RFPATTACHMENTNO2CDERTOSOW_Final.doc

SECTION 3:

CDER Document Control Center (DCC) Task Order Statement of Work (SOW)

- 15 -

PART I: CDER TASK ORDER

TABLE OF CONTENTS: CDER RECORDS MANAGEMENT TASK ORDER

- 3 -I.1

TASK ORDER INTRODUCTION:

- 3 -I.1.1

BACKGROUND

- 3 -I.1.2

CDER RECORDS MANAGEMENT ENVIRONMENT

- 3 -1. CDER REVIEW OFFICES

- 13 -I.1.3

OBJECTIVES

- 14 -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

- 20 -I.2.3

TWO-MONTH TRANSITION-IN PERIOD

- 22 -I.2.4

CDER RECORDS MATERIAL PROCESSING AND OPERATIONAL SUPPORT ACTIVITIES

- 33 -I.2.5

RELOCATION SUPPORT (OPTIONAL LINE ITEM/ SEPARATELY PRICED) (FIXED PRICE)

- 34 -I.2.6

TWO-MONTH TRANSITION-OUT (OPTIONAL LINE ITEM) (FIXED PRICE)

- 36 -I.3

CONTRACT ADMINISTRATION

- 36 -I.3.1

PERIOD OF PERFORMANCE

- 36 -I.3.2

PLACE OF PERFORMANCE

- 37 -I.3.3

HOURS OF OPERATION

- 38 -I.3.4

HOLIDAYS AND AFTER HOUR AVAILABILITY

- 38 -I.3.5

INVOICING

- 38 -I.3.6

GOVERNMENT FURNISHED EQUIPMENT (GFE)

- 39 -I.3.7

CONTRACT STAFF

- 41 -I.4

SPECIAL TERMS AND CONDITIONS

- 41 -I.4.2

HHSAR AND FAR FLOW DOWN CLAUSES

- 43 -I.5

CDER TASK ORDER PRICE LIST

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; reviews promotional material; and performs post market evaluation of drugs.

This Task Order supports CDER’s mission by having a contract vehicle in place to ensure CDER’s records material received in Document Control Centers (DCCs) is accurately processed. CDER’s Office of Business Informatics (OBI) is charged with overseeing and supporting daily records management 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. DDMSS has several Government liaisons that interface with CDER Records Project Managers (RPMs) and the reviewer community to facilitate effective and reliable customer service, communication, and collaboration. 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 2013 (CY’13) CDER’s document control staff processed approximately 256,702 incoming paper and electronic documents. 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 more information on the volume of CDER submissions please see CDER TO Attachment No. 12 titled, CY’13 Volume of Submissions. 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. 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:

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 drugs are safe and effective. 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, IND Safety Reports, periodic safety reports, Post Market Requirements and Communications (PMR and PMC), correspondence, and other associated forms.

Paper and Electronic records materials for OND are currently received and processed in the following DCC Facilities: Central Document Room (CDR), Document Room 1 (DR1), and the Electronic Document Room (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, periodic safety reports, and PMRs / PMCs. Paper and Electronic records materials for OGD are currently received at the Metro Park North (MPN) DCC facilities. It is anticipated OGD will be regrouped as a super office in 2014.

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 processed in the following DCC Facilities: Document Room 2 (DR2) and the 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 and reallocate resources appropriately.

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. OC Establishment Inspection Reports (EIRs) are stored at CDR. The Office of Scientific Investigation (OSI) files, such as BMIS applications are currently processed and stored at DR1. Overflow files are stored in Room 0471. OC files take up a small portion of DCC space at 1,500 linear footage in CDR Unit A and approximately 7,400 linear footage between in DR1 and DR2.

In support of OC, the DCC contractor also processes and validates OC’s Secure Supply Chain Program (SSCP) forms. The SSCP is a stand-alone subsequent submission that is received via paper and through the gateway. Between July 2013 and December 2013 CDER received 150 SSCPP forms. CDER anticipates receiving no more than 300 forms per year (150 electronic / 150 paper forms).

e. The Office of Surveillance and Epidemiology (OSE)

The Office of Surveillance and Epidemiology (OSE) participates in a post-market surveillance program by collecting and evaluating a variety of mandatory and voluntary Adverse Event (AE) reports. They work with OND and OGD safety reviewers to determine whether to add side effects to pharmaceutical labels or in rare occasions remove a drug from the market. OSE staff collects 15-Day Post Market Reports, Periodic Benefit Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs), and Periodic Adverse Event Reports (PAERS). Most reports are submitted on 3500, 3500A, or 3500B forms. 95% of AE reports are received via FDA’s Adverse Event Reporting System (FAERS) operated and maintained under a separate contract. The DCC contractor assists OSE by processing physical and electronic AE reports received via ESG or at the Central Document Room (CDR) and ensuring proper distribution to OSE/ OND/ and OGD stakeholders.

2. REGULATORY APPLICATION TYPES

CDER DCCs primarily process regulatory records material requiring FDA review and approval. Regulatory material is priority and 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’13 the document room processed 47,237 ANDA submissions. 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)

BLAs are submissions containing specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and the medical effects of the biologic product. In CY’13 the document room processed 3,090 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. EUAs and supporting documentation are usually received in CDR but can be received by the reviewer community. The document control room assists in processing EUAs by working directly with the reviewer community to track submissions and expediting distribution of EUAs to the reviewer community. In CY’13 the document room processed approximately 25 EUAs.

e. Investigational New Drug (IND) Application

INDs are applications filed with FDA by the sponsor who wishes to conduct clinical investigations. In CY’13 the document control room processed 103,642 IND related submissions. 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) and 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 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’13 the document room processed 25,224 NDA submissions.

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

a. 7-Day / 15-Day / follow-up IND Safety Reports, Periodic Reports, and 15-Day Post Market Reports Applicants, manufacturers, distributors, and packers are mandated to report to the FDA incidents, adverse reactions, and adverse events associated with the use of pharmaceutical products. In CY’13 the Document Room received and processed approximately 16,157 periodic reports and 42,605 IND safety related reports.

Please note the document room staff does not process Post Market 15-Day reports received at CDR. All paper post market 15-Day reports received at CDR are triaged and made available to OSE’s team for pick-up and processing in FAERS. In CY’13 CDR received and triaged approximately 35,000 post market 15-day reports. In addition, in CY’13 approximately 31,000 electronic post market 15-day reports were received through ESG; these reports are currently labeled as General correspondence and are not further processed by the document control room staff. DMST members are in the midst of developing procedures on how to notify OSE stakeholders when 15-day post market submissions are received through ESG. The contractor will be expected to execute agreed upon notification procedures when they are determined and implemented.

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. Bioresearch Monitoring Information System (BrMIS) Submissions

The Bioresearch Monitoring Information System (BrMIS) file contains information submitted to FDA identifying clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug studies with human investigational drugs. In CY’13 187,264 entries associated with 9,589 BrMIS submissions were processed. BrMIS submissions come via the gateway and paper. Please note the processing of Gateway and paper submissions requires the same level of manual data entry into the BrMIS system because the gateway submissions aren’t submitted directly into the BrMIS system. Please see attachment No. 6: SLAs and AQLs for acceptable processing of BrMIS submissions.

e. Desk Copies

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.

f. 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.

g. 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’13 the document room processed 25,756 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 are 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:

· DMF Annual Reports

Annual reports for DMFs are submitted on the anniversary date of the original submission. DMFs should contain general data elements associated with the original DMF and also identify all changes and additional information incorporated into the DMF since the previous annual report.

· 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

Overdue Notice Letters are outgoing communications 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.

h. Dunning Letters

Dunning Letters are outgoing communications from FDA to sponsors if FDA proposes to terminate an IND. The goal of the process is to issue the Dunning Letters to Sponsors of IND applications where there has been no recent activity.

i. 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.

j. 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. The document room is responsible for identifying and processing applications received with the FDA 3864 form.

k. Meeting Requests and Associated Documents Formal meeting requests from sponsors, applicants, and / or holders to meet with FDA reviewer community. In CY’13 the document room received and processed approximately 4,000 meeting requests for ANDAs, NDAs, and INDs. Meeting requests are high priority because reviewers have only 14 days to respond to industry.

l. OPDP Submissions

· Non-2253 Submissions (Red Jacket)

These submission packages are marketing related and generally do not include an FDA 2253 form. The submissions consist of requests for advisory and related correspondence, complaints and related correspondence, enforcement and other related correspondence, and general correspondence. In CY’13 the document room processed 1,971 non-2253 submissions.

· MAGTR submissions (Blue Jacket) Marketing and advertising supporting document and communication that is not associated with a regulatory application. In CY’13 the document control room only processed 25 MAGTR submissions.

· 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’13 the document room processed 49,757 2253 submissions.

m. Other Outgoing Communications The Document Control Room mails and faxes several FDA generated outgoing communications to sponsors on behalf of the reviewer community. Many communications utilize existing Communication Standard Templates (CST), while some others are unique and drafted based on reviewer community concerns. Acknowledgement letters, Approval letters, and Dunning Letters are examples of the FDA generated communications. The document room is typically notified of a communication that needs to be Mailed or faxed via the DARRTS system and should process them in accordance with SLAs. Please note, approximately 95% of all communications are currently sent via mail. In CY’13 the document control staff processed approximately 41,250 outgoing letters and faxes.

It is expected communications will become more electronic with the release of the Regulated Product Submissions (RPS) module in eCTD version 4.0. RPS will allow for two-way communications between sponsors and reviewers. This release can occur when final approvals are received from the International Conference on Harmonization (ICH) and Health Level 7 (HL7) committees. This is expected to occur in 2016 or 2017, the DCC contractor will be expected to accommodate to the shift in business processes as a result of the RPS implementation.

n. Post Marketing Requirements and Commitments (PMRs / PMCs)

The phrase post-marketing 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. In CY’13 the document room processed approximately 10,698 annual reports with PMRs /PMCs.

o. 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. In CY’13 the document control room processed approximately 548 proprietary name requests. The document room assists in this effort by properly identifying, coding, prioritizing, and distributing proprietary name requests.

p. 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.

q. Pre-Submissions

Documents that are submitted for review prior to submitting the application.

r. 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’13 twenty-five PEPFAR related applications were received and processed.

s. 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.

t. Subsequent Submissions Any submission associated with a regulatory application other than the original submission. This includes amendments, supplements, forms, reports, letters, correspondence, etc. Approximately 95% of submissions processed are subsequent submissions, 3% supplement, and 2% new submissions.

u. 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, and distributing supplement material. In CY’13 the document room processed approximately 7,700 supplement submissions.

v. 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.

w. 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.

x. 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 entering Title VIII information in DARRTs or other designated tracking system, scanning forms using desktop scanners, and uploading scanned forms to a shared folder. In FY’12 the document room processed approximately 4,000 Title VIII forms.

y. 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.

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) 2013 data indicates 51% of all incoming documents were processed via the gateway. Based on historical data CDER expects an increase in the volume of electronic submissions over the course of 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. Please note several new strategic capabilities are being initiated that will eventually lead to the retirement of DARRTS and migration of data to other tools and / or systems. The capabilities are geared on improving data quality, data management, reviewer workflow management, business management, and data analytics. The timeframe for migration of data and capability implementations have not been fully established but it is expected to occur within the next two years. Such changes shall not interrupt the contractor’s obligations to process submissions in a timely manner. The contractor shall communicate concerns regarding the new implementations during cross functional meetings and accommodate to shifts as they occur.

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 Gateway Submissions Tracking Tool is 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. Mail Tracking Tool The mail tracking tool electronically collects application metadata from physical submissions, monitors workflows, collects quality statistics, and produces management reports. CDER intends to provide the tracking tool as Government Furnished Property (GFP). The tracking tool and data shall reside within FDA’s Network. For tracking purposes the contractor shall enter metadata into the tool before physical submissions are entered into DARRTS (or other designated data management tool) and submit metric reports to OBI management upon request.

h. Gateway Submissions Tracking Tool / Solution The Gateway Submissions tracking tool accounts for electronic submissions received through the Gateway but not yet uploaded into the DARRTS production server (or other designated data management tools). This tool allows CDER to obtain metadata on electronic submissions and accurate statistics regarding the volume of submissions received regardless of their status of validated, failed, or 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 (or other designated data management tool) and do not account for rejected submissions.

The Gateway Submissions Tracking tool interfaces with the DCC Microsoft Outlook access database to populate and generate a consolidated and comprehensive view of the electronic submissions. It is used by the DMST staff to conduct quality assurance and ensure Service Level Agreements (SLA) and Acceptable Quality Levels (AQLs) are being met. CDER will provide the gateway submissions tool as GFP. The Gateway Submissions tracking tool and data shall reside within FDA’s Network. The contractor shall use the tool to obtain metrics on Gateway submissions and report metrics to eDMST management.

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 more efficient processes for handling 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.

· Little to no interruption in daily operations as a result of changes in business processes and implementation of tools to support new strategic capabilities.

· Implementation of operational efficiencies such as improved document distribution time, ability to accommodate changes in submission process, complete inventory lists;

· 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, adhering to 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 OPDP scanning, 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 all submissions received and CDER’S Document Room Processes. The Contractor Task Order Manager shall provide an approach to Quality Control (QC) 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 QC for ASR and paper submissions. The contractor shall maintain acceptable performance levels for all CDER DCC operational activities. The Contractor shall generate a monthly QC report 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 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.

· Resource Breakdown Structure (RBS) identifying personnel / labor categories responsible assigned to CDER DCCs.

· 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

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 elements identified in CDER TO Attachment No. 1: CDER December 2012 Monthly 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:

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 Gateway 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

Each day, the Contractor shall run a report that lists all of the finalized BLA communications in DARRTS from the prior day, conduct quality assurance of the transferred data from DARRTS, and conduct data entry as indicated in the BLA communications SOP. In CY’13 CDER received approximately 1,195 BLA communications.

The DARRTS report generated by the contractor shall be submitted to the eDMST liaison and COR. If any questions arise, the document room will contact the communication author for clarification. Please note CDER is working on an effort to receive all BLAs directly into DARRTS which will eliminate the need to conduct quality assurance of BLA communications transferred to RMS-BLA from DARRTs; this is expected to occur in June 2014. The contractor will be expected to accommodate to this shift and reallocate resources accordingly.

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.