP) through the ESG. 6. CDER SYSTEMS AND ELECTRONIC ENVIRONMENT The following CDER Systems are the primary database repositories and tracking systems in which data is manually entered or electronically uploaded: a. Document Archiving, Reporting and Regulatory Tracking (DARRTS) DARRTS is currently the archival system of record for all new and subsequent INDs, NDAs, Emergency Use Authorization (EUA) Applications, DMFs, BLAs, ANDAs, AINDAs, and subsequent submissions. b. Bioresearch Monitoring and Clinical Investigator System (BrMIS/CIS) BrMIS/CIS supports the Office of Scientific Investigations (OSI) oversight of the clinical investigators performing clinical studies of INDs/NDAs in the DARRTS database. OSI routinely sends FDA inspectors to audit these clinical investigators to ensure reputable inspections are conducted. CDER uses BrMIS/CIS system to fulfill regulatory requirements to notify the sponsor of any IND or approved New Drug Application (NDA) when submissions contain work performed by disqualified investigators (21 CFR 321.70).

c. IND/NDA Volume Accountability System (INVAS) INVAS is designed to electronically track reviewer assignments and locations of IND submissions, NDAs, ANDAs, DMFs, OC files, and OPDP materials. The primary purpose of the INVAS System is to allow CDER Review personnel and managers the ability to track volumes as they move through the FDA review process.

d. Regulatory Management System-Biologics License Application (RMS-BLA) RMS-BLA is a data management system built and maintained by the Center for Biologics and Research (CBER). RMS-BLA is the system of record for CDER related BLA communications. This system holds information; types, dates and status of incoming submissions; applicant information; product specific data; facility-related data, and types and dates of outgoing communications.

e. Business User Support System (BUSS) The DCC staff enters electronic submission rejection data into the BUSS system. Data is obtained from eCTD, non-eCTD, and electronic media sources. Rejection data from QCA is

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 13 - stored and saved in the BUSS system. BUSS is used by the eDMST to track rejections, categorize the cause of rejections, and identify resolutions taken. The data saved in BUSS is used to provide statistics and graphs regarding failures and rejections in the EDR Daily Report. The BUSS system offers a report tool named e-Sub Reports, which generates Excel spreadsheets used in analyses. The system also allows users to specify a particular timeframe for the reports. The eDMST uses the information from BUSS to report to upper management. f. Electronic Submission Gateway (ESG) The ESG enables the industry and sponsors to submit applications and submissions electronically through a secure environment and provides FDA with a single point of receipt for electronic submissions. The preferred format for ESG submissions is eCTD. Please note CDER also accepts non-eCTD submissions via the gateway. Automated Submission Receipt (ASR) notifies the document control contractor via email when submissions are received. The GS Validation application tool validates applications properly formatted or rejects applications that are not properly formatted. g. Automated Production Log System (APL) The APL is an internal management tool owned by Zimmerman and Associates Inc. (ZAI) and is used by CDER as an electronic mail receipt logging system. APL electronically tracks submission processing, monitors workflows, collects quality statistics, and produces management reports. CDER is considering “equal to” solutions as part of this procurement. h. Quality Control Agent (QCA) QCA is a ZAI owned tool that accounts for electronic submissions received through the Gateway but not yet uploaded into the DARRTS production server. This tool allows CDER to obtain accurate statistics regarding the volume of submissions received regardless of their status: validated, failed, and rejected. This is a critical function because CDER’s Business Objects reporting tool only provides reports on validated submissions that have been successfully uploaded into DARRTS and do not account for rejected submissions. The QCA tool provides efficiency by giving CDER users a comprehensive view of electronic submissions. The Gateway sends email notifications that need to be individually opened and viewed. Individually opening Gateway email notifications can be time consuming and may result in processing backlogs. QCA interfaces with the DCC Outlook email account to populate and generate a consolidated and comprehensive view of the electronic submissions. It is used by the DCC contractor as a workload management tool to ensure Service Level Agreements (SLA) and Acceptable Quality Levels (AQL) are met.

I.1.3 OBJECTIVES CDER has several business objectives associated with document control support activities, such as:

• Reduction in paper usage; • Reduction in document room space for storage of paper submissions; • Implementation of cost efficiencies as a result of moving towards a more electronic

environment; • Freed shelf space in document/file rooms and reduction in the cost of maintaining

inactive applications.


• Implementation of operational efficiencies such as improved document distribution time, ability to accommodate changes in submission process, complete inventory lists, and adherence to record schedules;

• Adherence to Service Level Agreements (SLAs) and Acceptable Quality Levels (AQLs); • Improved quality control for physical and electronic submissions; • Compliance with future regulatory mandates requiring movement towards a 100%

submittal rate of eCTD submissions by 2018.

I.1.4 SCOPE: The scope of this project encompasses receipt and processing all of applications, submissions, and mail received at CDER DCCs. The Contractor shall provide support for all incoming material and information received at CDER DCC facilities, the electronic gateway, email, and fax. Processing records materials includes triaging incoming submissions, document preparation, barcoding and labeling, jacketing files, preparing files for pick-up by off-site scanner contractor and / or other authorized persons such as FDA reviewers and couriers, document distribution, meta data entry, manual data entry into CDER tracking systems and repositories, uploading digitized images into EDRs, preparing Records Control Schedules (RCSs), tracking records material, storing files, file retention, retirement of files, and disposition of files. In addition to the processing tasks identified above, the Contractor shall provide the following support services: task order management, physical and network access control, courier services, responding to stakeholder requests, file management, inventory management, quality control, retrieval of files, staging and preparation of documents for special projects, on-site scanning services, processing outgoing correspondence, relocation services, and transition activities. The Contractor must be able to provide support in a dynamic and changing environment. In addition the Contractor shall provide best practice advice on methodologies for improving the receipt and handling of records material regardless of the method of delivery.

I.2 GENERAL AND SPECIFIC TASKS (FIXED PRICE)

I.2.1 QUALITY CONTROL In accordance with section D.I.15 of the IDIQ SOW the contractor shall conduct quality control of CDER’S Document Room Processes. The Contractor Task Order Manager shall provide an approach to Quality Control to ensure all SLAs and AQLs identified in CDER Appendix No. 6 are met. The contractor’s selected methodology shall identify the Contractor’s approach for conducting quality control for high priority, priority, and standard submissions and how they intend to maintain acceptable performance levels for all CDER DCC operational activities. The Contractor shall generate a quality control report monthly identifying the percentage of SLA’s and AQL’s met. In addition the Contractor shall identify SLA’s and AQL’s that were not met and provide an explanation regarding the circumstances.

I.2.2 TASK ORDER MANAGEMENT In accordance with section D.1.16 of the IDIQ SOW the contractor shall provide task order management services. Guided by this Statement of Work (SOW) and discussions with the COR

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 15 - and stakeholders the Contractor shall submit a Task Order Management Plan (TOMP). The TOMP shall include the following:

• An organizational chart for each CDER DCC facility. The organizational chart shall provide a list of employee names, job duties, job titles, and hierarchical structure.

• Work Breakdown Structure (WBS) identifying bottom-up activities and personnel / labor categories responsible for activities and risk management at activity levels identified.

• A detailed description of the Contractor’s approach for completing the tasks outlined in the SOW.

• An approach for mitigating risks pertaining to contract performance, cost, and schedule.

1. Kick-Off Meeting The Contractor shall participate in an initial meeting with the CDER Data Management Services Team (DMST) within 1 week of a receipt of a task order award. The Contractor is responsible for preparing meeting notes and providing a copy of those notes to the Task Order Contracting Officer Representative (COR) 3 days after the meeting. This discussion shall include the following:

• The objectives for the Task Order; • High level execution plan; • Introduction of the Federal Contracting Officer (CO) and Contracting Officer’s

Representative (COR), as well as the key members of the Contractor’s team; • Questions and answers regarding the engagement.

Meeting notes shall detail the discussion held at the initial meeting, capture pertinent clarifications to the scope of work, and reflect any areas of disagreement or misunderstanding on the part of either the FDA or the Contractor. The Contractor shall submit the final TOMP to the Task Order COR one month after the kick-off meeting.

2. Weekly Status Meetings The Contractor task order manager and on-site supervisors shall attend 1-hour weekly status meetings with the DMST. The Contractor shall be prepared to identify DCC submissions statistics, identify risks, and quality control issues. The program office will submit the agenda prior to the weekly meeting commencing. The Contractor shall record weekly status meeting minutes and provide to the Task Order COR for approval. The Contractor may be requested to revise meeting notes if they do not fully reflect document room discussions. 3. PMR / PMC Cross Functional Meetings The DCC Contractor shall attend and participate in monthly PMR / PMC meetings. The objective of the contractor’s attendance is to obtain information on forecasted changes and / or improvements, provide feedback to the PMR / PMC group regarding the impact on the document control processes, and to communicate impact of changes to the appropriate DDMSS liaison and COR. The contractor shall provide recommendations to DDMSS liaisons and COR for reducing overall risk to document control operations. 4. DARRTS Cross Functional Meetings

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 16 - Per the request of DDMSS liaisons the contractor shall attend DARRTS requirements and system improvement meetings. The objective of the contractor’s attendance is to obtain information on forecasted business / functional / and structural improvements; provide feedback to the DARRTS team regarding the impact on document control processes and feasibility of proposed changes; and report impact of changes on DCC operations to DDMSS liaisons and COR. The contractor shall provide risk mitigation recommendations to DDMSS liaisons and COR to reduce negative impact to DCC operations. The number of DARRTS meetings is not expected to exceed 12 annually. 5. OIM Cross Functional Meetings Per the request of DDMSS liaisons the contractor shall attend OIM requirements and system improvement meetings. The objective of the contractor’s attendance is to obtain information on forecasted business, functional, and structural improvements; provide feedback to the OIM team regarding the impact of proposed changes on document control processes and feasibility of the suggested changes; and report impact of changes to DDMSS liaisons and COR. The contractor shall provide risk mitigation recommendations to DDMSS liaisons and COR to reduce negative impact to DCC operations. The number of OIM meetings is not expected to exceed 6 annually. 6. DCC Monthly Project Status Report At the end of each month, the Contractor shall develop and generate a Monthly Project Status Report to capture the volume and type of submissions received per DCC Facility. Authorized contractor staff will have the ability to utilize FDA’s Business Objects analytical tool to obtain statistics on submission categories and subcategories. The reports are intended to summarize the work completed by the DCC operational staff during the specified month. The DCC Operation Monthly Project Status report shall contain information identified in CDER TO Attachment No. 1: CDER 2012 Annual report.

7. Communication with CDER Stakeholders One week after the 2-MonthTransition-in period the Contractor task order manager shall identify how they intend to communicate with CDER stakeholders by submitting a Communication approach to address interactions between contractor staff, the Task Order COR, and applicable CDER records stakeholders. The approach will provide contact information including roles and responsibilities, staff changes, and progress meeting schedules. Please see Attachment 5, DDMSS Communication Flow Chart.

8. Standard Operating Procedures The CDER DCC currently will provide the Contractor the 25 SOPs that cover the procedures for processing submissions received at the DCCs and EDR(s) and general support services. The current SOPs are as follows: No. DESCRIPTION 1 ANDA 2 BLA 3 BLA Communications

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 17 - 4 DMF 5 Converting CBER-to-CDER DMF 6 EDR 7 BRMIS 8 IND 9 Medical Gases 10 NDA 11 Office of Compliance 12 OSI Documents 13 OPDP File Replacements 14 Transfer documents from CBER to CDER 15 Barcode Inventory Management System 16 Overview of Delivery Method Processing 17 PMR / PMC Tracking 18 Mail Courier 19 Dunning Letter Process 20 FDA Eric Helpdesk Ticket Request 21 Title VIII 22 2253 and Non-2253 23 Drug Development Tools 24 Secure Supply Chain Pilot Program (FDA Form 3676) 25 Gateway Test Validation Procedures The Contractor Task Order Manager shall ensure SOPs are reviewed quarterly and updated to incorporate authorized changes. In addition the Contractor shall create new SOPs when new forms or submissions are introduced. On average 1 to 2 SOPs are created annually. See CDER TO Attachment No. 7 for more detail regarding the content of each SOP.

9. eDMST Meetings, Reports, and Tracking Tools

a. Daily Meeting and Report The Contractor Task Order Manager shall prepare and present a gateway report to CDER’s eDMST on a daily basis and forward to the COR(s) and eDMST liaison for review and comment on a daily basis. The Contractor shall maintain a reference file of these reports and these reports shall be made available to the COR(s) and eDMST liaison upon request. The Gateway daily report shall include:

• Total number of submissions received the previous day. • Total number of submissions processed • Total number of submissions partially processed • Total number of failed ASR submissions from the previous day. • Total pending submissions from the previous day. • Summary of rejected numbers from the previous day. • Total submissions received weekly. • Total submissions received monthly. • Total of rejection notifications sent out.

b. RMS-BLA Daily Report

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 18 - Each day, the Contractor shall run a report that lists all of the finalized BLA communications in DARRTS from the prior day and will enter the data accordingly into RMS-BLA. The report shall be submitted to the eDMST liaison and COR. If any questions arise, the document room will contact the communication author for clarification.

c. EDR Monthly Project Status Report At the end of each month, the Contractor shall develop and generate an EDR Monthly Project Status Report to capture electronic volume data, types of submissions received, and status of electronic submissions processed by EDR contractor staff. Authorized contractor staff shall utilize tracking tools such as FDA’s Business Objects analytical tool, APL, QCA, and BUSS to obtain statistics on electronic submissions. The reports are intended to summarize the work completed by the EDR contractor staff during the specified month. The EDR report shall contain information identified in CDER TO Attachment No. 4: EDR Monthly Status Report.

d. QCA or “equal to” tool (SEPARATELY PRICED / FIXED PRICE) Currently, CDER tracks Gateway submissions from the point of receipt, through Reviewer notification using ZAI’s QCA tool. The QCA tool operates in FDA’s technical environment. The Contractor may use an “equal to” tool for tracking, logging and reporting productivity, performance, and quality. In order for an “equal to” tool to be considered the proposed solution must be compatible with FDA’s technical environment and meet FDA’s IT security policies. In addition the Authorization to Operate (ATO) in FDA’s network must be completed by the end of the transition period. The Contractor shall propose a secure backup method for preserving QCA data on FDA servers. For quality assurance purposes the Contractor must provide access rights to authorized DMST staff to produce ad hoc QCA performance and quality reports. The Contractor shall use data from the QCA or “equal to” tool to create the daily Gateway report documenting the number of electronic Gateway submissions that were received and processed the previous day. The Contractor shall be responsible for maintaining stored QCA data by ensuring the quality and integrity of the data is preserved and accessible to DMST staff. The QCA tracking tool or “equal to” tool shall have the following functionalities:

• Capability to track submission before being uploaded into DARRTS • Capability to track volume of gateway submissions received on a daily, weekly, and

monthly basis • Capability to track gateway rejections • Capability to import gateway metadata from Microsoft Outlook to proposed “equal to”

tool • Capability to be configured to add unique Data fields for tracking Application No, Time

application received through gateway, name of person responsible for conducting quality control, time submission was processed etc..


• Capability to provide a consolidated view at of metadata imported from Outlook at an application level as well as a summary of daily, weekly, and monthly applications received

• Comment box for identifying discrepancies (if applicable) • Quality Control data field or check box indicating quality control was conducted to

ensure mandatory data elements were verified for accuracy and completeness. Table 1: Task Order Management Deliverables

Deliverable Title Quantity / Frequency

Deliverable Due Date

Task Order Management Plan • Organizational Chart • WBS • Quality Control

Approach • Risk Mitigation Plan

Updates as required

Final – One month after kick-off

Kick-Off Meeting Notes 1 EA 3-days after kick-off meeting Weekly Status Minutes Once per week 3-days after weekly status meeting PMR / PMC Cross Functional Monthly Meetings

Once per month Recommendations for business process improvements and implementations related to PMC / PMR

DARRTS Cross Functional Meetings

Not to exceed 12 annually

Report identified risks to DARRTS group and DDMSS liaisons. Provide risk mitigation recommendations.

OIM Cross Functional Meetings

Not to exceed 6 annually

Report identified risks to OIM and DDMSS liaisons. Provide risk mitigation recommendations

Electronic Gateway Submissions daily meeting and report

Daily continuously

RMS-BLA daily report Daily continuously Document Room Monthly Status Report

Once per month By the 7th day of each month

EDR Monthly Status Report Once per month By the 7th day of each month Communication Plan Updates as

required One week after 60-day Transition in period

ATO and Implementation of Quality Control Application System

Two months after task order

award

2 months after task order award

Review and Update SOPs Quarterly Two weeks after end of the quarter. Quality Control Approach 1 EA Update as necessary Quality Control Report Monthly By the 7th day of each month

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 20 - I.2.3 TWO-MONTH TRANSITION-IN PERIOD In accordance with section D.I.17.a of the IDIQ SOW the contractor shall provide transition-in services. CDER is planning a two-month Transition-In period to ensure a smooth transition between the incumbent and successor contractors. The transition-in period shall begin on the effective date of the contract award and shall conclude 2 months later. The incumbent contractor will be responsible for full performance of steady state operations during the transition-in period with the successor taking over performance and operational responsibilities by (TBD). In accordance with the First Rights to Refusal Act the Contractor shall identify incumbent employees that will transition over to the successor contract and provide letters of commitment with anticipated start dates of (TBD) (see CDER TO Attachment No. 2 for an example letter of commitment). The Contractor shall develop and propose a draft Transition-In Plan as part of their proposal that identifies the actions, plans, personnel, procedures, deliverables, work products, and timelines to ensure a smooth transition from contract start date to full operational status at the end of the two-month period. The finalized version shall incorporate changes based on discussions during the Kick-Off meeting and shall include:

• A description of activities that shadow the calendar of transition out events (please see CDER Appendix No. 3 for more detail on the transition-out calendar); and,

• Include an organizational chart for the transition period identifying personnel assignments, employee names, locations, and an updated list of contractor personnel with anticipated start dates and responsibilities.

It is expected that up to ten successor contractor’s new managers, project leads, and supervisors, will shadow the incumbent for the duration of the transition-in period. In addition successor contract employees will be given the opportunity to attend knowledge transfer class-room training sessions and walk through sessions of CDER DCCs. The Contractor shall document lessons learned and identify retraining needs during Daily Stand-up meetings with the incumbent. To conclude the first month and at the third week of the second month the Contractor shall create a Lessons Learned document identifying areas of improvement and need for refresher training. The Transition-In plan shall have a methodology for mitigating resource conflicts between the two companies. Organizational charts shall be provided to the Task Order COR at the beginning of the Transition-In period and the end of each month of the Transition-In period. Successor contractor management staff shall attend up to eight weekly transition status meetings with the Task Order COR and other DMST liaisons to identify risks, lessons learned, actions taken, level of operations transitioned, and next steps forward. The Contractor will be responsible taking meeting minutes and distributing to all attendees. At the end of the first month the successor contractor shall provide a plan for training employees on-boarding during the second month. The training plan shall identify how they

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 21 - intend to ensure employees are proficient and knowledgeable in DCC operational processes, procedures, and regulations. At the end of the second month the Contractor shall provide a plan for reducing operational inefficiencies and learning curves. To conclude the Transition-In Period the Contractor shall attend a Lessons Learned meeting with CDER DMST to identify potential areas of operational improvement and / or methodologies for implementing new processing techniques, tools, and / or technologies that may assist in improving DCC operations. Equipment Inventory –No later than 5 (five) days following the end of the transition-in period, the Contractor and a Government representative shall conduct a joint inventory of all accountable CDER furnished equipment. The Contractor shall acknowledge receipt for all accountable equipment provided by the Government. Table 2: TRANSITION-IN DELIVERABLE TABLE



Draft Transition-In Approach 1 ea With proposal

Final Transition-In Plan 1 ea 1 week after Task Order Award

Organizational chart and updates to organizational chart 3 ea

• 1 week after task order award

• At the end of the first month of the transition-in period

• At the end of the first month of the transition-in period

Signed Letters of Commitment 1 per key personnel With proposal

Transition-In Status Meeting Notes Weekly 2-business days following the status meeting

Training Plan 1 ea 1 month after task order award

Lessons Learned 3 ea

• 1 month after task order award,

• End of 3rd week of 2nd month of transition-in period,

• at the end of the second month of the transition-in period

Signed equipment inventory list 1 ea Last week of Transition-In period


I.2.4 CDER RECORDS MATERIAL PROCESSING AND OPERATIONAL SUPPORT ACTIVITIES In accordance with section D.1.18 of the IDIQ SOW the contractor shall provide the following records support activities.

1. Facility Management The Contractor shall ensure all of CDER’s DCC facilities are adequately secured in accordance with National Institute of Technology Standards (NIST) and supplemental FDA security policies. FDA identifies all CDER DCCs as highly secured areas. Therefore, each location is equipped with PIN pads and card readers. The Division of Data Management Services & Solutions (DDMSS) is responsible for maintaining and storing regulatory documents in these secured areas. Upon arrival and departure, the Contractor needs to enter their card reader code to deactivate or activate the alarm system. These codes are issued to a contractor by a DDMSS representative. These codes are issued to Program Managers, Project Managers, Supervisors, Senior Technical Information Specialists, and a limited number of contractors will be issued a card reader code. The Contractor shall report all CDER DCC Facility maintenance issues to the designated CDER DMST liaison and the Task Order COR. All general facility and building issues are handled by the CDER’s facilities representative and the DMST facility liaison in conjunction with the Contractor’s Program Manager. The Contractor shall direct any issues or concerns relating to malfunctioning or non-operational equipment to their immediate supervisor. The DMST liaison shall forward these issues to CDER’s Center Liaison for resolution. Requests for supplies and the accurate inventory of supplies shall be the responsibility of the Contractor. Supply requests shall be submitted to the Program Office for processing.

2. Mail Receipt and Handling a. General Mail Processing

The Contractor shall be responsible for processing all mail received at CDER DCCs to include regulatory applications, desk copies, duplicate and triplicate volumes, subsequent submissions, faxes, and U.S. postal mail. In addition the Contractor shall process electronic submissions received by CDER’s Electronic Document Room (s) (EDRs). When mail is received, it shall be immediately date stamped, identified, prioritized, sorted, and triaged. The Contractor shall process physical electronic media by creating an “x” labeled volume in accordance with the procedures identified in the SOPs. The Contractor shall forward the x-volumes to the EDR for processing. The Contractor shall sort and prioritize all physical and electronic applications, submissions, and mail received at CDER DCCs and EDR(s). FDA’s drug review and approval process requires CDER to complete the review process within the timeframes indicated in the User Fee Acts. To be compliant with regulatory timeframes CDER categories and assigns priorities to submissions received in the DCCs. CDER categorizes submissions as High Priority, Priority, or Standard. High Priority documents shall be processed within the same business day (see Attachment No. 6 for more detail on processing SLAs). Priority documents should be processed within 1-business day. Standard Forms shall be processed within 2 to 3 business days. The Contractor shall forward

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 23 - material labeled high priority and priority through the Internal CDER mail courier for delivery to the appropriate reviewing office. The Contractor shall conduct a quality control inspection on all priority documents prior to their release to CDER’s Regulatory Program Managers and Reviewers. FDA forms and cover letters usually identify submission type. See CDER TO Attachment No. 8 for a list of FDA forms

b. Courier Services The Contractor shall provide courier services between CDER DCCs, U.S. Mail Facilities, FDA employee offices, storage facilities, and reviewer facilities. The Contractor will be responsible for maintaining the security and integrity of all documents while performing courier services. The Contractor may be called upon by CDER’s Records Liaison Officer (RLO) to provide “Special” (Priority/Urgent) courier services to locations that are not normally serviced by DCC couriers. These “Special” courier services may entail the delivery or pick-up of a critical review document needed to finalize a submission review. An example of a Special courier services would be the pick-up of a submission that has been retired to the Federal Records Center in Suitland, Maryland. These courier services are on an as need basis with a maximum of 50 special delivery requests per year.

c. X-ray Scanning During the life of this task order the Contractor shall ensure X-ray Scanning is conducted at locations identified as Central Points of Entry (CPE). Currently CDR Unit A and MPN7 are identified as CPEs. The Contractor shall X-ray 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 identified in the IDIQ. The operation of the X-ray scanning machine (Name: Heiman-Smith System, Model: Hi-Scan Hitrax) 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 Contractor shall ensure all scanning operators are certified by the X-Ray manufacturer to operate FDA X-ray scanning machines. The COR will notify the Contractor in advance of any changes to the X-ray scanning machines. 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 Contracting Officer Representatives (COR), and the Contractor’s Management. The operator shall invoke assistance from FDA’s Security Office on how to proceed. FDA’s Security Office shall be responsible for handling and resolving unsafe situations. All Document Room facility manager(s) shall be responsible for evacuating the facility and instructing all personnel to a safe location away from the mail receipt area.

d. Mail Tracking Tool Currently CDER uses ZAI’s APL tool to initially track mail received at the DCCs prior to entering data into DARRTS. The Contractor shall propose an “equal to” solution for efficiently and accurately tracking and reporting submissions initially received in CDER DCCs. The proposed

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 24 - mail receipt, processing, and tracking tool (also known as: APL) shall be electronic and have the following functionalities:

• Standard Data fields for Commercial courier tracking and delivery numbers, Mail type, and Date/ time mail is received.

• Capability to add unique identifiers such as, Application types, Application numbers, sponsor addresses, and Priority levels

• Log Date and Time (system generated) • Track the Quantity of Materials received (boxes, volumes) • Name of person whom logged mail • Comment Field for problems or deficiencies such as Irregular Mail Receipt Cases (if

applicable) • Quality Control data field or check box indicating quality control was conducted to

ensure mandatory data elements were verified for accuracy and completeness. For quality assurance purposes the Contractor must provide access rights to authorized DMST staff to view, access, and create reports on the data logged into the Contractor’s mail receipt, processing, and tracking system. The Contractor shall train DMST staff on how to utilize the tool and provide a user manual. The system must have the capacity to store FDA data for the life of the task order. For data sanitization purposes, the Contractor shall download the data quarterly into a designated CDER data repository or encrypted external hard drive. On regular basis, the Contractor shall conduct quality control to ensure all APL data is successfully downloaded on the FDA server. The Contractor shall receive COR verification APL data was successfully downloaded and written approval to delete the historical data from the Contractor’s APL tool. The Contractor shall be responsible for maintaining the data uploaded onto FDA designated data repository or encrypted hard drive.

e. Processing Electronic Submissions

• ESG Submissions The Contractor shall verify, code, and categorize successful submissions received via ESG. The Contractor shall verify submissions are accurate and complete. Submissions shall be coded and categorized in appropriate system. Currently, electronic submissions are being coded in DARRTS, BRMIS, and RMS-BLA. The EDR production server is operated and maintained by the Office of Information Management (OIM). The Contractor shall collaborate with the COR and OIM team regarding server problems. If contractor identifies missing data they shall initiate data restore requests from OIM. The Contractor shall be responsible for reloading, troubleshooting, manually entering (if applicable), and updating links as part of electronic submissions operations support. The contractor shall check the status of ESG applications using the core id number and notify the ESG team of identified processing issues. For submissions that fail validation by ASR or the GS validate tool, the Contractor shall conduct quality control by identifying the problem, verify the accuracy of the data, and manually process and upload all valid submissions onto the DARRTs production server. For submissions that cannot be processed manually or for those submissions

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 25 - that fail eCTD validation, the Contractor shall perform cleanup on the production server and issue a rejection notification. Rejections must be within the limits of criteria provided by FDA, using wording approved by FDA. In addition, the Contractor shall answer stakeholder questions and recommend solutions to FDA’s eDMST staff. The contractor must consult with the eDMST liaison regarding any questions related to a rejection. The Contractor shall evaluate incoming Gateway Test Submissions and pass or fail them according to SOP provided by FDA. Historical data indicates CDER receives approximately 1,000 Gateway Test submissions annually that require evaluation.

The Contractor shall use the BUSS database or similar tracking database to track problem submissions and resolutions. The Contractor shall perform analysis to determine the types, frequencies and sources of problems with electronic submissions found, which will provide the foundation for system, policy and guidance improvements in order to minimize occurrences of these deficiencies. The Contractor shall be responsible for maintaining the data uploaded onto BUSS or “equal to” tracking tool for the lifecycle of this task order. The Contractor shall provide electronic submissions quality validation and resolution, analysis and recommendations for improving submissions quality and processing. The Contractor is encouraged to employ and recommend aides to facilitate the speed and accuracy of work. Recommendations that are outside the current work limitations, along with an “outside the box” perspective are encouraged. The contractor shall participate in User Acceptance Testing (UAT) for upgrades to document tracking systems. DARRTS undergoes several minor releases annually (approximately 1 per month). Testing for minor releases often involve pass or fail of new or updated data field entries. Major Releases for eCTD, ASR, and GS Validate, often consists of expansive test plans that involve review and testing of several modules and links. Major releases for eCTD, ASR, and GS Validate occur approximately 1-3 times annually. The contractor shall establish short term interim solutions during production upgrade failures to reduce impact to daily DCC operations and support.

• Physical Electronic Media The Contractor shall upload physical electronic media labeled as x-volumes onto identified production servers, copy content on production server, code submission type appropriately, and notify the appropriate reviewer / division staff that the information is available electronically. The Contractor shall temporarily store all physical electronic media for INDs, NDAs, and ANDAs as identified in Center policies. The Contractor may encounter difficulties in processing electronic media submissions due to the following situations:

• Damage or errors in the media resulting from transport (e.g., broken tape, label missing, etc).

• Media submitted in an incompatible, invalid, or unreadable format.

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 26 - The Contractor shall follow procedures identified in the EDR SOP for processing, rejecting, and entering information in DAARTS regarding damaged or invalid physical electronic media.

3. Mail Distribution a. General Distribution Activities

The Contractor shall distribute mail as identified and approved by CDER Regulatory Project Managers (RPMs) on the FDA transmittal forms. This includes records material received in CDER’s DCCs and stored material requested by authorized stakeholders. The Contractor shall also redistribute records material if the distribution list on the transmittal forms change. The Contractor shall ensure packages are created and routed to the appropriate CDER reviewer or project team as identified on the RPM approved transmittal form. Distribution lists are identified in processing SOPs, transmittal forms, and DARRTS. The Contractor shall also distribute CDER generated outgoing correspondence. The Contractor shall conduct quality control on all documents received to ensure they are accurate, complete, and not damaged. This entails ensuring all mandatory data elements are accurately captured and documented in accordance with SOP requirements. All records material shall be processed within the SLAs and AQLs identified in Attachment No. 6.

b. Distribution of OPDP Materials to Scanning Contractor The contactor shall prepare OPDP material for distribution to the scanning contractor. OPDP receives on average three boxes of promotional material per week that contains combined materials: paper, physical artifacts, and electronic media (CDs, DVDs, etc…). Each box contains on average 2,600 pages per box. All paper documents are processed and prepared by the Document Control Room contractor for pick-up by a scanning contractor twice a week. The Contractor shall prepare the material for pick-up by the scanning contractor by conducting the following activities:

• Place OPDP submissions including material in boxes • Perform a visual inspection after loading box to confirm that the material is in order

and the box has been packed appropriately with no damage to the box or contents • Number Boxes on the side and top of each box • Perform an inventory of box contents • Check-out box contents in INVAS to Scanning Contractor • Create 2 copies of the Shipping Log

o Place one copy of the Shipping Log inside its respective assigned box o Affix second copy of Shipping Log top side of box

• Perform a visual check to confirm that both Shipping Logs are the same and are attached to their respective assigned box

• Perform a box count and number the boxes in preparation for Scanner Contractor pick-up.

• Correcting anomalies or discrepancies with the material • The Contractor shall provide an electronic Document Tracking Chart which keeps

track of all the documents which were picked up, scanned, and dropped-off. Please note it is expected OPDP will start receiving electronic submissions starting June 2014 with the release of eCTD 3.2.2 and GSVersion 8. As a result, the amount of paper submissions

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 27 - processed annually should decrease substantially. The Contractor will be expected to accommodate to this shift.

4. Data Entry

a. DARRTS Data Entry

The DCC Contractor staff shall enter submission data from the physical records into the DARRTS system. The number of data fields requiring data entry varies per submission but typically fall within the range of 15 to 25 fields. Please see CDER TO Attachments No. 7, Standard Operating Procedures (SOPs), for more detail regarding the specific data fields requiring data entry per application type. As a part of steady state operational activities, the Contractor shall update SOPs to identify changes in data field entries, corrections, and / or recodes. The Contractor shall ensure processing staff receive on the job training in order to mitigate data entry errors.

The contractor shall conduct changes or recodes to data field as identified by DDMSS liaisons and the COR. Examples of events that would trigger data field changes are system upgrades, regulatory mandates, office reorganization, staff reallocation, data entry errors, and internal business decisions. Common fields that currently require updating are reviewer assignments, document coding, properties, category coding, reference fields, method of delivery, and submit & receipt dates. The Contractor will be expected to update the SOPs to reflect any data entry changes in the DARRTS database.

b. BrMIS /CIS Data Entry

The DCC Contractor staff shall conduct initial data entry in BrMIS / CIS on the Clinical Investigators (CIs), Institutional Review Boards (IRBs), and Contract Research Organizations (CROs) into the BrMIS system. Information to be entered regarding CIs, IRBs, and CROs is identified on FDA Forms 1572 and 1571. The Contractor shall also abstract information about protocol title and number from the FDA Form 1572. For more background and detail on initial data entry and abstraction requirements please refer to the BrMIS SOP.

c. RMS-BLA Data Entry

o RMS BLA The Contractor is responsible for entering BLA submission data into CBER RMS-BLA. There are approximately nine data fields that require data entry as identified in the BLA SOP. Data fields requiring data entry may change for various reasons. The Contractor shall update RMS-BLA data fields and execute modified procedures as authorized by DMST liaisons. Events that typically result in data field changes would be system upgrades, regulatory mandates, office reorganization, staff reallocation, and internal business decisions.

o DARRTS CDER BLA Communications

The Contractor shall enter information from the DARRTS generated RMS-BLA daily report into the RMS-BLA communications screen.

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 28 - 5. Collection Maintenance Activities The Contractor shall provide routine operational activities to support CDER DCC processes and ensure timely processing of all submissions in accordance with the SLA identified in the SOPs.

a. Records Management

The Contractor shall conduct the following tasks: • File Retrieval Activities:

o Obtain archived and / or stored files from various storage locations, such as the Federal Records Center (FRC).

o Respond to CDER reviewer requests for submissions and distribute accordingly. • Conduct File Shelving Management and Organization

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

o The Contractor shall ensure that adequate filing space is maintained for all CDER regulatory document rooms. There must be enough room for subsequent, subsequent amendments, and other correspondence to be filed next to the original application.

o Remove archival volumes from active file room for movement to storage as directed by DMST staff.

o Checking-in and Checking-Out Files and maintaining a tracking log. o Conducting Re-filing Activities

• Process Program Change Requests (PCRs) to address and resolve issues with submissions.

• Shred files as identified in Records Control Schedules and authorized by the Agency Records Liaison Officer (ARLO). In CY’12 approximately 84,000 volumes of material were shredded.

• Dispose of Electronic Media (CDs /DVDs) as identified in Records Control Schedules and authorized by ARLO.

• Return external hard drives as identified and directed by eDMST (maximum of 60 boxes annually)

• Process Records for Retirement - – In CY’12 approximately 80,000 volumes were retired to FRC (this equals 5,000 boxes).

• If an extra submission is marked “Desk Copy”, the document room Contractor shall be responsible for logging in the desk copy and delivering to the appropriate RPM.

• Conduct Data Entry and Data Abstraction • Run SAP Business Objects Reports from DARRTs • Develop, update, and adhere to Records Control Schedule as directed by CDER’s ARLO • Conduct Quality Control and Electronic Submissions Validation

o Ensuring data entered into tracking systems is accurate and complete o Documenting Discrepancies and notifying appropriate stakeholders

b. Jacketing, Bar-coding, and Labeling the Jacket

The Contractor shall prepare jackets, barcodes, and label jackets as specified in the SOPs for regulatory submissions. In addition, the Contractor shall create jackets, label, and barcode archival volumes. The Contractor shall conduct quality control to ensure the correct jacket colors, barcodes, and labels are applied to every submission. If submissions are received for

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 29 - processing without a jacket, the Contractor shall prepare a jacket as identified in the SOPs. All material to be jacketed first needs to be hole-punched. The Contractor shall perform barcoding and labeling of volume jackets. The barcode label identifies the application and volume number of each jacket and enables INVAS to track the application throughout the life cycle. 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. Volumes are numbered using a decimal system. (e.g. If there are twelve Archival volumes, volume 1 is recorded as A1.1, volume 2 is recorded as A1.2, and volume 3 is A1.3, etc. ) Desk copies of submissions are not labeled or bar-coded.

c. Inventory Management The Contractor shall inventory files stored at CDER DCCs, OND and OGD reviewer offices, mail stops, and common areas. Inventories shall be tracked using the CDER’s INVAS portable hand held scanners and uploaded into the INVAS database. The Contractor shall enter file location in INVAS and update file location when file is transferred to another reviewer and / or location. 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 and database upload is accurate. If data is illegible, inaccurate, or not properly uploaded, the Contractor shall document data discrepancies and forward to the Contractor’s quality control inspectors for corrective action. DCCs and files should be inventoried per the following occurrences and frequency: Table 3: Inventory Schedule Occurrence Frequency DCC Inventory: CDR Unit A, Unit B, and Unit H

Semi-Annually

DCC Inventory: MPN7, MPN2, MPN 1

Semi-Annually

DCC Inventory: DR1 and DR2

Semi-Annually

Office to Office Inventory

Monthly

Filing and Storage Per occurrence File Retrieval Per occurrence File Back Activities Per occurrence The Contractor shall develop and distribute an inventory calendar to the COR and DDMSS liaisons. 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. CDER “Office to Office” Inventory The Contractor shall perform “Office-to-Office” inventories monthly to track the custodian and location of documents amongst the OND and OGD reviewer community. The information is used by various CDER stakeholders to identify the physical location of documents. The Contractor shall provide document location information to authorized staff when requested. Office to Office inventories are conducted with handheld scanners. The Contractor shall identify locations to be scanned, enter appropriate tracking data in INVAS, create barcodes, and affix barcodes to the appropriate locations. The Contractor shall scan all bar-coded jackets and their appropriate location. In addition the Contractor shall update data to represent changes on a weekly basis if necessary. Examples of changes are relocations, reassignments, personnel changes, and additional staff. 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. Clearly labeled and barcoded boxes, buckets, and 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. See CDER TO Attachment No. 9 for an example of CDER’s Office to Office inventory schedule per month.

e. Inventories during System Outages In the event of a computer system outage the Contractor shall scan documents with Government furnished battery operated hand-held scanners to avoid disruption of normal processing operations. At least one hand-held scanner is available at each DCC triage station. In the event the scanner is not in operating condition the Contractor shall follow procedures identified in the COOP. When systems are restored the Contractor shall update data into the main system.

6. On-Site Scanning and Copying As part of steady state DCC operations and support, the Contractor shall scan, copy, upload onto FDA servers, and forward documents identified in the table below. Types of documents and the expected volume requiring copying and scanning, may change but shall not exceed 400,000 pages annually. CDER will provide the appropriate equipment on-site to support scanning, copying, and conversion activities. Table 4: Description of Scanning and Conversion Activities Scanning Activity Notes Action Packages The Contractor shall scan paper action packages and

upload into DARRTS. In FY’12 two-hundred and twenty seven (227) action


packages were received/ page range varies but can be as high as 1,200 pages per action package)

New Applications – Assignment verification

The Contractor shall scan the cover letter and form(s), and emails to the CPMS distribution list for confirmation of the appropriate responsible division. In FY’12 approximately four thousand (4,000) new application assignment requests were received / the assignment verifications are (3 pages).

Title VIII The Contractor shall scan every FDA Form 3674 included in incoming paper submissions. In FY’12 three thousand and fifty-four (3,054) Title VIII forms were received / the form is two (2) pages plus cover form.

Processing instructions – verification The Contractor shall scan the form(s) and cover letter to the appropriate FDA personnel and include verbiage to explain the request for assistance as requested by stakeholders. In FY’12 the document received approximately seven thousand (7,000) verification requests / the requests are typically 3 pages.

Transmittals requiring resolution The Contractor shall provide copies of transmittals to DMST staff with errors that require resolution. In FY’12 there were approximately 100 transmittals requiring resolutions / the transmittal form is 3 pages.

SSCPP The Contractor shall scan physical SSCPP forms and upload to the EDR. Please note it is expected most SSCPP forms will be received via ESG and will not require scanning. The FDA is estimating no more than 100 physical SSCPP forms per year / the form is seven (7) pages long plus cover form.

Administrative tasks As required, the Contractor shall scan forms, instructions, and other documents to facilitate DMST support services. The following administrative actions require scanning:

• Administrative Change of Applicant • Administrative Change of Name and Address • Administrative Change of U.S. Agent In FY’12 the document room scanned approximately one thousand five hundred and


fifty-five (1,555) administrative changes. Each administrative change is approximately five (5) pages long.

Charge and History Cards The Contractor shall scan Charge and History cards for

preservation and archiving purposes.

a. Quality Control for Scanning and Copying Activities The Contractor shall conduct quality control of scanned and copied material by conducting the following QC measures:

• Ensure electronic files and copies are an exact duplication of the materials received by the Contractor. This duplication includes correct bookmarks, sub-bookmarks, naming conventions, and order of material.

• Scan all pages in the correct direction. • Duplicate copies shall still be scanned and named as Copy1, Copy2, etc. The Contractor

shall notify an authorized DMST liaison if duplicate copies are found within the original document.

• Notify authorized DMST liaison of any missing pages in the documents or Exhibits, mis-numbered pages, and duplicate-numbered pages.

• Return the hardcopy documentation in the same order and format as before it was scanned. This includes sticky notes, staples, clips, and sleeves being replaced in the original location after scanning/conversion.

• The Contractor shall inspect documents to ensure all data has been captured and indexed properly including questionable words and characters. Problem documents should be corrected by rescanning the document and/or by correcting the errors in the file and saving the revisions.

7. Continuity of Operations Plan (COOP) Federal Continuity Directives and subsequent HHS Directives mandate that all federal agencies have viable plans and programs in place to insure that the Federal Government can continue to operate during a wide range of emergencies, including localized acts of nature, accidents, and technological or attack-related emergencies. These mandates also apply to all CDER Document Operations. In collaboration with the Program Office the Contractor shall provide services and support activities along with the following:

• Know the contents of the Plan (The COOP Plan will be available to the Contractor post award)

• Participate as a member of the relocation group • Participate in annual relocation exercises • Maintain the call down cascade for all document room contractors • Provide reports regarding findings of call down exercises and retest when necessary • Provide courier service to locations identified during COOP

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 33 - I.2.5 RELOCATION SUPPORT (OPTIONAL LINE ITEM/ SEPARATELY PRICED) (FIXED PRICE) In accordance with section D.1.20 of the IDIQ SOW the contractor shall provide support for relocating OGD staff and documents. CDER OGD reviewers and a select group of DCC contractors are anticipated to relocate to the White Oak Campus between Spring/Summer 2014. The selected personnel will be relocated to Bldg. 71, into a 1574 square foot space. All active and inactive files at MPN1 and MPN2 will be relocated to MPN7. Approximately 50,000 volumes will be transferred during the relocation. Please note the actual loading and movement of files will be supported by another contractor. The DCC contractor shall be responsible for collaborating with transportation and moving contractor and ensuring files are in proper order at the new location. For this effort the DCC Contractor shall participate in the following activities in support of the relocation: 1. Moving Document Control Staff:

a. Pre-move • Participate in move planning, including support for identifying workspace and access

requirements • Provide FDA with a list of the staff to move • Pack work related desk items in FDA provided crates or boxes • Remove any personal items, (not on contract time) • Inspect new work areas and provide FDA with a list of any outstanding issues

b. Post move • Unpack work items • Inspect vacated space to ensure that all documents and authorized equipment have

been moved 2. Relocating Document Room:

a. Pre-move • Participate in move planning, including support for identifying document room,

workspace and access requirements • Where possible consolidate records in the central document room (e.g. MPN7 for OGD or

CDR for OND) • Inspect new document room space and provide FDA with a list of any outstanding issues • Perform a dry run of new delivery routes (external and within buildings)

b. During Move • Collaborate with movers during packing operations to ensure all documents and

equipment are packed in the proper order • Collaborate with movers during unpacking operations to ensure documents and

equipment are placed properly on the shelves in the new document room

c. Post move • Perform a complete inventory of the new document room


• Inspect vacated space to ensure that all documents and authorized equipment has been moved

3. Relocating FDA Staff

a. Pre-move • Participate in move planning, including support for identifying access requirements • Obtain a list of FDA staff moving including current location and new location • Prepare barcodes for new location:

o Offices o Mail Stops

• Work with FDA to obtain required building access • Perform a walkthrough of new FDA staff location and provide FDA with a list of

document delivery/retrieval/inventory issues • Perform a pre-move office to office inventory

b. Post-move • Apply barcode labels in new location • Offices • Mail Stops

NOTE: If acceptable this step can be completed pre-move if the space is complete and safe to enter

• Perform a post move office to office inventory • Inspect vacated space to ensure that all documents and authorized equipment has been

moved I.2.6 TWO-MONTH TRANSITION-OUT (OPTIONAL LINE ITEM) (FIXED PRICE) In accordance with section D.1.17.b of the IDIQ SOW the contractor shall provide transition-out services. In the event the responsibilities for fulfillment of the tasks described in this SOW are transferred to a successor the Contractor shall participate in transition-out activities and develop a transition-out plan. During this period it is expected the successor new project managers and operational staff will be on site at DCC locations shadowing daily operations. The Transition-Out plan shall include the following:

• A description of all services, equipment, and documentation that must be transferred to successor contractor and / or the Government,

• A description of the roles and responsibilities for contractor employees during the transition,

• Provide a description of Classroom training. The content of the training shall at a minimum cover all aspects of DCC operations.

• Proposed problem mitigation techniques • Proposed methodologies for conducting and ensuring a seamless transition and

implementing an orderly process for the transfer of all historical information, system documentation.


• Names of employees that will be responsible for fully briefing their follow-on counterparts.

• Organizational chart identifying employee names, locations, point of contact information, and roles in transition activities.

• The Contractor shall be expected to provide the successor contractor Classroom training, knowledge transfer sessions, and shadowing activities related to CDER DCC operations.

During the transition-out period it is expected the Contractor will remain responsible for the proficiency of operational activities described in this SOW. Knowledge walkthrough sessions shall at a minimum cover the specific operations of each CDER Document Control Room, identification of forms and applications types, walk through of how to process each application type, office to office inventories, data entry into FDA tracking systems and repositories, and preparation of materials for scanning. The Contractor shall ensure the successor contractor’s managers and new technicians have the opportunity to shadow daily operations (to include courier route). The Contractor shall provide managerial oversight for shadowing activities. Note: The objective of shadowing is to enhance the learning process by allowing the Contractor to observe workflow processes learned in Classroom Training and Knowledge-Walk-Through-Sessions. The Contractor shall conduct lesson learned sessions and identify training areas that need to be revisited and offer additional follow-up training. Provide a bi-weekly transition-out report identifying activities accomplished, activities remaining, risks, lessons learned, and potential needs to re-baseline. In addition, if an employee is providing both transition-out and operational activities the Contractor shall identify in the report how they intend to reduce performance risks and resource conflicts. Equipment Accountability –At completion of the contract, a joint inventory of accountable equipment shall be conducted by the Contractor and a Government representative. TRANSITION MEETINGS The Contractor shall attend transition plan briefing and transition meetings to identify risks associated with the agreed upon Transition Plan and determine if a re-baseline is needed to ensure a successful transition to the successor contractor. The Contractor shall be responsible for scheduling all transition meetings, documenting meeting notes, and forwarding to the COR for review. The Transition Plan Briefing meetings will be between the FDA and incumbent to identify and discuss the need to re-baseline the transition-out plan and operation / transition concerns.

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 36 - The transition meetings will be conducted between the FDA, successor contractor personnel, and incumbent contractor to ensure the transition-in and out plans align and the two companies are on the same page regarding transition expectations and objectives. Table 5: TRANSITION-OUT DELIVERABLE TABLE



Transition-Out Plan 1 ea 6-months prior to contract expiring

Knowledge Walk through Sessions 6 ea TBD Classroom Training Sessions and Refresher Training 16 ea TBD Shadowing Sessions 45 ea TBD Training Plan and Materials 1 for each DCC TBD Bi-Weekly Transition-Out Report 4 ea TBD Lessons Learned 3 ea TBD Signed equipment inventory list 1 ea TBD Transition Plan Briefing Meeting Notes 3 EA Deliver next business day

Transition Meeting Notes 8 EA Deliver next business day

I.3 CONTRACT ADMINISTRATION

I.3.1 PERIOD OF PERFORMANCE

The order has one base 12-month period and four 12-month option periods. The estimated periods of performance are as follows:

The Base Period has two parts:

a. 2-month Transition-In period: April 1, 2013 thru May 31, 2013

b. 10-month Steady State Operations and Maintenance: June 1, 2013 – May 31, 2014

Option Period 1: June 1, 2014 – May 31, 2015




I.3.2 PLACE OF PERFORMANCE Work will typically be performed at CDER facilities, although the Contractor may have the ability to work remotely as well, if approved by the COR. Meetings, briefings and work sessions will be conducted at FDA offices as specified by the COR. The FDA will provide the Contractor office space at the DCCs identified below.

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 37 - The majority of work will be performed at the following CDER DCCs:

1. Central Document Room Facilities (CDR) 5901 Ammendale Road Units A, B, and H Beltsville, MD 20705

2. White Oak Facilities 10903 New Hampshire Ave. Bldg 22, Rms. 0103, 0471, and 0443 Silver Spring, MD 20903 3. OGD Facility - MPN1 7520 Standish Pl. Rm. 1310 Rockville, MD 20857

4. OGD Facility - MPN2 7500 Standish Pl. Rm. E150 Rockville, MD 20857

5. OGD Facility - MPN7 7620 Standish Pl. Rockville, MD 20857 In addition the Contractor will be expected to deliver mail to the following reviewer facilities: 6. OSI Submissions Review and (FOI) Legal Review Facility

Hillandale Building, 1001 New Hampshire Ave. Silver Spring, 20903 7. Office of Generic Drug (OGD) Review Facility:

Montrose Metro 2 (MM2) Building (3rd and 4th floor) 11919 Rockville Pike Rockville, MD 20852 I.3.3 HOURS OF OPERATION The Contractor shall be available during normal hours of operation for CDER DCCs. Normal operation hours are as follows:

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 38 - 1. White Oak: DR1- Monday through Friday 7am – 6:00pm / DR2 & EDR: Monday through

Friday: 7am to 7:00pm 2. CDR: Monday through Friday: 7am to 6:00pm 3. Metro Park North Facilities : Monday through Friday: 7am to 6:00pm

I.3.4 HOLIDAYS AND AFTER HOUR AVAILABILITY This Task Order shall comply with the Holiday Section identified in the IDIQ. After Hour Availability: The Contractor shall possess the capability to deliver records materials after hours. After hours are after normal business hours Monday through Friday, weekends, and holidays. The maximum number of after hour requests per year is 75 and is limited to expedited file, emergency, and storage requests. Typical amount of time needed to respond to each request is averaged between 2 to 4 hours.

I.3.5 INVOICING 1. In accordance with FDA's two-way method for processing invoices and FAR 52.232-25,

Prompt Payment, the Contractor must submit monthly invoices by mail and electronically to the Contract Specialist. An electronic courtesy copy shall also be submitted to the COR.

2. All invoices shall be broken down by task activities and must include the following information:

a. Name and address of the Contractor; b. Invoice date and number; c. Task order number and task activities performed during that month; d. Name of employee that performed the activity, identify whether the employee is a

subcontractor or prime, identify number of hours spent on the activity per employee listed, hourly rate if a Labor Hour CLIN and/or fixed monthly price if a FFP CLIN,

e. Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

f. Terms of any discount for prompt payment offered; g. Name and address of official to whom payment is to be sent h. Name, title, and phone number of person to notify in event of defective invoice; an i. Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the

invoice only if required elsewhere in this order j. Electronic funds transfer (EFT) banking information k. DUNS number. l. Monthly Status Report shall be attached to the Invoice m. Updated task mapping matrix (if applicable)

3. The Contractor shall submit a Release of Claims for final order and modification invoices (including final invoices for each option period)

I.3.6 GOVERNMENT FURNISHED EQUIPMENT (GFE) The Government will furnish office space at each CDER DCC location. Government furnished office space will be equipped with desk, chair, telephone, remote access key fob (if needed, as

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 39 - determined by the Project Officer), computer (either desktop or laptop - if necessary) including access to FDA/CDER systems required to perform the work outlined, email, internet, MS-Office suite of tools. Other software may be installed on request but will require approval by the Project Officer. In addition CDER will provide pallet jacks, portable handheld scanners, and stock chasers for DCC operations. Please see CDER TO Attachment No. 10 for a detailed list of GFE.

I.3.7 CONTRACT STAFF 1. Government Personnel

a. Task Order Contracting Officer

Contracting Officer’s Authority:

The Contracting Officer (CO) identified in Section 5.16 is responsible for ensuring the performance of all necessary actions for effective contracting; ensuring compliance with the terms of the contract and safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract, and notwithstanding any provision contained elsewhere in this contract, this authority remains solely with the CO. No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this Task Order. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the contract. The Government will not reimburse the Contractor for any work not authorized by the CO, including work outside the scope of the contract.

b. Task Order COR:

TBD post award

i. TO COR Roles and Responsibilities The TO COR shall serve as the Contractor’s first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; (5) assisting in the resolution of technical problems encountered during performance; and (6) providing technical direction; and, (7) reviewing of invoices/vouchers.

The TO COR does not have authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

SECTION 3: CDER Document Control Center (DCC) Task Order Statement of Work (SOW) - 40 - The Government may unilaterally change its COR designation.

Technical Leads may assist the COR. The Technical Leads will not have the authority to provide technical direction in accordance with the paragraphs above; however, they may be responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; (5) assisting in the resolution of technical problems encountered during performance; and (6) reviewing of invoices/vouchers.

ii. Technical Direction Performance of the work under this contract shall be subject to the technical direction of the Task Order COR. The term “technical direction: is defined to include, without limitation, the following:

• Directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

• Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work description.

• Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

Technical direction must be within the general Scope of Work stated in the contract. The TO COR does not have the authority to and may not issue any technical direction which:

• Constitutes an assignment of additional work outside the general Scope of Work of the contract.

• Constitutes a change as defined in the applicable contract clause entitled: FAR 52.243-2 “Changes - Cost Reimbursement” (AUG 1987) – Alternate 1 – (APR 1984); FAR 52.243-1 “Changes - Fixed Price” (AUG 1987) – Alternate 1 (APR 1984); or 52.243-3 “Changes – Time and Materials-Labor Hours” (SEP 2000).

• Change any of the expressed terms, conditions, or specifications of the contract.

All technical direction shall be issued in writing by the TO COR or shall be confirmed by him/her in writing within 5 working days after issuance.

If, in the opinion of the Contractor, any instruction or direction issued by the TO COR is within one of the categories as defined above, the Contractor shall not proceed but shall notify the Task Order Contracting Officer (TOCO) in writing within 5 working days after the receipt of any such instruction or direction and shall request the TOCO to modify the contract, accordingly. Upon receiving such notification from the Contractor, the TOCO shall issue an appropriate contract modification or advise the Contractor in writing that, in his/her opinion, the technical direction is within the scope of this contract. The


Contractor shall proceed immediately with the instructions or directions and shall be subject to the provision of the contract clause entitled “Disputes.”

2. Contractor Personnel The following labor categories are considered Key Personnel under this Task Order:

• Program Manager • Project Managers • Supervisors • Senior Technical Information Specialists

I.4 SPECIAL TERMS AND CONDITIONS I.4.1 SECURITY / NON-PUBLIC INFORMATION The Contractor shall abide by the security requirements described in the underlying IDIQ contract. The risk level for this Task Order is Level 5. The Contractor shall abide by the restriction about the treatment of Non-Public Information described in the Clauses FDA 1350 and 1354 incorporated into the IDIQ contract. I.4.2 HHSAR AND FAR FLOW DOWN CLAUSES Key Personnel (January 2006) The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(End of clause)

52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

(End of clause)

52.217-9 Option to Extend the Term of the Contract (Mar 2000)


(a) The Government may extend the term of this contract by written notice to the Contractor within 15 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months.

(End of clause)

52.217-7 Option for Increased Quantity—Separately Priced Line Item. (Mar 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of clause)