75F40120R00004.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

DAO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Haritha Raja

DHHS/FDA/OAGS/DAO

CODE 16. ADMINISTERED BYCODE

X

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAO

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

1700 ET240-402-7621HARITHA RAJA

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40120R00004

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 91 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Haritha Raja

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

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SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAO

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

X

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

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ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

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27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

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RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

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41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

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ITEM NO.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

91 2 of

SOLICITATION NO.: 75F40120R00004

On-site Record Information Management (RIM)

SBA REQUIREMENT #: 0353/19/0374

Table of Contents:

Table of Contents:

NOTICE OF FAC

1.0 IDIQ STATEMENT OF WORK

1.1 INTRODUCTION

1.2 BACKGROUND

1.2.1 REGULATORY SUBMISSION TYPES

1.2.2 NON-REGULATORY RECORDS MATERIAL

1.3 RECORDS MANAGEMENT TECHNICAL ENVIRONMENT

1.3.1 RECORDS MANAGEMENT ORGANIZATIONAL STRUCTURE

1.3.2 21ST CENTURY ELECTRONIC BASED RECORDS INFORMATION MANAGEMENT (RIM) ENVIRONMENT . 11

1.4 ACCESS CONTROL & INFORMATION SECURITY

1.4.1 PHYSICAL ACCESS

1.4.2 NETWORK ACCESS

1.4.3 INFORMATION SECURITY

1.5 PURPOSE

1.6 OBJECTIVES

1.7 PROJECT SCOPE

1.8 GENERAL AND SPECIFIC TASKS AREAS

1.8.1 Contract-Level Program Management Tasks

1.8.2 IDIQ Monthly Status Report

1.8.3 Escalation Procedures

1.9 QUALITY MANAGEMENT

1.10 TASK ORDER MANAGEMENT

1.11 TRANSITION ACTIVITIES

1.11.1 TRANSITION-IN

1.11.2 TRANSITION-OUT

1.12 TASK AREA 1: ON-SITE RECORDS MATERIAL PROCESSING AND OPERATIONS SUPPORT

1.12.1 ON-SITE FACILITY MANAGEMENT

SBA REQUIREMENT #: 0353/19/0374

1.12.2 MAIL RECEIPT AND HANDLING

1.12.3 MAIL DISTRIBUTION

1.12.4 DATA ENTRY, DATA ANALYSIS, AND TRACKING SYSTEM TASKS

1.12.5 COLLECTION MAINTENANCE

1.12.6 SCANNING, PRINTING, AND CONVERSION SERVICES

1.12.7 Support or Automated System Outages

1.13 TASK AREA 2: RECORDS MANAGEMENT SERVICES

1.13.1 MANAGEMENT SUPPORT FOR FILE PLANS

1.13.2 MANAGEMENT SUPPORT FOR RECORDS CONTROL SCHEDULES (RCS)

1.13.3 COMPREHENSIVE INFORMATION MANAGEMENT SUPPORT

1.13.4 MANAGEMENT SUPPORT FOR IMPLEMENTING NEW RIM POLICIES

1.13.5 RECORDS MANAGEMENT CONSULTATION SERVICES

1.13.6 MANAGEMENT SUPPORT FOR INVENTORY OVERFLOW AND BACKLOGS

1.13.7 TRAINING

1.14 TASK AREA 3: RELOCATION SERVICES

1.15 IDIQ LABOR CATEGORIES AND MINIMUM QUALIFICATIONS

1.15.1 PROGRAM MANAGER

1.15.2 PROJECT MANAGER

1.15.3 SUPERVISOR

1.15.4 SENIOR TECHNICAL INFORMATION SPECIALIST

1.15.5 TECHNICAL INFORMATION SPECIALIST

1.15.6 SUBJECT MATTER EXPERT II

1.15.7 SUBJECT MATTER EXPERT I

1.15.8 TASK LEADER

1.15.9 QUALITY ASSURANCE SPECIALIST

1.15.10 SENIOR ELECTRONIC DOCUMENT TECHNICIAN - KEEP ALL CHANGES/EDITS

1.16 SERVICE CONTRACT LABOR STANDARDS (SCLS)-COVERED LABOR CATEGORIES

1.16.1 DATA ENTRY OPERATOR I

1.16.2 DATA ENTRY OPERATOR II

1.16.3 GENERAL CLERK I

SBA REQUIREMENT #: 0353/19/0374

1.16.4 GENERAL CLERK II

1.16.5 GENERAL CLERK III

1.16.6 DOCUMENT PREPARATION CLERK

1.16.7 MESSENGER COURIER

1.16.8 COMPUTER OPERATOR I

1.16.9 COMPUTER OPERATOR II

1.16.10 COMPUTER OPERATOR III

1.16.11 COMPUTER OPERATOR IV

1.16.12 COMPUTER OPERATOR V

2.0 INFORMATIONAL DATA

2.1 FDA GLOSSARY OF TERMS GLOSSARY OF TERMS

2.2 DEFINITIONS

2.3 LIST OF RECORDS FACILITIES

2.4 TRACKING SYSTEMS AND REPOSITORIES BY CENTER

2.4.1 CDER

2.4.2 CBER

2.4.3 CDRH

2.4.4 CFSAN

2.4.5 CVM

2.4.6 Office of Commissioner (OC)

2.4.7 CTP DCC Tracking & Data Entry Tools

2.4.8 CTP Data Repository

2.4.9 CTP/DCC Internal Tracking Tools

2.4.10 CTP/DCC Mailroom Internal Tracking Tools

2.5 RECORDS SYSTEM SUPPORTING SOFTWARE BY CENTER

2.5.1 CDER

2.5.2 CBER

2.5.3 CDRH

2.5.4 CFSAN

2.5.5 CTP

SBA REQUIREMENT #: 0353/19/0374

2.5.6 CVM

2.5.7 OC

2.6 SUMMARY OF VOLUME OF REGULATORY SUBMISSIONS BY CENTER

2.7 SECURITY CHARTS A & B PERSONNEL SECURTIY CHARTS NON-PUBLIC DATA PROTECTION

CONTRACT TYPE AND MINIMUM/MAXIMUM AMOUNTS

ORDERING PROCEDURES

3.0 SCHEDULE OF DELIVERABLES

4.0 PLACE OF PERFORMANCE

5.0 PERIOD OF PERFORMANCE

QUESTION SUBMITTAL INSTRUCTIONS

PROPOSAL SUBMITTAL DUE DATE:

BASIS FOR AWARD AND EVALUATION FACTORS

Federal Acquisition Regulations (FAR) Provisions

Federal Acquisition Regulations (FAR) Clauses

Health & Human Services Acquisition Regulation (HHSAR) Clauses

FOOD & DRUG ADMINISTRATION (FDA) REQUIREMENTS

CONTRACTOR ADVERTISING OF CONTRACT AWARD

FDA PERSONNEL OBSERVICE THE FOLLOWING DAYS AS HOLIDAYS

REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

FDA PERSONNEL SECURITY CLEARANCE REQUIREMENTS

IDENTIFICATION OF CONTRACTOR EMPLOYEES

OFFEROR’S CERTIFICATION - ORGANIZATIONAL CONFLICTS OF INTEREST

ORGANIZATIONAL CONFLICT OF INTEREST

FDA 1350 ACCESS TO NON-PUBLIC INFORMATION

BRIEFINGS

GOVERNMENT-FURNISHED DATA AND MATERIALS

NOTICE TO THE GOVERNMENT OF DELAYS

PERSONNEL

NON-PERSONAL SERVICES AND INHERENTLY GOVERNMENT FUNCTIONS

CONTRACT MANAGEMENT

SBA REQUIREMENT #: 0353/19/0374

CONTRACTING OFFICER’S AUTHORITY

IDIQ CONTRACTING OFFICER REPRESENTATIVE (COR)

TASK ORDER CONTRACTING OFFICER REPRESENTATIVE

INVOICING INSTRUCTIONS AND REQUIREMENTS

CONTRACT FINANCIAL REPORTING FOR TIME-AND-MATERIALS AND LABOR-HOUR TASK ORDERS

TRANSITION

CONTRACTOR PERFORMANCE EVALUATION(S)

LIST OF ATTACHMENTS

SBA REQUIREMENT #: 0353/19/0374

Background

The mission of the Food and Drug Administration (FDA) is to protect the health of the American public (www.fda.gov). For more than one hundred (100) years, FDA has been the international leader ensuring safe food, cosmetics, human drugs and biologics, veterinary products, medical and radiological devices, and tobacco products. As part of its mission the FDA receives records materials from a variety of public and private entities including regulated industry. Throughout FDA‘s history, records management has played a vital role in the agency’s regulation process and, ultimately, in the mission to protect public health. This allows FDA to comply with federally mandated record keeping requirements while maintaining a high level of accountability to the citizens of the United States. In order to ensure proper organization and management of records, the FDA complies with regulations set forth in the Federal Records Act, per United States Code (U.S.C.), Title 44, Chapters 29 thru 33; Title 36 Code of Federal Regulations (CFR), Chapter 12; and National Archives and Records Administration (NARA) guidance. In addition, the FDA strives towards a streamlined, 21st Century, electronic Records Information Management (RIM) environment that preserves the integrity of public records, while creating cost efficiencies that allow the agency to focus on advancing in scientific and public health efforts.

It is the FDA’s intent to award an indefinite delivery-indefinite quantity (IDIQ) contract, with a performance period of five (5) years. The Government anticipates awarding an IDIQ contract with a ceiling of $112,000,000.00 and a guaranteed minimum of $3,000.00.

NOTICE OF COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

This is a request for proposal (RFP) for commercial items IAW the procedures of FAR Part 12 – Acquisition of Commercial Items, and FAR Part 15 – Contracting by Negotiation.

NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2020-03, effective December 13, 2019.

NOTICE OF NAICS/SET-ASIDE

This requirement is set-aside for firms certified with the socio-economic designation of 8(a) by the Small Business Administration (SBA). The associated NAICS code is 541990 (All Other Professional, Scientific and Technical Services), with a small business size standard of $16.5 Million. Offerors must have an active registration in www.SAM.gov, with completed representations and certifications, by the close date of the solicitation. The offeror’s SAM registration must include the offeror’s exit date from the 8(a) program.

Proposals submitted by offerors not registered in SAM.gov, with the offeror’s exit date from the 8(a) program, will not be considered.

SECTION 8(A) AWARD - PARTNERSHIP AGREEMENT BETWEEN SBA AND HHS

https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2012_6.html#wp1088488

SBA REQUIREMENT #: 0353/19/0374

Although the Small Business Administration (SBA) may not be identified as the prime contractor in Block 17a (SF1449), the SBA is still the prime contractor on this contract.

The SBA is required to approve novation agreements submitted by the 8(a) Participant. Additionally the U.S.

Department of Health and Human Services (HHS) shall provide advance notice to the SBA prior to issuing a final notice terminating this contract in whole or in part.

The SBA District Office:

U.S. Small Business Administration

WASHINGTON METROPOLITAN AREA DISTRICT OFFICE

409 3rd Street, S.W., 2nd FLOOR

WASHINGTON, DC 20416

The 8(a) partnership agreement between SBA and HHS applies to this requirement.

Link:

https://www.sba.gov/sites/default/files/files/Department%20of%20Health%20and%20Human%20Services.pdf

CONTRACT REQUIREMENTS:

1.0 IDIQ STATEMENT OF WORK

1.1 INTRODUCTION

The mission of the Food and Drug Administration (FDA) is to protect the health of the American public (www.fda.gov). For more than one hundred years, FDA has been the international leader ensuring safe food, cosmetics, human drugs and biologics, veterinary products, medical and radiological devices, and tobacco products. As part of its mission the FDA receives records materials from a variety of public and private entities including regulated industry. Throughout FDA ‘s history, records management has played a vital role in the agency’s regulation process and ultimately, in the mission to protect public health. This allows FDA to comply with federally mandated record keeping requirements while maintaining a high level of accountability to the citizens of the United States. In order to ensure proper organization and management of records the FDA complies with regulations set forth in the Federal Records Act per United States Code (U.S.C.), Title 44, Chapters 29 thru 33; Title 36 Code of Federal Regulations (CFR), Chapter 12; and National Archives and Records Administration (NARA) guidance. In addition, the FDA strives towards a streamlined 21st Century electronic Records Information Management (RIM) environment that preserves the integrity of public records while creating cost efficiencies that allows the agency to focus on advancing in scientific and public health efforts.

1.2 BACKGROUND

Over the last quarter century major shifts in records storage, multimedia management, disclosure requirements, electronic product submission, scientific computing and federally mandated records keeping requirements make it necessary for FDA to move from a paper centric agency to a media neutral information-based organization. This indefinite delivery-indefinite quantity (IDIQ) contract will provide direct support to FDA’s move to a broader information-based organization by supporting core functions related to the processing records material that support scientific advancement, public health issues and the regulatory review process. All FDA Offices and Centers are stakeholders under this IDIQ Vehicle.

https://www.sba.gov/sites/default/files/files/Department%20of%20Health%20and%20Human%20Services.pdf

SBA REQUIREMENT #: 0353/19/0374

The regulatory mission supports many laws and Federal regulations that give FDA its mandate. This includes, but is not limited to Federal Food, Drug and Cosmetic Act , Food and Drug Administration Safety and Innovation Act (FDASIA), and the following supplementary statutes: Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), Medical Device User Fee Act (MDUFA), Biosimilar User Fee Act (BsUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), Mammography Quality Standards Act (MQSA), Export Reform and Enhancement Act (EREA), Freedom of Information Act (FOIA), Family Smoking Prevention and Tobacco Control Act (FSPTCA), and Food Safety Modernization Act (FSMA).

1.2.1 REGULATORY SUBMISSION TYPES

The FDA is required by law to regulate the cosmetic, pharmaceutical, food, tobacco, and medical device industries. Regulatory submissions encompass a variety of applications and reporting requirements for regulated industry. Regulatory submissions vary across Centers but typically fall in one of the following categories, premarket and post-market. Premarket submissions include pre-application materials, Investigational applications, new product applications and license applications. Post-market submissions include supplemental applications to marketed products, adverse event reporting, and promotional materials.

1.2.2 NON-REGULATORY RECORDS MATERIAL

The FDA creates and receives a variety of non-regulatory Federal records. This includes but is not limited to, program records, office administration records, and dockets.

1.3 RECORDS MANAGEMENT TECHNICAL ENVIRONMENT

FDA’s Document Control Centers (DCC) ensure timely receipt, processing, and distribution of applications to the FDA reviewer committee. FDA’s DCCs are supported by eighteen (18) document control facilities / units within the Washington D.C.-metropolitan area. Most DCCs are currently located at the White Oak Campus with a few others in various locations. Fully operational DCCs provide full life cycle records operations and support. Please note, some DCCs can consist of one (1) or more facilities in multiple locations. It is expected that the number of document control facilities will fluctuate during the life of this IDIQ vehicle.

FDA’s DCCs processed over 640,000 paper and electronic application submissions in Calendar Year 2018 (CY’18). Each application submission may have multiple record keeping transactions or processing steps (e.g., document preparation, imaging, login, shelving); therefore, the number of transactions will be substantially greater than the number of unique application submissions (potentially 3 to 5 times greater). See D.3 for a list of Document Control Facilities and Centers, and D.6 for a Summary of Volume of Submissions by Center.

The FDA receives materials in multiple forms of media, to include, but not limited to, paper, electronic, and physical electronic (diskettes, CD, DVD, removable drives). Record materials include letters, memoranda, completed forms, statistical and narrative reports, graphics, photographs, and audio / video recordings. In addition, FDA receives physical artifacts such as labels, bottles, syringes, laboratory samples, feed bags, boxes and promotional materials. FDA records may be stored in a variety of formats, including paper, physical electronic, and microform, and server-based e-records repositories.

1.3.1 RECORDS MANAGEMENT ORGANIZATIONAL STRUCTURE

On November 28, 2011, the President issued a memorandum, titled, Managing Government Records Directive.

T he directive is further outlined in NARA directive M-12-18. In accordance with M-12-18 and Federal Records Act, the FDA has both a Senior Agency Official (SAO) and Agency Records Officer (ARO) that manages the

SBA REQUIREMENT #: 0353/19/0374

overall Records Management program. The SAO is responsible for ensuring agency-wide compliance with records management procedures / policies and collaborating with the ARO. The ARO is responsible for disseminating guidance information to each Center’s Assistant Records Liaison Officer (ARLO), developing policies and overseeing day today records management activities, such as, updating and creating Records Control Schedules (RCS). The SAO and ARO are appointed by the Commissioner and reside at FDA’s Office of Information Management (OIM). Each Center has one (1) ARLO whom is responsible for managing record lifecycle at the Center Level and records management guidance and training to center staff. The ARLO is also responsible for reporting any records management issues or problems to the ARO for resolution. Contractor staff assigned to this contract will primarily communicate with IDIQ and Task Order Contracting Officer Representatives (COR).

1.3.2 21ST CENTURY ELECTRONIC BASED RECORDS INFORMATION MANAGEMENT (RIM) ENVIRONMENT FDA recognizes that electronic submissions have many advantages over paper submissions. By storing electronic submissions in electronic document repositories, they are readily accessible to authorized FDA personnel at all times. The binding guidance with industry, “Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, Guidance to Industry,” was enacted in 2017 and 2018. The binding guidance with industry requires electronic submissions for certain products under the Prescription Drug User Fee Act (PDUFA).

Furthermore, the eCopy Guidance for medical devices requires an electronic copy for all Medical Device User Fee Act (MDUFA) submissions.

Currently, FDA receives electronic submissions in several formats, including electronic Common Technical Document (eCTD), Roadmap PDF and unstructured files in a native file format. The types of formats and file structures vary by Center / Office and will be outlined in the individual task orders issued under this contract.

The FDA intends to adopt the Regulatory Product Submission (RPS) format, which will improve the submission process by allowing for two-way communication between submitter and reviewers. The way electronic submissions are loaded and managed in repositories is reflected in the Centers’- business and review process.

D.4 provides a list of Tracking Systems and Repositories by Center. See D.5 for a list of applications that support Center tracking systems and repositories.

1.4 ACCESS CONTROL & INFORMATION SECURITY

1.4.1 PHYSICAL ACCESS

Entrance into all document control facilities must be through a controlled entry point(s). Visitors are required to sign in and out at the entrance and state the purpose of their visit. A log shall be kept of all such visits.

Persons that do not have a legitimate business need related to the facility operation shall not be allowed access.

For all facilities, the Contractor shall establish and implement a procedure for ensuring that all keys, lock combinations and access codes issued to Contractor personnel by the Government are not lost, misplaced and not used by unauthorized persons. The Government will furnish all keys, combinations and access codes. Keys issued to the Contractor shall not be duplicated. The Contractor shall provide the COR a roster of Contractor personnel that are employed for this contract and shall update the roster as necessary. The Contractor may be required upon request to arm and unarm FDA alarm systems when arriving and leaving document control facilities.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications

SBA REQUIREMENT #: 0353/19/0374

1.4.2 NETWORK ACCESS

Contractors authorized to access FDA’s Virtual Private Network (VPN) from alternate locations must be connected to the Agency’s network through an authorized secure channel. All Contractors accessing FDA’s network from remote locations are subject to the Federal Information Security Management Act (FISMA) regulations. Please note, the Contractor may not access the network via their personal computers (for more detail, see Special Requirements Section / Subsection System Access).

1.4.3 INFORMATION SECURITY

Non-disclosure Agreements will be required from the Contractor, from any proposed persons working on this contract, and between the Contractor and any other Contractors, where information may need to be shared in order to perform services under this contract. All individuals with access to FDA Information must undergo a background investigation initiated through FDA’s Office of Security Operations.

The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and Government Accountability Office (GAO). These can be primarily found at or through the Federal Chief Information Officers (CIO) Council website at:

http://www.cio.gov/. HHS documents are found at: http://www.hhs.gov/ocio/.

1.5 PURPOSE

The purpose of this IDIQ contract is to obtain Contractor services related to several records related activities throughout FDA. Initiatives include on-site records support activities, on-site facility management, and on- site scanning.

1.6 OBJECTIVES

The FDA has several business objectives for processing of records and information, such as:

Executing daily operations in support of FDA RIM requirements;

Managing efficient operation of DCC facilities at FDA locations;

Improving overall records management performance;

Standardizing records management processes;

Promoting transparency and accountability by better documenting agency actions and decisions;

Supporting the shift towards a 100% electronic environment for new submissions and agency generated records;

Minimizing costs associated with all aspects of Records Management;

Promoting operational efficiencies;

Maintaining compliance for safeguarding and handling FDA Records Material;

Obtaining quality scanned documents in a timely manner for review by the FDA reviewer community.

1.7 PROJECT SCOPE

The scope of this IDIQ contract entails operation, management, and support of FDA onsite document, records and information management related activities. Support encompasses records lifecycle activities, quality control, DCC management, storage services, onsite DCC scanning, training, meta data management, information governance and records management.

http://www.cio.gov/ http://www.hhs.gov/ocio/

SBA REQUIREMENT #: 0353/19/0374

Records include regulatory, administrative, and program materials that support the agency’s business functions and public health mission. Business functions of the FDA pertain to human and animal pharmaceutical and biological drugs, animal feed, scientific research, food safety, medical devices, tobacco products, cosmetics and public health issues.

The scope of this IDIQ contract does not include information technology automation or software development and does not support FDA IT services.

1.8 GENERAL AND SPECIFIC TASKS AREAS

1.8.1 Contract-Level Program Management Tasks

The Contractor shall provide contract-level program management to establish the program project plans, structures, processes, schedules, reporting requirements, communication channels, and quality control functions necessary to successfully execute records management goals throughout the contract’s period of performance and achieve the mission to manage submissions received by the FDA.

1.8.2 IDIQ Monthly Status Report

The Contractor Program Manager (PM) shall provide a monthly contract level status report to the IDIQ Contracting Officer’s Representative (COR), incorporating all tasks at a high level and their progress. Within the first 30 days after IDIQ contract award, the Government and the Contractor PM will design and agree upon a standard reporting format that includes the following information, at a minimum:

Summary status and progress of tasks, by task order;

Summary cost and schedule variances;

Coordination activities across all tasks;

Impact or influence of any task on other tasks;

Impact or influence of tasks on overall FDA program;

Significant risks to scheduled deliverables and plans to mitigate them; and, Recommendations for changes or additional activities to ensure that the tasks support progress on the overall records related objectives.

1.8.3 Escalation Procedures

The Contractor PM shall escalate issues related to any impediment to progress towards any deliverables defined in the IDIQ contract or an individual Task Order. The Contractor shall follow escalation procedures consistent with the line of command in FDA. The Contractor shall follow this order of escalation when reporting to FDA personnel:

1. Task Order Contracting Officer’s Representative (COR)

2. IDIQ COR

3. Contracting Officer

1.9 QUALITY MANAGEMENT

The Contractor shall provide Quality Management activities as identified in individual task orders. Quality Management activities for this contract include, but is not limited to, meeting Service Level Agreements identified in individual task orders; ensuring proper handling and safeguarding of sensitive data and material;

identifying and mitigating risks; resolving issues; and adhering to processes and procedures.

The Contractor shall develop and implement a proactive Quality Assurance Plan (QAP) based on American Society for Quality (ASQ) standards, detailing its methodology and processes for measuring and attaining

SBA REQUIREMENT #: 0353/19/0374

quality of performance under this contract. The Contractor’s QAP shall be submitted within thirty (30) calendar days of IDIQ contract award. The QAP shall be updated on an annual basis. The Contractor shall be responsible for the quality of products and services provided under the terms of this contract, to include those provided by subcontractors.

The Contractor shall develop Quality Control Plans (QCP) for individual task orders issued under this contract.

Specific contents of the QCP will be detailed in individual task orders.

The Contractor may also be tasked to provide guidance on proper quality assurance methods related to document control, records or information activities.

1.10 TASK ORDER MANAGEMENT

The Contractor shall provide task order level project management to effectively manage tasks, monitor task order performance, manage Contractor staff and provide subcontractor management; and establish notification mechanisms to ensure the individual task orders stay on track to meet the important milestones and performance measures within the awarded task order. For each task order, the Contractor shall prepare a Task Order Management Plan (TOMP), for COR approval, describing the technical approach, organizational resources and management controls, to include Quality Control Plans as required in individual task orders, to be employed to meet the cost, performance and schedule requirements throughout task order execution.

Representative activities include, but are not limited to:

• Status and progress of all tasks

• Track and report progress against Service Level Agreements

• Cost Management

• Comply with reporting requirements as stipulated in the task orders.

• Follow escalation procedures for problems, issues, and recommendations as specified in individual task orders.

• Participate in FDA’s program/project reviews, management briefings, stakeholder presentations, and cross-agency information exchanges, in order to provide expert counsel to DCC staff and document lessons learned as directed by the TO COR.

• Ensure proper exit criteria are followed when Contractor employees leave projects. This may be subject to change based on individual Task Order requirements.

1.11 TRANSITION ACTIVITIES

The purpose of this task is to transfer the program’s functional and technical knowledge and program artifacts from the incumbent contractor to the successor contractor in an efficient and orderly manner with minimal disruption of services and support for users. As tasked, the Contractor shall provide transition activities to ensure knowledge transfer occurs from its staff and any subcontractors, if applicable, to the successor Contractor.

1.11.1 TRANSITION-IN

During the transition-in period, the Contractor shall conduct transfer activities that provide full operating accountability and responsibility for all tasks. The requirement for transition-in or transition-out activities and duration of transition-in period will be specified in individual Task Orders. As tasked, the Contractor shall submit, to the COR, a comprehensive Transition-in Plan. The Transition-in Plan shall establish the operational framework that is necessary to ensure a seamless, low-risk transition from the incumbent contractor to the

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Contractor. The plan must outline the actions and timeline necessary for the transition to occur and the communications necessary to ensure a flawless implementation. The Transition-in Plan, at a minimum, must provide a description of parallel operations, personnel on-board process tracking, and an updated list of Contractor personnel with anticipated start dates and responsibilities. Individual task orders may require additional information. The Contractor shall cooperate fully in transition-in activities.

1.11.2 TRANSITION-OUT

The Contractor shall provide transition-out support services to ensure an orderly transition of functions to the successor contractor. It is the responsibility of the Contractor and the successor contractor to ensure a smooth transition. The Contractor shall be the lead of the transition activities during the transition period that will be specified in individual Task Orders. At the approved turnover date, the successor contractor will assume full responsibility of operations. As tasked, the Contractor shall submit and execute a Government-approved transition-out plan to ensure business continuity for the FDA. The Contractor shall cooperate fully in all transition activities.

The transition-out plan, at a minimum, must provide the following information:

Schedule of knowledge transfer sessions, to include shadowing session, Transfer of documentation, such as Standard Operating Procedures (SOPs), Transition-Out schedule and milestones for completing transition out activities, Roles and responsibilities for Contractor staff during the transition, including the identification of a transition lead and ensure availability of key personnel during transition period, Defining process for Transition-Out progress reviews, identifying problems, and ensuring prompt problem resolution.

Individual task orders may require additional information.

1.12 TASK AREA 1: ON‐SITE RECORDS MATERIAL PROCESSING AND OPERATIONS SUPPORT

The majority of effort under this IDIQ contract involves processing records material and information at Government facilities. The Contractor shall perform the following activities under this task area, to include mail receipt, inventory, distribution, maintenance, disposition, and destruction of records material and information received and/or stored at Government facilities.

1.12.1 ON-SITE FACILITY MANAGEMENT

The FDA currently has several DCCs that are managed by FDA personnel and supported by Contractor staff.

During the life of this contract, the FDA may add or consolidate document control facilities to accommodate changes in the volume of submissions, implementation of operational efficiencies, and movement towards an electronic environment. If there is an issue with Government facilities, the Contractor shall notify the responsible FDA staff and follow escalation procedures, as identified in individual task orders. Contractors shall adhere to FDA procedures for physical and facility security of non-public information. In addition, the Contractor shall follow regulations, procedures, and FDA policies for safety and security of physical records and content.

1.12.2 MAIL RECEIPT AND HANDLING

The White Oak mail room handles the mail delivery for the White Oak Campus. In some instances, mail room services are required for locations not serviced by the White Oak mail room. Generally, incoming submissions and records material are received at several central points of entry at FDA. U.S. Mail is received and screened at the FDA central mail facility. Commercial carrier and private couriers may deliver directly to a Center’s mail

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room or DCC. Screening processes for material received at a Center’s mail room or DCC will be outlined in the individual Task Orders. FDA DCCs process both non-regulatory and regulatory submissions. Each Center’s mail room processes will be identified in individual task orders. As tasked, the Contractor, operating document control facilities, shall staff the mail room, screen/x-ray scan incoming material, sort mail, prioritize, triage, track mail from initial receipt until upload into the appropriate system of record, and distribute both U.S. Mail and regulatory submissions to the FDA community or coordinate with the U.S. mail Contractor.

1.12.3 MAIL DISTRIBUTION

As tasked, the Contractor shall distribute mail between multiple locations and coordinate pick-up and drop-offs, as identified in individual task orders. Courier vehicles for distribution routes will be provided by the Government, as needed. The FDA distributes records materials to various FDA stakeholders. New incoming regulatory submissions are primarily distributed to the FDA reviewer community. Non-regulatory material may go to the FDA reviewer community, Contractor staff, administrative staff, and program managers, as needed/or instructed. New incoming records material may also be distributed to the off-site scanning vendor(s) under other FDA contracts. Distribution locations can be modified or changed throughout the review process for various reasons, thus requiring data entry changes.

1.12.4 DATA ENTRY, DATA ANALYSIS, AND TRACKING SYSTEM TASKS

As tasked, the Contractor shall process records material and information by:

Entering data into Center specific repositories and tracking systems;

Jacketing, labeling, and barcoding files;

Conducting document Quality Control (QC) to ensure all aspects of processing are accurate and complete, Uploading electronic submissions or scanned document/files into the appropriate FDA Electronic

Document Room or Tracking System.

The Contractor shall perform the following tasks related to records information processing, as directed in individual task orders:

Apply proper information security access controls, Prepare and enter metadata elements into information systems, Conduct data abstraction, Code and index submissions, Correct data entry errors, Respond to and resolve FDA stakeholder’s inquiries and/or questions regarding regulatory document and electronic submissions, Provide stakeholders assistance in submitting electronic information, Provide stakeholders assistance in complying with submission requirements, Perform redaction of submittals, Participate in user acceptance testing on records systems upgrades, Manage user roles and responsibilities as directed by records managers, Apply records schedules to various collections, Monitor physical and network storage availability, Organize and manage of electronic record collections, Compress files, Create backup copies, and Utilize existing FDA automated classification software (e.g. indices, scans and other form readers).

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1.12.5 COLLECTION MAINTENANCE

As tasked, the Contractor shall conduct scheduled media neutral collection inventories of records located at Government facilities and to track the file movement between locations. The collection inventory data is used to assist the FDA in managing storage and determine what records materials are ready for retirement.

Collection inventory data may be collected through, but is not limited to, a manual log, barcode system, and Radio Frequency Identification Device (RFID). Collection inventory data may be uploaded into Center specific tracking systems and databases.

The Contractor shall notify the Task Order COR and Records Manager when the Records Control Schedules (RCS) indicate a file is ready for retention and/or disposition. The FDA classifies retention and disposition schedules by the following record types: administrative, program, or Center specific. The Agency regularly analyzes, develops, produces, and updates FDA RCS(s). Adherence to retention and disposition schedules is a part of identifying files to be moved to off-site locations for retirement, storage, and/or disposition. The Contractor shall obtain technical direction from the COR before transferring or disposing files. The Contractor shall maintain a record of all documents or files destroyed on behalf of the FDA according to the method (tracking system, database, etc.) indicated in the task order. As tasked, the Contractor shall provide a certificate of destruction, as requested by the Task Order COR, Record Manager, and / or other authorized stakeholder.

Contractors must barcode and jacket files before storing records material at Government facilities. Electronic submissions are stored in appropriate Center specific repositories. The Contractor shall adhere to security procedures for handling FDA records information, as outlined in individual Task Orders.

1.12.6 SCANNING, PRINTING, AND CONVERSION SERVICES

As tasked, On-Site records support Contractor staff shall provide on-site scanning services. Scanning services range from digitizing legacy material to processing incoming physical record material. The majority of scanned services will be paper to electronic images. As tasked, the Contractor shall convert materials such as film, videos, microfilm, blowbacks, and physical artifacts into digitized images.

Requirements for onsite scanning, printing, and conversion to digital images services must follow the FDA Staff Manual Guide (SMG) (currently in draft form) for digital imaging. Individual Centers will be outlined additional requirements in the individual Task Orders. Generally, the Contractor shall:

Prepare physical documents/files for imaging Image document/files using FDA supplied hardware and software;

Produce duplicate copies of records material;

Provide photocopying services;

Provide methodology for digitizing images other than paper such as oversized material and physical artifacts;

Ensure that image standards for black & white are a minimum of 300 Dots Per Inch (DPI);

Ensure that image standards for color and graphics are a minimum of 600 Dots Per Inch (DPI);

Ensure that images adhere to formats (PDF, PDF/a, TIFF, etc.);

Process images for Optical Character Recognition (OCR);

Re-assemble documents/files to the pre-image condition;

Index images in specific FDA tracking systems;

Ensure that images are loaded to an FDA electronic records repository or copied to other media;

Complete various quality control checks throughout the imaging process, ensuring consistent image

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capture, OCR, indexing and repository upload/media transfer;

Maintain scanning equipment according to manufacturer specifications and warranty requirements;

Monitor imaging software license use for burn-rate.

1.12.7 Support or Automated System Outages

As tasked, the Contractor shall provide Emergency Support during system outages, which includes: adhering to a Disaster Recovery Plan or Continuity of Operations Plan (COOP) and creating backup files. Any facility required for disaster recovery or continuity of operations will be provided by the government.

1.13 TASK AREA 2: RECORDS MANAGEMENT SERVICES

As tasked, the Contractor shall update and enhance the records management and record-keeping processes.

Records Management initiatives and / or special projects shall require the Contractor to support Centers with obtaining business objectives identified in the Presidential Directive for Managing Government Records (NARA M12.18).

Current and future records management initiatives may include/require support for baseline records inventories; file plans; record control schedules development; comprehensive information management support; implementation of new RIM policies; consultation services; inventory overflow and backlogs; training;

information governance; and relocation services, as described below (See D.1.16).

1.13.1 MANAGEMENT SUPPORT FOR FILE PLANS

As tasked, the Contractor shall conduct baselines and follow-on records analyses to recommend filing system best practices and associated methodologies. The Contractor shall assist in the creation or revisions of file plans, as directed by the Task Order COR. A file plan is a taxonomical structure that provides a framework for a uniform approach to classifying records across an institution, irrespective of its organizational structure, the subjects/bodies/individuals it deals with or the media and formats in which its records are held.

File plans accommodate all records series identified during the baseline records survey. File plans map to existing FDA, HHS and NARA –General Records Schedules. File plan development includes, but is not limited to, researching, methodology development, drafting and updating. The file plans shall be media neutral. As directed, the Contractor shall use commercially available file plan development and taxonomy tools provided by the Government.

1.13.2 MANAGEMENT SUPPORT FOR RECORDS CONTROL SCHEDULES (RCS)

As tasked, the Contractor shall assist Center ARLOs with analyzing or updating FDA Records Control Schedules (RCS), as directed in individual task orders. The Contractor shall ensure that appropriate authority channels for improvement of records schedules are adhered to. Current RCS may be changed or updated to ensure best practices are followed such as:

Developing big bucket scheduling to support the implementation of electronic Records Management Applications (RMA) and, Flexible schedules, Applying Generally Accepted Record-keeping Principles developed by ARMA international, Supporting M-12-18 implementation across the agency.

1.13.3 COMPREHENSIVE INFORMATION MANAGEMENT SUPPORT

As tasked, as a part of FDA’s comprehensive information management environment, the Contractor shall

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provide of Information Management subject matter support to specific task orders. Projects include, but are not limited to:

Crosscutting data abstraction and from regulatory applications for Chemistry, Manufacturing and Controls (CMC), Advanced data quality for FDA regulatory database(s) that support bioinformatics initiatives, and Advanced Freedom of Information Act (FOIA) Support as directed by the Task Order COR.

1.13.4 MANAGEMENT SUPPORT FOR IMPLEMENTING NEW RIM POLICIES

Based on NARA guidance on improving the records management processes, as directed, the Contractor shall draft changes, including implementing changes to the General Record Schedules (GRS) and directives on electronic records management storage solutions, email management using a Capstone approach and the phasing out the transfer of paper records to the Federal Records Centers and the National Archives.

As tasked, the Contractor shall provide assistance with implementing and maintaining internal supplemental SOP’s and Quality Controls to ensure agency-wide adherence to new policies, changes in Federal legislative mandates and agency policies pertaining to records management.

1.13.5 RECORDS MANAGEMENT CONSULTATION SERVICES

As the FDA implements a 100% electronic environment, there may be requests for consultation services that identify paths forward for creating cost efficiencies related to records management. As tasked, the Contractor shall provide consultation services on the following:

Best practice strategies and solutions for enhancing, replacing, or implementing electronic repositories, tracking systems, repositories, and /or databases;

Evaluation support for NARA’s Federal Electronic Records Modernization Initiative (FERMI) and other document or records management software or tools selected or deployed by FDA;

Best practice advice for alternative document management solutions;

Development of Supplemental Internal Quality Controls and SOP’s based on industry best practices;

Best practice advice on alternative storage solutions;

Best practice advice on cost efficient facility solutions.

1.13.6 MANAGEMENT SUPPORT FOR INVENTORY OVERFLOW AND BACKLOGS

As directed, the Contractor shall provide support for inventory overflow, paper backlogs, and shared drives/collaborative tool clean-up initiatives.

As tasked, the Contractor shall retrieve, track, log, scan, archive, or dispose of retired records material that have exceeded their retention schedules. As tasked, the Contractor shall retrieve, organize, relocate, and clean-up electronic files.

1.13.7 TRAINING

As tasked, the Contractor shall train or assist in training FDA staff. Topic areas may include, but are not limited to, records management orientation for new employees, various records management topics for all employees, how to perform certain records management processes (pack records boxes, interpret records schedules, etc.), and how to use record management tools. Training methods will be specified in specific task orders. All training content must conform to agency and center regulations, policies, and procedures. The Contractor shall provide training materials for all classes offered to the FDA community.

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1.14 TASK AREA 3: RELOCATION SERVICES

To accommodate strategic initiatives for creating cost and operational efficiencies, the FDA anticipates DCC locations and housed documents may change between various locations during the life of this IDIQ vehicle.

As tasked, the Contractor shall assist with the preparation and movement of documents between current facilities and new or existing sites. This will occur in the event new facilities are set up. As tasked, the Contractor shall develop and implement security procedures and transition plans in support of document relocations.

1.15 IDIQ LABOR CATEGORIES AND MINIMUM QUALIFICATIONS

The Contractor staff for each task order will include positions selected from the following labor categories. Not all categories may be used for each task order. The labor categories specify minimum qualifications, and there may be additional requirements for any labor category on an individual task order.

For post-secondary education in Records Information Management, the following disciplines will be considered related: Records Management, Information Management, Library Sciences, Information Science, Archive Sciences, Law, History and/or Historical Administration.

One (1) year of directly related experience may be substituted for one (1) year of education. A baccalaureate degree is considered as four (4) years of education. Four (4) years of directly related experience may be substituted for a baccalaureate degree. Any experience substituted for education must be over and above the minimum experience requirements for the labor category.

1.15.1 PROGRAM MANAGER

The Program Manager must have a bachelor’s degree in a technical, business, public administration or Records Information Management related discipline.